Antithrombotic coating for drug eluting medical devices

• US 20070048350A1
• Filed: 08/31/2005
• Published: 03/01/2007
• Est. Priority Date: 08/31/2005
• Status: Abandoned Application

• Current Assignee: Wyeth (Pfizer Inc.)
• Original Assignee: Wyeth (Pfizer Inc.)
• Inventors: Falotico, Robert, Zhao, Jonathon
• Application Number:
  US11/216,312
• Publication Number:
  US 20070048350A1
• Time in Patent Office: Days
• US Class Current: 424/423
• 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 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/61 containing two or more active agents in different layers
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 33/0029 using an intermediate layer of polymer
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 41/00 Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• 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: A61P 9/14 Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers

Abstract

Medical devices, and in particular implantable medical devices, may be coated to minimize or substantially eliminate a biological organism'"'"'s reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. These therapeutic drugs, agents or compounds may also further reduce a biological organism'"'"'s reaction to the introduction of the medical device to the organism. In addition, these therapeutic drugs, agents and/or compounds may be utilized to promote healing, including the formation of blood clots. Various materials and coating methodologies may be utilized to maintain the drugs, agents or compounds on the medical device until delivered and positioned.

Claims

1. An intraluminal medical device comprising:

a scaffold structure having a luminal surface and an abluminal surface;

a first layer affixed to the luminal and abluminal surfaces, the first layer including at least one first therapeutic agent; and

a second layer affixed to the first layer, the second layer including at least one second therapeutic agent in combination with a water soluble polymeric material and a water insoluble polymeric material.

2. The intraluminal medical device according to claim 1, wherein the scaffold structure comprises a stent.

3. The intraluminal medical device according to claim 2, wherein the stent is balloon expandable.

4. The intraluminal medical device according to claim 2, wherein the stent is self-expanding.

5. The intraluminal medical device according to claim 1, wherein the first layer further includes a water insoluble polymeric coating.

6. The intraluminal medical device according to claim 5, wherein the water insoluble polymeric coating comprises poly(ethylene-co-vinylacetate) and poly(n-butylmethacrylate).

7. The intraluminal medical device according to claim 6, wherein the at least one first therapeutic agent comprises a rapamycin.

8. The intraluminal medical device according to claim 1, wherein the at least one second therapeutic agent comprises an antithrombogenic agent.

9. The intraluminal medical device according to claim 8, wherein the antithrombogenic agent comprises heparin.

10. The intraluminal medical device according to claim 9, wherein the water soluble polymeric material comprises polyvinylpyrrolidone.

11. The intraluminal medical device according to claim 10, wherein the water insoluble polymeric material comprises poly(n-butylmethacrylate).

12. An intraluminal medical device comprising:

a scaffold structure having a luminal surface and an abluminal surface;

a first layer affixed to the luminal and abluminal surfaces, the first layer including at least one first therapeutic agent;

a diffusion layer affixed to the first layer; and

a second layer affixed to the diffusion layer, the second layer including at least one second therapeutic agent in combination with a water soluble polymeric material and a water insoluble polymeric material.

13. The intraluminal medical device according to claim 12, wherein the first layer further includes a water insoluble polymeric coating.

14. The intraluminal medical device according to claim 13, wherein the water insoluble polymeric coating comprises poly(ethylene-co-vinylacetate) and poly(n-butylmethacrylate).

15. The intraluminal medical device according to claim 14, wherein the at least one first therapeutic agent comprises a rapamycin.

16. The intraluminal medical device according to claim 12, wherein the diffusion layer comprises poly(n-butylmethacrylate).

17. The intraluminal medical device according to claim 12, wherein the at least one second therapeutic agent comprises an antithrombogenic agent.

18. The intraluminal medical device according to claim 17, wherein the antithrombogenic agent comprises heparin.

19. The intraluminal medical device according to claim 18, wherein the water soluble polymeric material comprises polyvinylpyrrolidone.

20. The intraluminal medical device according to claim 19, wherein the water insoluble polymeric material comprises poly(n-butylmethacrylate).

21. A medical device comprising:

an implantable structure having luminal and abluminal surfaces;

a first layer affixed to the luminal and abluminal surfaces, the first layer having a thickness in the range from about five to about ten microns and including at least one first therapeutic agent; and

a second layer affixed to the first layer, the second layer having a thickness of about one micron and including at least one second therapeutic agent in combination with a water soluble polymeric material and a water insoluble polymeric material.

22. A medical device comprising:

an implantable structure having luminal and abluminal surfaces;

a first layer affixed to the luminal and abluminal surfaces, the first layer having a thickness in the range from about five to about ten microns and including at least one first therapeutic agent; and

;

a diffusion layer affixed to the first layer, the diffusion layer having a thickness of about one micron; and

a second layer affixed to the diffusion layer, the second layer having a thickness of about one micron and including at least one second therapeutic agent in combination with a water soluble polymeric material and a water insoluble polymeric material.