Thrombosis inhibiting graft

• US 20070032864A1
• Filed: 11/18/2005
• Published: 02/08/2007
• Est. Priority Date: 07/27/1998
• Status: Active Grant

• Current Assignee: Mirus LLC
• Original Assignee: ICON Interventional Systems, Inc.
• Inventors: Brodbeck, William, Furst, Joseph
• Granted Patent: US 8,070,796 B2
• Time in Patent Office: Days
• US Class Current: 623/1.420
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: C08L 65/04 Polyxylenes

Abstract

A medical method that is adapted for introducing the medical device into the vascular system of a body which is designed to inhibit or prevent thrombosis after the insertion of the medical device.

Claims

1. A method of treating a damaged vascular system of a patient with a medical device without having to use long term body-wide aggressive anti-platelet and/or anti-coagulation therapy after the implantation of the medical device comprising:

a) identifying a damaged region of the vascular system;

b) opening a section or replacing a section of said damaged region of the vascular system by or with said medical device, said medical device being a stent or surgical graft, said medical device including a biological agent, said biological agent inhibiting or preventing thrombosis; and

,

c) allowing said patient to recover from the surgical procedure with no use or short term use of less than about two months of post operative body-wide anti-platelet and/or anti-coagulation therapy.

2. The method as defined in claim 1, wherein said short term use is less than about forty days.

3. The method as defined in claim 2, wherein said short term use is less than about one week.

4. The method as defined in claim 3, wherein said short term use is less than about two days.

5. The method as defined in claim 1, wherein said one or more biological agents include trapidil, trapidil derivatives, warfarin, warfarin derivatives, aspirin, aspirin derivatives, clopidogrel, clopidogrel derivatives, ticlopadine, ticlopadine derivatives, hirdun, hirdun derivatives, dipyridamole, dipyridamole derivatives, heparin, heparin derivatives, or combinations thereof.

6. The method as defined in claim 2, wherein said one or more biological agents include trapidil, trapidil derivatives, warfarin, warfarin derivatives, aspirin, aspirin derivatives, clopidogrel, clopidogrel derivatives, ticlopadine, ticlopadine derivatives, hirdun, hirdun derivatives, dipyridamole, dipyridamole derivatives, heparin, heparin derivatives, or combinations thereof.

7. The method as defined in claim 5, wherein said one or more biological agents include trapidil, trapidil derivatives, or combinations there.

8. The method as defined in claim 6, wherein said one or more biological agents include trapidil, trapidil derivatives, or combinations there.

9. The method as defined in claim 7, wherein said one or more biological agents additionally include taxol, taxol derivatives, cytochalasin, cytochalasin derivatives, paclitaxel, paclitaxel derivatives, rapamycin, rapamycin derivatives, 5-Phenylmethimazole, 5-Phenylmethimazole derivatives, GM-CSF, GM-CSF derivatives, or combinations thereof.

10. The method as defined in claim 8, wherein said one or more biological agents additionally include taxol, taxol derivatives, cytochalasin, cytochalasin derivatives, paclitaxel, paclitaxel derivatives, rapamycin, rapamycin derivatives, 5-Phenylmethimazole, 5-Phenylmethimazole derivatives, GM-CSF, GM-CSF derivatives, or combinations thereof.

11. The method as defined in claim 1, wherein said medical device includes at least one polymer layer having a coating thickness, a molecular weight, a molecular structure or combinations thereof to at least partially controllably release at least one of said biological agent, said polymer designed to release said biological agent from said medical device for at least about one day after said medical device is introduced into or on the body of a patient.

12. The method as defined in claim 10, wherein said medical device includes at least one polymer layer having a coating thickness, a molecular weight, a molecular structure or combinations thereof to at least partially controllably release at least one of said biological agent, said polymer designed to release said biological agent from said medical device for at least about one day after said medical device is introduced into or on the body of a patient.

13. The method as defined in claim 11, wherein said polymer layer includes parylene, a parylene derivative, chitosan, a chitosan derivative, PLGA, a PLGA derivative, PLA, a PLA derivative, PEVA, a PEVA derivative, PBMA, a PBMA derivative, POE, POE derivative, PGA, PGA derivative, PLLA, PLLA derivative, PAA, PAA derivative, PEG, PEG derivative, or combinations thereof.

14. The method as defined in claim 12, wherein said polymer layer includes parylene, a parylene derivative, chitosan, a chitosan derivative, PLGA, a PLGA derivative, PLA, a PLA derivative, PEVA, a PEVA derivative, PBMA, a PBMA derivative, POE, POE derivative, PGA, PGA derivative, PLLA, PLLA derivative, PAA, PAA derivative, PEG, PEG derivative, or combinations thereof.

15. The method as defined in claim 1, wherein said medical device at least one micro-structure, surface structure or combinations thereof.

16. The method as defined in claim 14, wherein said medical device at least one micro-structure, surface structure or combinations thereof.

17. The method as defined in claim 15, wherein said at least one micro-structure, surface structure or combinations thereof includes a needle, a micro-needle or combinations thereof, and including the step of expanding said medical device until said medical device at least partially engages an inner surface of a body passageway of said vascular system and cause said needle, a micro-needle or combinations thereof to at least partially penetrate into said body passageway.

18. The method as defined in claim 16, wherein said at least one micro-structure, surface structure or combinations thereof includes a needle, a micro-needle or combinations thereof, and including the step of expanding said medical device until said medical device at least partially engages an inner surface of a body passageway of said vascular system and cause said needle, a micro-needle or combinations thereof to at least partially penetrate into said body passageway.

19. The method as defined in claim 16, wherein said at least one micro-structure, surface structure or combinations thereof includes at least one biological agent.

20. The method as defined in claim 18, wherein said at least one micro-structure, surface structure or combinations thereof includes at least one biological agent.

21. The method as defined in claim 20, wherein said at least one biological agent included in said at least one micro-structure, surface structure or combinations thereof at least partially inhibits thrombosis.

22. A method of treating a damaged vascular system of a patient with a medical device without having to use long term body-wide aggressive anti-platelet and/or anti-coagulation therapy after the implantation of the medical device comprising:

a) identifying a damaged region of the vascular system;

b) opening a section of said damaged region of the vascular system with use of said medical device, said medical device being a stent, said medical device including a biological agent, said biological agent including at least one agent selected from the group consisting of warfarin, warfarin derivatives, aspirin, aspirin derivatives, clopidogrel, clopidogrel derivatives, ticlopadine, ticlopadine derivatives, hirdun, hirdun derivatives, dipyridamole, dipyridamole derivatives, trapidil, trapidil derivatives, 5-Phenylmethimazole, 5-Phenylmethimazole derivatives, GM-CSF, GM-CSF derivatives, heparin, heparin derivatives, low molecular weight heparin, low molecular weight heparin derivatives, or combinations thereof.

c) allowing said patient to recover from the surgical procedure with no use or short term use of less than about forty days of post operative body-wide anti-platelet and/or anti-coagulation therapy.

23. The method as defined in claim 22, wherein said biological agent includes trapidil, trapidil derivatives, 5-Phenylmethimazole, 5-Phenylmethimazole derivatives, GM-CSF, GM-CSF derivatives.

24. The method as defined in claim 23, wherein said biological agent includes two different biological agents.

25. The method as defined in claim 24, wherein said biological agents includes at least two agents selected from the group consisting of trapidil, trapidil derivatives, taxol, taxol derivatives, cytochalasin, cytochalasin derivatives, paclitaxel, paclitaxel derivatives, rapamycin, rapamycin derivatives, 5-Phenylmethimazole, 5-Phenylmethimazole derivatives, GM-CSF, GM-CSF derivatives, or combinations thereof.

26. The method as defined in claim 22, wherein said medical device includes at least one polymer layer having a coating thickness, a molecular weight, a molecular structure or combinations thereof to at least partially controllably release at least one of said biological agent, said polymer designed to release said biological agent from said medical device for at least about one day after said medical device is introduced into or on the body of a patient.

27. The method as defined in claim 25, wherein said medical device includes at least one polymer layer having a coating thickness, a molecular weight, a molecular structure or combinations thereof to at least partially controllably release at least one of said biological agent, said polymer designed to release said biological agent from said medical device for at least about one day after said medical device is introduced into or on the body of a patient.

28. The method as defined in claim 26, wherein said polymer layer includes parylene, parylene C;

parylene F;

parylene N, parylene derivative, parylene C derivative;

parylene F derivative;

parylene N derivative, or combinations thereof.

29. The method as defined in claim 27, wherein said polymer layer includes parylene, parylene C;

parylene F;

parylene N, parylene derivative, parylene C derivative;

parylene F derivative;

parylene N derivative, or combinations thereof.

30. The method as defined in claim 22, wherein said medical device at least one micro-structure, said at least one micro-structure includes a micro-needle, and including the step of expanding said medical device until said medical device at least partially engages an inner surface of a body passageway of said vascular system and cause said micro-needle to at least partially penetrate into said body passageway.

31. The method as defined in claim 29, wherein said medical device at least one micro-structure, said at least one micro-structure includes a micro-needle, and including the step of expanding said medical device until said medical device at least partially engages an inner surface of a body passageway of said vascular system and cause said micro-needle to at least partially penetrate into said body passageway.

32. The method as defined in claim 30, wherein said at least one micro-structure includes at least one biological agent.

33. The method as defined in claim 31, wherein said at least one micro-structure includes at least one biological agent.