Thrombosis inhibiting graft

• US 8,070,796 B2
• Filed: 11/18/2005
• Issued: 12/06/2011
• Est. Priority Date: 07/27/1998
• Status: Expired due to Fees

• Current Assignee: Mirus LLC
• Original Assignee: ICON Interventional Systems, Inc.
• Inventors: Furst, Joseph G., Brodbeck, William G.
• Primary Examiner(s): Bui, Vy Q
• Application Number:
  US11/283,434
• Publication Number:
  US 20070032864A1
• Time in Patent Office: 2,209 Days
• Field of Search: 623/1.11, 623/1.15, 623/1.16, 623/1.42, 623/1.46, 427/261, 424/423, 514/44, 604/509
• US Class Current: 623/1.42
• 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, said biological agent including two or more agents selected from the group consisting of trapidil, trapidil derivatives, aspirin, aspirin derivatives, dipyridamole, dipyridamole derivatives, heparin, heparin derivatives, warfarin, warfarin derivatives, clopidogrel, clopidogrel derivatives, ticlopidine, ticlopidine derivatives, and hirudin, hirudin derivatives 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, 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, said medical device includes a plurality of micro-structures, surface structures or combinations thereof, said plurality of micro-structures, surface structures or combinations thereof include a needle, a micro-needle or combinations thereof that extends upwardly from an outer surface of said medical device; 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 2, wherein said biological agent consists of two or more agents selected from the group trapidil, trapidil derivatives, aspirin, aspirin derivatives, dipyridamole, dipyridamole derivatives, heparin, heparin derivatives, or combinations thereof.

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

7. The method as defined in claim 6, wherein said one or more biological agents additionally include cytochalasin, cytochalasin derivatives, paclitaxel, paclitaxel derivatives, rapamycin, rapamycin derivatives, GM-CSF, GM-CSF derivatives, or combinations thereof.

8. The method as defined in claim 7, 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 causes said plurality of needles, micro-needles, or combinations thereof to at least partially penetrate into said body passageway.

9. The method as defined in claim 8, wherein said plurality of needles, micro-needles, or combinations thereof includes at least one biological agent.

10. The method as defined in claim 9, wherein said at least one biological agent included in said plurality of needles, micro-needles or combinations thereof at east partially inhibits thrombosis.

11. The method as defined in claim 1, wherein said biological agent consists of two or more agents selected from the group trapidil, trapidil derivatives, aspirin, aspirin derivatives, dipyridamole, dipyridamole derivatives, heparin, heparin derivatives, or combinations thereof.

12. The method as defined in claim 11, wherein said one or more biological agents include trapidil, trapidil derivatives, or combinations thereof.

13. The method as defined in claim 12, wherein said one or more biological agents additionally include cytochalasin, cytochalasin derivatives, paclitaxel, paclitaxel derivatives, rapamycin, rapamycin derivatives, GM-CSF, GM-CSF derivatives, or combinations thereof.

14. The method as defined in claim 1, 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 causes said plurality of needles, micro-needles, or combinations thereof to at least partially penetrate into said body passageway.

15. The method as defined in claim 1, wherein said plurality of needles, micro-needles, or combinations thereof includes at least one biological agent.

16. 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 therapy, anti-coagulation therapy, and combinations thereof 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 and a plurality of microstructures, said biological agent inhibiting or preventing thrombosis, said biological agent including at least one agent selected from the group consisting of warfarin, warfarin derivatives, aspirin, aspirin derivatives, clopidogel, clopidogel derivatives, ticlopidine, ticlopidine derivatives, hirudin, hirudin derivatives, dipyridamole, dipyridamole derivatives, heparin, heparin derivatives, low molecular weight heparin, low molecular weight heparin derivatives, and combinations thereof, 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, 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, said plurality of one micro-structures including a plurality of micro-needles, said plurality of micro-needles formed of said polymer and said biological agent;

c) expanding said medical device until said medical device at least partially engages an inner surface of a body passageway of said vascular system and causes said plurality of micro-needles to at least partially penetrate into said body passageway and to directly introduce said biological agent in said penetrated region of said body passageway; and

,

d) 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.

17. The method as defined in claim 16, wherein said biological agent includes one or more agents selected from the group consisting of trapidil, and trapidil derivatives.

18. The method as defined in claim 17, wherein a plurality of said micro-needles includes an internal portion and an external coating that is formed on an outer surface of said internal portion, said external coating including said polymer, said internal portion including said biological agent.

19. The method as defined in claim 18, wherein said external coating is only formed of said polymer.

20. The method as defined in claim 19, wherein said internal portion is formed of both said polymer and said biological agent.

21. The method as defined in claim 16, wherein said biological agent includes two different biological agents.

22. The method as defined in claim 21, wherein said biological agents includes at least two agents selected from the group consisting of trapidil, trapidil derivatives, cytochalasin, cytochalasin derivatives, paclitaxel, paclitaxel derivatives, rapamycin, rapamycin derivatives, and combinations thereof.

23. The method as defined in claim 22, wherein said polymer layer includes one or more polymers selected from the group consisting of parylene, parylene C;

parylene F;

parylene N, parylene derivative, parylene C derivative;

parylene F derivative; and

parylene N derivative.

24. The method as defined in claim 23, wherein a plurality of said micro-needles includes an internal portion and an external coating that is formed on an outer surface of said internal portion, said external coating including said polymer, said internal portion including said biological agent.

25. The method as defined in claim 24, wherein said external coating is only formed of said polymer.

26. The method as defined in claim 25 wherein said internal portion is formed of both said polymer and said biological agent.