Coated endovascular AAA device

• US 20040148010A1
• Filed: 01/23/2003
• Published: 07/29/2004
• Est. Priority Date: 01/23/2003
• Status: Active Grant

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Rush, Scott Lyle
• Granted Patent: US 6,852,122 B2
• Time in Patent Office: Days
• US Class Current: 623/1.13
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/0684 having a forming anvil staying above the tissue during stapling
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/06057 Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: C08L 27/12 containing fluorine atoms

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. A system for bypassing an aneurysm comprising:

at least one prosthesis for establishing a fluid flow path through an aneurysmal section of artery;

an anchoring element operatively associated with the at least one prosthesis for securing and sealing the at least one prosthesis upstream of the aneurysmal section of artery;

a biocompatible vehicle affixed to at least one of the anchoring element and the at least one prosthesis; and

at least one agent in therapeutic dosages incorporated into the biocompatible material for the promotion of a wound healing response.

2. The system for bypassing an aneurysm according to claim 1, wherein the at least one prosthesis comprises a stent-graft.

3. The system for bypassing an aneurysm according to claim 2, wherein the stent-graft comprises a stent and a graft material secured to at least a portion of the stent.

4. The system for bypassing an aneurysm according to claim 3, wherein the stent is self-expanding.

5. The system for bypassing an aneurysm according to claim 4, wherein the graft material comprises a polymeric material.

6. The system for bypassing an aneurysm according to claim 5, wherein the anchoring element comprises a scaffold structure at least partially covered with a gasket material substantially impervious to blood.

7. The system for bypassing an aneurysm according to claim 6, wherein the biocompatible vehicle comprises a polymeric matrix.

8. The system for bypassing an aneurysm according to claim 7, wherein the biocompatible vehicle comprises a polyfluoro copolymer comprising polymerized residue of a first moiety selected from the group consisting of vinylidenefluoride and tetrafluoroethylene, and polymerized residue of a second moiety other than the first moiety and which is copolymerized with the first moiety, thereby producing the polyfluoro copolymer, wherein the relative amounts of the polymerized residue of the first moiety and the polymerized residue of the second moiety are effective to produce the biocompatible vehicle with properties effective for use in coating implantable medical devices when the coated medical device is subjected to a predetermined maximum temperature, and a solvent in which the polyfluoro copolymer is substantially soluble.

9. The system for bypassing an aneurysm according to claim 8, wherein the polyfluoro copolymer comprises from about fifty to about ninety-two weight percent of the polymerized residue of the first moiety copolymerized with from about fifty to about eight weight percent of the polymerized residue of the second moiety.

10. The system for bypassing an aneurysm according to claim 8, wherein said polyfluoro copolymer comprises from about fifty to about eighty-five weight percent of the polymerized residue of vinylidenefluoride copolymerized with from about fifty to about fifteen weight percent of the polymerized residue of the second moiety.

11. The system for bypassing an aneurysm according to claim 8, wherein said copolymer comprises from about fifty-five to about sixty-five weight percent of the polymerized residue of the vinylidenefluoride copolymerized with from about forty-five to about thirty-five weight percent of the polymerized residue of the second moiety.

12. The system for bypassing an aneurysm according to claim 8, wherein the second moiety is selected from the group consisting of hexafluoropropylene, tetrafluoroethylene, vinylidenefluoride, 1-hydropentafluoropropylene, perfluoro (methyl vinyl ether), chlorotrifluoroethylene, pentafluoropropene, trifluoroethylene, hexafluoroacetone and hexafluoroisobutylene.

13. The system for bypassing an aneurysm according to claim 8, wherein the second moiety is hexafluoropropylene.

14. The system for bypassing an aneurysm according to claim 1, wherein the at least one agent comprises a growth factor.

15. The system for bypassing an aneurysm according to claim 14, wherein the growth factor comprises Platelet-derived Growth Factor.

16. The system for bypassing an aneurysm according to claim 14, wherein the growth factor comprises Transforming Growth Factor-β

.

17. The system for bypassing an aneurysm according to claim 1, wherein the at least one agent comprises Transforming Growth Factor-β

and collagen.

18. The system for bypassing an aneurysm according to claim 1, wherein the at least one agent comprises Tissue Factor/VIIa.

19. The system for bypassing an aneurysm according to claim 1, wherein the at least one agent comprises collagen.

20. The system for bypassing an aneurysm according to claim 1, wherein the at least one agent comprises thrombus formation compounds.

21. A system for bypassing an aneurysm comprising:

at least one prosthesis for establishing a fluid flow path through an aneurysmal section of artery;

an anchoring element operatively associated with the at least one prosthesis for securing and sealing the at least one prosthesis upstream of the aneurysmal section of artery; and

at least one agent in therapeutic dosages affixed to at least one of the anchoring element and the at least one prosthesis for the promotion of a wound healing response.

22. The system for bypassing an aneurysm according to claim 21, wherein the at least one prosthesis comprises a stent-graft.

23. The system for bypassing an aneurysm according to claim 22, wherein the stent-graft comprises a stent and a graft material secured to at least a portion of the stent.

24. The system for bypassing an aneurysm according to claim 23, wherein the stent is self-expanding.

25. The system for bypassing an aneurysm according to claim 24, wherein the graft material comprises a polymeric material.

26. The system for bypassing an aneurysm according to claim 25, wherein the anchoring element comprises a scaffold structure at least partially covered with a gasket material substantially impervious to blood.

27. The system for bypassing an aneurysm according to claim 21, wherein the at least one agent comprises a growth factor.

28. The system for bypassing an aneurysm according to claim 27, wherein the growth factor comprises Platelet-derived Growth Factor.

29. The system for bypassing an aneurysm according to claim 27, wherein the growth factor comprises Transforming Growth Factor-β

.

30. The system for bypassing an aneurysm according to claim 21, wherein the at least one agent comprises Transforming Growth Factor-p and collagen.

31. The system for bypassing an aneurysm according to claim 21, wherein the at least one agent comprises Tissue Factor/VIIa.

32. The system for bypassing an aneurysm according to claim 21, wherein the at least one agent comprises collagen.

33. The system for bypassing an aneurysm according to claim 21, wherein the at least one agent comprises thrombus formation compounds.

34. The system for bypassing an aneurysm according to claim 33, wherein the thrombus formation compound comprises thrombin.

35. The system for bypassing an aneurysm according to claim 33, wherein the thrombus formation compound comprises fibrin.

36. The system for bypassing an aneurysm according to claim 33, wherein the thrombus formation compound comprises plasminogin-activator initiator.

37. The system for bypassing an aneurysm according to claim 33, wherein the thrombus formation compound comprises adenosine diphosphate.