ATRAUMATIC VASCULAR GRAFT REMOVAL SHEATH

• US 20110046713A1
• Filed: 09/08/2010
• Published: 02/24/2011
• Est. Priority Date: 03/04/2009
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: CULLY, EDWARD H., Duncan, Jeffrey B.
• Granted Patent: US 10,045,868 B2
• Time in Patent Office: Days
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/141 Plasticizers
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction
• CPC Class Codes: C08L 27/12 containing fluorine atoms

Abstract

The present invention comprises articles and methods for atraumatic removal of a chronically implanted medical device, such as a vascular graft. Specifically, the invention comprises a thin, lubricious and durable tubular cover that aids in protecting the indwelling implant during implantation while also acting as an atraumatic removal aid.

Claims

1. A medical device comprising:

a vascular graft;

a tubular cover positioned over a substantial portion of the outer surface of the vascular graft;

wherein said tubular cover is configured to evert upon application of a longitudinal force to the stent-graft following implantation.

2. The device of claim 1, wherein said vascular graft comprises a stent.

3. The device of claim 1, wherein said vascular graft comprises ePTFE.

4. The device of claim 1, wherein the tubular cover comprises ePTFE.

5. The device of claim 4, wherein said ePTFE comprises at least one additive.

6. The device of claim 5, wherein said additive is a lubricating agent.

7. The device of claim 5, wherein said additive elicits a bioactive response.

8. The device of claim 7, wherein said bioactive response is selected from the group consisting of an anti-inflammatory, an anti-microbial and an anti-proliferative response.

9. The device of claim 4, wherein said tubular cover modulates the degree of tissue ingrowth and/or adhesion.

10. The device of claim 4, wherein said tubular cover resists tissue ingrowth and/or adhesion.

11. A tubular cover for a vascular graft, said tubular cover comprising a material configured into a tubular cover positionable over a substantial portion of an outer surface of a vascular graft and will evert upon application of a longitudinal force.

12. The tubular cover of claim 11, wherein the material is ePTFE.

13. The tubular cover of claim 12, wherein said ePTFE comprises at least one additive.

14. The tubular cover of claim 13, wherein said additive is a lubricating agent.

15. The tubular cover of claim 13, wherein said additive is a antimicrobial.

16. The tubular cover of claim 13, wherein only a portion of said tubular cover comprises an additive.

17. The tubular cover of claim 13, wherein said additive elicits a bioactive response.

18. The tubular cover of claim 17, wherein said bioactive response is selected from the group consisting of an anti-inflammatory, an anti-microbial, and an anti-proliferative response.

19. The tubular cover of claim 12, wherein said tubular cover modulates the degree of tissue ingrowth and/or adhesion.

20. The tubular cover of claim 12, wherein said tubular cover resists tissue ingrowth and/or adhesion.

21. A vascular graft having a length extending between opposing ends comprising:

a first tubular element extending for the length of the vascular graft;

a first stent coaxially affixed around a first length portion of the first tubular element at one of said opposing ends;

a second tubular element coaxially affixed around a second length portion of the first tubular element that does not include a stent, wherein the length of the second portion is greater than the length of the first length portion; and

a tubular cover positioned over a substantial portion of the outer surface of the vascular graft, wherein said tubular cover is configured to evert upon application of a longitudinal force to the stent-graft following implantation.

22. The vascular graft of claim 21, wherein one end of said second tubular element is located adjacent to one end of said first stent.

23. The vascular graft of claim 21, wherein said first tubular element provides an uninterrupted luminal surface extending for the length of the vascular graft.

24. The vascular graft of claim 21, wherein said first stent is a self-expanding stent.

25. The vascular graft of claim 21, wherein said vascular graft comprises a therapeutic agent.

26. The vascular graft of claim 25, wherein said therapeutic agent comprises herparin.

27. The vascular graft of claim 21, wherein said vascular graft comprises ePTFE.

28. The vascular graft of claim 21, wherein said tubular cover comprises ePTFE.

29. The vascular graft of claim 28, wherein said ePTFE comprises at least one additive.

30. The vascular graft of claim 29, wherein said additive is a lubricating agent.

31. The vascular graft of claim 29, wherein said additive elicits a bioactive response.

32. The vascular graft of claim 31, wherein said bioactive response is selected from the group consisting of an anti-inflammatory, an anti-microbial and an anti-proliferative response.

33. The vascular graft of claim 28, wherein said tubular cover modulates the degree of tissue ingrowth and/or adhesion.

34. The vascular graft of claim 28, wherein said tubular cover resists tissue ingrowth and/or adhesion.