Atraumatic vascular graft removal sheath

• US 10,045,868 B2
• Filed: 09/08/2010
• Issued: 08/14/2018
• 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.
• Primary Examiner(s): Pellegrino, Brian
• Application Number:
  US12/877,777
• Publication Number:
  US 20110046713A1
• Time in Patent Office: 2,897 Days
• Field of Search: 623 113, 623 114, 623 111, 623 112
• 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 having a length, a distal end, a proximal end, an outer surface and a longitudinal axis;

a tubular cover having a length and being positioned over a substantial portion of the outer surface of the vascular graft, and the tubular cover being attached to the vascular graft at a first location along the length of the tubular cover and including a means of permitting circumferential tearing of the tubular cover, the tubular cover having a double wall wherein the cover is folded back on itself operable to slide over itself between the first location and a second location thus reducing the force necessary to extract the vascular graft;

wherein said tubular cover is configured to evert upon application of a longitudinal force to the vascular graft following implantation effective to cause the vascular graft to move in a proximal direction during removal of the vascular graft from anatomy, wherein upon eversion and exceeding a longitudinal tearing strength of the means of permitting tearing the tubular cover tears at the second location,

wherein the tubular cover is coupled to one or more predetermined locations defining sections therebetween so that if the tubular cover tears, the sections will evert, and wherein the means of permitting tearing of the tubular cover comprises perforations that are generally oriented circumferentially around the tubular cover.

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, the tubular cover having a length and being positioned over a substantial portion of an outer surface of a vascular graft, the vascular graft having a length, a distal end, a proximal end, an outer surface and a longitudinal axis, the tubular cover being coupled to the vascular graft at a first location along the length of the tubular cover, the tubular cover having means of permitting tearing at a second location along the length of the tubular cover, the tubular cover having a double wall wherein the cover is folded back on itself operable to slide over itself between the first location and the second location thus reducing the force necessary to extract the vascular graft, wherein the tubular cover will evert upon application of a longitudinal force to the vascular graft following implantation effective to cause the vascular graft to move in a proximal direction during removal of the vascular graft from anatomy, wherein upon eversion and upon exceeding a longitudinal tearing strength of the means of permitting tearing the tubular cover tears at the second location, wherein the tubular cover is coupled to one or more predetermined locations defining sections therebetween so that if the tubular cover tears, the sections will evert, and wherein the means of permitting tearing of the tubular cover comprises perforations being generally oriented circumferentially around the tubular cover.

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 an 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 medical device comprising:

a vascular graft having a length, a distal end, a proximal end, an outer surface and a longitudinal axis;

a tubular cover having a length and being positioned over the outer surface of the graft, the tubular cover coupled to the graft at a first location along the length of the tubular cover, and the tubular cover having means of permitting tearing at a second location along the length of the tubular cover; and

wherein the tubular cover is folded back on itself and operable to slide between the first location and the second location thus reducing the force necessary to extract the graft, and

wherein upon eversion of the graft, upon exceeding a longitudinal tearing strength of the means of permitting tearing the tubular cover tears at the second location and everts,

wherein the tubular cover is coupled to one or more predetermined locations defining sections therebetween so that if the tubular cover tears, the sections will evert, and wherein the means of permitting tearing of the tubular cover comprises perforations being generally oriented circumferentially around the tubular cover.