Vascular graft with kink resistance after clamping

• US 8,066,758 B2
• Filed: 12/28/2005
• Issued: 11/29/2011
• Est. Priority Date: 06/17/2005
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Bogert, David L., Abbott, Jamie
• Primary Examiner(s): Sweet; Thomas J
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US11/917,135
• Publication Number:
  US 20100179642A1
• Time in Patent Office: 2,162 Days
• Field of Search: 623/1.13, 623/1.3, 623/1.31, 606/191, 606/194, 606/198
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene

Abstract

A self-sealing vascular graft with kink resistance is described. The vascular graft includes a substrate that can be a PTFE, having a self-sealing region that may include several layers of material. The central section of the vascular graft may be constructed differently from surrounding self-sealing regions, in order to provide kink resistance following the clamping of the graft. Also described is a graft with a flared cuff attached to one or both ends, the attachment or transition region including reinforcement beading.

Claims

1. A self-sealing vascular graft, comprising:

a generally tubular ePTFE substrate, including a proximal end section, a distal end section and a central section positioned between the proximal end section and distal end section, the proximal end section and distal end section including a self-sealing region;

a first beading contiguous to a surface of the ePTFE substrate along the central section, the first beading having an elliptical cross-sectional shape with a first cross-sectional area and a solvent disposed on an outer surface thereof; and

a second beading along the proximal section, the second beading having a second cross-sectional area less than the first cross-sectional area.

2. The vascular graft according to claim 1, wherein the central section has a length in the range of about 5 cm to about 12 cm.

3. The vascular graft according to claim 1, wherein the self-sealing region includes a sealant layer having a thickness in the range of about 10 microns to about 300 microns.

4. The vascular graft according to claim 1, wherein the central section includes a foam layer disposed onto the ePTFE substrate over the first beading.

5. The vascular graft according to claim 1, wherein the proximal end section, the distal end section and the central section comprise an outer ePTFE member.

6. The vascular graft according to claim 5, wherein one of the distal and proximal end sections comprises another ePTFE member surrounding at least a portion of the outer ePTFE member.

7. The vascular graft according to claim 1, further comprising a radiopaque material selected from the group consisting essentially of barium sulfate, bismuth subcarbonate, bismuth trioxide, tungsten, or tantalum and combinations thereof.

8. A vascular graft, comprising:

a generally tubular ePTFE substrate defining a longitudinal axis;

a layer of polyurethane matrix disposed about the ePTFE substrate;

a first beading having a first cross-sectional area disposed in the polyurethane matrix along a mid-portion of the ePTFE substrate; and

a second beading having a second cross-sectional area less than the first cross-sectional area, the second beading spaced apart from the first beading.

9. The vascular graft according to claim 8, wherein the first beading and the second beading each have elliptical cross-sectional shapes.

10. The vascular graft according to claim 9, wherein the second beading is helically disposed about a proximal end and a distal end of the ePTFE substrate.

11. The vascular graft according to claim 10, wherein the layer of polyurethane matrix comprises a first foam layer, the second beading disposed over the first foam layer, the vascular graft further comprising a second foam layer disposed only over the mid-portion.

12. A self-sealing vascular cuff graft, comprising:

a generally tubular ePTFE substrate;

a self-sealing region extending along a length of the generally tubular substrate between a first and second end thereof, the self-sealing region including at least one of a sealant layer and a foam layer;

an outer ePTFE member positioned over at least a portion of the self-sealing region;

a first beading positioned over the substrate at the first end adjacent to the self-sealing region, the outer ePTFE member extending over at least a portion of the first beading;

a second beading positioned over the outer ePTFE member at the first end adjacent to the self-sealing region; and

a flared vascular cuff having a proximal end positioned over at least a portion of the first and second beadings.

13. The self-sealing vascular cuff graft according to claim 12, wherein the first beading contacts an outer surface of the substrate.

14. The self-sealing vascular cuff graft according to claim 12, wherein the first and second beadings are helically wound such that each winding of the second beading is positioned between adjacent windings of the first beading.

15. The self-sealing vascular cuff graft according to claim 12, wherein at least one of the first and second beadings comprises a plurality of rings spaced apart along a length of the first end.

16. The self-sealing vascular cuff graft according to claim 12, wherein the self-sealing region comprises a third beading having a larger cross-sectional area than both the first and second beadings.

17. The self-sealing vascular cuff graft according to claim 12, wherein the self-sealing region comprises a first foam layer and a second foam layer.

18. The self-sealing vascular cuff graft according to claim 17, wherein a third beading contacts both the first and second foam layers.