Vascular graft with kink resistance after clamping

• US 8,652,284 B2
• Filed: 11/21/2011
• Issued: 02/18/2014
• Est. Priority Date: 06/17/2005
• Status: Expired due to Fees

• 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): Lee, Katarzyna Wyrozebski
• Assistant Examiner(s): Gross, Carson
• Application Number:
  US13/301,655
• Publication Number:
  US 20120061001A1
• Time in Patent Office: 820 Days
• Field of Search: 623/1.22, 623/1.34, 623/1.38, 623/1.39, 623/1.4, 623/1.42, 623/1.44, 623/1.46, 623/1.49, 623/1.13, 623/1.35, 623 15- 154, 156/172, 156/173, 156/308.6
• US Class Current: 156/173
• 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 ePTFE, 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 method of making a kink resistant vascular graft, comprising:

positioning a generally tubular ePTFE substrate over a mandrel;

applying a base layer of polyurethane dissolved in a solvent to the ePTFE substrate leaving distal and proximal ends of the substrate uncovered, the base layer having a first thickness;

longitudinally compressing the ePTFE substrate with applied base layer;

applying a sealant layer of polyurethane dissolved in a solvent to the compressed ePTFE substrate with applied base layer, the sealant layer having a second thickness greater than the first thickness;

applying a first polyurethane foam layer over the sealant layer to create a preliminary graft assembly;

curing the preliminary graft assembly by heating to create a cured graft assembly;

helically wrapping a first polyurethane beading with a radiopaque component around the cured graft assembly under tension to embed the first beading into the foam layer;

applying a second polyurethane foam layer over the first polyurethane foam layer;

covering the second foam layer with a solvent-covered ePTFE tape and helically wrapping the ePTFE tape, under tension, such that the edges of the tape overlap followed by applying a layer of polyurethane to the uncovered proximal and distal ends of the substrate and helically wrapping a second beading over the layer of polyurethane at both the proximal and distal ends.

2. The method according to claim 1, wherein the first foam layer applied over the sealant layer has a third thickness at least two times a thickness of the ePTFE substrate.

3. The method according to claim 1, wherein the helically wrapping comprises contacting the first beading with a solvent prior to embedding in the foam layer.

4. The method according to claim 1, wherein the helically wrapping comprises spacing adjacent windings of the first beading about 1 mm to about 2 mm apart.

5. The method according to claim 1, wherein the second beading has a cross-sectional area less than a cross-sectional area of the first beading.

6. The method according to claim 1, further comprising incorporating one or more bioactive agents in at least one of the ePTFE substrate, first foam layer and second foam layer.

7. The method according to claim 1, further comprising bonding a flared vascular cuff to an end of the ePTFE substrate.