Self-sealing PTFE graft with kink resistance

• US 8,313,524 B2
• Filed: 08/30/2005
• Issued: 11/20/2012
• Est. Priority Date: 08/31/2004
• Status: Expired due to Fees

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Edwin, Tarun J., Abbott, Jamie, Pathak, Chandrashekhar P., Bogert, David L., Elton, Richard, Brown, Fitzroy, Shahriari, Kereshmeh, Cole, Heidi R.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): IWAMAYE, ANDREW MICHAEL
• Application Number:
  US11/661,250
• Publication Number:
  US 20080027534A1
• Time in Patent Office: 2,639 Days
• Field of Search: 285/334.5, 285/234, 623 132- 133, 623/1.44, 623/1.1, 623/1.13, 623/1.22, 623/1.28, 623/1.31, 623/1.34, 623/1.39, 623/1.4, 623/1.42, 623/1.46, 604/8
• US Class Current: 623/1.44
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/94 Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61L 2300/44 Radioisotopes, radionuclides
• CPC Class Codes: A61L 2300/442 Colorants, dyes
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: C08L 75/04 Polyurethanes

Abstract

A self-sealing vascular graft, including a substrate with a sealant layer and several optional additional layers, is described. The substrate can be ePTFE and the material used for the sealant and additional layers can be polyurethane. The sealant layer and additional layers may include one or more base layers, one or more foam layers, beading of different sizes and shapes, and ePTFE tape. A flared cuff may be integral to one or both ends of the substrate or may be attached to one or both ends. Various methods of making a self-sealing vascular graft are also described, including methods of disposition, methods of forming, methods of bonding and methods of attaching.

Claims

1. A self-sealing vascular graft, comprising:

a tubular ePTFE substrate having a first surface and a second surface spaced from the first surface;

a layer of sealant disposed over one of the first and second surfaces, the sealant comprising a polymeric material resistant to plastic deformation upon insertion of a puncture member through the sealant layer;

a first layer of foam disposed over the sealant layer;

a PTFE beading helically wrapped over the first foam layer circumscribing a longitudinal axis of the ePTFE substrate;

a second layer of foam disposed over the PTFE beading; and

an outer layer disposed over the second foam layer.

2. The self-sealing vascular graft according to claim 1, wherein the sealant comprises a material selected from the group consisting essentially of aromatic polycarbonate polyurethanes, polyetherurethanes, polyether/polyamide block copolymers, polydimethylsiloxane elastomers, or other silicone elastomers and combinations thereof.

3. The self-sealing vascular graft according to claim 1, wherein the sealant comprises a heat-treated aromatic polycarbonate polyurethane.

4. The self-sealing vascular graft according to claim 1, wherein the polymeric material comprises polyurethane having a weight-average molecular weight (MW) of about 50,000 g/mole.

5. The self-sealing vascular graft according to claim 1, wherein the sealant comprises particles of a material selected from the group consisting essentially of polyester, collagen, thrombin, or fibrinogen and combinations thereof.

6. The self-sealing vascular graft according to claim 1, wherein the ePTFE substrate is selected from the group consisting of a high porosity graft, a thin-wall graft and combinations thereof.

7. The self-sealing vascular graft according to claim 1, further comprising a bioactive agent incorporated into at least one of the substrate, sealant layer, first foam layer, second foam layer, and outer layer.

8. The self-sealing vascular graft according to claim 7, wherein the bioactive agent is selected from the group consisting essentially of carbon particles, silver particles, graphite particles, antibiotics, macrolide antibiotics, steroidal agents, anti-inflammation agents, antineoplastic agents, antifungals, antivirals, antibodies, genetic sequence agents, growth factors inhibitors, angiogenesis, anti-angiogenesis, proteinase inhibitors, antiproliferative compounds, or cell cycle modulators and combinations thereof.

9. The self-sealing vascular graft according to claim 1, wherein a tubular end of the graft is coupled to a flared end of a prosthetic cuff graft.

10. The self-sealing vascular graft according to claim 9, wherein the tubular end is threaded to a tubular portion of the prosthetic cuff graft.

11. The self-sealing vascular graft according to claim 9, wherein the tubular end is bonded to the tubular portion of the prosthetic cuff graft.