Self-sealing PTFE graft with kink resistance

• US 10,582,997 B2
• Filed: 01/09/2017
• Issued: 03/10/2020
• Est. Priority Date: 08/31/2004
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Edwin, Tarun J., Abbott, Jamie, Cole, Heidi R., Pathak, Chandrashekhar P, Bogert, David L., Elton, Richard, Brown, Fitzroy, Shahriari, Kereshmeh
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US15/401,412
• Publication Number:
  US 20170112611A1
• Time in Patent Office: 1,156 Days
• 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 vascular graft comprising:

a tubular ePTFE substrate having a first surface, a second surface, a first end portion, a second end portion, and a middle portion, wherein the tubular ePTFE substrate is one or both of a high porosity graft and a thin-wall graft; and

a sealant layer disposed over the first surface or the second surface, wherein the sealant layer is disposed over one or all of the first end portion, the second end portion, and the middle portion, the sealant layer having a plurality of radial or longitudinal grooves;

a base layer; and

one or more foam layers dispersed on the base layer, the one or more foam layers comprising a first foam layer and a second foam layer, wherein;

a beading is embedded in the first foam layer, and

the second foam layer is disposed over the first foam layer and the beading,

wherein the vascular graft is self-sealing.

2. The vascular graft of claim 1, further comprising a polymer outer layer.

3. The vascular graft of claim 1, wherein the sealant layer is disposed over the first end portion and the second end portion and the sealant layer has a plurality of radial grooves.

4. The vascular graft of claim 1, wherein the sealant layer is disposed over all of the tubular ePTFE substrate.

5. The vascular graft of claim 1, wherein the sealant layer is disposed on the middle portion, and wherein the sealant layer has a plurality of longitudinal grooves.