Self-sealing PTFE graft with kink resistance

• US 9,572,654 B2
• Filed: 11/14/2012
• Issued: 02/21/2017
• 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: Abbott, Jamie, Cole, Heidi R., Elton, Richard, Shahriari, Kereshmeh, Edwin, Tarun J., Pathak, Chandrashekhar P., Bogert, David L., Brown, Fitzroy
• Primary Examiner(s): Gross, Carson
• Application Number:
  US13/677,165
• Publication Number:
  US 20130071550A1
• Time in Patent Office: 1,560 Days
• Field of Search: 156/172, 156/173, 156/308.6, 623/1.13, 623/1.22, 623/1.34, 623/1.35, 623/1.38, 623/1.39, 623/1.4, 623/1.44, 623/1.46, 623/1.49, 623 15- 154
• US Class Current: 1/1
• 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 method of forming a vascular graft, comprising:

providing a tubular ePTFE substrate;

applying a sealant layer over the tubular ePTFE substrate;

compressing the tubular ePTFE substrate with sealant layer;

applying a foam layer over the sealant layer to form a preliminary graft assembly;

heating the preliminary graft assembly;

longitudinally compressing the preliminary graft assembly to form a longitudinally compressed graft assembly; and

wrapping a beading over the longitudinally compressed graft assembly.

2. The method according to claim 1, wherein the compressing the tubular ePTFE substrate with sealant layer includes longitudinal compression.

3. The method according to claim 2, wherein the compressing the tubular ePTFE substrate with sealant layer further includes radial compression.

4. The method according to claim 1, wherein the tubular ePTFE substrate with sealant layer is radially dilated to a dilated diameter and subsequently contracted via heating to a contracted diameter less than the dilated diameter.

5. The method according to claim 1, further comprising wrapping a layer of ePTFE tape over the longitudinally compressed graft assembly.

6. The method according to claim 5, wherein the wrapping a layer of ePTFE tape comprises passing the ePTFE tape through a solution prior to wrapping.

7. The method according to claim 5, wherein the wrapping a layer of ePTFE tape comprises radially compressing the longitudinally compressed graft assembly.

8. The method according to claim 1, further comprising applying a second foam layer over the longitudinally compressed graft assembly following the wrapping-a-beading step.

9. The method according to claim 1, wherein the step of applying a foam layer over the sealant layer comprises dissolving a polyurethane material in tetrahydrofuran (THF) and spraying onto the sealant layer such that the THF evaporates during the spraying.

10. The method according to claim 1, wherein the step of applying a sealant layer comprises dissolving a polyurethane material in tetrahydrofuran (THF) and spraying onto the tubular ePTFE substrate from a first distance while the tubular ePTFE substrate is rotated.

11. The method according to claim 10, wherein the step of applying a foam layer over the sealant layer comprises dissolving a polyurethane material in tetrahydrofuran (THF) and spraying onto the tubular ePTFE substrate from a second distance while the tubular ePTFE substrate is rotated, the second distance further from the tubular ePTFE substrate than the first distance.

12. The method according to claim 1, further comprising grooving the sealant layer at spaced apart intervals.

13. The method according to claim 1, wherein the step of applying a sealant layer comprises applying a sealant formed from a heat-treated aromatic polycarbonate polyurethane that is resistant to plastic deformation upon insertion of a puncture member through the sealant layer.

14. The method according to claim 1, wherein the step of wrapping a beading over the longitudinally compressed graft assembly includes at least partially embedding the beading in the foam layer.

15. The method according to claim 1, further comprising coupling a cuff to an end of the longitudinally compressed graft assembly.

16. The method according to claim 1, wherein the step of wrapping a beading over the longitudinally compressed graft assembly comprises providing a beading including a radiopaque material.

17. The method according to claim 1, further comprising incorporating a bioactive agent into at least one of the tubular ePTFE substrate, sealant layer and foam layer, the bioactive agent selected from the group consisting 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, cell cycle modulators, and combinations thereof.