Self-sealing PTFE vascular graft and manufacturing methods

• US 20040193242A1
• Filed: 04/09/2004
• Published: 09/30/2004
• Est. Priority Date: 01/22/1996
• Status: Active Grant

• Current Assignee: Lifeport Sciences LLC (Acacia Research Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Henderson, Jamie, Sowinski, Krzysztof, Rakos, Ronald, Lentz, David, Zdrahala, Richard, Dormier, Edward, Loomis, Gary
• Granted Patent: US 7,244,271 B2
• Time in Patent Office: Days
• US Class Current: 623/1.4
• 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: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene

Abstract

An implantable microporous ePTFE tubular vascular graft exhibits long term patency, superior radial tensile strength and suture hole elongation resistance. The graft includes a first ePTFE tube and a second ePTFE tube circumferentially disposed over the first tube. The first ePTFE tube exhibits a porosity sufficient to promote cell endothelization, tissue ingrowth and healing. The second ePTFE tube exhibits enhanced radial strength in excess of the radial tensile strength of the first tube.

Claims

1-28. -28. (canceled).

29. A multi-layered ePTFE graft comprising:

a first ePTFE tubular structure having a first porosity;

a second ePTFE tubular structure having a second porosity different than said first porosity, said second ePTFE tubular structure being disposed about said first ePTFE tubular structure; and

a self-sealing material interposed between said first and second ePTFE tubular structures.

30. A multi-layered graft according to claim 29 wherein said first porosity is greater than said second porosity.

31. A multi-layered graft according to claim 29 wherein said second ePTFE tubular structure is disposed externally about said first ePTFE tube.

32. A multi-layered graft according to claim 29 wherein said self-sealing material is selected from the group consisting of thermoplastic elastomers, silicones, silicone rubbers, synthetic rubbers, polyurethanes, polyethers, polyesters, polyamides, fluoropolymers and combinations thereof.

33. A multi-layered graft according to claim 29 wherein said self-sealing material comprises a single layer having resealable properties.

34. A multi-layered graft according to claim 29 wherein said self-sealing material comprises an elastomeric polymer layer.

35. A multi-layered graft according to claim 34 wherein said self-sealing elastomeric polymer layer adheres to said first and second ePTFE tubular structures.

36. A multi-layered graft according to claim 35, wherein said adherence is by chemical means, mechanical means or a combination thereof.

37. A multi-layered graft according to claim 34 wherein said elastomeric polymer layer is impregnated with a gel to enhance sealing properties thereof.

38. A multi-layered graft according to claim 34 wherein said elastomeric polymer layer comprises an internodal distance sufficient to promote cell endothelization and/or tissue ingrowth.

39. A multi-layered graft according to claim 34 wherein said elastomeric polymer layer comprises an internodal distance sufficient to promote enhanced strength and handling characteristics of the graft.

40. A multi-layered graft according to claim 29 wherein said self-sealing material is flowable.

41. A multi-layered ePTFE vascular graft useful for repeated hemoaccess comprising:

a first ePTFE tubular structure having a first porosity;

a second ePTFE tubular structure having a second porosity different than said first porosity, said second ePTFE tubular structure being disposed about said first ePTFE tubular structure; and

a self-sealing material interposed between said first and second ePTFE tubular structures.

42. A multi-layered graft according to claim 41 wherein said first porosity is greater than said second porosity.

43. A multi-layered graft according to claim 41 wherein said second ePTFE tubular structure is disposed externally about said first ePTFE tube.

44. A multi-layered graft according to claim 41 wherein said self-sealing material comprises a single layer having resealable properties.