PTFE vascular prosthesis and method of manufacture

• US 6,001,125 A
• Filed: 03/18/1998
• Issued: 12/14/1999
• Est. Priority Date: 01/22/1996
• Status: Expired due to Term

• Current Assignee: Lifeport Sciences LLC (Acacia Research Corporation)
• Original Assignee: Meadox Medicals, Inc. (Boston Scientific Corporation)
• Inventors: Lentz, David J., Golds, Ellen, Henderson, Jamie, Zdrahala, Richard J., Dormier, Edward J.
• Primary Examiner(s): Hirsch, Paul J.
• Application Number:
  US09/040,880
• Time in Patent Office: 636 Days
• Field of Search: 623/1, 623/12, 600/36
• US Class Current: 623/23.7
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2002/0086 for preferentially controlling or promoting the growth of specific types of cells or tissues of bone tissue onto implantable joints A61F2002/3093
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• 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
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

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. The stent provides patency to the endoprosthesis.

Claims

1. A tubular intraluminal prosthesis comprising:

a first PTFE tubular structure having a first porosity;

a second PTFE tubular structure having a second porosity less than said first porosity, said second PTFE tubular structure being disposed externally about said first PTFE tubular structure to define a distinct porosity change between said first and second PTFE tubular structure; and

a tubular diametrically deformable stent interposed between said first and second PTFE tubular structure.

2. A tubular prosthesis of claim 1 wherein said stent defines a tubular wall having a plurality of open spaces therethrough.

3. A tubular prosthesis of claim 2 wherein said first PTFE tubular structure is adheringly secured to said second PTFE tubular structure through said open spaces of said interposed stent.

4. A tubular prosthesis of claim 2 wherein said tubular wall of said stent includes opposed inner and outer tubular surfaces and wherein said first PTFE tubular structure is adheringly secured to said inner tubular surface of said stent and said second PTFE tubular structure is adheringly secured to said outer tubular surface of said stent.

5. A tubular prosthesis of claim 3 wherein said first PTFE tubular structure is laminated to said second PTFE tubular structure through said open spaces of said interposed stent.

6. A tubular prosthesis of claim 3 wherein said first PTFE tubular structure is adhesively secured to said second PTFE tubular structure through said open spaces of said interposed stent.

7. A tubular prosthesis of claim 4 wherein said first and second PTFE tubular structures are adheringly secured to said inner and outer tubular stent surface by an adhesive.

8. A method of making a tubular intraluminal prosthesis comprising the steps of:

providing a first tubular structure having a first porosity, consisting of an interior and exterior surface;

placing a tubular diametrically deformable stent circumferentially around the exterior surface of said first tubular structure;

disposing a second PTFE tubular structure externally about said tubular diametrically deformable stent, said second PTFE tubular structure having a second porosity less than said first porosity, and defining a distinct porosity change between said first and second PTFE tubular structures.

9. A method of making a tubular intraluminal prosthesis according to claim 8 wherein said stent defines a tubular wall having a plurality of open spaces therethrough.

10. A method of making a tubular intraluminal prosthesis according to claim 9 wherein said first PTFE tubular structure is adheringly secured to said second PTFE tubular structure through said open spaces of said stent.

11. A method of making a tubular prosthesis according to claim 10 wherein said first PTFE tubular structure is laminated to said second PTFE tubular structure through said open spaces of said stent.

12. A method of making a tubular prosthesis according to claim 10 wherein said first PTFE tubular structure is adhesively secured to said second PTFE tubular structure through said open spaces of said stent.

13. A method of making a tubular prosthesis according to claim 8 wherein said tubular wall of said stent includes opposed inner and outer tubular surfaces and wherein said first PTFE tubular structure is adheringly secured to said inner tubular surface of said stent and said second PTFE tubular structure is adheringly secured to said outer tubular surface of said stent.

14. A tubular prosthesis according to claim 13 wherein said first and second PTFE tubular structures are adheringly secured to said inner and outer tubular stent surface by an adhesive.