Radially expandable vascular graft with resistance to longitudinal compression and method of making same

• US 5,628,786 A
• Filed: 05/12/1995
• Issued: 05/13/1997
• Est. Priority Date: 05/12/1995
• Status: Expired due to Term

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: IMPRA Incorporated (Becton, Dickinson & Co)
• Inventors: Banas, Christopher E., Edwin, Tarun J., Randall, Scott, Hurry, Fariba
• Primary Examiner(s): ZIRKER, DANIEL R
• Application Number:
  US08/439,853
• Time in Patent Office: 732 Days
• Field of Search: 428/422, 428/35.7, 623/1, 623/11, 623/12, 623/901
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: B32B 1/08 Tubular products
• CPC Class Codes: B32B 2305/026 Porous
• CPC Class Codes: B32B 2327/18 PTFE, i.e. polytetrafluoroethylene
• CPC Class Codes: B32B 2597/00 Tubular articles, e.g. hoses, pipes
• CPC Class Codes: B32B 27/08 of synthetic resin
• CPC Class Codes: B32B 27/322 comprising halogenated polyolefins, e.g. PTFE
• CPC Class Codes: B32B 37/153 at least one layer is extruded and immediately laminated while in semi-molten state
• CPC Class Codes: B32B 7/12 using interposed adhesives or interposed materials with bonding properties
• CPC Class Codes: C08L 23/00 Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 23/12 Polypropene
• CPC Class Codes: C08L 27/12 containing fluorine atoms
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: C08L 39/06 Homopolymers or copolymers of N-vinyl-pyrrolidones
• CPC Class Codes: C08L 67/00 : Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain of polyester-amides C08L77/12; of polyester-imides C08L79/08; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 77/00 : Compositions of polyamides obtained by reactions forming a carboxylic amide link in the main chain of polyhydrazides C08L79/06; of polyamideimides or polyamide acids C08L79/08; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 79/08 : Polyimides; Polyester-imides; Polyamide-imides; Polyamide acids or similar polyimide precursors
• CPC Class Codes: Y10S 623/901 : Method of manufacturing prosthetic device
• CPC Class Codes: Y10T 428/31544 : Addition polymer is perhalogenated

Abstract

A microporous polytetrafluoroethylene ("PTFE") endovascular graft which has a reinforcing structure integrally bound to the graft which permits radial expansion of the graft and stabilizes the graft against longitudinal compression upon application of an axial force thereto and against axial foreshortening upon radial expansion of the graft. The graft is particularly useful as a covering for an endovascular stent.

Claims

1. A polytetrafluoroethylene graft, comprising:

a tubular graft member formed of expanded polytetrafluoroethylene having a plurality of nodes and fibrils interconnecting the nodes, and forming a microporous material matrix; and

structural support means for imparting resistance to longitudinal compression or axial shrinkage of the tubular graft member 12. reinforcing the microporous material matrix along a longitudinal axis of the tubular graft member, the structural support means being integrated into at least a portion of the microporous material matrix of the tubular graft member and extending axially along a substantial longitudinal section of the tubular graft member.

2. The graft of claim 1, wherein said structural support means further comprises a rib member bonded to at least one of an outer wall surface and an inner wall surface of the tubular graft member.

3. The graft of claim 2, wherein said rib member further comprises a biocompatible plastic selected from the group consisting of polyamides, polyimides, polyesters, polypropylenes, polyethylenes, polyfluoroethylenes, polyvinylpyrolidones, fluorinated polyolefins, fluorinated ethylene/propylene copolymers, tetrafluorethylene/hexafluropropylene copolymer, perfluoroalkoxy fluorocarbons, tetrafluoroethyl/perfluoro propyl vinyl ether copolymer, ethylene/tetrafluoroethylene copolymers, and polyvinylpyrrolidone.

4. The graft of claim 1, wherein said structural support means further comprises an aqueous dispersion of a biocompatible polymer in a coating medium, said aqueous dispersion being applied to at least one of an inner wall surface and an outer wall surface of said tubular graft member.

5. The graft of claim 1, wherein said structural support means further comprises a metal member co-extruded with said tubular graft member.

6. The graft of claim 1, wherein said structural support means further comprises a metal member co-extruded with a polytetrafluoroethylene beading member, said polytetrafluoroethylene beading member being sintered onto said tubular graft member.

7. The graft of claim 1, wherein said structural support means provides resistance to at least one of longitudinal compression and axial shrinkage of the tubular graft member, said compression of said graft being less than or equal to about 27 percent of the uncompressed length of said graft.

8. The graft of claim 1, wherein said structural support means further comprises a region integral within the wall thickness of said tubular graft member.

9. An expanded polytetrafluoroethylene endoluminal graff, comprising:

a radially expandable tubular expanded polytetrafluoroethylene graft member characterized by a microporous material microstructure of nodes interconnected by fibrils and having a first unexpanded diameter and a second radially expanded diameter greater than the first unexpanded diameter; and

a structural support member joined to the graft member, oriented substantially parallel to and extending substantially along an entire longitudinal axis of the tubular graft member, thereby providing longitudinal support to the graft member to restrict longitudinal foreshortening of the graft member during radial expansion of the graft member from the first unexpanded diameter to the second radially expanded diameter.

10. The expanded polytetrafluoroethylene endoluminal graft according to claim 9, further comprising a radially expandable stent member joined in intimate contact with the radially expandable tubular expanded polytetrafluoroethylene graft member.

11. The expanded polytetrafluoroethylene endoluminal graft according to claim 10, wherein the radially expandable stent member is joined to a luminal surface of the radially expandable tubular expanded polytetrafluoroethylene graft member.

12. The expanded polytetrafluoroethylene endoluminal graft according to claim 10, wherein the radially expandable stent member is joined to an abluminal surface of the radially expandable tubular expanded polytetrafluoroethylene graft member.

13. The expanded polytetrafluoroethylene endoluminal graft according to claim 9, wherein the structural support member further comprises a rib member bonded to at least one of an outer wall surface and an inner wall surface of the tubular graft member.

14. The expanded polytetrafluoroethylene endoluminal graft according to claim 13, wherein the rib member further comprises a biocompatible plastic selected from the group consisting of polyamides, polyimides, polyesters, polypropylenes, polyethylenes, polyfluoroethylenes, polyvinylpyrolidones, fluorinated polyolefins, fluorinated ethylene/propylene copolymers, tetrafluoroethylene/hexafluoropropylene copolymer, perfluoroalkoxy fluorocarbons, tetrafluoroethyl/perfluoro propyl vinyl ether copolymer, ethylene/tetrafluoroethylene copolymers, and polyvinylpyrrolidone.

15. The expanded polytetrafluoroethylene endoluminal graft according to claim 9, wherein the structural support member further comprises an aqueous dispersion of a biocompatible polymer in a coating medium, said aqueous dispersion being applied to at least one of an inner wall surface and an outer wall surface of said tubular graft member.

16. The expanded polytetrafluoroethylene endoluminal graft according to claim 9, wherein the structural support member further comprises a metal member co-extruded with said tubular graft member.

17. The expanded polytetrafluoroethylene endoluminal graft according to claim 9, wherein the structural support member further comprises a metal member co-extruded with a polytetrafluoroethylene beading member, said polytetrafluoroethylene beading member being sintered onto said tubular graft member.

18. The expanded polytetrafluoroethylene endoluminal graft according to claim 9, wherein the structural support member provides resistance to at least one of longitudinal compression and axial shrinkage of the tubular graft member, said compression of said graft being less than or equal to about 27 percent of the non-compressed length of said graff.

19. The expanded polytetrafluoroethylene endoluminal graft according to claim 9, wherein the structural support member further comprises a region integral within the wall thickness of said tubular graft member.