Methods for making a supported graft

• US 20010025131A1
• Filed: 05/15/2001
• Published: 09/27/2001
• Est. Priority Date: 03/10/1995
• Status: Abandoned Application

• Current Assignee: Brendan Mccrea, Chris Banas, Rajagopal R. Kowligi, Tarun J. Edwin
• Original Assignee: Brendan Mccrea, Chris Banas, Rajagopal R. Kowligi, Tarun J. Edwin
• Inventors: Edwin, Tarun J., McCrea, Brendan, Kowligi, Rajagopal R., Banas, Chris
• Application Number:
  US09/855,918
• Publication Number:
  US 20010025131A1
• Time in Patent Office: Days
• US Class Current: 600/36
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• 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 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30448 using adhesives
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene

Abstract

Shape memory alloy and elastically self-expanding endoluminal support structures which are at least partially encapsulated in a substantially monolithic expanded polytetrafluoroethylene (“ePTFE”) covering. An endoluminal stent, which has a reduced diametric dimension for endoluminal delivery and a larger in vivo final diametric diameter, is encapsulated in an ePTFE covering which circumferentially covers both the luminal and abluminal walls along at least a portion of the longitudinal extent of the endoluminal stent. The shape memory endoluminal stent is fabricated from a shape memory alloy which exhibits either shape memory or pseudoelastic properties or from an elastic material having an inherent spring tension such as spring steel, braided stainless steel wire, or composite materials, such as woven or braided carbon fibers.

Claims

1. An endoluminal prosthesis, comprising:

an tubular substrate having an abluminal surface and a luminal surface thereof; and

a wire member fabricated of an elastically deformable and elastically recoverable material circumferentially disposed about and adhered to the abluminal surface of the tubular substrate by adhesive means interfacing between the wire member and the tubular substrate.

2. The endoluminal prosthesis according to

claim 1

, wherein the elastically deformable and elastically recoverable material of the wire member is selected from the group of materials consisting of shape memory alloys, biocompatible spring steels, biocompatible spring metal alloys, and carbon fibers.

3. The endoluminal prosthesis according to

claim 2

, wherein the shape memory alloys further comprise nickel-titanium alloys.

4. The endoluminal prosthesis according to

claim 2

, wherein the wire member further comprises a shape memory alloy which a pre-programmed austenite dimensional state which is substantially the same diametric dimension as the diametric dimension of the tubular-shaped substrate.

5. The endoluminal prosthesis according to

claim 1

, further comprising a polymeric cladding concentrically surrounding the wire member, the cladding being in intimate contact with and joined to the abluminal surface of the tubular-shaped substrate.

6. The endoluminal prosthesis according to

claim 5

, wherein the adhesive means further comprises a polymeric covering on the wire member and is selected from the group consisting of polytetrafluoroethylene, polyurethane, polyethylene, polypropylene, polyamide, polyimide, polyesters, polypropylene, polyethylene, polyfluoroethylenes, silicone, fluorinated polyolefins, fluorinated ethylene/propylene copolymer, perfluoroalkoxy fluorocarbon, ethylene/tetrafluoroethylene copolymer, and polyvinylpyrolidone.

7. The endoluminal prosthesis according to

claim 1

, wherein the tubular-shaped substrate further comprises a biocompatible material selected from the group consisting of expanded polytetrafluoroethylene, polyethylene, polyethylene terepthalate, polyurethane, and collagen.

28. The use of an intraluminal prosthesis according to

claim 1

for bypass of an anatomical conduit.

29. The use of an intraluminal prosthesis according to

claim 1

for creating an arterio-venous shunt.

31. The use of an intraluminal prosthesis according to

claim 1

as an intraluminal support structure for maintaining luminal patency.

8. An endoluminal prosthesis comprising a support wire member joined to a planar expanded polytetrafluoroethylene film member, the support wire member and planar expanded polytetrafluoroethylene film member being helically wound into an open cylindrical configuration with adjacent windings forming overlapping regions of the expanded polytetrafluoroethylene film member bonded to one and other.

9. The endoluminal prosthesis according to

claim 8

, further comprising a planar polytetrafluoroethylene film member in intimate contact with and monolithically joined to the planar expanded polytetrafluoroethylene film member, the support wire member being intermediate the second planar expanded polytetrafluoroethylene film member and the planar expanded polytetrafluoroethylene film member.

10. The endoluminal prosthesis according to

claim 8

, further comprising a bonding agent joining the support wire member and the planar expanded polytetrafluoroethylene film member.

11. The endoluminal prosthesis according to

claim 9

, further comprising an adhesive interlayer interdisposed between the planar polytetrafluoroethylene film member and the planar expanded polytetrafluoroethylene film member.

12. The endoluminal prosthesis according to

claim 9

, wherein the planar polytetrafluoroethylene film member further comprises expanded polytetrafluoroethylene.

13. The endoluminal prosthesis according to

claim 10

, wherein the adhesive material is selected from the group consisting of polytetrafluoroethylene, polyurethane, polyethylene, polypropylene, polyamide, polyimide, polyesters, polypropylene, polyethylene, polyfluoroethylenes, silicone, fluorinated polyolefins, fluorinated ethylene/propylene copolymer, perfluoroalkoxy fluorocarbon, ethylene/tetrafluoroethylene copolymer, and polyvinylpyrolidone.

14. The endoluminal prosthesis according to

claim 10

, wherein the bonding agent is disposed intermediate the wire member and an abluminal wall surface of polytetrafluoroethylene tubular substrate.

15. The endoluminal prosthesis according to

claim 10

, wherein the bonding agent further comprises a concentric cladding surrounding the wire member.

16. An endoluminal prosthesis, comprising:

a expanded polytetrafluoroethylene tubular-shaped substrate; and

a wire member fabricated of a shape memory alloy helically wound about and adhered to an abluminal surface of the expanded polytetrafluoroethylene tubular-shaped substrate.

17. The endoluminal prosthesis according to

claim 16

, wherein the shape memory stent further comprises a nickel-titanium alloy.

18. The endoluminal prosthesis according to

claim 17

, wherein the nickel-titanium alloy further comprises an alloy consisting essentially of nickel present at about 50 at. %, titanium present at about 50 at. %.

19. The endoluminal prosthesis according to

claim 16

, wherein the wire member has a pre-programmed austenite dimensional state which is substantially the same diametric dimension as the diametric dimension of the expanded polytetrafluoroethylene tubular-shaped substrate.

20. The endoluminal prosthesis according to

claim 16

, further comprising a polymeric cladding concentrically surrounding the wire member, the cladding being in intimate contact with and joined to the abluminal surface of the tubular-shaped substrate.

21. The endoluminal prosthesis according to

claim 20

, wherein the polymeric covering is selected from the group consisting of polytetrafluoroethylene, polyurethane, polyethylene, polypropylene, polyamide, polyimide, polyesters, polypropylene, polyethylene, polyfluoroethylenes, silicone, fluorinated polyolefins, fluorinated ethylene/propylene copolymer, perfluoroalkoxy fluorocarbon, ethylene/tetrafluoroethylene copolymer, and polyvinylpyrolidone.

22. A method for making an endoluminal prosthesis, comprising the step of wrapping a wire member made of a shape memory alloy about and in intimate bonded contact with an abluminal surface of a seamless expanded polytetrafluoroethylene tubular member.

23. The method for making an endoluminal prosthesis according to

claim 22

, further comprising the step of providing the wire member with a concentric cladding fabricated of a material capable of bonding to the expanded polytetrafluoroethylene tubular member.

24. The method for making an endoluminal prosthesis according to

claim 23

, wherein the step of providing the wire member with a concentric cladding further comprises the step of selecting a cladding material from the group consisting of polytetrafluoroethylene, polyurethane, polyethylene, polypropylene, polyamide, polyimide, polyester, polyfluoroethylenes, silicone, fluorinated polyolefin, fluorinated ethylene/propylene copolymer, perfluoroalkoxy fluorocarbon, ethylene/tetrafluoroethylene copolymer, and polyvinylpyrrolidone.

25. The method for making an endoluminal prosthesis according to

claim 24

, wherein the step of providing the wire member further comprises the steps of co-extruding the wire member with a polytetrafluoroethylene cladding.

26. The method for making an endoluminal prosthesis according to

claim 25

, further comprising the steps of applying a helical wrapping of polytetrafluoroethylene tape circumferentially about the expanded polytetrafluoroethylene tubular substrate and the wire member co-extruded with the polytetrafluoroethylene cladding and along an entire longitudinal extent of the expanded polytetrafluoroethylene tubular substrate thereby radially and longitudinally securing the expanded polytetrafluoroethylene tubular substrate and sintering the assembly at a temperature above the crystalline melt point of polytetrafluoroethylene and for a period of time sufficient to bond the polytetrafluoroethylene cladding to the expanded polytetrafluoroethylene substrate.

27. The method for making an endoluminal prosthesis according to

claim 24

, further comprising the step of heating the expanded polytetrafluoroethylene tubular substrate and the concentrically clad wire member to a temperature above the melt point of the bonding agent for a period of time sufficient to mechanically bond the concentrically clad wire member to the abluminal surface of the polytetrafluoroethylene tubular substrate.

30. The use of an intraluminal prosthesis according to

claim 23

for creating a transluminal intrahepatic portosystemic shunt.

32. The use of an intraluminal prosthesis according to

claim 25

further comprising the use for restoring luminal patency in an anatomical fluid conduit.