Thin-wall intraluminal graft

• US 6,159,565 A
• Filed: 08/18/1993
• Issued: 12/12/2000
• Est. Priority Date: 08/18/1993
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Campbell, Carey V., Myers, David J., Lewis, James D.
• Primary Examiner(s): Woodward, Michael P.
• Assistant Examiner(s): Delaney, Patrick R.
• Application Number:
  US08/108,963
• Time in Patent Office: 2,673 Days
• Field of Search: 623/1, 428/35.7, 428/36.9, 428/36.91, 428/36.92, 428/420, 428/421, 428/422
• US Class Current: 428/35.7
• CPC Class Codes: A61B 17/3431 being collapsible, e.g. made of thin flexible material A61B17/3423 takes precedence
• 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 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 29/041 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: B29C 53/38 by bending sheets or strips at right angles to the longitudinal axis of the article being formed and joining the edges
• CPC Class Codes: B29C 53/58 helically
• CPC Class Codes: B29C 70/207 arranged in parallel planes of fibres crossing at substantial angles
• CPC Class Codes: B29C 70/30 Shaping by lay-up, i.e. applying fibres, tape or broadsheet on a mould, former or core; Shaping by spray-up, i.e. spraying of fibres on a mould, former or core
• CPC Class Codes: B29C 70/302 Details of the edges of fibre composites, e.g. edge finishing or means to avoid delamination
• CPC Class Codes: B29K 2027/18 PTFE, i.e. polytetrafluorethene , e.g. ePTFE, i.e. expanded polytetrafluorethene
• CPC Class Codes: B29K 2105/04 cellular or porous
• CPC Class Codes: B29K 2105/0827 Braided fabrics
• CPC Class Codes: B29L 2023/005 Hoses, i.e. flexible
• CPC Class Codes: B29L 2031/7542 Catheters
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: F16L 11/085 : comprising one or more braided layers in combination with layers of a helically wound core or wire F16L11/088
• CPC Class Codes: Y10T 428/13 : Hollow or container type article [e.g., tube, vase, etc.]
• CPC Class Codes: Y10T 428/1328 : Shrinkable or shrunk [e.g., due to heat, solvent, volatile agent, restraint removal, etc.]
• CPC Class Codes: Y10T 428/1352 : Polymer or resin containing [i.e., natural or synthetic]
• CPC Class Codes: Y10T 428/1369 : Fiber or fibers wound around each other or into a self-sustaining shape [e.g., yarn, braid, fibers shaped around a core, etc.]
• CPC Class Codes: Y10T 428/1379 : Contains vapor or gas barrier, polymer derived from vinyl chloride or vinylidene chloride, or polymer containing a vinyl alcohol unit
• CPC Class Codes: Y10T 428/139 : Open-ended, self-supporting conduit, cylinder, or tube-type article
• CPC Class Codes: Y10T 428/1393 : Multilayer [continuous layer]
• CPC Class Codes: Y10T 428/1397 : Single layer [continuous layer]
• CPC Class Codes: Y10T 428/31504 : Composite [nonstructural laminate]
• CPC Class Codes: Y10T 428/31536 : Including interfacial reaction product of adjacent layers
• CPC Class Codes: Y10T 428/3154 : Of fluorinated addition polymer from unsaturated monomers
• CPC Class Codes: Y10T 428/31544 : Addition polymer is perhalogenated

Abstract

An intraluminal vascular graft in the form of a tube of porous expanded polytetrafluoroethylene film wherein the porous polytetrafluoroethylene film has a microstructure containing a multiplicity of fibrils oriented substantially parallel to each other. The tube has a wall thickness of less than about 0.25 mm and is made from at least one first layer and at least one second layer of porous polytetrafluoroethylene film, wherein the fibrils of the first and second layers are oriented substantially perpendicular to each other. Preferably the fibrils of the at least one first layer are oriented substantially parallel to the longitudinal axis of the tube and the fibrils of the at least one second layer of porous polytetrafluoroethylene film are oriented substantially circumferential to the tube. The first and second layers may be inner and outer layers respectively, or alternatively their relationship may be reversed. Alternatively, either of the first and second film layers may be replaced with alternative reinforcing components such as a braid or at least one reinforcing rib.

Claims

1. An intraluminal graft comprising a tube having:

a) an inner layer comprised of porous PTFE film having a microstructure comprised of fibrils, said fibrils being substantially parallel to one another;

b) an outer layer concentrically covering said inner layer, said outer layer comprised of porous PTFE film having a microstructure comprised of fibrils, said fibrils being substantially parallel to one another and substantially perpendicular to the fibrils of the inner layer; and

c) a wall thickness of less than about 0.25 mm.

2. The graft of claim 1 in which said inner layer is formed from helically wrapped film.

3. The graft of claim 2 in which the wall thickness is less than 0.10 mm.

4. The graft of claim 3 in which the wall thickness is less than 0.06 mm.

5. The graft of claim 1 in which said outer layer is helically wrapped around said inner layer.

6. The graft of claim 5 in which the wall thickness is less than 0.10 mm.

7. The graft of claim 6 in which the wall thickness is less than 0.06 mm.

8. The graft of claim 1 in which said inner layer and said outer layer are formed from helically wrapped film.

9. The graft of claim 8 in which the wall thickness is less than 0.10 mm.

10. The graft of claim 9 in which the wall thickness is less than 0.06 mm.

11. The graft of claim 1 in which said inner layer is attached to said outer layer by an adhesive.

12. The graft of claim 11 wherein the adhesive is a thermoplastic fluoropolymer.

13. The graft of claim 12 wherein the thermoplastic fluoropolymer is fluorinated ethylene propylene.

14. The graft of claim 13 wherein the fluorinated ethylene propylene is porous.

15. The graft of claim 11 wherein the adhesive is porous.

16. The graft of claim 11 wherein the adhesive is non-porous.

17. The graft of claim 1 in which the wall thickness is less than 0.10 mm.

18. The graft of claim 17 in which the wall thickness is less than 0.06 mm.

19. The graft of claim 1 having a reinforcing material between said inner layer and said outer layer.

20. The graft of claim 19 in which the reinforcing material is braided.

21. The graft of claim 1 comprising a bifurcated graft.

22. The graft of claim 1 wherein said graft incorporates at least one reinforcing rib.

23. The graft of claim 1 wherein the intraluminal graft has a longitudinal axis and wherein the fibrils of the inner porous polytetrafluoroethylene layer are substantially parallel to the longitudinal axis.

24. The graft of claim 23 in which the wall thickness is less than 0.10 mm.

25. The graft of claim 24 in which the wall thickness is less than 0.06 mm.

26. The graft of claim 1 in which said inner layer is attached to said outer layer by heat bonding.