Stented, radially expandable, tubular PTFE grafts

• US 5,928,279 A
• Filed: 07/03/1996
• Issued: 07/27/1999
• Est. Priority Date: 07/03/1996
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: McIntyre, John, Kuo, Chris, Tu, Benny, Shannon, Donald T., Clinkenbeard, Ronald L., Chu, Yizi
• Primary Examiner(s): Isabella, David J.
• Assistant Examiner(s): Black, John M.
• Application Number:
  US08/675,644
• Time in Patent Office: 1,119 Days
• Field of Search: 623/1, 623/11, 623/12, 606/194, 606/195, 600/36
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: B29C 53/58 helically
• CPC Class Codes: B29K 2027/18 PTFE, i.e. polytetrafluorethene , e.g. ePTFE, i.e. expanded polytetrafluorethene
• CPC Class Codes: B29K 2227/18 PTFE, i.e. polytetrafluorethene , e.g. ePTFE, i.e. expanded polytetrafluorethene
• CPC Class Codes: B29L 2031/7534 Cardiovascular protheses
• CPC Class Codes: C08L 59/00 Compositions of polyacetals; Compositions of derivatives of polyacetals of polyvinyl acetals C08L29/14
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

Stented tubular grafts of expanded, sintered polytetrafluoroethylene (PTFE). The stented PTFE grafts of the present invention include an integrally stented embodiment, an externally stented embodiment, and an internally stented embodiment. In each embodiment, the stent may be either self-expanding or pressure-expandable. Also, in each embodiment, the stent may be coated or covered with a plastic material capable of being affixed (e.g., heat fused) to PTFE. Manufacturing methods are also disclosed by the individual components of the stented grafts are preassembled on a mandrel and are subsequently heated to facilitate attachment of the PTFE layer(s) to one another and/or to the stent. Optionally, the stented graft may be post-flexed and post-expanded following it'"'"'s removal from the mandrel to ensure that the stented graft will be freely radially expandable and/or radially contractible over it'"'"'s full intended range of diameters.

Claims

1. A tubular stented graft which is alternately deployable in a radially compact configuration having a first diameter and a radially expanded configuration having a second diameter, said stented graft comprising:

a) a stent comprising;

i) at least one member formed in a generally cylindrical shape having an outer surface and a hollow bore which extends longitudinally therethrough to define an inner surface;

ii) said stent being initially radially collapsible to a diameter which is substantially equal to said first diameter of the stented graft, and subsequently radially expandable to a diameter which is substantially equal to said second diameter of the stented graft; and

,

iii) a plurality of lateral openings existing in said stent when said stent is at its radially expanded second diameter;

b) a continuous, tubular PTFE covering formed on said stent, said PTFE covering comprising;

i) a tubular inner base graft formed of expanded, sintered PTFE, said tubular base graft having an outer surface and an inner surface, said tubular base graft being deployed coaxially within the hollow bore of said stent such that the outer surface of the tubular base graft is in contact with the inner surface of the stent, and the inner surface of said tubular base graft thereby defining a luminal passageway through the stented graft; and

,

ii) a tubular outer layer formed of expanded, sintered PTFE tape which has a width of less than about 1 inch, said tape having been wound about the outer surface of said stent to create said tubular outer layer thereon, such that said stent is captured between said outer layer and said tubular base graft;

said tubular outer layer being attached to said tubular base graft, through said lateral openings in said stent, to thereby form an integrally stented, continuous PTFE tube which is alternately disposable in said radially compact configuration of said first diameter and said radially expanded configuration of said second diameter.

2. The stented graft of claim 1 wherein said PTFE tape has a thickness of less than 0.015 inch and wherein said tape has been wound about said stent in overlapping fashion, such that said tubular outer layer comprises 1 to 10 layers of said tape.

3. The stented graft of claim 1 wherein said tape is helically wrapped about said stent.

4. The stented graft of claim 3 wherein said tape has a width of 1/2 inch, and wherein said tape is helically wrapped such that 6-8 revolutions of tape are applied per longitudinal inch of the stented graft.

5. The stented graft of claim 4 wherein said helical wrapping of said tape is applied twice, first in one direction and then in the opposite direction.

6. The stented graft of claim 5 wherein said helical wrappings of said tape form an outer tubular layer which is made up of 8 consecutive layers of said tape.

7. The stented graft of claim 1 wherein said stent is a self-expanding stent.

8. The stented graft of claim 7 wherein said self-expanding stent comprises a shape memory alloy which alternately exists in first and second crystalline states, and wherein the stent will assume it'"'"'s radially expanded configuration when said shape memory alloy is in it'"'"'s first crystalline state, and will assume it'"'"'s radially compact configuration when said shape memory alloy is in it'"'"'s second crystalline state.

9. The stented graft of claim 1 wherein said stent is a pressure-expandable stent.

10. The stented graft of claim 1 wherein said self-expanding stent is formed of a multiplicity of wire members which are braided into said generally cylindrical shape, and wherein said lateral openings in the stent are formed by gaps which exist between adjacent wire members.

11. The stented graft of claim 10 wherein said wire members are formed of a metal alloy wherein the alloying residue is iron and wherein the iron is alloyed with at least one other element selected from the group consisting of:

a) cobalt;

b) chromium;

c) nickel; and

,

d) molybdnenium.

12. The stented graft of claim 10 wherein some of the wire members of said stent are helically wound about a longitudinal axis in a first direction, and others of said wire members are helically wound about said longitudinal axis in a second direction such that they cross on opposite sides of the wire members which had been wound in the first helical direction, thereby forming a helically braided, cylindrical, wire stent.

13. The stented graft of claim 1 wherein said stent is formed of a multiplicity of plastic members which are braided into said generally cylindrical shape, and wherein said lateral openings in the stent are formed by gaps which exist between adjacent plastic members.

14. The stented graft of claim 13 wherein said plastic members are formed of a plastic selected from the group consisting of:

polytetrafluoroethylene;

fluorinated ethylene propylene;

polytetrafluoroethylene-perfluoroalkyl vinyl ether copolymer;

polyvinyl chloride;

polypropylene;

polyethylene terephthalate;

broad fluoride; and

,

other biocompatable plastics.

15. The stented graft of claim 1 wherein said tubular base graft comprises expanded, sintered PTFE of less than 0.10 inch thickness.

16. The stented graft of claim 1 wherein said tubular base graft comprises expanded, sintered PTFE having a density of less than 1.6 g/cc.

17. The stented graft of claim 1 wherein tubular base graft comprises expanded, sintered PTFE having a thickness of less than 0.10 inches and a density of less than 1.6 g/cc.

18. The stented graft of claim 1 wherein said tubular outer layer has a thickness of less than 0.1 inch.

19. The stented graft of claim 18 wherein said PTFE tape has a thickness of less than 0.015 inches, said tape being wrapped about said stent in overlapping fashion so as to form said tubular outer layer.

20. The stented graft of claim 1 wherein said PTFE tape has a density of less than 1.6 g/cc.

21. The stented graft of claim 1 wherein said tubular outer layer has a thickness of less than 0.1 inch and the PTFE tape has a density of less than 1.6 g/cc.

22. The stented graft of claim 1 wherein said stent further comprises:

iv) a polymer coating formed on said stent.

23. The stented graft of claim 22 wherein the polymer coating formed on said stent is of a polymer material selected from the group consisting of:

polytetrafluoroethylene;

fluorinated ethylene propylene;

polytetrafluoroethylene-perfluoroalkyl vinyl ether copolymer;

polyvinyl chloride;

polypropylene;

polyethylene terephthalate;

polyvinylidene fluoride; and

,

other biocompatable plastics.

24. The stented graft of claim 22 wherein said polymer coating was applied to said stent by the steps of:

immersing the stent in a liquid polymer dispersion;

removing the stent from the liquid polymer dispersion;

drying that liquid polymer dispersion which has remained on the stent, thereby forming said polymer coating thereon.

25. The stented graft of claim 22 wherein said polymer coating was formed on the stent by electron beam deposition.

26. The stented graft of claim 22 wherein said stent is formed of a plurality of elongate members, and wherein said polymer coating was formed on said elongate members by positioning a polymer tube around each elongate member.

27. The stented graft of claim 22 wherein said base graft and said tubular outer layer are adherent to the polymer coating which is formed on said stent.

28. The stented graft of claim 1 wherein said graft further comprises:

iv) polymer particles deposited between said inner base graft and said outer tubular layer and subsequently melted to promote attachment of said tubular base graft to said tubular outer layer.

29. The stented graft of claim 28 wherein said polymer particles are PTFE.

30. The stented graft of claim 28 wherein said polymer particles are melted by heat.

31. The stented graft of claim 29 wherein said polymer particles are melted by solvent.

32. The stented graft of claim 28 wherein said polymer particles are deposited by applying a liquid polymer particle dispersion to one of said base graft and said tubular outer layer, prior to assembly thereof.

33. The stented graft of claim 28 wherein said polymer particles are deposited between said tubular base graft and said tubular outer layer by applying a liquid dispersion of polymer particles to the exterior of said tubular outer layer, such that the polymer particles contained within the dispersion will migrate inwardly through the tubular outer layer.

34. A tubular stented graft which is alternately deployable in a radially compact configuration having a first diameter and a radially expanded configuration having a second diameter, said stented graft comprising:

a) a stent comprising;

i) at least one member formed in a generally cylindrical shape having an outer surface and a hollow bore which extends longitudinally therethrough to define an inner surface;

ii) said stent being initially radially collapsible to a diameter which is substantially equal to said first diameter of the stented graft, and subsequently radially expandable to a diameter which is substantially equal to said second diameter of the stented graft; and

,

iii) a plurality of lateral openings existing in said stent when said stent is at its radially expanded second diameter;

b) a continuous, tubular PTFE covering formed on said stent, said PTFE covering comprising;

i) a tubular inner base graft formed of expanded, sintered PTFE, said tubular base graft having an outer surface and an inner surface, said tubular base graft being deployed coaxially within the hollow bore of said stent such that the outer surface of the tubular base graft is in contact with the inner surface of the stent, and the inner surface of said tubular base graft thereby defining a luminal passageway through the stented graft; and

,

ii) a tubular outer layer formed of expanded, sintered PTFE tape which has a thickness of less than 0.015 inches, said tape being wrapped about the outer surface of said stent in overlapping fashion so as to form said tubular outer layer, such that said stent is captured between said outer layer and said tubular base graft;

c) said tubular outer layer being attached to said tubular base graft, through said lateral openings in said stent, to thereby form an integrally stented, continuous PTFE tube which is alternately disposable in said radially compact configuration of said first diameter and said radially expanded configuration of said second diameter.

35. A tubular stented graft which is alternately deployable in a radially compact configuration having a first diameter and a radially expanded configuration having a second diameter, said stented graft comprising:

a) a stent comprising;

i) at least one member formed in a generally cylindrical shape having an outer surface and a hollow bore which extends longitudinally therethrough to define an inner surface;

ii) said stent being initially radially collapsible to a diameter which is substantially equal to said first diameter of the stented graft, and subsequently radially expandable to a diameter which is substantially equal to said second diameter of the stented graft; and

,

iii) a plurality of lateral openings existing in said stent when said stent is at its radially expanded second diameter;

b) a continuous, tubular PTFE covering formed on said stent, said PTFE covering comprising;

i) a tubular inner base graft formed of expanded, sintered PTFE, said tubular base graft having an outer surface and an inner surface, said tubular base graft being deployed coaxially within the hollow bore of said stent such that the outer surface of the tubular base graft is in contact with the inner surface of the stent, and the inner surface of said tubular base graft thereby defining a luminal passageway through the stented graft; and

,

ii) a tubular outer layer formed of expanded, sintered PTFE, said outer layer being disposed about the outer surface of said stent such that said stent is captured between said outer layer and said tubular base graft; and

,

c) polymer particles deposited between said inner base graft and said outer tubular later and subsequently melted to promote attachment of said tubular base graft to said tubular outer layer;

said tubular outer layer being attached to said tubular base graft, through said lateral openings in said stent, to thereby form an integrally stented, continuous PTFE tube which is alternately disposable in said radially compact configuration of said first diameter and said radially expanded configuration of said second diameter.

36. The stented graft of claim 35 wherein said polymer particles are PTFE.

37. The stented graft of claim 35 wherein said polymer particles are melted by heat.

38. The stented graft of claim 35 wherein said polymer particles are melted by solvent.

39. The stented graft of claim 35 wherein said polymer particles are deposited by applying a liquid polymer particle dispersion to one of said base graft and said tubular outer layer, prior to assembly thereof.

40. The stented graft of claim 35 wherein said polymer particles are deposited between said tubular base graft and said tubular outer layer by applying a liquid dispersion of polymer particles to the exterior of said tubular outer layer, such that the polymer particles contained within the dispersion will migrate inwardly through the tubular outer layer.

41. A tubular stented graft which is alternately deployable in a radially compact configuration having a first diameter and a radially expanded configuration having a second diameter, said stented graft comprising:

a) a stent formed in a generally cylindrical shape having an outer surface and a hollow bore which extends longitudinally therethrough to define an inner surface, the stent having an initially radially collapsed state with a diameter which is substantially equal to said first diameter, and a radially expanded state with a diameter which is substantially equal to said second diameter, and wherein a plurality of lateral openings are formed in said stent in its radially expanded state;

b) a continuous, tubular PTFE covering formed on said stent, said PTFE covering comprising;

i) a tubular inner base graft formed of expanded, sintered PTFE, said tubular base graft having an outer surface and an inner surface, said tubular base graft being deployed coaxially within the hollow bore of said stent such that the outer surface of the tubular base graft is in contact with the inner surface of the stent, and the inner surface of said tubular base graft thereby defining a luminal passageway through the stented graft; and

,

ii) a tubular outer layer formed of expanded, sintered PTFE, said outer layer being disposed about the outer surface of said stent such that said stent is captured between said outer layer and said tubular base graft; and

,

c) PTFE particles deposited between said inner base graft and said outer tubular later and subsequently melted to promote attachment of said tubular base graft to said tubular outer layer;

said tubular outer layer being attached to said tubular base graft, through said lateral openings in said stent, to thereby form an integrally stented, continuous PTFE tube which is alternately disposable in said radially compact configuration of said first diameter and said radially expanded configuration of said second diameter.

42. The stented graft of claim 41 wherein said PTFE particles are melted by heat.

43. The stented graft of claim 41 wherein said PTFE particles are melted by solvent.

44. The stented graft of claim 41 wherein said PTFE particles are deposited by applying a liquid polymer particle dispersion to one of said base graft and said tubular outer layer, prior to assembly thereof.

45. The stented graft of claim 41 wherein said PTFE particles are deposited between said tubular base graft and said tubular outer layer by applying a liquid dispersion of polymer particles to the exterior of said tubular outer layer, such that the polymer particles contained within the dispersion will migrate inwardly through the tubular outer layer.