Limited expansion endoluminal prostheses and methods for their use

• US 20010000188A1
• Filed: 12/01/2000
• Published: 04/05/2001
• Est. Priority Date: 01/05/1996
• Status: Active Grant

• Current Assignee: Brian J. Cox, Jay A. Lenker, Michael A. Evans, Steven Weinberg
• Original Assignee: Brian J. Cox, Jay A. Lenker, Michael A. Evans, Steven Weinberg
• Inventors: Evans, Michael A., Lenker, Jay A., Cox, Brian J., Weinberg, Steven
• Granted Patent: US 6,592,614 B2
• Time in Patent Office: Days
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

The present invention provides controlled expansion endoluminal prostheses and methods for their deployment and expansion. The present stent-grafts generally comprise a radially expansible tubular frame and a plastically expansible liner on the frame. Either the frame or the liner includes a reinforcing element which limits expansion of the stent-graft at a predetermined expanded size. In some embodiments, the reinforcing element restrains the frame, for example, by limiting the circumferential diagonals of perforations on a perforate frame structure. Generally, however, the reinforcing element is included in the liner as circumferentially oriented yarn. A particularly advantageous liner includes composite circumferential yarns having inexpansible fibers wrapped around an expansible fiber, such as a partially oriented yarn, PTFE, or the like.

Claims

1. A controlled expansion endoluminal prosthesis comprising:

a radially expansible tubular frame having an inner surface and an outer surface; and

a plastically expansible liner disposed on at least one of the inner and the outer surface of the frame;

wherein at least one of the frame and the liner includes a reinforcing element which limits radial expansion of the prosthesis at a predetermined expanded size.

2. A prosthesis as claimed in

claim 1

, wherein the frame includes a plurality of reinforcing elements which restrain radial expansion of the frame so that the frame defines the predetermined size.

3. A prosthesis as claimed in

claim 2

, wherein the reinforcing elements releasably restrain resilient expansion of the frame at the predetermined size, the frame comprising a self-expanding structure.

4. A prosthesis as claimed in

claim 2

, wherein the reinforcing elements limit plastic expansion of the frame at the predetermined size, the frame comprising a plastically expansible structure.

5. A prosthesis as claimed in

claim 2

, wherein the frame comprises a perforate tubular structure, and wherein the reinforcing elements limit individual perforation dimensions.

6. A prosthesis as claimed in

claim 2

, wherein each reinforcing element comprises a circumferential frame belt.

7. A prosthesis as claimed in

claim 6

, wherein the frame belts attach the frame to the liner.

8. A prosthesis as claimed in

claim 1

, wherein the reinforcing element comprises a fill element of the liner so that the liner defines the predetermined expanded size.

9. A prosthesis as claimed in

claim 8

, wherein the fill element comprises a monofilament.

10. A prosthesis as claimed in

claim 8

, wherein the fill element comprises a composite yarn including serpentine inexpansible fiber and a second fiber, and wherein the inexpansible fiber straightens during expansion of the liner to the predetermined expanded size.

11. A prosthesis as claimed in

claim 10

, wherein the serpentine fiber comprises fully drawn fiber wrapped around the second fiber.

12. A prosthesis as claimed in

claim 8

, wherein the second fiber comprises a material selected from the group consisting of partially oriented yarn, monofilament, PTFE, collagen, natural wool proteins, side-chain crystallizable polymers, and hydrogels.

13. A prosthesis as claimed in

claim 8

, wherein the fill element comprises texturized fully drawn fiber.

14. A prosthesis as claimed in

claim 8

, wherein the fill element comprises annealed fully drawn fiber.

15. A prosthesis as claimed in

claim 1

, wherein the reinforcing element breaks or yields when a radial expansive force exceeding a predetermined threshold force is applied, thereby allowing the prosthesis to be expanded beyond the predetermined expanded size.

16. An expansible liner stent-graft comprising:

a radially expansible tubular frame; and

a plastically expansible liner disposed over at least a portion of an inner or outer surface of the frame, the liner comprising a circumferentially oriented yarn including fully drawn fiber which defines a maximum expanded perimeter of the liner.

17. An expansible liner stent-graft as claimed in

claim 16

, wherein the fully drawn fiber is wound around a second fiber, and wherein the maximum perimeter is defined by straightening the fully drawn fiber.

18. An expansible liner stent-graft as claimed in

claim 17

, wherein the second fiber comprises an elastic fiber.

19. An expansible liner stent-graft as claimed in

claim 18

, wherein the elastic fiber comprises a material selected from the group consisting of spandex and urethane.

20. An expansible liner stent-graft as claimed in

claim 17

, wherein the second fiber comprises an expansible fiber.

21. An expansible liner stent-graft as claimed in

claim 20

, wherein the expansible fiber comprises a material selected from the group consisting of partially oriented fiber, monofilament, PTFE, collagen, natural wool proteins, side-chain crystallizable polymers, and hydrogels.

22. An expansible liner stent-graft as claimed in

claim 17

, wherein the second fiber comprises a low strength fiber.

23. An expansible liner stent-graft as claimed in

claim 16

, wherein the circumferential yarn comprises texturized fully drawn fiber.

24. An expansible liner stent-graft as claimed in

claim 16

, wherein the circumferential yarn comprises annealed fully drawn fiber.

25. An expansible liner stent-graft as claimed in

claim 16

, wherein the frame self-expands beyond the maximum perimeter.

26. A limited expansion graft comprising a fabric including composite yarns having serpentine inexpansible fiber and expansible fiber so that the inexpansible fiber straightens during expansion of the graft to prevent expansion of the fabric beyond a predetermined limit.

27. A graft fabric as claimed in

claim 26

, wherein the fabric forms a tube, and wherein the composite yarns are substantially circumferentially oriented.

28. A graft fabric as claimed in

claim 26

, wherein the inexpansible fiber comprises fully drawn polyester.

29. A graft fabric as claimed in

claim 28

, wherein the expansible fiber comprises a partially oriented polyester over which the fully drawn polyester is wound.

30. An expansible graft comprising a fabric tube which defines an axial direction and a circumferential direction, the fabric tube including fully oriented polyester yarn oriented in the circumferential direction, wherein the fully oriented polyester yarn has been heat treated to facilitate in situ expansion of the graft.

31. An expansible graft as claimed in

claim 30

, wherein the fabric comprises a woven material, and wherein the heat treated yarn has been annealed at a temperature between about 150°

C. and 260°

C.

32. An expansible graft as claimed in

claim 30

, wherein the graft is expansible by an amount in the range between 25% and 60%.

33. An expansible graft comprising a fabric tube which defines an axial direction and a circumferential direction, the fabric tube including fully oriented polyester yarn oriented in the circumferential direction, wherein the fully oriented polyester yarn has been texturized by twisting the yarn and heat setting the twisted yarn to promote in situ expansion of the graft.

34. An expansible graft as claimed in

claim 33

, wherein the graft is expansible by up to 20%.

35. A method for deploying an endoluminal prosthesis at a target site within a diseased body lumen, the method comprising:

positioning the prosthesis at the target site; and

plastically expanding a liner of the prosthesis at the target site, wherein plastic expansion of the liner is limited to a predetermined size by an element of the prosthesis.

36. A method as claimed in

claim 35

, further comprising self-expanding a frame of the prosthesis at the target site, wherein the plastically expanded liner limits self-expansion of the frame.

37. A method as claimed in

claim 35

, further comprising further expanding the prosthesis at the target site beyond the predetermined size by applying a radially expansive force which is greater than a threshold force.

38. A method as claimed in

claim 35

, wherein a fill element of the liner limits plastic expansion of the liner.

39. A method as claimed in

claim 38

, wherein the expanding step further comprises straightening serpentine fiber of the liner toward a radially inexpansible circumferentially oriented configuration.

40. A method as claimed in

claim 39

, wherein the plastically expanding step comprises stretching an elastic fiber around which the serpentine fiber is wrapped.

41. A method as claimed in

claim 39

, wherein the plastically expanding step comprises elongating an expansible fiber around which the serpentine fiber is wrapped.

42. A method for deploying an endoluminal prosthesis at a target site within a diseased body lumen, the method comprising:

introducing the prosthesis into the body lumen and positioning the prosthesis at the target site;

altering a phase of a reinforcement element of the prosthesis at the target site to increase expansibility of the element;

expanding the cross-section of the prosthesis while the phase remains altered; and

returning the phase of the reinforcement element to reduce expansibility.

43. A method as claimed in

claim 42

, wherein the phase altering step comprises changing a temperature of the reinforcement element, wherein the reinforcement element comprises a side-chain crystallizable polymer fiber and is woven circumferentially into a prosthesis liner.

44. A method for producing a radially expansible graft, the method comprising:

drawing fiber to a fully drawn length;

texturizing the drawn fiber;

weaving the fiber into a tube so that at the fiber is circumferentially oriented.

45. A method as claimed in

claim 44

, wherein the texturizing step comprises twisting the fiber in alternating directions and heat setting the twisted fiber.

46. A method for producing a radially expansible graft, the method comprising:

drawing fiber to a fully drawn length;

annealing the drawn fiber;

weaving the fiber into a tube so that the fiber is circumferentially oriented.

47. A method as claimed in

claim 46

, wherein the annealing step comprises heating the fiber to a temperature between about 150°

C. and 260°

C.

48. A cuffed endoluminal stent-graft comprising:

a radially expansible tubular frame having an inner surface and an outer surface;

a tubular liner disposed on at least one of the inner and the outer surface of the frame, the liner having an axial end, wherein expansion of the stent-graft along the liner is limited to a predetermined expanded cross-section; and

a sealing cuff adjacent to the liner end, wherein the sealing cuff is extendable radially beyond the liner so as to seal between the liner and a surrounding body lumen.

49. A cuffed stent-graft as claimed in

claim 48

, wherein the sealing cuff is attached to the liner.

50. A cuffed stent-graft as claimed in

claim 48

, wherein the sealing cuff is separable from the liner.

51. A cuffed stent-graft as claimed in

claim 48

, wherein the sealing cuff comprises a braid.

52. A cuffed stent-graft as claimed in

claim 48

, wherein the sealing cuff comprises partially oriented yarn.

53. A sealing device for use with an endoluminal prosthesis, said sealing device comprising a fabric including partially oriented yarn so that the fabric is radially expansible to seal between the prosthesis and a surrounding body lumen.

54. A sealing device as claimed in

claim 53

, wherein the fabric is attached to the prosthesis.