Three-dimensional braided covered stent

• US 7,052,513 B2
• Filed: 07/15/2003
• Issued: 05/30/2006
• Est. Priority Date: 04/30/1996
• Status: Expired due to Fees

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Thompson, Paul J.
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US10/619,888
• Publication Number:
  US 20040073293A1
• Time in Patent Office: 1,050 Days
• Field of Search: 623/1.53, 623/23.64, 606/191, 606/198, 606/108, 87/2, 87/7, 87/13, 87/33, 87/34, 428/369
• US Class Current: 623/1.53
• 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 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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 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: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: D04C 1/06 Braid or lace serving particular purposes
• CPC Class Codes: D04C 3/36 Frames
• CPC Class Codes: D04C 3/40 for making tubular braids by circulating strand supplies around braiding centre at equal distances
• CPC Class Codes: D04C 3/48 Auxiliary devices
• CPC Class Codes: D10B 2401/061 elastic
• CPC Class Codes: D10B 2509/06 Vascular grafts; stents
• CPC Class Codes: Y10T 428/2922 : Nonlinear [e.g., crimped, coiled, etc.]

Abstract

A prosthesis for transluminal implantation consists of a flexible tubular three-dimensionally braided structure of metal or polymeric monofilaments, and polymeric multifilament yarns. The prosthesis can be elastically deformed to reduce its diameter through axial elongation. The monofilaments and multifilament yarns are arranged in axially spaced apart helices, concentric on a common central axis of the prosthesis. The monofilaments are selectively shaped before their interbraiding with the multifilament yarns, either by an age-hardening or other heat-setting stage, or a cold-working stage that controllably plastically deforms the strands. The shaped structural strands cooperate to impart to the prosthesis its nominal shape and resilience. The textile strands cooperate to provide one or more layers of sheeting that reduce permeability and thereby enhance the utility of the prosthesis as a vascular graft. An alternative embodiment prosthesis includes elastically and plastically deformable structural strands, selectively plastically deformed by cold working, then three-dimensionally braided to form the prosthesis.

Claims

1. A prosthesis, including:

a three-dimensionally braided structure including a plurality of structural strands and a plurality of textile strands interbraided with the structural strands and being more compliant than the structural strands, wherein the structural strands are formed of a structural material and have respective nominal shapes when in a relaxed state under no external stress and are elastically deformable away from their respective nominal shapes, wherein each of the structural strands further is adapted to be altered to acquire a selected nominal shape different from an original nominal shape;

wherein only the structural stands are so altered, and in their respective selected nominal shapes form windings about a longitudinal axis with tubular profiles, and further are oriented within the braided structure to impart to the braided structure a tubular predetermined nominal shape corresponding to said tubular profiles;

wherein each of the structural strands is adapted to be so altered according to a selective thermal setting including heating at least to a heat set temperature while maintaining the structural strand in the selected nominal shape, and the structural strands are susceptible to said selective thermal setting only when heated at least to a heat set temperature; and

wherein the textile strands have a melting temperature and tend to conform to the predetermined nominal shape imparted by the structural strands, and the heat set temperature is higher than the melting temperature.

2. A medical device including an elongate and flexible catheter, and, mounted thereon, a prosthesis according to claim 1.

3. The device of claim 2 further including:

a means for releasably maintaining the prosthesis at a distal end of the elongate and flexible catheter and in a resiliently radially compressed state, operable to release the prosthesis for a radial self-expansion at an intraluminal treatment site.

4. The prosthesis of claim 1 wherein:

the structural strands cooperate to form a latticework, and the textile strands cooperate to form a textile sheeting supported by the latticework and occupying interstices between adjacent structural strands of the latticework.

5. The prosthesis of claim 1 wherein:

the structural strands and textile strands are three-dimensionally braided into at least first and second discrete layers of the braided structure.

6. The prosthesis of claim 5 wherein:

at least one of the strands of the first layer is braided into the second layer to interlock the first and second layers.

7. The prosthesis of claim 5 wherein:

said first layer incorporates finer strands and has a greater permeability than the second layer.

8. The prosthesis of claim 5 wherein:

said structural strands form a latticework incorporated primarily into the first layer.

9. The prosthesis of claim 5 further including:

a plurality of drug eluting strands braided into the first layer.

10. The prosthesis of claim 5 further including:

a plurality of absorbable strands interbraided with the structural strands and the textile strands.

11. The prosthesis of claim 10 wherein:

the absorbable strands are braided primarily into the second layer.

12. The prosthesis of claim 1 wherein:

said structural material is a metal selected from the group consisting of;

stainless steel, an alloy including cobalt, and an alloy including titanium.

13. The prosthesis of claim 1 wherein:

said structural material is a polymer selected from the group of polymers consisting of;

PET, polypropylene, PEEK, HDPE, polysulfone, PTFE, FEP, polycarbonate urethane, and polyurethane.

14. The prosthesis of claim 1 wherein:

said textile strands are multifilament yarns in the range of about 10–

400 denier.

15. The prosthesis of claim 14 wherein:

said multifilament yarns are composed of filaments, each filament being in the range of about 0.25–

10 denier.

16. The prosthesis of claim 14 wherein:

said multifilament yarns are formed of a material selected from the group of materials consisting of;

PET, polypropylene, polyurethane, polycarbonate urethane, HDPE, polyethylene, silicone, PTFE, ePTFE, and polyolefin.

17. The prosthesis of claim 1 wherein:

said selected nominal shapes of the structural strands are helical.

18. The prosthesis of claim 17 wherein:

said structural strands cooperate to form a latticework including first and second sets of helices running in respective first and second opposite directions, wherein the interstices of the latticework are rhombic.

19. The prosthesis of claim 18 wherein:

the first and second sets of helices are interbraided.

20. The prosthesis of claim 18 wherein:

the first set of helices overlies the second set of helices.

21. The prosthesis of claim 18 wherein:

the first and second sets of helices define a braid angle in the range of about 60–

150 degrees.

22. The prosthesis of claim 1 further including:

at least one radiopaque strand interbraided with the structural strands and textile strands.

23. The prosthesis of claim 22 wherein:

said at least one radiopaque strand is incorporated within the first layer.

24. The prosthesis of claim 17 wherein:

said structural strands are wound in a single direction, wherein the interstices are helical.

25. The prosthesis of claim 1 wherein:

said structural material is a recovery metal, and the selected nominal shape of each structural strand is the shape to which the structural strand returns when heated at least to an activation temperature of the recovery metal.

26. The prosthesis of claim 1 wherein:

the original nominal shape of each structural strand is linear, and the selected nominal shape of each strand is helical.

27. A prosthesis, including:

a three-dimensionally braided structure including a plurality of resilient structural strands formed of a structural material and a plurality of compliant textile strands interbraided with the structural strands and being more compliant than the structural strands;

wherein each of the structural strands has a nominal shape when in a relaxed state under no external stress, and further is adapted to be thermally altered to acquire a selected nominal shape different from an original nominal shape by a heating of the structural strand at least to a thermal forming temperature while maintaining the structural strand in the selected nominal shape, wherein the structural strands are thermally formable only when heated at least to the thermal forming temperature;

wherein only the structural strands are so altered, and in their respective selected nominal shapes form windings about a longitudinal axis having tubular profiles, and are oriented within the braided structure to impart to the braided structure a tubular predetermined nominal shape corresponding to said tubular profiles; and

wherein the textile strands have a textile strand melting temperature and tend to conform to the predetermined nominal shape imparted by the structural strands, and the thermal forming temperature is higher than the textile strand melting temperature.

28. The prosthesis of claim 27 wherein:

the textile strands are thermally formable.

29. The prosthesis of claim 27 wherein:

the structural strands cooperate to form a latticework, and the textile strands cooperate to form a textile sheeting supported by the latticework and occupying interstices between adjacent structural strands and the latticework.

30. The prosthesis of claim 27 wherein:

the structural strands and the textile strands are three-dimensionally braided into at least first and second discrete layers of the braided structure.

31. The prosthesis of claim 30 wherein:

at least one of the strands of the first layer is braided into the second layer to interlock the first and second layers.

32. The prosthesis of claim 30 wherein:

said first layer incorporates finer strands and has a greater permeability than the second layer.

33. The prosthesis of claim 27 wherein:

said structural material is selected from the group consisting of;

stainless steel, an alloy including cobalt, and an alloy including titanium.

34. The prosthesis of claim 27 wherein:

said structural material is a polymer selected from the group consisting of;

PET, polypropylene, PEEK, HDPE, polysulfone, acetyl, PTFE, FEP, polycarbonate urethane, and polyurethane.

35. The prosthesis of claim 27 wherein:

the compliant textile strands are formed of a material selected from the group consisting of;

PET, polypropylene, polyurethane, polycarbonate urethane, HDPE, polyethylene, silicone, PTFE, ePTFE, and polyolefin.

36. The prosthesis of claim 27 wherein:

the structural strands cooperate to form a latticework including first and second sets of helices running in respective first and second opposite directions, whereby the interstices of the latticework are rhombic.

37. The prosthesis of claim 36 wherein:

the first and second sets of helices define a braid angle in the range of about 60–

150 degrees.

38. A prosthesis, including:

a three-dimensionally braided structure including a plurality of structural strands and a plurality of textile strands interbraided with the structural strands and being more compliant than the structural strands, wherein the structural strands are formed of a structural material and have respective nominal shapes when in a relaxed state under no external stress and are elastically deformable away from their respective nominal shapes, wherein each of the structural strands further is adapted to be altered to acquire a selected nominal shape different from an original nominal shape;

wherein only the structural stands are so altered, and in their respective selected nominal shapes form windings about a longitudinal axis with tubular profiles, and further are oriented within the braided structure to impart to the braided structure a tubular predetermined nominal shape corresponding to said tubular profiles;

wherein each of the structural strands is adapted to be so altered according to a selective thermal setting including heating at least to a heat set temperature while maintaining the structural strand in the selected nominal shape, and the structural strands are susceptible to said selective thermal setting only when heated at least to the heat set temperature; and

wherein the textile strands have a melting temperature, and the heat set temperature is higher than said melting temperature.

39. The prosthesis of claim 38 wherein:

the structural strands cooperate to form a latticework, and the textile strands cooperate to form a textile sheeting supported by the latticework and occupying interstices between adjacent structural strands of the latticework.

40. The prosthesis of claim 38 wherein:

the structural strands and textile strands are three-dimensionally braided into at least first and second discrete layers of the braided structure.

41. The prosthesis of claim 39 wherein:

at least one of the strands of the first layer is braided into the second layer to interlock the first and second layers.

42. The prosthesis of claim 38 wherein:

said structural material is a metal selected from the group consisting of;

stainless steel, an alloy including cobalt, and an alloy including titanium.

43. The prosthesis of claim 38 wherein:

said structural material is a polymer selected from the group of polymers consisting of;

PET, polypropylene, PEEK, HDPE, polysulfone, PTFE, FEP, polycarbonate urethane, and polyurethane.

44. The prosthesis of claim 38 wherein:

the compliant textile strands are formed of a material selected from the group consisting of;

PET, polypropylene, polyurethane, polycarbonate urethane, HDPE, polyethylene, silicone, PTFE, ePTFE, and polyolefin.

45. The prosthesis of claim 38 wherein:

said selected nominal shapes of the structural strands are helical.

46. The prosthesis of claim 38 wherein:

said structural material is a recovery metal, and the selected nominal shape of each structural strand is the shape to which the structural strand returns when heated at least to an activation temperature of the recovery metal.

47. The prosthesis of claim 38 wherein:

the original nominal shape of each structural strand is linear, and the selected nominal shape of each strand is helical.

48. The prosthesis of claim 38 wherein:

the textile strands are thermally formable.

49. A prosthesis, including:

a three-dimensionally braided structure including a plurality of structural strands and a plurality of textile strands interbraided with the structural strands and being more compliant than the structural strands, wherein the structural strands are formed of a recovery metal and have respective nominal shapes when in a relaxed state under no external stress and are elastically deformable away from their respective nominal shapes, wherein each of the structural strands further is adapted to be altered to acquire a selected nominal shape, different from an original nominal shape, to which the structural strand tends to return when heated at least to an activation temperature of the recovery metal;

wherein only the structural stands are so altered, and in their respective selected nominal shapes form windings about a longitudinal axis with tubular profiles, and further are oriented within the braided structure to impart to the braided structure a tubular predetermined nominal shape corresponding to said tubular profiles; and

wherein the textile strands tend to conform to the predetermined nominal shape imparted by the structural strands.

50. A medical device including an elongate and flexible catheter, and, mounted thereon, a prosthesis according to claim 49.

51. The device of claim 50 further including:

a means for releasably maintaining the prosthesis at a distal end of the elongate and flexible catheter and in a resiliently radially compressed state, operable to release the prosthesis for a radial self-expansion at an intraluminal treatment site.

52. The prosthesis of claim 49 wherein:

the structural strands cooperate to form a latticework, and the textile strands cooperate to form a textile sheeting supported by the latticework and occupying interstices between adjacent structural strands of the latticework.

53. The prosthesis of claim 49 wherein:

the structural strands and textile strands are three-dimensionally braided into at least first and second discrete layers of the braided structure.

54. The prosthesis of claim 49 wherein:

said textile strands comprise multifilament yarns.

55. The prosthesis of claim 49 wherein:

said selected nominal shapes of the structural strands are helical.

56. The prosthesis of claim 49 wherein:

each of the structural strands is adapted to be so altered according to a selective thermal setting including heating at least to a heat set temperature while maintaining the structural strand in the selected nominal shape, wherein the structural strands are susceptible to said selective thermal setting only when heated at least to a heat set temperature.

57. The prosthesis of claim 56 wherein:

the textile strands have a melting temperature, and the heat set temperature is higher than said melting temperature.