Process for manufacturing braided composite prosthesis

• US 5,758,562 A
• Filed: 04/30/1996
• Issued: 06/02/1998
• Est. Priority Date: 10/11/1995
• Status: Expired due to Term

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: Schneider Electric SE
• Inventors: Thompson, Paul J.
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US08/640,062
• Time in Patent Office: 763 Days
• Field of Search: 87/2, 87/7, 87/13, 87/33, 87/34, 428/369, 623/1
• US Class Current: 87/33
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• 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 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: D04C 1/06 Braid or lace serving particular purposes
• CPC Class Codes: D10B 2509/06 Vascular grafts; stents

Abstract

A process is disclosed for manufacturing a prothesis for intraluminal implantation. The prosthesis is formed with a flexible tubular interbraided structure of metal or polymeric monofilaments, and polymeric multifilament yarns, and can be elastically deformed to reduce its diameter through axial elongation. The monofilaments and multifilament yarns are wound on a mandrel 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 while wound on a mandrel, or by 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 are interbraided with the structural strands to provide a sheeting that occupies interstices between adjacent structural strands, to reduce permeability and thereby enhance the utility of the prosthesis as a vascular graft. An alternative process employs elastically and plastically deformable structural strands, selectively plastically deformed by cold-working as they are moved toward a station for interbraiding with textile strands to form the prosthesis.

Claims

1. A process for making a prosthesis, including:

providing a plurality of structural strands formed of structural material and having an original nominal shape;

providing a plurality of compliant textile strands;

altering the structural strands while they remain separate from the textile strands, to impart to each of the structural strands a selected nominal shape in lieu of the original nominal shape; and

after said altering, braiding the textile strands and the altered structural strands into an integrated structure in which the structural strands together provide a tubular shape of the integrated structure and the textile strands form a textile sheeting supported by the structural strands and adapted to compliantly conform to changes from said tubular shape due to deformations of the structural strands.

2. The process of claim 1 wherein:

said braiding includes forming a latticework of the structural strands, and the textile sheeting of the textile strands occupies interstices between adjacent structural strands of the latticework.

3. The process of claim 2 further including:

after said braiding, plastically deforming the latticework to reduce a diameter of the integrated structure while maintaining the structural strands below an activation temperature of the structural material, wherein said structural material is a recovery metal.

4. The process of claim 1 wherein:

said structural material is thermally formable, and said altering includes winding the structural strands around a selectively sized and shaped mandrel, then heating the strands while so wound to a heat forming temperature sufficient to thermally impart the selected nominal shape.

5. The process of claim 4 wherein:

said structural strands are heated by heating the mandrel, and the heat forming temperature exceeds a melting temperature of the textile strands.

6. The process of claim 4 wherein:

the structural material is a metal, and said heating includes maintaining the structural strands at a temperature in the range of 350°

C. to 1000°

C., followed by allowing the structural strands to cool before said braiding.

7. The process of claim 4 wherein:

said structural material is a thermoplastic, and said heating of the structural strands includes maintaining them at least at the heat forming temperature for at least 30 seconds, to impart to each of the structural strands its selected nominal shape.

8. The process of claim 7 wherein:

said heating includes maintaining the structural strands at least at the heat forming temperature for 5-15 minutes, and the heat forming temperature is in the range of 100°

-400°

C.

9. The process of claim 8 wherein:

said heat forming temperature is in the range of 150°

-250°

C.

10. The process of claim 1 wherein:

said braiding includes selectively orienting the structural strands to impart said tubular shape to the integrated structure based on the selected nominal shapes of the structural strands.

11. The process of claim 1 wherein:

the structural material is a metal, and said altering includes selectively plastically deforming the structural strands.

12. The process of claim 11 wherein:

said plastic deformation includes bending each of the strands about a form having a selected radius while maintaining the strands at a selected tension.

13. The process of claim 12 wherein:

each of said forms is a rotatable pulley, and each of the structural strands is maintained at said tension and wrapped about its associated pulley.

14. The process of claim 1 wherein:

the structural material is a metal, and said altering includes selectively applying a force to each of the structural strands, said force exceeding a yield stress of the structural material.

15. The process of claim 1 further including:

after said altering and before said braiding, winding each of the structural filaments onto a bobbin, wherein said braiding includes supplying the strands from their respective bobbins to a braiding station.

16. The process of claim 1 wherein:

said altering includes forming each of the structural strands into a helix.

17. The process of claim 16 wherein:

said braiding includes providing the structural strands as first and second sets of helices running in opposite directions, thereby braiding the structural strands into a latticework in which the interstices are rhombic.

18. The process of claim 17 wherein:

said braiding includes interbraiding the first and second sets of oppositely directed helices.

19. The process of claim 17 wherein:

said braiding includes winding the first and second sets of oppositely directed helices with one of the sets overlying the other set.

20. The process of claim 17 wherein:

said oppositely directed helices are-braided at a predetermined braid angle, and the braiding further includes braiding the textile strands in two oppositely directed textile strand sets and substantially at said braid angle.

21. The process of claim 16 wherein:

said braiding includes winding the helices in a single direction, whereby the interstices are helical.

22. The process of claim 1 wherein:

said braiding includes incorporating at least one strand comprising a radiopaque material.

23. The process of claim 1 wherein:

said braiding further includes incorporating at least one elastic strand running axially of the integrated structure, and fusing the elastic strand to the integrated structure.

24. The process of claim 1 further including:

forming a coating over the strands by plasma polymerization.

25. The process of claim 1 further including:

after said altering and prior to said braiding, coating the structural strands.

26. The process of claim 2 further including:

after said braiding, selectively heating the integrated structure to heat set the textile sheeting, wherein said textile strands are composed of a multifilament yarn amenable to heat shrinking.

27. The process of claim 1 further including:

after braiding, applying an adhesive at least to the ends of the integrated structure to reduce unraveling.

28. The process of claim 1 wherein:

said braiding the strands consists essentially of interbraiding the structural strands and the textile strands into a single layer, and the integrated structure is formed of said single layer.

29. A process for making a prosthesis, including:

providing a plurality of strands for interbraiding at a braiding station, said strands including elastically and plastically deformable structural strands formed of metal and having an original nominal shape;

moving said strands in concert toward the braiding station;

while so moving the structural strands, controllably plastically deforming the structural strands to impart to each structural strand a selected nominal shape; and

after plastically deforming the structural strands, braiding the strands into an integrated structure, and selectively orienting the structural strands while braiding to impart a predetermined configuration to the integrated structure.

30. The process of claim 29 wherein:

said plastic deformation includes wrapping each of the structural strands about a rotatable pulley and maintaining the strand wrapped about its associated pulley and at a selected tension while so moving the strand.

31. The process of claim 29 wherein:

said strands further include a plurality of compliant textile strands, and said braiding strands includes braiding the textile strands into a textile sheeting supported by the structural strands and occupying interstices between adjacent structural strands.

32. A process for making a prosthesis, including:

providing a plurality of thermally formable structural strands having an original nominal shape;

providing a plurality of compliant textile strands;

altering the structural strands by winding the structural strands around a selectively sized and shaped mandrel, then heating the strands while so wound to a heat-forming temperature sufficient to thermally impart to each of the structural strands a selected nominal shape in lieu of the original shape; and

after said altering, interbraiding the textile strands and the structural strands into an integrated structure.

33. The process of claim 32 wherein:

said interbraiding includes forming a latticework of the structural strands and forming a textile sheeting of the textile strands supported by the latticework and occupying interstices between adjacent structural strands of the latticework.

34. The process of claim 33 further including:

after said interbraiding, plastically deforming the latticework to reduce a diameter of the integrated structure while maintaining the structural strands below an activation temperature of the structural material, wherein said structural material is a recovery metal.

35. The process of claim 32 wherein:

said structural strands are heated by heating the mandrel, and the heat forming temperature exceeds a melting temperature of the textile strands.

36. The process of claim 32 wherein:

the structural material is a metal, and said heating includes maintaining the structural strands at a temperature in the range of 350°

C. to 1000°

C., followed by allowing the structural strands to cool before said interbraiding.

37. The process of claim 32 wherein:

said structural material is a thermoplastic, and said heating of the structural strands includes maintaining them at least at the heat forming temperature for at least 30 seconds, to impart to each of the structural strands its selected nominal shape.

38. The process of claim 32 wherein:

said interbraiding includes selectively orienting the structural strands to impart a predetermined configuration to the integrated structure based on the selected nominal shapes of the structural strands.

39. The process of claim 32 wherein:

said altering includes forming each of the structural strands into a helix.

40. The process of claim 32 wherein:

said integrated structure is tubular, and said interbraiding further includes incorporating at least one elastic strand running axially of the integrated structure, and fusing the elastic strand to the integrated structure.

41. The process of claim 32 wherein:

said interbraiding consists essentially of incorporating the structural strands and the textile strands into a single layer, and the integrated structure is formed of said single layer.

42. A process for making a prosthesis, including:

providing a plurality of structural strands formed of metal and having an original nominal shape;

providing a plurality of compliant textile strands;

altering the structural strands by bending each of the strands about a form having a selected radius while maintaining the strands at a selected tension, to selectively plastically deform the structural strands thereby imparting to each structural strand a selected nominal shape in lieu of the original nominal shape; and

after said altering, interbraiding the textile strands and the structural strands into an integrated structure.

43. The process of claim 42 wherein:

said interbraiding includes forming a latticework of the structural strands and forming a textile sheeting of the textile strands, supported by the latticework and occupying interstices between adjacent structural strands of the latticework.

44. The process of claim 42 wherein:

said interbraiding includes selectively orienting the structural strands, to impart a predetermined configuration to the integrated structure based on the selected nominal shapes of the structural strands.

45. The process of claim 42 wherein:

each of said forms is a rotatable pulley, and each of the structural strands is maintained at said tension while wrapped about its associated pulley.

46. The process of claim 42 wherein:

said altering includes forming each of the structural strands into a helix.

47. The process of claim 42 wherein:

said interbraiding consists essentially of incorporating the structural strands and the textile strands into a single layer, and the integrated structure is formed of said single layer.

48. A process for making a prosthesis, including:

providing a plurality of structural strands formed of structural material having an original nominal shape;

providing a plurality of compliant textile strands;

altering the structural strands to impart to each of the structural strands a selected nominal shape in lieu of the original nominal shape; and

after said altering, interbraiding the textile strands and the altered structural strands into an integrated structure by forming the structural strands into a latticework that shapes the integrated structure, and by forming the textile strands into a textile sheeting supported by the latticework, conforming to the latticework, and occupying interstices between adjacent structural strands of the latticework.

49. The process of claim 48 wherein:

said structural material is thermally formable, and said altering includes winding the structural strands around a selectively sized and shaped mandrel, then heating the strands while so wound to a heat forming temperature sufficient to thermally impart the selected nominal shape.

50. The process of claim 49 wherein:

said heat forming temperature exceeds a melting temperature of the textile strands.

51. The process of claim 49 wherein:

the structural material is a metal, and said heating includes maintaining the structural strands at a temperature in the range of 350°

C. to 1000°

C., followed by allowing the structural strands to cool before said interbraiding.

52. The process of claim 49 wherein:

said structural material is a thermoplastic, and said heating of the structural strands includes maintaining them at least at the heat forming temperature for at least 30 seconds, to impart to each of the structural strands its selected nominal shape.

53. The process of claim 48 wherein:

the structural material is a metal, and said altering includes selectively plastically deforming the structural strands.

54. The process of claim 48 wherein:

the structural material is a metal, and said altering includes selectively applying a force to each of the structural strands, said force exceeding a yield stress of the structural material.

55. The process of claim 48 wherein:

said interbraiding consists essentially of forming the structural strands and the textile strands into a single layer, and the integrated structure is formed of said single layer.

56. A process for making a prosthesis, including:

providing at least one structural strand formed of a structural material and having an original nominal shape;

providing a plurality of compliant textile strands;

altering the at least one structural strand while the at least one strand remains separate from the textile strands, to impart to each said structural strand a selected nominal shape in lieu of the original nominal shape; and

after said altering, interbraiding the textile strands and the at least one structural strand into an integrated structure in which the at least one structural strand provides a tubular shape of the integrated structure and the textile strands form a textile sheeting supported by the at least one structural strand and adapted to compliantly conform to changes from the predetermined shape due to deformations of the at least one structural strand.