Woven stent/graft structure

• US 6,159,239 A
• Filed: 08/14/1998
• Issued: 12/12/2000
• Est. Priority Date: 08/14/1998
• Status: Expired due to Fees

• Current Assignee: SECANT MEDICAL, LLC (Compagnie Generale DES Etablissements Michelin SCA)
• Original Assignee: Prodesco, Inc. (Compagnie Generale DES Etablissements Michelin SCA)
• Inventors: Greenhalgh, E. Skott
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): Phan, Hieu
• Application Number:
  US09/134,192
• Time in Patent Office: 851 Days
• Field of Search: 623/1.13, 623/1.22, 623/1.35, 623/1.37, 623/1.51, 623/1.53, 623/1.54, 623/12, 606/198, 606/194
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: D03D 11/02 Fabrics formed with pockets, tubes, loops, folds, tucks or flaps fabrics consisting of a single tube D03D3/02
• CPC Class Codes: D03D 13/00 Woven fabrics characterised by the special disposition of the warp or weft threads, e.g. with curved weft threads, with discontinuous warp threads, with diagonal warp or weft
• CPC Class Codes: D03J 5/00 Shuttles swivel shuttles D03D31/00; shuttles for smallware looms D03D35/00; circular loom shuttles D03D37/00; selvedge shuttles D03D47/46
• CPC Class Codes: D10B 2401/046 Shape recovering or form memory
• CPC Class Codes: D10B 2509/06 Vascular grafts; stents
• CPC Class Codes: Y10S 139/01 Bias fabric digest

Abstract

A combined stent/graft structure for repair of a body tube in a living body. The structure includes a textile graft adapted to enhance fluid integrity of the body tube and a stent expandable between a first position permitting easy insertion of the stent into the body tube and a second position wherein the stent presses securely against the inside surface of the body tube. The stent includes a first elongate wire-shaped stent member with both a stent member global axis and a stent member local axis, and is integrally secured to the graft by at least one graft yarn of which the graft is formed. Substantial portions of the first stent member global axis form a non-orthogonal angle with the graft main portion axis when projected into a plane containing the graft main portion axis. A woven textile is also part of the invention as is a method of manufacturing such a woven textile, which can be used to produce stent/graft structures according to the invention.

Claims

1. A combined stent/graft structure for repair of a body tube in a living body, the body tube having an inner surface, said combined stent/graft structure comprising:

a textile graft adapted to enhance fluid integrity of the body tube, said graft having a generally tubular graft main portion with a graft main portion axis and first and second graft main portion ends, said graft main portion being formed, at least in part, by at least one graft yarn; and

a stent expandable between a first position permitting easy insertion of said stent into the body tube and a second position wherein said stent presses securely against the inner surface of the body tube, said stent in turn comprising a first elongate wire-shaped stent member having both a first stent member global axis and a first stent member local axis, said first stent member being integrally secured to said graft by said at least one graft yarn of which said graft is formed, substantial portions of said first stent member global axis forming a non-orthogonal angle with said graft main portion axis when projected into a plane containing said graft main portion axis, said first stent member having material properties preselected to support said graft when in said second position, said first stent member local axis being generally defined by centroids of adjacent cross-sections of said first stent member, said first stent member global axis being generally defined by a straight-line curve fit to said first stent member local axis in a coordinate system substantially coincident with said generally tubular graft main portion.

2. The structure of claim 1, wherein said textile graft is woven.

3. The structure of claim 2, wherein:

said first stent member local axis and said first stent member global axis are substantially coincident; and

said non-orthogonal angle is a helix angle selected to permit said first stent member to extend substantially between said first and second graft main portion ends and to obtain substantially homogeneous compressive and flexural properties for said combined stent/graft structure.

4. The structure of claim 3, wherein said helix angle ranges from about 10 degrees to about 85 degrees.

5. The structure of claim 3, wherein said helix angle ranges from about 45 degrees to about 85 degrees.

6. The structure of claim 2, wherein said first stent member local axis defines a plurality of undulations extending on first and second sides of said first stent member global axis.

7. The structure of claim 6, wherein:

said woven graft is formed from a plurality of warp yarns and a plurality of fill yarns which are substantially orthogonal to said plurality of warp yarns;

said at least one graft yarn which integrally secures said first stent member is at least one of;

said plurality of warp yarns; and

said plurality of fill yarns;

said plurality of undulations are substantially periodic about said first stent member global axis; and

said first stent member global axis is substantially non-orthogonal to both said plurality of warp yarns and said plurality of fill yarns.

8. The structure of claim 7, wherein said non-orthogonal angle which said first stent member global axis forms with said graft main portion axis is a helix angle selected to permit said first stent member to extent substantially between said first and second graft main portion ends and to obtain substantially homogeneous compressive and flexural properties for said combined stent/graft structure.

9. The structure of claim 8, wherein said helix angle ranges from about 10 degrees to about 85 degrees.

10. The structure of claim 8, wherein said helix angle ranges from about 45 degrees to about 85 degrees.

11. The structure of claim 7, wherein said first stent member is a wire formed from a ductile material which undergoes plastic deformation induced by a separate expanding force in expanding from said first position to said second position.

12. The structure of claim 7, wherein said first stent member is a wire formed from an elastic material which undergoes substantially elastic deformation in expanding from said first position to said second position and wherein said first stent member expands between said first and second positions at least substantially via stored energy released upon removal of an external constraint.

13. The structure of claim 7, wherein said first stent member is integrally secured to said graft at a plurality of interweave points, said first stent member being secured by at least one warp yarn at each of said interweave points, adjacent interweave points being separated by a predetermined number of said fill yarns and a predetermined number of said warp yarns which together define a substantially non-orthogonal angle α

which said first stent member global axis forms with said plurality of warp yarns and a complementary substantially non-orthogonal angle β

=9°

-α

which said first stent member global axis forms with said plurality of fill yarns.

14. The structure of claim 13, wherein said plurality of warp yarns comprise:

a first group of warp yarns which are not employed at said interweave points and which are selected for desired graft properties;

a second group of warp yarns employed at said interweave points and having properties selected for securing said first stent member.

15. The structure claim 13, wherein said first stent member is secured by at least two warp yarns at each of said interweave points.

16. The structure of claim 7, wherein said first stent member has a plurality of securing portions which are positioned substantially parallel to said warp yarns and wherein said stent member is integrally secured to said graft at a plurality of interweave points, said first stent member being secured by at least one weft yarn engaging a respective one of said securing portions at each of said interweave points, adjacent interweave points being separated by a predetermined number of said fill yarns and a predetermined number of said warp yarns which together define a substantially non-orthogonal angle a which said first stent member global axis forms with said plurality of warp yarns and a complementary substantially non-orthogonal angle β

=90°

-α

which said first stent member global axis forms with said plurality of fill yarns.

17. The structure of claim 1, wherein:

said textile graft is bifurcated and further comprises first and second secondary portions emanating from said second graft main portion end in a substantially fluid-integrity-enhancing fashion, said first and second secondary portions being generally tubular and having first and second secondary portion axes respectively, said first secondary portion being formed at least in part by at least one first secondary portion yarn, said second secondary portion being formed, at least in part, by at least one second secondary portion yarn;

said stent further comprises a second elongate wire-shaped stent member having both a second stent member global axis and a second stent member local axis, said second stent member also being integrally secured to said graft by said at least one graft yarn of which said graft is formed, substantial portions of said second stent member global axis forming a non-orthogonal angle with said graft main portion axis when projected into a plane containing said graft main portion axis, said second stent member having material properties preselected to support said graft when in said second position, said second stent member local axis being generally defined by centroids of adjacent cross-sections of said second stent member, said second stent member global axis being generally defined by a straight-line curve fit to said second stent member local axis in a coordinate system substantially coincident with said generally tubular graft main portion;

said first and second stent members are both present in said graft main portion;

said first stent member is integrally secured to said first secondary portion by said at least one first secondary portion yarn, substantial portions of said first stent member global axis forming a non-orthogonal angle with said first secondary portion axis when projected into a plane containing said first secondary portion axis;

said second stent member is integrally secured to said second secondary portion by said at least one second secondary portion yarn, substantial portions of said second stent member global axis forming a non-orthogonal angle with said second secondary portion axis when projected into a plane containing said second secondary portion axis.

18. The structure of claim 17, wherein said first and second stent members are axially spaced in said graft main portion and form a substantially double helical structure therein.

19. The structure of claim 17, wherein said first and second stent members are substantially coextensive in said main graft portion.

20. The structure of claim 1, wherein said first stent member extends substantially from said first graft main portion end to said second graft main portion end.

21. The structure of claim 1, wherein said graft main portion tapers from said first graft main portion end to said second graft main portion end.

22. The structure of claim 1, wherein said first stent member is formed of an elastic material selected for flexible self-support of said graft main portion and wherein said first stent member extends along said graft main portion but terminates before reaching at least one of said first and second graft main portion ends;

said structure further comprising at least a second stent member formed of a ductile material selected for apposition of the body tube inner surface by balloon expansion, said second stent member being located at said at least one of said first and second graft main portion ends which said first stent member terminates before reaching, said second stent member being integrally secured to said graft by said at least one graft yarn of which said graft is formed.

36. The structure of claim 1, 2, 17 or 22, wherein said textile graft is comprised at least in part of microdenier yarns.

37. The structure of claim 7, wherein at least one of said warp yarns and said fill yarns is comprised at least in part of microdenier yarns.

38. The structure of claim 37, wherein both said warp yarns and said fill yarns are comprised at least in part of microdenier yarns.

23. A combined stent/graft structure for repair of a body tube in a living body, the body tube having an inner surface, said combined stent/graft structure comprising:

a woven graft adapted to enhance fluid integrity of the body tube, said graft having a generally tubular graft main portion with a graft main portion axis and first and second graft main portion ends, said graft being formed from a plurality of warp yarns and a plurality of fill yarns which are substantially orthogonal to said plurality of warp yarns; and

a stent expandable between a first position permitting easy insertion of said stent into the body tube and a second position wherein said stent presses securely against the inside surface of the body tube, said stent in turn comprising a first elongate wire-shaped stent member having a plurality of undulations, said first stent member being integrally secured to said graft at a first plurality of interweave points, said first stent member being secured by at least one warp yarn at each of said first plurality of interweave points, said first plurality of interweave points being spaced circumferentially about said graft and being separated from each other by a predetermined number of said warp yarns.

24. The structure of claim 23, wherein said plurality of warp yarns comprise:

a first group of warp yarns which are not employed at said interweave points and which are selected for desired graft properties;

a second group of warp yarns employed at said interweave points and having properties selected for securing said first stent member.

25. The structure claim 23, wherein said first stent member is secured by at least two warp yarns at each of said interweave points.

26. The structure of claim 23, wherein:

said first plurality of interweave points have a first substantially identical axial coordinate; and

said first stent member is also secured to said graft at a second plurality of interweave points having a second substantially identical axial coordinate, said first plurality of interweave points and said second plurality of interweave points being separated by a predetermined number of said fill yarns.

39. The structure of claim 23 or 27, wherein at least one of said warp yarns and said fill yarns is comprised at least in part of microdenier yarns.

40. The structure of claim 39, wherein both said warp yarns and said fill yarns are comprised at least in part of microdenier yarns.

27. A combined stent/graft structure for repair of a body tube in a living body, the body tube having an inner surface, said combined stent/graft structure comprising:

a woven graft adapted to enhance fluid integrity of the body tube, said graft having a generally tubular graft main portion with a graft main portion axis and first and second graft main portion ends, said graft being formed from a plurality of warp yarns and a plurality of fill yarns which are substantially orthogonal to said plurality of warp yarns; and

a stent expandable between a first position permitting easy insertion of said stent into the body tube and a second position wherein said stent presses securely against the inside surface of the body tube, said stent in turn comprising a first elongate wire-shaped stent member having a plurality of undulations, portions of said undulations being substantially parallel to said warp yarns at a plurality of securing portions, said first stent member being integrally secured to said graft at a first plurality of interweave points, said first stent member being secured by at least one fill yarn engaging a respective one of said securing portions at each of said first plurality of interweave points, said first plurality of interweave points being spaced circumferentially about said graft and being separated from each other by a predetermined number of said warp yarns.

28. A woven textile comprising:

(a) a plurality of warp yarns;

(b) a plurality of fill yarns which are substantially orthogonal to said plurality of warp yarns and form a base fabric therewith; and

(c) an elongate wire-shaped structural member having both a member global axis and a member local axis, said member local axis being generally defined by centroids of adjacent cross-sections of said structural member, said member global axis being generally defined by a straight-line curve fit to said member local axis in a coordinate system which is substantially coplanar with said warp and fill yarns, said structural member being integrally secured to said base fabric at a plurality of interweave points, said member being secured by at least one warp yarn at each of said interweave points, adjacent interweave points being separated by a predetermined number of said fill yarns and a predetermined number of said warp yarns which together determine a substantially non-orthogonal angle a between said member global axis and said warp yarns and a complimentary substantially non-orthogonal angle β

=90°

-α

between said member global axis and said fill yarns.

29. The woven textile of claim 28, wherein:

said structural member local axis and said structural member global axis are substantially coincident; and

said non-orthogonal angle α

ranges from about 10 degrees to about 85 degrees.

30. The woven textile of claim 28, wherein:

said structural member local axis and said structural member global axis are substantially coincident; and

said non-orthogonal angle α

ranges from about 45 degrees to about 85 degrees.

31. The woven textile of claim 28, wherein said structural member local axis defines a plurality of undulations extending on first and second sides of said structural member global axis.

32. The woven textile of claim 31, wherein said plurality of undulations are substantially periodic about said structural member global axis.

33. The woven textile of claim 28, wherein said plurality of warp yarns comprise:

a first group of warp yarns which are not employed at said interweave points and which are selected for desired base fabric properties; and

a second group of warp yarns employed at said interweave points and having properties selected for securing said structural member.

34. The woven textile of claim 28, wherein said structural member is secured by at least two warp yarns at each of said interweave points.

41. The woven textile of claim 31 or 38, wherein at least one of said warp yarns and said fill yarns is comprised at least in part of microdenier yarns.

42. The woven textile of claim 41, wherein both said warp yarns and said fill yarns are comprised at least in part of microdenier yarns.

35. A woven textile comprising:

(a) a plurality of warp yarns;

(b) a plurality of fill yarns which are substantially orthogonal to said plurality of warp yarns and form a base fabric therewith; and

(c) an elongate wire-shaped structural member having both a member global axis and a member local axis, said member local axis being generally defined by centroids of adjacent cross-sections of said structural member, said member global axis being generally defined by a straight-line curve fit to said member local axis in a coordinate system which is substantially coplanar with said warp and fill yarns, said structural member having a plurality of securing portions which are positioned substantially parallel to said warp yarns, said structural member being integrally secured to said base fabric at a plurality of interweave points, said member being secured by at least one fill yarn engaging a respective one of said securing portions at each of said interweave points, adjacent interweave points being separated by a predetermined number of said fill yarns and a predetermined number of said warp yarns which together determine a substantially non-orthogonal angle a between said member global axis and said warp yarns and a complimentary substantially non-orthogonal angle β

=90°

-α

between said member global axis and said fill yarns.