Stent graft with braided polymeric sleeve

• US 5,957,974 A
• Filed: 10/08/1997
• Issued: 09/28/1999
• Est. Priority Date: 01/23/1997
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Schneider Electric SE
• Inventors: Thompson, Paul J., Du, George W.
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/946,906
• Time in Patent Office: 720 Days
• Field of Search: 623/1, 623/11, 623/12
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• 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 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30448 using adhesives
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/005 using adhesives
• 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 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: B29C 35/02 Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mouldcold vulcanisation B29C35/18 ; vulcanising tyres, presses therefor B29D30/0601
• CPC Class Codes: B29C 53/58 helically
• CPC Class Codes: B29C 63/18 using tubular layers or sheathings B29C63/26 and B29C63/38 take precedence; placing tubular labels around rigid containers B65C3/065
• CPC Class Codes: B29D 23/001 Pipes; Pipe joints pleated hoses B29D23/18
• CPC Class Codes: B29K 2105/0827 Braided fabrics
• CPC Class Codes: B29K 2105/0845 Woven fabrics
• CPC Class Codes: B29K 2223/065 HDPE, i.e. high density polyethylene
• CPC Class Codes: B29K 2223/12 PP, i.e. polypropylene
• CPC Class Codes: B29K 2227/18 : PTFE, i.e. polytetrafluorethene , e.g. ePTFE, i.e. expanded polytetrafluorethene
• CPC Class Codes: B29K 2267/00 : Use of polyesters or derivatives thereof as reinforcement
• CPC Class Codes: B29K 2271/00 : Use of polyethers , e.g. PEEK, i.e. polyether-etherketone or PEK, i.e. polyetherketone or derivatives thereof, as reinforcement
• CPC Class Codes: B29K 2275/00 : Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as reinforcement
• CPC Class Codes: B29K 2281/06 : PSU, i.e. polysulfones or derivatives thereof; PES, i.e. polyethersulfones, or derivatives thereof
• CPC Class Codes: B29L 2023/007 : Medical tubes other than catheters catheters B29L2031/7542
• CPC Class Codes: D04C 1/06 : Braid or lace serving particular purposes
• CPC Class Codes: D10B 2509/06 : Vascular grafts; stents

Abstract

A stent graft for transluminal implantation includes a resilient tubular interbraided latticework of metal or polymeric monofilaments, a tubular interbraided sleeve of polymeric multifilament yarns, and an adhesive layer between the sleeve and latticework for bonding them together. The monofilaments and multifilament yarns are arranged in respective sets of axially spaced apart and oppositely directed helices, concentric on a common axis of the stent graft. The respective braid angles of the monofilaments and multifilament yarns are carefully matched to ensure that the latticework and sleeve behave according to substantially the same relationship governing the amount of radial reduction that accompanies a given axial elongation. According to a process for fabricating the stent graft, the latticework and sleeve are braided and thermally set independently, then bonded to one another by a silicone polymer adhesive applied evenly to the latticework in a liquid spray that also incorporates an organic solvent. Especially preferred yarns are composed of essentially untwisted filaments that define non-circular yarn cross sections. Alternative stent graft constructions feature exterior and interior sleeves on opposite sides of the latticework, two or more sleeves axially spaced from one another on the same latticework, a latticework formed of a recovery metal, and a plastically deformable latticework.

Claims

1. A body insertable stent graft, including:

a radially expandable stent adjustable between a nominal state and a radially-reduced axially-elongated state according to a first relationship of radial reduction versus axial elongation; and

a tubular first sleeve formed of a plurality of interwoven textile strands, adjustable between a nominal state and a radially-reduced and axially-elongated state according to a second relationship of radial reduction versus axial elongation substantially equivalent to said first relationship;

wherein the stent and the sleeve are attached together in an axial alignment with one another and in an engagement with one another with a selected one of the stent and sleeve surrounding the other.

2. The stent graft of claim 1 wherein:

the stent comprises a plurality of structural strands in a tubular open latticework, the structural strands having first and second sets of helices wound in opposite directions about a longitudinal axis of said stent graft and forming a first braid angle with the latticework in its nominal state; and

said textile strands are arranged as third and fourth sets of helices wound in opposite directions about said longitudinal axis, and form a second braid angle with the sleeve in its nominal state; and

wherein said second braid angle is within about 5 degrees of the first braid angle.

3. The stent graft of claim 2 wherein:

said second braid angle is within about one degree of the first braid angle.

4. The stent graft of claim 2 wherein:

said structural strands are resilient, whereby the stent tends to assume its nominal state when relaxed.

5. The stent graft of claim 1 wherein:

said sleeve is an exterior sleeve that surrounds said stent.

6. The stent graft of claim 1 wherein:

said structural strands are interbraided.

7. The stent graft of claim 1 wherein:

said structural strands are metal monofilaments constructed of at least one of the following materials;

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

8. The stent graft of claim 7 wherein:

said monofilaments are polymeric and constructed of at least one of the following materials;

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

9. The stent graft of claim 1 wherein:

said textile strands are multifilament yarns formed of at least one of the following materials;

PET, polypropylene, high molecular weight polyethylene, polyurethane, HDPE, polyethylene, silicone, PTFE, polyolefins, and ePTFE.

10. The stent graft of claim 1 wherein:

at least one of said strands incorporates a radiopaque material.

11. The stent graft of claim 1 further including:

at least one elastomeric strand running axially of the composite stent graft and fused to the stent graft along at least part of its axial length.

12. The stent graft of claim 1 further including:

a coating applied to the composite stent graft.

13. The stent graft of claim 5 further including:

a second sleeve formed of the textile strands and providing an interior sleeve surrounded by said stent, wherein the interior sleeve is attached to the stent and adjustable between a nominal state and a radially-reduced axially-elongated state according to a third relationship of radial reduction versus axial elongation substantially equivalent to said first and second relationships, said interior sleeve having substantially the same size and shape as the first sleeve and the stent when in their respective nominal states.

14. The stent graft of claim 1 wherein:

said attachment component comprises an adhesive consisting essentially of a siloxane polymer.

15. The stent graft of claim 14 wherein:

said siloxane polymer occupies at least proximal and distal end portions of a cylindrical region over which the latticework and the sleeve are adjacent one another.

16. The stent graft of claim 15 wherein:

said siloxane polymer occupies substantially all of said region.

17. The stent graft of claim 1 wherein the stent structurally supports the sleeve.

18. The stent graft of claim 2 wherein said second braid angle is between 100.91 and 105.45 percent of said first braid angle and the sleeve is attached about and in axial alignment with the stent.

19. The stent graft of claim 2 wherein said second braid angle is between 97.72 and 102.27 percent of said first braid angle and the sleeve is attached within and in axial alignment with the stent.

20. A body insertable stent graft, including:

a tubular stent adjustable between a nominal state and a radially-reduced and axially-elongated state; and

a tubular fabric sleeve adjustable between a nominal state and a radially-reduced and axially-elongated state, formed of a plurality of textile strands, wherein each of the textile strands consists essentially of a multifilament yarn in which the filaments have surface twist angles of at most about 15 degrees, said sleeve and said stent having substantially the same radii when in their respective nominal states;

wherein the stent and the sleeve are attached together in axial alignment with one another and with a selected one of the stent and sleeve surrounding the other.

21. The stent graft of claim 20 wherein:

said multiple filaments further are arranged to define a yarn cross section with an aspect ratio greater than 1.

22. The stent graft of claim 21 wherein:

said aspect ratio is in the range from about 2 to about 12.

23. The stent of claim 20 wherein the stent structurally supports the sleeve.

24. A body insertable stent graft, including:

a stent adjustable between a nominal state and radially-reduced and axially-elongated state; and

a tubular fabric sleeve formed of a plurality of textile strands, each textile strand consisting essentially of a multifilament yarn in which multiple filaments thereof are arranged to define a yarn cross-section having an aspect ratio of at least about 2, said fabric sleeve adjustable between a nominal state and a radially-reduced and axially-elongated state, said sleeve and said stent having substantially the same radii when in their respective nominal states;

wherein the stent and the sleeve are attached together in an axial alignment and with a selected one of the stent and sleeve surrounding the other, with the stent structurally supporting the sleeve.

25. The stent graft of claim 24 wherein:

the textile strands are oriented with their minimum cross-sectional dimensions aligned substantially radially of the tubular fabric sleeve and the filaments of the textile strands have surface twist angles of at most about 15 degrees.

26. A process for making a stent graft, including:

forming a plurality of structural strands into a tubular open latticework adjustable between a nominal state and a radially-reduced axially-elongated state according to a first relationship of radial reduction versus axial elongation, the tubular open latticework having at least two ends;

forming a plurality of compliant textile strands into a tubular sleeve adjustable between a nominal state and a radially-reduced axially-elongated state according to a second relationship of radial reduction versus axial elongation substantially equivalent to said first relationship; and

attaching a selected one of the latticework and sleeve within and in an axial alignment with the other of said latticework and sleeve so that said other surrounds the selected one except one end of the tubular open latticework is unsurrounded by the sleeve.

27. A body insertable stent graft, including:

a radially expandable stent adjustable between a nominal state and a radially-reduced axially-elongated state according to a first relationship of radial reduction versus axial elongation the stent having at least two ends; and

a tubular first sleeve formed of a plurality of interwoven textile strands, adjustable between a nominal state and a radially-reduced and axially-elongated state according to a second relationship of radial reduction versus axial elongation substantially equivalent to said first relationship;

wherein the stent and the sleeve are attached together in an axial alignment with one another and in an engagement with one another with a selected one of the stent and sleeve surrounding the other except one end of the stent is unsurrounded by the sleeve.

28. A body insertable stent graft, including:

a tubular stent adjustable between a nominal state and a radially-reduced and axially-elongated state, the tubular stent having at least two ends; and

a tubular fabric sleeve adjustable between a nominal state and a radially-reduced and axially-elongated state, formed of a plurality of textile strands, wherein each of the textile strands consists essentially of a multifilament yarn in which the filaments have surface twist angles of at most about 15 degrees, said sleeve and said stent having substantially the same radii when in their respective nominal states;

wherein the stent and the sleeve are attached together in axial alignment with one another and with a selected one of the stent and sleeve surrounding the other except at least one end being unsurrounded by the tubular fabric sleeve.