Bifurcated stent graft

• US 5,906,641 A
• Filed: 02/11/1998
• Issued: 05/25/1999
• Est. Priority Date: 05/27/1997
• Status: Expired due to Term

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: Schneider Electric SE
• Inventors: Du, George W., Thompson, Paul J.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): Nguyen, Dinh X.
• Application Number:
  US09/022,256
• Time in Patent Office: 468 Days
• Field of Search: 623/1, 623/11, 623/12, 623/66, 606/191, 606/192, 606/193, 606/194, 606/195
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• 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 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 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0017 Angular shapes
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped

Abstract

A bifurcated stent graft implantable in branched internal passageways includes an open-frame stent latticework formed of helically wound structural strands, and a graft sleeve formed of interwoven textile strands. The sleeve is substantially impervious to fluids and is adjustable along with the graft between a nominal state and radially-reduced axially-elongated state, according to substantially the same relationship of radial reduction versus axial elongation. The sleeve and stent are bonded to one another at least at proximal and distal end regions of the stent graft. The sleeve preferably is surrounded by the stent, and incorporates a flow dividing feature in the form of an axially extending seam. The seam brings together portions of the sleeve that otherwise would be circumferentially spaced apart in the tubular sleeve shape. The stent latticework and graft sleeve can be coextensive, the sleeve can extend distally beyond the latticework, or the latticework can extend proximally beyond the sleeve, depending on the intended use. In other alternative embodiments, the sleeve can surround the latticework.

Claims

1. An implantable prosthesis for branched internal passageways, including:

an open-frame structural member adjustable between a nominal state and a radially-reduced axially-elongated state according to a first relationship of radial reduction vs. axial elongation;

a fluid flow guide formed of textile strands, substantially impervious to fluids and adjustable between a nominal state and a radially-reduced axially-elongated state according to a second relationship of radial reduction vs. axial elongation substantially equivalent to said first relationship, said fluid flow guide including an axially-extending first region along which the fluid flow guide is tubular to provide a primary conduit;

wherein the structural member and the fluid flow guide are joined to one another to undergo radial enlargements and contractions in concert, with a selected one of the structural member and fluid flow guide surrounding the other; and

a flow dividing feature along a second axially-extending region of the fluid flow guide, to provide along the second region at least two secondary conduits, each secondary conduit open to the primary conduit.

2. The prosthesis of claim 1 wherein:

the textile strands forming the fluid flow guide are substantially inextensable.

3. The prosthesis of claim 1 wherein:

the structural member is tubular at least along a portion thereof adjacent the first region, and said first region and said portion of the structural member have substantially the same radii when in their respective nominal states.

4. The prosthesis of claim 1 wherein:

the structural member extends axially at least over the complete length of the fluid flow guide.

5. The prosthesis of claim 1 wherein:

a portion of the structural member extends proximally beyond a proximal end of the fluid flow guide.

6. The prosthesis of claim 1 wherein:

a distal portion of the fluid flow guide extends distally of the structural member.

7. The prosthesis of claim 1 wherein:

the second region comprises a medial region of the fluid flow guide disposed between proximal and distal end regions of the guide, and said first region comprises the proximal and distal end regions.

8. The prosthesis of claim 1 wherein:

the fluid flow guide is formed of a continuous fabric wall that tends to assume a cylindrical shape when not subject to an external force, and the flow dividing feature comprises a coupling of selected portions of the fabric wall that are circumferentially spaced apart from one another when the fluid flow guide is in the cylindrical shape.

9. The prosthesis of claim 8 wherein:

the coupling extends axially along the fluid flow guide.

10. The prosthesis of claim 8 wherein:

said selected portions of the fabric wall are spaced apart about 180 degrees when the fluid flow guide is in the cylindrical shape, and the fluid flow guide when shaped by said coupling forms two secondary conduits about equal to one another in size.

11. The prosthesis of claim 8 wherein:

the structural member surrounds the fluid flow guide, and the at least one coupling comprises a line of stitching through said portions of the fabric wall.

12. The prosthesis of claim 11 wherein:

the coupling includes two adjacent stitchings through the fabric wall, with fabric portions between the adjacent stitchings severed to form separate legs along the second region of the fluid flow guide.

13. The prosthesis of claim 1 wherein:

the fluid flow guide surrounds the structural member.

14. The prosthesis of claim 1 wherein:

the structural member is formed of structural strands wound in first and second sets of helices in opposite directions to form a first braid angle;

the textile strands are arranged in third and fourth sets of helices wound in opposite directions to form a second braid angle; and

the first and second braid angles are within about five degrees of one another.

15. The prosthesis of claim 14 wherein:

the first and second braid angles are within about three degrees of one another.

16. An implantable system of prosthetic components, including the prosthesis of claim 1, and further including:

a plurality of tubular stent grafts, each tubular stent graft being adjustable between a nominal state and a radially-reduced axially-elongated state, each tubular stent graft further being insertable into a corresponding one of the secondary conduits when in its radially-reduced axially-elongated state and, when so inserted, radially expandable into engagement with the fluid flow guide to secure the tubular stent graft within its associated secondary conduit.

17. A process for making a stent graft implantable in branched internal passageways, including:

providing a tubular stent comprised of a plurality of structural strands adjustable between a nominal state and a radially-reduced axially-elongated state according to a first relationship of radial reduction vs. axial elongation;

providing a compliant tubular sleeve comprised of a plurality of textile strands, having a nominal state in which the sleeve is substantially the same size and shape as the stent in its nominal state, and adjustable between the nominal state and a radially-reduced axially-elongated state according to a second relationship of radial reduction vs. axial elongation substantially equivalent to said first relationship;

forming, along an axially-extending selected region of the sleeve, a coupling of selected portions of the sleeve that are circumferentially spaced apart when the sleeve is in the tubular shape, to form at least two side-by-side fluid conduits along the selected region, thus forming the sleeve into a fluid flow guide having a primary fluid conduit along a proximal end region of the sleeve in fluid communication with the side-by-side fluid conduits;

positioning a selected one of the stent and the sleeve within the other of the stent and sleeve, so that said other surrounds the selected one, and with the selected one so positioned, bringing the stent and sleeve into an engagement; and

while maintaining the engagement, binding the stent and the sleeve together to form a composite stent graft.

18. The process of claim 17 wherein:

said selected one is the sleeve and said other is the stent, whereby said positioning comprises disposing the sleeve within the stent for said engagement and binding.

19. The process of claim 18 wherein:

said forming of a coupling comprises forming a first line of stitching running at least approximately axially of the sleeve and extending through the selected portions of the sleeve.

20. The process of claim 19 wherein:

said forming the coupling further includes forming a second line of stitching adjacent the first line of stitching, and severing the sleeve between the first and second stitching lines.

21. The process of claim 17 wherein:

said forming a coupling consists essentially of forming a single axially-extending coupling to form two of said side-by-side fluid conduits.

22. The process of claim 21 wherein:

said selected portions of the sleeve are spaced apart about 180 degrees, whereby the two side-by-side fluid conduits are approximately equal in size.

23. The process of claim 17 wherein:

said positioning of a selected one of the stent and sleeve further includes adjusting the selected one to reduce its radius from that in its nominal state, inserting the selected one into the other with the radius of the selected one reduced while maintaining the other in its nominal state, then radially expanding the selected one toward said engagement.

24. The process of claim 23 further including:

before said engagement of the stent and sleeve, applying an adhesive to at least one of the stent and sleeve.

25. The process of claim 24 wherein:

said adhesive is curable and applied uncured to the at least one of the stent and sleeve, and said binding of the stent and the sleeve comprises curing the adhesive with the stent and sleeve in said engagement.

26. The process of claim 17 wherein:

said providing a tubular stent comprises winding a plurality of structural strands into first and second sets of helices in opposite directions, and said providing a tubular sleeve comprises interweaving a plurality of compliant, substantially inextensable textile strands into third and fourth sets of helices wound in opposite directions.

27. The process of claim 26 wherein:

said winding comprises winding the structural strands so that the first and second sets of helices form a first braid angle, and interweaving the textile strands so that the third and fourth sets of helices form a second braid angle within about five degrees of the first braid angle when the stent and sleeve are in their respective nominal states.

28. A body insertable prosthesis, including:

a compliant and substantially fluid impervious sleeve having tubular proximal and distal end regions defining respective proximal end and distal end fluid conduits;

a tubular open-frame structural member surrounding the sleeve and fixed to the sleeve at least along said tubular end regions whereby the structural member and the sleeve are adjustable in concert between a nominal state and a reduced-radius state; and

a flow dividing feature defining a plurality of medial fluid flow conduits along a medial region of the sleeve, wherein each of the medial conduits is open to the proximal end conduit and to the distal end conduit.

29. The prosthesis of claim 28 wherein:

the sleeve is formed of a continuous fabric wall, and the flow dividing feature comprises a coupling of selected portions of the fabric wall circumferentially spaced apart from one another when the sleeve is in a cylindrical shape.

30. The prosthesis of claim 29 wherein:

the coupling comprises a line of stitching running axially of the sleeve.

31. The prosthesis of claim 30 wherein:

the selected portions of the fabric wall are circumferentially spaced apart about 180 degrees when the sleeve is a cylinder, whereby the coupling forms two medial conduits of approximately equal size.

32. The prosthesis of claim 29 wherein:

the structural member and sleeve are reduced radially as they are elongated axially, and behave according to substantially the same relationship of radial reduction vs. axial elongation.

33. The prosthesis of claim 32 wherein:

the structural member is formed of structural strands wound in first and second sets of helices in opposite directions to form a first braid angle, and the sleeve is formed of substantially inextensable textile strands wound in third and fourth sets of helices in opposite directions to form a second braid angle within about five degrees of the first braid angle.

34. A body implantable system of prosthetic devices including the prosthesis of claim 28 and further including:

a plurality of tubular stent grafts, each tubular stent graft being adjustable between a nominal state and a radially-reduced state, each tubular stent graft further being insertable via the distal end conduit into a corresponding one of the medial conduits, and when so inserted, radially expandable into engagement with the sleeve to secure the tubular stent graft within its associated medial conduit.