Coiled-sheet stent-graft with exo-skeleton

• US 6,325,820 B1
• Filed: 11/16/1998
• Issued: 12/04/2001
• Est. Priority Date: 11/16/1998
• Status: Expired due to Term

• Current Assignee: Endotex Interventional Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Endotex Interventional Systems Incorporated (Boston Scientific Corporation)
• Inventors: Khosravi, Farhad, Patel, Himanshu N.
• Primary Examiner(s): Reip, David O.
• Assistant Examiner(s): HO, TAN-UYEN THI
• Application Number:
  US09/192,977
• Time in Patent Office: 1,114 Days
• Field of Search: 606/198, 606/108, 623/1.15, 623/1.13, 623/1.44, 623/1.2, 623/1.35, 623/1-1-, 623/1.36
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• 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 2002/8486 provided on at least one of the ends
• 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A stent-graft having an exo-skeleton attached to a tubular graft, the tubular graft having a peripheral wall defining a lumen therein extending between first and second ends. The exo-skeleton may assume contracted and enlarged conditions, and includes one or more serpentine elements, each extending both peripherally and axially along at least a portion of the peripheral wall. Coiled-sheet stents are provided on the ends of the tubular graft for anchoring the ends within a body passage. Each serpentine element is a zigzag structure extending peripherally about the peripheral-wall, with a plurality of serpentine elements distributed axially along the peripheral wall. The serpentine elements are individually attached to the peripheral wall and/or connector elements may extend between adjacent serpentine elements. Alternatively, each serpentine element may define a generally sinusoidal shape extending axially along the peripheral wall. The tubular graft may have a bifurcated end from which a tubular graft extension segment may extend and to which a docking limb may be attached. A plurality of serpentine elements may also be attached to the extension segment and the docking limb.

Claims

1. A stent-graft, comprising:

a tubular graft having a peripheral wall defining a periphery and a lumen therein, the lumen extending axially between first and second ends of the tubular graft;

an exo-skeleton attached to an intermediate portion of the peripheral wall, the exo-skeleton comprising a plurality of independent serpentine elements, each serpentine element extending both peripherally and axially along at least a portion of the peripheral wall, the serpentine elements being distributed axially along the peripheral wall in phase with one another for providing articulation of the tubular graft between adjacent serpentine elements, each serpentine element being biased to an enlarged condition for maintaining the lumen substantially open, and constrainable in a contracted condition for facilitating introduction into a body passage; and

a stent on the first end for substantially anchoring the first end within a body passage.

2. The stent-graft of claim 1, wherein each serpentine element comprises a zigzag structure extending substantially peripherally about the peripheral wall of the tubular graft.

3. The stent-graft of claim 1, wherein each serpentine element defines a generally sinusoidal shape extending substantially axially along the peripheral wall.

4. The stent-graft of claim 3, further comprising a plurality of serpentine elements distributed substantially evenly about the periphery of the peripheral wall.

5. The stent-graft of claim 3, wherein each serpentine element includes substantially transverse peripheral elements, adjacent transverse peripheral elements being connected by alternating curved elements, thereby defining the generally sinusoidal shape.

6. The stent-graft of claim 1, wherein the tubular graft comprises a polymeric material.

7. The stent-graft of claim 1, wherein the polymeric material is selected from the group consisting of polyester, polytetrafluorethaline, dacron, teflon, and polyurethane.

8. The stent-graft of claim 1, wherein the exo-skeleton is attached to the tubular graft by sutures, staples, wires, or an adhesive.

9. The stent-graft of claim 1, wherein the exo-skeleton is attached to the tubular graft by a process selected from thermal bonding, chemical bonding, and ultrasonic bonding.

10. The stent-graft of claim 1, wherein each serpentine element comprises a wire formed into a serpentine shape.

11. The stent-graft of claim 1, wherein the stent on the first end comprises a coiled-sheet stent.

12. The stent-graft of claim 1, wherein the stent includes external outwardly oriented hooks for engaging a wall of a body passage.

13. The stent-graft of claim 1, further comprising pro-thrombotic material on an exterior surface of at least the stent, or one of the first and second ends of the tubular graft.

14. The stent-graft of claim 1, wherein the first end of the tubular graft has a cross-section that is substantially smaller than a cross-section of the second end of the tubular graft.

15. The stent-graft of claim 1, wherein the exo-skeleton is attached to an exterior surface of the tubular graft.

16. A stent-graft, comprising:

a tubular graft having a peripheral wall defining a periphery and a lumen therein, the lumen extending axially between first and second ends of the tubular graft; and

a plurality of independent serpentine elements attached to and distributed axially along the peripheral wall in a predetermined configuration in phase with one another for providing articulation of the tubular graft between adjacent serpentine elements, each serpentine element defining a zigzag shape extending substantially peripherally about the peripheral wall of the tubular graft, each serpentine element being biased to an enlarged condition for maintaining the lumen substantially open, and constrainable in a contracted condition for facilitating introduction into a body passage.

17. The stent-graft of claim 16, further comprising a stent on at least one of the first and second ends.

18. The stent-graft of claim 17, wherein the stent comprises a plurality of resilient mesh elements, the mesh elements being adapted to partially recoil when the stent is subjected to radially compressive forces.

19. The stent-graft of claim 18, wherein the entire stent is made of resilient mesh elements.

20. The stent-graft of claim 17, wherein the stent comprises a coiled-sheet stent located substantially within the lumen of the tubular graft.

21. The stent-graft of claim 20, wherein the coiled-sheet stent comprises a stretchable portion defined by a plurality of resilient mesh elements adapted to partially recoil when the stent is subjected to radially compressive forces.

22. The stent-graft of claim 21, wherein the stretchable portion extends longitudinally between first and second ends of the stent.

23. The stent-graft of claim 21, wherein the stretchable portion comprises a sleeve on an end of the coiled-sheet stent exposed beyond the respective end of the tubular graft.

24. The stent-graft of claim 16, wherein the plurality of serpentine elements are individually attached to the peripheral wall.

25. The stent-graft of claim 16, wherein the second end of the tubular graft is bifurcated, and wherein the stent-graft further comprises:

a tubular graft extension segment extending from the second end, the tubular graft extension segment having a peripheral wall; and

a plurality of serpentine elements attached to and distributed along the peripheral wall of the tubular graft extension segment in a predetermined configuration for providing articulation of the tubular graft extension segment between adjacent serpentine elements.

26. The stent-graft of claim 25, further comprising:

a tubular graft docking limb having a peripheral wall, the docking limb being attachable to the second end of the tubular graft adjacent the tubular graft extension segment; and

a plurality of serpentine elements attached to and distributed along the peripheral wall of the tubular graft docking limb in a predetermined configuration for providing articulation of the tubular graft docking limb between adjacent serpentine elements.

27. A stent-graft for placement within a bifurcation, comprising:

a first tubular graft segment having a first end and a second bifurcated end, the first tubular graft segment having a first peripheral wall;

a second tubular graft segment extending from the second bifurcated end, the second tubular graft segment having a second peripheral wall; and

an exo-skeleton attached to at least one of the first and second peripheral walls, the exo-skeleton comprising a plurality of independent serpentine elements, each serpentine element extending both peripherally and axially along at least a portion of the respective peripheral wall to which it is attached, the serpentine elements being distributed axially along the peripheral wall in phase with one another for providing articulation of the tubular graft between adjacent serpentine elements, each serpentine element being biased to an enlarged condition for maintaining the lumen substantially open, and constrainable in a contracted condition for facilitating introduction into a body passage.

28. The stent-graft of claim 27, further comprising a stent on the first end for substantially anchoring the first end within a body passage.

29. The stent-graft of claim 27, further comprising a stent on the second tubular graft segment opposite the second end of the first tubular graft segment.

30. The stent-graft of claim 27, further comprising a third tubular graft segment attachable to the second bifurcated end adjacent the second tubular graft segment, the third tubular graft segment having a third peripheral wall.

31. The stent-graft of claim 30, wherein the exo-skeleton comprises one or more serpentine elements attached to the third peripheral wall.

32. The stent-graft of claim 27, wherein the plurality of serpentine elements are individually attached to the respective peripheral wall.

33. A stent-graft, comprising:

a tubular graft having a peripheral wall defining a periphery and a lumen therein, the lumen extending axially between first and second ends of the tubular graft;

a plurality of independent serpentine elements attached to and distributed axially along the peripheral wall in a predetermined configuration for providing articulation of the tubular graft between adjacent serpentine elements, each serpentine element defining a zigzag shape extending substantially peripherally about the peripheral wall of the tubular graft, adjacent serpentine elements being in phase with one another; and

a stent secured to each of the first and second ends of the tubular graft for substantially anchoring the first and second ends within a body passage.

34. The stent-graft of claim 33, wherein the stent comprises a coiled-sheet stent.

35. The stent-graft of claim 33, wherein each serpentine element comprises a single strand of wire.

36. The stent-graft of claim 35, wherein each of the single strands of wire is attached to the tubular graft by sutures.

37. A stent-graft, comprising:

a tubular graft having a peripheral wall defining a periphery and a lumen therein, the lumen extending axially between first and second ends of the tubular graft;

a plurality of independent serpentine elements attached to and distributed axially along an intermediate region of the tubular graft in a predetermined configuration for providing articulation of the tubular graft between adjacent serpentine elements, each serpentine element defining a zigzag shape extending substantially peripherally about the peripheral wall of the tubular graft, each serpentine element being biased to an enlarged condition for maintaining the lumen substantially open, and constrainable in a contracted condition for facilitating introduction into a body passage; and

a stent secured to each of the first and second ends of the tubular graft for substantially anchoring the first and second ends within a body passage.

38. The stent-graft of claim 37, wherein the stent comprises a coiled-sheet stent.

39. The stent-graft of claim 37, wherein each serpentine element comprises a single strand of wire attached to the tubular graft by sutures.

40. The stent-graft of claim 39, wherein each of the single strands of wire is attached to the tubular graft by sutures.