Expandable stent grafts and methods of use thereof

• US 20070213805A1
• Filed: 03/05/2007
• Published: 09/13/2007
• Est. Priority Date: 03/09/2006
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated), MED Institute, Inc. (Cook Group Incorporated)
• Inventors: Grewe, David, Schaeffer, Darin
• Granted Patent: US 9,155,641 B2
• Time in Patent Office: Days
• US Class Current: 623/1.130
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/885 comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/30459 stapled
• CPC Class Codes: A61F 2002/30461 sutured, ligatured or stitched
• CPC Class Codes: A61F 2002/3052 unrestrained in only one direction, e.g. moving unidirectionally
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• 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

Abstract

This invention relates to a medical device and, in particular, to a prosthesis or stent graft assembly for use within the human or animal body and, more particularly, to the fastening of a stent to the graft material of the stent graft assembly or prosthesis.

Claims

1. A stent graft assembly comprising:

a tubular graft member having a lumen disposed about a longitudinal axis, the graft member comprising a graft material;

a support frame extending axially and circumferentially around the longitudinal axis, being movable between a compressed state and a radially expanded state; and

at least one fastener that secures the tubular graft member to the support frame in a manner that permits the support frame to move circumferentially with respect to the tubular graft member when the support frame is moved between the compressed state and the expanded state.

2. The stent graft assembly of claim 1, wherein the graft material is a bioremodelable material.

3. The stent graft assembly of claim 2, further comprising a bioactive material attached to the stent graft assembly.

4. The stent graft assembly of claim 2, wherein the support frame comprises nitinol.

5. The stent graft assembly of claim 2, wherein the graft material is selected from the group consisting of a reconstituted or naturally-derived coliagenous material, a collagenous extracellular matrix material, submucosa, renal capsule membrane, dermal collagen, dura mater, pericardium, fascia lata, serosa, peritoneum or basement membrane layers, intestinal submucosa, including small intestinal submucosa, stomach submucosa, urinary bladder submucosa, and uterine submucosa.

6. The stent graft assembly of claim 1, wherein the graft material comprises an angiogenic collagenous extracellular matrix material.

7. The stent graft assembly of claim 1, wherein the graft material comprises a biocompatible polyurethane.

8. The stent graft assembly of claim 7, wherein the support frame comprises nitinol.

9. The stent graft assembly of claim 7, further comprising a bioactive material attached to the stent graft assembly.

10. The stent graft assembly of claim 7, wherein the fastener is a suture, loop, staple, wire or fiber.

11. The stent graft assembly of claim 7, wherein the fastener is an elongate flexible fiber having a first end and a second end, wherein the first end and the second end are attached to the graft member to define a closed loop securing the tubular graft member to the support frame.

12. The stent graft assembly of claim 1, wherein the support frame comprises nitinol.

13. The stent graft assembly of claim 1, wherein the fastener is a suture, loop, staple, wire or fiber.

14. The stent graft assembly of claim 1, wherein the fastener is an elongate flexible fiber having a first end and a second end, wherein the first end and the second end are attached to the graft member to define a closed loop attaching the graft member to the support frame.

15. The stent graft assembly of claim 1, wherein the fastener is a mono-filament suture material or a braided suture material.

16. The stent graft assembly of claim 1, further comprising a bioactive material attached to the stent graft assembly.

17. The stent graft assembly of claim 1, wherein the graft material is selected from the group consisting of a biocompatible polyurethane, a reconstituted or naturally-derived collagenous material, a collagenous extracellular matrix material, submucosa, renal capsule membrane, dermal collagen, dura mater, pericardium, fascia lata, serosa, peritoneum or basement membrane layers, intestinal submucosa, including small intestinal submucosa, stomach submucosa, urinary bladder submucosa, and uterine submucosa;

wherein the support frame comprises nitinol; and

wherein the fastener is a suture, loop, staple, wire or fiber.

18. The stent graft assembly of claim 1, wherein the support frame comprises,

a sheet of biocompatible material having a specified thickness and reinforced with a reinforcing member extending longitudinally therealong and a plurality of cells extending laterally from said reinforcing member in a surface of said sheet of material, selected of said cells being a closed cell and including a fixedly sized aperture extending through said surface of said sheet of material, said sheet of material having a tubular shape including an overlapping state in which certain of said cells overlap said reinforcing member while none of cells overlap each other and form a combined thickness anywhere along said reinforcing member of no more than substantially twice said specified thickness of said sheet of material.

19. The stent graft assembly of claim 18, wherein the graft material is a bioremodelable material.

20. The stent graft assembly of claim 19, wherein the graft material is selected from the group consisting of a reconstituted or naturally-derived collagenous material, a collagenous extracellular matrix material, submucosa, renal capsule membrane, dermal collagen, dura mater, pericardium, fascia lata, serosa, peritoneum or basement membrane layers, intestinal submucosa, including small intestinal submucosa, stomach submucosa, urinary bladder submucosa, and uterine submucosa.

21. The stent graft assembly of claim 18, wherein the graft material comprises an angiogenic collagenous extracellular matrix material.

22. The stent graft assembly of claim 18, wherein the graft material comprises a biocompatible polyurethane.

23. The stent graft assembly of claim 18, further comprising a bioactive material attached to the stent graft assembly.

24. The stent graft assembly of claim 18, wherein the fastener is a suture, loop, staple, wire or fiber.

25. The stent graft assembly of claim 18, wherein the graft material is selected from the group consisting of a biocompatible polyurethane, a reconstituted or naturally-derived collagenous material, a collagenous extracellular matrix material, submucosa, renal capsule membrane, dermal collagen, dura mater, pericardium, fascia lata, serosa, peritoneum or basement membrane layers, intestinal submucosa, including small intestinal submucosa, stomach submucosa, urinary bladder submucosa, and uterine submucosa;

wherein the support frame comprises nitinol; and

wherein the fastener is a suture, loop, staple, wire or fiber.

26. The stent graft assembly of claim 1, wherein the graft material comprises a fluorinated polymer.

27. The stent graft assembly of claim 26, wherein the fluorinated polymer is selected from the group consisting of polytetrafluoroethylene and expanded polytetrafluoroethylene.

28. A stent graft assembly comprising:

a tubular graft member having a lumen disposed about a longitudinal axis;

a support frame extending axially and circumferentially around the longitudinal axis, being movable between a compressed state and a radially expanded state; and

means for securing the tubular graft member to the support frame in a manner that permits the support frame to move circumferentially with respect to the tubular graft member when the support frame is moved between the compressed state and the expanded state.