ENDOVASCULAR GRAFT INCLUDING SUBSTRUCTURE FOR POSITIONING AND SEALING WITHIN VASCULATURE

• US 20090299462A1
• Filed: 05/22/2009
• Published: 12/03/2009
• Est. Priority Date: 05/27/2003
• Status: Abandoned Application

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Inventors: Barkman, Kimberly, Vincent, Robert A., Reinhardt, Rodney H., Escano, Arnold M., Eckert, Robin W., Fawzi, Natalie V.
• Application Number:
  US12/470,632
• Publication Number:
  US 20090299462A1
• Time in Patent Office: Days
• 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 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/067 modular
• 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 2002/9511 the retaining means being filaments or wires

Abstract

An endovascular graft having an improved positioning mechanism capable of positioning and securing a bifurcated graft into a bifurcated vessel described. The graft can include a sleeve affixed to graft that is used in combination with a contralateral wire loop for placement of the graft within vasculature. The graft may include a structure for post deployment positioning into the bifurcated aneurysm area. Furthermore, the endovascular graft may be configured to form a sealing pocket that expands with induced fluid pressure and prevents fluid leaks at an attachment site.

Claims

1. An endovascular graft system, comprising:

a graft body;

an elongate positioning mechanism, the positioning mechanism facilitating intraluminally positioning the graft into a corporeal lumen; and

a sleeve attached to the graft body, the sleeve configured to route the elongate positioning mechanism through the graft.

2. The system of claim 1, the positioning mechanism includes a guide wire.

3. The system of claim 1, wherein the graft is bifurcated defining a superior member, an ipsilateral member and a contralateral member, and wherein the sleeve extends from the ipsilateral member of the bifurcated graft to the contralateral member.

4. The system of claim 2, wherein the sleeve is disposed about the guide wire prior to deployment into the corporeal lumen.

5. The system of claim 1, the elongate positioning mechanism further including a snaring means, wherein the snaring means is configured to engage a snare device.

6. The system of claim 1, wherein the sleeve is formed of a flexible surgical implantable material and affixed to the graft body with at least one suture or is woven into the graft body or thermally bonded thereto.

7. The system of claim 1, wherein the sleeve includes at least one radiopaque marker for positioning the graft body within vasculature.

8. The system of claim 1, the sleeve further including a pressure sensing means.

11. The system of claim 7, the graft pocket having a diameter in the range of 1 mm to 6 mm larger than a diameter of the graft body.

9. A system for treating a body lumen, comprising:

a graft body;

an attachment system capable of intraluminally attaching a graft to a vessel wall, the attachment system including a frame configured to be affixed to the graft body and to assert an outwardly directed bias, the frame having a plurality of wall engaging members when the attachment system is expanded; and

a graft pocket formed in the graft body, the graft pocket being responsive to pressure provided by blood flow, the graft pocket acting as a sealing member.

10. The system of claim 9, the graft pocket forming a circumferential seal against the vessel wall.

12. The system of claim 9, the attachment system wire frame is not attached to the graft pocket thereby allowing the graft pocket to expand independent of the attachment system.

13. The system of claim 9, the system including a plurality of graft pockets configured along the graft body.

14. The system of claim 12, wherein the attachment system is affixed to the graft body via a stitching pattern having at least two double loop knots and at least two suture loops around the attachment system, and a running stitch having threaded loops and double loop knots.

15. An endovascular graft, comprising:

a bifurcated graft formed of a superior member having a graft bifurcation and extending into an ipsilateral member and a contralateral member; and

a mating structure that releasably attaches the ipsilateral member and the contralateral members of the bifurcated graft, wherein the members are in the attached position during deployment and separated after post deployment positioning of the graft into the corporeal lumen.

16. The graft of claim 15, wherein the mating structure includes a plurality of suture loops affixed about an exterior inseam of the ipsilateral member and the contralateral member.

17. The graft of claim 16, wherein the mating structure further includes a release wire that is releasably threaded through the suture loops to secure the ipsilateral and contralateral members together, wherein the removal of the release wire separates the graft members allowing the bifurcated graft to conform to a bifurcation.

18. The graft of claim 15, the mating structure having a suture material releasably configured to form a running stitch pattern that is sewn to attach the ipsilateral member and contralateral member.

19. The mating structure of claim 18, wherein the suture running stitch begins at the graft bifurcation and is stitched in-and-out through the ipsilateral member and contralateral member.

20. An endovascular graft system, comprising:

a graft body;

a sleeve attached to the graft body;

an expandable attachment system capable of intraluminally attaching the graft body to a vessel; and

a sealing member configured to radially surround the graft body.

21. The system of claim 20, further comprising a guide wire configured to be received by the sleeve.

22. The system of claim 20, wherein the graft body is bifurcated and defines an ipsilateral member and a contralateral member, and wherein the sleeve starts on the ipsilateral member of the bifurcated graft and ends on the contralateral member.

23. The system of claim 20, wherein the sleeve is disposed about the guide wire prior to deployment into vasculature.

24. The system of claim 21, the guide wire having a terminal end including a hook.

25. The system of claim 24, further comprising a snare device configured to engage the hook.

26. The graft of claim 22, wherein the sleeve is configured of a flexible surgical implantable material, and affixed to the graft body with at least one suture or is woven into the graft body or thermally bonded thereto.

27. The graft of claim 22, wherein the sleeve is affixed to the to the graft body with a plurality of sutures.

28. The graft of claim 20, the sealing member includes a graft pocket configured to form a leak tight seal, wherein the graft pocket expands radially with induced fluid pressure forming a circumferential seal and redirects fluid flow into the graft.

29. The system of claim 20, wherein the attachment system further includes a plurality of wall-engaging members.

30. The system of claim 20, wherein the attachment system is attached to the superior end of the graft body.

31. An endovascular graft for repairing a blood vessel, comprising:

a graft body having a plurality of openings;

an expandable attachment system capable of intraluminally attaching a superior opening to a vessel; and

a sealing member radially affixed to the graft member attachment site to prevent blood leakage at the attachment site, the sealing member defined by tufted material formed of a suture that is stitched circumferentially in an in-and-out pattern forming suture loops around a circumference of the graft body.

32. The sealing member of claim 31, the suture material is polyethyleneterephthalate.

33. An endovascular graft for repairing a blood vessel, comprising:

a graft body having a plurality of openings;

an expandable attachment system capable of intraluminally attaching a superior opening to a vessel; and

a sealing member radially affixed to the graft member attachment site to prevent blood leakage at the attachment site, the sealing member defined by tufted material is fabric formed from a non-woven web of loose fibers attached to the graft member walls by a suture thread, wherein the non-woven web has an in-air thickness of approximately 0.01 in. and a compressed thickness in the range of 0.007 in. to 0.008 in., and a width of approximately 5 cm.

34. The sealing member of claim 33, the suture material is polyethyleneterephthalate.

35. An endovascular graft, comprising:

a bifurcated graft formed of a superior member having a graft bifurcation and extending into an ipsilateral member and a contralateral member; and

a mating structure that releasably attaches the ipsilateral member and the contralateral members of the bifurcated graft, wherein the members are in the attached position during deployment and separated after post deployment positioning of the graft into the corporeal lumen.

36. The graft of claim 35, wherein the mating structure includes a plurality of suture loops affixed about an exterior inseam of the ipsilateral member and the contralateral member, wherein the suture material is biocompatible and flexible.

37. The graft of claim 36, the mating structure further includes a release wire that is releasably threaded through the suture loops to secure the ipsilateral and contralateral members together, wherein the removal of the release wire separates the graft members allowing the bifurcated graft to conform to an aortic bifurcation.

38. The graft of claim 35, wherein the mating structure includes a suture material releasably configured to form a running stitch pattern that is sewn to attach the ipsilateral member and contralateral member.

39. The mating structure of claim 38, wherein the suture running stitch begins at the graft bifurcation and is stitched in-and-out through the ipsilateral member and contralateral member.

40. The graft of claim 38, further comprising a graft pocket.