Bifurcated graft deployment systems and methods

• US 8,236,040 B2
• Filed: 04/11/2008
• Issued: 08/07/2012
• Est. Priority Date: 04/11/2008
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Endologix
• Inventors: Mayberry, Kevin, Pham, Trinh, Schreck, Stefan G.
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): MILES, JONATHAN WADE
• Application Number:
  US12/101,863
• Publication Number:
  US 20090259298A1
• Time in Patent Office: 1,579 Days
• Field of Search: 606/108, 623/1.11, 623/1.12, 623/1.23, 623/1.1, 623/1.13, 623/1.15, 623/1.16, 623/1.17, 623/1.18, 623/1.19, 623/1.2, 623/1.22, 623/1.28, 623/1.29, 623/1.3, 623/1.31, 623/1.35
• US Class Current: 623/1.11
• 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 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• 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 2002/9511 the retaining means being filaments or wires

Abstract

A deployment catheter for deploying an endoluminal vascular prosthesis that has at least a main graft portion and a first branch graft portion. The deployment catheter preferably comprises an elongate, flexible catheter body having a proximal end and a distal end, and an outer sheath and an inner core that is axially moveable with respect to the outer sheath. The catheter preferably comprises a main graft restraint that has a main graft release mechanism comprising a main graft sheath and a suture threaded through a plurality of the openings in the main graft sheath. The catheter further comprises at least one branch graft restraint comprising at least one branch graft release mechanism.

Claims

1. An endoluminal prosthesis deployment system for deploying an endoluminal prosthesis having at least a main branch portion and a first branch portion, comprising:

a flexible catheter body comprising an outer sheath with a proximal and distal end, an inner core that extends through the outer sheath and is axially moveable with respect to the outer sheath;

a main branch restraint that surrounds and constrains at least the main branch portion of the prosthesis, the main branch restraint having a proximal portion adjacent to a proximal end of the main branch portion of the prosthesis, a distal portion adjacent a distal end of the main branch portion of the prosthesis, and an intermediate portion positioned between the proximal and distal portions of the main branch restraint;

a plurality of segments between perforations in the main branch restraint along the length of at least a portion of one side of the main branch restraint, wherein at least one of the perforations is positioned closer to the distal portion of the main branch restraint than another of the perforations;

a release wire extending through at least two of said perforations and looped around a segment of said plurality of segments between said at least two of said perforations; and

a first branch restraint comprising a tubular member coupled to a first branch release mechanism;

wherein;

when retracted, the release wire tears segments of the main branch restraint between perforations.

2. The deployment system of claim 1, further comprising a guidewire lumen extending through the inner core.

3. The deployment system of claim 1, wherein the release wire is routed through the perforations such that an end of the release wire is positioned proximally of a distal end of the main branch restraint.

4. The deployment system of claim 1, wherein the main branch restraint comprises a score line between at least some of the perforations.

5. The deployment system of claim 1, wherein the main branch restraint comprises a slit between at least some of the perforations.

6. The deployment system of claim 1, wherein the deployment system further comprises a hollow guidewire slidably positioned within the deployment catheter.

7. The deployment system of claim 6, wherein the deployment system further comprises an inner core wire slidably positionable within the hollow guidewire.

8. The deployment system of claim 6, wherein the deployment system further comprises an inner core wire slidably positionable within the hollow guidewire before the main branch restraint has been removed.

9. The deployment system of claim 6, wherein the hollow guidewire comprises a multi-filar Nitinol wire.

10. The deployment system of claim 1, wherein:

a hollow guidewire is slidably positioned within at least a portion of the main branch restraint; and

the hollow guidewire is coupled with the main branch restraint such that withdrawal of the hollow guidewire withdraws the main branch restraint.

11. The deployment system of claim 1, further comprising a second branch restraint constraining a second branch portion of the endoluminal prosthesis, the second branch restraint comprising a second branch release mechanism.

12. The deployment system of claim 11, wherein:

the second branch release mechanism comprises a hollow guidewire slidably positioned within the deployment catheter and at least a portion of the second branch restraint;

the hollow guidewire is coupled with the second branch restraint such that withdrawal of the hollow guidewire withdraws the second branch restraint after a predetermined length of the hollow guidewire has been axially withdrawn from the deployment catheter.

13. The deployment system of claim 1, wherein the main branch restraint is releasably supported at a first end by a distal tip member of the deployment catheter.

14. The deployment system of claim 1, wherein the prosthesis is supported within the outer sheath so that an axial centerline through the first branch portion is offset from an axial centerline of the outer sheath.

15. The deployment system of claim 1, wherein the deployment catheter holds the prosthesis in a substantially fixed rotational alignment with the inner core.

16. The deployment system of claim 1, wherein the release wire loops around one or more segments of the main branch restraint positioned between the perforations formed in the main branch restraint.

17. The deployment system of claim 16, wherein the release wire tears through the segments when the release wire is retracted relative to the main branch restraint.

18. The deployment system of claim 16, wherein the release wire passes through two or more of the openings formed in the main branch restraint at least two times.

19. The deployment system of claim 1, wherein in use the deployment system comprising the main branch restraint is advanced through a first access site and the main branch restraint is removed through a second access site that is different than the first access site.

20. The deployment system of claim 19, wherein the first access site is either one of the ipsilateral iliac artery and the contralateral iliac artery, and the second access site is the other of the ipsilateral iliac artery and the contralateral iliac artery.

21. The deployment system of claim 1, wherein the main branch restraint comprises a tubular member.

22. The deployment system of claim 1, wherein at least a portion of the distal portion of the main branch restraint defines a smaller cross-sectional diameter or size as compared to the intermediate portion of the main branch restraint.

23. The deployment system of claim 22, wherein a distal portion of the deployment system comprises an annular channel or depression, and at least a portion of the distal portion of the main branch restraint is in contact with the annular channel or depression.

24. The deployment system of claim 1, wherein the main branch restraint is axially attached to a proximal end portion of the distal tip before the main branch restraint is torn.

25. The deployment system of claim 1, wherein the plurality of perforations are linearly arranged along the length of at least a portion of the main branch restraint.

26. The deployment system of claim 1, wherein the plurality of segments between perforations comprise at least a first perforation and a second perforation, the second perforation being positioned distal to the first perforation.

27. The deployment system of claim 1, wherein the release wire loops around each and all of the plurality of segments.

28. The deployment system of claim 1, wherein the deployment system releases at least one of the proximal portion or the intermediate portion of the main branch restraint before releasing the distal portion of the main branch restraint when the release wire is proximally retracted.

29. The deployment system of claim 28, wherein the release wire is routed through the perforations such that withdrawal of the release wire releases the proximal portion of the main branch restraint before the distal portion of the main branch restraint when the release wire is proximally retracted, the proximal portion being downstream of the distal portion.

30. The deployment system of claim 29, wherein the release wire is routed through the perforations such that withdrawal of the release wire releases the distal portion of the main branch restraint before the intermediate portion of the main branch restraint.

31. The deployment system of claim 28, wherein the release wire is routed through the perforations such that withdrawal of the release wire releases the intermediate portion of the main branch restraint before the distal portion of the main branch restraint.

32. The deployment system of claim 1, wherein the main branch restraint is a tubular sheath having a generally uniform wall thickness and cross-section between the perforations.

33. An apparatus for deploying a stent graft in a passageway, comprising:

a flexible catheter body;

a stent graft supported by the catheter body, the stent graft comprising a main body portion;

a removable sheath that surrounds and constrains at least a portion of the main body portion of the stent graft, the removable sheath having a first portion, a second portion distal to the first portion, and an intermediate portion between the first and second portions;

a plurality of sheath segments between perforations in the removable sheath spaced along the first portion, the intermediate portion, and the second portion of the removable sheath; and

a release member passing through at least two of the perforations and looped around two or more of the plurality of sheath segments;

wherein;

at least one of the perforations is positioned closer to the second portion of the removable sheath than another of the perforations; and

retracting the release member relative to the removable sheath tears the sheath segments between the perforations formed in the removable sheath.

34. The apparatus of claim 33, wherein retracting the release member will tear sheath segments positioned in least one of the second portion or the intermediate portion of the removable sheath before tearing sheath segments positioned in the first portion of the removable sheath, wherein the first portion is distal to the second portion.

35. The apparatus of claim 33, wherein the stent graft further comprises a first branch portion in communication with the main body portion.

36. The apparatus of claim 33, wherein the catheter body comprises an outer sheath with a proximal and distal end, an inner core that extends through the outer sheath and is axially moveable with respect to the outer sheath.

37. The apparatus of claim 33, further comprising a hollow guidewire having at least a portion thereof slidably positioned within the catheter body, wherein in use when the flexible catheter body has been introduced through a first patient access site, the hollow guidewire is coupled with the removable sheath to withdraw the hollow guidewire through the second access site after the main body portion of the stent graft has been deployed the removable sheath through the second access site.

38. The apparatus of claim 37, wherein the deployment system further comprises an inner core wire slidably positionable within the hollow guidewire.

39. The apparatus of claim 33, wherein the stent graft further comprises a second branch portion and the apparatus further comprises a second branch restraint constraining the second branch portion of the stent graft.

40. The deployment system of claim 33, wherein at least a portion of the first portion of the removable sheath defines a smaller cross-sectional diameter or size as compared to the intermediate portion of the removable sheath.

41. The apparatus of claim 40, wherein a distal portion of the deployment system comprises an annular channel or depression, and at least a portion of the first portion of the removable sheath is in contact with the annular channel or depression.

42. The apparatus of claim 33, wherein the plurality of perforations are linearly arranged along the length of at least a portion of the main branch restraint.

43. The apparatus of claim 33, wherein the release wire loops around each and all of the plurality of sheath segments.

44. An apparatus for deploying a stent graft in a passageway, comprising:

a flexible catheter having a proximal end portion and a distal end portion and an outer sheath, wherein in use at least the distal end portion of the catheter is introduced through a first access site in a patient'"'"'s vasculature;

a bifurcated stent graft supported by a distal end portion of the catheter, the stent graft comprising a main body portion, a first branch portion in communication with the main body portion, and a second branch portion in communication with the main body portion;

a main body restraint comprising a sheath that surrounds and constrains at least a portion of the main body portion the main body restraint sheath comprising a plurality of segments between perforations in the main body restraint sheath, wherein at least one of the perforations is positioned closer to a distal end of the main branch restraint sheath than another of the perforations; and

a retraction wire coupled to the main body restraint;

wherein;

the outer sheath is axially retractable from a first position to at least a second position;

a distal end portion of the outer sheath is positioned closer to the distal end portion of the flexible catheter when the outer sheath is in the first position than when the outer sheath is in the second position;

the distal end portion of the outer sheath is positioned closer to the distal end portion of the flexible catheter than a proximal portion of the outer sheath;

a distal portion of the retraction wire is supported within the distal end portion of the outer sheath when the outer sheath is in the first position;

the retraction wire exits the distal end portion of the outer sheath when the catheter is in a pre-deployment state such that the retraction wire does not pass through the proximal end portion of the outer sheath;

retraction of the outer sheath exposes the retraction wire and releases the retraction wire from within the distal end portion of the outer sheath;

the stent graft, the removable sheath, and the distal end portion of the catheter in use are advanced into the passageway through the first access site in the patient'"'"'s body;

in use a proximal end portion of the retraction wire is retrieved through a second access site in the patient'"'"'s body;

the main body restraint is withdrawn by withdrawing the retraction wire through the second access site; and

the second access site is separate and apart from than the first access site.

45. The apparatus of claim 44, wherein the apparatus further comprises a first branch restraint constraining the first branch portion of the stent graft.

46. The apparatus of claim 44, further comprising a release wire attached to the removable sheath, wherein the release wire in use tears portions of the removable sheath when the release wire is proximally retracted.

47. The apparatus of claim 44, wherein the release wire is coupled with the removable sheath such that at least one of a proximal portion or an intermediate portion of the main body portion of the stent graft is deployable before a distal portion of the main body portion when the release wire is proximally retracted.

48. The apparatus of claim 44, wherein the removable sheath comprises a plurality of segments between perforations formed therein.

49. The apparatus of claim 44, wherein the outer sheath has a proximal and distal end and the catheter comprises an inner core that extends through the outer sheath and is axially moveable with respect to the outer sheath, and a distal tip that is positioned adjacent the distal end of the outer sheath and is coupled to the inner core.

50. The apparatus of claim 44, wherein the retraction wire is a hollow guidewire.

51. The apparatus of claim 50, wherein the deployment system further comprises a wire slidably positionable within the hollow guidewire.

52. The apparatus of claim 44, wherein the stent graft further comprises a second branch restraint constraining the second branch portion of the stent graft.

53. The apparatus of claim 52, wherein the retraction wire is also coupled to the second branch restraint such that withdrawal of the retraction wire through the second access site will also result in the withdrawal of the second branch restraint through the second access site.

54. The apparatus of claim 44, wherein the first access site is either one of the ipsilateral iliac artery and the contralateral iliac artery, and the second access site is the other of the ipsilateral iliac artery and the contralateral iliac artery.

55. The deployment system of claim 44, wherein the removable sheath has a first end portion defining a smaller cross-sectional diameter or size as compared to a middle portion of the removable sheath.

56. The apparatus of claim 55, wherein a distal portion of the apparatus comprises an annular channel or depression that receives the first end portion of the removable sheath.