DOCKING APPARATUS AND METHODS OF USE

• US 20090319029A1
• Filed: 06/04/2009
• Published: 12/24/2009
• Est. Priority Date: 06/04/2008
• Status: Abandoned Application

• Current Assignee: Endologix
• Original Assignee: Nellix, Inc.
• Inventors: Evans, Michael A., Kumar, Anant, Lee, Amy, Ganpath, Raj P., Rao, K.T. Venkateswara, Watanabe, Gwendolyn A., Tzvetanov, Ivan, Herbowy, Steven L.
• Application Number:
  US12/478,208
• Publication Number:
  US 20090319029A1
• Time in Patent Office: Days
• US Class Current: 623/1.350
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• 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 2/90 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 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/0034 D-shaped

Abstract

A system for treating an aneurysm in a blood vessel comprises a docking scaffold having with upstream and downstream ends, and a central passageway therebetween. The upstream end engages the blood vessel upstream of the aneurysm. A portion of a first and second scaffolds are slidably received in the central passageway such that an outside surface of the first and second scaffolds engage an inside surface of the docking scaffold. A double-walled filling structure has outer and inner walls and the filling structure is adapted to be filled with a hardenable fluid filling medium so that the outer wall conforms to an inside surface of the aneurysm and the inner wall forms a substantially tubular lumen to provide a path for blood flow therethrough. The double-walled filling structure is coupled with at least one of the first and second leg scaffolds in expanded configuration.

Claims

1. A system for treating an aneurysm in a blood vessel, said system comprising:

a docking scaffold radially expandable from a contracted configuration to an expanded configuration and having an upstream end, a downstream end and a central passageway therebetween, wherein in the expanded configuration the upstream end engages a portion of the blood vessel upstream of the aneurysm;

a first leg scaffold radially expandable from a contracted configuration to an expanded configuration, wherein a portion of the first leg scaffold is slidably received in the central passageway such that an outside surface of the first leg scaffold in the expanded configuration engages an inside surface of the docking scaffold;

a second leg scaffold radially expandable from a contracted configuration to an expanded configuration, wherein a portion of the second leg scaffold is slidably received in the central passageway such that an outside surface of the second leg scaffold in the expanded configuration engages an inside surface of the docking scaffold, and

a first double-walled filling structure, the filling structure having an outer wall and an inner wall, wherein the filling structure is adapted to be filled with a hardenable fluid filling medium so that the outer wall conforms to an inside surface of the aneurysm and the inner wall forms a first substantially tubular lumen to provide a path for blood flow therethrough,

wherein the first double-walled filling structure is coupled with at least one of the leg scaffolds in the expanded configuration.

2. A system as in claim 1, wherein in the expanded configuration the outer surface of the first leg scaffold engages the outer surface of the second leg scaffold in the expanded configuration to define a mating region, wherein the mating region is disposed at least partially within the central passageway.

3. A system as in claim 2, wherein the mating region forms a generally double D-shaped cross-section.

4. A system as in claim 1, wherein the first leg and the second leg scaffolds cross each other as they traverse the aneurysm.

5. A system as in claim 1, wherein the downstream end of the docking scaffold is disposed upstream of the aneurysm.

6. A system as in claim 1, wherein the downstream end of the docking scaffold is disposed in the aneurismal sac.

7. A system as in claim 1, wherein the downstream end of the docking scaffold is disposed below the aneurysm.

8. A system as in claim 1, wherein the docking scaffold is disposed in the blood vessel so as to traverse a renal artery bifurcation without inhibiting blood flow thereto.

9. A system as in claim 1, further comprising a second double-walled filling structure, the second filling structure having an outer wall and an inner wall, wherein the second filling structure is adapted to be filled with a hardenable fluid filling medium so that the outer wall conforms to an inside surface of the aneurysm and the inner wall forms a second substantially tubular lumen to provide a path for blood flow therethrough,

wherein the second double-walled filling structure is coupled with the second leg scaffold in the expanded configuration.

10. A system as in claim 1, further comprising a third double-walled filling structure, the third filling structure having an outer wall and an inner wall, wherein the third filling structure is adapted to be filled with a hardenable fluid filling medium so that the outer wall conforms to an inside surface of the aneurysm and the inner wall forms a third substantially tubular lumen to provide a path for blood flow therethrough,

wherein the third double-walled filling structure is disposed at least partially over the docking scaffold in the expanded configuration.

11. A system as in claim 10, wherein an upstream portion of the docking scaffold remains uncovered by the third double-walled filling structure in the expanded configuration.

12. A system as in claim 11, wherein the uncovered upstream portion engages the blood vessel in the expanded configuration.

13. A system as in claim 10, wherein when filled with filling medium, the third double-walled filling structure seals an upper portion of the aneurysm thereby preventing blood flow between the outer wall of the third double-walled filling structure and an inner wall of the blood vessel.

14. A system as in claim 10, wherein a downstream portion of the docking scaffold remains uncovered by the third double-walled filling structure in the expanded configuration.

15. A system as in claim 1, wherein the docking scaffold comprises an expandable region, the expandable region adapted to linearly expand and contract.

16. A system as in claim 1, wherein the docking scaffold comprises an external flange.

17. A system as in claim 1, wherein the docking scaffold comprises a self-expanding region and a balloon expandable region.

18. A system as in claim 1, wherein the docking scaffold comprises a restraining element, the restraining element limiting expansion of at least a portion of the docking scaffold to a target diameter.

19. A system as in claim 18, wherein the restraining element comprises a band disposed around the docking scaffold.

20. A system as in claim 18, wherein the restraining element forms a tapered region on one end of the docking scaffold in the expanded configuration.

21. A system as in claim 1, wherein the docking scaffold comprises an expandable restraining element, the expandable restraining element limiting expansion of at least a portion of the docking scaffold to a target diameter.

22. A system as in claim 1, wherein an upstream portion of the first leg scaffold remains uncovered in the expanded configuration.

23. A system as in claim 1, wherein a downstream portion of the first leg scaffold remains uncovered in the expanded configuration.

24. A system as in claim 23, wherein the downstream portion of the first leg scaffold is disposed in an iliac artery.

25. A system as in claim 1, wherein an upstream portion of the second leg scaffold remains uncovered in the expanded configuration.

26. A system as in claim 1, wherein a downstream portion of the second leg scaffold remains uncovered in the expanded configuration.

27. A system as in claim 26, wherein the downstream portion of the second leg scaffold is disposed in an iliac artery.

28. A system as in claim 1, wherein at least one of the first or second leg scaffolds comprise an external flange.

29. A system as in claim 1, wherein at least one of the first or second leg scaffolds comprise a self-expanding region and a balloon expandable region.

30. A system as in claim 1, wherein the first leg scaffold comprises a sealing element disposed at least partially along the portion of the first leg scaffold slidably received in the central passageway, the sealing element forming a seal between the outside surface of the first leg scaffold in the expanded configuration and the inside surface of the docking scaffold.

31. A system as in claim 30, wherein the sealing element is expandable.

32. A system as in claim 1, wherein the second leg scaffold comprises a sealing element disposed at least partially along the portion of the second leg scaffold slidably received in the central passageway, the sealing element forming a seal between the outside surface of the second leg scaffold in the expanded configuration and the inside surface of the second leg scaffold.

33. A system as in claim 32, wherein the sealing element is expandable.

34. A system as in claim 1, further comprising a third leg scaffold radially expandable from a contracted configuration to an expanded configuration, wherein a portion of the third leg scaffold is slidably received by the first or second leg scaffold such that a surface of the third leg scaffold in the expanded configuration engages a surface of the first or second leg scaffold.

35. A system as in claim 34, wherein a portion of the third leg scaffold is slidably received by the first or second leg scaffold such that an inside surface of the third leg scaffold in the expanded configuration engages an outside surface of the first or second leg scaffold.

36. A system as in claim 34, wherein the upstream end of the third leg scaffold is disposed in an iliac artery.

37. A system as in claim 34, further comprising a fourth double-walled filling structure, the fourth filling structure having an outer wall and an inner wall, wherein the fourth filling structure is adapted to be filled with a hardenable fluid filling medium so that the outer wall conforms to an inner surface of the aneurysm and the inner wall forms a fourth substantially tubular lumen to provide a path for blood flow therethrough,

wherein the fourth double-walled filling structure is coupled with the third leg scaffold.

38. A system as in claim 34, further comprising a fourth leg scaffold radially expandable from a contracted configuration to an expanded configuration, wherein a portion of the fourth leg scaffold is slidably received by the second leg scaffold such that a surface of the fourth leg scaffold in the expanded configuration engages a surface of the second leg scaffold, and wherein an inside surface of the fourth leg scaffold in the expanded configuration engages an outside surface of the second leg scaffold.

39. A system as in claim 38, further comprising a fifth double-walled filling structure, the fifth filling structure having an outer wall and an inner wall, wherein the fifth filling structure is adapted to be filled with a hardenable fluid filling medium so that the outer wall conforms to an inner surface of the aneurysm and the inner wall forms a fifth substantially tubular lumen to provide a path for blood flow therethrough,

wherein the fifth double-walled filling structure is coupled with the fourth leg scaffold.

40. A system as in claim 1, further comprising a crown scaffold radially expandable from a contracted configuration to an expanded configuration and having an upstream portion and a downstream portion, wherein the downstream portion of the crown scaffold is slidably received by the upstream end of the docking scaffold.

41. A system as in claim 40, wherein in the expanded configuration the downstream portion of the crown scaffold is slidably received in the central passageway such that an outside surface of the crown scaffold engages an inside surface of the docking scaffold.

42. A system as in claim 1, wherein the docking scaffold comprises a divider disposed within the docking scaffold and adapted to separate the slidably received portion of the first leg scaffold and from the slidably received portion of second leg scaffold.

43. A system as in claim 1, wherein the downstream end of the docking scaffold is bifurcated into a first portion and a second portion, wherein the first portion is adapted to slidably receive the first leg and the second portion is adapted to slideably receive the second leg.

44. A method for treating an aneurysm in a blood vessel, said method comprising:

advancing a docking scaffold through the blood vessel to a position upstream of the aneurysm;

radially expanding the docking scaffold from a contracted configuration to an expanded configuration, wherein in the expanded configuration the docking scaffold engages a portion of the blood vessel upstream of the aneurysm;

advancing a first leg scaffold through the blood vessel toward the docking scaffold so that the first leg scaffold is slidably received by the docking scaffold;

radially expanding the first leg scaffold from a contracted configuration to an expanded configuration, wherein in the expanded configuration the first leg scaffold engages at least a portion of an inner surface of the docking scaffold;

advancing a second leg scaffold through the blood vessel toward the docking scaffold so that the second leg scaffold is slidably received by the docking scaffold;

radially expanding the second leg scaffold from a contracted configuration to an expanded configuration, wherein in the expanded configuration the second leg scaffold engages at least a portion of the inner surface of the docking scaffold;

advancing a first double-walled filling structure through the blood vessel toward the aneurysm; and

filling the first double-walled filling structure with a fluid filling medium so that an outer wall of the first filling structure conforms to an inside surface of the aneurysm and an inner wall of the first filling structure forms a first substantially tubular lumen to provide a first blood flow path across the aneurysm,

wherein the first filling structure is coupled with at least one of the leg scaffolds in the expanded configuration.

45. A method as in claim 44, wherein advancing the docking scaffold comprises positioning at least a portion of the docking scaffold upstream of the aneurysm.

46. A method as in claim 44, wherein advancing the docking scaffold comprises positioning at least a portion of the docking scaffold across the aneurysm.

47. A method as in claim 44, wherein advancing the docking scaffold comprises positioning at least a portion of the docking scaffold downstream of the aneurysm.

48. A method as in claim 44, wherein advancing the docking scaffold comprises positioning at least a portion of the docking scaffold across a renal artery bifurcation without obstructing blood flow into the renal artery.

49. A method as in claim 44, further comprising restraining a portion of the docking scaffold during radial expansion.

50. A method as in claim 49, wherein restraining a portion of the docking scaffold forms a region of the docking scaffold having a constant predetermined diameter.

51. A method as in claim 49, wherein restraining a portion of the docking scaffold forms a tapered region.

52. A method as in claim 49, wherein restraining comprises limiting radial expansion of the docking scaffold with a band disposed circumferentially therearound.

53. A method as in claim 44, wherein radially expanding the first leg scaffold and second leg scaffold to the expanded configuration comprises engaging the first leg scaffold with the second leg scaffold.

54. A method as in claim 44, wherein advancing the first leg scaffold and second leg scaffold comprises crossing the first leg scaffold with the second leg scaffold.

55. A method as in claim 44, further comprising advancing a second double-walled filling structure through the blood vessel toward the aneurysm.

56. A method as in claim 55, further comprising filling the second double-walled filling structure with a fluid filling medium so that an outer wall of the second filling structure conforms to an inside surface of the aneurysm and an inner wall of the second filling structure forms a second substantially tubular lumen to provide a second blood flow path across the aneurysm,

wherein the second filling structure is disposed at least partially over the second leg scaffold in the expanded configuration.

57. A method as in claim 44, further comprising advancing a third double-walled filling structure through the blood vessel toward the aneurysm.

58. A method as in claim 44, wherein advancing the first leg scaffold comprises positioning a portion of the first leg scaffold in an iliac artery.

59. A method as in claim 44, wherein advancing the second leg scaffold comprises positioning a portion of the second leg scaffold in an iliac artery.

60. A method as in claim 44, further comprising sealing the first leg and the second leg scaffolds within the docking scaffold to prevent blood flow between an outer surface of the first leg and second leg scaffolds and an inner surface of the docking scaffold.

61. A method as in claim 60, wherein sealing comprises inflating a sealing element.

62. A method as in claim 44, further comprising advancing a third leg scaffold through the blood vessel toward the first or second leg scaffold so that the third leg scaffold is slidably received by the first or second leg scaffold;

and

radially expanding the third leg scaffold from a contracted configuration to an expanded configuration, wherein in the expanded configuration the third leg scaffold engages at least a portion of a surface of the first or second leg scaffold.

63. A method as in claim 62, wherein in the expanded configuration the third leg scaffold engages at least a portion of the outside surface of the first or second leg scaffold.

64. A method as in claim 62, further comprising advancing a fourth double-walled filling structure with a fluid filling medium so that an outer wall of the fourth filling structure conforms to an inside surface of the aneurysm and an inner wall of the fourth filling structure forms a fourth substantially tubular lumen to provide a fourth blood flow path.

65. A method as in claim 64, wherein the fourth filling structure is disposed at least partially over the third leg scaffold in the expanded configuration.

66. A method as in claim 62, further comprising advancing a fourth leg scaffold through the blood vessel towards the second leg scaffold so that the fourth leg scaffold is slidably received by the second leg scaffold;

and

radially expanding the fourth leg scaffold from a contracted configuration to an expanded configuration, wherein in the expanded configuration the fourth leg scaffold engages at least a portion of a surface of the second leg scaffold.

67. A method as in claim 66, wherein in the expanded configuration the fourth leg scaffold engages at least a portion of the outside surface of the second leg scaffold.

68. A method as in claim 66, further comprising advancing a fifth double-walled filling structure with a fluid filling medium so that an outer wall of the fifth filling structure conforms to an inside surface of the aneurysm and an inner wall of the fifth filling structure forms a fifth substantially tubular lumen to provide a fifth blood flow path.

69. A method as in claim 68, wherein the fifth filling structure is disposed at least partially over the fourth leg scaffold in the expanded configuration.

70. A method as in claim 44, further comprising:

advancing a crown scaffold through the blood vessel to a position upstream of the aneurysm; and

radially expanding the crown scaffold from a contracted configuration to an expanded configuration, wherein in the expanded configuration the crown scaffold engages the upstream end of the docking scaffold.