Methods and systems for aneurysm treatment using filling structures

• US 20070150041A1
• Filed: 05/31/2006
• Published: 06/28/2007
• Est. Priority Date: 12/22/2005
• Status: Abandoned Application

• Current Assignee: Endologix
• Original Assignee: Nellix, Inc.
• Inventors: Evans, Michael, Watanabe, Gwendolyn, Lee, Amy, Herbowy, Steven
• Application Number:
  US11/444,603
• Publication Number:
  US 20070150041A1
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2002/065 Y-shaped blood vessels
• 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 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

Aneurysms are treated by placing a scaffold across an aneurysmal sac to provide a blood flow lumen therethrough. An aneurysmal space surrounding the scaffold is filled with one or more expandable structures which are simultaneously or sequentially expanded to fill the aneurysmal space and reduce the risk of endoluminal leaks and scaffold migration. The expandable structures are typically inflatable and delivered by delivery catheter, optionally with an inflation tube or structure attached to the expandable structure.

Claims

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

placing a scaffold across the aneurysm to define an aneurysmal space between an outside surface of the scaffold and an inside surface of an aneurysmal wall; and

expanding at least one expandable structure with an expansion medium which passes by or through the scaffold or the aneurysmal wall to fill at least a portion of the aneurysmal space.

2. A method as in claim 1, wherein the scaffold comprises a bare stent.

3. A method as in claim 2, wherein the stent is balloon expandable in the aneurysm.

4. A method as in claim 2, wherein the stent is self-expanding in the aneurysm.

5. A method as in claim 1, wherein the scaffold comprises an at least partially covered graft.

6. A method as in claim 5, wherein the graft is balloon expandable in the aneurysm.

7. A method as in claim 5, wherein the graft is self-expanding in the aneurysm.

8. A method as in claim 1, wherein the aneurysm circumscribes the blood vessel and the scaffold defines an annular aneurysmal space.

9. A method as in claim 8, wherein the aneurysm is an aorta.

10. A method as in claim 9, wherein the aneurysm is in the abdominal aorta.

11. A method as in claim 9, wherein the aneurysm is in the thoracic aorta.

12. A method as in claim 8, wherein expandable structures are expanded to fill substantially all the annular aneurysmal space.

13. A method as in claim 1, wherein placing comprises placing a single scaffold across the aneurysm.

14. A method as in claim 1, wherein the blood vessel bifurcates from one main vessel to two branch vessels;

and

at least two parallel scaffolds across the aneurysm with at least one scaffold extending separately into each branch vessel.

15. A method as in claim 1, wherein placing comprises placing a bifurcated scaffold in the main vessel with one leg of the bifurcation extending into each branch of the main vessel.

16. A method as in claim 1, wherein expanding comprises inflating an inflatable structure with an inflation medium.

17. A method as in claim 16, wherein the inflatable structure is at least partly elastic.

18. A method as in claim 16, wherein the inflatable structure is at least partly inelastic.

19. A method as in claim 1, wherein expanding comprises extruding the expandable structure with the expansion medium.

20. A method as in claim 1, wherein expanding comprises positioning at least one delivery catheter inside of the scaffold and delivering the expansion medium through the delivery catheter.

21. A method as in claim 20, wherein expanding further comprises delivering the expandable structure through the delivery catheter prior to or simultaneous with delivering the expansion medium.

22. A method as in claim 1, wherein expanding comprises positioning at least one delivery catheter past one end of the scaffold and delivering the expansion medium through the delivery catheter.

23. A method as in claim 22, wherein expanding further comprises delivering the expandable structure through the delivery catheter prior to delivering the expansion medium.

24. A method as in claim 1, further comprising penetrating the aneurysmal wall from the outside to access the aneurysmal space.

25. A method as in claim 24, further comprising passing a cannula through the penetration and delivering the expandable structure and the expansion medium through the cannula.

26. A method as in claim 1, wherein expanding comprises expanding at least two expandable structures.

27. A method as in claim 26, wherein expanding comprises expanding at least five expandable structures.

28. A method as in claim 26, wherein said at least two expandable structures are expanded simultaneously.

29. A method as in claim 26, wherein said at least two expandable structures are expanded sequentially.

30. A method as in claim 1, wherein two or more delivery catheters are positioned simultaneously to deliver the expansion medium.

31. A method as in claim 1, wherein two or more delivery catheters are positioned sequentially to deliver the expansion medium.

32. A method as in claim 1, wherein the at least one expandable structure is positioned in the aneurysm prior to placing the scaffold across the aneurysm.

33. A method as in claim 1, wherein the scaffold is placed across the aneurysm prior to placing the at least one expandable structure.

34. A method as in claim 1, wherein the expansion medium comprises a liquid, a foam, a gel, a polymer, or a gas.

35. A method as in claim 34, wherein the expansion medium hardens after expanding the expandable structure.

36. A method as in claim 1, wherein the expansion medium comprises a powder, pellets, or coils.

37. A method as in claim 1, further comprising controlling pressurization within the aneurysmal space as the expandable structure is expanded.

38. A method as in claim 37, wherein the controlling pressurization comprises selectively bleeding expansion medium from the expandable structure if pressure within the aneurysmal space is excessive.

39. A method as in claim 38, wherein selectively bleeding comprises connecting a drain tube or lumen to the expandable structure to remove the expansion medium.

40. A method as in claim 37, wherein controlling pressurization comprises bleeding fluid from the aneurysmal space as the expandable structure is expanded.

62. A method as in claim 1, wherein the scaffold carries a medicament which elutes from the scaffold after implantation.

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

a scaffold adapted to be placed across the aneurysm;

an expandable structure adapted to be expanded with an expansion medium and to at least partly fill an aneurysmal space between an outside of the scaffold and an inside surface of the aneurysm; and

a delivery catheter for delivering the expansion medium to the expandable structure when the expandable structure is positioned in the aneurysmal space.

42. A system as in claim 41, wherein the scaffold comprises a bare stent.

43. A system as in claim 42, wherein the stent is balloon expandable.

44. A system as in claim 42, wherein the stent is self-expanding.

45. A system as in claim 41, wherein the scaffold comprises an at least partially covered stent.

46. A system as in claim 45, wherein the graft is balloon expandable.

47. A system as in claim 45, wherein the graft is self-expandable.

48. A system as in claim 41, wherein the scaffold has a window for receiving the delivery catheter.

49. A system as in claim 41, wherein the scaffold is adapted to cross an abdominal aortic aneurysm or a thoracic aortic aneurysm.

50. A system as in claim 49, wherein the scaffold comprises a bifurcated stent having a main body adapted to lie in the aorta and a pair of legs adapted to enter the iliac arteries.

51. A system as in claim 49, wherein the scaffold comprises a pair of stents adapted to be positioned in parallel in the aorta and to each enter one of the iliac arteries.

52. A system as in claim 41, wherein the expandable structure comprises an inflatable structure.

53. A system as in claim 52, wherein the inflatable structure is at least partly elastic.

54. A system as in claim 52, wherein the inflatable structure is at least partly inelastic.

55. A system as in claim 52, wherein the inflatable structure has a valve which removably couples to the delivery catheter.

56. A system as in claim 55, wherein the valve is self-closing when detached from the delivery catheter.

57. A system as in claim 41, comprising at least two expandable structures.

58. A system as in claim 57, comprising of at least five expandable structures.

59. A system as in claim 41, wherein the expandable structure is adapted to conform around the scaffold.

60. A system as in claim 59, wherein the expandable structure has a channel for receiving the scaffold.

61. A system as in claim 41, further comprising a cannula for penetrating the aneurysm from the outside to access the aneurysmal space and deliver the expandable structure and the delivery catheter to the aneurysmal space.

63. A system as in claim 41, wherein the scaffold carries a medicament which elutes from the scaffold after implantation.