Graft systems having filling structures supported by scaffolds and methods for their use

• US 20060212112A1
• Filed: 04/28/2006
• Published: 09/21/2006
• Est. Priority Date: 07/22/2004
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Nellix, Inc.
• Inventors: Evans, Michael A., Lee, Amy, Watanabe, Gwendolyn A., Herbowy, Steven L.
• Granted Patent: US 8,048,145 B2
• Time in Patent Office: Days
• US Class Current: 623/1.250
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• 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 2230/0034 D-shaped
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

Aneurysms are treated by filling at least one double-walled filling structure with a curable medium within the aneurysm. The filling structures may be delivered over balloon deployment mechanisms in order to shape and open tubular lumens therethrough. Scaffolds are placed into the tubular lumens in order to help maintain the shape, anchor the filling structures in place, and provide improved blood flow transition into and out of the tubular lumens.

Claims

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

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

at least a first scaffold separate from the first filling structure which can be expanded within at least a portion of the tubular lumen of the filling structure.

2. A system as in claim 1, wherein the scaffold extends over substantially the entire length of the generally tubular lumen.

3. A system as in claim 1, wherein the scaffold extends outwardly from at least one end of the generally tubular lumen into the adjacent blood vessel.

4. A system as in claim 3, wherein the scaffold extends outwardly from both ends of the generally tubular lumen into the adjacent blood vessel.

5. A system as in claim 1, comprising at least two scaffolds for placing in the tubular lumen.

6. A system as in claim 5, wherein the scaffolds are adapted to be placed in series.

7. A system as in claim 5, wherein the scaffolds are adapted to be overlapped with one another and/or attached to each other.

8. A system as in claim 1, wherein the scaffold is elastic and adapted to self-expand from a constrained configuration to a deployed configuration.

9. A system as in claim 8, wherein the scaffold is a self-expanding mesh.

10. A system as in claim 1, wherein the scaffold is malleable and adapted to be balloon expanded from a narrow diameter configuration to a deployed configuration.

11. A system as in claim 1, wherein the scaffold comprises a metal frame.

12. A system as in claim 11, wherein at least a portion of the metal frame is covered with a membrane.

13. A system as in claim 12, wherein a portion of the scaffold which is to be positioned with the tubular lumen is covered with the membrane and a portion which is to extend beyond the tubular lumen is not covered.

14. A system as in claim 1, wherein at least an outer wall of the filling structure is formed from a compliant material.

15. A system as in claim 1, wherein substantially the entire filling structure is formed from a compliant material.

16. A system as in claim 1, wherein at least a portion of an exterior surface of the filling structure is modified to enhance sealing or tissue ingrowth.

17. A system as in claim 16, wherein the surface modification comprises surface roughening, a foam layer, fibers, flocking, stipples, or drug coating.

18. A system as in claim 1, wherein at least a portion of an interior surface of the filling structure is modified to enhance hardening of the structure.

19. A system as in claim 18, wherein the surface modification comprises surface roughening, rings, stipples, flocking, a foam layer, or fibers.

20. A system as in claim 1, further comprising a delivery catheter having an expandable tubular support which can be positioned within the first tubular lumen to carry the double-walled filling structure.

21. A system as in claim 20, wherein the expandable tubular support extends upstream and downstream from the double-walled filling structure so that tubular support aligns and conforms each end of the filling structure with the blood vessel.

22. A system as in claim 20, wherein the tubular support comprises an inflatable support balloon having a non-compliant structure.

23. A system as in claim 22, wherein the tubular support comprises a mechanical structure expandable to one or more fixed diameters.

24. A system as in claim 1, further comprising:

a second double-walled filling structure having an outer wall and an inner wall, wherein said second double-walled filling structure is adapted to be placed adjacent to the first filling structure in the aneurysm and to be filled with a hardenable fluid filling medium so that the outer wall conforms to the inside surface of the aneurysm and to the first filling structure and forms a second generally tubular lumen to provide a bath for blood flow; and

at least a second scaffold separate from the first scaffold and the filling structures which can be expanded within at least a portion of the second tubular lumen of the second filling structure.

25. A system as in claim 24, wherein the second scaffold extends over substantially the entire length of the second generally tubular lumen.

26. A system as in claim 24, wherein the second scaffold extends outwardly from at least one end of the second generally tubular lumen into the adjacent blood vessel.

27. A system as in claim 24, wherein the second scaffold extends outwardly from both ends of the second generally tubular lumen.

28. A system as in claim 24, comprising at least two scaffolds for placing in the tubular lumen of the second double-walled filling structure.

29. A system as in claim 28, wherein the scaffolds are adapted to be placed in series.

30. A system as in claim 28, wherein the scaffolds are adapted to be overlapped with one another.

31. A system as in claim 24, wherein the second scaffold is elastic and adapted to self-expand from a constrained configuration to a deployed configuration.

32. A system as in claim 24, wherein the second scaffold is malleable and adapted to be balloon expanded from a narrow diameter configuration to a deployed configuration.

33. A system as in claim 24, wherein the second scaffold is a self-expanding mesh.

34. A system as in claim 24, wherein the second scaffold comprises a metal frame.

35. A system as in claim 34, wherein at least a portion of the metal frame is covered with a membrane.

36. A system as in claim 35, wherein a portion of the second scaffold which is to be positioned with the tubular lumen is covered with the membrane and a portion which is to extend beyond the tubular lumen is not covered.

37. A system as in claim 24, wherein respective ends of the first and second scaffolds extend outwardly in parallel in at least one direction from their respective tubular lumens into the adjacent blood vessel.

38. A system as in claim 37, wherein said respective ends have complementary shapes to together conform to the wall of the adjacent blood vessel.

39. A system as in claim 38, wherein said respective ends have mating D-shaped cross-sections.

40. A system as in claim 38, wherein said respective ends have mating C-shaped cross-sections.

41. A system as in claim 24, wherein further comprising;

a first delivery catheter having an expandable support which can be positioned within the tubular lumen of the first double-walled filling structure; and

a second delivery catheter having an expandable support which can be positioned within the tubular lumen of the second double-walled filling structure.

42. A system as in claim 41, wherein the expandable support on each delivery catheter extends upstream and downstream from the double-walled filling structure so that tubular support aligns and conforms each end of the filling structure with the iliac and aorta.

43. A system as in claim 24, wherein at least an outer wall of each filling structure is formed from a compliant material.

44. A system as in claim 24, wherein substantially the entire filling structure is formed from a non-compliant material.

45. A system as in claim 24, wherein the expandable support comprises an inflatable support balloon having a compliant structure.

46. A method as in claim 24, wherein the expandable support on each delivery catheter comprises a mechanical structure expandable to one or more fixed diameter.

47. A system as in claim 24, wherein at least a portion of an exterior surface is modified to enhance sealing or tissue ingrowth.

48. A system as in claim 47, wherein the surface modification comprises roughening, a foam layer, fibers, or drug coating.

49. A system as in claim 24, further comprising a filling material including a flowable polymer which is curable in situ.

50. A system as in claim 24, wherein the polymer comprises a polyurethane, a polyethylene glycol, a collagen.

51. A system as in claim 24, wherein the filling material has a specific gravity in the range from 0.1 to 5 when hardened.

52. A system as in claim 24, wherein the filling material comprises a two-part curable material which hardens after mixing.

53. A method for treating an aneurysm, said method comprising:

positioning at least a first double-walled filling structure across the aneurysm;

filling the at least first filling structure with a fluid filling medium so that an outer wall conforms to an inside surface of the aneurysm and an inner wall forms a first generally tubular lumen to provide a first blood flow path across the aneurysm; and

placing at least a first scaffold within at least a portion of the first generally tubular lumen.

54. A method as in claim 53, further comprising hardening the filling material in the first filling structure.

55. A method as in claim 53, wherein placing the scaffold comprises releasing an elastic scaffold structure within the tubular lumen after the filling structure has been filled.

56. A method as in claim 53, wherein placing the scaffold comprises inflating an expansion member within a malleable scaffold structure after the filling structure has been filled.

57. A method as in claim 55, wherein the scaffold is placed after the filling of the filling structure but before the material has hardened.

58. A method as in claim 55, wherein the scaffold is placed after the filling material has hardened.

59. A method as in claim 53, wherein the scaffold is placed to extend over substantially the entire length of the generally tubular lumen.

60. A method as in claim 53, wherein the scaffold is placed to extend outwardly from at least one end of the generally tubular lumen into the adjacent blood vessel.

61. A method as in claim 53, wherein the scaffold is placed to extend outwardly from both ends of the generally tubular lumen into the adjacent blood vessel.

62. A method as in claim 53, comprising placing at least two scaffolds in the tubular lumen.

63. A method as in claim 62, wherein the scaffolds are placed in series.

64. A method as in claim 62, wherein the scaffolds are overlapped with one another.

65. A method as in claim 53, wherein the scaffold is elastic and released from a constraint to self-expand from a constrained configuration to a deployed configuration.

66. A method as in claim 65, wherein the scaffold is a self-expanding mesh.

67. A method as in claim 53, wherein the scaffold is malleable and balloon expanded from a narrow diameter configuration to a deployed configuration.

68. A method as in claim 53, wherein the scaffold comprises a metal frame.

69. A method as in claim 68, wherein at least a portion of the metal frame is covered with a membrane.

70. A method as in claim 69, wherein a portion of the scaffold which is to be positioned with the tabular lumen is covered with the membrane and a portion which is to extend beyond the tubular lumen is not covered.

71. A method as in claim 53, further comprising supporting the first tubular lumen while and/or after the filling structure is being filled.

72. A method as in claim 71, wherein the tubular lumen support extends upstream and downstream from the double-walled filling structure so that tubular support aligns and conforms each end of the filling structure with the blood vessel.

73. A method as in claim 53, wherein at least an outer wall of the filling structure is formed from a non-compliant material.

74. A method as in claim 73, wherein substantially the entire filling structure is formed from a non-compliant material.

75. A method as in claim 73, wherein the tubular support comprises an inflatable support balloon having a compliant structure.

76. A method as in claim 73, wherein the tubular support comprises a mechanical structure expandable to one or more fixed diameters.

77. A method as in claim 53, wherein the filling structure is filled with fluid filling medium at filling pressure and the inflatable support balloon is inflated at an inflation pressure which is great than the filling pressure.

78. A method as in claim 77, wherein the filling pressure is in the range from 100 mm Hg to 1000 mm Hg and the inflation pressure is in the range from 200 mm Hg to 5000 mm Hg.

79. A method as in claim 53, further comprising positioning an anchor or sealing element of at least one opening from the tubular lumen of the filling structure to a lumen of the blood vessel.

80. A method as in claim 79, further comprising positioning an anchor or sealing element at each opening.

81. A method as in claim 53, wherein the filling material comprises a flowable polymer which is curable in situ.

82. A method as in claim 81, wherein the polymer comprises a polyurethane, a polyethylene glycol, a collagen.

83. A method as in claim 81, wherein the filling material has a density in the range form 0.1 gm/cc to 5 gm/cc when hardened.

84. A method as in claim 81, wherein the filling material comprises a two-part curable material which hardened after mixing.

85. A method as in claim 53, further comprising:

positioning at least a second double-walled filling structure across the aneurysm adjacent to the first double-walled filling structure;

filling the at least second double-walled filling structure with a fluid filling medium so that an outer wall of the second filling structure conforms to both the inside of the aneurysm and the outer wall of the first filling structure and that an inner wall of the second filling structure forms a second generally tubular lumen to provide a second blood flow path across the aneurysm; and

placing at least a second scaffold with at least a portion of the second generally tubular lumen.

86. A method as in claim 85, further comprising hardening the filling material in the second filling structure.

87. A method as in claim 86, comprising:

supporting the tubular lumen of the first filling structure while an/or after the first filling structure is being filled; and

supporting the tubular lumen of the second filling structure while and/or after the second filling structure is being filled.

88. A method as in claim 87, further comprising:

removing support from the tubular lumen of the first filling structure after the filling material has hardened; and

removing support from the tubular lumen of the second filling structure after the filling material has hardened.

89. A method as in claim 87, wherein the tubular lumen support extends upstream and downstream from each double-walled filling structure so that tubular support aligns and conforms each end of the filling structure with the iliac and aorta.

90. A method as in claim 87, wherein at least an outer wall of the filling structure is formed from a non-compliant material.

91. A method as in claim 90, wherein substantially the entire filling structure is formed from a non-compliant material.

92. A method as in claim 87, wherein the tubular support comprises an inflatable balloon having a compliant structure.

93. A method as in claim 87, wherein the tubular support comprises a mechanical structure expandable to one or more fixed diameters.

94. A method as in claim 87, wherein each filling structure is filled with fluid filling medium at filling pressure and each inflatable support balloon is inflated at an inflation pressure which is great than the filling pressure.

95. A method as in claim 94, wherein the filling pressure is in the range from 100 mm Hg to 1000 mm Hg and the inflation pressure is in the range from 200 mm Hg to 5000 mm Hg.

96. A method as in claim 87, wherein the scaffold provides an anchor or sealing element of at least one opening from the tubular lumen of at least one of the filling structures to a lumen of the iliac or aorta.

97. A method as in claim 96, wherein the scaffold provides an anchor or sealing element at each opening.

98. A method as in claim 87, wherein the filling material comprises a flowable polymer which is curable in situ.

99. A method as in claim 98, wherein the polymer comprises a polyurethane, a polyethylene glycol, a collagen.

100. A method as in claim 98, wherein the filling material has a specific gravity in the range from 0.1 to 5 when hardened.

101. A method as in claim 98, wherein the filling material comprises a two-part curable material which hardens after mixing.

102. A system as in claim 98, further comprising a filling material including a flowable polymer which is curable in situ.

103. A system as in claim 98, wherein the polymer comprises a polyurethane, a polyethylene glycol, a collagen.

104. A system as in claim 53, wherein the respective ends of the first and second scaffolds extend outwardly in parallel in at lest one direction from their respective tubular lumens into the adjacent blood vessel.

105. A system as in claim 104, wherein said respective ends have complementary shapes to together conform to the wall of the adjacent blood vessel.

106. A system as in claim 105, wherein said respective ends have mating D-shaped cross-section.

107. A system as in claim 105, wherein said respective ends have mating C-shaped cross-sections.