SEALING APPARATUS AND METHODS OF USE

• US 20090318949A1
• Filed: 06/04/2009
• Published: 12/24/2009
• Est. Priority Date: 06/04/2008
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Nellix, Inc.
• Inventors: Ganpath, Raj P., Rosenberg, Craig, Llamido, Sherwin, Evans, Michael A., Taylor, Charles S., Howell, Thomas A., Lee, Amy, Rao, K.T. Venkateswara, Herbowy, Steven L.
• Granted Patent: US 8,945,199 B2
• Time in Patent Office: Days
• US Class Current: 606/192
• CPC Class Codes: A61F 2/06 Blood vessels
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• 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 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• 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 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A system for treating an aneurysm comprises at least a first double-walled filling structure having an outer wall and an inner wall and the 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 surface forms a generally tubular lumen to provide blood flow. The first filling structure comprises a sealing feature which forms a fluid seal between the filling structure and the aneurysm or an adjacent endograft when the filling structure is filled with the hardenable fluid filling medium, thereby minimizing or preventing blood flow downstream of the seal.

Claims

1. A system for treating an aneurysm, said system comprising:

at least a first double-walled 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 the inside surface of the aneurysm and the inner surface forms a generally tubular lumen to provide blood flow,

wherein the first filling structure comprises a sealing feature, the sealing feature forming a fluid seal between the filling structure and the aneurysm or an adjacent endograft when the filling structure is filled with the hardenable fluid filling medium, thereby minimizing or preventing blood flow downstream of the seal.

2. A system as in claim 1, wherein the seal is disposed in a neck of the aneurysm.

3. A system as in claim 1, wherein the seal is disposed upstream of the aneurysm.

4. A system as in claim 1, wherein the tubular lumen has a substantially circular cross-section.

5. A system as in claim 1, wherein the first filling structure comprises an elliptical cross-section when filled with the hardenable filling medium.

6. A system as in claim 1, wherein the edges of the first filling structure are sealed together and adapted to withstand a filling pressure of up to 300 mm above normal systolic pressure without bursting.

7. A system as in claim 1, further comprising a thrombogenic material.

8. A system as in claim 7, wherein the thrombogenic material is selected from the group consisting of polyurethane, polycarbonate, polyester, ePTFE, polyolefin, parylene, gelatin and silicone.

9. A system as in claim 7, wherein the thrombogenic material is formed into one of sutures, felts, velours, weaves, knits, hydrogels, foams, coils, sheets and combinations thereof.

10. A system as in claim 7, wherein the thrombogenic material is coupled with an outer surface of the first double-walled filling structure.

11. A system as in claim 7, wherein the thrombogenic material comprises a thrombogenic drug.

12. A system as in claim 1, wherein the inner and outer walls comprise ePTFE.

13. A system as in claim 12, wherein the inner and outer walls are at least partially covered with polyurethane.

14. A system as in claim 1, wherein the first filling structure has a main body with a main body width and the sealing feature comprises a narrow neck region coupled with the main body, the narrow neck region having a width less than the main body width.

15. A system as in claim 1, wherein the sealing feature comprises a flat shoulder on an upper portion of the filling structure.

16. A system as in claim 14, wherein the narrow neck region width is approximately 2% to approximately 20% of the main body width.

17. A system as in claim 1, wherein the sealing feature comprises a tapered shoulder region on an upper portion of the filling structure.

18. A system as in claim 1, wherein the first filling structure comprises an upper layer of material having an upper layer width and a lower layer of material having a lower layer width wider than the upper layer width, the upper and lower layers fixedly coupled together so as to form the sealing feature, the sealing feature comprising a substantially flat upper outer surface and an arcuate lower outer surface when the first filling structure is filled with hardenable filling medium.

19. A system as in claim 18, wherein the first filling structure comprises a D-shaped cross-section when filled with hardenable filling medium.

20. A system as in claim 1, wherein the sealing feature comprises a tapered region in the tubular lumen, the taper disposed near an upper portion of the first filling structure.

21. A system as in claim 20, wherein the tapered region flares inwardly from the upper portion of the first filling structure to a lower portion of the first filling structure.

22. A system as in claim 1, wherein the first filling structure comprises an upper layer of material and a lower layer of material, wherein at least a portion of the upper layer is fixedly coupled with at least a portion of the lower layer of material, the sealing feature comprising an upper filling region and a lower filling region formed by the seal, two upper and lower filling regions in fluid communication with one another.

23. A system as in claim 22, wherein the upper filling region holds a smaller volume of filling medium than the lower filling region.

24. A system as in claim 22, wherein the upper and lower layers of material are sealed along a line.

25. A system as in claim 24, wherein the line extends from an outer edge of the first filling structure inward towards the tubular lumen.

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

a second double-walled 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 the inside surface of the aneurysm and the inner surface forms a generally tubular lumen to provide blood flow,

wherein the second filling structure comprises a sealing feature, the sealing feature forming a fluid seal between the filling structure and the aneurysm or an adjacent endograft when the second filling structure is filled with the hardenable fluid filling medium, thereby minimizing or preventing blood flow downstream of the seal,

wherein the sealing feature of first double-walled filling structure comprises an outer surface having a first shape and the sealing feature of the second double-walled filling structure comprises an outer surface having a second shape, the second shape complementary to the first shape.

27. A system as in claim 26, wherein the first and second shapes comprise complementary tapers.

28. A system as in claim 1, wherein the sealing feature comprises a foam filled region of the first filling structure.

29. A system as in claim 1, wherein the foam filled region is discrete from the remainder of the first filling structure.

30. A system as in claim 29, wherein the discrete foam filled region is fluidly isolated from the region filled with the hardenable filling medium.

31. A system as in claim 1, wherein the sealing feature comprises an arm in fluid communication with the region filled with the hardenable filling medium.

32. A system as in claim 1, wherein the sealing feature comprises a slot substantially transverse to a longitudinal axis of the first double-walled filling structure, the slot at least partially bisecting the first double-walled filling structure into two fillable sections.

33. A system as in claim 1, wherein the sealing feature comprises a winged region, the winged region flaring radially outward from the first double-walled filling structure.

34. A system as in claim 33, wherein the winged region comprises a tapered shoulder on an outer surface of the first double-walled filling structure.

35. A system as in claim 33, wherein the sealing feature further comprises a tapered lower region in the tubular lumen, the taper flaring radially outward from an upper part to a lower part of the first filling structure.

36. A system as in claim 33, wherein the sealing feature comprises a restraining element disposed at least partially around the tubular lumen, the restraining element adapted to restrict radial expansion of the tubular lumen to a predetermined size or shape.

37. A system as in claim 36, wherein the restraining element comprises a band extending circumferentially around the tubular lumen.

38. A system as in claim 1, wherein the sealing feature comprises an enlarged head region and a tapered lower region of the first filling structure, the tapered region flaring radially outward as the distance from the head region increases.

39. A system as in claim 1, wherein the sealing feature comprises a lower tubular cuff region coupled with the first filling structure and a winged portion of the first filling structure.

40. A system as in claim 39, wherein the sealing feature further comprises an upper tubular cuff region coupled with the first filling structure.

41. A system as in claim 1, wherein the sealing feature comprises a skeletal frame disposed in between the inner and outer walls of the first filling structure and wherein the inner wall radially expands inward as the first filling structure is filled with hardenable filling material.

42. A system as in claim 1, wherein the first filling structure is disposed on the inside surface of a radially expandable scaffold and the sealing feature comprises a portion of the inner wall adapted to radially expand inward to engage and seal against an adjacent endograft.

43. A system as in claim 33, wherein the sealing feature comprises an angled bottom edge of the first filling structure.

44. A system as in claim 43, wherein the first filling structure comprises a straight top edge and the angled bottom edge forms an acute angle relative thereto.

45. A system as in claim 1, wherein the sealing feature comprises a discrete filling compartment separate from the filling space of the first double-walled filling structure and fluidly uncoupled thereto.

46. A system as in claim 45, wherein the discrete filling compartment comprises a rectangular shaped region.

47. A system as in claim 45, wherein the filling medium surrounds the discrete filling compartment.

48. A system as in claim 45, further comprising an elongate flexible filling tube slidably engageable with the discrete filling compartment and the filling space.

49. A system as in claim 1, wherein the sealing feature comprises a shoulder disposed on a lower portion of the first filling structure.

50. A system as in claim 49, wherein the first filling structure has a main body width and the shoulder has a shoulder width less than the main body width.

51. A system as in claim 1, wherein the sealing feature comprises an undercut region of the first filling structure, the undercut region adapted to expand outwardly when the first filling structure is filled with hardenable filling material.

52. A system as in claim 1, wherein the sealing feature comprises a plurality of filaments coupled with the first filling structure and extending axially therefrom.

53. A system as in claim 52, wherein the filaments comprise a thrombogenic material.

54. A system as in claim 1, wherein the sealing feature comprises a cape disposed at least partially over the first filling structure and coupled thereto, the cape comprising a thrombogenic material.

55. A system as in claim 1, wherein the sealing feature comprises an annular ring disposed at least partially around the first filling structure, the ring comprising a thrombogenic material.

56. A system as in claim 1, wherein the sealing feature comprises a plurality of flanges coupled with the first filling structure.

57. A system as in claim 56, wherein each of the plurality of flanges have a width, the width progressively decreasing relative to an adjacent flange.

58. A system as in claim 56, wherein each of the plurality of flanges have a thickness, the thickness progressively decreasing relative to an adjacent flange.

59. A system as in claim 1, wherein the sealing feature comprises a skeletal frame coupled with the first filling structure.

60. A system as in claim 59, wherein the skeletal frame comprises a plurality of self-expanding struts, the self-expanding struts adapted to radially expand outward along with the outer wall of the first filling structure.

61. A system as in claim 59, wherein the skeletal frame comprises a wire-like helically shaped filament.

62. A system as in claim 59, wherein the skeletal frame comprises nitinol.

63. A system as in claim 1, wherein the sealing feature comprises an upper and a lower tubular shaped cuff coupled with the first filling structure.

64. A system as in claim 63, wherein at least one of the upper or lower tubular shaped cuffs comprises a reinforced region.

65. A system as in claim 64, wherein the reinforced region comprises a wire-like frame.

66. A system as in claim 63, wherein the upper and the lower cuffs are coupled together with a plurality of struts.

67. A system as in claim 1, wherein the sealing feature comprises a pair of fillable legs coupled with the first filling structure.

68. A system as in claim 1, wherein the sealing feature comprises a first region of the first filling structure having a first compliance and a second region of the first filling structure having a second compliance different than the first compliance.

69. A system as in claim 1, wherein the sealing feature comprises a first embossed region on the first filling structure and a second non-embossed region on the first filling structure.

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

71. A system as in claim 70, wherein the tubular support comprises a balloon.

72. A system as in claim 1, further comprising a scaffold radially expandable from a collapsed configuration to an expanded configuration.

73. A system as in claim 1, further comprising a filling port fluidly coupled with the filling structure, the filling port adapted to receive the hardenable filling medium and also adapted to provide a seal to prevent leakage thereof.

74. A system as in claim 73, wherein the filling port comprises an elastomeric plug.

75. A system as in claim 1, wherein the inner or the outer wall comprises a first layer of a first material and a second layer of a second material different than the first material.

76. A system as in claim 1, further comprising a filling port substantially contained within the inner lumen of the filling structure when the filling structure is filled with the hardenable filling medium.

77. A system for treating an aneurysm, said system comprising:

at least a first double-walled 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 the inside surface of the aneurysm and the inner surface forms a generally tubular lumen to provide blood flow; and

a filling port substantially contained within the generally tubular lumen of the filling structure when the filling structure is filled with the hardenable fluid filling medium.

78. A system as in claim 77, wherein the first filling structure comprises a sealing feature, the sealing feature forming a fluid seal between the filling structure and the aneurysm or an adjacent endograft when the filling structure is filled with the hardenable fluid filling medium, thereby reducing or preventing blood flow downstream of the seal.

79. A system as in claim 78, wherein the sealing feature comprises tapered shoulder region on at least one end of the filling structure.

80. A system as in claim 79, wherein the filling port is substantially contained within the tubular lumen of the filling structure.

81. A system as in claim 77, wherein the outer wall is invaginated into the filling structure forming a convex exterior surface on one end of the filling structure when the filling structure is filled with the hardenable fluid filling medium.

82. A system as in claim 81, wherein the convex exterior surface tapers radially inwardly and merges with the tubular lumen.

83. A system as in claim 81, wherein the outer wall is invaginated into the filling structure forming a second convex exterior surface on a second end of the filling structure when the filling structure is filled with the hardenable fluid filling medium, the second end opposite of the first end.

84. A system as in claim 83, wherein the second convex exterior surface tapers radially inwardly and merges with the tubular lumen.

85. A system as in claim 77, wherein a first end of the generally tubular lumen comprises an invaginated tapered portion that flares radially outward.

86. A system as in claim 85, wherein a second end of the generally tubular lumen comprises an invaginated tapered portion that flared radially outward, the second end opposite of the first end.