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

• US 8,870,941 B2
• Filed: 10/31/2011
• Issued: 10/28/2014
• Est. Priority Date: 07/22/2004
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Nellix, Inc.
• Inventors: Evans, Michael A., Watanabe, Gwendolyn A., Lee, Amy, Herbowy, Steven L.
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US13/285,897
• Publication Number:
  US 20120046684A1
• Time in Patent Office: 1,093 Days
• Field of Search: 606/191, 606/192, 606/194, 606/195, 606/200, 60410101-10105, 623/1.25, 623/1.27, 623/1.32, 623/1.24, 623/1.35, 623/1.11, 623/1.16
• US Class Current: 623/1.16
• 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 double-walled filling structure is adapted to be filled with a hardenable fluid filling medium so that when the first filling structure is deployed across the aneurysm,the outer wall conforms to the inside surface of the aneurysm across the aneurysm and the inner wall forms a first generally tubular lumen to provide a path for blood flow across the aneurysm such that blood flow is in direct contact with the inner wall along the first generally tubular lumen;

at least a first scaffold separate from the first double-walled filling structure which can be expanded within at least a portion of the first tubular lumen of the filling structure;

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 double-walled filling structure in the aneurysm and to be filled with a hardenable fluid filling medium so that when the second filling structure is deployed across the aneurysm, the outer wall conforms to the inside surface of the aneurysm across the aneurysm and to the first double-walled filling structure and forms a second generally tubular lumen to provide a path for blood flow across the aneurysm such that blood flow is in direct contact with the inner wall along the second generally tubular lumen; and

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

2. A system as in claim 1, wherein the first scaffold extends over substantially an entire length of the first generally tubular lumen extending through the first double-walled filling structure.

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

4. A system as in claim 1, further comprising at least two scaffolds for placing in the first generally tubular lumen, wherein the at least two scaffolds are separate from the first filing structure.

5. A system as in claim 4, wherein the at least two scaffolds are adapted to be placed in series.

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

7. A system as in claim 1, wherein substantially the entire first double-walled filling structure is formed from a compliant material.

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

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

10. A system as in claim 9, wherein the expandable tubular support is adapted to extend upstream and downstream from the first double-walled filling structure so that tubular support aligns and conforms each end of the first double-walled filling structure with the blood vessel.

11. A system as in claim 9, wherein the tubular support comprises an inflatable support balloon having a non-compliant structure.

12. A system as in claim 11, wherein the tubular support comprises a mechanical structure expandable to one or more fixed diameters.

13. A system as in claim 1, wherein each of the first and second scaffold have an end, wherein respective ends of the first and second scaffolds are adapted to extend outwardly in parallel in at least one direction from their respective tubular lumens into the adjacent blood vessel.

14. A system as in claim 13, wherein said respective ends have complementary shapes that are adapted to together conform to the wall of the adjacent blood vessel.

15. A system as in claim 14, wherein said respective ends have mating D-shaped cross-sections.

16. A system as in claim 1, 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.

17. A system as in claim 16, wherein the expandable support on each of the first and second delivery catheter is adapted to extend upstream and downstream from the respective double-walled filling structure so that the expandable support aligns and conforms each end of the respective double-walled filling structure with the iliac and aorta.

18. A system as in claim 16, wherein the expandable support on each delivery catheter comprises a mechanical structure expandable to one or more fixed diameter.

19. A system as in claim 1, further comprising a hardenable fluid filling medium including a flowable polymer which is curable in situ.

20. A system as in claim 1, wherein the hardenable fluid filling medium has a specific gravity in the range from 0.1 to 5 when hardened.