Stent graft delivery system

• US 8,926,682 B2
• Filed: 09/23/2011
• Issued: 01/06/2015
• Est. Priority Date: 04/25/2008
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Nellix, Inc.
• Inventors: Herbowy, Steven L., Evans, Michael A., Kumar, Anant, Rao, K. T. Venkateswara, Hellewell, Matthew R., Laroya, Gil
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US13/243,941
• Publication Number:
  US 20120016456A1
• Time in Patent Office: 1,201 Days
• Field of Search: 623/1.35
• US Class Current: 623/1.11
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/12195 comprising a curable material
• 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 2002/067 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 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30604 modular
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• 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 2250/006 modular
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/1018 Balloon inflating or inflation-control devices
• CPC Class Codes: A61M 25/10182 Injector syringes
• CPC Class Codes: A61M 25/10187 Indicators for the level of inflation or deflation
• CPC Class Codes: A61M 25/10188 : Inflation or deflation data displays

Abstract

A system for treating an aneurysm comprises an elongate flexible shaft and an expandable member. An expandable scaffold is disposed over the expandable member and may be expanded from a collapsed configuration to an expanded configuration. A double-walled filling structure is disposed over the scaffold and has an outer wall and an inner wall. The filling structure is adapted to be filled with a hardenable fluid filing 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. In the expanded configuration the scaffold engages the inner wall of the filling structure. A tether is releasably coupled with the filling structure and the flexible shaft thereby constraining axial movement of the structures relative to each other.

Claims

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

a first elongate flexible shaft having a proximal region and a distal region;

a first double-walled filling structure disposed over the distal region of the shaft, the filling structure having an outer wall and an inner wall, wherein the filling structure is adapted to be filled with a hardenable fluid filing 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, wherein the first filling structure comprises a first filling tube fluidly coupled therewith and adapted to fill the first filling structure with the filling medium;

at least a first expandable scaffold disposed adjacent the first filling structure, the first scaffold radially expandable within at least a portion of the tubular lumen of the first filling structure,

wherein the first filling structure is separate from the first scaffold;

a first tether releasably coupled with the first filling structure thereby constraining axial movement of the first filling structure relative the first elongate flexible shaft such that the first scaffold and the first filling structure remain concentric with each other along the first flexible shaft during delivery and during deployment of the first scaffold and the first filling structure;

a second elongate flexible shaft;

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 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 path 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,

wherein the second scaffold is separate from the second filling structure; and

a second tether releasably coupled with the second filling structure thereby constraining axial movement of the second filling structure relative the second elongate flexible shaft such that the second scaffold and the second filling structure remain concentric with each other along the second flexible shaft during delivery and during deployment of the second scaffold and the second filling structure.

2. The system according to claim 1, wherein the first scaffold extends proximally of the first filling structure when constrained by the first tether.

3. The system according to claim 1, wherein an axial spacing exists between one end of the first scaffold and one end of the first filling structure when constrained by the first tether.

4. The system according to claim 1, further comprising a first sheath disposed at least partially over the first filling structure the first scaffold disposed concentrically therein.

5. The system according to claim 1, further comprising a pusher tube disposed at least partially over the first flexible shaft and slidably engageable with the first double-walled filling structure.

6. The system according to claim 1, further comprising a pressure monitor, the pressure monitor coupled with the first filling structure so as to permit pressure monitoring of the first filling structure as the first filling structure is filled with the hardenable fluid filling medium.

7. The system according to claim 6, wherein the pressure monitor is fluidly coupled with the first filling structure.

8. The system according to claim 6, wherein the pressure monitor comprises a pressure gage.

9. The system according to claim 6, wherein the pressure monitor comprises a digital display or waveform monitor.

10. The system according to claim 1, further comprising an inflation device fluidly coupled with the first or second filling structure.

11. The system according to claim 10, wherein the inflation device comprises a syringe.

12. The system according to claim 1, wherein the first or second filling structure comprises a relief valve.

13. The system according to claim 12, wherein the first or second filling structure comprises a reservoir fluidly coupled with the relief valve.

14. The system according to claim 13, wherein the reservoir is adapted to receive the hardenable fluid filling medium from the relief valve at a predetermined pressure.

15. The system according to claim 1, further comprising a collapsible member fluidly coupled with a pressure gage, the collapsible member positioned between the outer wall of the first or second filling structure and the inside surface of the aneurysm, the pressure gage adapted to indicate pressure of the respective filling structure as it is filled.

16. The system according to claim 15, wherein the collapsible member comprises a balloon.

17. The system according to claim 1, further comprising a first expandable member expandable from a contracted configuration to an expanded configuration and coupled with the first shaft near the distal region.

18. The system according to claim 17, wherein the first expandable member comprises a balloon.

19. The system according to claim 18, wherein the balloon comprises a pre-shaped, curved or tapered region.

20. The system according to claim 17, wherein the expandable member is coupled to a pressure monitoring device.

21. The system according to claim 1, wherein the first or second scaffold is balloon expandable.

22. The system according to claim 1, wherein the first or second scaffold comprises a metal.

23. The system according to claim 1, wherein the first scaffold, the second scaffold, the first filling structure or the second filling structure carries a therapeutic agent adapted to being released therefrom in a controlled manner.

24. The system according to claim 1, wherein the first or second filling structure comprises a polymer.

25. The system according to claim 1, wherein the first filling tube comprises an inner tube slidably disposed in the first filling tube, both the inner tube and the filling tube fluidly coupled with the first filling structure.

26. The system according to claim 1, further comprising a flowable polymer filling material curable in situ.

27. The system according to claim 1, wherein the first tether extends between the proximal and distal regions of the shaft and is releasable coupled to a proximal end of the filling structure and is configured such that tension applied through the first tether constrains axial movement and reduces axial movement of the proximal end relative the filling structure.

28. The system according to claim 27, wherein a proximal portion of the first tether extends outside of a patient'"'"'s body.

29. The system according to claim 27, wherein a distal end of the first filling structure is directly coupled to a distal region of the first scaffold by one or more sutures.

30. The system according to claim 29, wherein the first scaffold includes one or more eyelets through which the one or more sutures directly couple the first scaffold to the first filling structure.

31. The system according to claim 30, wherein the first flexible shaft comprises an expandable member on the distal end of the first flexible shaft, the first scaffold being crimped on the expandable member at a fixed position such that the first tether and the one or more sutures constrain axial movement of the first filling structure and the first filling structure remains concentric with the first scaffold during delivery and deployment.

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

a first elongate flexible shaft having a proximal region and a distal region;

a first expandable member disposed adjacent the distal region;

a first expandable scaffold disposed over the expandable member, the first scaffold radially expandable from a collapsed configuration to an expanded configuration;

a first double-walled filling structure disposed over the first scaffold, the filling structure having an outer wall and an inner wall, wherein the filling structure is adapted to be filled with a hardenable fluid filing 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,

wherein the first scaffold in the expanded configuration engages the inner wall of the first filling structure;

a first releasable coupling mechanism releasably coupling the first filling structure with the first flexible shaft, wherein the first coupling mechanism constrains axial movement of the first filling structure relative to the flexible shaft such that the first scaffold and the first filling structure remain concentric with each other along the first elongate flexible shaft during delivery and during deployment of the first scaffold and the first filling structure;

a second elongate flexible shaft having a proximal region and a distal region;

a second expandable member disposed adjacent the distal region;

a second expandable scaffold disposed over the second expandable member, the second scaffold radially expandable from a collapsed configuration to an expanded configuration;

a second double-walled filling structure disposed over the second scaffold, 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 filing medium so that the outer wall conforms to an inside surface of the aneurysm and to the first double-walled filling structure, and the inner wall forms a second substantially tubular lumen to provide a path for blood flow,

wherein the second scaffold in the expanded configuration engages the inner wall of the second filling structure;

a second releasable coupling mechanism releasably coupling the second filling structure with the second flexible shaft, wherein the second releasable coupling mechanism constrains axial movement of the second filling structure relative to the second flexible shaft such that the second scaffold and the second filling structure remain concentric with each other along the second elongate flexible shaft during delivery and during deployment of the second scaffold and the second filling structure; and

a filling tube fluidly coupled with the first or second filling structure, the filling tube adapted to deliver the hardenable filling medium to the respective filling structure.

33. The system of claim 32, wherein the first releasable coupling mechanism comprises a first tether.

34. The system of claim 33, further comprising a first lockwire disposed alongside the first flexible shaft, wherein a distal end of the first lockwire is releasably coupled with the first flexible shaft.

35. The system of claim 34, wherein the first flexible shaft comprises a first tapered nosecone having an aperture therein, the first nosecone coupled with the distal region of the first flexible shaft, and wherein the distal end of the first lockwire is releasably coupled with and slidably received in the first nosecone aperture.

36. The system of claim 34, wherein the first tether is releasably coupled to the first lockwire.

37. The system of claim 36, wherein the first filling structure comprises a first tether loop fixedly attached thereto, and wherein the first tether passes through the first tether loop.

38. The system of claim 32, wherein the second coupling mechanism comprises a second tether.

39. The system of claim 38, wherein the second tether is releasably coupled to a second lockwire.

40. The system of claim 39, wherein the second tether is looped around the second lockwire.

41. The system of claim 32, wherein the filling tube comprises an inner filling tube and an outer filling tube slidably disposed thereover, both inner and outer tubes fluidly coupled with the respective filling structure.

42. The system of claim 32, further comprising a stylet disposed in the filling tube.

43. The system of claim 32, further comprising a filling tab fluidly coupled with the respective filling structure and fluidly coupled with the filling tube.

44. The system of claim 32, further comprising a first outer sheath having a lumen, wherein the first filling structure, the first scaffold and the first expandable member are disposed within the first outer sheath lumen during delivery of the system to a treatment site.

45. The system of claim 32, wherein the first or second expandable member comprises an inflatable balloon.

46. The system of claim 45, wherein the balloon comprises a pre-shaped, curved or tapered region.

47. The system of claim 32, further comprising a pressure monitor, the pressure monitor coupled with the first or second filling structure so as to permit pressure monitoring of the filling structure as the filling structure is filled with the hardenable fluid filling medium.

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

a first elongate flexible shaft having a proximal region and a distal region;

a first expandable member disposed adjacent the distal region;

a first expandable scaffold disposed over the expandable member, the first scaffold radially expandable from a collapsed configuration to an expanded configuration;

a first double-walled filling structure disposed over the first scaffold, the filling structure having an outer wall and an inner wall, wherein the filling structure is adapted to be filled with a hardenable fluid filing 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,

wherein the first scaffold in the expanded configuration engages the inner wall of the first filling structure;

a first releasable coupling mechanism releasably coupling the first filling structure with the first flexible shaft, wherein the first coupling mechanism constrains axial movement of the first filling structure relative to the flexible shaft;

a second elongate flexible shaft having a proximal region and a distal region;

a second expandable member disposed adjacent the distal region;

a second expandable scaffold disposed over the second expandable member, the second scaffold radially expandable from a collapsed configuration to an expanded configuration;

a second double-walled filling structure disposed over the second scaffold, 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 filing medium so that the outer wall conforms to an inside surface of the aneurysm and to the first double-walled filling structure, and the inner wall forms a second substantially tubular lumen to provide a path for blood flow,

wherein the second scaffold in the expanded configuration engages the inner wall of the second filling structure;

a second releasable coupling mechanism releasably coupling the second filling structure with the second flexible shaft, wherein the second releasable coupling mechanism constrains axial movement of the second filling structure relative to the second flexible shaft;

a filling tube fluidly coupled with the first or second filling structure, the filling tube adapted to deliver the hardenable filling medium to the respective filling structure; and

a filling tab fluidly coupled with the respective filling structure and fluidly coupled with the filling tube, wherein the filling tab comprises a scored or perforated region adapted to permit separation of the filling tab into two portions, the first portion remaining coupled with the respective filling structure after filling thereof with the hardenable filling medium and the second portion discrete and independent of the first portion.