Stent graft delivery system

• US 9,730,700 B2
• Filed: 04/23/2015
• Issued: 08/15/2017
• Est. Priority Date: 04/25/2008
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Nellix, Inc.
• Inventors: Venkateswara Rao, K. T., Kumar, Anant, Herbowy, Steven L., Evans, Michael A., Hellewell, Matthew R., Laroya, Gil
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US14/586,110
• Publication Number:
  US 20150216535A1
• Time in Patent Office: 845 Days
• 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:

an 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 across the aneurysm;

at least a first expandable scaffold disposed at least partly within the filling structure during delivery, the first scaffold radially expandable within at least a portion of the tubular lumen of the filling structure, wherein the first scaffold and the first double-walled filling structure are distinctly separate elements; and

one or more tethers coupling the first scaffold to the first filling structure, wherein the one or more tethers are configured to limit axial movement of the first filling structure relative the first scaffold so that the first scaffold and the first filling structure remain concentric with each other along the first flexible shaft during delivery and deployment of the first scaffold and the first double-walled filling structure, wherein the one or more tethers comprise a first releasable coupling mechanism that limits axial movement of the first filling structure relative the first scaffold.

2. The system of claim 1, wherein the first releasable coupling mechanism comprises a thin flexible rod that traverses the first filling structure and has a distal-most portion that extends substantially parallel to a longitudinal axis of the filling structure and one or more guides attached to the first filling structure through which the rod extends.

3. The system of claim 2, wherein the one or more guides comprise one or more loops.

4. The system of claim 2, wherein the one or more guides comprise one or more eyelets.

5. The system of claim 2, wherein the one or more guides comprise at least a first guide near a distal end of the filling structure and a second guide near a proximal end of the filling structure such that when the thin flexible rod extends through the first and second guides during delivery, axial movement of the proximal end relative a distal end of the filling structure is inhibited.

6. The system of claim 2, wherein the rod comprises a lock wire or a tether.

7. The system of claim 2, wherein the thin flexible rod extends proximally outside the patient during delivery so as to allow proximal retraction of the thin rod to withdraw the thin flexible rod from the one or more guides to release the filling structure from the coupling mechanism.

8. The system of claim 7, wherein the thin flexible rod extends distal of the one or more guides to the distal region of the elongate rod.

9. The system of claim 8, wherein the thin flexible rod is releasably coupled with a distal nosecone dispose on a distal end of the elongate shaft.

10. The system of claim 9, wherein the distal nosecone includes an aperture through which the thin flexible rod extends.

11. The system of claim 2, wherein the thin flexible rod comprises a lock wire and the one or more guides comprises a loop, wherein the releasable coupling mechanism further includes a hollow post through which the lock wire extends that includes an aperture near a distal region thereof, wherein the loop extends around a portion of the lock wire exposed within the aperture during delivery of the filling structure.

12. The system of claim 1 further comprising:

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

a second double-walled filling structure disposed over the distal region of the second 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 across the aneurysm; and

a second expandable scaffold disposed at least partly within the second filling structure during delivery, the second scaffold radially expandable within at least a portion of the tubular lumen of the second filling structure.

13. The system of claim 12, further comprising:

a second releasable coupling mechanism that limits axial movement of the second filling structure relative the first scaffold such that the second scaffold and the second filling structure remain concentric with each other along the second flexible shaft during delivery and deployment of the second scaffold and second filling structure.

14. The system of claim 13, wherein the second releasable coupling mechanism comprises a second thin flexible rod that traverses the second filling structure and has a distal-most portion that extends substantially parallel to a longitudinal axis of the filling structure and one or more guides attached to the second filling structure through which the rod extends.

15. The system of claim 14, wherein the one or more guides comprise at least a first guide near a distal end of the filling structure and a second guide near a proximal end of the filling structure such that when the second rod extends through the first and second guides during delivery, axial movement of the proximal end relative a distal end of the filling structure is inhibited.

16. The system of claim 14, wherein the second rod extends proximally outside the patient during delivery so as to allow proximal retraction of the thin rod to withdraw the thin flexible rod from the one or more guides to release the filling structure from the coupling mechanism.

17. The system of claim 14, wherein the thin flexible rod comprises a lock wire and the one or more guides comprises a loop, wherein the releasable coupling mechanism further includes a hollow post through which the lock wire extends that includes an aperture near a distal region thereof, wherein the loop extends around a portion of the lock wire exposed within the aperture during delivery of the filling structure.

18. The system of claim 1, further comprising one or both of:

a pressure monitor, the pressure monitor coupled with the filling structure so as to permit pressure monitoring of the filling structure as the filling structure is filled with the hardenable fluid filling medium; and

a visual indicator fluidly coupled therewith and having first and second positions, wherein the indicator moves from the first position to the second position when a predetermined pressure is applied to the visual indicator.

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

an 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 across the aneurysm;

at least a first expandable scaffold disposed at least partly within the filling structure during delivery, the first scaffold radially expandable within at least a portion of the tubular lumen of the filling structure, wherein the first scaffold and the first double-walled filling structure are distinctly separate elements;

a plurality of tether loops coupling the first scaffold to the first filling structure, the plurality of tether loops being distributed about a proximal end of each of the first filling structure and the first scaffold so as to limit axial movement of the first filling structure relative the first scaffold during delivery so that the first scaffold and the first filling structure remain concentric with each other during delivery and deployment; and

a first releasable coupling mechanism configured to limit relative movement of the first double-walled filling structure and the first expandable scaffold and release from the elongate flexible shaft to facilitate delivery and deployment.

20. The system of claim 19, wherein the first releasable coupling mechanism comprises a first tether interfacing with a first tether loop attached to the first double-walled filling structure.

21. The system of claim 20, wherein the first releasable coupling mechanism further comprises a lockwire releasably coupled to the first tether.