System and methods for endovascular aneurysm treatment

• US 8,906,084 B2
• Filed: 01/07/2010
• Issued: 12/09/2014
• Est. Priority Date: 07/07/2005
• Status: Expired due to Fees

• Current Assignee: Endologix
• Original Assignee: Nellix, Inc.
• Inventors: Evans, Michael A., Watanabe, Gwendolyn A., Lee, Amy, Herbowy, Steven L.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): PRESTON, REBECCA STRASZHEIM
• Application Number:
  US12/684,074
• Publication Number:
  US 20100106087A1
• Time in Patent Office: 1,797 Days
• Field of Search: 623/1.25
• US Class Current: 623/1.25
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12195 comprising a curable material
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• 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 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end

Abstract

Embodiments provide methods and systems for treating aneurysms using filling structures filled with a curable medium. An embodiment of a method comprises positioning at least one double-walled filling structure across the aneurysm and filling the structure(s) with a filling medium so that an outer wall conforms to the inside of the aneurysm and an inner wall forms a generally tubular lumen to provide for blood flow. The lumen is supported with a balloon or other expandable device while and/or after filling. The pressure within the structure and/or in the space between an external wall of the structure and the aneurysm wall is monitored and a flow of the medium into the structure is controlled responsive to the pressure. The pressure can also be used to determine a filling endpoint. The medium is hardened while the lumen remains supported by the balloon. The balloon is then removed after the medium hardens.

Claims

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

a hardenable fluid filling medium;

at least one double-walled filling structure having an outer wall and an inner wall, wherein the at least one double-walled filling structure is adapted to be filled with the hardenable fluid filling medium so that the outer wall conforms to an inside surface of the aneurysm and the inner wall forms a generally tubular lumen providing a path for blood flow therethrough, wherein in use blood flowing through said generally tubular lumen is in direct contact with a surface of the inner wall, and wherein the at least one double-walled filling structure substantially fills the aneurysm when filled with the hardenable fluid filling medium;

a drain device configured to drain blood or other fluid from a space between the aneurysm and the outer wall of the at least one double-walled filling structure so as to relieve pressure in that space wherein the drain device comprises at least one elongate tubular member having a distal portion sufficiently porous so as to receive blood or other fluid from the space therethrough, the porous distal portion having sufficient length so as to allow drainage from multiple locations in the space across the aneurysm; and

a delivery catheter having an expandable support structure which can be positioned within the generally tubular lumen to carry the at least one double-walled filling structure.

9. The system of claim 1, wherein the drain device is configured to remain implanted with the at least one double-walled filling structure to provide for post operative draining of fluid from the space.

10. The system of claim 1, wherein a portion of the drain device proximal of the distal portion is configured to be fluidly coupled to one of an artery or a vein so as to drain blood or other fluid from the space into the artery or vein.

11. The system of claim 10, wherein the portion of the drain device proximal of the distal portion is configured to be fluidly coupled and disposed within an arterial lumen proximal, distal or adjacent the aneurysm so as to drain blood or other fluid from the space into the arterial lumen.

2. The system of 1, wherein the drain device is configured to passively drain by a hydraulic pressure force within the space without the application of an external pressure or vacuum.

3. The system of 1, wherein the drain device is configured to drain by the application of a vacuum.

4. The system of 1, wherein the porous distal portion comprises a plurality of apertures.

5. The system of claim 4, wherein the plurality of apertures are axially distributed along a length of the porous distal portion.

6. The system of claim 4, wherein the porous distal portion is helically disposed around at least a portion of a circumference of the outer wall of the at least one double-walled filling structure.

7. The system of claim 4, wherein the porous distal portion comprises a plurality of connecting porous arm portions distributed around a circumference of the outer wall of the at least one double-walled filling structure.

8. The system of claim 4, wherein the porous distal portion is fixed to the outer wall of the at least one double-walled filling structure.