Methods for deploying a positioning anchor with a stent-graft

• US 9,113,999 B2
• Filed: 10/22/2007
• Issued: 08/25/2015
• Est. Priority Date: 09/20/2002
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Nellix, Inc.
• Inventors: Taylor, Charles S., Zarins, Christopher, Geshlider, Robert A., Morejohn, Dwight P., Johansson, Peter, McKinley, James T., Vican, Susan W.
• Primary Examiner(s): PELLEGRINO, BRIAN E
• Application Number:
  US11/876,458
• Publication Number:
  US 20080039923A1
• Time in Patent Office: 2,864 Days
• Field of Search: 623/1.11, 623/1.25, 623/1.27, 623/1.28, 623/1.29, 623/1.35, 604/103.07, 604/544, 604/916, 604/918, 606/191, 606/192, 606/194, 606/198
• US Class Current: 1/1
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• 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 2230/0069 cylindrical
• CPC Class Codes: A61F 2240/002 Designing or making customized prostheses
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

A positioning anchor is provided for a stent-graft for implantation to treat a damaged body lumen. The positioning anchor is generally tubular surrounding a primary fluid conduit. Arms extend laterally from the generally tubular structure of the anchor surrounding lateral fluid conduits. The form of these arms is preferably custom configured to match a particular patient'"'"'s luminal geometry. The anchor thus fits within the luminal geometry to remain in a desired fixed position for implantation of the anchor and any stent-graft coupled to the anchor. The anchor is most preferably formed with two walls having a void therebetween which can be filled with fixation media to further secure the anchor at the desired implantation site. A lumen shaper balloon and delivery catheter are also disclosed for proper delivery, expansion and inflation of the positioning anchor and stent-graft elements according to this invention.

Claims

1. A method for deploying a double walled anchor intraluminally at an intersection of a main vessel and at least two branch vessels, the anchor inflatable with a fixation media, the deployment method including the steps of:

providing the anchor, the anchor comprising an inner wall surrounding and defining a primary fluid conduit having an upper opening and a lower opening, an outer wall outside of an exterior of the inner wall, and a fillable void between the inner and outer wall, wherein the inner and outer walls further form at least two arms extending laterally outward from the primary fluid conduit between the upper and lower opening, the inner wall of each arm surrounding and defining at least one lateral fluid conduit in fluid communication with the primary fluid conduit, and wherein the fillable void surrounds the primary fluid conduit, extends into each arm and surrounds each lateral fluid conduit;

collapsing the anchor onto a catheter;

advancing the catheter from a lumen insertion point to an implantation site for the anchor;

expanding the inner wall and the outer wall of the anchor away from the catheter to a desired position for the inner wall so as to facilitate blood flow of the main vessel through the primary fluid conduit after deployment;

expanding each arm of the anchor into a separate branch vessel;

expanding the inner wall of each arm to a desired position for the inner wall so as to facilitate blood flow from the primary fluid conduit through the lateral fluid conduits into the branch vessels after deployment of the anchor; and

substantially filling a space between an outside surface of the outer wall and a wall of each of the main vessel and the branch vessels at the intersection of the main and branch vessels by filling the fillable void between the inner wall and the outer wall with the fixation media to inflate the anchor thereby expanding the outer wall to contact the walls of the main vessel and branch vessels.

2. The deployment method of claim 1, including the further step of supporting the inner wall adjacent an inside surface of the inner wall during said filling step, such that a position of the inner wall is not deflected inward during said filling step.

3. The deploying method of claim 2, wherein said supporting step includes the step of positioning a lumen shaper balloon inside of the inner wall of the anchor during said filling step.

4. The deploying method of claim 3, wherein said expanding step includes the step of inflating the lumen shaper balloon inside of the inner wall until the inner wall and the outer wall are expanded away from the catheter to the desired position for the inner wall, said lumen shaper balloon remaining inflated and adjacent the inner wall during said filling step to provide support for the inner wall.

5. The method of claim 4, wherein inserting each arm into a separate branch vessel comprises inflating a lumen shaper balloon so that at least two portions of the balloon corresponding to the at least two branch vessels expand toward the branch vessels thereby inserting each arm into a corresponding branch lumen.

6. The method of claim 4, wherein expanding the inner wall of each arm comprises inflating the lumen shaper balloon inside of the inner wall until the inner wall is expanded to the desired position for the inner wall so as to redefine a blood flow lumen through the each branch vessel.

7. The deploying method of claim 1, including the further step of allowing the fixation media to set from a more fluid form to a less fluid foam.

8. The deployment method of claim 1, including the further step of diverting fluid flow from passage through the main vessel and branch vessels at the implantation site to a pathway through the catheter, at least during said expanding step and said filling step, such that fluid flow through the main vessel and branch vessels continues.

9. The deployment method of claim 1, including the further step of providing a lumen shaper balloon having a deflated lesser diameter form and an inflated greater diameter form, said inflated greater diameter form having a contour at least partially matching a contour of the anchor adjacent the lateral conduit of the anchor, such that transition of the lumen shaper balloon from the deflated form to the inflated form during said expanding step causes the arm of the anchor adjacent the lateral conduit to be expanded into a lateral lumen extending from a primary lumen in which the implantation site is located.

10. The deployment method of claim 9, including the further steps of:

positioning a radially expandable stent on each of the at least two arms of the anchor and expanding each radially expandable stent until said radially expandable stent assists in engaging each of the at least two arms of the anchor with a branch vessel at the implantation site for the anchor.

11. The deployment method of claim 2, including the further step of coupling a graft to the anchor, the graft having a tubular form surrounding the primary fluid conduit and extending the primary fluid conduit beyond the anchor.

12. The deployment method of claim 11, wherein said coupling step precedes said collapsing step, such that said graft is coupled to the anchor before implantation thereof.

13. The deployment method of claim 12, including the further step of forming the graft together with the anchor before said collapsing step.

14. The deployment method of claim 12, including the further step of attaching the graft to the anchor before said implantation step.

15. The deployment method of claim 11, wherein said coupling step occurs after said advancing step, said coupling step including the step of attaching the graft to the anchor after the anchor has been located at the implantation site for the anchor.

16. The method of claim 1 wherein filling the void between the inner wall and the outer wall with the fixation media expands the outer wall to contact to an inside surface of an aneurysm substantially filling an aneurysmal space occurring at the intersection of the main vessel and branch vessels, thereby forming a redefined blood flow through the aneurysm and supporting the filled aneurysm.

17. The method of claim 1, wherein the void between the inner and outer wall extends over a majority of the inner and outer walls.

18. The method of claim 17, wherein the void between the inner and outer wall extends over substantially the entire inner and outer walls.

19. The method of claim 1, further comprising:

engaging the outer wall of the anchor so that a majority of the outside surface of the outer wall contacts the walls of the at least two branch vessels and the wall of the main vessel and/or aneurysm to securely hold the anchor at the implantation site.

20. The method of claim 1, further comprising:

filling an aneurysmal space between an inside surface of an aneurysm and the outside surface of the outer wall by filling the fillable void with the fixation media thereby expanding the outer wall outward toward the inside surface of the aneurysm.

21. The method of claim 1, wherein the anchor comprises an upper end adjacent the upper opening and a lower end adjacent the lower opening and further comprising expanding a stent adjacent the upper and/or lower end of the anchor to hold the upper and/or lower end of the anchor securely in contact with the wall of the main vessel.