Introducer for a side branch device

• US 10,201,414 B2
• Filed: 09/20/2017
• Issued: 02/12/2019
• Est. Priority Date: 10/14/2003
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation, Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cleveland Clinic Foundation, Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Hartley, David Ernest, Anderson, John Lennon, Greenberg, Roy K., Stelter, Wolf
• Primary Examiner(s): Ou, Jing
• Application Number:
  US15/710,255
• Publication Number:
  US 20180008396A1
• Time in Patent Office: 510 Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/962 having an outer sleeve
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires

Abstract

An introduction arrangement for a fenestrated or branched stent graft (13) intended for deployment into the lumen of a vessel having a blind vessel extending from it. The introducer (1) has a distal end intended to remain outside a patient in use and a proximal end with a nose cone dilator (11) and an arrangement to retain the branched stent graft distally of the nose cone dilator. A sheath (15) on the introducer extends over the branched stent graft to the nose cone dilator. An indwelling catheter (21) extends from the distal end of the introducer and enters the fenestration or side arm and through to the nose cone dilator, the indwelling catheter has a guide wire (29) extending through it. The guide wire can be extended beyond the nose cone dilator in use before the sheath is withdrawn from the branched stent graft so that it can be snared from the contra-lateral artery.

Claims

1. A method of deploying a branched stent graft into a body vessel having a main vessel, the body vessel having a first branch vessel extending from the main vessel, a second branch vessel extending from the main vessel, a bifurcation between the first and second branch vessels, and a third vessel extending from the first branch vessel and having an ostium;

the branched stent graft comprising a main body having a distal end, a proximal end with a main lumen therethrough, at least two main body stents, and a branch extending from the main body between the main body distal end and the main body proximal end and having an end more proximate the main body proximal end, the branch having a branch lumen therethrough in fluid communication with the main lumen, a distal open end, and a stent adjacent the distal open end;

the method comprising;

providing an introducer including the branched stent graft, the introducer comprising a sheath disposed over the branched stent graft, a first guide wire catheter configured to receive a first guide wire, a second guide wire catheter configured to receive a second guide wire, the second guide wire catheter disposed at least partially adjacent the first guide wire catheter, an outer catheter disposed over the first guide wire catheter and the second guide wire catheter and disposed within the sheath,

wherein the first guide wire catheter has a portion that extends from a distal portion of the introducer to the distal open end of the branch, a portion that extends outside of and at least partially along the main body of the branched stent graft, a portion that extends into the distal open end of the branch and through the branch lumen to the main lumen, and toward the proximal end of the branched stent graft;

advancing the first guide wire across the bifurcation such that a portion of the first guide wire is disposed in one of the first and second branches and another portion is disposed in the branch lumen of the branched stent graft;

advancing the second guide wire into the first branch vessel and past the bifurcation;

advancing the second guide wire catheter of the introducer with the branched stent graft over the second guide wire;

aligning the branched stent graft such that the distal opening of the branch is above the third branch ostium;

at least partially removing the sheath from the branched stent graft to expose the branched stent graft;

advancing an auxiliary sheath over the first guide wire and into the second branch vessel, over the bifurcation and into the branch of the branched stent graft;

advancing a third guide wire through the auxiliary sheath and into the branch of the branched stent graft and into the third branch vessel;

advancing a second introducer having leg extension over the third guide wire, through the auxiliary sheath, through the proximal end of the main body, through the lumen of the main body, into the branch of the branched stent graft, and at least partially into the third branch vessel;

deploying the leg extension at least partially in the branch lumen and at least partially in the third branch vessel;

expanding the leg extension to engage the branch and the third branch vessel;

releasing the distal end of the branched stent graft from the introducer.

2. The method of claim 1, wherein the first guide wire is introduced into the introducer and the branched stent graft by way of the first guide wire catheter.

3. The method of claim 2, wherein the first guide wire is advanced through the first guide wire catheter.

4. The method of claim 1, including introducing a snare to snare the first guide wire and place it across the bifurcation.

5. The method of claim 1, wherein the second introducer has a tapered nose cone.

6. The method of claim 5, wherein the second introducer comprises a balloon.

7. The method of claim 6, wherein the leg extension comprises a balloon expandable stent.

8. The method of claim 1, wherein the step of releasing the distal end of the branched stent graft comprises withdrawing a wire from the distal end of the branched stent graft.

9. The method of claim 1, further comprising retracting the second guide wire.

10. The method of claim 1, further comprising retracting the second guide wire catheter.

11. The method of claim 1, wherein the introducer comprises a nose cone dilator comprising a longitudinal groove.

12. The method of claim 11, wherein the first guide wire is advanced through the longitudinal groove.

13. A method of deploying a branched stent graft into a first common iliac artery of an abdominal aorta below a point of bifurcation between the first common iliac artery and a second common iliac artery and at a junction of the first common iliac artery and an internal iliac artery having an internal iliac ostium, the method comprising:

providing a branched stent graft comprising a main body having a distal end, a proximal end with a main lumen therethrough, and at least two main body stents, a branch extending from the main body between the main body distal end and the main body proximal end and having an end more proximate the main body proximal end, the branch having a branch lumen therethrough in fluid communication with the main lumen, a distal open end, and a stent adjacent the distal open end;

providing a delivery device including the branched stent graft, the delivery device comprising a retractable sheath disposed over the branched stent graft, a first guide wire catheter, a second guide wire catheter at least partially adjacent the first guide wire catheter, an outer catheter disposed over the first guide wire catheter and the second guide wire catheter and disposed within the retractable sheath,

wherein the first guide wire catheter has a portion that extends from a distal portion of the delivery device to the distal open end of the branch, a portion that extends outside of and at least partially along the main body of the branched stent graft, a portion that extends into the distal open end of the branch and through the branch lumen to the main lumen, and a portion that extends through the main lumen to a nose cone;

advancing a first guide wire across the aortic bifurcation such that a portion of the first guide wire is disposed in the first common iliac artery and extends into the first guide wire catheter and another portion is disposed in the second common iliac artery;

advancing a second guide wire into the first common iliac artery and extending it past the aortic bifurcation;

advancing the second guide wire catheter of the delivery device with the branched stent graft over the first guide wire;

aligning the branched stent graft such that the distal opening of the branch is above the internal iliac ostium;

at least partially removing the retractable sheath from the branched stent graft to expose the branched stent graft;

advancing an auxiliary sheath over the first guide wire and into the second common iliac artery, over the bifurcation, through the proximal end of the branched stent graft, and into the branch of the branched stent graft;

advancing a third guide wire through the auxiliary sheath, into the branch of the branched stent graft, and into the internal iliac artery;

advancing a leg extension over the third guide wire, through the auxiliary sheath, through the proximal end of the main body, through the lumen of the main body, through the branch of the branched stent graft, and at least partially into the internal iliac artery;

expanding the leg extension such that a first end of the leg extension resides in the branch of the branched stent graft and a second end of the leg extension resides in the internal iliac artery; and

releasing the distal end of the branched stent graft from the delivery device.

14. The method of claim 13, further comprising the step of retracting the second guide wire catheter.

15. The method of claim 13, further comprising snaring the first guide wire.

16. The method of claim 13, wherein the step of partially removing the retractable sheath from the branched stent graft comprises exposing the branch of branched stent graft.

17. The method of claim 13, further comprising retracting the second guide wire.

18. The method of claim 13, further comprising retracting the second guide wire catheter.

19. The method of claim 13, wherein the delivery device comprises a nose cone dilator comprising a longitudinal groove.

20. The method of claim 19, wherein the first guide wire is advanced through the longitudinal groove.