Introducer for an iliac side branch device

• US 9,788,982 B2
• Filed: 08/26/2014
• Issued: 10/17/2017
• Est. Priority Date: 10/14/2003
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation, Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Hartley, David Ernest, Anderson, John Lennon, Greenberg, Roy K., Stelter, Wolf
• Primary Examiner(s): OU, JING RUI
• Application Number:
  US14/469,268
• Publication Number:
  US 20140364934A1
• Time in Patent Office: 1,148 Days
• 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 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• 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 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/962 having an outer sleeve
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• 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
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2002/9665 with additional retaining means

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 (22) 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 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 second 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 a portion that extends out of the main lumen at the proximal stent graft end and into a groove in a nose cone;

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

advancing the second guide wire across the bifurcation such that a portion of the second 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 first guide wire catheter of the introducer 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 third branch ostium;

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

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

removing the second guide wire;

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

advancing a second introducer having leg extension over the third guide wire, through the auxiliary sheath, into the proximal end of the main body, into 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;

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

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

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

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

5. The method of claim 1, wherein the step of advancing the leg extension comprises introducing a second introducer including the leg extension.

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. 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 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 retractible sheath disposed over the branched stent graft, a first guide wire catheter, a second guide wire catheter, an outer catheter disposed over the first guide wire catheter and the second guide wire catheter and disposed within the retractible sheath,

wherein the second 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 out of the main lumen at the proximal stent graft end and into a groove in a nose cone;

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

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

advancing the first 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 retractible sheath from the branched stent graft to expose the branched stent graft;

advancing an auxiliary sheath into the second common iliac artery, over the bifurcation and into the branch of the branched stent graft;

removing the second guide wire;

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, into the proximal end of the main body, into the lumen of the main body, into the branch of the branched stent graft, and at least partially into the internal iliac artery;

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