Introducer for an iliac side branch device

• US 9,782,284 B2
• Filed: 08/26/2014
• Issued: 10/10/2017
• 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:
  US14/469,234
• Publication Number:
  US 20140364931A1
• Time in Patent Office: 1,141 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. An introduction arrangement for a branched stent graft intended for deployment into the lumen of a vessel having a branch vessel extending therefrom;

the introduction arrangement comprising an introducer in combination with the branched stent graft;

the branched stent graft comprising a main body having a distal end and a proximal end with a main lumen therethrough, a branch extending externally from the main body between the main body distal end and the main body proximal end, the branch having a branch lumen therethrough in fluid communication with the main lumen and a distal open end;

the introducer having a distal region intended to remain outside a patient in use, a proximal region to be introduced into a patient in use, a proximal end, a distal end, and a guide wire catheter extending from the distal end to the proximal end and through the lumen of the main body of the branched stent graft, wherein the branched stent graft is retained to the introducer distally of the nose cone dilator;

a nose cone dilator at the proximal end of the introducer;

a removable sheath disposed over the branched stent graft and constraining the branched stent graft; and

an indwelling catheter configured to receive a second guide wire extending therethrough, wherein the indwelling catheter extends from distal of the distal open end of the branch, then extends outside and partially along the main body of the branched stent graft, then extends into the distal open end of the branch, then extends through the branch lumen to the main lumen, and then extends out of the main lumen at the proximal stent graft end.

2. The introduction arrangement of claim 1 wherein the second guide wire is disposed through the indwelling catheter and proximal of the nose cone dilator before the sheath is removed from the branched stent graft.

3. The introduction arrangement of claim 1, wherein the indwelling catheter is axially movable relative to the introducer.

4. The introduction arrangement of claim 3, wherein the indwelling catheter is slideably removable from the introducer.

5. The introduction arrangement of claim 1, further comprising an arrangement to retain the branched stent graft, wherein the arrangement to retain the branched stent graft includes a stent graft proximal end retention and release mechanism.

6. The introduction arrangement of claim 5 wherein the stent graft proximal end retention and release mechanism comprises a trigger wire.

7. The introduction arrangement of claim 1, further comprising an arrangement to retain the branched stent graft, wherein the arrangement to retain the branched stent graft includes a stent graft distal end retention and release mechanism.

8. The introduction arrangement of claim 7 wherein the stent graft distal end retention and release mechanism comprises a trigger wire.

9. The introduction arrangement of claim 1, wherein the branched stent graft is retained to the introducer distally of the nose cone dilator with at least one retention and release thread cooperating to hold the stent graft in a compressed condition.

10. The introduction arrangement of claim 1, wherein the indwelling catheter extends from below the distal end of the branched stent graft and through the branched stent graft.

11. An introduction arrangement for a bifurcated stent graft intended for deployment into the lumen of a vessel having a branch vessel extending therefrom, the arrangement comprising:

a delivery device comprising;

a proximal end and a distal end;

a first guide wire catheter extending from the distal end of the delivery device to the proximal end of the delivery device, the first guide wire catheter having a proximal end, a distal end and a lumen therethrough configured to receive a first guide wire;

a nose cone dilator disposed at the proximal end of the first guide wire catheter;

a stent graft retention region proximate the proximal end of the delivery device;

a bifurcated stent graft disposed at the stent graft retention region, the bifurcated stent graft comprising a proximal end, a proximal end opening, a distal end, a main body, a main body lumen, a first limb, a first limb lumen, and a second limb shorter than the first limb, the second limb having a distal end opening and a second limb lumen;

a removable sleeve disposed over and constraining the bifurcated stent graft;

a stent graft end retention and release mechanism;

a second guide wire catheter having a guide wire lumen configured to receive a second guide wire, wherein the second guide wire catheter extends from distal of the distal open end of the second limb and externally to and at least partially along the first limb, then extends into the second limb distal opening, then extends through the second limb lumen, then extends through the main body lumen, and then extends out of the proximal end opening adjacent the nose cone, and wherein the second guide wire catheter is axially moveable relative to the stent graft.

12. The introduction arrangement of claim 11 wherein the retention and release mechanism comprises a wire.

13. The introduction arrangement of claim 12 further including a second delivery device in combination with a leg extension.

14. The introduction arrangement of claim 11 wherein the second guidewire catheter is removable from the delivery device.

15. The introduction arrangement of claim 11 wherein the second guidewire catheter includes a guide wire extending therethrough.

16. The introduction arrangement of claim 11, wherein the auxiliary catheter extends from distal of the distal end of the branched stent graft to the branched stent graft.

17. The introduction arrangement of claim 11 wherein the retention and release mechanism comprises a proximal stent graft end retention and release mechanism.

18. The introduction arrangement of claim 17, wherein the proximal stent graft end retention and release mechanism comprises a wire.

19. The introduction arrangement of claim 11 wherein the retention and release mechanism comprises a distal stent graft end retention and release mechanism.

20. The introduction arrangement of claim 19, wherein the distal stent graft end retention and release mechanism comprises a wire.