Branch stent graft deployment and method

• US 20040230287A1
• Filed: 04/05/2004
• Published: 11/18/2004
• Est. Priority Date: 04/03/2003
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated), William A. Cook Australia Pty. Ltd (Cook Group Incorporated), William Cook Europe ApS (Cook Group Incorporated)
• Inventors: Verhoeven, Eric L.G., Hartley, David Ernest, Ivancev, Krasnodar, Lawrence-Brown, Michael, Stelter, Wolf
• Granted Patent: US 7,537,606 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• 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 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• 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 2002/821 Ostial stents
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/006 modular

Abstract

A deployment system for introducing stent grafts which have a side arm or into which a side arm can be deployed. For instance the stent graft can be deployed into the thoracic arch of a patient. The deployment system including an introducer (1), an auxiliary catheter (13) disposed within the introducer and an auxiliary guide wire (14) disposed within the auxiliary catheter. The auxiliary guide wire extends to adjacent the proximal end (6) of the introducer an can be extended from the proximal end of the introducer so that it can be snared from a side branch artery (56) to assist with deployment of a side arm (23) of the stent graft into the side artery or for the deployment of a side arm stent graft into the stent graft.

Claims

1. A deployment system for a stent graft to be deployed into an internal lumen of a patient, the deployment system comprising an introducer with the stent graft retained thereon, the introducer having a proximal end intended to be deployed within a patient in use and a distal end intended to remain outside the patient and an auxiliary guide wire, the auxiliary guide wire extending to adjacent the proximal end of the introducer whereby the auxiliary guide wire can be extended from the proximal end of the introducer so that it can be snared from a side artery to assist with deployment of a stent graft into the side artery.

2. A deployment system as in claim 1 wherein the introducer includes a sheath to retain the stent graft in a retracted state on the introducer.

3. A deployment system as in claim 1 wherein the stent graft includes a side branch and the auxiliary guide wire extends through the side branch.

4. A deployment system as in claim 1 wherein the stent graft includes a fenestration and the auxiliary guide wire extends through the fenestration.

5. A deployment system as in claim 4 wherein the fenestration includes a side arm stent graft extending from the fenestration.

6. A deployment system as in claim 4wherein the fenestration includes a graft tube extending into the stent graft from the fenestration.

7. A deployment system as in claim 6 wherein the graft tube extending into the stent graft from the fenestration extends distally.

8. A deployment system as in claim 6 wherein the graft tube extending into the stent graft from the fenestration extends proximally.

9. A deployment system as in claim 1 wherein the auxiliary guide wire is retained in an auxiliary catheter extending to the distal end of the introducer.

10. A deployment system as in claim 1 wherein the auxiliary guide wire extends out between a nose cone on the proximal end of the introducer and a sheath on the introducer.

11. A deployment system as in claim 1 including a retention arrangement for the stent graft on the introducer which is adapted to retain the proximal and distal ends of the stent graft onto the introducer and includes trigger wires and trigger wire release mechanisms to release the proximal and distal retention arrangements.

12. A deployment system as in claim 5 wherein there are diameter reducing ties with an associated trigger wire and trigger wire release mechanisms for the side arm stent graft, the diameter reducing ties being used to hold the diameter of the side arm reduced against the force of self expanding stents in the side arm so that it can be drawn into the side branch artery without unduly engaging the walls of the artery.

13. A deployment device for deploying a branched stent graft in a thoracic arch of a patient, the stent graft being of a type having a main tubular body with a main lumen therethrough and a side arm with a side arm lumen extending therethrough, the deployment device including a main guide wire catheter extending from a proximal end to a distal end, a nose cone at the proximal end of the guide wire catheter an auxiliary guide wire catheter with an auxiliary guide wire extending therethrough extending from the distal end to the nose cone, the stent graft being retained on the main guide wire catheter distally of the nose cone with the main guide wire passing through the main lumen and the auxiliary guide wire extending through the main lumen and the side arm lumen and extending to the nose cone and the side branch being retained on the auxiliary guide wire catheter and a sheath coaxial with the main guide wire catheter and extending to the nose cone and enclosing the stent graft.

14. A deployment device as in claim 13 wherein the stent graft and side arm on the stent graft include self-expanding stents and a tubular biocompatible graft.

15. A deployment device as in claim 13 wherein the nose cone includes a longitudinal notch to allow the auxiliary catheter to exit the sheath.

16. A deployment device for deploying a fenestrated stent graft in a thoracic arch of a patient, the stent graft being of a type having a main tubular body with a main lumen therethrough and a fenestration in the tubular body, the deployment device including a main guide wire catheter extending from a proximal end to a distal end, a nose cone at the proximal end of the guide wire catheter, an auxiliary catheter with an auxiliary guide wire extending therethrough extending from the distal end to the nose cone, the stent graft being retained on the main guide wire catheter distally of the nose cone with the main guide wire passing through the main lumen and the auxiliary catheter extending through the main lumen and the fenestration and further extending to the nose cone and a sheath coaxial with the main guide wire catheter and extending to the nose cone and enclosing the stent graft.

17. A deployment device as in claim 16 wherein the nose cone includes a longitudinal notch to allow the auxiliary catheter to exit the sheath.

18. A deployment system as in claim 16 wherein the fenestration includes a graft tube extending into the stent graft from the fenestration.

19. A method of introducing a fenestrated stent graft into the thoracic arch of a patient such that a stent graft can be deployed into the fenestration from the branch artery in the thoracic arch, the method including the steps of;

(a) introducing an introducer via a femoral artery so that the fenestration is adjacent the branch artery to be grafted,

(b) extending an auxiliary guide wire from the introducer,

(c) snaring the auxiliary guide wire from the branch artery by means of a snare catheter introduced via a brachial artery and drawing the auxiliary guide wire into the brachial artery,

(d) withdrawing the sheath from the introducer,

(e) advancing a side arm stent graft on a side arm introducer over the auxiliary guide wire into the fenestration,

(f) releasing the distal and proximal ends of the stent graft, and

(g) releasing the side arm stent graft from the side arm introducer.

20. A method of introducing a branched stent graft into the thoracic arch of a patient such that the branch of the stent graft is deployed into the branch artery in the thoracic arch, the method including the steps of;

(a) introducing an introducer via a femoral artery to adjacent the branch artery to be grafted,

(b) extending an auxiliary guide wire from the introducer,

(c) snaring the auxiliary guide wire from the branch artery by means of a snare catheter introduced via a brachial artery and drawing the auxiliary guide wire into the brachial artery,

(d) inserting an artery wall protecting sleeve or catheter over the auxiliary guide wire via the brachial artery and clamping it to the auxiliary guide wire,

(e) withdrawing the sheath from the introducer,

(f) advancing the introducer proximally and drawing the side arm into the side branch artery using the artery wall protecting sleeve or catheter and the auxiliary guide wire,

(g) releasing the distal and proximal ends of the stent graft,

(h) releasing the diameter reducing ties on the side arm in the side branch artery, and

(i) removing the introducer.