Pre-loaded iliac branch device and methods of deployment

• US 9,545,324 B2
• Filed: 03/13/2013
• Issued: 01/17/2017
• Est. Priority Date: 03/13/2013
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Roeder, Blayne A.
• Primary Examiner(s): Severson, Ryan J
• Application Number:
  US13/799,881
• Publication Number:
  US 20140277330A1
• Time in Patent Office: 1,406 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• 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 2002/067 modular
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

Methods for accessing the common and internal iliac arteries and delivering and deploying an endovascular graft therein utilizing an ipsilateral approach are disclosed. A system including a pre-loaded delivery and deployment device to enable such a method to be practiced is also disclosed.

Claims

1. A system for the delivery and deployment of an endovascular graft comprising:

a. a delivery device comprising;

i. a pusher catheter having a proximal end portion and a distal end portion and at least one lumen extending at least partially between the proximal and distal end portions;

ii. a guide wire cannula having a proximal end portion and a distal end portion and extending longitudinally within the lumen of the pusher catheter;

b. a stent graft carried on the delivery device, the stent graft comprising;

i. a main tubular body of a biocompatible graft material having a proximal end and a distal end defining a main lumen therebetween,

ii. a side branch extending from the main tubular body, the side branch having a lumen extending therethrough and being in fluid communication with the main lumen,

c. an auxiliary guide wire extending proximally within the lumen of the pusher catheter and into the distal end of the main tubular body of the stent graft, the auxiliary guide wire further extending distally through at least a portion of the lumen of the side branch and through the lumen of the pusher catheter.

2. The system of claim 1 further comprising a second delivery device, the second delivery device comprising:

a. a second guide wire cannula having a proximal end portion and a distal end portion and a lumen extending therebetween;

b. a second stent graft carried on the proximal end portion of the second delivery device, the second stent graft comprising a tubular body of a biocompatible graft material defining a main lumen;

c. a second sheath mounted coaxially over at least a portion of the second stent graft.

3. The system of claim 2 further comprising a second guide wire extending longitudinally within the lumen of the second guide wire cannula.

4. The system of claim 1 wherein the auxiliary guide wire extends through the entire longitudinal length of the side branch lumen.

5. The system of claim 1 wherein the side branch comprises a tubular body of biocompatible graft material having a proximal end portion and a distal end portion, and wherein the auxiliary guide wire pierces through the graft material of the side branch.

6. The system of claim 5 wherein the auxiliary guide wire extends distally outside of the lumen of the side branch and outside of the lumen of the main tubular body.

7. The system of claim 6 wherein the auxiliary guide wire enters the lumen of the pusher catheter at a location distal to the distal end of the main graft tubular body.

8. The system of claim 1 wherein the distally extending portion of the auxiliary guide wire enters the lumen of the pusher catheter at a location distal to the distal end of the main graft tubular body.

9. The system of claim 1 further comprising an auxiliary sheath comprising a proximal end portion and a distal end portion and a lumen extending therebetween, wherein the auxiliary sheath comprises a first position wherein the sheath proximal end portion is located distal to the distal end portion of the main graft tubular body.

10. The system of claim 1 further comprising an auxiliary sheath comprising a proximal end portion and a distal end portion and a lumen extending therebetween, wherein the auxiliary sheath comprises a second position wherein the sheath is advanced over the auxiliary guide wire such that the proximal end portion of the sheath extends at least partially into the lumen of the side branch.

11. The system of claim 10 wherein the second delivery device extends at least partially through the lumen of the auxiliary sheath.

12. The system of claim 11 wherein the second stent graft carried by the second delivery device is configured to be positioned within the internal iliac artery.

13. The system of claim 10 further comprising a second delivery device carrying a second stent graft, the second stent graft comprising a tubular body of a biocompatible graft material defining a main lumen.

14. The system of claim 13 wherein the second delivery device extends through the lumen of the auxiliary sheath when the auxiliary sheath is in the second position such that the second stent graft carried by the second delivery device is positioned within an internal iliac artery.

15. The system of claim 1 further comprising a sheath mounted coaxially over at least a portion of the pusher catheter.

16. The system of claim 15 wherein the sheath has an external diameter of about 5 Fr to about 7 Fr.

17. A system for the delivery and deployment of an endovascular graft comprising:

a. a delivery device comprising;

i. a pusher catheter having a proximal end portion and a distal end portion and a first, second and third lumen extending at least partially between the proximal and distal end portions;

ii. an auxiliary sheath having a proximal end portion and a distal end portion extending longitudinally within the first lumen of the pusher catheter;

iii. a guide wire cannula having a proximal end portion and a distal end portion and extending longitudinally within the second lumen of the pusher catheter;

b. a stent graft carried on the delivery device, the stent graft comprising;

i. a main tubular body of a biocompatible graft material having a proximal end and a distal end defining a main lumen therebetween,

ii. a side branch extending from the main tubular body, the side branch having a lumen extending therethrough and being in fluid communication with the main lumen, whereby the stent graft is configured to be deployed into the vasculature of a patient with the main tubular body being located in the common iliac artery and the side branch being directed towards an internal iliac artery of the common iliac artery;

c. an auxiliary guide wire extending proximally within the lumen of the auxiliary sheath and into the distal end of the main tubular body of the stent graft, the auxiliary guide wire further extending distally through at least a portion of the lumen of the side branch and through the third lumen of the pusher catheter.

18. The system of claim 17 further comprising a second delivery device, the second delivery device comprising:

a. a second guide wire cannula having a proximal end portion and a distal end portion and a lumen extending therebetween;

b. a second stent graft carried on the proximal end portion of the second delivery device, the second stent graft comprising a tubular body of a biocompatible graft material defining a main lumen, whereby the second stent graft is configured to be deployed into the internal iliac artery;

c. a second sheath mounted coaxially over at least a portion of the second stent graft.

19. The system of claim 18 further comprising a second guide wire extending longitudinally within the lumen of the second guide wire cannula and configured for introduction into the internal iliac artery.

20. The system of claim 17 wherein the auxiliary guide wire extends through the entire longitudinal length of the side branch lumen.

21. The system of claim 17 wherein the side branch comprises a tubular body of biocompatible graft material having a proximal end portion and a distal end portion, and wherein the auxiliary guide wire pierces through the graft material at the proximal end portion of the side branch.

22. The system of claim 21 wherein the auxiliary guide wire extends distally outside of the lumen of the side branch and outside of the lumen of the main tubular body.

23. The system of claim 22 wherein the auxiliary guide wire enters the third lumen of the pusher catheter at a location distal to the distal end of the main graft tubular body.

24. The system of claim 17 wherein the distally extending portion of the auxiliary guide wire enters the third lumen of the pusher catheter at a location distal to the distal end of the main graft tubular body.

25. A method for treating a diseased vessel, the method comprising:

a. introducing a first delivery device into a patient'"'"'s vasculature comprising a common iliac artery, the delivery device comprising;

i. a pusher catheter having a proximal end portion and a distal end portion and a lumen extending therebetween;

ii. an auxiliary sheath having a proximal end portion and a distal end portion extending longitudinally within the lumen of the pusher catheter;

iii. a first prosthesis carried on the first delivery device, the first prosthesis comprising a main tubular body of a biocompatible graft material having a proximal end portion and a distal end portion defining a main lumen therebetween and a side branch extending from the main tubular body, the side branch having a lumen extending therethrough and being in fluid communication with the main lumen, whereby the first prosthesis is configured to be deployed into the vasculature of a patient with the main tubular body being located in the common iliac artery and the side branch being directed towards an internal iliac artery of the common iliac artery;

iv. an auxiliary guide wire extending longitudinally in a proximal direction within the lumen of the auxiliary sheath and into the distal end of the main tubular body of the stent graft, the auxiliary guide wire further extending through at least a portion of the lumen of the side branch and extending longitudinally in a distal direction through the lumen of the pusher catheter;

b. at least partially deploying the first prosthesis in the common iliac artery;

c. introducing a second delivery device ipsilaterally though the lumen of the main tubular body and through the lumen of the side branch of the first prosthesis, the second delivery device carrying a second prosthesis thereon, the second prosthesis comprising a tubular body defining a lumen;

d. positioning the second prosthesis within the internal iliac artery;

e. at least partially deploying the second prosthesis in the internal iliac artery.