SYSTEMS AND METHODS FOR GUIDEWIRE CROSSOVER FOR BIFURCATED PROSTHESES

• US 20170216064A1
• Filed: 04/19/2017
• Published: 08/03/2017
• Est. Priority Date: 01/10/2013
• Status: Active Grant

• Current Assignee: Trivascular Incorporated
• Original Assignee: Trivascular Incorporated
• Inventors: Stephens, William Patrick, Chobotov, Michael V.
• Granted Patent: US 10,987,238 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• 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 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

An endovascular delivery system an elongate outer tubular sheath, an elongate inner tubular member releasably disposed within the elongate outer tubular sheath and an elongate crossover guidewire slidably disposed within the elongate outer tubular sheath.

Claims

1. An endovascular delivery system, comprising:

an elongate outer tubular sheath having an open lumen and opposed proximal and distal ends, the proximal end of the outer tubular sheath securably disposed to a first handle at a handle assembly;

an elongate inner tubular member having a tubular wall with an open lumen and opposed proximal and distal ends, the inner tubular member being slidably disposed within the open lumen of the outer tubular sheath, the proximal end of the inner tubular member securably disposed to a second handle at the handle assembly;

an elongate crossover guidewire slidably disposed within the outer tubular sheath and having a proximal portion extending from the handle assembly, having a distal portion opposed to the proximal portion and having a medial portion disposed there between; and

a crossover guidewire member having an open lumen extending over at least a portion of the medial portion of the elongate crossover guidewire;

wherein a distal portion of the crossover guidewire member is releasably secured within the endovascular delivery system; and

wherein the distal portion of the crossover guidewire member is a non-tubular member portion.

2. The endovascular delivery system of claim 1, wherein the distal end of the outer tubular sheath being slidably disposed past and beyond the distal end of the inner tubular member and slidably retractable to a medial portion of the inner tubular member

3. The endovascular delivery system of claim 1, wherein the non-tubular member portion is a tether.

4. The endovascular delivery system of claim 3, wherein the tether is integral with a distal portion of the crossover guidewire member.

5. The endovascular delivery system of claim 4,

further comprising an elongate guidewire member having an open lumen and having an elongate guidewire slidably disposed with at least a portion of the elongate guidewire member;

wherein a distal portion of the tether is releasably secured to a proximal portion of the elongate guidewire member.

6. The endovascular delivery system of claim 5, further comprising:

a securement member secured to the proximal portion of the elongate guidewire member; and

a release wire slidably disposed through the securement member;

wherein the release wire releasably engages the distal portion of the tether.

7. The endovascular delivery system of claim 1, wherein the crossover guidewire member comprises a polymeric material.

8. The endovascular delivery system of claim 7 wherein the polymeric material for the crossover guidewire member comprises polytetrafluoroethylene.

9. The endovascular delivery system of claim 8, wherein the polymeric material for the crossover guidewire member further comprises a metallic braid or coil within the polymeric material.

10. The endovascular delivery system of claim 9, wherein the metallic braid or coil is a braided nitinol tube.

11. The endovascular delivery system of claim 1,

wherein a release wire is configured to releasably secure the crossover guidewire member within the endovascular delivery system.

12. The endovascular delivery system of claim 1, further comprising a bifurcated prosthesis comprising a main tubular body having an open end and opposed ipsilateral and contralateral legs defining a graft wall therein between, the ipsilateral and contralateral legs having open ends;

wherein the bifurcated prosthesis is disposed at a distal portion of the elongate inner tubular member; and

wherein the distal end of the outer tubular sheath is slidably disposed past and beyond the distal end of the inner tubular member to define a prosthesis delivery state and slidably retractable to a medial portion of the inner tubular member to define a prosthesis unsheathed state; and

wherein the medial portion of the elongate crossover guidewire is slidably disposed through the ipsilateral leg of the prosthesis and the distal portion of the elongate crossover guidewire is slidably disposed through the contralateral leg of the main tubular body of the prosthesis in the prosthesis delivery state.

13. An endovascular delivery system, comprising:

an elongate outer tubular sheath having an open lumen and opposed proximal and distal ends, the proximal end of the outer tubular sheath securably disposed to a first handle at a handle assembly;

an elongate inner tubular member having a tubular wall with an open lumen and opposed proximal and distal ends, the inner tubular member being slidably disposed within the open lumen of the outer tubular sheath, the proximal end of the inner tubular member securably disposed to a second handle at the handle assembly;

an elongate crossover guidewire slidably disposed within the outer tubular sheath and having a proximal portion extending from the handle assembly, having a distal portion opposed to the proximal portion and having a medial portion disposed there between;

a crossover guidewire member having an open lumen extending over at least a portion of the medial portion of the elongate crossover guidewire, wherein the elongate crossover guidewire is slidably deployable through the crossover guidewire member; and

a tether having a proximal portion disposed at a distal portion of the crossover guidewire member and a distal portion releasably secured to a release wire slidably disposed within the endovascular delivery system configured to releasably secure the distal portion of the crossover guidewire member within the endovascular delivery system.

14. The endovascular delivery system of claim 13, further comprising a bifurcated prosthesis comprising a main tubular body having an open end and opposed ipsilateral and contralateral legs defining a graft wall therein between, the ipsilateral and contralateral legs having open ends;

wherein the bifurcated prosthesis is disposed at a distal portion of the elongate inner tubular member; and

wherein the distal end of the outer tubular sheath is slidably disposed past and beyond the distal end of the inner tubular member to define a prosthesis delivery state and slidably retractable to a medial portion of the inner tubular member to define a prosthesis unsheathed state; and

wherein the medial portion of the elongate crossover guidewire is slidably disposed through the ipsilateral leg of the prosthesis and the distal portion of the elongate crossover guidewire is slidably disposed through the contralateral leg of the main tubular body of the prosthesis in the prosthesis delivery state.

15. An endovascular delivery system, comprising:

an elongate outer tubular sheath having an open lumen and opposed proximal and distal ends, the proximal end of the outer tubular sheath securably disposed to a first handle at a handle assembly;

an elongate inner tubular member having a tubular wall with an open lumen and opposed proximal and distal ends, the inner tubular member being slidably disposed within the open lumen of the outer tubular sheath, the proximal end of the inner tubular member securably disposed to a second handle at the handle assembly;

an elongate crossover guidewire slidably disposed within the outer tubular sheath and having a proximal portion extending from the handle assembly, having a distal portion opposed to the proximal portion and having a medial portion disposed there between;

a crossover guidewire member having an open lumen extending over at least a portion of the medial portion of the elongate crossover guidewire, wherein the elongate crossover guidewire is slidably deployable through the crossover guidewire member;

an elongate guidewire member having an open lumen and having an elongate guidewire slidably disposed with at least a portion of the elongate guidewire member;

a tether having a proximal portion and a distal portion, the proximal portion of the tether being integral with a distal portion of the crossover guidewire member;

a securement member secured to a proximal portion of the elongate guidewire member; and

a release wire slidably disposed through the securement member;

wherein the release wire releasably engages the distal portion of the tether; and

wherein a distal portion of the tether is releasably secured to a proximal portion of the elongate guidewire member.

16. The endovascular delivery system of claim 15,

wherein the tether is a non-tubular member portion of the elongate guidewire member.

17. The endovascular delivery system of claim 15, further comprising a bifurcated prosthesis comprising a main tubular body having an open end and opposed ipsilateral and contralateral legs defining a graft wall therein between, the ipsilateral and contralateral legs having open ends;

wherein the bifurcated prosthesis is disposed at a distal portion of the elongate inner tubular member; and

wherein the distal end of the outer tubular sheath is slidably disposed past and beyond the distal end of the inner tubular member to define a prosthesis delivery state and slidably retractable to a medial portion of the inner tubular member to define a prosthesis unsheathed state;

wherein the elongate guidewire is slidably disposed through the ipsilateral leg of the prosthesis and through the main tubular body of the prosthesis in the prosthesis delivery state; and

wherein the medial portion of the elongate crossover guidewire is slidably disposed through the ipsilateral leg of the prosthesis and the distal portion of the elongate crossover guidewire is slidably disposed through the contralateral leg of the main tubular body of the prosthesis in the prosthesis delivery state.