Bifurcated endovascular prosthesis having tethered contralateral leg

• US 9,132,025 B2
• Filed: 03/14/2013
• Issued: 09/15/2015
• Est. Priority Date: 06/15/2012
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Trivascular Incorporated
• Inventors: Aristizabal, Diego, Chobotov, Michael V.
• Primary Examiner(s): Manahan, Todd
• Assistant Examiner(s): HERBERMANN, ERICH G.
• Application Number:
  US13/803,067
• Publication Number:
  US 20130338760A1
• Time in Patent Office: 915 Days
• Field of Search: 623 111- 116, 623 123- 125, 623/1.35, 623/1.36, 606/198, 606/194, 606/108, 606/191, 606/192, 606/195
• US Class Current: 1/1
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

An endovascular delivery system includes a bifurcated and inflatable prosthesis including a main tubular body having an open end and opposed ipsilateral and contralateral legs defining a graft wall therein between. A tether is disposed securably disposed to the contralateral leg, and the contralateral leg is releasably restrained towards the ipsilateral leg tether to prevent undesirable movement of the contralateral leg. A release wire within the endovascular delivery system releasably retains the tether near the ipsilateral leg.

Claims

1. An endovascular delivery system, 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, said ipsilateral and contralateral legs having open ends;

said ipsilateral leg comprising an ipsilateral tab extending from the open end of said ipsilateral leg, said tab comprising at least two holes;

an elongate guidewire having at least two outwardly projecting members, said outwardly projecting members being sized to at least partially fit within the at least one of said at least two holes of said ipsilateral tab;

a release wire slidable disposed within the at least two outwardly projecting members of the elongate guidewire and within one of the at least two holes of said ipsilateral tab; and

a tether having opposed contralateral and ipsilateral ends, said contralateral end of the tether being securably disposed at said open end of said contralateral leg, said ipsilateral end of the tether having a hole, said release wire being slidably disposed through the hole of the tether to so engage the tether;

wherein withdrawal of the release wire releases the ipsilateral tab and the tether from the elongate guidewire.

2. The endovascular delivery system of claim 1, wherein, when said release wire engages said tether, the open end of the contralateral leg is proximally disposed and restrained towards the open end of the ipsilateral leg.

3. The endovascular delivery system of claim 2, wherein the contralateral leg is restricted from significant longitudinal movement so as to prevent bunching up of the contralateral leg.

4. The endovascular delivery system of claim 2, wherein the contralateral leg is restricted from significant rotational movement so as to prevent misalignment within a bodily lumen.

5. The endovascular delivery system of claim 1, wherein said elongate guidewire is extendable through the ipsilateral leg and through the main tubular body.

6. The endovascular delivery system of claim 1, further comprising:

an elongate outer tubular sheath having an open lumen and opposed proximal and distal ends with a medial portion therein between, the proximal end of the outer tubular sheath securably disposed to a first handle;

an elongate inner tubular member having a tubular wall with an open lumen and opposed proximal and distal ends with a medial portion therein between, the inner tubular member having a longitudinal length greater than a longitudinal length of the outer tubular sheath, 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;

said elongate guidewire slidably disposed within the inner tubular member;

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

7. The endovascular delivery system of claim 1, wherein the prosthesis comprises non-textile polymeric material.

8. The endovascular delivery system of claim 1, wherein the non-textile polymeric material of the prosthesis comprises extruded polytetrafluoroethylene.

9. The endovascular delivery system of claim 8, wherein said extruded polytetrafluoroethylene is non-porous polytetrafluoroethylene.

10. The endovascular delivery system of claim 1, wherein the prosthesis further comprises a metallic expandable member securably disposed at or near the open end of the main tubular body of said prosthesis.

11. The endovascular delivery system of claim 1, wherein the bifurcated prosthesis further comprises:

a web of biocompatible material disposed between the contralateral leg and the ipsilateral leg and secured to the contralateral leg and the ipsilateral leg;

wherein the contralateral leg is restricted from significant longitudinal movement so as to prevent bunching up of the contralateral leg during delivery of the endovascular prosthesis.

12. The endovascular delivery system of claim 11, wherein the contralateral leg is restricted from significant rotational movement so as to prevent misalignment within a bodily lumen.

13. The endovascular delivery system of claim 11, wherein the web is releasably secured to the contralateral leg and the ipsilateral leg.

14. The endovascular delivery system of claim 1, wherein the bifurcated prosthesis is a bifurcated and inflatable prosthesis.

15. The endovascular delivery system of claim 14, wherein said main tubular body and said ipsilateral and contralateral legs comprise inflatable channels.

16. A method for delivering a bifurcated prosthesis, comprising:

providing a bifurcated prosthesis comprising;

a main tubular body having an open end and opposed ipsilateral and contralateral legs defining a graft wall therein between, said ipsilateral and contralateral legs having open ends;

said ipsilateral leg comprising an ipsilateral tab extending from the open end of said ipsilateral leg, said tab comprising at least two holes;

providing an elongate guidewire having at least two outwardly projecting members, said outwardly projecting members being sized to at least partially fit within at least one of said at least two holes of said ipsilateral tab;

providing a release wire slidable disposed within the at least two outwardly projecting members of the elongate guidewire and within the at least two holes of said ipsilateral tab;

providing a tether having opposed contralateral and ipsilateral ends, said contralateral end of the tether being securably disposed at said open end of said contralateral leg, said ipsilateral end of the tether having a hole, said release wire being slidably disposed through the hole of the tether to so engage the tether; and

withdrawing the release wire to release the ipsilateral tab and the tether from the elongate guidewire.

17. The method of claim 16, wherein, when said release wire engages said tether, the open end of the contralateral leg is proximally disposed and restrained towards the open end of the ipsilateral leg.

18. The method of claim 17, wherein the contralateral leg is restricted from significant longitudinal movement so as to prevent bunching up of the contralateral leg.

19. The method of claim 17, wherein the contralateral leg is restricted from significant rotational movement so as to prevent misalignment within a bodily lumen.

20. The method of claim 16, wherein the bifurcated prosthesis is a bifurcated and inflatable prosthesis.

21. The method of claim 20, wherein the bifurcated prosthesis is a bifurcated and inflatable prosthesis.