GATE WIRE FOR CONTRALATERAL LEG ACCESS
An endovascular delivery system includes a pre-loaded, small guide wire for snaring via the contralateral side of a bifurcated prosthesis for deployment of a graft extension to the contralateral side of the bifurcated prosthesis. The pre-loaded guidewire avoids a cannulation step in the deployment of typical bifurcated stent grafts. Deployment methods using the pre-loaded guidewire and endovascular grafts having a pre-routed lumen for a secondary contralateral access guidewire are also described.
1 . An endovascular delivery system, comprising:
a bifurcated and inflatable prosthesis comprising a main tubular body having an open end and opposed ipsilateral and contralateral legs defining a graft wall therein between, said graft wall having an inner graft wall surface and an outer graft wall surface, and said ipsilateral and contralateral legs having open ends;
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 at a handle assembly;
an elongate inner tubular member having a tubular wall with an open lumen and opposed proximal and distal ends with a proximal portion near the proximal end, a distal portion near the distal end and 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 at the handle assembly; wherein 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;
a first elongate guidewire slidably disposed within the inner tubular member and extending from the handle assembly, through the ipsilateral leg of the prosthesis and through the main tubular body of the prosthesis in the prosthesis delivery state;
a second elongate guidewire slidably disposed within the inner tubular member and having a proximal portion extending from the handle assembly or from a proximal portion of the inner tubular member, a medial portion extending through the ipsilateral leg of the prosthesis and a distal portion extending through at least a portion of the contralateral leg of the main tubular body of the prosthesis in the prosthesis delivery state;
whereby the distal portion of the second elongate guidewire is engageable with a catheter to facilitate delivery of a contralateral graft extension within a portion of the contralateral leg of the main tubular body of the prosthesis in the prosthesis unsheathed state upon proximally retracting the second elongate guidewire.
2 . The endovascular delivery system of claim 1 , wherein and said main tubular body and said ipsilateral and contralateral legs comprise inflatable channels.
3 . The endovascular delivery system of claim 1 , wherein the distal portion of the second elongate guidewire is disposed beyond the open end of the contralateral leg of the main tubular body in the prosthesis unsheathed state.
4 . The endovascular delivery system of claim 1 ,
wherein the prosthesis further comprises a prosthesis guidewire lumen extending from at least a portion of the inner graft wall surface of the ipsilateral leg of the prosthesis and extending to at least a portion of the inner graft wall surface of the contralateral leg of the prosthesis; and
wherein at least a portion of the medial portion of the second elongate guidewire and at least a portion of the distal portion of the second elongate guidewire are disposed within prosthesis guidewire lumen of the prosthesis.
5 . The endovascular delivery system of claim 1 ,
further comprising a delivery system second guidewire lumen extending over at least a portion of the medial portion of the second elongate guidewire and over at least a portion of the distal portion of the second elongate guidewire and;
wherein in the prosthesis delivery state the delivery system second guide wire lumen extends from at least a portion of the ipsilateral leg of the prosthesis to a portion of the contralateral leg of the prosthesis.
6 . The endovascular delivery system of claim 1 ,
further comprising a third handle at the handle assembly;
wherein the proximal portion of the second elongate guidewire is secured to the third handle to proximally retract the second elongate guidewire.
7 . The endovascular delivery system of claim 1 ,
wherein the proximal portion of the second elongate guidewire extends through a wall of the proximal portion of the inner tubular member; and
wherein retraction of the outer tubular member engages the proximal portion of the second elongate guidewire to proximally retract the second elongate guidewire.
8 . The endovascular delivery system of claim 1 , wherein the prosthesis comprises non-textile polymeric material.
9 . The endovascular delivery system of claim 8 , wherein the non-textile polymeric material of the prosthesis comprises extruded polytetrafluoroethylene.
10 . The endovascular delivery system of claim 9 , wherein said extruded polytetrafluoroethylene is non-porous polytetrafluoroethylene.
11 . 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.
12 . A method for delivering a bifurcated prosthesis, comprising:
providing the endovascular delivery system of claim 1 ;
advancing the endovascular delivery system through a first branched artery and into an aneurysm in a main artery;
retracting the outer sheath to deploy the prosthesis so the proximal end of the main tubular body of the prosthesis is disposed beyond the aneurysm and so that the ipsilateral and contralateral legs are disposed within the aneurysm;
advancing a catheter through a second branched artery;
engaging the catheter with the distal portion of the second elongate guidewire;
retracting the second elongate guidewire proximally to advance the catheter within a portion of the contralateral leg of the prosthesis;
disengaging the second elongate guidewire and the catheter from one and the other; and
further retracting the second elongate guidewire at least partially through the ipsilateral leg of the prosthesis.
13 . The method of claim 12 further comprising:
maintaining the first elongate guidewire through the ipsilateral leg and the main tubular body of the prosthesis while retracting the second elongate guidewire through the ipsilateral leg of the prosthesis.
14 . The method of claim 12 further comprising:
deploying a contralateral graft extension having opposed proximal and distal open ends contained within a catheter so that the proximal end of the contralateral graft extension is disposed within a portion of the contralateral leg of the main tubular body of the prosthesis and so that the distal end of the contralateral graft extension is disposed distally of the aneurysm and within a portion of the second branched artery.
15 . The method of claim 12 further comprising:
advancing a second catheter through the first branched artery along the first elongate guidewire;
deploying a ipsilateral graft extension having opposed proximal and distal open ends contained within a second catheter so that the proximal end of the ipsilateral graft extension is disposed within a portion of the ipsilateral leg of the main tubular body of the prosthesis and so that the distal end of the ipsilateral graft extension is disposed distally of the aneurysm and within a portion of the first branched artery.
16 . A method for delivering a bifurcated prosthesis, comprising:
providing the endovascular delivery system comprising:
a bifurcated and inflatable prosthesis comprising a main tubular body having an open end and opposed ipsilateral and contralateral legs defining a graft wall therein between;
an elongate outer tubular sheath having an open lumen and opposed proximal and distal ends with a medial portion therein between;
an elongate inner tubular member having a tubular wall with an open lumen and opposed proximal and distal ends with a proximal portion near the proximal end, a distal portion near the distal end and 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, wherein 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;
a first elongate guidewire slidably disposed within the inner tubular member and extending through the ipsilateral leg of the prosthesis and through the main tubular body of the prosthesis in the prosthesis delivery state;
a second elongate guidewire slidably disposed within the inner tubular member and extending through the ipsilateral leg of the prosthesis and having a distal portion extending through at least a portion of the contralateral leg of the main tubular body of the prosthesis in the prosthesis delivery state;
advancing the endovascular delivery system through a first branched artery and into an aneurysm in a main artery;
retracting the outer sheath to deploy the prosthesis so the proximal end of the main tubular body of the prosthesis is disposed beyond the aneurysm and so that the ipsilateral and contralateral legs are disposed within the aneurysm;
advancing a catheter through a second branched artery;
engaging the catheter with the distal portion of the second elongate guidewire;
retracting the second elongate guidewire proximally to advance the catheter within a portion of the contralateral leg of the prosthesis;
disengaging the second elongate guidewire and the catheter from one and the other; and
further retracting the second elongate guidewire at least partially through the ipsilateral leg of the prosthesis.
17 . The method of claim 16 further comprising:
maintaining the first elongate guidewire through the ipsilateral leg and the main tubular body of the prosthesis while retracting the second elongate guidewire through the ipsilateral leg of the prosthesis.
18 . The method of claim 16 further comprising:
deploying a contralateral graft extension having opposed proximal and distal open ends contained within a catheter so that the proximal end of the contralateral graft extension is disposed within a portion of the contralateral leg of the main tubular body of the prosthesis and so that the distal end of the contralateral graft extension is disposed distally of the aneurysm and within a portion of the second branched artery.
19 . The method of claim 16 further comprising:
advancing a second catheter through the first branched artery along the first elongate guidewire;
deploying a ipsilateral graft extension having opposed proximal and distal open ends contained within a second catheter so that the proximal end of the ipsilateral graft extension is disposed within a portion of the ipsilateral leg of the main tubular body of the prosthesis and so that the distal end of the ipsilateral graft extension is disposed distally of the aneurysm and within a portion of the first branched artery.
20 . An endovascular prosthesis, comprising:
a bifurcated and inflatable prosthesis comprising:
a main tubular body having an open end and opposed ipsilateral and contralateral legs defining a graft wall therein between, said graft wall having an inner graft wall surface and an outer graft wall surface, and said ipsilateral and contralateral legs having open ends; and
a prosthesis guidewire lumen extending along at least a portion of the inner graft wall surface of the ipsilateral leg of the prosthesis and extending along at least a portion of the inner graft wall surface of the contralateral leg of the prosthesis;
wherein the prosthesis guidewire lumen is configured to receive a guidewire from a delivery system.
21 . The endovascular prosthesis of claim 20 , wherein said main tubular body and said ipsilateral and contralateral legs comprise inflatable channels.
22 . The endovascular prosthesis of claim 20 , wherein the prosthesis comprises non-textile polymeric material.
23 . The endovascular prosthesis of claim 22 , wherein the non-textile polymeric material of the prosthesis comprises extruded polytetrafluoroethylene.
24 . The endovascular prosthesis of claim 23 , wherein said extruded polytetrafluoroethylene is non-porous polytetrafluoroethylene.
25 . The endovascular prosthesis of claim 20 , 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.