Bilateral vessel closure
A system for sealing a large penetration in the wall of a femoral artery comprises an occlusion catheter and an applicator. An access catheter may further be provided in order to facilitate introduction of the occlusion catheter. The occlusion catheter is introduced through a contralateral penetration, advanced over the aortic bifurcation, and an occlusion element on the occlusion catheter is positioned at the large diameter penetration. The occlusion element is then inflated to temporarily seal the large penetration while blood perfusion past the occlusion element is provided by the catheter. A sealing material, such as a tissue adhesive or other hemostatic agent is then introduced into a tissue tract above the large diameter penetration in order to seal the penetration. The occlusion element may be left in place while the sealing material has time to set, cure or otherwise form a permanent seal of the large penetration. The occlusion catheter and all access sheaths may then be removed from the patient.
1. A method for closing a large penetration in an arterial wall of an artery of a patient at the end of a tissue tract formed from a skin surface of the patient to the arterial wall, said method comprising:
advancing an access catheter through a second penetration in the arterial wall, wherein the access catheter comprises a central passage and a flow diversion element;
deploying the flow diversion element of the access catheter at a location of the artery upstream of the large penetration, to inhibit blood flow towards the large penetration;
advancing an occlusion catheter through the central passage of the access catheter and through the second penetration in the arterial wall while the flow diversion element is deployed, to position an inflatable occlusion balloon of the occlusion catheter on a luminal side of the large penetration, the inflatable occlusion balloon being disposed on a distal region of the occlusion catheter;
inflating the occlusion balloon to temporarily seal the large penetration while allowing blood perfusion past the occlusion balloon;
collapsing the flow diversion element once the occlusion balloon is inflated, to allow blood flow towards the large penetration to resume;
introducing a sealant into the tissue tract from above the occluded large penetration opposite the luminal side of the large penetration, wherein the sealant is introduced with a distal tip of an applicator, the distal tip being positioned at least partially through the tissue tract and adjacent an outer wall of the artery; and
allowing the sealant to harden within the tissue tract to permanently occlude the tissue tract, while the occlusion balloon is inflated to temporarily seal the large penetration;
wherein blood perfuses in a direction transverse to a longitudinal axis of the artery into one or more inlet ports on the occlusion catheter and into a passage disposed in the occlusion catheter, wherein the one or more inlet ports on the occlusion catheter are spaced away from the occlusion element and face outwardly toward the arterial wall.
2. A method as in claim 1 , wherein the large penetration is in a first femoral artery and the second penetration is in a contralateral femoral artery, wherein the occlusion catheter is initially advanced in a retrograde direction from the second penetration through the contralateral femoral artery over the aortic bifurcation and then in an antegrade direction through the first femoral artery to the large penetration.
3. A method as in claim 2 , wherein the access catheter is advanced through the second penetration, over the aortic bifurcation, and into the first femoral artery.
4. A method as in claim 3 , wherein the flow diversion element is deployed to inhibit blood flow from the aorta into the first femoral artery while the occlusion balloon is being deployed to temporarily seal the large penetration.
5. A method as in claim 4 , wherein deploying the flow diversion element comprises inflating a flow diversion balloon on a distal region of the access catheter.
6. A method as in claim 1 , wherein introducing a sealant comprises injecting an adhesive into the tissue tract above the penetration.
7. A method as in claim 1 , wherein introducing a sealant comprises releasing a thrombogenic material.
8. A method as in claim 1 , wherein introducing a sealant comprises releasing a hemostatic plug.