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Publication Number
US-10376255-B2
Publication Date
2019-08-13
Expiration Date
Abstract
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.
Core Innovation
The invention relates to closing a large penetration in an arterial wall at the end of a tissue tract formed from a skin surface of a patient to the arterial wall. An occlusion catheter is advanced through a second penetration in the arterial wall to position an occlusion element on a luminal side of the large penetration, and the occlusion element is deployed to temporarily seal the large penetration while blood perfusion is allowed past the occlusion element.
A sealant is introduced into the tissue tract above the large penetration temporarily sealed by the occlusion element, such that the sealant is disposed within the tissue tract to promote hemostasis of the tissue tract. The occlusion element can be configured to radially expand to temporarily seal the large penetration when placed adjacent thereto within the first femoral artery, and the occlusion catheter comprises a sidewall with one or more inlet ports configured to allow blood perfusion in a direction transverse to a longitudinal axis of the artery.
The invention also includes a system that comprises an access catheter with a flow diversion element near a distal end thereof, and an occlusion catheter slidably disposed within the access catheter and having an occlusion element near a distal end thereof. An applicator is provided for delivering a sealing material into the tissue tract above the large penetration temporarily sealed by the occlusion element, so that the sealing material is disposed within the tissue tract to promote hemostasis.
Claims Coverage
The provided claims include two independent claims, a method and a system, that share a common inventive concept of combining a luminal occlusion element for temporary sealing with a sealant delivered into the tissue tract to promote hemostasis, while permitting blood perfusion past the occlusion element.
Temporary sealing with occlusion catheter and perfusion
Advancing an occlusion catheter through a second penetration in the arterial wall to position an occlusion element on a luminal side of the large penetration; deploying the occlusion element to temporarily seal the large penetration while allowing blood perfusion past the occlusion element; and introducing a sealant into the tissue tract above the large penetration temporarily sealed by the occlusion element such that the sealant is disposed within the tissue tract to promote hemostasis of the tissue tract.
Radially expanded occlusion element with transverse perfusion inlet ports
An access catheter having a flow diversion element near a distal end thereof; an occlusion catheter slidably disposed within the access catheter and having an occlusion element near a distal end thereof, wherein the occlusion element is configured to be radially expanded to temporarily seal the large penetration when placed adjacent thereto within the first femoral artery, wherein the occlusion catheter comprises a sidewall having one or more inlet ports therethrough, and wherein the one or more inlet ports are configured to allow blood perfusion in a direction transverse to a longitudinal axis of the artery; and an applicator adapted to deliver a sealing material into the tissue tract above the large penetration temporarily sealed by the occlusion element such that the sealing material is disposed within the tissue tract to promote hemostasis of the tissue tract.
Across the independent claims, the core coverage is the pairing of an occlusion element that temporarily seals a large penetration while allowing blood perfusion past it, including transverse perfusion via inlet ports, with delivery of sealing material into the tissue tract above the penetration to promote hemostasis.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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