Vascular closure devices and methods providing hemostatic enhancement

Inventors

Yassinzadeh, Zia • Weitz, Jeffrey I. • Stafford, Alan

Assignees

Cardiva Medical Inc

Abstract

Vascular closure devices and methods for closing a blood vessel puncture site disposed at a distal end of a tissue tract are described. A combination of the body's own natural mechanism with chemical and/or biological agents is relied upon to accelerate the hemostatic process. Included are steps of introducing a closure device through the tissue tract and deploying an expansible member at a distal end of the device within the blood vessel to occlude the puncture site. A sealing member disposed proximal the expansible member is then displaced by retracting and tensioning a coil spring so as to expose a chemical and/or biological region or release region of the device. The retraction and tensioning of the coil spring is limited by a coupling member. Exposure of blood and tissue to the chemical and/or biological sealing member promotes the clotting processing to accelerate the occlusion process in the tract.

Core Innovation

The invention provides methods for closing a blood vessel puncture site disposed at a distal end of a tissue tract. A closure device is introduced through the tissue tract and an expansible member is deployed at a distal end of the closure device within the blood vessel so that it is seated against the puncture site during retraction of the closure device through the tissue tract.

A tensioning coil is deployed proximal the deployed expansible member to seal the deployed expansible member against the puncture site. Tension applied to the deployed expansible member is gauged with the aid of the tensioning coil as the expansible member is seated against the puncture site, exposing a chemical and/or biological agent release region proximal the expansible member within the tissue tract as the tensioning coil is deployed.

The method exposes the chemical and/or biological agent release region within the tissue tract outside the blood stream, proximal the expansible member. The agent release region is defined so that it is exposed as the tensioning coil is deployed, including configurations where the release region is positioned at a predetermined distance from the puncture site and can be formed by the tensioning coil coated with the chemical and/or biological agent.

Claims Coverage

The independent claim describes a method with four inventive elements: introducing a closure device through a tissue tract, deploying an expansible member within a blood vessel against a distal puncture site, deploying a tensioning coil to seal while gauging tension, and exposing a chemical and/or biological agent release region proximal the expansible member within the tissue tract during coil deployment.

Overall claim coverage focuses on sealing a distal blood vessel puncture with an expansible member seated against the puncture site using a proximal tensioning coil, while gauging tension during seating and exposing a chemical and/or biological agent release region proximal the expansible member within the tissue tract during coil deployment.

Stated Advantages

Documented Applications