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

A drug-eluting, self-tensioning vascular closure device is described for closing a blood vessel puncture site disposed at a distal end of a tissue tract. The device includes a shaft configured to advance through the tissue tract and an expansible member disposed on the distal end of the shaft and deployable within the blood vessel to seat against the puncture site. A tensioning element is slidably disposed over the shaft and positioned proximal to the expansible member, and is configured to apply tension to the expansible member when deployed and seated.

A sealing member is slidably disposed over the shaft and positioned proximal to the expansible member. Under the sealing member is a chemical and/or biological agent release region, with the release region including an immobilized chemical and/or biological agent disposed on the distal end of the shaft proximal to the expansible member and distal to the tensioning element.

The described release configuration aims to promote clot formation with chemical and/or biological agents disposed in the immobilized release region while reducing entry of the agents into circulation. The device is described with self-tensioning and self-seating behavior enabled by a coil spring or similar tensioning element, with the sealing member displaced to expose the agent to tissue at a predetermined distance outside the blood stream.

Claims Coverage

The document provides one independent claim covering a self-tensioning, drug-eluting vascular closure device with an expansible occlusion member, a slidably mounted tensioning element, a proximal sealing member, and an immobilized chemical/biological agent release region disposed distal to the tensioning element and proximal to the expansible member. Dependent claims further refine the tensioning element mechanics and constraints by specifying lengthening behavior, a maximum tension limit tied to maximum elongation, coil/spring form, and a numeric tension range, along with additional relative positioning details under the sealing member.

Overall, the claim set is directed to closing a distal blood vessel puncture site using a deployed expansible member that is held with applied tension from a slidably disposed tensioning element, while a sealing member establishes a drug-eluting chemical/biological agent release region. The immobilized agent is disposed on the distal end of the shaft proximal to the expansible member and distal to the tensioning element, with dependent claims further constraining the tensioning element behavior, structure, and allowable tension/elongation.

Stated Advantages

Documented Applications