Apparatus and Method for Sealing a Vessel Puncture Opening

Abstract

A device for sealing a puncture opening in a wall of a blood vessel may include a base frame including a first bi-stable material having a first stable state corresponding to a delivery configuration of the base frame, in which the base frame is retracted to have a relatively smaller overall profile, and a second stable state corresponding to a deployed configuration of the base frame, in which the base frame is extended to have a relatively larger overall profile. The base frame is sized to engage an interior surface of the blood vessel wall when in the deployed configuration. A sealing section is coupled to the base frame and includes a second bi-stable material having a first stable state corresponding to an initial configuration of the sealing section, in which the sealing section permits fluid flow, and a second stable state corresponding to a barrier configuration of the sealing section, in which the sealing section prevents fluid flow. The sealing section in the barrier configuration is sized to block fluid flow through the puncture opening when the base frame is in the deployed configuration.

Description

FIELD OF THE DISCLOSURE [0001]The present disclosure generally relates to medical devices and methods, and more particularly to apparatus and methods for sealing a puncture opening after a surgical procedure.BACKGROUND OF THE DISCLOSURE[0002]A large number of diagnostic and interventional procedures involve the percutaneous introduction of instrumentation into a vein or artery. For example, coronary angioplasty, angiography, atherectomy, stenting of arteries, and many other procedures often involved accessing the vasculature through a catheter placed in the femoral artery or other blood vessel. Once the procedure is completed and the catheter or other instrumentation is removed, bleeding from the punctured artery must be controlled.[0003]Traditionally, external pressure has been applied to the skin entry site to stem bleeding from a puncture wound in a blood vessel. Pressure is continued until hemostasis has occurred at the puncture site. In some instances, pressure must be applied ...

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Problems solved by technology

In addition, a risk of hematoma exists since bleeding from the vessel may continue beneath the skin until sufficient clotting effects hemostasis.

Further, external pressure to close the vascular puncture site works best when the vessel is close to the skin surface and maybe unsuitable amounts of subcutaneous adipose tissue since the skin surface may be a considerable distance from the vascular puncture site.

The use of these conventional devices presents several drawbacks, including: (1) Complex and difficult applications; (2) Partial occlusion of the blood vessel by the anchor when placed properly; and (3) Complete blockage of the blood vessel or a branch of the blood vessel by the anchor if placed improperly.

These methods are a significant departure from the well-known pressure- or plug-based methods and can require a practitioner to learn an entirely new procedure using unfamiliar devices.

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