Method and devices for flow occlusion during device exchanges

Inventors

Joe, Wesley Chung • Hundertmark, Ronald • Hassan, Ali • YAZBECK, RICHARD DOMINGO

Assignees

Access Closure Inc

Abstract

A method of reducing the risk of clinical sequelae to catheter induced vascular injuries may include introducing a guide wire into a vascular sheath residing in a blood vessel, proximally retracting the vascular sheath while leaving the wire in place, and observing indicia of the presence or absence of a vascular injury caused to the blood vessel by the vascular sheath or a procedural catheter previously advanced through the vascular sheath. If indicia of a vascular injury are observed, the method may further involve proximally retracting the guide wire to position the inflatable balloon adjacent the injury and inflating the balloon to reduce blood flow past the injury, while leaving the guide wire in place to provide subsequent access to the injury. The inflatable balloon can be inflated and deflated through a valve positioned at the proximal end of the guide wire.

Core Innovation

The document describes a medical system and method for controlling blood flow and managing catheter-induced vascular injuries during large-bore device exchanges. It includes advancing a guide wire with a distal inflatable occlusion balloon, retracting a vascular sheath while maintaining guide wire position, detecting an injury, and inflating the occlusion balloon adjacent the injury to stabilize or bridge while leaving access for subsequent endovascular repair.

A guide wire balloon device is described with an elongate body that has a proximal portion, a flexible distal portion, and a lumen extending longitudinally. The device includes an inflatable balloon attached to the elongate body and in communication with the lumen, and a valve for closing and opening fluid flow through the lumen. In the open state, fluid is advanced through the lumen and an inner diameter of a sealing member to inflate and deflate the inflatable balloon.

The valve structure uses a sealing member positioned in the lumen at the proximal portion of the elongate body, and a piston assembly that moves to provide a closed state by insertion into the inner diameter of the sealing member. A frictional element connected to an outer diameter of the piston is larger than an inner diameter of the lumen in a relaxed state and partially collapses upon placement in the lumen, providing friction upon axial movement of the piston. The document further describes stiffness-flexibility profiling of the elongate body with flexible and stiffer regions and distal geometry including a J-tip.

The document also describes proximal valve and packaging features for the device, including locking of inflation fluid in a closed valve state to enable removal of the inflation unit and leaving a hubless proximal end configuration for advancing one or more devices. It includes structural embodiments such as sealing member configurations, piston handle features, and other valve elements, and provides experimental/angiographic validation in sheep showing effective occlusion at tortuous or bent sites.

Claims Coverage

The relevant independent claims are directed to a balloon guide-wire valve/piston device for intravascular procedures and a vascular guide wire system combining the balloon with a valve assembly that maintains fluid in the lumen. The inventive features center on the specific valve closure/opening mechanism, the inflatable balloon in fluid communication with the lumen, and system configurations supporting inflation control and a hubless proximal end.

Across the independent claims, the main coverage combines an inflatable balloon in fluid communication with a lumen and a valve assembly that selectively opens and closes fluid flow using a sealing member and a piston. The valve closure/opening is reinforced by a frictional element that collapses in the lumen to provide friction for piston axial movement, and the system includes structural features such as collars maintaining sealing member position and a hubless proximal end configuration.

Stated Advantages

Documented Applications