Devices and methods for delivery of valve prostheses

Inventors

Zhang, Ji

Assignees

JC Medical Inc

Abstract

Methods for delivering a pulmonary or mitral valve prosthesis using a transcatheter approach are provided. The implantation devices can utilize movable claspers for both positioning and anchoring the valve prostheses within the native cardiac valve, minimizing the extent of imaging necessary.

Core Innovation

The disclosed invention concerns a transcatheter, minimally invasive sutureless heart valve delivery in which a valve prosthesis is deployed within an aortic valve using an implantation device carrying a radially expandable support frame and a valve clasper movably coupled to the support frame. The valve prosthesis is carried in a compact condition by a first sheath and a second sheath positioned serially to and distally from the first sheath, and the valve clasper moves between an engagement configuration and a nesting configuration while the support frame moves into an expanded condition.

The implantation device includes a control unit, a track wire with a proximal end attached to the control unit and a distal end removably coupled with the valve clasper, and first and second sheaths that independently encase portions of the valve prosthesis. In deployment, at least the distal end of the implantation device is inserted into a femoral artery, advanced to the aortic valve, and the valve prosthesis is released at the aortic valve. The delivery concept is further grounded in longitudinal relative movement of an anchor sheath and a frame sheath to expose and engage the valve clasper and to permit expansion of the support frame.

The disclosure further describes flexible or biologic leaflets attached to the support frame, and optional coverings and fasteners for the support frame. The valve clasper and support frame relationship is managed using engagement and nesting configurations, detents for anchoring, and optional shape-memory materials such as Nitinol to support positioning in compact and expanded/deployed conditions.

Claims Coverage

The provided independent claims cover three main deployment approaches for an aortic valve: transcatheter deploying a heart valve prosthesis within an aortic valve using a radially expandable support frame and a movable valve clasper carried with serial first and second sheaths and a releasable track wire; deploying a heart valve prosthesis within an aortic valve annulus using anchor-sheath and frame-sheath longitudinal relative movement to expose, engage, position, and expand; and a method substantially matching the anchor-sheath/frame-sheath annulus deployment framework with sheaths serially arranged and continued support-frame expansion before device removal. Across these independent claims, the key inventive features total eight.

Across the independent claims, the coverage focuses on transcatheter deployment of an aortic-valve heart valve prosthesis using a movable valve clasper relative to a radially expandable support frame, with exposure, engagement, and expansion achieved by relative longitudinal movement of sheaths while the prosthesis is carried in a compact condition and deployment is completed by removing the implantation device.

Stated Advantages

Documented Applications