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Publication Number
US-10828156-B2
Publication Date
2020-11-10
Expiration Date
Abstract
Valve prostheses, implantation devices, and methods for use are provided. The devices may be used for transcatheter delivery of an aortic valve prosthesis or transapical delivery of a mitral valve prosthesis. The implantation device can utilize movable claspers for both positioning and anchoring the valve prosthesis, reducing the extent of imaging needed during the implantation procedure.
Core Innovation
The disclosed invention relates to a sutureless self-expanding heart valve prosthesis and a method for deploying the prosthesis within a native heart valve. The valve prosthesis includes a radially expandable support frame with an outer surface and a longitudinal axis, a plurality of flexible leaflets attached to the support frame, and a valve clasper movably coupled to the support frame.
The valve clasper is movable relative to the support frame along the longitudinal axis between an engagement configuration and a nesting configuration, where the valve clasper and the support frame are collapsed against the implantation device and where the support frame is positioned within the valve clasper. The implantation device includes a control unit, a track wire, and first and second sheaths arranged serially, with the first sheath encasing at least a portion of the valve clasper in a compact condition and the second sheath encasing at least a portion of the support frame.
A further disclosed deployment approach uses an implantation device having the radially expandable support frame within a frame sheath and the valve clasper within an anchor sheath, with the anchor sheath positioned serially and distally from the frame sheath. The method includes moving the anchor sheath longitudinally relative to the valve clasper to expose at least a portion of the valve clasper, engaging the valve clasper with the native valve annulus, moving the frame sheath longitudinally relative to the support frame to permit expansion of the support frame, and removing the implantation device from the patient.
Claims Coverage
The document contains two independent claims, each defining a method for deploying a heart valve prosthesis using a radially expandable support frame, flexible leaflets, and a longitudinally movable valve clasper, with deployment controlled by serial sheaths and, in one claim, an implantation device including a control unit and track wire.
Serial-sheath deployment with longitudinally movable valve clasper
A method for deploying a heart valve prosthesis within a native heart valve by providing an implantation device carrying a valve prosthesis with a radially expandable support frame, flexible leaflets, and a valve clasper movably coupled to the support frame for movement along the longitudinal axis between an engagement configuration and a nesting configuration, where the implantation device includes a control unit, a track wire, and first and second sheaths with the first sheath encasing at least a portion of the valve clasper in a compact condition and the second sheath encasing at least a portion of the support frame, and where the track wire removably couples a distal end with the valve clasper.
Engage-annulus deployment using anchor and frame sheath relative movement
A method for deploying a heart valve prosthesis within a native heart valve annulus by advancing an implantation device into a patient carrying a radially expandable support frame within a frame sheath and a valve clasper within an anchor sheath, where the valve clasper is longitudinally movably coupled to the support frame and the frame sheath is positioned serially to and distally from the anchor sheath; moving the anchor sheath longitudinally relative to the valve clasper to expose at least a portion of the valve clasper; engaging the valve clasper with the native valve annulus; moving the frame sheath longitudinally relative to the support frame to permit expansion of the support frame; and removing the implantation device from the patient.
Across the independent claims, the central coverage is deployment of a heart valve prosthesis using a radially expandable support frame and a valve clasper that is longitudinally movable relative to the support frame, with engagement and expansion enabled by relative longitudinal movement of serial sheaths and, in one approach, support by a control unit and track wire coupled to the valve clasper.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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