System for replacing a native valve of the heart
Inventors
Chau, Mark • Patterson, Marlowe E. • Yi, Seung-Beom • Geist, Stephen C. • Oba, Travis Zenyo
Assignees
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Publication Number
US-12433743-B2
Publication Date
2025-10-07
Expiration Date
Abstract
A system for replacing a native valve of the heart includes a delivery apparatus having a sheath and a prosthetic valve. The prosthetic valve includes a frame having an annular main body, a plurality of ventricular anchors attached to the main body, an atrial anchor attached to an atrial end portion of the main body, and a valve structure disposed within the main body of the frame. The prosthetic valve is disposed within a distal end portion of the sheath in a compressed, delivery state. When the prosthetic valve is deployed from the sheath, the main body of the frame radially expands to a radially expanded state, the ventricular anchors expand to a deployed state alongside the main body of the frame for capturing native leaflets of the native valve, and the atrial anchor expands to a deployed state extending radially outwardly from the main body.
Core Innovation
The invention relates to a system for replacing a native valve of the heart, in which a native annulus and native valve leaflets are engaged by a prosthetic valve delivered into the heart. The prosthetic valve includes a main body with a lumen configured for placement within the native annulus, where the main body is radially compressible to a radially compressed state for delivery and self-expandable to a radially expanded state. A valve structure coupled to the inner surface of the main body forms a one-way valve in the lumen with a plurality of valve leaflets.
To secure the prosthetic valve to the native valve leaflets, the system includes at least two ventricular anchors extending from a ventricular end portion of the main body and disposed outside of the main body. The ventricular anchors are configured to capture the native valve leaflets between the ventricular anchors and an outer surface of the main body. Each ventricular anchor is finger-like and pre-formed to extend along the outer surface of the main body in a functional deployed state, including configurations where the anchors are retained in a partially or completely straightened configuration while the prosthetic valve is within the distal end portion of a sheath.
During deployment, the system deploys the ventricular anchors from the sheath while the main body remains in the radially compressed state, allowing the ventricular anchors to spring back from the straightened configuration to the functional deployed state, followed by expansion of the main body to the radially expanded state. In addition, the invention includes an atrial end releasably attached to a pusher shaft in one embodiment and an atrial anchor attached to an atrial end portion of the main body in another embodiment, where the atrial anchor expands radially outwardly to contact an atrial side of the native valve and prevent blood from flowing between the main body and the native valve. The delivery apparatus is steerable and configured for delivery to the native valve in a trans-septal delivery approach in which the delivery apparatus extends through an atrial septum of the heart.
Claims Coverage
The provided independent claims are clm-00001, clm-00009, clm-00017, and clm-00021. Across these claims, the coverage centers on a self-expandable or radially expandable prosthetic valve with ventricular anchors that transition from a straightened or covered state to a deployed state for capturing native leaflets, delivered via a sheath using a steerable trans-septal approach; additional coverage includes releasable attachment of the atrial end to a pusher shaft and an atrial anchor to prevent blood flow between the prosthesis and the native valve.
Steerable sheath and pusher shaft trans-septal system with straightened finger-like ventricular anchors
A delivery apparatus comprising a sheath and a pusher shaft extending through the sheath, wherein the delivery apparatus is steerable within a vasculature of a patient, and wherein a trans-septal delivery approach extends through an atrial septum of the heart; and a prosthetic valve with a main body radially compressible to a radially compressed state and self-expandable to a radially expanded state, finger-like pre-formed ventricular anchors captured between the ventricular anchors and an outer surface of the main body, the ventricular anchors retained in a partially or completely straightened configuration in the sheath and deployed so they spring back to a functional deployed state while the main body expands after anchor deployment, with an atrial end releasably attached to the pusher shaft.
Shape-memory frame radially expands while straightened ventricular anchors transition to deployed configuration
A frame made of a shape-memory material with a main body having an atrial end, a ventricular end, and a longitudinal axis, the frame further comprising a ventricular anchoring portion with a plurality of ventricular anchors having a first end attached to the main body and a second end spaced from the first end and not attached to the main body; the prosthetic valve disposed within a distal end portion of a sheath with the main body retained in a radially compressed state and the ventricular anchors extending distally in a straightened configuration parallel to the longitudinal axis, and upon deployment the main body radially expands while the ventricular anchors transition to a deployed configuration alongside the main body for capturing native leaflets between the ventricular anchors and an outer surface of the main body, with the atrial end releasably attached to the pusher shaft.
Finger-like ventricular anchors transition from straightened configuration alongside shape-memory main body
A system in which a prosthetic valve includes a shape-memory frame with a main body having an atrial end, a ventricular end, and a longitudinal axis, the frame further comprising a ventricular anchoring portion comprising a plurality of finger-like ventricular anchors, each ventricular anchor having a first end attached to the main body and a second end spaced from the first end and not attached to the main body; the prosthetic valve disposed within a distal end portion of the sheath with the main body retained in a radially compressed state and the ventricular anchors extending distally in a straightened configuration parallel to the longitudinal axis, and upon deployment the main body radially expands while the ventricular anchors transition from the straightened configuration to a deployed configuration alongside the main body for capturing native leaflets between the ventricular anchors and an outer surface of the main body.
Atrial anchor expands to contact atrial side and prevent blood flow between prosthesis and native valve
A prosthetic valve with a shape-memory frame comprising an annular main body and a plurality of ventricular anchors, each ventricular anchor having a first end attached to the main body and a second end spaced from the first end and not attached to the main body; an atrial anchor attached to an atrial end portion of the main body; and a valve structure disposed within the main body of the frame, where the prosthetic valve is disposed within a distal end portion of the sheath in a compressed, delivery state and, when deployed, the main body radially expands to a radially expanded state, the ventricular anchors expand to a deployed state alongside the main body for capturing native leaflets, and the atrial anchor expands to a deployed state extending radially outwardly for contacting an atrial side of the native valve and for preventing blood from flowing between the main body and the native valve.
Across clm-00001, clm-00009, clm-00017, and clm-00021, the claim coverage is directed to prosthetic mitral or native valve replacement in which a radially compressible, self-expandable or shape-memory main body and a one-way valve structure are delivered within a sheath and deployed in a controlled manner such that finger-like ventricular anchors transition from a straightened configuration to a deployed configuration for capturing native leaflets; additional coverage includes releasable attachment of the atrial end to a pusher shaft and an atrial anchor that expands to contact the atrial side and prevent blood flow between the main body and the native valve.
Stated Advantages
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