Prosthetic heart valves
Inventors
Iyer, Ramji • Schneider, Lucas Tradd • Askegaard, Gunnar Paul • Olsen, Brett R. • Anderson, Rachel Jean
Assignees
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Publication Number
US-12064349-B1
Publication Date
2024-08-20
Expiration Date
Abstract
Prosthetic heart valves may be delivered to a targeted native heart valve site via one or more delivery catheters. In some embodiments, the prosthetic heart valves are implanted using catheter-based deployment systems that include multiple control wires. In particular implementations, the deployment systems can include a retrieval catheter that can be used to recapture the prosthetic heart valve back into a delivery sheath after being expressed from the delivery sheath. The prosthetic heart valves occupy a small delivery profile, thereby facilitating a smaller delivery catheter system for advancement to the heart. Some delivery catheter systems can include a curved control catheter and/or a deflectable catheter to facilitate deployment of the prosthetic heart valve to a native tricuspid valve site via a superior vena cava or inferior vena cava.
Core Innovation
The disclosed invention relates to a catheter-based prosthetic heart valve delivery system for delivering a prosthetic tricuspid heart valve using one or more clinician-controlled control wires that releasably attach the prosthetic heart valve to one or more catheters extending from a control handle. The delivery system includes a multi-catheter delivery arrangement with an outer sheath catheter, a selectively deflectable middle catheter, and a curved inner control catheter. The system enables deployment and subsequent retrieval using catheter components controlled through the control handle and control wires.
The prosthetic valve includes an occluder with flexible leaflets and an anterior flap and a posterior flap. Migration resistance is addressed by optional posterior arm and anterior arm configurations and leaflet engagement members. Paravalvular leakage mitigation is addressed in connection with the posterior flap and related leaflet engagement members, including the use of an optional posterior/anterior arm and/or leaflet engagement members for improving engagement with adjacent tissue.
The disclosure further describes deployment and retrieval concepts using low-profile delivery and controlled release/recapture mechanisms. The low-profile delivery is described in connection with radially cinching of inflow and outflow end portions and releasing mechanisms for flap/pin release. The retrieval system recaptures the expressed valve into the delivery sheath using a self-expandable funnel-shaped member and a diametrically-adjustable wire loop, including a clinician-initiated abort implant rationale.
Claims Coverage
This section covers two independent claims. Each independent claim focuses on a prosthetic heart valve delivery system that combines a clinician interface and releasable catheter attachment with a rail-based mounting and stabilization system, wherein the rail portions can be adjusted into nonlinear arrangements relative to each other.
Control handle with control wire releasable valve attachment
A prosthetic heart valve delivery system comprising a control handle; one or more catheters extending from the control handle, wherein the one or more catheters are configured to be releasably attached to the prosthetic heart valve by one or more control wires.
Nonlinear-adjustable rail system mounted to a procedure table
A rail system configured to releasably receive the control handle for adjustably mounting the control handle thereon; a mounting and stabilization system configured to releasably receive the rail system for removably attaching the rail system thereto, wherein the mounting and stabilization system is configured to be removably attached to a procedure table; wherein the rail system includes two rail portions that are movably coupled together by a hinge and thereby adjustable into nonlinear arrangements in relation to each other.
Removable linking member for separating rail portions and independent nonlinear adjustment
A rail system configured to releasably receive the control handle for adjustably mounting the control handle thereon, the rail system comprising a first rail portion, a second rail portion, and a removable linking member that can be installed to interconnect the first and second rails portions and that is disconnectable from the first and second rails portions by a clinician-user to totally separate the first and second rail portions from each other; wherein first and second rail portions are adjustable independently of each other and configured to be adjusted into nonlinear orientations in relation to each other; and a mounting and stabilization system configured to be removably attached to a procedure table.
Across both independent claims, the inventive coverage is directed to a prosthetic heart valve delivery system with a control handle linked to valve attachment via control wires and a procedure-table-mounted rail system. The key distinction is how the rail portions achieve nonlinear arrangements relative to each other, either via a hinge coupling between two rail portions or via a removable linking member enabling full separation and independent adjustment into nonlinear orientations.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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