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Publication Number

US-12440333-B1

Patent

Publication Date

2025-10-14

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 valve includes structural features that securely anchor the prosthetic heart valve to the anatomy at the site of the native heart valve. Such structural features can provide robust migration resistance. In addition, the prosthetic heart valves can include structural features that improve sealing between the prosthetic valve and native valve anatomy to mitigate paravalvular leakage. In particular implementations, 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 inner 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

A transcatheter prosthetic heart valve deployment is provided for deployment to a native tricuspid valve. The prosthetic heart valve includes a main body comprising an inflow end portion and an outflow end portion, with one or more anterior flaps extending from the outflow end portion. The valve is releasably coupled to a prosthetic heart valve deployment system and is diametrically constrained in a low-profile delivery configuration within a first lumen of an outer steerable sheath catheter.

The deployment positions a distal end portion of the outer steerable sheath catheter in a right atrium and deflects the distal end portion toward the native tricuspid valve. The prosthetic heart valve is expressed from the outer steerable sheath catheter while maintaining the outer steerable sheath catheter substantially stationary. The inflow end portion of the prosthetic heart valve is expressed only after an entirety of the outflow end portion has been expressed, such that the one or more anterior flaps extend into a right ventricular outflow tract (RVOT) as a result of expressing the prosthetic heart valve from the outer sheath.

The prosthetic heart valve deployment system includes a middle deflectable catheter slidably disposed in the first lumen and defining a second lumen, the middle deflectable catheter having a selectively deflectable distal end portion. The deployment system further includes an inner control catheter slidably disposed in the second lumen and including one or more control wires that are releasably coupled with the prosthetic heart valve. The delivery concepts described include trans-jugular via superior vena cava and trans-femoral via inferior vena cava approaches.

Claims Coverage

The partial content identifies one independent claim directed to a deploying method and does not provide independent claims beyond that single independent claim.

Transvenous deployment toward native tricuspid valve with outer steerable sheath deflection

Advancing, via a femoral vein and an inferior vena cava, the prosthetic heart valve toward a native tricuspid valve while the prosthetic heart valve is releasably coupled to a prosthetic heart valve deployment system and diametrically constrained in a low-profile delivery configuration within a first lumen of an outer steerable sheath catheter, with a distal end portion of the outer steerable sheath catheter in a right atrium, deflecting the distal end portion of the outer steerable sheath catheter toward the native tricuspid valve.

Sequential expression of outflow portion before inflow portion

Expressing the prosthetic heart valve from the outer steerable sheath catheter while maintaining a position of the outer steerable sheath catheter substantially stationary, wherein the inflow end portion of the prosthetic heart valve is expressed only after an entirety of the outflow end portion has been expressed, and wherein the one or more anterior flaps extend into a right ventricular outflow tract (RVOT) as a result of the expressing of the prosthetic heart valve from the outer sheath.

Deployment system with middle deflectable catheter and inner control catheter with control wires

Wherein the prosthetic heart valve deployment system comprises a middle deflectable catheter slidably disposed in the first lumen and defining a second lumen, the middle deflectable catheter comprising a selectively deflectable distal end portion, and an inner control catheter slidably disposed in the second lumen and including one or more control wires that are releasably coupled with the prosthetic heart valve.

Based on the provided independent claim, the core claim coverage is the transvenous deployment method using an outer steerable sheath that is deflected toward the native tricuspid valve, sequential expression of the outflow end portion prior to the inflow end portion while keeping the outer sheath substantially stationary, and a deployment system having a middle deflectable catheter and an inner control catheter with control wires coupled to the prosthetic heart valve.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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