Prosthetic heart valves

Inventors

Askegaard, Gunnar Paul • Schneider, Lucas Tradd • Iyer, Ramji

Assignees

Laplace Interventional Inc

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

The invention relates to transcatheter prosthetic heart valve systems for tricuspid replacement, where a prosthetic heart valve is delivered in a low-profile delivery configuration and deployed at a native tricuspid valve. The prosthetic heart valve includes a main body with an inflow end portion and an outflow end portion, and an occluder extending between the inflow end portion and the outflow end portion. The occluder defines a longitudinal axis and allows blood flow through the occluder from the inflow end portion toward the outflow end portion while preventing blood flow from the outflow end portion toward the inflow end portion.

The prosthetic heart valve further includes an anterior flap that extends from the outflow end portion, where the anterior flap has a first portion attached to the outflow end portion, a mid-body portion, and a terminal end portion that extends from the mid-body portion. The first portion extends substantially perpendicularly from the outflow end portion of the main body to the mid-body portion, and the mid-body portion is bent at an angle that directs the terminal end portion partially toward the inflow end portion. The terminal end portion tip is spaced apart from the main body by a distance greater than the radius of a circular cross-sectional shape of the occluder.

For deployment, the prosthetic heart valve is constrained in a first lumen of an outer sheath and releasably coupled to a prosthetic heart valve deployment system, where expressing the prosthetic heart valve includes releasing an entirety of the outflow end portion prior to expressing the inflow end portion. As a result of expressing the prosthetic heart valve from the outer sheath, one or more anterior flaps extend into a right ventricular outflow tract (RVOT), and the described geometry and coverage relationships are used to anchor during diastole and to improve sealing to mitigate paravalvular leakage.

Claims Coverage

The partial content includes two independent claims. Across the independent claims, the main inventive features concern occluder flow directionality combined with specific anterior flap geometry constraints, and constrained low-profile delivery and deployment sequencing that causes anterior flaps to extend into the RVOT.

Across the independent claims, the prosthetic heart valve innovation centers on unidirectional occluder flow combined with a defined anterior flap geometry, including a bent mid-body portion and a terminal-tip spacing constraint relative to the occluder radius. The method independent claim covers femoral-via-IVC advancement and low-profile sheath-constrained delivery with controlled expressing order, producing anterior flap extension into the RVOT.

Stated Advantages

Documented Applications