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 tricuspid heart valve systems, including a prosthetic heart valve and associated delivery. The prosthetic heart valve includes a main body having an inflow end portion and an outflow end portion, and an occluder extending between the inflow and outflow end portions. The occluder includes valve leaflets attached to the main body in an arrangement that allows blood flow through the occluder from the inflow end portion toward the outflow end portion along a central axis while preventing blood flow from the outflow end portion toward the inflow end portion.

The prosthetic heart valve further includes a first anterior flap extending from the outflow end portion in a first direction transverse to the central axis, and a posterior flap extending from the outflow end portion in a second direction opposite the first direction. A posterior arm extends from the inflow end portion in the second direction, with additional flap and arm structures configured to interact with right heart anatomy, including an RVOT and right atrium and structures associated therewith.

The invention also emphasizes geometries and features directed to sealing and reducing paravalvular leakage, including an oval or oblong main body having a major diameter and a minor diameter and anterior flap cross-sections that are arcuate. The described valve construction includes leaflet engagement members configured to capture native leaflets to provide migration resistance, and provides passageways to permit pacemaker lead pass-through. A delivery system is described that uses an outer sheath catheter with an inner control catheter that is elastically reconfiguring and a selectively deflectable middle catheter, enabling curved advancement and deployment via trans-jugular and trans-femoral approaches.

Claims Coverage

The independent claims in the provided set present one core valve structure, with the occluder and directional flow function, plus specified anterior flap and posterior flap/arm directional relationships. The coverage also includes dependent refinements addressing additional flap and arm features and geometric constraints on cross-sectional shapes and relative extension constraints.

Across the provided claims, the core inventive structure is a main-body-supported occluder with valve leaflets arranged to permit forward flow along a central axis while preventing reverse flow, combined with specific anterior and posterior flap and arm directions relative to the central axis. Dependent refinements further add named anterior flap and arm components and define geometric cross-sectional shapes and relative extension constraints.

Stated Advantages

Documented Applications