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Publication Number
US-11806235-B1
Publication Date
2023-11-07
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 o the prosthetic heart valve to a native tricuspid valve site via a superior vena cave or inferior vena cave.
Core Innovation
The invention relates to a transcatheter prosthetic tricuspid heart valve system that includes a main body having an inflow end portion and an outflow end portion, and an occluder extending between the inflow end 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, and prevents blood flow in the reverse direction along the central axis.
The prosthetic heart valve further includes a first anterior flap and a second anterior flap extending from the outflow end portion in a first direction transverse to the central axis. A cross-sectional shape of the first and second anterior flaps taken perpendicularly to the first direction is arcuate from an outer edge of the first anterior flap to an outer edge of the second anterior flap.
The described deployment system includes an outer sheath catheter and an inner control catheter that is curved and elastically deformable, together with a selectively deflectable middle catheter. The system provides large deflection angles and has a small delivery profile.
Claims Coverage
The independent claim is clm-00001. It defines 2 inventive features centered on the prosthetic heart valve structure and flap geometry. Dependent claims further refine the flap geometry, flap interaction, optional open space between flaps, and introduction of an optional posterior flap.
Occluder directionality with valve leaflets
An occluder extending between an inflow end portion and an outflow end portion and comprising 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 of the occluder and prevents blood flow in the reverse direction.
Arcuate anterior flap cross-sectional shape
A first anterior flap and a second anterior flap extending from the outflow end portion in a first direction transverse to the central axis, wherein a cross-sectional shape of the first and second anterior flaps taken perpendicularly to the first direction is arcuate from an outer edge of the first anterior flap to an outer edge of the second anterior flap.
Overall claim coverage centers on a prosthetic heart valve occluder that permits one-way blood flow along a central axis and includes first and second anterior flaps whose cross-sectional shape is arcuate between their outer edges, with dependent claims refining flap frame portions, overlap and/or open space between the anterior flaps, and adding an optional posterior flap.
Stated Advantages
Allows blood flow through the occluder from the inflow end portion toward the outflow end portion while preventing blood flow in the opposite direction.
Small delivery profile for transcatheter delivery.
Documented Applications
Transcatheter deployment via trans-jugular (SVC) and trans-femoral (IVC) approaches for a prosthetic tricuspid heart valve.
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