Prosthetic heart valves
Inventors
Schneider, Lucas Tradd • Askegaard, Gunnar Paul • Iyer, Ramji
Assignees
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Publication Number
US-11712336-B1
Publication Date
2023-08-01
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
The invention relates to transcatheter prosthetic tricuspid heart valve systems that are deployed by engaging anatomical structures of a native tricuspid valve. The prosthetic heart valve comprises a main body having an inflow end portion and an outflow end portion, and an occluder extending between these end portions with valve leaflets arranged to allow blood flow from the inflow end portion toward the outflow end portion along a central axis while preventing blood flow in the opposite direction.
The prosthetic heart valve further includes a lateral anterior flap extending from the outflow end portion in a first direction transverse to the central axis, where the flap extends into a right ventricular outflow tract (RVOT). An edge portion of the lateral anterior flap extends along and abuts against a lateral wall of the RVOT so that lateral wall tissue is present both superior to and inferior to the edge portion to provide anchoring, mitigate paravalvular leakage, and resist migration.
The valve system includes valve and delivery system geometry intended to match non-circular or oblong native tricuspid annulus anatomy, including an oval/oblong main body cross-sectional shape with major and minor diameter. Deployment is described as transcatheter via a catheter system including an outer sheath, a middle deflectable catheter, and an inner control catheter with a selectively deflectable distal end portion that can be elastically curved, and frame construction is described as a cellular frame with variable stiffness formed by differing cell sizes or structures along inflow vs outflow frame ends.
Optionally, additional flap structures are described, including a septal anterior flap extending in the first direction. In some embodiments, cross-sections of the lateral anterior flap and the septal anterior flap taken perpendicular to the first direction exhibit an arcuate shape from the outer edge of the lateral anterior flap to the outer edge of the septal anterior flap, and frame portions arranged at a non-zero angle relative to a central axis provide at least part of the arcuate cross-sectional shape.
Claims Coverage
The provided independent claim contains 3 principal inventive aspects: a one-way occluder with leaflet coaptation arranged with inflow and outflow end portions along a central axis, a lateral anterior flap that extends into the RVOT and is anchored by abutting the RVOT lateral wall with tissue superior and inferior to the flap edge portion, and deployment by engaging native tricuspid valve anatomical structures using the prosthetic configuration. Dependent refinements add a septal anterior flap and specific arcuate cross-sectional geometry.
Method of deploying the prosthetic heart valve using native tricuspid valve anatomy
Engaging the prosthetic heart valve with anatomical structures of a native tricuspid valve, wherein the prosthetic heart valve comprises a main body with an inflow end portion and an outflow end portion, an occluder extending between the inflow and outflow end portions, and a lateral anterior flap extending into an RVOT and anchored by abutting an RVOT lateral wall such that tissue is present superior and inferior to the flap edge portion.
One-way occluder using valve leaflets along a central axis
An occluder extending between the inflow end portion and outflow end portion and comprising valve leaflets attached to the main body in an arrangement that allows blood flow from the inflow end portion toward the outflow end portion along a central axis of the occluder and prevents blood flow in the opposite direction.
Lateral anterior flap extending into RVOT and anchored by RVOT lateral wall abutment
A lateral anterior flap extending from the outflow end portion in a first direction transverse to the central axis, wherein the lateral anterior flap extends into a right ventricular outflow tract (RVOT), and wherein an edge portion of the lateral anterior flap extends along and abuts against a lateral wall of the RVOT such that there is lateral wall tissue present both superior to and inferior to the edge portion to provide anchoring.
Septal anterior flap
The prosthetic heart valve includes a septal anterior flap extending in a first direction.
Arcuate cross-sectional relationship between lateral and septal anterior flaps
When cross-sections of the lateral anterior flap and septal anterior flap are taken perpendicular to the first direction, their shape is arcuate from the outer edge of the lateral anterior flap to the outer edge of the septal anterior flap.
Non-zero angle frame portion arrangement to form arcuate cross-sectional shape
Lateral anterior flap and septal anterior flap frame portions extend from their outer edges and are arranged at a non-zero angle relative to a central axis to form at least part of an arcuate cross-sectional shape.
Two elongate members and multiple bridging members in frame portions
Each frame portion includes two elongate members extending in a first direction and multiple members extending between the two elongate members.
Across the independent claim and its dependents, the coverage centers on a one-way leaflet occluder arranged between an inflow end portion and an outflow end portion along a central axis, combined with a lateral anterior flap that extends into the RVOT and is anchored by abutting the RVOT lateral wall with tissue positioned superior and inferior to the flap edge portion. Dependent claims further refine the prosthetic structure by adding a septal anterior flap and constraining flap and frame geometry to achieve an arcuate cross-sectional shape using a non-zero angle arrangement and a frame portion member pattern of two elongate members plus multiple members between them.
Stated Advantages
Prevents blood flow in a direction from the outflow end portion toward the inflow end portion.
Anchoring is provided by lateral wall tissue present both superior to and inferior to the edge portion of the lateral anterior flap.
Mitigates paravalvular leakage.
Resists migration.
Documented Applications
Transcatheter deployment of a prosthetic heart valve in engagement with anatomical structures of a native tricuspid valve, including deployment via anatomical engagement of a right ventricular outflow tract (RVOT) and described transcatheter delivery catheter systems.
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