Prosthetic heart valves
Inventors
Iyer, Ramji • Schneider, Lucas Tradd • Askegaard, Gunnar Paul
Assignees
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Publication Number
US-11510777-B1
Publication Date
2022-11-29
Expiration Date
Abstract
Some embodiments described herein include a heart valve replacement system that may be delivered to a targeted native heart valve site via one or more delivery catheters. In some embodiments, a prosthetic heart valve of the system includes structural features that securely anchor the prosthetic heart valve to the site of the native heart valve. Such structural features can provide robust migration resistance. In particular implementations, the prosthetic heart valves occupy a smaller delivery profile, thereby facilitating a smaller delivery catheter for advancement to the heart.
Core Innovation
The invention relates to a transcatheter prosthetic heart valve system with a main body having an oval shaped outer profile and an occluder with valve leaflets that allow blood flow from an inflow end portion toward an outflow end portion and prevent blood flow in the reverse direction. The occluder extends between the inflow end and outflow end portions and has a circular cross-sectional shape, while the transverse cross-section defines a major diameter and a minor diameter with the minor diameter shorter than the major diameter. The valve is configured to control flow directionality while maintaining the main-body profile geometry.
The prosthetic heart valve includes an anterior flap extending along a first direction transverse to the major diameter and away from the outflow end portion of the main body, and a posterior flap extending along a second direction transverse to the major diameter and away from the outflow end portion in a direction directionally opposite the first direction. A leaflet engagement member extends from the main body so that a portion extends toward the inflow end portion and terminates at a free end, and the leaflet engagement member extends in the second direction. The geometry and directional extension relate the flaps and leaflet engagement member to the oval-profile main body cross-section to interact with native tissue.
The invention further addresses deployment within a native heart valve annulus by using a delivery sheath to advance the prosthetic heart valve in a radially compressed state and then deploying it such that a first portion of an internal area defined by the native heart valve annulus is filled by the main body and a second portion is covered by the one or more anterior flaps. The claims also define structural refinements using a covering attached to the anterior flaps to form openings through terminal end portions, and define relationships between the annulus internal-area geometry and the prosthetic valve major/minor diameter alignment, including lateral offset of an occluder central longitudinal axis from an annulus geometric center.
Claims Coverage
The document includes three independent claims: clm-00001, clm-00010, and clm-00012 for the prosthetic heart valve structure, plus clm-00014 for a deployment method. Across these independent claims, the inventive features focus on an oval-profile main body with major and minor diameters, an occluder that permits forward flow and prevents reverse flow, transverse anterior and posterior flaps extending in opposing directions relative to the outflow end portion, and optional leaflet engagement member directionality, covering with openings, and deploy-time filling/coverage relationships within a native annulus.
Oval shaped outer profile main body with major and minor diameters
A main body comprising an inflow end portion and an outflow end portion, a transverse cross-section of the main body having an oval shaped outer profile that defines a major diameter and a minor diameter, wherein the minor diameter is shorter than the major diameter.
Occluder allowing forward flow and preventing reverse flow
An occluder extending between the inflow end and outflow end portions and comprising valve leaflets attached to the main body in an arrangement that: (i) allows blood flow through the occluder in a direction from the inflow end portion toward the outflow end portion and (ii) prevents blood flow through the occluder in a direction from the outflow end portion toward the inflow end portion, the occluder having a circular cross-sectional shape.
Opposing anterior and posterior flaps transverse to the major diameter
An anterior flap extending along a first direction that is transverse to the major diameter and away from the outflow end portion of the main body; and a posterior flap extending along a second direction that is transverse to the major diameter and away from the outflow end portion of the main body directionally opposite of the first direction.
Leaflet engagement member extending in the posterior flap direction
A leaflet engagement member extending from the main body, a portion of the leaflet engagement member extending toward the inflow end portion and terminating at a free end, wherein the leaflet engagement member extends in the second direction.
Two anterior flaps with terminal portions angled toward the inflow end
A first anterior flap with a first portion extending away from the outflow end portion of the main body along a first direction that is transverse to the major diameter; a second anterior flap with a first portion extending away from the outflow end portion of the main body along the first direction; and wherein the first anterior flap and the second anterior flap each include a mid-body portion that is bent at an angle that directs terminal end portions of each of the first anterior flap and the second anterior flap partially toward the inflow end of the main body.
Covering forming openings at terminal ends of anterior flaps
A covering attached to the first and second anterior flaps, wherein the covering defines a first opening through a terminal end portion of the first anterior flap, and wherein the covering defines a second opening through a terminal end portion of the second anterior flap.
Deploying a radially compressed prosthetic into a native annulus with filling and anterior-flap coverage
Advancing a delivery sheath containing the prosthetic heart valve in a radially compressed state to a location of the native heart valve annulus; and deploying the prosthetic heart valve from the delivery sheath and into engagement with the native heart valve annulus such that a first portion of an internal area defined by the native heart valve annulus is filled by the main body and a second portion of the internal area defined by the native heart valve annulus is covered by the one or more anterior flaps.
Overall, the claim set concentrates on a prosthetic heart valve with an oval shaped outer profile main body (major and minor diameters), a flow-direction occluder with valve leaflets that prevents reverse flow, and transverse anterior/posterior flaps extending in opposing directions from the outflow end portion. The structural refinements further include a leaflet engagement member directionality and, in other independent claim variants, a covering with openings at terminal ends of anterior flaps and anterior flap terminal portions partially directed toward the inflow end via a bent mid-body portion. The method claim requires deployment in a native heart valve annulus with radially compressed advancement followed by engagement that fills a first portion of the annulus internal area with the main body and covers a second portion with the anterior flaps.
Stated Advantages
Documented Applications
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