Device, system, and method for transcatheter treatment of valvular regurgitation
Inventors
Assignees
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Publication Number
US-11672659-B2
Publication Date
2023-06-13
Expiration Date
Abstract
The invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation assistance element for implantation across the valve; a system including the coaptation assistance element and anchors for implantation; a system including the coaptation assistance element and delivery catheter; and a method for transcatheter implantation of a coaptation element across a heart valve.
Core Innovation
The invention relates to a coaptation assistance element for treating mal-coaptation of a heart valve of a heart. The coaptation assistance element includes a first surface and an opposed second surface, with a first lateral edge, a second lateral edge, an inferior edge, and a superior edge. It further includes a superior zone and an inferior zone, where the superior zone is configured to reside within a heart superior to an annulus of the heart valve and the inferior zone extends downward from the superior zone.
The inferior zone comprises a leaflet-apposing valve body element and a leaflet surface. One or more chords extend between the leaflet-apposing valve body element and the leaflet surface, and the chords are configured to stabilize the leaflet-apposing valve body element and prevent or limit prolapse. In additional refinements, the chords extend between inferior edges and/or lateral edges of the leaflet-apposing valve body element and the leaflet surface.
In further embodiments, the leaflet-apposing valve body element includes at least one fixed end and at least one free end, and the leaflet-apposing valve body element is retained by one or more chords during systole. The leaflet-apposing valve body element is configured to expand and contract with each heartbeat, with movement relative to the opposed second surface during systole and diastole, and is characterized as mimicking the cardiac cycle by moving during that cycle.
Claims Coverage
The independent claims cover a coaptation assistance element for treating mal-coaptation, with a superior zone positioned relative to a valve annulus and an inferior zone extending downward from the superior zone. Across the independent claims, the inventive features center on the leaflet-apposing valve body element, one or more chords, fixed and free ends, and retention during systole.
Superior and inferior zone configuration for annulus positioning
A coaptation assistance element comprising a first surface and an opposed second surface, a first lateral edge, a second lateral edge, an inferior edge, and a superior edge, with a superior zone configured to reside within a heart superior to an annulus of the heart valve and an inferior zone extending downward from the superior zone.
Chords between leaflet-apposing valve body element and leaflet surface
The inferior zone comprises a leaflet-apposing valve body element and a leaflet surface, and one or more chords extend between the leaflet-apposing valve body element and the leaflet surface.
Leaflet-apposing valve body with fixed and free ends
The inferior zone comprises a leaflet-apposing valve body element and a leaflet surface, and the leaflet-apposing valve body element comprises at least one fixed end and at least one free end.
Leaflet-apposing valve body retained by one or more chords during systole
The inferior zone comprises a leaflet-apposing valve body element, and the leaflet-apposing valve body element is retained by one or more chords during systole.
Overall, the claims cover a coaptation assistance element arranged with a superior zone relative to an annulus and an inferior zone carrying a leaflet-apposing valve body element and leaflet surface. The principal inventive features are chord coupling, fixed and free end behavior, and retention of the leaflet-apposing valve body element during systole.
Stated Advantages
Enhances leaflet coaptation without annular/ventricular reshaping or leaflet fusion.
Supports long fatigue life with limited excursion.
Can be recaptured/repositioned.
Maintains a favorable blood flow path in diastole.
Chords are configured to stabilize the leaflet-apposing valve body element.
Chords are configured to prevent or limit prolapse.
The leaflet-apposing valve body element expands and contracts with each heartbeat.
The leaflet-apposing valve body element moves relative to the opposed second surface during systole and diastole.
The leaflet-apposing valve body element mimics the cardiac cycle by moving during that cycle.
Documented Applications
Use as a transcatheter coaptation assistance implant system for treating mitral valve regurgitation/mal-coaptation by placing a conformable coaptation assistance body across the valve so native leaflets coapt against a coaptation surface during the cardiac cycle.
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