Device, system, and method for transcatheter treatment of valvular regurgitation
Inventors
Assignees
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Publication Number
US-12285336-B2
Publication Date
2025-04-29
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 is directed 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. 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 positioned to lie over a portion of a posterior leaflet of the heart valve and configured to expand to maintain a valve seal at an annular ring. The leaflet-apposing valve body element is configured to be expanded by a force in systole and contracted by a force in diastole, and is configured to expand and contract with each heartbeat.
In further configurations, the leaflet-apposing valve body element is configured to expand based on motion of tissue during systole, blood flow during systole, or pressure build-up within the heart during systole. The coaptation assistance element may further be configured to be anchored to the annulus and/or anchored using a helical anchor, and the leaflet-apposing valve body element may include biological material.
Claims Coverage
The independent claims cover 4 principal feature areas: superior and inferior zoned placement relative to the annulus, a leaflet-apposing valve body element that maintains a valve seal at an annular ring, systole-based expansion and, in one configuration, diastole contraction with each heartbeat, and anchoring including a helical anchor.
Superior and inferior zoned placement relative to the annulus
A coaptation assistance element comprising 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.
Leaflet-apposing valve body element maintaining a valve seal at an annular ring
The inferior zone comprises a leaflet-apposing valve body element positioned to lie over a portion of a posterior leaflet of the heart valve, wherein the leaflet-apposing valve body element is configured to expand to maintain a valve seal at an annular ring.
Heartbeat- and systole-driven expand and contract behavior
The leaflet-apposing valve body element is configured to be expanded by a force in systole and contracted by a force in diastole, and is configured to expand and contract with each heartbeat; in further configurations it expands based on motion of tissue during systole, blood flow during systole, or pressure build-up within the heart during systole.
Anchoring using a helical anchor
The coaptation assistance element is configured to be anchored to the annulus and/or anchored using a helical anchor.
Collectively, the independent claims define a coaptation assistance element with superior and inferior zoned structure and an inferior leaflet-apposing valve body element that expands to maintain an annular ring valve seal. The claims further specify systole-based expansion triggers, and one configuration includes contraction in diastole with each heartbeat. The claim set also includes anchoring to the annulus and the use of a helical anchor.
Stated Advantages
Maintains a valve seal at an annular ring.
Documented Applications
Treating mal-coaptation of a heart valve of a heart.
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