Device, system, and method for transcatheter treatment of valvular regurgitation
Inventors
Khairkhahan, Alexander K. • Patel, Anuja • Essinger, Jacques • de Filippo, Roberto
Assignees
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Publication Number
US-11759321-B2
Publication Date
2023-09-19
Expiration Date
Abstract
Devices are disclosed for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation assistance element for implantation across the mitral valve and an edge to edge device. Methods are disclose for reducing mitral valve regurgitation at low left ventricle pressure and high left ventricle pressure during the cardiac cycle. Devices are disclosed for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation assistance element for implantation across the mitral valve with an adaptive coaptation element.
Core Innovation
The invention addresses mal-coaptation of a mitral valve of a heart by delivering a coaptation assistance element. The coaptation assistance element includes a body having a first surface disposed toward a posterior leaflet and an opposed second surface disposed toward an anterior leaflet, and the body is bounded by lateral edges, an inferior edge, and a superior edge, with an implant clip zone extending upward from the inferior edge and spaced inward from the lateral edges.
A single grasping device is positioned to interact with the coaptation assistance element in an open configuration and in a closed configuration within the implant clip zone. The single grasping device includes a first prong and a second prong directly connected at a central pivot, and in the open configuration at least a portion of the body is disposed between the prongs while the prongs extend outward from the body surfaces.
In the closed configuration, the first prong grasps the first surface of the body and the second prong grasps the anterior leaflet against the second surface of the coaptation assistance element, while the single grasping device does not grasp the posterior leaflet. The coaptation assistance element and the single grasping device are decoupled such that the single grasping device is delivered to the heart after the coaptation assistance element is delivered to the heart.
Claims Coverage
The independent claim coverage centers on one decoupled delivery method for treating mitral valve mal-coaptation. The inventive features combine a coaptation assistance element with opposed surfaces and an inward-spaced implant clip zone, together with a single grasping device that pivots between open and closed configurations to grasp the anterior leaflet while not grasping the posterior leaflet.
Decoupled delivery of coaptation assistance element and single grasping device
The coaptation assistance element and the single grasping device are decoupled such that the single grasping device is delivered to the heart after the coaptation assistance element is delivered to the heart.
Body having opposed posterior- and anterior-facing coaptation surfaces with inward implant clip zone
A body comprising a first surface disposed toward a posterior leaflet of the mitral valve and an opposed second surface disposed toward an anterior leaflet of the mitral valve, with the body bounded by lateral edges, an inferior edge, and a superior edge, and an implant clip zone extending upward from the inferior edge and spaced inward from the lateral edges.
Single grasping device pivoting between open and closed configurations within the implant clip zone
A single grasping device is positioned in an open configuration within the implant clip zone and includes a first prong and a second prong directly connected at a central pivot; in the open configuration, at least a portion of the body is disposed between the prongs, and in the closed configuration the device remains within the implant clip zone.
Anterior leaflet grasping without posterior leaflet grasping
In the closed configuration, the first prong grasps the first surface of the body and the second prong grasps the anterior leaflet against the second surface of the body, while the single grasping device does not grasp the posterior leaflet.
The claim coverage centers on treating mitral valve mal-coaptation by delivering a coaptation assistance element with opposed surfaces and an inward-spaced implant clip zone, then using a single grasping device that pivots between open and closed configurations to grasp the anterior leaflet against the element while not grasping the posterior leaflet. The method further specifies decoupled delivery so the grasping device is delivered after the coaptation assistance element.
Stated Advantages
Allows treating mal-coaptation of a mitral valve by supporting leaflet apposition using a coaptation assistance element.
The single grasping device grasps only the anterior leaflet and does not grasp the posterior leaflet.
Decoupled delivery enables delivering the single grasping device after the coaptation assistance element is delivered to the heart.
Improved coaptation.
Reduced MR.
Similar hemodynamics.
Reduced stenosis risk by allowing leaflet motion.
Improved valve seal by maintaining sealing at the annular ring.
Prevention of mal-coaptation or leak via thin flexible membranes over the implant clip zone.
Documented Applications
Treating mal-coaptation of a mitral valve of a heart.
Mitral coaptation assistance using leaflet-apposing valve body elements, including variants with expandable/inflatable embodiments.
Optional edge-to-edge clip/edge devices for grasping only the anterior leaflet or both leaflets with decoupled deployment [procedural detail omitted for safety].
Reducing mitral regurgitation (MR), including a two-stage MR reduction concept based on low versus high left-ventricle pressure during systole.
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