Systems and methods for transcatheter treatment of valve regurgitation
Inventors
Khairkhahan, Alexander K. • Lesh, Michael D. • Klenk, Alan R.
Assignees
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Publication Number
US-12350153-B2
Publication Date
2025-07-08
Expiration Date
Abstract
The invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation assistance devices for implantation across the valve; a system including the coaptation enhancement element and anchors for implantation; a system including the coaptation enhancement element, and one or more of the following: transseptal sheath, anchor delivery catheter, implant delivery catheter, and clip delivery catheter; and methods for transcatheter implantation of a coaptation element across a heart valve.
Core Innovation
The disclosed invention provides an implant for treating mal-coaptation of a heart valve in an open configuration and a closed configuration. The heart valve includes an annulus and posterior and anterior leaflets. The implant includes a coaptation assist body having a superior edge, an inferior edge, and lateral edges that bound a first surface and a second surface, where the first surface is configured to be disposed toward the posterior leaflet and the second surface is configured to be disposed toward the anterior leaflet to allow the anterior leaflet to coapt with the coaptation assist body.
The coaptation assist body comprises a central orifice or discrete central opening spaced inward from the superior edge, the inferior edge, and the lateral edges, and lateral orifices or discrete lateral openings spaced laterally from the central orifice. The coaptation assist body surrounds the central orifice and the lateral orifices. The implant further comprises a plurality of ribbons including at least one curve that are movable from a first compressed configuration to a second expanded configuration, and the plurality of ribbons comprises a shape memory material in at least one embodiment.
The implant provides fixation to the annulus using an atrial anchor and lateral anchors, where each anchor comprises a helical body. The atrial anchor is configured to extend through the central orifice or discrete central opening and is configured to rotate into the annulus, and each lateral anchor is configured to extend through a corresponding lateral orifice or discrete lateral opening and is configured to rotate into the annulus. In one embodiment, the atrial anchor and the lateral anchors provide the only fixation to the annulus, and the implant does not attach to an anterior aspect of the annulus and only attaches to a posterior aspect of the annulus with the atrial anchor and the lateral anchors.
Claims Coverage
The partial content includes two independent claims that define an implant with posterior-facing and anterior-facing coaptation assist body surfaces, central and lateral openings for helical anchor deployment, movable ribbons from a compressed to expanded configuration, and fixation limited to the posterior annulus via atrial and lateral helical anchors with no anterior attachment. Across the independent claims, the inventive features number three core functional groupings.
Coaptation assist body disposed toward posterior and anterior leaflets
A coaptation assist body comprising a superior edge, an inferior edge, and lateral edges that bound a first surface and a second surface, the first surface configured to be disposed toward the posterior leaflet and the second surface configured to be disposed toward the anterior leaflet to allow the anterior leaflet to coapt with the coaptation assist body.
Central orifice and lateral orifices for receiving anchors
A coaptation assist body comprising a central orifice spaced inward from the superior edge, the inferior edge, and the lateral edges, the coaptation assist body comprising lateral orifices spaced laterally from the central orifice, the coaptation assist body surrounding the central orifice and lateral orifices.
Movable curved ribbons transitioning from compressed to expanded configuration
A plurality of ribbons, the plurality of ribbons comprising at least one curve, the plurality of ribbons movable from a first compressed configuration to a second expanded configuration.
Atrial helical anchor rotated through central opening into annulus
An atrial anchor comprising a helical body configured to extend through the central orifice and wherein the atrial anchor is configured to rotate into the annulus.
Lateral helical anchors rotated through lateral openings into annulus as only fixation
Lateral anchors, each lateral anchor comprising a helical body configured to extend through a lateral orifice of the lateral orifices, wherein the lateral anchors are configured to rotate into the annulus, wherein the atrial anchor and the lateral anchors provide the only fixation to the annulus.
Implant body with discrete central opening and discrete lateral openings
The implant body comprising a discrete central opening spaced inward from the superior edge, the inferior edge, and the lateral edges, the implant body comprising discrete lateral openings spaced apart from the discrete central opening.
Shape memory ribbons movable from compressed to expanded configuration
A plurality of ribbons, the plurality of ribbons comprising a shape memory material comprising at least one curve, the plurality of ribbons movable from a first compressed configuration to a second expanded configuration.
Helical atrial anchor rotated into annulus tissue without anterior attachment
An atrial anchor comprising a helical body, wherein the atrial anchor is configured to be rotated relative to the discrete opening to be driven into tissue of an annulus, wherein the implant does not attach to an anterior aspect of the annulus and only attaches to a posterior aspect of the annulus with the atrial anchor and the lateral anchors.
Helical lateral anchors rotated into annulus tissue only attaching to posterior aspect
Lateral anchors, each lateral anchor comprising a helical body, wherein each lateral anchor is configured to be rotated relative to a discrete lateral opening of the lateral openings to be driven into tissue of the annulus, wherein the implant does not attach to an anterior aspect of the annulus and only attaches to a posterior aspect of the annulus with the atrial anchor and the lateral anchors.
Across the independent claims, the implant is defined by a coaptation assist body having posterior-facing and anterior-facing surfaces for coaptation, a central opening and lateral openings surrounded by the body, and a plurality of curved ribbons movable from compressed to expanded configuration using shape memory material. Fixation is achieved with helical atrial and lateral anchors rotated into annulus tissue, where the anchors provide the only fixation to the annulus and the implant attaches only to a posterior aspect of the annulus.
Stated Advantages
Provides an implant for treating mal-coaptation of a heart valve.
Allows the anterior leaflet to coapt with the coaptation assist body.
Provides fixation to the annulus using only the atrial anchor and the lateral anchors.
Does not attach to an anterior aspect of the annulus and only attaches to a posterior aspect of the annulus.
Documented Applications
Transcatheter treatment of mitral valve regurgitation using a coaptation assistance device implanted across the valve.
Treating mal-coaptation of a heart valve having an annulus and posterior and anterior leaflets.
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