Mitral valve implants for the treatment of valvular regurgitation
Inventors
Khairkhahan, Alexander K. • Lesh, Michael D.
Assignees
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Publication Number
US-11974921-B2
Publication Date
2024-05-07
Expiration Date
Abstract
The invention relates in some aspects to a device for use in the transcatheter treatment of mitral valve regurgitation, including steerable guidewires, implantable coaptation assistance devices, anchoring systems for attaching a ventricular projection of an implantable coaptation device, a kit, and methods of using an implantable coaptation assistance device among other methods.
Core Innovation
The invention relates to transcatheter treatment of mitral valve regurgitation with an implantable coaptation assistance device. The device includes an implant comprising a hub and a plurality of struts, and the implant is positioned over a posterior leaflet of a mitral valve. In this configuration, the implant is positioned such that a superior edge, an inferior edge, a first lateral edge, and a second lateral edge are defined on the implant, and the plurality of struts include a first section and a second section extending through portions of the implant between those edges.
The implant further includes a helical anchor and a shaft body, where the helical anchor comprises a proximal shoulder with one or more windows. The shaft body comprises one or more locking tabs that are pushed into engagement with the one or more windows when an elongate member is present within the shaft body. The helical anchor is rotated into the annulus by applying torque to the shaft body, and then the elongate member is retracted relative to the shaft body to cause the one or more locking tabs to fall back from the one or more windows, thus unlocking the helical anchor and the shaft body.
The device is configured for delivery and deployment as part of an implant over the mitral valve annulus, including placement on the annulus by positioning the hub of the implant on the annulus of the mitral valve and engaging the helical anchor. The disclosed system includes a new leaflet coaptation surface associated with the implant to address mal-coaptation, and it is described as providing treatment of mitral valve regurgitation, including reduced or regressed regurgitant flow. The disclosed context also indicates implantation without stopping the heart and without reliance on a heart-lung machine.
Claims Coverage
The independent claim set is directed to methods of using an implantable coaptation assistance device for transcatheter mitral valve regurgitation treatment. The independent claim includes five inventive features centered on implant positioning, hub placement, and helical anchor engagement and unlocking.
Helical anchor with proximal shoulder windows and locking tabs
Engaging a helical anchor and a shaft body, wherein the helical anchor comprise a proximal shoulder, wherein the proximal shoulder comprises one or more windows, wherein the shaft body comprises one or more locking tabs pushed into engagement with the one or more windows when an elongate member is present within the shaft body.
Torque rotation into the annulus
Rotating the helical anchor into the annulus by applying torque to the shaft body.
Unlocking by retracting an elongate member to disengage locking tabs
Retracting the elongate member relative to the shaft body causing the one or more locking tabs to fall back from the one or more windows of the proximal shoulder of the helical anchor, thus unlocking the helical anchor and the shaft body.
Posterior leaflet positioning with hub and struts implant structure
Positioning an implant over a posterior leaflet of a mitral valve, the implant comprising a hub and a plurality of struts, the implant comprising a superior edge, an inferior edge, a first lateral edge, and a second lateral edge, the plurality of struts comprising a first section and a second section, the first section extending through at least a portion of the implant between the superior edge and the inferior edge, the second section extending through at least a portion of the implant between the first lateral edge and the second lateral edge.
Hub placement on the mitral annulus
Positioning the hub of the implant on the annulus of the mitral valve.
Overall, the claim coverage centers on an implantable coaptation assistance device used by positioning an implant with a hub/strut structure over a posterior mitral leaflet and securing it by rotating a helical anchor into the mitral annulus. The engagement is mediated by proximal shoulder windows and shaft-body locking tabs, and the helical anchor and shaft body are then unlocked by retracting an elongate member so the locking tabs fall back from the windows.
Stated Advantages
Reducing or regressed regurgitant flow for mitral valve regurgitation.
Deployment and implementation without stopping the heart and without relying on a heart-lung machine.
Documented Applications
Transcatheter treatment of mitral valve regurgitation using an implantable coaptation assistance device positioned over a posterior leaflet of a mitral valve and secured on the annulus.
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