Device, system, and method for transcatheter treatment of valve regurgitation

Inventors

Khairkhahan, Alexander • Lesh, Michael D.

Assignees

Polares Medical Inc

Abstract

The invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation enhancement element for implantation across the valve; a system including the coaptation enhancement element and anchors for implantation; a system including the coaptation enhancement element, catheter and driver; and a method for transcatheter implantation of a coaptation element across a heart valve.

Core Innovation

A coaptation implant system includes a coaptation implant having a coaptation surface configured for an anterior leaflet of a valve to coapt against, with a superior edge, lateral edges, and an inferior edge. The coaptation implant is configured to overlie a posterior leaflet, and includes a hub and at least one strut. A helical anchor is configured to be rotated relative to the hub, so that the coaptation implant is configured to remain within a blood flow path as the valve leaflets move back and forth.

The coaptation implant system is further configured so that a curve of the coaptation implant generally corresponds to a posterior leaflet curve at or near the end of ventricular systole. In addition, the coaptation implant is configured so that, when positioned over the posterior leaflet, the coaptation implant substantially matches native anatomy, while maintaining a relatively normal heart chamber size. The coaptation implant is configured to functionally replace the posterior leaflet by coapting with the anterior leaflet during a cardiac cycle.

The coaptation implant system also provides a helical-anchor and hub arrangement in which the curve of the coaptation implant changes over the course of a heart cycle. The system can include geometry configured to traverse a valve, and the coaptation implant is configured to effectively replace the posterior leaflet by coapting with the anterior leaflet during the heart cycle. The described structure uses a hub, at least one strut, and a coaptation surface with edges for maintaining the intended coaptation relationships while the valve leaflets move.

Claims Coverage

The document excerpt provides three independent claims. The main inventive features cover an anterior-leaflet coaptation surface overlying a posterior leaflet, a hub with a rotatable helical anchor, retention within a blood flow path during leaflet motion, and curve/geometric behaviors tied to ventricular systole or the heart cycle.

Across the independent claims shown, the system centers on a coaptation implant with an anterior-leaflet coaptation surface that overlies a posterior leaflet, supported by a hub and a rotatable helical anchor, and configured to remain within a blood flow path during leaflet motion. Additional independent-claim limitations further tie implant curvature to posterior leaflet curvature at or near end of ventricular systole or require that the implant curve changes over the heart cycle, and the implant is characterized as functionally/effectively replacing the posterior leaflet by coapting with the anterior leaflet.

Stated Advantages

Documented Applications

No documented applications found