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

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.

1 - 30 . (canceled) 
     
     
         31 . A method for treating mal-coaptation of a mitral valve of a heart, the method comprising:
 delivering a coaptation assistance element to the mitral valve;   positioning the coaptation assistance element, the coaptation assistance element comprising:
 a first surface disposed toward a posterior leaflet and a second surface disposed toward an anterior leaflet, and 
 a first lateral edge, a second lateral edge, an inferior edge, and a superior edge, and 
 an implant clip zone spaced inward from the first lateral edge and the second lateral edge; 
   anchoring the coaptation assistance element to an annulus of the mitral valve;   delivering a single grasping device to the mitral valve, wherein 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 and anchored to the annulus;   positioning the single grasping device within the implant clip zone, wherein the single grasping device comprises a first arm and a second arm extending outward when the single grasping device is positioned within the implant clip zone; and   closing the single grasping device within the implant zone, wherein the second arm of the single grasping device grasps the anterior leaflet against the second surface of the coaptation assistance element when the single grasping device is closed within the implant clip zone.   
     
     
         32 . The method of  claim 31 , wherein the first arm of the single grasping device grasps the posterior leaflet against the first surface of the coaptation assistance element when the single grasping device is closed within the implant clip zone. 
     
     
         33 . The method of  claim 31 , wherein the first arm of the single grasping device grasps the first surface of the coaptation assistance element when the single grasping device is closed within the implant clip zone. 
     
     
         34 . The method of  claim 31 , wherein at least a portion of the coaptation assistance element is in between the first arm and the second arm when the single grasping device is closed within the implant clip zone. 
     
     
         35 . The method of  claim 31 , wherein at least a portion of the coaptation assistance element is in between the first arm and the second arm when the single grasping device is open within the implant clip zone. 
     
     
         36 . The method of  claim 31 , wherein the single grasping device comprises a roughened surface. 
     
     
         37 . The method of  claim 31 , wherein the single grasping device comprises teeth. 
     
     
         38 . The method of  claim 31 , wherein the first arm and the second arm comprise different configurations. 
     
     
         39 . The method of  claim 31 , wherein the single grasping device creates a double orifice for the mitral valve. 
     
     
         40 . The method of  claim 31 , wherein the single grasping device is positioned without stopping the heart. 
     
     
         41 . The method of  claim 31 , wherein the implant clip zone curves inward from the inferior edge. 
     
     
         42 . The method of  claim 31 , wherein the implant clip zone comprises a central arch. 
     
     
         43 . The method of  claim 31 , wherein the implant clip zone is completely below a coaptation surface configured to coapt with the anterior leaflet. 
     
     
         44 . The method of  claim 31 , wherein the coaptation assistance element is unattached to the posterior leaflet. 
     
     
         45 . The method of  claim 31 , wherein the posterior leaflet is left intact. 
     
     
         46 . The method of  claim 31 , wherein the single grasping device grasps the central scallops of the anterior leaflet. 
     
     
         47 . The method of  claim 31 , wherein the single grasping device is delivered closed and opened within the heart. 
     
     
         48 . The method of  claim 31 , wherein the single grasping device is delivered after further deterioration of heart function. 
     
     
         49 . The method of  claim 31 , wherein the single grasping device is delivered in a subsequent procedure. 
     
     
         50 . The method of  claim 31 , wherein the first arm and the second arm of the single grasping device open between 120 degrees and 180 degrees.