Systems for placing a coapting member between valvular leaflets

Abstract

A system for reducing regurgitation includes a catheter and a coaptation member disposed along a distal end portion of the catheter, wherein the coaption member is sized to be advanced through a patient’s vasculature in a compressed configuration and wherein the coaptation member is expandable for deployment between leaflets of a native tricuspid valve. The coaptation member includes a frame covered with one or more panels of bioprosthetic tissue or flexible polymer to form a three-sided shape having three convex sides separated by rounded corners. An anchor is coupled to a proximal end portion of the catheter and is shaped for attachment to a vessel wall. After deployment, the anchor secures the position of the coaptation member relative to the native tricuspid valve.

What is claimed is: 
     
         1 . A system for reducing regurgitation in a native tricuspid valve, comprising:
 a catheter;   a coaptation member disposed along a distal end portion of the catheter, wherein the coaption member is sized to be advanced through a patient’s vasculature in a compressed configuration and wherein the coaptation member is expandable for deployment between leaflets of a native tricuspid valve for coapting against the leaflets, the coaptation member including a frame covered with one or more panels of bioprosthetic tissue or flexible polymer to form a three-sided shape with three convex sides separated by rounded corners; and   an anchor coupled to a proximal end portion of the catheter and adapted for attachment to a vessel wall, wherein the anchor secures the position of the coaptation member relative to the native tricuspid valve.   
     
     
         2 . The system of  claim 1 , wherein an interior of the coaptation member is underfilled with fluid so as to compress and deform when the native tricuspid leaflets coapt against the coaptation member. 
     
     
         3 . The system of  claim 1 , wherein the anchor is configured to attach to a point above the native tricuspid valve open to the valve. 
     
     
         4 . The system of  claim 3 , wherein the anchor comprises a stent adapted to be secured within a blood vessel opening to the right atrium, and the coaptation member connects via a tether to the stent. 
     
     
         5 . The system of  claim 3 , wherein the anchor comprises a pair of anchors securable directly to the native tricuspid valve, and the coaptation member is adapted to be suspended within the valve via flexible cables attached to the anchors. 
     
     
         6 . The system of  claim 3 , wherein the anchor comprises a tissue anchor securable within a blood vessel opening to the right atrium, and the catheter connects via an adjustable sleeve and a rod to the tissue anchor, wherein the adjustable sleeve and rod permit adjustment of the relative positions of the tissue anchor and the coaptation member. 
     
     
         7 . The system of  claim 3 , wherein the anchor comprises two stent structures, one adapted to be expanded in the superior vena cava and the other in the inferior vena cava, and the coaptation member connects via a connecting wire or rod to both of the two stent structures. 
     
     
         8 . The system of  claim 1 , wherein the coaptation member has an asymmetric shape defining a gradual longitudinal curvature and an enlarged belly region distal from a midline thereof. 
     
     
         9 . The system of  claim 1 , further including a flexible rail having a length sufficient to extend from outside a body through the subclavian vein and past the native tricuspid valve into the right ventricle, a ventricular anchor on a distal end of the flexible rail being configured to anchor into tissue within the right ventricle, wherein the coaptation member is slidable over and configured to lock onto the flexible rail. 
     
     
         10 . The system of  claim 9 , wherein the catheter slides over the flexible rail and is lockable thereto. 
     
     
         11 . A system for reducing regurgitation in a native tricuspid valve, comprising:
 a catheter;   a coaptation member disposed along a distal end portion of the catheter, wherein the coaption member is sized to be advanced through a patient’s vasculature in a compressed configuration and wherein the coaptation member is expandable for deployment between leaflets of a native tricuspid valve for coapting against the leaflets, the coaptation member including a frame covered with one or more panels of bioprosthetic tissue or flexible polymer to form a three-sided shape underfilled with fluid so as to compress and deform when the native tricuspid leaflets coapt against the coaptation member; and   a stent coupled to a proximal end portion of the catheter and adapted to be secured within a blood vessel opening to the right, wherein the stent secures the position of the coaptation member relative to the native tricuspid annulus.   
     
     
         12 . The system of  claim 11 , further comprising a pair of annulus anchors securable directly to the native tricuspid valve, and the coaptation member is adapted to be suspended within the valve via flexible cables attached to the anchors. 
     
     
         13 . The system of  claim 11 , wherein the catheter connects via an adjustable sleeve and a rod to the stent, wherein the adjustable sleeve and rod permit adjustment of the relative positions of the stent and the coaptation member. 
     
     
         14 . The system of  claim 11 , wherein the stent comprises two stent structures, one adapted to be expanded in the superior vena cava and the other in the inferior vena cava, and the coaptation member connects via a connecting wire or rod to both of the two stent structures. 
     
     
         15 . The system of  claim 11 , wherein the coaptation member has an asymmetric shape defining a gradual longitudinal curvature and an enlarged belly region distal from a midline thereof. 
     
     
         16 . The system of  claim 15 , wherein the three-sided shape has three relatively flat convex sides separated by rounded corners. 
     
     
         17 . The system of  claim 11 , further including a flexible rail having a length sufficient to extend from outside a body through the subclavian vein and past the native tricuspid valve into the right ventricle, a ventricular anchor on a distal end of the flexible rail being configured to anchor into tissue within the right ventricle, wherein the coaptation member is slidable over and configured to lock onto the flexible rail. 
     
     
         18 . The system of  claim 17 , wherein the catheter slides over the flexible rail and is lockable thereto.