Methods of implantation of transcatheter atrial sealing skirt, anchor, and tether

Abstract

A method for endovascularly implanting a valve in the heart having a medical assembly including a replacement heart valve and an anchor assembly for positioning and restraining the valve. The method includes endovascularly introducing an anchor delivery system for anchoring the heart valve to replace the native heart valve and for endovascularly introducing a valve delivery systems for implanting the valve at the implantation site to replace a native heart valve.

What is claimed is: 
     
         1 . A method of endovascularly delivering and implanting a medical assembly for minimally invasively implanting a valve in the heart at a valve deployment site, sealing the valve against an atrial floor of the heart, and anchoring the valve on an intracardiac wall at an implantation site with an anchor and a tether including at least one cord connecting the anchor and the valve, said medical assembly comprising an anchor delivery system having an anchor delivery guide defining a longitudinally extending lumen and having an anchor delivery rod defining an inner rod lumen, said anchor delivery rod being removably positioned within the anchor delivery guide, and a valve delivery system including a valve delivery guide defining an inner guide lumen configured for receipt of the valve and a portion of the tether, and including at least one positioning rod, the method comprising the steps of:
 endovascularly introducing the anchor delivery system into the heart wherein the anchor delivery system includes at least a portion of the anchor and cord positioned within the anchor delivery rod lumen and at least a portion of the anchor delivery rod positioned within the anchor delivery guide lumen;   advancing a distal end of the anchor delivery guide into the heart, through the deployment site and to the implantation site;   advancing the anchor positioning rod and contacting the anchor screw against the implantation site;   manipulating the anchor delivery rod and implanting the anchor into the implantation site to anchor the anchor and tether to the intracardiac wall;   retracting the anchor delivery guide and anchor delivery rod leaving the anchor implanted at the implantation site and the cord of the tether extending through the valve deployment site and extending externally from the heart;   endovascularly introducing the valve delivery system by introducing the valve delivery guide having a valve which cooperates with the cord within the delivery guide inner lumen and the at least one cord of the tether extends within the valve delivery guide inner lumen;   advancing the valve delivery system so that the valve is positioned adjacent the deployment site;   positioning at least one positioning rod along a proximal portion of the at least one cord external to the heart wherein the positioning rod extends within the delivery guide inner lumen;   at least partially retracting the valve delivery guide to release the valve at the deployment site and expanding the valve;   advancing the positioning rod along the cord so as to contact the valve to position the valve;   manipulating the positioning rod to alter the position of the valve against the atrial floor and sealing the valve against the atrial floor, and   further retracting the valve delivery guide and retracting the positioning rod leaving the valve at the deployment site and the anchor at the implantation site.   
     
     
         2 . The method according to  claim 1  further comprising the step of endovascularly introducing a J-wire into the heart, through the deployment site and to the implantation site prior to said step of advancing the anchor delivery guide into the heart and said step of advancing the anchor delivery into the heart includes advancing the anchor guide over the inserted J-wire for guidance. 
     
     
         3 . The method according to  claim 1  wherein said step of manipulating the anchor delivery rod to implant the anchor includes the step of advancing a distal end of the anchor delivery rod to contact a proximal surface of the anchor and mating the surfaces to engage the delivery rod and the anchor. 
     
     
         4 . The method according to  claim 3  further comprising the step of rotating the anchor delivery rod and the anchor to implant the anchor screw at the implantation site. 
     
     
         5 . The method according to  claim 1  wherein said step of introducing the valve delivery system includes also providing a valve deployment knob for receiving a proximal portion of said valve delivery guide and in fluid communication with said valve delivery guide lumen and said step of at least partially retracting the valve delivery guide includes retracting the valve delivery guide within the deployment knob. 
     
     
         6 . The method according to  claim 1  wherein said step of implanting the anchor includes an interventricular implantation. 
     
     
         7 . The method according to  claim 1  wherein said step of implanting the anchor includes an epicardial implantation. 
     
     
         8 . The method according to  claim 1  further comprising the step, after said step of manipulating the positioning rod to seal the valve against the atrial floor, of locking the cord relative to the valve by providing a lock which mates with a distal end of the positioning rod. 
     
     
         9 . The method according to  claim 8  wherein said step of introducing the anchor delivery step including the cord includes introducing at least one suture which extends from a proximal end of the cord wherein the suture extends from a proximal of the cord. 
     
     
         10 . The method according to  claim 9  further comprising the step of cutting the at least one suture after the said step of locking the cord relative to the valve.