Transcatheter atrial anchors and methods of implantation

Abstract

Anchor assemblies for endovascular introduction and implantation for tethering a replacement heart valve to a cardiac wall. An anchor delivery system introduces the assembly. The anchor may be either implanted with a tether connected thereto or implanted and then connected to a tether. If the latter, a tether assembly is mounted to the implanted anchor to connect the anchor to the valve. The anchors may be implanted into any cardiac wall including the interventricular septum or the epicardial space and the valve may replace the mitral or tricuspid valve.

What is claimed is: 
     
         1 . An intracardiac anchor assembly for minimally invasively anchoring a cardiac device to a cardiac wall at an anchor implantation site by endovascular insertion and implantation and for tethering the cardiac device to the anchor, said anchor assembly comprising:
 an anchor comprising an anchor cap having a distal end facing an implantation site and a proximal end and a mating member;   an anchor screw extending from said anchor cap distal end configured for implantation into the cardiac wall;   at least one tether extending from said anchor cap proximal end configured for tethering the cardiac device and having a length sufficient to extend from the anchor cap and to the cardiac device to be implanted; and   an anchor delivery system comprising and anchor delivery rod defining a longitudinally extending lumen and having a distal end for cooperating with said anchor cap wherein forces applied to said anchor delivery rod actively fixate the anchor screw into the implantation site and being sized and configured for receipt of said at least one tether extending proximally from said anchor cap distal end.   
     
     
         2 . The intracardiac anchor assembly according to  claim 1  wherein said anchor screw is an active fixation screw having a substantially helical configuration wherein said forces applied to said anchor cap by said anchor delivery rod are rotational forces. 
     
     
         3 . The intracardiac anchor assembly according to  claim 1  wherein said anchor cap mating member is defined by a proximal end thereof. 
     
     
         4 . The intracardiac anchor assembly according to  claim 3  wherein said anchor delivery rod has a distal end having a first configuration and said anchor cap proximal end has a second configuration wherein said first and second configurations are mating configurations wherein rotational forces applied to said anchor delivery rod applies rotational forces to said anchor cap. 
     
     
         5 . The intracardiac anchor assembly according to  claim 1  further comprising an anchor delivery guide configured for endovascular implementation and having a proximal and distal end and defining a longitudinally extending lumen extending between said ends and said anchor is removably received within said delivery guide lumen and said anchor delivery rod is removably positioned within said delivery guide lumen for cooperation with said anchor. 
     
     
         6 . The medical assembly according to  claim 1  wherein a distal portion of said delivery rod is substantially flexible. 
     
     
         7 . The intracardiac anchor assembly according to  claim 5  further comprising a sheath removably coupled to said anchor delivery guide and being in fluid communication with said anchor delivery guide. 
     
     
         8 . The intracardiac anchor assembly according to  claim 5  further comprising a J-wire inserted within said anchor delivery system for placing said anchor delivery guide. 
     
     
         9 . The intracardiac anchor assembly according to  claim 1  wherein said anchor screw is sized and configured to penetrate the cardiac wall but not to exit the cardiac wall on an opposing side thereof. 
     
     
         10 . A method of endovascularly implanting an anchor assembly for minimally invasively implanting a medical device in the heart and anchoring the medical device to an intracardiac wall at an implantation site with an anchor and at least one tether connecting the anchor and the medical device, said anchor 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 lumen, 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 tether 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 a deployment site and to the implantation site;   advancing the anchor delivery 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; and   retracting the anchor delivery guide and anchor delivery rod leaving the anchor implanted at the implantation site.   
     
     
         11 . The method according to  claim 10  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 guide into the heart includes advancing the anchor guide over the inserted J-wire for guidance. 
     
     
         12 . The method according to  claim 10  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. 
     
     
         13 . The method according to  claim 10  further comprising the step of rotating the anchor delivery rod and the anchor to implant the anchor screw at the implantation site. 
     
     
         14 . The method according to  claim 12  wherein said step of implanting the anchor includes an interventricular implantation. 
     
     
         15 . The method according to  claim 10  wherein said step of implanting the anchor includes an epicardial implantation. 
     
     
         16 . An interventricular anchor assembly for endovascularly delivering and implanting an anchor in the septum comprising:
 a removable catheter having a proximal and distal end and defining a central lumen between said proximal and distal ends wherein said catheter distal end is configured to be endovascularly introduced into the heart and through the septum;   a removeable radio frequency wire extending through said central lumen and operatively connected to a radio frequency source for guiding said wire into the heart and through the septum;   a removeable J-wire extending within said catheter central lumen;   a removeable anchor delivery guide defining a central lumen, said delivery guide selectively positioned along said J-wire wherein said J-wire extend within said delivery guide lumen;   an anchor delivery rod defining a central lumen, said anchor delivery rod positioned within said anchor delivery guide lumen;   an anchor connected to a distal end of said delivery rod wherein the anchor is expandable so as to expand after piercing said septum upon exiting an opposing side of the septum; and   at least one cord connected to a proximal end of said anchor and extending along said delivery rod lumen.   
     
     
         17 . The interventricular anchor assembly according to  claim 16  wherein a distal end of said catheter is a screw for penetrating the septum with rotational forces applied to said delivery rod. 
     
     
         18 . A method of endovascularly implanting an interventricular anchor assembly for minimally invasively implanting a medical device into the septum of the heart and anchoring the medical device to the septum at an implantation site with an anchor and at least one tether connecting the anchor and the medical device, said anchor assembly comprising a catheter and an anchor delivery system, said catheter having a central lumen for receiving a removeable radio frequency wire extending through said catheter lumen and operatively connected to a radio frequency source, the anchor delivery system having an anchor delivery guide defining a longitudinally extending lumen and having an anchor delivery rod defining an inner rod lumen, wherein said anchor delivery rod is removably positioned within the anchor delivery guide lumen, the method comprising the steps of:
 endovascularly introducing and advancing the catheter and radio frequency wire into the heart wherein the radio frequency wire is positioned adjacent the septum;   advancing the radio frequency wire and then the catheter through the septum;   retracting the radio frequency wire from the catheter and heart;   inserting a J-wire through the catheter lumen so as to penetrate the septum and exit an opposing side of the septum;   inserting and advancing the anchor delivery guide over the J-wire reaching the implantation site;   inserting the anchor delivery rod within the delivery guide lumen and through the septum, reaching the implantation site;   advancing the anchor delivery rod to release the anchor which self-expands on the opposing side of the septum; and   removing the anchor delivery system and catheter.   
     
     
         19 . The method according to  claim 18  wherein said step of advancing the catheter includes applying rotational forces to the catheter to achieve penetration of the septum. 
     
     
         20 . An epicardial anchor assembly for endovascularly delivering and implanting an anchor in the pericardial space comprising:
 a removable catheter having a proximal and distal end and defining a central lumen between said proximal and distal ends wherein said catheter distal end is configured to be endovascularly introduced into the heart, penetrate the endocardium and into the pericardial space and wherein the catheter proximal end and central lumen are in fluid communication with a fluid source;   a removeable anchor delivery guide defining a central lumen;   an anchor delivery rod positioned within said anchor delivery guide lumen;   an anchor connected to a distal end of said delivery rod and said anchor delivery rod is advanced along said delivery guide lumen to as to position said anchor in the pericardial space wherein the anchor is expandable so as to expand within the pericardial space; and   at least one cord connected to a proximal end of said anchor and extending along said delivery rod lumen and extending proximally from said delivery rod and said catheter.   
     
     
         21 . The epicardial anchor assembly according to  claim 20  wherein said removable catheter distal end includes an outer surface including helical threads for penetrating the endocardium when the catheter is rotated. 
     
     
         22 . The epicardial anchor assembly according to  claim 20  wherein said fluid source comprises a fluid for insufflating the pericardial space. 
     
     
         23 . The epicardial anchor assembly according to  claim 20  further comprising a J-wire extending within said catheter central lumen wherein said delivery guide is configured to move along said J-wire. 
     
     
         24 . A method of endovascularly implanting an epicardial anchor assembly for minimally invasively implanting a medical device in the pericardial space of the heart and anchoring the medical device to the pericardium at an implantation site with an anchor and at least one tether connecting the anchor and the medical device, said anchor assembly comprising a catheter and an anchor delivery system, said catheter having proximal and distal ends and defining a central lumen between said proximal and distal ends wherein said catheter distal end is configured to be endovascularly introduced into the heart, penetrate the endocardium and into the pericardial space and wherein the catheter central lumen is in fluid communication with a fluid source, the anchor delivery system having an anchor delivery guide defining a longitudinally extending lumen and having an anchor delivery rod defining an inner rod lumen, and a said anchor delivery rod being removably positioned within the anchor delivery guide lumen, the method comprising the steps of:
 endovascularly introducing and advancing the catheter into the heart towards the implantation site adjacent the implantation site;   advancing the catheter to penetrate and exit the epicardial surface and entering the pericardial space;   injecting the fluid from the fluid source along the catheter lumen and insufflating the pericardial space;   inserting a J-wire through the catheter lumen until it reaches the pericardial space;   removing the catheter from the heart;   inserting and advancing the anchor delivery guide over the J-wire reaching the implantation site;   inserting the anchor delivery rod within the delivery guide lumen and to the implantation site;   advancing the anchor delivery rod to release the anchor in the pericardial space and expanding the anchor within the pericardial space; and   removing the anchor delivery system.   
     
     
         25 . The method according to  claim 24  further comprising the step of injecting a contrasting agent into the pericardial space after said step of advancing the catheter into the pericardial space. 
     
     
         26 . A method of endovascularly implanting an anchor assembly for minimally invasively implanting a medical device in the heart and anchoring the medical device to an intracardiac wall at an implantation site with an anchor, anchor assembly comprising an anchor including an anchor cap, an anchor screw and a removable anchor delivery cable sized and configured for endovascular introduction and having a distal end configured to mate with the anchor cap proximal end to removably couple the delivery cable to the anchor cap; said anchor assembly also including a tether assembly comprising a docking ring configured to cooperate with the anchor cap to selectively secure the docking ring to the anchor cap and at least one tether rod extending from the docking ring and said anchor 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 lumen, 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 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 a deployment site and to the implantation site;   advancing the anchor delivery 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;   endovascularly introducing the delivery cable and connecting it to the anchor cap of the implanted anchor;   endovascularly introducing the docking ring over the delivery cable to cooperate with the anchor cap; and   removing the delivery rod.   
     
     
         27 . The method according to  claim 26  wherein said step of manipulating the anchor delivery rod and implanting the anchor includes rotating the delivery rod so as to rotate the anchor screw to penetrate the intracardiac wall at the implantation site. 
     
     
         28 . The method according to  claim 26  wherein after said step of manipulating the anchor delivery rod and implanting the anchor includes the step of implanting the anchor screw so as to exit the opposing side of the intracardiac wall and the method includes the step of expanding a distal portion of the anchor screw.