Transcatheter atrial sealing skirt, anchor, and tether and methods of implantation

Abstract

A medical assembly implanting an atrial sealing skirt in the heart at an atrial sealing skirt deployment site and related methods of implantation and delivery. An anchor is endovascularly introduced into the heart and implanted to a cardiac wall with an anchor delivery system and delivery cable. A second delivery system introduces a tether which coupled to the implanted anchor and an atrial sealing skirt. The atrial sealing skirt includes a top brim which is positioned to conform to the atrial floor at the deployment site. The sealing skirt may be integrated with a valve or serve as a receptacle.

What is claimed is: 
     
         1 . A medical assembly for minimally invasively implanting an atrial sealing skirt in the heart at an atrial sealing skirt deployment site comprising:
 an atrial sealing skirt configured for receiving a valve and for endovascular introduction and implantation at a deployment site and configured and sized to replace a native heart valve, said atrial sealing skirt having a portion being configured to substantially conform to an atrial floor adjacent the valve deployment site;   an anchor assembly configured and sized for endovascular introduction for implanting an anchor to an intracardiac wall at an implantation site and comprising a delivery cable; and   at least one endovascular removable delivery system for endovascularly introducing said anchor assembly and for positioning and sealing said atrial sealing skirt endovascularly.   
     
     
         2 . The medical assembly according to  claim 1  further comprising a tether advanced over said delivery cable and including at least one cord connected to said anchor and said atrial sealing skirt for operatively connecting said atrial sealing skirt and said anchor. 
     
     
         3 . The medical assembly according to  claim 1  wherein said at least one endovascular removable delivery system includes a removable anchor assembly delivery system for introducing said anchor assembly endovascularly. 
     
     
         4 . The medical assembly according to  claim 3  wherein said at least one endovascular removable delivery system comprises at least two of said endovascular delivery systems further including a removable atrial sealing skirt delivery system for positioning and sealing the atrial sealing skirt. 
     
     
         5 . The medical assembly according to  claim 1  wherein said at least one endovascular removable delivery system includes a removable atrial sealing skirt delivery system for positioning and sealing the atrial sealing skirt. 
     
     
         6 . The medical assembly according to  claim 2  wherein said anchor assembly comprises an anchor cap having a proximal and distal end wherein said anchor extends from the anchor cap distal end and said anchor is configured for implantation to the intracardiac wall at the implantation site; and
 at least one lock on said anchor cap for locking said tether, said at least one lock being selectively moved from a first locked position to a second unlocked position. 
 
     
     
         7 . The medical assembly according to  claim 6  wherein said at least one lock is a locking arm extending radially outwardly from said anchor cap. 
     
     
         8 . The medical assembly according to  claim 6  wherein said anchor comprises at least two of said at least one locks. 
     
     
         9 . The medical assembly according to  claim 1  wherein said anchor assembly further comprises an anchor cap having a proximal and distal end wherein said proximal end includes a first surface configuration wherein said anchor extends from the anchor cap distal end said anchor is configured for implantation to the intracardiac wall at the implantation site; and
 said delivery cable comprises a distal end having a second surface configuration configured to mate with said anchor cap proximal end surface configuration. 
 
     
     
         10 . The medical assembly according to  claim 1  wherein said delivery cable comprises a flexible wire. 
     
     
         11 . The medical assembly according to  claim 9  wherein said anchor cap first surface configuration is defined by a cavity having threaded sidewalls and said second configuration of said delivery cable distal end is an outer surface configuration which is threaded to mate and engage said anchor cap wherein said anchor delivery cap rotates said anchor cap when rotational forces are applied thereto. 
     
     
         12 . The medical assembly according to  claim 9  further comprising a tether advanced over said delivery cable wherein said tether comprises a docking ring defining a central aperture for receiving at least a portion of the delivery cable, and at least one tether rod moveably connected to said docking ring. 
     
     
         13 . The medical assembly according to  claim 12  wherein said anchor cap comprises at least one lock, said lock being selectively moved from a first locked position to a second unlocked position and said tether docking ring cooperates with said at least one lock of the anchor cap for securing the tether on the anchor cap when said lock is in said first position. 
     
     
         14 . The medical assembly according to  claim 13  wherein said at least one tether rod is rotatably connected to said docking ring and is substantially rigid. 
     
     
         15 . The medical assembly according to  claim 14  wherein a distal end of said tether rod defines a hook and said docking ring includes an eyelet configured for receipt of said hook. 
     
     
         16 . The medical assembly according to  claim 12  wherein said tether further includes at least one suture extending from a proximal end of said at least one tether rod. 
     
     
         17 . The medical assembly according to  claim 16  wherein said tether comprises at least two of said tether rods and each of said at least two of said sutures extends from a respective one of said tether rods. 
     
     
         18 . The medical assembly according to  claim 3  wherein said anchor delivery assembly comprises:
 an anchor delivery guide defining a longitudinally extending lumen and having a proximal and distal end; 
 said anchor assembly comprises an anchor cap having a proximal and distal end wherein said proximal end includes a first surface configuration; 
 an anchor delivery rod defining a longitudinally extending lumen and having a proximal and distal end and having a distal portion wherein side walls of said delivery rod lumen have a second configuration and wherein a proximal portion of said anchor cap includes a first configuration for cooperating with said delivery rod lumen second configuration for selectively mating therewith for implantation of said anchor at the implantation site. 
 
     
     
         19 . The medical assembly according to  claim 18  wherein said anchor delivery assembly further comprises a sheath defining a longitudinally extending lumen for receiving a portion of said anchor delivery guide, said sheath having a length less than the length of the said anchor delivery guide defined between said proximal and distal ends. 
     
     
         20 . The medical assembly according to  claim 19  further comprising a guide handle for receiving a proximal portion of said anchor delivery sheath. 
     
     
         21 . The medical assembly according to  claim 3  further comprising a J-wire configured for endovascular insertion to guide said anchor delivery system. 
     
     
         22 . The medical assembly according to  claim 18  wherein said anchor delivery system further comprises a rotating handle on a proximal end of said delivery rod for facilitating rotation of said delivery rod to rotate said anchor. 
     
     
         23 . The medical assembly according to  claim 2  wherein said tether further comprises at least one suture extending from a proximal end of said at least one cord. 
     
     
         24 . The medical assembly according to  claim 2  further comprising a tether delivery assembly comprising a removeable tether delivery sheath defining a longitudinally extending lumen configured for receipt of said tether. 
     
     
         25 . The medical assembly according to  claim 5  wherein said atrial skirt delivery system comprises:
 an atrial sealing skirt delivery guide having proximal and distal ends and defining an inner guide extending lumen therebetween wherein a delivery sheath is removable and positioned along said delivery cable and wherein said sheath includes said atrial sealing skirt operatively connected to said cord which extends within a lumen of said sheath. 
 
     
     
         26 . The medical assembly according to  claim 25  further comprising a tether advanced over said delivery cable and including at least one cord connected to said tether and said atrial sealing skirt for operatively connecting said atrial sealing skirt and said anchor and wherein said tether comprises a docking ring defining a central aperture for receiving a flexible wire of the delivery cable and at least one tether rod moveably connected to said docking ring and said delivery guide also includes said tether within said lumen wherein said atrial sealing skirt is connected to said tether within said lumen. 
     
     
         27 . The medical assembly according to  claim 25  wherein said atrial skirt delivery system further comprises an atrial sealing skirt deployment knob having a central channel for receiving a proximal portion of said atrial sealing skirt delivery guide and wherein said atrial sealing skirt delivery guide is retractable within said atrial sealing skirt deployment knob when retracted. 
     
     
         28 . The medical assembly according to  claim 27  wherein said atrial skirt delivery system further comprises at least one positioning rod having a central lumen for being inserted over said at least one cord of said tether and wherein said at least one positioning rod has a length sufficient to extend proximal to said deployment knob and into the heart so as to contact said atrial sealing skirt. 
     
     
         29 . The medical assembly according to  claim 5  further comprising a tether advanced over said delivery cable and including at least one cord connected to said anchor and said atrial sealing skirt for operatively connecting said atrial sealing skirt and said anchor, said medical assembly further comprising a locking system for locking said atrial sealing skirt positioned on the atrial floor and wherein said atrial skirt delivery system further comprises at least one positioning rod having a central, said atrial sealing skirt comprising an atrial top brim, and said locking system comprises at least one conduit extending below said top brim and wherein said top brim defines at least one aperture of said conduit and said locking system further comprises a detachable lock positioned within said conduit configured to cooperate with said at least one positioning rod to lock said top brim on the atrial floor. 
     
     
         30 . The medical assembly according to  claim 29  wherein said detachable lock defines a central lumen and said cord of said tether is received within said lock lumen. 
     
     
         31 . The medical assembly according to  claim 30  wherein said locking system further comprises a first gateway hypotube defining a central lumen and configured for receipt by said detachable lock lumen and configured to cooperate with said detachable lock to secure said at least one cord. 
     
     
         32 . The medical assembly according to  claim 1  wherein said atrial sealing skirt defines a valve receptacle and said medical assembly comprises a valve within said valve receptacle. 
     
     
         33 . A medical assembly for minimally invasively implanting an atrial sealing skirt in the heart at an atrial sealing skirt deployment site comprising:
 an atrial sealing skirt configured for receiving a valve and for endovascular introduction and implantation at a valve deployment site and configured and sized to replace a native heart valve, said atrial sealing skirt having a portion being configured to substantially conform to an atrial floor adjacent the valve deployment site;   a tether including at least one cord, said tether connected to said anchor and said atrial sealing skirt for operatively connecting said atrial sealing skirt and said anchor; and   a removable atrial sealing skirt delivery system for positioning and sealing the atrial sealing skirt.   
     
     
         34 . The medical assembly according to  claim 33  said tether further comprising at least one suture extending from a proximal end of said at least one cord. 
     
     
         35 . The medical assembly according to  claim 33  further comprising a tether delivery assembly comprising a removeable tether delivery sheath defining a longitudinally extending lumen configured for receipt of at least a portion of said tether. 
     
     
         36 . The medical assembly according to  claim 33  wherein said atrial skirt delivery system comprises:
 an atrial sealing skirt delivery guide having proximal and distal ends and defining an inner guide extending lumen therebetween wherein a delivery sheath is removable and positioned along said delivery cable and wherein said sheath includes said atrial sealing skirt operatively connected to said cord which extends within a lumen of said sheath. 
 
     
     
         37 . The medical assembly according to  claim 33  wherein said tether comprises a docking ring defining a central aperture and at least one tether rod moveably connected to said docking ring and said delivery guide also includes said tether within said lumen wherein said atrial sealing skirt is connected to said tether within said lumen. 
     
     
         38 . The medical assembly according to  claim 36  wherein said atrial skirt delivery system further comprises an atrial sealing skirt deployment knob having a central channel for receiving a proximal portion of said atrial sealing skirt delivery guide and wherein said atrial sealing skirt delivery guide is retractable within said atrial sealing skirt deployment knob when retracted. 
     
     
         39 . The medical assembly according to  claim 33  wherein said atrial skirt delivery system further comprises at least one positioning rod having a central lumen for being inserted over said at least one cord of said tether and wherein said at least one positioning rod has a length sufficient to extend into the heart so as to contact said atrial sealing skirt. 
     
     
         40 . The medical assembly according to  claim 33  further comprising a locking system for locking said atrial sealing skirt positioned on the atrial floor and wherein said atrial skirt delivery system further comprises at least one positioning rod having a central lumen for being inserted over said at least one cord of said tether, said atrial sealing skirt comprising an atrial top brim, and said locking system comprises at least one conduit extending below said top brim and wherein said top brim defines at least one aperture of said conduit and said locking system further comprises a detachable lock positioned within said conduit configured to cooperate with said at least one positioning rod to lock said top brim on the atrial floor. 
     
     
         41 . The medical assembly according to  claim 40  wherein said detachable lock defines a central lumen and said cord of said tether is received within said lock lumen. 
     
     
         42 . The medical assembly according to  claim 40  wherein said locking system further comprises a first gateway hypotube defining a central lumen and configured for receipt by said detachable lock lumen and configured to cooperate with said detachable lock to secure said at least one cord. 
     
     
         43 . The medical assembly according to  claim 33  wherein said atrial sealing skirt defines a valve receptacle and said medical assembly comprises a valve within said valve receptacle.