Abstract: A medical assembly and methods for endovascularly implanting a valve in the heart having a valve and an anchor assembly for positioning and restraining the valve. An anchor delivery system introduces and implants the anchor into the implantation site and a valve delivery system introduces and seals the valve at the deployment site. The present invention also relates to methods of implantation of the medical assembly and the valve.

Abstract: A minimally invasively implanted anchor support for securing a medical prosthesis device with a tether to an implanted anchor. The anchor support includes a lock cap for connecting to the anchor, a tether swivel connected to the lock cap, a tock cone within the tether swivel and a tether collar on a proximal end of the tether swivel. An anchor support delivery system cooperates with the anchor support for securing to the lock cap.

Abstract: An endovascular medical assembly and method for restoring chordal support to a leaflet of a heart valve by implanting artificial chordae tendinea in the heart. A chord is inserted into the heart endovascularly with a leaflet grasper which pierces the leaflet and implants the chord through the leaflet. An anchor assembly is implanted into an intracardiac wall and has anchor lines extending therefrom. The chord and an anchor line are assembled by a line gathering member and the tension of the chord is adjusted and secured. The chord is, thus, secured to the anchor assembly to support the leaflet.

Abstract: An introducer sheath assembly having a handle portion including a distal end and a proximal end, and an introducer sheath extending outwardly from the distal end of the handle portion, the introducer sheath including a device lumen configured to slidably receive a corresponding device, a guidewire lumen configured to slidably receive a corresponding guidewire, and at least one steering cable disposed within at least one steering cable lumens that are disposed radially outwardly from the device lumen, and the handle portion including at least one steering assembly for modifying the tension of at least one of the at least one steering cables.

Abstract: An introducer sheath assembly having a handle portion including a distal end and a proximal end, and an introducer sheath extending outwardly from the distal end of the handle portion, the introducer sheath including a device lumen configured to slidably receive a corresponding device, a guidewire lumen configured to slidably receive a corresponding guidewire, and at least one steering cable disposed within at least one steering cable lumens that are disposed radially outwardly from the device lumen, and the handle portion including at least one steering assembly for modifying the tension of at least one of the at least one steering cables.

Abstract: An introducer sheath assembly having a handle portion including a front end and a rear end, and a introducer sheath extending outwardly from the front end of the handle portion, the introducer sheath including a device lumen configured to slidably receive a corresponding device, a guidewire lumen configured to slidably receive a corresponding guidewire, a first steering cable lumen, a second steering cable lumen, a first steering cable disposed in the first steering cable lumen and a second steering cable disposed in the second steering cable lumen, wherein the first steering cable lumen, the second steering cable lumen and the guidewire lumen are disposed radially outwardly from the device lumen.

Abstract: A medical assembly implanting a transcatheter heart valve in the heart at a valve 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 a transcatheter heart valve. The transcatheter heart valve includes either a top or bottom brim which is positioned to conform to the atrial floor at the deployment site.

Abstract: A medical assembly implanting a transcatheter heart valve in the heart at a valve 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 a transcatheter heart valve. The transcatheter heart valve includes either a top or bottom brim which is positioned to conform to the atrial floor at the deployment site.

Abstract: A minimally invasively implanted anchor support for securing a medical prosthesis device with a tether to an implanted anchor. The anchor support includes a lock cap for connecting to the anchor, a tether swivel connected to the lock cap, a tock cone within the tether swivel and a tether collar on a proximal end of the tether swivel. An anchor support delivery system cooperates with the anchor support for securing to the lock cap.

Abstract: A tether locking assembly for implanted cardiac medical devices, such as an artificial heart valve to replace the native heart valve, and which are secured at the implantation site by anchoring tethers secured to an intracardiac member, such as an intracardiac wall. The tether locking assembly includes at least one atrial positioning rod, at least one conduit, and a detachable lock. The detachable lock includes first and second hypotubes and a locking clip. The hypotubes are positioned within the positioning rod central lumen.

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.

Abstract: A dilator assembly comprising an elongated body having a proximal end and a distal end, a first lumen extending along the body, a second lumen extending along the body so that it is a parallel to the first lumen, and a joint lumen disposed adjacent the distal end of the body, wherein both the first lumen and second lumen are in fluid communication with the joint lumen. A guidewire has a first end and a second end, and the first end of the guidewire is slidably received in the first lumen and the second end of the guidewire is slidably received in the second lumen.

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.

Abstract: An atrial sealing skirt for transcatheter valves and an atrial sealing skirt with an integrated valve to reduce paravalvular regurgitation, with or without the presence of intracardiac leads. The atrial sealing skirt includes a top brim which is positioned to conform to the atrial floor at the deployment site.

Abstract: A dilator assembly comprising an elongated body having a proximal end and a distal end, a first lumen extending along the body, a second lumen extending along the body so that it is a parallel to the first lumen, and a joint lumen disposed adjacent the distal end of the body, wherein both the first lumen and second lumen are in fluid communication with the joint lumen. A guidewire has a first end and a second end, and the first end of the guidewire is slidably received in the first lumen and the second end of the guidewire is slidably received in the second lumen.

Abstract: A minimally invasively implanted anchor support for securing a medical device to a heart wall including an anchoring member and an expandable distal anchor restraint which is implanted through the anchoring member, through the heart wall, and expands on the opposing heart wall side to anchor a medical device. A single-stage anchor system includes the distal flange and a two-stage anchor system includes the distal flange and a proximal flange which cooperates with the distal flange to secure a medical device to the heart wall and methods of a single-stage anchor system and a two-stage anchor system.

Abstract: An endovascular medical assembly and method for restoring chordal support to a leaflet of a heart valve by implanting artificial chordae tendinea in the heart. A chord is inserted into the heart endovascularly with a leaflet grasper which pierces the leaflet and implants the chord through the leaflet. An anchor assembly is implanted into an intracardiac wall and has anchor lines extending therefrom. The chord and an anchor line are assembled by a line gathering member and the tension of the chord is adjusted and secured. The chord is, thus, secured to the anchor assembly to support the leaflet.

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.

Abstract: An introducer sheath assembly having a handle portion including a distal end and a proximal end, and an introducer sheath extending outwardly from the distal end of the handle portion, the introducer sheath including a device lumen configured to slidably receive a corresponding device, a guidewire lumen configured to slidably receive a corresponding guidewire, and at least one steering cable disposed within at least one steering cable lumens that are disposed radially outwardly from the device lumen, and the handle portion including at least one steering assembly for modifying the tension of at least one of the at least one steering cables.

Abstract: A method of endovascularly delivering and implanting a medical assembly for minimally invasively implanting an atrial sealing skirt in the heart at an atrial sealing skirt deployment site, sealing the top brim against a respective atrial floor of the heart, and anchoring the atrial sealing skirt on an intracardiac wall at an implantation site and tethering the anchor and the sealing skirt.