Abstract: A method of treating a mitral valve without open-heart surgery is disclosed. An expandable prosthesis comprises an anchoring portion and an occluding member coupled to the anchoring portion. The prosthesis is loaded into a distal end of a delivery catheter and advanced through a femoral vein and through a pre-made puncture in an atrial septum. The occluding member is then positioned in the mitral valve and the anchoring portion is positioned in the left atrium for maintaining the occluding member between the leaflets of the mitral valve. After deployment, the occluding member prevents blood from flowing from the left ventricle to the left atrium during systole.

Abstract: A multiple-fire securing device includes a hollow outer shaft, a reloader, a reloader movement assembly, a rail, and securing structures each defining an inner securing orifice. The reloader longitudinally moves within the outer shaft and has a distal end shaped to temporarily contact one of the securing structures. The rail is disposed within the reloader and has an installing location. The securing structures are disposed on the rail. The reloader movement assembly moves the reloader longitudinally in a distal direction to deliver a first securing structure to the installing location from a first proximal position and moves the reloader proximally away from the installing location without the first securing structure to a position in which the distal end of the reloader temporarily contacts a second one of the securing structures. The second and successive securing structures are moved one at a time to the installing location.

Abstract: There is disclosed a porous emboli deflector for preventing cerebral emboli while maintaining cerebral blood flow during an endovascular or open surgical procedure. The device prevents the entrance of emboli of a size able to cause stroke (such as greater than 100 microns) from entering either the right or left common carotid arteries, and/or the right or left vertebral arteries by deflecting emboli downstream of these vessels. The device can be placed prior to any manipulation of the heart or aorta allowing maximal protection of the brain during the index procedure. The deflector has a low profile within the aorta which allows sheaths, catheters, or wires used in the index procedure to pass. Also disclosed are methods for insertion and removal of the deflector.

Abstract: A method for replacing a native heart valve in need thereof comprises delivering to the native heart valve an apparatus comprising a valve member, a connecting member, and an anchor member suitable for anchoring the apparatus. The valve member reversibly moves between an open position and a closed position to augment or replace the function of the native valve leaflets, thereby reducing valve regurgitation. Some embodiments include a stent that is positioned in the native heart valve with the valve member disposed therein.

Abstract: A multiple-firing crimp device comprises crimps, a shaft, a crimp movement assembly, and a snare. Each crimp has an internal hollow. The shaft has a distal crimping location, an exterior surface, and an interior with the clips stacked therein, the crimps moving therein along a longitudinal axis. The shaft defines a lateral opening proximal to the crimping location and communicates the interior to the environment outside the exterior surface. The crimp movement assembly within the shaft delivers the first crimp to the distal crimping location by moving the first crimp longitudinally from a first proximal position into the distal crimping location and returning to a second proximal position without the first crimp. The snare pulls at least one cord from distal of the first crimp through the first crimp and through a portion of the shaft and out the side of the shaft through the lateral opening.

Abstract: A multiple-firing crimp device comprises crimps, a shaft, a crimp movement assembly, and a snare. Each crimp has an internal hollow. The shaft has a distal crimping location, an exterior surface, and an interior with the clips stacked therein, the crimps moving therein along a longitudinal axis. The shaft defines a lateral opening proximal to the crimping location and communicates the interior to the environment outside the exterior surface. The crimp movement assembly within the shaft delivers the first crimp to the distal crimping location by moving the first crimp longitudinally from a first proximal position into the distal crimping location and returning to a second proximal position without the first crimp. The snare pulls at least one cord from distal of the first crimp through the first crimp and through a portion of the shaft and out the side of the shaft through the lateral opening.

Abstract: The invention is a method for reducing regurgitation through a mitral valve. The device and method is directed to an anchor portion for engagement with the heart wall and an expandable valve portion configured for deployment between the mitral valve leaflets. The valve portion is expandable for preventing regurgitation through the mitral valve while allowing blood to circulate through the heart. The expandable valve portion may include apertures for reducing the stagnation of blood. In a preferred configuration, the device is preferably configured to be delivered in two-stages wherein an anchor portion is first delivered and the valve structure is then coupled to the anchor portion. In yet another embodiment, the present invention provides a method of forming an anchor portion wherein a disposable jig is used to mold the anchor portion into a three-dimensional shape for conforming to a heart chamber.

Abstract: A multiple-firing crimp device comprises crimps, a shaft, a crimp movement assembly, and a snare. Each crimp has an internal hollow. The shaft has a distal crimping location, an exterior surface, and an interior with the clips stacked therein, the crimps moving therein along a longitudinal axis. The shaft defines a lateral opening proximal to the crimping location and communicates the interior to the environment outside the exterior surface. The crimp movement assembly within the shaft delivers the first crimp to the distal crimping location by moving the first crimp longitudinally from a first proximal position into the distal crimping location and returning to a second proximal position without the first crimp. The snare pulls at least one cord from distal of the first crimp through the first crimp and through a portion of the shaft and out the side of the shaft through the lateral opening.

Abstract: A method for replacing a native heart valve in need thereof comprises delivering to the native heart valve an apparatus comprising a valve member, a connecting member, and an anchor member suitable for anchoring the apparatus. The valve member reversibly moves between an open position and a closed position to augment or replace the function of the native valve leaflets, thereby reducing valve regurgitation. Some embodiments include a stent that is positioned in the native heart valve with the valve member disposed therein.

Abstract: A method of treating a mitral valve without open-heart surgery is disclosed. An expandable prosthesis comprises an anchoring portion and an occluding member coupled to the anchoring portion. The prosthesis is loaded into a distal end of a delivery catheter and advanced through a femoral vein and through a pre-made puncture in an atrial septum. The occluding member is then positioned in the mitral valve and the anchoring portion is positioned in the left atrium for maintaining the occluding member between the leaflets of the mitral valve. After deployment, the occluding member prevents blood from flowing from the left ventricle to the left atrium during systole.

Abstract: The invention is a method for reducing regurgitation through a mitral valve. The device and method is directed to an anchor portion for engagement with the heart wall and an expandable valve portion configured for deployment between the mitral valve leaflets. The valve portion is expandable for preventing regurgitation through the mitral valve while allowing blood to circulate through the heart. The expandable valve portion may include apertures for reducing the stagnation of blood. In a preferred configuration, the device is preferably configured to be delivered in two-stages wherein an anchor portion is first delivered and the valve structure is then coupled to the anchor portion. In yet another embodiment, the present invention provides a method of forming an anchor portion wherein a disposable jig is used to mold the anchor portion into a three-dimensional shape for conforming to a heart chamber.

Abstract: An apparatus for treating a heart valve in need thereof comprises a valve member, a connecting member, and an anchor member suitable for anchoring the apparatus. The valve member reversibly moves between an open position and a closed position to augment or replace the function of the native valve leaflets, thereby reducing valve regurgitation. Some embodiments include a stent that is positioned in the native heart valve with the valve member disposed therein.

Abstract: A multiple-firing crimp device comprises crimps, a shaft, a crimp movement assembly, and a snare. Each crimp has an internal hollow. The shaft has a distal crimping location, an exterior surface, and an interior with the clips stacked therein, the crimps moving therein along a longitudinal axis. The shaft defines a lateral opening proximal to the crimping location and communicates the interior to the environment outside the exterior surface. The crimp movement assembly within the shaft delivers the first crimp to the distal crimping location by moving the first crimp longitudinally from a first proximal position into the distal crimping location and returning to a second proximal position without the first crimp. The snare pulls at least one cord from distal of the first crimp through the first crimp and through a portion of the shaft and out the side of the shaft through the lateral opening.

Abstract: A method for reducing regurgitation in a mitral valve using a blood flow controlling apparatus. The blood flow controlling apparatus comprises a leaflet coaptation member, a connecting member, and an anchor suitable for anchoring the apparatus to the interventricular septum. The leaflet coaptation member coapts with the native mitral valve leaflets during systole when disposed therebetween, thereby reducing mitral valve regurgitation. During diastole, the native leaflets release coaptation with the leaflet coaptation member, permitting blood flow from the left atrium into the left ventricle.

Abstract: There is disclosed a porous emboli deflector for preventing cerebral emboli while maintaining cerebral blood flow during an endovascular or open surgical procedure. The device prevents the entrance of emboli of a size able to cause stroke (greater than 100 microns in the preferred embodiment) from entering either the right or left carotid arteries by deflecting emboli downstream in the blood flow. The device can be placed prior to any manipulation of the heart or aorta allowing maximal protection of the brain during the index procedure. The device has a low profile within the aorta which allows sheaths, catheters, or wires used in the index procedure to pass. Also disclosed are methods for insertion and removal of the device.

Abstract: There is disclosed a porous emboli deflector for preventing cerebral emboli while maintaining cerebral blood flow during an endovascular or open surgical procedure. The device prevents the entrance of emboli of a size able to cause stroke (such as greater than 100 microns) from entering either the right or left common carotid arteries, and/or the right or left vertebral arteries by deflecting emboli downstream of these vessels. The device can be placed prior to any manipulation of the heart or aorta allowing maximal protection of the brain during the index procedure. The deflector has a low profile within the aorta which allows sheaths, catheters, or wires used in the index procedure to pass. Also disclosed are methods for insertion and removal of the deflector.

Abstract: A method of treating a mitral valve without open-heart surgery is disclosed. An expandable prosthesis comprises an anchoring portion and an occluding member coupled to the anchoring portion. The prosthesis is loaded into a distal end of a delivery catheter and advanced through a femoral vein and through a pre-made puncture in an atrial septum. The occluding member is then positioned in the mitral valve and the anchoring portion is positioned in the left atrium for maintaining the occluding member between the leaflets of the mitral valve. After deployment, the occluding member prevents blood from flowing from the left ventricle to the left atrium during systole.

Abstract: A system (1) for altering the geometry of a heart (100), comprising an annuloplasty ring; a set of elongate annulus-papillary tension members (21, 22, 23, 24), adapted for forming a link between said ring (10) and a papillary muscle, and a first set of papillary anchors (30) for connecting each of the tension members (21, 22, 23, 24) to the papillary muscle; and where said annuloplasty ring (10) has at least one aperture (12, 13); where each of said annulus-papillary tension members (21, 22, 23, 24) are extendable through said ring (10) through said apertures (11, 12, 13), and through an atrium to an exterior side of said atrium, such that the distance of each link between the annulus and the muscles is adjustable from a position exterior to the heart while the heart is beating.

Abstract: The invention is a method for reducing regurgitation through a mitral valve. The device and method is directed to an anchor portion for engagement with the heart wall and an expandable valve portion configured for deployment between the mitral valve leaflets. The valve portion is expandable for preventing regurgitation through the mitral valve while allowing blood to circulate through the heart. The expandable valve portion may include apertures for reducing the stagnation of blood. In a preferred configuration, the device is preferably configured to be delivered in two-stages wherein an anchor portion is first delivered and the valve structure is then coupled to the anchor portion. In yet another embodiment, the present invention provides a method of forming an anchor portion wherein a disposable jig is used to mold the anchor portion into a three-dimensional shape for conforming to a heart chamber.

Abstract: In one embodiment, the present invention provides a prosthesis that can be implanted within a heart to at least partially block gaps that may be present between the two mitral valve leaflets. In one preferred embodiment, the prosthesis includes an anchoring ring that expands within the left atrium to anchor the prosthesis and a pocket member fixed to the anchoring ring. When the mitral valve is open, blood flows past the pocket member, maintaining the pocket member in a collapsed state. When the mitral valve closes, the backpressure of the blood pushes into the pocket member, expanding the pocket member to an inflated shape. The mitral valve leaflets contact the expanded pocket member, allowing the prosthesis to block at least a portion of the openings between the leaflets, thereby minimizing regurgitated blood flow into the left atrium.