Abstract: An assembly for transvascular replacement of a native aortic heart valve can have a radially collapsible and self-expandable prosthetic heart valve and a delivery apparatus. The valve can have an annular metal frame made of a shape-memory material with a plurality of posts extending from an end portion of the frame. The delivery apparatus can have a shaft comprising a valve connection portion that is releasably coupled to the posts of the valve. The valve connection portion can have a plurality of discrete radially facing recesses that receive the posts. The delivery apparatus can have a delivery sheath that is positioned around the prosthetic heart valve and the valve connection portion of the shaft to maintain the prosthetic heart valve in a radially compressed state and maintain the posts within the recesses. The delivery apparatus can cause relative axial motion between the delivery sheath and the valve.

Abstract: An assembly for replacing a native heart valve can have a prosthetic heart valve with an annular metal frame made from shape-memory material and a valve member disposed in an interior of the metal frame. The assembly can have a delivery apparatus with a handle, a shaft with a proximal end portion and a distal end portion. The proximal end portion can be coupled to the handle and the distal end portion can be releasably coupled to the prosthetic heart valve. The delivery apparatus can also have a delivery sheath and a hydraulic power source operatively connected to the delivery sheath. The prosthetic heart valve can be positioned within the delivery sheath in a radially compressed state. The hydraulic power source can be configured to move the delivery sheath longitudinally relative to the valve to allow the valve to self-expand from the radially compressed state to a radially expanded state.

Abstract: Methods for delivering a prosthetic valve comprise introducing the prosthetic heart valve into a body of a patient. The prosthetic valve is mounted within a delivery sheath of a delivery apparatus in a radially compressed state. The prosthetic valve is advanced through the body to a delivery location. A motor is actuated to cause the delivery sheath to retract to expose the prosthetic valve and the prosthetic valve expands to a radially expanded state at the delivery location. The methods can also include releasing the prosthetic valve from the delivery apparatus and removing the delivery apparatus from the patient.

Abstract: A delivery assembly includes a prosthetic device, a catheter shaft, a release wire, a first line, and a second line. The prosthetic device has a first arm and a second arm. The release wire extends through the catheter shaft. The first line includes a first loop. The first line extends from the catheter shaft, through the first arm of the prosthetic device, and to the release wire, where the release wire extends through the first loop. The second line includes a second loop. The second line extends from the catheter shaft, through the second arm of the prosthetic device, and to the release wire, where the release wire extends through the second loop.

Abstract: A method of treating a defective mitral valve includes inserting a delivery catheter through a small incision in a patient's groin, wherein the delivery catheter has a prosthetic device positioned along a distal end thereof. The prosthetic device includes an insert member and an anchoring member, wherein the insert member is made from a shape memory material and is surrounded by a biocompatible fabric outer layer. The insert member is positioned within a mitral valve and self-expands in a gap between the native leaflets. The anchoring member is attached to surrounding tissue. After deployment of the prosthetic device, the native leaflets of the mitral valve form a tight seal against the biocompatible fabric outer layer and the insert member fills the gap between the native leaflets of the mitral valve for preventing regurgitation during ventricular systole.

Abstract: A method of treating a native mitral valve without open-heart surgery is disclosed. An expandable prosthesis includes an anchoring portion and an occluding member coupled to the anchoring portion. The prosthesis is loaded into a distal end portion of a delivery catheter and is advanced through a femoral vein and through a pre-made puncture in an atrial septum. The anchoring portion self-expands within the left atrium for anchoring the occluding member in a fixed position. The anchoring portion is preferably a laser cut structure that conforms to the left atrium and uniformly distributes anchoring forces within the left atrium. After deployment, the occluding member prevents blood from flowing from the left ventricle to the left atrium during systole. The occluding member is preferably made from a flexible material, such as pericardial tissue.

Abstract: A cardiac valve annulus may be constricted by using an apparatus to deliver a cord to the annulus, affixing the cord, and subsequently tightening that cord. In some embodiments, this apparatus includes an elongated core with a main channel, a set of first channels, and at least one second channel, all of which run through the core. The first channels accommodate pull wires for triggering the anchor launchers, and the second channels accommodate portions of the cord. Support arms extend distally beyond the core, and anchor launchers are mounted to each of these support arms. The support arms hold the distal ends of the anchor launchers at positions distributed about the annulus. The anchors are launched to affix the cord, and the cord is tightened in a subsequent procedure.

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 constricting cord can be delivered to the vicinity of an annulus using an apparatus that includes a set of support arms, with a respective anchor launcher supported by each of the support arms. An inflatable first balloon is configured to push the support arms away from each other when the first balloon is inflated. An inflatable second balloon is mounted to a shaft and is configured for inflation when the second balloon is disposed distally beyond the first balloon. In some embodiments, the distal balloon is inflated while it is in a ventricle. In some embodiments, the distal balloon is inflated while it is in a pulmonary artery.

Abstract: An annulus ring or a constricting cord may be delivered to the vicinity of a cardiac annulus using a set of anchor launchers, with each of the anchor launchers being supported by a respective support arm. An inflatable balloon is disposed between the support arms, and the balloon is configured so that when the balloon is inflated, the balloon will push the support arms away from each other. At least one retainer cord is connected to the support arms and is arranged with respect to the support arms to encompass the balloon and prevent the balloon from slipping out between the support arms.

Abstract: A constricting cord can be delivered to the vicinity of an annulus using an apparatus that includes a set of support arms, with a respective anchor launcher supported by each of the support arms. An inflatable first balloon is configured to push the support arms away from each other when the first balloon is inflated. An inflatable second balloon is mounted to a shaft and is configured for inflation when the second balloon is disposed distally beyond the first balloon. In some embodiments, the distal balloon is inflated while it is in a ventricle. In some embodiments, the distal balloon is inflated while it is in a pulmonary artery.

Abstract: A method of treating a defective mitral valve includes inserting a delivery catheter through a small incision in a patient's groin, wherein the delivery catheter has a prosthetic device positioned along a distal end thereof. The prosthetic device includes an insert member and an anchoring member, wherein the insert member is made from a shape memory material and is surrounded by a biocompatible fabric outer layer. The insert member is positioned within a mitral valve and self-expands in a gap between the native leaflets. The anchoring member is attached to surrounding tissue. After deployment of the prosthetic device, the native leaflets of the mitral valve form a tight seal against the biocompatible fabric outer layer and the insert member fills the gap between the native leaflets of the mitral valve for preventing regurgitation during ventricular systole.

Abstract: A handle for a prosthetic heart valve delivery apparatus includes a housing, a motorized mechanism, and a holding mechanism. The housing is configured to be hand-held by a user and includes a distal opening. The motorized mechanism is disposed within the housing and is configured to be releasably coupled to a proximal end portion of a first shaft of the prosthetic heart valve delivery apparatus. When actuated, the motorized mechanism is configured to rotate the first shaft relative to the housing. The holding mechanism is disposed inside the housing and is configured to engage a proximal end portion of a second shaft of the prosthetic heart valve delivery apparatus such that the second shaft is axially and rotationally fixed relative to the housing, and the first shaft extends through the second shaft.

Abstract: Tissue ingrowth on the distal loop portion of a constricting cord can dramatically improve the bond between the constricting cord and a cardiac valve annulus. But tissue ingrowth on the proximal portions of the constricting cord can interfere with the constricting action of the cord. This problem can be addressed by covering the proximal portions of the constricting cord with a material that resists tissue ingrowth, and waiting for tissue ingrowth to strengthen the bond between the distal loop portion of the constricting cord and the annulus. The reduced ingrowth on the proximal portions of the constricting cord make it easier to constrict the annulus when the constricting operation is eventually performed.

Abstract: Dislodgment of a constricting cord from an annulus can be prevented by delivering the distal loop portion of the constricting cord to the annulus using a percutaneous delivery tool, and launching anchors into the annulus so as to affix the distal loop portion of the constricting cord to the annulus. The percutaneous delivery tool is withdrawn in a proximal direction after the anchors have been launched. A pushing member is pressed in a distal direction so that the pushing member holds a portion of the constricting cord against the annulus with enough pressure to prevent dislodgment of any of the anchors during the withdrawal of the percutaneous delivery tool.

Abstract: Dislodgment of a constricting cord from an annulus can be prevented by delivering the distal loop portion of the constricting cord to the annulus using a percutaneous delivery tool, and launching anchors into the annulus so as to affix the distal loop portion of the constricting cord to the annulus. The percutaneous delivery tool is withdrawn in a proximal direction after the anchors have been launched. A pushing member is pressed in a distal direction so that the pushing member holds a portion of the constricting cord against the annulus with enough pressure to prevent dislodgment of any of the anchors during the withdrawal of the percutaneous delivery tool.

Abstract: A delivery assembly includes a prosthetic device, a catheter shaft, a release wire, a first line, and a second line. The prosthetic device has a first arm and a second arm. The release wire extends through the catheter shaft. The first line includes a first loop. The first line extends from the catheter shaft, through the first arm of the prosthetic device, and to the release wire, where the release wire extends through the first loop. The second line includes a second loop. The second line extends from the catheter shaft, through the second arm of the prosthetic device, and to the release wire, where the release wire extends through the second loop.

Abstract: A method of treating a defective mitral valve includes percutaneously advancing a prosthetic device into a patient's heart. The prosthetic device includes an insert member and anchoring member. The prosthetic device is contained within a sheath along a distal end of a delivery catheter during advancement. The anchoring member is secured to a muscular wall of the left ventricle and the insert member self-expands between native leaflets of the mitral valve. The insert member preferably includes a biocompatible fabric outer layer, a passageway, and a valve member disposed within the passageway. After deployment, the native leaflets of the mitral valve form a tight seal against the fabric outer layer of the insert member for preventing regurgitation, while blood passes through the passageway of the insert member for allowing blood to pass from the left atrium to the left ventricle.

Abstract: Dislodgment of a constricting cord from an annulus can be prevented by delivering the distal loop portion of the constricting cord to the annulus using a percutaneous delivery tool, and launching anchors into the annulus so as to affix the distal loop portion of the constricting cord to the annulus. The percutaneous delivery tool is withdrawn in a proximal direction after the anchors have been launched. A pushing member is pressed in a distal direction so that the pushing member holds a portion of the constricting cord against the annulus with enough pressure to prevent dislodgment of any of the anchors during the withdrawal of the percutaneous delivery tool.

Abstract: A method of treating a defective mitral valve includes percutaneously advancing a prosthetic device into a patient's heart. The prosthetic device includes an insert member and anchoring member. The prosthetic device is contained within a sheath along a distal end of a delivery catheter during advancement. The anchoring member is secured to a muscular wall of the left ventricle and the insert member self-expands between native leaflets of the mitral valve. The insert member preferably includes a biocompatible fabric outer layer, a passageway, and a valve member disposed within the passageway. After deployment, the native leaflets of the mitral valve form a tight seal against the fabric outer layer of the insert member for preventing regurgitation, while blood passes through the passageway of the insert member for allowing blood to pass from the left atrium to the left ventricle.