Abstract: An epicardial anchor device may include a base defining a radial slot, and a top component including a first piece and a second piece each operably coupled to the base. The first piece may include a first recess and the second piece may include a second recess. The epicardial anchor device may have (i) an unpinned condition in which the first piece and the second piece are spaced from each other a first distance so that a tether may be laterally slid within the radial slot and between the first piece and the second piece, and (ii) a pinned condition in which the first piece and the second piece are spaced from each other a second distance so that the tether may be confined within an aperture defined by the first recess and the second recess, the second distance being smaller than the first distance.

Abstract: A valve and tether fixation mechanism includes an anchor, a tether, and a prosthetic heart valve. The anchor may be for anchoring a prosthetic heart valve in a native heart valve. The tether may have a distal end coupled to the anchor. The tether may extend proximally from the anchor and connect to a tensioning mechanism. The prosthetic valve may be configured to translate along the tether. The valve may have a tether connecting portion configured to allow for adjustment of the tension in the tether and affix the prosthetic valve to the tether at a desired tension.

Abstract: An apical pad for securing a prosthetic heart valve within a native valve annulus. The apical pad includes an inner collar having a collapsed condition for transcatheter delivery and an expanded condition arranged to engage an interior surface of a heart wall, an outer collar having a collapsed condition for transcatheter delivery and an expanded condition arranged to engage an exterior of the heart wall, and a connector extending between the inner and outer collars. The inner collar is moveable relative to the outer collar to clamp the heart wall and to seal an incision extending through the heart wall.

Abstract: A prosthetic heart valve delivery system includes a prosthetic heart valve, an anchor, and a catheter extending from a proximal end to a distal end configured to receive the prosthetic heart valve and the anchor. The catheter includes a balloon circumferentially surrounding the catheter at the distal end of the catheter, and an inflation lumen positioned radially outward of the catheter extending from the proximal end to the distal end, the inflation lumen in communication with the balloon.

Abstract: A loading funnel for a prosthetic heart valve includes a proximal connector configured for releasably securing the funnel to a holding tube for a prosthetic heart valve, a distal end for receiving the prosthetic heart valve in an at least partially expanded state, and a passage extending between the distal end and the proximal connector. The passage includes a conical portion that is wider at a distal end and narrower at a proximal end and centered along a cone axis. One or more internal fins each extend from a relatively proximal location in the conical portion to a relatively distal location in the conical portion and protrude toward the cone axis.

Abstract: This invention relates to the design and function of a device which allows for retrieval of a previously implanted valve prosthesis from a beating heart without extracorporeal circulation using a transcatheter retrieval system, including a guide component to facilitate the compression of the valve and retraction into a retrieval catheter, as well as an improved prosthetic transcatheter heart valve having one or more of: a series of radially extending tines having a loop terminus to improve sealing a deployed prosthetic mitral valve against hemodynamic leaking, a pre-compressible stent-in-stent design, or an articulating cuff attached to a covered stent-valve and a commissural sealing skirt structure attached to the underside of the articulating cuff.

Abstract: A delivery catheter system includes an anchor catheter, a collapsible and expandable anchor, a balloon catheter, and a needle. The anchor may be for anchoring a prosthetic heart valve in a native heart valve. The anchor may be configured to be received within the anchor catheter. The balloon catheter may be positioned radially inward of the anchor catheter, and may include an inflatable balloon at a distal end thereof. The balloon may be in fluid communication with the balloon catheter. The needle may be positioned radially inward of the balloon catheter and may be translatable relative to the balloon, the needle having a sharp distal tip.

Abstract: A delivery catheter system includes a guide catheter, an anchor catheter, a collapsible and expandable anchor, a balloon formed from a portion of the positioning catheter, and a needle. The anchor may be for anchoring a prosthetic heart valve in a native heart valve. The anchor may be configured to be received within the anchor catheter. The balloon may be inflated or deflated and provide mechanical support to enable the needle to pierce a ventricle wall. A metallic guide wire can simultaneously be inserted through the aorta to outline the heart when viewed through fluoroscopic imaging.

Abstract: A delivery catheter system includes a guide catheter, an anchor catheter, a collapsible and expandable anchor, a balloon formed from a portion of the positioning catheter, and a needle. The anchor may be for anchoring a prosthetic heart valve in a native heart valve. The anchor may be configured to be received within the anchor catheter. The balloon may be inflated or deflated and provide mechanical support to enable the needle to pierce a ventricle wall. A metallic guide wire can simultaneously be inserted through the aorta to outline the heart when viewed through fluoroscopic imaging.

Abstract: Apparatus and methods are described herein for various embodiments of a prosthetic heart valve, delivery apparatus and delivery methods for delivering a prosthetic heart valve to a heart of a patient via a transapical or transvascular delivery approach. In some embodiments, a prosthetic heart valve includes an outer frame coupled to an inner frame and the outer frame is movable between a first configuration relative to the inner frame and a second inverted configuration relative to the inner frame. The valve can be delivered to a heart using an apparatus that includes a delivery sheath that defines a lumen that can receive the prosthetic heart valve therein when the outer frame is in the inverted configuration. Actuation wires are releasably coupled to the outer frame and can be used to help revert the outer frame after the valve is deployed outside of the delivery sheath and within the heart.

Abstract: An apical pad for securing a prosthetic heart valve within a native valve annulus. The apical pad includes a first collar, a second collar and plurality of struts extending between the first collar and the second collar. The plurality of struts has a delivery condition in which the plurality of struts collectively form a first cross-section and a deployed condition in which the plurality of struts collectively form a second cross-section greater than the first cross-section. The apical pad may be coupled to a tether extending from a prosthetic heart valve and may transition from the delivery condition to the deployed condition by tensioning the tether.

Abstract: An epicardial anchor system comprising a tether attachment member defining a portion of a tether passageway configured to receive a portion of a tether extending from a heart valve, a base having a rim defining a void along a circumference of the rim, and a tether capture device adjacent the tether attachment member and hingedly attached to the epicardial anchor, the tether capture device including an opening configured to receive the portion of the tether therethrough and a slot configured to capture the portion of the tether extending through the opening, and an actuation mechanism configured to flip the tether capture device from an unactuated condition to an actuated condition, wherein in the unactuated condition, the tether capture device is spaced from the void defined by the rim, and in the actuated condition, a first portion of the tether capture device is positioned within the void defined by the rim.

Abstract: Apparatus and methods are described herein for anchoring a prosthetic heart valve. In some embodiments, an apparatus includes a tether attachment member that includes a base member that defines at least a portion of a tether passageway through which a portion of a tether extending from a prosthetic heart valve can be received therethrough. The base member defines a locking pin channel that intersects the tether passageway. A locking pin is disposable within the locking pin channel and movable between a first position in which the locking pin is at a spaced distance from the tether passageway, and a second position in which the locking pin intersects the tether passageway and can engage the portion of a tether disposed therein to secure the tether to the tether attachment member.

Abstract: A prosthetic heart valve may include a valve portion, a tether connected to the valve portion, and an anchor for connecting the tether to the wall of the heart. The anchor may include a flexible first disc biased toward a first shape that is convex in a first direction and a neck extending from the first disc in a second direction opposite the first direction. The neck has a first end connected to the first disc and a second end. The anchor may further include a flexible second disc connected to the second end of the neck and biased toward a second shape that is convex in the first direction. When deployed, the first and second discs sandwich the wall of the heart.

Abstract: A heart valve delivery system may include a handle, a shaft having a proximal end fixedly connected to the handle and extending distally along an axis away from the handle to a free end, and a tube surrounding the shaft. The tube may have a proximal end connected to the handle and extend distally along the axis away from the handle to a distal end. The tube may be axially movable relative to the shaft and the handle between a fully extended position at which the tube extends distally farther than the shaft, and a fully retracted position at which the shaft extends distally farther than the tube. The system may include an inserter for guiding insertion of the tube. In addition or in alternative to the inserter, the system may include a funnel for loading the prosthetic valve into the tube.

Abstract: A self-expanding wire frame for a pre-configured compressible transcatheter prosthetic cardiovascular valve, a combined inner frame/outer frame support structure for a prosthetic valve, and methods for deploying such a valve for treatment of a patient in need thereof, are disclosed.

Abstract: Apparatus and methods are described herein for anchoring a prosthetic heart valve. In some embodiments, an apparatus includes a tether attachment member that includes a base member that defines at least a portion of a tether passageway through which a portion of a tether extending from a prosthetic heart valve can be received therethrough. The base member defines a locking pin channel that intersects the tether passageway. A locking pin is disposable within the locking pin channel and movable between a first position in which the locking pin is at a spaced distance from the tether passageway, and a second position in which the locking pin intersects the tether passageway and can engage the portion of a tether disposed therein to secure the tether to the tether attachment member.

Abstract: Apparatus and methods are described herein for use in the transfemoral delivery and deployment of a prosthetic mitral valve. In some embodiments, a method includes inverting an outer frame of a prosthetic mitral valve when in a biased expanded configuration. After inverting the outer frame, the prosthetic mitral valve is inserted into a lumen of a delivery sheath such that the mitral valve is moved to a collapsed configuration. The delivery sheath is inserted into a femoral vein and moved through the femoral vein and a septum of a heart until a distal end of the delivery sheath is disposed in the left atrium of the heart. The prosthetic mitral valve is moved distally out of the delivery sheath such that the inverted outer frame reverts and the prosthetic mitral valve assumes its biased expanded configuration. The prosthetic mitral valve is then positioned within a mitral annulus of the heart.

Abstract: Apparatus and methods are described herein for a secondary valve apparatus that can be deployed within an existing implanted prosthetic heart valve. In some embodiments, a secondary prosthetic heart valve apparatus is implanted in series with an existing deteriorating implanted prosthetic valve. The secondary valve apparatus can restore proper valve function without disruption to the failing previously implanted valve. In some embodiments, the secondary valve apparatus can be positioned on an atrial portion of the existing valve, and be delivered transseptally. In other embodiments, the secondary valve apparatus can be positioned at a ventricular portion of the existing valve and delivered transapically. Devices and methods to prepare the existing valve to receive a secondary valve apparatus are also described herein. In some embodiments, a balloon expansion device can be used to expand an inner diameter of the existing valve to provide space for the secondary valve to be disposed.

Abstract: A prosthetic mitral valve with improved blood flow to the left ventricular outflow tract (LVOT). The prosthetic mitral valve includes an expandable outer stent having an atrial end and a ventricular end, and an expandable inner stent attached to and at least partially positioned within the outer stent. The inner stent has an inflow end, an outflow end and a connector securing a tether. A valve assembly including a cuff and a plurality of leaflets may be disposed within the inner stent. The outer stent is expandable from a delivery condition in which the outer stent is axially elongated to a deployed condition in which a first portion of the outer stent is folded upon a second portion of the outer stent to define a flange for engaging an atrial surface of a native valve annulus and to stabilize the prosthetic heart valve within the native valve annulus.