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: A prosthetic heart valve may include a collapsible and expandable frame that, in an expanded condition, includes a central portion, an atrial portion flaring radially outwardly from the central portion, and a ventricular portion flaring radially outwardly from the central portion. A tube positioned within the frame may have a lumen extending along a longitudinal axis of the frame, wherein the tube is formed of tissue or fabric. Prosthetic leaflets may be directly coupled to the tube to form a valve allowing blood to flow through the lumen of the tube in an antegrade direction but substantially blocking blood from flowing through the lumen of the tube in a retrograde direction. A plurality of cords may each have a first end coupled to the frame and a second end coupled to the tube. Each of the plurality of cords may extend in a radial direction toward the longitudinal axis.

Abstract: In some examples, a prosthetic heart valve system includes an outer stent, an inner stent coupled to the outer stent, the inner stent supporting a valve assembly including a cuff and a plurality of leaflets, and at least one linking member coupling the outer stent to the inner stent, the at least one linking member being transitionable between a collapsed condition and a relaxed condition, the inner stent being axially spaced away from the outer stent when the at least one linking member is in the collapsed condition, and the inner stent being at least partially nested within the outer stent when the at least one linking member is in the relaxed condition.

Abstract: A prosthetic heart valve system may include a collapsible anchor frame which may include a support frame that has a central portion, and atrial and ventricular portions flared radially outwardly from the central portion. The atrial and ventricular portions may be sized to sandwich or clamp an annulus of the heart valve. An atrial sheet may be coupled to the atrial portion of the support frame and may extend radially inwardly to a central aperture in the atrial sheet, the atrial sheet being formed of a material that is substantially impermeable to blood. The system may include a leaflet support structure, an inflow end of the leaflet support structure coupled to the atrial sheet. The atrial sheet may define an opening positioned radially outside of the leaflet support structure so that blood flowing around an exterior of the leaflet support structure passes through the opening.

Abstract: A prosthetic heart valve system may include a balloon expandable prosthetic heart valve and a delivery catheter. The delivery catheter may have a balloon on a distal end portion of the delivery catheter. In a delivery condition of the system and in an activated condition of the system, the prosthetic heart valve is mounted over the balloon so that a leading edge of the prosthetic heart valve points toward a distal end of the delivery catheter and so that the prosthetic heart valve has an outer radial extent. The delivery catheter may include a protective member operably coupled to the delivery catheter. In the delivery condition of the system, the protective member does not extend radially beyond the outer radial extent of the prosthetic heart valve. In the activated condition of the system, the protective member does extend radially beyond the outer radial extent of the prosthetic heart valve.

Abstract: A prosthetic heart valve for replacing a native atrioventricular valve may include a self-expanding stent formed as a monolithic structure. The stent may include an atrial disk, a ventricular disk, and a center portion extending between the atrial disk and the ventricular disk. A plurality of prosthetic leaflets may be directly coupled to the center portion of the stent. An outer fabric may be coupled to the stent. In an implanted condition of the prosthetic heart valve, the atrial disk is sized to contact an atrial side of the native atrioventricular valve, the ventricular disk is sized to contact a ventricular side of the native atrioventricular valve, the center portion is sized to be positioned radially inside the native atrioventricular valve without pressing against the native atrioventricular valve, and the outer fabric is configured to directly contact the native atrioventricular valve.

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 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 prosthetic tricuspid heart valve system includes a collapsible anchor frame and a collapsible prosthetic heart valve. The anchor includes a support structure having a waisted central portion, and atrial and ventricular flared portions sized to clamp a native valve annulus. Atrial and ventricular sheets are coupled to the atrial and ventricular flared portions, and each include a central aperture. A generally cylindrical fabric valve-receiving member has an inflow end coupled to the atrial sheet and an outflow end coupled to the ventricular sheet to provide a conduit through the valve-receiving member between the atrial and ventricular sheet. The prosthetic heart valve may include a stent and a plurality of prosthetic leaflets, the prosthetic heart valve configured to be expanded into and received within the valve-receiving member of the anchor frame.

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: 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: 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 prosthetic heart valve system may include a prosthetic heart valve, a tether having a first end configured to connect to the prosthetic heart valve and a second end, and a collapsible and expandable anchor. The anchor includes a center rim configured to couple to the second end of the tether. The anchor further includes a plurality of struts extending radially outward from the center rim forming an inner dome that is concave toward a heart when the anchor is in a resting configuration implanted on an apex of the heart. The anchor further includes a plurality of wings extending radially outward from the struts.

Abstract: An epicardial anchor device may include a base and a hub each defining a radial slot. The hub is received within, and is rotatable relative to, the base. The radial slot of the hub defines a tether passageway for receiving a tether coupled to a prosthetic heart valve. The epicardial anchor device may have an unlocked configuration in which the radial slot of the base aligns with the radial slot of the hub so that the tether may be slid laterally through the radial slot of the base, and a locked configuration in which the radial slot of the base is out of alignment with the radial slot of the hub so that the tether cannot be slid laterally away from the radial center of the hub. Rotation of the hub may transition the epicardial anchor device from the locked to the unlocked configuration.

Abstract: Apparatus and methods are described herein for use in the delivery of a prosthetic mitral valve. In some embodiments, an apparatus includes a tether fixer assembly configured to engage an outside surface of a heart to secure a prosthetic heart valve in position within the heart. The fixer assembly defines a lumen configured to receive therethrough a tether extending from the prosthetic valve and a movable portion. The fixer assembly is movable between a first configuration, in which the movable portion is disengaged with the tether, and a second configuration in which the movable portion is engaged with the tether. The fixer assembly can be disposed against an epicardial pad positioned on the outside surface of the heart when in the second configuration to secure the prosthetic valve, the epicardial pad and tether in a desired position within the heart.

Abstract: A tether system for securing a prosthetic heart valve within a patient, the tether system comprising a tether defining a longitudinal axis, and a deformable element coupled to the tether, the deformable element having a first deformed shape in a first condition of the deformable element, and having a second substantially straight shape in a second condition of the deformable element so that, when the deformable element is in the second condition, the deformable element extends in a direction along the longitudinal axis.

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: 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 prosthetic heart valve system includes a collapsible and expandable stent, a plurality of prosthetic leaflets coupled to the stent, a collapsible anchor, and a tether configured to couple the stent to the anchor, wherein the collapsible anchor includes a flexible frame body defining a plurality of collapsible cells, each cell having at least one side shared with a neighboring cell, a center adjoining point defined by the cells formed in the flexible frame body, the center adjoining point configured to receive the tether, and a first tip end and a second tip end defining a major axis of the flexible frame body, the major axis passing through the center adjoining point.

Abstract: A prosthetic mitral valve with improved blood flow to the left ventricular outflow tract. 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 tether connector securing a tether. A valve assembly including a cuff and a plurality of leaflets may be disposed within the inner stent. The tether connector is positioned at the inflow end of the inner stent so as to shorten the overall length of the prosthetic valve.