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: 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: Apparatus and methods are described herein for use in the delivery and deployment of a prosthetic mitral valve into a heart. In some embodiments, an apparatus includes a catheter assembly, a valve holding tube and a handle assembly. The valve holding tube is releasably couplable to a proximal end portion of the catheter assembly and to a distal end portion of the handle assembly. The handle assembly includes a housing and a delivery rod. The delivery rod is configured to be actuated to move distally relative to the housing to move a prosthetic heart valve disposed within the valve holding tube out of the valve holding tube and distally within a lumen of the elongate sheath of the catheter assembly. The catheter assembly is configured to be actuated to move proximally relative to the housing such that the prosthetic valve is disposed outside of the lumen of the elongate sheath.

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

Abstract: In some embodiments, a method includes delivering to a native valve annulus (e.g., a native mitral valve annulus) of a heart a prosthetic heart valve having a body expandable from a collapsed, delivery configuration to an expanded, deployed configuration. The method can further include, after the delivering, causing the prosthetic heart valve to move from the delivery configuration to the deployed configuration. With the prosthetic heart valve in its deployed configuration, an anchor can be delivered and secured to at least one of a fibrous trigone of the heart or an anterior native leaflet of the native valve. With the prosthetic heart valve disposed in the native valve annulus and in its deployed configuration, an anchoring tether can extending from the anchor can be secured to a wall of the heart to urge the anterior native leaflet towards the body of the prosthetic heart valve.

Abstract: A prosthetic heart valve includes a self-expanding wire frame body, a valve disposed in the body, a leaflet clip coupled to the body, and a control element operably coupled to the leaflet clip. The body has a proximal end and a distal end. The leaflet clip is configured to be transitioned between a first configuration in which the prosthetic valve can be inserted into a heart, and a second configuration in which the leaflet clip is disposed to capture a native valve leaflet between the leaflet clip and the wire frame body when the body is disposed in a native annulus of an atrioventricular valve of a heart. The control element extends from the leaflet clip through a ventricle of the heart and out a wall of the ventricle to allow a user to transition the leaflet clip from its first configuration to its second configuration.

Abstract: In some embodiments, a method includes delivering to a native valve annulus (e.g., a native mitral valve annulus) of a heart a prosthetic heart valve having a body expandable from a collapsed, delivery configuration to an expanded, deployed configuration. The method can further include, after the delivering, causing the prosthetic heart valve to move from the delivery configuration to the deployed configuration. With the prosthetic heart valve in its deployed configuration, an anchor can be delivered and secured to at least one of a fibrous trigone of the heart or an anterior native leaflet of the native valve. With the prosthetic heart valve disposed in the native valve annulus and in its deployed configuration, an anchoring tether can extending from the anchor can be secured to a wall of the heart to urge the anterior native leaflet towards the body of the prosthetic heart valve.

Abstract: An apparatus for collapsing a prosthetic heart valve and retrieving the prosthetic heart valve from a native heart valve annulus includes a delivery tube having a lumen therethrough and a retrieval device extendable from the lumen. The retrieval device includes a first shaft including a plurality of first arms selectively moveable between a collapsed condition and an expanded condition, and a second shaft slidable relative to the first shaft, the second shaft including a plurality of second arms selectively moveable between a collapsed condition and an expanded condition. The first and second arms in the expanded condition grasp portions of the prosthetic heart valve, and in the collapsed condition collapse the prosthetic heart valve for removal through the delivery tube.

Abstract: In some embodiments, a method for transfemoral retrieval and/or repositioning of a prosthetic valve implanted within a heart includes inserting a retrieval assembly through a femoral vein and into a heart until a distal end portion of the retrieval assembly is disposed in an atrium of the heart. The prosthetic valve is formed with a shape-memory material. The retrieval assembly includes an outer catheter, a middle catheter, a snare catheter, and a snare member. The snare member is moved distally out of a lumen of the snare catheter and into engagement with an inner frame of the prosthetic valve. The retrieval assembly can invert an outer frame of the prosthetic valve to collapse and retract the valve into a lumen of the retrieval assembly. In some embodiments, a positioning catheter can be inserted through the apex of the heart to assist in positioning and inverting the prosthetic valve.

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: In some embodiments, an apparatus includes a catheter assembly and a handle assembly that can be removably coupled to the catheter assembly. A valve holding tube defines a lumen configured to receive a prosthetic mitral valve in a compressed configuration and can be removably coupled to a distal end portion of the handle assembly. The valve holding tube can be received within a hub of the catheter assembly when coupled to the handle assembly. The actuator when actuated is configured to cause the tensioning unit to travel along a traveler strap of the catheter assembly moving the handle assembly distally such that a distal end of an elongate shaft of the handle assembly moves the prosthetic mitral valve distally out of the valve holding tube and out a distal end of the sheath such that the prosthetic mitral valve is free to move to a biased expanded configuration.

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: A vascular closure device includes an anchor, a suture carrying portion, and at least three needles. The anchor is positionable through a vessel puncture in a vessel wall and operable between expanded and retracted positions. The suture carrying portion is positioned distal of the anchor and configured to carry at least one suture. The needles are operable between an advanced position extending through the vessel wall adjacent to the vessel puncture to connect to the at least one suture, and a retracted position in which the needles position the at least one suture through the vessel wall. The needles and sutures are configurable to close large bore openings in the vessel wall.

Abstract: Apparatus and methods are described herein for use in the delivery and deployment of a prosthetic mitral valve. In some embodiments, after a prosthetic valve has been at least partially delivered from a delivery sheath into the left atrium of a heart, a valve positioning device can be used to engage with and position the prosthetic valve within the mitral annulus. The valve positioning device can include an alignment member configured to engage with a prosthetic valve such that the alignment member can control the distal, proximal, lateral and/or rotational movement of the prosthetic valve. The prosthetic valve can include a tether that can be inserted or threaded through the alignment member such that the alignment member can be moved along the tether into engagement with the prosthetic valve.

Abstract: In some embodiments, a method for transfemoral retrieval and/or repositioning of a prosthetic valve (400) implanted within a heart includes inserting a retrieval assembly through a femoral vein and into a heart until a distal end portion of the retrieval assembly is disposed in an atrium of the heart. The prosthetic valve is formed with a shape-memory material. The retrieval assembly (402) includes an outer catheter (403), a middle catheter (404), a snare catheter (406), and a snare member (415). The snare member is moved distally out of a lumen of the snare catheter and into engagement with an inner frame (440) of the prosthetic valve. The retrieval assembly can invert an outer frame (410) of the prosthetic valve to collapse and retract the valve into a lumen of the retrieval assembly. In some embodiments, a positioning catheter (419) can be inserted through the apex of the heart to assist in positioning and inverting the prosthetic valve.

Abstract: Apparatus and methods are described herein for use in the transvascular delivery and deployment of a prosthetic mitral valve. In some embodiments, an apparatus includes a prosthetic heart valve that includes an inner frame and an outer frame couplable to the inner frame via sutures. The prosthetic heart valve is movable between a first configuration for delivery and a second configuration when implanted in a heart. When in the first configuration, the inner frame can be disposed axially proximal of the outer frame and loosely coupled together via the sutures. When in the second configuration, the inner frame and outer frame are disposed in a nested configuration and can be secured together with the sutures. In some embodiments, the sutures are secured with slip knots. In some embodiments, a delivery device can be used to secure the slip knots and sutures to the prosthetic valve.

Abstract: According to one aspect of the disclosure, a system may include a surgical prosthetic heart valve having a frame, prosthetic leaflets within the frame configured to allow blood to flow through the frame in an antegrade direction but to substantially block blood from flowing through the frame in a retrograde direction, and a cuff configured to be sutured to a native valve annulus of a heart of a patient. The system may include a valve tether having a first end configured to be coupled to the surgical prosthetic heart valve, and an anchor configured to be secured to a ventricular apex of the heart of the patient. The valve tether may include a second end opposite the first end, the second end configured to be operably coupled to the anchor.

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 device 10 for gathering tissue of a heart valve leaflet 2 may include an outer tube 16 extending in an elongation direction, a capture tool 22 moveable in the outer tube between a contained position and a use position, and a tissue securing component 32 disposed at a distal end 17 of the outer tube and adapted to be applied to tissue 8 captured by the capture tool to hold the captured tissue in a gathered configuration. The capture tool may include a first element 20 and a second element 22 that are moveable relative to one another in the elongation direction. The first and second elements 20, 22 may be operable to capture tissue 8 of the heart valve leaflet 2 therebetween and to draw the captured tissue into the outer tube 16 in the gathered configuration.

Abstract: Apparatus and methods are described herein for use in the delivery and deployment of a prosthetic mitral valve into a heart. In some embodiments, an apparatus includes a catheter assembly, a valve holding tube and a handle assembly. The valve holding tube is releasably couplable to a proximal end portion of the catheter assembly and to a distal end portion of the handle assembly. The handle assembly includes a housing and a delivery rod. The delivery rod is configured to be actuated to move distally relative to the housing to move a prosthetic heart valve disposed within the valve holding tube out of the valve holding tube and distally within a lumen of the elongate sheath of the catheter assembly. The catheter assembly is configured to be actuated to move proximally relative to the housing such that the prosthetic valve is disposed outside of the lumen of the elongate sheath.