Abstract: A prosthetic heart valve can include an outer support assembly, an inner valve assembly, which define between them an annular space, and a pocket closure that bounds the annular space to form a pocket in which thrombus can be formed and retained. Alternatively, or additionally, the outer support assembly and the inner valve assembly can be coupled at the ventricle ends of the outer support assembly and the inner valve assembly, with the outer support assembly being relatively more compliant in hoop compression in a central, annulus portion than at the ventricle end, so that the prosthetic valve can seat securely in the annulus while imposing minimal loads on the inner valve assembly that could degrade the performance of the valve leaflets.

Abstract: This invention relates to the design and function of a compressible valve replacement prosthesis, collared or uncollared, which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve.

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: 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: This invention relates to the design and function of a compressible valve replacement prosthesis, collared or uncollared, which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve.

Abstract: A prosthetic heart valve system includes a prosthetic heart valve, an anchor, a tether, and a tensioning member. The prosthetic heart valve has an expandable stent and a prosthetic valve assembly disposed within the stent. The anchor is adapted to be disposed on or adjacent an epicardial surface of a heart of a patient. The tether has a first end coupled to the anchor and a second end coupled to the prosthetic heart valve. The tensioning member is disposed along an intermediate portion of the tether between the first end of the tether and the second end of the tether, the tether forming a loop around the tensioning member. The tensioning member is adjustable to increase or decrease a size of the loop to change an effective length of the tether between the prosthetic heart valve and the anchor.

Abstract: A prosthetic heart valve can include an outer support assembly, an inner valve assembly, which define between them an annular space, and a pocket closure that bounds the annular space to form a pocket in which thrombus can be formed and retained. Alternatively, or additionally, the outer support assembly and the inner valve assembly can be coupled at the ventricle ends of the outer support assembly and the inner valve assembly, with the outer support assembly being relatively more compliant in hoop compression in a central, annulus portion than at the ventricle end, so that the prosthetic valve can seat securely in the annulus while imposing minimal loads on the inner valve assembly that could degrade the performance of the valve leaflets.

Abstract: This invention relates to the design and function of a compressible valve replacement prosthesis, collared or uncollared, which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve.

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: A prosthetic heart valve can include an outer frame coupled to an inner frame such that the outer frame can be moved between a first position and a second position in which the outer frame is inverted relative to the inner frame. The inner frame and the outer frame define between them an annular space, and a pocket closure can bound the annular space to form a pocket in which thrombus can form and be retained. The pocket closure can include a stretchable pocket covering that can move from a first position in which the pocket covering has a first length when the outer frame is in the first position relative to the inner frame and a second position in which the pocket covering has a second length greater than the first length when the outer frame is in the second position relative to the inner frame.

Abstract: A system comprising a prosthetic heart valve having a frame, prosthetic leaflets within the frame configured to allow blood to flow through the prosthetic heart valve in an antegrade direction but to substantially block blood from flowing through the prosthetic heart valve in a retrograde direction, an anchor configured to be secured against a ventricular apex of a heart of a patient, a tether coupled to the frame and through the anchor, and an end of the tether configured to extend beyond the anchor when the tether is fixed to the anchor, and a tether adjustment member having a collapsible tube defining an open leading end configured to receive the second end of the tether, and a wire leader extending from a second trailing end of the tube.

Abstract: This invention relates to the design and function of a compressible valve replacement prosthesis, collared or uncollared, which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve.

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 in establishing an improved AV loop with the use of a pulley/snare device at the base of a ventricle of a heart. In some methods described herein, a pulley/snare device is established to create a path with inherent concentricity to the aortic and mitral valves, allowing the valves to function normally during an interventional procedure in the heart, without impeding the motion of any leaflets. The pulley/snare device described herein minimizes the forces that are applied on the valves or associated cardiac tissue to “make the turn” from the aortic valve to the mitral valve.

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: This invention relates to the design and function of a compressible valve replacement prosthesis, collared or uncollared, which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve.

Abstract: Apparatus and methods are described herein for positioning an epicardial anchor device and measuring the load of a tether extending from a prosthetic heart valve and coupled to the epicardial anchor device. In some embodiments, an apparatus includes a handle assembly coupled to an elongate member and a docking member coupled to a distal end of the elongate member. The docking member can be releasably coupled to an epicardial anchor device configured to secure a tether extending from a prosthetic heart valve implanted with a heart at a location on an exterior of a ventricular wall of the heart. A force sensor device is coupled to the handle assembly and can measure a force exerted on the force sensor device. The force is associated with a tension of the tether extending through the elongate member and handle assembly.

Abstract: This invention relates to the design and function of a compressible valve replacement prosthesis, collared or uncollared, which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve.

Abstract: This invention relates to the design and function of a retrieval device for a prosthetic heart valve for re-positioning or removal of a previously implanted valve prosthesis from a beating heart without extracorporeal circulation using a transcatheter retrieval system.

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 (200) having a body (242) 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 anchoring tether (191) extending from the prosthetic heart valve can be secured to a wall (Vw) of the heart (H). An electrode (189) coupled to at least one of the prosthetic heart valve or the anchoring tether can then be used to at least one of pace the heart or sense a signal associated with the heart.