Abstract: A method can comprise deploying a prosthetic valve with a delivery apparatus, where the prosthetic valve comprises a frame and a rotatable screw connected to the frame, and where the screw comprises a screw head having an annular bore with internal threads. The delivery apparatus is releasably coupled to the screw and can comprise a first shaft and a first head disposed at an end of the first shaft, the first head comprising external threads releasably engaged with the internal threads of the screw head, and a second shaft that is coaxial with and surrounds the first shaft, the second shaft comprising a second head disposed at an end of the second shaft, the second head releasably engaged with an exterior surface of the screw head. Deploying the valve includes radially expanding the prosthetic valve by rotating the screw with the delivery apparatus.

Abstract: A delivery apparatus including a measurement device to monitor the real-time diameter of a prosthetic heart valve can include a handle, at least one first actuator extending from the handle and being configured to apply a distally directed force to a proximal end portion of a prosthetic heart valve, at least one second actuator extending from the handle and being configured to apply a proximally directed force to a distal end portion of a prosthetic heart valve, a sensor, and first and second motion-transmitting members coupled to the first and second actuators, respectively, and having proximal ends coupled to the sensor, wherein the sensor senses relative movement between the motion-transmitting members upon actuation of the first and second actuators to determine the diameter of the prosthetic heart valve as it expands from a radially compressed configuration to a radially expanded configuration.

Abstract: A delivery apparatus for implanting a prosthetic valve is disclosed. The prosthetic valve can comprise a mechanically actuatable frame comprising at least one actuator member, the actuator member configured to be rotated to radially expand or compress the frame. The delivery apparatus can comprise at least one actuator assembly configured to actuate the actuator member of the prosthetic valve, the actuator assembly comprising an outer sleeve member having a lumen and an inner driver member coaxially disposed within the lumen of the sleeve member, the driver member being rotatable relative to the sleeve member, wherein the actuator assembly is configured to be transitioned between an engaged state and a disengaged state with the prosthetic valve, and wherein the driver member is configured to be selectively magnetically coupled to the actuator member in the engaged state.

Abstract: An implantable prosthetic device can include a frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration. The frame can have a first set of a plurality of struts extending in a first direction, and a second set of a plurality of struts extending in a second direction, and each strut of the first set of struts can be pivotably connected to at least one strut of the second set of struts. Each strut can be curved helically with respect to a first, longitudinal axis of the frame, and each strut can be curved with respect to a second axis that is perpendicular to the first, longitudinal axis of the frame.

Abstract: A method of treating a deficient native mitral valve of a heart of a patient includes advancing a steerable, first catheter through the patient's vasculature, advancing the distal end portion of the first catheter into the heart to position the distal end portion of the first catheter adjacent the native mitral valve, adjusting the curvature of the distal end portion of the first catheter to form a first curve, advancing a distal end portion of a second catheter from a distal end of the first catheter, wherein the distal end portion of the second catheter is pre-shaped to form a second curve when advanced from the first catheter, and deploying a wire from the second catheter such that the wire extends around native leaflets of the native mitral valve.

Abstract: A crimping device includes a housing and a crimping band. The housing has a lumen and one or more band openings, wherein the lumen is configured to receive a prosthetic heart valve therein. The crimping band is adjustably coupled to the housing and comprises a first end portion, a second end portion, and a loop. The first end portion is coupled to the housing, and the second end portion extends through the one or more band openings. The loop of the crimping band is disposed within the lumen of the housing and can be moved between a first configuration and a second configuration. When in the first configuration, the loop of the crimping band has a first diameter and is configured such that the prosthetic heart valve in a radially expanded configuration can be positioned radially within the loop.

Abstract: A crimping device includes a housing and a crimping band. The housing has a lumen for receiving a prosthetic valve. The crimping band is adjustably coupled to the housing and has a first end portion, a second end portion, and a loop. The loop of the crimping band is disposed within the lumen and move between first and second configurations. In the first configuration, the loop has a first diameter and is configured such that the prosthetic valve in a radially expanded configuration can be positioned radially within the loop. In the second configuration, the loop has a second diameter and is configured to apply a radial force on the prosthetic valve to move the prosthetic valve to a radially compressed configuration. The loop of the crimping band is configured to contact less than half of an axial length of the prosthetic valve.

Abstract: A delivery apparatus for a prosthetic heart valve includes a handle, one or more actuator drivers, and a gearbox disposed within the handle and coupled to rotate the actuator drivers relative to the handle. The gearbox can include a counter-rotation gear train that can be operated to rotate two sets of actuator drivers in opposite directions. One or more of the actuator drivers can have an associated torque limiter that prevents overloading of the actuator driver. The gearbox can be pivotably mounted within the handle. The gearbox can be configured to engage a stop member within the handle to limit pivoting of the gearbox in a predetermined direction. The handle can include a sensor that is positioned to measure torque applied to the prosthetic heart valve while rotating the actuation drivers.

Abstract: Method and devices for displacing leaflets of an existing valvular structure at an aortic valve position away from coronary ostia of an aorta are disclosed. An example method can include implanting a prosthetic heart valve within a native valve or previously implanted heart valve such that a commissure of the prosthetic heart valve is circumferentially aligned with a mid-portion of a leaflet of the native or previously implanted heart valve. The method further includes, during radially expanding the prosthetic heart valve into the native or previously implanted heart valve, applying pressure to the mid-portion of the leaflet with the commissure such that the leaflet is displaced away from the commissure and toward an inflow end of the prosthetic heart valve.

Abstract: An assembly can comprise a prosthetic valve comprising a radially expandable and compressible frame and a rotatable screw connected to the frame, where the screw comprises a screw head having an annular bore with internal threads, and where the screw is rotatable to radially expand the frame. The assembly further comprises a delivery apparatus releasably coupled to the screw, the delivery apparatus comprising a first shaft and a first head disposed at an end of the first shaft, the first head comprising external threads configured to engage with the internal threads of the screw head, and a second shaft that is coaxial with and surrounds the first shaft, the second shaft comprising a second head disposed at an end of the second shaft. The second head is configured to releasably engage with an exterior surface of the screw head and rotate the screw.

Abstract: A replacement valve prosthesis includes a support structure and a valve body having three flexible leaflets. The support structure preferably includes an internal valve frame and an external sealing frame. The valve frame supports the flexible leaflets. The sealing frame is adapted to conform to the shape of the native heart valve annulus. The sealing frame may be coupled to an inlet end of the valve frame, an outlet end of the valve frame, or both. A plurality of anchors is coupled to the outlet end of the valve frame. The anchors extend radially outwardly for placement behind native leaflets. The prosthesis preferably includes a skirt disposed along an exterior of the external sealing frame. The prosthesis is collapsible for delivery into the heart via a delivery catheter. The prosthesis is configured to self-expand for deployment in the heart when released from the delivery catheter.

Abstract: A method can comprise deploying a prosthetic valve with a delivery apparatus, where the prosthetic valve comprises a frame and a rotatable screw connected to the frame, and where the screw comprises a screw head having an annular bore with internal threads. The delivery apparatus is releasably coupled to the screw and can comprise a first shaft and a first head disposed at an end of the first shaft, the first head comprising external threads releasably engaged with the internal threads of the screw head, and a second shaft that is coaxial with and surrounds the first shaft, the second shaft comprising a second head disposed at an end of the second shaft, the second head releasably engaged with an exterior surface of the screw head. Deploying the valve includes radially expanding the prosthetic valve by rotating the screw with the delivery apparatus.

Abstract: This disclosure is directed to self-expanding prosthetic heart valves having resistance-based mechanisms to control the rate of self-expansion of the prosthetic heart valves. In some examples, the prosthetic heart valve can be configured to radially self-expand to a partially radially expanded state, and can then be further radially expanded to the radially expanded state and/or locked in the radially expanded state by pulling an actuation member of the expansion and locking assembly. In other examples, the prosthetic heart valve can be configured to self-expand from the radially compressed state to the fully radially expanded state without mechanical actuation. In some examples, the resistance-based expansion control mechanisms can be disposed between delivery system actuators and valve frame components. In other examples, the resistance-based expansion control mechanisms can be disposed between delivery system actuators and other components of the delivery system.

Abstract: In one embodiment, a delivery apparatus handle, such as for a mechanical heart valve frame can comprise an actuation knob with a toggle mechanism that can toggle the actuation knob from a first state in which the actuation knob is operable to cause the linear or rotational movement of multiple elements or sets of elements, such as tubes that are attached to, e.g., a mechanical heart valve frame to cause expansion or collapsing of the frame, to a second state in which only a single element or set of elements is moved, allowing for additional operations, such as, e.g., locking the frame and/or releasing it from the delivery apparatus.

Abstract: Devices, systems and methods are described herein to provide improved steerability for delivering a prosthesis to a body location, for example, for delivering a replacement mitral valve to a native mitral valve location. The delivery system can include a number of advantageous steering and delivery features, in particular for the transseptal delivery approach.

Abstract: A method of treating a deficient native mitral valve of a heart of a patient includes advancing a steerable, first catheter through the patient's vasculature, advancing the distal end portion of the first catheter into the heart to position the distal end portion of the first catheter adjacent the native mitral valve, adjusting the curvature of the distal end portion of the first catheter to form a first curve, advancing a distal end portion of a second catheter from a distal end of the first catheter, wherein the distal end portion of the second catheter is pre-shaped to form a second curve when advanced from the first catheter, and deploying a wire from the second catheter such that the wire extends around native leaflets of the native mitral valve.

Abstract: Methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve are provided. For example, a support member is positioned to at least partially surround the native leaflets of a valve. A locking member is used to couple both ends of the support member, forming a support band. An expandable prosthetic heart valve is delivered into the native heart valve and expanded while the expandable prosthetic valve is at least partially within the support band, thereby causing one or more of the native leaflets of the native heart valve to be frictionally secured between the support band and the expanded prosthetic heart valve.

Abstract: In one embodiment, a delivery apparatus handle, such as for a mechanical heart valve frame can comprise an actuation knob with a toggle mechanism that can toggle the actuation knob from a first state in which the actuation knob is operable to cause the linear or rotational movement of multiple elements or sets of elements, such as tubes that are attached to, e.g., a mechanical heart valve frame to cause expansion or collapsing of the frame, to a second state in which only a single element or set of elements is moved, allowing for additional operations, such as, e.g., locking the frame and/or releasing it from the delivery apparatus.

Abstract: A method of treating a deficient native mitral valve of a heart of a patient includes advancing a steerable, first catheter through the patient's vasculature, advancing the distal end portion of the first catheter into the heart to position the distal end portion of the first catheter adjacent the native mitral valve, adjusting the curvature of the distal end portion of the first catheter to form a first curve, advancing a distal end portion of a second catheter from a distal end of the first catheter, wherein the distal end portion of the second catheter is pre-shaped to form a second curve when advanced from the first catheter, and deploying a wire from the second catheter such that the wire extends around native leaflets of the native mitral valve.

Abstract: A method of treating a deficient native mitral valve of a heart of a patient includes advancing a steerable, first catheter through the patient’s vasculature, advancing the distal end portion of the first catheter into the heart to position the distal end portion of the first catheter adjacent the native mitral valve, adjusting the curvature of the distal end portion of the first catheter to form a first curve, advancing a distal end portion of a second catheter from a distal end of the first catheter, wherein the distal end portion of the second catheter is pre-shaped to form a second curve when advanced from the first catheter, and deploying a wire from the second catheter such that the wire extends around native leaflets of the native mitral valve.