Abstract: A prosthetic valve, constituted of: a frame movable between a radially compressed and a radially expanded state; and a plurality of leaflets secured to the frame.

Abstract: Devices, assemblies, and methods for displacement of leaflets surrounding a prosthetic valve, such as native leaflets or host leaflets of a previously-implanted prosthetic valve, during valve implantation procedures are disclosed herein. As one example, a valve assembly can include a prosthetic valve and a leaflet engagement frame coupled to the frame of the prosthetic valve. The leaflet engagement frame can include a plurality of engagement frame struts defining one or more rungs, and a plurality of spikes that extend in a distal direction from a first rung of struts of the leaflet engagement frame. The distally extending spikes are configured to engage with one or more native or host leaflets positioned outside the valve assembly when the valve assembly is in a partially expanded state, and to distally fold the engaged native or host leaflets when the valve assembly is further expanded.

Abstract: A prosthetic heart valve has a frame and a valvular structure supported by the frame. The frame has cells distributed circumferentially around the frame and formed by struts. The struts includes a support arm, which has a fixed end portion extending from an axial end portion of the frame and a free end portion disposed toward an opposite axial end portion of the frame relative to the fixed end portion. The fixed end portion has a rotational position that is rotationally offset relate to that of the free end portion. When the frame is in a radially-compressed configuration, a second locking member of the struts is spaced apart from a first locking member of the free end portion of the support arm. When the frame is in the radially-expanded configuration, the second locking member engages the first locking member, thereby restricting the frame from moving from the radially-expanded configuration.

Abstract: The present invention relates to implantable prosthetic devices, such as mechanically expandable prosthetic heart valves, provided with frames that include more than one type of interconnected struts, wherein each type of struts can extend along a different portion of the frame.

Abstract: A docking device can include a radially expandable and compressible frame and an actuator. The frame can include a first sub-frame having a first plurality of struts pivotably coupled to one another, a second sub-frame having a second plurality of struts pivotably coupled to one another, and one or more linking struts extending from a first end of the frame to a second end of the frame and coupling the first sub-frame and the second sub-frame to one another. The actuator can include a first member coupled to the frame at a first location and a second member coupled to the frame at a second location axially spaced from the first location. The actuator can be used to mechanically expand the docking device.

Abstract: A prosthetic device, such as a prosthetic heart valve, can include a frame that is radially expandable and compressible between a radially compressed state and a radially expanded state. In some examples, the prosthetic device can include locking mechanisms that are configured to hold the prosthetic device in a radially expanded state. In some examples, the locking mechanisms can be integrated into the frame of the prosthetic device.

Abstract: The present invention relates to systems and methods for estimating prosthetic valve expansion diameter, and in particular, for system and methods for analyzing images acquired during prosthetic valve expansion, to identify structural components of the valve, determine dimensions thereof, and estimate at least one outer diameter of the prosthetic valve, and potentially a plurality of outer diameter along different axial positions of the prosthetic valve.

Abstract: The present invention relates to systems, assemblies and methods for estimating prosthetic valve expansion diameter, and in particular, for system and assemblies equipped with at least one sound or vibration sensor configured to provide real-time estimate of prosthetic valve expansion diameter.

Abstract: A prosthetic heart valve has a frame and a valvular structure coupled thereto. The valvular structure has multiple leaflets, with paired tabs from the leaflets forming commissure tab assemblies that couple the valvular structure to the frame. The frame is tapered with its inflow end diameter being smaller than its outflow end diameter. The valvular structure is constructed such that a flow channel formed by the leaflets is also tapered, with the inlet end cross-section being smaller than the outlet end cross-section. The commissure tab assemblies are attached to the frame with leaflet bending axes at or adjacent to the radially-inner surface of the frame. During systole, separation of blood flow induced by the tapered geometry of the flow channel generates an annular back flow region adjacent to the inner surface of the valve at the outflow end, which prevents the free edge of the leaflets from contacting the frame.

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: 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: 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 delivery assembly constituted of: a prosthetic valve comprising a plurality of intersecting struts, and a delivery apparatus comprising: a handle; a delivery shaft extending distally from the handle; and a flex sensing assembly, comprising: at least one flex sensor coupled to at least one of the plurality of struts; and a control unit in communication with the at least one flex sensor, wherein the prosthetic valve is movable between a radially compressed configuration and a radially expanded configuration, and wherein, responsive to an output of the at least one flex sensor, the control unit is configured to generate a signal indicative of a diameter of the prosthetic valve.

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 include a plurality of struts, each strut comprising a first portion and a second portion separated by a deflection point. Each strut can be curved helically with respect to a first, longitudinal axis of the frame. The first portion of each strut can be curved in a first direction with respect to a first line parallel to a second axis that is perpendicular to the first, longitudinal axis of the frame, and the second portion of each strut can be curved in a second direction with respect to a second line parallel to the second axis.

Abstract: The present disclosure relates to devices and methods for measuring expansion diameter, radial force exerted against surrounding tissue, and pressure recovery across prosthetic heart valves, during valve implantation procedures.

Abstract: An implantable prosthetic valve can include a frame movable between a radially compressed and a radially expanded configuration. The frame can include a first strut having a first locking feature disposed on a radially facing inner surface of the strut and a second strut having a second locking feature disposed on a radially facing outer surface of the strut. The first and second locking features can engage each other so as to allow pivoting of the first and second struts relative to one another in a first direction upon radial expansion of the frame and resist pivoting of the first and second struts relative to one another in a second direction to resist radial compression of the frame.

Abstract: Expandable sheaths are disclosed herein. In some embodiments, a braided layer is positioned radially outward from a first polymeric layer. The braided layer includes a plurality of filaments braided together. A second polymeric layer is positioned radially outward of the braided layer, such that the braided layer is encapsulated between the first and second polymeric layers. In some embodiments, a braided layer is adhered to a sealing layer that is impermeable to blood flow. Methods of making and using the devices disclosed herein are also disclosed, as are crimping devices that may be used in methods of making the devices disclosed herein.

Abstract: An assembly can comprise a radially expandable and compressible annular frame, at least one linear actuator assembly coupled to the frame and at least one locking mechanism coupled to the frame. The linear actuator can be configured to apply a distally directed force and/or a proximally directed force to the frame to radially expand or compress the frame. The locking mechanism can comprise a first sleeve member connected to the frame at a first location, a second sleeve member having internal threads and being connected to the frame at a second location, and a first screw configured to engage the internal threads of the second sleeve member to retain the frame in a radially expanded state.

Abstract: An implantable prosthetic device comprises a frame comprising a first set of first struts and a second set of second struts. The first struts are pivotably connected to each other at a plurality of distal and proximal apices at distal and proximal ends of the frame. The second struts are pivotably connected to each other at a plurality of distal and proximal apices at the distal and proximal ends of the frame. The first struts have a first thickness, and the second struts have a second thickness, wherein the first thickness is greater than the second thickness. One or more actuators are coupled only to one or more corresponding pairs of a distal apex and a proximal apex formed by the first struts, wherein the one or more actuators are configured to apply axially directed forces to the frame to radially expand the frame.

Abstract: Docking stations for transcatheter valves are described. The docking stations can include an expandable frame, at least one sealing portion, and a valve seat. The expandable frame can be configured to conform to an interior shape of a portion of the circulatory system when expanded inside the circulatory system. The sealing portion can be configured to contact an interior surface of the circulatory system to create a seal. The valve seat can be connected to the expandable frame and can be configured to support an expandable transcatheter valve. The docking stations are adaptable to different anatomies/locations to allow implantation of a transcatheter valve in a variety of anatomies/locations.