Abstract: A prosthetic valve has an annular frame including a plurality of strut members that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration. A leaflet structure is situated at least partially within the frame. The leaflet structure includes a plurality of leaflets, each leaflet having opposing commissure tab portions on opposite sides of the leaflet. Each commissure tab portion is paired with an adjacent commissure tab portion of an adjacent leaflet to form a commissure. The commissure tab portions of each leaflet are folded to form a plurality of layers positioned on the inside of the frame. A reinforcement member is positioned between the layers of each commissure tab portion.

Abstract: Embodiments of a prosthetic valve delivery apparatus are disclosed. The delivery apparatus includes a first portion configured to maintain a fixed spatial relationship relative to a first end of the prosthetic valve and a second portion configured to maintain a fixed spatial relationship relative to a second end of the prosthetic valve during radial expansion of the prosthetic valve. The first portion includes one or more reference radiopaque markers and the second portion includes an indicator radiopaque marker. A position of the indicator radiopaque marker relative to the one or more reference radiopaque markers measures an axial distance between the first and second ends of the prosthetic valve indicative of a corresponding diameter of the prosthetic valve as it is radially expanded from a radially compressed state to a radially expanded state.

Abstract: A prosthetic heart valve includes an annular frame including a plurality of strut members that is radially collapsible and expandable. A leaflet structure is situated within the frame, and includes a plurality of leaflets having opposing commissure tab portions on opposite sides of the leaflet. Each commissure tab portion is paired with an adjacent commissure tab portion of an adjacent leaflet to form one or more commissures. A commissure support element is positioned at each of the commissures, and comprise a first member and a second member that are separable from each other and configured to receive leaflets therebetween. The first and second members are detached from the frame and spaced radially inwardly from the frame such that the members contact the leaflets radially inward from the frame and limit movement of the leaflets so that they articulate at a location that is spaced radially inwardly from the frame.

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 radially expandable prosthetic valve can comprise an annular frame, at least one expansion mechanism and a cord. The annular frame can be radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. The expansion mechanism can comprise a first member attached to the frame at a first location and a second member attached to the frame at a second location axially spaced from the first location. The cord can extend at least partially along the expansion mechanism in a first direction, be reeved around a portion of the second member, and extend at least partially along the expansion mechanism in a second direction opposite the first direction. Applying a proximally directed force to a first portion of the cord can cause the second member to move relative to the first member, which can cause the frame to foreshorten axially and expand radially.

Abstract: Embodiments of an implantable prosthetic valve are disclosed. The valve can have an annular frame having a plurality of frame members and a skirt assembly. The skirt assembly can include a laminate having a fabric layer sandwiched between a first covering member and a second covering member. At least one surface of the fabric layer can be exposed at one or more windows in the second covering member. The skirt assembly can be coupled to the annular frame by a suture extending through the fabric layer at the one or more windows and around at least one of the plurality of frame members. Methods for making such an implantable prosthetic valve are also disclosed.

Abstract: In one embodiment, a prosthetic valve can comprise a radially expandable and compressible frame, which can include a plurality of struts which are pivotally joined together without requiring individual rivets. In some embodiments, the struts are interwoven, and can be joined using integral hinges formed in the struts, such as by performing alternate cuts on the struts, bending the struts to form stopper tabs adjacent to joints and/or drilling holes in the struts to facilitate interconnecting struts at joints, or otherwise forming integral hinges and corresponding holes at junction points between the struts. In another embodiment, the frame comprises a plurality of inner struts and outer struts which are connected by a plurality of chains of interconnected rivets, avoiding the need to provide individual rivets at each junction between struts. In still another embodiment, separate hinges or flanged rivets are provided to interconnect the struts.

Abstract: In one embodiment, a method of assembling a prosthetic valve can comprise forming a radially expandable and compressible frame by pivotally joining together a plurality of struts without requiring individual rivets. In some embodiments, the frame is formed by interweaving the struts, which can be joined using integral hinges formed in the struts, such as by performing alternate cuts on the struts, bending the struts to form stopper tabs adjacent to joints and/or drilling holes in the struts to facilitate interconnecting struts at joints, or otherwise forming integral hinges and corresponding holes at junction points between the struts. In other embodiments, separate hinges are provided to interconnect the struts. In still other embodiments, separate flanged rivets are provided to connect the struts.

Abstract: Embodiments of an implantable prosthetic valve are disclosed. The valve can have an annular frame having a plurality of frame members and a skirt assembly. The skirt assembly can include a laminate having a fabric layer sandwiched between a first covering member and a second covering member. At least one surface of the fabric layer can be exposed at one or more windows in the second covering member. The skirt assembly can be coupled to the annular frame by a suture extending through the fabric layer at the one or more windows and around at least one of the plurality of frame members. Methods for making such an implantable prosthetic valve are also disclosed.

Abstract: A prosthetic valve delivery apparatus can comprise a handle, a gearbox, an input torque shaft and a plurality of output torque shafts. The input torque shaft can extend distally from the handle and can have a distal end portion operatively connected to the gearbox. The output torque shafts can be operatively connected to and extend distally from the gearbox. Rotation of the input torque shaft can cause rotation of the output torque shafts via the gear box.

Abstract: In one embodiment, a prosthetic valve can comprise a radially expandable and compressible frame, which can include a plurality of struts which are pivotally joined together without requiring individual rivets. In some embodiments, the struts are interwoven, and can be joined using integral hinges formed in the struts, such as by performing alternate cuts on the struts, bending the struts to form stopper tabs adjacent to joints and/or drilling holes in the struts to facilitate interconnecting struts at joints, or otherwise forming integral hinges and corresponding holes at junction points between the struts. In another embodiment, the frame comprises a plurality of inner struts and outer struts which are connected by a plurality of chains of interconnected rivets, avoiding the need to provide individual rivets at each junction between struts. In still another embodiment, separate hinges are provided to interconnect the struts.

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 prosthetic valve delivery apparatus can comprise a handle, a gearbox, an input torque shaft and a plurality of output torque shafts. The input torque shaft can extend distally from the handle and can have a distal end portion operatively connected to the gearbox. The output torque shafts can be operatively connected to and extend distally from the gearbox. Rotation of the input torque shaft can cause rotation of the output torque shafts via the gear box.

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: A method for delivering a prosthetic valve to a native annulus of a heart can include inserting a delivery apparatus into a patient's body, advancing the delivery apparatus to an implantation location within the native annulus, retracting a delivery sheath of the delivery apparatus relative to the prosthetic valve to expose the prosthetic valve from a distal end of the delivery sheath, and after the prosthetic valve is exposed from the delivery sheath, expanding the prosthetic valve from a radially compressed state to a radially expanded state by reducing axial tension on a first end and a second end 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 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 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: A delivery apparatus for a prosthetic implant can include an elongate first shaft, a first suture guide coupled to the first shaft, an elongate second shaft, and a second suture guide coupled to the second shaft. The first shaft can extend coaxially through the second shaft and the second suture guide, the first suture guide can be disposed distal to the second suture guide, and the first suture guide and the second suture guide can be configured to be axially movable relative to each other.

Abstract: A frame for a prosthetic heart valve includes a plurality of strut members arranged to form an annular main body and coupled together by a plurality of pivot joints. The main body of the frame is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, and the frame has an inflow end and an outflow end. The frame further includes a plurality of leaflet clamps disposed on the exterior of the main body of the frame and coupled to the strut members. The leaflet clamps are movable between an open position corresponding to the collapsed configuration of the frame and a closed position corresponding to the expanded configuration of the frame. Motion of the main body of the frame between the collapsed configuration and the expanded configuration causes corresponding motion of the leaflet clamps between the open position and the closed position.

Abstract: An expandable sheath is disclosed herein, which has a first polymeric layer and a braided layer positioned radially outward of the first polymeric layer. The braided layer includes a plurality of filaments braided together. The expandable sheaths further include a resilient elastic layer positioned radially outward of the braided layer. The elastic layer is configured to apply radial force to the braided layer and the first polymeric layer. The expandable sheath further includes a second polymeric layer positioned radially outward of the elastic layer and bonded to the first polymeric layer such that the braided layer and the elastic layer are encapsulated between the first and second polymeric layers. 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.