Abstract: In some embodiments, a prosthetic valve assembly includes an annular frame being radially expandable and compressible between a radially compressed configuration and a radially expanded configuration, and a valvular structure comprising a plurality of leaflets mounted inside the annular frame. The annular frame includes a plurality of posts. Each post has a pair of commissure attachment members extending away from the post. Each pair of commissure tabs is attached to a corresponding pair of the commissure attachment members.

Abstract: A prosthetic valve can include a radially expandable and compressible frame having a plurality of struts, each strut having a first end, a second end, and a length extending from the first end to the second end. Each strut further including a plurality of recesses disposed on one or more longitudinal edges of the strut and extending into a width of the strut. The prosthetic valve further including a valvular structure disposed within and coupled to the frame, the valvular structure comprising a plurality of leaflets, and a skirt mounted to the frame via one or more sutures. The recesses retain the one or more sutures and prevent the one or more sutures from sliding along the length of the strut.

Abstract: A method of assembling a valvular structure can include folding an upper tab of a first leaflet onto a lower tab of the first leaflet, disposing a first end of a reinforcing member on the upper tab, disposing a commissure member adjacent the lower tab, and coupling the first end of the reinforcing member, the tabs of the first leaflet, and the commissure member to one another. The method can further include folding an upper tab of a second leaflet onto a lower tab of the second leaflet, disposing the second leaflet adjacent the first leaflet such that the commissure member is positioned between the lower tabs, disposing a second end of the reinforcing member on the upper tab of the second leaflet, and coupling the reinforcing member, the upper and lower tabs of the second leaflet, and the commissure member to one another to form a commissure.

Abstract: A method of assembling a valvular structure can include folding an upper tab of a first leaflet onto a lower tab of the first leaflet, disposing a first end of a reinforcing member on the upper tab, disposing a commissure member adjacent the lower tab, and coupling the first end of the reinforcing member, the tabs of the first leaflet, and the commissure member to one another. The method can further include folding an upper tab of a second leaflet onto a lower tab of the second leaflet, disposing the second leaflet adjacent the first leaflet such that the commissure member is positioned between the lower tabs, disposing a second end of the reinforcing member on the upper tab of the second leaflet, and coupling the reinforcing member, the upper and lower tabs of the second leaflet, and the commissure member to one another to form a commissure.

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: For repairing a valve situated between an atrium and a ventricle of a heart of a subject, and having a first leaflet and a second leaflet, apparatus is provided that includes an implant and a delivery tool. The implant includes a flexible patch defining slots along an edge of the patch; a first anchor; and a second anchor. The delivery tool is adapted to transluminally deliver the implant to the heart; and implant the implant in the ventricle by securing the patch against a ventricular surface of the first leaflet by anchoring the first anchor to the first leaflet, and against a ventricular surface of the second leaflet by anchoring the second anchor to the second leaflet, such that (i) chordae of the valve extend through the slots, and (ii) the patch bridges a gap between the first leaflet and the second leaflet. Other embodiments are also disclosed.

Abstract: The present disclosure relates to prosthetic valves that include valvular structures retained between two frames coupled to each other. In an example, the prosthetic valve includes a main frame, an inner frame which is disposed radially inwardly from, and is coupled to, the main frame, and a valvular structure disposed between the main frame and the inner frame. The main frame is movable between a radially compressed state and a radially expanded state. The inner frame comprises a plurality of struts and a plurality of spikes extending from at least some of the plurality of struts. The plurality of spikes are engaged with the valvular structure.

Abstract: A prosthetic valve assembly includes a radially expandable and compressible annular frame. The frame includes a plurality of interconnected struts, which include a plurality of inner struts and a plurality of outer struts. The inner struts overlap adjacent outer struts at a plurality of pivot joints. Radial expansion or compression of the annular frame causes the inner struts to pivot relative to the outer struts at the pivot joints. The assembly also includes a valvular structure having a plurality of leaflets, each leaflet having a cusp edge portion. The assembly further includes one or more leaflet-supporting cords, each having a plurality of anchoring portions and a plurality of suspended portions, each suspended portion extending between two adjacent anchoring portions. The anchoring portions are affixed to respective anchoring features of the frame adjacent the pivot joints. The cusp edge portions of the leaflets are connected to the suspended portions.

Abstract: An implantable device can include a radially expandable frame configured to move between a radially compressed state and a radially expanded state. The frame including a plurality of struts, at least one actuator mechanism configured to compress and expand the frame, and at least one locking mechanism coupled to the actuator mechanism. A first strut and a second strut can be pivotably coupled to one another at a common junction and configured to move toward one another as the frame is compressed and away from one another as the frame is expanded. The first and second struts can have first and second locking features that extend from respective longitudinal side edges of the struts. The locking mechanism can include a locking member configured to extend between and engage the first and second locking features when the frame is expanded to retain the frame in the radially expanded state.

Abstract: A prosthetic valve assembly includes a radially expandable and compressible annular frame. The frame includes a plurality of interconnected struts, which include a plurality of inner struts and a plurality of outer struts. The inner struts overlap adjacent outer struts at a plurality of pivot joints. Radial expansion or compression of the annular frame causes the inner struts to pivot relative to the outer struts at the pivot joints. The assembly also includes a valvular structure having a plurality of leaflets, each leaflet having a cusp edge portion. The assembly further includes one or more leaflet-supporting cords, each having a plurality of anchoring portions and a plurality of suspended portions, each suspended portion extending between two adjacent anchoring portions. The anchoring portions are affixed to respective anchoring features of the frame adjacent the pivot joints. The cusp edge portions of the leaflets are connected to the suspended portions.

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: Assembly methods for installing a leaflet assembly to an expandable frame of a prosthetic heart valve are described. The leaflet assembly comprises a plurality of leaflets coupled together at adjacent tabs, which form respective commissure tab assemblies. The commissure tab assemblies are inserted into corresponding windows of support members of the expandable frame. One or more wedge members are inserted into the commissure tab assembly, e.g., between the adjacent tabs or with the adjacent tabs therebetween, to restrain radial motion of the commissure tab assembly with respect to the window. The window can be a closed window, and the wedge member insertion can be after the commissure tab assembly is inserted into the window. Alternatively, the window can be an open window or channel, and the wedge member insertion can be before the commissure tab assembly is installed in the window.

Abstract: Examples of prosthetic heart valves and frames for use in prosthetic heart valve are disclosed herein. The prosthetic heart valves comprise frames that are movable between a radially compressed configuration and a radially-expanded configuration and comprise a row of inlet cells, a row of outlet cells, and a row of intermediate cells. The frames of the prosthetic heart valves include actuation members and locking mechanisms configured to secure the frame in one or more radially-expanded configurations. In some examples, the actuation members and locking members are integrally formed with the frame. The frames of the prosthetic heart valves can be coupled to one or more shafts of a delivery apparatus via a threaded connection or a non-threaded connection.

Abstract: A prosthetic device, such as a prosthetic heart valve, can include a radially compressible and expandable frame and a screw actuator that is coupled to the frame and configured to be rotated to radially expand the frame from a radially compressed state to a first radially expanded state. The frame includes an over-expansion structure that is configured to allow relative sliding movement between the screw actuator and the frame in a longitudinal direction to permit the frame to radially expand from the first radially expanded state to a second radially expanded state when an external expansion force applied to the prosthetic heart valve exceeds a predetermined force.

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 prosthetic heart valve comprises a radially expandable frame comprising an outflow end and an inflow end, and a plurality of valve leaflets disposed within and coupled to the frame. Each leaflet comprises a main body having an outflow edge portion and an inflow edge portion, wherein the leaflets are configured to move between an open state and a closed state in which the outflow edge portions coapt with each other and block the flow of blood through the frame from the outlet end to the inlet end, wherein the inflow edge portion of each leaflet includes a movable portion that can move radially inwardly when the leaflets move to the closed state to assist with the coaptation of the outflow edge portions of the leaflets and radially outwardly when the leaflets move to the open state.

Abstract: Assembly methods for installing a leaflet assembly to an expandable frame of a prosthetic heart valve are described. The leaflet assembly comprises a plurality of leaflets coupled together at adjacent tabs, which form respective commissure tab assemblies. The commissure tab assemblies are inserted into corresponding windows of support members of the expandable frame. One or more wedge members are inserted into the commissure tab assembly, e.g., between the adjacent tabs or with the adjacent tabs therebetween, to restrain radial motion of the commissure tab assembly with respect to the window. The window can be a closed window, and the wedge member insertion can be after the commissure tab assembly is inserted into the window. Alternatively, the window can be an open window or channel, and the wedge member insertion can be before the commissure tab assembly is installed in the window.

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: A skirt for an implantable prosthetic device can include an annular fabric matrix radially expandable from a radially compressed configuration to a first diameter upon application of a radially outwardly directed force via the implantable prosthetic device, and a plurality of frangible restriction filaments embedded in the fabric matrix. Each restriction filament can have a selected maximum diameter different from that of at least one of the other restriction filaments, and each restriction filament can break when a radially outwardly directed force applied to the restriction filament exceeds a predetermined threshold.

Abstract: A prosthetic heart valve includes an annular frame that is movable between a radially expanded state and a radially compressed state. The prosthetic heart valve includes one or more compliant actuators coupled to the annular frame. Each compliant actuator is configured to produce radial expansion of the annular frame and retain the annular frame in the radially expanded state. The prosthetic heart valve can be coupled to a handle of a delivery apparatus for delivery to an implantation site.