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: 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: 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 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.

Abstract: An implantable prosthetic device can include a hybrid frame movable between a radially compressed configuration and a radially expanded configuration. The hybrid frame can include a mechanically-expandable first sub-frame comprising a plurality of struts pivotably coupled to one another, and a plastically deformable second sub-frame coupled to the first sub-frame. When the hybrid frame is in the expanded configuration, the second sub-frame can be configured to resist radial compression of the frame.

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: Various examples of prosthetic heart valves, delivery apparatus, and methods of using such are disclosed herein. The prosthetic heart valves comprise frames that are movable between a radially-compressed configuration and one or more radially-expanded configurations. 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: In one embodiment, a prosthetic valve assembly includes an annular frame being radially expandable and compressible between a radially compressed configuration and a radially expanded configuration, a valvular structure comprising a plurality of leaflets mounted inside the annular frame, a plurality of posts mounted on an interior surface of the annular frame, and a pair of commissure attachment members extending outwardly from each post and away from each other. Each two adjacent leaflets can form a pair of commissure tabs. Each pair of commissure tabs can be attached to a corresponding pair of the commissure attachment members.

Abstract: The present invention relates to implantable prosthetic devices, and more particularly, to 3D-shaped skirts having various coatings and/or configurations thereof.

Abstract: Embodiments of a prosthetic heart valve are disclosed. An implantable prosthetic valve may be radially collapsible to a collapsed configuration and radially expandable to an expanded configuration. The prosthetic valve may comprise an annular frame, a leaflet structure positioned within the frame and a plurality of outer skirts positioned around an outer surface of the frame, each outer skirt comprising an inflow edge secured to the frame and an outflow edge secured at intervals to the frame. The plurality of outer skirts may include a first outer skirt and a second outer skirt, wherein in the expanded configuration the first and second outer skirts include openings unsecured to the frame between the intervals. The inflow edge of the first annular outer skirt may be secured to the frame with sutures including radiopaque material. The first annular outer skirt may include radiopaque dye.

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: 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: Embodiments of a prosthetic heart valve are disclosed. An implantable prosthetic valve may be radially collapsible to a collapsed configuration and radially expandable to an expanded configuration. The prosthetic valve may comprise an annular frame, a leaflet structure positioned within the frame and a plurality of outer skirts positioned around an outer surface of the frame, each outer skirt comprising an inflow edge secured to the frame and an outflow edge secured at intervals to the frame. The plurality of outer skirts may include a first outer skirt and a second outer skirt, wherein in the expanded configuration the first and second outer skirts include openings unsecured to the frame between the intervals. The inflow edge of the first annular outer skirt may be secured to the frame with sutures including radiopaque material. The first annular outer skirt may include radiopaque dye.

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 for improving leaflet prolapse and/or valve regurgitation associated with a heart valve involves delivering a spacer device into a ventricle of a heart using a delivery system comprising a catheter, fixing the spacer device to a wall of the ventricle, expanding the spacer device to reposition a papillary muscle disposed in the ventricle away from the wall, the papillary muscle being connected to a leaflet of an atrioventricular heart valve via chordae tendineae, and releasing the spacer device from the catheter.

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: An implantable prosthetic device can include a radially expandable and compressible frame including an inflow end portion and an outflow end portion. The frame can include an expansion and locking mechanism comprising a member having a first set of lateral extensions disposed adjacent an outflow end and a second set of lateral extensions axially spaced from the first set, each lateral extension comprising a bore extending into the lateral extension. The frame can further comprise a commissure attachment member having a first set of arms each extending into a respective inner bore of the first set of lateral extensions and a second set of arms each extending into a respective inner bore of the second set of lateral extensions such that the commissure attachment member is restrained from movement relative to the expansion and locking mechanism in the radial and axial directions.

Abstract: A prosthetic valve includes a radially expandable and compressible annular frame and a valvular structure. The frame includes a first strut and an adjacent second strut that overlap at a pivot joint. Radial expansion or compression of the frame causes the first strut to pivot relative to the second strut at the pivot joint. The valvular structure includes first and second leaflets attached to the first and second struts with a suture. The first and second struts define four strut segments connected by the pivot joint. The suture comprises three interconnected locking knots that are respectively attached to three of the four strut segments.

Abstract: An implantable prosthetic device can include a hybrid frame movable between a radially compressed configuration and a radially expanded configuration. The hybrid frame can include a mechanically-expandable first sub-frame comprising a plurality of struts pivotably coupled to one another, and a self-expanding second sub-frame coupled to the first sub-frame. When the hybrid frame is in the expanded configuration, the second sub-frame can be configured to resist radial compression of the frame.

Abstract: An expansion and locking mechanism for a prosthetic valve and associated methods are disclosed. As one example, an expansion and locking mechanism for an implantable prosthetic device can include a first member coupled to a frame of the device and including at least one extension member extending in a circumferential direction and having a free end biased radially inward, into an interior of the first member and a second member coupled to the frame at a second location spaced apart from the first location, the second member extending at least partially inside the first member and comprising a plurality of radial extensions spaced apart from one another along a portion of a length of the second member, the plurality of radial extensions arranged in a first side of the second member that is arranged opposite a second side of the second member, the second side not including any radial extensions.