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: A prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration can include an annular frame including a plurality of angled strut members, a plurality of leaflets disposed within the frame and secured to the frame, a valve component sutured to a leaflet of the plurality of leaflets and extending along an edge portion of the leaflet adjacent at least one strut member of the plurality of strut members, and a suture threaded around the valve component and extending generally in a direction along a longitudinal axis of the at least one strut member to secure the valve component and the leaflet to the at least one strut member.

Abstract: Described herein are annular frames for prosthetic heart valves that include commissure portions that are radially offset and/or are radially flexible relative to the rest of the frame. The commissure portions can extend radially outwardly from the rest of the frame such that they are positioned at a greater radius than the adjacent struts of the frame. The commissure portions can be cantilevered from the frame, such that only one axial end of the commissure portion is attached to the rest of the frame, allowing the commissure portions to flex radially inwardly and outwardly relative to the rest of the frame. Lateral arms can also couple upper ends of the commissure portions to adjacent apices to pull them in at larger diameters. The radial position of the commissure portions relative to the rest of the frame can affect the positioning of the leaflets and the effectiveness of the valve.

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: 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: An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration includes an annular frame including a plurality of angled strut members, a plurality of leaflets disposed within the frame and secured to the frame, and a skirt member secured to the frame. The skirt member is disposed about an edge portion of a leaflet of the plurality of leaflets, and the skirt member includes a plurality of extension portions wrapped around at least one strut member. A cord member is threaded through at least a portion of the plurality of extension portions in a direction along an axis of the at least one strut member to secure the skirt member to the at least one strut member.

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: A medical balloon sensing assembly constituted of: a handle; a first catheter extending distally from the handle; an inflatable medical balloon, the inflatable medical balloon secured by the first catheter; at least one sensor position member; and at least one sensor secured to the at least one sensor position member, wherein the at least one sensor position member is arranged to contact an outer face of the inflatable medical balloon.

Abstract: A system can include a delivery catheter comprising a balloon and an implantable prosthetic heart valve. The prosthetic valve can have a plastically expandable and compressible unitary frame comprising first, second, and third rows of angled struts that define two circumferentially extending rows of diamond-shaped cells that extend continuously around the frame, and a valvular structure comprising a plurality of leaflets. A cusp edge portion of each leaflet is connected to the frame by a skirt that is connected to and disposed between the frame and the cusp edge portions of the leaflets, the skirt being connected to consecutive struts in the first, second, and third rows of struts with sutures. The compressed prosthetic heart valve can be mounted around the balloon and radially expanded to the expanded configuration with the balloon inside a patient's body.

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, and more particularly, to 3D-shaped skirts having various coatings and/or configurations thereof.

Abstract: A system can include a delivery catheter comprising a balloon and an implantable prosthetic heart valve. The prosthetic valve can have a plastically expandable and compressible unitary frame comprising a plurality of circumferentially extending rows of angled struts, including first, second, and third rows of angled struts forming rows of diamond-shaped cells, and a valvular structure comprising a plurality of leaflets. A cusp edge portion of each leaflet is connected to the frame by a skirt that is disposed between the frame and the cusp edge portions, the skirt being sutured to selected struts of the frame along diagonal paths extending from an inflow end portion toward an outflow end portion. Each diagonal path along which the skirt is sutured to the frame extends along the first, second, and third rows of angled struts.

Abstract: A prosthetic heart valve can include a radially expandable and compressible frame having an inflow end, an outflow end, and a plurality of struts. The prosthetic valve can further include a valvular structure comprising a plurality of leaflets, each leaflet comprising a coaptation edge portion and a cusp edge portion. The cusp edge portion of each leaflet can be folded toward the outflow end of the frame along a bending axis and a reinforcing member extends along an outflow surface of the cusp edge portion along the bending axis. The prosthetic heart valve can include a plurality of connecting skirts, each disposed between the cusp edge portion of an adjacent leaflet and the frame. First stitching secures the reinforcing member and the connecting skirts to the cusp edge portions and second stitching secures the connecting skirts to selected struts of the frame.

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 sealing member for a prosthetic heart valve includes an annular fabric body having a first circumferential portion and a second circumferential portion. The first circumferential portion extends circumferentially around the annular fabric body and is resiliently stretchable in a direction along the longitudinal axis of the annular fabric body between an expanded configuration of the prosthetic heart valve and a collapsed configuration of the prosthetic heart valve. The second circumferential portion extends around the annular fabric body and is circumferentially offset from the first circumferential portion, the second circumferential portion being resiliently stretchable in a circumferential direction between the collapsed configuration of the prosthetic heart valve and the expanded configuration of the prosthetic heart valve.

Abstract: The present invention relates to implantable prosthetic devices, such as prosthetic heart valves, provided with a plurality of protective covers over various components of the frame or commissural support members of the valves.

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.