Abstract: Outer skirts for a prosthetic heart valve are disclosed. As one example, a prosthetic heart valve can include an annular frame and an outer skirt disposed around an outer surface of the frame. The outer skirt can include a first portion comprising a polymeric material and a second portion comprising a fabric, where the polymeric material has a greater thromboresistance than the fabric.

Abstract: Outer skirts for prosthetic heart valve are disclosed. As one example, a prosthetic heart valve can include an annular frame comprising a plurality of interconnected struts, the plurality of interconnected struts comprising a plurality of axially extending window struts forming a plurality of commissure windows spaced apart around the frame, and an outer skirt disposed around an outer surface of the frame. The outer skirt includes a first edge portion arranged at a first end of the frame, a second edge portion arranged at an intermediate portion of the frame, and one or more extension portions extending axially from the second edge portion and over at least a portion of a respective commissure window of the plurality of commissure windows.

Abstract: A prosthetic heart valve can include a radially expandable and compressible annular frame, a valvular structure, and a commissure cover. The frame can include a plurality of struts defining the annular frame, and a plurality of commissure support structures each defining a commissure opening positioned along a circumference of the annular frame. The valvular structure can be mounted within the frame, the valvular structure including a plurality of commissures each extending radially through a respective commissure opening to attach the valvular structure to the frame, each commissure having an outflow edge that extends from a radial outer surface of the frame. The commissure cover can be disposed at least partially over the outflow edge of the commissure and can define a ramped surface that extends from the radial outer surface of the frame to a radial outer surface of the 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: 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: Sealing members for an outer skirt of a prosthetic heart valve are disclosed. As one example, a prosthetic heart valve can include an annular frame, a plurality of leaflets arranged within an interior of the frame, and an outer skirt disposed around an outer surface of the frame. The outer skirt can comprise at least one folded portion and stitches extending through the folded portion to form a radially protruding rib.

Abstract: A prosthetic heart valve includes an annular frame including a plurality of strut members, the frame being 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 including a plurality of leaflets, each leaflet having opposing commissure tab portions on opposite sides of the leaflet, each commissure tab portion being paired with an adjacent commissure tab portion of an adjacent leaflet to form a commissure, the commissure tab portions of each leaflet being folded such that each commissure tab portion forms a plurality of layers. A reinforcement member of a plurality of reinforcement members is positioned between the layers of each commissure tab portion. Each commissure tab portion of each leaflet is positioned entirely within the frame.

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: Embodiments of a radially collapsible and expandable prosthetic heart valve and method for crimping the prosthetic heart valve are disclosed. A method of radially compressing a prosthetic valve can include partially inserting the valve while in a radially expanded configuration into a crimping device comprising crimper jaws, wherein a portion of the valve comprising an outer skirt extends outside of the crimper jaws. The method can further include crimping the valve to a first partially collapsed configuration, further inserting the valve into the crimping device, such that the outer skirt is between the crimper jaws, and crimping the valve to a second partially collapsed configuration, wherein a diameter of the valve is smaller in the second partially collapsed configuration than in the first partially collapsed configuration.

Abstract: A prosthetic heart valve including an annular frame and one or more detachable outer skirts and methods associated therewith. The frame has one or more outer skirts releasbly attached to an exterior surface of the frame. In some examples, an outer skirt is attached to the frame via at least one retaining suture formed by stitches looped around a pull suture and struts of the frame. Portions of the outer skirt are captured between the pull suture and the exterior surface of the frame along a suture line. Removal of the pull suture from the suture line enables the outer skirt and frame to separate as the stitches are pulled through openings in the outer skirt. In some examples, outer skirts can be releasably attached to the frame via bioresorbable couplers. Removability of the outer skirts can facilitate improvements in implant and explant procedures of the prosthetic valves.

Abstract: A prosthetic heart valve including a plurality of leaflets attached to the frame is disclosed. The plurality of leaflets is disposed within the frame and configured to regulate the flow of blood through the frame in one direction, each leaflet comprising a cusp edge portion. The prosthetic heart valve can further include at least one suture extending along a cusp edge portion of at least a first leaflet of the plurality of leaflets, a plurality of in-and-out stitches extending through the suture and the cusp edge portion of the first leaflet, and a plurality of whip stitches that extend around selected struts of the frame and the suture to couple the cusp edge portion of the first leaflet to the frame.

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: A method is provided for pre-stretching implantable biocompatible materials, such as material to be incorporated into an implantable device. A sheet of implantable biocompatible material is attached to one or more tensioning members, where tension is applied along one or more axes. Tension is applied for a period of time, and at an appropriate force, to produce a desired degree of thinning or pre-stretching of the implantable biocompatible material. During the tensioning, the implantable biocompatible material is maintained at an elevated temperature, such as a temperature that is at least substantially a temperature of an environment into which the material will be implanted.

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: A prosthetic valve includes an annular frame and a valvular structure mounted within the annular frame. The valvular structure comprises a plurality of leaflets defining a plurality of commissures coupled to the annular frame. Each leaflet includes a leaflet free edge that is offset in a downstream direction from the commissures by side edges that are not attached to the frame. A material portion of the leaflet disposed between the side edges contributes a material slack that extends a radial reach of the leaflet free edge for coaptation. The prosthetic valve can be releasably coupled to a delivery device to form a delivery apparatus. The prosthetic valve can be delivered to a selected implantation site by the delivery apparatus and released at the implantation site by a handle of the delivery device.

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 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: 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: Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. A prosthetic heart valve includes a valve structure and a frame. The valve structure includes a plurality of leaflets, and the leaflets are configured to move from an open configuration to a closed configuration. The valve structure is coupled to the frame. The frame includes an inflow end, an outflow end, a longitudinal axis extending from the inflow end to the outflow end, and a plurality of struts forming a plurality of rows of cells. Each row of cells extends in a circumferential direction perpendicular to the longitudinal axis. Adjacent cells in a row of cell are coupled together at a junction of the struts defining the adjacent cells, and at least one junction in one row of cells has a shape that is different than at least one other junction of the one row of cells.