Abstract: A heart valve assembly includes an annular prosthesis and a plurality of guide shields removably attached around a circumference of the annular prosthesis. A plurality of elongate guide rails extend from the annular prosthesis, which are releasably retained by the guide shields. During use, the annular prosthesis is directed into a biological annulus, e.g., with the guide rails retained by the guide shields, and secured to tissue surrounding the biological annulus using fasteners. The guide rails are released from the guide shields, and a valve prosthesis is advanced over the leaders and through a passage defined by the guide shields towards the annular prosthesis. The guide rails may include retentions elements that secure the valve prosthesis to the annular prosthesis. The guide shields are removed from the annular prosthesis, the guide rails are separated from the annular prosthesis, and are removed from the biological annulus.

Abstract: Multiple component heart valves and apparatus and methods for implanting them are provided. The heart valve generally includes a first annular prosthesis and a second valve prosthesis. The first prosthesis includes an annular member compressible from a relaxed condition to a contracted condition to facilitate delivery into a biological annulus, the annular member being resiliently expandable towards the relaxed condition. The first prosthesis also includes guide rails extending therefrom. The second prosthesis includes an annular frame, valve elements, and receptacles for receiving respective guide rails therethrough when the second prosthesis is directed towards the first prosthesis. In addition, a valve holder may releasably carry the valve prosthesis that includes channels for receiving respective guide rails therethrough when the guide rails are received through the valve prosthesis.

Abstract: Multiple component heart valves and apparatus and methods for implanting them are provided. The heart valve generally includes a first annular prosthesis and a second valve prosthesis. The first prosthesis includes an annular member compressible from a relaxed condition to a contracted condition to facilitate delivery into a biological annulus, the annular member being resiliently expandable towards the relaxed condition. The first prosthesis also includes guide rails extending therefrom. The second prosthesis includes an annular frame, valve elements, and receptacles for receiving respective guide rails therethrough when the second prosthesis is directed towards the first prosthesis. In addition, a valve holder may releasably carry the valve prosthesis that includes channels for receiving respective guide rails therethrough when the guide rails are received through the valve prosthesis.

Abstract: A fastener delivery tool includes a loading chamber for receiving a fastener having a pair of tines overlapping one another to define a loop in a parent or relaxed state. A retaining member retains the fastener in the loading chamber. The fastener delivery tool also includes a tongue, pusher member, and an ejection track communicating with the loading chamber. An actuator causes the tongue to move to engage the tines of the fastener to transform the fastener from the relaxed state to a constrained state defining a U-shape. The actuator also causes the pusher member to release the retaining member and advance the fastener down the ejection track in the constrained state. The tool also includes a trigger for ejecting the fastener completely from the ejection track. The fastener may be used to secure a prosthetic heart valve or components thereof into surrounding tissue, e.g., within a tissue annulus.

Abstract: A heart valve assembly includes a prosthesis and a prosthetic valve to replace a preexisting natural or prosthetic heart valve within a biological annulus. The prosthesis includes an annular member, a flexible core at least partially defining a sewing cuff extending radially outwardly from the annular member, a rail ring disposed between the flexible core and the annular member, and a plurality of guide rails extending from the rail ring through respective openings in the flexible core. A fabric covering covers the prosthesis, and the guide rails extend through respective openings in the fabric covering. The prosthetic valve includes a frame including receptacles for receiving respective guide rails. After implanting the prosthesis within a biological annulus, the prosthetic valve is advanced along the guide rails until retention elements on the guide rails engage the receptacles to secure the prosthetic valve relative to the prosthesis.

Abstract: A fastener delivery tool includes a belt including pairs of features for releasably engaging tines of respective fasteners in a relaxed state defining a loop. The tool includes a loading chamber for receiving a fastener from the belt, a retaining member for limiting movement of the fastener within the loading chamber, an ejection track communicating with the loading chamber, a handle including an actuator, and a tongue and pusher member coupled to the actuator. Activation of the actuator advances the tongue to transform the fastener from the relaxed state to a U-shaped constrained state, and advances the pusher member to direct the fastener from the loading chamber down the ejection track.

Abstract: A valve introducer is provided for delivering a valve prosthesis into a biological annulus. During use, a gasket member is introduced into the biological annulus, and secured relative to the biological annulus. A distal end of a valve introducer is introduced into a passage communicating with the biological annulus, and disposed adjacent the gasket member. A valve prosthesis is advanced through the valve introducer towards the gasket member, and secured to the gasket member. In one embodiment, the valve introducer and valve prosthesis have corresponding shapes, requiring the valve prosthesis to be oriented to properly align the valve prosthesis before advancing the valve prosthesis into the valve introducer. Optionally, the valve introducer is manipulated (e.g., by pivoting at a pivot point) to reduce a profile of the distal end before introduction into the passage, which may facilitate introducing the valve introducer through the passage, e.g., past the sino-tubular junction.

Abstract: A heart valve assembly includes a prosthesis and a prosthetic valve to replace a preexisting natural or prosthetic heart valve within a biological annulus. The prosthesis includes an annular member, a flexible core at least partially defining a sewing cuff extending radially outwardly from the annular member, a rail ring disposed between the flexible core and the annular member, and a plurality of guide rails extending from the rail ring through respective openings in the flexible core. A fabric covering covers the prosthesis, and the guide rails extend through respective openings in the fabric covering. The prosthetic valve includes a frame including receptacles for receiving respective guide rails. After implanting the prosthesis within a biological annulus, the prosthetic valve is advanced along the guide rails until retention elements on the guide rails engage the receptacles to secure the prosthetic valve relative to the prosthesis.

Abstract: A fastener delivery tool includes a belt including pairs of features for releasably engaging tines of respective fasteners in a relaxed state defining a loop. The tool includes a loading chamber for receiving a fastener from the belt, a retaining member for limiting movement of the fastener within the loading chamber, an ejection track communicating with the loading chamber, a handle including an actuator, and a tongue and pusher member coupled to the actuator. Activation of the actuator advances the tongue to transform the fastener from the relaxed state to a U-shaped constrained state, and advances the pusher member to direct the fastener from the loading chamber down the ejection track. The tool may include a trigger for ejecting the fastener completely from the ejection track. The fastener may be used to secure a prosthetic heart valve or components thereof into surrounding tissue, e.g., within a tissue annulus.