Abstract: A prosthetic valve includes an annular frame with a plurality of inflow apices and a plurality of outflow apices. Each one of the outflow apices can be circumferentially offset from a respective inflow apex. The prosthetic valve can further include a leaflet structure positioned within the frame and secured thereto. The prosthetic valve can further include an outer skirt secured to the frame. The outer skirt can include an upper edge portion disposed around an outer surface of the frame, a lower edge portion wrapped around the inflow apices, and a plurality of creases. Each crease can be circumferentially aligned with a corresponding outflow apex and can extend from the lower edge portion towards the upper edge portion. The inner skirt can be secured to an inner surface of the frame and can include a lower edge portion attached to the lower edge portion of the outer skirt.

Abstract: A prosthetic heart valve includes a frame, a valvular structure, and a skirt. The frame is movable between collapsed and expanded configurations and includes struts disposed between inflow and outflow ends, apices disposed at the inflow end formed by intersections of two or more struts, and junctions disposed between the apices and the outflow end and formed by intersections of two or more struts. The apices are circumferentially offset from the junctions. The valvular structure is positioned within and secured to the frame. The skirt is secured to the frame and includes a first edge portion and a second edge portion. The first edge portion is secured to the frame at the apices. The second edge portion is secured to the frame at the junctions. The skirt is configured to retract inwardly between the apices when the frame is moved from the radially expanded configuration to the radially collapsed configuration.

Abstract: A prosthetic heart valve includes an annular frame that has an inflow end and an outflow end and is radially compressible and expandable between a radially compressed configuration and a radially expanded configuration. The prosthetic heart valve further includes a leaflet structure positioned within the frame and secured thereto, and an outer sealing member mounted outside of the frame and adapted to seal against surrounding tissue when the prosthetic heart valve is implanted within a native heart valve annulus of a patient. The sealing member can include a mesh layer and pile layer comprising a plurality of pile yarns extending outwardly from the mesh layer.

Abstract: A prosthetic heart valve includes an annular frame that is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. The frame has a plurality of circumferentially extending rows of angled struts, each row of angled struts comprising angled struts arranged in a zig-zag pattern. The prosthetic heart valve further includes a leaflet structure positioned within the frame and secured thereto, and an outer sealing member mounted outside of the frame. The sealing member has an undulating outflow edge portion forming a plurality of triangular projections that are connected to and shaped to correspond to the zig-zag pattern of one of the rows of angled struts. The outer sealing member is sized to fit snugly against the outer surface of the frame when the frame is in the expanded configuration.

Abstract: Expandable docking stations for docking an expandable valve can include a valve seat, one or in ore sealing portions, and one or more retaining portions. A system for deploying an expandable docking station can include a catheter having a sleeve for retaining the docking station.

Abstract: A prosthetic heart valve includes an annular frame that has an inflow end and an outflow end and is radially compressible and expandable between a radially compressed configuration and a radially expanded configuration. The prosthetic heart valve further includes a leaflet structure positioned within the frame and secured thereto, and an outer sealing member mounted outside of the frame and adapted to seal against surrounding tissue when the prosthetic heart valve is implanted within a native heart valve annulus of a patient. The sealing member can include a mesh layer and pile layer comprising a plurality of pile yarns extending outwardly from the mesh layer.

Abstract: An expandable docking station frame includes a waist portion, a sealing portion connected to the waist portion, and a retaining portion connected to the sealing portion. The sealing portion is expandable radially outward of the waist portion to provide a seal against a first location of an inner surface of a circulatory system at a deployed position over a range of sizes of expansion. The retaining portion is expandable radially outward to engage a second location of the inner surface of the circulatory system at the deployed position, to retain the docking station at the deployed position in the circulatory system. When the expandable docking station frame is in an expanded and unconstrained state, the sealing portion and the retaining portion are joined by a concave profile portion radially inward of each of a first outermost diameter of the sealing portion and a second outermost diameter of the retaining portion.

Abstract: Docking devices for docking a prosthetic valve at a native valve of a heart can include a coiled docking anchor and a retrieval suture. The docking device and retrieval suture can be configured for improved retention and retrieval of the docking device after deployment. The docking devices can have an end portion with a central axis. The retrieval suture can be connected to the end portion such that a line of force applied by applying tension to the retrieval suture is substantially aligned with the central axis.

Abstract: A docking device for docking a prosthetic valve at a native valve of a heart can include a coil comprising a plurality of turns and having a proximal end and distal end. The docking device can further include a first covering disposed around and covering the coil from the distal end to the proximal end of the coil, and a second covering disposed over the first covering. A distal end and proximal end of the second covering are spaced away from a distal end and proximal end, respectively, of the first covering.

Abstract: A docking device for docking a prosthetic valve at a native valve of a heart includes a coiled body and a high friction sleeve. The coiled body has an upper region, a central region, and a lower region. The docking device is configured to be implanted at the native valve with the upper region positioned in a first chamber of the heart, the lower region positioned in a second chamber of the heart, and the central region positioned to extend around a plurality of leaflets of the native valve. A high friction sleeve covers at least a portion of the central region. The high friction sleeve comprises a material configured to generate more friction between the prosthetic valve and the docking device than an exterior surface of the coiled body.

Abstract: In a method of installing an expandable stent in a right ventricular outflow tract, a frame of the expandable stent is positioned at a deployed position in the right ventricular outflow tract, the frame including a waist portion, and first and second opposed sealing portions extending from the waist portion. The frame is expanded such that the waist portion expands to a first diameter, the first sealing portion expands to a second diameter larger than the first diameter and into contact with a first portion of an inner surface of the right ventricular outflow tract, and the second sealing portion expands to a third diameter larger than the first diameter and into contact with a second portion of the inner surface of the right ventricular outflow tract, wherein the waist portion is spaced apart from the inner surface of the right ventricular outflow tract at the deployed position.

Abstract: An expandable stent for implantation in a right ventricular outflow tract includes a frame having a waist portion that expands to a deployed size having a first diameter, first and second sealing portions extending in opposite directions from the waist portion and expanding radially outward of the waist portion. The first and second sealing portions are sized to seal against first and second portions of the inner surface of the right ventricular outflow tract at the deployed position over a range of sizes of expansion larger than the first diameter. A band is secured to the waist portion of the frame, restricting expansion of the waist portion substantially beyond the first diameter, such that the waist portion is configured to be spaced apart from the inner surface of the right ventricular outflow tract at the deployed position.

Abstract: Methods of implanting docking devices for prosthetic valves at a native heart valve include positioning a distal end of a delivery catheter into a first chamber of a heart, advancing a tubular body of a docking device from within the delivery catheter so that the distal end of the tubular body is advanced between native valve leaflets and positioned in a second chamber of the heart. The methods further include inserting a coil into a lumen of the docking device so that the tubular body adopts a configuration, releasing a proximal end of the docking device in the first chamber, inserting a replacement valve in an inner space of the docking device, and radially expanding the replacement valve until there is a retention force between the replacement valve and the docking device to hold the replacement valve in a stable position in the native valve.

Abstract: An expandable stent for implantation in a right ventricular outflow tract includes a frame having a plurality of struts that define a repeating pattern of cells. The repeating pattern of cells comprises a column of exactly three generally diamond shaped cells positioned in end-to-end alignment, and a column of exactly two generally diamond shaped cells positioned in end-to-end alignment. The frame has a substantially hourglass shape with a narrow portion in between a proximal end portion and a distal end portion, wherein the proximal end portion and the distal end portion are configured to expand radially outward to contact a right ventricular outflow tract.

Abstract: Anchoring or docking devices configured to be positioned at a native valve of a human heart and to provide structural support for docking a prosthetic valve therein. The docking devices can have coiled structures that define an inner space in which the prosthetic valve can be held. The docking devices can have enlarged end regions with circular or non-circular shapes, for example, to facilitate implantation of the docking device or to better hold the docking device in position once deployed. The docking devices can be laser-cut tubes with locking wires to assist in better maintaining a shape of the docking device. The docking devices can include various features to promote friction, such as frictional cover layers. Such docking devices can have ends configured to more securely attach the cover layers to cores of the docking devices.

Abstract: A prosthetic heart valve includes an annular frame that has an inflow end and an outflow end and is radially compressible and expandable between a radially compressed configuration and a radially expanded configuration. The prosthetic heart valve further includes a leaflet structure positioned within the frame and secured thereto, and an outer sealing member mounted outside of the frame and adapted to seal against surrounding tissue when the prosthetic heart valve is implanted within a native heart valve annulus of a patient. The sealing member can include a mesh layer and pile layer comprising a plurality of pile yarns extending outwardly from the mesh layer.

Abstract: Anchoring or docking devices configured to be positioned at a native valve of a human heart and to provide structural support for docking a prosthetic valve therein. The docking devices can have coiled structures that define an inner space in which the prosthetic valve can be held. The docking devices can have enlarged end regions with circular or non-circular shapes, for example, to facilitate implantation of the docking device or to better hold the docking device in position once deployed. The docking devices can be laser-cut tubes with locking wires to assist in better maintaining a shape of the docking device. The docking devices can include various features to promote friction, such as frictional cover layers. Such docking devices can have ends configured to more securely attach the cover layers to cores of the docking devices.

Abstract: An expandable stent for implantation in a right ventricular outflow tract includes a frame having a waist portion that expands to a deployed size having a first diameter, first and second sealing portions extending in opposite directions from the waist portion and expanding radially outward of the waist portion. The first and second sealing portions are sized to seal against first and second portions of the inner surface of the right ventricular outflow tract at the deployed position over a range of sizes of expansion larger than the first diameter. A band is secured to the waist portion of the frame, restricting expansion of the waist portion substantially beyond the first diameter, such that the waist portion is configured to be spaced apart from the inner surface of the right ventricular outflow tract at the deployed position.

Abstract: An expandable stent for implantation in a right ventricular outflow tract includes a frame having a plurality of struts that define a repeating pattern of cells. The repeating pattern of cells comprises a column of exactly three generally diamond shaped cells positioned in end-to-end alignment, and a column of exactly two generally diamond shaped cells positioned in end-to-end alignment. The frame has a substantially hourglass shape with a narrow portion in between a proximal end portion and a distal end portion, wherein the proximal end portion and the distal end portion are configured to expand radially outward to contact a right ventricular outflow tract.

Abstract: In a method of installing an expandable stent in a right ventricular outflow tract, a frame of the expandable stent is positioned at a deployed position in the right ventricular outflow tract, the frame including a waist portion, and first and second opposed sealing portions extending from the waist portion. The frame is expanded such that the waist portion expands to a first diameter, the first sealing portion expands to a second diameter larger than the first diameter and into contact with a first portion of an inner surface of the right ventricular outflow tract, and the second sealing portion expands to a third diameter larger than the first diameter and into contact with a second portion of the inner surface of the right ventricular outflow tract, wherein the waist portion is spaced apart from the inner surface of the right ventricular outflow tract at the deployed position.