Abstract: Described herein are systems and methods from delivering prosthetic devices, such as prosthetic heart valves, through the body and into the heart for implantation therein. The prosthetic devices delivered with the delivery systems disclosed herein are, for example, radially expandable from a radially compressed state mounted on the delivery system to a radially expanded state for implantation using an inflatable balloon of the delivery system. Exemplary delivery routes through the body and into the heart include transfemoral routes, transapical routes, and transaortic routes, among others.

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: Described herein are systems and methods from delivering prosthetic devices, such as prosthetic heart valves, through the body and into the heart for implantation therein. The prosthetic devices delivered with the delivery systems disclosed herein are, for example, radially expandable from a radially compressed state mounted on the delivery system to a radially expanded state for implantation using an inflatable balloon of the delivery system. Exemplary delivery routes through the body and into the heart include transfemoral routes, transapical routes, and transaortic routes, among others.

Abstract: A method of delivery a prosthetic heart valve includes inserting a delivery apparatus and a prosthetic heart valve into a patient's vasculature. The delivery apparatus includes a steerable guide catheter, a balloon catheter, and a flex indicator. The balloon catheter extends coaxially through the guide catheter, the prosthetic heart valve is mounted on a distal end portion of the balloon catheter, and the flex indicator is movably coupled to a handle of the guide catheter. The method further includes adjusting flexion of a steerable section of the guide catheter to position the prosthetic heart valve. The flex indicator moves relative to the handle of the guide catheter as the flexion of the steerable section is adjusted, and the handle comprises one or more visual indicators adjacent the flex indicator to provide visual indication of an amount of flexion of the steerable section of the guide catheter.

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: A sealing frame surrounds a radially-outer surface portion of a valve frame of a prosthetic heart valve. Both the valve frame and the sealing frame are radially collapsible and expandable between respective compressed and expanded configurations. The sealing frame has a first axial end coupled to the valve frame at its inflow end, and a second axial end coupled to the valve frame at a location between its inflow and outflow ends. The sealing frame also has an intermediate portion between the first and second axial ends that projects radially outward when the valve and sealing frames are in their expanded configurations. The sealing frame displaces an outer skirt of the prosthetic heart valve radially outward and urges the outer skirt into contact with surrounding native tissue, thereby reducing or avoiding paravalvular leakage. In some examples, the sealing frame can be formed of a shape memory material.

Abstract: Certain examples of the disclosure concern a docking device for securing a prosthetic valve at a native valve. The docking device includes a coil having a plurality of helical turns when deployed at the native valve, an expandable member extending radially outwardly from the coil and being movable between a radially-compressed/axially-elongated state and a radially-expanded/axially-foreshortened state, and a cover member surrounding an outer surface of the expandable member. A distal end portion of the cover member and a distal end portion of the expandable member are fixedly coupled to the coil via a distal suture including a plurality of knots and a plurality of wraps. A proximal end portion of the expandable member is fixedly coupled to a proximal end portion of the cover member. The proximal end portion of the expandable member and the proximal end portion of the cover member are axially movable relative to the coil.

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: 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: Described herein are systems and methods from delivering prosthetic devices, such as prosthetic heart valves, through the body and into the heart for implantation therein. The prosthetic devices delivered with the delivery systems disclosed herein are, for example, radially expandable from a radially compressed state mounted on the delivery system to a radially expanded state for implantation using an inflatable balloon of the delivery system. Exemplary delivery routes through the body and into the heart include transfemoral routes, transapical routes, and transaortic routes, among others.

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: 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: Described herein are systems and methods from delivering prosthetic devices, such as prosthetic heart valves, through the body and into the heart for implantation therein. The prosthetic devices delivered with the delivery systems disclosed herein are, for example, radially expandable from a radially compressed state mounted on the delivery system to a radially expanded state for implantation using an inflatable balloon of the delivery system. Exemplary delivery routes through the body and into the heart include transfemoral routes, transapical routes, and transaortic routes, among others.

Abstract: Systems, assemblies, and methods for treating valve regurgitation and other valve problems are described. Prosthetic valves can have integrated coverings or flanges. Prosthetic valves can have a flange attached to the inflow end of the annular frame and designed to extend outwardly therefrom. Docking devices can be used to repair or reshape native heart valves and to secure prosthetic heart valves at a specific location and position relative to a native heart valve. Delivery systems can be used to deploy a docking device into the heart, including a lubricous sleeve in the delivery system. Packaging and storage systems suitable for the delivery systems are described.

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: An implantable prosthetic valve can include an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. A leaflet structure can be positioned within the frame and secured thereto. An outer skirt can be positioned around an outer surface of the frame and secured to the frame and an annular sealing member can be positioned around an outer surface of the outer skirt and secured to the outer skirt.

Abstract: Expandable docking stations for docking an expandable valve can include a valve seat, one or more sealing portions, and/or one or more retaining portions. The valve seat can be unexpandable or substantially unexpandable beyond a deployed size. The one or more sealing portions can be connected to the valve seat and extend radially outward of the valve seat. The one or more sealing portions can be constructed to expand outward of the valve seat and provide a seal over a range of sizes. The one or more retaining portions can be connected to the one or more sealing portions. The one or more retaining portions are configured to retain the docking station at a deployed position.