Abstract: An assembly can comprise a radially expandable and compressible annular frame, at least one linear actuator assembly coupled to the frame and at least one locking mechanism coupled to the frame. The linear actuator can be configured to apply a distally directed force and/or a proximally directed force to the frame to radially expand or compress the frame. The locking mechanism can comprise a first sleeve member connected to the frame at a first location, a second sleeve member having internal threads and being connected to the frame at a second location, and a first screw configured to engage the internal threads of the second sleeve member to retain the frame in a radially expanded state.

Abstract: Delivery systems and catheters including lock and release connectors for implantable devices and methods for retaining, positioning, and deploying a medical device are disclosed. The lock and release connectors can include a body and at least one door engaged with the body, wherein the door is moveable from a first position to a second position. The lock and release connectors can further include at least one fastener connecting at least one end of the door to the body. The door can be integral with the body or connected and can comprise a shape memory material and/or other materials.

Abstract: Docking stations for transcatheter valves are described. The docking stations can include an expandable frame, at least one sealing portion, and a valve seat. The expandable frame can be configured to conform to an interior shape of a portion of the circulatory system when expanded inside the circulatory system. The sealing portion can be configured to contact an interior surface of the circulatory system to create a seal. The valve seat can be connected to the expandable frame and can be configured to support an expandable transcatheter valve. The docking stations are adaptable to different anatomies/locations to allow implantation of a transcatheter valve in a variety of anatomies/locations.

Abstract: Disclosed herein are embodiments of a balloon shaped to have one or more enlarged recons to selectively increase expansion forces on an implant. For example, the balloon may have a central portion that is enlarged to exert more force on the center of a stent-mounted prosthetic heart valve. This overcomes the stent-mounted prosthetic heart valve's tendency to expand with flared ends. This forms a more cylindrical or barrel shaped stent frame during expansion of the balloon—reducing or eliminating the instance wherein the cylindrical stent frame has flared ends. Alternatively, the balloon may have conical flares placed to cause or enhance flared ends of the cylindrical implant to enhance its anchoring capabilities.

Abstract: An expandable sheath is disclosed herein, which has a first polymeric layer and a braided layer positioned radially outward of the first polymeric layer. The braided layer includes a plurality of filaments braided together. The expandable sheaths further include a resilient elastic layer positioned radially outward of the braided layer. The elastic layer is configured to apply radial force to the braided layer and the first polymeric layer. The expandable sheath further includes a second polymeric layer positioned radially outward of the elastic layer and bonded to the first polymeric layer such that the braided layer and the elastic layer are encapsulated between the first and second polymeric layers. Methods of making and using the devices disclosed herein are also disclosed, as are crimping devices that may be used in methods of making the devices disclosed herein.

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: A prosthetic heart valve includes an annular frame that is radially collapsible and radially expandable, a plurality of leaflets situated within the frame, each leaflet having opposing commissure tab portions on opposite sides of the leaflet, each commissure tab portion paired with an adjacent commissure tab portion of an adjacent leaflet to form at least one commissure, and a plurality of post members mounted on an interior surface of the frame. The at least one commissure includes a commissure attachment assembly including a support member disposed at least partially around the commissure tab portions and the commissure tab portions are folded around the support member. The commissure attachment assembly is secured to a first post member of the plurality of post members such that the commissure tab portions are positioned between the first post member and the support member.

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 annular sealing member can be positioned around an outer surface of the frame, wherein the sealing member has a periodic, undulating shape. An outer skirt can be positioned around an outer surface of the sealing member and secured to the frame.

Abstract: The active introducer sheath systems disclosed herein are expanded by activating a translation mechanism at the handle. The sheath has an inner cylindrical structure of comingled fixed and mobile elongate rods bound together by an attachment line. Activating the translation mechanism causes the mobile rods to move axially with respect to the fixed rods, changing the internal tension in the attachment line. Increased tension draws the fixed and mobile rods closer together, decreasing the diameter of the cylindrical structure. Decreased tension in the attachment line enables the fixed and mobile rods to move apart, increasing the diameter of the cylindrical structure. A prosthetic device, such as a prosthetic heart valve, can be routed through the expanded sheath and to the implantation site. During implantation, the sheath can be contracted back to its original outer diameter, and expanded again for retrieval of the delivery apparatus.

Abstract: Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. A valve frame can have a tapered profile when mounted on a delivery shaft, with an inflow end portion having a smaller diameter than an outflow end portion. The valve can comprise generally V-shaped leaflets, reducing material within the inflow end of the frame. An outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack when the valve is expanded and lying flat against the frame when the valve is collapsed. A diagonally woven inner skirt can elongate axially with the frame. Side tabs of adjacent leaflets can extend through and be secured to window frame portions of the frame to form commissures. The window frame portions can be depressed radially inward relative to surrounding frame portions when the valve is crimped onto a delivery shaft.

Abstract: Valvular implants and blood vessel closure devices herein are configured to be positioned in the heart and to block regurgitant blood flow from the heart into blood vessels supplying blood to the heart. The valvular implants can have a cover, a membrane, a valve, a resilient frame, and/or other features. Some valvular implants can have anchors to be positioned in the blood vessels, such as in pulmonary veins, and can anchor the implant to the heart wall. Various embodiments of covers and/or membranes act as valves contracting and expanding, to alternately permit and block blood flow. The valvular implants can cover one or more blood vessels, such as one, two, three, or four pulmonary veins, and can also be configured and implanted to block an appendage to the heart, such as the left atrial appendage.

Abstract: A prosthetic heart valve includes an annular frame including a plurality of angled strut members that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration. The frame has an inflow end and an outflow end, and includes a leaflet structure positioned within the frame, the leaflet structure comprising a plurality of leaflets arranged to form a plurality of commissures. The frame includes a plurality of commissure support elements, each commissure support element being positioned at one of the commissures. Each of the commissure support elements has a coupling portion coupled to the frame and first and second members coupled to the coupling portion and extending in a direction toward the inflow end of the frame or toward the outflow end of the frame. The leaflets of each commissure are received between the first and second members of the respective commissure support element.

Abstract: A prosthetic heart valve can include a frame, a valve component, a sealing member, and a retaining member. The frame can be radially compressible and expandable between a radially-compressed configuration and a radially-expanded configuration. The valve component can be disposed within and coupled to the frame and have a plurality of leaflets. The sealing member can have a plurality of ribs and a plurality of connectors. The ribs can be coupled to and extend radially outwardly from the frame when the frame is in the radially-expanded configuration. The connectors can be coupled to and extend radially between the frame and the ribs. The sealing member can be configured to reduce or prevent perivalvular leakage around the prosthetic heart valve. The retaining member can be coupled to the frame and the sealing member and can retain the sealing member at a desired spacing relative to the frame.

Abstract: The active introducer sheath systems disclosed herein are expanded by activating a translation mechanism at the handle. The sheath has an inner cylindrical structure of comingled fixed and mobile elongate rods bound together by an attachment line. Activating the translation mechanism causes the mobile rods to move axially with respect to the fixed rods, changing the internal tension in the attachment line. Increased tension draws the fixed and mobile rods closer together, decreasing the diameter of the cylindrical structure. Decreased tension in the attachment line enables the fixed and mobile rods to move apart, increasing the diameter of the cylindrical structure. A prosthetic device, such as a prosthetic heart valve, can be routed through the expanded sheath and to the implantation site. During implantation, the sheath can be contracted back to its original outer diameter, and expanded again for retrieval of the delivery apparatus.

Abstract: Disclosed herein is a storage container for an expandable prosthetic heart valve that crimps the valve upon opening the container and removal of the valve from the container. The container includes a housing sized to receive the heart valve in its expanded configuration and a crimping mechanism. The crimping mechanism is incorporated into the container and engages the heart valve so as to operably convert the heart valve from its expanded configuration to its smaller crimped configuration upon opening the container and removing the valve.

Abstract: A method for improving leaflet prolapse and/or valve regurgitation associated with a heart valve involves delivering a spacer device into a ventricle of a heart using a delivery system comprising a catheter, fixing the spacer device to a wall of the ventricle, expanding the spacer device to reposition a papillary muscle disposed in the ventricle away from the wall, the papillary muscle being connected to a leaflet of an atrioventricular heart valve via chordae tendineae, and releasing the spacer device from the catheter.

Abstract: An implantable prosthetic valve can include a radially expandable and collapsible annular frame comprising an inflow end and an outflow end and a plurality of struts forming a plurality of cells, where each of the plurality of cells defines an opening in the frame. A leaflet structure can be positioned within the frame and secured thereto. A plurality of sealing members can be secured to the plurality of struts of the frame, where each sealing member of the plurality of sealing members includes two opposite sides that are not secured to the frame to allow blood to flow through each sealing member along a path formed between the frame and the sealing members.

Abstract: A prosthetic heart valve can include a frame, a valve component, and a sealing member. The frame can have an inflow end portion, an outflow end portion, an intermediate portion disposed between the inflow and outflow end portions, and a plurality of struts. The frame can be radially compressible and expandable between a radially-compressed configuration and a radially-expanded configuration. The valve component can be disposed within and coupled to the frame and have a plurality of leaflets. The sealing member can have a plurality of ribs and a plurality of drapes. The ribs can be coupled to and extend radially outwardly from the frame when the frame is in the radially-expanded configuration. The drapes can be coupled to and extend radially between the frame and the ribs. The sealing member can be configured to reduce or prevent perivalvular leakage around the prosthetic heart valve.

Abstract: Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. A valve frame can have a tapered profile when mounted on a delivery shaft, with an inflow end portion having a smaller diameter than an outflow end portion. The valve can comprise generally V-shaped leaflets, reducing material within the inflow end of the frame. An outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack when the valve is expanded and lying flat against the frame when the valve is collapsed. A diagonally woven inner skirt can elongate axially with the frame. Side tabs of adjacent leaflets can extend through and be secured to window frame portions of the frame to form commissures. The window frame portions can be depressed radially inward relative to surrounding frame portions when the valve is crimped onto a delivery shaft.

Abstract: The expandable sheath and methods of use disclosed herein are used to deliver a prosthetic device through a patient's vasculature. The sheath is constructed to be expandable in the circumferential direction, while maintaining sufficient stiffness in the longitudinal direction to withstand pushing and resist kinking. The sheath includes a plurality of curved arms extending outwardly from a longitudinally extending spine. The curved arms move away from the longitudinal axis of the sheath when pushed radially outwardly by a passing prosthetic device, and move back toward the longitudinal axis once the prosthetic device has passed.