Abstract: Devices, systems and methods are described herein to provide improved steerability for delivering a prosthesis to a body location, for example, for delivering a replacement mitral valve to a native mitral valve location. The delivery system can include a number of advantageous steering and delivery features, in particular for the transseptal delivery approach.

Abstract: This disclosure is directed to prosthetic heart valves having expansion and locking assemblies. As one example, a prosthetic heart valve can include an annular frame and an expansion and locking assembly that is configured to radially expand the frame to a radially expanded state and/or to lock the prosthetic valve in the radially expanded state to prevent the prosthetic valve from collapsing (i.e., radially compressing). In some examples, the prosthetic heart valve can be configured to radially self-expand to a partially radially expanded state, and can then be further radially expanded to the radially expanded state and/or locked in the radially expanded state by pulling an actuator member of the expansion and locking assembly. In some examples, the actuator member can extend through openings in vertical struts of the frame.

Abstract: Systems and methods usable in delivering a docking device to a native valve of a patient's heart. A distal region of a delivery catheter can be positioned in an atrium of the heart and a distal tip can be positioned at or near a commissure of the native valve. The docking device can be located within the delivery catheter. A pusher, such as a pusher wire or tube, of a pusher tool can be advanced distally through the delivery catheter, wherein the pusher can push the docking device along within the delivery catheter. The docking device can be connected to the pusher tool by a line, such as a suture. A member of the pusher tool can be rotatable to change the amount of the suture extending from the pusher tool.

Abstract: Systems and methods usable in delivering a docking device to a native valve of a patient's heart. A docking device can be connected to a pusher tool by a line, such as a suture. A member of the pusher tool can be rotatable to change the amount of the suture extending from the pusher tool.

Abstract: An assembly can include a prosthetic valve and a delivery apparatus having a handle and a plurality of actuator assemblies extending from the handle. The prosthetic valve can have a plurality of posts one or more of which are configured as actuators having an axially spaced first member and second member, and a threaded rod extending through first and second members. Each actuator assembly can include a first actuation member engaging an outflow end of the prosthetic valve and having first and second support extensions, and a second actuation member extending through the first actuation member and comprising a distal end portion having an engagement portion releasably coupled to the threaded rod. The first and second support extensions can inhibit rotation of the frame relative to the one or more actuator assemblies during expansion of the prosthetic valve.

Abstract: Methods and tools for folding and/or capturing leaflets of a heart valve are disclosed herein. Prior to or during installing of a prosthetic heart valve, part of a leaflet of an existing valvular structure can be positioned distally and/or folded upon itself. The existing valvular structure may be a native heart valve or a previously-implanted prosthetic heart valve. When the existing valvular structure is at the aortic position, the prosthetic heart valve can be subsequently installed within the existing valvular structure such that the leaflet is maintained in a location that avoids obstructing blood flow to one or more of the coronary arteries.

Abstract: A delivery apparatus for implanting a prosthetic heart valve includes one or more shafts and a handle coupled to the one or more shafts. The handle comprises one or more knobs, one or more adjustment mechanisms, and/or one or more control mechanisms. The knobs are configured for actuating the one or more adjustment mechanisms and/or the one or more control mechanisms. The one or more adjustment mechanisms are configured for moving the shafts relative to each other and/or relative to the handle. The one or more control mechanisms are configured for limiting the direction of movement and/or force applied to the one or more shafts.

Abstract: An implantable prosthetic device can include a frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration. The frame can have a first set of a plurality of struts extending in a first direction, and a second set of a plurality of struts extending in a second direction, and each strut of the first set of struts can be pivotably connected to at least one strut of the second set of struts. Each strut can be curved helically with respect to a first, longitudinal axis of the frame, and each strut can be curved with respect to a second axis that is perpendicular to the first, longitudinal axis of the frame.

Abstract: The present invention relates to devices, assemblies and methods for monitoring radial expansion of a prosthetic valve during prosthetic valve implantation procedures.

Abstract: An implantable prosthetic device can include a frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration. The frame can have a first set of a plurality of struts extending in a first direction, and a second set of a plurality of struts extending in a second direction, and each strut of the first set of struts can be pivotably connected to at least one strut of the second set of struts. Each strut can be curved helically with respect to a first, longitudinal axis of the frame, and each strut can be curved with respect to a second axis that is perpendicular to the first, longitudinal axis of the frame.

Abstract: A delivery apparatus for implanting a prosthetic valve includes a handle, a first shaft, a plurality of actuation shafts, and a control mechanism. The first shaft has one or more lumens extending from the first end portion to the second end portion. The actuation shafts each have a proximal end portion and a distal end portion, and the actuation shafts extend through the one or more lumens of the first shaft. The control mechanism is coupled to the actuation shafts and to the handle. The control mechanism is configured such that the actuation shafts can move axially relative to each other in a first operational mode and such that the actuation shafts can be moved axially simultaneously in a second operational mode. Additionally or alternatively, the first shaft can include a plurality of helical lumens configured for receiving the actuation shafts.

Abstract: An implantable prosthetic valve can include a frame movable between a radially compressed and a radially expanded configuration. The frame can include a first strut having a first locking feature disposed on a radially facing inner surface of the strut and a second strut having a second locking feature disposed on a radially facing outer surface of the strut. The first and second locking features can engage each other so as to allow pivoting of the first and second struts relative to one another in a first direction upon radial expansion of the frame and resist pivoting of the first and second struts relative to one another in a second direction to resist radial compression of the frame.

Abstract: A system includes a lock and release connector, an implantable medical device, and an outer tube. The lock and release connector includes a connector body defining a recess having planar lateral head portions extending to and intersecting with a cylindrical surface of the connector body, and a longitudinal neck portion extending from the head portion. The implantable medical device has an extension including a neck portion receivable in the longitudinal neck portion of the recess and a head portion receivable in the lateral head portions of the recess. The outer tube extends over the recess to retain the extension in the recess.

Abstract: An expandable docking station includes an annular valve seat having an end, an annular outer wall comprising struts disposed around the valve seat, and links that connect the end of the annular valve seat to the annular outer wall. Each of the links extends from the struts of the annular outer wall directly toward a longitudinal axis that runs longitudinally through a center of the docking station, and to a corresponding one of a plurality of circumferentially spaced axially extending legs at least partially defining the annular valve seat. The outer wall is configured to conform to an interior shape of a blood vessel, when expanded inside the blood vessel, such that the outer wall can expand in multiple locations to conform to multiple bulges of the blood vessel and can contract in multiple locations to conform to multiple narrowed regions of the blood vessel.

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: Various mechanically expandable prosthetic heart valves, as well as deliver apparatus, delivery assemblies, and methods for implanting such prosthetic heart valves. In one example, a prosthetic heart valve includes a mechanically expandable frame, a valve structure, and an actuator. The frame includes a plurality of struts and is movable between a radially compressed state and a radially expanded state. The valve structure includes a plurality of leaflets. The actuator is coupled to the frame and comprises an actuation lumen, a locking member, and a locking element. The actuation lumen is circumferentially spaced and axially parallel to the locking member. The actuation lumen is configured for receiving an axially movable actuation shaft that can move the frame between the radially compressed state and the radially expanded state. The locking element is rotatably coupled to the locking member and is configured to lock the frame at a desired state.

Abstract: A medical assembly can include a radially expandable prosthetic heart valve and a delivery apparatus. The delivery apparatus can include a handle, an actuation member, and a force limiting mechanism within the handle including a pivot arm coupled to a base portion. The actuation member can apply a proximally directed force to the prosthetic valve to cause the valve to expand. The actuation member can be coupled to the pivot arm such that a force applied to the actuation member causes the pivot arm to pivot. The force limiting mechanism can pinch the actuation member between the pivot arm and the base portion when the force applied to the actuation member exceeds a predetermined force to prevent proximal movement of the actuation member and can allow proximal movement of the actuation member to produce radial expansion of the prosthetic valve when the force applied is less than the predetermined force.

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: A method and device for placing a leaflet patch over a heart valve. The device comprises a first atrium anchor and a first ventricle anchor configured to be placed in an atrium, a second atrium anchor and a second ventricle anchor configured to be placed in a ventricle, a first artificial chord configured to attach to the first atrium anchor and the first ventricle anchor, a second artificial chord configured to attach to the second atrium anchor and the second atrium anchor, and the leaflet patch. The leaflet patch is placed partially in the atrium and partially in the ventricle. The leaflet patch comprises a first channel configured to contain the first artificial chord and a second channel configured to contain the second artificial chord. At least one of the anchors comprises a winching mechanism for adjusting the tension of one of the articular chords.

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.