Abstract: A system is provided for anchoring a prosthetic valve to a native valve of a heart. The system includes a steerable catheter, a low friction sleeve, and an anchoring device. The steerable catheter has a first lumen with a distal opening in a distal portion. The low-friction sleeve is configured for delivery through the first lumen. The low-friction sleeve has a second lumen. The anchoring device is configured for delivery through the second lumen such that the low-friction sleeve fits around at least a portion of the anchoring device. The low-friction sleeve is configured to be removed from the anchoring device to expose an exterior surface of the anchoring device when the anchoring device is in position in the native valve.

Abstract: Devices and methods for coupling a retention member to a prosthetic implant are disclosed. As an example, a delivery apparatus can include a handle and a shaft extending distally from the handle. The shaft can have a longitudinal axis, a distal end, and a proximal end. The shaft can include a first inner surface defining a main lumen and a second inner surface defining a minor lumen. The delivery apparatus can further include a retention member partially disposed within the minor lumen. The retention member can include a retention element and an actuation element, wherein the retention member is selectively axially movable relative to the minor lumen and configured to releasably couple to a prosthetic implant at a target location.

Abstract: A delivery apparatus for a prosthetic heart valve can comprise a shaft having a proximal end portion and a distal end portion, and an inflatable balloon mounted on the distal end portion of the shaft. The inflatable balloon can comprise a first conical portion, a second conical portion axially disposed relative to the first conical portion, and a central longitudinal axis extending between the first conical portion and the second conical portion. The first conical portion can have a first axial length and the second conical portion can have a second axial length that is different than the first axial length. The first conical portion has a first slope relative to the central longitudinal axis and the second conical portion has a second slope relative to the central longitudinal axis that is different than the first slope.

Abstract: A handle for a prosthetic implant delivery apparatus includes a plurality of knobs configured to control corresponding mechanisms of the delivery apparatus. Each knob has a color that is visually distinct from other knobs to indicate a unique function. In some instances, each knob is operably coupled to an indicator viewable through a window of the handle, and the indicator shares the same color as the corresponding knob to convey a functional relationship. Rotation or manipulation of a knob causes a corresponding adjustment mechanism, such as a pull wire, to actuate a feature of the delivery apparatus, for example, to control flex in different regions of a delivery shaft. A method for delivering a prosthetic implant includes manipulating one or more colored knobs to adjust aspects of the delivery apparatus and observing movement of matching-colored indicators to verify operation prior to or during implant deployment.

Abstract: A coil implant for treating a native heart valve includes a coil. The coil extends along a central axis and includes an adjustable section having an adjustable curvature. The adjustable section of the coil includes a plurality of cuts to allow the adjustable section to be moved from a first position with a first radius of curvature to a second position with a second radius of curvature. The coil is configured to draw native valve anatomy radially inwards.

Abstract: A system for crimping a prosthetic valve can include a radially compressible collet positioned around the prosthetic valve, a housing positioned around the collet, and a pusher at least partially disposed within the housing. The collet can include a first axial end portion, a second axial end portion, and an intermediate portion therebetween. The first axial end portion can have an outer diameter adjacent the intermediate portion that is greater than an outer diameter of the intermediate portion. The second axial end portion can have an outer diameter adjacent the intermediate portion that is greater than the outer diameter of the intermediate portion. The housing can include a housing internal annular ledge configured to slidably engage the second axial end portion of the collet. The pusher can include a pusher internal annular ledge configured to slidably engage the first axial end portion of the collet.

Abstract: Devices and methods for delivery devices for docking devices are disclosed. As an example, a delivery apparatus can include a housing, a linear actuator coupled to the housing, the linear actuator comprising a traveler and an articulation member coupled to the traveler, wherein the traveler translates axially relative to the housing based on rotation of the articulation member relative to the housing, a first shaft extending through the housing and configured to translate axially relative to the housing, a second shaft extending through the first shaft and coupled to the traveler of the linear actuator such that the second shaft and the traveler translate axially together, and a locking mechanism coupled to the housing, wherein the first shaft is prevented from moving relative to the housing in a locked configuration, and wherein the first shaft is moveable relative to the housing in an unlocked configuration.

Abstract: Devices and methods for seals are disclosed. As an example, a delivery apparatus comprises a sleeve shaft comprising a first segment and a second segment, wherein the second segment comprises an inwardly-facing outer surface and an outwardly-facing outer surface, wherein the second segment comprises a lubricious coating; and a seal coupled to the second segment of the sleeve shaft.

Abstract: The present disclosure relates to delivery assemblies for implantation of a prosthetic valve within a valvular structure in which an opening was formed in a host leaflet. In an example, the delivery assembly comprises a guest prosthetic valve and a delivery apparatus that includes an outer balloon, and an inner balloon axially movable relative to the outer balloon. The delivery apparatus can be advanced towards the host leaflet structure with the inner balloon kept in a concealed position. The inner balloon can then be advanced relative to the outer balloon, so as to be positioned inside the host leaflet, and inflated to form a leaflet opening within the host leaflet. The inner balloon can then be deflated and the outer balloon can be advanced into the leaflet opening, and inflated with the guest prosthetic valve disposed thereover, so as to expand the guest prosthetic valve inside the leaflet opening.

Abstract: Systems, assemblies, and methods for treating valve regurgitation and other valve problems are described. Prosthetic implants can be used to repair or reshape native heart valves and, in some examples, 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 prosthetic implant into the heart, including a lubricous sleeve in the delivery system. Packaging and storage systems suitable for the delivery systems are described.

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: A device for crimping a radially expandable and collapsible prosthetic valve comprises a crimping loop having a first end portion, a second end portion, and a loop portion extending between the first and second end portions and defining an opening configured to receive the prosthetic valve. The crimping loop is movable between a first state in which the opening has a first diameter and a second state in which the opening has a second diameter smaller than the first diameter such that when the prosthetic valve is positioned within the loop portion, movement of the crimping loop from the first state to the second state is effective to reduce a diameter of the prosthetic valve. A method for crimping a prosthetic valve comprises reducing a diameter of an opening of a crimping loop, thereby radially compressing an at least partially expanded prosthetic valve disposed within the opening.

Abstract: An expansion device for a prosthetic implant comprises a first balloon and a second balloon arranged radially outward of the first balloon. The expansion device can be configured to expand from an uninflated state to a first inflated state for stabilizing the prosthetic implant, and from the first inflated state to a second inflated state for radially expanding the prosthetic implant. In the first inflated state, the first balloon and the second balloon can each have radially enlarged distal end portions and radially enlarged proximal end portions relative to their respective center portions. In the second inflation state, a center portion of the second balloon radially expands radially beyond the expandable distal and proximal end portions of the first balloon while a center portion of the first balloon remains radially smaller than the expandable distal and proximal end portions of the first balloon.

Abstract: Systems and methods for delivering a docking device configured to receive a prosthetic valve are disclosed. A system can include a delivery catheter and a pusher device disposed in the delivery catheter and a docking device comprising a plurality of turns when in a coiled shape and having a proximal end portion and a distal end portion opposite the proximal end portion, where a retrieval line extends through a central lumen of the pusher device and is coupled to the proximal end portion of the docking device. The docking device is configured to move between a straightened shape when the docking device is arranged within the delivery catheter and the coiled shape after the docking device is pushed out of the docking device by the pusher device.

Abstract: A method of implanting a prosthetic heart valve includes advancing a distal end portion of a catheter shaft through a patient's vasculature. The distal end portion of the catheter shaft includes an expansion device. A prosthetic heart valve is mounted on the expansion device with the expansion device and the prosthetic heart valve in a compressed configuration. The method further includes positioning the distal end portion of the catheter shaft and the prosthetic heart valve to an implantation location and expanding the prosthetic heart valve and the expansion device to an expanded configuration. The expansion device includes a main body and a plurality of projections extending radially from the main body. The projections are spaced apart relative to each such that there are grooves extending between adjacent projections providing perfusion passageways between the expansion device and the prosthetic heart valve when the expansion device is in the expanded configuration.

Abstract: Anchor devices and methods used to secure a prosthetic valve to a native valve annulus are described. The anchor device can be a separate expandable element from the prosthetic valve that is first advanced to the annulus and deployed, after which an expandable prosthetic valve is advanced to within the annulus and deployed. The combination of the two elements can apply a clamping force to the valve leaflets which holds the prosthetic valve in place. The anchor device can have a lower or ventricular portion and an upper or atrial portion. The anchor device can include one or more leaflet clamping portions. One, two, or more upstanding vertical posts between the clamping portions can extend upward at the valve commissures and support the upper portion, which can include one or more structures for leak prevention.

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: Catheter shafts that can be used in a delivery apparatus for a prosthetic implant are disclosed. As one example, a catheter shaft can include a tube having a distal end portion comprising at least one axially extending slot, the slot extending proximally into the tube from a distal end of the tube and radially through a thickness of the tube. The catheter shaft can further include a polymeric layer comprising a jacket portion disposed around the tube, a tip portion extending distal to the jacket portion and the tube, and a channel portion disposed within the slot; and an inner liner disposed on an inner surface of the tube and an inner surface of the tip portion, where a material of the polymeric layer bonds with the inner liner.

Abstract: Suture lock assemblies with suture tensioners are disclosed herein. A suture lock assembly can comprise a suture tensioner configured to be selectively rotated to collect a length of a suture. The suture tensioner comprises a pair of spaced-apart posts and a connecting body coupled to each of the posts. A suture lock assembly also can comprise a suture tensioner, a tensioner housing, and a quick release suture mechanism. The tensioner housing at least partially receives the suture tensioner and includes a suture entry port and a suture exit port. The suture tensioner is configured to be selectively rotated relative to the tensioner housing to selectively increase a length of a suture that is enclosed by the tensioner housing. The quick release suture mechanism comprises a quick release dock port and a suture anchor cap configured to be selectively coupled to and uncoupled from the quick release dock port.

Abstract: Anchor devices and methods used to secure a prosthetic valve to a native valve annulus are described. The anchor device can be a separate expandable element from the prosthetic valve that is first advanced to the annulus and deployed, after which an expandable prosthetic valve is advanced to within the annulus and deployed. The combination of the two elements can apply a clamping force to the valve leaflets which holds the prosthetic valve in place. The anchor device can have a lower or ventricular portion and an upper or atrial portion. The anchor device can include one or more leaflet clamping portions. One, two, or more upstanding vertical posts between the clamping portions can extend upward at the valve commissures and support the upper portion, which can include one or more structures for leak prevention.