Abstract: Several heart wall remodeling devices and methods are disclosed. One heart wall remodeling device includes a trimming tool for trimming a line within a patient. The trimming tool includes an actuator for manipulation by a user, a moveable inner shaft coupled to the actuator, and an outer sleeve coupled to the inner shaft. The outer shaft includes a backstop disposed along an inner wall of the outer sleeve and a channel disposed between a first end and a second end of the outer sleeve. The inner shaft includes an inner shaft, a compressible member, and a cutter.

Abstract: An implantable prosthetic device has a coaptation element and at least one anchor. The coaptation element is configured to be positioned within the native heart valve orifice to help fill a space where the native valve is regurgitant and form a more effective seal. The coaptation element can have a structure that is impervious to blood. The coaptation element can be connected to leaflets of the native valve by the anchor.

Abstract: An implantable prosthetic device has a coaption element and at least one anchor. The coaption element is configured to be positioned within the native heart valve orifice to help fill a space where the native valve is regurgitant and form a more effective seal. The coaption element can have a structure that is impervious to blood. The coaption element can be connected to leaflets of the native valve by the anchor.

Abstract: Embodiments of the present disclosure include an implantable assembly for a native heart valve that includes a prosthetic heart valve and a braided support structure. The prosthetic valve includes a frame and prosthetic leaflets. The braided support structure has an inner braided layer and an outer braided layer. The outer braided layer is disposed over the inner braided layer. The outer braided layer is less porous to blood than the inner braided layer. The braided support structure defines a plurality of arms that are angularly spaced around the prosthetic heart valve such that each arm extends radially outwardly from the prosthetic heart valve. Other embodiments are also described.

Abstract: In a representative embodiment, a method comprises implanting first and second inflatable bodies within an annulus of a native heart valve by securing the inflatable bodies to tissue of the native heart valve with sutures, and implanting a prosthetic heart valve between the inflatable bodies such that the prosthetic heart valve is retained within the annulus by the inflatable bodies.

Abstract: An implantable device includes an adjustable spacer and at least one anchor. The adjustable spacer is configured to be positioned between native heart valve leaflets to reduce regurgitation therebetween. The adjustable spacer can comprise a first side and a second side opposite the first side. Each side can be adjustable between a first width and a second width. Each side can be independently moved between the first width and the second width. The adjustable spacer can be made from a sponge material.

Abstract: A cardiac implant system including a cardiac implant such as an annuloplasty ring, a prosthetic heart valve, or a valved conduit pre-assembled at the time of manufacture with devices for securing the implant to a heart valve annulus using knotless suture fasteners. The knotless suture fasteners may be embedded within a pliant sealing edge of the cardiac implant, or they may be positioned adjacent to the sealing edge. The knotless suture fasteners are spring-biased so as to grip onto annulus anchoring sutures pass to therethrough upon removal of a restraining device, such as a hypotube inserted within the suture fasteners. Guide tubes are assembled in line with the suture fasteners to permit introduction of suture snares that pass through the suture fasteners and through the sealing edge to facilitate capture of the pre-installed annulus anchoring sutures.

Abstract: An implantable prosthetic spacer device can include an inflatable spacer having a plurality of inflatable members and a frame, the frame comprising one or more anchors and one or more clasps. The inflatable spacer can be configured to be disposed between native leaflets of a heart. The implantable prosthetic spacer can be disposed in a symmetrical or an asymmetrical configuration. The inflatable spacers can be inflatable between an uninflated and an inflated configuration.

Abstract: Described herein are systems and methods for securing sutures that obviate the need for tying knots. Instead of tying two ends of a suture or two sutures together with a knot, two or more suture portions can be fused or cauterized together using heat. A device can be applied to adjacent suture portions that heats the suture portions and causes the suture portions to fuse together, effectively securing the suture portions together without a knot. Such devices can include a shaft, a heating element positioned within the shaft, and a suture holder at the distal end of the shaft. The holder in an open position receives sutures and in a closed position holds the sutures. Actuation of the device causes the heating element to apply heat and fuse together sutures held by the holder. The holder can separate from the fused sutures after the sutures are fused together.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a coaption element formed from a strip of material; a pair of extension members; a pair of paddles formed from the strip of material and connected to the coaption element; and a cap attached to the paddles. The paddles are movable between an open position and a closed position, are disposed over the extension member, and are configured to attach to the native valve of the patient. Movement of the cap toward the coaption element causes the pair of paddles to move to the closed position, and movement of the cap away from the coaption element causes the pair of paddles to move to the open position. The cap has a retention body for receiving attachment portions of the extension members, a retaining nut, and a retaining bolt for securing the retaining nut.

Abstract: A method of manufacturing a valve repair device for repairing a native valve of a patient includes: folding a strip of material formed from shape-memory alloy around a jig to form a coaption element and a pair of paddles connected to the coaption element, wherein the paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient; and heat treating the strip of material to shape-set the strip of material in the shape of the coaption element and paddles.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a coaption element; a pair of paddles connected to the coaption element; a first cover extending from a distal end of the device and covering at least a portion of the paddles; and a second cover extending from a proximal end of the device and covering at least a portion of the coaption element. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a strip of material; a coaption element formed from the strip of material; a collar connected to the coaption element; and a pair of paddles formed from the strip of material and connected to the coaption element. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a strip of material; a coaption element formed from the strip of material; a pair of paddles formed from the strip of material and connected to the coaption element; a cap attached to the paddles; and a pair of extension members connected to the cap and the paddles via attachment portions. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient. Movement of the cap toward the coaption element causes the pair of paddles to move to the closed position, and movement of the cap away from the coaption element causes the pair of paddles to move to the open position. The extension members extend to end portions attached to the strip material. The end portions extend beyond the strip of material.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a strip of material; a coaption element formed from the strip of material; a pair of paddles formed from the strip of material and connected to the coaption element; a cap attached to the paddles; and a pair of extension members connected to the cap and movable between an open position and a closed position. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient. Movement of the cap toward the coaption element causes the pair of paddles to move to the closed position, and movement of the cap away from the coaption element causes the pair of paddles to move to the open position. In the closed position the extension members are biased in a closing direction.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a coaption element having four layers; and a pair of paddles connected to the coaption element. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a coaption element; a pair of paddles connected to the coaption element; a catch point formed by a portion of at least one of the coaption element and the pair of paddles when the paddles are in the open position; and a cover covering connected to the coaption element and the paddles for covering the catch point. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a strip of material having first and second edges surrounding a central portion; a coaption element formed from the strip of material; and a pair of paddles formed from the strip of material and connected to the coaption element. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a collar; a coaption element attached to the collar; and a pair of paddles are connected to the coaption element. The collar has a plurality of engagement portions configured to releasably engage a delivery apparatus. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient. The paddles are circumferentially disposed between the engagement portions.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a strip of material; a coaption element formed from the strip of material; and a pair of paddles formed from the strip of material and connected to the coaption element. The paddles are movable between an open position and a closed position and the paddles are configured to attach to the native valve of the patient.