Devices, systems and methods for altering functioning of a tissue/organ by application of force thereto. In one preferred embodiment, a device for reducing or preventing regurgitation of blood through a valve of a heart is provided. A device may include a main body having a segment adapted to apply force to a surface of tissue/organ and a member that applies counterforce to the force applied by the segment. Kits are provided in which devices having varying lengths and widths can be selected for the best fit for a particular location of treatment. A width sizing instrument may be provided. A length sizing instrument may be provided. A separate sleeve and/or pad may be provided which may be first anchored to the tissue/organ before fixing the device thereto.

An implantable blood flow control system has an open passageway defined inside a radially inner wall, behind which is a closed passageway. The radially inner wall includes electroactive polymer actuator members for providing a variable flow restriction. The flow restriction has an undulating shape so that the volume of the closed passageway may remain constant during actuation of the electroactive polymer actuator members. In this way, the chamber behind the actuator members does not impede free movement of the actuator members. The undulating pattern presents no sharp edges, where blood coagulation could otherwise occur.

An implantable device includes an EAP actuator and a sensor. The sensor is configured to monitor a force external to the implantable device acting in a direction either with or counter to a direction of actuation of the actuator, and a controller is adapted to control the actuator to actuate at a moment when force counter to the direction of actuation is sensed to be at its lowest within a given time window or force with the direction of actuation is sensed to be at its highest within a given time window. In this way, actuation is effected at a moment of least resistance force, reducing the power needed for deployment of the actuator, and permitting actuation to occur even in conditions experiencing large variable forces.

This document describes methods and devices for securing epicardial devices. For example, this document describes methods and devices for securing epicardial devices by passing a sheath into a pericardial space of a patient through a first percutaneous access site, passing a guidewire through the sheath into the pericardial space of the patient, passing the guidewire through a transverse sinus of the patient, passing a snare device into the pericardial space through a second percutaneous access site, and capturing a free end portion of the guidewire using the snare device.

Devices are provided for mechanically induced ventricular growth in a single ventricle patient that include a body comprising a plurality of springs coupled together to define an open upper end and a closed lower end, wherein the springs surround an interior region of the body sized to receive a portion of a patient's heart. The device may be secured over a portion of a patient's heart, e.g., overlying the left ventricular region, and the bias of the springs may apply strain to the myocardium of the heart to induce ventricular chamber growth.

According to one aspect of the disclosure, a system may include a surgical prosthetic heart valve having a frame, prosthetic leaflets within the frame configured to allow blood to flow through the frame in an antegrade direction but to substantially block blood from flowing through the frame in a retrograde direction, and a cuff configured to be sutured to a native valve annulus of a heart of a patient. The system may include a valve tether having a first end configured to be coupled to the surgical prosthetic heart valve, and an anchor configured to be secured to a ventricular apex of the heart of the patient. The valve tether may include a second end opposite the first end, the second end configured to be operably coupled to the anchor.

An epicardial device for reducing or preventing regurgitation of blood through a valve of a heart includes a main body having a segment adapted to apply force to an epicardial surface of the heart. A member that applies counterforce to the force applied by the segment is also provided. A foundation is configured to be anchored to the epicardial surface of the heart. The foundation includes a surface configured with attachment features. The device further includes a surface configured with mating attachment features configured to attach to the attachment features of the foundation. The mating attachment features and attachment features are separable and reattachable to allow repositioning of at least a portion of the device relative to the foundation.

Apparatus and methods are described herein for a secondary valve apparatus that can be deployed within an existing implanted prosthetic heart valve. In some embodiments, a secondary prosthetic heart valve apparatus is implanted in series with an existing deteriorating implanted prosthetic valve. The secondary valve apparatus can restore proper valve function without disruption to the failing previously implanted valve. In some embodiments, the secondary valve apparatus can be positioned on an atrial portion of the existing valve, and be delivered transseptally. In other embodiments, the secondary valve apparatus can be positioned at a ventricular portion of the existing valve and delivered transapically. Devices and methods to prepare the existing valve to receive a secondary valve apparatus are also described herein. In some embodiments, a balloon expansion device can be used to expand an inner diameter of the existing valve to provide space for the secondary valve to be disposed.

The present teachings provide systems, devices, and methods for reshaping the heart and reducing valve regurgitation. A device can be positioned proximate the heart and have a delivery profile and an inflated profile. The device can have a primary cavity and a secondary cavity, and an adhesive inside the secondary cavity. An injectable medium can be injected to the primary cavity of the device. As the primary cavity is filled, the adhesive is forced out of the secondary cavity to adhere the device. The inflated device can exert pressure on the heart, change the shape of a valve annulus, and allow a better coaptation of the valve leaflets.

A radially compressible cardiac gripper for at least mechanical stimulation of a heart. The cardiac gripper has two gripper arms, wherein at least one of the gripper arms comprises a flexible section configured for movement of the arm having the flexible section.