Abstract: A method of replacing a native heart valve utilizing a support structure comprising a first fastener, a second faster, a first leaflet brace, and a second leaflet brace. The first leaflet brace is configured to be advanced over a first guide wire to be adjacent to a portion of a first native leaflet. The second leaflet brace is configured to be advanced over a second guide wire to be adjacent to a portion of a second native leaflet. The first fastener and the second fastener are configured to be advanced over the first and second guide wires to respectively engage with first and second ends of the first leaflet brace and the second leaflet brace. A replacement heart valve is deployed within the native heart valve, thereby capturing the first and second leaflets between the support structure and the replacement heart valve.

Abstract: The invention is a cardiac implant, and associated methods therefore, configured to repair and/or replace a native heart valve, and having a support frame configured to be reshaped into an expanded/changed form in order to receive and/or support an expandable prosthetic heart valve therein. The implant may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace/repair a native valve (or other prosthetic heart valve), but to assume a generally non-rigid and/or expanded/expandable form when subjected to an outward force such as that provided by a dilation balloon. The implant may be configured to have a generally D-shaped configuration when initially implanted, but to assume a generally circular form when subjected to an outward force such as that provided by a dilation balloon.

Abstract: A system for repairing a native heart valve can comprise a first fastener, a second faster, a first leaflet brace, and a second leaflet brace. The first leaflet brace can be configured to extend partially around a first native leaflet. The second leaflet brace can be configured to extend partially around a second native leaflet. The first fastener can be configured to be deployed on respective first end portions of the first and second braces so as to connect the first end portions to each other. The second fastener can be configured to be deployed on respective second end portions of the first and second braces so as to connect the second end portions to each other. When the first end portions are connected to each other and the second end portions are connected to each other, the first and second leaflet braces encircle the first and second native leaflets.

Abstract: A monitoring system includes a wearable patch device configured to be secured to a body of a patient, the wearable patch device comprising a patch body, a first discrete transducer associated with a first position of the patch body, a second discrete transducer associated with a second portion of the patch body, and a wireless transmitter, and electronics including one or more processors and one or more memory devices and configured to receive signals based on transducer readings of the first and second discrete transducers and determine an amount of blood flow through one or more valves of a heart of the patient based on the signals.

Abstract: An active annuloplasty ring holder having a template that can be folded or pivoted to the side allowing the template to align longitudinally with the handle and enter the patient's chest through a small incision. The holder may include a mechanism to remotely detach sutures fastening the ring to the holder, thereby detaching the ring while avoiding the risk associated with introducing a scalpel into the operating field. A detachment mechanism may include a movable pin actuated by a pull wire that releases a plurality of holding sutures, or a hot wire, knives, or pull wire that severs the sutures. The holder may have a built-in light source for better visualization of the ring inside the heart. The holder may also have an optical means of visualizing the inside of the heart from the proximal end of the handle.

Abstract: An annuloplasty implant comprises an elongate member, a plurality of anchors, and a gripper. The elongate member has a proximal end, and a distal portion that includes a distal end. The plurality of anchors are distributed along the elongate member. The elongate member extends proximally from a proximal-most anchor and through the gripper. The gripper comprises a locking element that, in a locked state, inhibits sliding of the elongate member through the gripper. An unlocker, disposed within the gripper, obstructs the locking element from assuming the locked state, and is pullable proximally out of the gripper. The gripper automatically assumes the locked state upon the unlocker being pulled proximally out of the gripper. A tool tensions the distal portion of the elongate member by pulling the elongate member proximally through the gripper while the unlocker obstructs the locking element from assuming the locked state. Other embodiments are also described.

Abstract: An active annuloplasty ring holder having a template that can be folded or pivoted to the side allowing the template to align longitudinally with the handle and enter the patient's chest through a small incision. The holder may include a mechanism to remotely detach sutures fastening the ring to the holder, thereby detaching the ring while avoiding the risk associated with introducing a scalpel into the operating field. A detachment mechanism may include a movable pin actuated by a pull wire that releases a plurality of holding sutures, or a hot wire, knives, or pull wire that severs the sutures. The holder may have a built-in light source for better visualization of the ring inside the heart. The holder may also have an optical means of visualizing the inside of the heart from the proximal end of the handle.

Abstract: An implant having an implant body, a gripper, an elastic pouch, and an elongate member. The pouch can be coupled to the gripper, can have a first part and a second part, can have a contracted state toward which the pouch is elastically biased, and can be reversibly stretchable into a stretched state. The elongate member can have a first end portion coupled to the implant body, a second end portion fastened to the second part of the pouch, and a mid-portion extending (i) from the second end portion, through the pouch to the first part of the pouch, and (ii) out of the pouch to the first end portion. In at least one state of the gripper, the mid-portion can be slidable through the gripper and into the pouch. Other embodiments are also described.

Abstract: The invention is a device, system, and method for monitoring function of heart valves. The invention includes a disposable patch having simple transducers and simple processing for monitoring heart valve performance via echo Doppler and processing the data to determine blood flow velocities and/or blood flow gradients.

Abstract: Embodiments of a heart shape preserving anchor are disclosed herein. The heart shape preserving anchor can include a frame having one or more wings extending from a lower end of the frame. The frame can be sized and shaped to distribute forces over a large surface area thereby reducing pressures applied on the heart. The anchor can include a tether for coupling to a prosthesis, such as a replacement heart valve prosthesis. In some embodiments, the anchor can include a tether adjustment mechanism which can be wirelessly operated to adjust a length of the tether relative to the frame.

Abstract: Sensor-integrated prosthetic valves that can comprise a variety of features, including a plurality of valve leaflets, a frame assembly configured to support the plurality of valve leaflets and define a plurality of commissure supports terminating at an outflow end of the prosthetic valve, a sensor device associated with the frame assembly and configured to generate a sensor signal, for example, a sensor signal indicating deflection of one or more of the plurality of commissure supports, and a transmitter assembly configured to receive the sensor signal from the sensor device and wirelessly transmit a transmission signal that is based at least in part on the sensor signal.

Abstract: Methods and devices for the treatment of cardiac valve dysfunction through the placement of lines and anchors. The lines and anchors can form artificial chordae between valve leaflets and the ventricular wall or papillary muscles or connect the two valve leaflets together. The methods and devices offer a mechanism for performing this technique with the heart still beating, and allows for the placement of multiple lines with a single device.

Abstract: Sensor-integrated prosthetic valves that can comprise a variety of features, including a plurality of valve leaflets, a frame assembly configured to support the plurality of valve leaflets and define a plurality of commissure supports terminating at an outflow end of the prosthetic valve, a sensor device associated with the frame assembly and configured to generate a sensor signal, for example, a sensor signal indicating deflection of one or more of the plurality of commissure supports, and a transmitter assembly configured to receive the sensor signal from the sensor device and wirelessly transmit a transmission signal that is based at least in part on the sensor signal.

Abstract: A prosthetic mitral valve assembly includes a valve component formed with a radially expandable frame and a valve structure supported inside of the frame. In one embodiment, the prosthetic mitral valve assembly further includes an expandable anchor having an annular base. A plurality of cantilevered fixation members extend from the base of the expandable anchor. The fixation members of the expandable anchor are adapted to rotate relative to a longitudinal axis as the valve component is radially expanded within the base of the expandable anchor. As the fixation members rotate, native mitral valve leaflets are securely captured between the fixation members of the anchor and the valve component.

Abstract: Methods and devices for the treatment of cardiac valve dysfunction through the placement of lines and anchors. The lines and anchors can form artificial chordae between valve leaflets and the ventricular wall or papillary muscles or connect the two valve leaflets together. The methods and devices offer a mechanism for performing this technique with the heart still beating, and allows for the placement of multiple lines with a single device.

Abstract: A two-stage or component-based valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be a non-expandable type, or may be expandable from a compressed state to an expanded state.

Abstract: The invention is a cardiac implant, and associated methods therefore, configured to repair and/or replace a native heart valve, and having a support frame configured to be reshaped into an expanded/changed form in order to receive and/or support an expandable prosthetic heart valve therein. The implant may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace/repair a native valve (or other prosthetic heart valve), but to assume a generally non-rigid and/or expanded/expandable form when subjected to an outward force such as that provided by a dilation balloon. The implant may be configured to have a generally D-shaped configuration when initially implanted, but to assume a generally circular form when subjected to an outward force such as that provided by a dilation balloon.

Abstract: The invention is a cardiac implant, and associated methods therefore, configured to repair and/or replace a native heart valve, and having a support frame configured to be reshaped into an expanded/changed form in order to receive and/or support an expandable prosthetic heart valve therein. The implant may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace/repair a native valve (or other prosthetic heart valve), but to assume a generally non-rigid and/or expanded/expandable form when subjected to an outward force such as that provided by a dilation balloon. The implant may be configured to have a generally D-shaped configuration when initially implanted, but to assume a generally circular form when subjected to an outward force such as that provided by a dilation balloon.

Abstract: A heart valve prosthesis for replacing a native mitral valve includes a self-expanding frame with a plurality of anchoring members disposed along the lower region. A valve body is positioned within the self-expanding frame and includes a plurality of leaflets configured to allow blood flow through the self-expanding frame in only one direction. A skirt surrounds the self-expanding frame and is spaced apart therefrom for contacting surrounding tissue and impeding blood flow around the self-expanding frame. The skirt may be reinforced with wires to help maintain a desired shape. The leaflets in the valve body are preferably connected to the self-expanding frame through one or more intermediate components such that the valve body is spaced radially inwardly from an inner surface of the self-expanding frame.

Abstract: A two-stage or component-based valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be a non-expandable type, or may be expandable from a compressed state to an expanded state.