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: An implant comprises an elongate member, and anchors distributed along the elongate member. A gripper comprises a locking element that, in a locked state thereof, inhibits sliding of the elongate member through the gripper by clamping the elongate member. A tool is configured to, while (i) the elongate member extends proximally from a proximal-most of the anchors, and through the gripper, and (ii) an unlocker is positioned within the gripper in a manner that obstructs the locking element from assuming the locked state: (A) advance transluminally toward the proximal-most anchor, and (B) tension the elongate member by pulling the elongate member proximally through the gripper while the unlocker obstructs the locking element from assuming the locked state. The tool is also configured to subsequently facilitate the locking element clamping the elongate member via withdrawal of the unlocker from the gripper. Other embodiments are also described.

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: A process of monitoring heart valve function involves placing one or more transducers on a patient's body, receiving, using the one or more transducers, one or more signals indicating a blood flow velocity profile associated with a heart of the patient, identifying a first peak in the blood flow velocity profile, and determining a severity of a dysfunction of a first heart valve of the heart based on the first peak.

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 implantable sensor device includes a sensor-support substrate, a microelectromechanical systems (MEMS) pressure sensor device mounted to the sensor-support substrate, a transduction medium applied over the pressure sensor device, and a biocompatibility layer applied over the transduction medium

Abstract: The invention is a device, system, and method for providing an initial assessment of potential heart valve disease and recommending and/or providing follow-up assessments for heart valve disease. The invention includes a simple ECHO device which uses ultrasonic signals to detect and determine maximum blood flow velocities, and compares the maximum blood flow velocities to set thresholds to determine if it is appropriate for the patient to be subjected to additional and more detailed assessments for heart valve disease.

Abstract: A method can comprise advancing a suction cup at a distal end of a suction catheter into a heart chamber, contacting the suction cup to a heart valve leaflet, and partially axially collapsing the suction cup while applying a negative pressure through the suction catheter and the suction cup and contacting the suction cup to the heart valve leaflet.

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: 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: 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: 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: 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: A steerable catheter comprises a flexible tube having a proximal portion and a distal portion and comprising a circumferential wall that defines an elongate lumen between the proximal portion and the distal portion. A pull-wire can extend, in association with the wall, from the proximal portion to the distal portion. A pull-ring can be coupled to the wall at the distal portion such that the pull-ring circumscribes the lumen, and coupled to the pull-wire, such that pulling on the pull-wire bends the distal portion. The pull ring can have (i) a first state in which the pull-ring is elliptical and has a first eccentricity, and (ii) a second state in which the pull-ring is elliptical and has a second eccentricity that is smaller than the first eccentricity. The pull ring can be biased toward the first state, and deformable to the second state. Other embodiments are also described.

Abstract: A prosthesis can be configured to grasp intralumenal tissue when deployed within a body cavity and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can include an expandable frame configured to radially expand and contract for deployment within the body cavity and a valve body. The expandable frame can include a frame body and a supplemental frame. The valve body can include a plurality of leaflets and one or more intermediate components. The one or more intermediate components can couple at least a portion of the leaflets to the expandable frame. The prosthesis can include an annular flap positioned around an exterior of the expandable 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.

Abstract: Methods, systems, and apparatuses for treating a heart are provided. Methods can include obtaining and using an implant. One or more catheters can be used to properly position and attach the implant in a desired location in a chamber of the heart, for example, such that (i) a first portion of the implant is anchored to a first site on a wall of the chamber, (ii) a second portion of the implant is anchored to a second site on the wall of the chamber, (iii) a mid-portion of the implant extends in a curved path along the wall of the chamber between the first site and the second site, and (iv) an elongate contraction member of the implant cuts across the chamber between the first site and the second site. Other embodiments are described.

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: Methods, systems, and apparatuses for treating a heart are provided. Methods can include obtaining and using an implant. One or more catheters can be used to properly position and attach the implant in a desired location in a chamber of the heart, for example, on a ventricular wall of the left ventricle between one or more papillary muscles of the left ventricle and the annulus. Then a distance along the implant or a region of the heart, for example, between the papillary muscle and the annulus, can be reduced by contracting the implant along its longitudinal axis by applying tension to a contraction member of the implant. Other embodiments are described.