Implantable coaptation assist devices with sensors, and associated systems and methods

Abstract

To provide simple, effective, and less invasive devices and methods for treating dysfunctional heart valves.SOLUTION: A coaptation assist device for repairing cardiac valves and associated systems and methods are disclosed herein. A coaptation assist device configured in accordance with embodiments of the present technology can include, for example, a fixation member configured to press against cardiac tissue proximate to a native valve annulus, and a stationary coaptation structure extending away from the fixation member. The coaptation structure can include an anterior surface configured to coapt with a first native leaflet during systole, and a posterior surface configured to displace at least a portion of a second native leaflet. The coaptation assist device can also include at least one sensor configured to detect parameters associated with at least one of the cardiac function and the device functionality. The sensors can be pressure sensors configured to detect left atrial pressure and / or left ventricular pressure.SELECTED DRAWING: Figure 1A

Description

[Technical field]

[0001] The present technology relates generally to valve repair devices. In particular, some embodiments relate to an implantable coaptation assist device with a sensor and associated systems and methods.

[0002] REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 793,273, filed January 16, 2019, which is incorporated by reference in its entirety. [Background technology]

[0003] Conditions that adversely affect the proper functioning of the mitral valve include, for example, mitral regurgitation, mitral valve prolapse, and mitral valve stenosis. Mitral regurgitation is a heart condition in which the leaflets of the mitral valve do not coapt and stick together at peak systolic pressure, resulting in abnormal leakage of blood from the left ventricle to the left atrium. There are several structural factors that may adversely affect the proper closure of the mitral valve leaflets. For example, many patients with heart disease have dilated myocardium, resulting in an enlarged mitral valve annulus. The enlargement of the mitral valve annulus makes it difficult for the leaflets to coapt during cardiac contraction. Stretching or avulsion of the chordae tendineae, the tendons that connect the papillary muscles to the underside of the mitral valve leaflets, may also adversely affect the proper closure of the mitral valve annulus. For example, rupture of the chordae tendineae may cause the leaflets to prolapse into the left atrium due to inappropriate tension on the leaflets. Abnormal regurgitation can also occur when papillary muscle function is impaired, for example due to ischemia: when the left ventricle contracts during systole, the affected papillary muscles do not contract sufficiently to effect proper closure.

[0004] Mitral valve prolapse, or abnormal upward bulging of the mitral valve leaflets into the left atrium, can cause irregular mitral valve behavior and result in mitral valve regurgitation. Normal mitral valve function can also be adversely affected by mitral valve stenosis, or narrowing of the mitral orifice, which creates left ventricular filling impedance during diastole.

[0005] Mitral regurgitation is often treated with diuretics and / or vasodilators to reduce the amount of blood that leaks back into the left atrium. Other treatments, such as surgical approaches (open and endovascular), have also been used to either repair or replace the mitral valve. For example, typical repair procedures involve cinching or ablation of portions of the dilated annulus.

[0006] Cinching of the annulus has commonly been accomplished by implantation of an annular or circumferential annular ring that is anchored to the annulus or surrounding tissue. Other repair techniques have also involved suturing or clipping the leaflets into their mutual attachments.

[0007] Alternatively, more invasive procedures have involved total heart valve replacement, in which a mechanical valve or biological tissue is implanted into the heart in place of the mitral valve. These invasive procedures have traditionally been performed through a large open thoracotomy and thus are extremely painful, involve significant morbidity, and require long recovery periods.

[0008] However, many repair and replacement procedures may present additional problems for the patient as a result of device durability or improper sizing of the annuloplasty ring or replacement valve. Additionally, many repair procedures are highly dependent on the skill of the cardiac surgeon, where poorly or incorrectly placed sutures may adversely affect the success of the procedure.

[0009] Compared to other heart valves, some parts of the mitral valve annulus have limited significant radial support from the surrounding tissues, and the mitral valve has an irregular and unpredictable shape. For example, the inner wall of the mitral valve is bounded only by a thin vascular wall that separates the mitral valve annulus from the lower portion of the aortic outflow tract. As a result, significant radial forces on the mitral valve annulus can cause collapse of the lower portion of the aortic tract, with potentially fatal consequences. Chordae tendineae in the left ventricle are often an obstacle when deploying mitral valve repair devices. The labyrinthine web of chordae tendineae in the left ventricle makes it extremely difficult to navigate and position a deployment catheter for mitral valve repair. Summary of the Invention [Problem to be solved by the invention]

[0010] Given the problems associated with current procedures, there continues to be a need for simple, effective and minimally invasive devices and methods for treating dysfunctional heart valves. [Means for solving the problem]

[0011] Many aspects of the present disclosure can be better understood with reference to the following drawings. The components depicted in the drawings are not necessarily drawn to scale, emphasis instead being placed on clearly illustrating the principles of the present disclosure. For ease of reference, the same reference numbers and / or characters are used throughout this disclosure to indicate the same or similar components or features, but the use of the same reference numbers does not imply that the parts should be considered identical. Indeed, in many examples described herein, components with the same numbers refer to different embodiments that are separate in structure and / or function. Headings provided herein are for convenience only. [Brief description of the drawings]

[0012] [Figure 1A]FIG. 13 is a plan view of a coaptation assistance instrument configured in accordance with some embodiments of the present technology. [Figure 1B] FIG. 1B illustrates a mitral valve repair and monitoring system including the coaptation assist device of FIG. 1A implanted in the heart in accordance with some embodiments of the present technology. [Figure 2A] FIG. 13 is a plan view of a coaptation assistance instrument configured in accordance with some embodiments of the present technology. [Figure 2B] FIG. 2B is a side view of a mitral valve repair and monitoring system including the coaptation assistance device of FIG. 2A in accordance with some embodiments of the present technology. [Figure 2C] FIG. 2B is a top view of the coaptation assistance instrument of FIG. 2A in a delivery state in accordance with some embodiments of the present technology. [Figure 3A] FIG. 13 is a plan view of a coaptation assistance instrument configured in accordance with some embodiments of the present technology. [Figure 3B] FIG. 13 is a side view of a coaptation assistance instrument configured in accordance with some embodiments of the present technology. [Figure 4A] FIG. 13 is a side view of a coaptation assist device shown implanted within the heart during systole in accordance with some embodiments of the present technology. [Figure 4B] FIG. 13 is a side view of a coaptation assist device shown implanted within a heart during diastole in accordance with some embodiments of the present technology. [Figure 5A] 14A-14C are side views illustrating procedural steps for delivering a sensor to an implantable coaptation assistance device in accordance with some embodiments of the present technology; [Figure 5B] 14A-14C are side views illustrating procedural steps for delivering a sensor to an implantable coaptation assistance device in accordance with some embodiments of the present technology; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] Disclosed herein is an implantable coaptation assist device with sensors and associated systems and methods. In some embodiments, for example, a coaptation assist device (also referred to as a "mitral valve repair device") has (a) a coaptation structure that replaces the native leaflet and coapts with one or more opposing native leaflets during systole, and (b) one or more sensors that monitor various physiological and / or device parameters that can be used to determine or guide patient care. Thus, the technology may also be referred to as a "smart" heart valve repair device. Specific details of some embodiments of the technology are described below with reference to FIGS. 1A-5B. Although many of the embodiments are described below in conjunction with implantable devices, systems, and methods for repair of the native mitral valve, in addition to those embodiments described herein, other applications and other embodiments are within the scope of the technology. For example, the technology can be used for other target sites, such as the tricuspid valve. In addition, some other embodiments of the technology can have different configurations, components, or procedures than those described herein, and features of the illustrated embodiments can be combined with each other. Accordingly, those skilled in the art will appreciate that the technology may be implemented in other embodiments that include additional elements or that do not include some of the features shown in and described below with reference to Figures 1A-5B.

[0014] With respect to the terms "distal" and "proximal" as used herein, unless otherwise specified, these terms can refer to the relative location of portions of a valve repair device and / or associated delivery device relative to an operator and / or a location in the vasculature or heart. For example, with respect to a delivery catheter suitable for delivering and positioning the various valve repair devices described herein, "proximal" refers to a location near the operator of the device or an incision into the vasculature, and "distal" refers to a location (e.g., the end of the catheter) that is further from the operator of the device or further from an incision along the vasculature. With respect to a heart valve repair device, the terms "proximal" and "distal" can refer to the location of portions of the device relative to the direction of blood flow. For example, "proximal" can refer to the upstream location or location where blood flows toward the device in its typical non-reflux path (e.g., the inlet region of the native valve), and "distal" can refer to the downstream location or location where blood flows away from the device (e.g., the outflow region of the native valve).

[0015] Overview The present technology includes a device for treating mitral regurgitation that places a coaptation structure (also called a "baffle") over a portion of the native leaflet to address the problem of regurgitation caused by dilation of the annulus or deterioration of the native leaflet. The coaptation structure fills at least a portion of the space occupied by the closed native leaflet and extends beyond the space to re-establish a coaptation relationship with the surrounding leaflets. For example, the coaptation structure extends in front of the central portion of the posterior leaflet (i.e., P2 of the posterior leaflet) and pushes the posterior leaflet back toward the ventricle so that the coaptation structure is positioned to coapt with the anterior leaflet during systole. The coaptation structure is held in place by a fixation member (also called an "anchoring member" or "brim") configured to anchor to the atrial heart tissue surrounding the mitral annulus. The fixation member may be a malleable nitinol mesh tube (e.g., a stent) shaped to fit the wall of the left atrium located just above the mitral annulus. In various embodiments, the fixation member may additionally or alternatively include a portion that presses against and secures to the accessory annular tissue. In some embodiments, the fixation member has a cleat or other frictional element to hold it in place against the atrial wall. Over a period of time after implantation (e.g., 3 days, 2 weeks, 1 month, 2 months), the fixation member or some portion thereof becomes covered with a layer of tissue, and this tissue ingrowth permanently attaches the fixation member to the atrial wall. The device may further include one or more clips that extend from the fixation member and / or coaptation structure to a location behind each mitral leaflet into the accessory annular space where further stabilization of the implant is obtained. In some embodiments, for example, the device includes a clip that reaches into the accessory annular space under the P2 or other portion of the posterior leaflet to further stabilize the implant. Further description of the implant device with coaptation assist device is set forth in International Application No. PCT / US2018 / 043566, filed July 24, 2018, and International Application No. PCT / US2018 / 061126, filed November 14, 2018, each of which is incorporated by reference in its entirety.

[0016] The mitral valve repair device has at least one sensor (also referred to as a "sensing component") that detects parameters associated with cardiac function, other physiological parameters, and / or device functionality to provide real-time monitoring of the detected parameters. The sensor may include a pressure sensor, an accelerometer, a strain gauge, an acoustic sensor (e.g., a microphone), a flow sensor, a temperature sensor, and / or other types of sensing mechanisms. The sensor may be communicatively coupled to a communication component or transmitter, e.g., an antenna, that wirelessly transmits the detected measurements to an external computing device located outside the body. Data may be displayed and / or further analyzed (e.g., compared to thresholds and interpreted to determine relevant parameters) via software techniques from the external computing device and / or devices communicatively coupled thereto. The sensor may be powered via an external power source and / or by a battery or capacitive element incorporated into the device or the sensor itself.

[0017] Because the mitral valve repair device has portions located in both the atrium and the ventricle when implanted, the mitral valve repair device may have sensors located in both the atrium and the ventricle that can monitor and wirelessly transmit parameters associated with both locations, such as atrial and ventricular pressure, in real time. If the mitral valve repair device has a pressure sensor (e.g., a capacitive pressure microsensor) in the atrial region (e.g., on or extending from the fixation member), the device may detect left atrial pressure ("LAP"). Monitoring LAP may be of particular interest due to its potential for pressure-guided management of congestive heart failure ("CHF"). Many patients with mitral valve disease also present with CHF, which may be the result of untreated mitral regurgitation or other conditions that damage or weaken the heart, such as coronary artery disease, heart attack, high blood pressure, cardiomyopathies, arrhythmias, and other chronic diseases. By monitoring parameters such as LAP and / or pulmonary artery pressure in real time with sensor devices, physicians can effectively manage CHF patients and catch worsening conditions before symptoms appear. LAP monitoring can also provide a means of monitoring proper device function as it is related to the disappearance of mitral regurgitation (i.e., increased regurgitation causes increased LAP).

[0018] If the mitral valve repair device has a pressure sensor in the ventricular region (e.g., on or in the coaptation structures, on or in the clip), the device can measure left ventricular pressure ("LVP"). This provides a means to assess left ventricular ("LV") contractility (i.e., rate of change of LV pressure or LV dP / dt), which is an important indicator of ventricular function. Because the sensor device can detect LVP, it can also provide an accurate measure of peak systolic arterial pressure, and this ability of the sensor device can serve as an indicator of aortic valve stenosis.

[0019] If the mitral valve repair device has pressure sensors in both the atrial and ventricular regions, the device may be configured to monitor the differential pressure between the LV and the left atrium ("LA"). During diastole, the differential pressure can provide an early indicator of mitral stenosis, whereas during systole, the differential pressure can provide an indicator of mitral regurgitation. By closely monitoring these two measurements (i.e., LVP and LAP) over the cardiac cycle, an estimate of cardiac output can also be obtained.

[0020] In some embodiments, the mitral valve repair device can have additional or other sensors. For example, the device can have one or more accelerometers and / or one or more strain gauges that can monitor the device's motion and / or the myocardial wall motion. As another example, the mitral valve repair device can have microphones that detect acoustic signals in the heart, which can be analyzed (e.g., by machine learning at a remote device) to provide important information about the function of the heart's valves and chambers. As yet another example, the mitral valve repair device can have a flow sensor (e.g., an inductively powered flow sensor) integrated into the atrium-facing side of the docking structure to measure flow patterns throughout the cardiac cycle and detect the improvement or worsening of mitral valve regurgitation.

[0021] SELECTED EMBODIMENTS OF A MITRAL VALVE REPAIR DEVICE WITH SENSORS FIG. 1A is a plan view of a coaptation assist device 100 (also referred to as "mitral valve repair device 100" or "device 100") configured in accordance with some embodiments of the present technology, and FIG. 1B illustrates a mitral valve repair and monitoring system 101 ("system 101") including the device 100 of FIG. 1A implanted within a heart in accordance with some embodiments of the present technology. The device 100 includes a fixation member 102 (also referred to as "atrial fixation member 102") configured to anchor the device 100 to cardiac tissue located near the native mitral valve annulus, a coaptation structure 104 configured to coapt to the opposing superscript leaflet, and at least one sensor (shown here as first sensor 106a and second sensor 106b, collectively referred to as "sensor 106") for detecting one or more parameters (e.g., pressure, acceleration) associated with cardiac function and / or functionality of the device 100. As shown in FIG. 1B, the system 101 may further include an external device 122 communicatively coupled to the sensor 106. The external device 122 can interrogate and / or power the sensors 106 to enable a technician, the patient, and / or others involved in the patient's care to monitor the patient's cardiac health and / or device performance.

[0022] The fixation member 102 may include an expandable mesh structure 108 (e.g., a stent) that has an oval or circular shape in the deployed state and an open central lumen 110 through which blood can pass. The mesh structure 108 may be a stent made of Nitinol or other suitable stent material. As shown in FIG. 1B, the fixation member 102 may be shaped to conform to the wall of the left atrium (LA) just above the mitral annulus to secure the device 100 to the annulus tissue. After implantation (e.g., after 3 days, 2 weeks, 1 month, 2 months), the fixation member 102, or some portion thereof, becomes covered with a layer of tissue, and this tissue ingrowth permanently attaches the device 100 to the atrial wall. The fixation member 102 may further include cleats or other frictional elements to enhance fixation and facilitate tissue ingrowth. In some embodiments, the fixation member 102 has a semicircular or other shape that does not extend completely around the circumference of the native valve. In some embodiments, the fixation member 102 may additionally or alternatively include one or more portions that press against the accessory annular tissue to effect fixation of the accessory annular tissue.

[0023] The attachment structure 104 extends in a generally downstream direction (along the longitudinal axis of either the central lumen 110 or the fixation member 102) away from a portion of the fixation member 102, and at least a portion of the attachment structure 104 extends radially inward from the fixation member 102 into the central lumen 110 to approximate a closed position of the natural leaflets. In the deployed state, the position of the attachment structure 104 relative to the fixation member 102 is at least substantially fixed. Thus, unlike the natural leaflets which move back and forth to open and close the natural valve, the attachment structure 104 remains stationary during diastole and systole. The attachment structure 104 can have an anterior portion 112 with a smooth, atraumatic surface that attaches to at least a portion of one or more natural leaflets, and a posterior portion 114 configured to displace and optionally engage at least a portion of another natural leaflet. 1B, for example, the attachment structure 104 can extend into the opening of the native mitral valve MV in front of the native anterior leaflet PL, so that the anterior portion 112 is positioned to re-establish a coaptation relationship with the contralateral anterior leaflet AL. The attachment structure 104 can include struts 116 that form a frame-like combination (e.g., a mesh structure, a laser cut stent frame) and a covering 118 (e.g., a fabric) that extends over at least a portion of the struts 116 to provide a smooth suitable surface for joining at the anterior portion 112. The covering 118 can also extend over the struts 116 along and between the anterior and posterior portions 112, 114 in a manner that forms an outer sidewall.

[0024] In some embodiments, the device 100 may further include one or more clips 109 extending in a downstream direction from the fixation member 102 and / or extending from the coaptation structure 104 to a location behind the native leaflet (e.g., the posterior leaflet PL) displaced by the coaptation structure 104. The clips 109 may grasp the native leaflet and / or engage the sub-annular heart tissue for sub-annular stabilization of the device 100. In some embodiments, for example, the device 100 has a clip that extends into the sub-annular space below a central portion of the posterior leaflet PL (i.e., P2).

[0025] Device 100 has a first or delivery state in which device 100 is compressed (e.g., by crimping) to a reduced cross-sectional state that allows delivery to the mitral valve, and a second or deployed state, shown in Figures 1A and 1B, in which device 100 has a larger cross-sectional area that allows it to engage the native valve. In some embodiments, the cross-sectional dimension of device 100 in the delivery state is less than 20 Fr (e.g., 16-18 Fr) to facilitate intravascular delivery via a transseptal approach.

[0026] One or more sensors 106 may be coupled to various portions of the device 100, and the coupling locations may be selected based on the desired sensed parameters and the type of sensor. In the embodiment shown in Figures 1A and 1B, for example, the first sensor 106a is coupled to the fixation member 102 such that the first sensor 106a is located in the left atrium LA after implantation, and the second sensor 106b is coupled to the junction structure 104 such that the first sensor 106a is located in the left ventricle LV after implantation. Specifically, the first sensor 106a is attached (e.g., welded) to the anterior atrial crown region 120 of the fixation member 102, and the second sensor 106b is attached (e.g., welded) to a strut 116 of the junction structure 104. In the illustrated embodiment, the device 100 has two sensors 106. In other embodiments, the device 100 can have a single sensor 106 or more than two sensors 106.

[0027] In some embodiments, the sensor 106 is a pressure sensor, e.g., a capacitive pressure sensor. Thus, in the example configuration shown in Figures 1A and 1B, the first sensor 106a can measure the LAP throughout the cardiac cycle, and the second sensor 106b can measure the LVP. The external reader 122 can establish a connection to each sensor 106 by an antenna associated with each sensor 106. For example, the stent frame of the fixation member 102 and the struts 116 of the joint structure 104 can be electroplated to form antennas for the first and second sensors 106a, 106b, respectively. Using these antennas, the external reader 122 can communicate with the sensors 106 to obtain the detected sensor data.

[0028] Capacitive pressure sensors (e.g., capacitive microelectromechanical systems (“MEMS”) pressure sensors) do not require batteries or electrical components, and they are small enough to be placed (e.g., crimped) into the delivery configuration where the device 100 is 16-20 Fr in diameter. Capacitive pressure sensors function as inductive capacitance tanks (LC tanks) and therefore include a fixed inductive element and a capacitive element consisting of a flexible plate whose separation changes with pressure. As a result, the resonant frequency of such devices changes precisely with pressure. Such capacitive pressure sensors (e.g., CardioMEMS, Abbott Laboratories, Atlanta, GA, USA) that provide remote pressure monitoring have a footprint of approximately 15 mm×2 mm×3.5 mm. Sensors of this size or smaller can be fitted or telescoped into the interface structure 104 and / or telescoped into the atrial fixation member 102. In some embodiments, the size of the capacitive pressure sensor can be reduced by placing the inductive element elsewhere within the device, such as around the fixation member 102. For example, the inductive element (e.g., a coil) can extend around the atrial edge region 120 of the fixation member 102 and / or be attached to the atrial apical portion 124 of the fixation member's stent frame. This configuration is expected to increase the exposure of the inductive element to external stimulating fields (e.g., magnetic fields).

[0029] In some embodiments, the inductive element may be enhanced or optimized by using a coil including multiple low resistance wires (e.g., gold wires). In this embodiment, the coil may be isolated from external electromagnetic stimulation fields to prevent the fixation member 102 and / or the stents and struts of the joint structure 104 from acting as a Faraday cage. For example, the desired isolation may be achieved by spacing the inductive element (e.g., coil) away from the middle or central portion of the fixation member 102, for example at the apical (atrial) edge of the fixation member 102 (e.g., along the atrial crown region 120). In this configuration, the inductive element may be exposed to and stimulated by external energy (e.g., external magnetic fields) without interference from the fixation member frame.

[0030] It is also envisioned that the inductive element of the capacitive sensor 106 is constituted by the stent of the fixation member 102 itself. This can be achieved by electroplating the mesh structure 108 (e.g., gold plating) to reduce electrical resistance and increase weldability. In this embodiment, the stent of the mesh structure 108 has two ends (e.g., formed by cutting the stent frame) at some points on its periphery to electrically isolate several parts from each other. For example, to facilitate keeping the ends electrically isolated from each other, the ends can be positioned at a location corresponding to the central region of the posterior leaflet PL where the mesh structure 108 is attached to the junction structure 104. The cut edges can be coupled to the capacitive components of the pressure sensor.

[0031] An external device 122 (also referred to as an “external wireless reader 122” or “external stimulus detector 122”) may communicate with the sensor 106 via an external antenna to interrogate the sensor 106. If the sensor 106 is a capacitive sensor that detects pressure using a tank circuit (also referred to as an “LC circuit” or “resonant circuit”) as described above, the external device 122 may stimulate the tank circuit via an oscillating external magnetic field at a frequency close to the tank circuit’s resonant frequency, and the resulting tank circuit resonant frequency is detectable by the external device 122. Since the resonant frequency is determined by the inductance and capacitance of the circuit, the detected resonant frequency may be used to determine the intracardiac pressure (e.g., processed by the external device 122 and / or other computing system). The resonant frequency of the LC circuit is specific to the specifications of the circuit components themselves, e.g., the inductors, capacitors, and relative positions of these features on the mitral valve repair device 100 and the features of the heart valve repair device 100 itself. For example, in some embodiments, the resonant frequency of the LC circuit may be between 100 kHz and 100 MHz, with smaller inductors having higher resonant frequencies than larger inductors. If more than one tank circuit is used (e.g., at the atrial portion of the device 100 to measure LAP and at the ventricular portion of the device 100 to measure LVP), the tank circuits may be designed to resonate at significantly different frequencies that allow both circuits (and thus both sensors 106) to be interrogated simultaneously by the external device 122 without interfering with each other. Alternatively, two or more circuits may be sequentially, i.e., interrogated, alternating between the circuits at regular intervals (e.g., every 1-50 milliseconds).

[0032] In some embodiments, the external device 122 may also be used to power the sensor 106. For example, the external device 122 may include a radio frequency source that has been shown to be capable of powering an implantable sensor from a distance of 1 meter at a depth of 10 cm. In other embodiments, a separate external device may provide the energy source for the sensor 106.

[0033] The external stimulation and detection device 122 may be carried by or integrated into a belt wrapped around the patient's chest, a vest, removable pads attached to the patient's skin or clothing, and / or another device that can be positioned close enough to the mitral valve repair device 100 to transmit energy (e.g., RF waves, ultrasound) to stimulate, interrogate, detect, and / or wirelessly power the sensor 106 of the implanted device 100. In some embodiments, the external stimulation and detection device 122 may be a separate handheld device that can be used by the patient, a volunteer, and / or another party involved in the patient's care. The external device 122 may further include a wireless communication detector (e.g., an antenna) that communicates with the sensor 106 of the implanted mitral valve repair device to receive sensor data. This sensor data may be stored locally on the external device 122 and / or transmitted to a separate device (e.g., a smart phone, a cloud service, another remote system). In some embodiments, the detector may be part of a device separate from the instrument that delivers energy to the implanted sensor.

[0034] Once information is detected from one or more sensors 106, the data may be processed locally at the external device 122 and / or transmitted via a communication medium (e.g., Wi-Fi, Bluetooth, etc.) to a separate device (e.g., a smart phone, a tablet, a back-end processing system, the cloud, a device in conjunction with a physician) for further processing and / or communication. The raw or processed data may be used to evaluate various parameters associated with the patient's cardiac function (e.g., LVP, LAP) and / or the functionality of the mitral valve repair device 100 (e.g., whether the device is working as expected). The information may be transmitted to the patient by a device communicatively coupled to the system 101, such as an application running on the patient's smart phone or tablet. The information may additionally or alternatively be sent to a physician and / or other person for remote tracking of the patient. In some embodiments, the system 101 can use the tracked data to initiate an alert for the patient (e.g., via a smart phone) and / or others involved in the patient's care based on predefined threshold parameters related to cardiac function, overall patient health, and / or device functionality.

[0035] In various embodiments, the device 100 can include other types of sensors in addition to or in place of the capacitive sensor 106 described above. For example, the device can include a temperature sensor 126 that detects temperature. The temperature sensor 126 can be attached to the exterior or interior of the baffle structure 104, to a portion of the fixation member 102, and / or to another portion of the mitral valve repair device 100. The temperature sensor 126 can detect temperature and / or data that can be used to determine temperature, which can be sent to the external device 122 (e.g., via an antenna) for real-time monitoring of the temperature around the implanted mitral valve repair device 100. In other embodiments, other sensors can be positioned on or integrated into the device 100 to detect cardiac function, other physiological parameters, and / or other parameters associated with device functionality, additionally or alternatively.

[0036] FIG. 2A is a plan view of a coaptation assistance device 200 ("device 200") configured in accordance with some embodiments of the present technology, and FIG. 2B illustrates a mitral valve repair and monitoring system 201 ("system 201") including the device 200 of FIG. 2A in accordance with some embodiments of the present technology. FIG. 2C is a plan view of the device 200 of FIG. 2A in a delivery state in accordance with some embodiments of the present technology. The system 201 and device 200 of FIGS. 2A-2C may have various features similar to those of the system 101 and device 100 described above with reference to FIGS. 1A-1B. For example, the device 200 includes a fixation member 102, a coaptation structure 104, and at least one sensor 206 configured to detect one or more parameters associated with cardiac function and / or device functionality. However, in the embodiment illustrated in FIGS. 2A-2C, the sensor 206 is a self-contained sensor with more sophisticated electronic circuitry. For example, the sensor 206 may be a self-contained pressure sensor incorporating both capacitive and inductive elements.

[0037] As shown in the illustrated embodiment, the self-contained sensor 206 can be attached to the front surface of the fixation member 102 by sutures, adhesives, welding, and / or other attachment mechanisms to monitor pressure (e.g., LAP). In other embodiments, the sensor 206 can be attached to other portions of the fixation member 102 and / or other portions of the device 200 (e.g., the interface structure 104). The sensor microchip and antenna can be made of a biocompatible material for long-term implantability. As will be appreciated by those skilled in the art, such a self-contained sensor can have dimensions of approximately 15 mm x 2 mm x 3.5 mm. In some embodiments, the fixation member 102 can be an expandable stent cut from 6 mm tubing with a wall thickness of 0.25 mm to 0.5 mm. As shown in FIG. 2C, such dimensions allow for a sufficient internal cross-sectional area (e.g., 5 mm inner diameter) for the sensor 206 to fit inside the fixation member 104 when compressed to a deployed state (e.g., 18 Fr outer diameter (6 mm)). In these and other embodiments, the instrument 200 may have multiple self-contained sensors 206 and / or one or more types of sensors (e.g., LC circuit pressure sensors, strain gauges, microphones, flow sensors, temperature sensors) coupled to various portions of the instrument 200.

[0038] With reference to FIG. 2B, the system 201 may further include an element for powering the instrument 200 and a transmitter for sending the detected data to the external reader 122. The power of this system 201 may come from an induction coil stimulated by an oscillating external magnetic field. The power may alternatively come from an external ultrasonic pressure wave or other source. This external power source may be integrated into the external reader 122 or a separate external device. In some embodiments, the instrument 200 may include a power storage element, such as a capacitor or a battery, in addition to or instead of an external power source. For example, the instrument 200 may store power until it has enough energy to measure via the sensor 206 and transmit via an associated antenna for a certain period of time, such as one or more heartbeats. In some embodiments, the antenna is integrated into the sensor 106. In some embodiments, the fixing member 102 or the joining structure 104 may itself serve as an antenna to improve the transmission of signals to the external reader 122.

[0039] In some embodiments, the sensor 206 may include one or more surface acoustic wave ("SAW") sensors for pressure monitoring. SAW sensors have been shown to be reliable in detecting in vivo pressure measurements. In addition, SAW sensors do not require a power source, exhibit long-term stability, are compact, and can communicate wirelessly with external devices positioned near the sensor. Furthermore, SAW sensors may be configured to be independently sensitive to pressure and temperature.

[0040] FIG. 3A is a plan view of a coaptation assistance device 300 ("device 300") configured in accordance with some embodiments of the present technology, and FIG. 3B illustrates a mitral valve repair and monitoring system 301 ("system 301") including the device 300 of FIG. 3A in accordance with some embodiments of the present technology. The system 301 and device 300 of FIGS. 3A and 3B can have various features similar to the features of the systems 101, 201 and devices 100, 200 described above with reference to FIGS. 1A-2C. For example, the device 300 includes a fixation member 102, a coaptation structure 104, and at least one sensor 306. In the embodiment illustrated in FIGS. 3A and 3B, the sensor 306 includes an accelerometer that measures device and / or heart motion. The accelerometer 306 can be disposed within the baffle structure 104 to monitor device motion and predict potential device breakage or migration. For example, the accelerometer 306 may be affixed to the baffle shroud 118 or baffle strut 116 (i.e., the frame of the junction structure 104) and positioned within the body of the junction structure 104 along an outwardly facing wall of the junction structure 104 and / or on another portion of the junction structure 104. In some embodiments, the accelerometer 306 may be freely positioned within an internal compartment defined by the walls of the junction structure 104. In this embodiment, natural clotting that occurs within the compartment after implantation of the device will eventually immobilize the free-floating accelerometer 306 and maintain a fixed position within the junction structure 104. There is a small, predictable amount of movement (e.g., as shown by arrow A) that occurs in the junction structure 104 throughout the cardiac cycle due to the application of systolic pressure to the device 300. If this movement becomes suddenly large, this may indicate movement or breakage of the device. Thus, the accelerometer 306 can detect such motion and provide an early signal of potential instrument abnormality, allowing for early intervention before instrument failure.

[0041] 4A and 4B illustrate a mitral valve repair and monitoring system 401 ("system 401") including a coaptation assist device 400 ("device 400") shown implanted within a heart during systole and diastole, respectively, in accordance with some embodiments of the present technology. The system 401 and device 400 of FIGS. 4A and 4B may have various features similar to those of the systems 101, 201, 301 and devices 100, 200, 300 described above with reference to FIGS. 1A-3B. For example, the device 400 includes a fixation member 102, a coaptation structure 104, and at least one sensor 406. In the embodiment illustrated in FIGS. 4A and 4B, the device 400 further includes an appendage 428 extending from the coaptation structure 104 or the posterior side of the posterior clip 109, and the sensor 406 is supported by the appendage 428. The sensor 406 may be an accelerometer that can be used to detect LV wall motion. The attachment 428 may include a flexible loop or frame structure 430 (e.g., a nitinol loop or stent structure) shaped to be biased outwardly away from the junction structure 104 so that the attachment 428 contacts or presses against the LV wall and moves with the LV wall throughout the cardiac cycle. The loop / frame structure 430 may have a fabric covering 432, e.g., PET, to promote rapid tissue ingrowth. The accelerometer 406 may be attached to the frame structure 430, covering 432 and / or positioned within the body of the attachment 428 so that the accelerometer moves with and detects the motion of the attachment imparted by the adjacent ventricular wall. The motion of the ventricular wall may be used to assess changes in ventricular function. In some embodiments, the sensor 406 is a strain gauge rather than an accelerometer, or the device 400 has both an accelerometer and a strain gauge. The strain gauges may be attached to the frame structure 430 and / or other portions of the appendage to detect when the heart wall applies a force to the appendage 428. The sensor 406 may be powered wirelessly by radio frequency and / or other provided external power source (e.g., external device 122 of FIG. 1B).In other embodiments, the sensor 406 may include or be coupled to a power source located on the instrument 400 itself. In some embodiments, the instrument 400 may have accelerometers, strain gauges located on other or additional portions of the instrument 400 to determine cardiac tissue motion and / or instrument functionality.

[0042] 5A and 5B are side views illustrating stages in a procedure for delivering a sensor 506 to an implanted coaptation assistance device 500 ("device 500") in accordance with some embodiments of the present technology. The device 500 of FIGS. 5A and 5B may have various features similar to those of the devices 100, 200, 300, 400 described above with reference to FIGS. 1A-4B. For example, the device 500 includes a fixation member 102, a coaptation structure 104, and at least one sensor 506. As described above, the sensor may be attached to or integrated with the device prior to delivery, such that the device and sensor are delivered together as a unit to a target site near the mitral valve. However, as shown in FIGS. 5A and 5B, the body of the device 500 (e.g., fixation member 102 and coaptation structure 104) and the sensor 506 may be delivered sequentially. For example, to accommodate packing of the device 500 into a small catheter 534 (only the distal end of the catheter 534 is shown) of a delivery system 536, any of the sensor components described above can be deployed after the fixation members 102 and interface structures 104 are already in place within the anatomy. As shown in FIG. 5A, for example, a line 538 (e.g., a suture) running from the fixation members 102 back into the delivery system 536 can provide a "rail" for the sensor 506 to slide along and then lock into place once properly positioned relative to the device 500.

[0043] The implantable devices described above can be delivered via a transfemoral approach and / or other approach that passes the device through the septum between the chambers of the heart. The implantable devices can also be delivered via minimally invasive surgical transapical or transatrial approaches, or via open surgical placement approaches. Catheter-based delivery approaches can utilize concepts for a variety of delivery systems that implant prosthetic heart valves and / or heart repair devices at target sites near the mitral, aortic, tricuspid, and / or other parts of the heart.

[0044] Implementation Several aspects of the present technology are described in the following embodiments section. [Embodiment 1] 1. A coaptation assist device for repairing a mitral valve, the coaptation assist device comprising: an atrial fixation member configured to press against cardiac tissue located near the native mitral valve annulus; an attachment structure extending radially inwardly away from and away from the atrial fixation member, the attachment structure having an anterior surface configured to attach to a first native cusp during cardiac systole and a posterior surface configured to displace at least a portion of a second native cusp, the attachment structure being substantially stationary during the cardiac cycle; and a sensor attached to a portion of the coaptation assist device and configured to sense one or more parameters associated with at least one of cardiac function and device functionality. [Embodiment 2] the sensor being a first pressure sensor coupled to the atrial fixation member and configured to sense left atrial pressure during a cardiac cycle; 2. The coaptation assist device of embodiment 1, further comprising a second pressure sensor coupled to the coaptation structure and configured to detect left ventricular pressure during the cardiac cycle. [Embodiment 3] the sensor is a first capacitive pressure sensor coupled to the atrial fixation member and configured to sense left atrial pressure during a cardiac cycle, the first capacitive pressure sensor having a first LC circuit with a first resonant frequency; the coaptation assist instrument further comprises a second capacitive pressure sensor coupled to the coaptation structure and configured to sense a left ventricular pressure during a cardiac cycle, the second capacitive pressure sensor having a second LC circuit with a second resonant frequency substantially different from the first resonant frequency; 2. The coaptation assistance instrument of embodiment 1, wherein the first and second LC circuits are configured to be simultaneously interrogated by an external device without interfering with each other. [Embodiment 4] the fixing member includes a wire mesh structure, at least a portion of the wire mesh structure being electroplated; The bonding assistance instrument according to any one of embodiment items 1 to 3, wherein the sensor comprises a capacitive pressure sensor attached to the wire mesh structure of the fixing member, and the wire mesh structure constitutes an antenna of the capacitive pressure sensor for transmitting and receiving signals from an external device. [Embodiment 5] the joint structure comprises a plurality of struts, at least a portion of the struts being electroplated; The joining assistance instrument according to any one of the first to fourth embodiments, wherein the sensor comprises a capacitance pressure sensor attached to the strut of the joining structure, and the strut constitutes an antenna of the capacitance pressure sensor for transmitting and receiving signals from an external device. [Embodiment 6] the fixation member having an atrial edge region; 6. The coaptation assist device of any one of embodiments 1 to 5, wherein the sensor is a capacitive pressure sensor attached to the atrial edge region, the capacitive pressure sensor having a capacitive element and an inductive element, the inductive element being a coil extending along the atrial edge region and configured to be stimulated by an external energy source. [Embodiment 7] The fixing member includes an electroplated mesh structure; The bonding assistance instrument according to any one of the first to sixth embodiments, wherein the sensor is a capacitive pressure sensor attached to the fixing member, the capacitive pressure sensor has a capacitive element and an inductive element, and the electroplated mesh structure constitutes the inductive element. [Embodiment 8] The coaptation assistance instrument according to any one of the first to seventh embodiments, wherein the sensor is a self-contained pressure sensor attached to the front surface of the fixing member. [Embodiment Item 9] The joining assistance instrument of any one of embodiments 1 to 8, further comprising a power storage element operatively coupled to the sensor, the power storage element configured to store energy until the power storage element has sufficient energy to detect a measurement value and transmit the detected measurement value to an internal device. [Embodiment 10] The coaptation assist instrument according to any one of the preceding embodiments, wherein the sensor comprises an accelerometer coupled to the coaptation structure and configured to detect movement of the coaptation structure during a cardiac cycle. [Embodiment 11] The coaptation assistance instrument according to any one of the first to tenth embodiments, wherein the coaptation structure is comprised of a plurality of struts forming a chamber, and the sensor is freely positioned within the chamber prior to instrument delivery. [Embodiment 12] and an appendage extending from a posterior portion of the attachment structure, the appendage including a flexible frame configured to be biased outwardly away from the attachment structure and to contact a left ventricular wall; 12. The coaptation assist instrument according to any one of the preceding embodiments, wherein the sensor comprises an accelerometer attached to the appendage for detecting movement of the left ventricular wall. [Embodiment 13] 13. The coaptation assist instrument according to any one of embodiments 1 to 12, wherein the sensor includes at least one of an accelerometer and a strain gauge configured to detect cardiac wall motion. [Embodiment 14] 14. The coaptation assistance instrument according to any one of the preceding embodiments, wherein the sensor comprises a microphone configured to detect acoustic signals during the cardiac cycle. [Embodiment 15] 15. The coaptation assist device of any one of embodiments 1-14, wherein the sensor comprises at least one flow sensor coupled to an atrium-facing surface of the coaptation structure and configured to measure flow patterns throughout the cardiac cycle. [Embodiment 16] 1. A heart valve repair and monitoring system comprising: a valve repair device, the valve repair device comprising: an interface structure having an anterior surface configured to interface with the first native cusp during cardiac contraction and a posterior surface configured to displace at least a portion of the second native cusp; a fixation member coupled to the attachment structure and configured to fix the attachment structure adjacent to the native heart valve annulus, the attachment structure being substantially stationary relative to the fixation member during the cardiac cycle; a pressure sensor configured to detect pressure during a cardiac cycle; A cardiac valve repair and monitoring system including an external stimulus and sensing device configured to interrogate the pressure sensor to wirelessly receive sensed data. [Embodiment 17] The heart valve repair and monitoring system of embodiment 16, wherein the external stimulation and detection device is configured to power the pressure sensor. [Embodiment 18] the pressure sensor is a first capacitive pressure sensor coupled to the fixation member and configured to detect left atrial pressure during a cardiac cycle, the first capacitive pressure sensor having a first LC circuit with a first resonant frequency; The valve repair device further comprises a second capacitive pressure sensor coupled to the interface structure and configured to sense a left ventricular pressure during a cardiac cycle, the second capacitive pressure sensor having a second LC circuit having a second resonant frequency substantially different from the first resonant frequency; The heart valve repair and monitoring system of embodiment 16 or 17, wherein the first and second LC circuits are configured to be simultaneously interrogated by an external device without interfering with each other. [Embodiment 19] the first capacitive pressure sensor having a first LC circuit with a first resonant frequency; the second capacitive pressure sensor having a second LC circuit having a second resonant frequency substantially different from the first resonant frequency; 20. The heart valve repair and monitoring system of embodiment 18, wherein the external stimulation and detection device is configured to simultaneously interrogate the first circuit and the second LC circuit. [Embodiment 20] The cardiac valve repair and monitoring system of any one of embodiments 16 to 19, further comprising a delivery system configured to deliver the sensor to the fixation device after the fixation member is deployed. [Embodiment 21] The fixing member includes a wire mesh structure, The joint structure is made up of a plurality of struts, A cardiac valve repair and monitoring system described in any one of embodiments 16 to 20, wherein at least one of the wire mesh structure and the plurality of struts constitutes an antenna for the pressure sensor which communicates with the external stimulus / detection device. [Embodiment 22] 22. The coaptation assist instrument of any one of embodiments 16-21, further comprising an accelerometer coupled to the coaptation structure and configured to detect movement of the coaptation structure during a cardiac cycle. [Embodiment 23] The valve repair device includes: an appendage extending from a posterior portion of the attachment structure, the appendage configured to be biased outwardly, away from the attachment structure, and to contact a ventricular wall; 23. The coaptation assist instrument according to any one of embodiments 16 to 22, further comprising an accelerometer attached to the appendage for detecting motion of the ventricular wall during the cardiac cycle. [Embodiment 24] 1. A method for monitoring a native mitral valve, the method comprising: deploying a fixation member of a mitral valve repair device in the left atrium of the heart such that the fixation member presses against cardiac tissue in the left atrium; deploying a coaptation structure of the mitral valve repair device such that the coaptation structure displaces a first native leaflet and coapts against a second native leaflet during systole; and interrogating a pressure sensor of the mitral valve repair device via an external device to receive pressure data during the cardiac cycle. [Embodiment 25] sliding the pressure sensor along a suture extending from a delivery system to the fixation member after deployment of the fixation member; 25. The method of embodiment 24, further comprising the step of coupling said pressure sensor to said deployed fixation member. [Embodiment 26] The method of embodiment 24 or 25, further comprising the step of detecting the motion of the left ventricular wall during the cardiac cycle by means of an accelerometer and / or a strain gauge.

[0045] conclusion The above description of the embodiments of the present technology is not exhaustive or intended to limit the present technology to the precise form disclosed above. Although specific embodiments and implementations of the present technology have been described above for illustrative purposes, those skilled in the art will recognize that various equivalent modifications are possible within the scope of the present technology. For example, while steps are provided in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0046] In view of the above, although specific embodiments of the present technology are described herein for illustrative purposes, well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present technology. Where the context permits, singular or plural terms may include the plural or singular terms, respectively.

[0047] Further, unless the term "or" is expressly limited to mean only a single item exclusive of the other items with reference to a list of two or more items, the use of "or" in such a list should be construed to include (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. In addition, "comprising" as used in the original specification is used throughout the specification to mean including at least the recited features, and therefore does not preclude any multiple of the same features and / or additional types of other features. It will also be understood that while certain embodiments have been described herein for illustrative purposes, various modifications can be made without departing from the technology. Furthermore, while advantages associated with certain embodiments of the technology have been described in the context of these examples, other embodiments may also enjoy such advantages, and not all embodiments necessarily enjoy such advantages to be within the scope of the technology. Thus, the disclosure and related technology can include other embodiments not expressly shown or described herein.

Claims

1. 1. A coaptation assist device for repairing a mitral valve, the coaptation assist device comprising: an atrial fixation member configured to press against cardiac tissue located near the native mitral valve annulus; an attachment structure extending radially inwardly away from and away from the atrial fixation member, the attachment structure having an anterior surface configured to attach to a first native cusp during cardiac systole and a posterior surface configured to displace at least a portion of a second native cusp, the attachment structure being substantially stationary during the cardiac cycle; and a sensor attached to a portion of the coaptation assist device and configured to sense one or more parameters associated with at least one of cardiac function and device functionality.

2. the sensor being a first pressure sensor coupled to the atrial fixation member and configured to sense left atrial pressure during a cardiac cycle; The coaptation assist device of claim 1 , further comprising a second pressure sensor coupled to the coaptation structure and configured to sense left ventricular pressure during a cardiac cycle.

3. the sensor is a first volumetric pressure sensor coupled to the atrial fixation member and configured to sense left atrial pressure during a cardiac cycle, the first volumetric pressure sensor having a first LC circuit with a first resonant frequency; the coaptation assist instrument further comprises a second capacitive pressure sensor coupled to the coaptation structure and configured to sense a left ventricular pressure during a cardiac cycle, the second capacitive pressure sensor comprising a second LC circuit having a second resonant frequency substantially different from the first resonant frequency; The coaptation assist instrument of claim 1 , wherein the first and second LC circuits are configured to be simultaneously interrogated by an external device without interfering with each other.

4. the fixing member includes a wire mesh structure, at least a portion of the wire mesh structure being electroplated; 2. The coaptation assistance instrument of claim 1, wherein the sensor comprises a capacitive pressure sensor attached to the wire mesh structure of the fixation member, the wire mesh structure forming an antenna for the capacitive pressure sensor for transmitting and receiving signals from an external device.

5. the joint structure comprises a plurality of struts, at least a portion of the struts being electroplated; 10. The coaptation assistance instrument of claim 1, wherein the sensor comprises a capacitive pressure sensor attached to a strut of the coaptation structure, the strut forming an antenna for the capacitive pressure sensor for transmitting and receiving signals from an external device.

6. the fixation member having an atrial edge region; 2. The coaptation assist instrument of claim 1, wherein the sensor is a capacitive pressure sensor attached to the atrial edge region, the capacitive pressure sensor having a capacitive element and an inductive element, the inductive element being a coil extending along the atrial edge region and configured to be stimulated by an external energy source.

7. The fixing member includes an electroplated mesh structure; 2. The coaptation assistance instrument of claim 1, wherein the sensor is a capacitive pressure sensor attached to the stationary member, the capacitive pressure sensor having a capacitive element and an inductive element, the electroplated mesh structure constituting the inductive element.

8. The coaptation assist instrument of claim 1 , wherein the sensor comprises a self-contained pressure sensor mounted on a front surface of the stationary member.

9. 10. The coaptation assistance instrument of claim 1, further comprising a power storage element operatively coupled to the sensor, the power storage element configured to store energy until the power storage element has sufficient energy to detect a measurement and transmit the detected measurement to an internal device.

10. The coaptation assist instrument of claim 1 , wherein the sensor comprises an accelerometer coupled to the coaptation structure and configured to detect movement of the coaptation structure during a cardiac cycle.

11. The coaptation assistance instrument of claim 1 , wherein the coaptation structure comprises a plurality of struts defining a chamber, and the sensor is freely positioned within the chamber prior to instrument delivery.

12. and an appendage extending from a posterior portion of the attachment structure, the appendage including a flexible frame configured to be biased outwardly away from the attachment structure and to contact a left ventricular wall; 2. The coaptation assist device of claim 1, wherein the sensor comprises an accelerometer attached to the appendage to detect motion of the left ventricular wall.

13. The coaptation assist instrument of claim 1 , wherein the sensor comprises at least one of an accelerometer and a strain gauge configured to detect cardiac wall motion.

14. The coaptation assist instrument of claim 1 , wherein the sensor comprises a microphone configured to detect acoustic signals during the cardiac cycle.

15. The coaptation assist instrument of claim 1 , wherein the sensor comprises at least one flow sensor coupled to an atrium-facing surface of the coaptation structure and configured to measure flow patterns throughout the cardiac cycle.

16. 1. A heart valve repair and monitoring system comprising: a valve repair device, the valve repair device comprising: an interface structure having an anterior surface configured to interface with the first native cusp during systole and a posterior surface configured to displace at least a portion of the second native cusp; a fixation member coupled to the attachment structure and configured to fix the attachment structure adjacent to the native heart valve annulus, the attachment structure being substantially stationary relative to the fixation member during the cardiac cycle; a pressure sensor configured to detect pressure during a cardiac cycle; A heart valve repair and monitoring system including an external stimulation and sensing device configured to interrogate said pressure sensor to wirelessly receive sensed data.

17. 17. The heart valve repair and monitoring system of claim 16, wherein the external stimulation and sensing device is configured to power the pressure sensor.

18. the pressure sensor is a first capacitive pressure sensor coupled to the fixation member and configured to sense left atrial pressure during a cardiac cycle, the first capacitive pressure sensor having a first LC circuit with a first resonant frequency; The valve repair device further comprises a second volumetric pressure sensor coupled to the interface structure and configured to sense a left ventricular pressure during a cardiac cycle, the second volumetric pressure sensor having a second LC circuit with a second resonant frequency substantially different from the first resonant frequency; 17. The heart valve repair and monitoring system of claim 16, wherein the first and second LC circuits are configured to be simultaneously interrogated by an external device without interfering with each other.

19. the first capacitive pressure sensor having a first LC circuit with a first resonant frequency; the second capacitive pressure sensor having a second LC circuit with a second resonant frequency substantially different from the first resonant frequency; 20. The heart valve repair and monitoring system of claim 18, wherein the external stimulation and sensing device is configured to simultaneously interrogate the first circuit and the second LC circuit.

20. 17. The heart valve repair and monitoring system of claim 16, further comprising a delivery system configured to deliver the sensor to the fixation device after the fixation members are deployed.

21. The fixing member includes a wire mesh structure, The joint structure comprises a plurality of struts; 17. The heart valve repair and monitoring system of claim 16, wherein at least one of the wire mesh structure and the plurality of struts forms an antenna for the pressure sensor in communication with the external stimulation and detection device.

22. 17. The coaptation assist instrument of claim 16, further comprising an accelerometer coupled to the coaptation structure and configured to detect movement of the coaptation structure during a cardiac cycle.

23. The valve repair device comprises: an appendage extending from a posterior portion of the attachment structure, the appendage configured to be biased outwardly away from the attachment structure and to contact a ventricular wall; 17. The coaptation assist instrument of claim 16, further comprising an accelerometer attached to the appendage for detecting motion of the ventricular wall during the cardiac cycle.

24. 1. A method for monitoring a native mitral valve, the method comprising: deploying a fixation member of a mitral valve repair device in the left atrium of the heart such that the fixation member presses against cardiac tissue in the left atrium; deploying a coaptation structure of the mitral valve repair device such that the coaptation structure displaces a first native leaflet and coapts against a second native leaflet during systole; and interrogating a pressure sensor of the mitral valve repair device via an external device to receive pressure data during the cardiac cycle.

25. sliding the pressure sensor along a suture extending from a delivery system to the fixation member after deployment of the fixation member; The method of claim 24 , further comprising: coupling the pressure sensor to the deployed fixation member.

26. 25. The method of claim 24, further comprising detecting the motion of the left ventricular wall during the cardiac cycle with an accelerometer and / or a strain gauge.

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