Artificial valve, patient monitoring system, and method for monitoring patients with artificial implants

Abstract

Various medical procedures involve the implantation of medical devices within the anatomical structure of the heart. Certain physiological parameters associated with these anatomical structures, such as fluid pressure, can affect the patient's health outlook. [Solution] The artificial valve (800) comprises a frame (810) having a first opening in a first portion (850) and a second opening in a second portion (852), and including a network of supports that form one or more cells; a conductive coil (808) attached to the frame; and a first sensor device (805) located in the first portion of the frame. The conductive coil is connected to the first sensor device, which is configured to sense physical parameters and provide sensor signals.

Description

Technical Field

[0001] Related Application This application claims priority to U.S. Provisional Patent Application No. 63 / 072,298, filed on August 31, 2020 and entitled MONITORING SYSTEMS AND DEVICES FOR HEART IMPLANTS, the disclosure of which is hereby incorporated by reference in its entirety into the present specification.

[0002] The present disclosure relates generally to the field of medical implant devices.

Background Art

[0003] Various medical procedures involve implantation of a medical implant device within the anatomical structure of the heart. Certain physiological parameters associated with such anatomy, such as fluid pressure, can affect a patient's health prognosis.

Summary of Invention

Means for Solving the Problems

[0004] One or more methods and / or devices for facilitating monitoring of physiological parameters associated with the left atrium using one or more sensor implant devices implanted in one or more pulmonary veins, or associated with one or more pulmonary veins, and / or associated anatomy / tissue are described herein.

[0005] Some implementations of the present disclosure include an artificial valve comprising a frame assembly having a first opening in the inlet portion of the frame assembly and a second opening in the outlet portion of the frame assembly, a first sensor device located in the inlet portion of the frame, and a second sensor device located in the outlet portion of the frame assembly. Each of the first and second sensor devices is configured to sense physical parameters and provide sensor signals. The artificial valve further comprises a transmitter assembly configured to receive sensor signals from the first and second sensor devices and to wirelessly transmit transmission signals based at least in part on the sensor signals.

[0006] In some embodiments, the frame assembly is configured to support a first post extending from the inlet portion of the frame assembly and a second post extending from the outlet portion of the frame assembly. The first sensor device may be located on the first post, and the second sensor device may be located on the second post. In some embodiments, the first sensor device is configured to slide within the first post.

[0007] The artificial valve may further include a third sensor device in the inlet portion of the frame assembly. In some embodiments, the artificial valve further includes a base band. The first and third sensor devices may be coupled to the base band.

[0008] In some embodiments, the artificial valve further comprises a first substrate extension that extends axially from the substrate band to the outflow portion of the frame assembly. A second sensor device may be coupled to the substrate extension.

[0009] The first base material extension may have a nonlinear structure. In some embodiments, the artificial valve further comprises a first base material extension that extends diagonally from the base material band to the outflow portion of the frame assembly.

[0010] In some embodiments, the first sensor device and the second sensor device are made of a polymer material.

[0011] The transmitter assembly may include a conductive coil configured to transmit a transmission signal wirelessly.

[0012] In some embodiments, the first sensor device is powered via wireless power transfer.

[0013] Some implementations of the present disclosure relate to a patient monitoring system including an artificial valve implantation device configured to be implanted in a patient. The artificial valve implantation device includes a frame assembly configured to support a first post extending from an inlet portion of the frame assembly and a second post extending from an outlet portion of the frame assembly; a first sensor device located at the first post; a second sensor device located at the second post, wherein each of the first and second sensor devices is configured to sense physical parameters and provide sensor signals; and a wireless transmitter assembly configured to receive sensor signals from the first and second sensor devices and to wirelessly transmit transmission signals based at least in part on the sensor signals. The patient monitoring system further includes a receiver device configured to wirelessly couple with the wireless transmitter assembly of the artificial valve implantation device and to receive transmission signals while the artificial valve implantation device is implanted in a patient and the receiver device is located outside the patient.

[0014] The patient monitoring system may further include a third sensor device in the inlet portion of the frame assembly. In some embodiments, the patient monitoring system further includes a substrate band, to which the first and third sensor devices are coupled.

[0015] The first and second sensor devices may be made of polymer material.

[0016] Some implementations of the present disclosure relate to methods for monitoring patients with artificial implants. The methods include wirelessly coupling an external receiver device to an artificial valve implant device implanted in a patient, measuring patient-associated physical parameters using a sensor device of the artificial valve implant device, and wirelessly transmitting signals based on the measurements of the physical parameters using a transmitter assembly. The transmitter assembly includes a frame assembly having a first opening in the inlet portion of the frame assembly and a second opening in the outlet portion of the frame assembly; a first sensor device located in the inlet portion of the frame assembly; a second sensor device located in the outlet portion of the frame assembly, wherein each of the first and second sensor devices is configured to sense physical parameters and provide sensor signals; and a transmitter configured to receive sensor signals from the first and second sensor devices and to wirelessly transmit transmission signals at least in part based on the sensor signals.

[0017] In some embodiments, the frame assembly is configured to support a first post extending from the inlet portion of the frame assembly and a second post extending from the outlet portion of the frame assembly.

[0018] The first sensor device may be located in the first post, and the second sensor device may be located in the second post.

[0019] For the purpose of summarizing this disclosure, specific aspects, advantages, and novel features are described. It should be understood that not all such advantages can necessarily be achieved according to any particular embodiment. Accordingly, the disclosed embodiments may be implemented in a manner that achieves or optimizes one or more advantages as taught herein, without necessarily achieving other advantages that can be taught or suggested herein. [Brief explanation of the drawing]

[0020] Various embodiments are illustrated in the accompanying drawings for illustrative purposes, and should not be construed as limiting the scope of the present invention in any way. In addition, various features of different disclosed embodiments can be combined to form additional embodiments that are part of the present disclosure. Throughout the drawings, reference numerals may be reused to indicate correspondence between reference elements.

[0021] [Figure 1] Provides a schematic diagram of a human heart. [Figure 2] Provides a schematic diagram of a surgical prosthetic heart valve implanted in the heart according to one or more embodiments. [Figure 3] It is a block diagram representing an implantable device according to one or more embodiments. [Figure 4] It is a block diagram representing a system for monitoring one or more physiological parameters associated with a patient according to one or more embodiments. [Figure 5] Provides a schematic diagram of an exemplary circuit of one or more sensors as described herein, which can be attached to a prosthetic valve for collecting and / or wirelessly transmitting data to an external receiver according to one or more embodiments. [Figure 6] Shows an exemplary frame comprising a network of struts forming one or more cells in accordance with one or more embodiments. [Figure 7] Shows a prosthetic valve comprising a frame and one or more posts extending from the frame according to one or more embodiments. [Figure 8] Shows a prosthetic valve comprising a frame and one or more sensors on one or more posts extending from the frame according to one or more embodiments. [Figure 9] Shows another valve comprising a frame and a base material band at least partially wound around or near a first portion of the frame according to one or more embodiments. [Figure 10]Shows a valve comprising a frame and a skirt at least partially wrapped around the inner and / or outer surface of the frame, according to one or more embodiments. [Figure 11] Shows how valve alignment may be changed as a result of a patient's breathing and / or other chest movements. [Figure 12] Shows a frame comprising a base material band and one or more base material extensions having an expandable structure, according to one or more embodiments. [Figure 13] Shows another exemplary valve including a frame, a base material band, and one or more base material extensions configured to extend from the base material band at a first portion of the frame to a second portion of the frame, in accordance with one or more embodiments. [Figure 14] Shows a valve including a frame and one or more posts configured to allow one or more sensors to slide within the post to adjust the position of the one or more sensors relative to the post and / or the frame, in accordance with one or more embodiments. [Figure 15] Is a flow diagram showing a process for monitoring a post-operative implant device and / or a patient associated therewith, according to one or more embodiments. DETAILED DESCRIPTION OF EMBODIMENTS FOR CARRYING OUT THE INVENTION

[0022] Headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0023] While certain preferred embodiments and examples are disclosed below, the subject matter of the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as their modifications and equivalents. Therefore, the claims that may arise from this specification are not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the action or operation of the method or process may be performed in any preferred order, and is not necessarily limited to any specific disclosed order. Various operations may be described sequentially as a plurality of distinct operations in a manner that may be useful for understanding a particular embodiment, but the order of description should not be interpreted as implying that these operations are order-dependent. Additionally, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For the purpose of comparing various embodiments, specific aspects and advantages of these embodiments are described. Not all such aspects or advantages are necessarily achieved by any specific embodiment. Therefore, for example, various embodiments may be implemented in a manner that achieves or optimizes one or more advantages as taught herein, without necessarily achieving other embodiments or advantages that may similarly be taught or suggested herein.

[0024] Specific standard anatomical terms for location are used herein to refer to animal, i.e., human, anatomical structures with respect to preferred embodiments. Certain spatially relative terms and similar terms such as “lateral,” “medial,” “upper,” “lower,” “below,” “up,” “vertical,” “horizontal,” “apex,” and “bottom” are used herein to describe the spatial relationship of one device / element or anatomical structure to another device / element or anatomical structure, but it is understood that these terms are used herein for ease of explanation to describe the positional relationships between elements / structures illustrated in the drawings. It should be understood that spatially relative terms are intended to encompass different orientations of the element / structure in use or operation, in addition to the orientation illustrated in the drawings, as well as the direction shown in the drawings. For example, an element / structure described as “above” another element / structure may mean a position below or to the side of such other element / structure with respect to the patient or alternative orientation of the element / structure in question, and vice versa.

[0025] This disclosure relates to systems, devices, and methods for telemetric monitoring of one or more physical / physiological parameters (e.g., blood pressure) of a patient in connection with cardiac shunts and / or other medical implantable devices (e.g., prosthetic valve implantable devices) and / or procedures. Such pressure monitoring may be performed using cardiac implantable devices (e.g., prosthetic valve implantable devices) having integrated pressure sensors and / or associated components. For example, in some implementations, this disclosure relates to cardiac shunts and / or other cardiac implantable devices that incorporate or associate pressure sensors or other sensor devices. The term “associated” is used herein in accordance with its broad and ordinary meaning. For example, when a first feature, element, component, device, or member is described as "associated with" a second feature, element, component, device, or member, such description should be understood to indicate that the first feature, element, component, device, or member is physically coupled, attached, connected, integrated, at least partially embedded, or otherwise physically related to the second feature, element, component, device, or member, directly or indirectly. Certain embodiments relating to cardiac implantable devices are disclosed herein. However, while certain principles disclosed herein are particularly applicable to the anatomical structure of the heart, it should be understood that sensor implantable devices according to this disclosure may be implanted in or configured for implantation in any suitable or desirable anatomical structure. Placing an artificial valve or stent within a patient's heart can also provide a unique opportunity to measure cardiac function. This may have clinical applications for monitoring cardiovascular health without requiring separate implantation. This solution provides a system for implanting a cardiac implantable device including specific sensors and wireless transmission components, and for collecting data to read transmission signals from the implantable device (e.g., an artificial heart valve) using a handheld reading device including a suitable RF antenna.These systems can be used to monitor patients during and / or after valve implantation to verify proper function using monitoring rather than spot checks using bioimaging. These solutions provide options for monitoring the valve status in real time and / or for a large number of patients over a relatively long postoperative period.

[0026] Some embodiments may be configured to operate via wireless power transfer and / or wireless communication and / or may consist of several components, including a heart valve, comprising one or more integrated sensors, an external readout unit consisting of a matching antenna, a signal processing unit (e.g., configured to transmit and / or receive transmission signals), and a wireless link to a secure cloud and patient monitoring system. Some systems may include flexible and / or biocompatible sensors that can be used in conjunction with existing medical implants (e.g., prosthetic valves) and delivery systems. Some embodiments may provide a soft sensing platform that can be developed using standard flexible and biocompatible materials that can be at least partially wrapped around the valve assembly without substantially affecting blood flow, thereby allowing for safe and effective application over long periods. In contrast, fixed sensors may be impossible and / or difficult to crimp, may be difficult to integrate with the valve, and / or may cause significant thrombosis during surgery.

[0027] Wireless communication may be facilitated using an inductor-capacitor (LC) resonant structure, for example, comprising one or more coil inductors and / or thin-film based capacitors. The LC resonant frequency may be tuned to match an external source configured to energize the system by transmitting electromagnetic excitations at the same frequency (i.e., at the resonant frequency). The resonant frequency may be selected to minimize tissue loss and / or maximize energy transfer to the resonant coil while avoiding minimal reflection and / or interference from the valve frame (e.g., at least partially metal frame). The terms “frame” and “frame assembly” are used herein in their plain and ordinary sense and may include any components that form the structure of an implantable device (e.g., an artificial valve). In some embodiments, the frame or frame assembly may include a network of struts forming one or more cells around an internal lumen.

[0028] One or more LC sensors may include one or more flexible substrates, induction coils, capacitive pressure sensors, chips for multiplexing and / or wirelessly transmitting data, and / or fixed capacitors. In some cases, the LC sensor may be configured to monitor several different parameters simultaneously.

[0029] One or more wireless sensors may be embedded in different parts of the artificial valve. For example, the sensor may be entirely contained within the valve body, comprise a plurality of separate sensing units located at one end of the valve body, and / or comprise a main sensor unit to which accessory units are attached. The sensor may be crimped to a smaller diameter to fit into the crimp valve. When the assembly expands, the sensor may be retracted into the valve using mechanical fittings. The sensor and / or valve may be made of at least partially metal, but may have different structures to support their respective expansions during valve deployment.

[0030] Embodiments of cardiac valve monitoring devices and systems disclosed herein may be applicable to any type of cardiac valve and / or biocompatible implant, whether implanted surgically or transcatheterically. Figure 1 provides a schematic diagram of a human heart 1. In humans and other vertebrates, the heart 1 generally comprises four cardiac chambers, namely the left atrium 2, left ventricle 3, right ventricle 4, and right atrium 5. The heart 1 further comprises four valves to assist blood circulation within it, including a tricuspid valve 8 that separates the right atrium 5 from the right ventricle 4. The tricuspid valve 8 may generally have three cusps or leaflets and may generally be closed during ventricular contraction (i.e., systole) and open during ventricular dilation (i.e., diastole). The pulmonary valve 9 may be configured to separate the right ventricle 4 from the pulmonary artery and open during systole so that blood can be pumped toward the lungs, and close during diastole to prevent backflow of blood from the pulmonary artery into the heart. The pulmonary valve 9 has three cusps / leaflets, each resembling a crescent shape. The mitral valve 6 has two cusps / leaflets and separates the left atrium 2 from the left ventricle 3. The mitral valve 6 is configured to open during diastole to allow blood from the left atrium 2 to flow into the left ventricle 3 and to close during diastole to prevent blood from flowing back into the left atrium 2. The aortic valve 7 separates the left ventricle 3 from the aorta 12. The aortic valve 7 is configured to open during systole to allow blood to flow out of the left ventricle 3 into the aorta 12 and to close during diastole to prevent blood from flowing back into the left ventricle 3.

[0031] A heart valve may generally consist of a relatively dense fibrous ring, referred to herein as the annulus, and several leaflets or cusps attached to the annulus. Some valves may further include a collection of chordae tendineae and papillary muscles that anchor the fovea. Generally, the size of the leaflets or cusps may be such that, when the heart contracts, the resulting increase in blood pressure generated in the corresponding chamber causes the leaflets to open at least partially, allowing flow from the chamber. When the pressure in the chamber decreases, the pressure in the subsequent chamber or blood vessel may become dominant and push back towards the leaflets. As a result, the leaflets / cusps juxtapose with each other, thereby closing the flow path.

[0032] Heart valve disease refers to a condition in which one or more of the heart valves do not function properly. Affected heart valves can be classified as stenotic, where the valve does not open wide enough to allow adequate forward flow of blood through the valve, and / or incapacitated, where the valve does not close completely, causing excessive backward flow of blood when the valve is closed. In certain conditions, valve disease can be severely debilitating and, if left untreated, can be fatal.

[0033] Figure 2 provides a schematic diagram of a surgically implanted artificial heart valve 10 in the heart 1 according to one or more embodiments. In a particular embodiment, the heart valve 10 may include one or more sensors (not shown) for measuring / sensing one or more physical / physiological parameters, as described herein. The heart valve 10 further includes means for wirelessly transmitting signals associated with sensor responses to an external receiving device, such means may include, for example, a wireless transmitter or transceiver.

[0034] The heart valve 10 may function to allow fluid flow in one direction, such as out of the heart relative to the aortic heart valve, while simultaneously blocking fluid flow in the opposite direction. The heart valve 10 represents an exemplary surgical prosthetic heart valve, which is shown to be implanted in the aortic valve 7. However, it should be understood that the heart valve disclosed herein may be any type of heart valve. Figure 2 provides an enlarged view of the aortic valve 7 shown in Figure 1. The aortic valve 7 includes an aortic annulus 11, which includes a fibrous ring extending inward as a projection into the flow orifice, and can be seen together with the prosthetic heart valve 10 positioned (e.g., sutured over it) on which it is placed. Prior to valve replacement, the natural valve leaflets may extend inward from the annulus 11 and come together within the flow orifice to allow outflow (e.g., upward in Figure 2) and prevent backflow or inflow (e.g., downward in Figure 2).

[0035] In a typical cardiac implantation procedure, the aorta may be incised, and in valve replacement surgery, the defective valve may be removed, leaving a desired placement site that may include the annulus. Sutures can be formed by passing through the fibrous tissue of the annular or desired placement site. The free ends of the sutures can each be passed through the suture-permeable sealing end of the artificial heart valve.

[0036] Artificial heart valves can be used to replace defective or deteriorated natural heart valves in patients with heart valve disorders such as aortic stenosis and mitral regurgitation. The valve replacement process generally involves surgical or transcatheter procedures to replace the existing valve with a new artificial valve. Because the artificial valve is a foreign body, many different challenges and problems can be involved in such procedures. For example, paravalvular leakage (PVL) occurs in about 10% of patients who undergo transcatheter aortic valve replacement (TAVR). Lobe thickening is another problem that occurs in about 10% of TAVR patients. Similarly, rejection of the surgically replaced heart valve due to thrombosis may occur, requiring the patient to use anticoagulants for proper valve function.

[0037] Several methods for monitoring valve performance after implantation involve the use of complex bioimaging techniques, such as echocardiography. These methods can generally only be performed in specialized medical facilities and can be quite time-consuming and expensive. Therefore, they are generally only used after symptoms of valve dysfunction have been detected. Some prosthetic valves may not offer the ability to detect changes in operation for early problem detection. Furthermore, many patients with valvular heart disease requiring prosthetic valves may also suffer from other cardiovascular disorders, including heart failure. Some prosthetic valve systems may not allow for the collection of data on the valve and / or the patient's postoperative condition in an outpatient setting (e.g., a cardiologist's visit in the ward) using existing patient monitoring systems. These systems may not provide routine data collection with sufficient resolution to enable the development of new digital solutions for better patient management as the number and diversity of patients increase over time.

[0038] Various surgical techniques can be used to replace or repair a diseased or damaged valve, including fixing a cardiac implant to the affected annulus. Cardiac implants include mechanical prosthetic heart valves, valved conduits, and valvuloplasty rings. In a valve replacement procedure, the damaged valve leaflet can be removed, the annulus shaped, and a replacement valve can be received.

[0039] Artificial heart valves may be composed of various synthetic and / or biologically derived materials / tissues. They may be independently implanted in one of the cardiac orifices and / or stenoses, and / or otherwise coupled to a flow conduit extending linearly with the valve. For example, a valved conduit may be designed to reconfigure the flow paths above and below the aortic valve, such as the ascending aorta, in addition to replacing the function of the valve itself. The introduction of sensors into the patient system may be by surgical or minimally invasive means.

[0040] Patients undergoing heart valve implantation may experience postoperative complications. For example, patients may be particularly susceptible to complications within 30 or 60 days of implantation surgery. However, during this period, patients may no longer be in a hospital or extended care facility / system, and therefore, complications that occur may require re-entry into the care system, potentially adding significant costs to the overall patient care. Furthermore, the inability to recognize complications until they manifest through perceptible symptoms that the patient interprets as requiring hospital care can delay the patient's return to the hospital, increasing health risks.

[0041] This specification discloses systems, devices, and methods for postoperative monitoring of artificial heart valve implantation recipients, possibly including in an environment outside a hospital or care facility. Certain embodiments disclosed herein provide heart valve devices / systems that include integrated sensing capabilities for sensing one or more conditions of a patient's heart valve and / or heart. The heart valve may be configured to wirelessly communicate such sensed parameters (e.g., critical patient issues) from a sensor system within the valve to, in some embodiments, a local or remote wireless receiver device that may be carried by the patient. The receiver may be configured to communicate the received sensor information and associated information to a care provider system, such as a remote hospital or care facility monitoring system. Sensor-integrated implantable devices according to the principles disclosed herein may include surgical valves (e.g., aortic valves or aortic valves), transcatheter heart valves (THVs), arthroplasty rings (e.g., aortic valves, tricuspid valves), pacemakers (e.g., in relation to electrical leads), or similar, or alternatively, may be applied to standalone sensor devices not integrated with a valve or other implantable device.

[0042] Physiological parameters that can be tracked by sensor-enabled heart valve implants may include arrhythmias, blood pressure, cardiac output (e.g., measured by an echo sensor, lead, ballist electrocardiogram, or similar), and / or other parameters. Furthermore, the implantable devices disclosed herein may incorporate any desired or practical type of sensor, such as strain gauges, pressure sensors, optical sensors, audio sensors, position sensors, or other types of sensors. The integrated implantable sensor may be advantageously configured to generate an electrical transmission signal that can be transmitted wirelessly to a receiver device (e.g., a box) located outside the patient's body. In certain embodiments, the receiver device may transmit information to a remote caregiver system / service provider based at least in part on the signal.

[0043] In certain embodiments, a sensor device associated with an implantable device may be configured to sense pressure and / or electrical activity. For example, pressure may provide information about how well the implant is functioning, and optionally information about hydration. An electroactive sensor may provide information used to detect arrhythmias. A pressure sensor integrated into a device according to this disclosure may include, for example, a microelectromechanical (MEMS) device (e.g., an accelerometer) which may be integrated into the implantable frame. In certain embodiments, two or more sensors may be utilized. For example, multiple sensors may be used to measure the differential pressure between the inlet and outlet ends of a valve implant, which may provide information indicating backflow.

[0044] Sensors and / or transmitters integrated into implantable devices according to embodiments of this disclosure may only need to operate for a limited monitoring period (e.g., 90-120 days) and therefore may be powered using a battery such as a lithium-ion or magnesium-based battery. For example, the battery may use a magnesium piece as the cathode in at least partial contact with bodily fluids (e.g., blood), which may degrade when generating power. In certain embodiments, an external power source configured to supply power through induction, radio frequency (RF) transmission, or other types of wireless power transmission may be used. In certain embodiments, an internal rechargeable battery or capacitor (e.g., a supercapacitor) may be used for limited power storage between charges. Such power transmitters may be integrated into an external data receiver. In certain embodiments, a portion of the frame of the implantable / sensor device may be used as an antenna for power transmission. Additionally or alternatively, the patient's body movements may be used to generate power, for example, by using one or more piezoelectric MEMS devices (e.g., strain gauges, accelerometers).

[0045] In certain embodiments, the embedded integrated sensor device may be configured to operate substantially continuously. Alternatively, the sensor may operate only at predetermined intervals, which may provide power savings compared to continuous operation. In certain embodiments, controller logic may be integrated with the implant / sensor to determine the timing and / or duration of operation based on the measured state. In certain embodiments, the sensor may operate only when wirelessly coupled to an external data / power transmission / receiving device. Even when the device is not coupled to an external device, in embodiments where the sensor collects data, it may be necessary or desirable for the implant / sensor to include a data storage unit such as flash memory, memristor, or other low-power memory.

[0046] Certain embodiments may, advantageously, operate in conjunction with an external power / data transfer device small enough to be carried by the patient (e.g., continuously), such as by using a chest strap. In certain embodiments, the external device comprises a patch having one or more antennas for input / output (I / O) and / or power, and the remaining circuitry may be contained in a separate box / device. In certain embodiments, the external device may comprise a device attached to an arm strap or a device that can be fitted into the patient's pocket. Bluetooth, near-field communication (NFC), or other low-power technologies or protocols may be used to connect the external device and / or implant / sensor to a telephone or other computing device and transmit data to a hospital or other data aggregator. In certain embodiments, the external device may comprise a mat designed to be positioned in or near the bed, which may, for example, collect and transfer data while the patient is sleeping.

[0047] In some embodiments, data may be collected using an existing patient monitoring system, which may include a handheld reading device with a suitable radio frequency (RF) antenna for reading transmission signals from the implanted valve. The received data can then be used to identify patients at risk and / or prescribe various treatments, including the use of anticoagulants to prevent valve malfunction. Furthermore, data received from the implanted valve can be used to monitor patients during and immediately after valve implantation and to verify proper operation.

[0048] The various devices and systems described herein provide a monitoring system that can advantageously offer an improved method for monitoring valve status in real time for a large number of patients over a long period of time. In some embodiments, a remote monitoring system can be used to monitor the status of an artificial heart valve and the condition and / or function of the surrounding cardiac tissue. The remote monitoring system may operate via wireless power supply and / or wireless communication and / or may include several components including a heart valve with one or more integrated sensors, an external readout unit including a matching antenna, a signal processing unit, and / or a wireless link to a secure cloud and / or patient monitoring system.

[0049] In some embodiments, the sensors described herein (e.g., soft and / or biocompatible sensors) can be advantageously used in conjunction with existing valve and / or delivery systems, and thus require minimal effort for development and validation. These soft sensing platforms can be developed using standard soft and / or biocompatible materials that can be at least partially wrapped around the valve assembly and / or do not have any significant impact on blood flow, which may be essential for safe and effective application over long periods.

[0050] One or more integrated sensors may be maintained within the valve frame / body during normal operation. In some cases, the presence of the valve frame (e.g., metal mesh) may make it difficult to ensure reliable wireless power transmission. Some embodiments may advantageously provide that one or more sensors are located outside the central lumen of the valve structure frame, maintaining a sensing platform outside the valve and improving power supply and / or communication to the remote sensing platform.

[0051] In some embodiments, one or more sensors and / or associated structures can be attached to the valve during manufacturing. One or more sensors may be configured to be held at least partially outside the valve using mechanical post and latch structures. For example, for transcatheter procedures, one or more sensors can be drawn into the valve once the valve is deployed and expanded. In some embodiments, a relatively thin sensing platform may be used to hold the sensing platform inside the valve during and / or after valve implantation.

[0052] In some embodiments, the electrical design of the system may include an LC resonant structure comprising a coil inductor and / or a thin-film-based capacitor. The LC resonant frequency may be tuned to match an external source energizing the system by transmitting electromagnetic excitations at a common frequency (i.e., the resonant frequency). The frequency may be selected to minimize losses in the structure and / or maximize energy transfer to the resonant coil while avoiding minimal reflection and / or interference from the valve frame. In some embodiments, one or more resistor-inductor-capacitor (RLC) sensors, application-specific integrated circuits (ASICs), radio frequency identification (RFID) circuits, and / or near-field communication (NFC) circuits may be used with or instead of one or more LC sensors. One or more sensors and / or surrounding structures may at least partially include biodegradable materials that can be absorbed over time as the sensor lifespan ends. One or more sensors may at least partially include materials that can be actively promoted to grow so that the encapsulation around the valve can be controlled to maintain a controlled environment for long-term measurements.

[0053] In some implementations, this disclosure relates to sensors associated with or integrated with cardiac shunts or other implantable devices / structures. Such integrated devices may be used to provide controlled and / or more effective therapies for treating and preventing heart failure and / or other health complications associated with cardiac function. Figure 3 is a block diagram illustrating an implantable device 300 comprising a cardiac implantable structure 320, which may comprise a shunt-type structure or any other type of implantable structure, as described in detail herein. The cardiac implantable structure 320 may include a frame 321, which may be configured to fix the implantable device 300 in place at the implantation site / location. For example, the frame 321 may be configured to expand and / or press at least partially against the walls of arteries and / or valves. In some embodiments, the frame 321 may include one or more arms, backs, sutures, suture engagement features, corkscrew-type or other tissue engagement features, etc.

[0054] In some embodiments, the cardiac implantation structure 320 is physically integrated with and / or connected to a sensor device 310. The sensor device 310 may be, for example, a pressure sensor or other type of sensor. In some embodiments, the sensor 310 comprises one or more transducers 312, such as one or more pressure transducers, which may be embodied in, for example, an application-specific integrated circuit (ASIC), and a specific control circuit 314. The sensor device 310 may generally have a flexible structure and / or may be moldable to fit into openings of various sizes in the cardiac implantation structure 420. For example, the sensor device 310 may be at least partially composed of a polymer and / or a thin metal. The sensor device 310 may be fixed to the implantation structure 320 by a specific sensor retaining structure 325 (e.g., a post), examples thereof are disclosed in detail herein. The sensor device 310 and / or the sensor retaining structure 325 may be fixed / stabilized using a stabilizer, which may be integrated with or associated with the sensor retaining structure 325 or other components of the sensor implantation device 300.

[0055] The control circuit 314 may be configured to process the transmission signal received from the transducer 312 and / or to communicate the signal wirelessly through biological tissue using the antenna 318. The antenna 318 may include one or more coils (e.g., conductive coils) or loops of a conductive material, such as copper wire. In some embodiments, at least a portion of the transducer 312, the control circuit 314, and / or the antenna 318 may be made of any type of material and, advantageously, may be at least partially sealed, and may be at least partially disposed or housed within a sensor housing 316. For example, a sheath may be used to at least partially cover the antenna 318 (e.g., a coil of one or more wires), the transducer 312, and / or the control circuit 314. In some embodiments, the housing 316 may be at least partially flexible. For example, the housing may include a polymer or other flexible structure / material that may advantageously allow the sensor 310 to be bent, flexed, or folded to allow transport through a catheter or other introduction means. In some embodiments, the sensor housing 316 (e.g., frame 321) has a shape that is at least partially cylindrical.

[0056] The transducer 312 may comprise any type of sensor means or mechanism. For example, the transducer 312 may be a force-collecting type pressure sensor. In some embodiments, the transducer 312 includes a diaphragm, piston, Bourdon tube, bellows, or other strain or deflection measuring component that measures strain or deflection applied across its area / surface. The transducer 312 may be associated with the housing 316 such that at least a portion of it is housed within or attached to the housing 316. The term “associated with” is used herein in accordance with its broad and ordinary meaning. With respect to sensor devices / components “associated with” a shunt or other embedded structure, such term may refer to a sensor device or component that is physically coupled, attached, connected to, or integrated with the embedded structure. That is, when a first feature, element, component, device, or member is described as being "associated with" a second feature, element, component, device, or member, such description should be understood to indicate that the first feature, element, component, device, or member is physically coupled, attached, connected, integrated, at least partially embedded within, or otherwise physically related to the second feature, element, component, device, or member, whether directly or indirectly.

[0057] In some embodiments, the transducer 312 includes or is a component of a piezoresistive strain gauge, which may be configured to use a bonded or formed strain gauge to detect strain resulting from an applied pressure, where the resistance increases as the pressure deforms the component / material. The transducer 312 can incorporate any type of material, including but not limited to, silicone (e.g., single crystal), polysilicon thin film, bonded metal foil, thick film, silicon-on-sapphire, sputtered thin film, and / or similar.

[0058] In some embodiments, the transducer 312 includes or is a component of a capacitive pressure sensor, which includes a diaphragm and a pressure cavity configured to form a variable capacitor to detect strain resulting from pressure applied to the diaphragm. The capacitance of the capacitive pressure sensor may generally decrease as the pressure deforms the diaphragm. The diaphragm may include any material, but is not limited to metal, ceramic, silicon, etc. In some embodiments, the transducer 312 includes or is a component of an electromagnetic pressure sensor, which may be configured to measure the displacement of the diaphragm by change in inductance, linear variable displacement transducer (LVDT) function, Hall effect, or eddy current sensing. In some embodiments, the transducer 312 includes or is a component of a piezoelectric strain sensor. For example, such a sensor may determine strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials, such as quartz.

[0059] In some embodiments, the transducer 312 includes or is a component of a strain gauge. For example, an embodiment of the strain gauge may include a pressure-sensitive element on or associated with the exposed surface of the transducer 312. In some embodiments, a metal strain gauge may be bonded to the surface of the sensor, or a thin-film gauge may be applied to the sensor by sputtering or other techniques. The measuring element or mechanism may include a diaphragm or a metal foil. The transducer 312 may include any other type of sensor or pressure sensor, such as an optical, potentiometric, resonant, thermal, ionizing, or other type of strain or pressure sensor.

[0060] The effectiveness of an implanted artificial heart valve may be measured based on pressure measurements, fluid flow through the valve, and / or other mechanisms that can provide general indicators of cardiac output and / or cardiac function. Acute monitoring of heart / valve performance may be performed in various ways, such as through the use of echo-based techniques (e.g., ultrasound) to measure the velocity of fluid flow through the valve, which may be used to derive other calculations such as pressure gradients. Imaging techniques (e.g., CT scans or X-rays) may also provide information related to the opening and closing of the heart valve, which may be used to determine blood volume, etc.

[0061] If an individual experiences a decline in cardiac function for a certain period, the transition to a new artificial heart valve may be somewhat delayed. Therefore, while acute heart / valve monitoring may be performed during and immediately after surgery, continuous monitoring of cardiac / valve function over a long period postoperatively may be necessary or desirable. Furthermore, implantation patients are often prescribed various medications to support the recovery process. However, inappropriate dosages can lead to cardiac / valve complications, which must be resolved as quickly as possible.

[0062] Therefore, for at least these reasons, postoperative monitoring (e.g., continuous monitoring) over a period of time, such as 15, 30, 45, 60, 90 days, or some other period, may be desirable. For example, continuous monitoring may provide an opportunity to intervene in the patient's recovery, such as by changing medication / dosage before symptoms of dysfunction become apparent, thus enabling early detection and response. Complications that may arise from heart valve implantation surgery may include decreased ejection fraction, undesirable changes in pressure or pressure regulation dysfunction, irregular cardiac rhythm (e.g., caused by surgical incision), and other conditions. Certain embodiments provide a heart valve equipped with one or more sensors for monitoring parameters related to such conditions, and a mechanism for transmitting such information to one or more external systems and / or subsystems.

[0063] Embodiments of the present disclosure provide systems, devices, and methods for determining and / or monitoring fluid pressure and / or other physiological parameters or conditions of the left atrium using one or more implantable sensor devices, such as permanently implanted sensor devices. By directly placing a permanent sensor monitoring device in the left atrium, embodiments of the present disclosure may advantageously enable physicians and / or technicians to collect real-time cardiac information, including left atrial pressure values ​​and / or other valuable cardiac parameters.

[0064] The disclosed solutions for embedding and maintaining a sensor-embedded device including specific ballast features may be implemented in conjunction with a pressure monitoring system. Figure 4 illustrates a system 400 for monitoring pressure and / or other parameters associated with a patient 415, according to an embodiment of the present disclosure. While the description of Figure 4 and other embodiments herein are generally presented in the context of pressure monitoring, the descriptions of pressure sensing and pressure sensor stabilization herein are applicable to sensing / stabilizing other types of sensors and sensing other types of physiological parameters, and sensor devices used for such purposes are stabilized using specific ballast features.

[0065] The patient 415 may have, for example, a pressure sensor implantation device 410 embedded in the patient's heart (not shown) or associated physiological function. For example, the sensor implantation device 410 may be at least partially implanted in the left atrium of the patient's heart. The sensor implantation device 410 may include one or more sensor transducers 412, such as one or more MEMS devices, such as microelectromechanical systems (MEMS) pressure sensors.

[0066] In certain embodiments, the monitoring system 400 may comprise at least two subsystems, including an implantable internal subsystem or device 410 comprising a sensor transducer 412 (e.g., a MEMS pressure sensor) and a control circuit 414 comprising one or more microcontrollers, discrete electronic components, and one or more power and / or data transmitters 418 (e.g., antenna coils). The monitoring system 400 may further comprise an external (e.g., non-implantable) subsystem comprising an external reader 450 (e.g., a coil) which may include a wireless transceiver electrically and / or communicatively coupled to a particular control circuit. In certain embodiments, both the internal and external subsystems include corresponding antennas for wireless communication and / or power delivery through patient tissue disposed between them. The sensor implantation device 410 may be any type of implantation device.

[0067] The term “control circuit” is used herein in accordance with its broad and ordinary meaning and may include processors, processing circuits, processing modules / units, chips, dies (e.g., semiconductor dies including coming or more active and / or passive devices and / or connection circuits), microprocessors, microcontrollers, digital signal processors, microcomputers, central processing devices, field-programmable gate arrays, programmable logic devices, state machines (e.g., hardware state machines), logic circuits, analog circuits, digital circuits, and / or any group of any devices that operate signals (analog and / or digital) based on a hard coating of circuits and / or operating instructions. Control circuits as referred herein may further include one or more storage devices that can be embodied in a single memory device, a plurality of memory devices, and / or embedded circuits of a device. Such data storage units may include read-only memory, random-access memory, volatile memory, non-volatile memory, static memory, dynamic memory, flash memory, cache memory, data storage registers, and / or any devices that store digital information. In embodiments in which the control circuit includes hardware and / or software state machines, analog circuits, digital circuits, and / or logic circuits, it should be noted that data storage devices / registers for storing any associated operation instructions may be incorporated within or outside the circuit including the state machine, analog circuits, digital circuits, and / or logic circuits.

[0068] Specific details of the sensor implantation device 410 are illustrated in the enlarged block 410 shown. The sensor implantation device 410 may include an implantation / anchor structure 420 as described herein. For example, the implantation structure 420 may include one or more shunt-type implants / anchors for anchoring to the cardiac tissue wall, as described in more detail below. The implantation structure 420 may further comprise, for example, one or more arm structures for physically holding / fixing the implantation structure 420 to the tissue wall. While certain components are illustrated in Figure 4 as part of the sensor implantation device 410, it should be understood that the sensor implantation device 410 may include only a subset of the illustrated components / modules and may include additional components / modules not illustrated. The sensor implantation device 410 may include one or more sensor transducers 412 configured to provide responses indicating one or more physiological parameters of a patient 415, such as atrial pressure and / or volume. Although a pressure transducer is described, the sensor transducer 412 may include any suitable or desirable type of sensor transducer for providing signals related to physiological parameters or states associated with the sensor implantation device 410.

[0069] The sensor transducer 412 may comprise one or more MEMS sensors, optical sensors, piezoelectric sensors, electromagnetic sensors, strain sensors / gauges, accelerometers, gyroscopes, and / or other types of sensors that can be positioned within the patient 415 to sense one or more parameters related to the patient's health. The transducer 412 may be a force collector type pressure sensor. In some embodiments, the transducer 412 includes a diaphragm, membrane, piston, Bourdon tube, bellows, or other strain or deflection measuring component that measures strain or deflection applied over an area / surface thereof. The transducer 412 may be associated with the housing 416 such that at least a portion of it is housed within or attached to the housing 416.

[0070] In some embodiments, the transducer 412 includes or is a component of a piezoresistive strain gauge, which may be configured to use a bonded or formed strain gauge to detect strain resulting from an applied pressure, where the resistance increases as the pressure deforms the component / material. The transducer 412 may incorporate any type of material, but is not limited to, silicon (e.g., single crystal), polysilicon thin film, bonded metal foil, thick film, silicon-on-sapphire, sputtered thin film, and / or similar materials.

[0071] In some embodiments, the transducer 412 includes or is a component of a capacitive pressure sensor, which includes a diaphragm and a pressure cavity configured to form a variable capacitor to detect strain resulting from pressure applied to the diaphragm. The capacitance of the capacitive pressure sensor may generally decrease as the pressure deforms the diaphragm. The diaphragm may include any material, but is not limited to, metal, ceramic, silicon, or other semiconductors. In some embodiments, the transducer 412 includes or is a component of an electromagnetic pressure sensor, which may be configured to measure the displacement of the diaphragm by change in inductance, linear variable displacement transducer (LVDT) function, Hall effect, or eddy current sensing. In some embodiments, the transducer 412 includes or is a component of a piezoelectric strain sensor. For example, such a sensor may determine strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials, such as quartz.

[0072] In some embodiments, the transducer 412 includes or is a component of a strain gauge. For example, an embodiment of the strain gauge may include a pressure-sensitive element on or associated with the exposed surface of the transducer 412. In some embodiments, a metal strain gauge may be bonded to the sensor surface, or a thin-film gauge may be applied to the sensor by sputtering or other techniques. The measuring element or mechanism may include a diaphragm or a metal foil. The transducer 412 may include any other type of sensor or pressure sensor, such as an optical, potentiometric, resonant, thermal, ionizing, or other type of strain or pressure sensor.

[0073] In some embodiments, the transducer 412 is electrically and / or communically coupled to a control circuit 414, which may include one or more application-specific integrated circuit (ASIC) microcontrollers or chips. The control circuit 414 may further include one or more discrete electronic components, such as regulating capacitors.

[0074] In certain embodiments, the sensor transducer 412 may be configured to generate an electrical signal that can be transmitted wirelessly to a device outside the patient's body 415, such as the local external monitoring system 450 shown. To carry out such wireless data transmission, the sensor implantation device 410 may include a signal processing circuit and a radio frequency (RF) transmitting circuit, such as an antenna / data transmitter 418. The antenna 418 may include an internal antenna coil or other structure implanted within the patient. The control circuit 414 may comprise any type of transducer circuit configured to transmit an electromagnetic signal, which may be radiated by the antenna 418, which may include one or more conductive wires, coils, plates, etc. The control circuit 414 of the sensor implantation device 410 may include, for example, one or more chips or dies configured to perform some amount of processing on the signal generated and / or transmitted using the device 410. However, due to size, cost, and / or other constraints, the sensor implantation device 410 may not include independent processing capabilities in some embodiments.

[0075] The radio signal generated by the sensor implantation device 410 may be received by a local external monitoring device or subsystem 450, which may include a transceiver module 453 configured to receive radio signal transmissions from the sensor implantation device 410, at least partially located within the patient 415. The external local monitor 450 may receive the radio signal and / or provide radio power using an external antenna 455, such as a wand device. The transceiver 453 may include a radio frequency (RF) front-end circuit configured to receive and amplify the signal from the sensor implantation device 410, such a circuit may include one or more filters (e.g., bandpass filters), amplifiers (e.g., low-noise amplifiers), analog-to-digital converters (ADCs) and / or digital control interface circuits, phase-locked loop (PLL) circuits, signal mixers, and the like. The transceiver 453 may be further configured to transmit the signal to a remote monitoring subsystem or device 460 via a network 475. The RF circuit of the transceiver 453 may further include one or more of the following for processing / handling signals transmitted over the network 475 and / or for receiving signals from the sensor embedding device 410: a digital-to-analog converter (DAC) circuit, a power amplifier, a low-pass filter, an antenna switch module, an antenna, etc. In certain embodiments, the local monitor 450 includes a control circuit 451 for performing processing of signals received from the sensor embedding device 410. The local monitor 450 may be configured to communicate with the network 475 according to a known network protocol such as Ethernet or Wi-Fi. In certain embodiments, the local monitor 450 is a smartphone, a laptop computer, or other mobile computing device, or any other type of computing device.

[0076] In certain embodiments, the sensor embedding device 410 includes some amount of volatile and / or non-volatile data storage. For example, such data storage may include solid-state memory utilizing an array of floating-gate transistors. The control circuit 414 may utilize the data storage to store sensed data collected over a period of time, and the stored data may be periodically transmitted to a local monitor 450 or other external subsystem. In certain embodiments, the sensor embedding device 410 does not include any data storage. The control circuit 414 is configured to facilitate wireless transmission of data generated by the sensor transducer 412, or other data associated therewith. The control circuit 414 may be further configured to receive input from one or more external subsystems, such as from a local monitor 450 or a remote monitor 460, via a network 475. For example, the sensor embedding device 410 may be configured to receive signals that at least partially control the operation of the sensor embedding device 410, such as by activating / deactivating one or more components or sensors, or by otherwise affecting the operation or performance of the sensor embedding device 410.

[0077] One or more components of the sensor implantation device 410 may be powered by one or more power supplies 440. Due to concerns about size, cost, and / or electrical complexity, it may be desirable that the power supplies 440 be relatively minimal in nature. For example, high-power drive voltages and / or currents within the sensor implantation device 410 may adversely affect or interfere with the operation of the heart or other anatomical structures associated with the implantation device. In certain embodiments, the power supplies 440 are at least partially passive in nature, and as a result, power may be received wirelessly from an external source by the passive circuitry of the sensor implantation device 410. Examples of wireless power transmission techniques that may be implemented include, but are not limited to, short-range or near-range wireless power transmission or other electromagnetic coupling mechanisms. For example, a local monitor 450 may act as an initiator that actively generates an RF field that can power the sensor implantation device 410, thereby allowing the power circuitry of the implantation device to adopt a relatively simple form factor. In certain embodiments, the power supplies 440 may be configured to obtain energy from an environmental source such as fluid flow, motion, or pressure. Additionally or alternatively, the power supply 440 may include a battery, which may be advantageously configured to provide sufficient power as needed over the relevant monitoring period.

[0078] In some embodiments, the local monitoring device 450 may serve as an intermediate communication device between the sensor implantation device 410 and the remote monitor 460. The local monitoring device 450 may be a dedicated external unit designed to communicate with the sensor implantation device 410. For example, the local monitoring device 450 may be a wearable communication device or other device that can be easily positioned in close proximity to the patient 415 and / or the sensor implantation device 410. The local monitoring device 450 may be configured to continuously, periodically, or sporadically examine the sensor implantation device 410 in order to extract or request sensor-based information from the sensor implantation device 410. In certain embodiments, the local monitor 450 may include a user interface that the user can use to view sensor data or interact with the local monitoring system 450 and / or the sensor implantation device 410.

[0079] System 400 may include, for example, a secondary local monitor 470, which may be a desktop computer or other computing device configured to provide a monitoring station or interface for displaying and / or interacting with monitored cardiac data. In one embodiment, the local monitor 450 may be a wearable device or other device or system configured to be physically positioned in close proximity to the patient and / or the sensor implantation device 410, and the local monitor 450 is primarily designed to receive / transmit signals to and / or from the sensor implantation device 410 and provide such signals to the secondary local monitor 470 for display, processing, and / or operation. The external local monitoring system 450 may be configured to receive and / or process specific metadata from or associated with the sensor implantation device 410, such as a device ID, which may also be provided from the sensor implantation device 410 via data linkage.

[0080] The remote monitoring subsystem 460 may be any type of computing device or group of computing devices configured to receive, process, and / or present monitoring data received via the network 475 from the local monitoring device 450, the secondary local monitor 470, and / or the sensor-embedded device 410. For example, the remote monitoring subsystem 460 may be advantageously operated and / or controlled by a healthcare entity such as a hospital, a physician, or other care entity associated with the patient 415.

[0081] In certain embodiments, the antenna 455 of the external monitoring system 450 comprises an external coil antenna matched and / or tuned to inductively pair with the antenna 418 of the internal embedding 410. In some embodiments, the sensor embedding device 410 is configured to receive wireless ultrasonic power charging and / or data communication between it and the external monitoring system 450. As referenced above, the local external monitor 450 may include a wand or other handheld reader.

[0082] In some embodiments, at least a portion of the transducer 412, control circuit 414, power supply 440, and / or antenna 418 is at least partially disposed or housed within a sensor housing 416, which may comprise any type of material and, advantageously, may be at least partially sealed. For example, in some embodiments, the housing 416 may include glass or other rigid material that can provide mechanical stability and / or protection to the components housed therein. In some embodiments, the housing 416 is at least partially flexible. For example, the housing may include a polymer or other flexible structure / material that can advantageously allow the sensor 410 to be bent, flexed, or folded to enable transport through a catheter or other percutaneous delivery means.

[0083] The sensor housing 416 may be fixed to a specific sensor holding structure (e.g., a post) that is physically coupled to and / or integrated with a cardiac implantation structure 420 (e.g., a valve frame). For example, in some embodiments, the sensor holding structure is integrated with a post extending from the implantation structure 420. Such a post may, in some cases, be a secondary element that can be added to an existing implantation structure 420. For example, a post may be added to extend from one or more struts of the valve frame.

[0084] The sensor implantation device 410 can be implanted at any location within the body of the patient 415. In some embodiments of the present disclosure, the sensor implantation device 410 is advantageously implanted in the heart of the patient 415, such as within or near the aortic valve of the heart, as described in detail herein. The sensor implantation device according to one or more embodiments of the present disclosure can be implanted using a transcatheter procedure or any other percutaneous procedure. Alternatively, the sensor implantation device according to embodiments of the present disclosure may be placed during open-heart surgery (e.g., sternotomy), minor sternotomy, and / or other surgical procedures.

[0085] Figure 5 provides a schematic diagram of an exemplary circuit 500 of one or more sensors, as described herein, which may be attached to an artificial valve for collecting and / or wirelessly transmitting data to an external receiver (e.g., outside the main body). In some embodiments, the circuit may include a voltage source (e.g., an AC voltage source) 502, an oscilloscope 504, a transformer 506 (e.g., including two coils), a variable capacitor 508, and / or another capacitor 510. The oscilloscope 504 may be used to display the shape of the electrical signals transmitted from the circuit 500.

[0086] Figure 6 shows an exemplary frame 610 including a network of pillars 615 that form one or more cells 620. The frame 610 may form a lumen through a central portion of the frame 610 and / or pass from a first end portion 650 to a second end portion 652, having a first opening at the first end portion 650 and / or a second opening at the second end portion 652. The dimensions and / or shape of the frame 610 may vary based on the specific application. In some cases, blood can freely pass through the cells 620 of the frame 610. In some embodiments, the frame 610 may have inner and / or outer inner layers and / or other layers that can prevent the flow of blood through the cells 620.

[0087] The network of struts 615 forming the frame 610 may form one or more endpoints 617 at a first end portion 650 and / or a second end portion 652 of the frame 610. One or more endpoints 617 may be located at the inflow portion (e.g., the first portion 650) and / or outflow portion (e.g., the second portion 652) of the frame 610. The frame 610 may be configured to allow blood flow through the frame 610 and / or otherwise act as an artificial valve of the heart.

[0088] In some embodiments, the frame 610 may be configured to be crimped to facilitate the introduction of the frame 610 into the patient's body and / or a target location within the body. The crimping may involve reducing the diameter of the frame and / or increasing the length of the frame (for example, increasing the distance between the first portion 650 and the second portion 652).

[0089] Figure 7 shows an artificial valve comprising a frame 710 and one or more posts 740 extending from the frame 710. Figure 7 shows two posts 740 extending from the frame 710, but the artificial valve may include any number of posts 740 extending from the frame 710. Furthermore, although a first post 740a is shown on the upper 750 of the frame 710 and a second post 740b is shown on the lower 752 of the frame 710, the frame 710 may include any number of posts 740 extending from the upper 750 and / or any number of posts 740 extending from the lower 752 of the frame 710. For example, the frame 710 may include four posts 740 extending from the upper 750 and four posts 740 extending from the lower 752.

[0090] In some embodiments, post 740 may include a wire form that forms an island 760 (i.e., a sensor receptor) having any preferred shape and / or size. The island 760 may be configured to receive one or more sensors and / or associated devices. Post 740 may be configured to position one or more sensors on or near the upper 750 of frame 710 and / or on or near the lower 752 of frame 710. Thus, one or more sensors may be configured to determine the pressure difference between the upper 750 and the lower 752 of frame 710.

[0091] One or more posts 740 may be configured to position one or more sensors around the frame 710, in direct contact with the blood flow through the frame 710. Furthermore, one or more sensors may be configured to extend from one or more end portions of the frame 710 so that the one or more posts 740 do not interfere with the function of the frame 710. For example, the frame 710 may be configured to be crimped and / or otherwise compressed to fit through a catheter and / or other delivery device. One or more posts 740 may be configured to facilitate and / or enable the crimping of the frame 710.

[0092] In some embodiments, one or more posts 740 may be added to an existing frame 710. For example, one or more posts 740 may function as secondary elements and / or “backpack” features, which can be attached to the frame 710 and / or woven throughout the frame 710. Thus, one or more posts 740 may, advantageously, be configured for use with various types of frames 710. Furthermore, by positioning the posts 740 at one or more end portions of the frame 710 without extending into the central lumen of the frame, it may be possible to make the posts function without altering the functionality of the frame 710.

[0093] As shown in Figure 7, one or more posts 740 may be configured to extend from end portions 717 of one or more support columns 715 of the frame. For example, the frame 710 may comprise one or more cells 720 that form empty spaces between the support columns 715 of the frame 710. The cells 720 may have any shape, including a roughly hexagon as shown in Figure 7. The support columns 715 surrounding the cells 720 may form various end portions 717 from which one or more posts 740 may extend.

[0094] The frame 710 and / or one or more posts 740 may be formed by the use of a laser cutting process. For example, one or more posts 740 may be added to the planar pattern frame 710 before the frame 710 is cut into the tubular shape (e.g., a 23 mm tube) shown in Figures 6 and 7.

[0095] Figure 8 shows an artificial valve 800 comprising a frame 810 and one or more sensors 805 on one or more posts 840 extending from the frame 810. In some embodiments, one or more sensors 805 may have a generally soft structure. For example, the sensors 805 may consist of a polymer that poses a lower risk of damaging surrounding tissue compared to metal devices. In some embodiments, one or more sensors 805 may consist of at least partially very thin metal so that the structure of one or more sensors 805 is relatively soft.

[0096] One or more conductive coils 808 may be attached to each of one or more sensors 805. One or more coils 808 may be configured to pass along the inner and / or outer surface of the frame 810, and / or otherwise, to be attached to the frame 810. One or more coils 808 may be configured to form internal packaging on the inner and / or outer surface of the frame 810, and / or to connect to one or more sensors in a first portion 850 (e.g., inlet portion) and / or a second portion 852 (e.g., outlet portion) of the frame 810. In some embodiments, one or more coils 808 may be configured to at least partially cover the periphery of the frame 810 structure. For example, the first coil 808 may cover the periphery in or near the first portion 850 of the frame 810. In some embodiments, separate coils 808 may be used and / or connected to separate sensors 805. For example, the first coil 808a may be configured to connect to the first sensor 805a in the first portion 850 of the frame 810, while the second coil 808b may be connected to the second sensor 805b in the second portion 852 of the frame 810. One or more sensors 805 in the first portion 850 of the frame 810 may be configured to function in parallel with one or more sensors 805 in the second portion 852 of the frame 810.

[0097] Sensor data collected by one or more sensors 805 may be transmitted to an external receiver (not shown) using a transmitter assembly. The transmitter assembly may include one or more conductive coils 808 electrically coupled to one or more electronic sensors 805 and / or circuits. One or more coils 808 may be configured to supply power to the sensors / circuits 805, transmit electromagnetic signals to the external receiver, and / or receive power / data from there. For example, a coil 808 may act as an antenna for receiving radio power and / or transmitting electromagnetic signals. In certain embodiments, the transmitter assembly may be embedded in or integrated with the frame 810. For example, the transmitter assembly may be at least partially nested within a recess, channel, or cavity of the frame 810. By incorporating the transmitter assembly into the external portion of the frame 810, the sensors 805 may be configured to effectively transmit electromagnetic signals to the remote receiver.

[0098] In certain embodiments, a transparent assembly including one or more sensors 805 may be configured to communicate power and / or data according to inductive coupling, resonant inductive coupling (e.g., RFID), capacitive coupling, etc. For example, the transparent assembly may be configured to transmit information relating to sensed biological or device parameters, as well as data identifying one or more of the following: valves (e.g., manufacturer, model, identification number, serial number) and / or patients (e.g., name, identification number, patient identifier).

[0099] The transmitter assembly may generally have a shape that conforms to the shape of a portion of the frame 810 assembly. One or more coils 808 may comprise one or more conductive wires wound around a circumferential path of the assembly. In certain embodiments, one or more coils 808 may be at least partially covered by a sheath or cover 809, which may provide electrical, thermal, and / or physical isolation between the coils 808 and external components or structures of the frame 810 to which the assembly is associated.

[0100] One or more coils 808 may be electrically coupled to one or more sensors 805 via one or more leads 811. The coils 808 may be coupled to any number of sensors 805 that are mounted on and / or extend from the frame 810. One or more sensors 805 may be assembled to wirelessly receive power and / or wirelessly transmit sensor and / or other data using one or more coils 808 as antennas.

[0101] Each of the first sensor 805a and the second sensor 805b may be coupled to a separate coil 808 (for example, the first coil 808a and the second coil 808b, respectively). The first coil 808a and the second coil 808b do not have to be attached to each other. Furthermore, although the second sheath 809 is not shown in Figure 8, the first coil 808a may be at least partially covered by the sheath 809, thereby at least partially covering and / or separating the first coil 808a.

[0102] The first sensor 805a and the second sensor 805b may be configured to measure differential pressure using pressure readings on both sides of the valve 800. Through the use of sensors in the first portion 850 and the second portion 852 of the frame 810, the valve 800 may be configured to provide uncalibrated readings of the pressure gradient across the valve 800. In some embodiments, the first sensor 805a and the second sensor 805b may be connected via the use of fluid connections and / or electrical connections. For example, a substrate and / or one or more coils may be configured to connect the first sensor 805a to the second sensor 805b. However, the first sensor 805a does not necessarily have to be physically connected to the second sensor 805b, and / or the first sensor 805a and / or the second sensor 805b may be configured to wirelessly transmit the measurements to an external receiver.

[0103] In some embodiments, one or more sensors 805 and / or other components may be configured to perform some signal processing for signal transmission, such as signal filtering, amplification, mixing, and / or similar. For example, one or more sensors 805 may include one or more processors, data storage devices, data communication buses, and / or similar.

[0104] The devices, systems, and methods disclosed herein may be used to identify symptoms or conditions indicating potential cardiac or implantation malfunctions in patients who have received an artificial heart valve implant or other implantable device. In some implementations, the use of one or more sensors 805 is provided to sense and / or transmit various measurements (e.g., blood pressure) and valve function in the heart valve device.

[0105] One or more sensors 805 may be applied to the wireform or stent components of the artificial valve 800. While sensors 805 for measuring blood pressure are discussed in detail herein, other sensors may be used, such as strain gauges, accelerometers, gyroscopes, optical sensors, or similar. Data provided by or derived from one or more sensors 805 of the implanted heart valve may be used to alert the patient or healthcare professional about changes in the patient's heart rate or blood pressure, and may provide early signs of changes in cardiac function. As described above, patients undergoing artificial heart valve implantation surgery may sometimes have morbidity / mortality associated with post-implantation heart failure. Heart valve sensor devices and wireless data transmission functions, such as those disclosed herein, can provide early information about cardiac function and thus enable early intervention for the patient.

[0106] In some embodiments, the valve 800 may include a first post 840a configured to receive a first sensor 805a, and / or a second post 840b configured to receive a second sensor 805b. The first post 840a may be configured to extend from the end of the frame 810 in the inlet portion of the frame 810, and / or the second post 840b may be configured to extend from the end of the frame 810 in the outlet portion of the frame 810. In response to the crimping of the valve 800, the distance between the first post 840a and the second post 840b may increase. In this way, the first sensor 805a and the second sensor 805b may, advantageously, be configured to extend with the valve 800 and may not restrict the movement of the valve 800 (e.g., during the delivery process involving the crimping of the valve 800).

[0107] A certain amount of power may be required to power one or more sensors 805. For example, the excitation voltage applied to the input leads of one or more sensors 805 may be provided from wireless power transmission, local power harvesting, local power storage, or other power generation and / or supply systems. In some embodiments, power may be generated using one or more piezoelectric crystals, which may be stored in a power storage device such as a capacitor or the like. Voltage readings of one or more sensors 805 may be obtained from one or more of the output leads 811. Frame 810 may include signal processing circuits (not shown) for pre-processing the sensor signals, such as filtering, signal amplification, or the like.

[0108] Figure 9 shows another valve including a frame 910 and a base band 912 that are at least partially wound around or near a first portion of the frame 910. In some embodiments, the base band 912 may be at least partially located along the inner surface 913 of the frame, as shown in Figure 9. However, the base band 912 may additionally or alternatively be located on the outer surface 917 of the frame 910. In some embodiments, the base band 912 may include a partially circular shape (e.g., a semicircle). The base band 912 may be sewn to the frame 910. In some embodiments, one or more coils may be sewn to the base band 912.

[0109] One or more substrate extensions 914 may extend from the substrate band 912. For example, the substrate band 912 may be located in or near a first portion of the frame 910 (e.g., the inlet portion), and the substrate extensions 914 may be configured to extend axially from the substrate band 912 to a second portion of the frame (e.g., the outlet portion). One or more sensors 905 may be configured to be attached to the end portion of the substrate extension 914 so that one or more sensors 905 may be configured to be located in or near the second portion of the frame 910, while one or more sensors 905 attached to the substrate band 912 may be configured to be located in the first portion of the frame 910. Although only a single substrate extension 914 is shown in Figure 9, any number of substrate extensions 914 may be included. For example, four substrate extensions 914 may extend from the substrate band 912, and each substrate extension 914 may be configured to position at least one sensor 905 in the second portion of the frame 910. One or more base material extensions 914 may be configured to pass along the inner surface 913 and / or outer surface 917 of the frame 910, and / or to be attached to one or more support posts 915 of the frame. In some embodiments, the base material extensions 914 may be configured to align with the posts 940 of the frame 910 so that a sensor 905 attached to the base material extension 914 may be positioned within an island of posts 940.

[0110] In some embodiments, a first sensor 905 located in or near a first portion of frame 910 may be powered via a separate circuit (e.g., an LC resonant circuit) from a circuit used by a second sensor 905 located in or near a second portion of frame 910, and / or transmitted wirelessly.

[0111] The base band 912 may include various contact lines. In some embodiments, the base band 912 may be configured to create conductive paths between multiple sensors, antennas, and / or other components. One or more base extensions 914 may be configured to further extend the conductive path from the inlet portion of the valve 900 to the outlet portion of the valve 900. In some embodiments, one or more base extensions 914 may be configured to pass at least partially through one or more cells 920 of the frame 910. For example, one or more base extensions 914 may be configured to extend across the space between the pillars 915 of the frame 910. At the point where one or more base extensions 914 pass through the pillars 915 of the frame 910, one or more base extensions 914 may be configured to contact and / or attach to the frame 910.

[0112] Figure 10 shows a valve comprising a frame 1010 and a skirt 1018 that is at least partially wrapped around the inner and / or outer surfaces of the frame 1010. In some embodiments, the skirt 1018 may be configured to prevent intrinsic growth of tissue through the cells of the frame 1010.

[0113] The valve may include any number of sensors 1005 and / or posts 1040. For example, the valve may have a first sensor 1005a, a second sensor 1005b, a third sensor 1005c, and a fourth sensor 1005d spaced circumferentially around a first portion of the valve. Each of the first sensor 1005a, the second sensor 1005b, the third sensor 1005c, and the fourth sensor 1005d may be located on and / or within a first post 1040a, the second post 1040b, the third post 1040c, and / or a fourth post 1040d, respectively. The valve may further include a fifth post 1040e, a sixth post 1040f, a seventh post 1040g, and / or an eighth post (not shown) in a second portion of the valve. The additional sensor 1005 is located in the post 1040 of the second part of the valve, and / or may be located within the post 1040.

[0114] In some embodiments, the valve may include one or more artificial valve leaves 1009 configured to replace a missing and / or malfunctioning valve in the patient's body. One or more artificial valve leaves 1009 may be configured to cover at least a portion of the internal lumen of the valve.

[0115] The valve frame 1010 may be configured to support one or more posts 1040 extending from the frame 1010. In some embodiments, one or more posts 1040 may be configured to be attached to the frame 1010. When the valve is crimped, one or more posts 1040 and / or one or more sensors 1005 may be configured to move with the frame.

[0116] Figure 11 illustrates how valve alignment may change as a result of a patient's breathing or other chest movements. In some cases, successful data transfer between one or more sensors in the valve may require a parallel configuration with a remote antenna (e.g., positioned along and / or parallel to a predetermined communication line 1101). The first valve 1100a is shown not parallel to the communication line 1101, the second valve 1100b is shown displaced from the communication line 1101, and the third valve 1100c is shown parallel and in a straight line to the communication line 1101.

[0117] If there is no clear communication line between the sensor antenna of valve 1100 and the receiver, data transmission may fail. Therefore, when the sensor is positioned within the frame of valve 1100, communication may fail in certain alignments, at least due to a portion of the valve blocking the wireless data path.

[0118] Some embodiments of the present disclosure provide sensor receptors in which one or more sensors can be advantageously positioned to extend away from the frame of the valve 1100. For example, the valve 1100 may include one or more posts configured to position one or more sensors at or beyond the outflow and / or inflow portions of the valve 1100. By positioning one or more sensors distal to the frame of the valve 1100, permeability from one or more sensors can be improved with various alignments of the valve 1100.

[0119] Figure 12 shows a frame 1210 comprising a base band 1212 and one or more base extensions 1214 having an expandable structure. One or more base extensions 1214 may be configured to extend substantially axially from the base band 1212. However, one or more base extensions 1214 may have a generally nonlinear (e.g., meandering and / or zigzag) structure in which the base extension 1214 comprises one or more bends, allowing the base extension 1214 to be stretched and / or compressed. The expandability of the base extensions 1214 may, advantageously, allow one or more sensors 1205 of a second portion of the frame 1210 to extend further from the base band 1212 when the frame 1210 is crimped and / or when the frame 1210 itself expands in response to crimping.

[0120] As shown in Figure 12, the valve 1200 may be equipped with multiple sensors 1205 in or near a first part of the valve 1200 and / or in or near a second part of the valve 1200. For example, the valve 1200 may be equipped with at least a first sensor 1205a in the first part. The valve 1200 may additionally be equipped with a second sensor 1205b in the first part, and a third sensor 1205c, a fourth sensor 1205d, a fifth sensor 1205e, and / or a sixth sensor 1205f in the second part. In some embodiments, the valve 1200 may be equipped with four sensors 1205 in or near the first part. The use of multiple sensors in the first part and / or second part may enable improved detection of pressure and / or flow changes around the valve 1200. In some embodiments, the multiple sensors 1205 may be connected to a common coil and / or separate coils. For example, the second sensor 1205b, the third sensor 1205c, the fourth sensor 1205d, and / or the fifth sensor 1205e can be connected to the same coil to obtain an average measurement, and / or each can be connected to a different coil to obtain distributed measurements around the valve 1200.

[0121] The valve 1200 may include any number of posts 1240, including a first post 1240a, at the first end portion of the valve 1200 and / or on or near the base band. As shown in Figure 12, the first post 1240a may be configured to extend at least partially along the base band 1212. The sensor 1205 may be configured to be located within the first post 1240a while simultaneously being attached to and / or coupled to the base band 1212. The valve 1200 may further include a second post 1240b and / or a third post 1240c extending from the endpoint of the second end portion of the valve 1200. A third sensor 1205c, a fourth sensor 1205d, a fifth sensor 1205e, and / or a sixth sensor 1205f may be configured to be located within the corresponding post and / or to be coupled to an extending substrate extension 1214 that forms a substrate band 1212.

[0122] In response to the crimping of the valve 1200 (for example, increasing the length of the valve 1200 to increase the distance between the base material band 1212 at the first end portion of the valve 1200 and the second post 1240b at the second end portion of the valve 1200), the base material extension 1214 may be configured to be more linear. For example, the curvature of the base material extension 1214 may be reduced. In some embodiments, the base material extension 1214 may be at least partially constructed from a flexible and / or elastic material so that the base material extension 1214 can be molded (e.g., extended) in response to the crimping and / or lengthening of the valve 1200 and / or after the crimping process (e.g., in response to the expansion of the valve 1200), so that it returns to the original form shown in Figure 12.

[0123] Figure 13 shows another exemplary valve 1300, comprising a frame 1310, a base band 1312, and one or more base extensions 1314, configured to extend roughly diagonally and / or at an angle of approximately 45 degrees from a base band 1312 in a first portion 1350 of the frame 1310 to a second portion 1352 of the frame 1310. The one or more base extensions 1314 may be configured to pass at least partially circumferentially around the outer and / or inner surfaces of the frame 1310, such that the end portions of the base extensions 1314 are not located directly below the point where the base extensions 1314 are attached to the base band 1312. The one or more base extensions 1314 may be at least partially flexible and / or at least partially curved to allow the base extensions 1314 to expand and / or contract in response to compression and / or expansion of the frame 1310.

[0124] In some embodiments, one or more base material extensions 1314 may be configured to have a generally “serpentine” structure and / or to form a generally thin, elongated structure extending from the base material band 1312. One or more base material extensions 1314 may be configured to be at least partially wound around the outer surface and / or inner surface in substantially diagonal directions between the axial direction (e.g., a straight line from the first portion 1350 to the second portion 1352) and the circumferential direction (e.g., a straight line with the base material band 1312). Multiple base material extensions 1314 may be configured to at least partially overlap. In some embodiments, one or more base material extensions 1314 may have one or more contact points along the frame 1310 to allow stretching and / or crimping of the frame 1310 and / or the base material extensions 1314. One or more base material extensions 1314 may be configured to bend so that one or more base material extensions 1314 can extend in the axial and / or circumferential directions (for example, they may be at least partially made of an elastic material and / or a flexible material).

[0125] One or more substrate extensions 1314 may generally have a nonlinear structure and / or be at least partially curved. In some embodiments, one or more substrate extensions 1314 may be configured to extend across one or more cells 1320 of the frame 1310. For example, one or more substrate extensions 1314 may be configured to extend across the space between the support columns 1315 of the frame 1310. At the point where one or more substrate extensions 1314 pass through the support columns 1315 of the frame 1310, one or more substrate extensions 1314 may be configured to contact and / or attach to the frame 1310.

[0126] In some embodiments, the curvature of the base material extension 1314 may advantageously allow the base material extension 1314 to extend and / or otherwise shape in response to the compression of the valve 1300. For example, when the valve 1300 is compressed, the curvature of the base material extension 1314 may decrease, and the base material extension 1314 may form a more linear shape. The base material extension 1314 may generally be made of a flexible and / or elastic material. In some embodiments, the base material extension 1314 may be configured to naturally return to its original curvature after the compression process (e.g., when the valve 1300 is expanded from its compressed orientation).

[0127] The valve 1300 may be configured to include at least a first sensor 1305a, which is coupled to the base band 1312 and / or at least partially located within a first post 1340a extending from the endpoint of the first end portion 1350 of the valve 1300. The valve 1300 may further include a second sensor 1305b (e.g., located within the second post 1340b and / or coupled to the base extension 1314), a third sensor 1305c (e.g., located within the post 1340 and / or coupled to the base extension 1314), a fourth sensor 1305d (e.g., located within the third post 1340c and / or coupled to the base extension 1314), and / or a fifth sensor 1305e (e.g., located within the post and / or coupled to the base extension 1314).

[0128] Figure 14 shows a valve 1400, which includes a frame 1410 and one or more posts 1440, and one or more sensors 1405 configured to slide within the posts 1440 to adjust the position of one or more sensors 1405 relative to the posts 1440 and / or frame 1410. For example, one or more sensors 1405 may be configured to slide and / or move during the crimping of the valve 1400. By sliding the sensors 1405 relative to the posts 1440, the positions of a first sensor 1405a in a first part of the frame 1410 and a second sensor 1405b in a second part of the frame 1410 can be maintained constant as the frame 1410 is crimped and / or compressed. In some embodiments, the valve 1400 may include a cover 1418 (e.g., made of polymer) which is at least partially wrapped around the outer surface of the frame 1410 and / or configured to allow the growth of tissue for better integration with the surrounding tissue of the valve 1400. In some embodiments, the valve 1400 may include one or more artificial valve leaves 1409 configured to perform functions similar to those of a valve leaf.

[0129] The valve 1400 may include one or more substrates 1412 configured to extend one or more sensors 1405 to a first portion and / or a second portion of the valve 1400. In some embodiments, one or more substrates 1412 may be configured to extend from the first portion to the second portion and / or from the second portion to the first portion.

[0130] The valve 1400 may have any number of sensors 1405 in a first portion of the valve 1400 (e.g., the inlet portion) and any number of sensors 1405 in a second portion of the valve 1400 (e.g., the outlet portion). Similarly, the valve 1400 may include any number of posts 1440 in the first portion of the valve 1400 and any number of posts 1440 in the second portion of the valve 1400. The first sensor 1405a may be located in the first portion of the valve 1400 (e.g., the inlet portion) within the first post 1440a. The second sensor 1405b may be located in the second portion of the valve 1400 (e.g., the outlet portion) within the second post 1440b and / or may be attached to the base material 1412. Both the first sensor 1405a and the second sensor 1405b may be configured to measure a pressure difference across the valve 1400. The additional sensor 1405 may be configured to measure various parameters around the circumferential region of the valve 1400 to help detect abnormal measurements. For example, the valve 1400 may further include a third sensor 1405c at a third post 1440c, a fourth sensor 1405d at a fourth post 1440d, and / or additional sensors 1405 at a fifth post 1440e and / or a sixth post 1440f.

[0131] When the valve 1400 is crimped (for example, during the process of delivery into a patient's body), at least a portion of the valve 1400 may be configured to compress laterally (for example, the diameter of the internal lumen of the valve 1400 may decrease) and / or stretch longitudinally (for example, the distance between the first post 1440a and the second post 1440b may increase). In some embodiments, one or more sensors 1405 may be configured to slide within the island (i.e., receptors) of the post 1440. For example, during crimping, the distance between the first sensor 1405a and the second sensor 1405b may remain unchanged while the distance between the first post 1440a and the second post 1440b increases.

[0132] Systems and devices that can be used for monitoring patients receiving implanted devices, such as heart valve implantation devices, as disclosed herein are disclosed herein. Figure 15 is a flowchart showing a process 1500 for monitoring a patient with a postoperative implanted device and / or associated therewith. Process 1500 can be implemented at least partially by one or more entities or components of the systems shown in Figures 3 and 4 and described above. In some embodiments, process 1500 or a portion thereof can be implemented by a physician or healthcare provider or other user / entity.

[0133] Process 1500, in block 1502, involves providing an implantable device, such as a heart valve implantable device, having one or more receptors for one or more sensors. In some embodiments, the receptors may include posts, as described herein, extending from the frame of the prosthetic valve. The receptors may additionally or alternatively include a substrate band and / or substrate extensions attached to the frame of the prosthetic valve. For example, one or more sensors may be attached to a substrate band forming a circular band around the inside or outside of a cylindrical frame, and / or one or more sensors may be attached to one or more substrate extensions extending from the substrate band. In some embodiments, the receptors may be added to an existing implantable device. One or more receptors may be located at a first end portion of the implantable device (e.g., the inflow portion), and / or one or more additional receptors may be located at a second end portion of the implantable device (e.g., the outflow portion).

[0134] In block 1504, process 1500 involves inserting and / or attaching one or more sensors into / to one or more receptors. For example, one or more sensors may be located within a post extending from an implantable device. In some embodiments, one or more sensors may be composed of polymers and / or similar materials and / or may have a generally soft structure. For example, one or more sensors may be configured to be molded and / or adapted to mate with receptors of various sizes, including posts as described herein.

[0135] In block 1506, process 1500 involves crimping an implantable device for delivery to a treatment site within the patient's body (e.g., the heart). The crimping may involve a reduction in the diameter of the implantable device (e.g., a reduction in the diameter of the internal lumen of the implantable device) and / or an increase in the length of the implantable device (e.g., an increase in the distance between a first end portion (e.g., the inflow portion) and a second end portion (e.g., the outflow portion) of the implantable device). Thus, crimping can increase the distance between a first receptor and / or a first sensor of the first receptor and a second receptor and / or a second sensor of the second receptor. In some embodiments, one or more sensors may be configured to slide within the receptor during the crimping process. For example, the receptor may include a sliding post that allows the sensor within the receptor to slide freely relative to the receptor. In some embodiments, as the position of the receptor changes in response to crimping, the sensor within the receptor may maintain its position by sliding within the receptor. The crimped implantable device may be placed within a catheter and / or other delivery device.

[0136] In block 1508, process 1500 involves delivering the implantable device to the desired therapeutic site. For example, the implantable device may be delivered to the patient's aortic valve. In block 1510, the process involves expanding the implantable device to its original configuration before crimping. In some cases, removing the implantable device from a catheter and / or other delivery device may cause expansion of the implantable device. As the implantable device reaches and / or returns to its expanded configuration, one or more sensors may be located on one or more end portions of the implantable device. For example, a first sensor may be located on a first end portion, and a second sensor may be located on a second end portion.

[0137] Depending on the embodiment, any particular action, event, or function of any of the processes or algorithms described herein may be performed in a different order, added, merged, or completely excluded. Therefore, in a particular embodiment, not all described actions or events are necessary for the practice of the process.

[0138] In particular, conditional language used herein, such as “can,” “could,” “might,” “may,” and “e.g.,” is intended in its ordinary sense unless otherwise stated or understood differently in the context in which it is used, and is generally intended to convey that certain features, elements, and / or steps are included in certain embodiments but not in other embodiments. Therefore, such conditional language is generally not intended to imply that features, elements, and / or steps are required in any way in one or more embodiments, or that one or more embodiments necessarily include, with or without input or prompting by the author, logic for determining whether these features, elements, and / or steps are included or performed in any particular embodiment. Terms such as “equip,” “include,” and “have” are synonymous and are used in their ordinary sense, in a comprehensive, non-restrictive manner, without precluding additional elements, features, actions, functions, etc. Furthermore, the term "or" is used in its inclusive sense (and not its exclusive sense), and therefore, for example, when used to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Unless otherwise specified, connecting phrases such as "at least one of X, Y, and Z" are understood in context to be used to generally convey that an item, term, element, etc., may be any of X, Y, or Z. Thus, such connecting phrases are generally not intended to imply that a particular embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z, respectively.

[0139] In the descriptions of the embodiments described above, it should be understood that various features may be grouped together in a single embodiment, figure, or description for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various aspects of the invention. However, this method of disclosure should not be interpreted as reflecting an intention that any claim requires more features than are explicitly enumerated in that claim. Furthermore, any component, feature, or step shown and / or described in a particular embodiment of this specification may be applied to or used in conjunction with any other embodiment. Moreover, a component, feature, step, or group of components, features, or steps is not required or essential to each embodiment. Accordingly, the scope of the invention of this specification disclosed and claimed below should not be limited by the particular embodiments described above, but should be determined solely by a fair reading of the following claims.

[0140] It should be understood that specific sequential terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply any physical characteristics or order. Therefore, sequential terms used herein to modify elements such as structure, components, and operations (e.g., "first," "second," "third," etc.) do not necessarily indicate the priority or order of an element relative to any other element, but rather may schematically distinguish an element from another element having a similar or identical name (other than the use of sequential terms). In addition, as used herein, the indefinite articles ("a" and "an") may indicate "one or more" rather than "one." Furthermore, actions performed "on the basis" of a condition or event may also be performed on the basis of one or more other conditions or events not explicitly listed.

[0141] Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as those generally understood by those skilled in the art to which the exemplary embodiments belong. Furthermore, terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and should not be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0142] The spatially relative terms “outside,” “inside,” “top,” “bottom,” “down,” “up,” “vertical,” “horizontal,” and similar terms may be used herein to facilitate explanation and to describe the relationship between one element or component and another, as shown in the drawings. It should be understood that the spatially relative terms are intended to encompass different orientations of a device in use or operation, in addition to the orientation shown in the drawings. For example, if a device shown in the drawings is turned over, a device positioned “below” or “directly below” another device may be positioned “above” the other device. Thus, the exemplary term “below” may include both the lower and upper positions. Devices may also be oriented in other directions, and therefore, the spatially relative terms may have different interpretations depending on the orientation.

[0143] Unless otherwise explicitly stated, comparative and / or quantitative terms such as “less,” “more,” and “greater” are intended to encompass the concept of equality. For example, “less” can mean not only “less” in the strict mathematical sense, but also “less than or equal to.”

Claims

1. Artificial valve (800), A frame (810) having a first opening in a first portion (850) of the frame and a second opening in a second portion (852) of the frame, the frame (810) including a network of support columns that form one or more cells, A conductive coil (808) attached to the frame, A first sensor device (805) is arranged in the first portion of the frame, Equipped with, The conductive coil is connected to the first sensor device. The first sensor device is configured to sense physical parameters and provide sensor signals, and is an artificial valve.

2. The artificial valve according to claim 1, wherein the conductive coil passes along the inner and / or outer surface of the frame.

3. The artificial valve according to claim 1 or 2, wherein the conductive coil is embedded in or integrated with the frame, and optionally the conductive coil is nested in a recess, channel, or cavity of the frame.

4. The artificial valve according to any one of claims 1 to 3, wherein the conductive coil has a shape that conforms to the shape of the frame or a part of the frame.

5. The artificial valve according to any one of claims 1 to 4, further comprising a post (740) extending from the first portion of the frame, wherein the first sensor is positioned on the post.

6. The artificial valve according to any one of claims 1 to 5, wherein the first sensor device is configured to slide within the first post.

7. The artificial valve according to any one of claims 1 to 6, wherein the conductive coil is at least partially covered by a cover (809), the cover being configured to provide electrical, thermal, and / or physical isolation between the coil and the external structure of the frame.

8. A second conductive coil (808b) is attached to the frame, A second sensor device (805b), wherein the second sensor device is positioned on the second portion of the frame and is electrically coupled to the second conductive coil, Furthermore, The artificial valve according to any one of claims 1 to 7, wherein the second sensor device is configured to sense physical parameters and provide sensor signals.

9. The artificial valve according to claim 8, further comprising a second post extending from the second portion of the frame, wherein the second sensor device is positioned on the second post.

10. The artificial valve according to any one of claims 1 to 9, wherein the first portion is the inlet portion of the frame, and the second portion is the outlet portion of the frame.

11. The artificial valve according to any one of claims 1 to 10, wherein the frame is operable between a first extended configuration and a second crimped configuration.

12. The artificial valve according to any one of claims 1 to 11, wherein the first sensor device and / or the second sensor device is a pressure sensor.

13. The artificial valve according to any one of claims 1 to 12, wherein the first sensor device and / or the second sensor device has a generally soft structure.

14. A patient monitoring system, An artificial valve according to any one of claims 1 to 13, wherein the conductive coil is configured to act as an antenna for receiving wireless power and / or transmitting electromagnetic signals, A receiving device, which is wirelessly coupled to the antenna of the artificial valve implantation device and configured to receive a transmission signal while the artificial valve implantation device is implanted in a patient and the receiving device is located outside the patient, A patient monitoring system, including a patient monitoring system.

15. A method for monitoring patients with artificial implants, A step of wirelessly connecting an external receiver device to an artificial valve implantation device implanted in a patient, wherein the artificial valve implantation device comprises an artificial valve according to any one of claims 1 to 13, The steps include measuring physical parameters associated with the patient using the sensor device of the artificial valve implantation device, The steps include: using the transmitter assembly of the artificial valve implantation device to wirelessly transmit a signal based on measured physical parameters; Methods that include...

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