Implantable fluid flow and acoustic sensor

Abstract

Devices, systems, and methods are disclosed for in vivo monitoring of flow of biological fluid in anatomy, such as blood flow through a heart valve (e.g., a mitral valve, a tricuspid valve, and / or an aortic valve) or a ventricle, as well as acoustic signals emanating from an internal bodily structure. The disclosed devices, systems, and methods enable continuous and autonomous measurement and assessment of cardiovascular and pulmonary function or dysfunction, and / or compilation with other monitoring data that can be used to measure or predict secondary factors.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] Any and all applications that identify foreign or domestic priority claims in the Application Data Sheet filed with this application are hereby incorporated by reference. Technical Field

[0003] The present disclosure relates generally to implantable medical devices and, more particularly, to sensors deployable within a patient-user for monitoring fluid flow and biological function within the body. Background Art

[0004] According to the World Health Organization (WHO), cardiovascular disease is one of the leading causes of death worldwide, claiming approximately 17.9 million lives annually. In the United States, heart disease is the leading cause of death, with coronary artery disease (CAD) being the most lethal type. It reduces blood flow to the heart, often leading to heart attacks. CAD and other heart valve diseases, such as mitral valve prolapse (MVP) and mitral valve regurgitation (MVR), are silent killers because people are often unaware of their underlying heart problems and therefore go undiagnosed until they experience signs or symptoms of a heart attack, heart failure, or arrhythmia, which can be too late for survival or a reasonable quality of life. Even now, a person typically must have a secondary medical condition, such as diabetes or obesity, or be identified as having one or more significant risk factors, such as high blood pressure, high cholesterol, alcohol abuse, or smoking, before doctors can begin a round of heart tests and remote monitoring. This is because there are no readily available, simple, and affordable devices or technologies to observe and track a person's heart function.

[0005] Currently, examining heart function to potentially diagnose heart disease is limited to clinical settings. Typically, patients will undergo a variety of different tests, including analyte tests from a blood sample; imaging, such as a chest x-ray, CT scan, or magnetic resonance imaging (MRI) of the heart; and physiological signal monitoring, such as an electrocardiogram (ECG or EKG), which is a recording of the heart's electrical signals that, when monitored remotely (e.g., by a Holter monitor), can indicate heart rate and detect irregular heartbeats, or an echocardiogram, which is a non-invasive acoustic (sound) signal monitoring technology used to create images of the heart and blood in motion. Furthermore, such tests are only prescribed to patients after an acute or emergency medical treatment has occurred, such as cardiac arrest, stroke, severe dizziness or unconsciousness, or extreme chest pain.

[0006] To date, some progress has been made in remote monitoring to begin to reverse the trend of heart disease. For example, wearable heart rate monitors are becoming a ubiquitous option for tracking heart rate during exercise or daily activities, monitoring stress and exercise levels, tracking sleep habits at night, and, in some versions of these wearable devices, testing certain vital signs outside of a clinic, such as an ECG, to identify single heart rhythm events, such as healthy sinus rhythm or dangerous atrial fibrillation. While these devices are well-suited to promoting a healthier, more active lifestyle that may help prevent heart attacks or mitigate mild to moderate heart disease in the long run, they cannot identify a wide range of symptoms or characteristics of heart disease and cannot identify any underlying biological or physiological factors at the root of heart disease.

[0007] The challenge for clinicians is to detect heart disease early or manage and monitor diagnosed heart disease after treatment. However, monitoring cardiac function relies on patient engagement and compliance; and existing systems and methods are too time-consuming, costly, and resource-intensive to be effective.

[0008] A new sensor paradigm is needed that can be deployed within a patient's body and that can monitor the dynamic flow of biological fluids in the body, such as blood flow through heart valves, to characterize overall cardiac function. Summary of the Invention

[0009] In short, the disclosure in vivo Devices, systems, and methods for monitoring the flow of biological fluids in anatomical structures, such as blood flow through heart valves or through heart chambers or vessels that flow blood into or out of the heart, and acoustic signals associated with physiological phenomena of internal body structures, such as the heart and / or lungs, all from within the host. The disclosed devices, systems, and methods include in vivo Fluid flow sensors and in vivo An acoustic sensor may be configured as a single device structure or as part of separate device structures implanted within a host.

[0010] In some embodiments according to the present technology, an implantable medical device comprises in vivo Invivo fluid flow sensor and in vivoIn vivo acoustic sensor. For example, in some implementations, an in vivo fluid flow sensor is configured to transmit an ultrasonic signal to propagate through an anatomical structure and detect the ultrasonic signal that has propagated through the anatomical structure and is indicative of fluid flow of a biological fluid in the anatomical structure; and an in vivo acoustic sensor is configured to detect an acoustic signal emanating from an internal body structure. For example, in some embodiments, the in vivo a fluid flow sensor comprising a linkage assembly including a first arm configured to attach to a first portion of the anatomical structure and a second arm configured to attach to a second portion of the anatomical structure opposite the first portion, and an ultrasonic sensor assembly including a plurality of ultrasonic transducer elements coupled to the linkage assembly; and in vivo The acoustic sensor includes a hermetically sealed housing, and a transducer element configured to receive the acoustic signal emitted from the internal body structure, such that the transducer element converts energy of the received acoustic signal into an electrical signal indicative of a physiological function of the internal body structure.

[0011] An implantable medical device for in vivo monitoring of an anatomical structure from within a host, comprising: an in vivo fluid flow sensor, the in vivo fluid flow sensor comprising: a connecting assembly including a first arm configured to attach to a first portion of the anatomical structure and a second arm configured to attach to a second portion of the anatomical structure opposite the first portion; a connecting device coupled to each of the first arm and the second arm; an ultrasonic sensor assembly including a plurality of ultrasonic transducer elements coupled to the connecting assembly, the plurality of ultrasonic transducer elements including a first ultrasonic transducer element configured to transmit the ultrasonic signal to propagate through the anatomical structure, and a second ultrasonic transducer element and a third ultrasonic transducer element configured to receive the ultrasonic signal that has propagated through the anatomical structure and is indicative of a fluid flow parameter of the biological fluid in the anatomical structure; An in-vivo acoustic sensor, comprising: an airtight sealed housing, and a transducer element, wherein the transducer element is configured to receive an acoustic signal emitted from a source within the host body, so that the transducer element converts the energy of the received acoustic signal into an electrical signal indicative of a physiological function of the source within the host body; and an electronic unit, wherein the electronic unit is at least partially housed in the connecting device of the in-vivo fluid flow sensor and / or at least partially housed in the airtight sealed housing of the in-vivo fluid flow sensor, wherein the electronic unit is in electrical communication with the multiple ultrasonic transducer elements of the ultrasonic sensor assembly and with the transducer elements of the in-vivo acoustic sensor, and the electronic unit is configured to process electrical signals associated with the received ultrasonic signals and the received acoustic signals into data, and to wirelessly transmit the data to an external processor.

[0012] In certain embodiments according to the present technology, a system for monitoring fluid flow in an anatomical structure in vivo includes an implantable medical device comprising an in vivo fluid flow sensor and an in vivo acoustic sensor; and a data processing system comprising a processor and a memory, the data processing system communicating data with the implantable medical device and being configured to receive the data from the implantable medical device and process the received data to determine fluid flow parameters associated with a biological fluid in the anatomical structure and / or acoustic signal parameters associated with a physiological function of an internal body structure.

[0013] The above and additional features of the present invention and the manner in which they are obtained will become apparent and will be best understood by reference to the following more detailed description. All references disclosed herein, including patent references and non-patent references, are hereby incorporated by reference in their entirety as if each reference were incorporated individually.

[0014] This brief summary is provided to introduce some concepts in a simplified form that are further described in the detailed description below. Unless otherwise expressly stated, this brief summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter.

[0015] The details of one or more embodiments are set forth in the following description. Features shown or described in conjunction with an exemplary embodiment may be combined with features of other embodiments. Thus, any of the various embodiments described herein may be combined to provide additional embodiments. Aspects of the embodiments may be modified, if necessary, to adopt concepts from the various patents, applications, and publications identified herein to provide yet further embodiments. Additional features, objects, and advantages will be apparent from the description, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Many aspects of the present disclosure may be better understood with reference to the following drawings. The features in the drawings are not necessarily drawn to scale, shown or depicted in the same manner as the physical construction. Instead, emphasis is placed on clearly illustrating the principles of the present disclosure. The drawings should not be used to limit the present disclosure to the specific embodiments depicted but are for explanation and understanding only.

[0017] Figure 1A The present invention is shown in in vivo Diagram of an exemplary embodiment of a system for monitoring biofluid flow and acoustic signals from within a patient having an implantable medical device (IMD) for monitoring, analyzing, and reporting events associated with the user's cardiovascular and / or pulmonary health in accordance with the present technology.

[0018] Figure 1B The present invention is shown Figure 1A of in vivo Block diagram of an exemplary embodiment of a fluid flow sensor device.

[0019] Figure 1C The present invention is shown Figure 1A of in vivo Block diagram of an exemplary embodiment of a fluid flow sensor device.

[0020] Figure 2A A diagram depicting the present technology Figure 1BFIG. 1 is a diagram of an exemplary embodiment of an in vivo fluid flow sensor device.

[0021] Figure 2B A diagram depicting the present technology Figure 1B FIG. 1 is a diagram of another exemplary embodiment of an in vivo fluid flow sensor device comprising a second set of ultrasonic sensor contingents.

[0022] Figure 2C A diagram depicting the present technology Figure 1B FIG. 1 is a diagram of another exemplary embodiment of an in vivo fluid flow sensor device.

[0023] Figure 2D A diagram depicting the present technology Figure 1B FIG. 1 is a diagram of another exemplary embodiment of an in vivo fluid flow sensor device.

[0024] Figure 3 Shown is a device according to the present technology attached to the heart of a patient user. Figure 2A FIG. 1 is a diagram of an exemplary embodiment of an in vivo fluid flow sensor device.

[0025] Figure 4A Shown is a diagram depicting an insertion location for implanting an in vivo fluid flow sensor device in accordance with the present technology.

[0026] Figure 4B Shown according to the present technology in vivo Diagram of exemplary shape configurations of exemplary embodiments of a fluid flow sensor device for use during implantation proximate to a target anatomical structure and during deployment for securing to the target anatomical structure.

[0027] Figure 5A A diagram depicting a method for in vivo Diagram of an exemplary embodiment of a single-sided acoustic transducer configuration for a fluid flow sensor device.

[0028] Figure 5B A diagram depicting a method for in vivo Diagram of another exemplary arrangement of a single-sided acoustic transducer configuration on an array of a fluid flow sensor device.

[0029] Figure 5C A diagram depicting a method for in vivo Diagram of another exemplary embodiment of a single-sided acoustic transducer configuration with a reflector for a fluid flow sensor device.

[0030] Figure 5D A diagram depicting a method for in vivo Diagram of an exemplary embodiment of a double-sided acoustic transducer configuration for a fluid flow sensor device.

[0031] Figure 6A 、 Figure 6B and Figure 6C Shown according to the present technology Figure 1B of in vivo Figures of other exemplary embodiments of fluid flow sensor devices.

[0032] Figure 6D Shown depiction Figure 6A 、 Figure 6B and Figure 6C Exploded view of an exemplary embodiment of the electronics unit and housing of an in vivo fluid flow sensor device.

[0033] Figure 7A A diagram depicting the present technology Figure 1B FIG. 1 is a diagram of an exemplary embodiment of an in vivo fluid flow sensor device.

[0034] Figure 7B and Figure 7C A diagram depicting the present technology Figure 1B FIG. 1 is a diagram of an exemplary embodiment of an in vivo fluid flow sensor device.

[0035] Figure 8 A diagram depicting the present technology Figure 1B of in vivo A diagram of another exemplary embodiment of a fluid flow sensor device.

[0036] Figure 9 Shows the remote in vivo Figure 1 is a diagram of an exemplary embodiment of a device that can be tethered to a Figure 1B of in vivo Exemplary embodiments of fluid flow sensor devices, such as Figure 7A 、 Figure 7B 、 Figure 7C and / or Figure 8 of in vivo Fluid flow sensor device.

[0037] Figure 10A and Figure 10B FIGURE 1 illustrates an exemplary implementation of the device attached to the heart of a patient user. Figure 1B FIG. 1 is a diagram of an exemplary embodiment of an in vivo fluid flow sensor device.

[0038] Figure 11A Show description Figure 1C of in vivo A diagram of an exemplary embodiment of an acoustic sensor device shown as part of an exemplary IMD of the present technology.

[0039] Figure 11B Show description Figure 11AA cross-sectional view of an enlarged portion of FIG. in vivo The membrane of the acoustic sensor is in a relaxed state.

[0040] Figure 11C Show description Figure 11A A cross-sectional view of an enlarged portion of the image, where in vivo The membrane of the acoustic sensor is in a deflected state.

[0041] Figure 12A and Figure 12B Show description Figure 1C of in vivo A diagram of an exemplary embodiment of an in-vivo acoustic sensor device configured as an example IMD of the present technology. in vivo Microphones including strain gauges and / or piezoelectric elements.

[0042] Figure 13A and Figure 13B Show description Figure 1C of in vivo A diagram of an exemplary embodiment of an in-vivo acoustic sensor device configured as an example IMD of the present technology. in vivo Microphone comprising a capacitive electrode sensor and / or a sensor having an electret condenser element.

[0043] Figure 14A shows a plot of the IMD Figure 1C of in vivo A top view of a diagram of an exemplary embodiment of an acoustic sensor device showing an exemplary form factor configuration of an IMD including a battery, electronics package, and antenna.

[0044] Figure 14B Shown Figure 14A Side view of an exemplary IMD.

[0045] Figure 15A shows a plot of the IMD Figure 1C of in vivo A top view of a diagram of an exemplary embodiment of an acoustic sensor device showing an exemplary form factor configuration of an IMD including a battery, an electronics package with a deflecting membrane, and an antenna.

[0046] Figure 15B Shown Figure 15A Side view of an exemplary IMD.

[0047] Figure 16A shows a plot of IMD in Figure 1C of in vivoA top view of a diagram of an exemplary embodiment of an acoustic sensor device showing an exemplary form factor configuration of an IMD including a battery, electronics package, and antenna, with an accelerometer contained within a tethered component.

[0048] Figure 16B Shown Figure 16A Figure 2 is a side view of an exemplary IMD with tethered components omitted.

[0049] Figure 17 A block diagram depicting an exemplary IMD of the present technology is shown, including a Figure 14A and Figure 14B and / or Figure 15A and Figure 15B Internal components of the IMD.

[0050] Figure 18 A block diagram depicting an exemplary IMD of the present technology is shown having a tethered component including an in-vivo acoustic sensor device including a high-fidelity (HF) accelerometer and including a corresponding Figure 16A and Figure 16B Internal components of the IMD.

[0051] Figure 19 A block diagram depicting an exemplary IMD of the present technology is shown, the IMD having a in vivo Microphone in an acoustic sensor device.

[0052] Figure 20A and Figure 20B A diagram depicting an exemplary embodiment of an IMD of the present technology having a stress-mediated acoustic sensor hermetically sealed with an electronics unit within a housing according to the present technology is shown.

[0053] Figure 21A 、 Figure 21B and Figure 21C Diagrams illustrating other exemplary embodiments of unimorph piezoelectric sensors according to the present technology.

[0054] Figure 22 Figures are shown depicting exemplary geometries of some example embodiments of single-layer piezoelectric sensor devices according to the present technology.

[0055] Figure 23 Figures illustrating exemplary embodiments of implantable medical devices according to the present technology are shown, incorporating in vivo Exemplary embodiments of a fluid flow sensor device and in vivo Exemplary embodiments of an acoustic sensor device.

[0056] Figure 24A and Figure 24B Figures illustrating exemplary embodiments of implantable medical devices according to the present technology are shown, interconnected with in vivo Exemplary embodiments of a fluid flow sensor device and in vivo Exemplary embodiments of an acoustic sensor device. DETAILED DESCRIPTION

[0057] The present technology provides a system for monitoring and collecting data from one or more implantable medical devices implanted in a living subject for the purpose of assessing one or more health and / or disease conditions. A living subject, which may also be referred to herein as a host, patient, or simply subject, may include a human or non-human animal. The IMD(s) of the present technology may be surgically implanted and removed from a host.

[0058] In some embodiments, for example, the IMD includes in vivo A fluid flow sensor comprising an ultrasound transducer array attachable to the exterior of an anatomical structure, such as an area leading to or leaving the heart or lungs or other organs, that can measure fluid flow through the anatomical structure. In some embodiments, for example, an IMD includes a transducer array that can detect and measure acoustic signals generated by the host. in vivo Acoustic sensor. Included in vivo The IMD of the fluid flow sensor may also include in vivo Acoustic sensors that can be configured as part of a single device structure (e.g., a shared housing) or can be configured as part of separate device structures that can be electrically connected to share electronic components, such as, but not limited to, a power supply, a wireless communication unit, a data processing unit, or other electronic resources and functionality.

[0059] As used herein, acoustic signals refer to mechanical waves in gases, liquids, and solids, including vibration, sound, ultrasound, and infrared. in vivo Fluid flow sensors and in vivo Acoustic sensors can detect and measure mechanical waves traveling through the gas, liquid, and / or solid bodies that make up the internal anatomy of a host. Acoustic signals originating from the body are generated by pressure changes, blood and air flow, and mechanical movement of organs and tissues. in vivo Examples of acoustic signals detectable by an acoustic sensor may be turbulence of a fluid, such as air flow into / out of the lungs or blood flow in the heart or vasculature, or pulses from motion / movement of cardiac structures (eg, valves).

[0060] In some embodiments, including in vivo Fluid flow sensors and / or in vivoAn acoustic sensor IMD may include one or more secondary sensors that detect and measure motion and / or position or orientation of a patient, electrophysiological signals associated with one or more anatomical structures of the host (e.g., the heart), and sensors that detect motion and / or position or orientation of the patient. in vivo Sensors for blood flow velocity and blood vessel diameter in a fluid, and / or an analyte or multiple analytes. in vivo Fluid flow sensors and / or in vivo Example embodiments of one or more secondary sensors of an acoustic sensor.

[0061] The term "sound" is generally used to refer to audible mechanical waves (e.g., sound waves) that can be detected by the human ear (i.e., heard by or audible to the human ear). While IMDs of the present technology can detect and measure such sound waves, IMDs can also detect and measure mechanical waves that are inaudible to the human ear. As used herein, and unless the context indicates otherwise, the terms "sound" and "acoustic," as well as "acoustic signal" and "mechanical wave," are used interchangeably without limiting the meaning of these terms to audible mechanical waves that can be heard by the human ear, i.e., mechanical waves in the frequency range of 20 Hz to 20 kHz.

[0062] Disclosed for in vivo Devices, systems, and methods for monitoring the flow of biological fluids in anatomical structures, such as blood flow through heart valves (e.g., the mitral, tricuspid, and / or aortic valves) or through heart chambers (e.g., the atria or ventricles) or major blood vessels entering and exiting the heart (e.g., the aorta, vena cava, or pulmonary veins or arteries). The disclosed devices, systems, and methods can continuously measure and assess forward and backward blood flow in cardiac regions (e.g., the inlet or outlet of a heart valve) for determining cardiac function or dysfunction (e.g., such as mitral valve regurgitation (MVR)) and / or compile with other monitoring data that can be used to measure or predict secondary factors (e.g., such as heart rate (HR), cardiac output (CO), or markers of congestive heart failure (CHF)).

[0063] Implementation of the disclosed technology is envisioned to shift the current paradigm from disparate acute or emergency medical treatments to remote and continuous monitoring and management for long-term diagnostic and predictive care. For example, acute management of treatment sites in the heart currently remains undetectable after treatment (e.g., implantation of stents, implants (e.g., mitral valvuloplasty, mitral valve, percutaneous mitral valve), pacemakers, etc.) unless the patient "feels" a serious functional problem, resulting in the patient returning to a health provider, in many cases in an emergency setting. in vivoThe in vivo fluid flow sensor devices of the fluid flow sensor platform can be implanted directly on the periphery of the heart (and in a manner agnostic to any existing biomedical devices implanted in the heart) to detect blood flow in the heart that indicates potential discrepancies, including, for example, cardiac output, stroke volume, total peripheral resistance, and / or the development of restenosis.

[0064] For example, in some embodiments, the disclosed in vivo The fluid flow sensor device can measure the flow of fluid through the atrial chambers to the ventricular chambers of the heart, for example, to determine the blood flow at the mitral valve on the left side of the heart or the tricuspid valve on the right side of the heart, thereby determining the fluid flow of the valve capacity called "valve flow" by measuring "Q", that is, the flow rate (blood volume / time) or the pressure difference between the two ends of the flow path divided by the resistance), which can be used to characterize the backflow of natural fluid blood flow, potential leakage and backflow of the valve. in vivo A fluid flow sensor device, when placed near a heart valve, can detect where valve dysfunction (e.g., leakage) has occurred, for example, once properly positioned and calibrated. in vivo Embodiments of the fluid flow sensor platform (i.e., devices, systems, and / or techniques) are also capable of detecting diameters of cardiac chambers or predicted regions and / or predicted volumes, as well as changes in baseline measurements over time, which can indicate potential adverse effects on cardiac function / performance relative to baseline and / or degradation following treatment (e.g., which may lead to cardiac diseases such as congestive heart failure (CHF), a chronic disease in which the heart is unable to pump blood as well as it should due to weakness or stiffness of cardiac tissue). For example, blood flow and backflow detection across cardiac valves can be used to correlate with cardiac function / performance and the effects of heart failure, as defined by CHF.

[0065] Furthermore, for example, data obtained by embodiments of the disclosed fluid flow sensor technology can be used to compile information to enable or optimize the administration of medication prescriptions (e.g., dosages) for optimal patient care. For example, data obtained by embodiments of the disclosed fluid flow sensor technology can be used to assess valve function and functional degradation, and can be used for valve therapy or vascular therapy (e.g., compiled with EKG data). As an illustrative example, the disclosed in vivo The fluid flow sensor platform can in vivoThe fluid flow sensor device is positioned over the vena cava and uses ultrasound signals to obtain information (e.g., the size (thickness) of the blood vessel and the blood flow velocity through the vena cava) that can be used to determine pulmonary wedge pressure and, thereby, monitor the efficacy of certain medication doses in treating patients with various forms of heart disease. In addition, for patients with heart disease who take a combination of medications to manage their heart condition (e.g., diuretics for fluid volume, ACE inhibitors for peripheral resistance, and beta-blockers for contractility), blood pressure and flow through the vena cava can indicate whether the patient is correctly adhering to the medication regimen or whether the regimen is suboptimal or ineffective, for example, because the body has developed a resistance to the medication over time.

[0066] The public in vivo The fluid flow sensor platform provides a method for obtaining acoustic signal measurements of fluid flow directly through an anatomical structure (and without other anatomical structures in the acoustic signal path) and providing the obtained acoustic signal measurements to a remote device (e.g., a in vivo Remote communication of fluid flow sensor devices in vivo equipment and / or in vivo Fluid flow sensor devices and / or remote in vivo The invention can also be used to perform these functions for a long time (e.g., several years to more than ten years) with low power requirements and a relatively small physical footprint (i.e., device volume).

[0067] Although in vivo The disclosed embodiments of the sensor are described herein primarily based on monitoring blood flow through cardiac structures (e.g., heart valves) within a patient's body to facilitate understanding of the basic concepts of the present technology, but it should be understood that the disclosed embodiments of the present technology may also include monitoring the dynamic flow of other biological fluids and other systems, including but not limited to fluid flow in the gastrointestinal system, renal system, or other systems.

[0068] For example, in some embodiments, a method for coupling with an anatomical structure in vivoA sensor device for monitoring fluid flow in an anatomical structure, such as an atrium, a ventricle, a valve therebetween, or a major blood vessel of the heart, the sensor device comprising a linkage assembly including a first arm configured to connect to a first portion of the anatomical structure and a second arm configured to connect to a second portion of the anatomical structure opposite the first portion; a connecting device connected to each of the first arm and the second arm; an ultrasonic sensor assembly including a plurality of acoustic transducer elements coupled to the connecting assembly, the plurality of acoustic transducer elements including a first acoustic transducer element, a second acoustic transducer element, and a third acoustic transducer element, the first acoustic transducer element being configured to transmit an acoustic signal to propagate through the anatomical structure, the second acoustic transducer element and the third acoustic transducer element being configured to receive the acoustic signal that has propagated through the anatomical structure and is indicative of a fluid flow parameter of a biological fluid in the anatomical structure; and an electronics unit housed in the connecting device and in electrical communication with the plurality of acoustic transducer elements of the ultrasonic sensor assembly, the electronics unit being configured to process electrical signals associated with the received acoustic signals as data and to wirelessly transmit the data to an external processor.

[0069] In some embodiments, for example, a method for coupling to an anatomical structure in vivo A sensor device for monitoring fluid flow in an anatomical structure, such as for monitoring blood flow in an atrium, a ventricle, a valve therebetween, or a major blood vessel of the heart, the sensor device comprising: a first ultrasound assembly including a first set of one or more acoustic transducer elements; a second ultrasound assembly including a second set of one or more acoustic transducer elements; a first linkage coupled to the first ultrasound assembly; a second linkage coupled to the second ultrasound assembly; an electronics unit in electrical communication with the first ultrasound assembly and the second ultrasound assembly, the electronics unit configured to process electrical signals associated with returned acoustic signals as data and wirelessly transmit the data to an external processor; and a spring connection coupled to each of the first and second linkages and operable to position the first ultrasound assembly at a first location on the anatomical structure and the second ultrasound assembly at a second location on the anatomical structure to form a plane passing through the first and second locations of the anatomical structure to transmit and receive acoustic signals from the first set of one or more acoustic transducer elements and the second set of one or more acoustic transducer elements indicative of a fluid flow parameter of a biological fluid in the anatomical structure.

[0070] Some embodiments of the disclosed apparatus, systems, and methods include in vivoMonitoring the status of a patient's cardiovascular and / or pulmonary disease to manage the patient's disease treatment and care, including heart failure, valvular disease, coronary artery disease, thoracic aortic aneurysm, chronic obstructive pulmonary disease (COPD), sleep apnea, asthma, and / or other acute or chronic diseases or conditions. In particular, the disclosed implantable medical devices, systems, and methods of the present technology can be implemented to assist a patient's healthcare provider (HCP) in managing medication for the patient's disease or condition.

[0071] For example, some embodiments of an exemplary IMD may be implemented to acoustically monitor cardiovascular function using the IMD's high-fidelity implantable acoustic sensors for continuous detection of abnormal blood flow associated with aortic stenosis (AS) and mitral regurgitation (MVR) for valve disease medication management. Additionally, for example, some embodiments of an exemplary IMD may be implemented to acoustically monitor both cardiovascular and pulmonary function using the IMD's high-fidelity acoustic sensors for continuous detection of abnormal blood flow associated with AS, MVR, and other heart valve acoustics, in conjunction with or excluding respiratory-related lung acoustics, including but not limited to edema in the lungs, asthma, sleep apnea, COPD, or other pulmonary conditions for cardiovascular and pulmonary disease medication management.

[0072] For example, the technology of the present invention includes in vivo Fluid flow sensors and in vivo The disclosed implantable medical devices, systems, and methods of acoustic sensors can simultaneously provide the patient's HCP with clinical data related to the contractility, resistance, and / or volume of blood pumped by the patient's heart, allowing the HCP to make immediate decisions affecting medications used to manage cardiovascular diseases or conditions. For example, including The body The IMD of the fluid flow sensor can continuously measure the in vivo Fluid flow sensors Continuous measurement of mechanical waves (acoustics) associated with stenosis or regurgitation Cardiac output – this can be based on (assistance) in vivo Real-time processing of the cardiac cycle from the ECG sensor - which together can provide a complete, continuous assessment of the patient's cardiovascular health to characterize cardiac function / dysfunction, as well as continuous assessment of the effectiveness of the patient's treatment regimen, including compliance therewith.

[0073] Currently, many forms of heart disease are treated with specific doses of one or more of the following: (i) angiotensin-converting enzyme (ACE) inhibitors, i.e., medications that relax veins and arteries to lower blood pressure by preventing the production of angiotensin 2, an enzyme required for the production of angiotensin II; (ii) beta-adrenergic blockers (beta blockers), which block the effects of the hormone adrenaline to cause the heart to beat more slowly and with less force, which can also cause the veins and arteries to widen, improving blood flow; and (iii) diuretics, i.e., medications that reduce the amount of fluid flowing through veins and arteries, thereby lowering blood pressure. This can also reduce the accumulation of fluid in the body, for example, by promoting kidney function to remove salt and water through urine. These medications are given to patients with heart disease, particularly in stages 3 or 4, to prevent the patient from decompensating, i.e., experiencing decompensated heart failure (DHF), a condition in which structural or functional changes in the patient's heart result in the heart's inability to pump and / or accommodate blood within physiological pressure levels, leading to life-threatening limitations in heart function and requiring immediate therapeutic intervention (e.g., emergency room visit). Some DHF symptoms include the patient being unable to breathe, low pulse oximetry, high heart rate or others, which may precede organ system failure.

[0074] The greatest challenge that patients and their healthcare professionals face in managing their cardiovascular and / or pulmonary conditions is patient compliance. Patients must adhere to two aspects of their health care: (1) taking their prescribed medications accurately and regularly (e.g., multiple times per day), and (2) measuring and recording multiple physiological measurements, including blood pressure (BP), weight (BW), and blood oxygen levels (PulseOx), regularly (e.g., once or more per day). Current cardiac monitoring systems are a compilation of external sensors, such as a blood pressure cuff (digital), a weight scale (digital), and a pulse oximeter (digital), which require discrete and separate measurements of the patient's BP, BW, and PulseOx, respectively. However, when patients adhere, the system can measure whether the patient is successfully managing their heart disease or risk level for developing DHF. For example, if a patient is developing a large amount of fluid in his / her lungs and the patient's heart rate is increasing, then the patient's BW is increasing and can be measured by a weight scale and the patient's heart rate is increasing and can be measured by a blood pressure cuff, which may together indicate that the patient may be decompensating and needs immediate medical attention (e.g., going to an emergency room where a healthcare professional can adjust the concentration of an ACE inhibitor, beta blocker, and diuretic to avoid DHF).

[0075] While studies have shown that patients can generally be relied upon to take their prescribed medications regularly, most struggle to adhere to a strict regimen for measuring and recording their BP, BW, and PulseOx. Conventional approaches to treating cardiovascular and pulmonary diseases are severely flawed by their reliance on patient compliance. The disclosed implantable medical devices, systems, and methods of the present technology can be implemented to continuously, passively, and autonomously (i.e., without patient interaction) monitor numerous physiological markers associated with cardiovascular and / or pulmonary health and disease from within a patient, thereby incorporating patient compliance into the physiological monitoring component of patient treatment and care.

[0076] The disclosed implantable medical devices, systems, and methods of the present technology can continuously and autonomously passively monitor heart rate, fluid flow and accumulation in tissues or organs, patient movement and activity, electrophysiological signals such as electrocardiogram (ECG or EKG), IMD-based (multiple) bodies Other physiological measurements of acoustic and / or fluid flow sensors, which can be combined with one or more secondary sensors, motion sensors or inertial measurement units, electrophysiological sensors, or other configurations as disclosed herein. For example, in some embodiments of an IMD that uses acoustic sensors and ECG sensors as time qualifiers, i.e., timing markers of events during the cardiac cycle, the IMD can interrogate specific sounds to distinguish healthy from unhealthy markers of cardiac function.

[0077] IMD of this technology in vivo Acoustic, fluid flow, and secondary sensors are non-blood contacting, i.e., the sensors are engineered to detect physiological phenomena, particularly including those associated with blood flow, without being positioned within a blood vessel. For example, once an IMD has the in vivo Fluid Flow Sensors ( The body The IMD is a device that uses an acoustic sensor and certain secondary sensors (e.g., ECG and IMU) and is implanted near the patient's heart. The IMD can monitor twelve disease states for each of the four valves of the heart, such as (1) stenosis (narrowing of the valve in the large blood vessels that branch off from or enter the heart, usually caused by calcification); (2) regurgitation (backward flow of blood through the valve due to a defect in the valve); and (3) myxoma, a combination of stenosis and regurgitation (degeneration of the heart valve). Continuous, autonomous, and passive monitoring performed by the disclosed embodiments of the IMD of the present technology in vivoMonitoring capabilities are important for advancing cardiovascular healthcare because these disease states are currently not easily observable because their temporal changes allow for their diagnosis, and conventional diagnostic systems, devices, and technologies are unable or severely limited in accurately, reliably, and conveniently tracking physiological markers over such sustained periods to effectively and optimally enable HCPs to make appropriate diagnoses. Additionally, the IMD of the present technology can utilize its IMU sensor to controllably collect data in both resting and active states to simulate stress testing, thereby increasing the IMD's ability to assess a patient's disease status. In such implementations, the disclosed embodiments of the IMD of the present technology are capable of subtly characterizing cardiovascular and / or pulmonary function across multiple states and conditions of a patient's condition without relying on patient compliance.

[0078] In some embodiments of the IMD of the present technology, for example, The body The IMD of acoustic sensors can operate like the HCP's internal stethoscope that continuously measures the patient's breathing. This can be used not only to monitor lung conditions such as asthma or COPD, but can also pick up mitral regurgitation and heart failure because respiratory acoustics change when fluid is present in the lungs, and MVR and heart failure can cause such fluid accumulation. Therefore, the present technology in vivo Disclosed embodiments of the acoustic sensor can supplement or replace external digital stethoscopes, which have poor fidelity and reliability (poor compliance) due to over 90% signal loss in acoustic signals transmitted from body tissue through the air to be transduced by the digital stethoscope's external microphone. in vivo The acoustic sensor can sense acoustic signals having a frequency of 1 Hz, or 2 Hz, or 10 Hz, up to about 20,000 Hz, or up to about 18,000 Hz, or up to about 16,000 Hz, or up to about 14,000 Hz, or up to about 12,000 Hz, or up to about 10,000 Hz. For example, in vivo Various embodiments of exemplary IMDs of acoustic sensors may be configured to detect acoustic signals within a frequency range or within a range of 0.1 Hz to 20 kHz, where the particular range may be defined based on the particular embodiment of the acoustic sensor.

[0079] Including according to the present technology in vivo In some embodiments of an acoustic sensor IMD, for example, in vivo Acoustic sensors include displacement-mediated acoustic sensors to measure conformational changes induced by mechanical waves on a transducer material. In some embodiments, for example, in vivo The acoustic sensor includes a microphone. In some embodiments, for example, in vivoThe acoustic sensor may include an accelerometer. In some embodiments, for example, in vivo An acoustic sensor may include a diaphragm that contacts the sound waves and vibrates or otherwise extends in response to the sound waves, wherein the extension is measured over time to provide a temporal measurement of the sound. In some embodiments, for example, in vivo The acoustic sensor includes a strain gauge operable to detect strain and / or deformation of a material by measuring resistivity. In some embodiments, for example, in vivo Acoustic sensors include piezoelectric sensors operable to measure changes in pressure, acceleration, temperature, or force by converting the pressure, acceleration, temperature, strain, or force into an electrical charge.

[0080] Including according to the present technology in vivo In some embodiments of an acoustic sensor IMD, for example, in vivo Acoustic sensors include stress-mediated acoustic sensors operable to measure stress applied to a material of a transducer. In some embodiments, the acoustic sensor includes a stress-mediated microelectromechanical sensor (MEMS) device that converts mechanical waves exerting a force on the MEMS device into electrical signals. Some examples of MEMS stress-mediated acoustic sensors may include piezoelectric stress sensors, and in some embodiments, for example, the piezoelectric stress sensor includes a single-layer piezoelectric sensor device.

[0081] These and other embodiments are discussed in more detail below through the examples.

[0082] Example Implementation

[0083] Figure 1A The present invention is shown in FIG. Fluid Flow FIGURE 1 is a diagram of an exemplary embodiment of a monitoring system 10. The system 10 includes an implantable medical device (IMD) 100 that includes one or more implantable medical devices that can be implanted in a patient-user. in vivo The fluid flow sensor device 100X and / or one or more implantable devices in a patient in vivo Acoustic sensor device 100Y, and one or more in vivo Fluid flow sensor device 100X and / or one or more in vivoAcoustic sensor device 100Y communicates with data processing system 150. In some embodiments, system 10 includes a receiver device 130 operable to: (i) receive wireless transmissions carrying data indicative of detection signals acquired from one or more in vivo fluid flow sensor devices 100X and / or from one or more in vivo acoustic sensor devices 100Y and (ii) transmit and / or store the data to data processing system 150, for example, to data processing system 150. In some embodiments, implantable medical device 100 and / or receiver device 130 communicate with data processing system 150 via computer network 140, which is in communication with one another and accessible via the Internet (e.g., referred to as the cloud), wherein data from one or more in vivo analyte sensor devices 100 and / or receiver device 130 can be transmitted to data processing system 150. Similarly, information from data processing system 150 can be transmitted to receiver device 130 and / or one or more analyte sensor devices 100. For example, the data processing system 150 can manage (multiple) data compiled into directions or change patterns to provide a continuous, long-term representation (i.e., a representation of more than one moment in time) of understanding the patient's health and disease, and it can also provide incremental change representations (whether on a short or long time scale) to help analyze the patient's health and disease from a certain point in time (e.g., any time point defined as an initial point (T0)) to a future time (TF), thereby providing a degradation or improvement in the physical state functionally from the implant point, and processing one or more of the implantable medical device 100 in vivo Fluid flow sensor device 100X and / or one or more in vivo Acoustic sensor device 100Y.

[0084] In an exemplary embodiment, the in vivo fluid flow sensor apparatus 100 includes a sensor unit 110 and an electronics unit 120, one or both of which are housed in and / or coupled via a housing or cover 101. The sensor unit 110 and the electronics unit 120 of the implantable medical device 100 may be configured for one or more of the implantable medical device 100. in vivo Fluid flow sensor device 100X and / or one or more in vivo Each of the acoustic sensor devices 100Y may be configured as a unit for one or more of the implantable medical devices 100. in vivo Fluid flow sensor device 100X and / or one or more in vivoMultiple separate or partially shared and partially separate units of the acoustic sensor device 100Y. In some examples, the housing or cover 101 is configured to shield components of the electronics unit 120 from bodily fluids or substances when the in vivo fluid flow sensor apparatus 100 (e.g., the in vivo fluid flow sensor and / or the in vivo acoustic sensor device 100Y) is deployed in the body of a patient-user.

[0085] exist Figure 1A In the example of system 10 shown in FIG, implantable medical device 100 includes a first implantable device: at least one in vivo The fluid flow sensor device 100X is deployed in a first portion of a patient-user's body, such as the chest, head, torso, appendage, or other area; and the implantable medical device 100 includes a second implantable device: at least one in vivo The acoustic sensor device 100Y is deployed in the second portion of the patient user's body. One or both of the in vivo fluid flow sensor device 100X and / or the acoustic sensor device 100Y can be directly coupled to an organ or tissue in the patient's body at the first portion and / or the second portion, respectively. In some embodiments, for example, the first in vivo The fluid flow sensor device 100Y can be coupled to an implant device deployed at or near a first portion of a patient-user's body, such as an implant for the heart, lungs, skull, neck, intestines and digestive tract, limbs or extremities, etc. Similarly, for example, in vivo Fluid flow sensor device 100X and / or in vivo The second device of either or both of the acoustic sensor devices 100Y may be respectively deployed at or near a third portion within the patient's body, or deployed In the body Fluid flow sensor device 100X and in vivo The acoustic sensor device 100Y is deployed at or near one of the first portion or the second portion.

[0086] In some embodiments of the implantable medical device 100, for example, one or more in vivo Fluid flow sensor device 100X and / or one or more in vivo The acoustic sensor device 100Y may be configured as part of a single device structure (eg, a common housing); and in some embodiments, for example, one or more in vivo Fluid flow sensor device 100X and / or one or more in vivo The acoustic sensor device 100Y may be configured as part of a separate device structure. In such embodiments having a separate device structure, the one or more in vivo The fluid flow sensor device 100X and / or the one or more in vivoThe acoustic sensor devices 100Y may be electrically connected to each other; in some embodiments, the (plural) separate in vivo The fluid flow sensor device 100X and the in vivo acoustic sensor device(s) 100Y may be configured to share electronic components, including but not limited to, for example, a power supply, a wireless communication unit, a data processing unit, or other electronic resources and functions.

[0087] In some exemplary embodiments of the in vivo fluid flow sensor device 100X, for example, Figure 1B As discussed above, the sensor unit 110 includes at least one of a first ultrasound sensor assembly and a second ultrasound sensor assembly, each assembly including one or more acoustic transducer elements configured to be positioned across and in contact with an anatomical structure, such as a heart, and electrically connected to an electronics unit 120 (e.g., housed in the housing 101) such that one or both of the first and second ultrasound sensor assemblies transmit and receive acoustic signals across a region of interest in the anatomical structure, and the electronics unit 120 processes and / or relays data associated with the monitored acoustic signals to a receiver device 130. The one or more acoustic transducer elements of the first and second ultrasound sensor assemblies of the sensor unit 110 are electrically coupled to the electronics unit 120, e.g., via electrical interconnects such as wires, to provide electrical signals to stimulate transmission of acoustic emission signals across the region of interest and to receive electrical signals converted from the received acoustic signals propagated across the region of interest in the anatomical structure. in vivo Further details of the sensor unit 110 and the electronics unit 120 of some embodiments of the fluid flow sensor apparatus 100X are provided in Figure 1B and other figures including Figures 2A-10B discussed above.

[0088] refer to Figure 1AIn some embodiments, one or more in vivo fluid flow sensor devices 100 (e.g., in vivo fluid flow sensor 100X and / or in vivo fluid flow sensor device 100Y) wirelessly transmits directly acquired data to a receiver device 130. For example, one or more analyte sensor devices 100 may transmit data to the receiver device 130 using a low-power wireless communication protocol, such as Bluetooth Low Energy (BLE), near-field communication (NFC), low-frequency radio frequency (RF) signals in the range of 3 kHz to 1.3 MHz, or other methods. Example embodiments of the receiver device 130 include a computing device 130A or a dedicated base station 130B. For example, the computing device 130A may include, but is not limited to, a smartphone, a tablet, a home device (e.g., Alexa, Nest, Echo, Google Home, a smart TV, etc.), a wearable computing device (e.g., a smartwatch, smart glasses, or a helmet), a laptop or desktop computer, or other devices. The dedicated base station 130B may include a data storage and / or data communication unit that facilitates the transmission of data from the one or more analyte sensor devices 100 to the data processing system 150 via Wi-Fi access or a cellular link to the network 140. In some embodiments, for example, the receiver device 130 may be embodied on multiple receiver devices, such as a computing device 130A (e.g., a smartphone, tablet, etc.) and a dedicated base station 130B, such as Figure 1A In some embodiments, for example, receiver device 130 can (i) at least partially process the received data for display on a display screen of receiver device 130 and / or for transmitting the received data to an external computer or computing system, such as data processing system 150. In some embodiments, for example, system 10 optionally includes a software application ("app") that resides on receiver device 130 to control various data processing, storage, and communication functions for managing the received data.

[0089] exist Figure 1AIn the example of the system 10 shown, the data processing system 150 may include one or more server computer devices 152, one or more client computer devices 154, and / or one or more databases 156 in data communication with one another. In an embodiment, for example, the computer device(s) 152, 154 and the database(s) 156 communicate with one another and / or with other devices of the system 10 via the network 140. In some implementations, for example, the data processing system 150 may remotely monitor data associated with the patient-user obtained by remotely operating aspects of the implantable medical device 100 and / or the system 10, such as, for example, modifying sensing parameters or protocols of one or more in vivo fluid flow sensor devices 100X and / or one or more acoustic sensor devices 100Y, data display or processing characteristics of an application on the receiver device 130, and the like.

[0090] In some embodiments, for example, the system 10 optionally includes a remote computing device 160 that is operated by a remote user to remotely monitor data associated with a patient user obtained by one or more analyte sensor devices 100, the data being transmitted to the data processing system 150. For example, the remote computer 160 may include a personal computer, such as a desktop computer or laptop computer, a mobile computing device, such as a smart phone, tablet computer, smart watch, etc., or other computing device. In some embodiments, for example, the remote computing device 160 is configured to only receive data curated (e.g., selected, pre-processed, and / or formatted) by the data processing system 150. In some embodiments, for example, the remote computing device 160 is configured to remotely operate one or more aspects (e.g., functions) of the system 10. For example, the remote computing device 160 may implement a remote user software application (remote user application) that is configured to provide such display, storage, and / or management features to the remote user. For example, the remote user may include a healthcare provider (HCP), such as a doctor, nurse, family member or other caregiver of the patient user, or a health insurance payer, or other types of stakeholder entities or individuals regarding the health of the patient user.

[0091] Figure 1B Shows the instructions Figure 1A A block diagram of an exemplary embodiment of an in vivo fluid flow sensor 100X is shown in FIG. Figure 1B In the example of FIG. 1 , the in vivo fluid flow sensor 100B includes an example embodiment of a sensor unit 110 (shown as sensor unit 110X) and an example embodiment of an electronics unit 120 (shown as electronics unit 120X). in vivo The sensor unit 110X of the fluid flow sensor 100X includes at least one ultrasonic component in electrical communication with an electronics unit 120X via an electrical interconnect 117X. Figure 1B 1 and 12. The ultrasonic sensor assembly 111 is depicted as having a first ultrasonic sensor assembly 111 and an optional second ultrasonic sensor assembly 112, each in electrical communication with an electronics unit 120X via an electrical interconnect 117X. The first ultrasonic sensor assembly 111 includes one or more acoustic transducer elements 113 (also referred to herein as "transducer 113" or "one or more transducers 113"); the optional second ultrasonic sensor assembly 112 includes one or more acoustic transducer elements 114 (also referred to herein as "transducer 114" or "one or more transducers 114"). The one or more transducers 113 of the first ultrasonic sensor assembly 111 include transducer element 113a and may optionally include additional one or more transducer elements, Figure 1B Similarly, the one or more transducers 114 of the optional second ultrasonic sensor assembly 112 include transducer element 114a and may optionally include additional one or more transducer elements, Figure 1B 114b. For example, an embodiment having multiple acoustic transducer elements may be configured as a transducer array of a corresponding ultrasonic sensor assembly. Electrical interconnect 117X is configured to couple each of the one or more acoustic transducer elements 113 of the first ultrasonic sensor assembly 111 and the optional one or more acoustic transducer elements 114 of the second ultrasonic sensor assembly 112 to an electrical interface of the electronics unit 120X. in vivo In various implementations of the exemplary embodiment of the fluid flow sensor 100X, the first ultrasonic sensor assembly 111 and the optional second ultrasonic sensor assembly 112 can transmit and receive acoustic signals at one or more frequencies within a frequency range of 2 MHz to 20 MHz. In various embodiments, for example, the first ultrasonic sensor assembly 111 and the optional second ultrasonic sensor assembly 112 can each include a frame, housing, or casing structure (not shown) to structurally support the one or more acoustic transducer elements 113 and the one or more acoustic transducer elements 114, respectively, and position them in a fixed position relative to each other.

[0092] For example, in some embodiments, the transducer elements of one or more acoustic transducer elements 113 and one or more acoustic transducer elements 114 include piezoelectric transducers that are operable to transmit acoustic signals based on electrical input signals and receive acoustic signals to generate electrical output signals. For example, the piezoelectric transducers may include solid piezoelectric ultrasonic transducers or piezoelectric micromachined ultrasonic transducers (PMUTs), such as MEMS-based piezoelectric ultrasonic transducers used for environmental acoustic imaging. For example, in some embodiments, the transducer elements of one or more acoustic transducer elements 113 and one or more acoustic transducer elements 114 include ferroelectric hafnium oxide transducers.

[0093] in vivo The fluid flow sensor device 100X includes a connecting rod assembly 103B that couples the first ultrasonic sensor assembly 111 to the electronics unit 120X (and, in embodiments including the second ultrasonic sensor assembly 112, couples the second ultrasonic sensor assembly 112 to the electronics unit 120X). In some embodiments, the connecting rod assembly 103B may include a pair of connecting rods that are configured to (1) couple the first ultrasonic sensor assembly 111 to the electronics unit 120X. in vivo The fluid flow sensor device 100X is fixed (eg, attached and anchored) to a target in vivo organ or tissue, and (2) carrying corresponding electrical interconnects 117X (connected to transducer 113 and / or transducer 114) from first ultrasonic sensor assembly 111 and / or optional second ultrasonic sensor assembly 112 to electronics unit 120X. For example, in some embodiments, a pair of links of link assembly 103B includes a spring connection device, which is later combined with Figure 2A However, in some embodiments, for example, a pair of links of linkage assembly 103B comprises flexible bands, with or without springs, as discussed later in this patent document.

[0094] For example, in in vivo In some embodiments of the fluid flow sensor device 100X, the sensor unit 110X may optionally include one or more secondary sensors 119X. For example, in some embodiments, the secondary sensor 119X may include an analyte sensor to measure a parameter (e.g., concentration) of an analyte in an area adjacent to an anatomical structure in which the sensor is deployed. in vivo Fluid flow sensor device 100X. In some examples, the optional auxiliary analyte sensor may include, but is not limited to, a glucose sensor. In addition to or as an alternative to the optional auxiliary analyte sensor, the secondary sensor 119X may optionally include a pH sensor to measure the pH level in an area proximate to the anatomical structure. In addition to the auxiliary analyte sensor and / or the auxiliary pH sensor, the secondary sensor 119X may optionally include a temperature sensor to measure the temperature in an area proximate to the anatomical structure. In this case, for example, the optional one or more secondary sensors 119X including the analyte sensor, the pH sensor, and / or the temperature sensor may be used to obtain information indicative of a clinically relevant condition of the anatomical structure and / or in vivo The fluid flow sensor device 100X is deployed to obtain data on the internal environment conditions, such as in vivo Potential infection or inflammatory response to implantation of the fluid flow sensor device 100B. In some embodiments, for example, optional one or more secondary sensors 119X may be attached to a structure of an example embodiment of the housing 101 (e.g., in vivohousing 101X of the fluid flow sensor device 100X), for example, by welding, chemical bonding, clips, clamps or other attachment means; and in some embodiments, for example, optional one or more secondary sensors 119X can be attached to one or both of the first ultrasonic sensor assembly 111 and / or the (optional) second ultrasonic sensor assembly 112, for example, by attachment to a frame or housing structure.

[0095] In some embodiments, for example, in vivo The optional one or more secondary sensors 119X of the fluid flow sensor device 100X may include an inertial measurement unit (IMU) configured to monitor the flow of fluid in multiple degrees of freedom. in vivo Movement of the fluid flow sensor device 100X. In some embodiments, for example, in vivo The optional one or more secondary sensors 119X of the fluid flow sensor device 100X may include an accelerometer in communication with a data processing unit of the electronics unit 120X. In some embodiments, for example, in vivo The optional one or more secondary sensors 119X of the fluid flow sensor device 100X may include a rate sensor in communication with the data processing unit of the electronics unit 120X. In some embodiments, for example, in vivo The optional one or more secondary sensors 119X of the fluid flow sensor device 100X may include a magnetometer in communication with the data processing unit of the electronics unit 120X. In such an embodiment, for example, when in vivo When the fluid flow sensor device 100X is deployed outside the heart (eg, in the pericardium), the in vivo fluid flow sensor device 100X is operable to measure heart rate along with fluid flow through the heart (eg, across the mitral or tricuspid valve).

[0096] Also in Figure 1BAs shown in the example of FIG. 1 , the electronics unit 120X of the in vivo fluid flow sensor device 100X includes a data processing unit 121, an optional signal conditioning unit 123, a power supply 129, a wireless communication unit 127, and an electrical interface 125. The electrical interface 125 may include conductive contacts (e.g., pads, pins, or other contact configurations) that are electrically connected to the electrical interconnects 117X of the sensor unit 110X. The electronics unit 120X is configured to receive and at least partially process electrical signals acquired from the one or more acoustic transducers 113 of the first ultrasonic sensor assembly 111 and the one or more acoustic transducers 114 of the second ultrasonic sensor assembly 112 of the sensor unit 110X. For example, in some embodiments, the electrical signals are received at corresponding contacts of the electrical interface 125 and provided to the data processing unit 121 (or, optionally, first provided to the signal conditioning unit 123 before being provided to the data processing unit 121 to improve the quality of the electrical signals acquired from the sensor unit 110X). In such an embodiment, the output of the data processing unit 121 may include raw or processed data associated with the detection data from the sensor unit 110X for wireless transmission to an external device via the wireless communication unit 127. In an example embodiment of the electronic unit 120X, the power supply 129 may include a battery (e.g., a primary battery or a rechargeable battery), a fuel cell, or other power source to power the components of the electronic unit 120X and / or the sensor unit 110X. For example, in some embodiments, the power supply 129 includes an ultra-low power system (e.g., operating in the microampere range).

[0097] For example, in some optional embodiments, the signal conditioning unit 123 may include circuits including one or more filters and / or one or more amplifiers to amplify the raw electrical signals detected by the ultrasonic sensor assemblies 111, 112 of the sensor unit 110X, thereby increasing the signal-to-noise ratio (SNR) of the electrical signals, thereby generating data including the processed electrical signals. In some optional embodiments, the signal conditioning unit 123 may include a driver circuit to generate an operating electrical signal that generates an electrical potential and / or current at the optional analyte sensor electrode set and / or temperature sensor set of the sensor unit 110X for operating an electrochemical sensing technique and / or an electrophysiological or kinetic sensing technique to be performed at the electrodes in an implementation of the optional secondary sensor 119X of the sensor unit 110X.

[0098] In some embodiments, for example, the wireless communication unit 127 includes a wireless transmitter, receiver, and / or transceiver device including an antenna that is capable of communicating with an external device to transmit raw, partially processed, or fully processed data from the signal conditioning unit 123 (and / or the data processing unit 121, described below). For example, the wireless communication unit 127 can be configured to manage a communication protocol for transmission or reception via the antenna. Examples of antennas can include, but are not limited to, whip antennas, loop antennas, or conformal antennas. An exemplary transceiver unit can include a BLE chipset to communicate with a BLE-enabled device, such as a smartphone, tablet, or other external computing device such as the receiver device 130. Additionally or alternatively, in some embodiments, for example, the wireless communication unit 127 is configured as a bracket around the electronic unit 120X, such as, for example, coupled to or integrated with the housing 101X, which is configured to provide wireless communication means to the in vivo fluid flow sensor device 100X.

[0099] In some embodiments, the electronics unit 120X includes a data processing unit 121 to at least partially process the conditioned electrical signals to (i) generate data, e.g., in analog or digital form, and / or (ii) control the functionality of the electronics unit 120X and / or the sensor unit 110X. For example, the data processing unit 121 can be configured to manage data acquisition on data channels associated with the one or more acoustic transducers 113 and the one or more acoustic transducers 114 of the sensor unit 110X.

[0100] In some embodiments of the data processing unit 121, for example, the data processing unit 121 may include a processor 121A to process data, and a memory 121B that communicates with the processor 121A to store and / or buffer data. In various embodiments, for example, the processor 121A may include one or more processors, and the memory 121B may include one or more memory units. For example, the processor 121A may include a central processing unit (CPU), a microcontroller unit (MCU), a graphics processing unit (GPU), or other types of processors. For example, the memory 121B may include and store processor executable code that, when executed by the processor, configures the data processing unit 121 to perform various operations, such as receiving information, commands, and / or data, processing information and data, and transmitting or providing information / data to another device. To support the various functions of the data processing unit 121, the memory 121B may store information and data, such as instructions, software, values, images, and other data processed or referenced by the processor 121A. For example, various types of random access memory (RAM) devices, read-only memory (ROM) devices, flash memory devices, and other suitable storage media may be used to implement the storage functionality of memory 121B. In some embodiments, data processing unit 121 includes an input / output (I / O) unit 121C to interface processor 121A and / or memory 121B to other modules, units, or devices associated with, for example, external devices such as receiver device 130, data processing system 150, remote computing device 160, and / or other external devices. In some embodiments, processor 121A, memory 121B, and / or I / O unit 121C communicate with wireless communication unit 127, such as a transmitter (Tx) or transmitter / receiver (Tx / Rx) unit. For example, in such embodiments, I / O unit 121C may interface processor 121A and memory 121B with wireless communication unit 127, for example, to utilize various types of wireless interfaces compatible with typical data communication standards that may be used for communication between data processing unit 121 and other devices. Data communication standards include, but are not limited to, Bluetooth, Bluetooth Low Energy (BLE), Zigbee, IEEE 802.11, wireless local area network (WLAN), wireless personal area network (WPAN), wireless wide area network (WWAN), WiMAX, IEEE 802.16 (Worldwide Interoperability for Microwave Access (WiMAX)), 3G / 4G / LTE / 5G / 6G cellular communication methods, and parallel interfaces. In some embodiments, the data processing unit 121 can interface with other devices using a wired connection via the I / O unit 121C, for example, before being implanted in a patient user.The data processing unit 121 can also be connected to other external interfaces, data storage sources and / or video or audio display devices to retrieve and transmit data and information that can be processed by the processor 121A, stored in the memory 121B, or displayed on the output unit of the receiver device 130 (for example, a smartphone, tablet computer, etc.) or other external devices. in vivo Fluid flow sensor device 100X.

[0101] exist in vivo In the implementation of the fluid flow sensor device 100X, the first ultrasonic sensor assembly 111 (and optionally the second ultrasonic sensor assembly 112) is controlled by the data processing unit 121 to transmit and receive acoustic signals. For example, in some embodiments, in vivo The fluid flow sensor device 100X is configured to measure the Doppler shift of an acoustic probe signal on an anatomical structure. For example, the propagation time of the acoustic signal indicates an estimated propagation distance, and the frequency shift of the received acoustic signal is proportional to the velocity of the fluid flowing along the acoustic path. The data processing unit 121 is configured to provide a set of electrical control signals to one or more transducers 113 and / or one or more transducers 114 to stimulate the transmission of the acoustic probe signal through a region of interest (e.g., the mitral valve of the heart), so that an opposing set of transducers in the one or more transducers 113 and / or one or more transducers 114 receive the acoustic probe signal shifted by the fluid flow; and based on the flight time of the acoustic probe signal and the known fixed positions of the one or more transducers 113 and one or more transducers 114, the data processing unit 121 processes the electrical signals associated with the received acoustic probe signal converted from the one or more transducers 113 and / or one or more transducers 114 to determine fluid flow, for example, forward flow or possible backward flow of blood through the mitral valve of the heart.

[0102] FIG1C shows a block diagram illustrating an example embodiment of the in-vivo acoustic sensor 100Y shown in FIG1A . Figure 1CIn an example embodiment, an in vivo fluid flow sensor 100Y includes an example embodiment of a sensor unit 110 (shown as sensor unit 110Y) and an example embodiment of an electronics unit 120 (shown as electronics unit 120Y). Sensor unit 110Y includes at least one acoustic sensor 111Y to detect acoustic signals originating from within a host. One or both of sensor unit 110Y and electronics unit 120Y are fully or at least partially housed in and / or coupled via a housing or shell 101Y that is deployable and biocompatible within a host. In some embodiments, for example, acoustic sensor 111Y includes a transducer element 112Y coupled to a shell structure 113Y. Transducer element 112Y is capable of receiving mechanical waves emitted from a source within the host (e.g., tissue, organ, or other body), such that the transducer element converts the energy of the received mechanical waves into electrical energy, thereby generating an electrical signal corresponding to the mechanical waves. In certain embodiments, for example, transducer element 112Y includes a piezoelectric material including, but not limited to, one or more of lead zirconate titanate (PZT), lead lanthanum zirconate titanate (PLZT), zinc oxide (ZnO), quartz, polyvinylidene fluoride or polyvinylidene fluoride (PVDF), aluminum nitride (AlN), scandium aluminum nitride (ScAlN), barium titanate (BaTiO3), lead titanate (PbTiO3), potassium niobate (KNbO3), lithium niobate (LiNbO3), lithium tantalate (LiTaO3), and / or sodium tungstate (Na2WO4). In example embodiments where transducer element 112Y includes PZT, the PZT may be PZT-5A, PZT-5H, or PZT-5K. In embodiments of acoustic sensor 111Y, for example, housing structure 113Y provides a strong, inflexible material and is configured to secure and / or position transducer element 112Y within acoustic sensor 111Y to receive mechanical waves for transduction into electrical signals indicative of acoustic signals within the body. In some embodiments, for example, housing structure 113Y of the acoustic sensor is a hermetically sealed containment structure that may comprise metal, plastic, a composite material, or other materials. Acoustic sensor 111Y is configured to electrically communicate with electronics unit 120Y via electrical interconnect(s) 117Y.

[0103] In some embodiments, the sensor unit 110Y may include an inertial measurement unit (IMU) 115Y to monitor the motion (in multiple degrees of freedom) of the in-vivo acoustic sensor 100Y and / or determine the orientation of the in-vivo acoustic sensor 100Y. The IMU 115Y is configured to electrically communicate with the electronics unit 120Y via electrical interconnect(s) 117Y. In some embodiments of the sensor unit 110Y, for example, the IMU 115Y may include an accelerometer and / or a rotation rate sensor (e.g., a gyroscope) to monitor patient motion and / or position. In some embodiments of the sensor unit 110Y, for example, the IMU 115Y may include a magnetometer. In exemplary embodiments including the IMU 115Y, the IMU 115Y communicates with a data processing unit of the electronics unit 120Y.

[0104] For example, in some embodiments of the in vivo fluid flow sensor device 100Y, the sensor unit 110Y may optionally include one or more secondary sensors 119Y. For example, in some embodiments, the secondary sensor(s) 119Y may include an analyte sensor to measure in vivoAcoustic sensor 100Y is deployed to measure an analyte parameter (e.g., concentration) in an area near a location (e.g., surrounding tissue) within a host, for example, at or near the heart and / or lungs. In some examples, optional auxiliary analyte sensors may include, but are not limited to, glucose sensors. In addition to or as an alternative to the auxiliary analyte sensor, secondary sensor 119Y may optionally include a pH sensor to measure the pH level in an area near the location where in-vivo acoustic sensor 100Y is deployed. In addition to or as an alternative to the auxiliary analyte sensor, secondary sensor 119Y may optionally include a temperature sensor to measure the pH level in an area near the location where in-vivo acoustic sensor 100Y is deployed. In this case, for example, the optional one or more secondary sensors 119Y, including an analyte sensor, a pH sensor, and / or a temperature sensor, may be used to obtain information indicating clinically relevant conditions regarding the anatomical structures and / or conditions of the in-vivo environment of the heart and / or lungs where in-vivo fluid flow sensor device 100B is deployed, such as potential infection or inflammatory response to implantation of in-vivo acoustic sensor 100Y. In some embodiments, for example, the optional one or more secondary sensors 119Y may include an ECG sensor comprising two electrodes separated by a space that generates an electrical potential, for example, positioned at or toward opposite ends of the housing 101Y, wherein the two electrodes are operable to measure electrical signals (e.g., spikes) that are indicative of electrophysiological signals of myocardial tissue to control the patient's heartbeat, wherein the spikes generate the patient's ECG signal. In some embodiments, for example, the optional one or more secondary sensors 119Y may be attached to the housing 101Y, for example, via welding, chemical adhesion, clips, clamps, or other attachment means. in vivo Housing 101Y of acoustic sensor device 100Y.

[0105] exist in vivoIn some embodiments of the acoustic sensor device 100Y, the housing 101Y itself can be a hermetically sealed containment structure, for example, comprised of metal, plastic, composite materials, or other materials. In some embodiments, for example, the housing 101Y comprises a titanium (Ti) container that houses one or more sensors of the sensor unit 110Y and / or electronic components of the electronics unit 120Y. These components may include, but are not limited to, any of the sensor(s), telemetry system, microprocessor, memory, and / or battery. In some examples, the housing or cover 101Y is configured to shield the components of the electronics unit 120Y from bodily fluids or substances when the in vivo fluid flow sensor device 100Y is deployed within a patient-user. As shown in FIG1C , 101Y may include a containment structure that completely covers the electronics unit 120Y and at least partially covers at least one, some, or all of the components of the sensor unit 110Y. In some embodiments, the containment structure of the housing 101Y may completely cover at least one, some, or all of the components of the sensor unit 110Y.

[0106] The electronics unit 120Y of the in vivo fluid flow sensor device 100Y includes a data processing unit 121Y, an optional signal conditioning unit 123Y, a power supply 129Y, a wireless communication unit 127Y, and an electrical interface 125Y, which may include conductive contacts (e.g., pads, pins, or other contact configurations) that are electrically connected to the electrical interconnects 117Y of the sensor unit 110Y. in vivo In some embodiments of the acoustic sensor device 100Y, for example, the electronic unit 120Y may be the same as or include in vivoThe electronic unit 120Y of the fluid flow sensor device 100X has some of the same components. The electronic unit 120Y is configured to receive and at least partially process the electrical signals obtained from the acoustic sensor 110Y of the sensor unit 111Y (as well as the signals obtained from the optional IMU 115Y or the optional secondary sensor(s) 119Y). For example, in some embodiments, the electrical signals are received at corresponding contact points of the electrical interface 125Y and provided to the data processing unit 121Y (or, optionally, first provided to the signal conditioning unit 123Y before being provided to the data processing unit 121Y to improve the quality of the electrical signals obtained from the sensor unit 110Y). In such an embodiment, the output of the data processing unit 121Y may include raw or processed data associated with the detection data from the sensor unit 110Y, for wireless transmission to an external device via the wireless communication unit 127Y. In an example embodiment of the electronics unit 120Y, the power supply 129Y may include a battery (e.g., a primary battery or a rechargeable battery), a fuel cell, or other power source to power the components of the electronics unit 120Y and / or the sensor unit 110Y. For example, in some embodiments, the power supply 129Y includes an ultra-low power system (e.g., operating in the microampere or nanoampere range).

[0107] In some embodiments, the data processing unit 121Y processes, at least in part, the conditioned electrical signals to (i) generate data, e.g., in analog or digital form, and / or (ii) control the functionality of the electronics unit 120Y and / or the sensor unit 110Y. For example, the data processing unit 121Y may be configured to manage data acquisition on data channels associated with the acoustic sensor 111Y and (optionally) the IMU 115Y and / or (optionally) the secondary sensor 119Y of the acoustic sensor 110Y.

[0108] In some embodiments, for example, the wireless communication unit 127Y includes a wireless transmitter, receiver, and / or transceiver device including an antenna that is capable of communicating with an external device to transmit raw, partially processed, or fully processed data from the signal conditioning unit 123Y (and / or the data processing unit 121Y, as described below). For example, the wireless communication unit 127Y can be configured to manage a communication protocol for transmission or reception via the antenna. Examples of antennas can include, but are not limited to, whip antennas, loop antennas, or conformal antennas. For example, the antenna system can be attached to the housing 101Y (e.g., a Ti containment structure) to implement a communication protocol for transmission or reception via the antenna. in vivoBidirectional communication for data transmission and device management between the acoustic sensor device 100Y and one or more remote devices (e.g., various embodiments of an external remote device 130, such as a base station or a phone-based interface system). An exemplary transceiver unit may include a BLE chipset to communicate with a BLE-enabled device such as a smartphone, tablet, or other external computing device. Additionally or alternatively, in some embodiments, for example, a wireless communication unit 127Y is configured as a bracket around the electronic unit 120Y, for example, such as coupled to or integrated with the housing 101Y, which is configured to provide wireless communication means to the in vivo fluid flow sensor device 100Y.

[0109] For example, in some optional embodiments, the signal conditioning unit 123 may include circuitry including one or more filters and / or one or more amplifiers to amplify the raw electrical signals detected by the ultrasonic sensor assemblies 111, 112 of the sensor unit 110B, thereby increasing the signal-to-noise ratio (SNR) of the electrical signals, thereby generating data comprising the processed electrical signals. In some optional embodiments, the signal conditioning unit 123y may include a driver circuit to generate an operating electrical signal that generates an electrical potential and / or current at a sensor, such as, but not limited to, example embodiments of the optional secondary sensor 119Y, such as an analyte sensor electrode set and / or a temperature sensor set, for operating electrochemical sensing techniques and / or electrophysiological or kinetic sensing techniques to be performed at the electrodes in an implementation of the optional secondary sensor 119Y of the sensor unit 110Y.

[0110] In some embodiments of the data processing unit 121Y, for example, the data processing unit 121Y may include a processor 121AY to process data, and a memory 121B that communicates with the processor 121AY to store and / or buffer data. In various embodiments, for example, the processor 121AY may include one or more processors, and the memory 121BY may include one or more memory units. For example, the processor 121AY may include a central processing unit (CPU), a microcontroller unit (MCU), a graphics processing unit (GPU), or other types of processors. For example, the memory 121BY may include and store processor executable code that, when executed by the processor, configures the data processing unit 121Y to perform various operations, such as receiving information, commands, and / or data, processing information and data, and transmitting or providing information / data to another device. In order to support the various functions of the data processing unit 121Y, the memory 121BY may store information and data, such as instructions, software, values, images, and other data processed or referenced by the processor 121AY. For example, various types of random access memory (RAM) devices, read-only memory (ROM) devices, flash memory devices, and other suitable storage media may be used to implement the storage functions of memory 121BY. In some embodiments, data processing unit 121Y includes an input / output (I / O) unit 121CY to interface processor 121AY and / or memory 121BY to other modules, units, or devices associated with, for example, external devices. In some embodiments, processor 121AY, memory 121BY, and / or I / O unit 121CY communicate with wireless communication unit 127Y, such as a transmitter (Tx) or transmitter / receiver (Tx / Rx) unit. For example, in such an embodiment, I / O unit 121CY interfaces processor 121AY and memory 121BY with wireless communication unit 127Y, for example, to utilize various types of wireless interfaces compatible with typical data communication standards, which may be used for communication between data processing unit 121Y and other devices. Data communication standards include, but are not limited to, Bluetooth, Bluetooth Low Energy (BLE), Zigbee, Medical Implant Communication Service (MICS), Industrial Scientific and Medical (ISM) band, IEEE 802.11, Wireless Local Area Network (WLAN), Wireless Personal Area Network (WPAN), Wireless Wide Area Network (WWAN), WiMAX, IEEE 802.16 (Worldwide Interoperability for Microwave Access (WiMAX)), 3G / 4G / LTE / 5G / 6G cellular communication methods, and parallel interfaces.In some embodiments, the data processing unit 121Y can use a wired connection via the I / O unit 121CY to interface with other devices, for example, before or during implantation in the patient-user, to communicate data and / or connect power to another implanted device in the patient-user's body or a wearable device worn on or attached to the patient-user's body. The data processing unit 121Y can also connect to other external interfaces, data storage sources, and / or video or audio display devices via wireless communication to retrieve and transmit data and information that can be processed by the processor 121AY, stored in the memory 121BY, or displayed on an output unit of a receiver device 130 (e.g., a smartphone, tablet computer, etc.) or other devices. in vivo Fluid flow sensor device 100Y. In some embodiments, for example, the electronics unit 120Y may include a global positioning system (GPS) to determine in vivo Position of the patient user of the acoustic sensor 100Y.

[0111] Combined with the following Figure 2A-10B describe in vivo Various exemplary embodiments of fluid flow sensor devices 100X and related in vivo The system and method of the fluid flow sensor device 100X; and the following Figure 11A-22 describe in vivo Various exemplary embodiments of the acoustic sensor device 100Y and related in vivo Systems and methods of acoustic sensor device 100Y.

[0112] In vivo fluid flow sensors

[0113] Figure 2A Shown depiction Figure 1B of in vivo FIGURE 100BX is a diagram of an example embodiment of a fluid flow sensor device 100BX. Figure 2A Shown in in vivo Fluid flow sensor device 200 . in vivoThe fluid flow sensor device 200 includes a sensor unit including an ultrasonic sensor assembly 211 and an ultrasonic sensor assembly 212, which are in electrical communication with an electronics unit 220 (e.g., coupled to or partially housed within a link, such as an arm, of the link assembly 203) via an electrical interconnect 217. The ultrasonic sensor assembly 211 includes a plurality of acoustic transducer elements 213, i.e., three acoustic transducer elements 213a, 213b, 213c in this example; and the ultrasonic sensor assembly 212 includes a plurality of acoustic transducer elements 214, i.e., three acoustic transducer elements 213a, 213b, 213c in this example. It should be understood that this embodiment is not limited to three acoustic transducer elements per ultrasonic sensor assembly and may include more than one acoustic transducer element. Figure 2A Fewer or more configurations than those shown in the figures may be provided, for example, including but not limited to one or more acoustic transducer elements for each of ultrasonic sensor assemblies 211 and 212. Ultrasonic sensor assemblies 211 and 212 include a frame, housing, or casing structure (not shown) to secure acoustic transducer element 213 and acoustic transducer element 214, respectively, to the arms of linkage assembly 203 and position them in fixed positions relative to each other.

[0114] in vivo The electronics unit 220 of the fluid flow sensor device 200 is configured to be surrounded by a spring connection 235 that is coupled to each link of the link assembly 203. The spring connection 235 provides sufficient movement of the arms of the link assembly 203 to couple to the intended deployment locations of the ultrasonic sensor assemblies 211 and 212, such as across the proximal and distal sides of the left atrium or right atrium of the heart, so that the forces exerted by the ultrasonic sensor assemblies 211 and 212 on the anatomical structure (e.g., the heart) are sufficient to fix the anatomical structure. in vivo Fluid flow sensor device 200, while not interfering with in vivo The normal function of the anatomical structure of the intended application of the fluid flow sensor device 200. For example, the spring connection device 235 includes a spring that, in addition to providing a compressive force on the linkage of the linkage assembly 203, transmits sufficient force to promote and / or maintain in vivo The fluid flow sensor device 200 is secured to a target portion of the heart (e.g., the left or right atrium), and the spring also allows for sufficient flexibility to be provided to the device 200 to stabilize its placement while withstanding the continuous motion (load cycles) of the anatomical structure to which it is attached (e.g., a heartbeat) without sustaining damage over hundreds of millions to billions of cycles—thus enabling in vivoThe fluid flow sensor device 200 has a relatively long lifespan (e.g., 50-60 million heartbeats per year) in decades of use. In addition, the linkage of the linkage assembly 203 is adjustable in all three planes (xy, xz, yz) to allow for initial correct alignment of the ultrasonic sensor assemblies 211, 212.

[0115] For example, in some embodiments, in vivo The fluid flow sensor device 200 may be secured to the anatomical structure by prongs, screws, barbs, sutures, adhesives (e.g., bio-inert glue), or a network of gripping mechanisms (not shown) disposed through the frames or housings of the ultrasonic sensor assemblies 211 and 212. in vivo Fluid flow sensor device 200 ( Figure 2A In some embodiments (not shown), the frame, housing, or shell structure may include one or more openings on each link of the linkage assembly 203 that may allow for auxiliary connection of the device 200 to the target anatomical structure, such as openings with anchor points for applying sutures that connect the links of the linkage assembly 203 to the anatomical structure (e.g., the atrial wall). In some embodiments, the linkage assembly 203 may include a material that provides sufficient flexibility and rigidity to allow for in vivo The fluid flow sensor device 200 is deployed over the anatomical structure without such harmful interference. For example, in some embodiments, the connecting assembly 203 can include nitinol, platinum, MP35N, or other materials or combinations thereof. In some embodiments, the connecting rod assembly 203 provides a closure that locks onto the heart, for example, not allowing further movement of the connecting rod.

[0116] Figure 2B Shown depiction Figure 1B of in vivo A diagram of another example embodiment of a fluid flow sensor apparatus 100X is provided. Figure 2B Shown in in vivo Fluid flow sensor device 200B. in vivo The fluid flow sensor device 200B includes a sensor unit comprising two or more sets of ultrasonic sensor teams 250 (in Figure 2B203B) are electrically connected to an electronics unit 220 via an electrical interconnect 217 (e.g., coupled to or partially housed within each set of connection assemblies 203A and 203B, respectively). Each set of ultrasound sensor assemblies 251 and 252 includes an ultrasound sensor assembly 211 and an ultrasound sensor assembly 212, each including a plurality of acoustic transducer elements 213 and a plurality of acoustic transducer elements 214, respectively, to enable measurement of multiple planes of acoustic signal propagation in a region of interest of an anatomical structure (e.g., the mitral valve of the heart). In this example, electronics unit 220 is partially surrounded by two or more sets of spring connections, illustrated by spring connection 235B corresponding to ultrasound sensor set 250B and spring connection 235A corresponding to ultrasound sensor set 250A.

[0117] Figure 2C Shown depiction Figure 1B of in vivo A diagram of another example embodiment of a fluid flow sensor apparatus 100X is provided. Figure 2C Shown in in vivo Fluid flow sensor device 200C. in vivo The fluid flow sensor device 200C may be configured similarly to in vivo Fluid flow sensor device 200 (previously in Figure 2A ), for example, where the sensor unit includes ultrasonic sensor assembly 211 and ultrasonic sensor assembly 212, ultrasonic sensor assembly 212 being in electrical communication with electronics unit 220 via electrical interconnect 217 (e.g., coupled to or partially housed within a link of link assembly 203). Figure 2C middle, in vivo The electronics unit 220 of the fluid flow sensor device 200C is configured to be enclosed by a flexible connection device 235C, which includes a first link 236 that is pivotally movable relative to a second link 237, and / or vice versa, thereby providing the device 200C with sufficient flexibility to maintain stable placement around an anatomical structure while withstanding continuous movement (load cycles) of the anatomical structure to which it is connected (e.g., a heartbeat) without sustaining damage over hundreds to billions of years. In some embodiments, the flexible connection device 235 includes a spring. In some embodiments, the first link 236 is movable within a cavity of the second link 237, and / or vice versa.

[0118] In addition, the flexible connection device 235C couples the sensor unit 220 to each link of the linkage assembly 203. Figure 2C 203C. However, in Figure 2CIn FIG. 2 , the link assembly 203C includes a linear arm portion proximal to the flexible connection 235C and a curved arm portion distal to the flexible connection and proximal to the ultrasonic sensor assembly 211 and the ultrasonic sensor assembly 212. In this manner, for example, in vivo The structure of the fluid flow sensor device 200C is capable of being attached to the curved geometry of an anatomical structure, such as the left or right atrium of the heart, and provides sufficient compressive force for attachment with sufficient flexure to alleviate load cycling. In some embodiments, for example, one or both of the connecting rods 203C can be used to attach an (optional) additional power source (e.g., one or more batteries), which can be electrically connected to the electronics unit and the ultrasonic sensor assemblies 211 and / or 212.

[0119] Additionally, ultrasonic sensor assembly 211 and ultrasonic sensor assembly 212 include a frame, housing, or shell structure 219 to secure acoustic transducer element 213 and acoustic transducer element 214, respectively, to the links of link assembly 203C and to position them in fixed positions relative to each other. Figure 2C 203C to the target anatomical structure, such as an opening with an anchoring location to apply sutures and secure the ultrasound sensor assembly 211 and the ultrasound sensor assembly 212 to the end of the arm of the linkage assembly 203C to the anatomical structure (e.g., the atrial wall). In some embodiments, similar to Figure 2C In the example shown in , the distal ends of the arms or links of the link assembly 203C of the in vivo fluid flow sensor device 200C are angled or bent inwardly, for example, which can facilitate connection and conformity with anatomical structures during placement, as well as facilitate delivery of the device 200C, for example, through a catheter.

[0120] Although Figure 2C Not shown, but in vivo The sensor unit of the fluid flow sensor device 200C may include two or more sets of ultrasonic sensor assemblies 250 (e.g., Figure 2B 2 (see configuration of ultrasonic sensor assemblies 250A and 250B shown), which are in electrical communication with electronics unit 220C via electrical interconnect 217 (eg, each coupled to or partially housed within a respective arm of connection assembly 203C).

[0121] Figure 2D Shown depiction Figure 1B of in vivo A diagram of another example embodiment of a fluid flow sensor apparatus 100X is provided. Figure 2D Shown in in vivo Fluid flow sensor device 200D. in vivoThe fluid flow sensor device 200D may be configured similarly to in vivo Fluid flow sensor device 200 (previously in Figure 2A shown in ) and / or in vivo Fluid flow sensor device 200C (previously Figure 2C ), for example, the sensor unit includes a Figure 2D An example embodiment of an ultrasonic sensor assembly (i.e., ultrasonic sensor assembly 211D and ultrasonic sensor assembly 212D) in electrical communication with an electronics unit 220 (not shown). Electronics unit 220 is housed in a connecting device 235. The acoustic transducer elements of ultrasonic sensor assemblies 211D and 212D are each coupled to a link of link assembly 203D, positioning them in a fixed position relative to each other. In some embodiments, for example, connecting device 235D includes a sealed package that can carry and support a power supply, a data processing unit, and a wireless communication unit (e.g., with an antenna for transmission), for example, to enable power transmission to achieve a charging system for power management for functional performance. For example, the mechanical force for closing by the link can be provided by a spring coil, a deflection spring, or other compression method to connect the ultrasonic sensor assemblies 211D and 212D to their intended positions about the anatomical structure. However, in Figure 2D middle, in vivo The link assembly 203D of the fluid flow sensor device 200D is configured to include an anchor support 233D on each link of the link assembly 203D. The anchor support 233D is an article that can be made of metal or polymer material and is located on the link between the connecting device 235D and the distal portion of the link 239D that supports the ultrasonic sensor assemblies 211D and 212D. In an exemplary embodiment of the device 200D, for example, the anchor support 233D enables the link to be sutured or connected to an anatomical structure (e.g., tissue, an organ, or a blood vessel) using a material such as a suture, a polymer thread, or a metal suture needle, which can pass through the opening 218 and bind the anchor support 233D to the wall of the anatomical structure.

[0122] Figure 3 FIG. 2 shows an example implementation of the device 200 attached to the heart of a patient user. in vivo FIGURE 2 shows an example embodiment of a fluid flow sensor device 200. Although Figure 3 Shown is an exemplary in vivo Fluid flow sensor device 200, but it should be understood that in vivoOther embodiments of the fluid flow sensor device 100X are attached to the heart of a patient user to assess blood flow in a target area of ​​the heart. In this example, a first ultrasonic sensor assembly 211 is positioned proximal to the outer surface of the left atrium (LA) of the heart, and a second ultrasonic sensor assembly 212 is positioned distal to the outer surface of the LA. body Inside The fluid flow sensor device 200 is configured to assess blood flow across the mitral valve, for example, for assessing mitral regurgitation (MR). For example, by clamping the first and second ultrasound sensor assemblies 211, 212 onto the LA, the in vivo The fluid flow sensor device 200 is fixed to the LA, which creates a plane perpendicular to the mitral valve for propagating the acoustic signal. Figure 3 As shown, the arms of the in vivo fluid flow sensor device 200 (e.g., the links of the link assembly 203 of the device 200) can be extended around an organ (e.g., the LA of the heart) with a specific spring constant that can support various orientations to optimize functional alignment with the target anatomical structure. In addition, optimal functional alignment can be maintained by the elastic constant or curvature of the connecting device, which can position and secure the device to the target anatomical structure alone or in conjunction with (optional) one or more second connecting mechanisms, such as sutures (secured at suture ports), adhesives, or anchoring structures (secured at anchor ports), which can be optimized for placement in the intended area of ​​the organ / tissue to achieve consistent measurements (e.g., initial monitoring to establish calibration, followed by comparison through ongoing monitoring and comparison to a baseline). In addition, in some embodiments, for example, multiple in vivo The fluid flow sensor device 200 can be deployed at different locations on the same anatomical structure, such as the LA of the heart (e.g., Figure 3 shown) and the major blood vessels of the heart, such as the vena cava or pulmonary artery or vein ( Figure 3 not shown).

[0123] Figure 4A Figures depicting insertion locations of various embodiments of a fluid flow sensor device 100X for implantation in vivo are shown, e.g. Figure 3 In vivo fluid flow sensor device 200 is shown. In some embodiments, for example, in vivo Fluid flow sensor device 200 (or in vivo Other embodiments of the fluid flow sensor device 100X) can be implanted and positioned on the heart via pericardial puncture and device delivery within the pericardial cavity, such as Figure 3 As shown. Example in vivoThe fluid flow sensor device 200 can be attached to a mechanism for loading, carrying, and delivering it into the chest cavity or placement in the pericardium on a cardiac surface (e.g., through the left or right atrium) for monitoring fluid flow rate (e.g., forward and reverse flow) and other cardiac functions. For example, an apical pericardial implantation procedure may include attaching the exemplary in vivo fluid flow sensor device 200 (or other embodiments of the in vivo fluid flow sensor device 100X) in a first configuration to a catheter that is inserted via one of the insertion sites 402, 404, 406, 408, or 410 or Figure 4A The exemplary in vivo fluid flow sensor device 100X can be inserted into the patient's body at another insertion site (not shown) and then during the implantation process, the exemplary in vivo fluid flow sensor device 100X can be changed to a second shape to confirm that the relative ultrasound sensor assembly passes through the target area of ​​the heart, such as the left atrium in the normal plane of the mitral valve. In some embodiments, for example, if necessary, a catheter can be used to communicate with the exemplary in vivo fluid flow sensor device 100X or to recharge a power source (e.g., power source 129) in the device 100X embodiment. In some embodiments, an embodiment of the in vivo fluid flow sensor device 100X can be implanted and positioned on the heart outside the pericardial sac.

[0124] In some embodiments, for example, in vivo The fluid flow sensor device 100X can be inserted into a patient-user of the device in a first stage (first configuration), for example, by a physician-user such as a thoracic surgeon, through the patient-user's chest cavity via a primary sternotomy or thoracotomy procedure. in vivo The fluid flow sensor device 100X can occur in a second stage (second configuration) for placement around the heart, for example, in the transition area between the atria and ventricles on the left side, or on the right side of the same location. in vivo The fluid flow sensor device 100X can be independently secured to the location of the anatomical structure where it is placed by the surgeon, for example based on the compression and bending properties of the connecting device and / or the arms (of the connecting assembly 103B), and / or can be anchored in place by the physician user with sutures or metal anchors, for example.

[0125] Figure 4B Shown according to the present technology in vivo Schematic diagram of an exemplary configuration of an exemplary embodiment of a fluid flow sensor device for use during implantation near a target anatomical structure and during deployment to secure to the target anatomical structure. FIG400A shows Figure 1B of in vivo Another exemplary embodiment of the fluid flow sensor device 100X, in Figure 4B Shown in body InsideThe fluid flow sensor device 400 has arms of the connection assembly 403 extending outwardly from the connection device 435 to be in a first configuration, such as for an insertion or implantation procedure, such as by a catheter. For example, in some embodiments, the body Inside The fluid flow sensor device 400 is inserted into the patient (e.g., through a port through the ribs, similar to Figure 4A The insertion location shown is positioned to approximate an area where the target anatomical structure is located, such as the heart. Prior to the insertion procedure, the patient can be prepared by undergoing an imaging session (e.g., a CT scan of the target area), which can be used to assist in the insertion.

[0126] FIG. 400B shows the in vivo Fluid flow sensor device 400 , having arms of linkage assembly 403 extending inwardly toward a centerline through connection means 435 , is used, for example, during deployment for attachment to anatomical structure 490 . in vivo The fluid flow sensor device 400 may be configured similarly to in vivo Fluid flow sensor device 200 (previously in Figure 2A ), for example, wherein the sensor unit includes an ultrasonic sensor assembly 411 and an ultrasonic sensor assembly 412 in electrical communication with an electronic unit 420 via an electrical interconnect (not shown). in vivo During or after the fluid flow sensor device 400 is connected to the anatomical structure 490, the ultrasonic sensor assemblies 411 and 412 on the distal portion of the connecting rod 403 can be oriented about the desired measurement location (e.g., by the insertion instrument before its withdrawal) so that the position line of the acoustic transducers of the ultrasonic sensor assemblies 411 and 412 can be established (e.g., by the transmission and reception of acoustic signals) for contact placement and / or calibration measurements. In addition, for example, before the insertion instrument is removed, the position line of the ultrasonic sensor assemblies 411 and 412 can be established (e.g., by the transmission and reception of acoustic signals) for contact placement and / or calibration measurements. in vivo Wireless data communication between the fluid flow sensor device 400 and a remote device (e.g., remote computing device 130A and / or remote base station 130b). In some embodiments, for example, sutures or other fixation techniques (e.g., adhesives or other) may be used to further secure the fluid flow sensor device 400 within the body.

[0127] In use Figure 1B of in vivoIn some exemplary embodiments of the ultrasonic sensor assembly of various embodiments of the fluid flow sensor device 100X, the transducer array is designed to spatially configure a single transmitter with at least two receivers that interleave and interchange the receivers and transmitters so that a single or multiple fields of ultrasonic energy are displaced around a cardiac chamber (e.g., an atrium or ventricle), for example, to detect Q-wave flow patterns or disruptions in the flow patterns. By detecting Q-wave flow patterns or disruptions in the flow patterns, this data can be interrogated and mapped to backflow of blood through and backflow of blood through the ventricular valves, which indicates wall / chamber dysfunction (e.g., which can be associated with disruptions in the electrical signal of the heart pulsation and / or clotting of static blood). Furthermore, mechanical analysis of chamber diameter changes can be calibrated and detected by the exemplary ultrasonic sensor assemblies 511 and / or 112 for use in changes, thereby serving as a tool for predicting changes in cardiac structure, for example, due to water absorption by cardiac cells, which can lead to saturation or supersaturation, indicating dysfunction in the removal of cellular analytes, such as water, electrolytes, and / or cellular waste products, which can lead to CHF in a patient.

[0128] Figure 5A Shows the instructions Figure 1B of in vivo FIGURE 1 shows an example implementation of a fluid flow sensor device 100X. Figure 5A 5 is shown as being attached to an anatomical structure 590 (e.g., an atrium or ventricle of the heart or a blood vessel through which blood flows into or out of the heart). in vivo Fluid flow sensor device 500 depicts an example embodiment of an acoustic transducer configuration according to the present technology. body Inside The fluid flow sensor device 500 includes an embodiment of an electronics unit 120X coupled to an embodiment of a connection assembly 103B, having two opposing arms with a first ultrasonic sensor assembly 511 disposed on the first arm and a second ultrasonic sensor assembly 512 disposed on the second arm at their distal ends. The first ultrasonic sensor assembly 511 includes at least one ultrasonic transmitter (Tx) transducer 513a and the second ultrasonic sensor assembly 512 includes at least two ultrasonic receiver (Rx) transducers 514b and 514c. Although Figure 5A, illustrates a single Tx transducer 513a on one arm of exemplary connection assembly 103B and two Rx transducers 514b and 514c on the opposite arm of exemplary connection assembly 103B, but in some exemplary embodiments, one or more additional Tx transducer elements may be included on first ultrasonic sensor assembly 511; and, in some exemplary embodiments, one or more additional Rx transducer elements may be included on second ultrasonic sensor assembly 512. Furthermore, for example, in some embodiments, first ultrasonic sensor assembly 511 may include two or more Rx transducer elements (e.g., at least two Rx transducers 514b and 514c); and, for example, in some embodiments, second ultrasonic sensor assembly 512 may include one or more Tx transducer elements (e.g., at least one Tx transducer 513a).

[0129] exist Figure 5A In the example shown, in vivo The fluid flow sensor device 500 provides a single-sided acoustic detection system in which one or more Tx transducers 513a are configured on one side of the device 500 (i.e., an arm of the link assembly) to transmit an acoustic signal (e.g., a pulse, waveform, etc.), and in which at least two Rx transducers 514b, 514c are configured on (i) an opposite side of the device 500 (i.e., the other arm of the link assembly as the Tx transducer 513a) to receive an acoustic signal corresponding to the transmitted acoustic signal that, after propagating through fluid in the anatomical structure 590, was subject to reflection, refraction, or other propagation change due to fluid flow, or (ii) the same side (i.e., the same arm of the link assembly as the Tx transducer 513a of the device 500) to receive an acoustic signal corresponding to the transmitted acoustic signal that, after propagating through fluid in the anatomical structure 590, was subject to reflection, refraction, or other propagation change due to fluid flow, and was reflected by a reflector structure ( Figure 5A shown later) on the opposite side.

[0130] In some example embodiments, Figure 5A As shown, the acoustic transducers on the first and second ultrasound sensor assemblies 511 and 512 are configured such that the Tx transducer 513a is located on / around another portion of the anatomical structure 590 (e.g., relative to the Rx transducers 514b, 514c), wherein the center (C Tx ) and the distance (Cd) between the center of the Rx transducers 514b and 514c Rx ) is aligned with the center of the Tx transducer 513a. Tx and Cd between Rx transducers 514b, 514c RxThe spatial alignment of is configured to minimize interference of acoustic energy during operation of the ultrasonic sensor assembly. Inset box 599T shows the center C of the Tx transducer 513a. Tx is the midpoint of the length (l), which defines the length of the Tx transducer 513a in that dimension (eg, along the x-axis), as Figure 5A 598. In the vertical dimension, for example, along the z-axis, the center C of the Tx transducer 513a is Tx The inset box 599R shows the center of the distance (d) separating the centers of the Rx transducers 514b, 514c, i.e., (Cd Rx ), is based on the relative lengths of the sides of the Rx transducers 514b, 514c in that dimension, for example, along the x-axis, as shown in the example coordinate graph 598. Notably, the fluid flow direction is the x-axis direction for the coordinate graph 598 corresponding to the ultrasound sensor assembly shown in insets 599T and 599R, and the x-axis direction for the coordinate graph 597 corresponding to the device 500 secured to the anatomical structure 590.

[0131] As shown in inset 599T, in some exemplary embodiments, Tx emitter 513a can be coupled to a backing or substrate 513s, which can be attached to the inner surface of an arm of link assembly 103B. For example, substrate 513s can provide thermal management for heat generated by the acoustic transducer. Similarly, inset 599R shows exemplary embodiments of Rx emitters 514b and 514c, which are coupled to a backing or substrate 514s, which can be attached to the inner surface of an arm of link assembly 103B. For example, in some embodiments, one or more of Rx emitters 514b and 514c can be provided in various combinations on a single substrate 514s or separate substrates 514s. Similarly, substrate 514s can provide thermal management for heat generated by the acoustic transducer, for example.

[0132] In some embodiments, for example, the Tx transducer 513a is configured to have a 4 mm 2 Transducer area (e.g., 2 mm × 2 mm) or with 4π mm 2 The transducer area (e.g., 2 mm diameter) is used for transmitting acoustic signals. It should be understood that the width, length, or diameter (or any dimension) of the Tx transducer 513a can be greater than or less than 2 mm; for example, the size (e.g., width, length, diameter, etc.) of the Tx transducer 513a can be between 1 mm and 4 mm. In some embodiments, for example, each of the Rx transducers 514b, 514c is configured to have a 4 mm diameter. 2Transducer area (e.g., 2 mm × 2 mm) or with 4π mm 2 The transducer area (e.g., 2 mm diameter) is used to receive acoustic signals. It should be understood that the width, length, or diameter (or any other dimension) of the Rx transducers 514b and 514c can be greater than or less than 2 mm; for example, the dimensions (e.g., width, length, diameter, etc.) of the Rx transducers 514b and 514c can be between 1 mm and 4 mm.

[0133] In some embodiments, for example, the Tx transducer 513a and the Rx transducers 514b, 514c are arranged to be positioned in a plane (0 degrees) for line-of-site and wave detection, such that the Rx transducers 514b, 514c detect and respond to acoustic signals from the Tx transducer 513a that have propagated through the anatomical structure 590 and been affected by fluid flow (e.g., blood flow in the heart or blood vessels leading to or from the heart). However, in some embodiments, for example, the Tx transducer 513a and the Rx transducers 514b, 514c are arranged to be positioned (e.g., rotated) 90 degrees relative to each other, out of the plane for line-of-site and wave detection. Similarly, in some embodiments, for example, the Tx transducer 513a and / or the Rx transducers 514b, 514c can be tilted up to 20 degrees relative to each other, out of the plane for line-of-site and wave detection.

[0134] In some embodiments, for example, the substrate 513s of the Tx transducer 513a may be configured to have a width (W Tx ) and 10 mm in length (L Tx ). In addition, for example, in some embodiments, the substrate 514s for the Rx transducers 514b, 514c may be configured to have a width (W Rx ) and 10 mm in length (L Rx ).

[0135] Figure 5B Shown for in vivo An exemplary embodiment of a fluid flow sensor device 100X, for example, Figure 5A shown in vivoA diagram depicting an exemplary arrangement of acoustic transducers on an ultrasonic sensor assembly 511B is provided for one or both of the first ultrasonic sensor assembly 511 and the second ultrasonic sensor assembly 512 of the fluid flow sensor device 500. The ultrasonic sensor assembly 511B includes a plurality of acoustic transducer elements 563, namely, two acoustic transducer transmitter elements 563a and 563b in this example, and a plurality of acoustic transducer elements 564, namely, three acoustic transducer receiver elements 564d, 564e, and 564f in this example. It should be understood that this embodiment is not limited to two acoustic transducer transmitter elements and three acoustic transducer receiver elements for the ultrasonic sensor assembly 511B, and may include more than one acoustic transducer element. Figure 5B The configuration shown in the figure is less or more. In this example, the placement of the transmitter elements 563a, 563b is in a row along a single direction, and the placement of the receiver elements 564d, 564e, 564f is along a different row above or below the transmitter row, with the different row being located at a distance (d1) relative to the center of the transmitter elements and the receiver elements. The configuration of the transmitter elements 563a, 563b and the receiver elements 564d, 564e, 564f is based on a line of site transmission and reception (LOSTR) for the operation of the acoustic transducers in the array. Figure 5B In the example embodiment shown, for a single transmitter element corresponding to at least two receiver transducers (e.g., transmitter element 563a corresponding to receiver elements 564d, 564e), the center (C Tx1 ) is aligned with the center of the distance (d) separating the centers of the Rx transducers 564d, 564e, i.e., (Cd Rx1 ), so that the C of the Tx transducer 563a Tx1 and Cd between Rx transducers 564d and 564e Rx1 The spatial alignment of is configured to minimize interference of acoustic energy during operation of the transmitter-receiver set of ultrasonic sensor assembly 511B. Similarly, for example, the center (C Tx2 ) and the distance (d) separating the centers of the Rx transducers 564e, 564f, i.e. (Cd Rx2 ) is aligned so that the C of the Tx transducer 563b Tx2 and Cd between Rx transducers 564e, 564f Rx2 The spatial alignment of is configured to minimize interference of acoustic energy during operation of the transmitter-receiver set of ultrasonic sensor assembly 51 IB.

[0136] It is noteworthy that, for example, some example embodiments of the ultrasound sensor assembly 511B may configure the transmitter and receiver rows to vary with combinations of transmitter elements and receiver elements integrated together in the same row. For example, in some embodiments, the Tx transducer 563a may be configured to transmit one or more acoustic signals that propagate through the anatomical structure 590 and are received by the Rx transducers 564d and 564e, and simultaneously or subsequently, the transducer 564e may be configured to transmit one or more acoustic signals that propagate through the anatomical structure 590 and are received by the transducers 563a and 563b.

[0137] In some embodiments, for example, the transmitter elements 563a, 563b may be configured to have a 2.25 mm 2 transducer area (e.g., 1.5 mm × 1.5 mm) or with a 2.25π mm 2 transducer area (e.g., 1.5 mm diameter) for transmission of acoustic signals; and receiver elements 564d, 564e, 564f may be configured to have a 2.25 mm 2 transducer area (e.g., 1.5 mm × 1.5 mm) or with a 2.25π mm 2 Transducer area (e.g., 1.5 mm diameter) for receiving acoustic signals (e.g., transmitted from opposing side arrays on opposing arms of the connecting assembly of device 500). It should be understood that the width, length, or diameter (or any dimension) of transmitter and / or receiver transducer elements 563a, 563b and / or 564d, 564e, 564f can be greater than or less than 1.5 mm. In some embodiments of ultrasonic sensor assembly 511B, the distance (d1) between the transmitter and receiver rows, i.e., the centerline-to-centerline distance, can be approximately 5 mm, for example, to achieve optimal LOSTR (e.g., as the minimum distance to minimize interference). For this example configuration of ultrasonic sensor assembly 511B, the distance spacing (d1) has been optimized to ensure that there are no cross-reflections, which would resemble ghost signals or signal interference that could produce erroneous readings. The carrier for the transmitter and receiver can serve as a coupler for electronic communication to the processor and power supply. For example, in some embodiments, one or more of the transmitter elements 563a and 563b can be rotated 90 degrees within the same plane relative to at least two of the corresponding receiver elements 564d, 564e, and 564f, or vice versa.

[0138] The ultrasonic sensor assembly 511B optionally includes a backing or substrate 563s that can be used to connect the ultrasonic sensor assembly 511B to the arm of the connection assembly of the device 500. For example, the substrate 563s can provide thermal management for managing heat generated by the acoustic transducers (e.g., acoustic transducers 563a, 563b, 564d, 564e, 564f). In some embodiments, for example, the substrate 563s can be configured to have a first side length (l) of 10 mm (perpendicular to the rows of transmitters and receivers). S1 ) and a second side length (l ) of 10 mm (parallel to the transmitter and receiver rows) S2 ).

[0139] In some embodiments, for example, the ultrasonic sensor assembly 511B may be used to in vivo In an exemplary single-sided acoustic detection system of a fluid flow sensor device 100X, one or more Tx transducers are configured on one side (i.e., an arm of a linkage assembly) to transmit an acoustic signal (e.g., a pulse, waveform, etc.) through an anatomical structure, such that at least two Rx transducers corresponding to the Tx transducers are configured on an opposite side (i.e., the other arm of the linkage assembly) to receive an acoustic signal corresponding to the transmitted acoustic signal after propagation through the fluid in the anatomical structure, the transmitted acoustic signal being subject to reflection, refraction, or other propagation changes caused by the fluid flow. However, some embodiments, for example, ultrasonic sensor assembly 511B may be used for in vivo In an exemplary dual-sided acoustic detection system of the fluid flow sensor device 100X, a first set of one or more Tx transducers is configured on one side of an anatomical structure (i.e., an arm of the connecting assembly) to transmit and receive signals from a first set of at least two corresponding receiver elements simultaneously with a second set of one or more Tx transducers on an opposite arm across the anatomical structure from a second set of at least two corresponding receiver elements. Examples of dual-sided acoustic detection systems are described later in Figure 5D Shown in.

[0140] Figure 5C Shows the instructions Figure 1B of in vivo FIGURE 1 shows an example implementation of a fluid flow sensor device 100X. Figure 5C 5 is shown as being attached to an anatomical structure 590 (e.g., an atrium or ventricle of the heart or a blood vessel through which blood flows into or out of the heart). in vivo Fluid flow sensor device 500C depicts an example embodiment of an acoustic transducer configuration according to the present technology. in vivoFluid flow sensor device 500C includes an embodiment of electronics unit 120X coupled to an embodiment of connection assembly 103B, having two opposing arms, wherein an ultrasonic sensor assembly 511C is located at the distal end of one arm 503C1, and a reflector 516 is located at the distal end of the opposing arm 503C2. For example, in some embodiments, reflector 516 can be configured as a specular reflector, having a substantially flat surface, a substantially smooth surface, and a boundary / region with dimensions greater than the wavelength of the acoustic signal. However, in some embodiments, for example, reflector 516 can be configured as a non-specular reflector, having a non-flat surface, and / or a rough or irregular surface texture, and / or a boundary / region with dimensions less than the wavelength of the acoustic signal. Furthermore, in some embodiments, reflector 516 can be configured to have a specular reflector portion and a non-specular reflector portion. In various embodiments, for example, reflector 516 can be configured in shape and size to conform to the contours of an anatomical site (e.g., an organ or vessel), in conjunction with focal reflection to achieve optimal energy response. Example materials for the reflector 516 may include, but are not limited to, polyester film (e.g., on a substrate); precious metals such as silver, platinum, gold, palladium (e.g., vacuum deposited precious metals); or standard metals such as silver, titanium, nitinol, or stainless steel (e.g., polished for the wavelength), or combinations thereof.

[0141] The ultrasonic sensor assembly 511C includes at least one ultrasonic transmitter (Tx) transducer 513a and at least two ultrasonic receiver (Rx) transducers 514b and 514c. in vivo The fluid flow sensor device 500 provides a single-sided acoustic detection system in which one or more Tx transducers 513a are configured in an array with at least two Rx transducers 514b, 514c on one side of the device 500C (i.e., an arm of the connecting assembly) to transmit an acoustic signal (e.g., a pulse, waveform, etc.) that propagates through the anatomical structure 590, is affected by the fluid flowing through the anatomical structure 590, is reflected from a reflector 516 configured on the opposite side of the device 500C (i.e., the other arm of the connecting assembly), and is received as an acoustic signal corresponding to the transmitted acoustic signal.

[0142] In some example embodiments, the acoustic transducers on the ultrasonic sensor assembly 511C may be configured to have a Figure 5A and 5B Example dimensions, spacings, materials, and structures are described for example acoustic transducers of first and second ultrasonic sensor assemblies 511 and 512, respectively.

[0143] in vivoAn example implementation of the fluid flow sensor device 500 was performed in a benchtop setup designed to simulate blood flow through a chamber or tube similar to the anatomical structure 590, which tested the characteristics of the received acoustic signal. Table 1 describes the function of frequency and sensitivity for an exemplary single-sided acoustic detection system, i.e., at least one transmitter configured on opposite arms of a connecting assembly to at least two receivers, e.g., a sensor incorporating a Figure 5A The ultrasonic sensor components 511, 512, Figure 5B 511B and / or Figure 5C The 511C shown in in vivo An exemplary embodiment of a fluid flow sensor apparatus 500 is illustrated.

[0144] Table 1.

[0145]

[0146] Table 1 describes the flow sensitivity ( / t) versus example frequencies (e.g., 3 MHz, 6 MHz, and 9 MHz), and the distance (mm) between the transmitting and receiving acoustic transducers for a single-sided transducer configuration. Φ is (deg / [l / min]); duration or function period The unit of t is (ps / [l / min]).

[0147] Figure 5D Shows the instructions Figure 1B of in vivo FIGURE 1 shows an example implementation of a fluid flow sensor device 100X. Figure 5D 5 is shown as being attached to an anatomical structure 590 (e.g., an atrium or ventricle of the heart or a blood vessel through which blood flows into or out of the heart). in vivo Fluid flow sensor device 500D depicts an example embodiment of an acoustic transducer configuration according to the present technology. in vivo The fluid flow sensor device 500D includes an embodiment of an electronics unit 120X coupled to an embodiment of a connection assembly 103B, having two opposing arms with a first ultrasonic sensor assembly 511D disposed on the first arm and a second ultrasonic sensor assembly 512D disposed on the second arm at their distal ends. The first ultrasonic sensor assembly 511D shown in illustration 595 includes at least one ultrasonic transmitter (Tx) transducer 523a. The second ultrasonic sensor assembly 512D shown in illustration 596 includes at least two ultrasonic receiver (Rx) transducers 534b and 534c, which correspond to the Tx transducer 523a. Figure 5DIn the example embodiment shown, the second ultrasonic sensor assembly 512D also includes at least one ultrasonic transmitter (Tx) transducer 533a, and the first ultrasonic sensor assembly 511D also includes at least two ultrasonic receiver (Rx) transducers 524b and 524c corresponding to the Tx transducer 533a.

[0148] exist Figure 5D In the example shown, in vivo The fluid flow sensor device 500D is in vivo The fluid flow sensor device 100X provides a dual-sided acoustic detection system in which a first set of one or more Tx transducers (e.g., Tx transducer 523a) is configured on one side of the anatomical structure 590 (i.e., an arm of a linkage assembly) starting from a first set of at least two corresponding receiver elements (e.g., Rx transducers 534b, 534c) and operates simultaneously (e.g., transmits and receives) with a second set of one or more Tx transducers (e.g., Tx transducer 533a) on the opposite arm of the anatomical structure 590 starting from a second set of at least two corresponding receiver elements (e.g., Rx transducers 524b, 524c).

[0149] In some example embodiments, the acoustic transducers on the first ultrasonic sensor assembly 511D and / or the second ultrasonic sensor assembly 512D may be configured to have a configuration such as in combination with Figure 5A and 5B Example dimensions, spacings, materials, and structures are described for example acoustic transducers of first and second ultrasonic sensor assemblies 511 and 512, respectively.

[0150] in vivo An example implementation of the fluid flow sensor device 500D was performed in a benchtop setup designed to simulate blood flow through a chamber or tube similar to the anatomical structure 590, which tested the characteristics of the received acoustic signal. Table 2 describes the function of frequency and sensitivity of an exemplary two-sided acoustic detection system, for example, Figure 5D The ultrasonic sensor components 511D and 512D are shown in combination. in vivo An exemplary embodiment of a fluid flow sensor apparatus 500D is illustrated.

[0151] Table 2.

[0152]

[0153] Table 2 shows the flow sensitivity ( The relationship between sensitivity (t) and example frequencies (e.g., 3 MHz, 6 MHz, and 9 MHz), and the distance (mm) between transmitting and receiving acoustic transducers for a bilateral transducer configuration, i.e., a first set of at least one transducer element on opposing arms on an anatomical structure operating (e.g., transmitting and receiving) simultaneously with a second set of at least one transducer element on opposing arms across the anatomical structure from a second set of at least two corresponding receiver elements. Units of sensitivity Φ is (deg / [l / min]); duration or function period The unit of t is (ps / [l / min]).

[0154] The example data in Table 2 demonstrates the damping effect of using two opposing transmitters (e.g., Tx transducer 523a of first ultrasonic sensor assembly 511D and Tx transducer 533a of second ultrasonic sensor assembly 512D) configured to simultaneously transmit acoustic signals in opposite directions from each other, which is approximately half the flow sensitivity compared to the example data in Table 1, which is based on a single-sided transmit transducer arrangement of ultrasonic sensor assemblies transmitting toward a reflector, with at least two receive transducers on the same side as the transmit transducer, or at least two receive transducers on opposite sides of the anatomy from the transmit transducer.

[0155] exist in vivo In some example implementations of various embodiments of the fluid flow sensor device 100X, the device can be operated to transmit and receive acoustic signals (e.g., ultrasound signals) in Doppler mode. Compared to typical ultrasound techniques that interrogate stationary objects, Doppler ultrasound can be used to characterize fluid flow characteristics. For example, when an object of interest (e.g., a blood cell in a bloodstream flowing through an anatomical structure) moves relative to the ultrasound signal, it encounters more oscillations per unit time than a stationary equivalent, causing the frequency of the reflected wave to increase; and as the object of interest moves away from the ultrasound signal, the frequency of the reflected signal decreases. The Doppler effect can be used to measure the velocity of blood flow through an anatomical structure.

[0156] in vivo An exemplary embodiment of the fluid flow sensor device 100X may be positioned at an angle (θ) relative to the direction of blood flow within the anatomical structure 590 such that the frequency shift measured by the Doppler mode is (f R - f T ) = 2 vf T cos(θ) / c , where f T is the frequency of the transmitted sound signal, f Ris the frequency of the received acoustic signal, c is the velocity of an acoustic signal of a given wavelength emitted in the medium, and v is the speed at which the acoustic signal moves toward the acoustic transducer that receives the signal.

[0157] For example, in vivo The fluid flow sensor device 100X can use Doppler technology in conjunction with the calculation of the mass flow of blood through the anatomical structure, so that the body mass flow in the confidence interval is equal to the density (known blood) and the diameter change (used to calculate the area), which enables the determination of velocity. And, based on the velocity and diameter, the device 100X can determine the Q of the fluid flow. In addition, in vivo The fluid flow sensor device 100X is capable of measuring planar dimensions of a target anatomical structure based on a determinable change in fluid flow relative to a baseline measurement, for example, because increased fluid quantity (volume) typically causes wall dilation, i.e., an increase in wall diameter, of the anatomical structure (e.g., a major blood vessel).

[0158] exist in vivo In some example implementations of various embodiments of the fluid flow sensor device 100X, the device can be operated to transmit and receive acoustic signals (e.g., ultrasound signals) to create an ultrasound image of a target anatomical structure, for example, using A-mode, B-mode, and / or C-mode ultrasound data acquisition techniques. In some examples, embodiments of the in vivo fluid flow sensor device 100X can be used in A-mode ultrasound acquisition to obtain a one-dimensional representation of acoustic signal waves transmitted and received in the direction in which the ultrasound transducer assembly is oriented, for example, where one axis represents depth and a perpendicular axis represents amplitude. In some examples, embodiments of the in vivo fluid flow sensor device 100X can be used in B-mode, also known as 2D mode, to obtain a two-dimensional representation of acoustic signal waves transmitted and received, for example, based on the angle at which the ultrasound transducer assembly is positioned relative to the anatomical structure. In some examples, embodiments of the in vivo fluid flow sensor device 100X can be used in C-mode to obtain depth range from A-mode and 2D information from B-mode.

[0159] Figure 6A Shown depiction Figure 1B of in vivo FIGURE 1 shows an example embodiment of a fluid flow sensor device 100X. Figure 6A Shown in in vivo Fluid flow sensor device 600A. in vivoThe fluid flow sensor device 600A includes a sensor unit comprising at least one ultrasonic sensor assembly 611 in electrical communication with an electronics unit 620 via an electrical interconnect (not shown) disposed on or within the body of material of the clamp 603. The electronics unit 620 is housed in a connection 635 connecting the arms of the clamp 603. The ultrasonic sensor assembly 611 includes a plurality of acoustic transducer elements 613, for example, five acoustic transducer elements 613a, 613b, 613c, 613d, 613e in this example, located on the inwardly facing sides of the arms of the clamp 603. It should be understood that this embodiment is not limited to five acoustic transducer elements per ultrasonic sensor assembly and may include more than one acoustic transducer element. Figure 6A The configurations shown in the figure are fewer or more, for example, including but not limited to one or more acoustic transducer elements for the ultrasonic sensor assembly 611. The other arm of the clamp 603 may include an embodiment of the reflector 516 (in Figure 6A 603 ). The ultrasonic sensor assembly 611 includes a plurality of ultrasonic transducer assemblies (shown as reflector 616) configured to reflect acoustic signals transmitted by the ultrasonic sensor assembly 611, which propagate through the anatomical structure, are affected by the fluid flow through the anatomical structure, are reflected from the reflector 616, and are received by the ultrasonic sensor assembly 611 as return acoustic signals (corresponding to the transmitted acoustic signals). In some embodiments, the reflector 616 may be attached to a backing or base 616s, which may be attached to the inner surface of the arms of the clamp 603.

[0160] The clamp 603 is configured to secure the acoustic transducer element 613 and the reflector 616 to position them in a fixed position relative to each other. In some embodiments, for example, the clamp 603 can be constructed of a composite material having durometer parameters of a polymer component (e.g., 20A to 95A) and a reinforcing material (e.g., made of a shape-setting material such as Nitinol), which allows the clamp 603 to be pre-formed and / or pre-trained (allowing the clamp 603 to be set in a first shape / configuration for delivery / implantation, after which it can assume a second shape / configuration for deployment / operation). Some non-limiting examples of composite materials for the clamp 603 can include Nitinol, gold, platinum, platinum / iridium, etc., encapsulated in a polymer such as silicone, polyethylene, polyimide, polyamide, or a hybrid polyimide-polyamide, or other polymer material.

[0161] exist in vivo In some embodiments of the fluid flow sensor device 600A, the clamp 603 may include one or more openings 618 on at least one or both arms of the clamp 603 that allow for auxiliary attachment of the device 600A to a target anatomical structure. For example, Figure 6AThe opening 618 shown in the example includes a portion of the clamp 603 between two gaps in the opening 618, which provides an anchoring location for applying a suture (e.g., suture, thread, etc.) to secure the arms of the clamp 603 to the anatomical structure (e.g., the atrial wall of the heart).

[0162] Figure 6B Shown depiction Figure 6A of in vivo FIGURE 6 shows an example embodiment of a fluid flow sensor apparatus 600A. Figure 6B Shown in in vivo Fluid flow sensor device 600B. in vivo The fluid flow sensor device 600B includes a sensor unit comprising an ultrasonic sensor assembly 611 and a second ultrasonic sensor assembly 612, both of which are in electrical communication with an electronics unit 620 via electrical interconnects (not shown), wherein the electrical interconnects are configured on or within the body of material of the clamp 603. The electronics unit 620 is housed in a connection device 635 connecting the arms of the clamp 603. The ultrasonic sensor assembly 612 includes a plurality of acoustic transducer elements 614 located on the arms of the clamp 603 opposite the arms on which the ultrasonic sensor assembly 611 is located. Figure 6B In the example shown, the plurality of acoustic transducer elements includes five acoustic transducer elements 614a, 614b, 614c, 614d, 614e positioned on the inwardly facing sides of the arms of the clamp 603 in a particular configuration relative to each other and relative to the acoustic transducer element 613 of the ultrasonic sensor assembly 611 on the opposite arm of the clamp 603. It should be understood that this embodiment is not limited to five acoustic transducer elements per ultrasonic sensor assembly and may include more than one acoustic transducer element. Figure 6B The configuration shown in the figure is less or more, for example, including but not limited to one or more acoustic transducer elements for ultrasonic sensor assembly 611. Clamp 603 is configured to fix acoustic transducer element 613 and acoustic transducer element 614 and position them in a fixed position relative to each other. In some embodiments, in vivo The clamp 603 of the fluid flow sensor device 600B may include one or more openings 618 on at least one or both arms of the clamp 603 that allow an auxiliary connection device of the device 600B to be connected to a target anatomical structure. Figure 6B The opening 618 shown in the example includes a portion of the clamp 603 between two gaps in the opening 618, which provides an anchoring location for applying a suture (e.g., suture, thread, etc.) to secure the arms of the clamp 603 to the anatomical structure (e.g., the atrial wall of the heart).

[0163] Figure 6C Shown depiction Figure 6A of in vivoFluid flow sensor device 600A and / or Figure 6B of in vivo FIGURE 6 shows an exemplary embodiment of a fluid flow sensor device 600B. Figure 6C Displayed as in vivo Fluid flow sensor device 600C. body Inside Fluid flow sensor device 600C includes a sensor unit comprising an ultrasonic sensor assembly 611 and / or a second ultrasonic sensor assembly 612, both of which are in electrical communication with an electronics unit 620 via electrical interconnects (not shown), wherein the electrical interconnects are configured on a surface of or within the body of material of the clamp 603. The electronics unit 620 is housed in a connection 635 connecting the arms of the clamp 603. in vivo The fluid flow sensor device 600C includes an inner curvature region 634 at the distal end of each arm of the clamp 603, for example, which can facilitate connection and conformity to anatomical structures during placement, as well as facilitate delivery of the device 600C, for example, via a catheter. One or more openings 618 can be provided on the inner curvature region 634 on at least one or both arms of the clamp 603 and / or on the arms proximal to the inner curvature region 634, for example, to allow a secondary attachment device of the device 600B to be attached to the target anatomical structure. In some embodiments, a connection device 635 can be attached to the clamp 603 (not shown) on the outside of the arms of the clamp 603, which may be preferred for in vivo applications where the device 600C is deployed on a blood vessel (e.g., such as the vena cava or the pulmonary artery or vein).

[0164] in vivo Fluid flow sensor devices 600A, 600B, and 600C Figures 6A-6C Exemplary embodiments of the present invention each include a flexible arm configuration of clamp 603 for flexibility and adaptability to the intended placement site. The arms of clamp 603 can facilitate and maintain electron transmission via an interconnect (not shown) to electronics unit 620 housed in connection assembly 635. Clamp 603 can enhance contact of devices 600A, 600B, and 600C with anatomical structures for ultrasound measurement. The arms of clamp 603 can comprise a flexible, non-conductive, bio-inert substrate material, upon or embedded within which are the flexible circuits and carriers for ultrasound sensor assembly 611 and / or second ultrasound sensor assembly 612. In this manner, clamp 603 can withstand and tolerate mechanical forces during placement during the act of connecting the device to the intended location, as well as during extended operation (e.g., hundreds of millions of cycles, such as a heartbeat). In some embodiments, the arms of connection assembly 603 can utilize a braided metal or polymer sheet that is subsequently interlaced with traces for electrical connection.

[0165] Figure 6DAn exploded view depicting an example embodiment of an electronics unit 620 is shown, housed within Figures 6A-6C of in vivo The fluid flow sensor devices 600A, 600B, and 600C are shown in a connecting device 635. In some embodiments, for example, the connecting device 635 includes a base housing 631 and a removably attached cap 633 that can be secured to (e.g., hermetically sealed) the base housing 631 to protect internal components (e.g., the electronics unit 620) from the external environment (e.g., biological fluids and / or biological components). For example, in some (optional) embodiments, the connecting device includes an intermediate housing 632 that houses the electronics unit 620; for example, the intermediate housing 632 can be manufactured separately and have a variety of physical configurations (e.g., shapes and sizes) to allow for easy installation. in vivo Any of the embodiments of the fluid flow sensor apparatus 100X may be modular with the various embodiments of the connection device 635 .

[0166] In some embodiments, the base shell 631, the intermediate shell 632 and / or the cover 633 can be connected via an airtight sealing material (for example, an impermeable material such as a metal or metal film (thin film) and / or a woven cloth or polymer such as polyparaxylene, ethyl carbamate or Teflon material) and coated to ensure an impermeable interface between any one of the base shell 631, the intermediate shell 632 and / or the cover 633, thereby preventing fluids (for example, water or blood) from breaking through the connecting device 635 and entering the electronic unit 620.

[0167] Electronics unit 620 includes a printed circuit board (PCB) 622 that facilitates a data processing unit, a wireless communication unit, and a power supply unit. For example, in some embodiments, PCB 622 includes an embodiment of data processing unit 121 to at least partially process the conditioned electrical signals to (i) generate data, for example, in analog or digital form, and / or (ii) control the functionality of electronics unit 620 and / or ultrasonic sensor assemblies 611 and / or 612. For example, data processing unit 121 can be configured to manage data acquisition on data channels associated with one or more acoustic transducers of ultrasonic sensor assemblies 611 and / or 612. Furthermore, for example, in some embodiments, PCB 622 includes a power supply unit, such as a supercapacitor or a small hermitic battery capable of being charged inductively and / or used alone or in combination as a hybrid supercapacitor battery, so that charging and run time are balanced to be efficient for the required monitoring power and communication consumption.

[0168] In some embodiments, the wireless communication unit of the electronic unit 620 includes an antenna, which may include platinum or 90 / 10 platinum iridium, gold, or platinum pure wire, for example, with a cross-sectional size ranging from 0.000001 inches.2 to 0.008 inches 2 , configured in a wire or tubular configuration. For example, a shaped nitinol wire with a gold plated or co-extruded gold outer layer can be used. Exemplary wires can be single or combined in a wound or braided configuration to obtain optimal density for receiving and transmitting single wires, thereby supporting information transmission in one or more directional modes. In some embodiments, the antenna can be configured in a flat flexible circuit geometry, such as any of the aforementioned patterns on a PCBA (printed circuit board assembly). For example, in some embodiments, the antenna can be configured as a serpentine antenna or a coil antenna suitable for electronic packaging; and / or in some embodiments, for example, the antenna can be configured as a power transmitting antenna base operable for battery charging.

[0169] In some embodiments, the wireless communication unit of the electronics unit 620 includes an integrated Bluetooth, current, or radio in antenna communication system. In some embodiments, the electrical signals converted by the ultrasound sensor assembly 611 and / or 612 can be transmitted as communication packets to a remote device outside the patient's body, for example, through the chest cavity to a receiving scanner, receiving transmitter, receiving card (e.g., similar to an EKG port contact), or base station equivalent.

[0170] Figure 7A Shown depiction Figure 1B of in vivo FIGURE 1 shows an example embodiment of a fluid flow sensor device 100X. Figure 7A Shown in in vivo Fluid flow sensor device 700 . in vivo The fluid flow sensor device 700 includes a sensor unit comprising a first ultrasonic sensor assembly 711 and a second ultrasonic sensor assembly 612, both of which are in electrical communication with an electronics unit 720 via an electrical interconnect 717, wherein the electrical interconnect 717 is configured on the clamp 603 (at Figure 7A The electronic unit 720 is housed in a connection device 735 connecting the arms of the clamp 703.

[0171] Connector 735 may include features of example embodiments of connectors 235, 235C, and / or 635, such as springs, interconnecting links, housing structures (e.g., bases, caps, etc.), and other features described with respect to other connector embodiments disclosed herein. Figure 7A , the connection device 735 includes a power and / or data port 751, which is operable to interface with (eg, conduct electrical and / or data communications with) the electronic unit 720 housed in the connection device 735. For example, in vivoThe electronics unit 720 of the fluid flow sensor device 700 may include a rechargeable power source or intermediate power source that may be connected to an independent power source and / or data processing unit remote from the device 700 via the power and / or data port 751. In some example embodiments, the remote power source and / or data processing unit may be located within the patient's body. in vivo device, but in an area where it is more accessible to replace batteries or communicate wirelessly with it. For example, a remote in vivo The device may be wired and communicate via cables, wires, cords, etc. in vivo The electronics unit 720 of the fluid flow sensor device 700 is provided with power (e.g., covered by an insulating, bioinert material) through a power and / or data port 751. As an illustrative example, the in vivo fluid flow sensor device 700 can be deployed in a confined space, such as within or around the pericardium at the atria or ventricles, or around the superior or inferior vena cava or pulmonary artery, tethered to a larger in vivo power supply device located in a cavity remote from the device 700 deployment location, for example, one or several centimeters or tens of centimeters away, such as a cavity within the pleural or abdominal cavity, where there is greater flexibility, size, and / or positioning to facilitate larger power and / or electronic components and allow replacement of these components. In some examples, a remote power supply can be located externally, with a power and / or data cable running from the power and / or data port 751 of the device 700 to the remote power supply outside the patient's body.

[0172] In some example embodiments, the apparatus 700 includes in vivo The fluid flow sensor platform may include one or more optional secondary sensors 119 located at a remote location. in vivo The secondary sensor 119 may be connected to the sensor unit 720 via a cable, wire, cord, etc., connected to the power and / or data port 751. For example, in some embodiments, the secondary sensor 119 may include an IMU to determine the patient user's movement (e.g., whether resting (e.g., lying down, sitting, etc.) or moving (e.g., walking, running, etc.). In addition, in some embodiments, as in vivo An example secondary sensor 119 that is part of a fluid flow sensor platform may include an acoustic sensor to monitor the patient user's breathing (breathing parameters) (e.g., inhalation and exhalation breathing rate, turbulent airflow, etc.) by in vivo The fluid flow sensor device 700 monitors. In addition, in some embodiments, as in vivo An example secondary sensor 119 that is part of a fluid flow sensor platform may include an EKG monitor (e.g., an external wearable heart monitor or in vivo Insertable heart monitor) to measure in vivoThe fluid flow sensor device 700 monitors the electrocardiogram of the patient user. In this manner, for example, in vivo The fluid flow sensor device 700 can measure blood flow through the target cardiac anatomy while sensing information about the patient-user's motion state, breathing state, and / or heart rate (temporally synchronized).

[0173] In some example embodiments, in vivo Remote control of fluid flow sensor platforms in vivo Device (with in vivo The fluid flow sensor device 700 (wired communication) may include a secondary transmitter (e.g., a wireless communication unit) for power control and optimal continuous data management, for example, which may be transmitted to the remote device 130 (e.g., base station 130B and / or mobile communication device 130A). For example, data transmission by an example auxiliary transmitter (deployed remotely from the device 700) may wirelessly transmit data collected by the device 700 every minute, every second, etc., because the power consumption limitations and challenges of the remote auxiliary transmitter are reduced relative to the device 700. In some embodiments, for example, the remote in vivo The secondary transmitting device of the device can be a transmitter, receiver and / or transceiver with an antenna that uses a low-power wireless communication protocol, for example, such as Bluetooth Low Energy (BLE), Near Field Communication (NFC), low-frequency radio frequency (RF) signals in the range of 3 kHz to 1.3 MHz, etc.

[0174] refer to Figure 7A shown in vivo In an exemplary embodiment of the fluid flow sensor device 700, the first ultrasonic sensor assembly 711 includes a plurality of acoustic transducer elements 713 located on an arm of the clamp 703 that is opposite the arm on which the second ultrasonic sensor assembly 712 is located. Figure 7A In the example shown, the plurality of acoustic transducer elements 713 of the first ultrasonic assembly 711 includes five acoustic transducer elements 713a, 713b, 713c, 713d, 713e positioned on the inwardly facing sides of the arms of the clamp 703 in a particular configuration relative to each other and relative to the acoustic transducer elements 714 of the second ultrasonic sensor assembly 712 on the opposite arm of the clamp 703. It should be understood that this embodiment is not limited to five acoustic transducer elements for the first ultrasonic sensor assembly 711 and may include more than one acoustic transducer element. Figure 7A The configuration shown in the figure may be fewer or more configurations, for example, including but not limited to one or more acoustic transducer elements for the first ultrasonic sensor assembly 711. The second ultrasonic sensor assembly 712 includes a plurality of acoustic transducer elements 714, which are located on the arm of the clamp 703, opposite the arm on which the first ultrasonic sensor assembly 711 is located. Figure 7A In the example shown, the plurality of acoustic transducer elements includes five acoustic transducer elements 714a, 714b, 714c, 714d, 714e positioned on the inwardly facing sides of the arms of the clamp 703 in a particular configuration relative to each other and relative to the acoustic transducer element 713 of the first ultrasonic sensor assembly 711 on the opposite arm of the clamp 703. It should be understood that this embodiment is not limited to five acoustic transducer elements per ultrasonic sensor assembly and may include more than one acoustic transducer element. Figure 7A Fewer or more configurations may be provided for example, including but not limited to one or more acoustic transducer elements of the second ultrasonic sensor assembly 712 .

[0175] Clamp 703 is configured to secure acoustic transducer element 713 and acoustic transducer element 714 and position them in a fixed position relative to each other. in vivo The clamp 703 of the fluid flow sensor device 700 may include one or more openings 718 on at least one or both arms of the clamp 703 that allow for auxiliary attachment of the device 700B to a target anatomical structure. For example, Figure 7A The opening 718 shown in the example includes a portion of the clamp 703 between two gaps in the opening 718, which provides an anchoring location for applying a suture (e.g., suture, thread, etc.) to secure the arms of the clamp 703 to the anatomical structure (e.g., the atrial wall of the heart).

[0176] exist in vivo In some embodiments of the fluid flow sensor device 700, similar to Figure 7A In the example shown in , the device 700 includes an internal bend region 734 at the distal end of each arm of the clamp 703, for example, which can facilitate attachment and conformity to the anatomical structure during placement, as well as facilitate delivery of the device 700, for example, via a catheter. One or more openings 718 can be provided on the internal bend region 734 on at least one or both arms of the clamp 703 and / or on arms proximal to the internal bend region 734, for example, to allow auxiliary attachment devices of the device 700 to be attached to the target anatomical structure.

[0177] Figure 7B and 7C Shown depiction Figure 1B of in vivo FIGURE 1 shows an example embodiment of a fluid flow sensor device 100X. Figure 7B and Figure 7C Shown in in vivo Fluid flow sensor device 700B. The in vivo fluid flow sensor device 700B can be constructed similarly to the in vivo fluid flow sensor device 700 (previously described in Figure 7A), for example, wherein the sensor unit includes an ultrasonic sensor assembly 711 and / or an ultrasonic sensor assembly 712 in electrical communication with an electronics unit 720 via an electrical interconnect 717 (e.g., coupled to or partially housed within an arm of a clamp 703), and wherein the connection device 735 includes a power and / or data port 751 in electrical communication with the electronics unit 720 and a remote device. However, as Figure 7B and Figure 7C As shown, in vivo The fluid flow sensor device 700B includes an acoustic transducer pad 771 to protect the acoustic transducers 713 and / or 714 and to improve acoustic signal transmission and reception (eg, improve acoustic impedance matching) between the transducers and biological tissue of the anatomical structure to which the device 700 is attached. Figure 7B The in vivo fluid flow sensor device 700B is shown in an exploded view with the acoustic transducer pad 771 separated from the ultrasonic sensor assembly 711 and Figure 7C To rotate the view relative to Figure 7B ) shows an in vivo fluid flow sensor device 700B, but in which the acoustic transducer pad 771 is coupled to the arms of the clamp 703 and / or to (at least one of) the plurality of acoustic transducer elements 713 of the ultrasonic sensor assembly 711 positioned on the arms of the clamp 703. Figure 7B and 7C Not shown, but the second acoustic transducer pad 771 may be coupled to the opposing arm of the clamp 703 and / or to (at least one of) the plurality of acoustic transducer elements 714 of the ultrasonic sensor assembly 712 .

[0178] In various embodiments, the acoustic transducer pad 771 may include a hydrogel, which may be packaged in gelatin form or fluid form, with a housing comprising a polymer material (e.g., silicone, polyethylene, or other) having a hardness up to 40A durometer. in vivo In an exemplary embodiment of the fluid flow sensor device 700, the acoustic transducer pad 771 can further provide contouring and cushioning against cardiac tissue, for example when in vivoThe external tissue of the atrial or ventricular wall when the fluid flow sensor device 700 is deployed within the pericardium, as well as the epithelial tissue of major blood vessels such as the vena cava or the pulmonary artery or vein. For example, the acoustic transducer pad 771 can address the contour changes of the anatomical structure that the device 700 directly interfaces with. In addition, for example, the acoustic transducer pad 771 can be operated to support signal-to-noise isolation and provide noise deflection to obtain optimal sensing capabilities. The acoustic transducer pad 771 can reduce the risk of damage from edge fragility, for example, by absorbing mechanical forces that may occur on the acoustic transducer element during deployment and during operation (e.g., cyclic movement of the anatomical structure), which may cause acute injury or long-term wear and tear, for example, while significantly not affecting the transmission of acoustic signals between the anatomical structure and the acoustic transducer element. Similarly, the acoustic transducer pad 771 can reduce the risk of tissue abrasion of the anatomical structure to maintain contact feasibility between the device and the biological tissue.

[0179] Figure 8 Shown depiction Figure 1B of in vivo FIGURE 1 shows an example embodiment of a fluid flow sensor device 100X. Figure 8 Shown in in vivo Fluid flow sensor device 800 . in vivo The fluid flow sensor device 800 may be configured similarly to in vivo Fluid flow sensor device 700 (previously in Figure 7A shown in ) and / or in vivo Fluid flow sensor device 700B (previously in Figure 7B and Figure 7C , having at least one acoustic transducer pad 771), for example, wherein the sensor unit includes an ultrasonic sensor assembly ( Figure 8 703) and wherein the connection means 735 includes a power and / or data port 751 in electrical communication with the electronics unit 720 and the remote device. Figure 8 As shown, in vivo The fluid flow sensor device 800 includes an embodiment of the reflector 516 (in Figure 8 703 ). The ultrasonic sensor assembly 712 is shown as a reflector 816 in the figure, which is configured to reflect the acoustic signal transmitted by the ultrasonic sensor assembly 712, which propagates through the anatomical structure, is affected by the fluid flow through the anatomical structure, is reflected from the reflector 816, and is received by the ultrasonic sensor assembly 712 as a return acoustic signal (corresponding to the transmitted acoustic signal). In some embodiments, the reflector 816 can be attached to a backing or substrate (not shown) that can be attached to the inner surface of the arm of the clamp 703 opposite the arm that facilitates the ultrasonic sensor assembly 712.

[0180] Figure 9 A schematic diagram illustrating an exemplary embodiment of a remote device 990 operable to communicate with an in-vivo device 990 is shown. Figure 1B of in vivo The fluid flow sensor device 100X is, for example, Figure 7A 、 7B - 7C and / or 8 or other embodiments disclosed herein for wired communication with the exemplary embodiments of the in vivo fluid flow sensor devices 700, 700B, and / or 800 shown in FIG. in vivo Device 990 includes a housing or casing 991 that houses a power supply 998 and a data processing and / or wireless communication unit 997 .

[0181] Examples of power source 998 may include batteries, fuel cells, or other power sources. For example, in some embodiments, power source 998 may be configured as a replaceable battery and / or a rechargeable battery. For example, in a remote in vivo In an example implementation where the device 990 is located in an area or location within the patient's body that is relatively easily and safely accessible to a clinician (e.g., a space in the pleural cavity or abdominal region), the power source 998 may be recharged. In this way, the electrical energy stored in the power source 998 may be used to power a power source in the electronics unit 120X of an example embodiment of the in vivo fluid flow sensor device 100X, which may have a relatively lower charge storage capacity than the power source 998. The transmission of electrical energy may be provided from the remote in vivo device 990 to an example in vivo fluid flow sensor device (e.g., in vivo fluid flow sensor device 700, 700B, 800, or other) via a cable, wire, or cord 993 that interfaces with the power and / or data port 751 of the example in vivo fluid flow sensor device 700, 700B, 800 via an interface terminal 992. At the remote in vivo In some embodiments of the device 990, for example, a cable, wire, or cord 993 may be connected at a receiving port 999 from in vivo The housing of the device 990 or the housing 991 is disassembled. Figure 9 In the exemplary illustration of FIG, the interface end 992 of the cable, wire or cord 993 is shown as having at least one protruding structure that can be used to create a locking system with the power and / or data port 751 to ensure fixation (e.g., to prevent the cable, wire or cord 993 from being removed from the patient's body). in vivo Unwanted detachment of the fluid flow sensor device 700, 700B, 800).

[0182] Examples of the data processing and / or wireless communication unit 997 may include a transmitter, receiver, and / or transceiver with an antenna for communicating data with one or more processors coupled to a memory using a low-power wireless communication protocol (e.g., Bluetooth Low Energy (BLE), Near Field Communication (NFC), low-frequency radio frequency (RF) signals). In this way, the data processing unit of the electronics unit 720 can manage data processing functions using less onboard power and offload more processing-intensive data processing tasks to one or more processors and memory of the data processing and / or wireless communication unit 997. In addition, the data processing and / or wireless communication unit 997 may be used to at least partially control example in vivo Certain device functions of the fluid flow sensor devices 700 , 700B, 800 .

[0183] Figure 10A and 10B Shows the description Figure 1B of in vivo FIGURE 1 shows an exemplary embodiment of a fluid flow sensor device 100X. Figure 10A and 10B are shown in in vivo Fluid flow sensor devices 1000A and 1000B, wherein in an exemplary embodiment of the device, in vivo The fluid flow sensor device 1000A, 1000B is attached to the heart of the patient user. In this example, the in vivo fluid flow sensor device 1000A, 1000B is configured to evaluate blood flow on the mitral valve by placing ultrasound sensor assemblies on opposite sides of the atrial outer surface around the mitral valve, for example, to evaluate MR. Figure 10A and 10B As shown, the arms of the in vivo fluid flow sensor devices 1000A and 1000B (e.g., the arms of an exemplary embodiment of the connection assembly 103 of the in vivo fluid flow sensor device 100X, such as the clamps 603 and / or 703) are capable of extending around an organ (e.g., an atrium of the heart) with sufficient flexibility to support various orientations for optimizing functional alignment with the target anatomical structure.

[0184] Additionally, optimal functional alignment can be maintained by connecting the arms of the assembly (e.g., curvature), which can in vivo The fluid flow sensor devices 1000A, 1000B are positioned and secured to the target anatomical structure alone or in conjunction with (optionally) one or more secondary attachment mechanisms, such as sutures (attached to suture ports), adhesives, or anchoring structures (attached to anchor ports), which can be optimally positioned for the intended region of the organ / tissue for consistent measurements (e.g., initial monitoring to establish calibration and then for comparison). In addition, in some embodiments, for example, multiple in vivoThe fluid flow sensor devices 1000A, 1000B may be deployed at different locations on the same anatomical structure.

[0185] in vivo An exemplary embodiment of the fluid flow sensor device 1000A includes a connection device disposed within the interior of the clip-band connection assembly (e.g., proximate to the anatomical structure to which the device 1000A is connected). in vivo An exemplary embodiment of the fluid flow sensor device 1000B includes a connection device disposed outside of the clamp connection assembly (e.g., away from the anatomical structure to which the device 1000B is connected). in vivo

[0066] With various embodiments of the fluid flow sensor apparatus 100X, including any embodiment of the connection assembly 103, the configuration of the connection device may be internal or external to the connection assembly.

[0186] Displacement-mediated in vivo acoustic sensor device

[0187] exist in vivo In some embodiments of the acoustic sensor device 100Y, for example, the acoustic sensor 111Y comprises a displacement-mediated acoustic sensor, which may include an internal microphone-based acoustic sensor, referred to herein as a microphone acoustic sensor, or simply a microphone.

[0188] FIG. 11A shows a diagram depicting Figure 11A A diagram of an exemplary acoustic sensor in an example embodiment of an implantable medical device 100 of the present technology, which is an IMD 1100A, is shown in FIG. Figure 11A As shown, IMD 1100A includes a housing 1102 and a membrane 1104, and the housing 1102 and the membrane 1104 together are in vivoExemplary embodiments of acoustic sensor 100Y create an airtight enclosure. In some embodiments, for example, membrane 1104 is a deflectable membrane, e.g., capable of elastically deforming to change conformation between a relaxed state and a flexed state (e.g., deflated and / or inflated). In such embodiments, the acoustic sensor can be configured to operate as a microphone—i.e., an instrument that converts sound (mechanical waves) into electrical signals that can be processed (e.g., amplified). In some embodiments, for example, membrane 1104 comprises titanium (Ti) or other strong, impermeable, biocompatible, and relatively inflexible metals, such as surgical-grade stainless steel (e.g., MP35N), cobalt-chromium alloy, or Nitinol, or strong, impermeable, biocompatible, and flexible high-purity alumina, to transduce pressure differentials. In some embodiments, housing 1102 and membrane 1104 are formed from the same material, however, membrane 1104 has properties, such as thickness or elasticity, that allow it to achieve the desired response to pressure changes while maintaining airtightness. In some embodiments, housing 1102 and membrane 1104 are made of different materials but are securely bonded together to create an airtight enclosure. In some embodiments, for example, the membrane 1104 can be configured in a circular shape so that in vivo Acoustic signals (e.g., mechanical waves) emitted by an anatomical structure, such as a portion of the heart or lungs, which are received at the membrane, can be detected by the relationship between the bending stiffness (D) of the membrane 1104 and the pressure difference (q) according to equation (1): (1) where ω = ω(r) is used where the membrane is constructed as a circular plate (i.e., a cylinder with coordinates: radius r , angle θ and height z ), such that: (2) and where D is the total thickness of the membrane material ( H ),Right now H = 2 h , elastic modulus ( E ) and Poisson's ratio ( v ) function.

[0189] (3)

[0190] In addition, if Figure 11A , 1106, indicating an external medium outside the housing 1102, such as a gas, liquid, or solid, including tissue within the host, which is capable of transmitting pressure changes. The external medium 1106 is in direct contact with the outer surface of the airtight housing, and in particular with the outer surface of the membrane 1104. In addition, as shown in FIG. Figure 11A1108 indicates the interior medium of housing 1102, such as for example IMD 1100A. in vivo The example embodiment of acoustic sensor 100Y includes a gas, liquid, gel, or other medium within a sealed housing, wherein internal medium 1108 is capable of transmitting pressure changes, such as acoustic signals. Internal medium 1108 is in direct contact with the inner surface of the sealed housing, and in particular, with the inner surface of membrane 1104, from housing 1102 and membrane 1104.

[0191] FIG. 11B shows a cross-sectional view showing that the Figure 11B 1107B of the example IMD 1100A in vivo An enlarged view of portion 1107 of an example embodiment of an acoustic sensor 100Y, wherein the membrane of the acoustic sensor is in a relaxed state. Figure 11B In FIG, as shown in cross-section, a housing 1102 is present on each end of a membrane 1104 and is shown. As shown in FIG11B , an external medium 1106 is present outside the housing 1102 and in contact with the outer surface of the membrane 1104, and a separate internal medium 1108 is present inside the housing 1102 and in contact with the inner surface of the membrane 1104. Figure 1B , the membrane 1104 is shown as traveling between portions of the housing 1102 in a substantially straight line to the other side of the membrane 1104 , indicating that the membrane 1104 is in a relaxed state due to equalization or balance of pressure in the media 1106 and 1108 .

[0192] FIG. 11C shows a cross-sectional view showing Figure 11A A magnified portion of the image, similar to Figure 11B , now in Figure 11C This is identified as portion 1107E, but the membrane 1104 of the acoustic sensor is in a deflected state. Figure 11C The effect of a pressure differential between the inner surface of a hermetic enclosure and the outer surface of the hermetic enclosure is shown. Specifically, the external pressure (Po) in the external medium 1106 acting on the IMD is greater than the internal pressure (Pi) in the internal medium 108 of the IMD. Consequently, the membrane 1104 deflects into the hermetic enclosure occupied by the internal medium 1108 by an amount that can be defined by the distance between point 1112a where the membrane 1104 is in a relaxed state and point 1112b where the membrane 1104 is in a deflected state. For example, the pressure differential across a plate, such as the membrane 1104, acts as a uniform load and will deform the plate, resulting in stress distribution(s) proportional to the pressure differential.

[0193] Once the deflectable membrane of an acoustic sensor (e.g., a microphone) is used to convert the pressure difference into a deflection, as shown in FIG11C , there are a number of ways to convert the deflection into an electrical signal that can be measured based on the presence and / or extent of the deflection, optionally based on time. Exemplary ways of converting the deflection into an electrical signal are as follows: Figure 12A , 12B, 13A and 13B.

[0194] 12A and 12B illustrate an IMD 100 configured in accordance with the present technology. in vivo Some example embodiments of the acoustic sensor 100Y in vivo Figure 12A shows a cross-sectional view of an exemplary acoustic sensor (e.g., microphone) in a portion of an exemplary IMD 1250 of the present technology, including sensor 1114, which may include one or both of a strain gauge and a piezoelectric element, configured with a membrane 1104 of the exemplary acoustic sensor (e.g., microphone) in a relaxed state. Figure 12B shows a cross-sectional view of an exemplary acoustic sensor (e.g., microphone) in a portion of an exemplary IMD 1250 of the present technology, including sensor 1114, which may include one or both of a strain gauge and a piezoelectric element. Figure 12A Similarly, an exemplary acoustic sensor (e.g., microphone) is shown in part of an exemplary IMD 1250, including a sensor 1114 (which includes one or both of a strain gauge and a piezoelectric element), but with the membrane 1104 of the exemplary acoustic sensor (e.g., microphone) in a deflected state.

[0195] 12A and 12B illustrate that an exemplary embodiment of a sensor 1114 (i.e., one or more strain gauges and / or one or more piezoelectric elements) can be mounted on the membrane 1104 such that deflection of the membrane 1104 imparts strain on the strain gauge(s) 1114 and / or piezoelectric element(s) 1114. The pressure differential between the inner surface ("Pi") and the outer surface ("Po") of the sealed enclosure of the IMD 1250, where membrane 1104 deflection is identified as the amount of distance between points 1112a and 1112b in response to the pressure differential between the inner and outer surfaces of the sealed enclosure, results in a bending moment (strain) in the exemplary strain gauge(s) 1114 and / or piezoelectric element(s) 1114. Thus, the sensor 114 can be used to detect and measure the degree of deflection, and therefore the pressure differential between the interior and exterior of the membrane 1104.

[0196] In an exemplary embodiment of a sensor 1114 comprising a strain gauge for an exemplary IMD 1250, for example, the resistance of the strain gauge 1114 changes in response to the strain imparted by the deflecting membrane 1104. This resistance can be converted proportionally into an electrical signal using well-known techniques, such as a Wheatstone bridge. Alternatively, detection of static pressure changes (e.g., atmospheric pressure, blood pressure, etc.) can also be achieved using a strain gauge and known techniques. In some embodiments, the present technology utilizes a strain gauge as a component of a microphone to form an acoustic sensor, and in particular, an acoustic sensor as a component of an IMD.

[0197] In an exemplary embodiment of a sensor 1114 comprising a piezoelectric element for an exemplary IMD 1250, for example, the piezoelectric element(s) 114 are mounted on the inner surface of the membrane 1104 such that the piezoelectric element(s) generate an electrical charge in response to strain imparted by deflecting the membrane 1104. This charge can be converted into a proportional electrical signal using well-known techniques, such as a charge amplifier. In some embodiments, the present technology utilizes piezoelectric elements as components of microphones to form acoustic sensors, and in particular, acoustic sensors as components of IMDs.

[0198] 13A and 13B illustrate an IMD 100 configured in accordance with the present technology. in vivo Some example embodiments of the acoustic sensor 100Y in vivo Figure 13A shows a cross-sectional view of an exemplary acoustic sensor (e.g., membrane 1104) in a portion of an exemplary IMD 1350 illustrating the present technology, including sensor 1116, which may include one or both of a capacitive electrode sensor and / or a sensor with an electret capacitor element, wherein the membrane 1104 of the microphone is in a relaxed state. Figure 13B shows a cross-sectional view of an exemplary acoustic sensor (e.g., membrane 1104) in a portion of an exemplary IMD 1350 illustrating the present technology, including sensor 1116, which may include one or both of a capacitive electrode sensor and / or a sensor with an electret capacitor element, wherein the membrane 1104 of the microphone is in a relaxed state. Figure 13A A cross-sectional view of the microphone's membrane 1104 in an extended or deflected state illustrates an exemplary acoustic sensor (e.g., microphone 1104) within a portion of an exemplary IMD 1350, including sensor 116 (including one or both of a capacitive electrode sensor and / or a sensor having an electret capacitor element).

[0199] In Figures 13A or 13B, a capacitive electrode 1116 or electret capacitor element 1116 is mounted on membrane 1104 such that deflection of membrane 1104 changes the separation between sensor 1116 (e.g., capacitive electrode or electret capacitor element) and fixed electrode 1118. Membrane 1104 deflects by the distance between points 1112a and 1112b in response to a pressure differential between the inner surface ("Pi") and the outer surface ("Po") of the hermetic envelope. The deflection of membrane 1104 also changes the separation between sensor 1116 (e.g., capacitive electrode or electret capacitor element) and fixed electrode 1118, causing a change in charge on fixed electrode 1118. The resulting charge change on fixed electrode 1118 is detected and amplified by a charge or voltage amplifier.

[0200] In an exemplary embodiment including an electret condenser element electrode 1116 for an exemplary IMD 1350, for example, the electret condenser element (at 1116) is mounted on the inner surface of the membrane 1104. The electret condenser element 116 on the deflecting surface (e.g., the inner surface of the membrane 1104) can generate a charging signal on a nearby electrode 1118. This charging signal can be converted into a proportional electrical signal using well-known techniques, such as using a charge or voltage amplifier. In some embodiments, the present technology utilizes the electret condenser element as a component of a microphone to form an acoustic sensor, and more specifically, utilizes the acoustic sensor as a component of an IMD.

[0201] In an exemplary embodiment comprising an electrode 1116 as a capacitive element for an exemplary IMD 1350, for example, a simple capacitive electrode (at 1116) is mounted on the inner surface of membrane 1104. Applying a constant voltage bias to a conductive moving surface (e.g., the inner surface of membrane 1104) generates a charging signal at a nearby electrode 1118, which can be extracted as an electrical signal. This charging signal can be converted into a proportional electrical signal using well-known techniques, such as using a charge or voltage amplifier. In some embodiments, the present technology utilizes the capacitive electrode as a component of a microphone to form an acoustic sensor, and more specifically, utilizes the acoustic sensor as a component of an IMD.

[0202] For example, an exemplary IMD with a microphone-type displacement-mediated acoustic sensor can be suitable for at least relatively short periods of time (e.g., several months up to a year). Over time, biofilm can deposit on the diaphragm, thereby altering the diaphragm's responsiveness to acoustic waves over time. However, in some embodiments of the IMD with a microphone as a displacement-mediated acoustic sensor, the IMD may include preventative or mitigative components for such biofouling, including, but not limited to, protective and non-obstructive membranes, coatings (e.g., chemical or biological), or elution mechanisms, enabling the IMD to manage the environment surrounding its location with minimal or no biological response for both short and long periods of functionality. Such environments may include intestinal fluids, muscle regeneration, scar tissue, or capillary ingrowth (e.g., by including a microporous membrane with an anti-coagulant eluting coating for capillary ingrowth, and / or a non-porous membrane itself or carrying a drug-eluting compound). However, for some embodiments of IMDs used for long-term acoustic detection and measurement, displacement-mediated acoustic sensors that do not have sensing elements that directly contact tissue in the host can be used in IMDs of the present technology. For example, one such acoustic sensor is an accelerometer, discussed later, which can be enclosed in a housing and thus prevented from direct contact with host tissue and host fluids, reducing sensitivity to biofilm deposits.

[0203] In use in vivo In some embodiments of the displacement-mediated acoustic sensor of acoustic sensor 100Y, for example, acoustic sensor 111Y includes an accelerometer, which may be referred to herein as an acoustic accelerometer. In some embodiments, the acoustic accelerometer is capable of high-fidelity (HF) acceleration sensing. For example, when performing HF acceleration sensing, the acoustic accelerometer can be configured to measure mechanical waves within a subject and resolve accelerations as small as 100 micrograms, 10 micrograms, or 1 microgram. In some embodiments, the acoustic accelerometer senses acceleration frequencies up to at least 5000 Hz, or up to at least 4000 Hz, or up to at least 3000 Hz, or up to 2000 Hz, or up to at least 1000 Hz, or up to approximately 900 Hz, or up to approximately 800 Hz, or up to approximately 700 Hz, or up to approximately 600 Hz, or up to approximately 500 Hz.

[0204] An acoustic accelerometer can sense acceleration frequencies of interest because the accelerometer can be designed to be limited to the frequencies of interest, i.e., it can only sense within the frequency range of interest to the acoustic accelerometer. Alternatively or additionally, the accelerometer can sense at frequencies of interest to the acoustic accelerometer as well as frequencies that are not of interest to the acoustic accelerometer. In this case, however, the IMD can include firmware that limits the accelerometer to sensing at frequencies of interest and not at frequencies that are not of interest to the performance of the acoustic accelerometer. In this way, for example, the accelerometer does not consume power and other IMD resources due to sensing at frequencies unrelated to the monitored acoustic signal.

[0205] In some embodiments, the acoustic accelerometer operates at a high-frequency sampling data rate. When operating at a high-frequency sampling data rate, the accelerometer samples acceleration data at up to 20,000 samples per second, or up to 18,000 samples per second, or up to 16,000 samples per second, or up to 14,000 samples per second, or up to 12,000 samples per second, or up to 10,000 samples per second, or up to 8,000 samples per second, or up to 6,000 samples per second, or up to 4,000 samples per second, or up to 2,000 samples per second, or up to 1,800 samples per second, or up to 1,600 samples per second, or up to 1,400 samples per second, or up to 1,200 samples per second, or up to 1,000 samples per second, or up to 800 samples per second. In some embodiments, the accelerometer operates at a data sampling rate of 1,400 to 14,000 samples per second. In some embodiments, the displacement-mediated acoustic sensor is configured such that the accelerometer operates at a high frequency sampling data rate.

[0206] In some embodiments, the acoustic accelerometer of the displacement-mediated acoustic sensor operates at low noise. When operating at a low noise level, the accelerometer has an input-referred noise level, referred to as spectral noise density, of less than 500 μg / rtHz, less than 400 μg / rtHz, less than 300 μg / rtHz, less than 200 μg / rtHz, less than 100 μg / rtHz, less than 75 μg / rtHz, less than 50 μg / rtHz, less than 25 μg / rtHz, less than 10 μg / rtHz, less than 5 μg / rtHz, less than 1 μg / rtHz, less than 0.8 μg / rtHz, less than 0.5 μg / rtHz, or less than 0.1 μg / rtHz. In some embodiments, the accelerometer operates at an input-referred noise level between 200 μg / rtHz and 0.5 μg / rtHz.

[0207] In some embodiments, the acoustic accelerometer of the displacement-mediated acoustic sensor operates with high precision. When operating with high precision, the accelerometer has a precision of less than 50 micrograms, or less than 40 micrograms, or less than 30 micrograms, or less than 20 micrograms, or less than 10 micrograms, or less than 5 micrograms, or less than 1 microgram, or less than 0.5 micrograms, or less than 0.1 micrograms, or less than 0.05 micrograms, or less than 0.01 micrograms. In some embodiments, the accelerometer operates with a precision between 10 micrograms and 1 microgram.

[0208] In some embodiments, the acoustic accelerometer is a single-axis accelerometer. In some embodiments, the acoustic accelerometer is a multi-axis accelerometer. In some embodiments, the multi-axis accelerometer is a dual-axis accelerometer. In some embodiments, the multi-axis accelerometer is a tri-axis accelerometer. Multi-axis (dual or tri-axis) is preferred for multi-directional acoustic detection, making sensing efficacy less dependent on placement within the host's anatomy or at least adaptable to variations in anatomical placement.

[0209] In some embodiments, the acoustic accelerometer operates at 16 to 24 bits. In some embodiments, the acoustic accelerometer operates at 0.01 to 0.1 milligram resolution.

[0210] In some embodiments, the acoustic accelerometer is rigidly mounted to the housing 101Y of the displacement-mediated acoustic sensor. In some embodiments, the housing is rigid, e.g., it does not compress when exposed to an acoustic signal. Instead, the housing moves within the host in response to the acoustic signal, and because the acoustic accelerometer is rigidly mounted, directly or indirectly, to the interior of the housing, it experiences the same movement as the housing when exposed to the acoustic signal.

[0211] As mentioned elsewhere in this document, acoustic waves (or sound) are pressure waves that propagate through various materials including gases, fluids or solids. Sound in air produces a vibratory motion of the air molecules due to the pressure wave, so that the velocity of the air molecules is proportional to the pressure wave amplitude. If the molecular velocity is 'v', then v = p / Z, where 'p' is the sound pressure, and 'Z' is the acoustic impedance of the material through which the sound is propagating. The acoustic impedance 'Z' is different for different materials. This relationship between the acoustic pressure wave and the particle / molecule velocity is the basis for sensing the acoustic pressure as particle acceleration. For a pressure wave of frequency 'f', the molecules vibrate at that frequency with a velocity v = p / Z as described above, and the acceleration 'a' of the molecules is a = 2 pi f v = 2 pi f p / Z. Therefore, molecular acceleration is proportional to the sound intensity or pressure wave amplitude (p) and frequency (f).

[0212] When an exemplary IMD with a suitable accelerometer according to the present technology is placed in a material through which acoustic pressure waves are propagating, then under certain conditions, the accelerometer will see the same acceleration as that seen or experienced by the surrounding tissue molecules. In some embodiments, the conditions under which the accelerometer "moves with" the tissue in response to the propagating acoustic pressure waves include: (i) the IMD mass density is similar to or lighter than the surrounding material, and (ii) the accelerometer's physical size (dimensions) in the direction of propagation of the acoustic pressure waves is similar to or smaller than the wavelength of the pressure waves. Therefore, in addition to considering the accelerometer performance requirements described above (i.e., sensed frequency range, sampling rate, noise, accuracy), the physical behavior of acoustic waves propagating in a medium can also impose size and mass density limitations on exemplary displacement-mediated acoustic sensors of IMDs that include acoustic accelerometers.

[0213] Exemplary Secondary Sensor for an In-Vivo Acoustic Sensor Device

[0214] In addition to one or more acoustic sensors, the IMD 100 may optionally include one or more secondary sensors. The secondary sensors may detect and optionally measure non-acoustic signals or characteristics of the host. In some embodiments, the secondary sensors provide data that is complementary to the data obtained by the acoustic sensors. In other words, the data obtained from the secondary sensors is evaluated in conjunction with an evaluation of the data obtained from the acoustic sensors to provide deeper insights into the host's physical state and the conditions under which the acoustic data was collected. In some embodiments, the acoustic sensors and the secondary sensors operate simultaneously such that data is obtained by the acoustic sensors simultaneously, i.e., during overlapping time periods. For example, during a single 10-second period, both the acoustic sensor and the secondary sensor are obtaining data. In another example, the data sensed by the secondary sensor prompts the IMD to activate the acoustic sensor, whereupon the acoustic sensor obtains measurements, optionally while the secondary sensor continues to obtain data.

[0215] In some embodiments, for example, in vivo The acoustic sensor device 100Y optionally includes a sensor to measure the host's electrocardiogram (ECG or EKG), for example, to obtain data that can be evaluated to provide a current-based EKG of the host. An exemplary ECG sensor that allows the creation of an EKG can look at the electrical conductivity of the heart. For example, in vivo The acoustic sensor device 100Y may include In the body Two electrodes on either end of the acoustic sensor device 100Y, where the ends of the two electrodes are separated by a space, generate a potential that produces spikes when the heart beats, where these spikes produce an EKG.

[0216] Considering the host's cardiac performance, the heart rate is cyclical, the rate of the heart beats is cyclical. These cycles can be tracked to the points where the heart valves open and close. If the HCP is interested in understanding the host's valve health, observing the cardiac function associated with the EKG can be very useful. The EKG can be used to identify threshold events at which the acoustic sensor begins acoustic monitoring, i.e., collecting data. The EKG can, for example, identify when the mitral valve is functioning, which can be a threshold event. The EKG also identifies the periodicity of the heartbeats, allowing the IMD to estimate the periodicity of mitral valve function with a high degree of accuracy. Using this information, in vivo The acoustic sensor device 100Y can respond by collecting data only during the opening and closing of the mitral valve (which can be approximately 100 to 200 milliseconds). If the host's heart beats at, for example, 60 beats per minute, the IMD can be configured to activate the acoustic sensor only during the heartbeat periods when the mitral valve opens and closes, and not collect data during other times that may not be of primary interest. In this way, the IMD power is conservative and only the data of primary interest (reflecting mitral valve function, such as mitral valve prolapse) is collected. Alternatively, in vivo Acoustic sensor device 100Y can continuously collect data at a sampling rate of 5,000 Hz for a longer period of time, such as 10 seconds, and from this large amount of data, acoustic signals from the function of the mitral valve can be extracted. This latter method uses more power and requires more information to be stored in memory.

[0217] In some embodiments, in vivo The EKG of the acoustic sensor device 100Y is used to identify the trigger From the body The acoustic sensor device 100Y collects threshold events of acoustic data. By combining EKG information with acoustic information, even higher fidelity data can be obtained. The present technology allows for correlating acoustic features at time points during an EKG, in other words, assessing cardiac performance at a specific time point or a specific family of time points with both EKG and acoustic features. In some embodiments, when in vivo When the acoustic sensor device 100Y includes both an acoustic sensor and an EKG monitor, the acoustic data is synchronized with the EKG data.

[0218] In some embodiments, for example, in vivoThe acoustic sensor device 100Y optionally includes a motion sensor. As used herein, a motion sensor is capable of detecting and / or measuring the movement and orientation of the host relative to the Earth's gravity. As used herein, a motion sensor is capable of detecting and / or measuring the position and / or movement of the host relative to the Earth. For example, the motion sensor can detect whether the host is standing or lying down, walking or jogging or running, climbing stairs, swimming or riding a bicycle, etc., and optionally make measurements describing the movement, such as how fast the host is running, or whether the host is going up or down stairs. Accelerometers such as three-axis accelerometers, inclinometers, and inertial measurement units (IMUs) are each exemplary motion sensors for this purpose.

[0219] The motion sensor can be used to confirm or ensure that acoustic data is collected during certain activities or activity levels. For example, the motion sensor can obtain measurements consistent with the host walking, thereby activating the acoustic sensor of the IMD to obtain acoustic data. For example, when the motion sensor detects that the host is walking or jogging or running, such as occurs during a stress test when the host moves on the pedals, the acoustic sensor can begin taking measurements. For example, the acoustic sensor can listen for sounds from a beating heart, which would provide information about heart function during walking or jogging or running. In this way, acoustic data can be associated with host position or host movement data. In some embodiments, when in vivo When the acoustic sensor device 100Y includes both an acoustic sensor and a motion sensor, the acoustic data is synchronized with the position and / or movement data.

[0220] Thus, motion sensors can be used to confirm or ensure that acoustic data is collected during certain activities or activity levels. For this purpose, accelerometers, inclinometers, inertial measurement units (IMUs), or preferably three-axis accelerometers are examples of motion sensors. To assess the position and / or movement of the patient, typically, the accelerometers of the IMU can be configured as low-fidelity accelerometers, rather than high-fidelity accelerometers, which can be used to detect and measure internal ( in vivo ) acoustic signals, for example, an acoustic accelerometer as described herein.

[0221] Other examples of secondary sensors include fluid pressure sensors, fluid volume sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, chemical sensors (e.g., for blood and / or other fluids), metabolic sensors (e.g., for blood and / or other fluids), pH sensors, and analyte sensors.

[0222] Electronic unit 120Y

[0223] in vivoExemplary embodiments of the acoustic sensor device 100Y may include electronic components in addition to the acoustic sensor, such as an acoustic accelerometer and / or electronic components associated with a membrane forming a microphone, and one or more secondary sensors (one or more secondary sensors). The following are some exemplary electronic components of the electronic unit 120Y, wherein body Inside For some embodiments of the acoustic sensor device 100Y, the exemplary electronic components may be optional.

[0224] In some embodiments, the electronics unit 120Y can have a power supply configured to, for example, generate a regulated supply signal in the approximate range of 1-24 volts (V) to power the power-consuming components of the IMD. The power supply can include one or more of a battery, a main cell, or a main cell (electrical cell) designed to be used once and discarded without electrical recharging; a rechargeable power device (e.g., a rechargeable battery or supercapacitor) that can, for example, be inductively rechargeable; or an energy harvester.

[0225] The power source can be any suitable battery, such as a lithium carbon fluoride (LiCFx) battery, or other storage unit configured to store energy to power components of the electronic assembly for the expected lifespan of the IMD (e.g., 2 to 25+ years). Alternatively, the power source can be a rechargeable power device, such as a lithium-ion battery or supercapacitor. In this case, the power source includes additional components for charging the power source via an external recharging unit. These additional components can include a power coil configured to generate a voltage and current in response to a near magnetic field generated by the external recharging unit.

[0226] As another option, the power source may include an energy harvester. The energy harvester is configured to convert environmental stimuli into energy for charging a rechargeable power device. For example, the harvester may convert one or more of body heat from the subject implanted with the IMD, kinetic energy generated by the subject's movement, pressure changes (e.g., air pressure or pressure within the subject, such as the subject's blood pressure), energy generated by electrochemical reactions within the subject, energy generated by radio frequency (RF) fields, and light into a battery charging current or voltage or a supercapacitor charging current.

[0227] In some embodiments, electronics unit 120Y includes a processor, such as a microcontroller. An example microcontroller can be any suitable microcontroller or microprocessor and is configured to control the configuration and operation of one or more other components. For example, the microcontroller can be configured to control one or more sensors of an implanted IMD to sense relevant measurement data and store the measurement data generated by the one or more sensors in a memory. The microcontroller can also be configured to generate messages for communication via one or more types of communication interfaces. For example, in the case of RF telemetry communication, the microcontroller generates messages that include stored data as a payload, groups the messages into packets, and provides the message packets to an RF transceiver for transmission to a base station. The microcontroller can also be configured to execute commands received from the base station via a communication interface, such as an antenna, filter, and RF transceiver. For example, the microcontroller can be configured to receive configuration data from the base station and provide the configuration data to the components of the sensor assembly to which the base station directs the configuration data. If the base station directs the configuration data to the microcontroller, the microcontroller circuit is configured to configure itself in response to the configuration data.

[0228] In some embodiments, electronics unit 120Y includes memory. Exemplary memory may include volatile memory and non-volatile memory. For example, the volatile memory may be configured to store an operating system and one or more application programs executed by the microcontroller. The non-volatile memory may be configured to store IMD configuration information and data written by the microcontroller, and provide data in response to a read command from the microcontroller.

[0229] In some embodiments, electronics unit 120Y may include an antenna with associated telemetry circuitry, which may also be referred to as a communication interface. These components are configured to enable the implanted IMD to transmit and receive wireless data between the implanted device and an external device. The antenna and telemetry circuitry may operate using a medical implant communication service (e.g., 400–405 MHz) or using Bluetooth (e.g., 2400–2500 MHz). In some embodiments, the antenna is a housed antenna, in other words, the antenna is completely housed within the implanted device. in vivo Inside the housing 101Y of the acoustic sensor device 100Y.

[0230] In some embodiments, the electronics unit 120Y may include a communication interface that facilitates in vivo Acoustic sensor device 100Y and another device or IMD 100 in vivoCommunication between fluid flow sensor devices 100X. For example, the other device may be an external device, such as a base station, located externally or remotely from a patient receiving an IMD, or may be an internal device located within a patient receiving an IMD. Exemplary modes of intra-body communication include: (i) RF telemetry communication, (ii) tissue conductive communication, such as galvanic coupling communication, and / or (iii) intra-body data communication, such as ultrasonic or acoustic communication.

[0231] The communication interface includes communication circuitry that is generally, but not necessarily, similar to in vivo The communication circuitry may include any hardware, firmware, software, or any combination thereof suitable for enabling one or more intra-body communication modes. To this end, the communication circuitry may include, for example, voltage regulators, current generators, oscillators, or circuits for generating signals, resistors, capacitors, inductors, and other filtering circuits for processing received signals, as well as circuits for modulating and / or demodulating signals according to a communication protocol.

[0232] Depending on the communication mode, the communication circuitry may also include transistors or other switching circuitry for selectively coupling transmitted signals to or receiving signals from a desired transceiver, such as an antenna (which may be used for electromagnetic communication, such as RF telemetry communication), an electrode (which may be used for tissue conduction communication), or an acoustic transducer (which may be used for acoustic data transmission). Under control of the microcontroller, the communication circuitry may receive downlink communication signals from an external device or another implanted device, and transmit uplink communication signals to an external device or another implanted device. Furthermore, the communication circuitry may communicate with a networked computing device via an external device and a computer network, such as the CareLink® network. Additional details regarding each of the intra-acoustic communication modes for RF telemetry communication, tissue conduction communication, and intracorporeal communication follow.

[0233] The RF telemetry mode of intra-body communication is implemented by an RF communication interface, which includes an antenna and RF telemetry circuitry, such as an RF transceiver and filters. The RF transceiver can be a conventional transceiver configured to allow the microcontroller (and optionally fuses) to communicate with another implanted medical device or with a base station configured for use with an implanted IMD. For example, the RF transceiver can be any suitable type of transceiver (e.g., Bluetooth, Bluetooth Low Energy, and WiFi®), can be configured to operate according to any suitable protocol (e.g., MICS, ISM, Bluetooth, Bluetooth Low Energy, and WiFi®), and can be configured to operate in a frequency band within the range of 1 MHz to 5.4 GHz, or within a suitable range. The filter can be any suitable bandpass filter, such as a surface acoustic wave (SAW) filter or a bulk acoustic wave (BAW) filter. The antenna can be any antenna suitable for the frequency bands in which the RF transceiver generates signals for transmission via the antenna and the frequency bands in which the base station generates signals for reception by the antenna.

[0234] A tissue conduction communication (TCC) mode of intracorporeal communication may include a TCC interface comprising a TCC circuit and a pair of electrodes. The TCC interface allows a microcontroller to communicate with another device having the same TCC interface as an implanted IMD. The other device may be an implanted medical device or a base station configured for use with an implanted IMD. TCC may be configured to rely on the ionic content of the body tissue of a patient in whom the IMD has been implanted, and is therefore often referred to as galvanic communication. The ionic content of the body tissue provides an electrical communication medium through which information is transmitted to and received from the implanted IMD. To communicate in transmit mode, the TCC circuit applies a voltage to the electrodes to cause a current to flow between the electrodes, and a corresponding electrical signal propagates through the host's body tissue. The propagated current can be detected by a receiving device by measuring the voltage generated between the two electrodes. To communicate in receive mode, the TCC circuit measures the voltage across the electrodes.

[0235] A data-in-acoustic mode of intra-vehicle communication may include a data-in-acoustic communication interface comprising data-in-acoustic circuitry and at least one acoustic transducer. The acoustic data interface allows an exemplary processor (e.g., a microcontroller) to communicate with another device having the same acoustic data interface as an implanted IMD. The other device may be another implanted medical device or a base station configured for use with exemplary embodiments of IMD 100.

[0236] In some embodiments, for example, the electronic components of the electronics unit 120Y may include a fuse. The fuse may be any suitable fuse (e.g., permanent) or circuit breaker (e.g., resettable) configured to prevent the power supply or current flowing from the power supply from injuring a patient and / or damaging in vivo One or more electronic components of the acoustic sensor device 100Y. For example, a fuse may be configured to prevent the power supply from generating enough heat to burn the patient, damage the electronic components, or damage the in vivo Structural components of the acoustic sensor device 100Y.

[0237] In some embodiments, for example, the electronic components of the electronics unit 120Y may include a clock associated with a power management unit. The clock and power management unit may be configured to generate clock signals for one or more of the other components of the electronics assembly and may be configured to generate periodic commands or other signals (e.g., interrupt requests) in response to an example processor (e.g., a microcontroller) causing one or more components of the electronics assembly to enter or exit a sleep or other low-power mode. The clock and power management unit may also be configured to regulate voltage from a power supply and provide the regulated power supply voltage to some or all of the other components of the in-vivo acoustic sensor device 100Y. For example, in some embodiments, the electronic components of the electronics unit 120Y may include a real-time clock (RTC).

[0238] In some embodiments, for example, IMD 100 in vivo Fluid flow device 100X and / or in vivo Acoustic sensor device 100Y includes a hermetic seal. The hermetic seal provides a barrier between one or more electronic components of an IMD, such as one or more sensors or memory, and the tissue surrounding the implanted IMD. The hermetic seal protects the internal electronics from degradation due to bodily fluids, and the host from any harmful effects that might result if the IMD's electronics came into contact with the host's tissue or fluids.

[0239] accommodate in vivo The housing 101Y of the acoustic sensor device 100Y has a mass density. In some embodiments, in vivo The mass density of the acoustic sensor device 100Y is in vivo The mass density of the tissue in which the acoustic sensor device 100Y has been implanted is comparable. In an embodiment, in vivo The mass density of the acoustic sensor device 100Y is in vivo The acoustic sensor device 100Y is within 1%, or within 2%, or within 3%, or within 4%, or within 5%, or within 6%, or within 7%, or within 8%, or within 9%, or within 10% of the mass density of the tissue. In some embodiments, in vivoThe mass density of the acoustic sensor device 100Y is less than the mass density of the surrounding tissue, that is, ,in vivo The mass density of the tissue in which the acoustic sensor device 100Y has been implanted. In an embodiment, The body Inside The mass density of the acoustic sensor device 100Y is 99% to <100% of the mass density of the surrounding tissue, or 98% to <100% of the mass density of the surrounding tissue, or 97% to <100% of the mass density of the surrounding tissue, or 96% to <100% of the mass density of the surrounding tissue, or 95% to <100% of the mass density of the surrounding tissue, or 94% to <100% of the mass density of the surrounding tissue, or 93% to <100% of the mass density of the surrounding tissue, or 92% to <100% of the mass density of the surrounding tissue, or 91% to <100% of the mass density of the surrounding tissue, or 90% to <100% of the mass density of the surrounding tissue.

[0240] Many living tissues have a density of 1 g / cc or 1000 kg / m 3 In an embodiment, the container according to the present technology has a mass density similar to that of water. in vivo The housing 101Y of the acoustic sensor device 100Y has a pressure of less than 1000 kg / m 3 , or less than 950kg / m 3 , or less than 900 kg / m 3 , or less than 850 kg / m 3 , or less than 800 kg / m 3 , or less than 750 kg / m 3 or having a mass density between any of these listed values, for example, between 1000 kg / m 3 and 950 kg / m 3 between.

[0241] In some embodiments, in vivo The acoustic sensor 111Y of the acoustic sensor device 100Y is located within a housing 101Y that provides and maintains the acoustic sensor 111Y and the acoustic sensor 111Y. Implanted in the body The housing 101Y may be formed of a biocompatible material, which term includes one or more biocompatible materials. The biocompatible material will not cause any damage to the host or the material in physical contact with the material. in vivo Any degradation products formed when in contact with the host cause harm. For example, the material itself or in vivoNone of the biodegradation products, if any, exhibit deleterious cytotoxic, genotoxic, mutagenic, carcinogenic, or immunogenic properties to the host. Exemplary biocompatible materials are biocompatible metals and metal alloys, such as titanium. Exemplary biocompatible materials are biocompatible polymers, such as plastics, such as polyetheretherketone (PEEK). The housing can be formed from a mixture of biocompatible materials; for example, both metal and plastic can be used to form housing 101Y.

[0242] In some embodiments, in vivo The acoustic sensor device 100Y includes a first housing structure containing a sensor, such as the acoustic sensor 111Y, and little else, which may be referred to herein as a tethering component, and a second housing structure containing in vivo Other components of the acoustic sensor device 100Y. Because the housing of the tethered component encloses very few components, e.g., only one or more sensors, such as acoustic sensor 111Y, the tethered component can be manufactured to have a particularly low mass density. As mentioned elsewhere herein, it can be advantageous to contain the acoustic sensor, in particular, within a housing that has a lower mass density than the surrounding tissue. By attaching only one or more sensors to the housing, the resulting tethered component can be manufactured to have a particularly low mass density. In some embodiments, the tethered component is physically connected to in vivo The base component of the acoustic sensor device 100Y, such as the second housing structure. In such an embodiment, for example, in vivo The base components of the acoustic sensor device 100Y contain most of the electronic components of the electronic unit 120Y, such as the antenna, telemetry circuitry, memory configured to store sensor data, power supply, secondary sensor(s), etc. body Inside In some embodiments, the base component has a mass density greater than that of the tether component.

[0243] In some embodiments, sensor(s) having performance that is not affected by the mass density of the component in which they are located may be located in vivo The performance of the motion sensor is not affected by the mass density of the component to which the motion sensor is physically attached. Therefore, the motion sensor can be placed in vivo Among the basic components of the acoustic sensor device 100Y.

[0244] The base component may be physically connected to the tether component by a lead extending between the base component and the tether component. The tether component may be said to be tethered to the base component via the lead. The lead may allow sensor data obtained by the sensor(s) located in the tether component to be transmitted to the base component. in vivo The base component of acoustic sensor device 100Y can transmit power, for example, to a memory located in the base component. Furthermore, the lead wire can allow power held in the base component to be transferred to the tether component and used to activate and / or power the tether component's sensor(s). In some embodiments, the lead wire is flexible. In some embodiments, the lead wire is biocompatible. By analogy, the tether component secured to the flexible lead wire is analogous to a fishing rod, with the base component being analogous to the rod and reel of a fly (analogous to the tether component) secured by a fishing line (analogous to the lead wire).

[0245] In some embodiments, in vivo The acoustic sensor device 100Y includes a base member and a tether member with leads extending therebetween. In some embodiments, in vivo The acoustic sensor device 100Y includes a base component and two tether components. In some embodiments, in vivo The acoustic sensor device 100Y includes a base member, two tether members, and two leads, wherein the leads extend between the base member and each of the two tether members. in vivo The acoustic sensor device 100Y includes a single base component and multiple tether components. In some embodiments, in vivo The acoustic sensor device 100Y includes a single base member, multiple tethered members, and one or more leads that allow data from the tethered members to be transferred to the base member. In some embodiments, in vivo The acoustic sensor device 100Y comprises a single base member, a plurality of tethered members, wherein at least one of the plurality of tethered members is directly physically associated with an accelerometer used as an acoustic sensor, and one or more leads that allow data from the tethered member to be transmitted to the base member. In effect, the tethered member(s) connect the entire in vivo The mass of the acoustic sensor device 100Y is decoupled so that, for example ,in vivo The acoustic sensor of the acoustic sensor device 100Y may be physically associated with a relatively small mass (present as a tethered component).

[0246] In some embodiments, in vivo The acoustic sensor device 100Y includes a tethered component including an accelerometer configured to function as an acoustic sensor, wherein the accelerometer is completely enclosed by a housing. in vivoAcoustic sensor device 100Y includes a base component and leads extending between the base component and a tether component. For example, the base component may include a housing that encloses one or more electrical components selected from a power supply, an antenna, telemetry circuitry, and a memory for storing sensor data. Optionally, the base component may also include a secondary sensor as disclosed herein, for example, one secondary sensor, two secondary sensors, or three or more secondary sensors. For example, in some embodiments, the base component may include a motion sensor. As another example, in some embodiments, the base component may include an ECG sensor. As yet another example, in some embodiments, the base component may include an ultrasonic sensor assembly comprising one or more ultrasonic transducer elements. In yet another example, in some embodiments, the base component may include one or more secondary sensors, including one or more of a temperature sensor, an analyte sensor, or a pressure sensor.

[0247] Figure 14A A top view is shown showing the IMD 1450. in vivo The implantable structure of an example embodiment of acoustic sensor device 100Y is shown, and the locations of the internal components, particularly battery 1121, electronics package 1122, and antenna 1124, are indicated therein. In IMD 1450, there are no tethered components. Each element of IMD 1450 is contained within a single housing. Figure 14A In the figures, the single housing is indicated as having dimensions of 28 mm (length) by 8 mm (width), where these dimensions are merely exemplary. In some embodiments, for example, the length of IMD 1450 can be from about 25 mm to about 35 mm, such as about 25 mm, or about 26 mm, or about 27 mm, or about 28 mm, or about 29 mm, or about 30 mm. In some embodiments, the width of IMD 1450 can be from about 6 mm to about 10 mm, such as about 6 mm, or about 7 mm, or about 8 mm, or about 9 mm, or about 10 mm. It is worth noting that the housing can be made of more than one material. For example, the housing enclosing antenna 1124 can be formed from a radio-transmitting material such as PEEK to form a radome for the antenna, while the housing surrounding battery 1121 and electronics package 1122 can be formed from a metal or plastic including PEEK.

[0248] Figure 14B Shown Figure 14A14. A side view of an exemplary IMD 1450 is shown. The side view of IMD 1450 indicates an exemplary dimension of 20 mm for the combined length of battery 1121 and electronics package 1122, and an exemplary height of 4 mm for IMD 1450. In some embodiments, for example, the height of IMD 1450 can be from about 3 mm to about 5 mm, e.g., about 3 mm, or about 4 mm, or about 5 mm.

[0249] Figure 15A A top view is shown showing the IMD 1550. in vivo The implantable structure of the example embodiment of the acoustic sensor device 100Y and indicates the location of the internal components, particularly the battery 1121, the electronic package 1122 with the membrane 1126 and the antenna 1124. For various embodiments, such as Figure 14A The features discussed in this paper can be applied to Figure 15A IMD1550.

[0250] Figure 15B Shown Figure 15A 1550. For various embodiments, such as Figure 14B The features discussed in this paper can be applied to Figure 15B IMD 1550.

[0251] Figure 16A A top view is shown showing the IMD 1650. in vivo The implantable structure of an example embodiment of the acoustic sensor device 100Y and indicates the location of the internal components, particularly the battery 1121, the electronics package 1122 and the antenna 1124, wherein the accelerometer is contained within a tethered component 1626 connected to the main component by leads 1128. For various embodiments, such as Figure 14A The features discussed in this paper can be applied to Figure 16A IMD 1650.

[0252] Figure 16B Shown Figure 16A 1650, but omits the tether component 1626 and associated leads 1128 from the figure. For various embodiments, such as Figure 14B The features discussed in this paper can be applied to Figure 16B IMD1650.

[0253] Figure 17 A block diagram depicting an exemplary IMD is shown, comprising in vivo An exemplary embodiment of acoustic sensor device 100Y, labeled IMD 1700, including an indication of its optional internal components. Figure 17In the IMD 1700 of FIG. 1 , an exemplary acoustic sensor is an accelerometer denoted as a high-fidelity (HF) accelerometer. Optional components of the IMD 1700 are also provided in FIG. Figure 17 , and may include a primary airtight housing, a low fidelity (LF) accelerometer that acts as a secondary sensor and more specifically a motion sensor. Figure 17 Optional components of the illustrated IMD 1700 may include a memory for storing sensor-derived data, a microcontroller, an RF wireless transceiver as part of a telemetry assembly, a battery as an exemplary power source, power management circuitry, and a real-time clock. In some embodiments, for example, the IMD 1700 may include an RF antenna connected to the main hermetic housing via a hermetic feedthrough. The RF antenna may be enclosed within the hermetic housing, or it may be enclosed within a non-hermetic antenna header, such as Figure 17 Example IMD 1700 may include other components that have been discussed in connection with other embodiments of IMDs disclosed herein.

[0254] In some embodiments of the IMD 1700, for example, when all components of the IMD 1700 are contained within a single housing, which can be a composite housing (e.g., metal surrounding and protecting the electronic components and a polymer surrounding and protecting the antenna), the IMD 1700 can be referred to as having a canister design.

[0255] Figure 18 A block diagram depicting an exemplary IMD is shown, the exemplary IMD including a In vivo acoustic sensing In an example embodiment of the device 100Y, the body The acoustic sensor device has a tethered component and includes an indication of its internal components. Figure 18 In the IMD 1800 of FIG. 1 , an exemplary acoustic sensor is an accelerometer, denoted as a high-fidelity (HF) accelerometer (also known as a vibration sensor, e.g., capable of measuring forces of ±1 g and / or ±10 g), capable of measuring and resolving accelerations as small as 100 μg, 10 μg, or 1 μg, which is located in a tethered component of the IMD 1800 and contained within a secondary sealed enclosure along with power / I / O circuitry. The tethered component is coupled to the primary component by a hermetic feedthrough, which is an exemplary lead and may be biocompatible. In the primary component, optional components of the IMD 1800 are Figure 18 , and may include a primary airtight housing, power / I / O, a low-fidelity (LF) accelerometer that acts as a secondary sensor and more specifically a motion sensor. Figure 18Optional components of the illustrated IMD 1800 may include a memory for storing sensor-derived data, a microcontroller, an RF wireless transceiver as part of a telemetry assembly, a battery as an exemplary power source, power management circuitry, and a real-time clock. In some embodiments, for example, IMD 1800 may include an RF antenna connected to the main hermetic housing via a hermetic feedthrough. The RF antenna may be enclosed within the hermetic housing, or it may be enclosed within a non-hermetic antenna head, such as Figure 18 Example IMD 1800 may include other components that have been discussed in connection with other embodiments of IMDs disclosed herein.

[0256] Figure 19 A block diagram depicting an exemplary IMD is shown, the exemplary IMD including a in vivo An example embodiment of an acoustic sensor device 100Y having a microphone as an acoustic sensor. Optional components of IMD 1900 are also provided in FIG. Figure 19 , and may include a primary airtight housing, a low fidelity (LF) accelerometer that acts as a secondary sensor and more specifically a motion sensor. Figure 19 Optional components of the illustrated IMD 1900 may include a memory for storing sensor-derived data, a microcontroller for processing the data, an RF wireless transceiver as part of a telemetry assembly, a battery as an exemplary power source, power management circuitry, and a real-time clock. In some embodiments, for example, the IMD 1900 may include an RF antenna connected to the main hermetic housing via a hermetic feedthrough. The RF antenna may be enclosed within the hermetic housing, or it may be enclosed within a non-hermetic antenna header, such as Figure 19 Example IMD 1900 may include other components that have been discussed in connection with other embodiments of IMDs disclosed herein.

[0257] In some embodiments, the housing of an IMD of the present technology includes a fixation aid that facilitates maintaining the IMD in a specific position within the host. For example, the housing of either or both the main component and the tethered component can include a loop that allows sutures to be used to secure the component to the host's tissue. The loop is secured, for example, by welding, to the exterior of the housing, and sutures can be passed through the loop and also through the host's tissue to secure the housing, and thus the IMD, to the host at a selected location.

[0258] In some embodiments, the present technology provides a method comprising one or more of the following: manufacturing an IMD as described herein; performing quality control on the IMD; packaging the IMD for shipment or storage; making the IMD available to a surgeon; providing instructions for use of the IMD; identifying a host having a medical condition requiring monitoring; implanting the IMD into the host; assisting a surgeon in implanting the IMD into the host; operating a robot to assist the surgeon in implanting the IMD into the host; transmitting a wireless signal to the implanted IMD and thereby activating the implanted IMD; sensing an acoustic signal generated by the host using the acoustic sensor of the implanted IMD, wherein optionally, the acoustic signal is generated by one or more of the host's heart, the host's blood flow, or the host's respiration; storing the sensed acoustic signal or a derivative thereof in a memory located within the IMD to provide stored data, wherein optionally, the stored data is stored in the memory for at least 1 hour, or at least 6 hours, or at least 12 hours, or at least 18 hours, or at least 24 hours, or at least 48 hours; transmitting stored data from the implanted IMD to a receiving device external to the host, providing the received data stored on a memory of the receiving device; analyzing the received data to generate health information regarding the physical condition of the host; providing the health information to a healthcare provider (HCP); and evaluating the health information as part of developing a healthcare plan for the host.

[0259] exist in vivo In some embodiments of the acoustic sensor device 100Y, the present technology provides a method comprising measuring internal sounds with a medical implant and using these sounds to diagnose and / or detect and / or quantify a host's physical condition, such as the host's cardiac and / or respiratory health. In some embodiments, the measurements are made within a sound spectrum starting at approximately 1 Hz, or 2 Hz, or 5 Hz, or 10 Hz, or 50 Hz, or 100 Hz, or 200 Hz, or 500 Hz. In some embodiments, the measurements are made within a sound spectrum extending up to approximately 10,000 Hz, or up to approximately 8,000 Hz, or up to approximately 6,000 Hz, or up to approximately 4,000 Hz, or up to approximately 2,000 Hz, or up to approximately 1,000 Hz. In embodiments, measurements are made over a range of the acoustic spectrum extending from 1 Hz to 2,000 Hz, or from 10 Hz to 10,000 Hz, or from 50 Hz to 2,000 Hz.

[0260] Exemplary embodiments of an IMD 100 according to the present technology can be partially or completely placed (implanted) within a host. If only partially implanted within a host, in some embodiments, the IMD can include a tethered component that is completely implanted within the host, wherein optionally, a base component of the IMD can be located on the exterior of the host, or partially located within and partially located outside the host. In some embodiments, the IMD can include both a base component and a tethered component, with the entire IMD implanted within the host.

[0261] In some example embodiments of IMD 100, in vivo Acoustic sensor device 100Y and / or in vivo The fluid flow sensor device 100X can be used to acoustically monitor and acoustically quantify a medical condition of a host. For example, the IMD 100 can monitor and quantify cardiac conditions, such as heart disease, including valve disease such as stenosis (narrowing), valvular prolapse (leakage), and myxomatous disease, for any of the tricuspid, pulmonary, pulmonary, mitral, or aortic valves. Myxomatous disease is a particular problem with the mitral valve and is currently the most common form of valvular heart disease. The pathological presentation of myxomatous mitral valve disease varies between valve thickness, degree of leaflet prolapse, and the presence or absence of leaflets. For each of the heart valves, each of these different diseases produces a unique acoustic signature that can be detected using the IMD of the present technology. Other cardiac conditions that can be acoustically detected and assessed using the IMD 100 include congestive heart failure, atrial fibrillation, coronary artery disease, and other adverse heart-related medical conditions.

[0262] The IMD 100 may also or instead monitor and quantify respiratory conditions such as lung disease, chronic obstructive pulmonary disease (COPD, a condition involving airway constriction and difficulty or discomfort breathing), emphysema, pulmonary emphysema (PE), and asthma.

[0263] IMD 100 is intended to be implanted in a host. For example, it can be implanted in the host's backbone, into the host's abdominal cavity, into the host's dorsal cavity, into the host's thoracic cavity, into the host's upper abdominal cavity, into the host's lower abdominal cavity, into the host's upper dorsal cavity, into the host's lower dorsal cavity, into the host's thoracic cavity, into the host's pericardial cavity, into the host's abdominopelvic cavity, into the host's abdominal cavity; into the host's pelvis, into the host's spinal cavity, or into the host's lower trunk adipose tissue. IMD 100 can be implanted in and secured to the host's heart. For example, it can be secured through the heart's septum between the two ventricles, or it can be in or secured to the left atrial appendage, i.e., within the left atrium. After implantation, it can be operated to collect daily information reflecting the host's health status. For example, when implanted in the host's lower trunk adipose tissue, it can collect daily cardiovascular and / or respiratory acoustic characteristics of the host.

[0264] The present technology also provides a method in which an implanted IMD as described herein is removed from a host. The IMD can be removed for any of a variety of reasons, such as when the host no longer requires the IMD to monitor a medical condition, to make way for a different implanted device, to recharge a battery, etc. The method includes selecting a host having an implanted IMD as described herein, performing a surgical procedure on the host to provide access to the implanted IMD, and then removing the implanted IMD from the host through the surgically created access.

[0265] In some embodiments, in vivo The acoustic sensor device 100Y includes both an acoustic sensor and a motion sensor, and in vivo The acoustic sensor device 100Y is configured so that acoustic information is obtained when the motion sensor detects a threshold event. For example, if the motion sensor detects that the host has begun walking, where walking is a threshold event, the IMD is configured to activate the acoustic sensor to begin taking measurements. In some embodiments, after the motion sensor detects a threshold movement, in vivo The acoustic sensor device 100Y waits to acquire acoustic data. In some embodiments, the acquisition of acoustic data lasts for 5 to 30 seconds. The threshold motion may be walking. The threshold movement may be a stationary state. Thus, when in vivo When the acoustic sensor device 100Y detects some movement or non-movement of the host ,in vivo Acoustic sensor device 100Y operates to acquire acoustic data under controlled conditions, then begins collecting acoustic data that has been influenced by a specific threshold activity performed by the subject. For example, when the subject moves, this puts stress on the subject's body, and the cardiovascular system must respond by increasing output. Under these conditions, the sounds generated by the cardiovascular system can reflect health issues that would otherwise not be apparent from the acoustic signals acquired when the subject is at rest. This is the reason for stress testing, in which the subject is asked to run on a treadmill while the HCP listens to the subject's heart.

[0266] Information collected from an example embodiment of the IMD 100 implanted in a host can be used to inform clinical decisions. For example, the information can characterize the effectiveness of ongoing treatment, potentially prompting the HCP to consider and implement alternative treatments. The information can characterize disease progression, which, upon consideration by the HCP, can prompt the HCP to change, such as escalate, the treatment regimen. In addition to providing valuable information to the HCP, information from the implanted IMD can also reduce the need for emergency medical visits by the host due to early detection of congestive heart failure and potential non-compliance with medications. In effect, the example embodiment of the IMD 100 provides the HCP with a "remote stethoscope" for routine remote monitoring of a patient's medical condition, such as the health of the patient's cardiovascular system.

[0267] Stress-mediated in vivo acoustic sensor device

[0268] exist in vivo In some embodiments of the acoustic sensor device 100Y, for example, the acoustic sensor 111Y comprises a stress-mediated acoustic sensor. Exemplary stress-mediated acoustic sensors according to the present technology are configured to measure stress—rather than displacement—to provide an indication of acoustic energy (mechanical waves) emanating from the body. in vivo Sensing, for example, from anatomical structures of the cardiovascular and / or pulmonary systems, such as the heart and lungs. The disclosed stress-mediated acoustic sensor is operable to detect mechanical forces by measuring the mechanical forces applied to an electromechanical transducer component of the sensor to convert the received mechanical energy (acoustic signal) into electrical energy (electrical signal). in vivo Acoustic signals that are addressable and processable to decipher physiological phenomena associated with the detected acoustic signals and determine clinically relevant information about the patient's health and / or disease. In some embodiments of the stress-mediated acoustic sensor, the transducer component includes a piezoelectric material and a conductive non-piezoelectric material(s) constructed in the piezoelectric sensing cell.

[0269] Figure 20A and 20B A diagram depicting an exemplary IMD of the present technology, labeled 2000 , with a stress-mediated acoustic sensor is shown. Figure 20A shows multiple views of the exterior of IMD 2000 depicting an exemplary body structure; and Figure 20B An exploded view of IMD 2000 depicting an exemplary configuration of components of IMD 2000 is shown.

[0270] Figure 20A illustrates a perspective view of an exemplary body of an IMD 2000 showing a housing 2001 hermetically sealed within a sensor unit of the IMD 2000, the sensor unit including a stress-mediated acoustic sensor 2011 (shown in phantom) and an electronics unit 2020 (shown in phantom) in communication with the stress-mediated acoustic sensor 2011. Figure 20A The perspective view also shows an example embodiment of a wireless communication unit 2027, e.g., embodied as a wired antenna, disposed in a distal chamber 2001C of the housing 2001, e.g., to facilitate wireless communication transmission(s) and / or reception(s) between the IMD 2000 and an external device (e.g., the external remote device 130).

[0271] FIG20A is a top view, a bottom view, and a side view of an exemplary body of an IMD 2000 illustrating one example of the shape, size, and dimensions of an exemplary embodiment of a housing 2001 of the IMD 2000. It should be understood that the IMD 2000 can be configured to have a range of sizes and shapes to accommodate the stress-mediated acoustic sensor 2011 and the electronics unit 2020 contained therein, which exceed the exemplary IMD 2000. Figure 20A The specific sizes, dimensions and shapes shown in Figure 20A In the non-limiting example shown, the end-to-end length of housing 2001 is configured to be 51.6 mm, the end-to-end width of housing 2001 is configured to be 14.72 mm, and the end-to-end height of housing 2001 is configured to be 6.78 mm. Other non-limiting example shapes for various portions of IMD 2000 and housing 2001 are contemplated, including rectangular, square, triangular, oval, circular, cylindrical, conical, or other shapes, or combinations thereof, or other shapes.

[0272] FIG20B illustrates an exploded view of an example embodiment of an IMD 2000, featuring components of a stress-mediated acoustic sensor 2011 and an electronics unit 2020 sealed within a housing 2001, including a first chamber enclosed by a housing top 2001T and a housing bottom 2001B, and an adjacent second chamber (i.e., distal chamber 2001C) enclosed by a housing end 2001E. In some embodiments of the IMD 2000, for example, the stress-mediated acoustic sensor 2011 includes a transducer assembly 2012 coupled to a housing structure 2013 configured to secure the transducer assembly 2012. For example, in some embodiments of the stress-mediated acoustic sensor 2011, the transducer assembly 2012 includes a piezoelectric material and at least one electrically conductive non-piezoelectric material coupled to the piezoelectric material to receive a transduced electrical signal generated when stress is applied to the stress-mediated acoustic sensor 2011, which is received by the piezoelectric material. In some embodiments, for example, at least one electrically conductive non-piezoelectric material is positioned on the inwardly facing side of the piezoelectric material and coupled to the electrical interface component(s) 2025. In some embodiments, for example, the electrical interface component may be constructed in or on the housing structure 2013. In some embodiments, for example, the housing structure 2013 or a portion thereof may include at least a portion of the at least one electrically conductive non-piezoelectric material to receive and transmit the generated electrical signals. In some embodiments, for example, the transducer assembly 2012 includes a non-piezoelectric material ( Figure 20B 1B ), the non-piezoelectric material is positioned on the outwardly facing side of the piezoelectric material and disposed at the housing opening 2001O (i.e., the side of the opening through the housing bottom 2001B), hermetically sealed when assembled, wherein the non-piezoelectric material has a Young's modulus that is close to (e.g., within 2X-3X of) the Young's modulus of the piezoelectric material or substantially matches (e.g., within 20% of) the Young's modulus of the piezoelectric material.

[0273] In some embodiments of the IMD 2000, for example, the electronics unit 2020 includes a data and / or signal processing unit 2020 PCB, which may be embodied by any of the exemplary embodiments of the data processing unit 121Y and / or the optional signal conditioning unit 123Y, respectively, disclosed herein. Figure 20BIn the illustrated example, the data and / or signal processing unit 2020 PCB includes a processor coupled to a memory that receives digital signal data from a signal processing circuit, all of which is mounted on a printed circuit board (PCB). In some example embodiments, the signal processing circuit includes, for example, a differential amplifier and / or a charge amplifier to amplify the electrical signal received from the stress-mediated acoustic sensor 2011 (e.g., received from at least one electrically conductive non-piezoelectric material via the electrical interface component(s) 2025 connecting the stress-mediated acoustic sensor 2011 to the electronics unit 2020), and / or an analog-to-digital (A / D) converter to digitize the electrical signal. In some example embodiments, the signal processing circuit includes, for example, a filter circuit to remove signals outside of a frequency range(s) not of interest. The frequency range(s) not of interest may include low-pass, band-pass, and / or high-pass filters, for example, to improve the signal-to-noise ratio of the detected acoustic signal of interest. For some embodiments, the exemplary data and / or signal processing unit 2020 PCB may be programmable. In some embodiments, for example, the data and / or signal processing unit 2020 PCB can be fixed and / or positioned within the first chamber of the housing 2001 by an (optional) internal housing frame 2001F, which, for some example embodiments, can also be used to fix and / or position one or more components of the stress-mediated acoustic sensor 2011.

[0274] In some embodiments of the IMD 2000, for example, the electronics unit 2020 includes a power source 2029 that is electrically connected to the data and / or signal processing unit 2020 PCB and other components of the electronics unit 2020 (or other units of the IMD 2000, such as some embodiments of the stress-mediated acoustic sensor 2011 when it is necessary to supply power to such units) via components of the electrical interface 2025 (e.g., wires or other connectors). The power source 2029 can be embodied by any of the exemplary embodiments of the power source 129 disclosed herein. For example, the power source 2029 can include a battery (e.g., a primary battery or a rechargeable battery), a fuel cell, or other power source to power the components of the electronics unit 2020 (and optionally the stress-mediated acoustic sensor 2011). In some example embodiments, for example, the power source 2029 can be an electrical receiving port for receiving wires that can supply power to the IMD 2000 from a remote power source, such as an implantable ( in vivo ) power source (e.g., a battery associated with one or more other implanted medical devices) and / or a wearable ( in vitro ) power source (e.g., a battery worn by the user with a wire connecting the battery to another device implanted in the patient) in vivo device).

[0275] In some embodiments of the IMD 2000, for example, the electronics unit 2020 includes a wireless communication unit 2027 that is electrically connected to the data processing unit 2020 PCB and other components of the electronics unit 2020 (or other units of the IMD 2000, such as some embodiments of the stress-mediated acoustic sensor 2011, for example, for transmitting raw electrical signals transduced by the acoustic sensor) via components of the electronic interface 2025 (e.g., wires or other connectors). The wireless communication unit 2027 includes a wireless transmitter, receiver, and / or transceiver device, such as a wireless transmitter, receiver, and / or transceiver device. Figure 20B , the antenna 2027A is shown in FIG. , and the antenna is capable of communicating with an external device to communicate raw, partially processed, or fully processed data from the data and / or signal processing unit 2020PCT. For example, the wireless communication unit 2027 can be configured to manage a communication protocol for transmission or reception via the antenna. The wireless communication unit 2027 can be embodied by any exemplary embodiment of the wireless communication unit 127Y disclosed herein. Examples of the antenna 2027A can include, but are not limited to, a whip antenna, a loop antenna, a chip antenna, a planar inverted F antenna (PIFA), a dipole antenna, and / or a conformal antenna.

[0276] Single-layer piezoelectric sensor

[0277] exist in vivoIn some embodiments of acoustic sensor 100Y, such as the exemplary stress-mediated acoustic sensor, a unimorph structure for sensing stress includes a piezoelectric material coupled to a biocompatible, electrically conductive, non-piezoelectric material having a Young's modulus similar to that of the piezoelectric material, providing a piezoelectric sensing element that generates a measurable electrical signal proportional to the applied stress (force or torque) on the unimorph structure and that can be used by receiving circuitry (e.g., for signal processing and / or data processing). This stress-mediated unimorph piezoelectric acoustic sensor (also referred to herein as a "unimorph piezoelectric sensor") is advantageous due to (i) a stress sensing approach that does not require displacement of the transducing component and (ii) a material selection for the tissue-facing outer (non-piezoelectric) material component to minimize granulation tissue formation (e.g., from an immune response to an implanted IMD). Furthermore, the single-layer piezoelectric sensor can exhibit significantly lower noise and significantly higher acoustic resolution, for example, to improve sensitivity to dynamic range compared to displacement-mediated acoustic sensors, such as electret microphones or condenser microphones. In some embodiments, for example, the stress-mediated acoustic sensor includes a charge amplifier circuit to condition the electrical signal generated by the piezoelectric material in various embodiments of the stress-mediated acoustic sensor, including but not limited to the single-layer piezoelectric sensor.

[0278] In some embodiments of a single-layer piezoelectric structure, the device structure includes an active piezoelectric material (e.g., a piezoelectric film) capable of imparting or detecting stress, and a stable non-piezoelectric material (e.g., a metal substrate) disposed on one side of the active piezoelectric material. When a load is applied to the single-layer piezoelectric structure (e.g., the metal substrate), it induces a bending moment (stress) that propagates to the active piezoelectric film, thereby generating an electrical signal corresponding to the applied stress. This electrical signal can be detected as a mechanical force sensor, i.e., capable of detecting acoustic signals (mechanical waves). In some embodiments of the acoustic sensor 111Y, the piezoelectric material of an exemplary single-layer piezoelectric sensor may include, but is not limited to, PZT (e.g., PZT-5A, PZT-5H, or PZT-5K), PLZT, quartz, ZnO, AlN, ScAlN, BaTiO3, PbTiO3, KNbO3, LiNbO3, LiTaO3, and / or Na2WO4. In some embodiments of the acoustic sensor 111Y, the non-piezoelectric material of the exemplary single-layer piezoelectric sensor may include, but is not limited to, titanium (Ti), biocompatible stainless steel, cobalt chromium, nitinol, or high-purity ceramics (eg, aluminum Al 2 O 3 ).

[0279] In an example embodiment of IMD 100, for example, Figure 20A and Figure 20BIn the IMD 2000, the single-layer piezoelectric sensor can be integrated into a biocompatible, hermetically sealed housing structure, ensuring longevity and safety when implanted in a patient. The non-piezoelectric component (e.g., Ti) is positioned on (or forms) the device housing and is exposed to the external environment (tissue-facing); and the piezoelectric component (e.g., PZT material) is not exposed to the external environment of the IMD 100 but is instead contained within the hermetically sealed interior of the IMD. In such an embodiment, for example, the piezoelectric and non-piezoelectric materials are selected and engineered such that the single-layer piezoelectric sensor is sensitive enough to receive and transduce low-amplitude acoustic signals across a wide frequency range, i.e., exhibits a large dynamic range. For example, the single-layer piezoelectric sensor is capable of measuring and interpreting sound levels as low as 20 dB SPL (e.g., barely above the human hearing threshold) and as high as 110 dB SPL (e.g., nearing the human pain threshold).

[0280] Figures 21A-21C Figures are shown depicting example embodiments of single-layer piezoelectric sensor devices, respectively labeled 2111A, 2111B, and 2111C, according to the present technology. Figure 21A An example embodiment of a single-layer piezoelectric sensor device having at least one electrode electrically interfacing with a piezoelectric transducer material coupled to a biocompatible, electrically conductive, non-piezoelectric material is shown; Figure 21B An example embodiment of a single-layer piezoelectric sensor device having at least one electrode electrically interfacing with a piezoelectric transducer material coupled to a biocompatible, non-conductive, non-piezoelectric material with an intermediary electrically-conductive material layer therebetween is shown; Figure 21C An example embodiment of a single layer piezoelectric sensor device having at least two electrodes electrically interfacing with a piezoelectric transducer material is shown.

[0281] like Figure 21AAs shown, a single-layer piezoelectric sensor device 2111A includes a piezoelectric material 2112 disposed between and coupled to a first layer 2113 and a second layer 2115. The first layer 2113 comprises a biocompatible, conductive, non-piezoelectric material and has a Young's modulus that is close to (e.g., within 2X-3X of) or substantially the same as (e.g., within 20% of) the Young's modulus of the piezoelectric material 2112. In an embodiment of the single-layer piezoelectric sensor device 2111A, the first layer 2113 is configured as a sensing layer that receives mechanical waves emanating from a patient's body, such that an applied force on the first layer 2113 is transmitted through the piezoelectric material 2112 and into the piezoelectric material, which acts as a converter of mechanical energy (stress) into electrical energy. First layer 2113 is positioned within the single-layer piezoelectric sensor device 2111A to be located at the orifice of the IMD. First layer 2113 is tightly coupled to the IMD housing wall to hermetically seal the other components of the single-layer piezoelectric sensor device 2111A within the housing. Second layer 2115 comprises a non-piezoelectric conductive material. In embodiments of the single-layer piezoelectric sensor device 2111A, second layer 2115 provides at least one electrically addressable electrode to receive the electrical signal generated by the piezoelectric material 2112, and the conductive material of first layer 2113 provides the electrically addressable electrode for the piezoelectric sensing element. Furthermore, for some embodiments of the single-layer piezoelectric sensor device 2111A, because the material of first layer 2113 is biocompatible, the IMD housing (e.g., housing wall(s)) can be configured as first layer 2113, thereby allowing the piezoelectric material 2112 (and second layer 2115) to be fabricated on a region of the IMD housing structure.

[0282] In some embodiments of a single-layer piezoelectric sensor device 2111A, for example, the piezoelectric material comprises PZT (e.g., PZT-5A, PZT-5H, or PZT-5K), the first layer 2113 comprises titanium, and the second layer 2115 comprises at least one of titanium, gold, platinum, silver, copper, nickel, aluminum, palladium, or other conductive materials, including alloys thereof. In such example embodiments, where the first layer 2113 is conductive, biocompatible, and mechanically matched to the piezoelectric material 2112 (e.g., having a close Young's modulus), such as titanium having PZT-5A, the first layer 2113 can be coupled to the electronics unit 2020, and the second layer 2115 is a non-piezoelectric, conductive material, such that both sides of the piezoelectric material 2112 can be connected to amplifier circuitry to amplify the transduced electrical signal, i.e., the trapped charge generated by the piezoelectric material 2112 in response to an applied stress. The amplifier circuit may be configured as a charge amplifier (or other type of amplifier) ​​that conditions, processes, and passes the acoustic / stress signal through the IMD for higher-order electronic functions, such as data processing, data storage, wireless transmission, or others.

[0283] However, in some example embodiments of the single-layer piezoelectric sensor device of the disclosed technology, the first layer 2113 may be configured from a biocompatible but non-conductive material, wherein in such embodiments, an intermediate conductive layer is included for the single-layer piezoelectric sensor device, i.e., coupled to the piezoelectric material 2112 and the first layer 2113.

[0284] Figure 21B An example embodiment of a single-layer piezoelectric sensor device 2111B is shown, comprising a piezoelectric material 2112 disposed between (i) a first layer 2113B comprising a biocompatible, non-conductive, non-piezoelectric material and (ii) a conductive, non-piezoelectric second layer 2115, wherein the piezoelectric material 2112 is coupled to the second layer 2115 and an intermediate layer 2116 comprising a conductive, non-piezoelectric material. Figure 1B In the example shown in FIG, the first layer 2113B is positioned in the single-layer piezoelectric sensor device 2111B at the aperture of the IMD housing, wherein the first layer 2113B is tightly coupled to the IMD housing wall to hermetically seal the other components of the single-layer piezoelectric sensor device 2111A within the housing. Figure 21A The first floor of 2113, Figure 21B2113B comprises a biocompatible non-piezoelectric material having a Young's modulus that is close to (e.g., within 2X-3X thereof) or substantially the same as (e.g., within 20% thereof) the Young's modulus of the piezoelectric material 2112. In embodiments of the single-layer piezoelectric sensor device 2111B, at least one electrode of the second layer 2115 and the conductive material of the intermediate layer 2116 are electrically interfaced with the piezoelectric material 2112 and amplifier circuitry (e.g., of the electronics unit 2020) to receive the transduced electrical signal generated from the piezoelectric material 2112 for signal processing at the amplifier.

[0285] The single layer piezoelectric sensor devices 2111A and 2111B can be configured in various shapes and geometries or in their IMD configurations. Figure 21A and 21B In the example shown, the single-layer piezoelectric sensor devices 2111A and 2111B are configured with a cylindrical geometry and a circular sensor profile, as shown in the following figure, which shows the top side of the devices 2111A and 2111B contained within the housing of an IMD, wherein at least one electrically addressable electrode 2115 is centrally positioned on the piezoelectric material 2112 (e.g., the electrode 2115 has a radius b , and the piezoelectric material 2112 has a radius a ). Figure 21A and 21B The lower diagram of FIG shows stress vectors σrr and σθθ, ie, radial stress vectors and / or tangential stress vectors, radiating from the center or tangentially, respectively. The stress vectors add linearly to produce a net polarization (charge) in the piezoelectric material 2112.

[0286] Figure 21C An example embodiment of a single layer piezoelectric sensor device 2111C is shown, comprising a circular / cylindrical shape / geometry with two electrode structures of the second layer 2115: a central electrode 2115C and a ring electrode 2115A positioned around and separated from the central electrode 2115C by a gap c. c An electrical discontinuity is provided between the two electrode structures 2115C and 2115A to generate a voltage difference (potential) across the two electrodes. When a mechanical wave is incident (i.e., an applied force or torque) on the first layer 2113 (i.e., the tissue interface layer 2113 in the IMD), a compressive stress caused by the applied force or torque propagates through the piezoelectric material 2112. Due to the different potentials induced by the dipoles in the material structure at the two electrode structures, an electric field is generated, generating an addressable electrical signal across the central electrode 2115C and the ring electrode 2115A of the IMD.

[0287] The circular electrode, Figure 21CThe example single-layer piezoelectric device 2111C shown in FIG. 4 has many advantages, including (but not limited to) the ability to provide a uniform distribution of stress in the material of the single-layer piezoelectric device 2111C, such that there are no "hot spots" where fractures / cracks can nucleate and propagate; and the reliability and safety of the device 2111, particularly because the example single-layer piezoelectric device 2111C is part of a hermetic housing of an implantable device, wherein the circular / cylindrical configuration of the example single-layer piezoelectric device 2111C mitigates potential degradation issues, such as corners that create stress risers and / or crack nucleation sites.

[0288] Figure 22 Shown in Figure 22 Marked as 2211 Figure 21A FIG. 22 shows an example geometry of an example embodiment of a single-layer piezoelectric sensor device. The single-layer piezoelectric sensor device 2211 includes at least two electrode structures of the second layer 2115, Figure 22 12 as first and second electrodes 2115X and 2115Y, separated from each other by a gap and coupled to piezoelectric material 2112 coupled to first layer 2113 (e.g., positioned in the housing of the IMD so as to be exposed through an aperture). As depicted in the lower portions of FIG. 12 , 1211A, 1211B, and 1211C, at least two electrodes of single-layer piezoelectric sensor device 1211 can be configured in a variety of geometric shapes and configurations, including but not limited to rectangular, elliptical, and triangular, and can include three or more electrodes.

[0289] Integrated / interconnected in vivo fluid flow sensor and in vivo acoustic sensor

[0290] Figure 23 A diagram illustrating an example embodiment of an implantable medical device 100 labeled IMD 2300 is shown, depicting a device comprising in vivo An example embodiment of a fluid flow sensor device 100X (in this example embodiment, as in vivo Fluid flow sensor device 700B) and in vivo An example embodiment of the acoustic sensor device 100Y (ie, in this exemplary embodiment, as in vivo In this example, in vivo Acoustic sensor device 2000 is coupled to in vivoThe entrainment 703 of the fluid flow sensor device 700B enables the electronic unit 2020 of the device 2000 to be in electrical and / or data communication with the electronic unit 720 of the device 700B. For example, in some embodiments of the IMD 2300, the power supply of the IMD 2300 may be configured in only one of the electronic unit 2020 or the electronic unit 720; or similarly, the data processing unit of the IMD 2300 may be configured in only one of the electronic unit 2020 or the electronic unit 720; and / or other components of the electronic unit 2020 and the electronic unit 720 may be shared and / or combined. In addition, for example, in vivo Acoustic sensor device 2000 and in vivo Fluid flow sensor device 700B is in data communication, allowing data communication between electronics unit 2020 of device 2000 and electronics unit 720 of device 700B, which may be used for synchronized data collection and processing protocols of IMD 2300 .

[0291] Figure 24A A diagram illustrating an example embodiment of an implantable medical device 100 labeled IMD 2400A is shown, depicting an electrical and communication interconnect comprising in vivo Example embodiment of a fluid flow sensor device 100X (in this exemplary embodiment, as in vivo Fluid flow sensor device 700B) and in vivo An example embodiment of the acoustic sensor device 100Y (ie, in this exemplary embodiment, as in vivo Acoustic sensor device 2000). In this example, in vivo The acoustic sensor device 2000 is connected to the remote in vivo The cable, wire, or cord 993 of the device 990 is electrically and / or communicatively connected to the strap 703 of the in vivo fluid flow sensor device 700B. In some embodiments of the IMD 2400A, for example, because the electronics unit 2020 of the device 2000 can be in electrical and / or data communication with the electronics unit 720 of the device 700B, various components of the respective electronics units can be shared and / or combined. In this example, in vivo Acoustic sensor device 2000 and in vivo Fluid flow sensor device 700B is in data communication (wired), allowing data communication between electronics unit 2020 of device 2000 and electronics unit 720 of device 700B, which can be used for synchronized data collection and processing protocols of IMD 2400A.

[0292] Figure 24BA diagram illustrating an example embodiment of an implantable medical device 100 labeled IMD 2400B is shown, depicting a wireless communication interconnect comprising in vivo Example embodiment of a fluid flow sensor device 100X (in this exemplary embodiment, as in vivo Fluid flow sensor device 700B) and in vivo An example embodiment of the acoustic sensor device 100Y (ie, in this exemplary embodiment, as in vivo Acoustic sensor device 2000). In this example, in vivo Acoustic sensor device 2000 and in vivo Fluid flow sensor device 700B communicates wirelessly, thereby allowing data communication between electronics unit 2020 of device 2000 and electronics unit 720 of device 700B, which can be used for synchronized data collection and processing protocols of IMD 2400B.

[0293] Example

[0294] In some embodiments according to the present technology (Example A1), a device for fluid flow in an anatomical structure in vivo The monitored sensor device includes a first ultrasound assembly, which includes a first group of one or more acoustic transducer elements; a second ultrasound assembly, which includes a second group of one or more acoustic transducer elements; a first link coupled to the first ultrasound assembly; a second link coupled to the second ultrasound assembly; an electronics unit in electrical communication with the first ultrasound assembly and the second ultrasound assembly, the electronics unit being configured to process electrical signals associated with returned acoustic signals as data and to wirelessly transmit the data to an external processor; and a spring connection device connected to each of the first and second linkages and operable to position the first ultrasound assembly at a first location on the anatomical structure and to position the second ultrasound assembly at a second location on the anatomical structure to form a plane passing through the first and second locations of the anatomical structure, thereby sending and receiving acoustic signals from the first group of one or more acoustic transducer elements and the second group of one or more acoustic transducer elements indicating a fluid flow parameter of a biological fluid in the anatomical structure.

[0295] Example A2 includes the sensor device of any of Examples A1-A4, wherein the anatomical structure is a heart.

[0296] Example A3 includes the sensor apparatus of any of Examples A1-A4, wherein the first location and the second location are located on a left atrium of the heart, and wherein planes across which the acoustic signals are transmitted and received cross at a mitral valve of the heart.

[0297] Example A4 includes the sensor apparatus of any of Examples A1-A3, wherein the first location and the second location are located on a right atrium of the heart, and wherein planes across which the acoustic signals are transmitted and received cross at a tricuspid valve of the heart.

[0298] In some embodiments according to the present technology (Example B1), a device for fluid flow in an anatomical structure in vivo The monitored sensor device includes a linkage assembly including a first arm configured to attach to a first portion of an anatomical structure and a second arm configured to attach to a second portion of the anatomical structure opposite the first portion; a connecting device connected to each of the first arm and the second arm; an ultrasonic sensor assembly including a plurality of acoustic transducer elements coupled to the connecting assembly, the plurality of acoustic transducer elements including a first acoustic transducer element, a second acoustic transducer element, and a third acoustic transducer element, the first acoustic transducer element being configured to transmit an acoustic signal to propagate through the anatomical structure, the second acoustic transducer element and the third acoustic transducer element being configured to receive the acoustic signal that has propagated through the anatomical structure and is indicative of a fluid flow parameter of a biological fluid in the anatomical structure; and an electronics unit housed in the connecting device and in electrical communication with the plurality of acoustic transducer elements of the ultrasonic sensor assembly, the electronics unit being configured to process electrical signals associated with the received acoustic signals as data and to wirelessly transmit the data to an external processor.

[0299] Example B2 includes the sensor apparatus of any of Examples B1-B50, wherein the ultrasonic sensor assembly includes a first ultrasonic sensor assembly disposed on the first arm of the linkage assembly and a second ultrasonic sensor assembly disposed on the second arm of the linkage assembly.

[0300] Example B3 includes the sensor device of Example B2 or any one of Examples B1-B50, wherein the first ultrasonic sensor assembly includes a first acoustic transducer element configured to transmit an acoustic signal, the first acoustic transducer element being located on a distal region of a first arm to interface with a first portion of an anatomical structure, wherein the second ultrasonic sensor assembly includes second and third acoustic transducer elements configured to receive an acoustic signal, the second and third acoustic transducer elements being located on a distal region of the second arm to interface with a second portion of the anatomical structure, and wherein a first center point (C Tx ) and a second center point (Cd) located between the center spacing distance (d) of the second sound transducer element and the third sound transducer element Rx ) to align.

[0301] Example B4 includes the sensor device of Example B2 or any one of Examples B1-B50, wherein the first ultrasonic sensor assembly includes a first acoustic transducer element configured to transmit an acoustic signal, the first acoustic transducer element being located on a distal region of a first arm to interface with a first portion of an anatomical structure, wherein the second ultrasonic sensor assembly includes second and third acoustic transducer elements configured to receive acoustic signals, which are located on a distal region of the second arm to interface with a second portion of the anatomical structure, wherein the first ultrasonic sensor assembly further includes fourth and fifth acoustic transducer elements located on a distal region of the second arm to interface with the second portion of the anatomical structure and configured to receive a first set of acoustic signals associated with the acoustic signal emission by the first acoustic transducer element, wherein the second ultrasonic sensor assembly includes a sixth acoustic transducer element located on a distal region of the first arm to interface with the first portion of the anatomical structure and configured to transmit a second acoustic signal associated with the acoustic signals received at the second and third acoustic transducer elements, and wherein a first center point (C Tx1 ) and the second center point (Cd Rx1 ) is aligned, the second center point is located between the centers of the fourth and fifth sound transducer elements, which are separated by a first distance (d1), and wherein the third center point (C Tx2 ) and a fourth center point (Cd d ) separated by a second distance (d2) from the center of the second sound transducer element Rx2 )alignment.

[0302] Example B5 includes the sensor apparatus of any of Examples B1-B50, wherein the plurality of acoustic transducer elements of the ultrasonic sensor assembly are disposed on a first arm of the linkage assembly, and wherein the sensor apparatus further includes a reflector disposed on a second arm of the linkage assembly.

[0303] Example B6 includes the sensor device of any of Examples B1-B50, wherein at least one of the first acoustic transducer element, the second transducer element, or the third acoustic transducer element is configured to have a size between 1 mm and 4 mm.

[0304] Example B7 includes the sensor device of any of Examples B1-B50, wherein the ultrasonic sensor assembly further comprises a substrate connected to an interior-facing surface of at least one of the first arm or the second arm of the linkage assembly, the substrate coupling at least one of the plurality of acoustic transducer elements.

[0305] Example B8 includes the sensor device of Example B7 or any of Examples B1-B50, wherein the substrate is configured to provide thermal synchronization for managing heat generated by the at least one acoustic transducer element.

[0306] Example B9 includes the sensor device of any of Examples B1-B50, wherein at least one of the plurality of acoustic transducer elements includes a piezoelectric micromachined ultrasonic transducer (PMUT).

[0307] Example B10 includes the sensor device of any of Examples B1-B50, wherein the sensor device further includes an acoustic transducer pad coupled to at least some of the acoustic transducer elements of the ultrasonic sensor assembly and configured to provide contouring and padding against the anatomical structure.

[0308] Example B11 includes the sensor device of Example B10 or any of Examples B1-B50, wherein the acoustic transducer pad comprises a hydrogel.

[0309] Embodiment B12 includes the sensor device of any of embodiments B1-B50, wherein the connecting assembly is operable to secure the sensor device to a flexible anatomical structure, stabilizing the position of the sensor device relative to the anatomical structure while accommodating continuous movement of the anatomical structure to which it is connected.

[0310] Embodiment B13 includes the sensor device of embodiment B12 or any one of embodiments B1-B50, wherein the connecting assembly includes a clamp operable to provide a compressive force through each of the first and second arms of the clamp to facilitate securing the sensor device to the first and second portions of the anatomical structure and to absorb forces applied by the anatomical structure to the first and second arms of the clamp due to continued movement of the anatomical structure.

[0311] Example B14 includes the sensor device of Example B13 or any of Examples B1-B50, wherein the clamp comprises a composite material having a flexible polymer component and a preformed and shape-changing shape-reinforcing component.

[0312] Example B15 includes the sensor device of example B14 or any of examples B1-B50, wherein the shape-reinforcing member of the composite material comprises one or more of nitinol, gold, platinum, or iridium, which is encased in a polymer member of the composite material comprising one or more of silicone, polyethylene, polyimide, polyamide, or a mixture thereof.

[0313] Example B16 includes the sensor device of any of Examples B1-B50, wherein the connecting device is operable to secure the linkage assembly to the anatomical structure using mechanical elasticity to stabilize the position of the sensor device relative to the anatomical structure while withstanding continuous movement of the anatomical structure to which it is connected.

[0314] Example B17 includes the sensor device of Example B16 or any one of Examples B1-B50, wherein the connecting device includes a spring that is operable to provide a compressive force on the first arm and the second arm of the linkage assembly to facilitate securing the sensor device to the first and second parts of the anatomical structure and to absorb forces applied by the anatomical structure to the first arm and the second arm of the linkage assembly due to continuous movement of the anatomical structure.

[0315] Example B18 includes the sensor device of any of Examples B1-B50, wherein the electronics unit includes a power source and a wireless communication unit, the wireless communication unit including a wireless transmitter or a wireless transceiver.

[0316] Example B19 includes the sensor device of example B18 or any of examples B1-B50, wherein the power source includes at least one of a battery or a fuel cell.

[0317] Example B20 includes the sensor device of Example B18 or any one of Examples B1-B50, wherein the electronic unit includes a signal conditioning unit that communicates with a plurality of acoustic transducer elements of the ultrasonic sensor assembly via one or more electrical interface components, the signal conditioning unit including circuitry configured to process electrical signals associated with the received acoustic signals by one or more of amplifying the electrical signals, filtering the electrical signals, or converting the electrical signals from analog to digital.

[0318] Example B21 includes the sensor device of Example B20 or any one of Examples B1-B50, wherein the electronic unit includes a data processing unit in communication with the signal conditioning unit, the data processing unit including a processor and a memory and configured to process the amplified, filtered, or converted electrical signal into data representing a fluid flow parameter of the biological fluid.

[0319] Example B22 includes the sensor device of Example B18 or any one of Examples B1-B50, wherein the electronic unit includes a data processing unit that communicates with the wireless communication unit, the data processing unit includes a processor and a memory, and is configured to process the electrical signal as data representing a fluid flow parameter of the biological fluid.

[0320] Example B23 includes the sensor device of Example B18 or any one of Examples B1-B50, wherein the electronics unit includes a printed circuit board (PCB) having a substrate and electrical interconnects disposed on the substrate, wherein the electrical interconnects are coupled to a plurality of electrical interconnect lines that span between a plurality of acoustic transducer elements of the ultrasonic sensor assembly and the PCB of the electronics unit.

[0321] Example B24 includes the sensor device of Example B23 or any one of Examples B1-B50, wherein the electronics unit includes a housing that surrounds the electronics unit to be inserted into and deployed by the sensor device. in vivo Protect the electronics unit from exposure to body fluids.

[0322] Example B25 includes the sensor device of Example B24 or any of Examples B1-B50, wherein the housing includes one or both of flat sides or curved sides to provide a form factor of the sensor device including at least one of a rectangular, cylindrical, conical, elliptical, pyramidal, trapezoidal, or non-uniform shape.

[0323] Example B26 includes the sensor device of example B24 or any of examples B1-B50, wherein the housing includes connection to the link assembly on an inward surface of the link assembly facing the anatomy, or wherein the housing includes connection to the link assembly on an outward surface of the link assembly facing away from the anatomy.

[0324] Example B27 includes the sensor device of example B24 or any of examples B1-B50, wherein the PCB of the electronics unit is sealed within the housing by an impermeable material covering the PCB to provide electrical shielding from bodily fluids.

[0325] Example B28 includes the sensor device of Example B27 or any of Examples B1-B50, wherein the impermeable material includes at least one of parylene, polyurethane, or Teflon material.

[0326] Example B29 includes the sensor device of any of Examples B1-B50, further comprising a secondary sensor coupled to at least one of the linking components or the connecting device and in communication with the electronic unit, the secondary sensor being operable to measure one or more biological parameters, physiological parameters, electrophysiological parameters, or physical parameters of the body in which the sensor device is deployed.

[0327] Example B30 includes the sensor device of Example B29 or any of Examples B1-B50, wherein the secondary sensor includes an analyte sensor configured to detect an analyte of a biological fluid in the anatomical structure or an analyte of a bodily fluid in an area of ​​the anatomical structure adjacent to where the sensor device is deployed.

[0328] Example B31 includes the sensor device of Example B29 or any of Examples B1-B50, wherein the secondary sensor includes a pH sensor configured to detect a pH level of a biological fluid in the anatomical structure or a bodily fluid in an area of ​​the anatomical structure adjacent to where the sensor device is deployed.

[0329] Example B32 includes the sensor device of Example B29 or any of Examples B1-B50, wherein the secondary sensor includes a temperature sensor configured to detect the temperature of a biological fluid in the anatomical structure or the temperature of a body fluid in an area of ​​the anatomical structure adjacent to where the sensor device is deployed.

[0330] Example B33 includes the sensor device of Example B29 or any of Examples B1-B50, wherein the secondary sensor includes an inertial measurement unit (IMU) configured to detect motion of the sensor device in multiple degrees of freedom.

[0331] Example B34 includes the sensor device of any of Examples B1-B50, further comprising a second attachment component comprising one or more of a suture, a prong, a screw, a barb, an adhesive, or a gripping mechanism, the second attachment component being disposed on at least a portion of the linkage assembly and configured to secure the ultrasonic sensor assembly to the anatomical structure via the linkage assembly.

[0332] Embodiment B35 includes the sensor device of any one of embodiments B1-B50, wherein the connecting assembly is capable of changing shape from a first shape configuration to a second shape configuration, wherein in the first shape configuration, the first arm and the second arm of the connecting assembly are extended outward from the centerline through at least one of the connecting assembly or the connecting device for insertion into the patient's body, and wherein the first arm and the second arm of the link assembly are extended inward toward the centerline through at least one of the connecting assembly or the connecting device for connection to the anatomical structure for operation of the sensor device.

[0333] Example B36 includes the sensor device of any of Examples B1-B50, further including a second linkage assembly comprising a third arm configured to connect to a third portion of the anatomical structure and a fourth arm configured to connect to a fourth portion of the anatomical structure opposite the third portion, wherein a connecting device is coupled to each of the third arm and the fourth arm, and wherein the ultrasonic sensor assembly includes a set of additional multiple acoustic transducer elements connected to the second connecting assembly, the set of additional acoustic transducer elements being configured to transmit a second acoustic signal to propagate through the anatomical structure through the third portion and the fourth portion, and to receive a second set of acoustic signals that have propagated through the anatomical structure through the third portion and the fourth portion and are indicative of a second fluid flow parameter of a biological fluid in the anatomical structure.

[0334] Example B37 includes the sensor device of any of Examples B1-B50, wherein the connecting device includes a port for electrically communicating with an electronic unit housed in the connecting device and is operable to electrically couple to a remote power source housed in a remote device via at least one of a cable, wire, or cord, wherein the remote device is located at another location different from and at a distance from the anatomical structure.

[0335] Example B38 includes the sensor device of Example B37 or any one of Examples B1-B50, wherein the port communicates data with an electronic unit housed in a connecting device and is operable to interface the electronic unit to a data processing unit provided in a remote device via at least one of a cable, wire, or cord to output data from the electronic unit of the sensor device to the data processing unit of the remote device through the port via at least one of the cables, wires, or cords.

[0336] Example B39 includes the sensor device of Example B38 or any of Examples B1-B50, wherein the sensor device is configured to wirelessly transmit the data to the external processor via a secondary transmission device comprising a wireless transmitter or transceiver.

[0337] Example B40 includes the sensor device of Example B37 or any one of Examples B1-B50, wherein the remote device is located at another location at least 2 cm from the anatomical structure.

[0338] Example B41 includes the sensor device of Example B37 or any of Examples B1-B50, wherein the other location includes the pleural cavity, a cavity in the abdominal cavity, a subcutaneous space, or an external location.

[0339] Example B42 includes the sensor device of any of Examples B1-B50, wherein an external processor capable of receiving data to be wirelessly transmitted by an electronic unit of the sensor device is located outside the body of a patient-user, and the sensor device is implantable in the body of the patient-user and deployable at the anatomical structure.

[0340] Example B43 includes the sensor device of any of Examples B1-B50, wherein the fluid flow parameter of the biological fluid in the anatomical structure includes at least one of an amount of pressure difference between ends of a flow path in the anatomical structure or a flow rate.

[0341] Example B44 includes the sensor device of example B43 or any of examples B1-B50, wherein the device is operable to detect a size dimension of the anatomical structure or a predicted area or volume of the anatomical structure based on a baseline measurement of flow rate and a change in flow rate over time.

[0342] Example B45 includes the sensor device of any of Examples B1-B50, wherein the anatomical structure is a heart and the biological fluid is blood.

[0343] Example B46 includes the sensor device of example B45 or any of examples B1-B50, wherein the sensor device is deployable within at least one layer of the heart's pericardium, or wherein the sensor device is deployable on an outer layer of the heart's pericardium.

[0344] Example B47 includes the sensor device of Example B45 or any of Examples B1-B50, wherein the first arm and the second arm of the linkage assembly are located on opposing portions of the left atrium of the heart, and wherein the received acoustic signal indicates blood flow at a mitral valve of the heart.

[0345] Example B48 includes the sensor device of Example B45 or any of Examples B1-B50, wherein the first arm and the second arm of the linkage assembly are located on opposing portions of the right atrium of the heart, and wherein the received acoustic signal indicates blood flow at the tricuspid valve of the heart.

[0346] Example B49 includes the sensor device of Example B45 or any of Examples B1-B50, wherein the first arm and the second arm of the link assembly are located on the superior vena cava or the inferior vena cava near the heart, and wherein the received acoustic signal indicates blood flow at the superior vena cava or the inferior vena cava.

[0347] Example B50 includes the sensor device of Example B45 or any of Examples B1-B49, wherein the first arm and the second arm of the link assembly are located on a pulmonary artery or pulmonary vein proximal to the heart, and wherein the received acoustic signal indicates blood flow at the pulmonary artery or pulmonary vein.

[0348] In some embodiments (Example B51) according to the present technology, a in vivo A sensor device for monitoring blood flow in a heart or blood vessel comprises: a link assembly comprising a first arm configured to be attached to a first portion of a heart or blood vessel and a second arm configured to be attached to a second portion of the heart or blood vessel; a connecting device connected to each of the first arm and the second arm; an ultrasonic sensor assembly comprising a plurality of acoustic transducer elements coupled to the link assembly, the plurality of acoustic transducer elements comprising a first acoustic transducer element, a second acoustic transducer element, and a third acoustic transducer element, the first acoustic transducer element being configured to emit an acoustic signal to propagate through the heart or blood vessel, the second acoustic transducer element and the third acoustic transducer element being configured to receive an acoustic signal that has propagated through the heart or blood vessel, and an electronics unit housed in a connection device and in electrical communication with a plurality of acoustic transducer elements of the ultrasonic sensor assembly, the electronics unit being configured to process an electrical signal associated with the received acoustic signal as data and to wirelessly transmit the data to an external processor, wherein the connection assembly includes a clamp operable to provide a compressive force through each of a first arm and a second arm of the clamp to facilitate securing the sensor assembly to the first and second portions of the heart or blood vessel and to absorb forces applied to the first and second arms of the clamp by heartbeats or changes in size of the heart or blood vessel.

[0349] Example B52 includes the sensor device of any of Examples B51-B60, wherein the clamp comprises a composite material having a flexible polymer component and a preformed and shape-changing shape-reinforcing component.

[0350] Example B53 includes the sensor device of example B52 or any one of examples B51-B60, wherein the shape-reinforcing member of the composite material comprises one or more of nitinol, gold, platinum, or iridium, which is encapsulated in a polymer member of the composite material, the polymer member comprising one or more of silicone, polyethylene, polyimide, polyamide, or a mixture thereof.

[0351] Example B54 includes the sensor device of any of Examples B51-B60, wherein the ultrasonic sensor assembly includes a first ultrasonic sensor assembly disposed on a first arm of the clamp and a second ultrasonic sensor assembly disposed on a second arm of the clamp, or wherein a plurality of acoustic transducer elements of the ultrasonic sensor assembly are disposed on the first arm of the clamp, and wherein the sensor device further includes a reflector disposed on the second arm of the clamp.

[0352] Example B55 includes the sensor device of any of Examples B51-B60, wherein the sensor device further includes an acoustic transducer pad that includes a hydrogel coupled to at least some of the acoustic transducer elements of the ultrasonic sensor assembly and configured to provide contouring and cushioning against the heart or blood vessels.

[0353] Example B56 includes the sensor device of any of Examples B51-B60, wherein the sensor device is deployable within at least one layer of the heart's pericardium, or wherein the sensor device is deployable on an outer layer of the heart's pericardium.

[0354] Example B57 includes the sensor device of any of examples B51-B60, wherein the first and second arms of the clamp are positioned on opposing portions of a left atrium of the heart, and wherein the received acoustic signal is indicative of blood flow at a mitral valve of the heart.

[0355] Example B58 includes the sensor device of any of examples B51-B60, wherein the first and second arms of the clamp are positioned on opposing portions of a right atrium of the heart, and wherein the received acoustic signal is indicative of blood flow at a tricuspid valve of the heart.

[0356] Example B59 includes the sensor apparatus of any of Examples B51-B60, wherein the first and second arms of the clamp are positioned on the superior vena cava or the inferior vena cava proximal to the heart, and wherein the received acoustic signal indicates blood flow at the superior vena cava or the inferior vena cava.

[0357] Example B60 includes the sensor device of any of Examples B51-B59, wherein the first and second arms of the clamp are positioned on a pulmonary artery or pulmonary vein proximal to the heart, and wherein the received acoustic signal indicates blood flow at the pulmonary artery or pulmonary vein.

[0358] In some embodiments according to the present technology (Example B61), a method for fluid flow in an anatomical structure body Inside The monitoring system includes a device operably deployed within a patient user and attached to an anatomical structure. in vivo Sensor devices, and in vivo A data processing system for data communication between sensor devices. in vivo The sensor device includes a linkage assembly including a first arm configured to be connected to a first portion of an anatomical structure and a second arm configured to be connected to a second portion of the anatomical structure opposite the first portion; a connecting device connected to each of the first arm and the second arm; an ultrasonic sensor assembly including a plurality of acoustic transducer elements coupled to the connecting assembly, the plurality of acoustic transducer elements including a first acoustic transducer element, a second acoustic transducer element, and a third acoustic transducer element, the first acoustic transducer element being configured to transmit an acoustic signal to propagate through the anatomical structure, the second acoustic transducer element and the third acoustic transducer element being configured to receive an acoustic signal that has propagated through the anatomical structure and is indicative of a fluid flow parameter of a biological fluid in the anatomical structure; and an electronics unit housed in the connecting device and in electrical communication with the plurality of acoustic transducer elements of the ultrasonic sensor assembly, the electronics unit being configured to process electrical signals associated with the received acoustic signals as data and to wirelessly transmit the data to an external processor. The data processing system includes a processor and a memory and is configured to receive signals from in vivo The device receives data from the sensor device and processes the received data to determine fluid flow parameters related to the biological fluid in the anatomical structu...

Claims

1. An implantable medical device comprising: in vivo Fluid flow sensors; as well as in vivo Acoustic sensor.

2. The device according to claim 1, wherein the in vivo The fluid flow sensor is configured to transmit ultrasonic signals to propagate through an anatomical structure and to detect ultrasonic signals that have propagated through the anatomical structure and are indicative of fluid flow of a biological fluid in the anatomical structure.

3. The device of claim 2, wherein the in vivo Fluid flow sensors include: a connecting assembly comprising a first arm configured to attach to a first portion of the anatomical structure and a second arm configured to attach to a second portion of the anatomical structure opposite the first portion, and an ultrasonic sensor assembly comprising a plurality of ultrasonic transducer elements coupled to the connecting assembly.

4. The apparatus of claim 3 , wherein the plurality of ultrasonic transducer elements comprises a first ultrasonic transducer element configured to transmit the ultrasonic signal to propagate through the anatomical structure, and a second ultrasonic transducer element and a third ultrasonic transducer element configured to receive the ultrasonic signal that has propagated through the anatomical structure and is indicative of a fluid flow parameter of the biological fluid in the anatomical structure.

5. The device according to claim 1, wherein the in vivo The acoustic sensor is configured to detect acoustic signals emanating from internal body structures.

6. The device of claim 5, wherein the in vivo Acoustic sensors include: a hermetically sealed housing, and a transducer element configured to receive the acoustic signal emanating from the internal body structure such that the transducer element converts energy of the received acoustic signal into an electrical signal indicative of a physiological function of the internal body structure.

7. The device of claim 1, wherein the in vivo The acoustic sensor comprises a displacement mediated acoustic sensor for measuring a conformational change of a transducer element caused by the acoustic signal on the transducer element.

8. The device of claim 7, wherein the in vivo The acoustic sensor includes a microphone.

9. The device of claim 7, wherein the in vivo Acoustic sensors include accelerometers.

10. The device of claim 7, wherein the in vivo Acoustic sensors include strain gauges.

11. The device of claim 7, wherein the in vivo Acoustic sensors include pressure sensors.

12. The device of claim 1, wherein the in vivo The acoustic sensor comprises a stress-mediated acoustic sensor operable to measure stress induced by the acoustic signal applied to the transducer element.

13. The device of claim 12, wherein the in vivo The acoustic sensor includes a single-layer piezoelectric sensor device.

14. The apparatus of claim 1, wherein the acoustic signal comprises a transmission of mechanical energy propagating in an in vivo medium comprising one or more of a gas, a liquid, or a solid.

15. The device according to claim 1, comprising in vivo Fluid flow sensor and the in vivo The acoustic sensor is electrically connected to an electronics unit, wherein the electronics unit is located in a hermetically sealed housing.

16. The device of claim 15, wherein the electronic unit comprises a signal processing unit and a wireless communication unit, the wireless communication unit being configured to process electrical signals associated with the detected ultrasonic signals and / or the detected acoustic signals into data and to wirelessly transmit the data to an external processor.

17. The apparatus of claim 15, wherein the electronics unit comprises a power supply.

18. The apparatus of claim 15, wherein the signal processing unit comprises a signal conditioning circuit configured to process the electrical signal associated with the received ultrasonic signal by one or more of amplifying the electrical signal, filtering the electrical signal, or converting the electrical signal from analog to digital.

19. The apparatus of claim 18, wherein the electronic unit comprises a data processing unit in communication with the signal conditioning circuit, the data processing unit comprising a processor and a memory, and configured to process the amplified electrical signal, the filtered electrical signal, or the converted electrical signal into biomedical data.

20. The apparatus of claim 15, wherein the electronic unit comprises a printed circuit board (PCB) having a substrate and an electrical interconnect disposed on the substrate, wherein the electrical interconnect is coupled to a plurality of electrical interconnect lines spanning across the in vivo Fluid flow sensor and the in vivo between said sensors of the acoustic sensor.

21. A method for removing an anatomical structure from a host body. in vivo Implantable medical devices for monitoring, including: in vivo a fluid flow sensor comprising: a connecting assembly including a first arm configured to be attached to a first portion of the anatomical structure and a second arm configured to be attached to a second portion of the anatomical structure opposite the first portion; a connecting device coupled to each of the first arm and the second arm; an ultrasonic sensor assembly including a plurality of ultrasonic transducer elements coupled to the connecting assembly, the plurality of ultrasonic transducer elements including a first ultrasonic transducer element configured to transmit the ultrasonic signal to propagate through the anatomical structure, and a second ultrasonic transducer element and a third ultrasonic transducer element configured to receive the ultrasonic signal that has propagated through the anatomical structure and is indicative of a fluid flow parameter of the biological fluid in the anatomical structure; in vivo An acoustic sensor comprising: a hermetically sealed housing; and a transducer element configured to receive an acoustic signal emitted from a source within the host body, such that the transducer element converts energy of the received acoustic signal into an electrical signal indicative of a physiological function of the source within the host body; and an electronics unit at least partially housed within the housing. in vivo The connection device of the fluid flow sensor is housed in the in vivo The hermetically sealed housing of the fluid flow sensor, wherein the electronics unit is in electrical communication with the plurality of ultrasonic transducer elements of the ultrasonic sensor assembly and with the in vivo The transducer elements of the acoustic sensor are in electrical communication, and the electronics unit is configured to process electrical signals associated with the received ultrasonic signal and the received acoustic signal into data and wirelessly transmit the data to an external processor.

22. The device of claim 21, wherein the in vivo Acoustic sensors include stress-mediated acoustic sensors.

23. The device of claim 22, wherein the transducer element comprises a piezoelectric material.

24. The device of claim 23, wherein the piezoelectric material comprises one or more of lead zirconate titanate (PZT), lead lanthanum zirconate titanate (PLZT), zinc oxide (ZnO), quartz, polyvinylidene fluoride or polyvinylidene fluoride (PVDF), aluminum nitride (AlN), scandium aluminum nitride (ScAlN), barium titanate (BaTiO3), lead titanate (PbTiO3), potassium niobate (KNbO3), lithium niobate (LiNbO3), lithium tantalate (LiTaO3) and / or sodium tungstate (Na2WO4).

25. The apparatus of claim 23, wherein the stress-mediated acoustic sensor comprises a single-layer piezoelectric sensor comprising: A biocompatible conductive non-piezoelectric material coupled to a first side of the piezoelectric material and configured in the hermetically sealed housing to face the piezoelectric material. in vivo an exterior of the acoustic sensor, the biocompatible conductive non-piezoelectric material having a Young's modulus within a range of 2 to 3 times the Young's modulus of the piezoelectric material, and a conductive non-piezoelectric material coupled to a second side of the piezoelectric material opposite the first side, wherein the biocompatible conductive non-piezoelectric material is configured to receive an applied force caused by the acoustic signal emitted from the source within the host body, such that stress caused by the applied force on the biocompatible conductive non-piezoelectric material is transmitted through and into the piezoelectric material to convert stress into electrical energy corresponding to the electrical signal captured at the conductive non-piezoelectric material.

26. The device of claim 25, wherein the biocompatible electrically conductive non-piezoelectric material comprises one or more of titanium (Ti), biocompatible stainless steel, cobalt-chromium alloy, nitinol, or a combination thereof.

27. The apparatus of claim 23, wherein the stress-mediated acoustic sensor comprises a single-layer piezoelectric sensor comprising: A biocompatible electrically insulating non-piezoelectric material is disposed in the hermetically sealed housing to face the in vivo an exterior of the acoustic sensor, the biocompatible, electrically insulating, non-piezoelectric material having a Young's modulus within a range of 2 to 3 times the Young's modulus of the piezoelectric material, a first conductive non-piezoelectric material coupled to a first side of the piezoelectric material, and a conductive non-piezoelectric material coupled to a second side of the piezoelectric material opposite the first side, wherein the biocompatible, electrically insulating, non-piezoelectric material is configured to receive an applied force caused by the acoustic signal emitted from the source within the host body, such that stress caused by the applied force on the biocompatible, electrically insulating, non-piezoelectric material is transmitted through the piezoelectric material and into the piezoelectric material to convert stress into electrical energy corresponding to the electrical signal captured at the first and second conductive non-piezoelectric materials.

28. The device of claim 27, wherein the biocompatible electrically insulating non-piezoelectric material comprises a high purity ceramic.

29. The apparatus of claim 22, wherein the stress-mediated acoustic sensor does not involve displacement of the transducer element.

30. The device of claim 21, wherein the in vivo The acoustic sensor further includes a housing structure providing a strong, non-flexible material and configured to secure and / or position the transducer element within the hermetically sealed housing.

31. The apparatus of claim 30, wherein the housing structure is part of the hermetically sealed casing.

32. The device of any one of claim 30 or claim 31 , wherein the housing structure comprises titanium (Ti).

33. The device of claim 21, wherein the in vivo Acoustic sensors include displacement-mediated acoustic sensors.

34. The apparatus of claim 33, wherein the transducer element comprises a microphone.

35. An apparatus as claimed in claim 34, wherein the microphone includes a membrane that undergoes deflection in response to sound waves contacting an outer surface of the membrane, wherein the membrane is coupled to the hermetically sealed housing or is a component of the hermetically sealed housing, and wherein the microphone further includes electronic components responsive to the deflection.

36. A device as described in claim 35, wherein the electronic component responsive to the deflection comprises at least one of a strain gauge, a piezoelectric element, a capacitor element, a capacitive electrode, or a fixed position electrode that does not change position relative to the membrane when the membrane undergoes deflection in response to the acoustic wave contacting the outer surface of the flexible membrane.

37. The apparatus of claim 33, wherein the transducer element comprises an accelerometer.

38. The device of claim 21, wherein the ultrasonic sensor assembly comprises a first ultrasonic sensor assembly and a second ultrasonic sensor assembly, the first ultrasonic sensor assembly being disposed on the first arm of the connecting assembly, and the second ultrasonic sensor assembly being disposed on the second arm of the connecting assembly.

39. The apparatus of claim 38 , wherein the first ultrasonic sensor assembly comprises the first ultrasonic transducer element configured to transmit the ultrasonic signal, the first ultrasonic transducer element being positioned on a distal region of the first arm to interface with the first portion of the anatomical structure, wherein the second ultrasonic sensor assembly comprises the second ultrasonic transducer element and the third ultrasonic transducer element configured to receive the ultrasonic signal, the second ultrasonic transducer element and the third ultrasonic transducer element being positioned on a distal region of the second arm to interface with the second portion of the anatomical structure, and wherein a first center point (C) of the first ultrasonic transducer element Tx ) and a second center point (Cd) located between the center of the second ultrasonic transducer element and the center of the third ultrasonic transducer element by a distance (d) Rx )alignment.

40. The apparatus of claim 38 , wherein the first ultrasonic sensor assembly comprises the first ultrasonic transducer element configured to transmit the ultrasonic signal, the first ultrasonic transducer element being positioned on a distal region of the first arm to interface with the first portion of the anatomical structure, wherein the second ultrasonic sensor assembly comprises the second ultrasonic transducer element and the third ultrasonic transducer element configured to receive the ultrasonic signal, the second ultrasonic transducer element and the third ultrasonic transducer element being positioned on a distal region of the second arm to interface with the second portion of the anatomical structure, wherein the first ultrasonic sensor assembly further comprises a fourth ultrasonic transducer element and a fifth ultrasonic transducer element, the fourth and fifth ultrasonic transducer elements being positioned on the distal region of the second arm to interface with the second portion of the anatomical structure and being configured to receive a first set of ultrasonic signals associated with the transmission of the ultrasonic signals by the first ultrasonic transducer element, wherein the second ultrasonic sensor assembly includes a sixth ultrasonic transducer element being positioned on the distal region of the first arm to interface with the first portion of the anatomical structure and being configured to transmit a second ultrasonic signal associated with the ultrasonic signals received at the second and third ultrasonic transducer elements, and wherein a first center point (C) of the first ultrasonic transducer element Tx1 ) and a second center point (Cd d ) located between a first distance (d1) separating the center of the fourth ultrasonic transducer element and the center of the fifth ultrasonic transducer element Rx1 ) is aligned, and wherein the third center point (C Tx2 ) and a fourth center point (Cd ) located between a second distance (d2) separating the center of the second ultrasonic transducer element and the center of the third ultrasonic transducer element Rx2 )alignment.

41. The apparatus of claim 21 , wherein the plurality of ultrasonic transducer elements of the ultrasonic sensor assembly are disposed on the first arm of the connecting assembly, and wherein the in vivo The fluid flow sensor also includes a reflector disposed on the second arm of the connecting assembly.

42. The device of claim 21, wherein at least one of the first ultrasonic transducer element, the second ultrasonic transducer element, or the third ultrasonic transducer element is configured to have a size between 1 mm and 4 mm.

43. The apparatus of claim 21 , wherein the ultrasonic sensor assembly further comprises a substrate connected to an interior-facing surface of at least one of the first arm or the second arm of the connecting assembly, and the substrate couples at least one of the plurality of ultrasonic transducer elements.

44. The apparatus of claim 43, wherein the substrate is configured to provide thermal synchronization for managing heat generated by the at least one ultrasonic transducer element.

45. The apparatus of claim 21, wherein at least one of the plurality of ultrasonic transducer elements comprises a piezoelectric micromachined ultrasonic transducer (PMUT).

46. ​​The device of claim 21, wherein the in vivo The fluid flow sensor also includes an ultrasonic transducer pad coupled to at least some of the ultrasonic transducer elements of the ultrasonic sensor assembly and configured to conform to the contours of the anatomical structure and provide cushioning.

47. The device of claim 46, wherein the ultrasound transducer pad comprises a hydrogel.

48. The device of claim 21, wherein the connecting assembly is operable to connect the in vivo The fluid flow sensor is fixed to the anatomical structure so that the in vivo The fluid flow sensor is stable in its placement relative to the anatomical structure while withstanding continuous movement of the anatomical structure to which it is attached.

49. The apparatus of claim 48, wherein the connecting assembly comprises a clamping band operable to provide a compressive force through each of the first and second arms of the clamping band to facilitate the in vivo A fluid flow sensor is secured to the first and second portions of the anatomical structure and absorbs forces exerted by the anatomical structure on the first and second arms of the entrainment due to the continued movement of the anatomical structure.

50. The apparatus of claim 49, wherein the band comprises a composite material having a flexible polymer component and a shape-reinforcing component that is preformed and capable of undergoing a shape change.

51. The apparatus of claim 50, wherein the shape-reinforcing component of the composite material comprises one or more of nitinol, gold, platinum, or iridium, the shape-reinforcing component being encapsulated in the polymer component of the composite material, the polymer component comprising one or more of silicone, polyethylene, polyimide, polyamide, or a mixture thereof.

52. The apparatus of claim 51, wherein the attachment device is operable to secure the attachment assembly to the anatomical structure using mechanical elasticity to allow the attachment assembly to in vivo The fluid flow sensor is stable in its placement relative to the anatomical structure while withstanding continuous movement of the anatomical structure to which it is attached.

53. The apparatus of claim 52, wherein the connecting device comprises a spring operable to provide a compressive force on each of the first and second arms of the connecting assembly to facilitate the in vivo A fluid flow sensor is secured to the first and second portions of the anatomical structure and absorbs forces exerted by the anatomical structure on the first and second arms of the connecting assembly due to the continued movement of the anatomical structure.

54. The apparatus of claim 21, wherein the electronic unit comprises a power supply and a wireless communication unit, the wireless communication unit comprising a wireless transmitter or a wireless transceiver.

55. The device of claim 54, wherein the power source comprises at least one of a battery or a fuel cell.

56. The apparatus of claim 54, wherein the electronics unit comprises a signal conditioning unit in communication with the plurality of ultrasonic transducer elements of the ultrasonic sensor assembly via one or more electrical interface components, the signal conditioning unit comprising circuitry configured to process the electrical signal associated with the received ultrasonic signal by one or more of amplifying the electrical signal, filtering the electrical signal, or converting the electrical signal from analog to digital.

57. An apparatus as described in claim 56, wherein the electronic unit includes a data processing unit in communication with the signal conditioning unit, the data processing unit including a processor and a memory, and is configured to process the amplified electrical signal, the filtered electrical signal or the converted electrical signal into the data representing the fluid flow parameter of the biological fluid.

58. The apparatus of claim 54, wherein the electronic unit comprises a data processing unit in communication with the wireless communication unit, the data processing unit comprising a processor and a memory and configured to process the electrical signal into the data representing the fluid flow parameter of the biological fluid.

59. The apparatus of claim 54, wherein the electronics unit comprises a printed circuit board (PCB) having a substrate and electrical interconnects disposed on the substrate, wherein the electrical interconnects are coupled to a plurality of electrical interconnects spanning between the plurality of ultrasonic transducer elements of the ultrasonic sensor assembly and the PCB of the electronics unit.

60. The device of claim 54, wherein the electronics unit includes a housing that surrounds the electronics unit to allow insertion and deployment of the implantable medical device. in vivo The electronic unit is protected from exposure to body fluids.

61. The device of claim 60, wherein the housing comprises one or both of flat sides or curved sides to provide a form factor of the implantable medical device comprising at least one of a rectangular, cylindrical, conical, elliptical, pyramidal, trapezoidal, or non-uniform shape.

62. A device as described in claim 60, wherein the housing is coupled to the connecting component on an inward-facing surface of the connecting component facing the anatomical structure, or wherein the housing is coupled to the connecting component on an outward-facing surface of the connecting component facing away from the anatomical structure.

63. The apparatus of claim 60, wherein the PCB of the electronics unit is hermetically sealed within the housing by an impermeable material covering the PCB to provide electrical shielding from the body fluids.

64. The device of claim 63, wherein the impermeable material comprises at least one of parylene, polyurethane, or Teflon.

65. The apparatus of claim 21, further comprising: A secondary sensor is coupled to the in vivo Fluid flow sensor or the in vivo At least one of the secondary sensors is in communication with the electronics unit and is operable to measure one or more of a biological parameter, a physiological parameter, an electrophysiological parameter, or a physical parameter of a body in which the device is deployed.

66. The device of claim 65, wherein the secondary sensor comprises an analyte sensor configured to detect an analyte of the biological fluid in the anatomical structure or an analyte of a bodily fluid in an area where the implantable medical device is deployed.

67. The device of claim 65, wherein the secondary sensor comprises a pH sensor configured to detect a pH level of the biological fluid in the anatomical structure or a pH level of a bodily fluid in an area where the implantable medical device is deployed.

68. The device of claim 65, wherein the secondary sensor comprises a temperature sensor configured to detect a temperature of the biological fluid in the anatomical structure or a temperature of a bodily fluid in an area where the implantable medical device is deployed.

69. The device of claim 65, wherein the secondary sensor comprises an inertial measurement unit (IMU) configured to detect motion of the implantable medical device in multiple degrees of freedom.

70. The apparatus of claim 21, further comprising: a secondary attachment component comprising one or more of a suture, a pin, a screw, a barb, an adhesive, or a gripping mechanism, disposed on at least a portion of the connection assembly and configured to secure the ultrasound sensor assembly to the anatomical structure via the connection assembly.

71. The apparatus of claim 21 , wherein the connecting component is capable of changing shape from a first shape conformation in which the first arm and the second arm of the connecting component are deployed outwardly from a centerline passing through at least one of the connecting component or the connecting device to enable insertion into a patient, to a second shape conformation in which the first arm and the second arm of the connecting component span inwardly toward the centerline passing through at least one of the connecting component or the connecting device to enable attachment to the anatomical structure to manipulate the in vivo Fluid flow sensor.

72. The apparatus of claim 21, further comprising: a second connection component comprising a third arm configured to attach to a third portion of the anatomical structure and a fourth arm configured to attach to a fourth portion of the anatomical structure opposite the third portion, wherein the connection device is coupled to each of the third arm and the fourth arm, and wherein the ultrasonic sensor assembly comprises an additional group of the plurality of ultrasonic transducer elements, the additional group of the plurality of ultrasonic transducer elements being coupled to the second connection component and configured to transmit a second ultrasonic signal to propagate through the anatomical structure across the third portion and the fourth portion, and to receive a second group of ultrasonic signals that have propagated through the anatomical structure across the third portion and the fourth portion and are indicative of a second fluid flow parameter of the biological fluid in the anatomical structure.

73. An apparatus as described in claim 21, wherein the connecting device includes a port that is electrically connected to the electronic unit housed in the connecting device and is capable of being electrically coupled to a remote power supply housed in a remote device via at least one of a cable, wire or cord, wherein the remote device is located in another location different from the anatomical structure and at a certain distance from the anatomical structure.

74. An apparatus as claimed in claim 73, wherein the port performs data communication with the electronic unit housed in the connecting device and is capable of operating to dock the electronic unit with a data processing unit provided in the remote device via at least one of the cable, the wire or the soft wire, so as to output the data from the electronic unit of the sensor device to the data processing unit of the remote device through the port via at least one of the cable, the wire or the soft wire.

75. The apparatus of claim 74, wherein the implantable medical device is configured to wirelessly transmit the data to the external processor via a secondary transmission device comprising a wireless transmitter or transceiver.

76. The device of claim 73, wherein the remote device is located at a further location at least 2 cm from the anatomical structure.

77. The device of claim 73, wherein the other location comprises the pleural cavity, a cavity in the abdominal space, a subcutaneous space, or an extracorporeal location.

78. The device of claim 21 , wherein the external processor capable of receiving the data to be wirelessly transmitted by the electronic unit of the sensor device is located outside the body of a patient-user, the sensor device being implantable in the patient-user and deployable at the anatomical structure.

79. The device of any one of claims 21 to 78, wherein the fluid flow parameter of the biological fluid in the anatomical structure comprises at least one of a flow rate or a pressure difference between two ends of a flow path in the anatomical structure.

80. The apparatus of claim 79, wherein the apparatus is operable to detect a size dimension of the anatomical structure or a predicted area or volume of the anatomical structure based on a baseline measurement of the flow rate and a change in the flow rate over time.

81. The device of any one of claims 21 to 80, wherein the anatomical structure is a heart and the biological fluid is blood.

82. The device of claim 81, wherein the in vivo The fluid flow sensor can be deployed within at least one layer of the pericardium of the heart, or wherein the sensor device can be deployed on an outer layer of the pericardium of the heart.

83. The apparatus of claim 81 , wherein the first arm and the second arm of the connecting assembly are positioned on opposing portions of the left atrium of the heart, and wherein the received ultrasound signal indicates blood flow at a mitral valve of the heart.

84. The apparatus of claim 81 , wherein the first arm and the second arm of the connecting assembly are positioned on opposing portions of the right atrium of the heart, and wherein the received ultrasound signal indicates blood flow at the tricuspid valve of the heart.

85. The apparatus of claim 81, wherein the first arm and the second arm of the connecting assembly are positioned on the superior vena cava or the inferior vena cava proximal to the heart, and wherein the received ultrasound signal indicates blood flow at the superior vena cava or the inferior vena cava.

86. The apparatus of claim 81, wherein the first arm and the second arm of the connecting assembly are positioned on a pulmonary artery or a pulmonary vein proximal to the heart, and wherein the received ultrasound signal indicates blood flow at the pulmonary artery or the pulmonary vein.

87. A method for in vivo Systems for monitoring fluid flow in anatomical structures, including: An implantable medical device according to any one of claims 1 to 86; and a data processing system comprising a processor and a memory, the data processing system being in data communication with the implantable medical device and being configured to receive the data from the implantable medical device and to process the received data to determine fluid flow parameters associated with a biological fluid in the anatomical structure and / or acoustic signal parameters associated with a physiological function of an internal body structure.

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