In-vivo fluid flow sensor

Abstract

Devices, systems, and methods are disclosed for in vivo monitoring of flow of biological fluid in an anatomical structure, such as blood flow through a heart valve (e.g., a mitral valve, a tricuspid valve, and / or an aortic valve) or a ventricle. The disclosed devices, systems, and methods enable continuous measurement and evaluation of forward and reverse blood flow at the entrance of a heart valve for determining cardiac function or dysfunction, and / or compilation with other monitoring data that can be used to measure or predict secondary factors.

Description

[0001] Cross-references to related applications

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

[0003] The present disclosure relates 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, killing approximately 17.9 million people each year. In the United States, heart disease is the leading cause of death, with coronary artery disease (CAD) being the deadliest, which results in reduced blood flow to the heart, often leading to a heart attack. 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 are not diagnosed until they develop signs or symptoms of a heart attack, heart failure, or arrhythmia, which may be too late to survive or regain 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 a doctor can begin a round of tests and remote monitoring of that person's heart. This is because there is no accessible, simple, and affordable device or technology 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, a patient 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., via a Holter monitor), can indicate heart rate and detect irregular heartbeats, or an echocardiogram, which is a noninvasive acoustic (sound) signal monitoring technology used to create images of the heart and blood in motion. In addition, 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, there have been some advances in remote monitoring that are beginning to turn the tide on 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, active lifestyle that may help prevent the onset of heart disease or mitigate mild to moderate heart disease in the long run, they do not recognize the symptoms or characteristics of a wide range of heart disease conditions 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 participation and compliance; and existing systems and methods are too time-consuming, costly, and resource-intensive to be ineffective.

[0008] There is a need for a new sensor paradigm that can be deployed within a patient and that is capable of monitoring the dynamic flow of biofluids in vivo, such as blood flow through heart valves, to characterize overall cardiac function. Summary of the invention

[0009] Briefly, devices, systems, and methods are disclosed for in vivo monitoring of the flow of a biological fluid in an anatomical structure, such as blood flow through a heart valve or blood flow through a heart chamber.

[0010] In some embodiments, a sensor device for monitoring fluid flow in an anatomical structure in vivo includes a connection assembly, the connection assembly including a first arm configured to be connected to a first portion of the anatomical structure and a second arm configured to be connected to a second portion of the anatomical structure opposite the first portion; a connection 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 connection 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 emit 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 electronic unit housed in the connection device and in electrical communication with the plurality of acoustic transducer elements of the ultrasonic sensor assembly, the electronic 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.

[0011] In some embodiments, a sensor device for in vivo monitoring of blood flow in a heart or blood vessel, the heart or blood vessel being introduced into or out of the heart in a patient's body, the sensor device comprising: a link assembly, the link assembly comprising a first arm configured to be attached to a first portion of the 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 a third acoustic transducer element configured to receive an acoustic signal that has propagated through the heart or blood vessel and is indicative of a fluid flow parameter of blood flowing in the heart or blood vessel; and an electronics unit housed in the connection device and in electrical communication with the plurality of acoustic transducer elements of the ultrasonic sensor assembly, the electronics unit 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 the first and second arms of the clamp to facilitate securing the sensor device 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 the size of the heart or blood vessel.

[0012] In some embodiments, a system for in vivo monitoring of fluid flow in an anatomical structure includes an in vivo sensor device operably deployed within a patient-user and attached to the anatomical structure, and a data processing system in data communication with the in vivo sensor device. The in vivo 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 connection device connected to each of the first arm and the second arm; an ultrasound sensor assembly including a plurality of acoustic transducer elements coupled to the connection 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 connection device and in electrical communication with the plurality of acoustic transducer elements of the ultrasound 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. The data processing system includes a processor and a memory and is configured to receive data from the in vivo sensor device and process the received data to determine a fluid flow parameter associated with the biological fluid in the anatomical structure.

[0013] In some embodiments, a sensor device for in vivo monitoring of cardiac function includes a connection assembly comprising a first arm configured to attach to a first external portion of a heart, and an optional second arm that can be configured to attach to a second external portion of the heart; a housing connected to the linkage assembly; a sensor assembly coupled to the first arm and configured to detect a functional parameter of the heart; and an electronic unit disposed in the housing and in electrical communication with the sensor assembly, the electronic unit configured to process an electrical signal associated with the detected functional parameter as data and wirelessly transmit the data to an external processor.

[0014] The above and additional features of the present invention and the manner in which they are obtained will become apparent and the present invention 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 document was incorporated individually.

[0015] 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.

[0016] 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. Therefore, 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 the concepts of the various patents, applications, and publications identified herein to provide further embodiments. Other features, objects, and advantages will be apparent from the description, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] 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, fully 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 only used for explanation and understanding.

[0018] Figure 1A A schematic diagram of an example embodiment of a system for in vivo monitoring of biological fluid flow in accordance with the present technology is shown.

[0019] Figure 1B The present invention is shown Figure 1A A block diagram of an example embodiment of an in vivo fluid flow sensor device.

[0020] Figure 2A A diagram depicting a method according to the present technology is shown. Figure 1B FIG. 1 is a diagram of an example embodiment of an in vivo fluid flow sensor device.

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

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

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

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

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

[0026] Figure 4B Schematic diagrams showing exemplary shape configurations of exemplary embodiments of in vivo fluid flow sensor devices according to the present technology for implantation procedures near a target anatomical structure and deployment procedures for fixation to the target anatomical structure.

[0027] Figure 5A A diagram depicting an example embodiment of a single-sided acoustic transducer configuration for an in vivo fluid flow sensor device in accordance with the present technology is shown.

[0028] Figure 5B A diagram is shown depicting another example arrangement of a single-sided acoustic transducer configuration on an array for an in vivo fluid flow sensor device in accordance with the present technology.

[0029] Figure 5C A diagram is shown depicting another example embodiment of a single-sided acoustic transducer configuration with a reflector for an in vivo fluid flow sensor device in accordance with the present technology.

[0030] Figure 5D A diagram depicting an example embodiment of a double-sided acoustic transducer configuration for an in vivo fluid flow sensor device in accordance with the present technology is shown.

[0031] Fig. 6A , 6B and 6C show the Figure 1B Schematic diagrams of other example embodiments of in vivo fluid flow sensor devices.

[0032] Fig.6D Shows a depiction Fig. 6A , 6B Exploded view of an example embodiment of an electronics unit and housing for an in vivo fluid flow sensor device of 6C and 6C.

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

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

[0035] Fig.7D A diagram depicting a method according to the present technology is shown. Figure 1B FIG. 1 is a diagram of another example embodiment of an in vivo fluid flow sensor device.

[0036] Fig. 7EA schematic diagram showing an exemplary embodiment of a remote in vivo device that can be connected to Figure 1B Exemplary embodiments of an in vivo fluid flow sensor device, such as Fig. 7A , 7B , 7C and / or 7D in vivo fluid flow sensor device.

[0037] Fig. 8A and 8B A diagram is shown of an example implementation of a device attached to a patient user's heart. Figure 1B FIG. 1 is a diagram of an example embodiment of an in vivo fluid flow sensor device. DETAILED DESCRIPTION

[0038] Disclosed are devices, systems and methods for in vivo monitoring of the flow of biological fluids in anatomical structures, such as blood flow through heart valves (e.g., mitral, tricuspid and / or aortic valves) or through heart chambers (e.g., atria or ventricles) or major blood vessels entering and exiting the heart (e.g., aorta, vena cava or pulmonary veins or arteries). The disclosed devices, systems and methods can continuously measure and evaluate forward and backward blood flow in cardiac regions (e.g., inlet or outlet of a heart valve) for determining cardiac function or dysfunction (e.g., such as mitral valve regurgitation (MVR)) and / or compiled 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)).

[0039] 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 a treatment site in the heart currently remains undetectable after treatment (e.g., implantation of a stent, 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. The in vivo fluid flow sensor devices of the disclosed in vivo fluid flow sensor platform can be implanted directly into 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.

[0040] For example, in some embodiments, the disclosed in vivo fluid flow sensor device can measure fluid flow through the atrial chamber to the ventricular chamber of the heart, for example, to determine 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 known as "valve flow" by measuring "Q", i.e., flow rate (blood volume / time) or pressure difference between the two ends of the flow path divided by resistance), which can be used to characterize the backflow of natural fluid blood flow, potential leakage and backflow of the valve. The disclosed in vivo fluid flow sensor device, when placed near the heart valve, can detect the location where valve dysfunction (e.g., leakage) occurs, for example, once placed in the appropriate position and properly calibrated. Embodiments of the disclosed in vivo fluid flow sensor platform (i.e., device, system and / or technology) 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 deleterious effects on cardiac function / performance relative to baseline and / or degradation following treatment (e.g., which may lead to cardiac disease 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 a cardiac valve can be used to correlate with cardiac function / performance and the effects of heart failure, as defined by CHF.

[0041] In addition, for example, data obtained by embodiments of the disclosed fluid flow sensor technology can be used to compile with 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 fluid flow sensor platform can position an in vivo fluid flow sensor device on the vena cava and apply ultrasound signals to obtain information (e.g., the size (thickness) of the blood vessel and the blood flow velocity through the vena cava), which can be used to determine pulmonary wedge pressure and thereby monitor the efficacy of certain medication doses when 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 properly complying with the medication therapy or whether the therapy is not optimal or effective, for example because the body has developed resistance to the medication over time.

[0042] The disclosed in vivo fluid flow sensor platform provides for obtaining acoustic signal measurements of fluid flow directly through anatomical structures (and without other anatomical structures in the acoustic signal path) and providing the obtained acoustic signal measurements to a remote device (e.g., a remote in vivo device that communicates with the in vivo fluid flow sensor device and / or an in vitro remote device that communicates with the in vivo fluid flow sensor device and / or the remote in vivo device), while also being able 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).

[0043] Although the disclosed embodiments of the in vivo sensors 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, 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, the renal system, or other systems.

[0044] For example, in some embodiments, a sensor device for in vivo monitoring of fluid flow in an anatomical structure when coupled to the 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, the linkage assembly comprising a first arm configured to be connected to a first portion of the 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 comprising a plurality of acoustic transducer elements coupled to the connecting 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 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 electronic unit housed in the connecting device and in electrical communication with the plurality of acoustic transducer elements of the ultrasonic sensor assembly, the electronic 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.

[0045] In some embodiments, for example, a sensor device for in vivo monitoring of fluid flow in an anatomical structure when coupled to the anatomical structure, such as monitoring blood flow in an atrium, a ventricle, a valve therebetween, or a major blood vessel of the heart, comprises: a first ultrasonic assembly comprising a first set of one or more acoustic transducer elements; a second ultrasonic assembly comprising a second set of one or more acoustic transducer elements; a first link coupled to the first ultrasonic assembly; a second link coupled to the second ultrasonic assembly; an electronics unit in electrical communication with the first ultrasonic assembly and the second ultrasonic 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 ultrasonic assembly at a first location on the anatomical structure and the second ultrasonic 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 transmitting and receiving 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.

[0046] These and other embodiments are discussed in more detail by way of the following examples.

[0047] Example Implementation

[0048] Figure 1A A diagram illustrating an example embodiment of a system 10 for in vivo fluid flow monitoring in a patient-user according to the present technology is shown. The system 10 includes one or more in vivo fluid flow sensor devices 100 implantable in a patient's body, and a data processing system 150 in communication with the one or more in vivo fluid flow sensor devices 100. In some embodiments, the system 10 includes a receiver device 130 operable to receive wireless transmissions carrying data indicative of detection signals obtained from the one or more in vivo fluid flow sensor devices 100, and transmit and / or store the data to the data processing system 150. In some embodiments, the one or more in vivo fluid flow sensor devices 100 and / or the receiver device 130 communicate with the data processing system 150 via a computer network 140 that communicates with each other and can be accessed via the Internet (e.g., referred to as the cloud), wherein data from the one or more in vivo fluid flow sensor devices 100 and / or the receiver device 130 can be transmitted to the data processing system 150. Similarly, information from the data processing system 150 can be transmitted to the receiver device 130 and / or the one or more in vivo fluid flow sensor devices 100.

[0049] In an example embodiment, the in vivo fluid flow sensor device 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. 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 device 100 is deployed within a patient-user.

[0050] exist Figure 1A In the example of the system 10 shown, one or more in vivo fluid flow sensor devices 100 include a first in vivo fluid flow sensor device 100Y, which is deployed at a first portion of the patient-user's body, such as the chest, head, torso, appendage, or other area; and one or more in vivo fluid flow sensor devices 100 include a second in vivo fluid flow sensor device 100X deployed at a second portion of the patient-user's body. One or both of the first and / or second in vivo fluid flow sensor devices 100Y and / or 100X 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 fluid flow sensor device 100Y can be coupled to an implant device deployed at or near the first portion of the 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, the second in vivo fluid flow sensor device 100X can be coupled to a second implant device deployed at or near the second portion of the patient-user's body.

[0051] In some exemplary embodiments, for example, the following 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 contact an anatomical structure, such as a heart, and electrically connected to an electronics unit 120 (e.g., housed in a 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, for example, 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. Further details of the sensor unit 110 and the electronics unit 120 of some embodiments of the in vivo fluid flow sensor device 100 are described in detail in the accompanying drawings. Figure 1B and other figures.

[0052] refer to Figure 1A In some embodiments, one or more in vivo fluid flow sensor devices 100 wirelessly transmit directly acquired collected data to a receiver device 130. For example, one or more in vivo fluid flow sensor devices 100 can transmit data to the receiver device 130 using a low-power wireless communication protocol, such as Bluetooth Low Energy (BLE), Near Field Communication (NFC), a low-frequency radio frequency (RF) signal in the range of 3kHz to 1.3MHz, etc. An example embodiment of the receiver device 130 includes 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, smart TV, etc.), a wearable computing device (e.g., a smart watch, smart glasses or helmet, etc.), a laptop or desktop computer, or others. The dedicated base station 130B may include a data storage and / or data communication unit that facilitates the transmission of data from one or more in vivo fluid flow sensor devices 100 to a 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 in multiple receiver devices, such as a computing device 130A (e.g., a smartphone, a 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.

[0053] exist Figure 1A In 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 each other. In an embodiment, for example, the computer device(s) 152, 154 and the database(s) 156 communicate with each other 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 a patient-user obtained by one or more in vivo fluid flow sensor devices 100 and / or remotely operate aspects of the system 10, such as, for example, modifying sensing parameters or protocols of one or more in vivo fluid flow sensor devices 100, data display or processing features of an application on the receiver device 130, and the like.

[0054] In some embodiments, for example, the system 10 optionally includes a remote computing device 160 operated by a remote user to remotely monitor data associated with a patient-user obtained by one or more in vivo fluid flow sensor devices 100, which is 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, a tablet computer, a smart watch, etc., or other computing devices. 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, a nurse, a family member or other caregiver of a patient-user, or a medical insurance payer, or other types of stakeholder entities or individuals regarding the health of the patient-user.

[0055] Figure 1B Shows the description Figure 1A , which is a block diagram of an exemplary embodiment of an in vivo fluid flow sensor 100. Figure 1B In FIG. 1 , an in vivo fluid flow sensor 100B is shown. 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 110B) and an example embodiment of an electronics unit 120 (shown as electronics unit 120B). The sensor unit 110B of the in vivo fluid flow sensor 100B includes at least one ultrasonic component in electrical communication with the electronics unit 120 via an electrical interconnect 117. Figure 1B 1 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 120 via an electrical interconnect 117. 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, in Figure 1BSimilarly, 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 a plurality of acoustic transducer elements may be configured as a transducer array of a corresponding ultrasonic sensor assembly. The electrical interconnect 117 is configured to couple each of the one or more acoustic transducer elements 113 of the first ultrasonic sensor assembly 111 and the one or more acoustic transducer elements 114 of the optional second ultrasonic sensor assembly 112 to an electrical interface of the electronic unit 120B. In various implementations of the example embodiment of the in vivo fluid flow sensor 100B, the first ultrasonic sensor assembly 111 and the optional second ultrasonic sensor assembly 112 may transmit and receive acoustic signals at one or more frequencies in the 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 may each include a frame, housing, or shell 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.

[0056] 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 send acoustic signals based on electrical input signals and receive acoustic signals to generate electrical output signals. For example, the piezoelectric transducer may include a solid piezoelectric ultrasonic transducer or a piezoelectric micromachined ultrasonic transducer (PMUT), such as a MEMS-based piezoelectric ultrasonic transducer 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.

[0057] The in vivo fluid flow sensor device 100B includes a connecting assembly 103B that couples the first ultrasonic sensor assembly 111 to the electronics unit 120B (and, in embodiments that include the second ultrasonic sensor assembly 112, couples the second ultrasonic sensor assembly 112 to the electronics unit 120B). In some embodiments, the connecting rod assembly 103B may include a pair of connecting rods that are configured to (1) secure (e.g., attach and anchor) the in vivo fluid flow sensor device 100B to a target in vivo organ or tissue, and (2) carry corresponding electrical interconnects 117 (connected to the transducer 113 and / or the transducer 114) from the first ultrasonic sensor assembly 111 and / or the optional second ultrasonic sensor assembly 112 to the electronics unit 120B. For example, in some embodiments, the pair of connecting rods of the connecting rod assembly 103B include spring connections that are later combined with the connecting rods 117 to carry the corresponding electrical interconnects 117 (connected to the transducer 113 and / or the transducer 114) from the first ultrasonic sensor assembly 111 and / or the optional second ultrasonic sensor assembly 112 to the electronics unit 120B. 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.

[0058] For example, in some embodiments of the in vivo fluid flow sensor device 100B, the sensor unit 110B may optionally include one or more secondary sensors 119. For example, in some embodiments, the auxiliary sensor 119 may include an analyte sensor to measure a parameter (e.g., concentration) of an analyte in a region adjacent to an anatomical structure in which the in vivo fluid flow sensor device 100B is deployed. In some examples, the optional second analyte sensor may include, but is not limited to, a glucose sensor. In addition to or as an alternative to the auxiliary analyte sensor, the auxiliary sensor 119 may include a pH sensor to measure the pH level in a region close to the anatomical structure. In addition to the auxiliary analyte sensor and / or the auxiliary pH sensor, the auxiliary sensor 119 may include a temperature sensor to measure the temperature in a region close to the anatomical structure. In this case, for example, the optional one or more secondary sensors 119 including the analyte sensor, the pH sensor, and / or the temperature sensor may be used to obtain data indicating a clinically relevant condition of the anatomical structure and / or a condition of the in vivo environment in which the in vivo fluid flow sensor device 100B is deployed, such as a potential infection or inflammatory response to the implantation of the in vivo fluid flow sensor device 100B. In some embodiments, for example, optional one or more secondary sensors 119 can be attached to the housing 101 of the in vivo fluid flow sensor device 100B, for example, by welding, chemical bonding, clips, clamps or other attachment means; and in some embodiments, for example, optional one or more second sensors 119 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.

[0059] In some embodiments, for example, the optional one or more auxiliary sensors 119 of the in vivo fluid flow sensor device 100B may include an inertial measurement unit (IMU) configured to monitor the movement of the in vivo fluid flow sensor device 100B in multiple degrees of freedom. In some embodiments, for example, the optional one or more auxiliary sensors 119 of the in vivo fluid flow sensor device 100B may include an accelerometer in communication with the data processing unit 121 of the electronic unit 120B. In some embodiments, for example, the optional one or more secondary sensors 119 of the in vivo fluid flow sensor device 100B may include a rate sensor in communication with the data processing unit 121 of the electronic unit 120B. In some embodiments, for example, the optional one or more auxiliary sensors 119 of the in vivo fluid flow sensor device 100B may include a magnetometer in communication with the data processing unit 121 of the electronic unit 120B. In such an embodiment, for example, when the in vivo fluid flow sensor device 100B is deployed outside the heart (e.g., in the pericardium), the in vivo fluid flow sensor device 100B is operable to measure heart rate along with fluid flow through the heart (e.g., across the mitral valve or tricuspid valve).

[0060] Also in Figure 1BAs shown in the example of FIG. 1 , the electronic unit 120B of the in vivo fluid flow sensor device 100B 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, which may include conductive contact points (e.g., pads, pins, or other contact configurations) electrically connected to the electrical interconnect 117 of the sensor unit 110B. The electronic unit 120B is configured to receive and at least partially process electrical signals acquired from one or more acoustic transducers 113 of the first ultrasonic sensor assembly 111 and one or more acoustic transducers 114 of the second ultrasonic sensor assembly 112 of the sensor unit 110B. For example, in some embodiments, the electrical signals are received at corresponding contact points 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 110B). 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 110B to be wirelessly transmitted to an external device via the wireless communication unit 127. In an example embodiment of the electronic unit 120B, 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 120B and / or the sensor unit 110B. For example, in some embodiments, the power supply 129 includes an ultra-low power system (e.g., operating in the microampere range).

[0061] For example, in some optional embodiments, the signal conditioning unit 123 may include a circuit including one or more filters and / or one or more amplifiers to increase the raw electrical signal detected by the ultrasonic sensor assembly 111, 112 of the sensor unit 110B, thereby increasing the signal-to-noise ratio (SNR) of the electrical signal, thereby generating data including the electrical signal after signal processing. In some optional embodiments, the signal conditioning unit 123 may include a drive circuit to generate an operating electrical signal, which generates an electrical potential and / or current at the optional analyte sensor electrode group and / or temperature sensor group of the sensor unit 110B, for operating the electrochemical sensing technology and / or electrophysiological or kinetic sensing technology to be performed at the electrode in the implementation of the optional secondary sensor 119 of the sensor unit 110B.

[0062] In some embodiments, for example, the wireless communication unit 127 includes a wireless transmitter, receiver and / or transceiver device including an antenna, which 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, as described below). For example, the wireless communication unit 127 can be configured to manage a communication protocol for transmission or reception via an 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 computer, or other external computing device such as a receiver device 130. Additionally or alternatively, in some embodiments, for example, the wireless communication unit 127 is configured as a scaffold around the electronic unit 120B, such as, for example, coupled to or integrated with the housing 101, which is configured to provide a wireless communication device to the in vivo fluid flow sensor device 100B.

[0063] In some embodiments, the electronic unit 120B includes a data processing unit 121 to at least partially process the conditioned electrical signal to (i) generate data, for example in analog or digital form, and / or (ii) control the functionality of the electronic unit 120B and / or the sensor unit 110B. For example, the data processing unit 121 can be configured to manage data acquisition on data channels associated with one or more acoustic transducers 113 and one or more acoustic transducers 114 of the sensor unit 110B.

[0064] 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, which 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, which configures the data processing unit 121 to perform various operations when executed by the processor, 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 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 functions of memory 121B. In some embodiments, data processing unit 121 includes input / output (I / O) unit 121C to interface processor 121A and / or memory 121B to other modules, units, or devices associated with 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 an embodiment, 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, which may be used for communication of data processing unit 121 with 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 be connected to 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 120B 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 an output unit of a receiver device 130 (e.g., a smartphone, tablet computer, etc.) or other external devices connected to the in vivo fluid flow sensor device 100.

[0065] In an implementation of the in vivo fluid flow sensor device 100B, 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, the in vivo fluid flow sensor device 100B is configured to measure the Doppler shift of the acoustic probe signal on the anatomical structure. For example, the propagation time of the acoustic signal indicates the 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 an acoustic probe signal through a region of interest (e.g., the mitral valve of the heart) so that a relative set of transducers in the one or more transducers 113 and / or one or more transducers 114 receive the acoustic probe signal deflected 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 signals 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.

[0066] Figure 2A Shows a depiction Figure 1B FIG. 10B is a diagram of an example embodiment of an in vivo fluid flow sensor device 100B, in Figure 2AAn in vivo fluid flow sensor device 200 is shown in FIG. The in vivo fluid flow sensor device 200 includes a sensor unit, which includes an ultrasonic sensor assembly 211 and an ultrasonic sensor assembly 212, which are in electrical communication with an electronic unit 220 via an electrical interconnect 217 (e.g., coupled to or partially housed within a connecting rod such as an arm of the connecting rod assembly 203). The ultrasonic sensor assembly 211 includes a plurality of acoustic transducer elements 213, namely, three acoustic transducer elements 213a, 213b, 213c in this example; and the ultrasonic sensor assembly 212 includes a plurality of acoustic transducer elements 214, namely, 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 The configurations shown in the figures are fewer or more, for example, including but not limited to one or more acoustic transducer elements of each ultrasonic sensor assembly 211 and 212. Ultrasonic sensor assembly 211 and ultrasonic sensor assembly 212 include a frame, housing or shell structure (not shown) to fix acoustic transducer element 213 and acoustic transducer element 214 to the arms of linkage assembly 203, respectively, and position them in fixed positions relative to each other.

[0067] The electronic unit 220 of the in vivo fluid flow sensor device 200 is configured to be surrounded by a spring connection device 235, which is coupled to each link of the link assembly 203. The spring connection device 235 provides sufficient movement of the arm of the link assembly 203 to couple to the intended deployment location of the ultrasound sensor assembly 211 and the ultrasound sensor assembly 212, such as across the proximal and distal sides of the left atrium or the right atrium of the heart, so that the force applied by the ultrasound sensor assembly 211 and the ultrasound sensor assembly 212 on the anatomical structure (e.g., the heart) is sufficient to fix the in vivo fluid flow sensor device 200 while not interfering with the normal function of the anatomical structure of the intended application of the in vivo 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 to transmit sufficient force to promote and / or maintain the fixation of the in vivo fluid flow sensor device 200 to the target portion of the heart (e.g., the left atrium or the right atrium), allows the device 200 to be provided with sufficient flexibility to stabilize its placement while withstanding the continuous movement (load cycle) of the anatomical structure to which it is connected (e.g., heartbeat) without suffering damage from hundreds of millions to billions of cycles - thereby allowing the in vivo fluid flow sensor device 200 to have a considerable lifespan (e.g., 50 to 60 million heartbeats per year) over decades of use. In addition, the linkage of the linkage assembly 203 is adjustable in all three planes (xy, xz, yz) to allow initial correct alignment of the ultrasound sensor assemblies 211, 212.

[0068] For example, in some embodiments, the in vivo fluid flow sensor device 200 may be secured to the anatomical structure by means of a network of prongs, screws, barbs, sutures, adhesives (e.g., bio-inert glue), or gripping mechanisms (not shown) disposed via the frames or housings of the ultrasonic sensor assemblies 211 and 212. Figure 2A In some embodiments (not shown in the drawings), the frame, housing, or shell structure may include one or more openings on each link of the linkage assembly 203 that may allow for an auxiliary connection device of the device 200 to the target anatomical structure, such as an opening with an anchor point to apply a suture that connects the link of the linkage assembly 203 to the anatomical structure (e.g., the atrial wall). In some embodiments, the connection assembly 203 may include a material that provides sufficient flexibility and rigidity to allow the in vivo fluid flow sensor device 200 to be deployed on the anatomical structure without such harmful interference. For example, in some embodiments, the connection assembly 203 may include nitinol, platinum, MP35N, or other materials or combinations thereof. In some embodiments, the linkage assembly 203 provides a closure that locks onto the heart, for example, not allowing further movement of the link.

[0069] Figure 2BShows a depiction Figure 1B FIG. 10B is a diagram of another example embodiment of an in vivo fluid flow sensor device 100B, in Figure 2B The in vivo fluid flow sensor device 200B is shown in FIG. The in vivo fluid flow sensor device 200B includes a sensor unit, which includes two or more sets of ultrasonic sensor teams 250 (in Figure 2B 203A and 203B), which are electrically connected to the electronic unit 220 via electrical interconnect 217 (e.g., coupled to or partially housed in each set of connection components 203A and 203B, respectively). Each set of ultrasound sensor units 251 and 252 includes an ultrasound sensor assembly 211 and an ultrasound sensor assembly 212, which include a plurality of acoustic transducer elements 213 and a plurality of acoustic transducer elements 214, respectively, so that multiple planes of acoustic signal propagation are measured in a region of interest of an anatomical structure (e.g., the mitral valve of the heart). In this example, the electronic unit 220 is partially surrounded by two or more sets of spring connection devices, shown by a spring connection device 235B corresponding to the ultrasound sensor group 250B and a spring connection device 235A corresponding to the ultrasound sensor group 250A.

[0070] Figure 2C Shows a depiction Figure 1B FIG. 10B is a diagram of another example embodiment of an in vivo fluid flow sensor device 100B, in Figure 2C The in vivo fluid flow sensor device 200C is shown in FIG. The in vivo fluid flow sensor device 200C may be configured similarly to the in vivo fluid flow sensor device 200 (previously described in Figure 2A ), for example, where the sensor unit includes an ultrasonic sensor assembly 211 and an ultrasonic sensor assembly 212, and the ultrasonic sensor assembly 212 is in electrical communication with the electronics unit 220 via an electrical interconnect 217 (e.g., coupled to or partially housed within a link of the link assembly 203). However, in Figure 2C In the embodiment of the invention, the electronic unit 220 of the in vivo fluid flow sensor device 200C is configured to be surrounded by a flexible connection device 235C, which includes a first link 236 that can be pivotally moved relative to a second link 237, and / or vice versa, thereby providing the device 200C with sufficient flexibility to stabilize its placement around the anatomical structure while withstanding continuous movement (load cycle) of the anatomical structure to which it is connected (e.g., heartbeat) without suffering damage hundreds of times. In some embodiments, the flexible connection device 235 includes a spring. In some embodiments, the first link 236 can move within the cavity of the second link 237, and / or vice versa.

[0071] In addition, the flexible connection device 235C couples the sensor unit 220 to each link of the link assembly 203. Figure 2C203C. However, Figure 2C In the embodiment, the connecting rod assembly 203C includes a linear arm portion near the flexible connection device 235C and a curved arm portion away from the flexible connection device and near the ultrasonic sensor assembly 211 and the ultrasonic sensor assembly 212. In this way, for example, the structure of the in vivo fluid flow sensor device 200C can be attached to the curved geometry of the anatomical structure, such as the left atrium or the right atrium of the heart, and provide sufficient compression force for attachment with sufficient flexure to alleviate the load cycle. In some embodiments, for example, one or two 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 electronic unit and the ultrasonic sensor assembly 211 and / or 212.

[0072] In addition, 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 to the connecting rod of connecting rod assembly 203C, respectively, and to position them in a fixed position relative to each other. Figure 2C 203C to the anatomical structure (e.g., the atrial wall). 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.

[0073] Although in Figure 2C 200C, but the sensor unit of the in vivo fluid flow sensor device 200C may include two or more sets of ultrasonic sensor components 250 (e.g., Figure 2B 203C) are in electrical communication with the electronics unit 220C via electrical interconnect 217 (eg, each coupled to or partially housed within a respective arm of the connection assembly 203C).

[0074] Figure 2D Shows a depiction Figure 1B FIG. 10B is a diagram of another example embodiment of an in vivo fluid flow sensor device 100B, in Figure 2D In vivo fluid flow sensor device 200D is shown in FIG. In vivo fluid flow sensor device 200D may be configured similarly to in vivo fluid flow sensor device 200 (previously described in Figure 2A ) and / or in vivo fluid flow sensor device 200C (previously shown in 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 connection device 235. The acoustic transducer elements of ultrasonic sensor assemblies 211D and 212D are each coupled to a link of a link assembly 203D and position them in a fixed position relative to each other. In some embodiments, for example, connection 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., having an antenna for transmission), for example, to enable power transmission to implement a charging system for power management for functional performance. For example, the mechanical force for closing 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 around the anatomical structure. However, in Figure 2D , the link assembly 203D of the in vivo 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 item that can be made of a metal or polymer material and is located on the link between the connecting device 235D and the distal end portion of the link 239D supporting 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., a tissue or organ or a blood vessel) by a material such as a suture, a polymer thread, a metal suture needle, which can pass through the opening 218 and bind the anchor support 233D to the wall of the anatomical structure.

[0075] Figure 3 A diagram is shown illustrating an example embodiment of an in vivo fluid flow sensor device 200 attached to the heart of a patient-user in an example implementation of the device 200. Figure 3An exemplary in vivo fluid flow sensor device 200 is shown, but it should be understood that other embodiments of the in vivo fluid flow sensor device 100 may be attached to the heart of a patient-user to evaluate blood flow in a target area of ​​the heart. In this example, the in vivo fluid flow sensor device 200 is configured to evaluate blood flow across the mitral valve, such as for evaluating mitral regurgitation (MR), by placing a first ultrasonic sensor assembly 211 proximal to the outer surface of the left atrium (LA) of the heart and a second ultrasonic sensor assembly 212 distal to the outer surface of the LA. For example, the in vivo fluid flow sensor device 200 may be secured to the LA by clamping the first and second ultrasonic sensor assemblies 211, 212 to the LA, which creates a plane perpendicular to the mitral valve for propagating acoustic signals. As shown in FIG. Figure 3 As shown, the arms of the in vivo fluid flow sensor device 100 (e.g., the links of the link assembly 203 of the device 200) can extend around an organ (e.g., the LA of the heart) with a specific spring constant that can support a variety of 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 (optionally) 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 fluid flow sensor devices 100 can be deployed at different locations of the same anatomical structure, for example, 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).

[0076] Figure 4A Figures depicting insertion locations of various embodiments of a fluid flow sensor device 100 for implantation in vivo, such as Figure 3 In some embodiments, for example, the in vivo fluid flow sensor device 200 (or other embodiments of the in vivo fluid flow sensor device 100) can be implanted and positioned on the heart via pericardial puncture and device delivery in the pericardial cavity, such as Figure 3As shown. The exemplary in vivo fluid flow sensor device 200 can be attached to a mechanism for loading, carrying, and delivering into the thoracic cavity or placement in the pericardium on the surface of the heart (e.g., through the left atrium 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 100) in a first shape 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 100 may be inserted into the patient's body at other insertion sites not shown in the figure, and then during the implantation process, the exemplary in vivo fluid flow sensor device 100 may change to a second shape to confirm to ensure that the relative ultrasound sensor assembly passes through the target area of ​​the heart, such as through the left atrium in the normal plane of the mitral valve. In some embodiments, for example, if necessary, the catheter can be used to communicate with the exemplary in vivo fluid flow sensor device 100, or to recharge a power source (e.g., power source 129) in an embodiment of the device 100. In some embodiments, an embodiment of the in vivo fluid flow sensor device 100 can be implanted and positioned on the heart outside the pericardial sac.

[0077] In some embodiments, for example, the in vivo fluid flow sensor device 100 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 chest cavity of the patient-user through a major sternotomy or thoracotomy procedure. After insertion, the in vivo fluid flow sensor device 100 can undergo a second stage (second configuration) for placement around the heart, for example, in the transition area between the atria to the ventricles on the left side, or on the right side of the same location. The in vivo fluid flow sensor device 100 can be independently fixed to the location of the anatomical structure placed by the surgeon, for example, based on the compression and bending characteristics 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.

[0078] Figure 4B A schematic diagram showing an exemplary shape configuration of an exemplary embodiment of an in vivo fluid flow sensor device according to the present technology for use in an implantation process near a target anatomical structure and a deployment process secured to a target anatomical structure. FIG. 400A shows Figure 1B Another exemplary embodiment of the in vivo fluid flow sensor device 100B, in Figure 4B4 shows an in vivo fluid flow sensor device 400 having arms of a connection assembly 403 extending outwardly from a 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 in vivo fluid flow sensor device 400 can be inserted into a patient's body (e.g., through a port through a rib, similar to Figure 4A The insertion location shown) is positioned to approach the 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.

[0079] FIG. 400B shows the in vivo fluid flow sensor device 400 in a second configuration with the arms of the linkage assembly 403 extending inwardly toward the centerline through the connection means 435, e.g., for use during deployment to attach to an anatomical structure 490. The in vivo fluid flow sensor device 400 may be configured similarly to the in vivo fluid flow sensor device 200 (previously described in Figure 2A ), for example, wherein the sensor unit includes an ultrasonic sensor assembly 411 and an ultrasonic sensor assembly 412 that are in electrical communication with an electronic unit 420 via an electrical interconnect (not shown). For example, during or after connecting the in vivo fluid flow sensor device 400 to the anatomical structure 490, the ultrasonic sensor assemblies 411 and 412 on the distal portion of the connecting rod 403 can be oriented around the expected measurement location (e.g., by an insertion instrument before it is withdrawn) 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 removing the insertion instrument, the wireless data communication of the in vivo fluid flow sensor device 400 with a remote device (e.g., a remote computing device 130A and / or a remote base station 130b) can be tested. In some embodiments, for example, sutures or other fixation techniques (e.g., adhesives or other) can be used to further fix the in vivo fluid flow sensor device 400.

[0080] In use Figure 1BIn some example embodiments of the ultrasound sensor assembly of various embodiments of the in vivo fluid flow sensor device 100B, the transducer array is designed to spatially configure a single transmitter with at least two receivers that interleave and exchange the receivers and transmitters so that a single or multiple fields of ultrasound energy are displaced around a heart chamber (e.g., an atrium or ventricle), for example, to detect a Q-wave flow pattern or a disruption in the flow pattern. By detecting a Q-wave flow pattern or a disruption in the flow pattern, the data can be interrogated and mapped to backflow of blood flowing through a chamber valve and backflowing through a chamber valve, which indicates wall / chamber dysfunction (e.g., which can be associated with a disruption in the electrical signal of the heart pulsation and / or clotting of static blood). In addition, mechanical analysis of chamber diameter changes can be calibrated and detected by the exemplary ultrasound sensor assembly 511 and / or 112 for changes in use, and therefore, 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 a dysfunction in the removal of cellular analytes, such as water, electrolytes and / or cellular waste products, which can lead to CHF in a patient.

[0081] Figure 5A Shows the description Figure 1B FIG. 1 is a diagram of an example implementation of an in vivo fluid flow sensor device 100B, in Figure 5A , shown as an in vivo fluid flow sensor device 500 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), depicts an example embodiment of an acoustic transducer configuration according to the present technology. The exemplary in vivo fluid flow sensor device 500 includes an embodiment of an electronics unit 120B coupled to an embodiment of a connection assembly 103B, having two opposing arms, wherein at their distal ends are a first ultrasonic sensor assembly 511 disposed on the first arm and a second ultrasonic sensor assembly 512 disposed on the second arm. 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 5AThe figure in shows a single Tx transducer 513a on one arm of the exemplary connection assembly 103B and two Rx transducers 514b and 514c on the opposite arm of the exemplary connection assembly 103B, but in some exemplary embodiments, one or more additional Tx transducer elements may be included on the first ultrasonic sensor assembly 511; and, in some exemplary embodiments, one or more additional Rx transducer elements may be included on the second ultrasonic sensor assembly 512. In addition, for example, in some embodiments, the 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, the second ultrasonic sensor assembly 512 may include one or more Tx transducer elements (e.g., at least one Tx transducer 513a).

[0082] exist Figure 5A In the illustrated example, the in vivo fluid flow sensor device 500 provides a unilateral acoustic detection system, wherein one or more Tx transducers 513a are configured on one side of the device 500 (i.e., an arm of a link assembly) to transmit an acoustic signal (e.g., a pulse, a waveform, etc.), and wherein 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 the fluid in the anatomical structure 590, is subject to reflection, refraction, or other propagation changes due to fluid flow, or (ii) the same side (i.e., the arm of the same link assembly as the Tx transducer 513a of the device 500) to receive an acoustic signal that, after propagating through the fluid in the anatomical structure 590, is subject to reflection, refraction, or other propagation changes due to fluid flow, and is reflected by the reflector structure ( Figure 5A not shown in; shown later) on the opposite side.

[0083] 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., a portion 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 Rx The spatial alignment of is configured to minimize interference of acoustic energy during operation of the ultrasound sensor assembly. Inset 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), such 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, e.g., along the x-axis, as shown in the example coordinate graph 598. Notably, the fluid flow direction is the x-axis direction of the coordinate graph 598 corresponding to the ultrasonic sensor assembly shown in insets 599T and 599R, and the x-axis direction of the coordinate graph 597 corresponding to the device 500 fixed to the anatomical structure 590.

[0084] As shown in inset box 599T, in some exemplary embodiments, the Tx transmitter 513a can be coupled to a backing or substrate 513s, which can be attached to the inner surface of the arm of the link assembly 103B. For example, the substrate 513s can provide thermal synchronization for managing the heat generated by the acoustic transducer. Similarly, inset box 599R shows an exemplary embodiment of the Rx transmitter 514b, 514c, which is coupled to a backing or substrate 514s, which can be attached to the inner surface of the arm of the link assembly 103B. For example, in some embodiments, one or some of the Rx transmitters 514b, 514c can be disposed on a single substrate 514s or separate substrates 514s in various combinations. Similarly, for example, the substrate 514s can provide thermal synchronization for managing the heat generated by the acoustic transducer.

[0085] In some embodiments, for example, the Tx transducer 513a is configured to have a 4 mm 2 Transducer area (e.g., 2 mm x 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. 2 Transducer area (e.g., 2 mm x 2 mm) or with 4π mm 2The 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 size) of the Rx transducers 514b, 514c may be greater than or less than 2 mm; for example, the size (e.g., width, length, diameter, etc.) of the Rx transducers 514b, 514c may be between 1 mm and 4 mm.

[0086] 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 site line and wave detection, such that the Rx transducers 514b, 514c detect and respond to an acoustic signal from the Tx transducer 513a that has propagated through the anatomical structure 590 and is 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) to 90 degrees relative to each other, out of the plane for site line 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 site line and wave detection.

[0087] In some embodiments, for example, the substrate 513s of the Tx transducer 513a may be configured to have a width (W) of 5 mm. Tx ) and 10mm 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 of 5 mm). Rx ) and 10mm in length (L Rx ).

[0088] Figure 5B An exemplary embodiment of an in vivo fluid flow sensor device 100B is shown, for example Figure 5A One or both of the first ultrasonic sensor assembly 511 and the second ultrasonic sensor assembly 512 of the in vivo fluid flow sensor device 500 are shown, and a diagram depicting an exemplary arrangement of acoustic transducers on the ultrasonic sensor assembly 511B is shown. 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, which may include more than one acoustic transducer element. Figure 5BThe 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, and the different row is 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 illustrated example embodiment, for a single transmitter element corresponding to at least two receiver transducers (eg, 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, 564e Rx1 The spatial alignment of is configured to minimize interference of acoustic energy during operation of the transmitter-receiver set of the 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 ) 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 511B.

[0089] It is noteworthy that, for example, some example embodiments of ultrasound sensor assembly 511B may configure the transmitter rows and receiver rows to vary with combinations of transmitter elements and receiver elements integrated together in the same row. For example, in some embodiments, Tx transducer 563a may be configured to transmit one or more acoustic signals that propagate through anatomical structure 590 and may be received by Rx transducers 564d and 564e, and simultaneously or subsequently transducer 564e may be configured to transmit one or more acoustic signals that propagate through anatomical structure 590 and may be received by transducers 563a and 563b.

[0090] 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 2.25 π mm2 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 x 1.5 mm) or with a 2.25 π mm 2 Transducer area (e.g., 1.5 mm diameter) for receiving acoustic signals (e.g., transmitted from opposite side arrays on opposite arms of the connecting assembly of the device 500). It should be understood that the width, length, or diameter (or any dimension) of the 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 the ultrasonic sensor assembly 511B, the distance (d1) between the transmitter row and the receiver row, i.e., the centerline to centerline distance, can be approximately 5 mm, for example, to achieve optimal LOSTR (e.g., as a minimum distance to minimize interference). For this example configuration of the 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 may 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.

[0091] 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 insulation for managing the 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 transmitter and receiver rows). S1 ) and a second side length of 10 mm (parallel to the transmitter and receiver rows) (l S2 ).

[0092] In some embodiments, for example, the ultrasound sensor assembly 511B can be used in an exemplary single-sided acoustic detection system for the in vivo fluid flow sensor device 100, wherein one or more Tx transducers are configured on one side (i.e., an arm of the linkage assembly) to transmit an acoustic signal (e.g., a pulse, waveform, etc.) through the anatomical structure, such that at least two Rx transducers corresponding to the Tx transducers are configured on the 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, the ultrasound sensor assembly 511B can be used in an exemplary double-sided acoustic detection system for the in vivo fluid flow sensor device 100, wherein a first set of one or more Tx transducers are configured on one side of the anatomical structure (i.e., an arm of the linkage assembly), and transmission and reception (from the first set of at least two corresponding receiver elements) are performed simultaneously with a second set of one or more Tx transducers on the opposite arm of the anatomical structure from a second set of at least two corresponding receiver elements. An example of a two-sided acoustic detection system is given later in Figure 5D Shown in.

[0093] Figure 5C Shows the description Figure 1B FIG. 1 is a diagram of an example implementation of an in vivo fluid flow sensor device 100B, in Figure 5C500C is shown as an in vivo fluid flow sensor device 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), depicting an example embodiment of an acoustic transducer configuration according to the present technology. The exemplary in vivo fluid flow sensor device 500C includes an embodiment of an electronic unit 120B coupled to an embodiment of a connection assembly 103B, having two opposing arms, wherein at the distal end of one arm 503C1 is an ultrasonic sensor assembly 511C, and at the distal end of the opposing arm 503C2 is a reflector 516. For example, in some embodiments, the reflector 516 can be configured as a specular reflector, having a substantially flat surface, a substantially smooth surface, and a border / region having a size greater than the wavelength of the acoustic signal. However, in some embodiments, for example, the 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 border / region having a size less than the wavelength of the acoustic signal. And, in some embodiments, the 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 the contours of an anatomical site (e.g., an organ or a vessel), compiled with focal reflectance for optimal energy response. Example materials for reflector 516 can include, but are not limited to, polyester film (e.g., on a substrate); noble metals such as silver, platinum, gold, palladium (e.g., vacuum deposited noble metals); or standard metals such as silver, titanium, nitinol, or stainless steel (e.g., polished for wavelength), or combinations thereof.

[0094] 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 this configuration, the in vivo fluid flow sensor device 500 provides a single-sided acoustic detection system, wherein 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., the 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.

[0095] 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.

[0096] An example implementation of the in vivo fluid flow sensor device 500 is performed in a benchtop setup designed to simulate blood flow through a chamber or tube similar to the anatomical structure 590, which tests the characteristics of the received acoustic signal. Table 1 describes the functions of frequency and sensitivity of 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., by incorporating Figure 5A The ultrasonic sensor components 511, 512, Figure 5B 511B and / or Figure 5C This is illustrated by an exemplary embodiment of an in vivo fluid flow sensor device 500 shown at 511C.

[0097] Table 1.

[0098] X 3MHz 6MHz 9MHz (mm) ΔΦΔt ΔΦΔt ΔΦΔt 1 0.18 164.1 0.35 164.1 0.53 164.1 2 0.35 328.1 0.71 328.1 1.06 328.1 3 0.53 492.2 1.06 492.2 1.59 492.2 4 0.71 656.3 1.42 656.3 2.13 656.2 6 1.06 984.4 2.13 984.4 3.19 984.2 8 1.42 1312.5 2.84 1312.5 4.25 1312.5

[0099] Table 1 describes the relationship between flow sensitivity (φ / t) and 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. The unit of sensitivity ΔΦ is (deg / [l / min]); the unit of duration or function period Δt is (ps / [l / min]).

[0100] Figure 5D Shows the description Figure 1B FIG. 1 is a diagram of an example implementation of an in vivo fluid flow sensor device 100B, in Figure 5D 595 is shown as an in-vivo fluid flow sensor device 500D 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), depicting an example embodiment of an acoustic transducer configuration according to the present technology. The exemplary in-vivo fluid flow sensor device 500D includes an embodiment of an electronics unit 120B coupled to an embodiment of a connection assembly 103B, having two opposing arms, wherein at their distal ends are a first ultrasonic sensor assembly 511D disposed on the first arm and a second ultrasonic sensor assembly 512D disposed on the second arm. 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 5D In 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.

[0101] exist Figure 5D In the example shown, the in vivo fluid flow sensor device 500D provides a dual-sided acoustic detection system for the in vivo fluid flow sensor device 100, wherein a first group 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 the linkage assembly) starting from a first group of at least two corresponding receiver elements (e.g., Rx transducers 534b, 534c), which operate simultaneously (e.g., transmit and receive) with a second group of one or more Tx transducers (e.g., Tx transducer 533a) on the opposite arm of the anatomical structure 590 starting from a second group of at least two corresponding receiver elements (e.g., Rx transducers 524b, 524c).

[0102] 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.

[0103] An example implementation of the in vivo fluid flow sensor device 500D is performed in a benchtop setup designed to simulate blood flow through a chamber or tube similar to the anatomical structure 590, which tests the characteristics of the received acoustic signals. Table 2 describes the functions of frequency and sensitivity of an exemplary two-sided acoustic detection system, for example, Figure 5D The illustrated exemplary embodiment of an in vivo fluid flow sensor device 500D incorporating ultrasonic sensor assemblies 511D, 512D is illustrated.

[0104] Table 2.

[0105] X 3MHz 6MHz 9MHz (mm) ΔΦΔt ΔΦΔt ΔΦΔt 1 0.09 82.0 0.18 82.0 027 82.0 2 0.18 164.1 0.35 164.1 0.53 164.1 3 0.27 246.1 0.53 246.1 0.08 264.1 4 0.35 328.1 0.71 328.1 1.06 328.1 6 0.53 492.2 1.06 492.2 1.59 492.2 8 0.71 656.3 1.42 656.3 2.13 656.3

[0106] Table 2 shows the relationship between flow sensitivity (φ / t) and example frequencies (e.g., 3 MHz, 6 MHz, and 9 MHz) and the distance (mm) between the transmitting and receiving acoustic transducers for a bilateral transducer configuration, i.e., a first set of at least one transducer element on opposite arms on the anatomical structure operating (e.g., transmitting and receiving) simultaneously with a second set of at least one transducer element on opposite arms through the anatomical structure from a second set of at least two corresponding receiver elements. The units of sensitivity ΔΦ are (deg / [l / min]); the units of duration or function period Δt are (ps / [l / min]).

[0107] The example data of 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) that are configured to simultaneously transmit acoustic signals in opposite directions from each other, which is approximately half the flow sensitivity compared to the example data of Table 1, which is based on a single-sided transmit transducer arrangement of ultrasonic sensor assemblies that transmit to a reflector, wherein at least two receive transducers are on the same side as the transmit transducer, or at least two receive transducers are on opposite sides of the anatomical structure from the transmit transducer.

[0108] In some example implementations of various embodiments of the in vivo fluid flow sensor device 100B, the device can be operated to send 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 blood flow 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 when 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.

[0109] An exemplary embodiment of the in vivo fluid flow sensor device 100B 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 )=2v f T cos(θ) / c, where f T is the frequency of the emitted sound signal, f R is 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.

[0110] For example, the in vivo fluid flow sensor device 100B can use Doppler technology in conjunction with a mass flow calculation of blood through an anatomical structure, such that the body mass flow in a confidence interval is equal to the density (known blood) and the diameter change (used to calculate the area), which enables the velocity to be determined. And, from the velocity and diameter, the device 100B can determine the Q of the fluid flow. In addition, the in vivo fluid flow sensor device 100B can measure the planar dimensions of the target anatomical structure based on a determinable change in fluid flow relative to a baseline measurement, for example, because an increased amount (volume) of fluid generally results in a wall dilation of the anatomical structure (e.g., a major blood vessel), i.e., an increase in the wall diameter.

[0111] In some example implementations of various embodiments of the in vivo fluid flow sensor device 100B, the device may 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 100B may be used in A-mode ultrasound acquisition to obtain a one-dimensional representation from acoustic signal waves transmitted and received in a direction in which the ultrasound transducer assembly is oriented, for example, where one axis represents depth and a vertical axis represents amplitude. In some examples, embodiments of the in vivo fluid flow sensor device 100B may be used in B-mode, also referred to as 2D mode, to obtain a two-dimensional representation from 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 100B may be used in C-mode to obtain a depth range from the A-mode and 2D information from the B-mode.

[0112] Fig. 6A Shows a depiction Figure 1B FIG. 10B is a diagram of an example embodiment of an in vivo fluid flow sensor device 100B, in Fig. 6A 600A. The in vivo fluid flow sensor device 600A includes a sensor unit including at least one ultrasonic sensor assembly 611, which is in electrical communication with an electronic unit 620 via an electrical interconnect (not shown), wherein the electrical interconnect is configured on the surface of or within the material body of the clamp 603. The electronic unit 620 is housed in a connection device 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, which are located on the inner facing side 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. Fig. 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 Fig. 6A 616 ), which is configured to reflect an acoustic signal emitted by the ultrasonic sensor assembly 611, which propagates through the anatomical structure, is affected by the fluid flow through the anatomical structure, is reflected from the reflector 616, and is received by the ultrasonic sensor assembly 611 as a return acoustic signal (corresponding to the emitted acoustic signal). In some embodiments, the reflector 616 may be attached to a backing or substrate 616s, which may be attached to the inner surface of the arm of the clamp 603.

[0113] 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 may be composed of a composite material having a hardness parameter 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 take a second shape / configuration for deployment / operation). Some non-limiting examples of composite materials for the clamp 603 may 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.

[0114] In some embodiments of the in vivo 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. Fig. 6A 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).

[0115] Figure 6B Shows a depiction Fig. 6A FIG. 6 shows an example embodiment of an in vivo fluid flow sensor device 600A, in which Figure 6B 600B is shown in the figure. The in vivo fluid flow sensor device 600B includes a sensor unit, which includes an ultrasonic sensor assembly 611 and a second ultrasonic sensor assembly 612, both of which are in electrical communication with an electronic unit 620 via an electrical interconnect (not shown), wherein the electrical interconnect is configured on the surface or inside the material body of the clamp 603. The electronic 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, which are located on the arms of the clamp 603, opposite to the arms on which the ultrasonic sensor assembly 611 is disposed. 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 side of the arms of the clamp 603 in a particular configuration relative to each other and relative to the acoustic transducer elements 613 of the ultrasonic sensor assembly 611 on the opposite arm of the clamp 603. It should be understood that the embodiment is not limited to five acoustic transducer elements per ultrasonic sensor assembly and may include more than one acoustic transducer element. Figure 6BThe 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 clamp 603 is configured to fix the acoustic transducer element 613 and the acoustic transducer element 614 and position them in a fixed position relative to each other. In some embodiments, the clamp 603 of the in vivo fluid flow sensor device 600B may include one or more openings 618 on at least one or both arms of the clamp 603, which allow an auxiliary connection device of the device 600B to be connected to the target anatomical structure. For example, 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).

[0116] Figure 6C Shows a depiction Fig. 6A In vivo fluid flow sensor device 600A and / or Figure 6B FIG. 6 is a diagram of an exemplary embodiment of an in vivo fluid flow sensor device 600B, in Figure 6C 600C. The in vivo fluid flow sensor device 600C includes a sensor unit including an ultrasonic sensor assembly 611 and / or a second ultrasonic sensor assembly 612, both of which are in electrical communication with an electronic unit 620 via an electrical interconnect (not shown), wherein the electrical interconnect is configured on the surface or in the body of material of the clamp 603. The electronic unit 620 is housed in a connection device 635 connecting the arms of the clamp 603. The in vivo fluid flow sensor device 600C includes an internal bending region 634 at the distal end of each arm of the clamp 603, for example, which can facilitate connection and conformity to anatomical structures when placed, as well as facilitate delivery of the device 600C, for example, via a catheter, and one or more openings 618 can be provided on the internal bending region 634 on at least one or both arms of the clamp 603 and / or on the arms near the internal bending region 634, for example, to allow an auxiliary attachment device of the device 600B to be attached to the target anatomical structure. In some embodiments, connection device 635 may be attached to clamp 603 on the outside of the arms of clamp 603 (not shown), which may be preferred for in vivo applications where device 600C is deployed on a vessel (e.g., such as the vena cava or pulmonary artery or vein).

[0117] In vivo fluid flow sensor devices 600A, 600B, and 600C Figures 6A-6CThe exemplary embodiments of the present invention respectively include a soft arm configuration of the clamp 603 for flexibility and adaptability to the intended placement site. The arms of the clamp 603 can promote and maintain electronic emission through an interconnect (not shown) to the electronic unit 620 housed in the connection device 635. The clamp 603 can enhance the contact of the device 600A, 600B, 600C with the anatomical structure for ultrasonic measurement. The arms of the clamp 603 can include a flexible, non-conductive, bio-inert substrate material, on which or embedded therein are flexible circuits and carriers for the ultrasonic sensor assembly 611 and / or the second ultrasonic sensor assembly 612. In this way, the clamp 603 can withstand and withstand mechanical forces during placement in the action of connecting the device to the intended location and during long periods of operation (e.g., hundreds of millions of cycles, such as heartbeats). In some embodiments, the arms of the connection assembly 603 can use a braided metal or polymer sheet, which is then interlaced with traces for electrical connection.

[0118] Fig.6D An exploded view of an example embodiment depicting an electronics unit 620 is shown, the electronics unit 620 being housed in Figures 6A-6C In some embodiments, for example, the connection device 635 includes a base housing 631 and a removably attached cap 633, which can be fixed to (e.g., hermetically sealed) the base housing 631 to protect the internal components (e.g., the electronic unit 620) from the external environment (e.g., biological fluids and / or biological components). For example, in some (optional) embodiments, the connection device includes an intermediate housing 632 that houses the electronic 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 modularization with various embodiments of the connection device 635 in any embodiment of the in vivo fluid flow sensor device 100, 100B.

[0119] 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 a metal film (thin film) and / or a woven cloth or polymer such as polyparaxylene, ethyl formate 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.

[0120] The electronic 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, the PCB 622 includes an embodiment of the data processing unit 121 to at least partially process the conditioned electrical signal to (i) generate data, such as in analog or digital form, and / or (ii) control the functions of the electronic unit 620 and / or the ultrasonic sensor assembly 611 and / or 612. For example, the data processing unit 121 can be configured to manage data acquisition on a data channel associated with one or more acoustic transducers of the ultrasonic sensor assembly 611 and / or 612. In addition, for example, in some embodiments, the PCB 622 includes a power unit, such as a supercapacitor or a small hermitic battery that can be charged by induction and / or used alone or in combination as a hybrid supercapacitor battery, so that the charging and running time are balanced to be effective for the required monitoring power and communication consumption.

[0121] 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, 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 structure to obtain optimal density for receiving and transmitting a single wire, thereby supporting information transmission in one or more directional modes. In some embodiments, the antenna can be configured into 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 reference operable for battery charging.

[0122] In some embodiments, the wireless communication unit of the electronic 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 a communication data packet 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 EKG port contacts) or base station equivalent.

[0123] Fig. 7A Shows a depiction Figure 1B FIG. 10B is a diagram of an example embodiment of an in vivo fluid flow sensor device 100B, in Fig. 7AThe in vivo fluid flow sensor device 700 is shown in FIG. The in vivo fluid flow sensor device 700 includes a sensor unit, which includes a first ultrasonic sensor assembly 711 and a second ultrasonic sensor assembly 612, both of which are in electrical communication with an electronic unit 720 via an electrical interconnect 717, wherein the electrical interconnect 717 is configured on the clamp 603 (at Fig. 7A The electronic unit 720 is housed in a connection device 735 connecting the arms of the clamp 703.

[0124] 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. Fig. 7A , the connection device 735 includes a power and / or data port 751, which is operable to interface with (e.g., conduct electrical and / or data communications with) the electronic unit 720 housed in the connection device 735. For example, the electronic unit 720 of the in vivo fluid flow sensor device 700 may include a rechargeable power source or intermediate power source, which can be connected to an independent power and / or data processing unit remote from the device 700 through the power and / or data port 751. In some example embodiments, the remote power and / or data processing unit can be an in vivo device located within the patient's body, but in an area that is more easily accessible to replace batteries or communicate wirelessly with it. For example, the remote in vivo device can be wired communication and provide power to the electronic unit 720 of the in vivo fluid flow sensor device 700 via a cable, wire, cord, etc. (e.g., covered by an insulating bio-inert material) through the power and / or data port 751. As an illustrative example, the in vivo fluid flow sensor device 700 may be deployed in a confined space, such as within or around the pericardium at the atrium or ventricle, or around the superior or inferior vena cava or pulmonary artery, tethered to a larger in vivo power supply device located in a cavity away from the location where the device 700 is deployed, for example, a centimeter or several centimeters or tens of centimeters away, such as a cavity within the pleural cavity or the abdominal cavity, where there is greater flexibility, size and / or positioning to facilitate larger power supplies and / or electronic components and allow replacement of these components. In some examples, the remote power supply may be located outside the body, 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.

[0125] In some example embodiments, an in vivo fluid flow sensor platform including the device 700 may include optional one or more secondary sensors 119 disposed within a remote in vivo device in wired communication with the sensor unit 720 via a cable, wire, cord, etc., which is connected via a power and / or data port 751. For example, in some embodiments, the example secondary sensor 119 may include an IMU to determine the motion of the patient-user (e.g., whether resting (e.g., lying down, sitting, etc.) or moving (e.g., walking, running, etc.). In addition, in some embodiments, the example secondary sensor 119 as part of the in vivo fluid flow sensor platform may include an acoustic sensor to monitor the breathing (respiratory parameters) of the patient-user (e.g., inhalation and exhalation breathing rate, turbulent airflow, etc.) monitored by the in vivo fluid flow sensor device 700. In addition, in some embodiments, the example secondary sensor 119 as part of the in vivo fluid flow sensor platform may include an EKG monitor (e.g., an external wearable heart monitor or an in vivo insertable heart monitor) to measure an electrocardiogram of the patient-user monitored by the in vivo fluid flow sensor device 700. In this manner, for example, the in vivo 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 (synchronously in time).

[0126] In some example embodiments, a remote in vivo device of the in vivo fluid flow sensor platform (which is in wired communication with the in vivo fluid flow sensor device 700) may include a secondary transmitting device (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., the base station 130B and / or the mobile communication device 130A). For example, data transmission by an example auxiliary transmitting device (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 transmitting device are reduced relative to the device 700. In some embodiments, for example, the secondary transmitting device of the remote in vivo device may be a transmitter, a receiver, and / or a transceiver having an antenna that uses a low-power wireless communication protocol, such as, for example, Bluetooth Low Energy (BLE), Near Field Communication (NFC), a low-frequency radio frequency (RF) signal in the range of 3kHz to 1.3MHz, etc.

[0127] refer to Fig. 7A In the exemplary embodiment of the in vivo fluid flow sensor device 700 shown, the first ultrasonic sensor assembly 711 includes a plurality of acoustic transducer elements 713, which are located on an arm of the clamp 703, the arm being opposite to the arm on which the second ultrasonic sensor assembly 712 is disposed. Fig. 7AIn the example shown, the plurality of acoustic transducer elements 713 of the first ultrasonic assembly 711 include five acoustic transducer elements 713a, 713b, 713c, 713d, 713e that are positioned on the inwardly facing side 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 the 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. Fig. 7A The configuration shown in the figure is less or more, 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, and the acoustic transducer elements 714 are located on the arms of the clamp 703, opposite to the arms on which the first ultrasonic sensor assembly 711 is disposed. Fig. 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 side of an arm 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 the embodiment is not limited to five acoustic transducer elements per ultrasonic sensor assembly and may include more than one acoustic transducer element. Fig. 7A The configurations shown in the figures may be fewer or more configurations, for example, including but not limited to one or more acoustic transducer elements of the second ultrasonic sensor assembly 712.

[0128] The clamp 703 is configured to secure the acoustic transducer element 713 and the acoustic transducer element 714 and position them in a fixed position relative to each other. In some embodiments, the clamp 703 of the in vivo fluid flow sensor device 700 may include one or more openings 718 on at least one or both arms of the clamp 703, which allow for auxiliary connection of the device 700B to the target anatomical structure. For example, Fig. 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).

[0129] In some embodiments of the in vivo fluid flow sensor device 700, similar to Fig. 7AIn 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 when placed, 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, allowing an auxiliary attachment device of the device 700 to be attached to the target anatomical structure.

[0130] Figure 7B and 7C Shows a depiction Figure 1B FIG. 10B is a diagram of an example embodiment of an in vivo fluid flow sensor device 100B, in Figure 7B and Figure 7C The in vivo fluid flow sensor device 700B is shown in FIG. The in vivo fluid flow sensor device 700B may be configured similarly to the in vivo fluid flow sensor device 700 (previously described in Fig. 7A ), for example, where 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 contained within an arm of a clamp 703), and where 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, the in vivo 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, wherein the acoustic transducer pad 771 is 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 arm of the clamp 703 and / or (at least one of) the plurality of acoustic transducer elements 713 of the ultrasonic sensor assembly 711 positioned on the arm 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 .

[0131] In various embodiments, the acoustic transducer pad 771 may include a hydrogel, which may be packaged in a gelatin form or a fluid form, having a housing including a polymer material (e.g., silicone, polyethylene, or other) having a hardness up to 40A durometer. In an exemplary embodiment of an in vivo fluid flow sensor device 700 employing an acoustic transducer pad 771, the acoustic transducer pad 771 may further provide contouring and padding against cardiac tissue, such as the outer tissue of the atrial or ventricular walls when the in vivo fluid flow sensor device 700 is deployed within the pericardium, and epithelial tissue of major blood vessels such as the vena cava or pulmonary artery or vein. For example, the acoustic transducer pad 771 may account for contour variations in anatomical structures that the device 700 directly interfaces with. In addition, for example, the acoustic transducer pad 771 may be operable to support signal-to-noise isolation and provide noise deflection for 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.

[0132] Fig.7D Shows a depiction Figure 1B FIG. 10B is a diagram of an example embodiment of an in vivo fluid flow sensor device 100B, in Fig.7D In vivo fluid flow sensor device 700D is shown in FIG. In vivo fluid flow sensor device 700D may be configured similarly to in vivo fluid flow sensor device 700 (previously described in Fig. 7A ) and / or in vivo fluid flow sensor device 700B (previously shown 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 ( Fig.7D 703) and wherein the connection means 735 includes a power and / or data port 751 for electrical communication with the electronics unit 720 and the remote device. However, as Fig.7D As shown, the in vivo fluid flow sensor device 700D includes an embodiment of the reflector 516 (in Fig.7D716), which is configured to reflect acoustic signals emitted by the ultrasonic sensor assembly 712, which propagate through the anatomical structure, are affected by the fluid flow through the anatomical structure, are reflected from the reflector 716, and are received by the ultrasonic sensor assembly 712 as a return acoustic signal (corresponding to the emitted acoustic signal). In some embodiments, the reflector 716 may be attached to a backing or substrate (not shown), which may be attached to the inner surface of the arm of the clamp 703 opposite the arm that facilitates the ultrasonic sensor assembly 712.

[0133] Fig. 7E A schematic diagram of an exemplary embodiment of a remote device 790 is shown, which is operable to communicate with Figure 1B An exemplary embodiment of an in vivo fluid flow sensor device of the present invention is wired to communicate with each other, for example, respectively at Fig. 7A , 7B - The in vivo fluid flow sensor apparatus 700, 700B and / or 700D shown in FIG7C and / or 7D. The remote in vivo device 790 includes a housing or casing 791 in which a power source 798 and a data processing and / or wireless communication unit 797 are housed.

[0134] Examples of power source 798 may include batteries, fuel cells, or other power sources. For example, in some embodiments, power source 798 may be configured as a replaceable battery and / or a rechargeable battery. For example, in an example implementation where remote in-vivo device 790 is located in an area or location within the patient's body that is relatively easy and safe for a clinician to access (e.g., a space in the pleural cavity or abdominal region), power source 798 may be recharged. In this way, the electrical energy stored in power source 798 may be used to power a power source in electronics unit 720, which may have a relatively lower charge storage capacity than power source 798. The transmission of electrical energy may be provided from remote in-vivo device 790 to example in-vivo fluid flow sensor device 700, 700B, 700D via cable, wire, or cord 793, which interfaces with power and / or data port 751 of example in-vivo fluid flow sensor device 700, 700B, 700D via interface terminal 792. In Fig. 7E In the exemplary illustration, the interface end 792 of the cable, wire or cord 793 is shown as having at least one protrusion structure that can be used to create a locking system with a power and / or data port 751 to ensure fixation (e.g., to prevent unwanted detachment of the cable, wire or cord 793 from the exemplary in vivo fluid flow sensor device 700, 700B, 700D within the patient's body).

[0135] An example of the data processing and / or wireless communication unit 797 may include a transmitter, receiver and / or transceiver with an antenna for data communication 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 797. In addition, the data processing and / or wireless communication unit 797 can be used to at least partially control certain device functions of the example in vivo fluid flow sensor device 700, 700B, 700D.

[0136] Fig. 8A and 8B Shows the description Figure 1B FIG. 1 is a diagram of an exemplary embodiment of an in vivo fluid flow sensor device 100B, in Fig. 8A and 8B , in vivo fluid flow sensor devices 800A and 800B are shown respectively, wherein in an exemplary embodiment of the device, the in vivo fluid flow sensor devices 800A, 800B are attached to the heart of a patient user. In this example, the in vivo fluid flow sensor devices 800A, 800B are configured to evaluate blood flow on the mitral valve by placing an ultrasound sensor assembly on opposite sides of the atrial outer surface around the mitral valve, for example, for evaluating MR. Fig. 8A and 8B As shown, the arms of the in vivo fluid flow sensor devices 800A and 800B (e.g., the arms of an exemplary embodiment of the connecting assembly 103 of the device 100B, 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 a variety of orientations for optimizing functional alignment with the target anatomical structure.

[0137] Additionally, optimal functional alignment may be maintained by the arms of the connecting assembly (e.g., curvature), which may position and secure the in vivo fluid flow sensor device 800A, 800B to the target anatomical structure alone or in conjunction with (optionally) one or more secondary connection mechanisms, such as sutures (secured to suture ports), adhesives, or anchoring structures (secured to anchor ports), which may be optimally placed for consistent measurements in the intended region of the organ / tissue (e.g., initial monitoring to establish calibration and then comparison). Additionally, in some embodiments, for example, multiple in vivo fluid flow sensor devices 800A, 800B may be deployed at different locations on the same anatomical structure.

[0138] The exemplary embodiment of the in vivo fluid flow sensor device 800A includes a connection device disposed inside the clamp band connection assembly (e.g., proximal to the anatomical structure to which the device 800A is connected). However, the exemplary embodiment of the in vivo fluid flow sensor device 800B includes a connection device disposed outside the clamp band connection assembly (e.g., away from the anatomical structure to which the device 800B is connected). It should be understood that for various embodiments of the in vivo fluid flow sensor device 100B, including any embodiment of the connection assembly 103, the configuration of the connection device can be inside or outside the connection assembly.

[0139] Example

[0140] In some embodiments according to the present technology (Example A1), a sensor device for in vivo monitoring of fluid flow in an anatomical structure includes a first ultrasonic component, which includes a first group of one or more acoustic transducer elements; a second ultrasonic component, which includes a second group of one or more acoustic transducer elements; a first link coupled to the first ultrasonic component; a second link coupled to the second ultrasonic component; an electronic unit in electrical communication with the first ultrasonic component and the second ultrasonic component, the electronic unit being configured to process an electrical signal associated with a returned acoustic signal as data and to wirelessly transmit the data to an external processor; and a spring connection device, which is connected to each of the first and second linkage mechanisms and is operable to position the first ultrasonic component at a first position on the anatomical structure and to position the second ultrasonic component at a second position on the anatomical structure to form a plane passing through the first and second positions 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 fluid flow parameters of a biological fluid in the anatomical structure.

[0141] Example A2 includes the sensor device of any of Examples A1-A4, wherein the anatomical structure is a heart.

[0142] Example A3 includes the sensor device 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.

[0143] Example A4 includes the sensor device of any of Examples A1-A3, wherein the first location and the second location are located on the 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.

[0144] In some embodiments according to the present technology (Example B1), a sensor device for in vivo monitoring of fluid flow in an anatomical structure includes a linkage assembly, the linkage 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 to 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 emit 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 electronic unit housed in the connecting device and in electrical communication with the plurality of acoustic transducer elements of the ultrasonic sensor assembly, the electronic 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.

[0145] Example B2 includes the sensor device of any of Examples B1-B50, wherein the ultrasonic sensor assembly includes a first ultrasonic sensor assembly disposed on a first arm of the linkage assembly and a second ultrasonic sensor assembly disposed on a second arm of the linkage assembly.

[0146] Exemplary B3 includes the sensor device of any one of Exemplary B2 or Exemplary 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 is 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 are 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.

[0147] Example B4 includes the sensor device of Example B2 or any one of Examples B1-B50, wherein the first ultrasound 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 ultrasound 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 ultrasound sensor assembly further includes fourth and fifth acoustic transducer elements, which are located on a distal region of the second arm to interface with the second portion of the anatomical structure and are configured to receive a first group of acoustic signals associated with the acoustic signal emission of the first acoustic transducer element, wherein the second ultrasound sensor assembly includes a sixth acoustic transducer element, which is located on a distal region of the first arm to interface with the first portion of the anatomical structure and is 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 ), the second center point is located between the first distance (d1) separating the centers of the fourth and fifth sound transducer elements, and 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.

[0148] Example B5 includes the sensor device 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 device further includes a reflector disposed on a second arm of the linkage assembly.

[0149] 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.

[0150] Example B7 includes the sensor device of any of Examples B1-B50, wherein the ultrasonic sensor assembly further includes 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.

[0151] 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 at least one acoustic transducer element.

[0152] 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).

[0153] 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 ultrasound sensor assembly and configured to provide contouring and padding against the anatomical structure.

[0154] Example B11 includes the sensor device of Example B10 or any of Examples B1-B50, wherein the acoustic transducer pad includes a hydrogel.

[0155] 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 withstanding continuous movement of the anatomical structure to which it is connected.

[0156] 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 arm and the second arm of the clamp to facilitate securing the sensor device to the first portion and the second portion of the anatomical structure and to absorb forces applied by the anatomical structure to the first arm and the second arm of the clamp due to continuous movement of the anatomical structure.

[0157] Example B14 includes the sensor device of Example B13 or any of Examples B1-B50, wherein the clamp includes a composite material having a flexible polymer component and a preformed and shape-changing shape-reinforcing component.

[0158] Example B15 includes the sensor device of Example B14 or any of Examples B1-B50, wherein the shape reinforcement member of the composite material includes one or more of nitinol, gold, platinum or iridium, which is encapsulated in a polymer member of the composite material, the polymer member including one or more of silicone, polyethylene, polyimide, polyamide or a mixture thereof.

[0159] 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.

[0160] 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 portions of the anatomical structure and to absorb force applied by the anatomical structure to the first and second arms of the linkage assembly due to continuous movement of the anatomical structure.

[0161] Example B18 includes the sensor device of any of Examples B1-B50, wherein the electronic unit includes a power source and a wireless communication unit, the wireless communication unit including a wireless transmitter or a wireless transceiver.

[0162] 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.

[0163] 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 multiple acoustic transducer elements of the ultrasonic sensor assembly via one or more electrical interface components, the signal conditioning unit including a circuit configured to process an electrical signal associated with a received acoustic signal by amplifying the electrical signal, filtering the electrical signal, or converting the electrical signal from analog to digital.

[0164] 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 that communicates with the signal conditioning unit, the data processing unit includes a processor and a memory, and is configured to process the amplified, filtered, or converted electrical signal into data representing a fluid flow parameter of the biological fluid.

[0165] 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.

[0166] Example B23 includes the sensor device of Example B18 or any one of Examples B1-B50, wherein the electronic 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 interconnects that span between a plurality of acoustic transducer elements of the ultrasonic sensor assembly and the PCB of the electronic unit.

[0167] 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 protect the electronics unit from exposure to body fluids when the sensor device is inserted and deployed in the body.

[0168] 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.

[0169] Example B26 includes the sensor device of example B24 or any of examples B1-B50, wherein the housing includes connection to the linkage assembly on an inward surface of the linkage assembly facing the anatomy, or wherein the housing includes connection to the linkage assembly on an outward surface of the linkage assembly facing away from the anatomy.

[0170] 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 body fluids.

[0171] 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.

[0172] 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 devices and in communication with the electronic unit, the secondary sensor being 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 sensor device is deployed.

[0173] 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.

[0174] Example B31 includes the sensor device of Example B29 or any of Examples B1-B50, wherein the second 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.

[0175] Example B32 includes the sensor device of Example B29 or any of Examples B1-B50, wherein the second 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.

[0176] 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 movement of the sensor device in multiple degrees of freedom.

[0177] 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.

[0178] Embodiment B35 includes the sensor device of any one of embodiments B1-B50, wherein the connecting component is capable of changing shape from a first shape configuration to a second shape configuration, in which in the first shape configuration, the first arm and the second arm of the connecting component are extended outward from the center line through at least one of the connecting component or the connecting device to be inserted into the patient's body, and wherein the first arm and the second arm of the connecting rod assembly extend inward toward the center line through at least one of the connecting rod assembly or the connecting device to be connected to the anatomical structure for operation of the sensor device.

[0179] Example B36 includes the sensor device of any of Examples B1-B50, further comprising a second link 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 ultrasound sensor assembly comprises a set of additional multiple acoustic transducer elements connected to the second connecting assembly, the set of additional acoustic transducer elements being configured to emit 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.

[0180] 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 the anatomical structure and at a certain distance from the anatomical structure.

[0181] 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 disposed in a remote device via at least one of a cable, wire, or cord so as 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.

[0182] Example B39 includes the sensor device of example B38 or any of examples B1-B50, wherein the sensor device is configured to wirelessly transmit data to an external processor via a secondary transmission device including a wireless transmitter or transceiver.

[0183] Example B40 includes the sensor device of Example B37 or any of Examples B1-B50, wherein the remote device is located at another location at least 2 cm from the anatomical structure.

[0184] 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.

[0185] 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.

[0186] 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.

[0187] 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 an anatomical structure or a predicted area or volume of an anatomical structure based on a baseline measurement of flow rate and a change in flow rate over time.

[0188] 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.

[0189] 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.

[0190] 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 the mitral valve of the heart.

[0191] 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.

[0192] Example B49 includes the sensor device of Example B45 or any one 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 proximal to the heart, and wherein the received acoustic signal indicates blood flow at the superior vena cava or the inferior vena cava.

[0193] Example B50 includes the sensor device of Example B45 or any one of Examples B1-B49, wherein the first arm and the second arm of the link assembly are located on a pulmonary artery or a pulmonary vein proximal to the heart, and wherein the received acoustic signal indicates blood flow at the pulmonary artery or the pulmonary vein.

[0194] In some embodiments (Example B51) according to the present technology, a sensor device for monitoring blood flow in a heart or blood vessel in vivo includes: a link assembly, which includes a first arm configured to be attached to a first part of a heart or a blood vessel and a second arm configured to be attached to a second part of the heart or the blood vessel; 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 link 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 emit an acoustic signal to propagate through the heart or the blood vessel, the second acoustic transducer element and the third acoustic transducer element configured to receive an acoustic signal that has propagated through a heart or a blood vessel and is indicative of a fluid flow parameter of blood flowing in the heart or the 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 so as to secure the sensor device to a first portion and a second portion of the heart or a blood vessel and to absorb forces applied to the first arm and the second arm of the clamp by a heartbeat or changes in the size of the heart or the blood vessel.

[0195] Example B52 includes the sensor device of any of Examples B51-B60, wherein the clamp includes a composite material having a flexible polymer component and a preformed and shape-changing shape-reinforcing component.

[0196] Example B53 includes the sensor device of Example B52 or any one of Examples B51-B60, wherein the shape reinforcement member of the composite material includes one or more of nitinol, gold, platinum or iridium, which is encapsulated in a polymer member of the composite material, the polymer member including one or more of silicone, polyethylene, polyimide, polyamide or a mixture thereof.

[0197] 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.

[0198] 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 that is coupled to at least some of the acoustic transducer elements of the ultrasound sensor assembly and is configured to provide contouring and cushioning against the heart or blood vessels.

[0199] 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.

[0200] Example B57 includes the sensor device of any of Examples B51-B60, wherein the first arm and the second arm of the clamp are located 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.

[0201] Example B58 includes the sensor device of any of Examples B51-B60, wherein the first arm and the second arm of the clamp are located 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.

[0202] Example B59 includes the sensor device of any of Examples B51-B60, wherein the first arm and the second arm of the clamp are positioned 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.

[0203] Example B60 includes the sensor device of any of Examples B51-B59, wherein the first arm and the second arm of the clamp are located on a pulmonary artery or a pulmonary vein proximate to the heart, and wherein the received acoustic signal indicates blood flow at the pulmonary artery or the pulmonary vein.

[0204] In some embodiments according to the present technology (Example B61), a system for in vivo monitoring of fluid flow in an anatomical structure includes an in vivo sensor device operably deployed within a patient user and attached to the anatomical structure, and a data processing system for data communication with the in vivo sensor device. The in vivo 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 connection device connected to each of the first arm and the second arm; an ultrasound sensor assembly including a plurality of acoustic transducer elements coupled to the connection 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 connection device and in electrical communication with the plurality of acoustic transducer elements of the ultrasound 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. The data processing system includes a processor and a memory and is configured to receive data from the in vivo sensor device and process the received data to determine a fluid flow parameter associated with the biological fluid in the anatomical structure.

[0205] Example B62 includes the sensor device of any of Examples B61-B72, wherein the in vivo sensor device includes one or more features associated with the sensor device described in any of Examples B1-B50 and / or any of Examples B51-B60.

[0206] Example B63 includes the sensor device of any one of Examples B61-B72, further including a remote intermediate device, which includes a power supply, a wireless communication unit including at least one of a transmitter or a transceiver, and a data processing unit including a data processor and a data storage device, wherein the remote in vivo intermediate device communicates wirelessly or by wire with the in vivo sensor device and is located at another location of the body that is different from the anatomical structure and away from the anatomical structure.

[0207] Example B64 includes the sensor device of Example B63 or any one of Examples B61-B72, wherein the in-vivo sensor device is in wired communication with a remote in-vivo intermediate device via at least one of a cable, wire, or cord, wherein the cable, wire, or cord is coupled to a port of a connecting device of the in-vivo sensor device that is in electrical communication with an electronic unit of the in-vivo sensor device, and wherein the remote in-vivo intermediate device is operable to provide electrical energy stored in a power supply to the electronic unit of the in-vivo sensor device.

[0208] Example B65 includes the sensor device of Example B63 or any one of Examples B61-B72, wherein the remote in vivo intermediate device is operable to connect an electronic unit of the in vivo sensor device to a data processing unit disposed in the remote in vivo intermediate device to process data and determine fluid flow parameters associated with a biological fluid in the anatomical structure.

[0209] Example B66 includes the sensor device of Example B63 or any one of Examples B61-B72, wherein the remote in vivo intermediate device is operable to connect an electronic unit of the in vivo sensor device to a wireless communication unit disposed in the remote in vivo intermediate device to wirelessly transmit data directly or indirectly to a data processing system.

[0210] Example B67 includes the sensor device of Example B63 or any of Examples B61-B72, wherein the remote device is located at another location at least 2 cm from the anatomical structure.

[0211] Example B68 includes the sensor device of Example B63 or any of Examples B61-B72, wherein the other location includes a pleural cavity, a cavity in the abdominal cavity, a subcutaneous space, or an external location.

[0212] Example B69 includes the sensor device of any of Examples B61-B72, wherein the data processing system includes a server computer comprising a processor and a memory and one or more databases in data communication with the server computer, wherein the data processing system is configured to remotely monitor data associated with a patient user obtained by the sensor device.

[0213] Example B70 includes the sensor device of any of Examples B61-B72, further including a receiver device comprising a data processor and a data storage device, operable to (i) receive wireless transmissions carrying data indicative of electrical signals acquired from the sensor device, and (ii) transmit the data to a data processing system.

[0214] Example B71 includes the sensor device of Example B64 or any of Examples B61-B72, wherein the receiver device is configured to store data in a memory of the receiver device, and / or wherein the receiver device communicates with a data processing system via a computer network that communicates with each other and is accessible via the Internet.

[0215] Example B72 includes the sensor device of any of Examples B61-B71, further comprising a remote client computing device comprising a data processor and a data storage device, communicating data with the data processing system, and configured to receive processed data selected, filtered and / or formatted by the data processing system.

[0216] In some embodiments according to the present technology (Example B73), a sensor device for in vivo monitoring of cardiac function includes a linkage assembly, the linkage assembly including a first arm configured to attach to a first external portion of the heart, and an optional second arm that can be configured to attach to a second external portion of the heart; a housing connected to the linkage assembly; a sensor assembly coupled to the first arm and configured to detect a functional parameter of the heart; and an electronic unit disposed in the housing and in electrical communication with the sensor assembly, the electronic unit being configured to process an electrical signal associated with the detected functional parameter as data and wirelessly transmit the data to an external processor.

[0217] Example B74 includes the sensor device of any of Examples B73-B76, 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.

[0218] Example B75 includes the sensor device of any of Examples B73-B76, wherein the sensor component includes at least one of an accelerometer, a gyroscope, a magnetometer, an acoustic transducer, a temperature sensor, an analyte sensor, or a pH sensor.

[0219] Example B76 includes the sensor device of any of Examples B73-B76, wherein the sensor device includes one or more features associated with the sensor device described in any of Examples B1-B50 and / or any of Examples B51-B60.

[0220] in conclusion

[0221] The embodiments of the subject matter and functional operations described in this patent document can be implemented in various systems, digital electronic circuits or in computer software, firmware or hardware, including the structures disclosed in this specification and their structural equivalents, or in a combination of one or more of them. The embodiments of the subject matter described in this specification can be implemented as one or more computer program products, that is, one or more modules of computer program instructions encoded on a tangible and non-transitory computer-readable medium for execution by a data processing device or controlling the operation of the data processing device. The computer-readable medium can be a machine-readable storage device, a machine-readable storage substrate, a memory device, a material composition that affects a machine-readable propagation signal, or a combination of one or more of them. The term "data processing unit" or "data processing device" covers all devices, devices and machines for processing data, including, for example, a programmable processor, a computer or multiple processors or computers. In addition to hardware, the device may also include code that creates an execution environment for the computer program in question, for example, code that constitutes processor firmware, a protocol stack, a database management system, an operating system, or a combination of one or more of them.

[0222] A computer program (also referred to as a program, software, software application, script, or code) may be written in any form of programming language, including compiled or interpreted languages, and may be deployed in any form, including as a stand-alone program or as a module, component, subroutine, or other unit suitable for use in a computing environment. A computer program does not necessarily correspond to a file in a file system. A program may be stored in a portion of a file that holds other programs or data (e.g., one or more scripts stored in a markup language document), in a single file dedicated to the program in question, or in multiple coordinated files (e.g., files storing one or more modules, subroutines, or code portions). A computer program may be deployed to execute on one computer or on multiple computers located at one site or distributed over multiple sites and interconnected by a communications network.

[0223] The processes and logic flows described in this specification can be performed by one or more programmable processors executing one or more computer programs to perform functions by operating on input data and generating output. The processes and logic flows can also be performed by special purpose logic circuits, and the device can also be implemented as special purpose logic circuits, such as FPGAs (field programmable gate arrays) or ASICs (application-specific integrated circuits).

[0224] For example, processors suitable for executing computer programs include general and special purpose microprocessors and any one or more processors of any type of digital computer. Typically, the processor will receive instructions and data from a read-only memory or a random access memory or both. The basic elements of a computer are a processor for executing instructions and one or more memory devices for storing instructions and data. Typically, a computer will also include or be operably coupled to one or more large-capacity storage devices for storing data, such as magnetic disks, magneto-optical disks, or optical disks, to receive data from the large-capacity storage device or to transmit data to it, or both. However, a computer does not need to have such a device. Computer-readable media suitable for storing computer program instructions and data include all forms of non-volatile memory, media, and memory devices, such as semiconductor memory devices, such as EPROM, EEPROM, and flash memory devices. The processor and memory can be supplemented or incorporated into a dedicated logic circuit system.

[0225] It is intended that the specification, together with the drawings, be considered exemplary only, wherein exemplary means example. As used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. In addition, the use of "or" is intended to include "and / or" unless the context clearly indicates otherwise.

[0226] Although this patent document contains many details, these should not be interpreted as limitations on the scope of any invention or the content that can be claimed, but rather as descriptions of the features of specific embodiments of specific inventions. Certain features described in the context of separate embodiments in this patent document may also be implemented in combination in a single embodiment. On the contrary, the various features described in the context of a single embodiment may also be implemented individually or in any suitable sub-combination in multiple embodiments. In addition, although the features may be described above as working in certain combinations, and even initially claimed as such, in some cases, one or more features from the claimed combination may be cut out from the combination, and the claimed combination may involve a sub-combination or a variation of the sub-combination.

[0227] Similarly, while operations are depicted in a particular order in the drawings, this should not be understood as requiring that such operations be performed in the particular order shown or in sequence, or that all of the illustrated operations be performed to achieve the desired results. Furthermore, the separation of various system components in the embodiments described in this patent document should not be understood as requiring such separation in all embodiments.

[0228] Only a few implementations and examples are described, and other implementations, enhancements, and variations can be made based on what is described and illustrated in this patent document.

Claims

1. A sensor device for in vivo monitoring of fluid flow in an anatomical structure, comprising: a linkage 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; a connection device attached to each of the first arm and the second arm; an ultrasonic sensor assembly comprising a plurality of acoustic transducer elements coupled to the linkage assembly, the plurality of acoustic transducer elements comprising a first acoustic transducer element configured to transmit an acoustic signal to propagate through the anatomical structure, and second and third acoustic transducer elements 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; as well as An electronics unit housed in the connection 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 into data and to wirelessly transmit the data to an external processor.

2. The sensor device of claim 1, 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.

3. The sensor device of claim 2, wherein the first ultrasound sensor assembly includes the first acoustic transducer element positioned on a distal region of the first arm to interface with the first portion of the anatomical structure and configured to transmit the acoustic signal, wherein the second ultrasound sensor assembly includes the second acoustic transducer element and the third acoustic transducer element positioned on a distal region of the second arm to interface with the second portion of the anatomical structure and configured to receive the acoustic signal, and wherein the first center point (C Tx ) and a second center point (Cd ) located between the center of the second sound transducer element and the center of the third sound transducer element by a distance (d) Rx )alignment.

4. The sensor device of claim 2, wherein the first ultrasound sensor assembly includes the first acoustic transducer element positioned on a distal region of the first arm to interface with the first portion of the anatomical structure and configured to transmit the acoustic signal, wherein the second ultrasound sensor assembly includes the second acoustic transducer element and the third acoustic transducer element positioned on a distal region of the second arm to interface with the second portion of the anatomical structure and configured to receive the acoustic signal, wherein the first ultrasound sensor assembly further includes a fourth acoustic transducer element and a fifth acoustic transducer element, the fourth acoustic transducer element and the fifth acoustic transducer element a transducer element positioned on the 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 transmission of the acoustic signals by the first acoustic transducer element, wherein the second ultrasound sensor assembly includes a sixth acoustic transducer element positioned on the 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 acoustic transducer element and the third acoustic transducer element, and wherein a first center point (C Tx1 ) and a second center point (Cd ) located between a first distance (d1) separating the center of the fourth sound transducer element from the center of the fifth sound 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 sound transducer element from the center of the third sound transducer element Rx2 )alignment.

5. The sensor device of claim 1, wherein the plurality of acoustic transducer elements of the ultrasonic sensor assembly are disposed on the first arm of the linkage assembly, and wherein the sensor device further comprises a reflector disposed on the second arm of the linkage assembly.

6. The sensor device of claim 1, 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 dimension between 1 mm and 4 mm.

7. The sensor device of claim 1, wherein the ultrasonic sensor assembly further comprises a substrate connected to an inwardly facing surface of at least one of the first arm or the second arm of the linkage assembly, and the substrate couples at least one of the plurality of acoustic transducer elements.

8. The sensor device of claim 7, wherein the substrate is configured to provide a heat sink for managing heat generated by the at least one acoustic transducer element.

9. The sensor device of claim 1, wherein at least one of the plurality of acoustic transducer elements comprises a piezoelectric micromachined ultrasonic transducer (PMUT).

10. The sensor device of claim 1, wherein the sensor device further comprises an acoustic transducer pad coupled to at least some of the acoustic transducer elements of the ultrasound sensor assembly and configured to provide contouring and padding against the anatomical structure.

11. The sensor device of claim 10, wherein the acoustic transducer pad comprises a hydrogel.

12. The sensor device of claim 1, wherein the linkage assembly is operable to secure the sensor device to the anatomical structure, the linkage assembly having flexibility that stabilizes the placement of the sensor device relative to the anatomical structure while being able to withstand continuous movement of the anatomical structure to which it is attached.

13. The sensor device of claim 12, wherein the linkage assembly includes a clamp operable to provide a compressive force through each of a first arm and a second arm of the clamp so as to secure the sensor device to the first and second portions of the anatomical structure and absorb forces applied by the anatomical structure to the first and second arms of the clamp due to the continuous movement of the anatomical structure.

14. The sensor device of claim 13, wherein the clamp comprises a composite material having a flexible polymer component and a preformed and shape-changing shape-reinforcing component.

15. The sensor device of claim 14, 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.

16. A sensor device as described in claim 1, wherein the connecting device is capable of being operated to fix the connecting rod assembly to the anatomical structure, and the mechanical elasticity of the connecting device enables the placement of the sensor device relative to the anatomical structure to be stable while being able to withstand continuous movement of the anatomical structure to which it is attached.

17. A sensor device as described in claim 16, wherein the connecting device includes a spring, which is capable of operating to provide a compressive force to each of the first arm and the second arm of the connecting rod assembly so as to fix the sensor device to the first part and the second part of the anatomical structure and absorb the force applied by the anatomical structure to the first arm and the second arm of the connecting rod assembly due to the continuous movement of the anatomical structure.

18. The sensor device of claim 1, 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.

19. The sensor device of claim 18, wherein the power source comprises at least one of a battery or a fuel cell.

20. The sensor device of claim 18, wherein the electronics unit comprises a signal conditioning unit, the signal conditioning unit communicating with the plurality of acoustic 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 acoustic signal by one or more of amplifying the electrical signal, filtering the electrical signal, or converting the electrical signal from analog to digital.

21. The sensor device of claim 20, wherein the electronic unit comprises a data processing unit in communication with the signal conditioning unit, 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 data representing the fluid flow parameter of the biological fluid.

22. The sensor device of claim 18, 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 data representing the fluid flow parameter of the biological fluid.

23. The sensor device of claim 18, wherein the electronics 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 interconnects spanning between the plurality of acoustic transducer elements of the ultrasonic sensor assembly and the PCB of the electronics unit.

24. The sensor device of claim 23, wherein the electronics unit includes a housing that surrounds the electronics unit to protect the electronics unit from exposure to body fluids when the sensor device is inserted and deployed in the body.

25. The sensor device of claim 24, wherein the housing comprises one or both of flat sides or curved sides to provide a form factor of the sensor device, the form factor comprising at least one of a rectangular, cylindrical, conical, elliptical, pyramidal, trapezoidal, or non-uniform shape.

26. The sensor device of claim 24, wherein the housing is coupled to the linkage assembly on an inward-facing surface of the linkage assembly that faces the anatomical structure, or wherein the housing is coupled to the linkage assembly on an outward-facing surface of the linkage assembly that faces away from the anatomical structure.

27. The sensor device of claim 24, wherein the PCB of the electronics unit is hermetically sealed within the housing by a non-permeable material covering the PCB to provide electrical shielding from the body fluid.

28. The sensor device of claim 27, wherein the non-permeable material comprises at least one of parylene, polyurethane, or Teflon material.

29. The sensor device of claim 1, further comprising: A secondary sensor connected to at least one of the linkage assembly or the connection device and in communication with the electronic unit, the secondary sensor being 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 sensor device is deployed.

30. The sensor device of claim 29, 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 adjacent to the anatomical structure where the sensor device is deployed.

31. The sensor device of claim 29, 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 adjacent to the anatomical structure where the sensor device is deployed.

32. The sensor device of claim 29, 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 adjacent to the anatomical structure where the sensor device is deployed.

33. The sensor device of claim 29, wherein the secondary sensor comprises an inertial measurement unit (IMU) configured to detect motion of the sensor device in multiple degrees of freedom.

34. The sensor device of claim 1, further comprising: A secondary attachment component comprising one or more of a suture, a prong, a screw, a barb, an adhesive, or a gripping mechanism, the secondary attachment component being disposed on at least a portion of the linkage assembly and being configured to secure the ultrasound sensor assembly to the anatomical structure via the linkage assembly.

35. A sensor device as described in claim 1, wherein the link assembly is capable of changing shape from a first shape configuration to a second shape configuration, wherein the first shape configuration, the first arm and the second arm of the link assembly are extended outward from a center line through at least one of the link assembly or the connecting device so as to be inserted into the patient's body, and wherein the first arm and the second arm of the link assembly are extended inward toward the center line through at least one of the link assembly or the connecting device so as to be attached to the anatomical structure for operation of the sensor device.

36. The sensor device of claim 1, further comprising: A second linkage assembly, the second linkage assembly comprising a third arm constructed to be attached to a third portion of the anatomical structure and a fourth arm constructed to be attached to a fourth portion of the anatomical structure opposite the third portion, wherein the connecting device is coupled to each of the third arm and the fourth arm, and wherein the ultrasound sensor assembly comprises an additional set of the plurality of acoustic transducer elements coupled to the second linkage assembly, the additional set of acoustic transducer elements being coupled to the second linkage assembly and being configured to transmit a second acoustic signal to propagate through the anatomical structure across the third portion and the fourth portion and being configured to receive a second set of acoustic 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.

37. A sensor device as described in claim 1, wherein the connecting device includes a port, which is electrically connected to the electronic unit contained in the connecting device and is capable of being operated to be electrically connected to a remote power supply contained in a remote device via at least one of a cable, a wire or a soft cord, wherein the remote device is located in another location different from the anatomical structure and at a certain distance from the anatomical structure.

38. A sensor device as described in claim 37, wherein the port communicates data with the electronic unit accommodated in the connecting device and is capable of operating to interface the electronic unit with a data processing unit arranged 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.

39. The sensor device of claim 38, wherein the sensor device is configured to transmit the data wirelessly to the external processor via a secondary transmission device comprising a wireless transmitter or transceiver.

40. The sensor device of claim 37, wherein the remote device is located at another location at least 2 cm from the anatomical structure.

41. The sensor device of claim 37, wherein the another location comprises a pleural cavity, a cavity in the abdominal space, a subcutaneous space, or an extracorporeal location.

42. A sensor device as described in claim 1, 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, and the sensor device is implantable in the body of the patient-user and can be deployed at the anatomical structure.

43. The sensor device of any one of claims 1 to 42, wherein the fluid flow parameter of the biological fluid in the anatomical structure comprises at least one of a flow rate or an amount of pressure difference between ends of a flow path in the anatomical structure.

44. The sensor device of claim 43, 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 the flow rate and a change in the flow rate over time.

45. The sensor device of any one of claims 1 to 44, wherein the anatomical structure is a heart and the biological fluid is blood.

46. ​​The sensor device of claim 45, wherein the sensor device is deployable within at least one layer of the pericardium of the heart, or wherein the sensor device is deployable on an outer layer of the pericardium of the heart.

47. The sensor device of claim 45, wherein the first arm and the second arm of the linkage assembly 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.

48. The sensor device of claim 45, wherein the first arm and the second arm of the linkage assembly 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.

49. The sensor device of claim 45, wherein the first arm and the second arm of the linkage assembly are positioned on the superior vena cava or the inferior vena cava adjacent to the heart, and wherein the received acoustic signal indicates blood flow at the superior vena cava or the inferior vena cava.

50. The sensor device of claim 45, wherein the first arm and the second arm of the linkage assembly are positioned on a pulmonary artery or a pulmonary vein adjacent to the heart, and wherein the received acoustic signal is indicative of blood flow at the pulmonary artery or the pulmonary vein.

51. A sensor device for in vivo monitoring of blood flow in a heart or a blood vessel leading to or leaving the heart in a patient's body, comprising: a connecting rod assembly comprising a first arm configured to attach to a first portion of the heart or the blood vessel and a second arm configured to attach to a second portion of the heart or the blood vessel; a connection device attached to each of the first arm and the second arm; an ultrasonic sensor assembly including a plurality of acoustic transducer elements coupled to the linkage assembly, the plurality of acoustic transducer elements including a first acoustic transducer element configured to transmit an acoustic signal to propagate through the heart or the blood vessel, and second and third acoustic transducer elements configured to receive an acoustic signal that has propagated through the heart or the blood vessel and is indicative of a fluid flow parameter of the blood flowing in the heart or the blood vessel; as well as an electronics unit housed in the connection 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 into data and to wirelessly transmit the data to an external processor, The linkage assembly includes a clamp operable to provide a compressive force through each of the first arm and the second arm of the clamp so as to secure the sensor device to the first and second portions of the heart or the blood vessel and absorb forces applied to the first and second arms of the clamp due to heartbeats or changes in size of the heart or the blood vessel.

52. The sensor device of claim 51, wherein the clamp comprises a composite material having a flexible polymer component and a shape-reinforcing component that is preformed and capable of undergoing shape change.

53. A sensor device as described in claim 52, wherein the shape reinforcing component of the composite material includes one or more of nitinol, gold, platinum or iridium, and the shape reinforcing component is encapsulated in the polymer component of the composite material, and the polymer component includes one or more of silicone, polyethylene, polyimide, polyamide or a mixture thereof.

54. The sensor device of claim 51, wherein the ultrasonic sensor assembly comprises a first ultrasonic sensor assembly disposed on the first arm of the clamp and a second ultrasonic sensor assembly disposed on the second arm of the clamp, or Wherein the 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 comprises a reflector disposed on the second arm of the clamp.

55. The sensor device of claim 51 , wherein the sensor device further comprises an acoustic transducer pad comprising a hydrogel coupled to at least some of the acoustic transducer elements of the ultrasound sensor assembly and configured to provide a contour and cushion against the heart or the blood vessel.

56. The sensor device of claim 51, wherein the sensor device is deployable within at least one layer of the pericardium of the heart, or wherein the sensor device is deployable on an outer layer of the pericardium of the heart.

57. The sensor device of claim 51, wherein the first arm and the second arm of the clamp are positioned on opposing portions of the left atrium of the heart, and wherein the received acoustic signal is indicative of the blood flow at a mitral valve of the heart.

58. The sensor device of claim 51, wherein the first arm and the second arm of the clamp are positioned on opposing portions of the right atrium of the heart, and wherein the received acoustic signal is indicative of the blood flow at the tricuspid valve of the heart.

59. The sensor device of claim 51, wherein the first arm and the second arm of the clamp are positioned on the superior vena cava or the inferior vena cava adjacent to the heart, and wherein the received acoustic signal is indicative of the blood flow at the superior vena cava or the inferior vena cava.

60. The sensor device of claim 51, wherein the first arm and the second arm of the clamp are positioned on a pulmonary artery or a pulmonary vein adjacent to the heart, and wherein the received acoustic signal is indicative of the blood flow at the pulmonary artery or the pulmonary vein.

61. A system for in vivo monitoring of fluid flow in an anatomical structure, comprising: An in-vivo sensor device operable to be deployed in a body of a patient-user and attached to the anatomical structure, the in-vivo sensor device comprising: a linkage 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; a connection device attached to each of the first arm and the second arm; an ultrasonic sensor assembly comprising a plurality of acoustic transducer elements coupled to the linkage assembly, the plurality of acoustic transducer elements comprising a first acoustic transducer element configured to transmit an acoustic signal to propagate through the anatomical structure, a second acoustic transducer element and a third acoustic transducer element 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 connection 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 into data and to wirelessly transmit the data to an external processor; and A data processing system comprising a processor and a memory, the data processing system being in data communication with the in vivo sensor device and configured to receive the data from the in vivo sensor device and to process the received data to determine the fluid flow parameters associated with the biological fluid in the anatomical structure.

62. The system of claim 61, wherein the in vivo sensor device comprises one or more features associated with the sensor device of any one of claims 1 to 50 and / or any one of claims 51 to 60.

63. The system of claim 61, further comprising: a remote in-vivo intermediate device comprising a power source, a wireless communication unit comprising at least one of a transmitter or a transceiver, and a data processing unit comprising a data processor and a data memory, The remote in-vivo intermediate device is in wireless or wired communication with the in-vivo sensor device and is located in another location of the body that is different from the anatomical structure and is at a distance from the anatomical structure.

64. A system as described in claim 63, wherein the in-vivo sensor device communicates with the remote in-vivo intermediate device via wired communication via at least one of a cable, a wire or a soft wire, the cable, the wire or the soft wire is connected to a port of the connecting device of the in-vivo sensor device, the port is in electrical communication with the electronic unit of the in-vivo sensor device, and wherein the remote in-vivo intermediate device is capable of operating to supply electrical energy stored in the power supply to the electronic unit of the in-vivo sensor device.

65. A system as described in claim 63, wherein the remote in vivo intermediate device is capable of operating to connect the electronic unit of the in vivo sensor device to the data processing unit disposed in the remote in vivo intermediate device to process the data and determine the fluid flow parameters associated with the biological fluid in the anatomical structure.

66. A system as described in claim 63, wherein the remote in vivo intermediate device is capable of operating to connect the electronic unit of the in vivo sensor device to a wireless communication unit disposed in the remote in vivo intermediate device to wirelessly transmit the data directly or indirectly to the data processing system.

67. The system of claim 63, wherein the remote device is located at another location at least 2 cm from the anatomical structure.

68. The system of claim 63, wherein the another location comprises the pleural cavity, a cavity in the abdominal space, a subcutaneous space, or an extracorporeal location.

69. A system as described in claim 61, wherein the data processing system includes a server computer, the server computer includes the processor and the memory and one or more databases in data communication with the server computer, wherein the data processing system is configured to remotely monitor data associated with the patient user obtained by the sensor device.

70. The system of claim 61, further comprising: A receiver device includes a data processor and a data memory, the receiver device being operable to (i) receive a wireless transmission carrying data indicative of the electrical signal acquired from the sensor device, and (ii) transmit the data to the data processing system.

71. A system as claimed in claim 64, wherein the receiver device is configured to store the data in the memory of the receiver device and / or wherein the receiver device communicates with the data processing system via a network of computers that communicate with each other and can be accessed via the Internet.

72. The system of claim 61, further comprising: A remote client computing device including a data processor and a data memory is in data communication with the data processing system and is configured to receive processed data selected, filtered and / or formatted by the data processing system.

73. A sensor device for in vivo monitoring of cardiac function, comprising: a linkage assembly comprising a first arm configured to attach to a first external portion of a heart and an optional second arm configurable to attach to a second external portion of the heart; a housing attached to the connecting rod assembly; a sensor assembly coupled to the first arm and configured to detect a functional parameter of the heart; as well as An electronics unit is disposed in the housing and in electrical communication with the sensor assembly, the electronics unit being configured to process electrical signals associated with the detected functional parameters into data and to wirelessly transmit the data to an external processor.

74. The sensor device of claim 73, wherein the sensor device is deployable within at least one layer of the pericardium of the heart, or wherein the sensor device is deployable on an outer layer of the pericardium of the heart.

75. The sensor device of claim 73, wherein the sensor component comprises at least one of an accelerometer, a gyroscope, a magnetometer, an acoustic transducer, a temperature sensor, an analyte sensor, or a pH sensor.

76. A sensor device as claimed in claim 73, wherein the sensor device includes one or more features associated with the sensor device of any one of claims 1 to 50 and / or any one of claims 51 to 60.

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