In vivo fluid flow sensor

Abstract

Disclosed are devices, systems, and methods for in vivo monitoring of biological fluid flow within anatomical structures, such as blood flow through heart valves (e.g., mitral, tricuspid, and / or aortic valves) or heart chambers. The disclosed devices, systems, and methods can continuously measure and evaluate blood flow back and forth at the inlet of a heart valve to determine cardiac function or dysfunction and / or to compile with other monitored data that can be used to measure or predict secondary factors.

Description

[Technical field]

[0001] The present disclosure relates to sensors deployable within a patient-user's body to monitor fluid flow and biological functions in vivo.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS All applications filed with this application for which a claim of foreign or domestic priority is identified in the Application Data Sheet are hereby incorporated by reference. [Background technology]

[0003] According to the World Health Organization (WHO), cardiovascular disease is one of the leading causes of death worldwide, causing an estimated 17.9 million deaths each year. In the United States, heart disease is the leading cause of death, with coronary artery disease (CAD) being the most detrimental class by causing reduced blood flow to the heart, often leading to heart attacks. CAD and other heart valve diseases, such as mitral valve prolapse (MVP) and mitral valve regurgitation (MVR), are silent killers because the presence of the underlying heart problem is typically unknown, and therefore not diagnosed until the person experiences signs or symptoms of a heart attack, heart failure, or arrhythmia, which may be too late to survive or recover with a reasonable quality of life. Yet currently, physicians must typically have a secondary medical condition, such as diabetes or obesity, or be identified with one or more significant risk factors, such as high blood pressure, high cholesterol, high alcohol use, or smoking, before initiating rounds of cardiac testing and remote monitoring of the patient. This is because there are no accessible, complex, and affordable devices or technologies to observe and track a person's cardiac function.

[0004] Currently, testing of cardiac function to potentially diagnose cardiac disease is limited to clinical settings. Typically, patients undergo a variety of tests, including analyte testing from blood samples, imaging tests such as chest x-rays, CT scans, and cardiac magnetic resonance imaging (MRI), and physiological signal monitoring such as an electrocardiogram (ECG or EKG), a non-invasive acoustic (sound) signal monitoring technique used to create an image of the moving heart and blood. Furthermore, patients are prescribed such tests only after experiencing an acute or emergency medical event, such as cardiac arrest, stroke, severe dizziness or loss of consciousness, or extreme chest pain.

[0005] To date, there have been several advances in remote monitoring to turn the tide against heart disease. For example, wearable heart rate monitors track heart rate during exercise or daily activities, monitor stress and movement levels, track nighttime sleep habits, and some versions of these wearable devices have become ubiquitous options for testing certain vital signs outside the clinic, such as ECG, to determine single heart rhythm events, such as healthy sinus rhythm or at-risk atrial fibrillation. Although these devices are well suited to promote a healthier active lifestyle that may contribute to preventing the onset of heart disease or reducing mild to moderate heart disease over the long term, they have the ability to identify a wide range of heart disease symptoms or characteristics and are unable to determine any underlying biological or physiological factors at the root of heart disease.

[0006] The challenge for clinicians is to catch cardiac disease early or to manage and monitor diagnosed cardiac disease after treatment. However, monitoring cardiac function depends on patient participation and compliance, and existing systems and methods are too time-consuming, expensive, and resource-starved to be effective.

[0007] There is a need for new paradigms of sensors that can be deployed on a patient-user's body and monitor the dynamic in vivo flow of biological fluids, such as blood flow across heart valves, to characterize overall cardiac function. Summary of the Invention

[0008] Briefly, devices, systems and methods are disclosed for in vivo monitoring of biological fluid flow in anatomical structures, such as blood flow across a heart valve or through a heart chamber.

[0009] In some embodiments, a sensor device for in vivo monitoring of fluid flow within an anatomical structure comprises: a 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 the first portion; a connection device coupled to each of the first arm and the second arm; and an ultrasonic sensor assembly including a plurality of acoustic transducer elements coupled to the linkage assembly, wherein the plurality of acoustic transducer elements include a first acoustic transducer element configured to transmit an acoustic signal to propagate through the anatomical structure, and a second acoustic transducer element and a third acoustic transducer element configured to propagate through the anatomical structure and receive an acoustic signal indicative of a fluid flow parameter of a biological fluid within the anatomical structure; and an electronics unit contained within the connection device and in electrical communication with the plurality of acoustic transducer elements of the ultrasonic sensor assembly, wherein the electronics unit is configured to process electrical signals associated with the received acoustic signals as data and to wirelessly transmit the data to an external processor.

[0010] In some embodiments, a sensor device for in vivo monitoring of blood flow in a heart or blood vessel leading to or from a heart within a patient's body comprises a linkage assembly including a first arm configured for attachment to a first portion of the heart or blood vessel and a second arm configured for attachment to a second portion of the heart or blood vessel, a connection device coupled to each of the first arm and the second arm, and 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 for propagation through the heart or blood vessel and a second acoustic transducer element configured to receive an acoustic signal propagating through the heart or blood vessel and indicative of a fluid flow parameter of blood flowing within the heart or blood vessel. and an electronics unit housed within the connection device and in electrical communication with the plurality of acoustic transducer elements of the ultrasonic sensor assembly, wherein the electronics unit is configured to process electrical signals associated with the received acoustic signals as data and to wirelessly transmit the data to an external processor, and the linkage assembly includes a clip band operable to provide a compressive force by each of the first and second arms of the clip band to facilitate securing the sensor device to the first and second portions of the heart or blood vessel, and to absorb forces exerted on the first and second arms of the clip band due to heartbeat or changes in size of the heart or blood vessel.

[0011] In some embodiments, a system for in vivo monitoring of fluid flow in an anatomical structure includes an in vivo sensor device operable to be deployed within a patient-user's body 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 comprises a 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 the first portion, a connection device coupled 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 anatomical structure, a second acoustic transducer element configured to propagate through the anatomical structure and receive an acoustic signal indicative of a fluid flow parameter of a biological fluid within the anatomical structure, and a third acoustic transducer element, and an electronics unit contained within 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 the 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 within the anatomical structure.

[0012] In some embodiments, a sensor device for in vivo monitoring of cardiac function includes a linkage assembly comprising a first arm configured for attachment to a first external portion of the heart, the sensor device, and an optional second arm that may be configured for attachment to a second external portion of the heart, a housing coupled to the linkage assembly, a sensor assembly coupled to the first arm and configured to detect a functional parameter of the heart, and an electronics unit disposed within the housing and in electrical communication with the sensor assembly, the electronics unit configured to process the electrical signal associated with the detected functional parameter as data and to wirelessly transmit the data to an external processor.

[0013] The above-mentioned and additional features of the invention, and the manner of obtaining them, will become apparent and the invention will be best understood by reference to the following more detailed description, in which: All references disclosed herein are incorporated by reference in their entirety as if each were individually incorporated.

[0014] This Summary is provided to introduce certain concepts in a simplified form that are described in more detail below in the Detailed Description. Unless expressly stated otherwise, this Summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter.

[0015] Details of one or more embodiments are set forth in the following description. Features illustrated or described in connection with one exemplary embodiment may be combined with features of other embodiments. Thus, any of the various embodiments described herein can be combined to provide further embodiments. Aspects of the embodiments can be modified, as necessary, to employ 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.

[0016] Many aspects of the present disclosure can be better understood with reference to the following drawings. Features in the drawings are not necessarily shown to scale or in the same manner as they are physically constructed. Emphasis instead is placed on clearly illustrating the principles of the present disclosure. The drawings should not be taken to limit the disclosure to the specific embodiments illustrated, but are for purposes of explanation and understanding only. [Brief description of the drawings]

[0017] [Figure 1A] 1 shows a diagram illustrating an exemplary embodiment of a system for in vivo monitoring of biological fluid flow, according to the present embodiments. [Figure 1B] 1B shows a block diagram illustrating an exemplary embodiment of the in-vivo fluid flow sensor device of FIG. 1A, in accordance with the present embodiments. [Figure 2A] FIG. 1C shows a diagram illustrating an exemplary embodiment of the in-vivo fluid flow sensor device of FIG. 1B, according to the present embodiment. [Figure 2B] FIG. 1C shows a diagram illustrating another exemplary embodiment of the in-vivo fluid flow sensor device of FIG. 1B including a second set of ultrasonic sensor assemblies according to the present embodiment. [Figure 2C] 1C shows a diagram of another exemplary embodiment of the in-vivo fluid flow sensor device of FIG. 1B, in accordance with the present embodiment. [Figure 2D] 1C shows a diagram of another exemplary embodiment of the in-vivo fluid flow sensor device of FIG. 1B, in accordance with the present embodiment. [Diagram 3] 2B shows a diagram of an exemplary embodiment of the in-vivo fluid flow sensor device of FIG. 2A attached to a patient-user's heart, according to the present embodiment. [Figure 4A] 1 shows a diagram illustrating an insertion site for implanting an in vivo fluid flow sensor device according to an embodiment. [Figure 4B] 1A-1C show diagrams illustrating exemplary configurations of an exemplary embodiment of an in vivo fluid flow sensor device according to the present embodiment for the process of implantation near a target anatomical structure and the process of positioning to fixate to the target anatomical structure. [Figure 5A] 1A-1C show diagrams illustrating an exemplary embodiment of a single-sided acoustic transducer configuration for an in-vivo fluid flow sensor device according to the present embodiments. [Figure 5B] 1 shows a diagram illustrating another exemplary arrangement of a one-sided acoustic transducer configuration on an array for an in vivo fluid flow sensor device according to the present embodiments. [Figure 5C] 1 shows a diagram illustrating another exemplary embodiment of a one-sided acoustic transducer configuration with a reflector for an in-vivo fluid flow sensor device according to the present embodiments. [Figure 5D] 1A-1C show diagrams illustrating an exemplary embodiment of a double-sided acoustic transducer configuration for an in-vivo fluid flow sensor device according to the present embodiments. [Figure 6A] 1C shows a diagram of another exemplary embodiment of the in-vivo fluid flow sensor device of FIG. 1B, in accordance with the present embodiment. [Figure 6B] 1C shows a diagram of another exemplary embodiment of the in-vivo fluid flow sensor device of FIG. 1B, in accordance with the present embodiment. [Figure 6C] 1C shows a diagram of another exemplary embodiment of the in-vivo fluid flow sensor device of FIG. 1B, in accordance with the present embodiment. [Figure 6D] 6B and 6C show enlarged views illustrating an exemplary embodiment of the electronics unit and housing of the in-vivo fluid flow sensor device of FIGS. 6A, 6B, and 6C. [Figure 7A] FIG. 1C shows a diagram illustrating an exemplary embodiment of the in-vivo fluid flow sensor device of FIG. 1B, according to the present embodiment. [Figure 7B] 1C shows a diagram of an exemplary embodiment of the in-vivo fluid flow sensor device of FIG. 1B, in accordance with the present embodiment. [Figure 7C] 1C shows a diagram of an exemplary embodiment of the in-vivo fluid flow sensor device of FIG. 1B, in accordance with the present embodiment. [Figure 7D] 1C shows a diagram of another exemplary embodiment of the in-vivo fluid flow sensor device of FIG. 1B, in accordance with the present embodiment. [Figure 7E] 1B, such as the in vivo fluid flow sensor device of FIGS. 7A, 7B, 7C, and / or 7D. FIG. 1C shows an example embodiment of a remote in-vivo device that may be coupled to the example embodiment of the in-vivo fluid flow sensor device of FIG. [Figure 8A] 1C shows a diagram illustrating an exemplary embodiment of the in vivo fluid flow sensor device of FIG. 1B attached to a patient-user's heart in an exemplary implantation of the device. [Figure 8B] 1C shows a diagram illustrating an exemplary embodiment of the in vivo fluid flow sensor device of FIG. 1B attached to a patient-user's heart in an exemplary implantation of the device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] Disclosed are devices, systems, and methods for in vivo monitoring of blood flow through a heart valve (e.g., mitral, tricuspid, and / or aortic valve), or through a heart chamber, e.g., atrium or ventricle, or flow of biological fluids in an anatomical structure, such as a major blood vessel into or out of the heart, e.g., the aorta, vena cava, or pulmonary vein or artery. The disclosed devices, systems, and methods can continuously measure and evaluate blood flow forward and backward in a region of the heart (e.g., inlet or outlet of a heart valve), compiled with other monitored data that can be used to determine cardiac function or dysfunction (e.g., mitral valve regulation (MVR), etc.) and / or to measure or predict secondary factors (e.g., heart rate (HR), cardiac output (CO), or characteristics of congestive heart failure (CHF), etc.).

[0019] Implementation of the disclosed technology is envisioned to shift the paradigm from different acute or emergency medical procedures to remote and continuous monitoring and management for long-term diagnostic and predictive care. For example, acute management of treatment sites in the heart currently remains undetectable after treatment (e.g., implantation of stents, implants (mitroplasty, mitral valve, percutaneous mitral valve, etc.). However, this is often in an emergency situation when a patient develops severe functional problems that cause the patient to return to the medical professional. The disclosed in vivo fluid flow sensor platform in vivo fluid flow sensor device can be implanted directly around the heart (and in a manner independent of any existing biomedical devices implanted in the heart) to detect blood flow within the heart that indicates potential differences, including, for example, cardiac output, stroke volume, total peripheral resistance, and / or the onset of restenosis.

[0020] For example, in some implementations, the disclosed in vivo fluid flow sensor device can measure fluid flow through the atria into the ventricles of the heart, for example, to determine blood flow at the mitral valve of the left or right tricuspid valve, thereby determining the fluid flow rate of the valve volume, known as the "valve flow volume," by measuring "Q," i.e., flow rate (volume of blood / time) or the amount of pressure difference between the ends of the flow path divided by resistance), which can be used to characterize backflow of natural fluid blood flow, potential leaks through the valve, and interrupted backflow. The disclosed in vivo fluid flow sensor device, when placed in close proximity to a heart valve, for example, once in place and properly calibrated, can detect where valve malfunction (e.g., leaks) are occurring. The disclosed in vivo fluid flow sensor platforms (i.e., devices, systems and / or techniques) can also detect diameters, or predicted areas and / or volumes of heart chambers, changes over time relative to baseline measurements, which may indicate potential adverse effects on cardiac function / performance with respect to that baseline and / or deterioration following treatment (e.g., may lead to cardiac diseases such as congestive heart failure (CHF), a chronic condition in which the heart is unable to pump blood, often attributed to weak or stiff tissue in the heart). For example, detection of blood flow and regurgitation across heart valves may be used to correlate with cardiac function / performance and the effects of heart failure, as defined by CHF.

[0021] Also, for example, data obtained by embodiments of the disclosed fluid flow sensor technology may be used in compilations containing information to enable or optimize the administration of pharmaceutical prescriptions (e.g., dosage) for optimal patient care. For example, data obtained by embodiments of the disclosed fluid flow sensor technology may be used to assess valve function and deterioration, and may be used in valve treatments or vascular treatments (e.g., compilation with EKG data). As an illustrative example, the disclosed in-vivo fluid flow sensor platform may position an in-vivo fluid flow sensor device over the vena cava and apply an ultrasound signal to obtain information (e.g., blood vessel dimensions (thickness) and velocity of blood flow through the vena cava) that may be used to determine pulmonary wedge pressure, thereby monitoring the effectiveness of specific pharmaceutical dosages in treating patients with various forms of cardiac disease. Additionally, for patients with cardiac disease who take a cocktail of drugs to manage their cardiac conditions (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 adequately adhering to the drug regimen or whether the regimen is not optimal or effective, such as due to the body developing resistance to the drugs over time.

[0022] The disclosed in vivo fluid flow sensor platform provides the ability to acquire acoustic signal measurements of fluid flow directly through anatomical structures (without other anatomical structures in the acoustic signal path) and provide the acquired acoustic signal measurements to a remote device (e.g., a remote in-vivo device in communication with the in-vivo fluid flow sensor device, and / or a remote device outside the body in communication with the in-vivo fluid flow sensor device and / or the remote in-vivo device), as well as low power requirements and a relatively small physical footprint (i.e., for long periods of time (e.g., 10 years or more)).

[0023] Although the disclosed embodiments of the in-vivo sensor are described herein primarily in terms of monitoring blood flow across cardiac structures (such as heart valves) within a patient's body to facilitate understanding of the concepts underlying the present technology, it is understood that the disclosed embodiments of the present technology can also include monitoring the dynamic flow of other biological fluids and other systems, including, but not limited to, fluid flow within the gastrointestinal system, kidneys, etc.

[0024] In some embodiments, a sensor device for in vivo monitoring of fluid flow within an anatomical structure, for example while coupled to an anatomical structure such as an atrium, a ventricle, a chamber, or a great vessel, comprises: a linkage assembly including a first arm configured for attachment to a first portion of the anatomical structure and a second arm configured for attachment to a second portion of the anatomical structure opposite the first portion; a connection device coupled to each of the first and second arms; and 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 anatomical structure, and a second acoustic transducer element and a third acoustic transducer element configured to propagate through the anatomical structure and receive an acoustic signal indicative of a fluid flow parameter of a biological fluid within the anatomical structure; and an electronics unit contained within 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 electrical signals associated with the received acoustic signals as data and to wirelessly transmit the data to an external processor.

[0025] In some embodiments, the present invention includes a sensor device for in vivo monitoring of fluid flow within an anatomical structure, for example while coupled to the anatomical structure, the sensor device comprising a first ultrasonic assembly including a first set of one or more acoustic transducer elements in a major blood vessel of the heart, such as for monitoring blood flow within the atria, ventricles, and valves therebetween, a second ultrasonic assembly including a second set of one or more acoustic transducer elements, a first linkage coupled to the first ultrasonic assembly, a second linkage coupled to the second ultrasonic assembly, and an electronics unit in electrical communication with the first ultrasonic assembly and the second ultrasonic assembly, the electronics unit comprising: The unit is configured to process the electrical signals associated with the returned acoustic signals as data and to wirelessly transmit the data to an external processor, and comprises a spring connection device operable to couple to each of the first and second linkages and position the first ultrasonic assembly at a first location on the anatomical structure and position the second ultrasonic assembly at a second location on the anatomical structure to form a plane across the first and second locations of the anatomical structure, and to transmit and receive acoustic signals from the first set of one or more acoustic transducer elements and the second set of one or more acoustic transducer elements indicative of fluid flow parameters of the biological fluid within the anatomical structure.

[0026] These and other embodiments are discussed in more detail in the examples that follow.

[0027] Exemplary embodiments FIG. 1A shows a diagram illustrating an exemplary embodiment of a system 10 for in vivo monitoring of patient-user fluid flow, according to the present embodiments. The system 10 includes one or more in-vivo fluid flow sensor devices 100 that may be implanted within a patient-user, 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 detected signals obtained from the one or more in-vivo fluid flow sensor devices 100, and to transmit and / or store the data in the data processing system 150. In some embodiments, the one or more in-vivo fluid flow sensor devices 100 and / or receiver device 130 communicate with each other and with the data processing system 150 via a network of computers 140 accessible via the Internet (e.g., referred to as the cloud), and data from the one or more in-vivo fluid flow sensor devices 100 and / or receiver device 130 may be transferred to the data processing system 150. Similarly, information from the data processing system 150 may be transferred to the receiver device 130 and / or to one or more in-vivo fluid flow sensor devices 100 .

[0028] In an exemplary 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 contained within and / or coupled via a housing or casing 101. In some examples, the housing or casing 101 is configured to protect components of the electronics unit 120 from body fluids or substances when the in-vivo fluid flow sensor device 100 is deployed inside a patient-user.

[0029] In the example of the system 10 shown in FIG. 1A, the one or more in-vivo fluid flow sensor devices 100 include a first in-vivo fluid flow sensor device 100Y deployed in a first portion of the patient-user's body, such as, for example, the chest, head, torso, appendages, or other region, and the one or more in-vivo fluid flow sensor devices 100 include a second in-vivo fluid flow sensor device 100X deployed in 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 may be directly coupled to an organ or tissue within the patient's body at the first portion and / or second portion, respectively. In some implementations, for example, the first in-vivo fluid flow sensor device 100Y may be coupled to an implant device deployed at or near the first portion of the patient-user's body, such as an implant in the heart, lungs, skull, neck, intestines, and digestive tracks, limbs, or extremities, etc. Similarly, for example, a second in-vivo fluid flow sensor apparatus 100X may be coupled to a second implant device deployed at or near a second portion of the patient's body.

[0030] In some exemplary embodiments, a sensor unit 110, such as that described below in connection with FIG. 1B, includes at least one of a first ultrasonic sensor assembly and a second ultrasonic sensor assembly, each including one or more acoustic transducer elements, and is configured to be positioned over and in contact with an anatomical structure, such as a heart, and an electronics unit 120 (e.g., housed within a casing 101, wherein one or both of the first and second ultrasonic sensor assemblies transmit and receive acoustic signals over a region of interest in the anatomical structure, and the electronics unit 120 stores data associated with the monitored acoustic signals. The sensor unit 110 is configured to process and / or relay acoustic data to a receiver device 130. One or more acoustic transducer elements of the first and second ultrasonic sensor assemblies of the sensor unit 110 are electrically coupled, e.g., via electrical interconnects such as wires, to an electronics unit 120 to provide electrical signals to stimulate transmission of an acoustic transmit signal across the region of interest and to receive electrical signals transmitted from a received acoustic signal propagating across the region of interest of the anatomical structure. Further details of the sensor unit 110 and electronics unit 120 for some embodiments of the in vivo fluid flow sensor device 100 are shown in FIG. 1B and other figures.

[0031] 1A, in some implementations, one or more in-vivo fluid flow sensor devices 100 wirelessly communicate acquired data directly to a receiver device 130. For example, one or more in-vivo fluid flow sensor devices 100 may transfer data to the receiver device 130 using a low-power wireless communication protocol, such as Bluetooth Low Energy (BLE), Near Field Communication (NFC), low-frequency radio frequency (RF) signals in the range of 3 kHz to 1.3 MHz, or others. Exemplary embodiments of the receiver device 130 include a computing device 130A or a dedicated base station 130B. For example, the computing device 130A may include, but is not limited to, a smartphone, a tablet, a home device (e.g., Alexa, Nest, Echo, Google Home, smart TV, etc.), a wearable computing device (e.g., smart watch, smart glasses, or headgear, etc.), a laptop or desktop computer, or others. The dedicated base station 130B may include data storage and / or data communication units to facilitate communication of data from one or more in-vivo fluid flow sensor devices 100 to the data processing system 150 via Wi-Fi access or a cellular link to the network 140. In some implementations, for example, the receiver device 130 may be embodied on multiple receiver devices, such as both a computing device 130A (e.g., a smartphone, tablet, etc.) and a dedicated base station 130B, as shown in the example of FIG. 1A. In some implementations, for example, the receiver device 130 may at least partially process the received data for display on a display screen of the receiver device 130 and / or for forwarding the received data to an external computer or computing system, such as the data processing system 150. In some embodiments, for example, the system 10 optionally includes software applications (apps) resident on the receiver device 130 to control various data processing, storage, and communication functions for management of the received data.

[0032] 1A , data processing system 150 may include one or more server computing devices 152, one or more client computing devices 154, and / or one or more databases 156 in data communication with each other. In implementations, for example, computing devices 152, 154 and database 156 communicate with each other and / or with other devices of system 10 via network 140. In some implementations, for example, data processing system 150 may remotely monitor data related to a patient-user acquired by one or more in-vivo fluid flow sensor devices 100 and / or remotely control aspects of 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 app on receiver device 130, or others.

[0033] In some embodiments, for example, system 10 optionally includes a remote computing device 160 operated by a remote user to remotely monitor data associated with the patient-user acquired by one or more in-vivo fluid flow sensor devices 100 that are forwarded to data processing system 150. For example, remote computer 160 may include a personal computer, such as a desktop or laptop computer, a mobile computing device, such as a smartphone, tablet, smartwatch, or other computing device. In some implementations, for example, remote computing device 160 is configured to receive only data that has been curated (e.g., selected, pre-processed, and / or formatted) by data processing system 150. In some implementations, for example, remote computing device 160 is configured to operate one or more aspects (e.g., functions) of system 10 remotely. For example, remote computing device 160 may implement a remote user software application (remote user app) configured to provide such display, storage, and / or management capabilities to the remote user. Remote users may include, for example, healthcare providers (HCPs), such as doctors, nurses, family members or other caregivers of the patient user, or health insurance payers or other types of stakeholder entities or individuals regarding the patient user's health.

[0034] FIG 1B shows a block diagram illustrating an exemplary embodiment of the in-vivo fluid flow sensor 100 shown in FIG 1A, which is shown in FIG 1B as in-vivo fluid flow sensor 100B. In the example of FIG 1B, the in-vivo fluid flow sensor 100B includes an exemplary embodiment of a sensor unit 110 (shown as sensor unit 110B) and an exemplary embodiment of an electronics unit 120 (shown as electronics unit 120B). The sensor unit 100B of the in-vivo fluid flow sensor 110B includes at least one ultrasonic assembly in electrical communication with the electronics unit 120 via an electrical interconnect 117, which is shown as having a first ultrasonic sensor assembly 111 and an optional second ultrasonic sensor assembly 112 in FIG 1B, each in electrical communication with the 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"), and 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 optionally include an additional transducer element, represented as transducer element 113b in FIG. 1B. Similarly, the one or more transducers 114 of the second ultrasonic sensor assembly 112 include transducer element 114a and optionally include an additional transducer element, represented as transducer element 114b in FIG. 1B. For example, embodiments having multiple acoustic transducer elements may be configured as an array of transducers in each 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 electronics unit 120B.In various implementations of the exemplary embodiment of in-vivo fluid flow sensor 100B, first ultrasonic sensor assembly 111 and optional second ultrasonic sensor assembly 112 may transmit and receive acoustic signals at one or more frequencies within a frequency range of 2 MHz to 20 MHz. In various embodiments, for example, first ultrasonic sensor assembly 111 and optional second ultrasonic sensor assembly 112 may each include a frame, casing, or housing structure (not shown) for structurally supporting one or more acoustic transducer elements 113 and one or more acoustic transducer elements 114, respectively, and positioning them in fixed positions relative to one another.

[0035] In some embodiments, for example, a transducer element or elements of the one or more acoustic transducer elements 113 and the one or more acoustic transducer elements 114 include a piezoelectric transducer operable to transmit an acoustic signal based on an electrical input signal, receive an acoustic signal, and generate an electrical output signal. For example, the piezoelectric transducer may include a solid-state piezoelectric ultrasonic transducer or a piezoelectric micromachined ultrasonic transducer (PMUT), such as a MEMS-based piezoelectric ultrasonic transducer for acoustic imaging of the environment. In some embodiments, for example, a transducer element or elements of the one or more acoustic transducer elements 113 and the one or more acoustic transducer elements 114 include a ferroelectric hafnium oxide transducer.

[0036] The in vivo fluid flow sensor device 100B includes a linkage assembly 103B that couples the first ultrasonic sensor assembly 111 to the electronics unit 120B (and, in embodiments including the second ultrasonic sensor assembly 112, couples the second ultrasonic sensor assembly 112 to the electronics unit 120B). In some embodiments, the linkage assembly 103B may include a pair of linkages 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 respective electrical interconnects 117 (connecting to the transducers 113 and / or transducers 114) from the first ultrasonic sensor assembly 111 and / or any second ultrasonic sensor assembly 112 to the electronics unit 120B. In some embodiments, for example, the pair of linkages of the linkage assembly 103B include a spring connection device, discussed below in connection with FIG. 2A. On the other hand, in some embodiments, for example, the linkage pairs of linkage assembly 103B include flexible bands, with or without springs, as described later in this patent document.

[0037] In some embodiments of the in vivo fluid flow sensor device 100B, for example, the sensor unit 110B may optionally include one or more secondary sensors 119. For example, in some implementations, the secondary sensor 119 may include an analyte sensor for measuring a parameter (e.g., concentration) of an analyte in a region proximate to the anatomical structure in which the in vivo fluid flow sensor device 100B is deployed. In some examples, the optional secondary analyte sensor may include, but is not limited to, a glucose sensor. In addition to or in the alternative to the secondary analyte sensor, the secondary sensor 119 may include a pH sensor for measuring a pH level in a region proximate to the anatomical structure. In addition to or in the alternative to the secondary analyte sensor and / or the secondary pH sensor, the secondary sensor 119 may include a temperature sensor for measuring a temperature in a region proximate to the anatomical structure. In such cases, any one or more secondary sensors 119, including, for example, an analyte sensor, a pH sensor, and / or a temperature sensor, may be used to obtain data indicative of clinically relevant conditions related to the anatomy and / or conditions 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 implantation of the in vivo fluid flow sensor device 100B. In some embodiments, for example, the optional one or more secondary sensors 119 may be attached to the casing 101 of the in vivo fluid flow sensor device 100B, e.g., via welding, chemical bonding, clips, clamps, or other attachment means, and in some embodiments, for example, the optional one or more secondary sensors 119 may be attached to one or both of the first ultrasonic sensor assembly 111 and / or the (optional) second ultrasonic sensor assembly 112, e.g., via attachment to a frame or casing structure.

[0038] In some embodiments, for example, the optional one or more secondary 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 secondary 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 electronics 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 velocity sensor in communication with the data processing unit 121 of the electronics 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 magnetometer in communication with the data processing unit 121 of the electronics unit 120B. In such an implementation, for example, the in-vivo fluid flow sensor device 100B is operable to measure heart rate compiled with fluid flow through the heart (e.g., across the mitral or tricuspid valve) when the in-vivo fluid flow sensor device 100B is deployed outside the heart, e.g., within the pericardium.

[0039] 1B, the electronics unit 100B of the in-vivo fluid flow sensor device 120B includes a data processing unit 121, an optional signal conditioning unit 123, a power source 129, a wireless communication unit 127, and an electrical interface 125 that may include conductive contact sites (e.g., pads, pins, or other contact configurations) that electrically couple with the electrical interconnects 117 of the sensor unit 110B. The electronics unit 120B is configured to receive and at least partially process electrical signals obtained from the one or more acoustic transducers 113 of the first ultrasonic sensor assembly 111 and the one or more acoustic transducers 114 of the second ultrasonic sensor assembly 112 of the sensor unit 110B. For example, in some embodiments, the electrical signals are received at the corresponding contact sites of the electrical interface 125 and provided to the data processing unit 121 (or, optionally, first provided to the signal conditioning unit 123 to improve the quality of the electrical signals obtained from the sensor unit 110B before providing them to the data processing unit 121). In such implementations, the output of the data processing unit 121 may include raw or processed data wirelessly transmitted by the wireless communication unit 127 to an external device, associated with the wirelessly transmitted detected data from the sensor unit 110B. In an exemplary embodiment of the electronics unit 120B, the power source 129 may include a battery (e.g., primary or rechargeable), a fuel cell, or other power source for powering the components of the electronics unit 120B and / or the sensor unit 110B. In some implementations, for example, the power source 129 includes an ultra-low power system (e.g., operating in the microampere range).

[0040] In some optional embodiments, for example, the signal conditioning unit 123 may include circuitry including one or more filters and / or one or more amplifiers to enhance the raw electrical signals detected by the ultrasonic sensor assemblies 111, 112 of the sensor unit 110B to increase a signal-to-noise ratio (SNR) of the electrical signals, thereby generating data including signal-processed electrical signals. In some optional embodiments, the signal conditioning unit 123 may include drive circuitry to generate operating electrical signals to generate electrical potentials and / or currents at the electrode assemblies and / or temperature sensor assemblies of the analyte sensors of the sensor unit 110B for operating electrochemical and / or electrophysical or dynamic sensing methods to be performed at the electrodes in the implementation of the optional secondary sensor 119 of the sensor unit 110B.

[0041] In some embodiments, for example, the wireless communication unit 127 includes a wireless transmitter, receiver, and / or transceiver device including an antenna capable of communicating with an external device to communicate raw, partially processed, or fully processed data from the signal conditioning unit 123 (and / or the data processing unit 121 discussed below). For example, the wireless communication unit 127 may be configured to manage a communication protocol for transmission or reception via the antenna. Examples of antennas may include, but are not limited to, a whip antenna, a loop antenna, or a conformal antenna. An exemplary transceiver unit may include a BLE chipset for communicating with a BLE-enabled device, for example, a smartphone, a tablet, or other external computing device, such as the receiver device 130. Additionally or alternatively, in some embodiments, for example, the wireless communication unit 127 is configured as a scaffold around the electronics unit 100B, for example, coupled to or integrated with the casing 101, which is structured to provide wireless communication means to the in-vivo fluid flow sensor device 120B.

[0042] In some embodiments, the electronics unit 120B includes a data processing unit 121 that at least partially processes the conditioned electrical signals to (i) generate data, for example in analog or digital form, and / or (ii) control the functionality of the electronics unit 120B and / or the sensor unit 110B. For example, the data processing unit 121 may be configured to manage data acquisition on data channels associated with the one or more acoustic transducers 113 and the one or more acoustic transducers 114 of the sensor unit 110B.

[0043] In some embodiments of the data processing unit 121, for example, the data processing unit 121 may include a processor 121A for processing data, and a memory 121B in communication with the processor 121A for storing and / or buffering data. In various embodiments, for example, the processor 121A may include one or more processors, and the memory 121B may include one or more memory units. For example, the processor 121A may include a central processing unit (CPU), a microcontroller unit (MCU), a graphics processing unit (GPU), or other types of processors. For example, the memory 121B may include and store processor executable code that, when executed by the processor, configures the data processing unit 121 to perform various operations, such as, for example, receiving information, commands, and / or data, processing information and data, and transmitting or providing information / data to another device. To support 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 that are 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 can be used to implement the storage functionality of memory 121B. In some embodiments, data processing unit 121 includes an input / output (I / O) unit 121C for interfacing 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, the I / O unit 121C can interface the processor 121A and memory 121B with the wireless communication unit 127 to utilize various types of wireless interfaces compatible with typical data communication standards that may be used, for example, for communication between the data processing unit 121 and other devices. Data communication standards include, but are not limited to, Bluetooth, Bluetooth Low Energy (BLE), Zigbee, IEEE 802.11, Wireless Local Area Network (WLAN), Wireless Personal Area Network (WPAN), Wireless Wide Area Network (WWAN), WiMAX, IEEE 802.16 (Worldwide Microwave Access Interoperability (WiMAX)), 3G / 4G / LTE / 5G / 6G cellular communication methods, and parallel interfaces. In some implementations, the data processing unit 121 can interface with other devices using a wired connection via the I / O unit 121C, for example, prior to implantation in a patient-user. The data processing unit 120B may also interface with other external interfaces, data storage sources, and / or visual or audio display devices, etc. to obtain and transfer data and information that may be processed by the processor 121A, stored in the memory 121B, or presented on an output unit of the receiver device 130 (e.g., a smartphone, tablet, etc.) or other external device to the in-vivo fluid flow sensor device 100.

[0044] In an implementation of the in-vivo fluid flow sensor device 100B, the first ultrasonic sensor assembly 111 (and optional second ultrasonic sensor assembly 112) are controlled by the data processing unit 121 to transmit and receive acoustic signals. For example, in some implementations, the in-vivo fluid flow sensor device 100B is configured to measure a Doppler shift of an acoustic probe signal across an anatomical structure. For example, the travel time of the acoustic signal indicates an estimated distance traveled, 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 the one or more transducers 113 and / or the one or more transducers 114 to stimulate transmission of the acoustic probe signal across a region of interest, such as the mitral valve of the heart, such that the opposing sets of transducers of the one or more transducers 113 and / or the one or more transducers 114 receive a fluid flow shifted acoustic probe signal, and based on the time of flight of the acoustic probe signal and the known fixed positions of the one or more transducers 113 and the one or more transducers 114, the data processing unit 121 processes the electrical signals transduced from the one or more transducers 113 and / or the one or more transducers 114 associated with the received acoustic probe signal to determine fluid flow, for example determining a forward flow or possible backward flow of blood across the mitral valve of the heart.

[0045] 2A shows a diagram illustrating an exemplary embodiment of the in-vivo fluid flow sensor device 100B of FIG. 1B, shown in FIG. 2A as in-vivo fluid flow sensor device 200. The in-vivo fluid flow sensor device 200 includes a sensor unit (e.g., coupled to or partially contained within a linkage, such as an arm of the linkage assembly 203) comprising an ultrasonic sensor assembly 211 and an ultrasonic sensor assembly 212 in electrical communication with an electronics unit 220 via an electrical interconnect 217. The ultrasonic sensor assembly 211 includes a plurality of acoustic transducer elements 213, i.e., three acoustic transducer elements 213a, 213b, 213c in this example, and the ultrasonic sensor assembly 212 includes a plurality of acoustic transducer elements 214, i.e., three acoustic transducer elements 213a, 213b, 213c in this example. This embodiment is not limited to three acoustic transducer elements for each ultrasonic sensor assembly, and may include fewer or more configurations than shown in the diagram of Figure 2A, including, for example, but not limited to, one or more acoustic transducer elements for each of ultrasonic sensor assemblies 211 and 212. Ultrasonic sensor assembly 211 and ultrasonic sensor assembly 212 include a frame, casing, or housing structure (not shown) for securing acoustic transducer element 213 and acoustic transducer element 214, respectively, to arms of linkage assembly 203 and positioning them in fixed positions relative to each other.

[0046] The electronics unit 220 of the in vivo fluid flow sensor device 200 is configured to be encased by a spring connection device 235 that couples to each linkage of the linkage assembly 203. The spring connection device 235 provides sufficient travel of the arms of the linkage assembly 203 to couple the ultrasonic sensor assemblies 211 and 212 to their intended placement locations, for example across the proximal and distal sides of the left or right atrium of the heart, sufficient to secure the in vivo fluid flow sensor device 200 to the anatomical structure (e.g., the heart) without interfering with the normal function of the anatomical structure of the intended use of the in vivo fluid flow sensor device 200. For example, the spring connection device 235 may include a spring that provides a compressive force to the linkage set of the linkage assembly 203 to transmit sufficient force to facilitate and / or maintain fixation of the in vivo fluid flow sensor device 200 to the target portion of the heart (e.g., the left and right atria), and the spring also allows the device 200 to be both stable in its position while surviving continuous movement (duty cycles) of the anatomical structure to which it is attached (e.g., heart beats) without suffering damage for millions to billions of cycles, thus giving the in vivo fluid flow sensor device 200 a significant lifespan (e.g., 50-60 million heart beats per year) during decades of use. Additionally, the linkage set of the linkage assembly 203 may be adjusted in all three planes (xy, xz, yz) to allow for initial proper alignment of the ultrasonic sensor assemblies 211, 212.

[0047] In some embodiments, for example, the in vivo fluid flow sensor device 200 can be secured to the anatomical structure by a network of prongs, screws, barbs, sutures, adhesives (e.g., bio-inert adhesives), or gripping mechanisms (not shown) disposed through the frame or casing of the ultrasonic sensor assembly 211 and ultrasonic sensor assembly 212. In some embodiments of the in vivo fluid flow sensor device 200 (not shown in FIG. 2A ), the frame, casing, or housing structure can include one or more openings on each linkage of the linkage assembly 203 that can allow for secondary means of attachment of the device 200 to the target anatomical structure, for example, openings having anchor sites for application of sutures connecting the linkages of the linkage assembly 203 to the anatomical structure (e.g., the wall of the atrium of the heart). In some embodiments, the linkage assembly 203 can 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 deleterious interference. For example, in some embodiments, the linkage assembly 203 may include Nitinol, platinum, MP35N, or other materials or combinations thereof. In some embodiments, the linkage assembly 203 provides a catch to lock onto the heart, e.g., not allow further movement of the linkage.

[0048] FIG. 2B shows a diagram illustrating another exemplary embodiment of the in-vivo fluid flow sensor device 100B of FIG. 1B, which is shown in FIG. 2B as in-vivo fluid flow sensor device 200B. The in-vivo fluid flow sensor device 200B includes a sensor unit comprising two or more sets of ultrasonic sensor assemblies 250 (shown in FIG. 2B as sets 250A and 250B) in electrical communication with an electronics unit 220 (e.g., coupled to or partially contained within sets of linkage assemblies 203A and 203B, respectively) via electrical interconnect 217. Each set of ultrasonic sensor assemblies 251 and 252 includes an ultrasonic sensor assembly 211 and an ultrasonic sensor assembly 212, each comprising a plurality of acoustic transducer elements 213 and a plurality of acoustic transducer elements 214, respectively, such 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 embodiment, the electronics unit 220 is partially encased by a set of spring connection devices 235B corresponding to the set of ultrasonic sensor clusters 250B, and by two or more sets of spring connection devices 235A represented by ultrasonic sensor clusters 250A.

[0049] Figure 2C shows a diagram illustrating another exemplary embodiment of the in-vivo fluid flow sensor apparatus 100B of Figure 1B, which is shown in Figure 2C as in-vivo fluid flow sensor apparatus 200C. The in-vivo fluid flow sensor apparatus 200C can be configured similarly to the in-vivo fluid flow sensor apparatus 200 (described above in Figure 2A), e.g., the sensor unit includes an ultrasonic sensor assembly 211 and an ultrasonic sensor assembly 212 in electrical communication with an electronics unit 220 via an electrical interconnect 217 (e.g., coupled to or partially contained within a linkage of the linkage assembly 203). 2C, however, the electronics unit 220 of the in vivo fluid flow sensor device 200C is configured to be encased by a flex connection device 235C that includes a first link 236 that can pivotally move relative to a second link 237, and / or vice versa, providing the device 200C with sufficient flexibility to be both stable in its position while enduring continuous movements (load cycles) of the anatomical structure to which it is attached (e.g., heartbeat) without suffering damage for millions to billions of cycles. In some embodiments, the flex 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.

[0050] Also, the flex connection device 235C couples the sensor unit 220 to each linkage of the linkage assembly 203C shown in FIG. 2C as linkage 203C. Still in FIG. 2C, the linkage assembly 203C includes a linear arm portion proximal to the flex connection device 235C and a curved arm portion distal to the flex connection device and proximate to the ultrasonic sensor assembly 211 and the ultrasonic sensor assembly 212. In this manner, for example, the structure of the in vivo fluid flow sensor device 200C can be mounted in a curved geometry for an anatomical structure, such as the left or right atrium of the heart, and can provide sufficient compressive force for mounting with appropriate flexion to reduce duty cycle. In some embodiments, for example, one or both of the linkages 203C can be used to mount an additional power source (e.g., one or more batteries) that can be electrically connected to the electronics unit and the ultrasonic sensor assembly 211 and / or 212 (optional).

[0051] Additionally, ultrasonic sensor assembly 211 and ultrasonic sensor assembly 212 include a frame, casing, or housing structure 219 for securing acoustic transducer element 213 and acoustic transducer element 214, respectively, to the linkage of linkage assembly 203C and positioning them in fixed positions relative to each other. Although not shown in FIG. 2C, frame, casing, or housing structure 219 may include one or more openings to allow for secondary attachment means of device 200 to a target anatomical structure, such as openings having anchor sites for applying sutures to secure ultrasonic sensor assembly 211 and ultrasonic sensor assembly 212 to an anatomical structure (e.g., a wall of the atrium of the heart) at the ends of the arms of linkage assembly 203C. In some embodiments, similar to the example shown in FIG. 2C, the distal ends of the arms or linkages of the linkage assembly 203C of the in vivo fluid flow sensor device 200C are angled or curved inwardly, which can help, for example, to facilitate attachment and conformation to the anatomical structure during placement, as well as aid in delivery of the device 200C, for example, via a catheter.

[0052] Although not shown in FIG. 2C, the sensor unit of the in-vivo fluid flow sensor device 200C may include a set of two or more ultrasonic sensor assemblies 250 (such as an arrangement of ultrasonic sensor assemblies 250A and 250B as shown in FIG. 20) that are in electrical communication with the electronics unit 220C via electrical interconnect 217 (e.g., each coupled to or partially contained within a respective arm of the linkage assembly 203C).

[0053] FIG. 2D shows a diagram illustrating another exemplary embodiment of the in-vivo fluid flow sensor device 100B of FIG. 1B, which is shown in FIG. 2D as in-vivo fluid flow sensor device 200D. The in-vivo fluid flow sensor device 200D may be configured similarly to the in-vivo fluid flow sensor device 200 (previously shown in FIG. 2A) and / or the in-vivo fluid flow sensor device 200C (previously shown in FIG. 2C), for example, where the sensor unit is comprised of an exemplary embodiment of an ultrasonic sensor assembly (i.e., ultrasonic sensor assemblies 211D and 212D) in electrical communication with an electronics unit 220 via an electrical interconnect (not shown in FIG. 2D). The electronics unit 220 is housed within a connection device 235. The acoustic transducer elements of the ultrasonic sensor assemblies 211D and 212D are each coupled to a linkage of the linkage assembly 203D, positioning them in a fixed position relative to one another. In some embodiments, for example, the connection device 235D includes a hermetically sealed package body that can carry and support a power source, a data processing unit, and a wireless communication unit (e.g., having an antenna for transmission), allowing, for example, power transfer to implement a charging system for power management of functional performance. For example, the mechanical force for closure by the linkage can be provided by a spring coil, a biasing spring, or other compression method to connect the ultrasonic sensor assemblies 211D and 212D with the intention of placing them around the anatomical structure. Still in FIG. 2D, the linkage assembly 200D of the in-vivo fluid flow sensor device 203D is configured to include an anchor support 203D on each linkage of the linkage assembly 233D. The anchor support 233D is an article that can be made of a metallic material or a polymeric material and can be positioned on the linkage between the connection device 235D and the distal portion of the linkage 239D that supports the ultrasonic sensor assemblies 211D and 212D. In an exemplary implementation of device 200D, for example, anchor support 233D passes through opening 218, allowing the linkage to be sutured or connected onto an anatomical structure (e.g., a tissue or organ or vessel) by a material capable of binding anchor support 233D to the anatomical structure's 233D wall, such as suture silk, polymer thread, or metal suture needle.

[0054] FIG. 3 shows a diagram illustrating an exemplary embodiment of the in-vivo fluid flow sensor device 200 attached to a patient-user's heart in an exemplary implementation of the device 200. Although FIG. 3 illustrates an exemplary in-vivo fluid flow sensor device 200, it is understood that other embodiments of the in-vivo fluid flow sensor device 100 may be attached to a patient-user's heart to assess blood flow at a target region of the heart. In this example, the in-vivo fluid flow sensor device 200 is configured to assess blood flow across the mitral valve by placing a first ultrasonic sensor assembly 211 proximal to an outer surface of the left atrium (LA) of the heart and a second ultrasonic sensor assembly 212 distal to an outer surface of the LA to assess mitral regurgitation (MR), for example. 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 onto the LA, which creates a plane perpendicular to the mitral valve for propagating acoustic signals. As shown in Figure 3, the arms of the in vivo fluid flow sensor device 100 (e.g., the linkages of the linkage assembly 203 of the device 200) can extend around an organ, such as the LA of the heart, with a particular spring constant that can support various orientations to optimize functional alignment with the target anatomical structure. Additionally, optimal functional alignment can be maintained by the spring constant or degree of flexion of the connection device, which can be positioned and secured to the target anatomical structure individually or (optionally) compiled with one or more secondary attachment mechanisms, such as, for example, secured with sutures (secured to suture ports), adhesives, or anchor structures (secured to anchor ports), and placement relative to the intended region of the organ / tissue can be optimized for consistent measurements (e.g., by initial monitoring to establish calibration, then comparison with constant monitoring and comparison from a baseline). Also, in some implementations, for example, multiple in vivo fluid flow sensor devices 100 may be deployed in different locations of the same anatomical structure, such as the LA of the heart (as shown in FIG. 3), and major blood vessels of the heart, such as the vein or pulmonary artery or vein (not shown in FIG. 3).

[0055] 4A shows a diagram illustrating insertion sites for implanting various embodiments of the in vivo fluid flow sensor device 100, such as the in vivo fluid flow sensor device 200 shown in FIG. 3. In some implementations, for example, the in vivo fluid flow sensor device 200 (or other embodiments of the in vivo fluid flow sensor device 100) may be implanted and positioned on the heart via apical pericardial puncture and delivery of the device within the pericardial sac, as shown in FIG. 3. The exemplary in vivo fluid flow sensor device 200 may be attached to a mechanism for loading, transporting, and delivering to the thoracic cavity, or for placement on the surface of the heart (e.g., across the left or right atrium) within the pericardium to monitor fluid flow (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 configuration to a catheter that is inserted into one of the insertion sites 402, 404, 406, 408, or 410, or another implantation site not shown in FIG. 4A, and during a subsequent implantation procedure, the exemplary in vivo fluid flow sensor device 100 may change to a second configuration to secure the opposing ultrasonic sensor assembly over a target region of the heart, for example, over the left atrium in the normal plane of the mitral valve. In some implementations, for example, the catheter may 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, as needed. In some implementations, an embodiment of the in vivo fluid flow sensor device 100 may be implanted and positioned on the heart outside the pericardial sac.

[0056] In some implementations, for example, the in-vivo fluid flow sensor device 100 may be inserted in a first stage (first configuration) into a patient-user of the device by a physician-user, such as, for example, a thoracic surgeon, through the patient-user's thoracic cavity via a main sternotomy or thoracotomy procedure. After insertion, the in-vivo fluid flow sensor device 100 may undergo a second stage (second configuration) for placement around the heart, for example, on the left side in the transition region between the atrium and ventricle, or on the right side in the same location. The in-vivo fluid flow sensor device 100 may be secured to the anatomical site by itself, for example, based on the compression and bending characteristics of the connecting device and / or arms (of the linkage assembly 103B), and / or may be secured in place with, for example, sutures or metal anchors performed by the physician-user.

[0057] FIG. 4B shows a diagram illustrating an exemplary configuration of an exemplary embodiment of an in vivo fluid flow sensor device according to the present embodiment for the implantation process near the target anatomical structure and the positioning process for fixing to the target anatomical structure. FIG. 400A shows another exemplary embodiment of the in vivo fluid flow sensor device 100B of FIG. 1B, shown in FIG. 4B as in vivo fluid flow sensor device 400, with the arms of the linkage assembly 403 flaring outward from the connection device 435 and in a first configuration for the insertion or implantation process, such as implemented by a catheter. For example, in some implementations, the in vivo fluid flow sensor device 400 can be inserted into the patient's body (e.g., through a port through a rib like the insertion site shown in FIG. 4A) to approach the area where the target anatomical structure is located, such as the heart. Prior to the insertion process, the patient can be prepared by undergoing an imaging session (e.g., a CT scan of the target area) that can be used to assist with the insertion.

[0058] FIG. 400B illustrates the in vivo fluid flow sensor device 400 in a second configuration with the arms of the linkage assembly 403 extending inward toward a centerline through the connection device 435, for example, for a deployment process for attachment to the anatomical structure 490. The in vivo fluid flow sensor device 400 may be configured similarly to the in vivo fluid flow sensor device 200 (described above in FIG. 2A), for example, where the sensor unit includes an ultrasonic sensor assembly 411 and an ultrasonic sensor assembly 412 in electrical communication with an electronics unit 420 via an electrical interconnect (not shown). For example, during or after attachment of 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 linkage 403 can be oriented (e.g., via contact placement and / or transmission and reception of acoustic signals for calibration measurements) such that a line of sight to the intended measurement site (e.g., by the insertion tool before the insertion tool is withdrawn) of the acoustic transducers of the ultrasonic sensor assemblies 411 and 412 can be established. Also, for example, prior to withdrawal of the insertion tool, the in vivo fluid flow sensor device 400 can be tested for wireless data communication with a remote device (e.g., remote computing device 130A and / or remote base station 130b). In some implementations, the in vivo fluid flow sensor device 400 can be further secured using, for example, sutures or other securement techniques (e.g., adhesive or other).

[0059] In some exemplary embodiments of the ultrasonic sensor assembly for various embodiments of the in vivo fluid flow sensor device 100B of FIG. 1B, the transducer array is designed to spatially configure a single transmitter with at least two receivers interleaving and alternating receivers and transmitters as a field or fields of ultrasonic energy move around a heart chamber (e.g., atrium or ventricle) to detect, for example, Q-wave flow patterns or disruptions in the flow pattern. By detecting Q-wave flow patterns or disruptions in the flow pattern, this data can be interrogated and mapped to regurgitation of blood flowing through and back through the heart chamber valves, indicating wall / chamber dysfunction (e.g., may be related to electrical signal disruptions of the heartbeat and / or static blood clotting). Mechanical analysis of changes in cardiac chamber diameter can also be calibrated for and detected for changes in use by the exemplary ultrasonic sensor assemblies 511 and / or 112, and thus can be a tool for predicting cardiac structural changes indicative of dysfunction in the removal of cellular analytes such as water, electrolytes, and / or cellular waste products, which may result in CHF in a patient, for example, due to water absorption by cardiac cells, which may result in saturation or supersaturation.

[0060] FIG. 5A shows a diagram illustrating an exemplary implementation of the in-vivo fluid flow sensor device 100B of FIG. 1B, shown as an in-vivo fluid flow sensor device 500 attached to an anatomical structure 590 (e.g., an atrium or ventricle of a heart or a blood vessel that feeds or drains blood to the heart), illustrating an exemplary embodiment of an acoustic transducer configuration according to the present embodiment. The exemplary in-vivo fluid flow sensor device 500 includes an embodiment of an electronics unit 120B coupled to a linkage assembly 103B having two opposing arms, at their distal ends 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. 5A graphically depicts a single Tx transducer 513a on one arm of the exemplary linkage assembly 103B and two Rx transducers 514b and 514c on opposing arms of the exemplary linkage assembly 103B, in some exemplary embodiments, additional Tx transducer elements or additional Tx transducer elements can be included on the first ultrasonic sensor assembly 511, and in some exemplary embodiments, additional Rx transducer elements or additional Rx transducer elements can be included on the second ultrasonic sensor assembly 512. Also, for example, in some embodiments, the first ultrasonic sensor assembly 511 can include two or more Rx transducer elements (e.g., at least two Rx transducers 514b and 514c), and in some embodiments, the second ultrasonic sensor assembly 512 can include one or more Tx transducer elements (e.g., at least one Tx transducer 513a).

[0061] In the embodiment shown in FIG. 5A, the in vivo fluid flow sensor device 500 provides a single sided acoustic detection system, with one or more Tx transducers 513a receiving on one side (i.e., an acoustic signal (e.g., a pulse, waveform, etc.)) and at least two Rx transducers 514b and 514c receiving on either (i) the opposite side (i.e., the other arm of the linkage assembly as the Tx transducer 513a of the device 500) and receiving an acoustic signal corresponding to the transmitted acoustic signal after propagating through the fluid in the anatomical structure 590 and being subjected to reflections, refraction, or other propagation changes due to fluid flow, or (ii) on the same side (i.e., the same arm of the linkage assembly as the Tx transducer 513a of the device 500) and receiving an acoustic signal corresponding to the transmitted acoustic signal after propagating through the fluid in the anatomical structure 590 and being subjected to reflections, refraction, or other propagation changes due to fluid flow, being reflected back by a reflector structure (not shown in FIG. 5A, described below).

[0062] In some exemplary embodiments, as shown in FIG. 5A , the acoustic transducers on the first and second ultrasonic sensor assemblies 511 and 512 are configured such that the Tx transducer 513a is positioned on / around another portion (e.g., an opposing portion) of the anatomical structure 590 from the Rx transducers 514b, 514c, and the center (C Tx ) is the distance (d) separating the centers of the Rx transducers 514b, 514c, i.e., (Cd Rx ) of the Tx transducer 513a. Tx and Rx converters 514b, 514c Rx The spatial alignment of the Tx transducers 513a, C is configured to minimize interference of acoustic energy during operation of the ultrasonic sensor assembly. Tx 5A , defines the length of the side of the Tx transducer 513a in that dimension along the x-axis. In the vertical dimension, for example, along the z-axis, the center of the Tx transducer 513a, C TxThe center of is also the midpoint of the width (w). The insert box 599R is connected to the Rx transducers 514b, 514c, i.e., (Cd Rx 5 shows that the distance (d) separating the centers of Rx transducers 514b, 514c is based on the relative lengths of the sides of Rx transducers 514b, 514c in that dimension, for example, along the x-axis, as shown by exemplary coordinate map 598. In particular, the fluid flow direction is in the direction of the x-axis of coordinate map 598, which corresponds to the ultrasound sensor assemblies shown in inserts 599T and 599R, as well as in the direction of coordinate map 597, which corresponds to the view of device 500 affixed to anatomical structure 590.

[0063] As shown in insert box 599T, in some exemplary embodiments, Tx transmitter 513a may be coupled to a backing or base 513 that may be attached to an inner surface of an arm of linkage assembly 103B. For example, base 513 may provide thermal synchronization for management of heat generation by the acoustic transducer. Similarly, insert box 599R shows an exemplary embodiment of Rx transmitters 514b, 514c coupled to a backing or base 514 that may be attached to an inner surface of an arm of linkage assembly 103B. For example, in some embodiments, one or several of Rx transmitters 514b, 514c may be disposed on a single base 514 or individual bases 514 in various combinations. Similarly, for example, base 514s may provide thermal synchronization for management of heat generation by the acoustic transducer.

[0064] In some embodiments, for example, the Tx transducer 513a may be 4 mm 2 (e.g., 2 mm × 2 mm) or 4π mm 2 It is understood that the width, length, or diameter (or any size dimension) of the Tx transducer 513a may be greater than or less than 2 mm, for example, the size dimension (e.g., width, length, diameter, etc.) of the Tx transducer 513a may be between 1 mm and 4 mm. In some embodiments, for example, each of the Rx transducers 514b, 514c may have a transducer area of ​​4 mm for reception of acoustic signals.2 (e.g., 2 mm × 2 mm) or 4π mm 2 (e.g., 2 mm diameter). It is understood that the width, length, or diameter (or any size dimension) of the Rx transducers 514b, 514c may be greater than or less than 2 mm, for example, the size dimension (e.g., width, length, diameter, etc.) of the Rx transducers 514b, 514c may be between 1 mm and 4 mm.

[0065] In some embodiments, for example, the Tx transducer 513a and the Rx transducers 514b, 514c are positioned 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 acoustic signals from the Tx transducer 513a propagating across the anatomy 590 and effected by fluid flow (e.g., blood flow in the heart or blood vessels leading to or from the heart). Also, in some embodiments, for example, the Tx transducer 513a and the Rx transducers 514b, 514c are positioned to be positioned (e.g., rotated) out of plane for site line and wave detection up to 90 degrees relative to each other. Similarly, in some embodiments, for example, the Tx transducer 513a and / or the Rx transducers 514b, 514c can be tilted out of plane for site line and wave detection up to 20 degrees relative to each other.

[0066] In some implementations, for example, the substrate 513s of the Tx transducer 513a has a width (W Tx ) and 10mm length (L Tx For example, in some implementations, the base 514 of the Rx transducers 514b, 514c may be configured to have a width (W Rx ) and 10mm length (L Rx )

[0067] 5B shows a diagram illustrating an example arrangement of acoustic transducers on an ultrasonic sensor assembly 511B for an exemplary embodiment of an in vivo fluid flow sensor device 100B, such as for one or both of the first ultrasonic sensor assembly 511B and the second ultrasonic sensor assembly 512 of the in vivo fluid flow sensor device 500 shown in FIG. 5A. The ultrasonic sensor assembly 511B includes a plurality of acoustic transducer elements 563, in this example, two acoustic transducer elements 563a and 563b, and a plurality of acoustic transducer elements 564, in this example, three acoustic transducer receiver elements 564d, 564e, and 564f. This embodiment is not limited to two acoustic transducer transmitter elements and three acoustic transducer receiver elements for the ultrasonic sensor assembly 511B, and may include fewer or more configurations than shown in the diagram of FIG. 5B. In this example, the arrangement of the transmitter elements 563a, 563b is in a row along a single direction, and the arrangement of the receiver elements 564d, 564e, 564f is along different rows above and below the transmitter row, positioned at a distance (d1) relative to the centers of the transmit and receiver elements. The configuration of the transmitter elements 563a, 563b and the receiver elements 564d, 564e, 564f is based on a line-of-sight transmit and receive (LOSTR) for operation of acoustic transducers in an array. In the exemplary embodiment shown in FIG. 5B, for a single transmitter element corresponding to at least two receiver transducers (e.g., the transmitter element 563a corresponding to the receiver elements 564d, 564e), the center of the Tx1 transducer 563a is located at a distance (d1) from the center of the Rx transducers 564d, 564e, i.e., (Cd Rx1 ) and C of Tx converter 563a. Tx1 and Cd between Rx converters 564d and 564e Rx1 The spatial alignment of the is configured to minimize interference of acoustic energy during operation of the transmitter-receiver group of the ultrasonic sensor assembly 511B. Similarly, for example, the center of the Tx transducer 563b (C Tx2 ) is connected to Rx converters 564e, 564f, i.e., (Cd Rx2 ) of the Tx transducer 563b. Tx2 and Cd between Rx converters 564e and 564fRx2 The spatial alignment with is configured to minimize interference of acoustic energy during operation of that transmitter-receiver group of the ultrasonic sensor assembly 511B.

[0068] In particular, for example, some exemplary embodiments of the ultrasonic sensor assembly 511B may configure the transmitter and receiver arrays to vary with combinations of transmitter and receiver elements integrated together in the same array. For example, in some implementations, Tx transducer 563a may be configured to transmit one or more acoustic signals that propagate through the anatomical structure 590 and are receivable 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 the anatomical structure 590 and are receivable by transducers 563a and 563b.

[0069] In some embodiments, for example, the transmitter elements 563a, 563b may be 2.25 mm 2 (e.g., 1.5 mm × 1.5 mm) or 2.25π mm 2 and receiver elements 564d, 564e, 564f can be configured to have a transducer area (e.g., 1.5 mm diameter) of 2.25 mm for receiving acoustic signals. 2 (e.g., 1.5 mm × 1.5 mm) or 2.25π mm 2 1.5 mm×1.5 mm) for reception of acoustic signals (e.g., transmitted from opposing arrays on opposing arms of the linkage assembly of the device 500). 2The ultrasonic sensor assembly 511B may be configured to have a transducer area of ​​1.5 mm (e.g., 1.5 mm diameter). It is understood that the width, length, or diameter (or any size dimension) of the transmitter and / or receiver transducer elements 563a, 563b and / or 564d, 564e, 564f may be greater than 1.5 mm or less than 1.5 mm. In some embodiments of the ultrasonic sensor assembly 511B, the distance (d1) between the transmitter and receiver arrays, i.e., the distance between the centerlines, may be substantially 5 mm, for example, to achieve optimal LOSTR (e.g., as a minimum distance to minimize interference). For this exemplary configuration of the ultrasonic sensor assembly 511B, the distance separation (d1) is optimized to ensure no cross reflections, which may resemble ghost signals or signal jamming that may generate false readings. The carrier for the transmitter and receiver may act as a coupler for electronic communication to a processing unit and a power source. In some embodiments, for example, one or more of transmitter elements 563a and 563b can be rotated up to 90 degrees from the scene in the same plane relative to at least two corresponding of receiver elements 564d, 564e, and 564f, or vice versa.

[0070] Ultrasonic sensor assembly 511B optionally includes a backing or base 563 that can be used to attach ultrasonic sensor assembly 511B to an arm of a linkage assembly of device 500. For example, base 563 can provide a thermal sync for managing heat generation by the acoustic transducers (e.g., acoustic transducers 563a, 563b, 564d, 564e, 564f). In some embodiments, for example, base 563 has a first side length ( S1 1) (perpendicular to the rows of transmitters and receivers), and a second side length (l S2 ) (parallel to the rows of transmitters and receivers).

[0071] In some implementations, for example, the ultrasonic sensor assembly 511B may be used in an exemplary single-sided acoustic detection system of the in vivo fluid flow sensor device 100, where at least two Rx transducers corresponding to one or more Tx transducers are configured to transmit acoustic signals (e.g., pulses, waveforms, etc.) across the anatomical structure on one side (i.e., the other arm of the linkage assembly) such that at least two Rx transducers corresponding to the Tx transducers are configured to receive acoustic signals on the opposite side (i.e., the other arm of the linkage assembly) that correspond to the transmitted acoustic signals after propagating through the fluid in the anatomical structure, subject to reflection, refraction, or other propagation changes due to fluid flow. However, in some implementations, for example, the ultrasonic sensor assembly 511B may be used in an exemplary dual-sided acoustic detection system of the in vivo fluid flow sensor device 100, where a first set of one or more Tx transducers are configured on one side (i.e., an arm of a linkage assembly) of at least two corresponding first set of receiver elements to operate (e.g., transmit and receive) simultaneously across the anatomy from a second set of at least two corresponding receiver elements on an opposing arm of the anatomy. An example of a dual-sided acoustic detection system is described below in FIG. 5D.

[0072] 5C shows a diagram illustrating an exemplary implementation of the in vivo fluid flow sensor device 100B of FIG. 1B, shown as an in vivo fluid flow sensor device 500C attached to an anatomical structure 590 (e.g., an atrium or ventricle of a heart or a blood vessel that feeds or drains blood to the heart) illustrating an exemplary embodiment of an acoustic transducer configuration according to the present embodiment. The exemplary in vivo fluid flow sensor device 500C includes an embodiment of an electronics unit 120B coupled to an embodiment of a linkage assembly 103B having two opposing arms, the distal end of one of the arms 503C1 being an ultrasonic sensor assembly 511C and the distal end of the opposing arm 503C2 being a reflector 516. In some embodiments, for example, the reflector 516 may be configured as a specular reflector having a substantially flat surface, a substantially smooth surface, and a boundary / area of ​​a size larger than the acoustic signal wavelength. However, in some embodiments, for example, the reflector 516 may be configured as a non-specular reflector having an uneven surface, and / or a rough or irregular surface texture, and / or a boundary / area that is smaller in size than the acoustic signal wavelength. Also, in some embodiments, the reflector 516 may be configured to have specular and non-specular reflector portions. In various embodiments, for example, the reflector 516 may be configured in a shape and size that conforms to the contours of an anatomical site (e.g., an organ or blood vessel) coupled with a focal length reflection for optimal energy response. Exemplary materials for the reflector 516 may include, but are not limited to, Mylar (e.g., on a substrate), precious metals (e.g., vacuum deposited precious metals) such as silver, platinum, gold, palladium, or standard metals (e.g., polished to wavelength) such as silver, titanium, nitinol, or stainless steel, or combinations thereof.

[0073] 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 one-sided acoustic detection system, where one or more Tx transducers 513a are configured in an array with at least two Rx transducers 514b, 514c on one side of the device 500C (i.e., an arm of the linkage assembly) to transmit an acoustic signal (e.g., a pulse, waveform, etc.) that propagates across the anatomical structure 590 and is affected by fluid flow through the anatomical structure 590, and is reflected off a reflector 516 on the opposite side of the device 500C (i.e., the other arm of the linkage assembly) and received as an acoustic signal corresponding to the transmitted acoustic signal.

[0074] In some exemplary embodiments, these acoustic transducers on the ultrasonic sensor assembly 511C may be configured with exemplary sizes, spacing, materials and structures as described for the exemplary acoustic transducers for the first and second ultrasonic sensor assemblies 511 and 512 in connection with Figures 5A and 5B, respectively.

[0075] An exemplary implementation of the in vivo fluid flow sensor device 500 was performed in a laboratory bench-top apparatus designed to simulate blood flow through a chamber or tube similar to an anatomical structure 590, which tests the characteristics of the received acoustic signal. Table 1 illustrates the frequency and sensitivity functions of an exemplary single-sided acoustic detection system, i.e., at least one transmitter configured on opposing arms of a linkage assembly to at least two receivers, as exemplified by an exemplary embodiment of the in vivo fluid flow sensor device 500 incorporating, for example, ultrasonic sensor assemblies 511, 512 shown in FIG. 5A, 511B shown in FIG. 5B, and / or 511C shown in FIG. 5C.

[0076] [Table 1]

[0077] Table 1 shows the relationship between flow sensitivity (ΔΦ / Δt) and exemplary frequencies (e.g., 3 MHz, 6 MHz, and 9 MHz) as well as the distance (mm) between the transmitting and receiving acoustic transducers for a single-sided transducer configuration. ΔΦ, the unit of sensitivity, is (degrees / [l / min]) and Δt, the period or duration of function, is (ps / [l / min]).

[0078] FIG. 5D shows a diagram illustrating an exemplary implementation of the in-vivo fluid flow sensor device 100B of FIG. 1B, shown as an in-vivo fluid flow sensor device 500D attached to an anatomical structure 590 (e.g., an atrium or ventricle of a heart or a blood vessel that feeds or drains blood to the heart), illustrating an exemplary embodiment of an acoustic transducer configuration according to the present embodiment. The exemplary in-vivo fluid flow sensor device 500D includes an embodiment of an electronics unit 120B coupled to a linkage assembly 103B having two opposing arms, the distal ends of which 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 insert 595 includes at least one ultrasonic transmitter (Tx) transducer 523a, and the second ultrasonic sensor assembly 512D shown in insert 596 includes at least two ultrasonic receiver (Rx) transducers 534b and 534c corresponding to the Tx transducer 523a. In the exemplary embodiment shown in FIG. 5D, 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.

[0079] In the embodiment shown in FIG. 5D , the in vivo fluid flow sensor device 500D provides a double-sided acoustic detection system of the in vivo fluid flow sensor device 100, where a first set of one or more Tx transducers (e.g., Tx transducer 523a) are configured to operate (e.g., transmit and receive) simultaneously with a second set of one or more Tx transducers on an opposing arm across the anatomical structure 590 from a second set of at least two corresponding receiver elements (e.g., Rx transducers 524b, 524c) on an opposing arm, and from a first set of at least two corresponding receiver elements (e.g., Rx transducers 534b, 534c) from the first set of Rx transducers across the anatomical structure 590.

[0080] In some exemplary embodiments, these acoustic transducers on the first ultrasonic sensor assembly 511D and / or the second ultrasonic sensor assembly 512D may be configured with exemplary sizes, spacing, materials and structures as described for exemplary acoustic transducers for the first and second ultrasonic sensor assemblies 511 and 512 in connection with Figures 5A and 5B, respectively.

[0081] An exemplary implementation of the in vivo fluid flow sensor device 500D was performed in a laboratory bench-top device 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 2 sets forth the frequency and sensitivity functions of an exemplary dual-sided acoustic detection system, as exemplified by the exemplary embodiment of the in vivo fluid flow sensor device 500D incorporating ultrasonic sensor assemblies 511D, 512D shown in FIG. 5D.

[0082] [Table 2]

[0083] Table 2 shows flow sensitivity (ΔΦ / Δt) and exemplary frequencies (e.g., 3 MHz, 6 MHz, and 9 MHz), as well as the distance (mm) between transmitting and receiving acoustic transducers for a double-sided transducer configuration, i.e., a first set of at least one transducer element on an opposing arm across the anatomy from a first set of at least two corresponding receiver elements operating simultaneously (e.g., transmitting and receiving) with a second set of at least one transducer element on an opposing arm across the anatomy from a second set of at least two corresponding receiver elements. ΔΦ, the units of sensitivity, are (degrees / [l / min]), and Δt, the period or duration of function, is (ps / [l / min]).

[0084] The exemplary data in Table 2 shows a damping effect using two opposing transmitters (e.g., Tx transducer 523a of the first ultrasonic sensor assembly 511D and Tx transducer 533a of the second ultrasonic sensor assembly 512D configured to simultaneously transmit acoustic signals in opposing directions from each other), which is approximately half the flow sensitivity compared to the exemplary data in Table 1, which is based on a unilateral transmitter transducer arrangement of the ultrasonic sensor assembly transmitting toward a reflector with at least two receiver transducers on the same side as the transmitter transducer, or with at least two receiver transducers on the opposite side of the anatomical structure from the transmitter transducer.

[0085] In some exemplary 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) in a Doppler mode. In contrast to typical ultrasound techniques for interrogating stationary objects, Doppler ultrasound may be used to characterize the properties of fluid flow. For example, if a target of interest (such as blood cells in blood flow through an anatomical structure) is moving relative to the ultrasound signal, more vibrations per unit time are encountered than a stationary equivalent such that the frequency of the reflected wave increases, and if the target of interest is moving away from the ultrasound signal, the frequency of the reflected signal is reduced. The Doppler effect may be used to measure the velocity of blood flow through an anatomical structure.

[0086] An exemplary embodiment of the in-vivo fluid flow sensor device 100B may be positioned at an angle (θ) relative to the blood flow direction in 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 transmitted acoustic signal, and f R is the frequency of the received acoustic signal, c is the velocity of an acoustic signal of a given wavelength propagating in the medium, and v is the velocity of the acoustic signal traveling towards the acoustic transducer receiving the signal.

[0087] For example, the in vivo fluid flow sensor device 100B can use Doppler techniques in conjunction with blood mass flow calculations through the anatomical structure such that the body mass flow in a confidence interval equates to the density (blood known) and diameter change (used to calculate the area), which allows for the determination of velocity. From the velocity and diameter, the device 100B can also determine the Q of the fluid flow. Additionally, the in vivo fluid flow sensor device 100B can measure the planar dimensions of the target anatomical structure based on determinable changes in fluid flow relative to a baseline measurement, for example, because increased fluid volume typically causes the walls of the anatomical structure (e.g., major blood vessels) to expand, i.e., increase in the diameter of the walls.

[0088] In some exemplary embodiments 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 ultrasound images of the target anatomical structure, for example, using A-mode, B-mode, and / or C-mode ultrasound data acquisition techniques. In some examples, the in vivo fluid flow sensor device 100B embodiments may be used in A-mode ultrasound acquisition to obtain a one-dimensional representation from the transmitted and received acoustic signal waves in the direction in which the ultrasound transducer assembly is oriented, e.g., one axis represents depth and a perpendicular axis represents amplitude. In some examples, the in vivo fluid flow sensor device 100B embodiments may be used in B-mode, also referred to as 2D mode, to obtain a two-dimensional representation from the transmitted and received acoustic signal waves, for example, based on the angle at which the ultrasound transducer assembly is positioned relative to the anatomical structure. In some examples, the in vivo fluid flow sensor device 100B embodiments may be used in C-mode to obtain both a range of depth from A-mode and 2D information from B-mode.

[0089] FIG. 6A shows a diagram illustrating an exemplary embodiment of the in-vivo fluid flow sensor device 100B of FIG. 1B, which is shown in FIG. 6A as in-vivo fluid flow sensor device 600A. The in-vivo fluid flow sensor device 600A includes a sensor unit with at least one ultrasonic sensor assembly 611 in electrical communication with an electronics unit 620 via an electrical interconnect (not shown), which is configured on a surface of the clip band 603 or within a body of material. The electronics unit 620 is housed within a connection device 635 that connects the arms of the clip band 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, which are positioned on the inward-facing sides of the arms of the clip band 603 in this example. This embodiment is not limited to five acoustic transducer elements for each ultrasonic sensor assembly, and may include fewer or more configurations than shown in the diagram of FIG. 6A, including, for example, but not limited to, one or more acoustic transducer elements for ultrasonic sensor assembly 611. The other arm of clip band 603 may include an embodiment of reflector 516 (shown as reflector 616 in FIG. 6A) configured to reflect acoustic signals transmitted by ultrasonic sensor assembly 611 propagating across the anatomical structure, affected by fluid flow through the anatomical structure, reflected from reflector 616, and received as a returned acoustic signal by ultrasonic sensor assembly 611 (corresponding to the transmitted acoustic signal). In some embodiments, reflector 616 may be attached to a backing or substrate 616, which may be attached to an inner surface of the arm of clip band 603.

[0090] The clip band 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 clip band 603 may be composed of a composite material having a durometer parameter of a polymer component (e.g., 20A-95A) and a reinforcement material (e.g., made of a shape-setting material such as Nitinol), which allows the clip band 603 to be pre-shaped and / or pre-trained (allowing the clip band 603 to be set in a first shape / configuration for delivery / implantation and then be able to assume a second shape / configuration for deployment / operation). Some non-limiting examples of composite materials for the clip band 603 can include Nitinol, gold, platinum, platinum / iridium, etc., encased in a polymer such as silicone, polyethylene, polyimide, polyamide, or mixed polyimide-polyamide, or other polymeric materials.

[0091] In some embodiments of the in vivo fluid flow sensor device 600A, the clip band 603 may include one or more openings 600A18 on at least one or both arms of the clip band 603 that allow for a secondary means of attachment of the device 600A to a target anatomical structure. For example, the opening 618 shown in the example of FIG. 6A includes a portion of the clip band 603 between two gaps that are openings 618, which provide an anchor site for application of a suture (e.g., stitch thread, wire, etc.) that affixes the arms of the clip band 603 to the anatomical structure (e.g., the wall of the atrium of the heart).

[0092] FIG 6B shows a diagram illustrating an exemplary embodiment of the in vivo fluid flow sensor device 600A of FIG 6A, which is shown in FIG 6B as in vivo fluid flow sensor device 600B. The in vivo fluid flow sensor device 600B includes a sensor unit including an ultrasonic sensor assembly 611 and a second ultrasonic sensor assembly 612, both in electrical communication with an electronics unit 620 via an electrical interconnect (not shown), which is configured on a surface of the clip band 603 or within a body of material. The electronics unit 620 is housed within a connection device 635 that connects the arms of the clip band 603. The ultrasonic sensor assembly 612 includes a plurality of acoustic transducer elements 614 positioned on an arm of the clip band 603 opposite the arm on which the ultrasonic sensor assembly 611 is located. In the example shown in FIG. 6B, the plurality of acoustic transducer elements includes five acoustic transducer elements 614a, 614b, 614c, 614d, 614e that are positioned on the inner surface of the arms of the clip band 603 in a specific configuration relative to each other and to the acoustic transducer elements 613 of the ultrasonic sensor assembly 611 on the opposing arm of the clip band 603. This embodiment is not limited to five acoustic transducer elements for each ultrasonic sensor assembly and may include fewer or more configurations than shown in the diagram of FIG. 6B, including, for example, but not limited to, one or more acoustic transducer elements for the ultrasonic sensor assembly 611. The clip band 603 is configured to secure the acoustic transducer elements 613 and 614 and position them in a fixed position relative to each other. In some embodiments, the clip band 603 of the in vivo fluid flow sensor device 600B may include one or more openings 618 on at least one or both of the arms of the clip band 603 that allow for a secondary means of attachment of the device 600B to a target anatomical structure. For example, the opening 618 shown in the embodiment of FIG. 6B includes a portion of the clip band 603 between the two gaps that are the opening 618, which provides an anchor site for applying a suture (e.g., stitch thread, wire, etc.) that affixes the arms of the clip band 603 to an anatomical structure (e.g., the wall of the atrium of the heart).

[0093] Figure 6C shows a diagram illustrating an exemplary embodiment of the in vivo fluid flow sensor device 600A of Figure 6A and / or the in vivo fluid flow sensor device 600B of Figure 6B, shown in Figure 6C as in vivo fluid flow sensor device 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 in electrical communication with an electronics unit 620 via an electrical interconnect (not shown), which is configured on a surface of the clip band 603 or within the body of material. The electronics unit 620 is housed within a connecting device 635 that connects the arms of the clip band 603. The in vivo fluid flow sensor device 600C includes an inner curved region 634 at the distal end of each arm of the clip band 603, which can aid in the delivery of the device 600C, for example, via a catheter, as well as help facilitate attachment and conformation to the anatomy during deployment. One or more openings 618 can be disposed on the inner curved region 634 and / or on at least one or both of the arms of the clip band 603 proximate the inner curved region 634, for example, to allow for a secondary means of attachment of the device 600B to the target anatomy. In some embodiments, the connection device 635 can be attached to the clip band 603 (not shown) on the outside of the arms of the clip band 603, which can be preferred for in vivo applications where the device 600C is deployed on a blood vessel (such as, for example, the vena cava or pulmonary artery or vein).

[0094] Each of the exemplary embodiments of the in vivo fluid flow sensor devices 600A, 600B, and 600C in FIGS. 6A-6C includes a soft arm configuration of the clip band 603 for flexibility and conformance to the intended placement site. The arms of the clip band 603 can facilitate and maintain electronic transmission to the electronics unit 620 housed within the connection device 635 through an interconnect (not shown). The clip band 603 can enhance contact of the device 600A, 600B, 600C with the anatomical structure so that ultrasonic measurements are detected. The arms of the clip band 603 can include a flexible, non-conductive, bio-inert substrate material thereon or embedded therein that is a flexible circuit and carrier for the ultrasonic sensor assembly 611 and / or the second ultrasonic sensor assembly 612. In this manner, the clip band 603 can undergo and withstand mechanical forces during placement of the operation to connect to the device at its intended location and during operation for extended periods of time (e.g., hundreds of cycles of heartbeats, etc.). In some embodiments, the arms of the linkage assembly 603 may use braided metal or polymer sheets that are then interwoven with trace lines for electrical connection.

[0095] 6D shows an enlarged view illustrating an exemplary embodiment of an electronics unit housed in the connection device 635 of the in vivo fluid flow sensor devices 600A, 600B, and 600C of FIGS. 6A-6C. In some embodiments, for example, the connection device 635 includes a base housing 631 and a removably attachable cap 633 that can be secured (e.g., hermetically sealed) to the base housing 631 to protect the internal components (e.g., electronics unit 620) from the external environment (e.g., biological fluids and / or biological substituents). In some (optional) embodiments, for example, the connection device includes an intermediate housing 632 that houses the electronics unit 620, and the intermediate housing 632 can be manufactured separately and in multiple physical configurations (e.g., shapes and sizes) to allow modularity with various embodiments of the connection device 635 in any embodiment of the in vivo fluid flow sensor devices 100, 100B.

[0096] In some embodiments, the base housing 631, the intermediate housing 632, and / or the cap 633 may be connected via a hermetic sealing material (e.g., a non-permeable material, such as a metal or metal film (thin film) and / or a woven fabric or polymer, a urethane such as Parylene, or a Teflon (registered trademark) material) and coated to ensure a non-permeable interface between any of the base housing 631, the intermediate housing 632, and / or the cap 633, to prevent fluids such as water or blood from entering the connection device 635 into the electronics unit 620.

[0097] The electronics unit 620 includes a printed circuit board (PCB) 622 that facilitates a data processing unit, a wireless communication unit, and a power unit. For example, in some embodiments, the PCB 622 includes an embodiment of 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 functioning of the electronics unit 120B and / or the ultrasonic sensor assemblies 611 and / or 612. For example, the data processing unit 121 may be configured to manage data acquisition on one or more acoustic transducers and data channels associated with the ultrasonic sensor assemblies 611 and / or 612. Also, for example, in some embodiments, the PCB 622 includes a power cell, which may be a supercap or miniature Hermitian battery, which may be recharged by inductance, and / or may function in conjunction with a hybrid supercapacitor battery, such that recharge and run time are balanced to be efficient relative to the required monitoring power and communication drain.

[0098] In some embodiments, the wireless communication unit of the electronics unit 620 may be, for example, 0.000001 in. 2 ~0.008 in 2The antenna may include platinum, or 90 / 10 platinum iridium, gold, or platinum pure wire, with a cross-sectional size of 100 mm. As an example, a molded nitinol wire with a gold plated or co-extruded gold outer layer may be used. Exemplary wires may be single or combined in a wound or braided configuration for optimal density to receive and transmit single supporting the movement of information in a single or multi-directional pattern. In some embodiments, the antenna may be configured in any of the aforementioned patterns on a flat flexible circuit form such as a PCBA (printed circuit board assembly). In some embodiments, for example, the antenna may be configured as a snake antenna or coil antenna that fits into an electronic package, and / or in some embodiments, the antenna may be configured as a power transfer antenna reference operable for battery charging.

[0099] In some embodiments, the wireless communication unit of the electronics unit 620 includes a Bluetooth, galvanic, or radio integrated in antenna communication system. In some implementations, the electronic signals transduced by the ultrasonic sensor assemblies 611 and / or 612 may be transmitted as a communication data package to a remote device outside the patient's body, for example, through the thoracic cavity to a receiving scanner, receiver transmitter, receiving card (e.g., similar to an EKG port contact), or base station equivalent.

[0100] 7A shows a diagram illustrating an exemplary embodiment of the in-vivo fluid flow sensor device 100B of FIG. 1B, shown in FIG. 7A as in-vivo fluid flow sensor device 700. The in-vivo fluid flow sensor device 700 includes a sensor unit including a first ultrasonic sensor assembly 711 and a second ultrasonic sensor assembly 612, both in electrical communication with an electronics unit 720 via an electrical interconnect 717 configured on a surface or within a body of material of an exemplary embodiment of a clip band 603 (shown in FIG. 7A as clip band 703). The electronics unit 720 is housed within a connecting device 735 that connects the arms of the clip band 703.

[0101] The connection device 735 may include features of the exemplary embodiments of the connection devices 235, 235C, and / or 635, such as springs, interconnecting links, housing structures (e.g., base, cap, etc.), and other features described in connection with other connection device embodiments disclosed herein. With reference to FIG. 7A, the connection device 735 includes a power and / or data port 751 operable to interface (e.g., in electrical and / or data communication) with an electronics unit 720 housed within the connection device 735. For example, the electronics unit 720 of the in-vivo fluid flow sensor device 700 may include a rechargeable power source or an intermediate power source that may be tethered via the power and / or data port 751 to a separate power source and / or data processing unit remote from the device 700. In some exemplary embodiments, the remote power source and / or data processing unit may be an in-vivo device located within the patient's body, but in an area that is easily accessible for replacing batteries or communicating wirelessly. For example, the remote in-vivo device may communicate wired and provide power to the electronics unit 720 of the in-vivo fluid flow sensor device 700 via a cable, wire, cord, or the like (e.g., coated with 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 closed space, such as inside or around the pericardium located in the atrium or ventricle, or around the superior or inferior vena cava or pulmonary artery, tethered to a larger in-vivo power source device located in a cavity far from the deployment site of the device 700, such as a centimeter away, or centimeters away, or tens of centimeters away, such as the pleural or intraperitoneal cavity, and having greater flexibility, size, and / or positioning to facilitate larger power sources and / or electronic components and allowing replacement of such components. In some embodiments, the remote power source may be located outside the patient's body, with a power and / or data cable passing from the power and / or data port 751 of the device 700 to the remote power source outside the patient's body.

[0102] In some example implementations, the in-vivo fluid flow sensor platform including the device 700 may include any 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. connected via a power and / or data port 751. For example, in some implementations, the exemplary secondary sensor 119 may include an IMU to determine the patient-user's motion (e.g., whether they are resting (e.g., sleeping, sitting, etc.) or moving (e.g., walking, running, etc.). Additionally, the exemplary secondary sensor 119 as part of the in-vivo fluid flow sensor platform may include an acoustic sensor (e.g., inhalation and exhalation respiration rate, turbulent airflow, etc.) for monitoring respiration by the patient-user (respiratory parameters) which, in some embodiments, are monitored by the in-vivo fluid flow sensor device 700. Still further, the exemplary secondary sensor 119 as part of the in-vivo fluid flow sensor platform may include an EKG monitor (e.g., an external wearable cardiac monitor or an in-vivo insertable cardiac monitor) for measuring the patient's electrocardiogram which is monitored by the in-vivo fluid flow sensor device 700. In this manner, for example, the in-vivo fluid flow sensor device 700 may measure blood flow through the target cardiac anatomical structure simultaneously (time-synchronized) with sensed information of the patient's motion state, respiratory state, and / or heart rate.

[0103] In some exemplary embodiments, a remote in-vivo device (in wired communication with the in-vivo fluid flow sensor device 700) of the in-vivo fluid flow sensor platform may include a secondary transmitting device (e.g., a wireless communication unit) for power control and optimal continuous data management, which may be communicated, for example, to the remote device 130 (e.g., the base station 130B and / or the mobile communication device 130A). For example, data transmission by the exemplary secondary transmitting device (deployed remotely from the device 700) may wirelessly transmit data collected by the device 700 every minute, every second, etc., due to reduced constraints and challenges on power consumption by the remote secondary transmitting device relative to the device 700. In some embodiments, for example, the secondary transmitting device of the remote in-vivo device may include a transmitter, receiver, and / or transceiver and have an antenna using a low power wireless communication protocol, for example, Bluetooth Low Energy (BLE), Near Field Communication (NFC), low frequency radio frequency (RF) signals in the range of 3 kHz to 1.3 MHz, or others.

[0104] With reference to the exemplary embodiment of the in vivo fluid flow sensor device 700 shown in FIG. 7A, the first ultrasonic sensor assembly 711 includes a plurality of acoustic transducer elements 713 positioned on an arm of the clip band 703 opposite the arm on which the second ultrasonic sensor assembly 712 is disposed. In the example shown in FIG. 7A, the plurality of acoustic transducer elements 713 of the first ultrasonic assembly 711 includes five acoustic transducer elements 713a, 713b, 713c, 713d, 713e that are positioned on the medial side of the arm of the clip band 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 opposing arm of the clip band 703. It is understood that this embodiment is not limited to five acoustic transducer elements for the first ultrasonic sensor assembly 711 and may include fewer or more configurations than those shown in the diagram of FIG. 7A, including, for example, 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 positioned on an arm of the clip band 703 opposite the arm on which the first ultrasonic sensor assembly 711 is located. In the example shown in Figure 7A, the plurality of acoustic transducer elements includes five acoustic transducer elements 714a, 714b, 714c, 714d, 714e that are positioned in a particular configuration on the inwardly facing side of the arm of the clip band 703 relative to each other and relative to the acoustic transducer elements 713 of the first ultrasonic sensor assembly 711 on the opposing arm of the clip band 703. It is understood that this embodiment is not limited to five acoustic transducer elements for each ultrasonic sensor assembly and may include fewer or more configurations than those shown in the diagram of Figure 7A, including, for example, but not limited to, one or more acoustic transducer elements for the second ultrasonic sensor assembly 712.

[0105] Clip band 703 is configured to secure acoustic transducer element 713 and acoustic transducer element 714 and position them in a fixed position relative to each other. In some embodiments, clip band 703 of in vivo fluid flow sensor device 700B may include one or more openings 718 on at least one or both arms of clip band 703 that allow for a secondary means of attachment of device 700B to a target anatomical structure. For example, opening 718 shown in the example of FIG. 7A includes a portion of clip band 703 between two gaps that are openings 718, which provide an anchor site for application of a suture (e.g., stitch thread, wire, etc.) that affixes the arms of clip band 703 to an anatomical structure (e.g., the wall of the atrium of the heart).

[0106] In some embodiments of the in vivo fluid flow sensor device 700, similar to the example shown in FIG. 7A, the device 700 includes an inner curved region 734 at the distal end of each arm of the clip band 703, e.g., which can help facilitate attachment and conformation to the anatomical structure during deployment as well as aid in delivery of the device 700, e.g., via a catheter. One or more openings 718 can be located on the inner curved region 734 and / or on at least one or both of the arms of the clip band 703 proximate the inner curved region 734, e.g., to allow for a secondary means of attachment of the device 700 to the target anatomical structure.

[0107] 7B and 7C show diagrams illustrating another exemplary embodiment of the in-vivo fluid flow sensor device 100B of FIG. 1B, which is designated in FIG. 7B and 7C as in-vivo fluid flow sensor device 700B. The in-vivo fluid flow sensor device 700B may be configured similarly to the in-vivo fluid flow sensor device 700 (previously shown in FIG. 7A), for example, the sensor unit includes an ultrasonic sensor assembly 712 in electrical communication with an electronics unit 720 via an electrical interconnect 717 (e.g., coupled to or partially housed within an arm of the clip band 703), and the connection device 735 includes a power and / or data port 751 in electrical communication with the electronics unit 720 and a remote device. 7B and 7C, 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 (e.g., improve acoustic impedance match) between the transducers and the biological tissue of the anatomical structure to which the device 700 is attached. FIG. 7B shows the in vivo fluid flow sensor device 700B in an exploded view in which the acoustic transducer pad 771 is removed from the ultrasonic sensor assembly 711, and FIG. 7C shows the in vivo fluid flow sensor device 700B in a rotated view (with respect to FIG. 7B) but with the acoustic transducer pad 771 coupled to an arm of the clip band 703 and / or a plurality of acoustic transducer elements 713 of the ultrasonic sensor assembly 711 positioned on (at least one) of the arms of the clip band 703. Although not shown in FIGS. 7B and 7C, a second acoustic transducer pad 771 may be coupled to an opposing arm of the clip band 703 and / or to at least one of the acoustic transducer elements 714 of the ultrasonic sensor assembly 712 .

[0108] In various embodiments, the acoustic transducer pad 771 may include a hydrogel that may be packaged in a gelatinous or fluid form with a casing that includes a polymeric material having a hardness of up to 40A durometer (e.g., silicone, polyethylene, or other). In an exemplary implementation of the in vivo fluid flow sensor device 700 using the acoustic transducer pad 771, the acoustic transducer pad 771 may further provide contour and cushioning to cardiac tissue, e.g., the outer tissue of the walls of the atria or ventricles, as well as the epithelial tissue of major blood vessels, such as the vena cava or pulmonary arteries or veins, when the in vivo fluid flow sensor device 700 is deployed within the pericardium. For example, the acoustic transducer pad 771 may account for contour changes with anatomical structures with which the device 700 directly interacts. Additionally, for example, the acoustic transducer pad 771 may be operable to support signal separation from noise and provide noise deflection for optimal sensing capabilities. The acoustic transducer pads 771 can reduce the risk of damage from edge abrasiveness, for example, by absorbing mechanical forces potentially occurring on the acoustic transducer elements during deployment and operation (e.g., cyclical motion of the anatomical structures) that can result in acute harm or long-term wear and tear, particularly while not affecting acoustic signal transmission between the anatomical structures and the acoustic transducer elements. Similarly, the acoustic transducer pads 771 can reduce the risk of tissue abrasion to the anatomical structures to maintain contact viability between the device and biological tissue.

[0109] Figure 7D shows a diagram illustrating an exemplary embodiment of the in-vivo fluid flow sensor device 100B of Figure 1B, which is shown in Figure 7D as in-vivo fluid flow sensor device 700D. The in-vivo fluid flow sensor device 700D can be configured similarly to the in-vivo fluid flow sensor device 700 (previously shown in Figure 7A) and / or the in-vivo fluid flow sensor device 700B (previously shown in Figures 7B and 7C and having at least one acoustic transducer pad 771), for example, the sensor unit includes an ultrasonic sensor assembly (shown in Figure 7D as ultrasonic sensor assembly 712) in electrical communication with an electronics unit 720 via an electrical interconnect 717 (e.g., coupled to or partially housed within an arm of the clip band 703), and the connection device 735 includes a power and / or data port 751 in electrical communication with the electronics unit 720 and / or a remote device. 7D, the in vivo fluid flow sensor device 700D includes an embodiment of a reflector 516 (shown in FIG. 7D as reflector 716) configured to reflect acoustic signals transmitted by the ultrasonic sensor assembly 712 propagating across the anatomical structure, affected by fluid flow through the anatomical structure, reflected from the reflector 716, and received as a returned acoustic signal by the ultrasonic sensor assembly 712 (corresponding to the transmitted acoustic signal). In some embodiments, the reflector 716 may be attached to a backing or substrate (not shown), which may be attached to an arm that facilitates the ultrasonic sensor assembly 712 to an inner surface of an opposing arm of the clip band 703.

[0110] Figure 7E shows a diagram of an exemplary embodiment of a remote in-vivo device 790 operable to communicate by wire with the exemplary embodiment of the in-vivo fluid flow sensor device of Figure 1B, in-vivo fluid flow sensor devices 700, 700B, and / or 700D shown in Figures 7, 7B-7C, and / or 7D, respectively. The remote in-vivo device 790 includes a casing or housing 791 within which a power source 798 and a data processing and / or wireless communication unit 797 are housed.

[0111] Examples of the power source 798 may include a battery, a fuel cell, or other power source. In some embodiments, for example, the power source 798 may be configured to be a replaceable battery and / or a rechargeable battery. For example, in implementations where the remote in-vivo device 790 is located within the patient's body in an area or region that is relatively easy and safe for a clinician to access, such as a space in the pleural cavity or abdominal region, the power source 798 may be recharged. In this manner, electrical energy stored in the power source 798 may be used to provide power within the electronics unit 720, which may have a relatively lower charge storage capacity than the power source 798. Transmission of electrical energy may be provided from the remote in-vivo device 790 to the exemplary in-vivo fluid flow sensor device 700, 700B, 700D via a cable, wire, or cord 793 that interfaces with a power and / or data port 751 of the exemplary in-vivo fluid flow sensor device 700, 700B, 700D via an interface termination 792. In the exemplary illustration of FIG. 7E, the mating end 792 of the cable, wire, or cord 793 is shown having at least one protruding structure that can be used to create a locking system with power and / or data port 751 to secure fixation (e.g., exemplary in vivo fluid flow sensor devices 700, 700B, 700D).

[0112] Examples of the data processing and / or wireless communication unit 797 may include a transmitter, receiver, and / or transceiver having an antenna using a low power wireless communication protocol, such as, for example, Bluetooth Low Energy (BLE), Near Field Communication (NFC), low frequency radio frequency (RF) signals, in data communication with one or more processors coupled to a memory. In this manner, the data processing unit of the electronics unit 720 may manage data processing functions using less on-board 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. Additionally, the data processing and / or wireless communication unit 797 may function to at least partially control certain device functions of the exemplary in-vivo fluid flow sensor device 700, 700B, 700D.

[0113] 8A and 8B show diagrams illustrating an exemplary embodiment of the in-vivo fluid flow sensor device 100B of FIG. 1, shown as in-vivo fluid flow sensor devices 800A and 800B, respectively, which are attached to the heart of a patient-user in an exemplary implementation of the device. In this example, the in-vivo fluid flow sensor devices 800A and 800B are configured to assess blood flow across the mitral valve by placing an ultrasound sensor assembly on opposing sides of the outer surface of the atrium of the heart around the mitral valve, for example, to assess MR. As shown in FIG. 8A and 8B, the arms of the in-vivo fluid flow sensor devices 800A and 800B (e.g., the arms of the exemplary embodiment of the linkage assembly 103 of the device 100B as clip bands 603 and / or 703) can extend around an organ, such as the atrium of the heart, with sufficient flexibility to support various orientations to optimize functional alignment with the target anatomical structure.

[0114] Additionally, optimal functional alignment can be maintained by the arms (e.g., degree of flexion) of the linkage assembly, and the in vivo fluid flow sensor devices 800A, 800B can be positioned and secured to the target anatomical structure individually or (optionally) compiled with one or more secondary attachment mechanisms, for example, secured with sutures (secured to suture ports), adhesives, or anchor structures (secured to anchor ports), and placement relative to the intended region of the organ / tissue can be optimized for consistent measurements (e.g., by initial monitoring to establish calibration, then comparison with constant monitoring and comparison from a baseline). Also, in some implementations, for example, multiple in vivo fluid flow sensor devices 800A, 800B can be deployed at different locations in the same anatomical structure.

[0115] An exemplary embodiment of the in vivo fluid flow sensor device 800A includes a connection device disposed on the inside of the clip band linkage assembly (e.g., proximate to the anatomical structure to which the device 800A is attached). Yet, an exemplary embodiment of the in vivo fluid flow sensor device 800B includes a connection device disposed on the outside of the clip band linkage assembly (e.g., distal from the anatomical structure to which the device 800B is attached). It is understood that the configuration of the connection device can be on the inside or outside of the linkage assembly for various embodiments of the in vivo fluid flow sensor device 100B, including any embodiment of the linkage assembly 103.

[0116] Working Example In some embodiments (Example A1) according to the present technology, a sensor device for in vivo monitoring of fluid flow in an anatomical structure comprises a first ultrasonic assembly including a first set of one or more acoustic transducer elements in a major blood vessel of the heart, a second ultrasonic assembly including a second set of one or more acoustic transducer elements, a first linkage coupled to the first ultrasonic assembly, a second linkage coupled to the second ultrasonic assembly, and an electronics unit in electrical communication with the first ultrasonic assembly and the second ultrasonic assembly, wherein the electronics unit is configured to process electrical signals associated with the returned acoustic signals as data and wirelessly transmit the data to an external processor, and a spring connection device coupled to each of the first and second linkages, positioning the first ultrasonic assembly at a first location on the anatomical structure and positioning the second ultrasonic assembly at a second location on the anatomical structure to form a plane across the first and second locations of the anatomical structure, and operable to transmit and receive acoustic signals from the first set of one or more acoustic transducer elements and the second set of one or more acoustic transducer elements indicative of a fluid flow parameter of a biological fluid in the anatomical structure.

[0117] Example A2 includes the sensor device of any of Examples A1-A4, where the anatomical structure is the heart.

[0118] Example A3 includes a sensor device described in any of Examples A1 to A4, wherein the first position and the second position are positioned over the left atrium of the heart and the plane through which the acoustic signal is transmitted and received intersects at the mitral valve of the heart.

[0119] Example A4 includes a sensor device described in any of Examples A1 to A3, wherein the first location and the second location are positioned over the right atrium of the heart and the plane through which the acoustic signal is transmitted and received intersects at the tricuspid valve of the heart.

[0120] In some embodiments (Example B1) according to the present technology, a sensor device for in vivo monitoring of fluid flow within an anatomical structure comprises: a linkage assembly having a first arm configured to be attached to a first portion of the anatomical structure and a second arm configured to be attached to a second portion of the anatomical structure opposite the first portion; a connection device coupled to each of the first arm and the second arm; and an ultrasonic sensor assembly including a plurality of acoustic transducer elements coupled to the linkage assembly, wherein the plurality of acoustic transducer elements include a first acoustic transducer element configured to transmit an acoustic signal to propagate through the anatomical structure, and a second acoustic transducer element and a third acoustic transducer element configured to propagate through the anatomical structure and receive an acoustic signal indicative of a fluid flow parameter of a biological fluid within the anatomical structure; and an electronics unit contained within the connection device and in electrical communication with the plurality of acoustic transducer elements of the ultrasonic sensor assembly, wherein the electronics unit is configured to process an electrical signal associated with the received acoustic signal as data and wirelessly transmit the data to an external processor.

[0121] Example B2 includes the sensor device of any of Examples B1 to B50, and 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.

[0122] Example B3 includes the sensor device of example B2 or any of examples B1-B50, wherein the first ultrasonic sensor assembly includes a first acoustic transducer element positioned on a distal region of the first arm and configured to transmit an acoustic signal to interface with a first portion of the anatomical structure, and the second ultrasonic sensor assembly includes second and third acoustic transducer elements positioned on a distal region of the second arm and configured to receive the acoustic signal to interface with a second portion of the anatomical structure, and a first center point (C Tx) is located between a distance (d) separating the centers of the second acoustic transducer element and the third acoustic transducer element and a second center point (Cd Rx ) and align them.

[0123] Example B4 includes the sensor device of example B2 or any of examples B1-B50, wherein the first ultrasonic sensor assembly includes a first acoustic transducer element positioned on a distal region of the first arm and configured to transmit acoustic signals to interface with a first portion of the anatomical structure, the second ultrasonic sensor assembly includes second and third acoustic transducer elements positioned on the distal region of the second arm and configured to receive acoustic signals to interface with the second portion of the anatomical structure, the first ultrasonic sensor assembly further includes a fourth acoustic transducer element and a fifth acoustic transducer element positioned on the distal region of the second arm and configured to interface with the second portion of the anatomical structure and receive a first set of acoustic signals associated with the transmission of the acoustic signals by the first acoustic transducer element, the second ultrasonic sensor assembly includes a sixth acoustic transducer element positioned on the distal region of the first arm and configured to interface with the first portion of the anatomical structure and transmit second acoustic signals associated with the acoustic signals received at the second and third acoustic transducer elements, and a first center point (C Tx1 ) is a first distance (d ) separating the centers of the fourth and fifth acoustic transducer elements. Rx1 1) and the second center point (Cd Rx1 ) and a third center point (C Tx2 ) is the second distance (d Rx2 2) and the fourth center point (Cd Rx2 ) and align them.

[0124] Example B5 includes the sensor device of any of Examples B1-B50, wherein the multiple acoustic transducer elements of the ultrasonic sensor assembly are disposed on a first arm of the linkage assembly, and the sensor device further includes a reflector disposed on a second arm of the linkage assembly.

[0125] Example B6 includes the sensor device of any of Examples B1 to B50, wherein at least one of the first acoustic transducer element, the second acoustic transducer element, or the third acoustic transducer element is configured to have a size dimension between 1 mm and 4 mm.

[0126] Example B7 includes the sensor device of any of Examples B1-B50, wherein the ultrasonic sensor assembly further includes a base connected to an inward-facing surface of at least one of the first arm or the second arm of the linkage assembly and coupling at least one of the plurality of acoustic transducer elements.

[0127] 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 management of heat generation by the at least one acoustic transducer element.

[0128] 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).

[0129] Example B10 includes the sensor device of any of Examples B1-B50, wherein the sensor device further includes an acoustic transducer pad configured to couple to at least some of the acoustic transducer elements of the ultrasonic sensor assembly and provide contouring and cushioning to the anatomical structure.

[0130] Example B11 includes the sensor device of Example B10 or any of Examples B1-B50, wherein the acoustic transducer pad includes a hydrogel.

[0131] Example B12 includes the sensor device of any of Examples B1-B50, wherein the linkage assembly is operable to flexibly secure the sensor device to the anatomical structure such that the sensor device is stable in its position relative to the anatomical structure while withstanding continuous movement of the anatomical structure to which it is attached.

[0132] Example B13 includes the sensor device of example B12 or any of examples B1-B50, and the linkage assembly includes a clip band operable to provide a compressive force by each of the first and second arms of the clip band to facilitate securing the sensor device to the first and second portions of the anatomical structure, and to absorb forces exerted by the anatomical structure on the first and second arms of the clip band due to continued movement of the anatomical structure.

[0133] Example B14 includes the sensor device of Example B13 or any of Examples B1-B50, wherein the clip band includes a composite material having a flexible polymer component and a shape stabilizer component that is preformed and capable of undergoing a shape change.

[0134] Example B15 includes the sensor device of example B14 or any of examples B1-B50, wherein the shape stabilizer component of the composite includes one or more of nitinol, gold, platinum, or iridium, which is encased in a polymer component of the composite including one or more of silicone, polyethylene, polyimide, polyamide, or mixtures thereof.

[0135] Example B16 includes the sensor device of any of Examples B1-B50, wherein the connection device is operable to mechanically resiliently secure the linkage assembly to the anatomical structure such that the sensor device is stable in its position relative to the anatomical structure while withstanding continuous movement of the anatomical structure to which it is attached.

[0136] Example B17 includes the sensor device of example B16 or any of examples B1-B50, wherein the connection device includes a spring operable to provide a compressive force to each of the first and second arms of the linkage assembly to facilitate fixing the sensor device to the first and second portions of the anatomical structure and to absorb forces exerted by the anatomical structure on the first and second arms of the linkage assembly due to continuous movement of the anatomical structure.

[0137] Example B18 includes the sensor device of any of examples B1-B50, wherein the electronics unit includes a power source and a wireless communication unit including a wireless transmitter or a wireless transceiver.

[0138] Example B19 includes the sensor device of example B18 or any of examples B1 to B50, wherein the power source includes at least one of a battery or a fuel cell.

[0139] Example B20 includes the sensor device of any of Examples B18 or B1-B50, wherein the electronics unit comprises a signal conditioning unit in communication with the plurality of acoustic transducer elements of the ultrasonic sensor assembly via one or more electrical interface components, the signal conditioning unit comprising electrical circuitry configured to process an 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.

[0140] Example B21 includes the sensor device of Example B20 or any of Examples B1 to B50, wherein the electronics unit comprises a data processing unit in communication with the signal conditioning unit, the data processing unit comprising a processor and memory and configured to process the amplified, filtered or converted electrical signal as data representative of a fluid flow parameter of the biological fluid.

[0141] Example B22 includes the sensor device of Example B18 or any of Examples B1 to B50, wherein the electronics unit comprises a data processing unit in communication with the wireless communication unit, the data processing unit comprises a processor and a memory, and is configured to process the electrical signals as data representative of fluid flow parameters of the biological fluid.

[0142] Example B23 includes the sensor device of Example B18 or any of Examples B1 to B50, wherein the electronics unit comprises a printed circuit board (PCB) having a substrate and electrical interconnects disposed on the substrate, the electrical interconnects being coupled to a plurality of electrical interconnect wires extending between the plurality of acoustic transducer elements of the ultrasonic sensor assembly and the PCB of the electronics unit.

[0143] Example B24 includes the sensor device of example B23 or any of examples B1-B50, wherein the electronics unit comprises a casing that contains the electronics unit to protect the electronics unit from exposure to bodily fluids when the sensor device is inserted and deployed in vivo.

[0144] Example B25 includes the sensor device of example B24 or any of examples B1-B50, wherein the casing includes one or both of flat 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.

[0145] Example B26 includes the sensor device of example B24 or any of examples B1-B50, and includes that the casing is coupled to the linkage assembly on an inward facing surface of the linkage assembly that faces toward the anatomical structure, or the casing is coupled to the linkage assembly on an outward facing surface of the linkage assembly that faces away from the anatomical structure.

[0146] Example B27 includes the sensor device of example B24 or any of examples B1-B50, wherein a PCB of an electronics unit is sealed within the casing with a non-permeable material covering the PCB and providing an electrical shield from the bodily fluids.

[0147] Example B28 includes the sensor device of example B27 or any of examples B1-B50, wherein the non-permeable material includes at least one of a parylene, a urethane, or a Teflon material.

[0148] Example B29 includes the sensor device of any of Examples B1 to B50, and further includes a secondary sensor coupled to at least one of the linkage assemblies or the connection device and in communication with the electronics unit, the secondary sensor 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.

[0149] 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 or bodily fluid in a region adjacent to an anatomical structure in which the sensor device is deployed.

[0150] Example B31 includes the sensor device of example B29 or any of examples B1-B50, and the secondary sensor includes a pH sensor configured to detect a pH level of a biological fluid within the anatomical structure in which the sensor device is deployed, or within an area adjacent to the anatomical structure.

[0151] Example B32 includes the sensor device of example B29 or any of examples B1-B50, and the secondary sensor includes a temperature sensor configured to detect a temperature of a biological fluid within the anatomical structure in which the sensor device is deployed, or within an area proximate to the anatomical structure.

[0152] 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.

[0153] Example B34 includes the sensor device of any of Examples B1-B50, and further includes a secondary attachment component including one or more of a suture, prongs, screws, barbs, adhesive, or gripping mechanism disposed on at least a portion of the linkage assembly and configured to secure the ultrasound sensor assembly to an anatomical structure via the linkage assembly.

[0154] Example B35 includes the sensor device of any of Examples B1-B50, wherein the linkage assembly has the ability to change shape from a first shape configuration and expand to a second shape configuration such that the first arm and the second arm of the linkage assembly extend outward from the centerline through at least one of the linkage assemblies or the connecting device and are insertable into a patient's body, and the first arm and the second arm of the linkage assembly extend inward toward the centerline through at least one of the linkage assemblies or the connecting device and are attachable to an anatomical structure for operation of the sensor device.

[0155] Example B36 includes the sensor device of any of Examples B1-B50, and includes a second linkage assembly having a third arm configured for attachment to a third portion of the anatomical structure and a fourth arm configured for attachment to a fourth portion of the anatomical structure opposite the third portion, a connection device coupled to each of the third arm and the fourth arm, and an ultrasonic sensor assembly coupled to the second linkage assembly and including an additional set of multiple acoustic transducer elements configured to transmit second acoustic signals that propagate through the anatomical structure across the third and fourth portions and receive a second set of acoustic signals that propagate through the anatomical structure across the third and fourth portions and are indicative of a second fluid flow parameter of the biological fluid within the anatomical structure.

[0156] Example B37 includes the sensor device of any of Examples B1-B50, wherein the connection device includes a port in electrical communication with an electronics unit housed within the connection device and operable to electrically couple to a remote power source housed within the remote device via at least one of a cable, wire, or cord, and the remote device is located at another location distinct from and at a distance from the anatomical structure.

[0157] Example B38 includes the sensor device of example B37 or any of examples B1-B50, wherein the port is housed within the connection device and is operable to interface the electronics unit to a data processing unit located in the remote device via at least one of a cable, wire, or cord, and output data from the electronics unit of the sensor device through the port to the data processing unit of the remote device via at least one of the cable, wire, or cord.

[0158] 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 by a secondary transmitting device including a wireless transmitter or transceiver.

[0159] Example B40 includes the sensor device of example B37 or any of examples B1-B50, wherein the other location where the remote device is located is at least 2 cm from the anatomical structure.

[0160] Example B41 includes the sensor device of example B37 or any of examples B1-B50, and the other locations include the pleural cavity, the intraperitoneal cavity, the subcutaneous space, or an extracorporeal location.

[0161] Example B42 includes the sensor device of any of Examples B1-B50, wherein an external processor capable of receiving data wirelessly transmitted by the electronics unit of the sensor device is located outside the patient-user's body where the sensor device is implantable and deployable in an anatomical structure.

[0162] Example B43 includes the sensor device of any of Examples B1-B50, and the fluid flow parameter of the biological fluid in the anatomical structure includes at least one of a flow rate or an amount of pressure difference between ends of a flow path in the anatomical structure.

[0163] 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.

[0164] 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.

[0165] 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 pericardium of the heart, or the sensor device is deployable on an outer layer of the pericardium of the heart.

[0166] 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 positioned on opposing portions of the left atrium of the heart, and the received acoustic signal is indicative of blood flow at the mitral valve of the heart.

[0167] 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 positioned on opposing portions of the right atrium of the heart, and the received acoustic signal is indicative of blood flow at the tricuspid valve of the heart.

[0168] Example B49 includes the sensor device of Example B45 or any of Examples B1-B50, wherein the first arm and the second arm of the linkage assembly are positioned over the superior vena cava or the inferior vena cava adjacent to the heart, and the received acoustic signal is indicative of blood flow in the superior vena cava or the inferior vena cava.

[0169] Example B50 includes the sensor device of example B45 or any of examples B1-B49, wherein the first arm and the second arm of the linkage assembly are positioned on a pulmonary artery or pulmonary vein adjacent to the heart, and the received acoustic signal is indicative of blood flow in the pulmonary artery or pulmonary vein.

[0170] In some embodiments (Example B51) according to the present technology, a sensor device for in vivo monitoring of blood flow in a heart or blood vessel leading to or from a heart within a patient's body includes a linkage assembly including 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 connection device coupled to each of the first arm and the second arm, and an ultrasonic sensor assembly including a plurality of acoustic transducer elements coupled to the linkage assembly, the first acoustic transducer element configured to transmit an acoustic signal to propagate through the heart or blood vessel, and a second arm configured to transmit an acoustic signal to propagate through the heart or blood vessel and indicative of a fluid flow parameter of blood flowing within the heart or blood vessel. and an electronics unit housed within 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 the electrical signals associated with the received acoustic signals as data and to wirelessly transmit the data to an external processor, the linkage assembly including a clip band operable to provide a compressive force by each of the first and second arms of the clip band to facilitate securing the sensor device to the first and second portions of the heart or blood vessel, and to absorb forces exerted on the first and second arms of the clip band due to heartbeat or changes in size of the heart or blood vessel.

[0171] Example B52 includes the sensor device of any of Examples B51-B60, wherein the clip band includes a composite material having a flexible polymer component and a shape stabilizer component that is preformed and capable of undergoing a shape change.

[0172] Example B53 includes the sensor device of example B52 or any of examples B51-B60, wherein the shape stabilizer component of the composite includes one or more of nitinol, gold, platinum, or iridium and is encased in a polymer component of the composite including one or more of silicone, polyethylene, polyimide, polyamide, or mixtures thereof.

[0173] 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 clip band and a second ultrasonic sensor assembly disposed on a second arm of the clip band, wherein the multiple acoustic transducer elements of the ultrasonic sensor assembly are disposed on the first arm of the clip band, and the sensor device further includes a reflector disposed on the second arm of the clip band.

[0174] Example B55 includes the sensor device of any of Examples B51-B60, wherein the sensor device further includes an acoustic transducer pad comprising a hydrogel configured to couple to at least some of the acoustic transducer elements of the ultrasonic sensor assembly and provide contouring and cushioning to the heart or blood vessel.

[0175] 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 pericardium of the heart, or the sensor device is deployable on an outer layer of the pericardium of the heart.

[0176] Example B57 includes the sensor device of any of Examples B51 to B60, wherein the first arm and the second arm of the clip band are positioned on opposing portions of the left atrium of the heart, and the received acoustic signal is indicative of blood flow at the mitral valve of the heart.

[0177] Example B58 includes the sensor device of any of Examples B51-B60, wherein the first arm and the second arm of the clip band are positioned on opposing portions of the right atrium of the heart, and the received acoustic signal is indicative of blood flow at the tricuspid valve of the heart.

[0178] Example B59 includes the sensor device of any of Examples B51 to B60, wherein the first arm and the second arm of the clip band are positioned on the superior vena cava or the inferior vena cava adjacent to the heart, and the received acoustic signal is indicative of blood flow in the superior vena cava or the inferior vena cava.

[0179] Example B60 includes the sensor device of any of Examples B51 to B59, wherein the first arm and the second arm of the clip band are positioned over a pulmonary artery or pulmonary vein adjacent to the heart, and the received acoustic signal is indicative of blood flow in the pulmonary artery or pulmonary vein.

[0180] In some embodiments (Example B61) according to the present technology, a system for in vivo monitoring of fluid flow within an anatomical structure includes an in vivo sensor device operable to be deployed on a patient-user's body 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 comprises a 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 the first portion, a connection device coupled 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 anatomical structure, a second acoustic transducer element configured to propagate through the anatomical structure and receive an acoustic signal indicative of a fluid flow parameter of a biological fluid within the anatomical structure, and a third acoustic transducer element, and an electronics unit contained within 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 the 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 within the anatomical structure.

[0181] Example B62 includes the sensor device of any of Examples B61-B72, where the in vivo sensor device includes one or more features associated with the sensor device recited in any of Examples B1-B50 and / or Examples B51-B60.

[0182] Example B63 includes a sensor device of any of Examples B61 to B72, and comprises a remote in-vivo intermediate device having a power source, 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 memory, wherein the remote in-vivo intermediate device is in wireless or wired communication with the in-vivo sensor device and is located at another location in the body that is different from the anatomical structure and at a distance from the anatomical structure.

[0183] Example B64 includes the sensor device of Example B63 or any of Examples B61 to 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 coupled to a port of a connection device of the in-vivo sensor device that electrically communicates with the electronics unit of the in-vivo sensor device, and the remote in-vivo intermediate device is operable to supply electrical energy stored in the power source to the electronics unit of the in-vivo sensor device.

[0184] Example B65 includes the sensor device of example B63 or any of examples B61 to B72, wherein the remote in-vivo intermediate device is operable to interface an electronics unit of the in-vivo sensor device to a data processing unit disposed within the remote in-vivo intermediate device to process data and determine fluid flow parameters associated with the biological fluid within the anatomical structure.

[0185] Example B66 includes the sensor device of example B63 or any of examples B61 to B72, wherein the remote in-vivo intermediate device is operable to interface an electronics unit of the in-vivo sensor device to a wireless communication unit disposed within the remote in-vivo intermediate device to wirelessly transmit data directly or indirectly to a data processing system.

[0186] Example B67 includes the sensor device of example B63 or any of examples B61-B72, wherein the other location where the remote device is located is at least 2 cm from the anatomical structure.

[0187] Example B68 includes the sensor device of example B63 or any of examples B61-B72, and the other locations include the pleural cavity, the intraperitoneal cavity, the subcutaneous space, or an extracorporeal location.

[0188] Example B69 includes a sensor device of any of Examples B61 to B72, and a data processing system includes a server computer having a processor and memory, and one or more databases in data communication with the server computer, and the data processing system is configured to remotely monitor data associated with the patient-user acquired by the sensor device.

[0189] Example B70 includes a sensor device of any of Examples B61 to B72, and further includes a receiver device including a processor and a memory operable to (i) receive wirelessly transmitted carrier data indicative of an electrical signal obtained from the sensor device, and (ii) transmit the data to a data processing system.

[0190] Example B71 includes the sensor device of example B64 or any of examples B61 to B72, and the receiver device is configured to store data in a memory of the receiver device and / or the receiver devices communicate with each other and with a data processing system via a network of computers accessible via the Internet.

[0191] Example B72 further includes a remote client computing device including a sensor device of any of Examples B61 to B71, and including a data processor and a data memory configured to data communicate with the data processing system and receive processed data that is selected, filtered, and / or formatted by the data processing system.

[0192] In some embodiments (Example B73) according to the present technology, a sensor device for monitoring cardiac function in vivo includes a linkage assembly having a first arm configured for attachment to a first external portion of the heart and an optional second arm that may be configured for attachment to a second external portion of the heart, a housing coupled to the linkage assembly, a sensor assembly coupled to the first arm and configured to detect a cardiac functional parameter, and an electronics unit disposed within the housing and in electrical communication with the sensor assembly, wherein the electronics unit is configured to process an electrical signal associated with the detected functional parameter as data and wirelessly transmit the data to an external processor.

[0193] 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 pericardium of the heart, or the sensor device is deployable on an outer layer of the pericardium of the heart.

[0194] Example B75 includes the sensor device of any of examples B73-B76, wherein the sensor assembly includes at least one of an accelerometer, a gyroscope, a magnetometer, an acoustic transducer, a temperature sensor, an analyte sensor, or a pH sensor.

[0195] Example B76 includes the sensor device of any of examples B73-B76, where the sensor device includes one or more features associated with the sensor device recited in any of examples B1-B50 and / or examples B51-B60.

[0196] conclusion Implementations of the subject matter and functional operations described in this patent document may be implemented in various systems, digital electronic circuits, or computer software, firmware, or hardware, including the structures disclosed herein and their structural equivalents, or in any combination of one or more of them. Implementations of the subject matter described herein may be implemented as one or more computer program products, i.e., one or more modules of computer program instructions coded on a tangible and non-transitory computer-readable medium for execution by or for controlling the operation of a data processing device. The computer-readable medium may be a machine-readable storage device, a machine-readable storage substrate, a memory device, a composition of matter affecting a machine-readable propagated signal, or one or more combinations thereof. The term data processing unit or data processing device encompasses all apparatus, devices, and machines for processing data, including, for example, a programmable processor, a computer, or multiple processors or computers. An apparatus may include, in addition to hardware, code that creates an environment for the execution of the computer program in question, such as code constituting a processor firmware, a protocol stack, a database management system, an operating system, or one or more combinations thereof.

[0197] A computer program (also known as a program, software, software application, script, or code) can be written in any form of programming language, including compiled or interpreted languages, and can 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 can be stored in part 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 several coordinated files (e.g., a file that stores one or more modules, subprograms, or portions of code). A computer program can be deployed to be executed on one computer, or on several computers located at one site or distributed across several sites and interconnected by a communication network.

[0198] The processes and logic flows described herein may be implemented 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 may also be implemented by, and an apparatus may be implemented as, special purpose logic circuitry, such as an FPGA (field programmable gate array) or an ASIC (application specific integrated circuit).

[0199] Processors suitable for executing a computer program include, by way of example, both general purpose and special purpose microprocessors, as well as any one or more processors of any kind of digital computer. Typically, a processor receives instructions and data from a read-only memory or a random access memory, or both. The essential elements of a computer are a processor for executing instructions and one or more memory devices for storing instructions and data. Generally, a computer also includes, or is operatively coupled to receive data from, or transfer data to, one or more mass storage devices for storing data, such as, for example, magnetic disks, magneto-optical disks, or optical disks. However, a computer need not have such devices. Suitable computer-readable media for storing computer program instructions and data include all forms of non-volatile memory, media, and memory devices, examples of which include, for example, semiconductor memory devices, such as, for example, EPROM, EEPROM, and flash memory devices. The processor and memory may be supplemented by, or incorporated in, special purpose logic circuitry.

[0200] This specification, together with the drawings, where illustrative examples are meant to be exemplary only. As used herein, the singular forms "a," "an," and "an" are intended to include the plural forms unless the context clearly indicates otherwise. Further, the use of "or" is intended to include "and / or" unless the context clearly indicates otherwise.

[0201] Although this patent document contains many details, these should not be interpreted as limitations on the scope of any invention or claims, but as descriptions of features that may be specific to certain embodiments of a particular invention. Certain features described in this patent document in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Furthermore, even if features may be described above as acting in a particular combination and are initially claimed as such, one or more features from the claimed combination may, in some cases, be separated from the combination, and the claimed combination may be directed to a subcombination or variation of the subcombination.

[0202] Similarly, although operations are illustrated in the figures in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown, or in any sequential order, or that all of the illustrated operations be performed to achieve a desired result. Further, 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.

[0203] Only some implementations and examples have been described; 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 monitoring blood flow in a blood vessel in vivo, A first arm configured to be attached to the first external portion of the blood vessel, A second arm configured to be attached to the second external portion of the blood vessel, A connecting device is attached to each of the first arm and the second arm, An ultrasonic sensor assembly comprising a first ultrasonic sensor assembly and a second ultrasonic sensor assembly, wherein the first ultrasonic sensor assembly comprises a first set of one or more acoustic transducer elements connected to the first arm, and the second ultrasonic sensor assembly comprises a second set of one or more acoustic transducer elements connected to the second arm, and one or both of the first set of one or more acoustic transducer elements of the first ultrasonic sensor assembly and the second set of one or more acoustic transducer elements of the second ultrasonic sensor assembly comprises at least one of the first acoustic transducer elements configured to transmit and propagate an acoustic signal through the blood vessel, or the second acoustic transducer element configured to propagate through the blood vessel and receive an acoustic signal indicating fluid flow parameters of blood in the blood vessel, wherein at least one of the first set or the second set of one or more acoustic transducer elements comprises a piezoelectric micromachine ultrasonic transducer (PMUT) in the ultrasonic sensor assembly, A sensor device comprising: an electronic device unit housed within the connecting device and electrically communicating with the first ultrasonic sensor assembly and the second ultrasonic sensor assembly, the electronic device unit configured to process the electrical signal associated with the received acoustic signal as data and to wirelessly transmit the data to an external processor.

2. The sensor device according to claim 1, further comprising a reflector disposed on one or both of the first arm and the second arm.

3. The sensor device according to claim 1, wherein at least one of the first acoustic transducer element, the second acoustic transducer element, or the third acoustic transducer element is configured to have a size dimension of 1 mm to 4 mm.

4. The sensor device according to claim 1, wherein the ultrasonic sensor assembly further comprises a base, the base being connected to an inward-facing surface of at least one of the first arm or the second arm, and coupling at least one of the first set or the second set of one or more acoustic transducer elements.

5. The sensor device according to claim 7, wherein the substrate is configured to provide thermal synchronization for managing heat generation by the at least one acoustic transducer element.

6. The sensor device according to claim 1, further comprising an acoustic transducer pad, the acoustic transducer pad being coupled to at least some of the acoustic transducer elements of the ultrasonic sensor assembly and configured to provide contour and cushioning to the outer portion of the blood vessel.

7. The sensor device according to claim 6, wherein the acoustic transducer pad contains a hydrogel.

8. The sensor device according to claim 1, wherein the first arm and the second arm are operable to flexibly fix the sensor device to the external portion of the blood vessel such that it is stable in its position relative to the blood vessel while withstanding the continuous movement of the blood vessel to which it is attached.

9. The sensor device according to claim 12, wherein at least one of the first arm and the second arm contains a shape-stabilizing component that is pre-molded and subject to shape changes.

10. The sensor device according to claim 9, wherein the shape-stabilizing component comprises one or more of nitinol, gold, platinum, or iridium.

11. The sensor device according to claim 1, wherein the electronic device unit comprises a power supply and a wireless communication unit including a wireless transmitter or wireless transceiver.

12. The sensor device according to claim 1, wherein the electronic device unit comprises a signal conditioning unit that communicates with the plurality of acoustic transducer elements of the ultrasonic sensor assembly via one or more electrical interface components, and the signal conditioning unit comprises an electrical circuit configured to process the electrical signal associated with the received acoustic signal by one or more of the following: amplifying the electrical signal, filtering the electrical signal, or converting the electrical signal from analog to digital.

13. The sensor device according to claim 12, wherein the electronic device unit comprises a data processing unit that communicates with the signal adjustment unit, and the data processing unit comprises a processor and memory, and is configured to process the amplified, filtered, or converted electrical signal as data representing the blood in the blood vessel.

14. The sensor device according to claim 1, wherein the electronic device unit comprises a casing that encloses the electronic device unit to protect the electronic device unit from exposure to bodily fluids when the sensor device is inserted and deployed in vivo.

15. The sensor device according to claim 1, further comprising a secondary sensor, the secondary sensor being coupled to at least one of the first arm, the second arm, or the connecting device, communicating with the electronic device unit, and the secondary sensor being operable to measure one or more of the biological parameters, physiological parameters, electrophysiological parameters, or physical parameters of the body in which the sensor device is installed.

16. The sensor device according to claim 1, further comprising a secondary mounting component, the secondary mounting component being positioned on one or both of the first arm and the second arm and configured to fix the sensor device to the blood vessel.

17. The sensor device according to claim 1, wherein each of the first arm and the second arm has the ability to change shape from a first shape structure, the first arm and the second arm extend outward from the centerline through the connecting device to a second shape structure so as to be insertable into the patient's body, and the first arm and the second arm extend inward toward the centerline through at least one of the first arm, the second arm, or the connecting device so as to be attachable to the external portion of the blood vessel for operation of the sensor device.

18. The sensor device according to claim 1, wherein the fluid flow parameter of the blood in the blood vessel includes at least one of the amount of flow rate or pressure difference between the ends of the flow path in the blood vessel.

19. The sensor device according to claim 1, wherein the first arm and the second arm are positioned on the superior vena cava or the inferior vena cava, and the received acoustic signal indicates blood flow within the superior vena cava or the inferior vena cava.

20. The sensor device according to claim 1, wherein the first arm and the second arm are positioned on the pulmonary artery or pulmonary vein, and the received acoustic signal indicates blood flow in the pulmonary artery or pulmonary vein.

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