Wearable ultrasound device, system, and method

Abstract

Wearable medical devices, systems, and methods are disclosed herein. The wearable medical device is deployable to a target site on a subject's body and includes a rotating coupling component and an electrode patch. When the electrode patch is attached to the rotating coupling component, the electrodes of the electrode array on the patch are electrically coupled to corresponding tracks on conductive tracks. The wearable medical device also includes an ultrasound scanning and biomarker monitoring module having a set of conductive contacts. When the ultrasound scanning and biomarker monitoring module is attached to the rotating coupling component on the opposite side of the electrode patch, the set of conductive contacts engages with corresponding tracks on conductive tracks. The ultrasound scanning and biomarker monitoring module is further configured to rotate around the rotating coupling component while the conductive contacts remain engaged with the corresponding tracks during rotation.

Description

Technical Field

[0001] Related Applications This application claims priority to U.S. Provisional Patent Application No. 18 / 122,111, filed on March 15, 2023, the content of which is incorporated herein by reference.

[0002] The present disclosure generally relates to ultrasonic devices, and more specifically to wearable ultrasonic devices configured for use related to various biomedical applications.

Background Art

[0003] Ultrasound is a sound wave having a frequency above 20 kilohertz. This frequency is approximately the upper limit of human hearing for healthy young adults. The physical principles of sound waves apply to any frequency range including ultrasound. Ultrasonic devices operate at frequencies from 20 kHz to several gigahertz. Ultrasonic waves are used in many different fields. Ultrasonic devices are used to detect objects and measure distances. In the medical field, ultrasonic imaging or sonography is often used.

[0004] Medical ultrasound includes not only diagnostic techniques (mainly imaging techniques) using ultrasound, but also therapeutic uses of ultrasound. In diagnosis, medical ultrasound is used to create images of internal structures such as tendons, muscles, joints, blood vessels, and internal organs to measure some characteristics (such as distance and speed), or to generate audible sounds of informational value. The use of ultrasound to generate visual images in medicine is called medical ultrasound examination or simply sonography, or echography.

[0005] Ultrasound for musculoskeletal diagnosis has become an important component of sports medicine and orthopedics. With the development of higher-resolution probes, musculoskeletal ultrasound for the diagnosis of small joints is becoming more common in sports medicine, soft tissue injury, rheumatology, and rehabilitation. Tendon and ligament instability is also often recognized with the help of dynamic ultrasound (US) analysis. Partial or complete muscle or tendon ruptures can be accurately identified and differentiated. In addition to using musculoskeletal ultrasound for scanning tendon, ligament, and muscle injuries, common orthopedic applications include its use as an aid in joint analysis and as a guide in joint injections, identification of various sports-related soft tissue problems, and ultrasound-guided injections, often in regenerative medicine (stem cell therapy and platelet-rich plasma). [Overview of the project] [Problems that the invention aims to solve]

[0006] Medical ultrasound imaging has become the industry standard for many medical imaging applications. However, conventional medical ultrasound imaging equipment is large and requires patients to visit a clinic with a technician or healthcare provider. Furthermore, patients must remain still during imaging. Therefore, patients and target muscles / tissues cannot be evaluated while walking or moving in any other way. There is a need for more portable and user-friendly medical ultrasound imaging equipment. In addition, there is a need for imaging systems that can be used on muscles while moving / active. [Means for solving the problem]

[0007] Embodiments of the present invention include wearable ultrasound devices for use in various biomedical applications, including musculoskeletal ("MSK") imaging and analysis. The embodiments of the present invention satisfy these needs and provide further relevant advantages, as described in the following summary of the invention.

[0008] In accordance with the aspects of the disclosed subject matter, a wearable ultrasound device configured for use in relation to various biomedical applications, including musculoskeletal ("MSK") imaging and analysis, is described.

[0009] In embodiments, the apparatus includes an ultrasound module configured to acquire an ultrasound image of a portion of the user's body (hereinafter referred to as the “target site” for the purposes of simplification) on which at least one ultrasound module is positioned, and a surface biosignaling (e.g., sEMG or aECG) module configured to detect muscle contractions in the target site. Diagnostic ultrasound can provide a rapid, non-invasive method for diagnosing soft tissue injuries, as well as a method for monitoring them during treatment and rehabilitation. Diagnostic ultrasound can also confirm that an injury has healed and can determine the appropriate time to return to activity or sports.

[0010] The ultrasound modules described herein may be configured to adjust between different operating axes to acquire ultrasound images of a target site through different cross-sections. In some embodiments, the ultrasound module is communicably connected (e.g., via a communication network) to an image processing system configured to process and analyze images together with biomedical data acquired by the sEMG module to identify biomarkers and biosignals, and to generate structured reports for evaluation by qualified medical professionals.

[0011] In one embodiment, the device includes one or more flexible fabric adhesive patches that can be attached to clothing or otherwise attached to the body near a target site. In another embodiment, there is no (or minimal) movement or displacement of any functional ultrasonic components (e.g., ultrasonic transducers, ultrasonic sensors, or ultrasonic transceivers) during image acquisition.

[0012] In embodiments, the wearable medical device includes a biosignal sensing device (e.g., sEMG or aECG) together with a sensing and motion detector (e.g., an IMU (motion unit), accelerometer, gyroscope, or microelectromechanical system (MEMS)). In embodiments, the biosignal sensing device and sensing and motion detector are utilized by an ultrasound imaging and biomarker system to simultaneously trigger the acquisition of images and biosignals of a target site during active movement of the subject's body.

[0013] Embodiments also include wearable medical devices that can be positioned on a target site on a subject's body. The wearable medical device may include (a) a rotating coupling component having a plurality of conductive tracks; (b) an electrode patch having an electrode array configured for attachment to the rotating coupling component, such that when the electrode patch is attached, the electrodes of the electrode array are electrically coupled to the corresponding tracks of the conductive tracks; and (c) a scanning and monitoring module having a set of conductive contacts. The scanning and monitoring module may be configured for attachment to the rotating coupling component on the opposite side of the electrode patch, such that when the scanning and monitoring module is attached, the set of conductive contacts engages with the corresponding tracks of the plurality of conductive tracks. In embodiments, the scanning and monitoring module is further configured to rotate around the rotating coupling component while the plurality of conductive contacts remain engaged with the corresponding tracks during the rotation of the scanning and monitoring module.

[0014] Embodiments also include wearable medical devices that can be positioned on a target site on a subject's body. The wearable medical device may include (a) a rotating coupling component configured for attachment to an electrode patch, comprising an electrode array, the electrode array comprising a plurality of conductive tracks configured for attachment to the rotating coupling component, the electrode patch configured for attachment to the rotating coupling component, and when the electrode patch is attached, the conductive tracks of the electrode array are electrically coupled to the rotating coupling component; and (b) a scanning and monitoring module comprising a set of conductive contacts, configured for attachment to the rotating coupling component on the opposite side of the electrode patch. In embodiments, the scanning and monitoring module is attached to the set of conductive contacts and engages with corresponding tracks of the plurality of conductive tracks. In embodiments, the scanning and monitoring module is further configured to rotate around the rotating coupling component while the plurality of conductive contacts remain engaged with the corresponding tracks during rotation of the scanning and monitoring module.

[0015] The embodiment also includes an ultrasound imaging and biomarker monitoring system, which includes (a) a wearable wireless medical device comprising an ultrasound transducer for acquiring ultrasound images and a biosignal sensor for acquiring biosignals, configured to simultaneously acquire ultrasound images and biosignals from a target site of a subject wearing the wireless medical device while the subject is performing an activity; and (b) an analysis platform configured to extract biomarkers from the acquired ultrasound images and acquired biosignals; and (c) a user device configured to display the extracted biomarkers after or during the subject's activity, and / or to display the acquired ultrasound images and biosignals after or during the subject's activity.

[0016] In one embodiment, the device displays biomarkers, images, and signals. In another embodiment, the device displays biomarkers (i.e., radiological characteristics that are signs of a normal or abnormal process, condition, or disease).

[0017] Embodiments also include methods using a wearable wireless medical device. The method may include (a) placing the wearable wireless medical device on a target site on a subject's body; (b) acquiring an ultrasound image of the target site and obtaining biosignals of the target site via the wireless medical device while the subject is performing an activity; (c) extracting biomarkers by processing and quantifying the acquired ultrasound image and biosignals; and (d) simultaneously displaying the ultrasound image, biosignals, and biomarkers of the target site on a user device.

[0018] In embodiments, the systems and methods described herein can detect diseases such as soft tissue injuries in subjects / patients. Other diseases may include, for example, muscle or tendon ruptures, inflammation, latent synovitis, asymptomatic enthesitis, sarcopenia, bone erosion, and crystal deposition. In embodiments, muscle thickness may be analyzed to assess muscle size and muscle quality. Muscle ultrasound may also be used to predict health-related outcomes such as mortality and disability.

[0019] The preceding paragraphs are provided as a general introduction and are not intended to limit the scope of the following claims. The embodiments described, along with their further advantages, will be best understood by referring to the following detailed description in conjunction with the accompanying drawings.

[0020] A more complete understanding of this disclosure and many of its associated benefits will be readily apparent, as can be better understood by referring to the following detailed description, when considered in conjunction with the attached drawings. [Brief explanation of the drawing]

[0021] [Figure 1]A diagram showing an ultrasonic imaging and biomarker system according to one or more aspects of the disclosed subject matter. [Figure 2] A diagram showing a display of real-time dynamic ultrasonic imaging data extracted from an ultrasonic imaging and biomarker system according to one or more aspects of the disclosed subject matter. [Figure 3A] A perspective view of a wearable medical device according to one or more aspects of the disclosed subject matter. [Figure 3B] An exploded view of a wearable medical device according to one or more aspects of the disclosed subject matter. [Figure 3C] An enlarged view of a wearable medical device according to one or more aspects of the disclosed subject matter. [Figure 3D] A perspective view of alternative configurations (PE Double WUSP and PE Double+Mounted WUSP) of a biosignal rotary connection portion. The biosignal rotary connection portion is provided by bending a substrate. Electrodes and rotary connection pads are printed on the other end thereof, and the substrate is disposed on the components. [Figure 3E] A perspective view of alternative configurations (PE Double WUSP and PE Double+Mounted WUSP) of a biosignal rotary connection portion. The biosignal rotary connection portion is provided by bending a substrate. Electrodes and rotary connection pads are printed on the other end thereof, and the substrate is disposed on the components. [Figure 4] An exploded view of a rotary coupling member and a surface mount adapter according to one or more aspects of the disclosed subject matter. [Figure 5A] An exploded view of a scanning and monitoring module according to one or more aspects of the disclosed subject matter. [Figure 5B] A perspective view of a scanning and monitoring module according to one or more aspects of the disclosed subject matter. [Figure 6] An exploded view of a wearable medical device according to one or more aspects of the disclosed subject matter. [Figure 7]This figure shows cross-sectional views and enlarged sections of scanning and monitoring modules, rotating connectors, and skin adapters according to one or more embodiments of the disclosed subject matter. [Figure 8] This is a functional block diagram showing a user device connected to a networked system of one or more networked computers and servers, in some exemplary aspects of the disclosed subject matter. [Modes for carrying out the invention]

[0022] The following description, in conjunction with the accompanying drawings, is intended to describe various embodiments of the disclosed subject matter and is not necessarily intended to represent only one embodiment. In some examples, the description includes specific details for the purpose of providing an understanding of the disclosed subject matter. However, it will be apparent to those skilled in the art that the embodiments can be practiced even without these specific details. In some examples, well-known structures and components may be shown in block diagram form so as not to obscure the concepts of the disclosed subject matter.

[0023] Throughout this specification, any reference to “one embodiment” or “embodiment” means that any particular mechanism, structure, characteristic, operation, or function described in relation to an embodiment is included in at least one embodiment of the disclosed subject matter. Therefore, any occurrence of the phrase “in one embodiment” or “in an embodiment” in this specification does not necessarily refer to the same embodiment. Furthermore, any particular mechanism, structure, characteristic, operation, or function may be combined in any suitable manner in one or more embodiments. Furthermore, embodiments of the disclosed subject matter may and are intended to cover modifications and variations of the embodiments described.

[0024] When used herein and in the appended claims, it should be noted that the singular forms “a,” “an,” and “the” refer to multiple objects unless the context explicitly states otherwise. That is, unless explicitly stated otherwise, when used herein, the words “a,” “an,” etc., have the meaning of “one or more.” Furthermore, it should be understood that terms such as “left,” “right,” “top,” “bottom,” “front,” “back,” “side,” “height,” “length,” “width,” “upper,” “lower,” “inside,” “external,” “inside,” and “outside,” which may be used herein, merely describe points of reference and do not necessarily limit the embodiments of the disclosed subject matter to any particular orientation or configuration. In addition, terms such as “first,” “second,” and “third” merely identify one of several parts, components, points of reference, actions, and / or functions as described herein and similarly do not necessarily limit the embodiments of the disclosed subject matter to any particular configuration or orientation.

[0025] Embodiments of wearable medical devices, systems, and methods are disclosed herein. The wearable medical device is positionable on a target site of a subject's body and includes a rotating coupling component and an electrode patch. When the electrode patch is attached to the rotating coupling component, the electrodes of the electrode array on the patch are electrically coupled to corresponding tracks of conductive tracks. The wearable medical device also includes a scanning and monitoring module having a set of conductive contacts. When the scanning and monitoring module is attached to the rotating coupling component on the opposite side of the electrode patch, the set of conductive contacts engage with corresponding tracks of a plurality of conductive tracks. The scanning and monitoring module is further configured to rotate around the rotating coupling component while the plurality of conductive contacts remain engaged with the corresponding tracks during the rotation of the scanning and monitoring module.

[0026] Next, referring to the drawings, similar reference numbers point to the same or corresponding parts throughout multiple drawings.

[0027] Referring next to Figure 1, this figure shows an ultrasound imaging and biomarker system 100 in one or more aspects of the disclosed subject matter. The ultrasound imaging and biomarker system 100 may include a wearable medical device 101, a wireless access point 103, a user device 105, and an ultrasound imaging and biomarker analysis technology platform 121. The ultrasound imaging and biomarker analysis technology platform 121 may also be referred to herein as an artificial intelligence (AI)-powered ultrasound imaging technology system.

[0028] The wearable medical device 101 may be customized to fit and monitor a target area 107 on the subject's body 109. For example, wearable medical devices 101a, 101b, and 101c may be customized to fit and monitor a target area 107a (e.g., around the waist), a target area 107b (e.g., the calf area), and a target area 107c (e.g., the chest). The wearable medical devices 101a, 101b, and 101c may be configured to acquire ultrasound (US) images (e.g., sonomyography (SMG), echocardiography, Doppler ultrasound, etc.) along with other physiological and motion parameters (e.g., surface electromyography (sEMG), ambulatory electrocardiogram (aECG), or inertial measurement unit (IMU) (motion), etc.). Physiological and motion parameters may also be referred to herein as biomarker data or biomarker parameters. While examples are illustrated and described herein with respect to target regions 107a, 107b, and 107c, the wearable medical device 101 may be customized to fit and monitor any other target region 107 of the subject's body 109 without departing from the spirit and scope of the invention. The wearable medical devices 101a, 101b, and 101c, and the target regions 107a, 107b, and 107c may be referred to herein collectively or individually as the wearable medical device 101 and the target region 107, respectively. The wearable medical device 101 may also be referred to herein as a wearable ultrasound and biomarker monitoring device, a wearable ultrasound device, a wearable monitoring device, and / or a wearable scanning device.

[0029] The shape of the wearable medical device 101 may be designed to conform to the anatomical location of a target site 107 on the subject's body 109, enabling accurate measurements from ultrasound and biomarker data acquired during a monitoring session. In some embodiments, the wearable medical device 101a may be designed with a customized adhesive patch and electrode array (e.g., 2-lead to 12-lead) to conform to a target site 107a (e.g., around the waist) for acquiring IMU (motion), SMG, and sEMG data. In some embodiments, the wearable medical device 101b may be designed with a customized adhesive patch and electrode array (e.g., 2-lead to 12-lead) to conform to a target site 107b (e.g., the calf region) for acquiring US and sEMG data. In some embodiments, the wearable medical device 101c may be designed with a customized adhesive patch and electrode array (e.g., 3-lead) to conform to a target site 107c (e.g., the chest) for acquiring US and aECG data.

[0030] The wearable medical device 101 can communicate wirelessly with a user device 105 and / or a wireless access point 103 via a local area network 111 and / or a body area network (BAN), according to some embodiments. Thus, the wearable medical device 101 is a portable ultrasound system that can be used for both still images and videos. It can be appropriately adapted to all body surfaces through different types of patches. The wearable medical monitoring device 101 can be fixed to a flexible fabric adhesive patch (e.g., nonwoven polyester) or to clothing, so that there is no movement or displacement of functional ultrasound components (e.g., ultrasound transducer, ultrasound sensor, or ultrasound transceiver, etc.) during image acquisition.

[0031] According to one or more embodiments of the disclosed subject matter, two or more wireless medical devices 101 may be placed on the subject's body 109 and may operate in cooperation with each other during operation. In some embodiments, the two or more wireless medical devices 101 may communicate via a personal area network (e.g., a body area network or Bluetooth®). During operation, the two or more wireless medical devices 101 may perform synchronization procedures to establish timing and control signaling with a user device 105 and / or a wireless access point 103. In some embodiments, each of the wireless medical devices 101 establishes signaling and control with the user device 105 and / or the wireless access point 103. In other embodiments, the two or more wireless medical devices 101 establish a mesh network and / or star network to transmit and receive signaling and control with the user device 105 and / or the wireless access point 103. In this embodiment, one of the wireless medical devices 101 acts as a body area gateway for communicating with the user device 105 and / or the wireless access point 103, and communication from the body area gateway device to the remaining wireless medical devices 101 and from the remaining wireless medical devices 101 propagates through the mesh network.

[0032] The wireless access point 103 may provide communication between the user device 105 and / or the network server 113 via a wide-area network 115 (e.g., the Internet, a campus area network, or a city area network). In some embodiments, the wireless access point 103 may communicate between one or more of the user devices 105 and / or wearable medical devices 101 and the network server 113 via a wireless access network 117 (e.g., UMTS or 5G) interfacing with the wide-area network 115. However, the wireless access point 103 may also be configured to communicate with the user device 105 and / or the network server 113 via a wired and / or fiber optic network.

[0033] The user device 105 may be any user computing device (e.g., a computer (PC), laptop, smartphone, mobile phone, notebook computer, tablet, netbook, personal digital assistant (PDA), or any other programmable electronic device capable of communicating with other devices via a local area network 111 and / or a wide area network 115). The user device 105 may be operated by the user to monitor and interact with the wearable medical device 101 and / or the network server 113, as further described herein. For example, a user (e.g., a qualified healthcare provider) may use the user device 105 to select the user's preferred settings and operating modes of the wearable medical device 101 in the ultrasound imaging and biomarker system 100, as further described herein. In one embodiment, the user device 105 interacts with the ultrasound imaging and biomarker system 100 via a software application (e.g., a mobile application, a web application, etc.), as further described herein.

[0034] In some embodiments, the first user device 105a may display data acquired from the wearable medical device 101 in a first format suitable for a desktop computer, for example, in a web browser. The same or similar data may be displayed on the second user device 105b (e.g., a smartphone) in a second format, for example, a compressed mobile phone video format (e.g., 3GPP, MPEG-4, or RTSP). In some embodiments, the information displayed on the first user device 105a may be segmented onto a separate display and appropriately formatted for display on the second user device 105b. The first user device 105a and the second user device 105b may be collectively referred to herein as user device 105.

[0035] According to some embodiments, an optional video camera 119 may be used to capture real-time video of a moving subject 109 during dynamic ultrasound imaging and biomarker monitoring of the ultrasound imaging and biomarker system 100. Herein, real-time is used to mean real-time or near real-time in which delays due to electronic devices, communication networks, and / or processing time are negligible. In some embodiments, the optional video camera 119 may be communicably connected to a user device 105 and / or access point 103 via a wireless connection. However, the optional video camera 119 may also be configured to communicate with the wireless access point 103, user device 105, and / or network server 113 via a wired and / or fiber optic network. The optional video camera 119 may be any type of camera capable of capturing and transmitting video and / or still images of the subject's body 109.

[0036] The ultrasound imaging and biomarker analysis technology platform 121 may be a software application and / or hardware application that resides entirely or partially on the network server 113, according to one or more aspects of the disclosed subject matter. In some embodiments, the software application and / or hardware application resides entirely or partially within the user device 105. In some embodiments, the software application and / or hardware application resides entirely or partially within the wearable medical device 101. In embodiments where a portion of the software application and / or hardware application resides within the user device 105 and / or the wearable medical device 101, these portions of the software application and / or hardware application cooperate with each other and / or with other portions of the software application and / or hardware application that reside within the network server 113 via the wide-area network 115. The separate portions of the software application and / or hardware application may cooperate synchronously or asynchronously. In some embodiments, the wearable medical device 101 may store information (e.g., in local memory) for uploading to a network server 113 and / or for subsequent analysis. In other embodiments, the wearable medical device 101 may actively transmit data to one or more user devices 105 for uploading to a network server 113 and / or for storage of the data (e.g., in the local memory of one or more user devices 105) for subsequent analysis.In yet another embodiment, the wearable medical device 101 may actively transmit data to one or more user devices 105 in order to actively upload some or all of the data to the network server 113 and / or remote computer 1001 for storage (e.g., to the local memory of one or more of the network server 113 and / or remote computer 1001), and / or for later analysis. Software applications and / or hardware applications may reside on the first user device 105a (e.g., a desktop computer), the second user device 105b (e.g., a smartphone), the remote computer 1001, and / or the network server 113.

[0037] In some embodiments, the ultrasound imaging and biomarker analysis technology platform 121 is software-as-a-medical device (SaMD) and, when executed by the network server 113 circuit, the wearable medical device 101 circuit, and / or the user device 105 circuit, utilizes an artificial intelligence engine (e.g., a cloud computing engine) to monitor a target site 107 of a subject in real time by controlling the processing of algorithms for the extraction and advanced analysis of quantitative imaging biomarkers from dynamic ultrasound images acquired by the wearable medical device 101. When the ultrasound imaging and biomarker analysis technology platform 121 is executed by the network server 113 circuit and / or the user device 105 circuit, it causes the circuit to generate an advanced structured report and display the dynamic ultrasound image along with the extracted quantitative imaging biomarkers and analysis data generated from the acquired ultrasound image. Examples of musculoskeletal (MSK) imaging biomarkers (e.g., muscle architecture parameters: MAP) include, but are not limited to, muscle thickness, cross-sectional area, wing angle, and muscle fascicle length. Therefore, a qualified healthcare professional (QHP) can monitor in real time an advanced analysis of dynamic ultrasound images (e.g., SMG) along with the subject's physiological parameters (e.g., sEMG, aECG, or IMU) during the test activity.

[0038] The network server 113 can represent one or more servers connected to a wearable medical device 101 and / or user device 105 via a wide-area network 115. The network server 113 may be configured to perform various processes for ultrasound imaging and biomarker system 100, as further described herein. The network server 113 can also represent a dedicated bank of servers, cloud-based processing, and / or a serverless computing system, corresponding to a virtualized set of hardware resources.

[0039] The wide-area network 115 may be a public network such as the Internet, a private network such as a LAN or WAN, or any combination thereof, and may also include a PSTN or ISDN subnetwork. The wide-area network 115 may also be wired, such as an Ethernet network, or wireless, such as a cellular network, including EDGE, 3G, 4G, and 5G wireless cellular systems. The wireless network may also be Wi-Fi, Bluetooth, or any other known wireless form of communication.

[0040] Figure 2 shows a display of real-time dynamic ultrasound imaging data 200 extracted from the ultrasound imaging and biomarker system 100 according to one or more embodiments of the disclosed subject. According to some embodiments, the real-time dynamic ultrasound imaging data 200 (e.g., sonomyography (SMG)) includes a series of dynamic ultrasound images 203, a series of analytical data values ​​207, and / or one or more analytical graphs 209. The series of dynamic ultrasound images 203 show how muscles change during exercise (e.g., test activity, test squat, exercise). For example, contraction and relaxation of the gastrocnemius muscle may be observed in real time or near real time during exercise.

[0041] During a test activity, the wearable medical device 101 can acquire ultrasound images 203 and biomarker data from a target site 107 in real time while the test activity (e.g., test squat) is performed by the subject wearing the wearable medical device 101. According to one or more embodiments, the wearable medical device 101 comprises a biosignal sensing device (e.g., sEMG or aECG) together with a high-precision sensing and motion detector (e.g., an IMU (motion), accelerometer, gyroscope, or microelectromechanical system (MEMS)). In some embodiments, the biosignal sensing device and the high-precision sensing and motion detector are utilized by the ultrasound imaging and biomarker system 100 to trigger the simultaneous acquisition of images and biosignals from the target site 107 during active movement of the subject's body 109.

[0042] The acquired ultrasound images 203 and biomarker data are transmitted to the user device 105 and / or network server 113 for analysis by the ultrasound imaging and biomarker analysis technology platform 121. According to some embodiments, the ultrasound imaging and biomarker analysis technology platform 121 generates an overlay 205 on the dynamic ultrasound image 203, calculates an analysis data value 207 (e.g., cross-sectional area (CSA)) associated with the overlay 205, and generates a dynamic ultrasound image 203 with the corresponding overlay 205 and analysis data value 207 for each acquired image. Thus, the subject's ultrasound images 203 may be monitored and analyzed in real time by a qualified healthcare provider during the test activity. In some embodiments, an analysis graph 209 (e.g., contraction-relaxation pair time by CSA measurement) may be generated in association with the analysis data value 207. For example, the cross-sectional area of ​​the overlay 205 may be graphed in real time in relation to the timing of the analysis data values ​​207 to show contraction-relaxation that correlates with the overlay 205, the dynamic ultrasound image 203, and the relative position of the subject's body 109 during the test activity.

[0043] According to some embodiments, a first series of dynamic ultrasound images 203, overlays 205, analytical data values ​​207, and a first analytical graph 209 may be generated and displayed together with a second series of dynamic ultrasound images 203, overlays 205, analytical data values ​​207, and a second analytical graph 209. The first series of dynamic ultrasound images 203 may be associated with a first wearable medical device 101 attached to a first target site 107b (e.g., the right calf) of the subject's body 109, and the second series of dynamic ultrasound images 203 may be associated with a second wearable medical device 101 attached to a second target site 107b (e.g., the left calf) of the subject's body 109. Thus, dynamic ultrasound images 203, overlays 205, analytical data values ​​207, and analytical graphs 209 of multiple target sites 107 of the subject's body 109 may be monitored simultaneously in real time.

[0044] According to one or more embodiments, an image analysis algorithm for automated segmentation of dynamic ultrasound images 203 is implemented by an ultrasound imaging and biomarker analysis technology platform 121. The ultrasound imaging and biomarker analysis technology platform 121 implements an optimized automated pipeline of processing modules to provide advanced image processing using a retrospective dataset of ultrasound images of a target site 107 (e.g., thigh muscle). According to some embodiments, the processing modules include, but are not limited to, image acquisition, image processing (RD), image analysis, measurement calculation, and structured reporting.

[0045] During automated segmentation, according to some embodiments, a convolutional neural network, along with several algorithms, may be applied to the ultrasound imaging and biomarker analysis technology platform 121. For example, to detect aponeurosis, the convolutional network returns predictions in the form of a mask superimposed on the raw image. To improve the final result, a heuristic algorithm is applied (e.g., skeletonization is performed to refine the heuristic and create a single-node path). Once the aponeurosis is detected and labeled, an algorithm is applied to this image to calculate different biomarkers included in the muscle structure parameters (MAP), for example, subcutaneous fat or muscle thickness may be shown to the user device 105. Thus, the ultrasound imaging and biomarker analysis technology platform 121 provides a cloud computing and AI-based system for advanced analysis of quantitative ultrasound imaging biomarkers with other physiological parameters that are compatible with and interoperable with the DICOM medical imaging standard.

[0046] According to some embodiments, the ultrasound imaging and biomarker analysis technology platform 121 may display one or more images acquired from raw images (e.g., background-separated ultrasound images, threshold ultrasound images, aponeurotic pathway exploration images, skeletonized pathway exploration images, and / or labeled images). According to one or more aspects of the disclosed subject matter, the ultrasound imaging and biomarker analysis technology platform 121 is implemented based on deep learning models and deep neural network (DNN) technologies that enable analysis of multivariate imaging biomarkers extracted from automated processing of ultrasound imaging, classification performed, prognosis estimation, and monitoring of treatment efficacy and progression for individualized medical decision support (e.g., clinical decision support systems).

[0047] The structured report may also be generated by the ultrasound imaging and biomarker analysis technology platform 121 according to one or more embodiments. In some embodiments, a user (e.g., a healthcare provider) can connect to the ultrasound imaging and biomarker analysis technology platform 121, create an examination, and upload acquired images. The images are processed and quantified using the ultrasound imaging and biomarker analysis technology platform 121 (e.g., a convolutional neural network) and a developed algorithm to extract several image biomarkers, and some image biomarkers are then associated with a structured report so that healthcare professionals can evaluate the results. The structured report may include, according to some embodiments, one or more of the following: a patient profile section, a target area indicator, muscle structure parameters (MAP) and index sections, and a muscle quality index section. The patient profile section includes profile information (e.g., patient ID, patient, name, weight, height, sex, ethnicity, date of birth, responsible person, examination ID, and examination date). The target area indicator specifies a target site 107 on the subject's body 109 used during the test activity (e.g., longitudinal of the right medial gastrocnemius muscle). The MAP and index section includes multiple MAP parameters used by the wearable medical device 101 to acquire dynamic ultrasound images 203 from the target site 107, and measurements calculated by the ultrasound imaging and biomarker analysis technology platform 121 during the test activity. The multiple MAP parameters and calculated measurements are reported for multiple phases (e.g., 10 phases) of the test activity.According to some embodiments, MAP parameters include, but are not limited to, feather angle, cosα, muscle fiber length, muscle thickness, subcutaneous fat thickness, muscle force (Fm) (e.g., an estimate of maximum isometric force), force transmitted to the tendon (Ft) (e.g., an estimate of the force transmitted to the tendon), muscle to no muscle index (Mi), no muscle to muscle index (NMi), fat to muscle index (FATi), and no muscle / no fat to muscle index (NMNFi). According to some embodiments, the muscularity index section includes a pie chart showing the percentages of muscle to no muscle index (Mi), fat to muscle index (FATi), and no muscle / no fat to muscle index (NMNFi) for each of several phases (e.g., 10 phases). However, any appropriate structured report may be generated by the ultrasound imaging and biomarker analysis technology platform 121. For example, the ultrasound imaging and biomarker analysis technology platform 121 can be used to analyze ultrasound images of different muscles obtained in the same examination as those used for the analysis of motion images discussed above. Thus, qualified medical professionals can evaluate the integrated results presented in the structured report.

[0048] Figures 3A, 3B, and 3C show perspective, exploded, and magnified views, respectively, of a wearable medical device 101 according to an embodiment of the present invention. According to some embodiments, the wearable medical device 101 may include a scanning and monitoring module 501, an adhesive electrode patch 503, and an electrode array including a first electrode 505, a second electrode 507, and a third electrode 509.

[0049] As shown in Figure 3B, the scanning and monitoring module 501 can be detachably attached to the adhesive electrode patch 503 by a rotary connector member 511, according to one or more embodiments of the disclosed subject matter. The rotary connector member 511 and the scanning and monitoring module 501 can be adapted to a cooperating snap-to-fit configuration 513, according to some embodiments. However, other suitable configurations (e.g., screw-in fittings) may be used, as long as the scanning and monitoring module 501 can be detachably attached to the adhesive electrode patch 503. The scanning and monitoring module 501 may be referred to herein as an ultrasonic scanner, a wireless scanning device, and / or an ultrasonic module.

[0050] As shown in Figure 3A, when mounted on the rotating coupling member 511, the scanning and monitoring module 501 can rotate about the Z-axis as indicated by the directional arrow 515. According to one or more embodiments of the disclosed subject matter, the scanning and monitoring module 501 may rotate through a rotation angle that allows imaging at different cross-sections. According to some embodiments, the rotation angle may be an angle between 0 and 90 degrees (±20 degrees). In some embodiments, the scanning and monitoring module 501 may be configured to rotate a full 360 degrees.

[0051] In some embodiments, the scanning and monitoring module 501 can be tilted away from the Z-axis, as indicated by the tilt angle "α" as shown in Figure 3A. In such embodiments, tilting the scanning and monitoring module 501 helps to locate and / or focus on a region of interest (ROI) within the target site 107. According to some embodiments, the tilt angle α may be an angle between 0 and 45 degrees (±5 degrees).

[0052] The rotary coupling member 511 may further include a biosignal rotary connector 517 disposed within the channel 519 of the rotary coupling member 511. In some embodiments, the biosignal rotary connector 517 may be integrally formed and / or embedded within the channel 519. In other embodiments, the biosignal rotary connector 517 is detachable from the rotary coupling member 511.

[0053] Figure 3C shows an enlarged view of the rotating coupling member 511 according to an embodiment. Figure 3C shows a biosignal rotating connector 517 installed within the channel 519 of the rotating coupling member 511 according to several embodiments. According to some embodiments, the biosignal rotating connector 517 is a printed circuit board (PCB) comprising a non-conductive substrate 521 (e.g., an insulating substrate, a polyamide material layer, or glass fiber reinforced epoxy resin (FR-4)) and conductive tracks 523 (e.g., patterned metal traces, patterned copper foil, conductive wires, or circuit traces).

[0054] Figure 3C further illustrates the rotation angle "θ" limited by the length of the conductive track 523 exposed at the top of the biosignal rotation connector 517, according to one or more embodiments of the disclosed subject matter. In some embodiments, the conductive track 523 may be configured such that the rotation angle θ is limited to an angle between 0 and 90 degrees (±20 degrees), but is sufficient to accommodate the rotation of the scanning and monitoring module 501 for both longitudinal and transverse imaging. However, any suitable rotation angle θ may be used. In some embodiments, the conductive track 523 may be configured as a perfect circle or a nearly perfect circle so that the scanning and monitoring module 501 can rotate a full 360 degrees or nearly 360 degrees. Figure 3C further illustrates an enlarged view of the snap-to-fit configuration 513 of the rotation connector member 511.

[0055] According to one or more embodiments of the disclosed subject matter, a full rotation of the scanning and monitoring module 501 allows the ultrasound imaging to capture a full 3D scan of the target site 107. In some embodiments, a convex transducer is used in the scanning and monitoring module 501. In such embodiments, the resulting 3D image is conical. In other embodiments, a planar transducer may be used in the scanning and monitoring module 501. In such embodiments, the resulting 3D image is cylindrical.

[0056] According to some aspects of the disclosed subject matter, the scanning and monitoring module 501 and / or ultrasonic transducer may be tilted about an axis on the transducer surface to assist in locating and / or focusing on a region of interest (ROI) within the target site 107. In such embodiments, a planar sector is obtained, and the angular separation between images is adjustable depending on the rotation speed and image frame rate.

[0057] When installed, the biosignal rotation connector 517 electrically connects the electrode array of the first electrode 505, the second electrode 507, and the third electrode 509 to the scanning and monitoring module 501 and maintains the electrical connection between them during the rotation of the scanning and monitoring module 501. According to some embodiments, the scanning and monitoring module 501 is manually rotated and / or tilted by a qualified medical professional to obtain an appropriate cross-section for the ultrasound image 203 to be acquired. In other embodiments, the rotation and / or tilt angle of the scanning and monitoring module 501 may be automatically achieved by the ultrasound imaging and biomarker system 100 controlling a MEMS device (e.g., a rotary motor, linear motor, or servo motor) incorporated into the scanning and monitoring module 501 and / or incorporated into the rotation coupling member 511. However, any suitable rotation actuator and / or tilt mechanism may be used, as long as the electrical connection between the electrodes and the scanning and monitoring module 501 is maintained during rotation and / or tilting.

[0058] According to one or more embodiments, the scanning and monitoring module 501 can simultaneously acquire ultrasound images 203 and / or biosignals at rotation and / or tilt angles for acquiring images along a predetermined cross-section (e.g., a longitudinal or transverse cross-section). However, any suitable rotation and / or tilt angle for acquiring images along a predetermined cross-section may be used. The predetermined rotation angle, tilt angle, and predetermined cross-section may be determined by a qualified expert or by machine determination (e.g., thresholds, algorithms, machine learning, or automated intelligence: AI).

[0059] In some embodiments, the ultrasound image 203 and / or biosignals can be acquired simultaneously while the scanning and monitoring module 501 is rotating and / or while the scanning and monitoring module 501 is stopped. Furthermore, the scanning and monitoring module 501 and / or the user device 105 may be configured to determine one or more optimal rotation angles for acquiring the ultrasound image 203 and / or biosignals.

[0060] According to the embodiment, the determined optimal rotation angle and / or optimal tilt angle may have a tolerance of less than a predetermined amount from the angle of a given cross-section. For example, a tolerance of less than about ±0.5 degrees from the angle of a given cross-section may be used to measure the blade angle. For more basic imaging applications, a tolerance of less than about ±2.5 degrees to less than about ±5.0 degrees from the angle of a given cross-section may be used. When manual adjustment of the scanning and monitoring module 501 is used, a tolerance of less than about ±20 degrees from the angle of a given cross-section may be used. Nevertheless, any appropriate tolerance may be used based on the accuracy of a given target area 107 and a given cross-section.

[0061] One or more optimal rotation angles and / or optimal tilt angles may be determined by a person skilled in the art (e.g., a physiotherapist). In some embodiments, the rotation of the scanning and monitoring module 501 may be adjusted in increments of 1 degree. However, any appropriate incremental adjustment (e.g., 5-degree or 10-degree increments) may be utilized in the arrangement of the scanning and monitoring module 501. According to one or more aspects of the disclosed subject matter, biomarkers extracted by the ultrasound imaging and biomarker analysis technology platform 121 may be used to help determine one or more optimal rotation angles and / or optimal tilt angles. In such embodiments, the ultrasound imaging and biomarker analysis technology platform 121 utilizes one or more resources from the scanning and monitoring module 501, the user device 105, and / or the network server 113 to develop an algorithm in determining one or more optimal rotation angles. In some embodiments, artificial intelligence techniques (e.g., convolutional neural networks) may be used to determine one or more optimal rotation angles.

[0062] According to some embodiments, the logic, accelerometer, gyroscope, and / or object recognition of the scanning and monitoring module 501, the user device 105, and / or optional camera 119 may be used to determine the rotation angle of the scanning and monitoring module 501 with respect to an optimal rotation angle. In one or more embodiments of the disclosed subject matter, the wearable medical device 101 and / or the user device 105 include an optimal angle indicator that is activated when the scanning and monitoring module 501 has been rotated to the determined optimal rotation angle. The optimal angle indicator may be a visual indicator (e.g., a light-emitting diode (LED)), an auditory indicator (e.g., a chime, voice cue, or ringtone), a tactile indicator (e.g., vibration), a text indicator (e.g., an on-screen notification, pop-up notification, or icon), or a combination thereof. However, any other suitable indicator may be used.

[0063] According to another embodiment, the biosignal rotational connector is provided by bending the substrate 503 itself, with electrodes and rotational connector pads printed on its other end, and the substrate is positioned on component 511 as depicted in Figures 3D and 3E. In this design, the flexible substrate is directly connected without the need for a printed circuit board (PCB). During use (e.g., during subject activity), the track maintains the connection, so no signal is lost. This design is depicted in Figure 3E together with the connecting member 511.

[0064] Referring next to Figure 4, this figure shows an exploded view of a rotary connector 511 and a surface mount adapter 601 according to one or more embodiments of the disclosed subject matter. The rotary connector 511 shown in Figure 4 is similar to the rotary connector 511 shown in Figures 3B and 3C, except that the rotary connector 511 in Figure 4 includes a lip 603 instead of the channel 519 shown in Figures 3B and 3C. The biosignal rotary connector 517 shown in Figure 4 is fixed to the rotary connector 511 via a tab and slot configuration. According to the embodiment, the lip 603 of the rotary connector 511 includes a slot 605, and the biosignal rotary connector 517 includes a tab 607 adapted to fit into the slot 605, fixing the biosignal rotary connector 517 to the rotary connector 511. According to the embodiment, a conductive track 523 is electrically connected to an external contact on the bottom side of the biosignal rotary connector 517 via a non-conductive substrate 521. In another embodiment, as shown in Figure 3D, the biosignal rotational connector is provided by bending the substrate 503 itself, with electrodes and rotational connector pads printed on its other end, and the substrate is placed on component 511. In one or more embodiments, the external contact is exposed on the bottom side of the tab 607. However, any suitable location may be used for the external contact.

[0065] According to some embodiments, the surface mount adapter 601 is adapted to connect to the bottom side of a swivel connector 511 with an adhesive electrode patch 503 sandwiched between them. The surface mount adapter 601 and the swivel connector 511 are adapted using a cooperating snap-to-fit mechanism according to one or more embodiments of the disclosed subject matter. In some embodiments, the surface mount adapter 601 includes a raised tab 609 that fits snugly into a hole 611 in the swivel connector 511. In other embodiments, the surface mount adapter 601 includes a hole 611, and the swivel connector 511 includes a raised tab 609 that fits snugly into the hole 611. According to one or more embodiments of the disclosed subject matter, further snap-to-fit mechanisms and / or other connection mechanisms may be used to secure the surface mount adapter 601 to the swivel connector 511. Thus, the top surface of the surface mount adapter 601 fits coplanar with the bottom surface of the swivel connector 511. The surface mount adapter 601 is formed of an elastic material (e.g., an elastic adhesive pad, a biocompatible adhesive silicone gel, a biocompatible adhesive, a biocompatible ionic gel, a soft silicone adhesive (SSA), a silicone gel elastomer, or solid silicone), and the bottom surface of the elastic material may be formed to any size and shape so as to fit and conform to any target area 107 (e.g., 107a, 107b, 107c) of the subject's body 109, according to one or more embodiments of the disclosed subject. As shown in Figure 4, the surface mount adapter 601 may be formed to a size and shape so as to fit and conform to the target area region 107a (e.g., around the waist) of the subject's body 109.

[0066] Figures 5A and 5B show exploded and perspective views, respectively, of the scanning and monitoring module 501 according to its configuration. The scanning and monitoring module 501 may be configured to acquire an ultrasonic image 203 of a target area 107 of the user's body 109 on which the scanning and monitoring module 501 is positioned. According to some embodiments, the scanning and monitoring module 501 includes an ultrasonic transducer 701, a lower housing 703, conductive contacts 705, a printed circuit board (PCB) 707, and an upper housing 709.

[0067] According to several embodiments, the ultrasonic transducer 701 is based on a highly active piezoelectric or capacitive micromachined ultrasonic transducer (CMUT) sensor array for acquiring an ultrasonic image of a target site 107. Such an ultrasonic transducer 701 is described in international patent application PCT / EP2021 / 051377, which is incorporated herein by reference.

[0068] According to one or more embodiments of the disclosed subject matter, the ultrasonic transducer 701 is intended to operate in the range of 7 to 14 MHz for surface scanning and 2 to 6 MHz for deeper targets. However, in further embodiments, the ultrasonic transducer 701 may operate in any other range currently known or to be developed in the future that can enable the scanning and monitoring module 501 to substantially perform the functions described herein. Also, in at least one embodiment, the ultrasonic transducer 701 is configured to operate in a pulse-echo configuration. For example, the ultrasonic transducer 701 is configured to emit and then receive ultrasonic pulses to acquire an ultrasonic image 203. In at least one embodiment, the ultrasonic transducer 701 comprises one or more piezoelectric elements. In at least one such embodiment, the ultrasonic transducer 701 comprises an array of piezoelectric elements, the number of piezoelectric elements in the array is in the range of 2 to 256. However, in further embodiments, any other number of piezoelectric elements may be utilized.

[0069] In some embodiments, the ultrasonic transducer 701 includes an acoustic lens to shift the focal length of the ultrasonic transducer 701 and increase the acoustic energy density at a given location (improving the imaging resolution of that region). The shift in focal length, the increase in acoustic energy density, and the given location may be determined by a qualified expert or by machine determination (e.g., threshold, algorithm, machine learning, or automated intelligence (AI)). For flexible and conformal ultrasonic transducers 701, the use of a lens may be utilized to control the propagation of sound waves according to the specific shape of the target site. In at least one embodiment, the acoustic lens is constructed from at least one of room temperature vulcanizing (RTV) rubber, polyurethane, plexiglass, silicone rubber, polystyrene, and epoxy. However, the acoustic lens may be constructed from any other material (or combination of materials) currently known or to be developed, as long as the scanning and monitoring module 501 can substantially perform the functions described herein.

[0070] In some embodiments, the ultrasonic transducer 701 is provided with an acoustic standoff pad (e.g., a gel pad or probe standoff). The acoustic standoff pad, like an acoustic lens, improves the transmission of acoustic energy and helps enable the acquisition of high-quality images. The acoustic standoff pad contains a gel material (e.g., a flexible polymer) that is comfortable for the patient during the examination, has a long lifespan, and is reusable.

[0071] According to some embodiments, the ultrasonic transducer 701 is mounted in a retaining slot 711 of the lower housing 703 and is physically and electrically connected to a ribbon cable connector 713 via a ribbon cable 715. The ribbon cable connector 713 connects the ultrasonic transducer 701 to a printed circuit board (PCB) 707 and is supported by a protrusion 717 of the lower housing 703.

[0072] The conductive contact 705 is fixed within a pin-mount structure 723 of the lower housing 703, protruding from the bottom surface of the lower housing 703, and electrically connects to a printed circuit board (PCB) 707 by one or more embodiments of the disclosed subject. In some embodiments, the conductive contact 705 is provided as a pogo pin connector or a spring-loaded pin connector, etc.

[0073] First, it should be noted that the specific arrangements of the components shown in Figures 5A and 5B are merely illustrative. Therefore, in further embodiments, as will be discussed later, various components may take on several other arrangements.

[0074] Figure 6 shows an exploded view of a second wearable ultrasound and biomarker monitoring device 801 according to one or more embodiments of the disclosed subject matter. The second wearable ultrasound and biomarker monitoring device 801 comprises a scanning and monitoring module 501, a biosignal rotation connector 517, an integrated rotation connector and surface mount adapter 803, a double-sided adhesive section 805, and an adhesive electrode patch 503.

[0075] The biosignal rotation connector 517 fits within the channel 519 and is attached to the integrated rotation connector and surface mount adapter 803 using slots 605 and tabs 607 in a snap-to-fit configuration according to one or more aspects of the disclosed subject. However, other configurations are also possible, including integrally forming and / or embedding the biosignal rotation connector 517 in the channel 519 of the integrated rotation connector and surface mount adapter 803.

[0076] The integrated rotary coupling and surface mount adapter 803 is a integrally formed component comprising a rotary coupling section 807 and a surface mount section 809. The rotary coupling section 807 is similar to the rotary coupling member 511 described herein, but the rotary coupling section 807 is not detachable from the surface mount section 809.

[0077] The surface mount section 809 is similar to the surface mount adapter 601 as described herein, but the surface mount section 809 is not detachable from the rotary connecting section 807. The surface mount section 809 may be formed to any size and shape to conform to and fit any target area 107 (e.g., 107a, 107b, 107c) of the subject's body 109. As shown in Figure 6, according to some embodiments, the surface mount section 809 may be formed to conform to and fit a target area 107b (e.g., calf area) of the subject's body 109. However, according to one or more aspects of the disclosed subject matter, the surface mount section 809 may also have the same shape as the surface mount adapter 601.

[0078] The double-sided adhesive layer 805 enables the detachable attachment of the integrated rotary coupling and surface mount adapter 803 to the adhesive electrode patch 503, as described in several aspects of the disclosed subject matter. The double-sided adhesive layer 805 may be an adhesive film (e.g., a tape-based adhesive, a nanofilm, a flexible and stretchable film-based adhesive, a pressure-sensitive adhesive film, or a biomedical adhesive). However, without departing from the spirit and scope of the disclosed subject matter, any suitable adhesive (e.g., a liquid or paste) may be used for the double-sided adhesive layer 805.

[0079] The adhesive electrode patch 503 comprises a conductive adhesive pad 811, a bottom patch 813, an electrode pad 815, an electrode trace array 817, and a top patch 819, according to one or more embodiments of the disclosed subject matter. The adhesive electrode patch 503 may be formed using two or more electrode portions (e.g., a first electrode portion 821, a second electrode portion 823, and a third electrode portion 825). In the embodiment described in Figure 6, there are five electrode portions. However, any suitable number of electrode portions may be used.

[0080] Each conductive adhesive pad 811 adheres the corresponding electrode pad 815 to a predetermined electrode site on the subject's body 109. According to some embodiments, the conductive adhesive pad 811 includes a conductive adhesive film (e.g., a conductive film, a conductive pressure-sensitive adhesive, or conductive ink printed on a polyimide film), but any suitable conductive adhesive may be used.

[0081] Each electrode pad 815 is connected by an electrode trace 817 to a connection point 827 for electrical connection to the scanning and monitoring module 501 above. The electrode traces 817 may be collectively referred to herein as the electrode array. In some embodiments, the connection points 827 are located adjacent to each other at a common connection point, as shown in Figure 6. However, the electrode traces 817 may have connection points 827 at different locations, which are not located in common but are still located at locations accessible for connection to the scanning and monitoring module 501 above. According to some embodiments, the electrode pads 815 and electrode traces 817 include conductive materials (e.g., printed silver chloride conductive ink, nanosilver-based ink, conductive patterns, punched metal sheets, conductive films, metal nanoplates, conductive films printed on polyimide films, or metal wires). However, any suitable conductive material may be used.

[0082] According to some aspects of the disclosed subject matter, the electrode array is sandwiched between a bottom patch 813 and a top patch 819. In some embodiments, the electrode pads 815 and electrode traces 817 are printed on either the bottom patch 813 or the top patch 819. In such embodiments, the electrode pads 815 and electrode traces 817 may include printable conductive ink (e.g., printed silver chloride conductive ink). In some embodiments, each of the bottom patch 813 and the top patch 819 is provided as an undivided material patch. In such embodiments, when sandwiched between the bottom patch 813 and the top patch 819, the electrode traces 817 are completely covered except for the connection portion 827. In other embodiments, one or more portions of the electrode traces 817 may not be covered when sandwiched between the bottom patch 813 and the top patch 819. For example, the portion of the electrode trace 817 corresponding to the third electrode 825 in Figure 6 is not covered by the bottom patch 813 and the top patch 819. In such embodiments, each of the bottom patch 813 and the top patch 819 may be provided as a group of material patches. These groups of material patches may include a main body of material and one or more sub-bodies of material. The main body of material covers at least a portion of each electrode trace 817 near the connection site 827 when the electrode array is sandwiched between the bottom patch 813 and the top patch 819. One or more sub-bodies of material sandwich one or more electrode pads 815 between the bottom patch 813 and the top patch 819, leaving a portion of the corresponding electrode trace 817 exposed. In such embodiments, the corresponding trace 817 may be provided with a dielectric cladding or sheath surrounding the exposed portion of the corresponding trace 817.

[0083] According to some embodiments, one or more connection site access areas 829 may be provided on the top patch 819 corresponding to the connection site 827 to enable electrical connection of the electrode trace 817 to the scanning and monitoring module 501 above. In some aspects of the disclosed subject matter, the biosignal rotational connector 517 includes an external contact exposed on the underside of the biosignal rotational connector 517 for external connection to a conductive track 523 located on the upper side of the biosignal rotational connector 517. According to other embodiments, in Figure 3D, the biosignal rotational connector is provided by bending the substrate 503 itself, the electrode and rotational connector pad are printed on its other end, and the substrate is placed on the component 511. For example, the external contact is electrically connected to the conductive track 523 via a tab 607 for external connection to the bottom side of the biosignal rotational connector 517. Therefore, the portion of the electrode trace 817 exposed through the connection site access area 829 is sandwiched between the top patch 819 and bottom patch 813 that form the adhesive electrode patch 503, and is electrically connected to the external contacts exposed at the bottom of the biosignal rotational connector 517 when the electrode array is attached to the adhesive electrode patch 503 and the integrated rotational connector and surface mount adapter 803 is attached to the adhesive electrode patch 503. However, in order to enable electrical connection of the electrode trace 817 to the scanning and monitoring module 501, any suitable arrangement of conductive contacts and / or connectors may be provided at the bottom of the scanning and monitoring module 501 and / or the integrated rotational connector and surface mount adapter 803.

[0084] Referring next to Figure 7, this figure shows a cross-sectional view and an enlarged view of section 901 of a second wearable ultrasound and biomarker monitoring device 801 according to one or more embodiments of the disclosed subject matter. In particular, Figure 7 shows, according to several embodiments, a biosignal rotation connector 517 mounted on an integrated rotation connector and surface mount adapter 803, and a scanning and monitoring module 501 attached to the integrated rotation connector and surface mount adapter 803 by a snap-to-fit configuration 513 and a ridge portion of the lower housing 703. Figure 7 further shows a directional arrow 515 indicating that the scanning and monitoring module 501 rotates about the Z axis, according to one or more embodiments of the disclosed subject matter.

[0085] In some aspects of the disclosed subject matter, the angle of incidence to the image acquired by the ultrasonic transducer 701 may be tilted by an angle α from the perpendicular, as shown in Figure 7. Tilting the angle of incidence to the image acquired by the ultrasonic transducer 701 helps the user locate and / or focus on a region of interest (ROI) located at a target site 107 on the subject's body 109.

[0086] In enlarged section 901, Figure 7 further shows that the conductive contact 705 protrudes from the bottom surface of the lower housing 703 and physically engages with the conductive track 523 of the biosignal rotation connector 517. As the scanning and monitoring module 501 rotates around the Z-axis, the conductive contact 705 remains engaged with the conductive track 523 of the biosignal rotation connector 517 and remains in physical contact. According to some aspects of the disclosed subject matter, the biosignal rotation connector 517 electrically connects the electrodes of an electrode array (e.g., a first electrode 505, a second electrode 507, and a third electrode 509) to the scanning and monitoring module 501 and maintains the electrical connection and reception of biosignals throughout the rotation of the scanning and monitoring module 501.

[0087] Figure 7 further illustrates one or more semiconductor chips 719 and one or more batteries 721 on a first side of a printed circuit board (PCB) 707, and a second semiconductor chip 903 on a second side of the printed circuit board (PCB) 707 opposite to the first side, according to one or more embodiments of the subject matter disclosed. In some embodiments, one or more semiconductor chips 719 comprises a processor (e.g., a system on a chip (SoC)) for controlling the operation of an ultrasonic transducer 701, and the second chip 903 comprises a second process (e.g., a second system on a chip (SoC)) for controlling the communication of biosignals. In other embodiments, one or more semiconductor chips 719 may be on a second side of the printed circuit board (PCB) 707, and the second semiconductor chip 903 may be on a first side of the printed circuit board (PCB) 707. In yet another embodiment, one or more semiconductor chips 719 and a second semiconductor chip 903 may be located on the same side of the printed circuit board (PCB) 707.

[0088] In some other embodiments, a second semiconductor chip 903 for controlling the communication of biosignals is provided on a printed circuit board (PCB) 707, but the ultrasonic transducer 701 and the processor (e.g., a system-on-a-chip (SoC)) for controlling the operation of the ultrasonic transducer 701 are not provided on the printed circuit board (PCB) 707. In such embodiments, the scanning and monitoring module 501 performs only the function of wireless biosignal monitoring. Thus, the wearable medical device 101 and the second wearable ultrasonic and biomarker monitoring device 801 are referred to as wearable biomarker monitoring devices.

[0089] According to one or more aspects of the disclosed subject matter, the various components of the wearable medical device 101 described above are configured as a self-sufficient wearable patch, which may be attached to the user's skin (or clothing in direct contact with the user's skin) or, alternatively, attached to or otherwise integrated with the fabric of clothing in direct contact with the user's skin. In each such example, the wearable medical device 101 is configured as a wearable and flexible solution for providing remote gait monitoring of a target site. Therefore, in embodiments where the wearable medical device 101 is used in relation to MSK ultrasound (typically used to generate ultrasound images of muscles, tendons, ligaments, and joints throughout the body, and to help diagnose sprains, muscle strains, tears, and other soft tissue conditions), the wearable medical device 101 enables real-time data acquisition in the fields of sports medicine and real-time healthcare monitoring, while also being useful for numerous advanced applications, including, to name a few, human-machine interfaces, smart medical prosthetics (bionics), electronic skin, wearable home appliances, and soft robotics. Furthermore, by incorporating a scanning and monitoring module 501 with biosignal sensing in at least one embodiment, the wearable medical device 101 can function as a multimodal system for biomedical and clinical applications, simultaneously acquiring ultrasound imaging information, electrophysiological information, hemodynamic information, and oxidative metabolism information of muscle activity.

[0090] Finally, with respect to exemplary embodiments of the Invention as shown and described herein, it will be seen that a wearable ultrasound device is disclosed and configured for use in various biomedical applications, including musculoskeletal ("MSK") imaging and analysis. Since the principles of the Invention may be practiced in several configurations other than those shown and described, it should be understood that the Invention is not limited in any way by exemplary embodiments and can take numerous forms to cover wearable ultrasound devices in general and to do so without departing from the spirit and scope of the Invention. It will also be seen that the Invention is not limited to the specific shapes and materials of the disclosed constructs and may instead require other functionally equivalent structures or materials that are currently known or to be developed in the future, without departing from the spirit and scope of the Invention.

[0091] In the above description, any process, description, or block in the flowchart may be understood to represent a module, segment, or portion of code containing one or more executable instructions for implementing a specific logical function or step within the process, and it will be understood by those skilled in the art that alternative implementations in which the functions may be performed in an order different from the one shown or described, including substantially simultaneous or reverse order, depending on the function, are included within the scope of the exemplary embodiments of this advance. The various elements, mechanisms, and processes described herein may be used independently of each other or in various combinations. All possible combinations and subcombinations are intended to fall within the scope of this disclosure.

[0092] Figure 8 is a functional block diagram showing a user device 105 connected to a networked system 1000 of one or more networked computers and servers. In embodiments, the hardware and software environment shown in Figure 8 may provide an exemplary platform for implementing the software and / or methods according to this disclosure.

[0093] According to some embodiments, the networked system 1000 may include, but is not limited to, a user device 105, a network 115, a remote computer 1001, a web server 1003, a cloud storage server 1005, and a computer server 1007. It should also be understood that the user device 105 may represent one or more of the remote computer 1001, the web server 1003, the cloud storage server 1005, and the computer server 1007.

[0094] Additional details of user device 105 are shown in Figure 8. The functional blocks shown within user device 105 are provided for illustrative purposes only and are not intended to be exhaustive. Details for remote computer 1001, web server 1003, cloud storage server 1005, and computer server 1007 are not provided, but these other computers and devices may include functionalities similar to those shown for user device 105.

[0095] The user device 105 may be a personal computer (PC), desktop computer, laptop computer, notebook computer, tablet computer, netbook computer, personal digital assistant (PDA), smartphone, or any other programmable electronic device capable of communicating with other devices on the network 115.

[0096] The user device 105 may include a processor 1009, a bus 1011, memory 1013, non-volatile storage 1015, a network interface 1017, a peripheral interface 1019, and a display interface 1021. Each of these functions may, in some embodiments, be implemented as a separate electronic subsystem (an integrated circuit chip, or a combination of a chip and associated devices), or in other embodiments, any combination of the functions may be implemented on a single chip (sometimes called a system-on-a-chip or SoC).

[0097] Processor 1009 may be one or more single or multi-chip microprocessors, such as those designed and / or manufactured by Intel Corporation, Advanced Micro Devices, Inc. (AMD), Arm Holdings (Arm), or Apple Computer. Examples of microprocessors include Intel Corporation's Celeron, Pentium, Core i3, Core i5, and Core i7; AMD's Opteron, Phenom, Athlon, Turion, and Ryzen; and Arm's Cortex-A, Cortex-R, and Cortex-M.

[0098] Bus 1011 may be a proprietary or industry-standard high-speed parallel or serial peripheral interconnect bus such as ISA, PCI, PCI Express (PCI-e), and AGP.

[0099] The memory 1013 and non-volatile storage 1015 may be computer-readable storage media. The memory 1013 may include any suitable volatile storage device, such as dynamic random access memory (DRAM) and static random access memory (SRAM). The non-volatile storage 1015 may include one or more of the following: flexible disks, hard disks, solid-state drives (SSDs), read-only memory (ROMs), erasable programmable read-only memory (EPROMs, or flash memory), compact discs (CDs, or CD-ROMs), digital versatile disks (DVDs), and memory cards or sticks.

[0100] The program 1023 may be a set of machine-readable instructions and / or data stored in the non-volatile storage 1015, which is discussed in detail elsewhere in this disclosure and used to create, manage, and control certain software functions shown in the drawings. In some embodiments, the memory 1013 may be significantly faster than the non-volatile storage 1015. In such embodiments, the program 1023 may be transferred from the non-volatile storage 1015 to the memory 1013 before execution by the processor 1009.

[0101] The user device 105 may be able to communicate and interact with other computers via the network 115 through the network interface 1017. The network 115 may be, for example, a local area network (LAN), a wide area network (WAN) such as the Internet, or a combination of the two, and may include wired, wireless, or fiber optic connections. In general, the network 115 may be any combination of connections and protocols that support communication between two or more computers and associated devices.

[0102] The peripheral interface 1019 may enable data input and output between the user device 105 and other devices that may be locally connected. For example, the peripheral interface 1019 may provide a connection to an external device 1025. The external device 1025 may include devices such as a keyboard, mouse, keypad, touchscreen, and / or other suitable input devices. The external device 1025 may also include portable computer-readable storage media such as a thumb drive, portable optical or magnetic disk, and memory card. Software and data used to practice embodiments of the present disclosure, for example, program 1023, may be stored on such portable computer-readable storage media. In such embodiments, the software may be loaded into non-volatile storage 1015, or alternatively, directly into memory 1013 via the peripheral interface 1019. The peripheral interface 1019 may use industry-standard connections such as RS-232 or Universal Serial Bus (USB) to connect to the external device 1025.

[0103] The display interface 1021 may connect the user device 105 to the display 1027. In some embodiments, the display 1027 may be used to present a command line or a graphical user interface to the user of the user device 105. The display interface 1021 may connect to the display 1027 using one or more proprietary or industry-standard connections such as VGA, DVI, DisplayPort, and HDMI.

[0104] As described above, the network interface 1017 provides communication with other computing and storage systems or devices outside the user device 105. The software programs and data discussed herein may be downloaded to the non-volatile storage 1015 via the network interface 1017 and network 115 from, for example, a remote computer 1001, a web server 1003, a cloud storage server 1005, and a computer server 1007. Furthermore, the systems and methods described herein may be executed by one or more computers connected to the user device 105 via the network interface 1017 and network 115. For example, in some embodiments, the systems and methods described herein may be executed by a remote computer 1001, a computer server 1007, or a combination of interconnected computers on network 115. The mobile applications, subscription website data, datasets, and / or databases used in embodiments of the systems and methods described herein may be stored and / or downloaded from one or more of the remote computer 1001, web server 1003, cloud storage server 1005, and computer server 1007.

[0105] The control and computational modes of this disclosure may be embodied as systems, methods, and / or computer program products. A computer program product may include a computer-readable storage medium on which computer-readable program instructions are recorded that may cause one or more processors to execute modes of the embodiments.

[0106] A computer-readable storage medium may be a tangible device capable of storing instructions for use by an instruction-executing device (processor). A computer-readable storage medium may, but is not limited to, electronic storage devices, magnetic storage devices, optical storage devices, electromagnetic storage devices, semiconductor storage devices, or any suitable combination thereof. A non-exclusive list of more specific examples of computer-readable storage media includes (and suitable combinations of) flexible disks, hard disks, solid-state drives (SSDs), random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash), static random access memory (SRAM), compact disks (CDs or CD-ROMs), digital multipurpose disks (DVDs), and memory cards or memory sticks. Computer-readable storage media as used in this disclosure should not be construed as transient signals themselves, such as radio waves or other freely propagating electromagnetic waves, electromagnetic waves propagating through waveguides or other transmission media (e.g., light pulses passing through optical fiber cables), or electrical signals transmitted through wires.

[0107] The computer-readable program instructions described herein may be downloaded from a computer-readable storage medium to a suitable computing or processing device, or may be downloaded to an external computer or external storage device via a global network (i.e., the Internet), a local area network, a wide area network, and / or a wireless network. The network may include copper transmission wires, optical fiber, wireless transmission, routers, firewalls, switches, gateway computers, and / or edge servers. A network adapter card or network interface within each computing or processing device may receive computer-readable program instructions from the network and transfer the computer-readable program instructions for storage in a computer-readable storage medium within the computing or processing device.

[0108] The computer-readable program instructions for performing the operations of the Disclosure may include machine language instructions and / or microcode, which may be compiled or interpreted from source code written in any combination of one or more programming languages, including assembly language, Basic, Fortran, Java, Python, R, C, C++, C#, or similar programming languages. The computer-readable program instructions may be executed entirely on the user's personal computer, notebook computer, tablet, or smartphone, entirely on a remote computer or computer server, or on any combination of these computing devices. The remote computer or computer server may be connected to one or more of the user's devices through a computer network, including a local area network, a wide area network, or a global network (i.e., the Internet). In some embodiments, an electronic circuit including, for example, a programmable logic circuit, a field-programmable gate array (FPGA), or a programmable logic array (PLA) may execute computer-readable program instructions by using information from computer-readable program instructions for configuring or customizing the electronic circuit in order to carry out an aspect of the present disclosure.

[0109] According to some aspects of the disclosed subject matter, a wearable medical device that can be positioned on a target site of a subject's body includes a rotating coupling component comprising a plurality of conductive tracks, an electrode patch comprising an electrode array configured for attachment to the rotating coupling component, wherein when the electrode patch is attached, the electrodes of the electrode array are electrically coupled to corresponding tracks of the conductive tracks, and a scanning and monitoring module comprising a set of conductive contacts configured for attachment to the rotating coupling component on the opposite side of the electrode patch, wherein when the scanning and monitoring module is attached, the set of conductive contacts engages with corresponding tracks of the plurality of conductive tracks, and the scanning and monitoring module is further configured to rotate around the rotating coupling component while the scanning and monitoring module rotates, with the plurality of conductive contacts remaining engaged with the corresponding tracks. In some embodiments, the scanning and monitoring module further includes an ultrasonic transducer configured to acquire an ultrasonic image of a target site, a biosignal sensor configured to acquire a biosignal of the target site from an electrode array, and a printed circuit board electrically coupled to the ultrasonic transducer and the biosignal sensor, the printed circuit board including a circuit configured to simultaneously acquire an ultrasonic image and a biosignal while the scanning and monitoring module is rotating. According to some embodiments, the conductive contacts are pogo pins. In some embodiments, the ultrasonic transducer acquires an image in a longitudinal cross-section when the scanning and monitoring module is rotated to a first rotation angle, and acquires an image in a transverse cross-section when the scanning and monitoring module is rotated to a second rotation angle. According to one or more aspects of the disclosed subject matter, the scanning and monitoring module is rotated manually. In some embodiments, the wearable medical device further includes a motor electrically coupled to the printed circuit board, the motor configured to automatically rotate the scanning and monitoring module.According to some embodiments, the wearable medical device further includes a wireless transceiver electrically connected to a printed circuit board and configured to wirelessly communicate acquired ultrasound images and acquired biosignals to a user device.

[0110] According to one or more embodiments, an ultrasound imaging and biomarker monitoring system includes a wearable wireless medical device comprising an ultrasound transducer for acquiring ultrasound images and a biosignal sensor for acquiring biosignals, configured to simultaneously acquire ultrasound images and biosignals from a target site of a subject wearing the wireless medical device while the subject is performing an activity; an analysis platform configured to extract image biomarkers from the acquired ultrasound images and acquired biosignals; and a user device configured to display the acquired ultrasound images and acquired biosignals and to display the extracted image biomarkers while the subject is performing an activity. In some embodiments, the ultrasound transducer is rotatable, and the ultrasound transducer acquires images in a longitudinal cross-section at least a first rotation angle and images in a transverse cross-section at a second rotation angle. In some embodiments of the disclosed subject matter, the wearable wireless medical device further includes a motor configured to automatically rotate the ultrasound transducer. According to some embodiments, a wearable wireless medical device further includes an indicator configured to provide a first indication when an ultrasonic transducer is rotated to a first rotation angle, and a second indication when the ultrasonic transducer is rotated to a second rotation angle, wherein the second indication is distinct from the first indication. In some embodiments, an ultrasound imaging and biomarker monitoring system further includes an indicator light for providing the first and second indications as visual indicators.According to some embodiments, a wearable wireless medical device further includes a rotary coupling component comprising a plurality of conductive tracks, an electrode patch comprising an electrode array configured for attachment to the rotary coupling component, wherein when the electrode patch is attached, the electrodes of the electrode array are electrically coupled to the corresponding tracks of the conductive tracks, and an ultrasonic transducer housing comprising a set of conductive contacts configured for attachment to the rotary coupling component opposite to the electrode patch, wherein when the ultrasonic transducer housing is attached, the set of conductive contacts engages with the corresponding tracks of the plurality of conductive tracks, and the ultrasonic transducer housing is further configured to rotate around the rotary coupling component while the plurality of conductive contacts remain engaged with the corresponding tracks during rotation of the ultrasonic transducer housing. In some embodiments of the disclosed subject matter, an analysis platform is further configured to process and quantify acquired ultrasound images and physiological and motion parameters using a convolutional neural network and developed algorithms to extract biomarkers.

[0111] According to one or more embodiments, a method of using a wearable wireless medical device includes: positioning the wearable wireless medical device on a target site on a subject's body; acquiring an ultrasound image of the target site and biosignals of the target site via the wireless medical device while the subject is performing an activity; extracting biomarkers by processing and quantifying the acquired ultrasound image and biosignals; and simultaneously displaying the ultrasound image, biosignals, and biomarkers of the target site on a user device. In some embodiments, positioning the wearable wireless medical device on a target site includes: mounting a scanning and monitoring module to a rotary coupling component, wherein the scanning and monitoring module rotates around the rotary coupling component, and the conductive contacts of the scanning and monitoring module are physically engaged with and electrically coupled to conductive tracks of the rotary coupling component; and mounting an electrode patch to the rotary coupling component on the opposite side of the scanning and monitoring module, wherein the electrode array of the electrode patch is electrically coupled to external contacts of the rotary coupling component, and the external contacts are electrically coupled to conductive tracks through the rotary coupling component. According to some embodiments, the method further includes rotating a scanning and monitoring module to acquire an ultrasound image in a longitudinal cross-section at a first rotation angle and an ultrasound image in a transverse cross-section at a second rotation angle. In one or more embodiments, extracting image biomarkers by processing and quantifying the acquired ultrasound images and biosignals further includes extracting biomarkers using a convolutional neural network and a developed algorithm. In some aspects of the disclosed subject matter, the wearable wireless medical device further includes a motor, and rotating the scanning and monitoring module further includes using the motor to automatically rotate the ultrasound transducer. According to embodiments, the wearable wireless medical device further includes a wireless transceiver, and the method further includes using the wireless transceiver to wirelessly communicate the acquired ultrasound images and acquired biosignals to a user device.

[0112] While embodiments of the disclosed subject matter have been described herein, it will be apparent to those skilled in the art that these are merely illustrative, not limiting, and are presented only as examples. Therefore, while certain configurations are discussed herein, other configurations may also be used. Numerous modifications and other embodiments (e.g., combinations, rearrangements, etc.) are possible by this disclosure, are within the scope of those skilled in the art, and are considered to fall within the scope of the disclosed subject matter and any equivalents thereto. The mechanisms of the disclosed embodiments can be combined, rearranged, omitted, etc., within the scope of the invention to generate additional embodiments. Furthermore, certain mechanisms may be used advantageously without corresponding uses of other mechanisms. Accordingly, the applicant intends to encompass all such alternatives, modifications, equivalents, and variations that fall within the spirit and scope of the disclosed subject matter.

Claims

1. A wearable medical device that can be placed on a target area of ​​a subject's body, a) A rotary coupling component having multiple conductive tracks, b) An electrode patch comprising an electrode array, configured for attachment to the rotating coupling component, wherein when the electrode patch is attached, the electrodes of the electrode array are electrically connected to the corresponding tracks of the conductive track, c) A scanning and monitoring module comprising a set of conductive contacts, configured for attachment to the rotating coupling component opposite to the electrode patch, wherein when the scanning and monitoring module is attached, the set of conductive contacts engages with the corresponding tracks of the plurality of conductive tracks, and the scanning and monitoring module Equipped with, A wearable medical device wherein the scanning and monitoring module is further configured to rotate around the rotating coupling component while the scanning and monitoring module rotates, the plurality of conductive contacts remain engaged with the corresponding tracks.

2. A wearable medical device that can be placed on a target area of ​​a subject's body, a) A rotary coupling component configured for attachment to an electrode patch, comprising an electrode array, the electrode array comprising a plurality of conductive tracks configured for attachment to the rotary coupling component, the electrode patch configured for attachment to the rotary coupling component, and when the electrode patch is attached, the conductive tracks of the electrode array are electrically coupled to the rotary coupling component, b) A scanning and monitoring module comprising a set of conductive contacts, configured for attachment to the rotating coupling component on the opposite side of the electrode patch, and Equipped with, When the scanning and monitoring module is installed, the set of conductive contacts engages with the corresponding tracks of the plurality of conductive tracks. A wearable medical device wherein the scanning and monitoring module is further configured to rotate around the rotating coupling component while the scanning and monitoring module rotates, the plurality of conductive contacts remain engaged with the corresponding tracks.

3. The scanning and monitoring module is An ultrasound transducer configured to acquire an ultrasound image of the target area, A biosignal sensor configured to acquire biosignals from the target site from the electrode array, A printed circuit board electrically connected to the ultrasonic transducer and the biosignal sensor. The wearable medical device according to claim 1 or 2, further comprising the printed circuit board having a circuit, which is configured to simultaneously acquire the ultrasound image and acquire the biosignal.

4. The wearable medical device according to any one of claims 1 to 3, wherein the conductive contact is a pogo pin.

5. The wearable medical device according to any one of claims 1 to 4, wherein the ultrasonic transducer acquires an image in a longitudinal cross-section when the scanning and monitoring module is rotated to a first rotation angle, and acquires an image in a transverse cross-section when the scanning and monitoring module is rotated to a second rotation angle.

6. The wearable medical device according to any one of claims 1 to 5, wherein the scanning and monitoring module is manually rotated.

7. The wearable medical device according to any one of claims 1 to 5, further comprising a motor electrically connected to the printed circuit board, wherein the motor is configured to automatically rotate the scanning and monitoring module.

8. The wearable medical device according to any one of claims 1 to 7, further comprising a wireless transceiver electrically connected to the printed circuit board and configured to wirelessly communicate the acquired ultrasound image and the acquired biosignals to a user device.

9. An ultrasound imaging and biomarker monitoring system, a) A wearable wireless medical device comprising an ultrasound transducer for acquiring ultrasound images and a biosignal sensor for acquiring biosignals, wherein the wireless medical device is configured to simultaneously acquire ultrasound images and biosignals from a target area of ​​the subject wearing the wireless medical device while the subject is performing an activity. b) An analytical platform configured to extract biomarkers from the acquired ultrasound images and acquired biological signals, c) A user device configured to display the extracted biomarkers after or while the subject has performed the activity, and / or to display the acquired ultrasound images and biosignals after or while the subject has performed the activity. An ultrasound imaging and biomarker monitoring system equipped with these features.

10. The ultrasonic imaging and biomarker monitoring system according to claim 9, wherein the ultrasonic transducer is rotatable, and the ultrasonic transducer acquires an image in a longitudinal cross-section at a first rotation angle and an image in a transverse cross-section at a second rotation angle.

11. The ultrasonic imaging and biomarker monitoring system according to claim 9 or 10, further comprising a motor configured to automatically rotate the ultrasonic transducer, the wearable wireless medical device.

12. The wearable wireless medical device further comprises an indicator configured to provide a first indication when the ultrasonic transducer is rotated to a first rotation angle, and a second indication when the ultrasonic transducer is rotated to a second rotation angle, wherein the second indication is different from the first indication, according to any one of claims 9 to 11.

13. The ultrasound imaging and biomarker monitoring system according to any one of claims 9 to 12, further comprising an indicator light for providing the first indication and the second indication as visual indicators.

14. The aforementioned wearable wireless medical device is A rotating coupling component having multiple conductive tracks, An electrode patch comprising an electrode array, configured for attachment to the rotating coupling component, wherein when the electrode patch is attached, the electrodes of the electrode array are electrically connected to the corresponding tracks of the conductive track, or the electrode array and the conductive track may be an integrated unit configured on a single substrate, and A scanning and monitoring module / device housing comprising a set of conductive contacts, wherein the ultrasonic transducer housing is configured for attachment to the rotating coupling component on the opposite side of the electrode patch, and Furthermore, When the ultrasonic transducer housing is installed, the set of conductive contacts engages with the corresponding tracks of the plurality of conductive tracks. The ultrasonic imaging and biomarker monitoring system according to any one of claims 9 to 13, wherein the ultrasonic transducer housing is further configured to rotate around the rotating coupling component while the plurality of conductive contacts remain engaged with the corresponding tracks during rotation of the ultrasonic transducer housing.

15. The ultrasound imaging and biomarker monitoring system according to any one of claims 9 to 14, wherein the analysis platform is further configured to process and quantify the acquired ultrasound images and the physiological and motion parameters using a convolutional neural network and a developed algorithm to extract the biomarkers.

16. A method of using a wearable wireless medical device, The wearable wireless medical device is placed on a target area of ​​the subject's body, While the subject is performing the activity, an ultrasound image of the target area is acquired and biosignals of the target area are acquired via the wireless medical device. The acquired ultrasound images and biosignals are processed and quantified to extract biomarkers, and / or the ultrasound images, biosignals, and biomarkers of the target site are simultaneously displayed on the user device. Methods that include...

17. Placing the wearable wireless medical device on the target site is Mounting a scanning and monitoring module to a rotating coupling component, wherein the scanning and monitoring module rotates around the rotating coupling component, and the conductive contacts of the scanning and monitoring module are physically engaged with and electrically coupled to the conductive tracks of the rotating coupling component. Attaching an electrode patch to the rotary coupling component on the opposite side of the scanning and monitoring module, wherein the electrode array of the electrode patch is electrically connected to the external contacts of the rotary coupling component, or is an extension of the electrode patch itself, and the external contacts are electrically connected to the conductive track through the rotary coupling component; The method according to claim 16, including the method described in claim 16.

18. The method according to claim 16 or 17, further comprising rotating the scanning and monitoring module to acquire an ultrasonic image in a longitudinal cross-section at a first rotation angle and an ultrasonic image in a transverse cross-section at a second rotation angle.

19. The method according to any one of claims 16 to 18, further comprising extracting the biomarker by processing and quantifying the acquired ultrasound images and the biological signals using a convolutional neural network and a developed algorithm.

20. The method according to any one of claims 16 to 19, wherein the wearable wireless medical device further comprises a motor, and the rotation of the scanning and monitoring module further comprises using the motor to automatically rotate the ultrasonic transducer.

21. The method according to any one of claims 16 to 20, wherein the wearable wireless medical device further comprises a wireless transceiver.

22. The method according to claim 21, further comprising wirelessly communicating the acquired ultrasound image and the acquired biosignals to the user device using the wireless transceiver.

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