A split-type vascular ultrasound monitoring device and control method

Abstract

This application discloses a split-type vascular ultrasound monitoring device and control method, relating to the field of medical device technology. Specifically, this application includes a flexible patch and a transmitter that are independent and detachably connected. The flexible patch includes a flexible substrate, an ultrasound transducer array and an identification unit disposed on the substrate, and a first interface. The transmitter, serving as a multiplexing terminal, includes a second interface detachably electrically connected to the first interface, an ultrasound drive unit, and a control unit. The control unit reads and verifies the identification information of the identification unit through the interface, and after successful verification, controls the ultrasound drive unit to drive the transducers. This application, through the split-type design of the flexible patch and transmitter, effectively solves the problems of poor adhesion and low comfort caused by the bulky structure of existing ultrasound monitoring devices, while also reducing the design cost of the flexible patch and avoiding cross-infection problems caused by repeated use.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a split-type vascular ultrasound monitoring device and control method. Background Technology

[0002] Currently, wearable patches are mainly used for continuous, real-time monitoring of deep vein thrombosis in the limbs. By attaching the acquisition device to the area along the blood vessels on the patient's body surface for an extended period, continuous ultrasound echo signals can be obtained, thereby assisting medical staff in detecting the risk of thrombosis at an early stage and compensating for the monitoring blind spots of traditional single clinical imaging examinations.

[0003] In existing technologies, to achieve continuous monitoring without manual probe handling, a flexible, integrated ultrasonic patch is typically used. This integrates the ultrasonic transducer array, high-voltage drive circuit, signal acquisition and processing unit, wireless communication module, and power supply battery, all within a single flexible or semi-rigid substrate, forming a fully functional independent patch unit. During use, this integrated unit is directly adhered to the patient's skin surface using medical adhesive or coupling agent.

[0004] However, the aforementioned existing technologies have the following drawbacks: First, because electronic components with a certain size and rigidity, such as high-voltage drive circuits, signal processing chips, and batteries, are all integrated inside the patch, the overall thickness of the device is relatively large and its flexibility is limited. When it is attached to curved surfaces with small radii of curvature, such as limbs, it is difficult to maintain a tight fit, and poor contact can easily occur due to the patient's limb movements, seriously affecting the stability of signal acquisition and the patient's wearing comfort. Second, the patch adopts a highly integrated design. If it is used as a disposable consumable, the cost of the patch is too high; if the patch is used as a reusable device, strict and complex cleaning and disinfection are required, which not only increases the number of disinfection and cleaning steps but also makes it difficult to eliminate the risk of cross-infection.

[0005] Therefore, this application aims to solve the problems of poor stability and low comfort of curved surface attachment caused by the heavy structure of existing ultrasonic monitoring devices, while also solving the problems of high patch manufacturing cost and patch cross-infection. Summary of the Invention

[0006] The main objective of this application is to provide a split-type vascular ultrasound monitoring device and control method, which aims to solve the problems of poor stability and low comfort of curved surface attachment caused by the heavy structure of existing ultrasound monitoring devices. At the same time, it can also solve the problems of high cost of patch manufacturing and eliminate the problem of patch cross-infection.

[0007] To achieve the above objectives, this application proposes a split-type vascular ultrasound monitoring device, including a flexible patch and a transmitting host; The flexible patch includes: Flexible substrate; Both the ultrasonic transducer array and the identification unit are mounted on the flexible substrate. The first interface is located at one end of the flexible substrate and is electrically connected to the ultrasonic transducer array and the identification unit. The transmitting host includes: The second interface is detachably electrically connected to the first interface; The ultrasonic drive unit is electrically connected to the second interface; The control unit is electrically connected to the second interface and the ultrasonic drive unit; the control unit is configured to read and verify the identity information of the identity recognition unit through the second interface, and drive the ultrasonic transducer array through the ultrasonic drive unit and the second interface after the verification is successful.

[0008] Furthermore, the flexible substrate has an elongated strip structure; the ultrasonic transducer array includes multiple transducer units arranged linearly along the length of the flexible substrate to form an elongated monitoring area.

[0009] Furthermore, the flexible patch also includes an acoustic impedance matching layer and an acoustic coupling layer sequentially stacked on the ultrasonic transducer array; The acoustic coupling layer is located on the side of the flexible patch facing the organism and is used to establish an acoustic channel during attachment.

[0010] Furthermore, the acoustic coupling layer is made of a solid gel or hydrogel material.

[0011] Furthermore, the transmitter also includes a housing and a wearable component disposed on the housing, the wearable component being used to detachably connect the transmitter to a limb of an organism; the second interface is disposed on the side wall of the housing.

[0012] Furthermore, the ultrasonic driving unit is integrated inside the housing and includes: An excitation circuit, whose input terminal is electrically connected to the control unit, is used to generate pulse signals; A switching switch, the first end of which is electrically connected to the output end of the excitation circuit and the second end of which is electrically connected to the second interface, is used to transmit the pulse signal to the ultrasonic transducer array through the second interface; An analog front-end circuit, whose input terminal is electrically connected to the third terminal of the switching switch, is used to amplify and filter the echo signal from the second interface; and An analog-to-digital converter circuit, with its first terminal electrically connected to the output terminal of the analog front-end circuit and its second terminal electrically connected to the control unit, is used to convert the amplified and filtered echo signal into a digital signal and send it to the control unit.

[0013] Furthermore, the ultrasonic transducer array is any one of a piezoelectric ceramic array, a piezoelectric thin film array, a piezoelectric composite material array, a capacitive micromechanical ultrasonic transducer array, or a piezoelectric micromechanical ultrasonic transducer array.

[0014] Furthermore, the transmitting host also includes a wireless communication module, which is electrically connected to the control unit and is used to transmit the processed echo signal to an external terminal.

[0015] This application also discloses a control method based on the above-mentioned split-type vascular ultrasound monitoring device, including: The control unit reads the identity information in the identity recognition unit when the first interface and the second interface are connected. Determine whether the identity information is marked as available; If the identity information is available, the control unit outputs a drive signal to the ultrasonic transducer array through the ultrasonic drive unit and the second interface to excite the ultrasonic transducer array to work. If the identity information is unavailable, the control unit keeps the ultrasonic drive unit in a locked state.

[0016] Furthermore, after stimulating the ultrasonic transducer array to work, the method also includes determining whether the monitoring duration or number of uses of the identification unit has reached a preset threshold. When the control unit determines that the monitoring duration or the number of uses has reached the preset threshold, it updates the identity information of the identity recognition unit to an unavailable state through the second interface.

[0017] The above technical solution has the following advantages: This application employs a flexible patch and a separate transmitter unit, separating the high-value, high-rigidity transmitter unit from the low-cost, flexible patch. The flexible patch is designed as a disposable consumable containing an ultrasonic transducer array and an identification unit. Simultaneously, a control unit reads the identification information for verification and drive control. This allows the flexible patch to be extremely thin and low-cost, effectively solving the problem of poor comfort when applying it to curved surfaces caused by the bulky structure of existing integrated patches. Furthermore, the identification information enforces single-use, reducing overall consumable costs and eliminating the risk of cross-infection from reuse.

[0018] This application designs a flexible substrate as a long strip structure and combines it with an array of ultrasound transducers arranged linearly along the length direction to form a narrow monitoring area that adapts to the anatomical direction of veins in the limbs, compensating for minor deviations in the attachment position. Combined with a pre-coated solid gel or hydrogel acoustic coupling layer, it not only eliminates the tedious clinical steps of applying coupling agent, but also ensures the stability of the acoustic channel during long-term attachment, avoiding signal interruption caused by the drying or flowing of liquid coupling agent.

[0019] By writing a failure flag to the identification unit when the monitoring task ends or a preset threshold is reached, the used flexible patch can be locked to prevent it from being illegally reused, thus further ensuring the accuracy of monitoring data and medical safety. Attached Figure Description

[0020] The present application will now be described in detail with reference to specific embodiments and accompanying drawings, wherein: Figure 1 This is a structural diagram illustrating the usage state of this application; Figure 2 This is a structural diagram of the flexible patch in this application; Figure 3 This is a structural diagram of the ultrasonic transducer array of this application; Figure 4 This is an exploded view of the flexible patch of this application; Figure 5 This is a block diagram of the electrical connections of the flexible patch in this application; Figure 6 This is a schematic diagram of the structure of the transmitter host of this application; Figure 7 This is an electrical connection block diagram of the transmitter host of this application; Figure 8 This is a logic block diagram of the control method of this application.

[0021] In the diagram: 100, patch body; 101, transmitter host; 1011, outer shell; 1012, wearing component; 1013, control unit; 1014, ultrasonic drive unit; 10141, excitation circuit; 10142, switching switch; 10143, analog front-end circuit; 10144, analog-to-digital conversion circuit; 1015, second interface; 1016, wireless communication unit; 102, flexible patch; 1021, flexible substrate; 1022, ultrasonic transducer array; 10221, transducer unit; 1023, identification unit; 1024, acoustic impedance matching layer; 1025, acoustic coupling layer; 1026, contact layer; 1027, first interface. Detailed Implementation

[0022] To make the objectives, technical solutions, and advantages of this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and embodiments. It should be understood that the following specific embodiments are merely illustrative of this application and do not constitute a limitation thereof.

[0023] In existing technologies, vascular ultrasound monitoring typically employs integrated, encapsulated patches that incorporate high-voltage drive circuitry, signal processing units, batteries, and transducers. This presents two main technical challenges: First, the integrated patch is thick and rigid, usually exceeding 5mm. When applied to areas with small radii of curvature, such as the posterior calf or forearm, it cannot adhere tightly to the skin, leading to signal loss or interference even with slight patient movement. Second, the integrated patch design results in high manufacturing costs, making it unsuitable for single-use applications. Reuse, on the other hand, involves complex disinfection procedures and the unavoidable risk of nosocomial cross-infection.

[0024] To address the aforementioned issues, this application proposes a split architecture. The core concept lies in separating and electrically decoupling high-cost, high-rigidity, and reusable functional units from low-value, flexible functional units. By embedding an identification unit at the flexible patch end, coupled with the host's logical verification, one-time management of consumables is enforced, thereby solving the problem of cross-infection control while ensuring low cost and high comfort.

[0025] like Figure 1 , Figure 2 , Figure 5 as well as Figure 6 As shown, a split-type vascular ultrasound monitoring device is a single patch body 100, which includes a flexible patch 102 and a transmitter host 101. The flexible patch 102 includes a flexible substrate 1021, an ultrasound transducer array 1022, an identification unit 1023, and a first interface 1027. The ultrasound transducer array 1022 and the identification unit 1023 are both disposed on the flexible substrate 1021. The first interface 1027 is disposed at one end of the flexible substrate 1021 and is electrically connected to the ultrasound transducer array 1022 and the identification unit 1023. The transmitting host 101 includes a second interface 1015, an ultrasonic driving unit 1014, and a control unit 1013. The second interface 1015 is detachably electrically connected to the first interface 1027. The ultrasonic driving unit 1014 is electrically connected to the second interface 1015. The control unit 1013 is electrically connected to the second interface 1015 and the ultrasonic driving unit 1014. The control unit 1013 is configured to read and verify the identity information of the identity recognition unit 1023 through the second interface 1015, and drive the ultrasonic transducer array 1022 through the ultrasonic driving unit 1014 and the second interface 1015 after the verification is successful.

[0026] In this embodiment, the traditional ultrasonic monitoring patch is decoupled into two independent entities: the flexible patch 102 used as a disposable consumable and the transmitter host 101 used as a reusable device.

[0027] The flexible patch 102 includes a flexible substrate 1021, which serves as a carrier supporting the ultrasonic transducer array 1022 and the identification unit 1023. A first interface 1027 extends from or is provided at one end of the flexible substrate 1021. The signal lines of the ultrasonic transducer array 1022 and the data lines of the identification unit 1023 converge at the first interface 1027, making the first interface 1027 the sole port for electrical interaction between the flexible patch 102 and the outside world. Preferably, the flexible substrate 1021 is made of a biocompatible polymer film material, such as polyimide or thermoplastic polyurethane, with a thickness preferably between 0.1 mm and 0.3 mm to ensure skin adhesion. The identification unit 1023 can be a memory chip with a unique serial number (such as Electrically Erasable Programmable Read-Only Memory, EEPROM) or an encryption authentication chip. The first interface 1027 preferably uses an FPC gold finger.

[0028] The transmitter host 101 is provided with a second interface 1015 that is detachably electrically connected to the first interface 1027. The detachable electrical connection between the first interface 1027 and the second interface 1015 means that the user can establish or disconnect the electrical connection by means of plugging, magnetic attraction, or pressing. The transmitter host 101 integrates an ultrasonic drive unit 1014 and a control unit 1013. The ultrasonic drive unit 1014 is responsible for generating pulse signals to drive the ultrasonic transducer array 1022, and the control unit 1013 is responsible for logic control. It can be a microcontroller unit (MCU) or a field programmable gate array (FPGA). After the control unit 1013 is connected to the flexible patch 102 through the second interface 1015, it first reads the identity information of the identification unit 1023. Only when the verification is successful, for example, if the status bit shows that it is not used and the identity information conforms to the manufacturer's coding rules, will the control unit 1013 enable the ultrasonic drive unit 1014 to send an excitation signal to the ultrasonic transducer array 1022.

[0029] During operation, after the first interface 1027 is connected to the second interface 1015, the control unit 1013 communicates with the identification unit 1023 through the second interface 1015 to read the identification information of the identification unit 1023, such as the unique serial number, production batch, expiration date, or usage status flag. The control unit 1013 verifies the identification information. Only when the verification is successful can the control unit 1013 activate the ultrasonic drive unit 1014, causing the ultrasonic drive unit 1014 to send an excitation signal to the ultrasonic transducer array 1022 through the second interface 1015 and the first interface 1027 to start monitoring. If the verification fails, such as when the flexible patch 102 is identified as used, illegal, or expired, the control unit 1013 will not activate the ultrasonic drive unit 1014, thereby enforcing the usage specifications of disposable consumables and effectively preventing cross-contamination when the flexible patch 102 is reused.

[0030] In this embodiment, the flexible patch 102 and the transmitting host 101 are separated. The flexible patch 102 is a disposable consumable. Its internal flexible substrate 1021, ultrasonic transducer array 1022 and identification unit 1023 are inexpensive to manufacture. As for the transmitting host 101, its internal control unit 1013 and ultrasonic drive unit 1014 are reused due to their high cost, which significantly reduces the cost of consumables per use. At the same time, by verifying the identity information of the identification unit 1023 through the control unit 1013, the disposable use of the flexible patch 102 is enforced, eliminating the risk of cross-infection caused by the reuse of medical devices and solving the problem of high cost and difficulty in control of integrated patches in the prior art.

[0031] like Figure 2 and Figure 3 As shown, the flexible substrate 1021 has a long strip-shaped structure; the ultrasonic transducer array 1022 includes multiple transducer units 10221 arranged linearly along the length direction of the flexible substrate 1021 to form a long strip-shaped monitoring area. Figure 3 The arrows indicate the approximate distribution direction of the blood vessels.

[0032] In this embodiment, considering that the projection of deep veins in the limbs is usually elongated, the flexible substrate 1021 is designed as an elongated strip structure, such as a rectangular or rounded rectangular strip with an aspect ratio greater than 3:1.

[0033] The ultrasound transducer array 1022 consists of multiple independent transducer units 10221. These transducer units 10221 are arranged in one or more rows, such as a linear arrangement, along the length of the flexible substrate 1021. This arrangement allows multiple independent transducer units 10221 to cover a relatively long vascular region when the flexible patch 102 is attached along the limb axis. The resulting elongated monitoring area closely matches the anatomical orientation of the limb's blood vessels. Compared to point probes, the elongated monitoring area can resolve some deviations in the attachment position. Even with minor limb movements, the blood vessels remain within the monitoring area, ensuring the continuity and stability of signal acquisition.

[0034] The flexible patch 102 also includes an acoustic impedance matching layer 1024 and an acoustic coupling layer 1025 stacked sequentially on the ultrasonic transducer array 1022; the acoustic coupling layer 1025 is located on the side of the flexible patch 102 facing the organism and is used to establish an acoustic channel during attachment.

[0035] like Figure 2 and Figure 4 As shown, to ensure that ultrasound waves can be efficiently transmitted to the human body, the flexible patch 102 adopts a multi-layer composite structure. An acoustic impedance matching layer 1024 is provided on the side of the ultrasound transducer array 1022 facing the skin. That is, the acoustic impedance matching layer 1024 is provided on the side of multiple transducer units 10221 facing the skin, or it can cover the periphery of the transducer units 10221. The acoustic impedance matching layer 1024 is usually made of epoxy resin doped with metal powder or other materials with acoustic impedance between the transducer unit 10221 material and human tissue, to reduce the reflection of sound waves at the interface.

[0036] The acoustic coupling layer 1025 is a tiny gap filled between the flexible patch 102 and the skin, that is, between the acoustic impedance matching layer 1024 and the skin, which eliminates air and establishes an acoustic channel for sound wave transmission. The acoustic coupling layer 1025 is made of solid gel or hydrogel material.

[0037] Specifically, the acoustic coupling layer 1025 is made of solid gel or cross-linked hydrogel material, which has both good acoustic transmission performance and a certain degree of viscosity and elasticity. Compared with traditional liquid coupling agents, solid gel does not flow, evaporate, or dry out, and can maintain stable acoustic contact for a long time, making it very suitable for long-term continuous monitoring scenarios. At the same time, the solid gel itself has pressure-sensitive adhesive, which can help the flexible patch 102 to be fixed to the skin surface, reducing the reliance on additional adhesive tape.

[0038] like Figure 2 and Figure 4As shown, further, this application may also provide a contact layer 1026 on the skin-facing side of the acoustic coupling layer 1025. The contact layer 1026 is used for direct contact with the skin. The contact layer 1026 is preferably made of a soft, skin-friendly material and coated with a tear-off pressure-sensitive adhesive tape for easy one-time adhesion and single-use. When the flexible patch 102 is needed, the acoustic coupling layer 1025 can be attached to the skin simply by tearing off the contact layer 1026. The skin-friendly material of the contact layer 1026 also improves the comfort of using the flexible patch 102. Preferably, the acoustic coupling layer 1025 is located in the middle of the contact layer 1026, and the skin-facing sides of the acoustic coupling layer 1025 and the contact layer 1026 are flush and both have adhesive properties, making it easy to directly adhere to the skin.

[0039] like Figure 1 and Figure 6 As shown, the transmitter 101 also includes a housing 1011 and a wearing member 1012 disposed on the housing 1011. The wearing member 1012 is used to detachably connect the transmitter 101 to the limb of an organism. The second interface 1015 is disposed on the side wall of the housing 1011.

[0040] The transmitter 101 has a rigid or semi-rigid housing 1011 to protect the internal circuitry. For easy carrying by the patient, a wearing component 1012, such as an elastic wristband, Velcro strap, medical silicone band, or Velcro, is attached to the housing 1011. In use, the transmitter 101 can be secured to a non-monitoring area such as the patient's wrist, ankle, or calf, like a watch, avoiding pressure on the monitored blood vessels.

[0041] The second interface 1015 is located on the side wall of the outer casing 1011. The second interface 1015 is positioned on the side wall to facilitate cable routing along the limb and reduce cable bending stress. In this embodiment, the transmitter 101, which has a certain weight and volume, is spatially separated from the thin, flexible patch 102 for wearing. This avoids the weight of the transmitter 101 directly compressing the blood vessels in the monitoring area, preventing venous deformation due to external pressure and thus affecting the accuracy of measurement data. It also improves the patient's comfort and freedom of movement.

[0042] like Figure 6 and Figure 7As shown, the ultrasonic drive unit 1014 is integrated inside the housing 1011. It includes an excitation circuit 10141, a switching switch 10142, an analog front-end circuit 10143, and an analog-to-digital converter circuit 10144. The input terminal of the excitation circuit 10141 is electrically connected to the control unit 1013 to generate a pulse signal. The first terminal of the switching switch 10142 is electrically connected to the output terminal of the excitation circuit 10141, and the second terminal is electrically connected to the second interface 1015 to transmit the pulse signal to the ultrasonic transducer array 1022 through the second interface 1015. The input terminal of the analog front-end circuit 10143 is electrically connected to the third terminal of the switching switch 10142 to amplify and filter the echo signal from the second interface 1015. The first terminal of the analog-to-digital converter circuit 10144 is electrically connected to the output terminal of the analog front-end circuit 10143, and the second terminal is electrically connected to the control unit 1013 to convert the amplified and filtered echo signal into a digital signal and send it to the control unit 1013.

[0043] This embodiment details the circuit topology of the ultrasonic drive unit 1014 inside the transmitter host 101. This is also the main factor contributing to the high-cost reusability of the transmitter host 101 in the split design. Specifically: The excitation circuit 10141 includes a DC-DC boost module and a pulse generator. Under the timing control of the control unit 1013, the DC-DC boost module boosts the low-voltage power supply and modulates it through the pulse generator into a high-voltage pulse required to generate the ultrasonic transducer array 1022, such as boosting a 3.7V battery and modulating it into a square wave or sine wave of ±30V to ±100V.

[0044] The switching switch 10142 is a critical protection device used to isolate the high-voltage transmitting circuit from the low-voltage receiving circuit, protecting sensitive downstream circuitry. The switching switch 10142 can be a power device or a switching chip, such as a metal-oxide-semiconductor field-effect transistor (MOSFET) or an analog switching chip 74HC4052. During the transmitting phase, the switching switch 10142 turns on both the first and second terminals, sending the high-voltage pulse to the second interface 1015 to drive the ultrasonic transducer array 1022; simultaneously, it turns off the third terminal to prevent high voltage damage to the downstream low-voltage receiving circuit. During the receiving phase, the switching switch 10142 turns on both the second and third terminals. At this time, the weak echo signal received by the ultrasonic transducer array 1022 enters the analog front-end circuit 10143 through the second interface 1015. The analog front-end circuit 10143 includes a low-noise amplifier (LNA), a variable-gain amplifier (VGA), and a bandpass filter, which are responsible for low-noise amplification and filtering of the signal.

[0045] The conditioned analog echo signal enters the analog-to-digital converter (ADC) circuit 10144, which converts the analog echo signal into a digital echo signal and transmits it to the control unit 1013 for digital echo signal synthesis or feature extraction. The entire circuit architecture integrates the complex signal chain onto the reusable transmitter host 101, allowing the flexible patch 102 to retain only the passive ultrasonic transducer array 1022, greatly reducing consumable costs while retaining the ability to capture minute blood flow signals.

[0046] like Figures 2 to 5 As shown, the ultrasonic transducer array 1022 is any one of a piezoelectric ceramic array, a piezoelectric thin film array, a piezoelectric composite material array, a capacitive micromechanical ultrasonic transducer array 1022, or a piezoelectric micromechanical ultrasonic transducer array 1022.

[0047] To accommodate the bending characteristics of the flexible substrate 1021, the ultrasonic transducer array 1022 preferably uses a piezoelectric micromechanical ultrasonic transducer or a capacitive micromechanical ultrasonic transducer manufactured using microelectromechanical systems (MEMS) technology. This ensures that the prepared chip thickness meets the required specifications. The flexible packaging process can achieve good bending performance and facilitates mass production to reduce costs. In addition, depending on whether the vein is deep or superficial, the most suitable acoustic sensor solution can be flexibly selected based on the specific application scenario and cost budget, thus improving the universality and scalability of the technical solution.

[0048] As an alternative, a piezoelectric composite material array can be used. This involves cutting piezoelectric ceramic pillars and filling them with flexible polymers to give them a certain degree of flexibility, making them suitable for attachment to limbs with small curvatures.

[0049] like Figure 7 As shown, the transmitter host 101 also includes a wireless communication module, which is connected to the control unit 1013 and is used to transmit the processed ultrasonic echo data to an external terminal.

[0050] To enable unrestricted remote monitoring, the transmitter 101 also integrates a wireless communication module, such as a Bluetooth Low Energy (BLE) module, a Wi-Fi module, or a ZigBee chip. The control unit 1013 packages the acquired ultrasound data and sends it via the wireless communication module to the monitoring host at the nurse station, the doctor's handheld tablet, or a cloud server. This allows medical staff to monitor the patient's venous blood flow in real time without frequent bedside visits. The ultrasound data can be raw radio frequency data or characteristic data such as blood flow velocity and vessel diameter extracted from digital echo signals.

[0051] In addition, the transmitter host 101 also includes a battery and a battery management module. The battery management module is electrically connected to the battery to facilitate real-time monitoring of the battery's power consumption and charging status. It collects data through voltage, current, and temperature sensors and also has an internal protection mechanism to prevent abnormal conditions such as overcharging and over-discharging. The battery is preferably a rechargeable battery, which can be charged through interfaces such as Universal Serial Bus (USB) and Type-C when used repeatedly. The battery also mainly provides power to the control unit 1013, the ultrasonic drive unit 1014, and the wireless communication unit 1016.

[0052] like Figure 8 As shown, this application also discloses a control method for a split-type vascular ultrasound monitoring device, comprising: When the first interface 1027 and the second interface 1015 are connected, the control unit 1013 reads the identity information in the identity recognition unit 1023; Determine whether the identity information is marked as available; If the identity information is available, the control unit 1013 outputs a drive signal to the ultrasonic transducer array 1022 through the ultrasonic drive unit 1014 and the second interface 1015 to excite the ultrasonic transducer array 1022 to work. If the identity information is unavailable, the control unit 1013 keeps the ultrasonic drive unit 1014 in a locked state.

[0053] This embodiment relates to a control logic that works in conjunction with the aforementioned device. Specifically, the control unit 1013 of the transmitting host 101 can detect level changes of a specific pin on the second interface 1015 or periodically poll the identification bus. Once a connection is detected between the first interface 1027 and the second interface 1015, the control unit 1013 immediately initiates a reading program to read identity information from the identification unit 1023 through the first interface 1027 and the second interface 1015. A serial communication protocol, such as I2C (Inter-Integrated Circuit), Serial Peripheral Interface, or I-Wire, can be used between the first interface 1027 and the second interface 1015.

[0054] The identification information includes a specific status bit, which the control unit 1013 parses. If the status bit indication is available, the excitation circuit 10141 is enabled, allowing it to drive the ultrasonic transducer array 1022 via the switch 10142, the second interface 1015, and the first interface 1027, thus initiating the normal ultrasonic monitoring process. If the status bit indication is unavailable, for example, if the flexible patch 102 has been marked as faulty by a previous monitoring task, the control unit 1013 will not enable the excitation circuit 10141, keeping the ultrasonic drive unit 1014 in a closed or locked state. A prompt to replace consumables can be issued via an indicator light or buzzer on the transmitter host 101, thereby preventing the use of faulty flexible patches 102 or illegal reuse of patches. This ensures that only legitimate and brand-new patches can be driven by the transmitter host 101, preventing the reuse of contaminated flexible patches 102 due to human error or improper operation, and guaranteeing medical safety.

[0055] After the ultrasonic transducer array 1022 is activated, the control unit 1013 also determines whether the monitoring duration or number of uses of the identification unit 1023 has reached a preset threshold. When the control unit 1013 determines that the monitoring duration or number of uses has reached the preset threshold, it updates the identification information of the identification unit 1023 to an unavailable state through the second interface 1015.

[0056] To improve the full lifecycle management of consumables, during the monitoring process, the timer or counter inside the control unit 1013 records the current usage status of the flexible patch 102 in real time. For example, the system is set to allow a maximum of 24 hours for a single monitoring session. When the cumulative monitoring time reaches 24 hours, the number of uses reaches the requirements set by the manufacturer, or when a complete monitoring task is manually ended, it indicates that the flexible patch 102 has reached the preset threshold. The control unit 1013 will then send a command to the identification unit 1023 via the second interface 1015.

[0057] The write command modifies the status bit in the internal memory of the identification unit 1023 to unavailable. Since the identification unit 1023 typically uses EEPROM, once the status is rewritten, it will be identified as invalid during the initialization verification phase when it is inserted into any transmitting host 101 again. This completely realizes the resealable connection, and the identification information is identified as unavailable, preventing the possibility of illegal reuse through simple cleaning methods and strictly ensuring compliance with single-use requirements.

[0058] In the above embodiments, the first interface 1027 and the second interface 1015 adopt magnetic contact connectors. The first interface 1027 is composed of a gold-plated contact plate exposed at the end of a flexible circuit board, and the second interface 1015 is composed of an elastic pin on the transmitter host 101. Both are surrounded by magnets that attract each other. In addition to realizing a detachable electrical connection, it also has the advantages of automatic alignment and easy cleaning, making it particularly suitable for rapid clinical operation.

[0059] The technical solution of this application can be used not only for monitoring deep vein thrombosis in the lower extremities, but also extended to vascular scenarios such as catheter-related thrombosis in the upper extremities. By reasonably selecting the attachment position and array direction, the acquisition of corresponding vascular ultrasound signals can be achieved. Any substitutions or adjustments made by those skilled in the art to materials, dimensions, wiring methods, etc., without altering the core concept of this application, are all feasible implementations of this application.

[0060] The above description is merely a preferred embodiment of this application and does not limit the patent scope of this application. Any equivalent structural transformations made based on the content of this application's specification and drawings under the concept of this application, or direct / indirect applications in other related technical fields, are included within the patent protection scope of this application.

Claims

1. A split-type vascular ultrasound monitoring device, characterized in that, Includes flexible patches and the main unit of the transmitter; The flexible patch includes: Flexible substrate; Both the ultrasonic transducer array and the identification unit are mounted on the flexible substrate. The first interface is located at one end of the flexible substrate and is electrically connected to the ultrasonic transducer array and the identification unit. The transmitting host includes: The second interface is detachably electrically connected to the first interface; The ultrasonic drive unit is electrically connected to the second interface; The control unit is electrically connected to the second interface and the ultrasonic drive unit; the control unit is configured to read and verify the identity information of the identity recognition unit through the second interface, and drive the ultrasonic transducer array through the ultrasonic drive unit and the second interface after the verification is successful.

2. The split-type vascular ultrasound monitoring device as described in claim 1, characterized in that, The flexible substrate has a long strip-shaped structure; the ultrasonic transducer array includes multiple transducer units arranged linearly along the length of the flexible substrate to form a long strip-shaped monitoring area.

3. The split-type vascular ultrasound monitoring device as described in claim 1, characterized in that, The flexible patch further includes an acoustic impedance matching layer and an acoustic coupling layer that are sequentially stacked on the ultrasonic transducer array; The acoustic coupling layer is located on the side of the flexible patch facing the organism and is used to establish an acoustic channel during attachment.

4. The split-type vascular ultrasound monitoring device as described in claim 3, characterized in that, The acoustic coupling layer is made of solid gel or hydrogel material.

5. The split-type vascular ultrasound monitoring device as described in claim 1, characterized in that, The transmitter also includes a housing and a wearable component disposed on the housing, the wearable component being used to detachably connect the transmitter to a limb of an organism; the second interface is disposed on the side wall of the housing.

6. The split-type vascular ultrasound monitoring device as described in claim 5, characterized in that, The ultrasonic driving unit is integrated inside the housing and includes: An excitation circuit, whose input terminal is electrically connected to the control unit, is used to generate pulse signals; A switching switch, the first end of which is electrically connected to the output end of the excitation circuit and the second end of which is electrically connected to the second interface, is used to transmit the pulse signal to the ultrasonic transducer array through the second interface; An analog front-end circuit, whose input terminal is electrically connected to the third terminal of the switching switch, is used to amplify and filter the echo signal from the second interface; and An analog-to-digital converter circuit, with its first terminal electrically connected to the output terminal of the analog front-end circuit and its second terminal electrically connected to the control unit, is used to convert the amplified and filtered echo signal into a digital signal and send it to the control unit.

7. The split-type vascular ultrasound monitoring device according to any one of claims 1 to 6, characterized in that, The ultrasonic transducer array is any one of piezoelectric ceramic array, piezoelectric thin film array, piezoelectric composite material array, capacitive micromechanical ultrasonic transducer array, or piezoelectric micromechanical ultrasonic transducer array.

8. The split-type vascular ultrasound monitoring device as described in claim 6, characterized in that, The transmitting host also includes a wireless communication module, which is electrically connected to the control unit and is used to transmit the processed echo signal to an external terminal.

9. A control method for a split-type vascular ultrasound monitoring device according to any one of claims 1 to 8, characterized in that, include: The control unit reads the identity information in the identity recognition unit when the first interface and the second interface are connected. Determine whether the identity information is marked as available; If the identity information is available, the control unit outputs a drive signal to the ultrasonic transducer array through the ultrasonic drive unit and the second interface to excite the ultrasonic transducer array to work. If the identity information is unavailable, the control unit keeps the ultrasonic drive unit in a locked state.

10. The control method according to claim 9, characterized in that, After stimulating the ultrasonic transducer array to work, the method also includes determining whether the monitoring duration or number of uses of the identification unit has reached a preset threshold. When the control unit determines that the monitoring duration or the number of uses has reached the preset threshold, it updates the identity information of the identity recognition unit to an unavailable state through the second interface.

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