Wearable hydronephrosis dynamic monitoring and early warning equipment special for nephrotic patients

Abstract

The invention relates to a special wearable hydronephrosis dynamic monitoring and early warning device for patients with nephropathy, which belongs to the technical field of medical instruments, and comprises a flexible ultrasonic sensor array fixed on the kidney part of the patient through a wearable carrier (waistband type or patch type), and a signal processing and control unit is responsible for processing and analyzing ultrasonic signals transmitted by sensors. And the low-power-consumption Bluetooth module wirelessly transmits the data to a mobile terminal and uploads the data to a remote monitoring system at the same time. The mobile terminal is used for a patient to check data in real time, and the remote monitoring system is used for medical staff to conduct remote monitoring. The visual monitoring data display structure is integrated on the wearable carrier, and monitoring information is visually displayed. The device can continuously monitor the hydronephrosis condition in real time, accurately analyze data, timely give an early warning when hydronephrosis is abnormal, provide a convenient self-monitoring means for a patient, assist medical staff in formulating an accurate treatment scheme, and effectively improve the monitoring and treatment level of hydronephrosis.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a wearable hydronephrosis dynamic monitoring and early warning device specially designed for kidney disease patients. Background Art

[0002] In the field of clinical diagnosis and treatment of kidney disease, hydronephrosis is a common and critical disease. Accurate and real-time monitoring of the degree of hydronephrosis is crucial for patients with potential risk of hydronephrosis, such as patients with urinary stones, ureteral stenosis, ureteropelvic junction obstruction, and certain congenital urinary malformations. The formation mechanism of hydronephrosis is complex, usually due to obstructive factors in the urinary system, which leads to obstruction of urine excretion and increased pressure in the renal pelvis, which in turn causes dilatation and hydronephrosis of the renal pelvis and calyces. If the changes in the degree of hydronephrosis are not detected in time and effective intervention measures are not taken, the continuous increase in hydronephrosis will cause progressive compression on the renal parenchyma, damage the renal units, and eventually lead to irreversible decline in renal function, seriously affecting the patient's prognosis and quality of life.

[0003] At present, clinical practice mainly relies on regular ultrasound examinations to monitor hydronephrosis. However, this traditional monitoring mode has significant inherent defects. On the one hand, the time interval of regular ultrasound examinations is relatively fixed, and it is often difficult to capture the rapid progression of hydronephrosis that may occur between two examinations. For example, in unstable conditions such as stone movement, ureteral spasm, or combined infection, the degree of hydronephrosis may change dramatically in a short period of time, and the established examination cycle cannot reflect these dynamic changes in time, greatly increasing the risk of missing the best treatment window, making renal function damage that could have been reversed by timely intervention develop into irreversible damage. On the other hand, frequently requiring patients to go to the hospital for ultrasound examinations not only brings many inconveniences to patients, consumes a lot of time and energy, but also increases the economic burden on patients, and to a certain extent causes inefficient use of medical resources.

[0004] In addition, the existing monitoring methods cannot achieve continuous and dynamic tracking of the patient's hydronephrosis in daily life, which is a clear obstacle to fully understanding the true evolution of the patient's condition. Due to the lack of dynamic data on hydronephrosis in patients' daily lives, medical staff find it difficult to formulate treatment and care plans that accurately match the changes in the patient's individual condition. They rely more on empirical judgment and are unable to adjust treatment strategies in a targeted manner, which, to a certain extent, affects the improvement of treatment effects and the patient's recovery process.

[0005] In summary, the development of an innovative device that can break through the limitations of existing monitoring and achieve real-time, continuous and convenient monitoring of the degree of hydronephrosis has become a key issue that needs to be urgently addressed in the field of clinical diagnosis and treatment of kidney disease. It has important significance and urgent practical needs for improving the overall treatment level of kidney disease, optimizing patient management strategies, and protecting patients' renal function to the greatest extent. Summary of the invention

[0006] In view of this, the present invention aims to provide a wearable hydronephrosis dynamic monitoring and early warning device dedicated to kidney disease patients, which integrates a flexible ultrasonic sensor array (including an ultrasonic transducer unit, an acoustic matching layer, and a flexible frame), a signal processing and control unit connected to the sensor array (with a microprocessor and other components), a belt-type or patch-type wearable carrier, a low-power Bluetooth module integrated in the control unit, and a mobile terminal paired with the Bluetooth module and capable of displaying data and alarms and connecting to a remote monitoring system (including a server, a database, and a monitoring terminal). The device effectively solves the problem of the prior art of untimely monitoring of hydronephrosis patients and reliance on regular examinations that easily delays treatment and causes renal function damage, realizes real-time, continuous, and convenient monitoring and early warning of the degree of hydronephrosis, provides strong support for precision medicine, and improves the treatment effect and quality of life of patients.

[0007] The present invention is achieved through the following technical solutions:

[0008] A wearable hydronephrosis dynamic monitoring and early warning device specially designed for kidney disease patients comprises a wearable carrier, a flexible ultrasonic sensor array and a signal processing and control unit are fixedly arranged on the inner side of the wearable carrier, a visual monitoring data display structure is fixedly arranged on the outer side of the wearable carrier, the signal processing and control unit is externally connected to a mobile terminal and a remote monitoring system via a Bluetooth signal, and the signal processing and control unit is respectively connected to the flexible ultrasonic sensor array and the visual monitoring data display structure via lines.

[0009] Furthermore, the flexible ultrasonic sensor array is composed of ultrasonic transducer units arranged on a flexible substrate, the front side of the flexible ultrasonic sensor array is covered with an acoustic matching layer, and the edge of the flexible ultrasonic sensor array is provided with a flexible frame.

[0010] Furthermore, the signal processing and control unit includes a microprocessor, a signal amplifier, a filter, an analog-to-digital converter and a power management module.

[0011] Furthermore, the wearable carrier is a belt-type wearable carrier, and the belt-type wearable carrier is provided with a pocket for placing the flexible ultrasonic sensor array and a storage bag for placing a signal processing and control unit.

[0012] Furthermore, the signal processing and control unit is integrated with a low-power Bluetooth module, and the low-power Bluetooth module includes a Bluetooth chip, a radio frequency front-end circuit and an antenna.

[0013] Furthermore, the mobile terminal is paired and connected with the low-power Bluetooth module to receive and display data monitored by the device, and to issue an audible and visual alarm when the degree of hydronephrosis is abnormal, and to synchronously transmit the data to a remote monitoring system.

[0014] Furthermore, the remote monitoring system includes a server, a database and a monitoring terminal for receiving, storing and processing monitoring data of multiple patients and providing remote monitoring and diagnosis support for medical staff.

[0015] Furthermore, the visual monitoring data display structure includes a display driver chip, a backlight module and a touch screen control chip, which are used to display quantitative data of the degree of hydronephrosis, a hydronephrosis change curve and device status information.

[0016] The beneficial effects of the present invention are:

[0017] The present invention realizes real-time and continuous monitoring of hydronephrosis through the coordinated work of a flexible ultrasonic sensor array and a signal processing and control unit, which is conducive to timely capturing changes in the degree of hydronephrosis, accurately assessing the condition, providing a basis for medical staff to intervene early, effectively preventing irreversible damage to renal function, and improving the timeliness and effectiveness of hydronephrosis treatment.

[0018] The present invention achieves multi-terminal transmission and storage of monitoring data through wireless connection between a low-power Bluetooth module and a mobile terminal and a remote monitoring system, which is beneficial for medical staff to make scientific medical decisions based on a large amount of real-time and historical data and the individual conditions of patients, improve the efficiency of medical resource utilization, and promote the precision and efficiency of medical services.

[0019] The present invention takes into account the convenience and comfort of patients wearing the wearable carrier through the diversified design of the wearable carrier and the application of the visual monitoring data display structure, while facilitating patients to intuitively understand their own condition, which is beneficial to enhancing patients' compliance with treatment and self-management ability, promoting patients to actively participate in the treatment process, and improving the overall treatment effect.

[0020] The present invention ensures the stability and reliability of equipment operation through reasonable selection and optimized design of various components, and each component is easy to maintain and replace, which is conducive to extending the service life of the equipment, reducing the cost of use, ensuring that the equipment continues to provide stable support for hydronephrosis monitoring during long-term use, and improving the quality and sustainability of rehabilitation services. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 is a structural schematic diagram of a first support plate;

[0022] Figure 2 Schematic diagram of the wearable carrier structure;

[0023] Figure 3 It is a front view of the wearable carrier;

[0024] Figure 4 A top view of the wearable carrier;

[0025] Figure 5 It is a schematic diagram of the structure of a flexible ultrasonic sensor array;

[0026] Figure 6 It is a schematic diagram of the structure of the signal processing and control unit;

[0027] Figure 7 A schematic diagram of the structure for visualizing monitoring data display.

[0028] Description of reference numerals:

[0029] 1. Flexible ultrasonic sensor array; 11. Ultrasonic transducer unit; 12. Acoustic matching layer; 13. Flexible frame; 2. Signal processing and control unit; 21. Microprocessor; 22. Signal amplifier; 23. Filter; 24. Analog-to-digital converter; 25. Power management module; 3. Wearable carrier; 31. Pocket; 32. Storage bag; 34. Connecting wire; 4. Low-power Bluetooth module; 5. Mobile terminal; 6. Remote monitoring system; 7. Visual monitoring data display structure; 71. Display driver chip; 72. Backlight module; 73. Touch screen control chip. DETAILED DESCRIPTION

[0030] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings here can be arranged and designed in various different configurations.

[0031] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0032] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0033] In the above description of the present invention, it should be noted that the terms "one side", "the other side", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of the invention is usually placed when in use, which is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", etc. are only used to distinguish the description, and cannot be understood as indicating or implying relative importance.

[0034] In addition, the term "same" does not mean that the parts must be absolutely the same, but slight differences are allowed. The term "vertical" only means that the positional relationship between the parts is more vertical than "parallel", and does not mean that the structure must be completely vertical, but can be slightly tilted.

[0035] like Figure 1-6 As shown, an embodiment of the present invention is: a wearable hydronephrosis dynamic monitoring and early warning device for kidney disease patients, comprising a flexible ultrasonic sensor array (1):

[0036] The flexible ultrasonic sensor array (1) is specially designed for kidney monitoring, and its size has been precisely considered to adapt to the physiological characteristics of the human kidney. The length is set at 10-15 cm, the width is 5-8 cm, and the thickness is strictly controlled to be less than 0.5 cm to ensure comfort and fit when worn. It consists of multiple ultrasonic transducer units (11) arranged in a precise arrangement on a flexible substrate. These ultrasonic transducer units (11) are made of high-performance piezoelectric ceramic materials and have excellent piezoelectric conversion performance. They can efficiently convert electrical signals into ultrasonic signals for transmission and accurately convert received ultrasonic echo signals into electrical signals. The spacing between adjacent ultrasonic transducer units (11) has been strictly acoustically calculated and experimentally verified and is controlled between 1-2 mm to ensure uniform transmission and reception of ultrasonic signals and avoid signal interference and the generation of blind spots.

[0037] In order to optimize the transmission of ultrasonic signals, an acoustic matching layer (12) is evenly covered on the front of the sensor array. The acoustic matching layer (12) is made of carefully selected high molecular polymer materials, whose acoustic properties are highly matched with human tissue, and the thickness is precisely controlled at 0.1-0.2 mm. Through precise material selection and thickness control, the acoustic matching layer (12) can effectively reduce the reflection of ultrasonic signals at the interface between the sensor and human tissue, greatly improving the transmission efficiency of ultrasonic signals, ensuring that high-quality ultrasonic signals can penetrate into human tissue and reach the kidney and renal pelvis area, providing a reliable signal basis for subsequent precise monitoring.

[0038] In order to protect the delicate ultrasonic transducer unit (11) and its microcircuit structure, a flexible frame (13) is provided at the edge of the sensor array. The flexible frame (13) is made of a rubber material with good flexibility and wear resistance, and its width is designed to be 0.5

[0039] -1 cm. It can not only physically protect the sensor array from external extrusion, collision and friction damage, but also ensure the structural integrity and maintain stable working performance when the sensor array bends and deforms with human body activities. At the same time, the design of the flexible frame (13) also facilitates stable connection with the wearable carrier (3), ensuring that the sensor array can maintain the correct position and posture in various usage scenarios and work continuously and stably.

[0040] Signal processing and control unit (2):

[0041] The signal processing and control unit (2) is designed as a small rectangular box structure with optimized dimensions of 3×4

[0042] ×2 cm, and the shell is made of lightweight aluminum alloy. This material effectively reduces the overall weight of the device while ensuring structural strength, making it easier for patients to wear. The aluminum alloy shell also has good heat dissipation performance, which can promptly dissipate the heat generated by the internal electronic components when they are working, ensuring the stability and reliability of the device during long-term operation.

[0043] The unit has a highly integrated number of key electronic components. The microprocessor (21) is the core control component, and a high-performance, low-power microcontroller chip is selected, such as the ARM Cortex-M4 series chip. The chip has powerful computing power and efficient processing speed, and can quickly and accurately execute various complex control algorithms and signal processing tasks. At the same time, its low power consumption ensures that the energy consumption of the device is at a low level during long-term operation, extending the battery life.

[0044] The signal amplifier (22) is responsible for amplifying the extremely weak ultrasonic echo signal received by the ultrasonic transducer unit (11) so that the signal reaches a signal strength range that can be effectively processed by the subsequent analog-to-digital converter (24). The signal amplifier (22) has a high-precision gain adjustment function and can adjust the gain in real time according to the actual received signal strength through the intelligent control of the microprocessor (21), ensuring that the signal will not be too weak to be accurately measured during the amplification process, nor will it be too strong to cause signal distortion, thereby providing a stable and reliable signal source for subsequent signal processing.

[0045] The filter (23) adopts an advanced bandpass filter design, with a center frequency precisely set at 2-5 MHz and a bandwidth of 1-2 MHz. This parameter range is carefully selected to specifically filter out various noise and interference components mixed in the ultrasonic echo signal, and only allow effective signals that match the working frequency of the ultrasonic sensor to pass. Through the fine filtering processing of the filter (23), the purity and quality of the signal are significantly improved, providing a reliable data basis for subsequent accurate analysis and calculation.

[0046] The analog-to-digital converter (24) undertakes the key task of converting the analog signal after amplification and filtering into a digital signal. Its sampling accuracy is as high as 12-16 bits, and the sampling frequency is set to 10-20MHz. It can perform high-resolution sampling of the analog signal and accurately capture the detailed information of the signal. Such high sampling accuracy and frequency ensure that the converted digital signal can truly and accurately reflect the characteristics of the original ultrasonic echo signal, providing rich and accurate data support for the microprocessor (21) to perform complex digital signal processing and analysis.

[0047] The power management module (25) uses a high-performance rechargeable lithium battery as a power source, and the battery capacity is 500-1000mAh. This module is not only responsible for providing a stable and reliable power supply for the entire signal processing and control unit (2) and the flexible ultrasonic sensor array (1), but also integrates an advanced charging management circuit and a low-battery detection circuit. The charging management circuit can intelligently control the charging process of the battery to ensure that the battery is charged in a safe and efficient state, thereby extending the service life of the battery. The low-battery detection circuit monitors the battery power status in real time. When the battery power is lower than the preset safety threshold, it can promptly send a low-battery alarm message to the mobile terminal (5) through the low-power Bluetooth module (4), reminding the patient to charge the device in time, so as to avoid interruption of the device operation due to insufficient power, which affects the continuity and integrity of the monitoring data.

[0048] Wearable carrier(3):

[0049] Wearable belt-type carrier: The main body of the wearable belt-type carrier is made of a breathable, soft and elastic fabric material, such as spandex and cotton blended material. The selection of this material fully considers the patient's wearing comfort and convenience of daily activities. Its width is designed to be 8-12 cm, and its length can be flexibly adjusted according to the patient's waist circumference to ensure that it can adapt to patients of different body shapes. On the inside of the belt, corresponding to the position of the human kidney, a pocket (31) is carefully sewn for placing the flexible ultrasonic sensor array (1). The pocket (31) is made of a thin non-woven material, which has a certain degree of flexibility and can fit well with the flexible ultrasonic sensor array (1), while not causing obvious obstruction to the transmission of ultrasonic signals. The size of the pocket (31) is precisely designed to fit closely with the flexible ultrasonic sensor array (1), ensuring that the sensor array can always maintain a stable position and posture during wearing, avoiding shaking or displacement that affects the detection accuracy of ultrasonic signals. At the same time, the opening direction and size design of the pocket (31) also make it easy for the patient to easily put in and take out the flexible ultrasound sensor array (1) when wearing and taking off the device.

[0050] A storage bag (32) is provided on the outside of the waistband for placing the signal processing and control unit (2). The storage bag (32) is made of waterproof and wear-resistant nylon material, which can effectively protect the signal processing and control unit (2) from the influence of the external environment, such as the erosion of rain and sweat and daily friction and wear. The size of the storage bag (32) is slightly larger than the signal processing and control unit (2), and a soft pad or fixed structure is used inside to ensure that the signal processing and control unit (2) can be placed firmly in the storage bag to avoid shaking or collision during the patient's daily activities, which affects the normal operation of the device. The storage bag (32) is connected to the waistband body by a zipper or snap button, etc., and is easy to open and close, so that the patient can operate the signal processing and control unit (2) when needed, such as checking the device status, replacing the battery, etc. The storage bag (32) is located at a position on the patient's waist that is convenient for operation and viewing, such as the side or front of the waist, so as to improve the convenience of the patient in using the device.

[0051] Patch-type wearable carrier: The patch-type wearable carrier is made of medical silicone material, and its shape is designed to be round or oval, with a diameter of 10-15 cm and a thickness of 0.3-0.5 cm. The medical silicone material has good biocompatibility, flexibility and viscosity, and can be directly adhered to the skin near the patient's kidney area to ensure close fit with the skin, providing stable support and fixation for the flexible ultrasonic sensor array (1). A window is opened at the center of the patch-type wearable carrier, and the diameter of the window is precisely matched with the effective working area of ​​the flexible ultrasonic sensor array (1), ensuring that the ultrasonic transducer unit (11) can directly contact the human skin through the window to achieve effective transmission and reception of ultrasonic signals. The edge of the window is edged with soft rubber material, which not only ensures the fit between the window and the skin, prevents external liquids or debris from entering and affecting the transmission of ultrasonic signals, but also avoids scratching the patient's skin.

[0052] The conductive cable is led out from the edge of the window, using a soft shielded wire, with an outer layer wrapped with a medical silicone insulation layer, and a length of 30-50 cm. The design of the conductive cable fully considers the patient's freedom of movement and the stability of signal transmission. The soft shielded wire can effectively prevent the influence of external electromagnetic interference on the transmission signal, ensuring the integrity and accuracy of the signal. The medical silicone insulation layer not only provides good electrical insulation performance, but also has good flexibility and wear resistance, and can adapt to various body movements and posture changes of the patient in daily activities. When installing the conductive cable, it is reasonably wired along the back or side of the patch-type wearable carrier, and fixed by pasting or clamping to prevent the cable from being entangled and pulled during the patient's activities, ensuring that it can stably transmit the signal of the flexible ultrasonic sensor array (1) to the signal processing and control unit (2). At the connection part between the conductive cable and the signal processing and control unit (2), a sealed plug and socket are used for connection to ensure the reliability and waterproof performance of the electrical connection, and to avoid short circuit or abnormal signal transmission due to the infiltration of sweat or other liquids.

[0053] Bluetooth Low Energy Module(4):

[0054] The low-power Bluetooth module (4) is highly integrated on the circuit board of the signal processing and control unit (2), and its core component, the Bluetooth chip (41), adopts an advanced low-power Bluetooth 4.0 or higher version chip, such as the Nordic nRF52 series chip. The chip has excellent low-power performance and stable communication capabilities, and can minimize energy consumption while ensuring the data transmission rate, thereby extending the battery life of the device. The Bluetooth chip (41) is connected to the microprocessor (21) via a high-speed data bus, thereby achieving fast and stable data transmission. This high-speed connection method ensures that the microprocessor (21) can transmit the processed monitoring data to the Bluetooth chip (41) in a timely manner and send it out through the Bluetooth module.

[0055] The RF front-end circuit (42) serves as the front end for transmitting and receiving Bluetooth signals, and adopts a series of high-performance RF components, such as low-noise amplifiers, power amplifiers, and filters. These components are carefully selected and optimized in design, and can effectively amplify, filter, modulate, and demodulate Bluetooth signals, thereby improving the transmission quality and distance of the signals. The RF front-end circuit (42) is connected to the Bluetooth chip (41) via a microstrip line. The design and layout of the microstrip line are precisely simulated and optimized to ensure that the signal loss during transmission is minimized and the signal integrity is maximized.

[0056] The antenna (43) adopts a miniaturized ceramic antenna or a printed antenna, and its design and layout fully consider the overall structure and use environment of the device. The antenna (43) is connected to the radio frequency front-end circuit (42) through a feeder, and is reasonably arranged inside or on the surface of the housing of the signal processing and control unit (2). By optimizing the gain and directivity of the antenna, it is ensured that stable and reliable communication with the mobile terminal (5) can be carried out in the complex electromagnetic environment around the human body, and the communication distance can reach 10-15 meters. During the device assembly process, the installation position and direction of the antenna are strictly debugged and optimized to ensure the best transmission and reception effect of the Bluetooth signal.

[0057] Mobile terminals(5):

[0058] The mobile terminal (5) can be a smart device such as a smartphone or tablet computer with powerful computing and communication capabilities. These devices run a monitoring application developed specifically for the monitoring device, which is carefully designed and optimized and has a simple, intuitive user interface and rich functions. Through the Bluetooth function, the mobile terminal (5) can quickly and stably pair with the low-power Bluetooth module (4). Once the connection is successful, the mobile terminal (5) can receive real-time device monitoring data transmitted from the low-power Bluetooth module (4), including ultrasound images of the kidneys, quantitative data on the degree of hydronephrosis, hydronephrosis change curves, and information such as the device's power level and connection status.

[0059] When the monitoring data shows that the degree of hydronephrosis exceeds the preset safety threshold or the growth rate of hydronephrosis is abnormal, the mobile terminal (5) can immediately activate the sound and light alarm function. Its built-in speaker will emit a loud and clear alarm sound, and a striking alarm prompt message will pop up on the screen to attract the patient's attention in various ways. In addition, the mobile terminal (5) also has powerful data storage and transmission capabilities, and can synchronously transmit the received monitoring data to the remote monitoring system (6) via a mobile network (such as 4G or 5G), ensuring that medical staff can obtain the patient's latest condition information in a timely manner, providing strong support for remote diagnosis and treatment.

[0060] Remote monitoring system(6):

[0061] The remote monitoring system (6) is composed of a server (61), a database (62) and a monitoring terminal (63), and is a powerful and highly integrated medical information management platform. The server (61) uses high-performance server hardware and advanced server operating systems, such as the Linux operating system, and has strong computing and data processing capabilities. It is responsible for receiving monitoring data uploaded from multiple patient mobile terminals (5), and processing, analyzing and storing the data in real time. The server (61) is connected to the database (62) via a high-speed network to ensure fast storage and query of data.

[0062] The database (62) uses a professional relational database management system, such as MySQL database, to perform structured storage and management of patients' basic information, historical monitoring data, hydronephrosis diagnosis reports, etc. The design of the database follows strict database design specifications and data security standards to ensure data integrity, consistency and security. Through reasonable database indexing and query optimization technology, it can quickly and accurately retrieve and query relevant information of patients, providing strong data support for medical staff's diagnosis and treatment.

[0063] The monitoring terminal (63) is an interface for medical staff to interact with the remote monitoring system (6), and is usually a computer or mobile device. Medical staff can view the patient's hydronephrosis monitoring data, ultrasound images, equipment status and other information in real time through the monitoring terminal (63), and remotely monitor and diagnose the patient's condition. The monitoring terminal (63) also has data analysis and report generation functions, which can conduct in-depth analysis of the patient's historical monitoring data and generate various visual reports and charts to help medical staff more intuitively understand the patient's condition change trend and formulate a more scientific and reasonable treatment plan.

[0064] Visual monitoring data display structure (7):

[0065] The visual monitoring data display structure (7) uses a small organic light-emitting diode (OLED) display screen with a size of 2-3 inches. This display screen has the advantages of high contrast, high brightness, wide viewing angle and fast response, and can clearly display the quantitative data of the degree of hydronephrosis, the hydronephrosis change curve and the device status information under various ambient light conditions. The display driver chip (71) is responsible for converting the data transmitted by the signal processing and control unit (2) into a format suitable for display on the display screen, and is connected to the signal processing and control unit (2) through a high-speed data bus to ensure fast and stable data transmission.

[0066] The backlight module (72) uses a low-power light-emitting diode array and is connected to the power management module (25) through a brightness adjustment circuit. The brightness adjustment circuit can automatically adjust the brightness of the backlight module (72) according to the ambient light intensity, ensuring that the display screen can be clearly read in both strong light and weak light environments. While ensuring the display effect, the intelligent brightness adjustment effectively reduces the power consumption of the device and prolongs the battery life.

[0067] If the display screen has a touch function, the touch screen control chip (73) is responsible for detecting the user's touch operation and transmitting the touch signal to the signal processing and control unit (2) to realize the human-computer interaction function. The touch screen control chip (73) is connected to the touch layer of the display screen through a flat cable to ensure the sensitivity and accuracy of the touch operation. The patient can conveniently view historical monitoring data, device settings and other information by touching the display screen, thereby improving the convenience of use of the device and the user experience.

[0068] Device usage steps

[0069] Equipment wearing:

[0070] Medical staff select appropriate wearable carriers for patients based on their specific conditions, physical conditions, and personal needs (3). During the selection process, they fully consider factors such as the patient's mobility and skin sensitivity to ensure that the patient can wear the device comfortably and stably.

[0071] For the belt-type wearable carrier, the medical staff assists the patient to carefully place the flexible ultrasonic sensor array (1) into the pocket (31), ensuring that the front of the ultrasonic transducer unit (11) is tightly fitted with the patient's kidney area. During the placement process, care should be taken to avoid the sensor array from twisting or folding, which will affect the transmission and reception of the ultrasonic signal. At the same time, the signal processing and control unit (2) is placed in the storage bag (32), ensuring that it is firmly placed in the storage bag without shaking or collision. Then, according to the patient's waist circumference, adjust the length of the belt, tie the belt around the patient's waist with Velcro or buckle, and ensure that the tightness of the belt is moderate. A belt that is too tight may affect the patient's blood circulation and breathing comfort, while a belt that is too loose may cause the device to shift or shake during wearing, affecting the accuracy of the monitoring data. After fastening the belt, check again whether the flexible ultrasonic sensor array (1) and the signal processing and control unit (2) are in the correct position to ensure the stability of the device during wearing.

[0072] For the patch-type wearable carrier, the medical staff first cleans the skin near the kidney area of ​​the patient, uses a mild detergent and clean water to clean the skin surface, and then wipes it dry with a clean towel to ensure that the skin surface is dry and free of grease and dirt. This step is to ensure that the patch-type wearable carrier can be well adhered to the skin to avoid the impurities on the skin surface affecting the adhesion effect and the transmission of the ultrasonic signal. The flexible ultrasonic sensor array (1) is accurately attached to the skin near the kidney area of ​​the patient through the window, and the edge of the patch is gently pressed to make the patch fit the skin fully and expel the air bubbles between the patch and the skin. The presence of air bubbles may interfere with the propagation of ultrasonic signals and cause inaccurate monitoring data. After attaching the sensor array, place the signal processing and control unit (2) in a nearby position convenient for connecting the conductive cable, and connect the conductive cable. Ensure that the conductive cable is firmly connected and the wiring is reasonable, and will not cause obstruction or discomfort to the patient's daily activities. Check the sealing of the connection part again to prevent sweat or other liquids from penetrating and affecting the electrical performance and normal operation of the device.

[0073] Device startup

[0074] The patient or medical staff turns on the power switch of the signal processing and control unit (2). At this time, the power management module (25) starts to work and performs real-time detection of parameters such as the battery power level and voltage. If the battery power level is sufficient and within the normal working range, the power management module (25) will provide a stable DC power supply for the entire device to ensure that all components start normally. At the same time, the power management module (25) will also intelligently manage the power consumption of the device and dynamically adjust the power supply strategy according to the working status of each component to extend the battery life.

[0075] The microprocessor (21) in the signal processing and control unit (2) starts the initialization program. During the initialization process, the microprocessor (21) initializes its own internal resources such as registers and caches, and performs communication handshakes and status detection on various connected peripheral devices, such as the ultrasonic sensor array (1), the low-power Bluetooth module (4), and the visual monitoring data display structure (7). Ensure that these devices are in normal working condition and the communication link is unobstructed, so as to prepare for the subsequent monitoring data collection and processing.

[0076] The patient turns on the mobile terminal (5) and turns on the Bluetooth function in the settings of the mobile terminal (5). The mobile terminal (5) starts searching for Bluetooth devices in the surrounding area. When the broadcast signal emitted by the low-power Bluetooth module (4) of the signal processing and control unit (2) is found, the device name is displayed on the mobile terminal (5). The patient selects the corresponding device name and completes the pairing process according to the system prompts. After the pairing is successful, a stable wireless communication link is established between the mobile terminal (5) and the low-power Bluetooth module (4), laying the foundation for subsequent data transmission.

[0077] Monitoring data collection

[0078] Ultrasonic signal transmission and reception:

[0079] After the device is started and the connection is established, the microprocessor (21) of the signal processing and control unit (2) sends control instructions to the flexible ultrasonic sensor array (1) according to the preset monitoring parameters and timing. These instructions accurately control the working state of the ultrasonic transducer unit (11), including parameters such as the frequency, pulse width, and emission interval of the transmitted ultrasonic signal. The ultrasonic transducer unit (11) converts the electrical signal into an ultrasonic signal according to the instructions, and transmits it to the human kidney and renal pelvis area at a specific frequency and energy. These ultrasonic signals propagate in human tissues and generate reflected echo signals when encountering tissue interfaces with different acoustic impedances, such as the interface between the kidney parenchyma and the hydronephrosis.

[0080] The ultrasonic transducer unit (11) is also responsible for receiving these reflected echo signals and converting them into electrical signals. During the entire transmission and reception process, the microprocessor (21) continuously monitors the working state of the ultrasonic transducer unit (11) to ensure its stable operation. For example, by detecting the driving current, feedback voltage and other parameters of the ultrasonic transducer unit (11), it is determined whether it is working normally. If a certain ultrasonic transducer unit (11) is found to have a fault, such as being unable to transmit or receive signals normally, the microprocessor (21) will record the fault information and send an alarm to the patient and medical staff through the visual monitoring data display structure (7) and the mobile terminal (5), prompting the need to inspect and repair the equipment.

[0081] Signal Processing and Analysis:

[0082] The weak echo electrical signal received by the ultrasonic transducer unit (11) is first transmitted to the signal amplifier (22) of the signal processing and control unit (2). The signal amplifier (22) accurately amplifies the signal according to the control instruction of the microprocessor (21). Its gain can be dynamically adjusted according to the actual received signal strength to ensure that the amplified signal can meet the input requirements of the subsequent analog-to-digital converter (24) and will not cause signal distortion due to excessive amplification. The amplified signal enters the filter (23).

[0083] The filter (23) uses bandpass filtering technology to effectively filter out noise and interference components in the signal. By accurately setting the passband frequency range (2-5MHz) and stopband attenuation characteristics of the filter, only valid signals related to the working frequency of the ultrasonic sensor are allowed to pass, greatly improving the quality and purity of the signal. The filtered signal enters the analog-to-digital converter (24).

[0084] The analog-to-digital converter (24) converts the analog signal into a digital signal. Its high-precision sampling capability (12-16 bit sampling accuracy, 10-20 MHz sampling frequency) ensures accurate capture of signal details. The converted digital signal is transmitted to the microprocessor (21).

[0085] The microprocessor (21) uses advanced digital signal processing algorithms and image processing algorithms to conduct in-depth analysis of digital signals. By calculating the time delay, intensity change, and frequency characteristics of the echo signal, combined with the preset kidney model and hydronephrosis assessment algorithm, the morphological parameters of the kidney, such as the size, shape, and position change of the kidney, as well as the depth, area, and volume of hydronephrosis, are accurately calculated. At the same time, the microprocessor (21) draws a hydronephrosis change curve based on the continuously collected monitoring data, intuitively showing the dynamic change trend of the hydronephrosis over time.

[0086] Data transmission:

[0087] The microprocessor (21) transmits the processed monitoring data, including the quantitative data of the degree of hydronephrosis, the hydronephrosis change curve, and the device status information, to the mobile terminal (5) through the low-power Bluetooth module (4). During the transmission process, the low-power Bluetooth module (4) packages, encodes and modulates the data and sends it out in the form of a wireless signal. After the mobile terminal (5) receives the data, its built-in monitoring application parses and decodes the data, extracts the effective information, and stores it in the local database, and displays it in real time on the screen of the mobile terminal (5) so that the patient can view it at any time.

[0088] After receiving the data, the mobile terminal (5) immediately transmits the data synchronously to the server (61) of the remote monitoring system (6) through a mobile network (such as a 4G or 5G network). During the data transmission process, an encrypted transmission protocol, such as the SSL / TLS protocol, is used to ensure the security and privacy of the patient's medical data during network transmission and prevent the data from being stolen or tampered with. After receiving the data, the server (61) stores it in a database (62) and performs structured storage according to the patient's identification and time sequence, so that medical staff can conduct subsequent inquiries and analysis.

[0089] Early warning and handling

[0090] Monitoring and early warning of abnormal degree of hydronephrosis:

[0091] In the process of analyzing the hydronephrosis data, the microprocessor (21) continuously compares the current quantified data of the degree of hydronephrosis and the hydronephrosis change curve with the preset safety threshold and normal change range. These safety thresholds and normal change ranges are formulated based on a large amount of clinical research data and the experience of medical experts and have a high clinical reference value. When the microprocessor (21) detects that the degree of hydronephrosis exceeds the preset safety threshold, or the hydronephrosis growth rate is abnormal and exceeds the normal change range, the early warning mechanism is immediately triggered.

[0092] The microprocessor (21) sends a warning signal to the mobile terminal (5) via the low-power Bluetooth module (4). After receiving the warning signal, the mobile terminal (5) quickly activates the sound and light alarm function. Its built-in speaker emits a loud and rapid alarm sound, and at the same time, a striking red warning prompt box pops up on the screen, displaying specific warning information, such as "The degree of hydronephrosis is seriously beyond the normal range, please contact medical staff immediately!" In addition, the mobile terminal (5) may further remind the patient to pay attention by vibration and other means.

[0093] At the same time, the mobile terminal (5) quickly transmits the warning information and related monitoring data, including the latest hydronephrosis quantitative data, change curves, and device status, to the remote monitoring system (6) via the mobile network. After receiving the warning information, the server (61) immediately pushes it to the corresponding medical staff's monitoring terminal (63). After receiving the warning reminder on the monitoring terminal (63), the medical staff can quickly view the patient's detailed condition information, including comparative analysis of historical monitoring data, so as to timely evaluate the severity of the patient's condition.

[0094] Medical staff response and treatment:

[0095] After checking the patient's warning information and detailed monitoring data on the monitoring terminal (63), the medical staff will take appropriate treatment measures according to the severity of the disease and the patient's specific situation. For mild abnormalities, the medical staff may communicate with the patient through telephone or mobile applications to understand the patient's recent physical condition and living habits, give appropriate advice on diet, rest, etc., and require the patient to pay close attention to his or her symptoms and increase the frequency of monitoring.

[0096] If the condition is more serious, medical staff may arrange for the patient to go to the hospital for further examination and diagnosis as soon as possible, such as a more detailed renal ultrasound examination, CT examination or renal function test. At the same time, according to the patient's historical condition and current monitoring data, the treatment plan is adjusted, which may include adjusting the drug dosage, changing the treatment drug or arranging surgical treatment. Throughout the process, the remote monitoring system (6) provides medical staff with comprehensive and timely information about the patient's condition, which helps to improve the accuracy and timeliness of medical decision-making.

[0097] Technical effects of the device

[0098] Real-time continuous monitoring: Through the coordinated work of the flexible ultrasonic sensor array (1) and the signal processing and control unit (2), the hydronephrosis can be monitored in real time and continuously. Compared with the traditional regular hospital check-ups, the timeliness and continuity of the data are greatly improved. Medical staff can promptly detect the dynamic changes of hydronephrosis based on the real-time monitoring data, adjust the treatment plan in time, and effectively prevent the deterioration of the disease.

[0099] Wearable comfort and convenience: The design of the wearable carrier (3) fully considers the patient's wearing comfort and convenience in daily activities. Both belt-type and patch-type wearable carriers are made of soft and breathable materials, and are light in weight and small in size, so they will not cause obvious restrictions on the patient's daily life and activities. Patients can easily wear the device during normal work, study and life, and monitor hydronephrosis anytime and anywhere, which improves the patient's compliance with monitoring.

[0100] Wireless data transmission and telemedicine: With the help of low-power Bluetooth modules (4) and mobile network technology, wireless transmission of monitoring data from the device to the mobile terminal (5) and then to the remote monitoring system (6) is achieved. This feature allows patients to conduct self-monitoring in places far away from the hospital, and medical staff can obtain patients' condition data in real time through the remote monitoring system (6) to achieve remote diagnosis and medical management. This telemedicine model not only improves the utilization efficiency of medical resources, but also provides patients with more convenient and efficient medical services, especially for patients with limited mobility or in remote areas.

[0101] Visual monitoring and patient participation: The visual monitoring data display structure (7) and the monitoring application of the mobile terminal (5) show the quantitative data of the degree of hydronephrosis, the hydronephrosis change curve and the device status information to the patient in an intuitive and easy-to-understand way. Patients can understand the changes in their condition in real time, which enhances their cognition and participation in their own disease. When early warning information appears, patients can take appropriate measures in time, such as contacting medical staff or adjusting their lifestyle, which helps to improve patients' self-management ability and disease treatment effect.

[0102] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention rather than to limit it. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solution of the present invention can be modified or replaced by equivalents without departing from the purpose and scope of the technical solution of the present invention, which should be included in the scope of the claims of the present invention.

Claims

1. A wearable hydronephrosis dynamic monitoring and early warning device for kidney disease patients, characterized by: It includes a wearable carrier, a flexible ultrasonic sensor array and a signal processing and control unit are fixedly arranged on the inner side of the wearable carrier, a visual monitoring data display structure is fixedly arranged on the outer side of the wearable carrier, the signal processing and control unit is connected to an external mobile terminal and a remote monitoring system through a Bluetooth signal, and the signal processing and control unit is respectively connected to the flexible ultrasonic sensor array and the visual monitoring data display structure through lines.

2. A wearable hydronephrosis dynamic monitoring and early warning device for kidney disease patients according to claim 1, characterized in that: The flexible ultrasonic sensor array is composed of ultrasonic transducer units arranged on a flexible substrate, the front side of the flexible ultrasonic sensor array is covered with an acoustic matching layer, and the edge of the flexible ultrasonic sensor array is provided with a flexible frame.

3. The wearable hydronephrosis dynamic monitoring and early warning device for kidney disease patients according to claim 1, characterized in that: The signal processing and control unit includes a microprocessor, a signal amplifier, a filter, an analog-to-digital converter and a power management module.

4. The wearable hydronephrosis dynamic monitoring and early warning device for kidney disease patients according to claim 1, characterized in that: The wearable carrier is a belt-type wearable carrier, and the belt-type wearable carrier is provided with a pocket for placing the flexible ultrasonic sensor array and a storage bag for placing a signal processing and control unit.

5. The wearable hydronephrosis dynamic monitoring and early warning device for kidney disease patients according to claim 3 is characterized by: The signal processing and control unit is integrated with a low-power Bluetooth module, which includes a Bluetooth chip, a radio frequency front-end circuit and an antenna.

6. A wearable hydronephrosis dynamic monitoring and early warning device for kidney disease patients according to claim 5, characterized in that: The mobile terminal is paired with the low-power Bluetooth module to receive and display data monitored by the device, and to issue an audible and visual alarm when the degree of hydronephrosis is abnormal, and to synchronously transmit the data to a remote monitoring system.

7. A wearable hydronephrosis dynamic monitoring and early warning device for kidney disease patients according to claim 6, characterized in that: The remote monitoring system includes a server, a database and a monitoring terminal, which are used to receive, store and process monitoring data of multiple patients and provide remote monitoring and diagnosis support for medical staff.

8. The wearable hydronephrosis dynamic monitoring and early warning device for kidney disease patients according to claim 1, characterized in that: The visual monitoring data display structure includes a display driver chip, a backlight module and a touch screen control chip, and is used to display quantitative data of the degree of hydronephrosis, a hydronephrosis change curve and device status information.

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