Integrated intelligent hemodialysis monitoring system

Abstract

The invention relates to an integrated intelligent hemodialysis monitoring system. The system comprises a monitoring module, a main control module, a display module and an alarm module. The main control module is electrically connected with the monitoring module, the display module and the alarm module. The monitoring module comprises a blood pressure monitoring unit and a multi-mode monitoring sub-module; the multi-modal monitoring sub-module comprises a first blood path tube, a second blood path tube and a plurality of monitoring units; the monitoring module is used for collecting blood temperature, clearance rate, blood volume and blood pressure data in the hemodialysis process; and a processing control unit and an algorithm analysis unit are integrated in the main control module, and compared with the prior art, the system has the advantages of high applicability, realization of compatible upgrading of equipment, accurate risk monitoring and early warning and the like.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of dialysis monitoring, in particular to an integrated intelligent hemodialysis monitoring system. BACKGROUND

[0002] Hemodialysis is an important treatment method for patients with end-stage renal disease. Real-time monitoring of key parameters such as blood temperature, blood pressure, online clearance rate, and blood volume during treatment, as well as timely identification of risks such as blood recirculation and hypotension, are directly related to the safety and effectiveness of dialysis treatment. However, there are still many technical bottlenecks in the field of hemodialysis monitoring in current clinical practice, which seriously hinders the improvement of dialysis treatment quality.

[0003] It is difficult to upgrade the monitoring capability of traditional dialysis equipment. Most of the traditional dialysis instruments widely used in current clinical practice cannot completely realize the synchronous monitoring of the four core parameters of blood temperature, blood pressure, online clearance rate, and blood volume. If the monitoring capability is to be upgraded, the original module upgrade scheme provided by the equipment manufacturer needs to be adopted. This method often requires structural modification of the dialysis equipment, which not only has poor adaptability and cannot quickly complete the monitoring capability upgrade of traditional instruments, but also due to the "closed system" design of equipment manufacturers, different brands and models of dialysis instruments cannot be compatible with the general monitoring upgrade scheme, forming a technical barrier.

[0004] The monitoring data is scattered and the risk judgment relies on manual analysis, lacking intelligent analysis capability. The existing dialysis monitoring mostly uses scattered single parameter monitoring equipment, and the data of blood temperature, blood pressure, clearance rate, and blood volume are isolated from each other. Medical staff need to manually integrate multi-source data and judge the risk, which is low in efficiency and prone to subjective errors. For blood recirculation risk, the traditional method mostly relies on single parameter changes for judgment, lacking quantitative correlation analysis model, making it difficult to accurately identify the early risk state, and easy to cause incomplete toxin removal and reduced dialysis efficiency due to missed judgment. For hypotension risk, traditional monitoring can only alarm when blood pressure drops to a dangerous threshold, and cannot predict the trend in advance based on the dynamic correlation of blood volume and blood pressure, missing the intervention opportunity and further causing adverse reactions such as dizziness and nausea in patients.

[0005] At the same time, the unreasonable arrangement of the monitoring unit leads to the breakage of the whole process monitoring chain. The blood path connection path and the arrangement of the monitoring unit of the existing dialysis monitoring system lack scientific planning, and cannot form a complete monitoring chain from the arterial end to the dialysis instrument and from the dialysis instrument to the venous end. It is difficult to synchronously capture multi-dimensional risk points such as blood temperature, blood volume, clearance rate, and needle removal, and cannot provide complete data support for comprehensive evaluation of the treatment state, further reducing the comprehensiveness and timeliness of risk identification.

[0006] In summary, the current hemodialysis monitoring field has the technical problems of difficulty in upgrading and adapting traditional equipment monitoring, scattered multi-parameter monitoring data and lack of intelligent risk analysis, insufficient real-time and accuracy of core parameter monitoring, and incomplete full-process monitoring chain. SUMMARY

[0007] The purpose of the present application is to overcome the defects of the prior art and provide an integrated intelligent hemodialysis monitoring system.

[0008] The purpose of the present application can be achieved by the following technical solutions: According to one aspect of the present application, an integrated intelligent hemodialysis monitoring system is provided, which comprises a monitoring module, a main control module 3, a display module 4 and an alarm module 5; The main control module 3 is electrically connected with the monitoring module, the display module 4 and the alarm module 5 respectively; The monitoring module comprises a blood pressure monitoring unit 1 and a multi-modal monitoring sub-module 2; the multi-modal monitoring sub-module 2 comprises a first blood line 21, a second blood line 22 and a plurality of monitoring units; one end of the first blood line 21 is connected with an arterial end output blood line, and the other end is connected with an input end of a dialysis instrument 6; one end of the second blood line 22 is connected with a venous end input blood line, and the other end is connected with an output end of the dialysis instrument 6; the monitoring module is used for collecting multi-modal data in the hemodialysis process, and the multi-modal data comprises blood temperature, clearance rate, blood volume and blood pressure; The main control module 3 comprises a processing control unit and an algorithm analysis unit; a blood line recirculation risk analysis model and a hypotension risk analysis model are integrated in the algorithm analysis unit; the main control module 3 controls the monitoring module to collect multi-modal data, and completes data monitoring and risk analysis through these data; the monitoring results are transmitted to the display module 4 on one hand, and are used as a basis to control the alarm module 5 to send an alarm signal on the other hand.

[0009] As a preferred technical solution, the blood pressure monitoring unit 1 comprises a cuff, an inflation device, an exhaust device and a flexible pressure sensor; the flexible pressure sensor is arranged inside the cuff, and the cuff is connected with the inflation device and the exhaust device through a closed gas passage respectively; The blood pressure monitoring unit 1 further comprises a signal conditioning circuit composed of an amplifier and a filter; the input end of the signal conditioning circuit is connected with the output end of the flexible pressure sensor, and the output end of the signal conditioning circuit is connected with the input end of the main control module 3.

[0010] The use of the flexible pressure sensor improves the fit and comfort of blood pressure monitoring, and the inflation and exhaust devices realize accurate regulation and control of blood pressure; the amplification and filtering processing of the sensor signal by the signal conditioning circuit effectively reduces the influence of interference signals on the monitoring results, ensuring the accuracy of the blood pressure data transmitted to the main control module 3, and providing reliable basic data support for subsequent hypotension risk analysis.

[0011] As a preferred technical solution, the plurality of monitoring units include a blood temperature monitoring unit 23, an online clearance rate monitoring unit 24, a blood volume monitoring unit 25, and a needle-off monitoring unit 26; on the first blood line 21, the blood temperature monitoring unit 23, the blood volume monitoring unit 25, and the needle-off monitoring unit 26 are sequentially arranged from the arterial end to the input end of the dialysis instrument 6; on the second blood line 22, the blood temperature monitoring unit 23, the needle-off monitoring unit 26, and the online clearance rate monitoring unit 24 are sequentially arranged from the output end of the dialysis instrument 6 to the venous end.

[0012] As a preferred technical solution, the blood temperature monitoring unit 23 includes an arterial temperature sensor or a venous temperature sensor, the arterial temperature sensor is arranged on the first blood line 21, and the venous temperature sensor is arranged on the second blood line 22; the output end of the arterial temperature sensor or the venous temperature sensor is sequentially connected to the input end of the main control module 3 through a signal conditioning circuit and an analog-to-digital converter.

[0013] The dedicated temperature sensors are configured for the arterial and venous blood lines respectively, precise differentiation and monitoring of the arterial blood temperature and the venous blood temperature during hemodialysis are realized, the combination of the signal conditioning circuit and the analog-to-digital converter ensures that the temperature signal can be stably and accurately converted into a digital signal and transmitted to the main control module 3, and high-precision data is provided for temperature correlation calculation in blood line recirculation risk analysis.

[0014] As a preferred technical solution, the online clearance rate monitoring unit 24 is specifically an optical detection device, including a photodetector and an ultraviolet light source; the output end of the photodetector is connected to the input end of the main control module 3 through a signal processing device; When the online clearance rate monitoring unit 24 is working, the ultraviolet light source emits ultraviolet light to the blood line, and the photodetector receives the light intensity signal of the transmitted light; the higher the urea concentration, the more light is absorbed, and the weaker the received light intensity signal; the main control module 3 calculates the clearance rate based on the collected light intensity signals of the transmitted light of the first blood line 21 and the second blood line 22.

[0015] As a preferred technical solution, the ultraviolet light source is configured with multiple wavelengths, and when the online clearance rate monitoring unit 24 is working, dual-wavelength detection is adopted, and two wavelengths of ultraviolet light are emitted at the same time, one is the urea characteristic absorption peak, and the other is the reference absorption peak of red blood cells or hemoglobin; the real absorbance of urea is obtained by automatically deducting the interference of red blood cell scattering and hemoglobin absorption through the difference calculation of the light intensity signals of the two wavelengths.

[0016] As a preferred technical solution, the blood volume monitoring unit 25 is specifically an optical detection device, including a photodetector and a light-emitting diode; The blood volume monitoring unit 25 works by emitting a light beam from a light-emitting diode to the blood line, collecting the light intensity signal of the transmitted light by a photodetector, and then converting the hemoglobin concentration value based on the Lambert-Beer law according to the detected light intensity signal of the transmitted light, and calculating the blood volume based on the hemoglobin concentration value.

[0017] As a preferred technical solution, the needle-off monitoring unit 26 adopts a tube clamp type or wrapped type pressure sensor group, which is arranged on the first blood line 21 and the second blood line 22 respectively, and simultaneously detects the pressure of the arterial end and the venous end; the output end of the pressure sensor group is connected to the input end of the main control module 3 through a signal conditioning circuit.

[0018] The tube clamp type or wrapped type pressure sensor group design can tightly fit the blood line to achieve sensitive capture of pressure, and simultaneously monitor the pressure of the arterial end and the venous end in two ways, which can quickly discover the pressure abnormalities caused by needle-off, and the signal conditioning circuit ensures stable transmission of the pressure signal, so that the main control module 3 can trigger the alarm in time, and minimize the safety risks such as blood loss caused by needle-off.

[0019] As a preferred technical solution, in the blood line recirculation risk analysis model, first, the correlation deviation value of clearance rate and blood temperature is calculated based on the clearance rate and blood temperature, and then it is judged whether the deviation value is within the preset deviation value range, if not, the alarm module 5 is directly triggered to send an alarm signal; if yes, the blood line recirculation risk value is further calculated, if the blood line recirculation risk value is greater than the preset risk value, it is determined that there is a blood line recirculation risk at present and the alarm module 5 is triggered to send an alarm signal; otherwise, it is determined that there is no blood line recirculation risk at present, and the alarm module 5 is not triggered; the specific calculation formula of the process is: Wherein, is the correlation deviation value; is the real-time clearance rate; is the clearance rate change in the preset unit time; is the preset correlation coefficient of clearance rate and blood temperature; is the blood temperature change in the preset unit time; is the blood line recirculation risk value; is the blood temperature fluctuation frequency.

[0020] As a preferred technical solution, in the low blood pressure risk analysis model, first, the predicted systolic pressure is calculated based on the blood pressure and blood volume, and the vascular compensation coefficient is calculated based on the blood pressure and blood volume change; then, the predicted systolic pressure and the vascular compensation coefficient are comprehensively judged to determine whether there is a low blood pressure risk; if the predicted systolic pressure is less than the preset minimum systolic pressure or the vascular compensation coefficient is less than the preset minimum compensation value, it is determined that there is a low blood pressure risk at present and the alarm module 5 is triggered to issue an alarm signal; otherwise, it is determined that there is no low blood pressure risk at present, and the alarm module 5 is not triggered; the specific calculation formula of the process is: Wherein, is the predicted systolic pressure; is the real-time systolic pressure; is the blood volume change rate in the lag time; is the preset blood volume and blood pressure correlation coefficient; is the lag time of blood volume change and blood pressure change; is the diastolic pressure change in the lag time; is the vascular compensation coefficient; is the systolic pressure change in the lag time; is the blood volume change in the lag time; is the preset dialysis baseline diastolic pressure.

[0021] According to another aspect of the present application, a working method of an integrated intelligent hemodialysis monitoring system is provided, and the method steps include: The main control module 3 triggers the monitoring module to work, collects blood pressure, blood temperature, blood volume and clearance rate data, and all data are uploaded to the main control module 3 in real time; The main control module 3 processes and analyzes the data, and monitors whether each data is within the safety threshold in real time; and the algorithm analysis unit synchronously calls the blood circuit recirculation and low blood pressure risk model to complete the joint risk judgment based on multiple data; The main control module 3 presents the data and analysis results through the display module 4; if it is determined that there is a risk, the alarm module 5 is immediately triggered by the main control module 3, and the display module 4 synchronously marks the risk information; The process of repeated collection, analysis and output at a preset time interval dynamically adapts to the dialysis treatment process.

[0022] When the system starts, the main control module 3 self-checks the connection state of the monitoring, display and alarm module 5; The multi-modal data threshold of blood pressure, blood temperature and the like, and the analysis parameters of the double risk model can be set by medical staff, and the data is stored in the main control module 3.

[0023] Compared with the prior art, the present application has the following beneficial effects: 1. This invention connects the patient's arterial and venous blood circuits to the dialysis instrument via a first and second blood circuit, respectively. It achieves compatibility without structural modifications to existing dialysis equipment, making it highly adaptable and enabling rapid upgrades to the monitoring capabilities of traditional dialysis instruments. Simultaneously, the algorithm analysis unit integrates a blood circuit recirculation risk analysis model and a hypotension risk analysis model. The blood circuit recirculation risk analysis model, based on multimodal data such as clearance rate and blood temperature, accurately identifies potential blood circuit recirculation risks through quantitative correlation calculations, avoiding incomplete toxin removal due to recirculation. The hypotension risk analysis model, combined with dynamic data on blood pressure and blood volume, predicts blood pressure trends, overcoming the limitations of traditional monitoring which only provides post-event alarms. This system breaks through the limitations of traditional scattered monitoring data and reliance on manual risk assessment, allowing medical staff to intuitively grasp treatment dynamics through the display module and obtain timely risk warnings through the alarm module. Ultimately, it achieves equipment compatibility upgrades and accurate risk monitoring and early warning, significantly reducing equipment upgrade costs for medical institutions and improving the safety and monitoring efficiency of hemodialysis treatment.

[0024] 2. In this invention, by rationally planning the connection path of the first and second blood circuits and the arrangement order of the monitoring units, the comprehensiveness and accuracy of monitoring key parameters of the entire hemodialysis process are achieved. The monitoring chain from the arterial end to the dialysis instrument and from the dialysis instrument to the venous end is complete, and it can simultaneously capture multiple risk points such as blood temperature, blood volume, clearance rate and needle dislodgement, providing a complete data link for the system to comprehensively assess the treatment status.

[0025] 3. This invention employs ultraviolet light optical detection principles to achieve online real-time monitoring of the clearance rate, eliminating the need for offline sampling and detection. Through the direct correlation between light intensity signals and urea concentration, the main control module 3 can quickly calculate the clearance rate data. Medical personnel can monitor the toxin clearance effect in patients in real time, providing a dynamic basis for timely adjustments to dialysis plans and improving the targeted nature of treatment. The dual-wavelength detection design effectively solves the interference problem of red blood cell scattering and hemoglobin absorption on urea concentration detection in traditional optical detection. By calculating the signal difference between the characteristic absorption peak and the reference absorption peak, the true absorbance of urea can be accurately extracted, greatly improving the accuracy of online clearance rate monitoring and avoiding misjudgments of the clearance rate due to interference, providing a reliable guarantee for treatment effect evaluation.

[0026] 4. In this invention, based on the Lambert-Beer law, the indirect and accurate measurement of blood volume is achieved through the optical combination of light-emitting diodes and photodetectors. This method does not require invasive operation, which not only ensures patient safety but also allows for real-time acquisition of hemoglobin concentration and blood volume data. This enables medical staff to keep abreast of changes in the patient's blood volume and effectively avoid treatment risks caused by excessive fluctuations in blood volume.

[0027] 5. In this invention, a blood circulation recirculation risk analysis model is used to achieve quantitative assessment and graded early warning of blood circulation recirculation risk. The model constructs a correlation calculation logic between clearance rate and blood temperature, introduces correlation deviation values ​​for preliminary risk screening, and then completes accurate determination using blood circulation recirculation risk values. Compared with single-parameter judgment methods, this completely eliminates subjective errors and biases. This model can capture abnormal signals when blood circulation recirculation just begins to show signs, avoiding problems such as decreased dialysis efficiency and inadequate toxin clearance due to missed risk assessments. Simultaneously, the quantitative risk assessment results provide medical staff with clear intervention guidelines, reducing unnecessary alarm interference, thus ensuring the effectiveness of dialysis treatment and improving clinical work efficiency.

[0028] 6. This invention achieves a breakthrough from passive monitoring to proactive prediction through a hypotension risk analysis model, realizing both forward-looking early warning and comprehensive assessment. The model incorporates dual-indicator analysis of predicted systolic blood pressure and vascular compensation coefficient. It uses parameters such as blood volume change rate and blood pressure lag time to predict blood pressure trends in advance, while simultaneously assessing the patient's self-regulation potential based on vascular compensation capacity. This not only issues warnings before blood pressure drops to dangerous levels but also distinguishes between temporary blood pressure fluctuations and genuine hypotension risk, avoiding excessive intervention. This precise and forward-looking analytical capability allows medical staff time to adjust dialysis protocols, significantly reducing the incidence of intradialysis hypotension, minimizing adverse reactions such as dizziness and nausea caused by hypotension, and greatly improving patient comfort and safety. It is particularly suitable for elderly patients and high-risk dialysis populations with weakened vascular function. Attached Figure Description

[0029] Figure 1 This is a schematic diagram of the overall structure of the integrated intelligent hemodialysis monitoring system of the present invention; Figure 2 This is a schematic diagram of the integrated intelligent hemodialysis monitoring system of the present invention being wall-mounted on a dialysis instrument; Figure 3 This is a schematic diagram of the working process of the blood pressure monitoring unit in this invention; Figure 4 This is a schematic diagram of the working process of the blood temperature monitoring unit in this invention; Figure 5 This is a schematic diagram of the workflow of the online clearance rate monitoring unit in this invention; Figure 6 This is a schematic diagram of the working process of the blood volume monitoring unit in this invention; Figure 7 This is a schematic diagram of the working process of the needle removal monitoring unit in this invention; Figure 8 This is a schematic diagram of the workflow of the blood circulation risk analysis model in this invention; Figure 9A schematic diagram of a workflow of the low blood pressure risk analysis model in the present application; In the figure, 1 is a blood pressure monitoring unit, 2 is a multi-modal monitoring sub-module, 21 is a first blood path tube, 22 is a second blood path tube, 23 is a blood temperature monitoring unit, 24 is an online clearance rate monitoring unit, 25 is a blood volume monitoring unit, 26 is a needle dislodgement monitoring unit, 3 is a main control module, 4 is a display module, 5 is an alarm module, and 6 is a dialysis instrument. DETAILED DESCRIPTION

[0030] The technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative work should fall within the protection scope of the present application.

[0031] Embodiment 1 In the present embodiment, an integrated intelligent hemodialysis monitoring system is adopted, as shown in the figure, which comprises a monitoring module, a main control module 3, a display module 4 and an alarm module 5. Figure 1 The main control module 3 is electrically connected with the monitoring module, the display module 4 and the alarm module 5 respectively. The monitoring module comprises a blood pressure monitoring unit 1 and a multi-modal monitoring sub-module 2; the multi-modal monitoring sub-module 2 comprises a first blood path tube 21, a second blood path tube 22 and a plurality of monitoring units; one end of the first blood path tube 21 is connected with an arterial end output blood path tube, and the other end is connected with an input end of a dialysis instrument 6; one end of the second blood path tube 22 is connected with a venous end input blood path tube, and the other end is connected with an output end of the dialysis instrument 6; the monitoring module is used for collecting multi-modal data in a hemodialysis process, and the multi-modal data comprises blood temperature, clearance rate, blood volume and blood pressure. The main control module 3 comprises a processing control unit and an algorithm analysis unit; the algorithm analysis unit is integrated with a blood path recirculation risk analysis model and a low blood pressure risk analysis model; the main control module 3 controls the monitoring module to collect multi-modal data, and then completes data monitoring and risk analysis through the data; the monitoring result is transmitted to the display module 4 on one hand, and is used as a basis to control the alarm module 5 to send an alarm signal on the other hand.

[0032] ​In hardware implementation, the core processor of the master module 3 adopts an STM32F407VGT6 microcontroller, which uses its built-in DSP instruction set to accelerate floating-point operations. For optical signals, a 16-bit high-precision external ADC (such as ADS1115) is used, with a sampling rate of 20 SPS to distinguish subtle absorbance changes. For pressure signals, a 12-bit ADC built into the MCU is used, with a sampling rate of 100 SPS, and a second-order RC low-pass filter circuit with a cutoff frequency of 20 Hz is used to capture pulse waveforms in real time.

[0033] In terms of circuit connection of the master module 3, the processing control unit (MCU) serves as the core hub of the system, and data interaction is achieved through different hardware interfaces: Analog signal acquisition interface: The flexible pressure sensor of the blood pressure monitoring unit 1 and the thermistor output of the blood temperature monitoring unit 23 both output analog voltage signals. The MCU is connected to the output end of the signal conditioning circuit through the built-in multi-channel 12-bit ADC interface, with the pin configured in analog input mode and the sampling reference voltage set to high-precision 3.3V to ensure the accuracy of analog quantity acquisition.

[0034] Digital bus interface: The photoelectric acquisition part in the online clearance monitoring unit 24 and the blood volume monitoring unit 25 has an independent analog-to-digital conversion chip integrated. The MCU communicates with it through the I2C bus or SPI bus to read digitized light intensity data. At the same time, the MCU connects an EEPROM memory through the I2C interface for saving historical monitoring data and calibration parameters of the patient during power failure.

[0035] Control output interface: The MCU connects the drive circuits of the inflation device and the exhaust device through the GPIO (general input / output) interface, outputs high and low level control to start and stop the air pump and open and close the valve, and connects the display screen backlight adjustment circuit and the alarm buzzer through the PWM (pulse width modulation) interface to realize frequency control of the alarm tone.

[0036] Communication interface: The MCU connects the Wi-Fi / Bluetooth communication module through the UART (universal asynchronous receiver-transmitter) interface to realize wireless data transmission.

[0037] The system supports wall hanging or placement on the dialysis instrument 6. Wall hanging on the dialysis instrument 6 is shown in Figure 2 The blood circuit and dialysate circuit sensors are connected via an integrated cable.

[0038] In addition, in order to facilitate medical staff to configure and intervene in different monitoring functions flexibly, the main control module 3 is also connected with a man-machine interactive operation panel. The operation panel is integrated with a plurality of physical function buttons, specifically including: a power button, a total control switch, a timing setting button, and independent control switches for each sub-function, which are respectively a BVM (blood volume) monitoring button, a BTM (blood temperature) monitoring button, a Kt / V (clearance rate) monitoring button, a needle-off detection button and a BPM (blood pressure) monitoring button.

[0039] In a specific circuit implementation, the above-mentioned buttons all adopt a light touch type mechanical switch or a membrane switch structure.

[0040] The power button is connected to the enable end of the power management circuit or the external wake-up pin of the MCU. When the power button is pressed for a long time, the power management circuit is turned on, and the voltage of the lithium battery is converted into 3.3V / 5V system voltage to supply power to the whole machine. When it is pressed again for a long time, the system shutdown interrupt is triggered, and the MCU executes data saving and then cuts off the power supply.

[0041] The function button connection mode: the total control switch, the timing setting button and each sub-function monitoring button are connected to the general input and output interface of the MCU of the main control module 3, and are configured as input mode. In order to prevent false triggering caused by button jitter, an RC hardware anti-jitter circuit composed of a resistor and a capacitor is connected in parallel in the circuit of each button, or the pull-up resistor in the MCU is turned on and software anti-jitter is performed through software delay algorithm.

[0042] Button control logic: Total control switch: defined as the running / standby state switching of the system. Pressing the button, the system enters the full-function monitoring mode, and all enabled sensors are started according to the preset logic.

[0043] Sub-function monitoring button (BVM / BTM / Kt / V / needle-off / BPM): adopts self-locking or trigger flip logic. Taking the BVM monitoring button as an example, pressing the button, the BVM function flag in the MCU is "1", the system starts to collect optical data and calculate blood volume; pressing the button again, the flag is "0", and the monitoring is stopped to save power consumption. Each button is bypassed or internally integrated with an LED status indicator light, which is lit by the MCU through GPIO output high and low level, directly feeding back whether the function is in the open state.

[0044] Timing setting button: used for setting the monitoring time or alarm. By pressing it for a short time to add time step (such as increasing 30 minutes each time) or pressing it for a long time to enter the time setting menu, the dialysis treatment time countdown setting is completed with the display module 4.

[0045] The working process of the blood pressure monitoring unit 1 (BPM) is as follows Figure 3As shown, the blood pressure monitoring unit 1 includes a cuff, an inflation device, a deflation device, and a flexible pressure sensor; the flexible pressure sensor is arranged inside the cuff, and the cuff is connected with the inflation device and the deflation device through a closed gas passage respectively; the blood pressure monitoring unit 1 further includes a signal conditioning circuit composed of an amplifier and a filter, an input end of the signal conditioning circuit is connected with an output end of the flexible pressure sensor, and an output end of the signal conditioning circuit is connected with an input end of the main control module 3.

[0046] The core principle of blood pressure monitoring is the oscillometric method, which does not directly listen to Korotkoff sounds, but calculates blood pressure values by analyzing pressure fluctuations (oscillatory waves) generated by arterial pulsation after cuff inflation. When the cuff pressure is higher than the systolic pressure, the artery is completely closed and blood flow cannot pass through, and the pressure in the cuff is stable. When the cuff pressure is equal to or lower than the pressure in the artery, the arterial blood vessels will periodically open and close with the heartbeat, thereby generating a small pulse pressure fluctuation in the cuff. By detecting and analyzing these fluctuations, the blood pressure can be calculated.

[0047] In this embodiment, the blood pressure monitoring unit 1 specifically includes the following components: Cuff: wrapped around the limb (usually the upper arm), composed of an inelastic wrapping cloth and an inflatable rubber air bag. It is the executive component of applying pressure and sensing pressure fluctuations.

[0048] Inflation pump and valve: The air pump inflates the cuff quickly according to the instructions of the microprocessor, so that the pressure exceeds the expected systolic pressure. The inflation valve or deflation valve precisely controls the inflation and deflation of the gas in the cuff. During measurement, the deflation valve will deflate at a slow and constant speed.

[0049] Flexible pressure sensor: continuously monitors the static pressure (from inflation) and dynamic, small pulse pressure fluctuations (from arterial pulsation) in the cuff.

[0050] Signal conditioning circuit: includes an amplifier and a filter, the amplifier amplifies the weak electrical signal from the pressure sensor. The filter filters out low-frequency interference and electrical high-frequency noise caused by breathing, muscle activity, etc., and only retains the heartbeat-related pulse oscillatory wave.

[0051] The microprocessor of the corresponding main control module 3 participates in the control and processing of the following processes: controls the entire inflation and deflation process; receives and digitizes the signals from the pressure sensor; runs algorithms to calculate systolic pressure, diastolic pressure, and mean pressure from a series of oscillatory waves; outputs the results to the display screen.

[0052] During the inflation stage, the air pump inflates quickly, the cuff pressure rises rapidly to a preset value of 180 mmHg, exceeding the systolic pressure, and the artery is completely closed, at which time no oscillatory wave is generated. During the slow deflation stage, the deflation valve slowly deflates at a constant speed, and the cuff pressure linearly decreases.

[0053] When the cuff pressure equals the systolic pressure, the arterial blood begins to break through the compression flow for the first time, and the first detectable oscillatory wave is generated. As the pressure continues to drop, the amplitude of the oscillatory wave gradually increases. When the cuff pressure equals the mean arterial pressure, the degree of arterial expansion is the largest, and the amplitude of the oscillatory wave reaches the maximum value. Subsequently, the amplitude of the oscillatory wave gradually decreases. When the cuff pressure equals the diastolic pressure, the artery is fully open, the pulsation is no longer affected by the cuff, and the amplitude of the oscillatory wave rapidly decreases. In the calculation stage, the microprocessor in the main control module 3 records the pressure values and the corresponding oscillatory wave amplitudes in the entire deflation process.

[0054] The mean arterial pressure directly corresponds to the cuff pressure at the point of the maximum amplitude of the oscillatory wave.

[0055] The systolic pressure (SBP) and the diastolic pressure (DBP) are calculated by an empirical algorithm according to the amplitude-pressure curve. The method used is: SBP corresponds to the maximum amplitude value, i.e. the cuff pressure at the 0.55 times; DBP corresponds to another proportion, i.e. the cuff pressure at the 0.85 times. The proportion coefficient is variable, and is determined by the device algorithm of each manufacturer.

[0056] The several monitoring units include a blood temperature monitoring unit 23, an online clearance rate monitoring unit 24, a blood volume monitoring unit 25, and a needle dislodgement monitoring unit 26; on the first blood line 21, the blood temperature monitoring unit 23, the blood volume monitoring unit 25, and the needle dislodgement monitoring unit 26 are sequentially arranged from the arterial end to the input end of the dialysis instrument 6; on the second blood line 22, the blood temperature monitoring unit 23, the needle dislodgement monitoring unit 26, and the online clearance rate monitoring unit 24 are sequentially arranged from the output end of the dialysis instrument 6 to the venous end.

[0057] Signal conditioning circuit for blood pressure and needle dislodgement monitoring: Since the voltage signals output by the flexible pressure sensor and the needle dislodgement pressure sensor are at the millivolt (mV) level, and are accompanied by high-frequency interference, the signal conditioning circuit is a cascade structure including an instrument amplifier and an active low-pass filter.

[0058] Specifically, the differential signal output by the sensor first enters the instrument amplifier (INA333 or AD620 chip is selected in this embodiment), and the signal is amplified by 100-500 times through the setting of the external gain resistor, and is converted into a single-ended signal in the range of 0-3.3V.

[0059] Subsequently, the amplified signal is connected to a second-order Butterworth low-pass filter composed of an operational amplifier, and the cutoff frequency is set to 20Hz. This circuit can effectively filter out power frequency interference (50Hz / 60Hz) and high-frequency electromagnetic noise, while retaining the complete pulse wave characteristic signal, and finally output to the ADC input end of the main control module 3.

[0060] The blood temperature monitoring unit 23 (BTM) workflow is shown in Figure 4 The blood temperature monitoring unit 23 includes an arterial temperature sensor or a venous temperature sensor, the arterial temperature sensor is arranged on the first blood line 21, and the venous temperature sensor is arranged on the second blood line 22; the output end of the arterial temperature sensor or the venous temperature sensor is connected to the input end of the main control module 3 in sequence through a signal conditioning circuit and an analog-to-digital converter.

[0061] The principle of the BTM function in hemodialysis is based on the heat dilution method; mainly by precisely controlling the slight temperature change of the dialysate, and detecting this change with a thermistor on the arterial and venous blood circuit. Its functions include: calculating the real blood flow rate by analyzing the decay of the venous end temperature peak; judging the blood vessel recirculation by observing whether there is an abnormal temperature change at the arterial end after cooling; monitoring the absolute temperature of the blood in real time to ensure safety; and calculating the energy balance of the patient during treatment.

[0062] The dedicated temperature sensors are configured for the arterial and venous blood lines respectively, which realizes the accurate differentiation and monitoring of the arterial blood and venous blood temperature during hemodialysis. The combination of the signal conditioning circuit and the analog-to-digital converter ensures that the temperature signal can be stably and accurately converted into a digital signal and transmitted to the main control module 3, providing high-precision data for temperature-related calculations in blood recirculation risk analysis.

[0063] The online clearance rate (Kt / V) monitoring unit 24 workflow is shown in Figure 5 The online clearance rate monitoring unit 24 is specifically an optical detection device, including a photodetector and an ultraviolet light source; the output end of the photodetector is connected to the input end of the main control module 3 through a signal processing device; When the online clearance rate monitoring unit 24 is working, the ultraviolet light source emits ultraviolet light to the blood line, and the photodetector receives the light intensity signal of the transmitted light; the higher the urea concentration, the more light is absorbed, and the weaker the received light intensity signal; then the main control module 3 calculates the clearance rate based on the light intensity signals of the transmitted light of the first blood line 21 and the second blood line 22 collected.

[0064] The ultraviolet light source is configured with multiple wavelengths, and when the online clearance rate monitoring unit 24 is working, dual-wavelength detection is adopted, and two wavelengths of ultraviolet light are emitted at the same time, one is the urea characteristic absorption peak, and the other is the reference absorption peak of red blood cells or hemoglobin. Through the difference calculation of the light intensity signals of the two wavelengths, the interference of red blood cell scattering and hemoglobin absorption is automatically deducted to obtain the true absorbance of urea.

[0065] The principle of this method is that urea has a strong absorption effect on specific wavelength ultraviolet light (usually around 280-290nm). By directly measuring the change of urea concentration in blood before and after dialysis through an optical sensor, the clearance rate is calculated.

[0066] First, the optical measurement is carried out, the sensor emits ultraviolet light of a specific wavelength through the venous blood path tube, and then signal capture is carried out, the probe receives the light intensity signal of the transmitted light, the higher the urea concentration, the more light is absorbed, and the weaker the received light intensity signal. Then signal processing is carried out, the system converts the light intensity signal into an electrical signal, which is amplified and filtered to remove noise. The concentration calculation system calculates the relative concentration of urea in the blood in real time according to the Lambert-Beer Law through the change value of the light intensity. Finally, the clearance rate calculation is carried out, and the system will simultaneously or alternately measure the urea concentration at the arterial end and the venous end.

[0067] According to the formula, the urea clearance rate (K) and the urea reduction rate (URR) are calculated: Among them, is the urea concentration at the arterial end before the dialyzer; is the urea concentration at the venous end after the dialyzer; is the blood flow rate.

[0068] In this embodiment, dual-wavelength detection is used, and two wavelengths of ultraviolet light are used simultaneously, one is the urea characteristic absorption peak, which uses 210 nm, and the other is the reference absorption peak of red blood cells or hemoglobin, which uses 230 nm. The difference between the absorbances of the two wavelengths is calculated to automatically deduct the interference of red blood cell scattering and hemoglobin absorption, and the true absorbance of urea is indirectly obtained.

[0069] And a dynamic correction model is integrated in the main control unit, a mathematical model of hematocrit (Hct) - absorbance interference is established through pre-experiment, and the Hct value of the patient is monitored in real time; part of the equipment can be linked with the Hct monitoring function of the hemodialysis machine, and the detection results are automatically corrected according to the model, reducing the influence of red blood cells on urea detection at different Hct levels.

[0070] In order to ensure the accuracy of optical detection and solve the influence of hose deformation on optical path, the online clearance rate monitoring unit 24 and the blood volume monitoring unit 25 in this embodiment are both equipped with a fixed optical path clamp. The clamp is made of black light-shielding ABS material, and has a limiting groove with a width of 4.5 mm inside. When the clamp is buckled on the blood path tube, the standard PVC blood path tube (outer diameter 6.8 mm) is slightly flattened to a fixed thickness of 4.0 mm (i.e. optical path d=4 mm). This mechanical structure design ensures the constancy of the optical path variable in the Lambert-Beer Law, so that the absorbance change is only related to the concentration of blood components.

[0071] Specific implementation of the driving and receiving circuit of the optical monitoring unit: Light source driving circuit: constant current source driving circuit is adopted, the main control module 3 outputs control voltage to the constant current driving chip, so as to accurately control the current of the light emitting diode (LED) or ultraviolet light source to be constant, and avoid the light intensity jitter caused by the battery voltage fluctuation.

[0072] Photoelectric receiving circuit: transimpedance amplification circuit is adopted. The weak photoelectric current (nA level) output by the photodetector (photodiode) is connected to the inverting input terminal of the operational amplifier, and the current signal is converted into a voltage signal by cooperating with the feedback resistor. In order to adapt to different light transmittances, a multi-channel analog switch controlled by the MCU is connected in parallel in the feedback loop, which is used to automatically switch the resistance value of the feedback resistor, so as to realize automatic switching of the range and ensure that the output signal is always within the optimal sampling range of the ADC.

[0073] The working process of the blood volume monitoring unit 25 (BVM) is as shown in the following figure: Figure 6 The blood volume monitoring unit 25 is specifically an optical detection device, which includes a photodetector and a light emitting diode; when the blood volume monitoring unit 25 works, the light emitting diode emits a light beam to the blood path tube, the photodetector collects the light intensity signal of the transmitted light, and then the main control module 3 converts the detected light intensity signal of the transmitted light into a hemoglobin concentration value based on the Lambert-Beer law, and calculates the blood volume based on the hemoglobin concentration value.

[0074] The core principle of the BVM is to measure the relative concentration change of a component in the blood which is not easy to penetrate the dialyzer membrane, so as to inversely deduce the change of the blood volume. The optical principle is to use the absorption characteristics of hemoglobin to specific wavelength light. Hemoglobin basically does not pass through the dialyzer membrane.

[0075] The basic logic is as follows: When the blood volume decreases, the blood is concentrated, and the relative concentration of red blood cells and hemoglobin increases. When the blood volume increases, the blood is diluted, and the relative concentration of red blood cells and hemoglobin decreases. The BVM system calculates the percentage change of the relative blood volume (RBV) by continuously monitoring the relative change of the concentration.

[0076] The working process is specifically as follows: Firstly, a baseline is established: when the dialysis treatment starts, the blood volume is in the initial state. The BVM system will automatically set the signal intensity at this time as the reference value (i.e. 100%).

[0077] During the whole treatment process, the optical sensor continuously monitors the light absorption rate of the blood flowing through the blood path tube. According to the Lambert-Beer law, the system converts the detected light intensity signal into a hemoglobin concentration value: Wherein, is the relative blood volume percentage at time t; is the hemoglobin concentration at the beginning of treatment (baseline) calculated from the light intensity signal; is the hemoglobin concentration at time t calculated from the light intensity signal, is the hemoglobin concentration at time t calculated from the light intensity signal.

[0078] The calculation results processed by the main control module 3 are displayed in real time on the display module 4 to form an RBV trend curve. The core value of BVM is not a single value, but the trend change in the whole treatment process.

[0079] If the RBV curve drops very steeply, it indicates that the patient is very sensitive to dehydration and has poor vascular refilling rate (i.e., the speed of water in the tissue returning to the blood vessels is slow), which is a high-risk signal for hypotension. At this time, medical staff should adjust the ultrafiltration rate to make the curve flat. If the RBV curve is flat: it indicates that the patient can tolerate the current dehydration speed and has good vascular refilling.

[0080] When the patient approaches his true dry weight, the body's compensatory mechanism will weaken, and the vascular refilling ability will decrease. At this time, the RBV curve will have an inflection point, i.e., the slope of the curve suddenly becomes steep. This provides an objective reference for doctors to assess dry weight. By observing the RBV curve, doctors can develop individualized ultrafiltration programs for patients, such as a fast-then-slow curve ultrafiltration mode, rather than a constant dehydration speed, thereby greatly improving the safety and comfort of treatment. The process is non-invasive, real-time and continuous, and can provide critical prognostic information, significantly reducing hypotension events during dialysis.

[0081] The physical essence of needle disconnection is that the blood line system changes from closed to open. This will cause a dramatic and characteristic change in pressure.

[0082] The working process of the needle disconnection monitoring unit 26 is shown in Figure 7 The needle disconnection monitoring unit 26 adopts a tube clamp type or wrapped type pressure sensor group, which is arranged on the first blood line tube 21 and the second blood line tube 22 respectively, and simultaneously detects the pressure of the arterial end and the venous end. The output end of the pressure sensor group is connected to the input end of the main control module 3 through a signal conditioning circuit.

[0083] The tube clamp type or wrapped type pressure sensor group design can closely adhere to the blood line tube to achieve sensitive capture of pressure, and simultaneously monitor the pressure of the arterial end and the venous end in double channels, which can quickly discover pressure abnormalities caused by needle disconnection. The signal conditioning circuit ensures stable transmission of the pressure signal, so that the main control module 3 can trigger an alarm in time, thereby minimizing the safety risks such as blood loss caused by needle disconnection.

[0084] The sensor is a medical-grade miniature pressure sensor, characterized by high accuracy and fast response. It is installed at the pressure monitoring point of the arterial and venous tubing. The optimal solution is to connect it directly to the pressure monitoring port of the existing dialysis machine 6 via a T-connector, or to use a clamp-type or wrap-around sensor that is directly clipped onto the blood tubing, eliminating the need for puncture and avoiding the risk of infection. It is essential to monitor the pressure at both the arterial and venous ends simultaneously.

[0085] The signal conditioning circuit in the needle removal monitoring unit 26 includes an amplifier and a filter. The instrumentation amplifier is used to amplify the weak signal from the sensor. A low-pass filter is designed to filter out high-frequency noise generated by the machine pump and fluid flow, while retaining low-frequency and DC signals of pressure changes.

[0086] During needle removal monitoring, data acquisition is performed first, with the sampling rate set to 50-100Hz.

[0087] The algorithm for detecting needle removal is as follows: Condition 1: Sudden change in absolute pressure value: Calculate the real-time slope of the pressure value, i.e., the first derivative.

[0088] Characteristics of needle removal: Arterial pressure suddenly rises sharply, negative values ​​decrease, and approach zero; venous pressure suddenly drops sharply and approaches zero.

[0089] Set a slope threshold; exceeding this threshold will trigger an initial warning.

[0090] Condition 2: Sudden change in stable pressure value: After the needle is removed, the pressure will stabilize at a new level.

[0091] The algorithm needs to monitor whether the pressure jumps from one stable value to another within a short period of time, such as 1-3 seconds, and maintains that value.

[0092] Condition 3: Correlation between arterial and venous signals: To determine whether a needle has truly dislodged, the pressure at both the arterial and venous ends will undergo abrupt changes in opposite directions almost simultaneously. The algorithm should establish a correlation model between arterial and venous pressures; only when both signals meet the characteristics of needle dislodgment and are highly synchronized in time should it be definitively confirmed as needle dislodged.

[0093] The system will only recognize a suspected needle detachment signal as a valid needle detachment event and trigger an alarm when the signal is detected, persists, and is confirmed by a verification algorithm. This improves alarm accuracy and reduces false alarms.

[0094] The needle removal monitoring system is equipped with an anti-interference design, featuring an extremely short confirmation delay window (e.g., 500ms) to avoid false alarms caused by momentary disturbances such as coughing or turning over. The normal baseline pressure can drift slowly due to ultrafiltration, blood flow rate adjustments, etc. The algorithm incorporates an adaptive baseline that should automatically track these slow changes and be sensitive only to rapid abrupt shifts.

[0095] Also can collect a large number of normal treatment and simulate the pressure data of needle shedding, train a simple classification model (such as support vector machine SVM), embed in MCU, further improve the recognition accuracy.

[0096] The system automatically performs sensor and alarm circuit self-checking when starting; it must meet the medical electrical equipment safety standards to prevent electric leakage and ensure patient safety.

[0097] The alarm module 5 includes a buzzer and a diode, and the main control module 3 is integrated with a communication module, which specifically adopts a Wi-Fi or Bluetooth module. When the main control module 3 triggers the alarm module 5 to alarm, the alarm signal is synchronously pushed to the central monitoring system of the nurse station or the medical staff terminal, realizing remote alarm.

[0098] The sound alarm adopts a buzzer with >85dB, and the sound mode should be sharp and continuous; the light alarm adopts a red diode, which flashes red when alarming.

[0099] The system also includes a power module, which includes a lithium battery and a power management circuit. The output end of the power management circuit supplies power to the main control module 3 and each monitoring unit. The structure of the lithium battery and the power management circuit has a complete technical solution in the prior art, which will not be described here.

[0100] The system follows the design principles of high integration and safety priority, integrates multiple parameter monitoring functions into an integrated host, effectively reduces external devices through a unified hardware platform and software system, and simplifies the clinical operation process. The system supports wall hanging or placement on the dialysis instrument 6, connects blood and dialysate pipeline sensors through an integrated cable, realizes multi-source data fusion and intelligent correlation analysis (such as synchronous interpretation of blood pressure and blood volume trend), and provides deeper disease insight and risk warning (such as dynamic assessment of needle shedding risk) for clinical practice. The host is equipped with a ≥7-inch color touch screen, which can display comprehensive parameter trend charts on the same screen, facilitating intuitive observation of parameter correlations; the alarm system adopts a hierarchical alarm mechanism combining sound and light, distinguishes alarm types through different sound modes, and is equipped with a one-key mute function, which maximizes the reduction of interference to medical staff while ensuring the reliability of the alarm.

[0101] Example 2 In this embodiment, an integrated intelligent hemodialysis monitoring system is used, which includes a monitoring module, a main control module 3, a display module 4, and an alarm module 5. The main control module 3 is electrically connected with the monitoring module, the display module 4, and the alarm module 5, respectively. The monitoring module comprises a blood pressure monitoring unit 1 and a multi-modal monitoring submodule 2; the multi-modal monitoring submodule 2 comprises a first blood path tube 21, a second blood path tube 22 and a plurality of monitoring units; one end of the first blood path tube 21 is connected to an arterial end output blood path tube, and the other end is connected to an input end of a dialysis instrument 6; one end of the second blood path tube 22 is connected to a venous end input blood path tube, and the other end is connected to an output end of the dialysis instrument 6; the monitoring module is used for collecting multi-modal data in a hemodialysis process, and the multi-modal data comprises blood temperature, clearance rate, blood volume and blood pressure; The main control module 3 comprises a processing control unit and an algorithm analysis unit; a blood path recirculation risk analysis model and a hypotension risk analysis model are integrated in the algorithm analysis unit; the main control module 3 controls the monitoring module to collect multi-modal data, and then completes data monitoring and risk analysis through the data; the monitoring result is transmitted to the display module 4 on one hand, and is used as a basis for controlling the alarm module 5 to send an alarm signal on the other hand.

[0102] The difference between the embodiment and the embodiment 1 is that, in the system, a blood temperature monitoring module and a blood volume monitoring module share an optical sensor system; the module is equipped with a specific wavelength (such as 810 nm) LED and a photodetector, and is installed on a detection loop of a venous blood path tube; the energy balance and the relative blood volume percentage are calculated synchronously through the light absorption principle. When the blood temperature is monitored, the energy balance is calculated according to the difference between the temperature of the blood before returning to the body and the set temperature; when the blood volume is monitored, the relative blood volume percentage is calculated according to the change in the absorption of light by hemoglobin. The blood temperature monitoring and the blood volume monitoring share an optical system, thereby saving space and cost.

[0103] In the system, blood pressure monitoring is completed by a high-precision pressure sensor, which is respectively arranged at an arterial pressure monitoring point and a venous pressure monitoring point, and real-time pressure data are collected and trends and alarms are provided. Online clearance rate monitoring adopts an ultraviolet absorption spectrum method, directly detects the change in urea concentration in blood through an optical sensor fixed on a venous tube, and evaluates the dialysis efficiency in real time. Needle detachment detection reuses pressure sensor data, identifies the stepwise mutation characteristics of arterial and venous pressures through a special algorithm, and can be combined with optical signals for auxiliary verification, thereby improving the alarm reliability.

[0104] Data unified processing and intelligent alarm are performed by the algorithm in the main control module 3. All sensor data are synchronously collected and time-stamped in a unified platform, and multi-parameter correlation analysis is realized through an intelligent alarm engine. For example, the system can issue an early warning in combination with the steep trend of blood volume at the initial stage of blood pressure drop. The engine also has a false alarm suppression capability, such as confirming the continuous abnormal state after the pressure mutation in the needle detachment detection. In addition, the system provides clinical decision support, can automatically generate a comprehensive treatment report, comprehensively presents Kt / V, RBV curve, blood pressure trend, body temperature change and the like, records historical data, and is convenient for doctors to refer, thereby recommending treatment parameters for patients in a personalized manner.

[0105] The blood circuit recirculation risk analysis model workflow is as shown in Figure 8 In the blood circuit recirculation risk analysis model, first, the correlation deviation value of clearance rate and blood temperature is calculated based on the clearance rate and blood temperature, and then it is judged whether the deviation value is within the preset deviation value range. If not, the alarm module 5 is directly triggered to issue an alarm signal. If it is, the blood circuit recirculation risk value is further calculated. If the blood circuit recirculation risk value is greater than the preset risk value, it is determined that there is a blood circuit recirculation risk at present and the alarm module 5 is triggered to issue an alarm signal. Otherwise, it is determined that there is no blood circuit recirculation risk at present, and the alarm module 5 is not triggered. The specific calculation formula of the process is: wherein, is the correlation deviation value; is the real-time clearance rate; is the clearance rate change amount per unit time; is the preset clearance rate and blood temperature correlation coefficient; is the blood temperature change amount per unit time; is the blood circuit recirculation risk value; is the blood temperature fluctuation frequency.

[0106] In order to make the above risk analysis model have operability in actual application, the key parameters in the model are calibrated and verified in this embodiment. In the blood circuit recirculation risk analysis model, the parameter , i.e. the preset clearance rate and blood temperature correlation coefficient, is obtained based on a large amount of clinical data regression analysis, and is preferably set to 0.18; the parameter , i.e. the blood temperature fluctuation frequency, is set to 0.05 Hz, which is used to filter non-pathological high-frequency temperature noise; in terms of determination threshold, when the correlation deviation value exceeds 0.15 and the calculated risk value is greater than 0.8, the system determines that it is high risk and alarms.

[0107] The low blood pressure risk analysis model workflow is as shown in Figure 9 In the low blood pressure risk analysis model, first, the predicted systolic pressure is calculated based on the blood pressure and blood volume, and the vascular compensation coefficient is calculated based on the blood pressure and blood volume change amount. Then, whether there is a low blood pressure risk is judged comprehensively based on the predicted systolic pressure and the vascular compensation coefficient. If the predicted systolic pressure is less than the preset minimum systolic pressure or the vascular compensation coefficient is less than the preset minimum compensation value, it is determined that there is a low blood pressure risk at present and the alarm module 5 is triggered to issue an alarm signal. Otherwise, it is determined that there is no low blood pressure risk at present, and the alarm module 5 is not triggered. The specific calculation formula of the process is: wherein, predict systolic pressure; real-time systolic pressure; rate of blood volume change in the lag time; preset blood volume and blood pressure correlation coefficient; lag time of blood volume change and blood pressure change; diastolic pressure change in the lag time; vascular compensation coefficient; systolic pressure change in the lag time; blood volume change in the lag time; preset dialysis baseline diastolic pressure.

[0108] In the low blood pressure risk analysis model, the parameters , the blood volume and blood pressure correlation coefficient, are set to 2.8, that is, the model considers that for every 1% decrease in relative blood volume, there is a tendency for a 2.8 mmHg decrease in systolic pressure; the lag time is set to 900 seconds (i.e., 15 minutes), representing the average physiological response time for the body to decrease blood volume to a substantial decrease in blood pressure; the preset dialysis baseline diastolic pressure is the average diastolic pressure value measured within 10 minutes before dialysis. The alarm threshold is set as follows: when the predicted systolic pressure is less than 90 mmHg or the vascular compensation coefficient is less than 1.2, an alarm is triggered.

[0109] The system breaks through the limitations of traditional monitoring of a single parameter and independent alarm, and upgrades to a smart monitoring platform with multi-parameter fusion, intelligent early warning, and decision support, which can significantly improve treatment quality, ensure patient safety, and reduce the workload of medical staff.

[0110] In terms of mode innovation, the system breaks industry monopolies and provides core support for the large-scale popularization of monitoring solutions. It creates an external high-compatibility solution that deeply adapts to existing various types of dialysis instruments and 6 stock equipment in hospitals, without the need for replacement or upgrade of the original hardware. It can conveniently access the dialysis extracorporeal circulation pipeline through a set of independent systems and fully implement various monitoring functions. This mode completely breaks down the adaptation barriers between different brands and models of equipment, significantly reduces the landing threshold and promotion difficulty of medical institutions at all levels, effectively avoids core pain points such as complex equipment modification, high adaptation cost, and long deployment period in large-scale applications, and helps monitoring technology to quickly cover more diagnosis and treatment scenarios, providing an efficient and feasible implementation path for the standardized development of the industry.

[0111] At the level of technical innovation, the breakthrough lies in the integration of multi-sensor fusion and algorithm: first, the integration design integrates the functions of monitoring blood temperature, monitoring blood pressure, monitoring online clearance rate and monitoring blood volume into a compact module connected in parallel with the blood line, realizing single-point access for comprehensive monitoring; second, the unique clearance rate monitoring scheme directly detects the concentrations of urea, creatinine and other metabolites in dialysis waste liquid by ultraviolet spectroscopy, and calculates Kt / V value in real time. Compared with the traditional conductivity method, this method is more direct and accurate, and is not affected by the ion concentration of dialysate; third, intelligent data interconnection, device monitoring data can be uploaded to the hospital dialysis management system in real time through wireless or wired way, and the monitoring record meeting the policy requirements is automatically generated, which is convenient for medical team to trace back and analyze, and ensures that the diagnosis and treatment behavior is compliant and traceable.

[0112] The implementation of the scheme will bring significant clinical value and industry development value: the product can improve the treatment quality and safety in dialysis treatment, and the multi-parameter integrated monitoring can provide comprehensive real-time data for medical staff, provide data support for individualized dialysis and early warning of adverse reactions such as hypotension, and ultimately benefit patients; at the same time, as a data acquisition terminal, the system can form a large amount of dialysis clinical database, provide training data basis for artificial intelligence or large language assisted diagnosis and treatment model, optimize dry weight evaluation and realize precise ultrafiltration, and become the core infrastructure of intelligent dialysis department; in addition, the scheme successfully breaks through the technical barriers of the original equipment manufacturers, can be applied to large-scale medical equipment upgrade, and is expected to promote the development of blood dialysis monitoring field to a more open and compatible direction.

[0113] The above is only a specific embodiment of the present application, but the protection scope of the present application is not limited thereto, any skilled person in the art can easily think of various equivalent modifications or replacements within the technical scope disclosed by the present application, and these modifications or replacements should be covered within the protection scope of the present application. Therefore, the protection scope of the present application should be subject to the protection scope of the claims.

Claims

1. An integrated intelligent hemodialysis monitoring system, characterized in that, The system comprises a monitoring module, a main control module (3), a display module (4) and an alarm module (5); The main control module (3) is electrically connected with the monitoring module, the display module (4) and the alarm module (5) respectively; The monitoring module comprises a blood pressure monitoring unit (1) and a multi-modal monitoring sub-module (2); the multi-modal monitoring sub-module (2) comprises a first blood line (21), a second blood line (22) and a plurality of monitoring units; one end of the first blood line (21) is connected with an arterial end output blood line, and the other end is connected with an input end of a dialysis instrument (6); one end of the second blood line (22) is connected with a venous end input blood line, and the other end is connected with an output end of the dialysis instrument (6); the monitoring module is used for collecting multi-modal data in a hemodialysis process; the multi-modal data comprises blood temperature, clearance rate, blood volume and blood pressure; The main control module (3) comprises a processing control unit and an algorithm analysis unit; a blood line recirculation risk analysis model and a hypotension risk analysis model are integrated in the algorithm analysis unit; the main control module (3) controls the monitoring module to collect multi-modal data, and then completes data monitoring and risk analysis through the data; the monitoring result is transmitted to the display module (4) on one hand, and is used as a basis for controlling the alarm module (5) to send an alarm signal on the other hand.

2. The integrated intelligent hemodialysis monitoring system according to claim 1, wherein, The blood pressure monitoring unit (1) comprises a cuff, an inflation device, an exhaust device and a flexible pressure sensor; the flexible pressure sensor is arranged on the inner side of the cuff, and the cuff is connected with the inflation device and the exhaust device through a closed gas passage respectively; The blood pressure monitoring unit (1) further comprises a signal conditioning circuit composed of an amplifier and a filter; an input end of the signal conditioning circuit is connected with an output end of the flexible pressure sensor; and an output end of the signal conditioning circuit is connected with an input end of the main control module (3).

3. The integrated intelligent hemodialysis monitoring system of claim 1, wherein, The plurality of monitoring units comprise a blood temperature monitoring unit (23), an online clearance rate monitoring unit (24), a blood volume monitoring unit (25) and a needle-off monitoring unit (26); on the first blood line (21), from the arterial end to the input end of the dialysis instrument (6), the blood temperature monitoring unit (23), the blood volume monitoring unit (25) and the needle-off monitoring unit (26) are sequentially arranged; on the second blood line (22), from the output end of the dialysis instrument (6) to the venous end, the blood temperature monitoring unit (23), the needle-off monitoring unit (26) and the online clearance rate monitoring unit (24) are sequentially arranged.

4. The integrated intelligent hemodialysis monitoring system of claim 3, wherein, The blood temperature monitoring unit (23) comprises an arterial temperature sensor or a venous temperature sensor; the arterial temperature sensor is arranged on the first blood line (21), and the venous temperature sensor is arranged on the second blood line (22); an output end of the arterial temperature sensor or the venous temperature sensor is connected with an input end of the main control module (3) through a signal conditioning circuit and an analog-to-digital converter in sequence.

5. The integrated intelligent hemodialysis monitoring system of claim 3, wherein, The online clearance rate monitoring unit (24) is specifically an optical detection device, which comprises a photodetector and an ultraviolet light source; an output end of the photodetector is connected with an input end of the main control module (3) through a signal processing device; When the online clearance rate monitoring unit (24) works, the ultraviolet light source emits ultraviolet light to the blood line, and the photodetector receives the light intensity signal of the transmitted light; The higher the urea concentration is, the more light is absorbed, and the weaker the received light intensity signal is; the main control module (3) calculates the clearance rate based on the collected light intensity signals of the transmitted light of the first blood line pipe (21) and the second blood line pipe (22).

6. The integrated intelligent hemodialysis monitoring system of claim 5, wherein, The ultraviolet light source is configured with multiple wavelengths, and when the online clearance rate monitoring unit (24) is working, dual-wavelength detection is adopted, and ultraviolet light of two wavelengths is emitted at the same time, one is the urea characteristic absorption peak, and the other is the reference absorption peak of red blood cells or hemoglobin; the real absorbance of urea is obtained by automatically deducting the interference of red blood cell scattering and hemoglobin absorption through the difference calculation of the light intensity signals of the two wavelengths.

7. The integrated intelligent hemodialysis monitoring system of claim 3, wherein, The blood volume monitoring unit (25) is specifically an optical detection device, which comprises a photodetector and a light-emitting diode. When the blood volume monitoring unit (25) is working, the light-emitting diode emits a light beam to the blood line pipe, the photodetector collects the light intensity signal of the transmitted light, and then the main control module (3) converts the hemoglobin concentration value based on the detected light intensity signal of the transmitted light based on the Lambert-Beer law, and calculates the blood volume based on the hemoglobin concentration value.

8. The integrated intelligent hemodialysis monitoring system of claim 3, wherein, The needle removal monitoring unit (26) adopts a pipe clamp type or a wrapped type pressure sensor group, which is arranged on the first blood line pipe (21) and the second blood line pipe (22) respectively, and simultaneously detects the pressure of the arterial end and the venous end; the output end of the pressure sensor group is connected to the input end of the main control module (3) through a signal conditioning circuit.

9. The integrated intelligent hemodialysis monitoring system of claim 3, wherein, In the blood line recirculation risk analysis model, first, the associated deviation value of the clearance rate and the blood temperature is calculated based on the clearance rate and the blood temperature, and then it is judged whether the deviation value is within the preset deviation value range; if not, the alarm module (5) is directly triggered to send an alarm signal; if yes, the blood line recirculation risk value is further calculated; if the blood line recirculation risk value is greater than the preset risk value, it is determined that there is a blood line recirculation risk at present and the alarm module (5) is triggered to send an alarm signal; otherwise, it is determined that there is no blood line recirculation risk at present, and the alarm module (5) is not triggered; the specific calculation formula of the process is: wherein, is an association bias value; is a real-time clearance rate; is a clearance rate change amount per preset unit time; is a preset clearance rate and blood temperature association coefficient; is a blood temperature change amount per preset unit time; is a blood circuit recirculation risk value; is a blood temperature fluctuation frequency.

10. The integrated intelligent hemodialysis monitoring system of claim 3, wherein, In the low blood pressure risk analysis model, first, the predicted systolic pressure is calculated based on the blood pressure and the blood volume, and the vascular compensation coefficient is calculated based on the blood pressure and the blood volume change; then, the predicted systolic pressure and the vascular compensation coefficient are comprehensively judged to determine whether there is a low blood pressure risk; if the predicted systolic pressure is less than the preset minimum systolic pressure or the vascular compensation coefficient is less than the preset minimum compensation value, it is determined that there is a low blood pressure risk at present and the alarm module (5) is triggered to send an alarm signal; otherwise, it is determined that there is no low blood pressure risk at present, and the alarm module (5) is not triggered; the specific calculation formula of the process is: wherein, is a predicted systolic blood pressure; is a real-time systolic blood pressure; is a rate of blood volume change over a lag time; is a preset blood volume and blood pressure correlation coefficient; is a lag time of blood volume change and blood pressure change; is a diastolic blood pressure change amount over a lag time; is a vascular compensation coefficient; is a systolic blood pressure change amount over a lag time; is a blood volume change amount over a lag time; is a preset dialysis baseline diastolic blood pressure.

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