A blood purification device and an operating method thereof

Abstract

The present application belongs to the field of medical device technology, and discloses a blood purification device and an operation method thereof, wherein the device comprises: a mobile trolley, a fixed bracket, a purification mechanism and an abnormal monitoring mechanism; a fixed bracket is provided on the mobile trolley, and a purification mechanism is provided on the fixed bracket; an abnormal monitoring mechanism is fixedly provided on the fixed bracket; the purification mechanism comprises an arterial pot, a dialyzer, a venous pot, a blood pump, a replacement fluid storage box, an ultrafiltrate collection box, a dialysate storage box, a replacement fluid pump, an ultrafiltrate pump, an arterial tube, a venous tube, a dialysate pump and a heparin pump, and a purification capacity evaluation module is fixedly provided on the fixed bracket. The present invention continuously monitors the blood purification process through the abnormal monitoring mechanism, promptly discovers abnormal conditions in the blood purification process, evaluates the dialysis effect of the dialyzer according to the monitoring data, and ensures that when the main dialyzer fails or has problems, the standby dialyzer can be immediately activated by setting two dialyzers, so as to ensure the continuity of the dialysis process and the safety of the patient.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and more specifically, to a blood purification device and an operating method thereof. Background Art

[0002] Hemodialysis (HD) is one of the renal replacement therapies for patients with acute and chronic renal failure. It removes metabolic wastes, maintains electrolyte and acid-base balance, removes excess water from the body, and returns the purified blood to the body. The whole process is called hemodialysis.

[0003] The document with the prior art publication number CN113893398B provides a blood purification ultrafiltration device, wherein a plurality of filter components are connected to the base, each filter component includes an inlet pipe, a heating device, a No. 1 outlet pipe, a blood filter and an infusion tube, wherein a buffer mechanism is connected inside the No. 1 outlet pipe, and after the blood is introduced into the inlet pipe, it is insulated and anticoagulated by the heating device and decelerated by the No. 1 outlet pipe before entering the blood filter, and the output end of the blood filter is connected to the infusion tube, and the blood flows out of the blood filter and is output through the infusion tube. The heating device includes a water bath and a heater. The buffer mechanism includes a liquid level rack, a buffer rack and a liquid level ring. The liquid level ring includes an outer ring, a center rod and a plurality of connecting columns rotatably connected to the left and right sides of the center rod, and buffer leaves are connected to the connecting columns. A stirring rod is connected inside the water bath. The stirring rod is detachably connected through a cross block and a cross embedding hole. The invention has a simple structure and can adjust the speed at which blood enters the dialysis device under the premise of protecting the filter membrane.

[0004] Although the above-mentioned prior art solutions can achieve relevant beneficial effects through the structure of the prior art, they still have the following defects: 1. They cannot automatically detect abnormal conditions during the blood purification process, and cannot timely detect dangerous conditions and potential dangers. 2. When the dialyzer fails or the dialysis effect does not meet the requirements, the operation of hemodialysis purification needs to be stopped, which results in low work efficiency.

[0005] In view of this, we propose a blood purification device and an operating method thereof. Summary of the invention

[0006] 1. Technical issues to be solved

[0007] The purpose of this application is to provide a blood purification device and an operating method thereof, which solves the technical problems raised in the above-mentioned background technology, realizes continuous monitoring of the blood purification process through an abnormal monitoring mechanism, timely discovers abnormal conditions in the blood purification process, and ensures patient safety; evaluates the dialysis effect of the dialyzer based on the monitoring data to ensure that the purification needs are met. Timely adjust the working state of the dialyzer to improve the purification efficiency; by setting up two dialyzers, ensure that when the main dialyzer fails or has problems, the spare dialyzer can be immediately activated to ensure the continuity of the dialysis process and the technical effect of patient safety.

[0008] 2. Technical solution

[0009] The technical solution of the present application provides a blood purification device, comprising:

[0010] Mobile trolley, fixed bracket, purification mechanism and abnormality monitoring mechanism.

[0011] A fixed bracket is fixedly arranged on the mobile trolley, and a purification mechanism is fixedly arranged on the fixed bracket.

[0012] An abnormal monitoring mechanism is fixedly arranged on the fixed bracket; the abnormal monitoring mechanism monitors the blood purification process and finds abnormal problems in time. A PLC control module is fixedly arranged on the fixed bracket. The PLC control module is connected to the abnormal monitoring mechanism and the purification mechanism network.

[0013] The purification mechanism includes an arterial pot, a dialyzer, a venous pot, a blood pump, a replacement fluid storage tank, an ultrafiltrate collection tank, a dialysate storage tank, a replacement fluid pump, an ultrafiltrate pump, an arterial tube, a venous tube, a dialysate pump and a heparin pump.

[0014] An arterial tube is connected to the arterial pot; a blood pump is arranged on the arterial tube.

[0015] A replacement fluid pump is fixedly arranged on the replacement fluid storage box; the input end of the replacement fluid pump extends into the replacement fluid storage box; and the output end of the replacement fluid pump is communicated with the arterial pot.

[0016] The lower end of the arterial kettle is detachably fixed with a tee A, and the tee A is connected with two dialyzers; the input end of the dialyzer is connected with the tee A.

[0017] A tee B is fixedly provided on the intravenous pot, and the tee B is respectively connected to the output ends of the two dialyzers; the input end and the output end of the dialyzer are both provided with medical solenoid valves.

[0018] A venous tube is arranged at the lower end of the venous pot; a return pump and a return solenoid valve are arranged on the venous tube; an ultrafiltrate pump is fixedly arranged on the ultrafiltrate collection box; the input end of the ultrafiltrate pump is connected to the dialyzer; the input end of the ultrafiltrate pump is connected to the ultrafiltrate collection box; the dialyzer is connected to the ultrafiltrate pump through a hose, and a solenoid valve is arranged on the hose.

[0019] A dialysate pump is fixedly installed on the dialysate storage box, and the input end of the dialysate pump is connected to the dialysate storage box; the output end of the dialysate pump is connected to the dialyzer. The dialyzer and the dialysate pump are connected by a hose, and a solenoid valve is installed on the hose. An automatic exhaust valve and a manual exhaust valve are fixedly installed on the upper ends of the arterial pot and the venous pot.

[0020] A purification capacity evaluation module is fixedly installed on the fixed bracket. The purification capacity evaluation module combines the arterial pressure, venous pressure, blood pump output, blood return pump return, and replacement fluid pressure information to evaluate the dialysis effect of the dialyzer during the blood purification process and determine whether the current dialysis capacity of the dialyzer meets the demand.

[0021] Through the above technical solution, two dialyzers are provided, one of which is used for normal dialysis and the other is a spare. When the dialyzer in operation fails or has problems, the spare dialyzer is activated to ensure the continuity of the dialysis process. When the spare dialyzer is not in use, no expenses are incurred, and the existence of the spare dialyzer does not bring additional burden to the patient.

[0022] As an optional solution of the present invention, a heparin pump and an arterial pressure detector are provided on the arterial tube; the arterial pressure detector can monitor the pressure in the arterial tube in real time to ensure the stability of blood flow. The heparin pump is used to inject heparin into the blood to prevent blood from coagulation during extracorporeal circulation.

[0023] The venous line is equipped with a venous pressure detector and a reinfusion pump.

[0024] A replacement fluid pressure detector is provided on the hose at the output end of the replacement fluid pump.

[0025] The arterial and venous blood vessels are both fixed with bubble detection mechanisms, which are used to monitor in real time whether there are bubbles in the blood. Once bubbles are found, an alarm is immediately sounded to prevent the occurrence of air embolism.

[0026] As an optional solution of the present invention, the bubble detection mechanism includes:

[0027] Ultrasonic transmitter: Use high-performance piezoelectric ceramics as ultrasonic transmitters. It has good stability and high efficiency in converting electrical energy to acoustic energy. By applying high-frequency electrical signals to the piezoelectric ceramics, it generates mechanical vibrations and emits ultrasonic waves.

[0028] Ultrasonic receiver: uses piezoelectric ceramics as receiving elements, matched with the transmitter to ensure efficient signal reception. The receiver receives ultrasonic signals that have traveled through the blood and may be reflected or scattered back by bubbles. These signals are then converted into electrical signals.

[0029] Signal processing circuit: performs a series of processing on the electrical signal output by the receiver, including amplification and filtering, signal enhancement and feature extraction, in order to identify the signal characteristics related to bubbles.

[0030] Amplification and filtering: The received signal is amplified to improve the signal-to-noise ratio. Subsequently, unnecessary noise and interfering signals are removed through filters.

[0031] Feature extraction and comparison: Use algorithms to extract features from the processed signal, such as analyzing the signal's amplitude, frequency change, or time delay, to determine whether bubbles are present. When a bubble feature matching a preset threshold is detected, the circuit will output an alarm signal.

[0032] The mechanical vibration of the ultrasonic wave is expressed as: x(t) = A*sin(2πft+Φ); where A is the amplitude determined by the physical properties of the piezoelectric ceramic, f is the set ultrasonic frequency, t is the time variable, and Φ is the phase angle determined by the initial conditions. x(t) is the ultrasonic vibration displacement generated by the transmitter at time t.

[0033] The received ultrasonic signal is expressed as: y(t) = B*sin(2πf(t-τ)+ψ)+n(t); where B is the amplitude of the received signal, τ is the round trip time delay of the signal, ψ is the phase of the received signal, and n(t) is noise or interference, usually Gaussian white noise. y(t) is the ultrasonic signal detected by the receiver at time t.

[0034] Signal processing circuit: Amplification and filtering are expressed as: z(t) = G*L{y(t)}; where G is the amplification gain and L{·} represents the filter operation, which is used to remove noise outside the frequency range. z(t) is the signal after amplification and filtering.

[0035] Feature extraction: Use fast Fourier transform (FFT) to perform frequency domain analysis on the amplified and filtered signal z(t): Z(f) = FFT{z(t)}; the amplitude spectrum P(f) represents the signal strength at different frequencies: P(f) = |Z(f)|.

[0036] Signature Analysis: Identify peaks in the amplitude spectrum that may indicate the presence of bubbles. peak = argmaxP(f); calculate the peak energy as the intensity index of the bubble feature: E peak =P(f peak ).

[0037] Feature comparison: Set the threshold T to distinguish noise and bubble signals.

[0038] Bubble_Presence={(True, if E peak>T); (False, otherwise)}.

[0039] Where Z(f) is the frequency domain representation of the received signal after fast Fourier transform (FFT). z(t) is the received signal in the time domain. P(f) is the amplitude spectrum, i.e. |Z(f)|, which represents the signal strength at different frequencies. peak It is the frequency corresponding to the maximum value in the amplitude spectrum, that is, the peak frequency. peak is the peak energy, that is, P(f peak ), as the strength indicator of the bubble feature. T is the preset threshold used to distinguish noise from bubble signals. Bubble_Presence is a Boolean value indicating whether there is a bubble feature. If E peak >T, then it is true (bubbles exist), otherwise it is false (no bubbles exist).

[0040] Alarm device: includes sound alarm and visual alarm.

[0041] Display module: displays the detected bubble information in real time, such as the size, quantity, position, etc. of the bubbles.

[0042] Through the above technical solution, the bubble detection mechanism realizes efficient detection of bubbles in the blood through ultrasonic technology, ensuring the accuracy and timeliness of the detection.

[0043] As an optional solution of the present invention, the abnormality monitoring mechanism monitors the blood purification process and promptly discovers abnormal problems, including:

[0044] Historical data collection module: collects a large amount of patient information, including historical medical conditions, medication history, allergies, etc.; collects a large number of images of patients in abnormal conditions, annotates the images, and uses them as reference samples.

[0045] Data acquisition module: real-time acquisition of physiological parameters directly related to the blood purification process (such as arterial pressure, venous pressure, blood flow and replacement fluid pressure, etc.) and the patient's basic vital signs (such as heart rate, blood pressure, respiration, oxygen saturation, etc.). These data are important bases for evaluating the patient's status and blood purification effect, and can quickly reflect whether the patient is in an abnormal state.

[0046] An electrocardiograph, an automatic sphygmomanometer, a respiratory monitor and a pulse oximeter (SpO2) are installed on the fixed bracket to obtain the patient's heart rate, heart rhythm, blood pressure, respiration and oxygen saturation data in real time.

[0047] Image acquisition module: including high-definition camera; collects high-definition images of patients during the blood purification process; uses high-definition camera to continuously collect images of patients during the blood purification process. Image information can directly reflect the patient's body movements, facial expressions, etc., providing intuitive visual basis for abnormality identification.

[0048] Image preprocessing module: preprocess the collected images, including filtering, denoising, normalization and grayscale conversion, etc.; improve image quality to facilitate subsequent feature extraction and recognition.

[0049] Feature extraction module: extract features from the preprocessed images to extract body and facial expression features, including color, texture, and shape; these features can reflect the body and facial expression status of the patient.

[0050] Abnormality recognition module: Compare and analyze the extracted features with reference samples, and use machine learning or deep learning algorithms to identify abnormal conditions of patients. Abnormal limbs or facial expressions of patients can be detected in a timely manner.

[0051] Comprehensive evaluation module: Combines the results of the abnormality identification module with information on arterial pressure, venous pressure, blood pump output, blood pump return, replacement fluid pressure, heart rate, heart rhythm, blood pressure, respiration and oxygen saturation to conduct a comprehensive evaluation of the blood purification process and assess dangerous situations and potential dangers; can comprehensively consider the patient's overall condition, assess existing dangerous situations and potential risks, and provide decision support for doctors.

[0052] Alarm module: includes an alarm, which will sound the alarm in time when dangerous situations and potential dangers are detected.

[0053] Through the above-mentioned technical solution, by comprehensively applying a variety of technical means and data analysis methods, real-time monitoring of the patient's condition and abnormal warning are achieved, providing a strong guarantee for the safety and effectiveness of blood purification treatment.

[0054] As an optional solution of the present invention, the comprehensive evaluation module combines the results of the abnormal identification module with the information of arterial pressure, venous pressure, blood pump output, blood pump return, replacement fluid pressure, heart rate, heart rhythm, blood pressure, respiration and oxygen saturation to comprehensively evaluate the blood purification process and assess dangerous situations and potential dangers; including the following steps:

[0055] 1. Data integration: Collect data from various data sources in real time (including whether an abnormality is detected, the type of abnormality, the degree of abnormality, etc. It also includes physiological parameter monitoring data: arterial pressure, venous pressure, blood pump output, blood pump return, replacement fluid pressure, patient consciousness, heart rate, heart rhythm, blood pressure, respiratory rate, oxygen saturation, etc.). Clean, verify and format the data to ensure data consistency and accuracy. Integrate the abnormality identification results with various physiological parameter data to form a complete patient status data set.

[0056] 2. Comprehensive analysis: including analysis of the association between abnormalities and physiological parameters, application of risk assessment models and trend prediction.

[0057] Abnormality and physiological parameter correlation analysis: Analyze the correlation between abnormality recognition results and physiological parameters, and identify which changes in physiological parameters may be related to abnormal conditions. Calculate the correlation coefficient between abnormality recognition results and physiological parameters according to the following formula: Among them, X and Y represent the abnormal recognition result and physiological parameter value respectively. and is their average value. X,Y It is the Pearson correlation coefficient between the abnormal recognition result X and the physiological parameter Y, indicating the strength and direction of the linear correlation between the two.

[0058] Application of risk assessment model: Use a preset risk assessment model (which may be based on statistical methods, machine learning algorithms or expert systems) to analyze the integrated data and assess the patient's current dangerous conditions and potential risks.

[0059] The output of the logistic regression model is represented as: Among them, Risk is the risk value calculated according to the logistic regression model, which indicates the probability of the patient experiencing a dangerous situation. 0 ,β 1 ,…,β n are the parameters of the logistic regression model, which are learned through training data. 1 ,…,X n It is the input feature, including physiological parameters such as arterial pressure and venous pressure.

[0060] Trend prediction: Based on the changing trends of historical data and current data, predict possible changes in the patient's condition in the future, including worsening of the disease, occurrence of complications, etc.

[0061] Forecast future values ​​using the Autoregressive Integrated Moving Average (ARIMA) model:

[0062] X t+1 =c+φ 1 *X t +...+φp*X t-p-θ 1 *ε t-1 -...-θ q *ε t-q +ε t+1 ; Among them, X t+1 is

[0063] The predicted value at time t+1. c is a constant term. φ 1 ,…,φ p is the coefficient of the autoregressive term. 1 ,…,θ q is the coefficient of the difference term. t+1 is the error term, representing the prediction error at time t+1.

[0064] 3. Dangerous situation and potential risk assessment: including dangerous situation assessment and potential risk assessment; dangerous situation is determined by comparing the risk assessment results with the preset threshold.

[0065] Hazardous situation assessment: List the currently identified hazardous situations, including abnormality type, severity, possible impact, etc.

[0066] Potential risk assessment: Assess the potential risks that patients may face in the future, including risk type, probability of occurrence, and recommended preventive measures.

[0067] Prioritize assessment findings to ensure that physicians focus on the most serious dangers and potential risks first.

[0068] 4. Decision support and recommendation generation: Automatically generate decision support recommendations based on the assessment results of dangerous situations and potential risks. Recommendations may include adjusting treatment plans, strengthening monitoring measures, taking emergency intervention measures, etc. Ensure the feasibility and effectiveness of the recommendations, taking into account the specific conditions of the patient and the limitations of medical resources.

[0069] 5. Generate reports: Generate comprehensive assessment reports: A complete report containing dangerous situation assessment, potential risk assessment and decision support recommendations. Send emergency notifications or reminder messages to doctors to ensure that they are aware of the patient's dangerous situation and potential risks in a timely manner.

[0070] 6. Continuous optimization and feedback: Regularly collect feedback from doctors on evaluation results and decision support suggestions. Optimize and improve the comprehensive evaluation model based on feedback and actual results.

[0071] In this technical solution, the comprehensive evaluation module can comprehensively consider the patient's overall condition, conduct an in-depth comprehensive evaluation of the blood purification process, and provide doctors with timely and accurate decision-making support.

[0072] The present invention provides a blood purification method, comprising the following steps:

[0073] S1. Move the mobile cart to the bedside of the patient who needs blood purification. Check whether the purification mechanism, abnormal monitoring mechanism, PLC control module and other parts are firmly connected, without looseness or damage. Fill the replacement fluid storage tank and dialysate storage tank, and empty the ultrafiltrate collection tank. Check whether the arterial pot, venous pot, dialyzer and other parts are clean and uncontaminated, and confirm that their connecting pipes are correct.

[0074] S2. Check whether the blood pump, replacement fluid pump, ultrafiltrate pump, dialysate pump, and reinfusion pump and other pump equipment are operating normally through the PLC control module. Open the automatic exhaust valve and manual exhaust valve on the arterial and venous pots to remove the air in the pipeline.

[0075] S3. Start the purification process: Introduce the patient's arterial blood into the arterial pot through the arterial tube, start the blood pump, and circulate the blood in the pipeline. The replacement fluid pump starts working, pumping the replacement fluid from the replacement fluid storage tank into the arterial pot, and then mixing with the blood and entering the dialyzer together.

[0076] S4. In the dialyzer, blood exchanges substances with dialysate through a semipermeable membrane to remove harmful substances from the blood. The purified blood flows out of the dialyzer, enters the venous pot, and then returns to the patient's body through the return pump and return solenoid valve on the venous tube.

[0077] S5. The ultrafiltrate generated during the dialysis process is discharged into the ultrafiltrate collection box through the ultrafiltrate pump. The bubble detection mechanism monitors in real time whether there are bubbles in the blood of the arterial pot and the venous pot.

[0078] S6. Abnormal monitoring mechanism continuously monitors various parameters in the blood purification process, such as arterial pressure, venous pressure, blood flow, dialysate flow, etc. Abnormal conditions in the blood purification process are discovered in a timely manner.

[0079] S7. The purification capacity evaluation module evaluates the dialysis effect of the currently operating dialyzer based on the monitoring data to determine whether it meets the purification requirements.

[0080] S8. When the abnormality recognition module detects a dangerous situation or the comprehensive assessment module detects a potential danger, the alarm module issues an alarm in a timely manner.

[0081] S9. Once the purification capacity evaluation module finds that the currently working dialyzer does not meet the hemodialysis purification requirements, it automatically starts the switching mechanism, closes the medical solenoid valve of the current dialyzer, and stops its operation. At the same time, it opens the medical solenoid valve of the standby dialyzer, switches the blood flow path to the standby dialyzer, and continues the hemodialysis purification operation.

[0082] S10. When bubbles are detected in the blood of the arterial or venous pot, the blood pump and the reinfusion pump stop working, and the automatic exhaust valve on the arterial or venous pot automatically starts to automatically remove the bubbles in the blood of the arterial or venous pot; during this process, the system will continue to monitor the bubbles in the arterial or venous pot to ensure that the bubbles are completely removed. After the bubbles in the blood are completely removed, the blood pump and the reinfusion pump are automatically started to continue the blood purification operation.

[0083] 3. Beneficial effects

[0084] One or more technical solutions provided in the technical solution of this application have at least the following technical effects or advantages.

[0085] 1. The present invention continuously monitors the blood purification process through an abnormality monitoring mechanism, promptly discovers abnormal conditions in the blood purification process, and ensures patient safety.

[0086] 2. Evaluate the dialyzer's dialysis effect based on monitoring data to ensure that the purification needs are met. Adjust the dialyzer's working status in a timely manner to improve purification efficiency.

[0087] 3. When a dangerous situation or potential danger is detected, the alarm module will promptly issue an alarm to remind medical staff to deal with it. By timely alarming, the risk of complications or accidents for patients is reduced.

[0088] 4. Two dialyzers are set up to ensure that when the main dialyzer fails or has problems, the backup dialyzer can be immediately activated to ensure the continuity of the dialysis process and patient safety. When it is found that the current dialyzer does not meet the requirements, the switching mechanism is automatically started to switch to the backup dialyzer to ensure that the purification process is uninterrupted. The use of the backup dialyzer improves the reliability and stability of the entire blood purification system. The backup dialyzer does not incur additional costs when not in use, and does not bring additional burden to the patient. Instead, it provides important safety guarantees.

[0089] 5. The purification capacity evaluation module evaluates the dialysis effect of the dialyzer based on multiple monitoring data to ensure that the purification effect meets the requirements.

[0090] 6. Automatic and manual exhaust valves are set on the arterial and venous pots to effectively remove air from the pipeline and prevent air embolism. The bubble detection mechanism monitors the bubbles in the blood in real time. Once found, it will immediately alarm and stop the operation of related pumps to ensure the safety of the patient. When bubbles are detected, the blood pump and the return pump will be stopped immediately to prevent bubbles from entering the patient's body. It can automatically exhaust and automatically remove bubbles in the blood to ensure the safety and effectiveness of the blood purification process. BRIEF DESCRIPTION OF THE DRAWINGS

[0091] Figure 1 This is a schematic flow chart of a blood purification method disclosed in a preferred embodiment of the present application.

[0092] Figure 2 This is a schematic diagram of the overall structure of a blood purification device disclosed in a preferred embodiment of the present application.

[0093] Figure 3 This is a schematic diagram of a purification mechanism of a blood purification device disclosed in a preferred embodiment of the present application.

[0094] Figure 4 This is a circuit diagram of a bubble detection mechanism of a blood purification device disclosed in a preferred embodiment of the present application.

[0095] Figure numerals: 1. arterial pot; 2. dialyzer; 3. venous pot; 4. blood pump; 5. replacement fluid storage box; 6. ultrafiltrate collection box; 7. dialysate storage box; 8. replacement fluid pump; 9. ultrafiltrate pump; 10. dialysate pump; 11. heparin pump; 12. arterial pressure detector; 13. venous pressure detector; 14. arterial tube; 15. venous tube; 16. three-way A; 17. return pump; 18. replacement fluid pressure detector; 19. return solenoid valve; 20. bubble detection mechanism; 21. automatic exhaust valve; 22. manual exhaust valve; 23. mobile trolley; 24. fixed bracket; 25. purification mechanism; 26. three-way B. DETAILED DESCRIPTION

[0096] The present application is further described in detail below in conjunction with the accompanying drawings.

[0097] Reference Figure 2 and Figure 3 The embodiment of the present application provides a blood purification device, including: a mobile cart 23, a fixed bracket 24, a purification mechanism 25 and an abnormality monitoring mechanism.

[0098] The mobile trolley 23 is fixedly provided with a fixed bracket 24, and the fixed bracket 24 is fixedly provided with a purification mechanism 25; the mobile trolley 23 is equipped with wheels, a brake system and a handle, so that the medical staff can easily operate it. It can be flexibly moved in different medical environments, and is convenient for rapid deployment and transportation.

[0099] The purification mechanism 25 is the core part of the blood purification device and is responsible for removing harmful substances in the blood, such as toxins, wastes, excess water, etc.

[0100] An abnormality monitoring mechanism is fixedly arranged on the fixed support 24; the abnormality monitoring mechanism monitors the blood purification process and finds abnormal problems in time. A PLC control module is fixedly arranged on the fixed support 24. The PLC control module is connected to the abnormality monitoring mechanism and the purification mechanism 25 through a network.

[0101] The purification mechanism 25 includes an arterial pot 1, a dialyzer 2, a venous pot 3, a blood pump 4, a substitution fluid storage tank 5, an ultrafiltrate collection tank 6, a dialysate storage tank 7, a substitution fluid pump 8, an ultrafiltrate pump 9, an arterial tube 14, a venous tube 15, a dialysate pump 10 and a heparin pump 11.

[0102] An arterial tube 14 is connected to the arterial pot 1; a blood pump 4 is arranged on the arterial tube 14; a replacement fluid pump 8 is fixedly arranged on the replacement fluid storage tank 5; the input end of the replacement fluid pump 8 extends into the replacement fluid storage tank 5; the output end of the replacement fluid pump 8 is connected to the arterial pot 1; a tee A16 is detachably fixedly arranged at the lower end of the arterial pot 1, and the tee A16 is connected to two dialyzers 2; the input end of the dialyzer 2 is connected to the tee A16.

[0103] A tee B26 is fixedly provided on the intravenous pot 3, and the tee B26 is respectively connected to the output ends of the two dialyzers 2; the input and output ends of the dialyzer 2 are both provided with medical solenoid valves; the dialyzer 2 is the core component of blood purification, and through the semi-permeable membrane principle, it can remove toxins, waste and excess water in the blood.

[0104] A venous tube 15 is provided at the lower end of the venous pot 3; a reinfusion pump 17 and a reinfusion solenoid valve 19 are provided on the venous tube 15; an ultrafiltrate pump 9 is fixedly provided on the ultrafiltrate collecting box 6; the input end of the ultrafiltrate pump 9 is connected to the dialyzer 2; the input end of the ultrafiltrate pump 9 is connected to the ultrafiltrate collecting box 6; the dialyzer 2 is connected to the ultrafiltrate pump 9 through a hose, and a solenoid valve is provided on the hose.

[0105] A dialysate pump 10 is fixedly arranged on the dialysate storage box 7, and the input end of the dialysate pump 10 is connected to the dialysate storage box 7; the output end of the dialysate pump 10 is connected to the dialyzer 2. The dialyzer 2 is connected to the dialysate pump 10 through a hose, and a solenoid valve is arranged on the hose. A heating plate is fixedly arranged below the dialysate storage box 7, and a temperature controller is fixedly arranged on the dialysate storage box 7.

[0106] The upper ends of the arterial pot 1 and the venous pot 3 are fixedly provided with an automatic exhaust valve 21 and a manual exhaust valve 22. The automatic exhaust valve 21 and the manual exhaust valve 22 can effectively remove the air in the pipeline to prevent air embolism.

[0107] A purification capacity evaluation module is fixedly arranged on the fixed bracket 24. The purification capacity evaluation module combines the arterial pressure, venous pressure, blood pump output, blood return pump return, and replacement fluid pressure information to evaluate the dialysis effect of the dialyzer 2 during the blood purification process, and judge whether the dialysis capacity of the current dialyzer 2 meets the requirements. If the dialysis capacity cannot meet the requirements, the current dialyzer 2 is stopped, and the standby dialyzer 2 is immediately put into operation to continue the blood dialysis purification operation.

[0108] In this technical solution, the blood pump 4, the replacement fluid pump 8, the ultrafiltrate pump 9, the dialysate pump 10 and the return pump 17 provide the necessary power support for the entire purification process, ensuring the smooth flow of blood, replacement fluid, dialysate and ultrafiltrate. The replacement fluid storage tank 5, the ultrafiltrate collection tank 6 and the dialysate storage tank 7 are used to store replacement fluid, collect ultrafiltrate and store dialysate respectively to ensure the continuous progress of the purification process. Two dialyzers 2 are provided, one of which is used for normal dialysis and the other is spare. When the dialyzer 2 in operation fails or has problems, the spare dialyzer 2 is activated to ensure the continuous progress of the dialysis process; one dialyzer is in working state and is responsible for performing the main blood purification task. Blood enters the dialyzer in operation through the arterial pot, and after dialysis, the purified blood returns to the patient's body through the venous pot. The spare dialyzer remains in standby state, but is ready to be activated at any time. The abnormal monitoring mechanism continuously monitors the working state of the main dialyzer, including key parameters such as dialysis efficiency, flow rate, and pressure. Once the main dialyzer is detected to have failure, blockage, leakage or any other problems that may affect the dialysis effect, the abnormal monitoring mechanism will immediately sound an alarm. At the same time, the system automatically starts the switching mechanism to switch the blood flow path from the working dialyzer to the backup dialyzer. When the backup dialyzer is not in use, there is no cost. The existence of the backup dialyzer does not bring additional burden to the patient. It provides additional safety protection for the patient and is an important consideration in the design of blood purification equipment.

[0109] Furthermore, a heparin pump 11 and an arterial pressure detector 12 are provided on the arterial tube 14; the arterial pressure detector 12 can monitor the pressure in the arterial tube in real time to ensure the stability of blood flow. The heparin pump 11 is used to inject heparin into the blood to prevent blood from coagulation during extracorporeal circulation.

[0110] The venous tube 15 is provided with a venous pressure detector 13 and a reinfusion pump 17 .

[0111] A replacement fluid pressure detector 18 is provided on the hose at the output end of the replacement fluid pump 8 .

[0112] Furthermore, the arterial pot 1 and the venous pot 3 are both fixedly provided with a bubble detection mechanism 20. The bubble detection mechanism 20 is provided on the arterial pot 1 and the venous pot 3 to monitor in real time whether there are bubbles in the blood, and to immediately alarm once bubbles are found to prevent the occurrence of air embolism.

[0113] Further, the bubble detection mechanism 20 includes:

[0114] Ultrasonic transmitter: High-performance piezoelectric ceramics are used as ultrasonic transmitters. They have good stability and high efficiency in converting electrical energy to acoustic energy. By applying a high-frequency electrical signal to the piezoelectric ceramic, it generates mechanical vibrations and emits ultrasonic waves. The ultrasonic beam is sent directionally into the blood flow path to be detected. The frequency, beam width, and transmission power of the ultrasonic wave are optimized according to the specific application scenario to ensure that tiny bubbles can be detected without causing damage to the blood or surrounding tissues.

[0115] Ultrasonic receiver: Use piezoelectric ceramics as receiving elements, matched with the transmitter to ensure efficient signal reception. The receiver receives ultrasonic signals that have traveled through the blood and may be reflected or scattered back by bubbles. These signals are then converted into electrical signals. The receiver should have high sensitivity to capture weak reflected signals while maintaining a low noise level to ensure signal accuracy.

[0116] Signal processing circuit: performs a series of processing on the electrical signal output by the receiver, including amplification and filtering, signal enhancement and feature extraction, in order to identify the signal characteristics related to bubbles.

[0117] Amplification and filtering: The received signal is amplified to improve the signal-to-noise ratio. Subsequently, unnecessary noise and interfering signals are removed through filters.

[0118] Feature extraction and comparison: Use algorithms to extract features from the processed signal, such as analyzing the signal's amplitude, frequency change, or time delay, to determine whether bubbles are present. When a bubble feature matching a preset threshold is detected, the circuit will output an alarm signal.

[0119] The mechanical vibration of the ultrasonic wave is expressed as: x(t) = A*sin(2πft+Φ); where A is the amplitude determined by the physical properties of the piezoelectric ceramic, f is the set ultrasonic frequency, t is the time variable, and Φ is the phase angle determined by the initial conditions. x(t) is the ultrasonic vibration displacement generated by the transmitter at time t.

[0120] The received ultrasonic signal is expressed as: y(t) = B*sin(2πf(t-τ)+ψ)+n(t); where B is the amplitude of the received signal, τ is the round trip time delay of the signal, ψ is the phase of the received signal, and n(t) is noise or interference, usually Gaussian white noise. y(t) is the ultrasonic signal detected by the receiver at time t.

[0121] Signal processing circuit:

[0122] The amplification and filtering process is expressed as: z(t) = G*L{y(t)}; where G is the amplification gain, L{·} represents the filter operation, which is used to remove noise outside the frequency range. z(t) is the signal after amplification and filtering.

[0123] Feature extraction: Use fast Fourier transform (FFT) to perform frequency domain analysis on the amplified and filtered signal z(t): Z(f) = FFT{z(t)}; the amplitude spectrum P(f) represents the signal strength at different frequencies: P(f) = |Z(f)|.

[0124] Signature analysis: Identify peaks in the amplitude spectrum that may indicate the presence of bubbles: peak = argmaxP(f); calculate the peak energy as the intensity index of the bubble feature: E peak =P(f peak );

[0125] Feature comparison: Set the threshold T to distinguish noise and bubble signals.

[0126] Bubble_Presence={(True, if E peak >T); (False, otherwise)}.

[0127] Where Z(f) is the frequency domain representation of the received signal after fast Fourier transform (FFT). z(t) is the received signal in the time domain. P(f) is the amplitude spectrum, i.e. |Z(f)|, which represents the signal strength at different frequencies. peak It is the frequency corresponding to the maximum value in the amplitude spectrum, that is, the peak frequency. peak is the peak energy, that is, P(f peak ), as the strength indicator of the bubble feature. T is the preset threshold used to distinguish noise from bubble signals. Bubble_Presence is a Boolean value indicating whether there is a bubble feature. If E peak >T, then it is true (bubbles exist), otherwise it is false (no bubbles exist).

[0128] Alarm device: includes an audible alarm and a visual alarm (such as an LED light). The audible alarm emits a high-decibel alarm, while the visual alarm attracts the attention of medical staff through flashing lights. After receiving the alarm signal output by the signal processing circuit, the alarm device immediately starts and emits an audible and visual alarm until it is manually turned off or the fault is resolved.

[0129] Display module: Displays the detected bubble information in real time, such as the size, quantity, and location of the bubbles. LCD or LED display can be used to provide a clear and easy-to-read interface. The display content is dynamically updated according to the output results of the signal processing circuit to ensure that medical staff can understand the bubble situation during the blood purification process in a timely manner.

[0130] In this technical solution, the bubble detection mechanism 20 realizes efficient detection of bubbles in the blood through ultrasonic technology, thereby ensuring the accuracy and timeliness of the detection.

[0131] Reference Figure 4 , Circuit diagram of bubble detection mechanism 20: The microcontroller PIC12F675 generates a pulse with a frequency of about 500kHz, which is output through the I / O port to supply the waveform conversion and driving circuit. The pulse frequency is consistent with the resonance frequency of the piezoelectric chip. When the frequency of the AC voltage applied to its two ends is equal to the resonance frequency of the chip, the output energy is the largest and the sensitivity is the highest. The transducer at the receiving end sends the detected weak signal to the first-stage high-speed op amp for amplification and rectification and filtering, and then sends it to the A / D converter port of PIC12F675 through the emitter follower buffer. The ten-bit A / D conversion inside PIC12F675 converts the voltage sent by the emitter follower that is proportional to the strength of the received ultrasonic signal, and the conversion result is stored in the buffer. When bubbles pass through the cross section of the sensor or even the liquid level is lower than the sensor detection surface, the converted value will be reduced a lot, and an alarm will be generated after comparison and digital filtering. By setting the comparison value size and the A / D conversion sampling time, the sensitivity of the alarm can be changed, thereby realizing the recognition of bubbles of different sizes. When the signal changes due to changes in ambient temperature, sensor installation, and differences in pipe contact surfaces, the microcontroller can automatically change the trigger alarm threshold based on the sampled value, and filter out abnormal attenuation signals generated by bubbles to generate an alarm.

[0132] Furthermore, the abnormality monitoring agency monitors the blood purification process and promptly detects abnormal problems, including:

[0133] Historical data collection module: collects a large amount of patient information, including historical medical conditions, medication history, allergies, etc.; collects a large number of images of patients in abnormal conditions, annotates the images, and uses them as reference samples.

[0134] Data acquisition module: real-time acquisition of physiological parameters directly related to the blood purification process (such as arterial pressure, venous pressure, blood flow and replacement fluid pressure, etc.) and the patient's basic vital signs (such as heart rate, blood pressure, respiration, oxygen saturation, etc.). These data are important bases for evaluating the patient's status and blood purification effect, and can quickly reflect whether the patient is in an abnormal state.

[0135] The fixed support 24 is provided with an electrocardiograph, an automatic sphygmomanometer, a respiratory monitor and a pulse oximeter (SpO2); the patient's heart rate, heart rhythm, blood pressure, respiration and oxygen saturation data are acquired in real time.

[0136] Image acquisition module: including high-definition camera; collects high-definition images of patients during the blood purification process; uses high-definition camera to continuously collect images of patients during the blood purification process. Image information can directly reflect the patient's body movements, facial expressions, etc., providing intuitive visual basis for abnormality identification.

[0137] Image preprocessing module: preprocess the collected images, including filtering, denoising, normalization and grayscale conversion, etc.; improve image quality to facilitate subsequent feature extraction and recognition.

[0138] Feature extraction module: extract features from the preprocessed images to extract body and facial expression features, including color, texture, and shape; these features can reflect the body and facial expression status of the patient.

[0139] Abnormality recognition module: Compare and analyze the extracted features with reference samples, and use machine learning or deep learning algorithms to identify abnormal conditions of patients. Abnormal limbs or facial expressions of patients can be detected in a timely manner.

[0140] Comprehensive evaluation module: Combines the results of the abnormality identification module with information on arterial pressure, venous pressure, blood pump output, blood pump return, replacement fluid pressure, heart rate, heart rhythm, blood pressure, respiration and oxygen saturation to conduct a comprehensive evaluation of the blood purification process and assess dangerous situations and potential dangers; can comprehensively consider the patient's overall condition, assess existing dangerous situations and potential risks, and provide decision support for doctors.

[0141] Alarm module: includes an alarm, which will sound the alarm in time when dangerous situations and potential dangers are detected.

[0142] In this technical solution, through the comprehensive use of multiple technical means and data analysis methods, real-time monitoring of the patient's condition and abnormal warning are achieved, providing strong guarantees for the safety and effectiveness of blood purification treatment.

[0143] Furthermore, the comprehensive evaluation module combines the results of the abnormal identification module with the information of arterial pressure, venous pressure, blood pump output, blood pump return, replacement fluid pressure, heart rate, heart rhythm, blood pressure, respiration and oxygen saturation to comprehensively evaluate the blood purification process and assess dangerous situations and potential dangers; including the following steps:

[0144] 1. Data integration: Collect data from various data sources in real time (including whether an abnormality is detected, the type of abnormality, the degree of abnormality, etc. It also includes physiological parameter monitoring data: arterial pressure, venous pressure, blood pump output, blood pump return, replacement fluid pressure, patient consciousness, heart rate, heart rhythm, blood pressure, respiratory rate, oxygen saturation, etc.). Clean, verify and format the data to ensure data consistency and accuracy. Integrate the abnormality identification results with various physiological parameter data to form a complete patient status data set.

[0145] 2. Comprehensive analysis: including analysis of the association between abnormalities and physiological parameters, application of risk assessment models and trend prediction.

[0146] Abnormality and physiological parameter correlation analysis: Analyze the correlation between abnormality identification results and physiological parameters, and identify which changes in physiological parameters may be related to abnormal conditions.

[0147] Calculate the correlation coefficient between the abnormality recognition results and the physiological parameters:

[0148] Among them, X and Y represent the abnormal recognition result and physiological parameter value respectively. and is their average value. X,Y It is the Pearson correlation coefficient between the abnormal recognition result X and the physiological parameter Y, indicating the strength and direction of the linear correlation between the two.

[0149] Application of risk assessment model: Use a preset risk assessment model (which may be based on statistical methods, machine learning algorithms or expert systems) to analyze the integrated data and assess the patient's current dangerous conditions and potential risks.

[0150] The output of the logistic regression model is represented as:

[0151] Among them, Risk is the risk value calculated according to the logistic regression model, which indicates the probability of the patient experiencing a dangerous situation. 0 ,β 1 ,…,β n are the parameters of the logistic regression model, which are learned through training data. 1 ,…,X n It is the input feature, including physiological parameters such as arterial pressure and venous pressure.

[0152] Trend prediction: Based on the changing trends of historical data and current data, predict possible changes in the patient's condition in the future, including worsening of the disease, occurrence of complications, etc.

[0153] Forecast future values ​​using an autoregressive integrated moving average (ARIMA) model.

[0154] X t+1 =c+φ 1 *X t +...+φp*X t-p -θ 1 *ε t-1 -...-θ q *ε t-q +ε t+1 ; Among them, X t+1 is

[0155] The predicted value at time t+1. c is a constant term. φ 1 ,…,φ p is the coefficient of the autoregressive term. 1 ,…,θ q is the coefficient of the difference term. t+1 is the error term, representing the prediction error at time t+1.

[0156] 3. Dangerous situation and potential risk assessment: including dangerous situation assessment and potential risk assessment; dangerous situation is determined by comparing the risk assessment results with the preset threshold.

[0157] Hazardous situation assessment: List the currently identified hazardous situations, including abnormality type, severity, possible impact, etc.

[0158] Potential risk assessment: Assess the potential risks that patients may face in the future, including risk type, probability of occurrence, and recommended preventive measures.

[0159] Prioritize assessment findings to ensure that physicians focus on the most serious dangers and potential risks first.

[0160] 4. Decision support and recommendation generation: Automatically generate decision support recommendations based on the assessment results of dangerous situations and potential risks. Recommendations may include adjusting treatment plans, strengthening monitoring measures, taking emergency intervention measures, etc. Ensure the feasibility and effectiveness of the recommendations, taking into account the specific conditions of the patient and the limitations of medical resources.

[0161] 5. Generate reports: Generate comprehensive assessment reports: A complete report containing dangerous situation assessment, potential risk assessment and decision support recommendations. Send emergency notifications or reminder messages to doctors to ensure that they are aware of the patient's dangerous situation and potential risks in a timely manner. Send notification messages to doctors through electronic medical record systems, message push or other communication methods.

[0162] 6. Continuous optimization and feedback: Regularly collect feedback from doctors on evaluation results and decision support suggestions. Optimize and improve the comprehensive evaluation model based on feedback and actual results.

[0163] In this technical solution, the comprehensive evaluation module can comprehensively consider the patient's overall condition, conduct an in-depth comprehensive evaluation of the blood purification process, and provide doctors with timely and accurate decision-making support.

[0164] Furthermore, the purification capacity evaluation module evaluates the dialysis effect of the dialyzer 2 during the blood purification process, including the following steps:

[0165] 1. Data collection: Collect key parameter vectors; collect key parameters such as arterial pressure, venous pressure, blood pump output, blood return pump return, and replacement fluid pressure in real time through sensors. Ensure that all sensors are working properly and the data is accurate, and perform necessary verification and filtering to reduce noise and errors.

[0166] 2. Data preprocessing: Standardize the collected raw data so that the subsequent algorithms can uniformly process data of different dimensions. Calculate the derivative values ​​of key indicators, such as blood flow difference (the difference between blood output and blood return), pressure difference (the difference between arterial pressure and venous pressure), etc. These derivative values ​​may be more direct for evaluating the dialysis effect.

[0167] The blood flow difference ΔQ and pressure difference ΔP are calculated as follows:

[0168] ΔQ=|Q out -Q ret |;ΔP=|P art- P ven ∣.

[0169] Where ΔQ is the blood flow difference, which indicates the blood volume output by the blood pump (Q out ) and the amount of blood transfused by the reinfusion pump (Q ret ). This difference reflects the actual change in blood volume during dialysis and is one of the important indicators for evaluating dialysis effect. Qout is the blood output of the blood pump, which refers to the blood flow from the blood pump to the dialyzer during dialysis. ret It is the amount of blood returned by the infusion pump, which refers to the blood flow from the dialyzer back to the patient's body after dialysis is completed. ΔP is the pressure difference, which represents the difference between arterial pressure and venous pressure. This difference can reflect the pressure change of blood during dialysis and is a parameter for evaluating the working status of the dialyzer. art P is arterial pressure, which refers to the pressure at the arterial end during dialysis, reflecting the pressure level of blood before it enters the dialyzer. ven It is venous pressure, which refers to the pressure at the venous end during dialysis and reflects the pressure level of blood after leaving the dialyzer.

[0170] 3. Evaluation of dialysis effect.

[0171] Step 3.1: Define an evaluation model that takes into account all the above parameters based on medical knowledge, historical data analysis, and expert experience.

[0172] E dial =w 1 *P art +w 2 *P ven +w 3 *Q out +w4*Q ret +w 5 *P dial , where E dial is the dialysis effect evaluation value, that is, the output result of the model, which represents the comprehensive quantitative index of the dialyzer performance. 1 ,w 2 ,…,w 5 are weight coefficients, corresponding to the importance of different parameters. These weight coefficients reflect the contribution of each parameter to the final evaluation result when evaluating the dialysis effect. The weight coefficients are usually determined based on medical knowledge, historical data analysis and expert experience. art P is the arterial pressure, the blood pressure before the blood enters the dialyzer during dialysis. ven is the venous pressure, the blood pressure after it leaves the dialyzer. out Q is the blood output of the blood pump, which is the blood flow from the blood pump to the dialyzer during dialysis. ret It is the blood volume returned by the infusion pump, which is the blood volume returned from the dialyzer to the patient after dialysis is completed. dial It is the replacement fluid pressure, the pressure of the replacement fluid used during dialysis.

[0173] Step 3.2: Input the preprocessed data into the evaluation model to calculate the quantitative indicators of dialysis effect, such as dialysis efficiency, clearance rate, etc.

[0174] The dialysis efficiency η is the ratio of the actual removal to the theoretical removal: η = (Q out- Q ret ) / Q out ; Clearance rate CR is the ratio of blood flow difference to blood output: CR = ΔQ / Q out ; Where η is the dialysis efficiency, which represents the ratio of actual clearance to theoretical clearance. CR is the clearance rate, which represents the ratio of blood flow difference to blood output.

[0175] Step 3.3: Compare the calculated dialysis effect index with a preset threshold or standard to determine whether the currently operating dialyzer 2 meets the dialysis requirements.

[0176] 4. Decision and execution: If the evaluation results show that the dialysis capacity of dialyzer 2 does not meet the requirements, the alarm system is triggered and the next step of enabling the standby dialyzer 2 is automatically executed. The operation of the current dialyzer 2 is stopped immediately to ensure safe shutdown to prevent blood backflow or other unexpected situations. The standby dialyzer 2 is automatically started and necessary initialization settings are performed, such as adjusting blood flow, pressure and other parameters to preset values. The startup process of the standby dialyzer 2 is monitored to ensure that it works normally before continuing the hemodialysis purification operation.

[0177] 5. Monitoring and feedback: Continuously monitor the dialyzer's working status, the patient's vital signs, and the dialysis effect throughout the process to ensure safety and effectiveness. Record the evaluation results, switching operations, and key data in the subsequent dialysis process for subsequent analysis, optimization, and improvement.

[0178] In this technical solution, the dialysis effect of the dialyzer 2 can be effectively evaluated, and the dialyzer can be automatically switched to a spare one when necessary, thereby ensuring the continuity and safety of the hemodialysis purification process.

[0179] Reference Figure 1 The present invention provides a blood purification method, comprising the following steps:

[0180] S1. Move the mobile cart 23 to the bedside of the patient who needs blood purification. Check whether the purification mechanism 25, abnormal monitoring mechanism, PLC control module and other parts are firmly connected and not loose or damaged. Fill the replacement fluid storage tank 5 and dialysate storage tank 7, and empty the ultrafiltrate collection tank 6. Check whether the arterial pot 1, venous pot 3, dialyzer 2 and other parts are clean and uncontaminated, and confirm that their connecting pipes are correct.

[0181] S2. Check whether the blood pump 4, replacement fluid pump 8, ultrafiltrate pump 9, dialysate pump 10, and reinfusion pump 17 and other pump equipment are operating normally through the PLC control module. Open the automatic exhaust valve 21 and the manual exhaust valve 22 on the arterial pot 1 and the venous pot 3 to remove the air in the pipeline.

[0182] S3, start the purification process: introduce the patient's arterial blood into the arterial pot 1 through the arterial tube 14, start the blood pump 4, and circulate the blood in the pipeline. The replacement fluid pump 8 starts working, pumping the replacement fluid from the replacement fluid storage tank 5 into the arterial pot 1, and then mixing with the blood and entering the dialyzer 2 together.

[0183] S4. In the dialyzer 2, the blood exchanges substances with the dialysate through the semipermeable membrane to remove harmful substances in the blood. The purified blood flows out of the dialyzer 2, enters the venous pot 3, and then returns to the patient's body through the return pump 17 and the return solenoid valve 19 on the venous tube 15.

[0184] S5. The ultrafiltrate generated during the dialysis process is discharged into the ultrafiltrate collection box 6 through the ultrafiltrate pump 9. The bubble detection mechanism 20 monitors in real time whether there are bubbles in the blood of the arterial pot 1 and the venous pot 3.

[0185] S6. Abnormal monitoring mechanism continuously monitors various parameters in the blood purification process, such as arterial pressure, venous pressure, blood flow, dialysate flow, etc. Abnormal conditions in the blood purification process are discovered in a timely manner.

[0186] S7. The purification capacity evaluation module evaluates the dialysis effect of the currently operating dialyzer 2 according to the monitoring data to determine whether it meets the purification requirements.

[0187] S8. When the abnormality recognition module detects a dangerous situation or the comprehensive assessment module detects a potential danger, the alarm module issues an alarm in a timely manner.

[0188] S9. Once the purification capacity evaluation module finds that the currently working dialyzer 2 does not meet the hemodialysis purification requirements, the switching mechanism is automatically started to close the medical solenoid valve of the current dialyzer 2 and stop its operation. At the same time, the medical solenoid valve of the standby dialyzer 2 is opened to switch the blood flow path to the standby dialyzer 2 and continue the hemodialysis purification operation.

[0189] S10, when bubbles are detected in the blood of the arterial pot 1 or the venous pot 3, the blood pump 4 and the reinfusion pump 17 stop working, and the automatic exhaust valve 21 on the arterial pot 1 or the venous pot 3 is automatically started to automatically remove bubbles from the blood of the arterial pot 1 or the venous pot 3; during this process, the system will continue to monitor the bubbles in the arterial pot 1 or the venous pot 3 to ensure that the bubbles are completely removed. After the bubbles in the blood are completely removed, the blood pump 4 and the reinfusion pump 17 are automatically started to continue the blood purification operation.

[0190] The working principle of a blood purification device of the present invention is as follows: first, the mobile trolley 23 is moved to the side of the bed of the patient who needs blood purification. Check whether the connection of the purification mechanism 25, the abnormal monitoring mechanism, the PLC control module and other parts is firm, without looseness or damage. Fill the replacement fluid storage box 5 and the dialysate storage box 7, and empty the ultrafiltrate collection box 6. Check whether the components such as the arterial pot 1, the venous pot 3, and the dialyzer 2 are clean and free of pollution, and confirm that their connecting pipelines are correct. Check whether the pump equipment such as the blood pump 4, the replacement fluid pump 8, the ultrafiltrate pump 9, the dialysate pump 10 and the return pump 17 are operating normally through the PLC control module. Open the automatic exhaust valve 21 and the manual exhaust valve 22 on the arterial pot 1 and the venous pot 3 to remove the air in the pipeline. The patient's arterial blood is introduced into the arterial pot 1 through the arterial tube 14, and the blood pump 4 is started to circulate the blood in the pipeline. The replacement fluid pump 8 starts to work, pumps the replacement fluid from the replacement fluid storage tank 5 into the arterial pot 1, and enters the dialyzer 2 together after mixing with the blood. In the dialyzer 2, the blood exchanges substances with the dialysate through a semipermeable membrane to remove harmful substances in the blood. The purified blood flows out of the dialyzer 2, enters the venous pot 3, and then returns to the patient's body through the return pump 17 and the return solenoid valve 19 on the venous tube 15. The ultrafiltrate generated during the dialysis process is discharged into the ultrafiltrate collection box 6 through the ultrafiltrate pump 9. The bubble detection mechanism 20 monitors in real time whether there are bubbles in the blood of the arterial pot 1 and the venous pot 3. The abnormal monitoring mechanism continuously monitors various parameters in the blood purification process, such as arterial pressure, venous pressure, blood flow, dialysate flow, etc. Abnormal conditions in the blood purification process are discovered in time. The purification capacity evaluation module evaluates the dialysis effect of the currently working dialyzer 2 based on the monitoring data and determines whether it meets the purification requirements. When the abnormal identification module detects a dangerous situation or the comprehensive evaluation module detects a potential danger, the alarm module issues an alarm in time. Once the purification capacity evaluation module finds that the currently working dialyzer 2 does not meet the dialysis purification requirements, it automatically starts the switching mechanism, closes the medical solenoid valve of the current dialyzer 2, and stops its work. At the same time, the medical solenoid valve of the standby dialyzer 2 is opened to switch the blood flow path to the standby dialyzer 2, and the hemodialysis purification operation is continued. When bubbles are detected in the blood of the arterial pot 1 or the venous pot 3, the blood pump 4 and the return pump 17 stop working, and the automatic exhaust valve 21 on the arterial pot 1 or the venous pot 3 is automatically started to automatically remove the bubbles in the blood of the arterial pot 1 or the venous pot 3; during this process, the system will continue to monitor the bubbles in the arterial pot 1 or the venous pot 3 to ensure that the bubbles are completely removed. After the bubbles in the blood are completely removed, the blood pump 4 and the return pump 17 are automatically started to continue the blood purification operation.

[0191] The present invention continuously monitors the blood purification process through an abnormal monitoring mechanism, and promptly discovers abnormal conditions in the blood purification process. Ensure patient safety: adjust the purification process through monitoring data to ensure patient safety. Evaluate the dialysis effect of the dialyzer according to the monitoring data to ensure that the purification requirements are met. Timely adjust the working state of the dialyzer to improve the purification efficiency. When a dangerous situation or potential danger is detected, the alarm module promptly issues an alarm to remind medical staff to deal with it. By timely alarming, the risk of complications or accidents in patients is reduced. Two dialyzers (one main and one backup) are set to ensure that when the main dialyzer fails or has problems, the backup dialyzer can be immediately enabled to ensure the continuity of the dialysis process and patient safety. When it is found that the current dialyzer does not meet the requirements, the switching mechanism is automatically started and switched to the backup dialyzer to ensure that the purification process is uninterrupted. The use of the backup dialyzer improves the reliability and stability of the entire blood purification system. The backup dialyzer does not incur additional costs when not in use, and does not bring additional burdens to patients, but provides important safety guarantees. Automatic and manual exhaust valves are set on the arterial pot and the venous pot to effectively remove air in the pipeline and prevent air embolism. The bubble detection mechanism monitors the bubbles in the blood in real time. Once found, it will immediately alarm and stop the operation of related pumps to ensure the safety of patients. When bubbles are detected, the blood pump and the return pump will be stopped immediately to prevent bubbles from entering the patient's body. It can automatically exhaust and remove bubbles in the blood to ensure the safety and effectiveness of the blood purification process.

[0192] As described above, the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that the technical solutions described in the aforementioned embodiments may still be modified, or some of the technical features thereof may be replaced by equivalents. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A blood purification method, characterized in that: The following steps are involved: S1. Check whether the connections of each part are firm, check whether the arterial pot, venous pot and dialyzer parts are clean and free of contamination, and confirm that the connection pipelines are correct; S2. Check whether the blood pump, replacement fluid pump, ultrafiltrate pump, dialysate pump and reinfusion pump are operating normally. Open the manual exhaust valves on the arterial and venous pots to remove the air in the pipelines. S3, the patient's arterial blood is introduced into the arterial pot through the arterial tube, and the blood pump is started to circulate the blood in the pipeline; the replacement fluid pump starts to work, pumping the replacement fluid from the replacement fluid storage tank into the arterial pot, and after mixing with the blood, it enters the dialyzer together; S4, the blood exchanges substances with the dialysate through the semipermeable membrane, the purified blood flows out of the dialyzer, enters the venous pot, and then returns to the patient's body through the return pump and return solenoid valve on the venous tube; S5. The ultrafiltrate generated during the dialysis process is discharged into the ultrafiltrate collection box through the ultrafiltrate pump; the bubble detection mechanism monitors in real time whether there are bubbles in the blood of the arterial pot and the venous pot; S6. The abnormality monitoring mechanism monitors abnormal conditions during the blood purification process; S7, the purification capacity evaluation module evaluates the dialysis effect of the currently working dialyzer according to the monitoring data to determine whether it meets the purification requirements; S8. When a dangerous situation or potential danger is detected, the alarm module will issue an alarm in time; S9, when the purification capacity evaluation module finds that the currently working dialyzer does not meet the hemodialysis purification requirements, it automatically starts the switching mechanism, closes the medical solenoid valve of the current dialyzer, and stops its operation; at the same time, it opens the medical solenoid valve of the standby dialyzer, switches the blood flow path to the standby dialyzer, and continues the hemodialysis purification operation; S10. When bubbles are detected in the blood of the arterial pot or the venous pot, the blood pump and the reinfusion pump stop working, and the automatic exhaust valve on the arterial pot or the venous pot starts automatically to automatically remove the bubbles in the blood of the arterial pot or the venous pot; after the bubbles in the blood are completely removed, the blood pump and the reinfusion pump are automatically started to continue the blood purification operation.

2. The blood purification method according to claim 1, characterized in that: Step S6 includes the following steps: S61, the historical data collection module collects a large amount of patient information, including historical medical conditions, medication history, and allergy information; collects a large amount of images of patients in abnormal conditions, annotates the images, and uses them as reference samples; S62, the data acquisition module collects physiological parameters directly related to the blood purification process and the patient's basic vital signs in real time; S63, the image acquisition module continuously acquires images of the patient during the blood purification process; S64, the image preprocessing module preprocesses the collected image, including filtering, denoising, normalization and grayscale conversion; S65, the feature extraction module performs feature extraction on the preprocessed image, extracting body and facial expression features, including color, texture and shape; S66, abnormality identification module: compare and analyze the extracted features with reference samples, use deep learning algorithms to identify abnormal conditions of patients, and promptly detect abnormal limbs or facial expressions of patients; S67, the comprehensive assessment module combines the results of the abnormality identification module with the information of arterial pressure, venous pressure, blood pump output, blood pump return, replacement fluid pressure, heart rate, heart rhythm, blood pressure, respiration and oxygen saturation to comprehensively assess the blood purification process and evaluate dangerous situations and potential dangers; S68. When a dangerous situation or potential danger is detected, the alarm module issues an alarm in a timely manner.

3. The blood purification method according to claim 2, characterized in that: Step S67 includes the following steps: S671, Data Integration: Collect data from various data sources in real time; clean, verify and format the data, integrate the abnormality recognition results with various physiological parameter data to form a complete patient status data set; S672, Comprehensive analysis: including analysis of association between abnormalities and physiological parameters, application of risk assessment models and trend prediction; S673, Dangerous situation and potential risk assessment: including dangerous situation assessment and potential risk assessment; determining dangerous situations based on the comparison of risk assessment results with preset thresholds; S674, Decision support and suggestion generation: Automatically generate decision support suggestions based on the evaluation results of dangerous situations and potential risks; S675, Generate Report: Generate a comprehensive assessment report, including a complete report of hazardous situation assessment, potential risk assessment and decision support recommendations; S676. Continuous optimization and feedback: Regularly collect feedback from doctors on evaluation results and decision support recommendations; optimize and improve the comprehensive evaluation model based on feedback and actual results.

4. The blood purification method according to claim 3, characterized in that: In step S672, the correlation coefficient between the abnormality recognition result and the physiological parameter is calculated using the following formula: Among them, X and Y represent the abnormal recognition result and physiological parameter value respectively. and is their average value; ρ X,Y is the Pearson correlation coefficient between the abnormal recognition result X and the physiological parameter Y; The integrated data were analyzed using a preset risk assessment model to assess the patient's current risk status and potential risks; the output of the logistic regression model was expressed as: Among them, Risk is the risk value calculated according to the logistic regression model, which indicates the probability of the patient being in a dangerous situation; β0,β1,…,β n are the parameters of the logistic regression model; X1,…,X n are the input features.

5. The blood purification method according to claim 3, characterized in that: In step S672, based on the trend of historical data and current data, the possible changes in the patient's status in the future are predicted, including the deterioration of the condition and the occurrence of complications; the autoregressive integrated moving average ARIMA model is used to predict the future value: X t+1 =c+φ1*X t +...+φp*X t-p -θ1*ε t-1 -...-θ q *ε t-q +ε t+1 ; Among them, X t+1 is the predicted value at time t+1; c is a constant term; φ1,…,φ p are the coefficients of the autoregressive term; θ1,…,θ q is the coefficient of the difference term; ε t+1 represents the prediction error at time t+1.

6. The blood purification method according to claim 1, characterized in that: Step S7 includes the following steps: S71, data collection: real-time collection of key parameters such as arterial pressure, venous pressure, blood pump output, blood pump return blood volume, and replacement fluid pressure, and verification and filtering; S72, data preprocessing: standardizing the collected raw data and calculating the derived values ​​of key indicators, including blood flow difference and pressure difference; S73, dialysis effect evaluation: input the pre-processed data into the evaluation model, calculate the quantitative index of dialysis effect, and evaluate the dialysis purification capacity; S74, decision and execution: If the evaluation result shows that the dialyzer's dialysis capacity does not meet the requirements, the alarm system is triggered, and the next step of enabling the standby dialyzer is automatically executed; the current dialyzer is immediately stopped to ensure safe shutdown to prevent blood backflow or other unexpected situations; the standby dialyzer is automatically started, and necessary initialization settings are performed, and the startup process of the standby dialyzer is monitored to ensure that it works normally before continuing the hemodialysis purification operation; S75. Monitoring and feedback: Continuously monitor the dialyzer's operating status, patient vital signs, and dialysis results throughout the process to ensure safety and effectiveness; record evaluation results, switching operations, and key data from subsequent dialysis processes for subsequent analysis, optimization, and improvement.

7. The blood purification method according to claim 6, characterized in that: Step S73 includes the following steps: S731: Define an evaluation model that takes into account all parameters based on medical knowledge, historical data analysis and expert experience; From dial =w1*P art +w2*P ven +w3*Q out +w4*Q ret +w5*P dial ; In the formula, E dial is a comprehensive quantitative index of dialyzer performance; w1, w2, …, w5 are weight coefficients; P art is arterial pressure; P ven is the venous pressure; Q out is the blood output of the blood pump; Q ret is the amount of blood returned by the reinfusion pump; P dial is the displacement fluid pressure; S732: inputting the preprocessed data into the evaluation model to calculate quantitative indicators of dialysis effect, including dialysis efficiency and clearance rate; The dialysis efficiency η is the ratio of the actual removal to the theoretical removal: η=(Q out- Q ret ) / Q out ; Clearance rate CR is the ratio of blood flow difference to blood output: CR = ΔQ / Q out ; Where η is the ratio of actual clearance to theoretical clearance; CR represents the ratio of blood flow difference to blood output; S733: Compare the calculated dialysis effect index with a preset threshold or standard to determine whether the currently working dialyzer meets the dialysis requirements.

8. The blood purification method according to claim 1, characterized in that: The bubble detection mechanism includes: Ultrasonic transmitter: Use high-performance piezoelectric ceramics as ultrasonic transmitting elements; Ultrasonic receiver: Using piezoelectric ceramics as receiving elements, matched with the transmitter, the receiver receives ultrasonic signals that are transmitted through the blood and may be reflected or scattered back by bubbles; Signal processing circuit: processes the electrical signal output by the receiver, including amplification and filtering, signal enhancement and feature extraction, to identify the signal features related to bubbles; Alarm device: including sound alarm and visual alarm; Display module: Displays the detected bubble information in real time, including the size, quantity and location of the bubbles.

9. The blood purification method according to claim 8, characterized in that: The signal processing circuit processes the electrical signal output by the receiver, including the following: Amplification and filtering: Amplify the received signal to improve the signal-to-noise ratio; remove unnecessary noise and interference signals through filters; Feature extraction and comparison: Extract features from the processed signal to determine whether bubbles exist; The mechanical vibration of the ultrasonic wave is expressed as: x(t) = A*sin(2πft+Φ); where A is the amplitude determined by the physical properties of the piezoelectric ceramic, f is the set ultrasonic frequency, t is the time variable, and Φ is the phase angle determined by the initial conditions; x(t) is the ultrasonic vibration displacement generated by the transmitter at time t; the received ultrasonic signal is expressed as: y(t) = B*sin(2πf(t-τ)+ψ)+n(t); where B is the amplitude of the received signal, τ is the time delay of the signal round trip, ψ is the phase of the received signal, and n(t) is noise or interference, usually Gaussian white noise; y(t) is the ultrasonic signal detected by the receiver at time t; The amplification and filtering process is expressed as: z(t)=G*L{y(t)}; where G is the amplification gain, L{·} represents the filter operation; z(t) is the signal after amplification and filtering; Feature extraction: Use fast Fourier transform FFT to perform frequency domain analysis on the amplified and filtered signal z(t): Z(f) = FFT{z(t)}; the amplitude spectrum P(f) represents the signal strength at different frequencies: P(f) = |Z(f)|; Feature analysis: identifying peaks in the amplitude spectrum; f peak = argmaxP(f); calculate the peak energy as the intensity index of the bubble feature: E peak =P(f peak ); Feature comparison: set the threshold T to distinguish noise and bubble signals; Bubble_Presence={(True,if E peak >T);(False,otherwise)}; Where Z(f) is the frequency domain representation of the received signal after fast Fourier transform FFT; z(t) is the received signal in the time domain; P(f) represents the signal strength at different frequencies; f peak is the frequency corresponding to the maximum value in the amplitude spectrum; E peak is the strength indicator of the bubble feature; T is the preset threshold; Bubble_Presence is a Boolean value indicating whether there is a bubble feature.

10. A blood purification device, comprising: Mobile trolley, fixed bracket, purification mechanism and abnormal monitoring mechanism; characterized by: A fixed bracket is fixedly arranged on the mobile trolley, and a purification mechanism is fixedly arranged on the fixed bracket; An abnormality monitoring mechanism is fixedly arranged on the fixed bracket; a PLC control module is fixedly arranged on the fixed bracket; The purification mechanism includes an arterial pot, a dialyzer, a venous pot, a blood pump, a replacement fluid storage tank, an ultrafiltrate collection tank, a dialysate storage tank, a replacement fluid pump, an ultrafiltrate pump, an arterial tube, a venous tube, a dialysate pump and a heparin pump; The arterial pot is connected with an arterial tube; the arterial tube is provided with a blood pump; the replacement fluid pump is fixedly provided on the replacement fluid storage tank; the input end of the replacement fluid pump extends into the replacement fluid storage tank; the output end of the replacement fluid pump is connected with the arterial pot; The lower end of the arterial pot is detachably fixed with a tee A, which is connected to two dialyzers; the input end of the dialyzer is connected to the tee A; the venous pot is fixed with a tee B, which is respectively connected to the output ends of the two dialyzers; the lower end of the venous pot is provided with a venous tube; the venous tube is provided with a reinfusion pump and a reinfusion solenoid valve; An ultrafiltrate pump is fixedly arranged on the ultrafiltrate collection box; the input end of the ultrafiltrate pump is connected to the dialyzer; the input end of the ultrafiltrate pump is connected to the ultrafiltrate collection box; the dialyzer is connected to the ultrafiltrate pump through a hose, and a solenoid valve is arranged on the hose; a dialysate pump is fixedly arranged on the dialysate storage box, and the input end of the dialysate pump is connected to the dialysate storage box; the output end of the dialysate pump is connected to the dialyzer; the dialyzer is connected to the dialysate pump through a hose; automatic exhaust valves and manual exhaust valves are fixedly arranged on the upper ends of the arterial pot and the venous pot; a purification capacity evaluation module is fixedly arranged on the fixed bracket.

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