Preparation process and system for accurately regulating and controlling component proportion of blood product

Through microfluidic centrifugal separation and AI intelligent control, the problems of low accuracy of blood product components separation and lag detection are solved, and high-precision and rapid blood component regulation are achieved, meeting personalized needs and reducing costs, and improving blood resource utilization.

CN120491429APending Publication Date: 2025-08-15NANYUE BIOPHARMING
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Patent Information

Application Number
CN202510482851.2
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-04-17
Publication Date
2025-08-15

AI Technical Summary

Technical Problem

The existing blood product component separation technology has the problems of low separation accuracy, lagging detection methods and poor dynamic adjustment capabilities, making it difficult to achieve real-time closed-loop regulation, resulting in fluctuations in quality between batches and the inability to meet personalized needs.

Method used

The microfluidic centrifugal separation technology is used to combine high-precision sensors and AI intelligent control, and through deep reinforcement learning and PID closed-loop control, real-time component detection and dynamic regulation are achieved to ensure the accuracy and consistency of blood component ratios.

Benefits of technology

High-precision control of blood component ratio (≤±1% error), improve preparation efficiency (30-50%), meet personalized needs, reduce labor costs (more than 30%), and improve blood resource utilization.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention belongs to the technical field of medical treatment, and discloses a preparation process for accurately regulating and controlling the component proportion of a blood product. The process comprises the following steps: blood collection and pretreatment; blood components are accurately separated; performing real-time component detection; intelligent regulation and control and closed-loop feedback are realized; and optimizing a finished product and monitoring quality. According to the preparation process capable of accurately regulating and controlling the component proportion of the blood product, by integrating AI intelligent control, microfluid separation, real-time sensor detection, dynamic feedback regulation and control and other technologies, high-precision, automatic and intelligent blending of blood components is achieved. The AI intelligent optimization algorithm is adopted, the composition proportion is dynamically adjusted, and the precision error of a finished product is reduced to be within + / -1% from traditional + / -5%. Intelligent feedback closed-loop control avoids deviation caused by human intervention, and the consistency is improved. In the traditional centrifugal separation, parameters need to be manually adjusted, and the separation efficiency is low, while the micro-fluid centrifugal technology is adopted in the method, efficient separation can be completed within 5-10 minutes, and the overall productivity is improved by 30%-50%.
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Description

Technical Field

[0001] The present invention belongs to but is not limited to the field of medical technology, and in particular relates to a preparation process and system for accurately controlling the ratio of components of blood products. Background Art

[0002] Currently, the preparation of blood products (such as plasma, platelets, and red blood cells) mainly relies on centrifugation and membrane filtration technologies. Common methods include:

[0003] Continuous flow automatic blood separator: uses the different effects of centrifugal force to separate and collect different components in the blood, and is commonly used for the preparation of platelets, plasma or red blood cells.

[0004] Column chromatography and filtration technology: Specific blood components are enriched or removed through filter membranes or adsorption materials of different pore sizes to improve the purity of the target product.

[0005] Intelligent automated proportioning system: In the production of some high-end blood products, automatic proportioning and control technology based on AI algorithms has been introduced to optimize the proportions of each component and ensure the consistency of different batches of products.

[0006] The technical problems existing in the prior art are as follows:

[0007] Although current blood separation and manipulation technologies have been widely used, the following core issues still exist:

[0008] 1. Low separation accuracy:

[0009] Traditional centrifugation methods make it difficult to accurately control the exact ratio of plasma, red blood cells, and platelets, which often leads to quality fluctuations between product batches.

[0010] The existing automated control systems have limited intelligence and are difficult to adapt to the personalized needs of different groups of people or for different purposes.

[0011] 2. Detection methods are lagging behind:

[0012] The detection of blood product components mostly relies on optical measurement (such as flow cytometry) or conductivity measurement, but it lacks real-time performance and accuracy, and is easily affected by operational errors that affect component regulation.

[0013] 3. Poor dynamic adjustment capabilities:

[0014] Traditional preparation processes are based on fixed parameter settings, making it difficult to achieve real-time closed-loop control. When the proportion of blood product components deviates from the target value, it is difficult to make quick adjustments. Summary of the Invention

[0015] In response to the problems existing in the prior art, the present invention provides a preparation process for accurately controlling the proportion of blood product components.

[0016] The present invention is achieved by providing a preparation process for accurately controlling the ratio of blood product components, the process comprising:

[0017] S1: blood collection and pretreatment;

[0018] S2: precise separation of blood components;

[0019] S3: Real-time component detection;

[0020] S4: Intelligent control and closed-loop feedback;

[0021] S5: Finished product optimization and quality monitoring.

[0022] Furthermore, the S1 specifically includes:

[0023] After whole blood is collected, anticoagulants, such as sodium citrate, are used to prevent blood coagulation and the blood is stored at a low temperature of 4°C. Preliminary filtration is performed to remove impurities such as cell debris and clots to ensure the stability of the subsequent separation process.

[0024] Furthermore, the S2 specifically includes:

[0025] A microfluidic centrifugal separation device is used to separate different components of plasma, red blood cells, platelets, etc. according to density differences at a set speed, such as 500-3000rpm; different components are accurately exported through microfluidic control channels to form multiple independent component pools.

[0026] Furthermore, the S3 specifically includes:

[0027] High-precision sensors are used, including optical sensors to detect red blood cell concentration, conductivity sensors to detect electrolyte concentration, and flow cytometry to analyze platelet counts, to obtain real-time data on each component; data is analyzed through AI computing models and compared with target parameters.

[0028] Furthermore, the S4 specifically includes:

[0029] AI algorithm calculates the optimal control plan: Based on deep reinforcement learning (DRL) + fuzzy control algorithm, it optimizes the blood component ratio control strategy; based on historical data and real-time monitoring data, it dynamically adjusts blood separation parameters such as flow rate, rotation speed, and tangential pressure;

[0030] PID closed-loop control: If the concentration of a component is too high, the system automatically reduces the corresponding flow rate or increases the diluent, such as saline; if the concentration of a component is too low, the system automatically adjusts the microfluidic flow channel to improve the recovery rate of the corresponding component.

[0031] Furthermore, the S5 specifically includes: blood products after intelligent regulation enter the quality control link, and the component ratio is retested by a fully automatic blood analyzer to ensure compliance with international blood product standards, such as AABB and WHO standards; a blockchain traceability system is used to record the entire production process to ensure that the data is transparent and traceable.

[0032] Another object of the present invention is to provide a preparation system for accurately controlling the ratio of blood product components based on the preparation process for accurately controlling the ratio of blood product components, the system specifically comprising:

[0033] The blood separation module uses continuous flow microfluidic centrifugal separation technology to accurately separate blood components based on their density and fluid dynamics.

[0034] The real-time detection module integrates high-precision sensors, optical, biochemical, conductivity, and flow cytometers to monitor the proportion of each component in real time and transmit the data to the AI control system;

[0035] The intelligent control module, based on an adaptive AI algorithm, analyzes historical data and calculates the optimal control strategy in real time, adjusting the centrifugal speed, flow rate and ratio to ensure that the target component ratio reaches the preset value;

[0036] The dynamic feedback closed-loop control module adjusts the blood product ratio in real time based on sensor data through a PID control system and a deep learning model, ensuring an accuracy error of less than ±1%.

[0037] Furthermore, the detailed processing process of the system's internal signal data is as follows:

[0038] S21: sensor data acquisition and preprocessing;

[0039] S22: AI intelligent analysis and composition control calculation;

[0040] S23: AI intelligent analysis and composition control calculation;

[0041] S24: Final data storage and output.

[0042] Furthermore, the S21 specifically includes:

[0043] (1) The multimodal sensor data acquisition system integrates different types of sensors such as optical sensors, biochemical sensors, conductivity sensors, and flow cytometers to simultaneously monitor key indicators of blood components, including:

[0044] Hematocrit (HCT): blood cell count analyzed by flow cytometry;

[0045] Platelet concentration (PLT): platelet count is measured using impedance or fluorescence methods;

[0046] Plasma protein concentration (TP): analysis of total plasma protein content by biochemical sensor;

[0047] Electrolyte ion concentration (Na + , K + , Ca 2+ ): Use conductivity sensor to detect blood electrolyte balance;

[0048] (2) Signal conditioning

[0049] Analog-to-digital conversion (ADC): The analog signal collected by the sensor is converted into a digital signal through the ADC for subsequent calculation and analysis;

[0050] Data denoising:

[0051] Kalman filtering processes the signal from the flow cytometer to improve the accuracy of cell counting;

[0052] Wavelet transform filters out high-frequency noise in the conductivity sensor signal;

[0053] Mean filtering processes the data from biochemical sensors to smooth out short-term fluctuations and ensure stable readings;

[0054] Timing alignment: Since different sensors have different sampling frequencies, the flow cytometer may be 5Hz and the biochemical sensor may be 1Hz, the linear interpolation method is used to time align the data to ensure the time consistency of each set of data.

[0055] Furthermore, the S22 specifically includes:

[0056] After pre-processing, the data is input into the AI control system for intelligent analysis. The core processing steps are as follows:

[0057] (1) Feature extraction and data modeling

[0058] Use principal component analysis (PCA) to reduce dimensionality and improve computational efficiency;

[0059] Construct the data feature matrix:

[0060] Set characteristic variables X = {HCT, PLT, TP, Na + , K + , Ca 2+ , flow rate, pressure};

[0061] Target variable Y = {target component ratio};

[0062] Real-time calculation of blood component deviations:

[0063] Calculate the difference between the current collected data and the target standard value:

[0064] △X=X current -X target

[0065] If △X exceeds the set threshold, AI automatic control is triggered;

[0066] (2) Intelligent control strategy calculation

[0067] Using deep reinforcement learning combined with fuzzy control methods, we can calculate the optimal control strategy:

[0068] Predict the blood component change trend at the next moment based on deep neural network DNN:

[0069] X pred =DNN(X current )

[0070] Reinforcement learning optimizes control parameters:

[0071] Set the reward function:

[0072] R=-|△X|-λ·E

[0073] Where E is the energy loss term and λ is the trade-off parameter;

[0074] The policy gradient algorithm PPO is used to calculate the optimal control strategy and adjust the blood composition ratio:

[0075]

[0076] Dynamically adjust centrifugal speed, flow rate, and microfluidic channel width.

[0077] Furthermore, the S23 specifically includes:

[0078] The parameters calculated by AI intelligent control are transmitted to the dynamic feedback closed-loop control module to ensure the accuracy of component control is ≤±1%:

[0079] (1) PID control, proportional-integral-differential control,

[0080] Use PID controller to adjust key variables in real time:

[0081]

[0082] Where: Error value e(t) = X target -X current

[0083] K p , K i , K d To adjust the coefficient, the AI model is optimized in real time;

[0084] (2) Dynamic adjustment strategy

[0085] If the platelet concentration is low, increase the microfluidic flow rate to improve the platelet collection rate;

[0086] If the red blood cell concentration is too high, reduce the centrifugal speed and reduce the amount of red blood cell recovery;

[0087] Electrolyte ion imbalance: adjust the diluent / saline flow rate to ensure electrolyte balance.

[0088] Furthermore, the S24 specifically includes:

[0089] Cloud storage: Record the component data of each batch of blood products and upload it to the blockchain traceability system to ensure data transparency and traceability;

[0090] Quality assessment: Data stability was assessed using 95% confidence intervals:

[0091]

[0092] If the blood component ratio deviates from the target value by more than 3 standard deviations, the system will automatically alarm and readjust.

[0093] In combination with the above technical solutions and the technical problems solved, the advantages and positive effects of the technical solutions to be protected by the present invention are as follows:

[0094] The signal data processing process of the present invention is based on high-precision sensors, AI intelligent analysis and dynamic feedback control to achieve:

[0095] Precise blood composition control (≤±1% error)

[0096] Real-time data monitoring to reduce manual intervention

[0097] AI deep learning optimization to improve stability

[0098] PID closed-loop control, dynamic correction

[0099] This method will be widely used in clinical blood transfusion, blood product manufacturing, and biomedical research, promoting the development of precision medicine and improving the utilization rate of blood resources.

[0100] (1) Improve the accuracy of blood component regulation

[0101] Using AI intelligent optimization algorithm, the ingredient ratio is dynamically adjusted to reduce the precision error of the finished product from the traditional ±5% to within ±1%.

[0102] Intelligent feedback closed-loop control avoids deviations caused by human intervention and improves consistency.

[0103] (2) Improve preparation efficiency and output

[0104] Traditional centrifugal separation requires manual adjustment of parameters and has low separation efficiency. However, this system uses microfluidic centrifugal technology to complete efficient separation within 5-10 minutes, increasing overall production capacity by 30%-50%.

[0105] Through intelligent flow control, the blood cell loss rate is reduced, the recovery rate of platelets and red blood cells is increased, and waste is reduced.

[0106] (3) Solve personalized needs and improve medical adaptability

[0107] Traditional blood product preparation cannot meet the personalized needs of different patients (such as anemia patients and patients with coagulation dysfunction). This system is based on patient data + intelligent matching algorithm, which can accurately allocate blood components for people with different needs and improve treatment effects.

[0108] (4) Reduce costs and improve quality stability

[0109] Traditional methods rely on manual inspection and experience-based control, resulting in high labor costs and large quality fluctuations between batches. The fully automatic intelligent control of this system reduces manual dependence, improves quality stability, and reduces labor costs by more than 30%.

[0110] Combined with the automatic traceability system, it improves production transparency and reduces quality problems caused by improper human operation.

[0111] The invention's process for precisely controlling the ratio of blood product components integrates AI intelligent control, microfluidic separation, real-time sensor detection, dynamic feedback control, and other technologies to achieve high-precision, automated, and intelligent preparation of blood components. Compared to traditional methods, this system has:

[0112] 1. Higher accuracy (±1% error control)

[0113] 2. Faster production efficiency (preparation time shortened by 30-50%)

[0114] 3. Better medical adaptability (meeting personalized needs)

[0115] 4. Lower costs (reducing labor costs by more than 30%)

[0116] This technology will be widely used in blood product production, clinical blood transfusion, biomedical research and other fields, and will promote the development of precision medicine, improve the utilization efficiency of blood resources, and ensure medical safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0117] Figure 1 This is a flow chart of a preparation process for precisely controlling the ratio of components in a blood product provided by an embodiment of the present invention;

[0118] Figure 2This is a structural diagram of a preparation system for precisely controlling the ratio of blood product components provided by an embodiment of the present invention;

[0119] Figure 3 is a flowchart of a detailed process of processing signal data within the system provided by an embodiment of the present invention;

[0120] In the figure: 1. Blood separation module; 2. Real-time detection module; 3. Intelligent control module; 4. Dynamic feedback closed-loop control module. DETAILED DESCRIPTION

[0121] In order to make the purpose, technical solutions and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0122] like Figure 1 As shown, an embodiment of the present invention provides a preparation process for accurately controlling the ratio of components of a blood product, the process comprising:

[0123] S1: blood collection and pretreatment;

[0124] S2: precise separation of blood components;

[0125] S3: Real-time component detection;

[0126] S4: Intelligent control and closed-loop feedback;

[0127] S5: Finished product optimization and quality monitoring.

[0128] This step aims to standardize the collection and preliminary pretreatment of blood samples through an efficient and safe collection system. Blood collection uses a closed, fully automatic collection system to prevent external contamination and physical or chemical denaturation of blood components. After the collection is completed, pretreatment operations are performed immediately, including temperature control (maintained between 4°C and 8°C to slow cell metabolism) and the addition of anticoagulants (such as citrate, EDTA, etc.) to avoid coagulation reactions. At the same time, cell debris and large molecular impurities are removed by low-speed centrifugation (500-1000g, 10 minutes) to ensure the efficiency and stability of subsequent separation processes. The standardized treatment of this step ensures the integrity and activity of blood components, providing a reliable initial sample for subsequent separation operations.

[0129] In order to achieve high-precision separation of blood product components, the present invention adopts a multi-stage separation technology that combines high-speed centrifugation and chromatographic separation. First, high-speed centrifugation (3000-5000g, 20 minutes) is used to achieve crude separation of plasma, red blood cells and white blood cells. Subsequently, ultracentrifugation (100,000g, 1 hour) is used to further separate and purify the protein components (such as albumin, globulin, fibrinogen) in the plasma. For the refined extraction of specific blood components, affinity chromatography (Affinity Chromatography), ion exchange chromatography (Ion Exchange Chromatography) and size exclusion chromatography (Size Exclusion Chromatography) and other technologies are used to ensure the purity and activity of each component. By combining gradient elution with an automated separation system, accurate collection and concentration of different components can be achieved.

[0130] To ensure precise control of blood component ratios, the present invention introduces a multimodal sensor system and a high-throughput detection platform. Real-time component detection includes: Laser Scattering Detection for precise determination of the concentration of cellular components (red blood cells, white blood cells, platelets); UV-Vis Spectroscopy and Fluorescence Spectroscopy for quantitative analysis of protein content; and Electrochemical Sensors for online monitoring of glucose, lactate, and electrolytes. The system uses a Data Fusion Algorithm to perform a multi-dimensional comprehensive analysis of the data from each sensor, achieving real-time feedback control of the blood component ratios.

[0131] In order to achieve precise control of the proportion of blood product components, the present invention adopts an intelligent control system based on adaptive control algorithm (Adaptive Control Algorithm) and deep reinforcement learning (Deep Reinforcement Learning, DRL). By comparing the real-time data output by the detection module with the target component ratio, the system automatically adjusts the separation and extraction parameters, including centrifugal speed, chromatography elution rate and buffer concentration. The closed-loop feedback control module optimizes the control accuracy through Kalman filter (Kalman Filter) and particle filtering (Particle Filtering) technology, thereby ensuring the stability and accuracy of the component ratio during the preparation process. Experimental results show that the response time of the intelligent control system under different conditions is less than 1 second, and the control accuracy reaches 98.7%.

[0132] After the preparation of blood products is completed, a series of quality monitoring and optimization steps are carried out to ensure the high quality and high stability of the finished products. The quality monitoring modules include: high performance liquid chromatography (HPLC) and capillary electrophoresis (CE) for purity analysis of protein components; enzyme-linked immunosorbent assay (ELISA) for activity detection of specific components (such as albumin and coagulation factors); optical microscopy and flow cytometry for morphology and concentration detection of cell components. At the same time, genetic algorithms (GA) and Bayesian optimization algorithms are introduced to adaptively optimize the preparation parameters to improve the consistency and stability of the finished product. The final test data showed that the component concentration deviation of the blood products was less than 2%, meeting the high precision requirements of clinical applications.

[0133] The preparation process for accurately controlling the proportion of blood product components proposed in the present invention significantly improves the preparation accuracy and efficiency of blood products by integrating multi-stage separation technology, real-time detection system and intelligent control algorithm. Compared with traditional processes, the present invention shows obvious advantages in component purification efficiency, product purity and activity retention. In clinical applications, it has broad application prospects, especially in the preparation of high-quality plasma products, albumin injections and specific antibody preparations. At the same time, the closed-loop feedback control system of the present invention provides flexibility and scalability for the preparation of personalized blood products, and has significant industrialization and market promotion value.

[0134] Said S1 specifically includes:

[0135] After whole blood is collected, anticoagulants, such as sodium citrate, are used to prevent blood coagulation and the blood is stored at a low temperature of 4°C. Preliminary filtration is performed to remove impurities such as cell debris and clots to ensure the stability of the subsequent separation process.

[0136] The S2 specifically includes:

[0137] A microfluidic centrifugal separation device is used to separate different components of plasma, red blood cells, platelets, etc. according to density differences at a set speed, such as 500-3000rpm; different components are accurately exported through microfluidic control channels to form multiple independent component pools.

[0138] The S3 specifically includes:

[0139] High-precision sensors are used, including optical sensors to detect red blood cell concentration, conductivity sensors to detect electrolyte concentration, and flow cytometry to analyze platelet counts, to obtain real-time data on each component; data is analyzed through AI computing models and compared with target parameters.

[0140] The S4 specifically includes:

[0141] AI algorithm calculates the optimal control plan: Based on deep reinforcement learning (DRL) + fuzzy control algorithm, it optimizes the blood component ratio control strategy; based on historical data and real-time monitoring data, it dynamically adjusts blood separation parameters such as flow rate, rotation speed, and tangential pressure;

[0142] PID closed-loop control: If the concentration of a component is too high, the system automatically reduces the corresponding flow rate or increases the diluent, such as saline; if the concentration of a component is too low, the system automatically adjusts the microfluidic flow channel to improve the recovery rate of the corresponding component.

[0143] The S5 specifically includes: blood products after intelligent regulation enter the quality control link, and the component ratio is retested by a fully automatic blood analyzer to ensure compliance with international blood product standards, such as AABB and WHO standards; a blockchain traceability system is used to record the entire production process to ensure that the data is transparent and traceable.

[0144] This invention provides a preparation process for precisely controlling the ratio of blood product components. Based on the deep integration of microfluidic centrifugal separation technology, AI intelligent control algorithms, and a closed-loop feedback system, it achieves refined separation and intelligent control of blood components through five key steps: S1: blood collection and pretreatment; S2: precise separation of blood components; S3: real-time component detection; S4: intelligent control and closed-loop feedback; and S5: finished product optimization and quality monitoring. The following details the technical principles and implementation process.

[0145] 1. Blood collection and pretreatment (S1)

[0146] In the initial stage of this process, whole blood samples are collected by venipuncture or plasma exchange. To prevent blood coagulation, an appropriate amount of anticoagulant (such as sodium citrate) is added immediately during the collection process and stored at a low temperature of 4°C to inhibit blood metabolism and cell activity attenuation. Pretreatment is performed immediately after collection, and a preliminary filtration device is used to remove cell fragments, clots and tiny impurities in the blood. The purpose of this step is to ensure the stability and purity of the fluid state during the subsequent separation process, and to reduce the interference of impurities on the separation efficiency and detection accuracy. Filtration through a fine pore filter membrane (such as a 0.2μm or 0.45μm filter membrane) during the pretreatment process effectively improves the purity and accuracy of subsequent blood component separation.

[0147] 2. Precise separation of blood components (S2)

[0148] The blood components are separated with high precision based on the microfluidic centrifugal separation device. The core of the device consists of a microfluidic chip and a centrifugal drive module. By setting the rotation speed (500-3000rpm), different components (plasma, red blood cells, platelets, etc.) are separated in layers according to the density gradient difference. A number of precision control channels are set up in the microfluidic chip, and different components are guided to their respective independent component pools through the principles of fluid mechanics (such as laminar flow and turbulent flow switching control). In this process, by adjusting the flow rate, rotation speed and tangential pressure parameters, the separation purity and recovery rate of each component can be precisely controlled. At the same time, the high efficiency and precision of the microfluidic device are used to avoid the loss and cross-contamination problems caused by traditional large-volume centrifugation methods.

[0149] 3. Real-time component detection (S3)

[0150] During the separation process, in order to ensure the accuracy and consistency of the proportions of each component, the present invention introduces a multi-dimensional sensor network and high-precision analysis equipment. The physical and chemical parameters of each component are collected and monitored in real time through optical sensors (to detect red blood cell concentration), conductivity sensors (to detect electrolyte concentration) and flow cytometers (to analyze platelet counts). The data is input into the AI computing module via a high-speed data bus, and processed and analyzed by a deep learning model (such as a hybrid architecture of a convolutional neural network CNN and a recurrent neural network RNN). The test results are compared with the preset target parameters to generate a multi-dimensional data map, which provides basic data support and optimization decision-making basis for subsequent intelligent regulation.

[0151] 4. Intelligent Control and Closed-Loop Feedback (S4)

[0152] The intelligent control module of this invention is based on the integration of deep reinforcement learning (DRL) and fuzzy control algorithms. It generates the optimal control strategy through training with historical data and dynamic analysis of real-time data. The system first constructs a multi-objective optimization model with blood component ratio as the objective function. Through continuous training and learning, it forms an accurate parameter adjustment plan. Intelligent control consists of two core parts:

[0153] AI algorithm calculation: Based on the difference between input data and target parameters, the DRL algorithm optimizes key parameters such as flow rate, rotation speed and tangential pressure to ensure the separation efficiency and purity of each component are optimal.

[0154] PID closed-loop control: When test results deviate, the system automatically implements feedback adjustments. If the concentration of a component is too high, the corresponding flow rate is reduced or a diluent (such as saline) is introduced. If the concentration is too low, the microfluidic channel's transport efficiency is increased or the centrifugal force is increased to improve component recovery. This closed-loop feedback mechanism ensures the adaptability and stability of the entire separation and control process.

[0155] 5. Finished product optimization and quality monitoring (S5)

[0156] After regulation, blood products enter the quality control phase, where they are retested using a fully automated hematology analyzer to verify that the composition ratios meet international standards (such as AABB and WHO standards). Furthermore, the system incorporates blockchain traceability technology to record and trace the entire blood product preparation process, ensuring the transparency and credibility of production data. In the data analysis module, all production data is aggregated and provided as feedback using big data analysis algorithms and model optimization tools, continuously improving the accuracy and reliability of the process.

[0157] This invention achieves precise separation and dynamic regulation of blood components through the deep integration of microfluidic separation, AI intelligent control, and a closed-loop feedback system. Throughout the entire process, the integration of a multimodal sensor network and AI algorithms significantly improves the system's intelligence and detection accuracy. Compared to traditional blood separation methods, the system of this invention boasts greater accuracy, stability, and automation, providing strong technical support for the preparation of high-purity blood products.

[0158] like Figure 2 As shown, the present invention provides a preparation process and preparation system based on the precise control of the ratio of blood product components, which specifically includes:

[0159] Blood separation module 1 uses continuous flow microfluidic centrifugation technology to accurately separate blood components based on their density and fluid dynamics.

[0160] Real-time detection module 2 integrates high-precision sensors, optical, biochemical, conductivity, and flow cytometers to monitor the proportions of each component in real time and transmit the data to the AI control system;

[0161] Intelligent control module 3, based on adaptive AI algorithm, analyzes historical data and calculates the optimal control strategy in real time, adjusting the centrifugal speed, flow rate and ratio to ensure that the target component ratio reaches the preset value;

[0162] The dynamic feedback closed-loop control module 4 adjusts the blood product ratio in real time based on sensor data through a PID control system and a deep learning model to ensure an accuracy error of less than ±1%.

[0163] like Figure 3 As shown in the figure, the detailed processing process of the system's internal signal data is as follows:

[0164] S21: sensor data acquisition and preprocessing;

[0165] S22: AI intelligent analysis and composition control calculation;

[0166] S23: dynamic feedback closed-loop control;

[0167] S24: Final data storage and output.

[0168] During the S21 sensor data acquisition and preprocessing phase, the system uses a high-precision sensor network to collect multi-dimensional data of the target object in real time, including physical parameters (such as temperature, pressure, and flow rate), chemical composition (such as pH value and concentration), and other environmental variables. To improve the validity of the data, the system uses an adaptive filtering algorithm to denoise the collected signals and combines it with a dynamic threshold correction mechanism to ensure the accuracy and stability of the input data. In addition, the preprocessing module also normalizes, extracts features, and detects anomalies on the raw data to eliminate invalid data and optimize the computational burden of subsequent analysis.

[0169] In the S22AI intelligent analysis and component control calculation link, the system performs pattern recognition and feature analysis on pre-processed data based on deep learning models and adaptive optimization algorithms. By constructing high-dimensional mapping relationships, the system can predict the changing trends of key variables and calculate the optimal control parameters in combination with multi-objective optimization algorithms. To improve computing efficiency, the system adopts a parallel computing architecture and uses the Tensor Processing Unit (TPU) or high-efficiency matrix operation unit for inference calculations to ensure the output of the optimal control strategy with low latency and high precision.

[0170] The S23 dynamic feedback closed-loop control is responsible for executing the control parameters output by the intelligent analysis module and monitoring the execution results in real time to achieve adaptive adjustment of the system. This closed-loop control strategy is based on incremental PID (Proportional-Integral-Derivative) control or fuzzy control algorithm to ensure the stability and accuracy of the adjustment process. Through high-frequency sampling and error compensation mechanism, the system can quickly adjust the operating status of actuators (such as solenoid valves, stepper motors, and servo controllers) to optimize system performance. At the same time, the system has an abnormal event trigger mechanism that can automatically execute emergency response in the event of an emergency or parameter out-of-limit to prevent the spread of faults.

[0171] During the S24 final data storage and output phase, the system structures the processed signal data and analyzes and presents it using data visualization tools. Data storage utilizes a distributed database architecture to ensure high throughput and availability, while blockchain technology is incorporated to verify data integrity and prevent tampering and information loss. Data is transmitted at the output end via an API interface or industrial protocols (such as Modbus and OPC UA), enabling seamless system integration into host SCADA systems, cloud management platforms, or Internet of Things (IoT) architectures. This enables data sharing and remote monitoring, enhancing the system's intelligence and scalability.

[0172] The S21 specifically includes:

[0173] (1) The multimodal sensor data acquisition system integrates different types of sensors such as optical sensors, biochemical sensors, conductivity sensors, and flow cytometers to simultaneously monitor key indicators of blood components, including:

[0174] Hematocrit (HCT): blood cell count analyzed by flow cytometry;

[0175] Platelet concentration (PLT): platelet count is measured using impedance or fluorescence methods;

[0176] Plasma protein concentration (TP): analysis of total plasma protein content by biochemical sensor;

[0177] Electrolyte ion concentration (Na + , K + , Ca 2+ ): Use conductivity sensor to detect blood electrolyte balance;

[0178] (2) Signal conditioning

[0179] Analog-to-digital conversion (ADC): The analog signal collected by the sensor is converted into a digital signal through the ADC for subsequent calculation and analysis;

[0180] Data denoising:

[0181] Kalman filtering processes the signal from the flow cytometer to improve the accuracy of cell counting;

[0182] Wavelet transform filters out high-frequency noise in the conductivity sensor signal;

[0183] Mean filtering processes the data from biochemical sensors to smooth out short-term fluctuations and ensure stable readings;

[0184] Timing alignment: Since different sensors have different sampling frequencies, the flow cytometer may be 5Hz and the biochemical sensor may be 1Hz, the linear interpolation method is used to time align the data to ensure the time consistency of each set of data.

[0185] The S22 specifically includes:

[0186] After pre-processing, the data is input into the AI control system for intelligent analysis. The core processing steps are as follows:

[0187] (1) Feature extraction and data modeling

[0188] Use principal component analysis (PCA) to reduce dimensionality and improve computational efficiency;

[0189] Construct the data feature matrix:

[0190] Set characteristic variables X = {HCT, PLT, TP, Na + , K + , Ca 2+ , flow rate, pressure};

[0191] Target variable Y = {target component ratio};

[0192] Real-time calculation of blood component deviations:

[0193] Calculate the difference between the current collected data and the target standard value:

[0194] △X=X current -X target

[0195] If △X exceeds the set threshold, AI automatic control is triggered;

[0196] (2) Intelligent control strategy calculation

[0197] Using deep reinforcement learning combined with fuzzy control methods, we can calculate the optimal control strategy:

[0198] Predict the blood component change trend at the next moment based on deep neural network DNN:

[0199] X pred =DNN(X current )

[0200] Reinforcement learning optimizes control parameters:

[0201] Set the reward function:

[0202] R=-|△X|-λ·E

[0203] Where E is the energy loss term and λ is the trade-off parameter;

[0204] The policy gradient algorithm PPO is used to calculate the optimal control strategy and adjust the blood composition ratio:

[0205]

[0206] Dynamically adjust centrifugal speed, flow rate, and microfluidic channel width.

[0207] The S23 specifically includes:

[0208] The parameters calculated by AI intelligent control are transmitted to the dynamic feedback closed-loop control module to ensure the accuracy of component control is ≤±1%:

[0209] (1) PID control, proportional-integral-differential control,

[0210] Use PID controller to adjust key variables in real time:

[0211]

[0212] Where: Error value e(t) = X target -X current

[0213] K p , K i , K d To adjust the coefficient, the AI model is optimized in real time;

[0214] (2) Dynamic adjustment strategy

[0215] If the platelet concentration is low, increase the microfluidic flow rate to improve the platelet collection rate;

[0216] If the red blood cell concentration is too high, reduce the centrifugal speed and reduce the amount of red blood cell recovery;

[0217] Electrolyte ion imbalance: adjust the diluent / saline flow rate to ensure electrolyte balance.

[0218] The S24 specifically includes:

[0219] Cloud storage: Record the component data of each batch of blood products and upload it to the blockchain traceability system to ensure data transparency and traceability;

[0220] Quality assessment: Data stability was assessed using 95% confidence intervals:

[0221]

[0222] If the blood component ratio deviates from the target value by more than 3 standard deviations, the system will automatically alarm and readjust.

[0223] The present invention is applicable to a number of high-precision control fields such as intelligent manufacturing, industrial automation, intelligent medical care, Internet of Things (IoT) and new energy systems, and has a wide range of application value, especially in high-precision parameter control, complex environment monitoring, and dynamic feedback control. In the field of intelligent manufacturing, the present invention can be integrated into intelligent production lines, CNC precision processing equipment and robotic systems to achieve high-precision data acquisition and intelligent optimization control, thereby improving manufacturing accuracy and production efficiency. In the field of intelligent medical care, this technology can be used for medical image processing, intelligent biosensors and surgical robot control, enhancing the system's real-time data processing capabilities and precise adjustment capabilities. In addition, in the field of new energy, the present invention can be applied to smart grids, energy storage systems, hydrogen fuel cells and photovoltaic inverter optimization control to achieve intelligent and efficient scheduling of energy management systems and improve overall energy efficiency.

[0224] The technical solution of the present invention has been verified by experiments, comparative tests and industrial application evaluations, demonstrating its superior performance in a variety of application scenarios. During the laboratory testing phase, the present invention, based on high-precision data acquisition and intelligent control algorithms, achieved significant improvements in dynamic control accuracy, system response speed and energy consumption optimization. Experimental data showed that the control accuracy was improved by 23.7%, the response delay was reduced by 40.5%, and the energy consumption optimization rate was increased by 18.9%. In industrial environment application tests, the system was integrated into high-end CNC equipment. After long-term stability testing, its error compensation capability was improved to the sub-micron level, and the equipment abnormality rate was reduced to 0.03%, significantly enhancing the stability and robustness of the system.

[0225] Furthermore, in the verification of intelligent medical applications, this invention was integrated into medical image processing and precision surgical control systems. Through AI intelligent analysis + dynamic control algorithms, the medical image data processing speed was increased by approximately 5.2 times, the lesion identification accuracy was increased to 98.4%, and the system's precise control capabilities were verified in a real surgical simulation scenario. In terms of new energy scheduling optimization, this invention was applied to photovoltaic energy storage systems. Data showed that its dynamic power control accuracy was increased to 0.02%, energy loss was reduced by 12.6%, and intelligent scheduling efficiency was increased by 37.1%, ensuring the efficiency and reliability of system operation.

[0226] Through the above experimental data, industrial tests and application cases, the technical advantages of the present invention have been fully verified, proving its technological advancement in high-precision control, intelligent scheduling and data optimization processing, and can be industrialized and applied in multiple fields.

[0227] It should be noted that the embodiments of the present invention can be implemented by hardware, software, or a combination of software and hardware. The hardware portion can be implemented using dedicated logic; the software portion can be stored in a memory and executed by an appropriate instruction execution system, such as a microprocessor or dedicated design hardware. Those skilled in the art will appreciate that the above-mentioned devices and methods can be implemented using computer-executable instructions and / or contained in processor control code, for example, such as a carrier medium such as a disk, CD or DVD-ROM, a programmable memory such as a read-only memory (firmware), or a data carrier such as an optical or electronic signal carrier. The devices and modules of the present invention can be implemented by hardware circuits such as very large-scale integrated circuits or gate arrays, semiconductors such as logic chips, transistors, or programmable hardware devices such as field programmable gate arrays, programmable logic devices, etc., can also be implemented by software executed by various types of processors, or can be implemented by a combination of the above-mentioned hardware circuits and software, such as firmware.

[0228] The above description is only a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any modifications, equivalent substitutions and improvements made by any technician familiar with this technical field within the technical scope disclosed by the present invention and within the spirit and principles of the present invention should be covered by the scope of protection of the present invention.

Claims

1. A preparation process for accurately controlling the ratio of blood product components, characterized in that: The process includes: S1: blood collection and pretreatment; After whole blood is collected, an anticoagulant is added to prevent blood coagulation and the blood is stored at a low temperature of 4°C. Cell debris, clots, and impurities are removed through preliminary filtration to ensure the stability of the subsequent separation process. S2: precise separation of blood components; The pre-treated blood sample is placed in a microfluidic centrifuge. The speed is set at 500-3000 rpm to separate the plasma, red blood cells, platelets and other components according to density differences. The microfluidic control channels are used to accurately extract different components to form multiple independent component pools. S3: Real-time component detection; The concentration and ratio data of each component are collected in real time through a multimodal sensor network, including optical sensors for detecting red blood cell concentration, conductivity sensors for detecting electrolyte concentration, and flow cytometry for analyzing platelet count. The detection data is processed by an AI computing module and compared with the target parameters for analysis. S4: Intelligent control and closed-loop feedback; The deep reinforcement learning (DRL) algorithm and fuzzy control algorithm are used to optimize the blood component ratio control strategy and dynamically adjust blood separation parameters, including flow rate, rotation speed, and tangential pressure. When the test results deviate from the target value, the PID closed-loop control system automatically adjusts the microfluidic flow channel and centrifugal speed to maintain precise control of the concentration of each component. S5: Finished product optimization and quality monitoring; After intelligent regulation, blood products enter the quality control stage, and the component ratios are retested by a fully automatic blood analyzer to ensure compliance with international standards; a blockchain traceability system is used to record all data of the preparation process to ensure data transparency and traceability.

2. The preparation process for accurately controlling the ratio of blood product components according to claim 1, characterized in that: The intelligent control and closed-loop feedback step (S4) includes: Build a multi-objective optimization model based on deep reinforcement learning (DRL) and fuzzy control algorithms, and train and learn through historical data and real-time detection data to form the optimal control strategy; The optimized parameters output by the AI calculation module are input into the PID closed-loop control system. When the concentration of a certain component is too high, the system automatically reduces the corresponding flow rate or increases the diluent. When the concentration of a certain component is too low, the system automatically adjusts the flow channel velocity or increases the centrifugal strength. The test results are corrected in real time through a closed-loop feedback control system to ensure that the proportion of blood product components meets the preset targets.

3. The preparation process for accurately controlling the ratio of blood product components according to claim 1, characterized in that: Said S1 specifically includes: After whole blood is collected, anticoagulants, such as sodium citrate, are used to prevent blood coagulation and the blood is stored at a low temperature of 4°C. Cell debris and clot impurities are removed through preliminary filtration to ensure the stability of the subsequent separation process.

4. The process for preparing blood product components by precisely controlling the ratio of blood product components according to claim 1, wherein: The S2 specifically includes: A microfluidic centrifugal separation device is used to separate different components of plasma, red blood cells, and platelets according to density differences at a set speed, such as 500-3000 rpm. Different components are accurately extracted through microfluidic control channels to form multiple independent component pools. The S3 specifically includes: High-precision sensors are used, including optical sensors to detect red blood cell concentration, conductivity sensors to detect electrolyte concentration, and flow cytometry to analyze platelet counts, to obtain real-time data on each component; data is analyzed through AI computing models and compared with target parameters.

5. The process for preparing blood product components by precisely controlling the ratio of blood product components according to claim 1, wherein: The S4 specifically includes: AI algorithm calculates the optimal control plan: Based on deep reinforcement learning (DRL) + fuzzy control algorithm, it optimizes the blood component ratio control strategy; based on historical data and real-time monitoring data, it dynamically adjusts blood separation parameters such as flow rate, rotation speed, and tangential pressure; PID closed-loop control: If the concentration of a component is too high, the system automatically reduces the corresponding flow rate or adds a diluent, such as normal saline; if the concentration of a component is too low, the system automatically adjusts the microfluidic flow channel to improve the recovery rate of the corresponding component; the S5 specifically includes: blood products after intelligent regulation enter the quality control link, and the component ratio is retested by a fully automatic blood analyzer to ensure compliance with international blood product standards, such as AABB and WHO standards; a blockchain traceability system is used to record the entire production process to ensure data transparency and traceability.

6. A system for precisely controlling the ratio of blood product components based on the process for precisely controlling the ratio of blood product components as described in claims 1-5, characterized in that: The system specifically includes: The blood separation module uses continuous flow microfluidic centrifugal separation technology to accurately separate blood components based on their density and fluid dynamics. The real-time detection module integrates high-precision sensors, optical, biochemical, conductivity, and flow cytometers to monitor the proportion of each component in real time and transmit the data to the AI control system; The intelligent control module, based on an adaptive AI algorithm, analyzes historical data and calculates the optimal control strategy in real time, adjusting the centrifugal speed, flow rate and ratio to ensure that the target component ratio reaches the preset value; The dynamic feedback closed-loop control module adjusts the blood product ratio in real time based on sensor data through a PID control system and a deep learning model, ensuring an accuracy error of less than ±1%.

7. The preparation system for accurately controlling the ratio of blood product components according to claim 6, characterized in that: The detailed processing process of the system's internal signal data is as follows: S21: sensor data acquisition and preprocessing; S22: AI intelligent analysis and composition control calculation; S23: AI intelligent analysis and composition control calculation; S24: Final data storage and output.

8. The preparation system for accurately controlling the ratio of blood product components according to claim 7, characterized in that: The S21 specifically includes: (1) The multimodal sensor data acquisition system integrates different types of sensors such as optical sensors, biochemical sensors, conductivity sensors, and flow cytometers to simultaneously monitor key indicators of blood components, including: Red blood cell concentration: blood cell count analyzed by flow cytometry; Platelet concentration: platelet count is measured using impedance or fluorescence methods; Plasma protein concentration: Analyze the total plasma protein content using a biochemical sensor; Electrolyte ion concentration: Conductivity sensor is used to detect blood electrolyte balance; (2) Signal conditioning Analog-to-digital conversion (ADC): The analog signal collected by the sensor is converted into a digital signal through the ADC for subsequent calculation and analysis; Data denoising: Kalman filtering processes the signal from the flow cytometer to improve the accuracy of cell counting; Wavelet transform filters out high-frequency noise in the conductivity sensor signal; Mean filtering processes the data from biochemical sensors to smooth out short-term fluctuations and ensure stable readings; Timing alignment: Since different sensors have different sampling frequencies, the flow cytometer may be 5Hz and the biochemical sensor may be 1Hz, the linear interpolation method is used to time align the data to ensure the time consistency of each set of data.

9. The preparation system for accurately controlling the ratio of blood product components according to claim 7, characterized in that: The S22 specifically includes: After preprocessing, the data is input into the AI control system for intelligent analysis. The core processing steps are as follows: (1) Feature extraction and data modeling Use principal component analysis (PCA) to reduce dimensionality and improve computational efficiency; Construct the data feature matrix: Set characteristic variables X = {HCT, PLT, TP, Na + , K + , Ca 2+ , flow rate, pressure}; Target variable Y = {target component ratio}; Real-time calculation of blood component deviations: Calculate the difference between the current collected data and the target standard value: △X=X current -X target If △X exceeds the set threshold, AI automatic control is triggered; (2) Intelligent control strategy calculation Using deep reinforcement learning combined with fuzzy control methods, we can calculate the optimal control strategy: Predict the blood component change trend at the next moment based on deep neural network DNN: X pred =DNN(X current ) Reinforcement learning optimizes control parameters: Set the reward function: R=-|△X|-λ·E Where E is the energy loss term and λ is the trade-off parameter; The policy gradient algorithm PPO is used to calculate the optimal control strategy and adjust the blood composition ratio: Dynamically adjust centrifugal speed, flow rate, and microfluidic channel width.

10. The preparation system for accurately controlling the ratio of blood product components according to claim 7, characterized in that: The S23 specifically includes: The parameters calculated by AI intelligent control are transmitted to the dynamic feedback closed-loop control module to ensure the accuracy of component control is ≤±1%: (1) PID control, proportional-integral-differential control, Use PID controller to adjust key variables in real time: Where: Error value e(t) = X target -X current K p , K i , K d To adjust the coefficient, the AI model is optimized in real time; (2) Dynamic adjustment strategy If the platelet concentration is low, increase the microfluidic flow rate to improve the platelet collection rate; If the red blood cell concentration is too high, reduce the centrifugal speed and reduce the amount of red blood cell recovery; If there is electrolyte imbalance, adjust the diluent / saline flow rate to ensure electrolyte balance; The S24 specifically includes: Cloud storage: Record the component data of each batch of blood products and upload it to the blockchain traceability system to ensure data transparency and traceability; Quality assessment: Data stability was assessed using 95% confidence intervals: If the blood component ratio deviates from the target value by more than 3 standard deviations, the system will automatically alarm and readjust.

Citation Information

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