PBSC and PRP mixed product acquisition method based on synchronous acquisition

Abstract

The invention discloses a PBSC and PRP mixed product obtaining method and system based on synchronous collection, and the method comprises the steps: collecting basic information of a patient, treatment appeals and target specifications of a mixed product, selecting adaptive blood cell separation equipment and a sterile pipeline under the condition that a mobilizing agent is not used, and carrying out the collection of the mixed product; and a closed loop circulation system is constructed, and preparation setting is completed for synchronous collection of PBSC and PRP mixed products. After the program is started, blood components and fluid-physiological data are collected in real time through the sensing module and transmitted to the control unit. A multi-target control model is constructed based on improved particle swarm optimization, and parameters such as the centrifugal rotating speed are adjusted every 2 seconds under the constraint that component concentration reaches the standard and impurity residues meet the standard. After the peripheral blood is centrifuged and layered, the PBSC and the PRP are synchronously mixed, and red blood cells and redundant plasma are transfused back. Parameters are compared in real time to calculate deviation, and iteration adjustment is carried out when the threshold value exceeds; if the physiological parameters are abnormal, the flow rate is adjusted or an alarm is given, collection and quality inspection are terminated after the product reaches the standard, and if the product is qualified, a target mixed product is obtained. And the preparation safety and reliability are improved.

Description

Technical Field

[0001] This invention belongs to the field of clinical biological product preparation technology, and more specifically, relates to a method and system for obtaining a mixed product of PBSC and PRP based on simultaneous acquisition. Background Technology

[0002] In clinical treatment, autologous peripheral blood stem cell (PBSC) and platelet-rich plasma (PRP) blends have significant applications in tissue repair and immune regulation, and their preparation quality directly impacts treatment efficacy and patient safety. Currently, methods for obtaining PBSC and PRP blends generally suffer from poor collection coordination and delayed parameter control. Traditional collection methods often employ fixed parameters for centrifugation and component extraction, failing to adjust equipment operating parameters in real-time based on dynamic changes in blood components and the patient's physiological state. This easily leads to large fluctuations in the concentration of effective components in the blend, and difficulty in consistently controlling residual impurities within a safe range, thereby reducing the reliability of the product's clinical application.

[0003] Meanwhile, the existing collection process lacks a real-time monitoring and linkage control mechanism for patients' physiological indicators. Abnormal tubing pressure or mismatched flow rates during the collection process cannot be responded to in a timely manner, which not only affects collection efficiency but may also cause physiological discomfort to patients, increasing clinical collection risks. Furthermore, the open operation of the mixing step in traditional preparation methods easily leads to reduced activity of the active ingredient or exogenous contamination. In addition, the use of mobilizing agents before PBSC separation generally limits the clinical promotion and application of mixed products.

[0004] With the deepening advancement of the precision medicine concept, regenerative medicine has placed higher demands on the quality stability, collection safety, preparation efficiency, and feasibility of collection without the use of mobilizing agents for mixed PBSC and PRP products. Developing a method for obtaining mixed products that enables simultaneous collection of non-mobilizing components, dynamic parameter optimization, and a safe and controllable process has become an urgent need to address current clinical preparation challenges, improve treatment efficacy, and promote the widespread application of related technologies in the clinical field. Summary of the Invention

[0005] This invention aims to solve the problems of fixed parameters, poor coordination, and large quality fluctuations in traditional methods for obtaining mixed PBSC and PRP products. By constructing a dynamic control system, it enables real-time monitoring and parameter optimization of the collection process, ensuring that the concentration of effective components in the product meets the standards and that impurity residues comply with regulations, thereby improving the safety and reliability of preparation and meeting the clinical application needs of precision medicine.

[0006] To address the aforementioned deficiencies or improvement needs of existing technologies, as a first aspect of this invention, the present invention provides a method for acquiring a hybrid PBSC and PRP product based on simultaneous acquisition, comprising: S1. Collect basic patient information and treatment needs and clarify the target specifications of the mixed product; without using mobilizing agents, select suitable blood cell separation equipment and sterile tubing components and complete the construction of a closed-loop circulation system, and complete the preparatory settings before starting the collection procedure; S2. After starting the separation and acquisition program, the device collects blood component data and fluid-physiological data in real time through the sensor module on the device, and transmits the collected data to the device control unit in real time. S3. A multi-objective control model is constructed based on the improved particle swarm optimization method. The optimal control parameters are dynamically output under the constraints of meeting the concentration of effective components and the amount of impurities in the mixed product. The centrifuge speed, PBSC branch flow rate, PRP branch flow rate and anticoagulant ratio are automatically adjusted. S4. After peripheral blood is centrifuged and separated into layers according to density, the PBSC layer and PRP layer are introduced into the corresponding branches through the diversion valve and simultaneously delivered to the sterile finished product collection bag to complete the closed mixing. Red blood cells and excess plasma are returned to the patient in real time through the reinfusion tube. S5. Real-time comparison of the actual component concentration and volume of the mixed product with the target parameters, calculation of the deviation value, and triggering the algorithm to re-iterate and adjust the parameters when the deviation exceeds the preset threshold; if the patient's physiological parameters exceed the safe range, the collection flow rate is automatically adjusted or the collection is paused and an alarm is triggered; when the mixed product reaches the target volume or the total amount of components meets clinical needs, the device automatically terminates the collection, performs quality inspection on the finished product, and the qualified product is the PBSC and PRP mixed product.

[0007] Furthermore, the closed-loop circulation system in S1 includes a main acquisition path, a PBSC separation branch, a PRP separation branch, and a hybrid confluence branch.

[0008] Furthermore, S1 also includes configuring anticoagulation-related reagents and setting an initial application ratio, and inputting patient-related parameters into the device control module.

[0009] Furthermore, in S2, the blood component data is monitored by an optical sensor to detect the light transmittance of the blood components in the centrifuge cup, and the blood components are separated and identified by the difference in light transmittance. When the white film layer is detected, the collection process of the corresponding component is initiated. At the same time, the required blood component collection volume is calculated in real time by combining the preset patient hematocrit, target platelet volume and basic blood parameters, and the number of collection cycles is dynamically determined. All blood component-related data are displayed in real time on the device operation interface, which is convenient for medical staff to view intuitively and monitor the whole process.

[0010] Furthermore, the fluid-physiological data in S2 is collected and linked for regulation and early warning in the following way: the DPM pressure sensor and SPM pressure sensor configured in the device detect the pressure in the tubing flowing into and out of the patient and centrifuge cup, respectively. The normal pressure range is 0-30 kPa. The electronically controlled pressure monitor works in conjunction with relevant filters on the consumables to measure the pressure inside the pipeline. After the pressure monitor feeds back the detected pressure data to the system, the MCS9000 program automatically adjusts the pump speed based on this data; the flow rate collected in the main pipeline is accurately recorded by a flow sensor. Simultaneously, the device connects to a matching physiological monitoring module to synchronously collect the patient's heart rate. ,blood pressure The system collects data such as total blood volume processed, product volume collected per cycle, and other blood component processing volume. All collected fluid-physiological data are linked in real time with the equipment control system. When the data exceeds the preset safety range, the system automatically triggers the abnormal warning function to provide real-time alerts for abnormal data.

[0011] Furthermore, the construction process of the multi-objective control model in S3 is as follows: First, a sub-model for achieving the target concentration of active ingredients is constructed, with the degree of fit between the effective ingredient concentration and the target concentration as the core optimization direction. Mathematically, this is expressed as: in, The sensor module monitors the derived effective concentration of autologous peripheral blood stem cells in real time, and the data comes from blood stratification and nucleated cell concentration distribution monitoring. The concentration threshold is preset based on clinical treatment needs; The platelet concentration in platelet-rich plasma, which is captured in real time by the sensing module, is obtained by monitoring the degree of platelet enrichment in the plasma layer. To meet the concentration threshold for optimal clinical efficacy, the two active ingredients were optimized to achieve synergistic efficacy by making the product of their concentration ratios approach 1. Secondly, a dynamic inhibition sub-model for impurity residue is constructed to correlate the concentration relationship between impurities and active ingredients, mathematically expressed as follows: in, The data for real-time detection of residual impurities such as red blood cells comes from blood stratification test results. By optimizing the ratio of impurities to total concentration of active ingredients to approach 0, the linkage regulation of impurity inhibition and active ingredient enrichment is achieved, avoiding the loss of active ingredients caused by simple impurity control and ensuring product purity. Next, a process safety collaborative adaptation sub-model is constructed to integrate the adaptability of equipment operation with the patient's physiological state, mathematically expressed as: in, The pressure inside the pipe is collected in real time by a pressure sensor; The preset pressure reference value is designed to combine all equipment parameters with the human body's tolerance range; The flow rate is collected on the main path by the flow sensor; To achieve adaptive flow rate based on real-time heart rate and blood pressure; through optimization to make the pressure-flow rate adaptation ratio approach 1, dynamic matching between equipment operation and physiological state is realized. Finally, a volume control sub-model is constructed, mathematically expressed as follows: in, The volume of mixed products as counted in real time by the equipment; The target volume is preset based on treatment needs; the improved particle swarm optimization method dynamically adjusts the centrifuge speed, branch flow rate and anticoagulant ratio through iterative search, so that the optimization target of the above sub-model synchronously approaches the ideal value, and outputs the optimal parameters every 2 seconds to ensure synchronous acquisition coordination, product quality stability and process safety.

[0012] Furthermore, the specific process of the improved particle swarm optimization method is as follows: First, initialize the particle population and set the particle positions. The particle velocity corresponds to the combination of parameters such as centrifuge speed, PBSC branch flow rate, PRP branch flow rate, and anticoagulant ratio. The adjustment step size for each parameter, population size, and number of iterations are set based on the dynamic response requirements of the data collection process; Calculate the fitness value of each particle in the initial population. The fitness value is directly adopted from the comprehensive optimization function of the multi-objective control model, that is: The fitness value reflects the optimization effect of the corresponding parameter combination of the particle. The closer the fitness value is to 1, the better the parameter combination. Next, the particle velocity and position are iteratively updated. The velocity update formula is: The position update formula is: in, They represent the first During the nth iteration, the 1st The velocity corresponding to each particle has the physical meaning of the adjustment step size of the equipment control parameters; They represent the first During the nth iteration, the 1st The position of each particle represents the physical meaning of the specific combination of device control parameters in the current iteration. For the first In the next iteration, particles The optimal position for an individual particle, i.e., the parameter combination whose history fitness value is closest to 1. For the first The global optimal position of the population in the next iteration is the parameter combination whose historical fitness value is closest to 1. Finally, the iteration termination condition is set: when the fitness value corresponding to the global optimal position of the population approaches 1 and there is no significant change after several consecutive iterations, or when the preset number of iterations is reached, the iteration is terminated and the parameter combination corresponding to the global optimal position is output as the optimal control parameter of the device.

[0013] Furthermore, the calculation process for the deviation value in S5 is as follows: The deviation value for the effective concentration of autologous peripheral blood stem cells in the mixed product was calculated as follows: ,in The effective concentration of autologous peripheral blood stem cells in the mixed product was detected in real time. The data came from the dynamic monitoring results of blood stratification and nucleated cell distribution by the sensor module. The target concentration of autologous peripheral blood stem cells is set as a preset effective concentration, and is determined based on the repair efficacy required for clinical treatment. The deviation value of platelet concentration in platelet-rich plasma was calculated as follows: ,in The platelet concentration in platelet-rich plasma of the mixed product is obtained by the sensor module monitoring the degree of platelet enrichment in the plasma layer. The target platelet concentration in platelet-rich plasma is set with reference to the clinically optimal therapeutic concentration standard. The deviation value of the mixed product volume is calculated as follows: ,in The volume of mixed products, as statistically analyzed in real time by the equipment, is calculated cumulatively by the flow monitoring unit. The target volume of the mixed product is predetermined and determined based on the patient's treatment needs and clinical dosage requirements.

[0014] As a second aspect of the present invention, a hybrid product acquisition system for PBSC and PRP based on synchronous acquisition is also provided, comprising: The information collection and system preparation unit is used to collect basic patient information and treatment needs and to determine the target specifications of the mixed product; select suitable blood cell separation equipment and sterile tubing components and complete the construction of the closed-loop circulation system, and complete the preparatory settings before the collection procedure is started; The multi-dimensional data real-time acquisition unit is used to collect blood component data and fluid-physiological data in real time through the sensor module on the device after the separation acquisition program is started, and transmit the collected data to the device control unit in real time. The model building and parameter optimization unit is used to build a multi-objective control model based on improved particle swarm optimization. With the concentration of effective ingredients in the mixed product meeting the standard and the amount of impurity residue meeting the requirements as constraints, it dynamically outputs the optimal control parameters and automatically adjusts the centrifugal speed, PBSC branch flow rate, PRP branch flow rate and anticoagulant ratio of the equipment. The stratification and synchronous mixing unit is used to separate peripheral blood into layers by density after centrifugation. The PBSC layer and PRP layer are introduced into the corresponding branches through the diversion valve and simultaneously delivered to the sterile finished product collection bag to complete the closed mixing. Red blood cells and excess plasma are returned to the patient in real time through the reinfusion tube. The quality control and finished product quality inspection unit is used to compare the actual component concentration and volume of the mixed product with the target parameters in real time, calculate the deviation value, and trigger the algorithm to re-iterate and adjust the parameters when the deviation exceeds the preset threshold. If the patient's physiological parameters exceed the safe range, the collection flow rate is automatically adjusted or the collection is paused and an alarm is triggered. When the mixed product reaches the target volume or the total amount of components meets the clinical needs, the equipment automatically terminates the collection and performs quality inspection on the finished product. Once qualified, it is a PBSC and PRP mixed product.

[0015] As a third aspect of the invention, a computer-readable storage medium is also provided, on which a computer program is stored, which is executed by a processor as described in any one of the claims, a method for acquiring a PBSC and PRP hybrid product based on synchronous acquisition.

[0016] In summary, compared with the prior art, the above-described technical solutions conceived by this invention can achieve the following beneficial effects: 1. The present invention provides a method for acquiring a hybrid PBSC and PRP product based on simultaneous collection. By collecting basic patient information and treatment needs and defining the target specifications of the hybrid product, a closed-loop circulation system is constructed using suitable blood cell separation equipment and sterile tubing components without the use of mobilizing agents. This completes pre-collection setup, providing precise target guidance and a stable hardware foundation for subsequent simultaneous collection. After initiating the separation and collection procedure, the device's onboard sensing module collects blood component data and fluid-physiological data in real time and transmits them to the control unit. The blood component data includes key information such as blood stratification and white membrane characteristics. The fluid-physiological data includes tubing pressure, main collection flow rate, and patient heart rate and blood pressure, enabling real-time monitoring of blood components and the patient's physiological state during collection. This provides comprehensive and accurate data support for subsequent parameter adjustments, avoiding collection deviations due to missing information and ensuring the safety and controllability of the collection process.

[0017] 2. The present invention provides a method for acquiring a mixed PBSC and PRP product based on synchronous acquisition. This method utilizes a multi-objective control model constructed using improved particle swarm optimization. With the constraints of achieving the required concentration of active ingredients and meeting impurity residue requirements, the model dynamically outputs optimal control parameters. Every 2 seconds, it automatically adjusts the centrifuge speed, PBSC branch flow rate, PRP branch flow rate, and anticoagulant ratio to achieve dynamic adaptation of the acquisition parameters. This model requires no additional coefficients or weight adjustments, directly linking real-time acquired data with preset target parameters. Through iterative optimization, it ensures that the concentration of active ingredients in the mixed product consistently meets the standards, and that the impurity residue is controlled within a safe range. This solves the problems of component concentration fluctuations and excessive impurity residue caused by fixed parameters in traditional acquisition methods, thus improving the quality stability and clinical safety of the mixed product.

[0018] 3. The present invention provides a method for obtaining a PBSC and PRP mixed product based on simultaneous collection. After peripheral blood is centrifuged and stratified by density, the PBSC and PRP layers are introduced into their respective branches using a diversion valve and simultaneously delivered to a sterile finished product collection bag for closed-loop mixing. Simultaneously, red blood cells and excess plasma are returned to the patient via a reinfusion tube in real time. This achieves simultaneous collection and closed-loop mixing of PBSC and PRP, avoiding the risk of reduced activity and contamination due to component exposure. During collection, the actual component concentration and volume of the mixed product are compared with the target parameters in real time, and the deviation value is calculated. When the deviation exceeds a preset threshold, the algorithm is triggered to iterate and adjust the parameters. When the patient's physiological parameters are abnormal, the collection flow rate is automatically adjusted or collection is paused and an alarm is triggered. Once the product meets the standards, collection is terminated and quality inspection is performed, forming a closed-loop management system of collection, control, and quality inspection to ensure that the final PBSC and PRP mixed product meets clinical treatment requirements. Attached Figure Description

[0019] Figure 1 This is a flowchart of a method for acquiring a hybrid PBSC and PRP product based on synchronous acquisition according to an embodiment of the present invention; Figure 2 This is a schematic diagram of the centrifuge cup layering process according to an embodiment of the present invention; Figure 3 This is a schematic diagram of cell separation according to an embodiment of the present invention; Figure 4 This is a system unit diagram of an embodiment of the present invention. Detailed Implementation

[0020] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention. Furthermore, the technical features involved in the various embodiments of this invention described below can be combined with each other as long as they do not conflict with each other.

[0021] Example 1 Please refer to Figure 1 This embodiment 1 provides a method for obtaining a mixed PBSC and PRP product based on synchronous acquisition, including: S1. Collect basic patient information and treatment needs and clarify the target specifications of the mixed product; without using mobilizing agents, select suitable blood cell separation equipment and sterile tubing components and complete the construction of a closed-loop circulation system, and complete the preparatory settings before starting the collection procedure; S2. After starting the separation and acquisition program, the device collects blood component data and fluid-physiological data in real time through the sensor module on the device, and transmits the collected data to the device control unit in real time. S3. A multi-objective control model is constructed based on the improved particle swarm optimization method. The optimal control parameters are dynamically output under the constraints of meeting the concentration of effective components and the amount of impurities in the mixed product. The centrifuge speed, PBSC branch flow rate, PRP branch flow rate and anticoagulant ratio are automatically adjusted. S4. After peripheral blood is centrifuged and separated into layers according to density, the PBSC layer and PRP layer are introduced into the corresponding branches through the diversion valve and simultaneously delivered to the sterile finished product collection bag to complete the closed mixing. Red blood cells and excess plasma are returned to the patient in real time through the reinfusion tube. S5. Real-time comparison of the actual component concentration and volume of the mixed product with the target parameters, calculation of the deviation value, and triggering the algorithm to re-iterate and adjust the parameters when the deviation exceeds the preset threshold; if the patient's physiological parameters exceed the safe range, the collection flow rate is automatically adjusted or the collection is paused and an alarm is triggered; when the mixed product reaches the target volume or the total amount of components meets clinical needs, the device automatically terminates the collection, performs quality inspection on the finished product, and the qualified product is the PBSC and PRP mixed product.

[0022] This embodiment 1 further elaborates on the above steps.

[0023] (1) Information collection and system preparation Stem cells, including CD34+ hematopoietic stem cells, possess regenerative and repair functions, capable of repairing damaged joint tissues such as cartilage and bone. Their mechanisms of action—differentiating into target cells to repair damaged cells, regulating immunity to reduce inflammation, and paracrine growth factors to promote regeneration—make them a novel treatment for joint injuries and degenerative diseases such as osteoarthritis. The combined treatment of PBSC and PRP exhibits the advantages of "factor synergy and functional complementarity," demonstrating definite efficacy in analgesia, cartilage repair, and joint function improvement, particularly suitable for the treatment of osteoarthritis and cartilage repair. This highly efficient treatment mechanism places stringent requirements on the precision, safety, and feasibility of preparing the mixed products without the use of mobilization agents. Pre-collection preparation and input of basic parameters are the primary steps to ensure the quality of the preparation.

[0024] The pre-collection preparation and basic parameter input process begins with patient information collection, including basic vital signs such as age and weight, as well as baseline blood routine values ​​such as platelet count and hematocrit. The patient's treatment needs, such as pain location, are also identified. Based on this information, the treatment plan and target mixed product specifications are determined, including key indicators such as PBSC+PRP and PRP injection dosage and number of injections. Unlike traditional partial collection protocols, this protocol eliminates the need for pre-collection mobilization, simplifying the collection process.

[0025] Equipment and consumable preparation must strictly follow standard operating procedures. The core equipment used is the Haemonetics MCS9000 blood cell separator. After powering on, insert the program card to complete the self-test, select the PBSC-specific collection program, and complete initialization to ensure the equipment is in a suitable operating state for collection needs. The accompanying disposable consumables are model 971E. Before use, verify the integrity of the packaging and the expiration date to avoid contamination or equipment malfunction due to consumable issues. Connect the main collection tubing, PBSC separation branch, PRP separation branch, and mixing manifold tubing according to the equipment operation manual. During operation, ensure the tubing is free of twists and that the interfaces are well sealed. These consumables use a fully enclosed aseptic packaging design and can be used directly after opening without additional sterilization. After installation, the equipment automatically loads the pump tubing, ensuring compatibility between the tubing and the equipment.

[0026] Anticoagulant preparation and parameter input are crucial steps before starting the procedure. Introduce anticoagulant such as sodium citrate solution into the anticoagulant injection module of the device at an initial ratio of 1:10. After introduction, check the patency of the anticoagulant tubing and remove any air bubbles to prevent blockage or air ingress that could affect the anticoagulant effect and collection safety. Then, input basic parameters such as the patient's height, weight, and hematocrit, as well as operational parameters such as the target product volume, collection rate, and reinfusion rate. These parameters directly affect the safety of the collection process and the quality of the final product. Once the input is complete and confirmed to be correct, the procedure can be started.

[0027] (2) Real-time acquisition of multi-dimensional data After completing the pre-collection preparations and basic parameter input, start the PBSC-specific collection program on the MCS9000 blood cell separator. Since the effective component concentration, purity, and safety of the collection process of the PBSC / PRP mixed product all rely on real-time data support, the equipment uses an integrated sensor array to simultaneously collect multi-dimensional data. All collected data is transmitted to the equipment control unit in real time, providing a precise basis for subsequent dynamic parameter adjustments.

[0028] Blood component data acquisition is achieved through an integrated optical sensor, with the core technology based on the differences in light transmittance of different blood components to achieve separation and identification. After peripheral blood enters the centrifuge cup, it stratifies according to density under centrifugal force, such as... Figure 2As shown in the schematic diagram of the centrifuge apparatus, blood is clearly separated into a bottom layer of red blood cells, a middle layer of white blood cells, and an upper layer of plasma; while Figure 3 The cell layer diagram further reveals the microscopic composition of each layer—the white membrane layer is the core region rich in peripheral blood stem cells (PBSC), platelets, and leukocytes, and is also the target layer in this collection process. These different components exhibit different translucency due to their varying optical properties. Optical sensors monitor changes in translucency within the centrifuge cup in real time to identify each component layer. When the sensor detects a signal from the white membrane layer, the system automatically initiates the collection process for the corresponding component, extracting PBSC from the white membrane layer and simultaneously collecting the upper platelet-rich plasma (PRP). Simultaneously, the system retrieves the patient's hematocrit, target product volume, and basic blood parameters entered before collection, calculates the required blood component collection volume for the current collection cycle in real time, and dynamically determines the number of collection cycles based on the difference between the collected volume and the target volume, ensuring that the final mixed product meets the preset specifications. All blood component-related data, including the identification results of each component layer, real-time collection volume, and the number of completed cycles, are displayed in real time on the device's operating interface, allowing medical personnel to intuitively grasp the collection progress and component separation status, achieving full-process monitoring.

[0029] Fluid and physiological data acquisition employs a multi-sensor precision linkage mode, deeply integrated with the equipment control system to form an early warning closed loop. The equipment is equipped with DPM and SPM pressure sensors to detect the pressure in the tubing flowing into and out of the patient and centrifuge cup, respectively. The normal pressure range is controlled between 0 and 30 kPa. The electronically controlled pressure monitor works in conjunction with the matching filter to achieve real-time and accurate measurement of the pressure inside the disposable pipeline. The pressure data is directly fed back to the MCS9000 equipment program, which automatically adjusts the pump speed accordingly to prevent pipeline damage or blood backflow caused by abnormal pressure. The flow sensor accurately records the flow rate collected in the main pipeline. This ensures that the data acquisition efficiency is compatible with the dynamic adjustment of subsequent parameters.

[0030] Simultaneously, the device connects to a supporting physiological monitoring module to collect key physiological indicators such as the patient's heart rate and blood pressure, as well as crucial data such as total processed blood volume, product volume collected per cycle, and the amount of other blood components processed. This allows for real-time monitoring of the patient's tolerance and collection progress. All collected fluid and physiological data are transmitted to the device's control system in real time. The system has built-in safety thresholds; if the tubing pressure, collection flow rate, or patient heart rate exceeds the device's safe operating range, the system will take action. ,blood pressure When the data deviates from the normal physiological range, the system immediately triggers an abnormality warning function, providing real-time feedback through interface prompts, audible and visual alarms, etc., so that medical staff can intervene in a timely manner and ensure the safety and controllability of the data collection process in all aspects.

[0031] (3) Model building and parameter optimization Multi-dimensional real-time data acquisition provides precise data support for subsequent parameter control. To achieve synergy between PBSC and PRP synchronous acquisition, product quality stability, and the safety of the acquisition process, a multi-objective control model needs to be constructed based on improved particle swarm optimization. The core constraints are that the concentration of effective ingredients in the mixed product meets the standards and the amount of impurities remains in compliance with requirements. At the same time, process safety and volume accuracy are taken into account. The optimal control parameters are dynamically output and the equipment operating status is automatically adjusted.

[0032] The multi-objective control model takes the dynamic optimization of the improved particle swarm optimization algorithm as its core logic, combines the coupling characteristics of simultaneous acquisition of PBSC and PRP with clinical quality requirements, and constructs a "multi-objective dynamic convergence" modeling system. It achieves the synergistic optimization of each objective through the proportional relationship between the associated parameters, and specifically includes four sub-models.

[0033] First, a sub-model for achieving synergistic target concentrations is constructed, with the degree of fit between the effective component concentration and the target concentration as the core optimization direction. Mathematically, this is expressed as: in, The sensor module monitors the derived effective concentration of autologous peripheral blood stem cells in real time, and the data comes from blood stratification and nucleated cell concentration distribution monitoring. The concentration threshold is preset based on clinical treatment needs; The platelet concentration in platelet-rich plasma, which is captured in real time by the sensing module, is obtained by monitoring the degree of platelet enrichment in the plasma layer. To meet the concentration threshold for optimal clinical efficacy, the two active ingredients were optimized to achieve synergistic efficacy by making the product of their concentration ratios approach 1. Secondly, a dynamic inhibition sub-model for impurity residue is constructed to correlate the concentration relationship between impurities and active ingredients, mathematically expressed as follows: in, The data for real-time detection of residual impurities such as red blood cells comes from blood stratification test results. By optimizing the ratio of impurities to total concentration of active ingredients to approach 0, the linkage regulation of impurity inhibition and active ingredient enrichment is achieved, avoiding the loss of active ingredients caused by simple impurity control and ensuring product purity. Next, a process safety collaborative adaptation sub-model is constructed to integrate the adaptability of equipment operation with the patient's physiological state, mathematically expressed as: in, The pressure inside the pipe is collected in real time by a pressure sensor; The preset pressure reference value is designed to combine all equipment parameters with the human body's tolerance range; The flow rate is collected on the main path by the flow sensor; To achieve adaptive flow rate based on real-time heart rate and blood pressure; through optimization to make the pressure-flow rate adaptation ratio approach 1, dynamic matching between equipment operation and physiological state is realized. Finally, a volume control sub-model is constructed, mathematically expressed as follows: in, The volume of mixed products as counted in real time by the equipment; The target volume is preset based on treatment needs; the improved particle swarm optimization method dynamically adjusts the centrifuge speed, branch flow rate and anticoagulant ratio through iterative search, so that the optimization target of the above sub-model synchronously approaches the ideal value, and outputs the optimal parameters every 2 seconds to ensure synchronous acquisition coordination, product quality stability and process safety.

[0034] The optimization process of the model is achieved through an improved particle swarm optimization method, which is based on the dynamic iterative update of the particle positions and velocities. First, the particle population is initialized, and the particle positions are set. The particle velocity corresponds to the combination of parameters such as centrifuge speed, PBSC branch flow rate, PRP branch flow rate, and anticoagulant ratio. The adjustment step size for each parameter, population size, and number of iterations are set based on the dynamic response requirements of the data collection process; Calculate the fitness value of each particle in the initial population. The fitness value is directly adopted from the comprehensive optimization function of the multi-objective control model, that is: The fitness value reflects the optimization effect of the corresponding parameter combination of the particle. The closer the fitness value is to 1, the better the parameter combination. Next, the particle velocity and position are iteratively updated. The velocity update formula is: The position update formula is: in, They represent the first During the nth iteration, the 1st The velocity corresponding to each particle has the physical meaning of the adjustment step size of the equipment control parameters; They represent the first During the nth iteration, the 1st The position of each particle represents the physical meaning of the specific combination of device control parameters in the current iteration. For the first In the next iteration, particles The optimal position for an individual particle, i.e., the parameter combination whose history fitness value is closest to 1. For the first The global optimal position of the population in the next iteration is the parameter combination whose historical fitness value is closest to 1. Finally, the iteration termination condition is set: when the fitness value corresponding to the global optimal position of the population approaches 1 and there is no significant change after several consecutive iterations, or when the preset number of iterations is reached, the iteration is terminated and the parameter combination corresponding to the global optimal position is output as the optimal control parameter of the device.

[0035] The model must also adhere to explicit constraints during operation. Specifically, the constraint is that the concentration of the active ingredient must meet the target: and ,in The effective concentration of autologous peripheral blood stem cells in the mixed product collected in real time was derived from the blood stratification status and nucleated cell concentration distribution trend monitored by the sensor module. The preset effective concentration threshold for autologous peripheral blood stem cells is determined based on the cell activity and repair efficacy required for clinical treatment. The platelet concentration in platelet-rich plasma of the mixed product is obtained by monitoring the degree of platelet enrichment in the plasma layer through a sensor module. The preset platelet concentration threshold for platelet-rich plasma is set with reference to the clinically optimal therapeutic concentration standard to ensure the basic efficacy of the two in synergistic repair.

[0036] Compliance constraints on residual impurities: ,in The amount of impurities remaining in the mixed product for real-time detection, mainly the content of components that do not meet clinical use standards, such as residual red blood cells, is deduced through blood stratification monitoring and centrifugation separation effects; The upper limit of the preset impurity residue is determined based on product purity requirements and clinical safety, to avoid impurities affecting the activity of the mixed product and the safety of treatment.

[0037] Security constraints during data acquisition: and ,in The pressure inside the pipeline is collected in real time by a pressure sensor. , These are the preset upper and lower limits of pipeline safety pressure, set in combination with equipment operating safety parameters and the tolerance range of human blood circulation. The flow rate is collected in real time by the flow sensor and collected from the main path. To ensure the minimum flow rate threshold for efficient collection of active ingredients, To ensure the maximum safe flow rate derived from real-time patient heart rate and blood pressure, and to ensure that the data acquisition process is compatible with the patient's physiological state.

[0038] Data acquisition volume constraints: ,in The volume of mixed products as counted in real time by the equipment. , These are the upper and lower limits of the preset target volume for the mixed product, determined based on the patient's treatment needs, clinical dosage, and effective dosage per treatment, to ensure the stability and consistency of the treatment effect.

[0039] The model continuously iterates and optimizes by combining real-time acquired data, outputting optimal control parameters at a frequency of no less than once every 2 seconds, and automatically adjusting the centrifuge speed, PBSC branch flow rate, PRP branch flow rate, and anticoagulant ratio to ensure that all constraints are continuously met.

[0040] (4) Layered separation and synchronous mixing The optimal control parameters output by the multi-objective control model provide precise guidance for equipment operation. Among them, the dynamic adjustment of centrifugation speed lays the foundation for efficient stratification of peripheral blood. On this basis, the equipment achieves synchronous separation of PBSC and PRP through the regulation of the diversion valve, and then completes the mixing through a closed pipeline. At the same time, useless components are reinfused in real time, which not only ensures product quality but also improves collection safety.

[0041] The synchronous separation process centers on the centrifugation module of the MCS9000 device. Peripheral blood enters this module via the main collection tube. Under the optimal centrifugation speed dynamically output by the multi-objective control model, the blood naturally stratifies due to differences in the density of its components: the densest red blood cells aggregate at the bottom to form the red blood cell layer; the intermediate-density white blood cell layer (rich in PBSC, the core collection target layer) is located in the middle layer; and the least dense plasma layer is located at the top layer, rich in platelets. The device's built-in diversion valve precisely controls the flow direction of each layer based on the stratification signals monitored by optical sensors, guiding the white blood cell layer into the PBSC separation branch for PBSC collection. After PBSC collection is complete, the program card is switched to PRP collection mode to continue collecting the upper plasma layer as the PRP source, which is then guided into the PRP separation branch. During separation and collection, red blood cells without effective components and excess plasma are returned to the patient in real time via the reinfusion tube, forming a closed-loop process of "collection-separation-reinfusion," avoiding waste of blood components and reducing the burden on the patient's body.

[0042] The mixing process is completed relying on the closed structure of the 971E disposable consumables, ensuring that the product is not contaminated by external sources. During the operation of the PBSC collection procedure, the separated PBSC and PRP are synchronously transported through their respective branches to the finished product collection bag supporting the 971E consumables, and directly mixed to form the injection solution required for the first treatment; the mixed product then flows into the sterile storage bag自带 by the consumables, and the entire transportation and mixing process is carried out within the closed pipeline composed of disposable consumables and equipment, without any external contact links, fundamentally avoiding the pollution risk. For subsequent multiple treatment requirements, the subsequently collected PRP can be separately transported to another finished product collection bag of the 971E consumables and stored in multi-chamber bags. Considering the active preservation characteristics of the two components - the activity of PBSC will significantly decrease within 24 to 48 hours and it needs to be used as soon as possible, while the storage validity period of PRP can be up to one year under the environment of -80 °C or liquid nitrogen, the multi-bag design of the 971E consumables can respectively adapt to the storage requirements of the two components, which is not only convenient for the flexible development of subsequent treatments, but also further reduces the infection risk and labor cost due to the reduction of manual transfer and packaging links.

[0043] (5)Quality control regulation and finished product quality inspection During the synchronous separation and closed mixing of PBSC and PRP, the stability of product quality and the safety of the collection process need to be ensured through real-time monitoring and dynamic regulation. When the product meets the clinical requirements, the collection should be terminated in a timely manner and quality inspection should be completed to ensure that the final product meets the treatment standards.

[0044] The device will carry out deviation calculation in real time during the mixing process, continuously comparing the actual parameters of the mixed product with the preset target parameters. The actual parameters include the PBSC concentration, PRP platelet concentration and product volume in the mixed product. Among them, the deviation value calculation for the effective concentration of autologous peripheral blood stem cells in the mixed product is , where is the effective concentration of autologous peripheral blood stem cells in the mixed product detected in real time, and the data is derived from the dynamic monitoring results of blood stratification and nucleated cell distribution by the sensing module; is the preset target value of the effective concentration of autologous peripheral blood stem cells, determined according to the repair efficiency required for clinical treatment; The deviation value calculation for the platelet concentration of platelet-rich plasma is , where is the platelet concentration of platelet-rich plasma in the mixed product detected in real time, obtained by the sensing module monitoring the platelet enrichment degree of the plasma layer; is the preset target value of the platelet concentration of platelet-rich plasma, set by referring to the clinical best treatment concentration standard; The deviation value calculation for the volume of the mixed product is , where The volume of mixed products, as statistically analyzed in real time by the equipment, is calculated cumulatively by the flow monitoring unit. The target volume of the mixed product is predetermined and determined based on the patient's treatment needs and clinical dosage requirements.

[0045] Dynamic correction and safety protection mechanisms based on deviation data operate synchronously. When the deviation value of PBSC concentration, PRP platelet concentration, or product volume exceeds 5%, the deviation signal triggers the optimization model to iterate again, quickly generating new control parameters and sending them to the MCS9000 device. By adjusting parameters such as centrifugation speed, branch flow rate, and anticoagulant ratio, the actual parameters of the product are brought back to the target range. The protection mechanism for patient physiological safety operates independently. The device tracks the patient's heart rate and blood pressure in real time through the matching physiological monitoring module. When the heart rate exceeds 120 beats / min or the blood pressure is lower than 90 / 60 mmHg, the system automatically reduces the main channel collection flow rate to 50% of the original flow rate, with a minimum of 3 ml / min. If the patient's physiological parameters still do not return to normal after adjustment, the device will pause the collection program and trigger an audible and visual alarm. A combination of a buzzer sound and a flashing red light on the operation interface will notify medical staff to intervene in a timely manner.

[0046] When the volume of the mixed product counted by the device reaches the target capacity, or when the total number of cells collected by PBSC and the total number of platelets collected by PRP meet the clinical treatment needs, the MCS9000 device automatically terminates the collection program and prompts medical staff to complete tubing separation via the interface. Subsequently, a comprehensive quality inspection is conducted on the mixed product, including tests for cell viability, sterility, and component concentration: Wright-Giemsa staining to count the proportion of mononuclear cells, requiring a mononuclear cell proportion of no less than 90%, indirectly monitoring collection quality; flow cytometry to identify and count CD34+ viable cells, ensuring that the concentrated viable stem cells can play a regenerative and repair role; bacterial culture sampling of the finished product to prevent contamination; and component concentration testing covering CD34+ cell concentration, PRP platelet concentration, and residual red blood cells, all of which must meet preset target requirements. After passing the quality inspection, the mixed product can be used for clinical treatment.

[0047] Given the strict limitations of preservation conditions and time on the activity of autologous peripheral blood stem cells (PBSCs), under standard conditions of 23 degrees Celsius, the effective activity of stem cells is maintained for no more than 24 to 48 hours. Beyond this time limit, stem cells gradually lose their regenerative and repair functions, failing to meet clinical treatment needs. Therefore, the PBSC and PRP mixture prepared through simultaneous collection must be injected into the patient on the day of collection or the following day. This mixture not only contains a high concentration of active stem cells that can directly participate in the repair and regeneration of damaged joint tissues, but also contains platelet-rich plasma at a suitable concentration, which can provide a suitable growth microenvironment for stem cells by releasing various growth factors. The synergistic effect of both ensures the clinical treatment effect.

[0048] For PRP obtained separately during synchronous collection, a differentiated preservation scheme is adopted to adapt to the needs of subsequent multiple treatments. First, the PRP undergoes static depolymerization to break up platelet aggregation and ensure its active components can function normally in subsequent use. After depolymerization, the platelet-rich plasma is transferred to multi-unit bags for aliquoting and then cryopreserved at -80 degrees Celsius or in liquid nitrogen. This cryopreservation method maximizes the stability of active factors in platelet-rich plasma, with a storage life of up to one year. During subsequent treatment cycles, the cryopreserved PRP can be retrieved as needed for thawing and reuse, meeting the clinical needs of fractionated treatments while avoiding the physical burden and time costs associated with multiple collections.

[0049] Furthermore, this embodiment also verifies its effectiveness through specific experiments, as follows: This study used knee osteoarthritis (KOA) as the treatment subject, and its core objective was to verify the therapeutic advantages of the PBSC and PRP combination product compared to PRP alone. The study employed a randomized controlled design and strictly controlled variables to ensure the reliability of the results.

[0050] Please refer to Tables 1 and 2 to first determine the study sample. A total of 10 patients with knee osteoarthritis who met the clinical research criteria were included and randomly divided into group A (PBSC and PRP mixed product treatment group) and group B (PRP treatment alone group), with 5 patients in each group. To exclude the interference of baseline differences on efficacy assessment, the baseline information and pre-collection indicators of the two groups were tested for balance: In terms of age, group A was 44-73 years old, with a mean of 60.8 years (standard variance 11.8), and group B was 45-67 years old, with a mean of 58.4 years (standard variance 11.4); in terms of gender, both groups had 2 males and 3 females, and there were no statistically significant differences in age and gender (P>0.05). Pre-collection blood routine tests showed that the mean platelet count in group A was... ( The mean hematocrit was 42.2 (38-48), and the mean platelet count in group B was... ( The mean hematocrit was 40.4 (35-45), and the white blood cell count, hemoglobin and other blood routine indicators in both groups were within the normal range. There was no statistically significant difference in the baseline data (P>0.05).

[0051] Simultaneously, the baseline status of knee joint function was assessed using three scoring systems: VAS, WOMAC, and Lysholm. In Group A, the mean VAS score was 3.5 (standard variance 1.2), the mean WOMAC score was 63.5 (standard variance 40), and the mean Lysholm score was 68.8 (standard variance 10.5). In Group B, the mean VAS score was 3.8 (standard variance 1.6), the mean WOMAC score was 82.8 (standard variance 43.4), and the mean Lysholm score was 60.4 (standard variance 10), laying the foundation for comparing treatment efficacy.

[0052] During the experimental phase, Group A used the MCS9000 instrument with 971E consumables to collect and prepare a mixed product of PBSC and PRP, while Group B prepared a PRP-only product. All products underwent comprehensive quality testing after collection. Cell marker detection was performed using flow cytometry. Results showed that in Group A's PBSC product, the average percentage of CD34+ viable cells among viable nucleated cells was 0.05% (standard deviation 0.02), with an absolute count of 43 cells / cell. (Standard variance 16), all higher than the peripheral blood reference values ​​(percentage 0.006-0.045%, count 0.32-3.5 / ). This confirmed the effectiveness of the collection and cell viability; PRP concentration was detected by a fully automated hematology analyzer. Some cases reached The above results indicate sufficient active ingredients; centrifugation precipitation showed no significant residual red blood cells, mononuclear cells accounted for ≥90%, and no bacterial growth was observed after 48 hours of bacterial culture. All quality indicators met clinical standards. Subsequently, the two groups of patients received intra-articular injections of the corresponding preparations. Patients were followed up regularly after treatment, and efficacy data were collected before treatment, 1 month after treatment, and 3 months after treatment.

[0053] Please refer to Tables 3 and 4. Use independent samples t-test to analyze the efficacy data of the two groups. By analyzing the patients before treatment, one month after treatment, and three months after treatment, the results show that there are statistically significant differences between group A and group B in terms of knee function repair, pain index, inflammation index, and mobility after three months.

[0054] In the three-month VAS score comparison, the average VAS score of group A decreased by 3.2 after three months, while the average VAS score of group B decreased by 1.2 after three months; the Sig(2-tailed) value was 0.02, which is less than 0.05, indicating statistical significance.

[0055] In the three-month Lysholm score, the average Lysholm score of group A increased by 22.4 after three months, and the average Lysholm score of group B increased by 5.4 after three months; the Sig(2-tailed) value was 0.004, which was less than 0.05, and was statistically significant.

[0056] In the three-month WOMAC score, the p-value was greater than 0.05, which was not statistically significant.

[0057] The method for obtaining a PBSC and PRP hybrid product in this embodiment has direct and broad application prospects in clinical settings for osteoarthritis treatment, cartilage repair, and other orthopedic degenerative diseases. Its product quality is ensured through precise separation and closed-loop mixing, and its safety system, built upon real-time physiological monitoring and dynamic parameter adjustment, perfectly meets the core clinical needs of "efficient treatment + safe collection." For middle-aged and elderly patients with osteoarthritis, and patients with cartilage defects due to sports injuries, the hybrid product prepared by this method can enhance treatment efficacy through the synergistic effect of "PBSC regeneration and repair + PRP microenvironment regulation," while avoiding problems such as component activity loss and exogenous contamination in traditional preparation methods. It can be quickly integrated into the clinical treatment processes of orthopedic and sports medicine departments at all levels of hospitals, becoming a preferred alternative to traditional single-component treatments.

[0058] In terms of medical technology transformation and industrial promotion, the application prospects of this embodiment are equally promising. The MCS9000 blood cell separator and 971E disposable sterile consumables used are both clinically mature equipment and consumables, reducing equipment investment and operational learning costs for medical institutions and facilitating rapid technology implementation. Simultaneously, without the use of mobilization agents, the closed-loop process of "collection-separation-mixing-reinfusion" and automated control achieved by this method reduces manual intervention and improves clinical preparation efficiency, making it particularly suitable for expanded applications in primary healthcare institutions and health check-up centers. Furthermore, the aliquot storage design for multiple treatment needs is adaptable to long-term treatment scenarios for chronic diseases. Combined with the research hotspot of stem cell and PRP combined therapy, it can be further expanded to more clinical fields such as wound repair and immune modulation in the future, promoting the standardization and large-scale development of regenerative medicine treatment technologies.

[0059] Example 2 Please refer to Figure 4 This embodiment 2 provides a hybrid product acquisition system for PBSC and PRP based on synchronous acquisition, including: The information collection and system preparation unit is used to collect basic patient information and treatment needs and to determine the target specifications of the mixed product; without using mobilizing agents, it selects suitable blood cell separation equipment and sterile tubing components and completes the construction of a closed-loop circulation system, completing the preparatory settings before the collection procedure is started. The multi-dimensional data real-time acquisition unit is used to collect blood component data and fluid-physiological data in real time through the sensor module on the device after the separation acquisition program is started, and transmit the collected data to the device control unit in real time. The model building and parameter optimization unit is used to build a multi-objective control model based on improved particle swarm optimization. With the concentration of effective ingredients in the mixed product meeting the standard and the amount of impurity residue meeting the requirements as constraints, it dynamically outputs the optimal control parameters and automatically adjusts the centrifugal speed, PBSC branch flow rate, PRP branch flow rate and anticoagulant ratio of the equipment. The stratification and synchronous mixing unit is used to separate peripheral blood into layers by density after centrifugation. The PBSC layer and PRP layer are introduced into the corresponding branches through the diversion valve and simultaneously delivered to the sterile finished product collection bag to complete the closed mixing. Red blood cells and excess plasma are returned to the patient in real time through the reinfusion tube. The quality control and finished product quality inspection unit is used to compare the actual component concentration and volume of the mixed product with the target parameters in real time, calculate the deviation value, and trigger the algorithm to re-iterate and adjust the parameters when the deviation exceeds the preset threshold. If the patient's physiological parameters exceed the safe range, the collection flow rate is automatically adjusted or the collection is paused and an alarm is triggered. When the mixed product reaches the target volume or the total amount of components meets the clinical needs, the equipment automatically terminates the collection and performs quality inspection on the finished product. Once qualified, it is a PBSC and PRP mixed product.

[0060] Example 3 This embodiment 3 also provides a computer-readable storage medium storing a computer program that, when executed by a processor, can implement any step of a method for acquiring a hybrid PBSC and PRP product based on synchronous acquisition.

[0061] The computer-readable storage medium may include various media capable of storing program code, such as USB flash drives, portable hard drives, read-only memory (ROM), random access memory (RAM), magnetic disks, or optical disks.

[0062] For a description of the computer-readable storage medium provided in this application, please refer to the above method embodiments; further details will not be repeated here.

[0063] Those skilled in the art will readily understand that the above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A method for acquiring a hybrid PBSC and PRP product based on synchronous acquisition, characterized in that, include: S1. Collect basic patient information and treatment needs, and determine the target specifications for the hybrid product; Without using mobilizing agents, select suitable blood cell separation equipment and sterile tubing components and complete the construction of a closed-loop circulation system, and complete the preparatory settings before starting the collection procedure. S2. After starting the separation and acquisition program, the device collects blood component data and fluid-physiological data in real time through the sensor module on the device, and transmits the collected data to the device control unit in real time. S3. A multi-objective control model is constructed based on the improved particle swarm optimization method. The optimal control parameters are dynamically output under the constraints of meeting the concentration of effective components and the amount of impurities in the mixed product. The centrifuge speed, PBSC branch flow rate, PRP branch flow rate and anticoagulant ratio are automatically adjusted. S4. After peripheral blood is centrifuged and separated into layers according to density, the PBSC layer and PRP layer are introduced into the corresponding branches through the diversion valve and simultaneously delivered to the sterile finished product collection bag to complete the closed mixing. Red blood cells and excess plasma are returned to the patient in real time through the reinfusion tube. S5. Real-time comparison of the actual component concentration and volume of the mixed product with the target parameters, calculation of the deviation value, and triggering the algorithm to re-iterate and adjust the parameters when the deviation exceeds the preset threshold; if the patient's physiological parameters exceed the safe range, the collection flow rate is automatically adjusted or the collection is paused and an alarm is triggered; when the mixed product reaches the target volume or the total amount of components meets clinical needs, the device automatically terminates the collection, performs quality inspection on the finished product, and the qualified product is the PBSC and PRP mixed product.

2. The method for acquiring a hybrid PBSC and PRP product based on synchronous acquisition according to claim 1, characterized in that, The closed-loop circulation system in S1 includes a main acquisition path, a PBSC separation branch, a PRP separation branch, and a mixed confluence branch.

3. The method for acquiring a mixed PBSC and PRP product based on synchronous acquisition according to claim 1, characterized in that, The S1 also includes configuring anticoagulation-related reagents and setting the initial application ratio, and inputting patient-related parameters into the device control module.

4. The method for acquiring a hybrid PBSC and PRP product based on synchronous acquisition according to claim 1, characterized in that, In S2, the blood component data is monitored by an optical sensor to detect the light transmittance of the blood components in the centrifuge cup. The blood components are separated and identified by the difference in light transmittance. When the white film layer is detected, the collection process of the corresponding component is started. At the same time, the required blood component collection volume is calculated in real time by combining the preset patient hematocrit, target platelet volume and basic blood parameters, and the number of collection cycles is dynamically determined. All blood component related data are displayed in real time on the device operation interface, which is convenient for medical staff to view intuitively and monitor the whole process.

5. The method for obtaining a mixed PBSC and PRP product based on synchronous acquisition according to claim 1, characterized in that, The fluid-physiological data in S2 is collected and linked for regulation and early warning in the following way: the DPM pressure sensor and SPM pressure sensor configured in the device detect the pressure in the tubing flowing into and out of the patient and centrifuge cup, respectively. The normal pressure range is 0-30 kPa. The electronically controlled pressure monitor works in conjunction with relevant filters on the consumables to measure the pressure inside the pipeline. After the pressure monitor feeds back the detected pressure data to the system, the MCS9000 program automatically adjusts the pump speed based on this data; the flow rate collected in the main pipeline is accurately recorded by a flow sensor. Simultaneously, the device connects to a matching physiological monitoring module to synchronously collect the patient's heart rate. ,blood pressure The system collects data such as total blood volume processed, product volume collected per cycle, and other blood component processing volume. All collected fluid-physiological data are linked in real time with the equipment control system. When the data exceeds the preset safety range, the system automatically triggers the abnormal warning function to provide real-time alerts for abnormal data.

6. The method for obtaining a mixed PBSC and PRP product based on synchronous acquisition according to claim 1, characterized in that, The construction process of the multi-objective control model in S3 is as follows: First, a sub-model for achieving the target concentration of active ingredients is constructed, with the degree of fit between the effective ingredient concentration and the target concentration as the core optimization direction. Mathematically, this is expressed as: in, The sensor module monitors the derived effective concentration of autologous peripheral blood stem cells in real time, and the data comes from blood stratification and nucleated cell concentration distribution monitoring. The concentration threshold is preset based on clinical treatment needs; The platelet concentration in platelet-rich plasma, which is captured in real time by the sensing module, is obtained by monitoring the degree of platelet enrichment in the plasma layer. To meet the concentration threshold for optimal clinical efficacy, the two active ingredients were optimized to achieve synergistic efficacy by making the product of their concentration ratios approach 1. Secondly, a dynamic inhibition sub-model for impurity residue is constructed to correlate the concentration relationship between impurities and active ingredients, mathematically expressed as follows: in, The data for real-time detection of residual impurities such as red blood cells comes from blood stratification test results. By optimizing the ratio of impurities to total concentration of active ingredients to approach 0, the linkage regulation of impurity inhibition and active ingredient enrichment is achieved, avoiding the loss of active ingredients caused by simple impurity control and ensuring product purity. Next, a process safety collaborative adaptation sub-model is constructed to integrate the adaptability of equipment operation with the patient's physiological state, mathematically expressed as: in, The pressure inside the pipe is collected in real time by a pressure sensor; The preset pressure reference value is designed to combine all equipment parameters with the range of human tolerance. The flow rate is collected on the main path by the flow sensor; To achieve adaptive flow rate based on real-time heart rate and blood pressure; through optimization to make the pressure-flow rate adaptation ratio approach 1, dynamic matching between equipment operation and physiological state is realized. Finally, a volume control sub-model is constructed, mathematically expressed as follows: in, The volume of mixed products as counted in real time by the equipment; The target volume is preset based on treatment needs; the improved particle swarm optimization method dynamically adjusts the centrifuge speed, branch flow rate and anticoagulant ratio through iterative search, so that the optimization target of the above sub-model synchronously approaches the ideal value, and outputs the optimal parameters every 2 seconds to ensure synchronous acquisition coordination, product quality stability and process safety.

7. The method for obtaining a mixed PBSC and PRP product based on synchronous acquisition according to claim 6, characterized in that, The specific process of the improved particle swarm optimization method is as follows: First, initialize the particle population and set the particle positions. The particle velocity corresponds to the combination of parameters such as centrifuge speed, PBSC branch flow rate, PRP branch flow rate, and anticoagulant ratio. The adjustment step size for each parameter, population size, and number of iterations are set based on the dynamic response requirements of the data collection process; Calculate the fitness value of each particle in the initial population. The fitness value is directly adopted from the comprehensive optimization function of the multi-objective control model, that is: The fitness value reflects the optimization effect of the corresponding parameter combination of the particle. The closer the fitness value is to 1, the better the parameter combination. Next, the particle velocity and position are iteratively updated. The velocity update formula is: The position update formula is: in, They represent the first During the nth iteration, the 1st The velocity corresponding to each particle has the physical meaning of the adjustment step size of the equipment control parameters; They represent the first During the nth iteration, the 1st The position of each particle represents the physical meaning of the specific combination of device control parameters in the current iteration. For the first In the next iteration, particles The optimal position for an individual particle, i.e., the parameter combination whose history fitness value is closest to 1. For the first The global optimal position of the population in the next iteration is the parameter combination whose historical fitness value is closest to 1. Finally, the iteration termination condition is set: when the fitness value corresponding to the global optimal position of the population approaches 1 and there is no significant change after several consecutive iterations, or when the preset number of iterations is reached, the iteration is terminated and the parameter combination corresponding to the global optimal position is output as the optimal control parameter of the device.

8. The method for obtaining a mixed PBSC and PRP product based on synchronous acquisition according to claim 1, characterized in that, The calculation process for the deviation value in S5 is as follows: The deviation value for the effective concentration of autologous peripheral blood stem cells in the mixed product was calculated as follows: ,in The effective concentration of autologous peripheral blood stem cells in the mixed product was detected in real time. The data came from the dynamic monitoring results of blood stratification and nucleated cell distribution by the sensor module. The target concentration of autologous peripheral blood stem cells is set as a preset effective concentration, and is determined based on the repair efficacy required for clinical treatment. The deviation value of platelet concentration in platelet-rich plasma was calculated as follows: ,in The platelet concentration in platelet-rich plasma of the mixed product is obtained by the sensor module monitoring the degree of platelet enrichment in the plasma layer. The target platelet concentration in platelet-rich plasma is set with reference to the clinically optimal therapeutic concentration standard. The deviation value of the mixed product volume is calculated as follows: ,in The volume of mixed products, as statistically analyzed in real time by the equipment, is calculated cumulatively by the flow monitoring unit. The target volume of the mixed product is predetermined and determined based on the patient's treatment needs and clinical dosage requirements.

9. A hybrid product acquisition system for PBSC and PRP based on synchronous acquisition, characterized in that, include: The information collection and system preparation unit is used to collect basic patient information and treatment needs and to define the target specifications of the hybrid product. Without using mobilizing agents, select suitable blood cell separation equipment and sterile tubing components and complete the construction of a closed-loop circulation system, and complete the preparatory settings before starting the collection procedure. The multi-dimensional data real-time acquisition unit is used to collect blood component data and fluid-physiological data in real time through the sensor module on the device after the separation acquisition program is started, and transmit the collected data to the device control unit in real time. The model building and parameter optimization unit is used to build a multi-objective control model based on improved particle swarm optimization. With the concentration of effective ingredients in the mixed product meeting the standard and the amount of impurity residue meeting the requirements as constraints, it dynamically outputs the optimal control parameters and automatically adjusts the centrifugal speed, PBSC branch flow rate, PRP branch flow rate and anticoagulant ratio of the equipment. The stratification and synchronous mixing unit is used to separate peripheral blood into layers by density after centrifugation. The PBSC layer and PRP layer are introduced into the corresponding branches through the diversion valve and simultaneously delivered to the sterile finished product collection bag to complete the closed mixing. Red blood cells and excess plasma are returned to the patient in real time through the reinfusion tube. The quality control and finished product quality inspection unit is used to compare the actual component concentration and volume of the mixed product with the target parameters in real time, calculate the deviation value, and trigger the algorithm to re-iterate and adjust the parameters when the deviation exceeds the preset threshold. If the patient's physiological parameters exceed the safe range, the collection flow rate is automatically adjusted or the collection is paused and an alarm is triggered. When the mixed product reaches the target volume or the total amount of components meets the clinical needs, the equipment automatically terminates the collection and performs quality inspection on the finished product. Once qualified, it is a PBSC and PRP mixed product.

10. A computer-readable storage medium having a computer program stored thereon, characterized in that, The computer program is executed by a processor as described in any one of claims 1-8: a method for acquiring a mixed PBSC and PRP product based on synchronous acquisition.

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