Blood component single sampling equipment capable of monitoring in real time

Abstract

The invention discloses blood component single sampling equipment capable of monitoring in real time in the field of blood treatment equipment. The equipment comprises a blood sampling module, a centrifugal separation module, a component collection module and an anticoagulant conveying module, and further integrates a multi-dimensional real-time monitoring system and a closed-loop self-adaptive regulation and control module. The multi-dimensional real-time monitoring system comprises an online micro-fluidic component detection unit, a physiological parameter monitoring unit and an equipment operation monitoring unit, can realize real-time online detection of blood component purity, cell activity and pollutant residue in the separation process, and synchronously monitors circulation physiological parameters of a blood donor and an equipment operation state at the same time; the closed-loop self-adaptive regulation and control module can dynamically adjust parameters such as the centrifugal rotating speed, the fluid pump speed and the anticoagulant ratio according to real-time monitoring data, and precise closed-loop control over the separation process is achieved. The quality stability of blood single-sampling components can be remarkably improved, meanwhile, the operation risk is greatly reduced, and the method is suitable for clinical blood component single-sampling and preparation scenes.

Description

Technical Field

[0001] This invention relates to the field of blood processing equipment, specifically a blood component collection device capable of real-time monitoring. Background Technology

[0002] Apheresis is a technique that separates and collects specific components (such as platelets, plasma, and stem cells) from whole blood through centrifugation, while returning the remaining components to the donor. It is widely used in clinical blood transfusion, blood product preparation, and hematopoietic stem cell collection.

[0003] Most existing blood component apheresis equipment can only perform basic monitoring of the equipment's operating parameters (such as centrifuge speed, pump speed, and pipeline pressure). They cannot perform real-time online detection of the quality of the separated blood components (such as purity, cell viability, and residual contaminants). Quality verification can only be carried out through offline laboratory testing after apheresis. If the component quality does not meet the standards, the entire batch must be scrapped, resulting in a waste of blood resources. At the same time, it is impossible to adjust the separation parameters in a timely manner, making it difficult to guarantee the stability of component quality.

[0004] Furthermore, existing equipment cannot simultaneously monitor changes in the donor's physiological parameters during apheresis, relying solely on manual observation by operators. This makes it difficult to detect adverse reactions in a timely manner, posing certain operational safety risks. Simultaneously, the equipment's operating parameters need to be manually set by operators based on experience, failing to adapt to individual differences among donors, making it difficult to simultaneously achieve separation efficiency and component quality. Therefore, those skilled in the art have provided a blood component apheresis device capable of real-time monitoring to address the problems mentioned in the background section. Summary of the Invention

[0005] The purpose of this invention is to provide a blood component apheresis device that can monitor blood components in real time, so as to solve the problems mentioned in the background art.

[0006] To achieve the above objectives, the present invention provides the following technical solution: A blood component apheresis device capable of real-time monitoring includes a blood collection module, a centrifugation module, a component collection module, an anticoagulant delivery module, a multi-dimensional real-time monitoring system, and a closed-loop adaptive control module. The output end of the blood collection module is connected to the input end of the centrifugation module, and the multiple output ends of the centrifugation module are respectively connected to the corresponding input ends of the component collection module and the return end of the blood collection module; the output end of the anticoagulant delivery module is connected to the input end of the blood collection module. The multi-dimensional real-time monitoring system includes an online microfluidic component detection unit, a physiological parameter monitoring unit, and an equipment operation monitoring unit. The online microfluidic component detection unit is installed in the component output pipeline of the centrifugal separation module and is used to detect the purity of blood components, target cell activity, free hemoglobin content and bacterial contaminant residues in real time after separation. The physiological parameter monitoring unit is used to collect data on changes in heart rate, blood pressure, blood oxygen saturation, and circulating blood volume of the blood donor in real time. The equipment operation monitoring unit is used to collect real-time data on the equipment's centrifugal speed, pipeline pressure, fluid pump speed, and anticoagulant infusion flow rate. The closed-loop adaptive control module is electrically connected to the multi-dimensional real-time monitoring system, blood collection module, centrifugation module, component collection module, and anticoagulant delivery module, respectively. It is used to dynamically adjust the operating parameters of the equipment according to real-time monitoring data to realize closed-loop adaptive control of the blood component collection process.

[0007] As a further aspect of the present invention: the online microfluidic component detection unit includes a microfluidic chip, a laser excitation module, a fluorescence detection module, and a data processing subunit; the microfluidic chip is integrated into the target component output pipeline of the centrifugal separation module, and the separated blood components continuously flow through the detection channel of the microfluidic chip; the laser excitation module and the fluorescence detection module work together to realize the counting of target cells, activity identification, and quantitative detection of impurity components.

[0008] As a further aspect of the present invention: the detection channel of the microfluidic chip is provided with a sheath flow focusing structure, which is used to arrange the flowing blood cells in a single row through the detection area to improve the detection accuracy; the microfluidic chip is also provided with a control channel, which is used to eliminate the interference of ambient light and fluid disturbance on the detection results.

[0009] As a further aspect of the present invention: the physiological parameter monitoring unit includes a wearable acquisition terminal and a data transmission submodule. The wearable acquisition terminal is worn on the blood donor's body surface, and the physiological data collected in real time is transmitted to the closed-loop adaptive control module in real time through the data transmission submodule. When the physiological parameters exceed the preset safety threshold, the closed-loop adaptive control module triggers the corresponding graded early warning and emergency handling process.

[0010] As a further aspect of the present invention: the centrifugation separation module adopts a continuous flow centrifugation separation structure, including a centrifuge chamber, a separation cup, a rotary drive motor, and a multi-channel rotary sealing joint; the separation cup is provided with a gradient separation chamber, which can realize continuous stratified separation of plasma, platelets, white blood cells, and red blood cells in whole blood; the rotary drive motor is electrically connected to a closed-loop adaptive control module, which can dynamically adjust the centrifugation speed according to the detection results of the online microfluidic component detection unit.

[0011] As a further aspect of the present invention: the component collection module includes multiple independent component collection units, each corresponding to a separated blood component, and each component collection unit is equipped with an electromagnetic control valve at its input end. The electromagnetic control valve is electrically connected to the closed-loop adaptive control module. When the online microfluidic component detection unit detects that the purity of the component in the corresponding pipeline does not meet the preset requirements, the closed-loop adaptive control module controls the corresponding electromagnetic control valve to switch, and delivers the non-compliant blood component to the reinfusion pipeline to return it to the blood donor's body.

[0012] As a further embodiment of the present invention: the anticoagulant delivery module includes a storage bag, a precision infusion pump, and a flow sensor. Both the precision infusion pump and the flow sensor are electrically connected to the closed-loop adaptive control module. The closed-loop adaptive control module dynamically adjusts the infusion rate of the precision infusion pump based on the blood collection flow rate of the blood collection module and the circulating blood volume data of the donor collected by the physiological parameter monitoring unit, thereby achieving adaptive adjustment of the ratio of anticoagulant to whole blood.

[0013] As a further aspect of the present invention: the closed-loop adaptive control module has a built-in parameter optimization model based on machine learning. The parameter optimization model takes historical single-donor data and real-time monitoring data as input and the optimal separation parameters as output, and can dynamically match the optimal single-donor operation parameters according to the individual differences of different blood donors.

[0014] As a further aspect of the present invention, it also includes a data traceability and storage module, which is electrically connected to a multi-dimensional real-time monitoring system. This module is used to store all monitoring data, equipment operating parameters, and component detection results throughout the single-collection process, and to generate a unique traceability code that is bound to the corresponding blood component, thereby achieving full traceability of blood components from collection to use.

[0015] As a further aspect of the present invention, it also includes a human-machine interaction module, which is electrically connected to the closed-loop adaptive control module. The human-machine interaction module is used to display real-time monitoring data and equipment operating status, and supports operators to manually set operating parameters, view historical data, and process early warning information.

[0016] As a further aspect of the present invention: the graded early warning and emergency response process includes a first-level early warning, a second-level early warning, and a third-level emergency response; the first-level early warning is when physiological parameters slightly deviate from the threshold, triggering only an audible and visual alert without adjusting the equipment operation; the second-level early warning is when physiological parameters moderately deviate from the threshold, the closed-loop adaptive control module automatically reduces the blood collection and separation speed, while simultaneously alerting the operator; the third-level emergency response is when physiological parameters severely exceed the safety threshold, the closed-loop adaptive control module immediately stops blood collection, initiates the saline flushing and blood reinfusion process, and simultaneously triggers an emergency call.

[0017] Compared with the prior art, the beneficial effects of the present invention are: 1. This invention achieves real-time online detection of blood components after separation by integrating an online microfluidic component detection unit. It can obtain key quality data such as component purity, cell activity, and contaminant residues in real time without the need for offline detection, thus avoiding the collection and waste of unqualified components. At the same time, it provides a real-time basis for adjusting separation parameters.

[0018] 2. This invention uses a multi-dimensional real-time monitoring system to simultaneously monitor component quality, donor physiological parameters, and equipment operating status, achieving full-process monitoring of the blood collection process. It can promptly detect and handle abnormal situations, significantly reducing operational risks and ensuring the safety of blood donors.

[0019] 3. This invention uses a closed-loop adaptive control module to dynamically adjust parameters such as centrifuge speed, pump speed, and anticoagulant ratio based on real-time monitoring data, achieving optimal matching for individual differences among blood donors without the need for manual adjustment, thus improving separation efficiency and the stability of component quality.

[0020] 4. This invention, through its data traceability and storage module, enables complete storage and traceability of data throughout the entire blood collection process, providing comprehensive data support for the quality control of blood components and meeting the standardized requirements of clinical blood management. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of the overall structure of the present invention; Figure 2 This is a schematic diagram of the online microfluidic component detection unit in this invention; Figure 3 This is a schematic diagram of the centrifugal separation module in this invention; Figure 4 This is a schematic diagram of the control flow of the closed-loop adaptive control module in this invention; Figure 5 This is a logic block diagram of the graded emergency response process in this invention. Detailed Implementation

[0022] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0023] Example 1: Platelet apheresis application The blood component apheresis device with real-time monitoring described in this embodiment is used for platelet apheresis of healthy blood donors. The specific implementation process is as follows: Preoperative preparation: The puncture needle of the blood collection module is inserted into the donor's elbow vein. The reservoir bag of the anticoagulant delivery module is filled with ACD anticoagulant. The platelet collection bag, plasma collection bag, and red blood cell reinfusion tubing of the component collection module are connected. The donor is fitted with a wearable collection terminal of the physiological parameter monitoring unit to collect the donor's baseline heart rate, blood pressure, and blood oxygen saturation data. The data is entered into the closed-loop adaptive control module. Based on the built-in parameter optimization model, the module generates the initial apheresis operation parameters: blood collection flow rate 50 mL / min, anticoagulant to whole blood ratio 1:10, centrifugation speed 3000 rpm.

[0024] Apheresis process startup: The equipment is started, the blood collection module collects whole blood at a rate of 50 mL / min, the anticoagulant delivery module infuses anticoagulant at a rate of 5 mL / min, and the anticoagulant whole blood enters the centrifugation separation module. At a centrifugation speed of 3000 rpm, the whole blood is separated into plasma, platelet, white blood cell, and red blood cell layers. The separated platelet layer flows through the online microfluidic component detection unit, which detects the purity, activity, and free hemoglobin content of platelets in real time. At the same time, the physiological parameter monitoring unit collects the donor's physiological data in real time, and the equipment operation monitoring unit collects data such as pipeline pressure and pump speed in real time.

[0025] Closed-loop adaptive adjustment: When the online microfluidic component detection unit detects that the platelet purity is lower than the preset threshold (≥90%), the closed-loop adaptive control module automatically adjusts the centrifugation speed to 3200 rpm and reduces the flow rate of the platelet collection tubing to improve the separation purity of the platelets; when the platelet activity is detected to be lower than the preset threshold (≥95%), the module automatically adjusts the temperature control unit of the tubing to maintain the tubing temperature within the optimal platelet storage temperature range of 22±2℃; when the physiological parameter monitoring unit detects a slight decrease in the blood donor's blood pressure, the module automatically reduces the blood collection flow rate to 40 mL / min and triggers a secondary warning to alert the operator to pay attention to the blood donor's condition.

[0026] Apheresis Completion and Traceability: When the platelet collection volume reaches the preset target... At this time, the equipment automatically stops blood collection and starts the process of flushing the tubing with saline and reinfusing the remaining blood; the data traceability and storage module stores all monitoring data and equipment operating parameters throughout the single apheresis process, generates a unique traceability code and binds it to the platelet collection bag, and realizes full traceability.

[0027] Example 2: Application of plasma collection The equipment described in this embodiment is used for clinical raw material plasma collection operations, and the specific implementation process is as follows: Preoperative preparation: Complete the tubing connection, use sodium citrate as the anticoagulant, have the blood donor wear a wearable physiological data collection terminal, enter basic data, and the closed-loop adaptive control module generates initial parameters: blood collection flow rate 60mL / min, anticoagulant to whole blood ratio 1:8, centrifugation speed 4000rpm.

[0028] Apheresis process: Anticoagulated whole blood enters the centrifugation module, where it is separated into a plasma layer and a blood cell layer at 4000 rpm. The separated plasma flows through an online microfluidic component detection unit to monitor the free hemoglobin content, protein concentration, and bacterial endotoxin residue in the plasma in real time. When the free hemoglobin content exceeds the preset threshold (≤0.5 g / L), the closed-loop adaptive control module automatically reduces the centrifugation speed to 3800 rpm and adjusts the flow rate of the return pipeline to avoid hemolysis caused by red blood cell rupture. When the plasma protein concentration is detected to be below 60 g / L, the module automatically adjusts the plasma collection ratio to reduce the amount of plasma collected and ensure the safety of the blood donor.

[0029] Emergency Response: When the physiological parameter monitoring unit detects a Grade III abnormality in the blood donor, such as excessively fast heart rate and decreased blood oxygen saturation, the module immediately stops blood collection, initiates the saline flushing and whole blood reinfusion process, and triggers an emergency call to notify medical staff for further action.

[0030] Example 3: Application of peripheral blood hematopoietic stem cell apheresis The device described in this embodiment is used for peripheral blood hematopoietic stem cell apheresis in cancer patients. The specific implementation process is as follows: Preoperative preparation: Connect the tubing to the sterile collection bag, put the patient on a physiological parameter monitoring terminal, and enter the patient's basic data such as weight, circulating blood volume, and white blood cell count. The closed-loop adaptive control module generates the initial parameters: blood collection flow rate 40 mL / min, anticoagulant ratio 1:12, and centrifugation speed 2800 rpm.

[0031] Apheresis process: After anticoagulation, whole blood enters the centrifugation module to separate a mononuclear cell layer (containing hematopoietic stem cells). The mononuclear cell layer flows through an online microfluidic component detection unit to monitor the proportion, activity, and white blood cell contamination rate of CD34+ hematopoietic stem cells in real time. When the proportion of CD34+ cells is detected to be lower than a preset threshold, the module automatically adjusts the centrifugation speed and the valve opening and closing of the collection pipeline to improve the purity of hematopoietic stem cell collection. At the same time, the module dynamically adjusts the infusion rate of anticoagulant according to the changes in the patient's circulating blood volume to avoid the risk of sodium citrate poisoning.

[0032] Data storage: After single-cell apheresis is completed, the data traceability module binds data such as CD34+ cell count, activity, and collection volume to the collection bag, providing complete quality data support for subsequent transplantation treatment.

[0033] Example 4: Application of apheresis in the treatment of patients with polycythemia vera The specific implementation process is as follows: Preoperative preparation: The patient was a 52-year-old male diagnosed with polycythemia vera. Preoperative blood routine showed a hematocrit (HCT) of 65%, requiring apheresis to reduce the HCT to below 45%. The equipment tubing was connected and pre-flushed with normal saline. ACD-A anticoagulant was used. The patient was fitted with a wearable terminal with physiological parameter monitoring unit to record data such as patient weight, baseline HCT, and circulating blood volume. The machine learning model built into the closed-loop adaptive control module generated initial operating parameters based on the high viscosity of pathological blood: blood collection flow rate 30 mL / min, anticoagulant to whole blood ratio 1:12, centrifugation speed 3500 rpm, and target red blood cell removal volume 800 mL.

[0034] Apheresis process startup: The equipment is started, and the anticoagulated whole blood enters the centrifugation module, where it is separated into plasma, white blood cell, and red blood cell layers at 3500 rpm. The separated red blood cell layer flows through the online microfluidic component detection unit to detect hematocrit and free hemoglobin content in real time (monitoring hemolysis). The plasma layer is returned to the patient. At the same time, the physiological parameter monitoring unit collects the patient's heart rate, blood pressure, and blood oxygen data in real time.

[0035] Closed-loop adaptive adjustment: When the online microfluidic component detection unit detects that the HCT of the separated red blood cell layer is below 80% (preset threshold), the closed-loop adaptive control module automatically increases the centrifugation speed to 3800 rpm and adjusts the flow rate of the red blood cell collection tubing to improve red blood cell separation efficiency; when the free hemoglobin content exceeds 0.6 g / L, the module automatically reduces the centrifugation speed and blood collection flow rate to avoid red blood cell rupture and aggravation of hemolysis; when the patient's blood pressure rises slightly, the module automatically reduces the red blood cell removal rate, triggers a level one warning, and prompts the operator to pay attention.

[0036] Treatment complete: When the cumulative red blood cell removal volume monitored online reaches the preset 800mL, and the patient's real-time HCT drops to 43%, the device automatically stops single apheresis and starts the saline flushing and remaining blood reinfusion process; the data traceability and storage module generates a unique traceability code for all monitoring data, operating parameters, and red blood cell removal volume of this treatment, and binds it to the patient's medical record to provide data support for subsequent treatments.

[0037] Example 5: Application of platelet apheresis in blood donors of low-weight children The specific implementation process is as follows: Preoperative preparation: The blood donor is a 12-year-old low-weight child, weighing 32kg, who needs to have a single therapeutic dose of platelets collected. (One unit); complete the tubing connection, using a child-specific low-volume tubing, and have the child wear a suitable wearable physiological monitoring terminal to record weight, circulating blood volume, and basic blood routine data; the closed-loop adaptive control module's machine learning model automatically matches a child-specific parameter template to generate initial parameters, taking into account the characteristics of low-weight children's small circulating blood volume and low tolerance to anticoagulants: blood collection flow rate 25mL / min, anticoagulant to whole blood ratio 1:12, centrifugation speed 2800rpm, and maximum plasma processing volume not exceeding 15% of the child's circulating blood volume.

[0038] Apheresis process: After anticoagulation, whole blood enters the centrifugation module. The separated platelets are then laminarly flowed through the online microfluidic component detection unit, which monitors platelet purity and activity in real time. At the same time, the equipment operation monitoring unit monitors changes in circulating blood volume in real time, strictly controlling the extracorporeal circulating blood volume to not exceed 80mL (less than 0.5% of the circulating blood volume in children). When the platelet purity is detected to be lower than 85%, the module automatically adjusts the centrifugation speed to 3000rpm and reduces the platelet collection flow rate, thereby improving platelet purity without increasing the extracorporeal circulating blood volume.

[0039] Safety Controls: The physiological parameter monitoring unit monitors the child's heart rate and blood pressure throughout the procedure. If a slight increase in heart rate is detected, the module automatically reduces the blood collection flow rate to 20 mL / min, while simultaneously adjusting the anticoagulant infusion rate and reducing the sodium citrate infusion rate to prevent hypocalcemia. No adverse reactions were observed throughout the apheresis procedure, and the final platelet count was ≥ [missing value]. Each sample contains 92% purity and 96% activity, meeting clinical requirements.

[0040] Example 6: Graded Emergency Response under Abnormal Operating Conditions The specific implementation process is as follows: Basic setup: A simulated whole blood circulation system is used to simulate the blood collection process of a healthy blood donor. The initial parameters are set as follows: blood collection flow rate of 50 mL / min, anticoagulant ratio of 1:10, and centrifugation speed of 3000 rpm. The physiological parameter monitoring unit simulates the input of abnormal physiological data at different levels to verify the emergency handling logic of the equipment.

[0041] Level 1 warning verification: When the simulated blood donor's blood pressure drops slightly (systolic blood pressure drops from 120 mmHg to 105 mmHg, still within the safe threshold), the device immediately triggers a Level 1 audible and visual warning. The human-machine interaction module prompts the operator to pay attention to the blood donor's status. The device maintains the original operating parameters and continuously monitors blood pressure changes. When the blood pressure returns to the normal range, the warning is automatically lifted.

[0042] Level 2 Early Warning Verification: When simulating a moderate increase in the donor's heart rate (from 80 beats / min to 115 beats / min), the device immediately triggers a Level 2 audible and visual early warning, automatically reducing the blood collection flow rate to 35 mL / min and simultaneously reducing the anticoagulant infusion rate. The human-machine interface prompts the operator to continue monitoring. After 5 minutes of continuous monitoring, if the heart rate recovers to below 90 beats / min, the device automatically returns to its initial operating parameters, and the early warning is lifted. If the simulated heart rate continues to rise to 125 beats / min, the device automatically upgrades to Level 3 emergency response.

[0043] Level 3 Emergency Validation: Simulating a rapid drop in the blood oxygen saturation of the input blood donor (from 98% to 88%), the device immediately triggers a Level 3 emergency, instantly stopping the blood collection module's blood collection action. Simultaneously, it initiates a saline flushing procedure, returning all blood in the extracorporeal circulation tubing to the simulated blood donor. At the same time, an emergency call prompt is triggered, and the emergency treatment progress is displayed on the human-machine interface module. There is no blood residue or tubing blockage throughout the process, and the emergency treatment procedure is initiated and completed within 10 seconds, meeting clinical safety requirements.

[0044] Example 7: Parameter Optimization Validation Based on Machine Learning Model The specific implementation process is as follows: Model foundation: The machine learning model built into the closed-loop adaptive control module is trained based on more than 100,000 historical clinical apheresis data in China. Input features include donor age, weight, blood routine indicators, and circulating blood volume. Output parameters include optimal blood collection flow rate, centrifugation speed, anticoagulant ratio, and separation time. The model can update and optimize parameters every 30 seconds during the apheresis process based on real-time monitoring data.

[0045] Validation process: 200 healthy platelet donors were selected and randomly divided into two groups of 100 each: the observation group was optimized using the machine learning adaptive parameters of the present invention, while the control group was optimized using the fixed template parameters of the existing technology (blood collection flow rate 50 mL / min, centrifugation speed 3000 rpm, fixed anticoagulant ratio 1:10).

[0046] Validation results: The average apheresis time in the observation group was 38 minutes, a 19.1% reduction compared to the 47 minutes in the control group; the average platelet purity in the observation group was 93.2%, a 5.7 percentage point increase compared to the 87.5% in the control group; the average platelet activity in the observation group was 96.8%, a 4.7 percentage point increase compared to the 92.1% in the control group; and the incidence of adverse reactions among donors in the observation group was 1%, a 83.3% decrease compared to the 6% in the control group, fully validating the optimization effect of the machine learning model.

[0047] Comparative Example 1: Comparative Validation of Existing Conventional Blood Component Apheresis Equipment One hundred healthy platelet donors, the same as in Supplementary Example 7, were selected for apheresis. Apheresis was performed using commercially available conventional apheresis equipment (which only monitors equipment operating parameters, lacks online component detection, physiological parameter linkage, and adaptive parameter adjustment). The results are as follows:

[0048] The comparative examples clearly show that, compared with the prior art, the present invention has made significant progress in terms of component quality, separation efficiency, operational safety, and quality control, and fully meets the requirements of inventiveness for invention patents.

[0049] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A blood component apheresis device capable of real-time monitoring, characterized in that, It includes a blood collection module, a centrifugation module, a component collection module, an anticoagulant delivery module, a multi-dimensional real-time monitoring system, and a closed-loop adaptive control module; The output end of the blood collection module is connected to the input end of the centrifugation module, and the multiple output ends of the centrifugation module are respectively connected to the corresponding input ends of the component collection module and the return end of the blood collection module; the output end of the anticoagulant delivery module is connected to the input end of the blood collection module. The multi-dimensional real-time monitoring system includes an online microfluidic component detection unit, a physiological parameter monitoring unit, and an equipment operation monitoring unit. The online microfluidic component detection unit is installed in the component output pipeline of the centrifugal separation module and is used to detect the purity of blood components, target cell activity, free hemoglobin content and bacterial contaminant residues in real time after separation. The physiological parameter monitoring unit is used to collect data on changes in heart rate, blood pressure, blood oxygen saturation, and circulating blood volume of the blood donor in real time. The equipment operation monitoring unit is used to collect real-time data on the equipment's centrifugal speed, pipeline pressure, fluid pump speed, and anticoagulant infusion flow rate. The closed-loop adaptive control module is electrically connected to the multi-dimensional real-time monitoring system, blood collection module, centrifugation module, component collection module, and anticoagulant delivery module, respectively. It is used to dynamically adjust the operating parameters of the equipment according to real-time monitoring data to realize closed-loop adaptive control of the blood component collection process.

2. The blood component apheresis device capable of real-time monitoring according to claim 1, characterized in that, The online microfluidic component detection unit includes a microfluidic chip, a laser excitation module, a fluorescence detection module, and a data processing subunit. The microfluidic chip is integrated into the target component output pipeline of the centrifugation separation module. The separated blood components continuously flow through the detection channel of the microfluidic chip. The laser excitation module and the fluorescence detection module work together to realize the counting of target cells, activity identification, and quantitative detection of impurity components.

3. The blood component apheresis device capable of real-time monitoring according to claim 2, characterized in that, The microfluidic chip has a sheath flow focusing structure in its detection channel to arrange the flowing blood cells into a single line through the detection area, thereby improving detection accuracy. The microfluidic chip also has a control channel to eliminate the interference of ambient light and fluid disturbances on the detection results.

4. The blood component apheresis device capable of real-time monitoring according to claim 1, characterized in that, The physiological parameter monitoring unit includes a wearable acquisition terminal and a data transmission submodule. The wearable acquisition terminal is worn on the blood donor's body surface, and the physiological data collected in real time is transmitted to the closed-loop adaptive control module in real time through the data transmission submodule. When physiological parameters exceed the preset safety threshold, the closed-loop adaptive control module triggers the corresponding graded early warning and emergency response process. The tiered early warning and emergency response process includes Level 1, Level 2, and Level 3 emergency responses. Level 1 early warning occurs when physiological parameters slightly deviate from the threshold, triggering only an audible and visual alert without adjusting equipment operation. Level 2 early warning occurs when physiological parameters moderately deviate from the threshold, in which case the closed-loop adaptive control module automatically reduces the blood collection and separation speed while alerting the operator. Level 3 emergency response occurs when physiological parameters severely exceed the safety threshold, in which case the closed-loop adaptive control module immediately stops blood collection, initiates the saline flushing and blood reinfusion process, and triggers an emergency call.

5. The blood component apheresis device capable of real-time monitoring according to claim 1, characterized in that, The centrifugal separation module adopts a continuous flow centrifugal separation structure, including a centrifugal chamber, a separation cup, a rotary drive motor, and a multi-channel rotary sealing joint; The separation cup is equipped with a gradient separation chamber, which can realize continuous stratified separation of plasma, platelets, white blood cells and red blood cells in whole blood; the rotary drive motor is electrically connected to the closed-loop adaptive control module, which can dynamically adjust the centrifugation speed according to the detection results of the online microfluidic component detection unit.

6. The blood component apheresis device capable of real-time monitoring according to claim 1, characterized in that, The component collection module includes multiple independent component collection units, each corresponding to a separated blood component. Each component collection unit is equipped with an electromagnetic control valve at its input end, which is electrically connected to the closed-loop adaptive control module. When the online microfluidic component detection unit detects that the purity of the component in the corresponding pipeline does not meet the preset requirements, the closed-loop adaptive control module controls the corresponding electromagnetic control valve to switch, delivering the non-compliant blood component to the return pipeline and returning it to the blood donor.

7. The blood component apheresis device capable of real-time monitoring according to claim 1, characterized in that, The anticoagulant delivery module includes a storage bag, a precision infusion pump, and a flow sensor. Both the precision infusion pump and the flow sensor are electrically connected to the closed-loop adaptive control module. The closed-loop adaptive control module dynamically adjusts the infusion rate of the precision infusion pump based on the blood collection flow rate of the blood collection module and the circulating blood volume data of the donor collected by the physiological parameter monitoring unit, thereby achieving adaptive adjustment of the ratio of anticoagulant to whole blood.

8. The blood component apheresis device capable of real-time monitoring according to claim 1, characterized in that, The closed-loop adaptive control module has a built-in parameter optimization model based on machine learning. The parameter optimization model takes historical single-donor data and real-time monitoring data as input and the optimal separation parameters as output, and can dynamically match the optimal single-donor operation parameters according to the individual differences of different blood donors.

9. The blood component apheresis device capable of real-time monitoring according to claim 1, characterized in that, It also includes a data traceability and storage module, which is electrically connected to the multi-dimensional real-time monitoring system. This module is used to store all monitoring data, equipment operating parameters, and component detection results throughout the single collection process, and to generate a unique traceability code that is bound to the corresponding blood component, thereby enabling full traceability of blood components from collection to use.

10. The blood component apheresis device capable of real-time monitoring according to claim 1, characterized in that, It also includes a human-machine interaction module, which is electrically connected to the closed-loop adaptive control module. This module is used to display real-time monitoring data and equipment operating status, and also supports operators to manually set operating parameters, view historical data, and process early warning information.

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