Blood separation device

Abstract

The application discloses a blood separation device, which is suitable for synchronous centrifugal motion with a centrifugal driving device, and comprises a sample bin, a flow guide pipe, a sensing assembly, a valve assembly, a distribution bin and a controller. The sample bin is communicated with the inlet end of the valve assembly through the flow guide pipe. The valve assembly can be switched among three states of closing the inlet end, communicating the inlet end with the first outlet end and communicating the inlet end with the second outlet end. The distribution bin is provided with independent storage cavities communicated with the two outlet ends respectively. The controller controls the valve state switching according to the detection signal of the sensing assembly. The blood component export and component separation are completed by centrifugal force driving. The device can complete component separation without stopping centrifugation, and the pump body and rotary sealing joint are omitted, so that the structure is simplified. The secondary mixing of blood components caused by stopping is avoided, and the separation efficiency and purity are improved. The whole process is automatically operated, and the manual operation and pollution risk are reduced.

Description

Technical Field

[0001] This invention relates to the field of blood separation, and particularly to a blood separation device. Background Technology

[0002] Blood centrifugation is a core foundational technology in fields such as clinical testing and cell therapy. Currently, all blood separation equipment worldwide follows a fixed process of "centrifugation to separate layers, stop centrifugation, and export and collect." No mature technology can complete the separation and storage of different blood components while the centrifugation process is running continuously.

[0003] There has long been a deep-seated technical bias in the industry: the belief that centrifugation must be stopped after blood has separated into layers before it can be exported; otherwise, the continuous centrifugal force will disturb the separation interface, causing the components to remix and the separation purity to drop significantly. All technical improvements have been made within this framework, and this premise has never been broken.

[0004] This inherent process has insurmountable flaws: convection and diffusion inevitably occur during the centrifugation process, causing secondary mixing of blood components; in order to ensure purity, only part of the boundary layer mixture can be discarded, resulting in a serious waste of precious samples such as umbilical cord blood and bone marrow blood; at the same time, the process is cumbersome, the separation efficiency is low, and the cells stay in vitro for too long, leading to a decrease in survival rate.

[0005] Therefore, developing a blood separation device that can accurately separate and export blood while centrifugation is in progress is a core technical problem that urgently needs to be solved in this field. Summary of the Invention

[0006] The main objective of this invention is to provide a blood separation device that can improve the efficiency of blood separation.

[0007] To achieve the above objectives, the present invention proposes a blood separation device, suitable for synchronous centrifugal motion with a centrifugal drive device, the blood separation device comprising: A sample compartment defines a cavity for storing blood samples; A flow guide pipe is connected to the sample chamber, the flow guide pipe defines a flow channel, the flow channel has a flow inlet and a flow outlet, and the flow inlet communicates with the sample chamber; A sensing component configured to sense the type of separated sample after the blood sample has been separated and flows through the flow channel; A valve assembly has an inlet end, a first outlet end and a second outlet end, wherein the inlet end is connected to the flow guide outlet; The material distribution bin defines a first storage chamber and a second storage chamber that are separate from each other. The first storage chamber is connected to the first outlet end, and the second storage chamber is connected to the second outlet end. The controller is connected to the valve assembly and the sensing assembly respectively, and controls the valve assembly to be in a first state, a second state and a third state according to the detection signal transmitted by the sensing assembly; In the first state, the inlet end is closed; in the second state, the inlet end is connected to the first outlet end, so that the first separated sample of the blood sample is guided to the first storage chamber under the centrifugal drive of the centrifugal drive device; in the third state, the inlet end is connected to the second outlet end, so that the second separated sample of the blood sample is guided to the second storage chamber under the centrifugal drive of the centrifugal drive device.

[0008] In some embodiments, the flow channel is at least partially transparent, and the sensing component is an optical sensing component configured to detect the optical properties of the separated sample to identify the type of the separated sample.

[0009] In some embodiments, the blood separation device includes a base, and the dispensing chamber includes a first storage chamber and a second storage chamber, wherein the first storage chamber, the second storage chamber, and the sample chamber are all detachably connected to the base.

[0010] In some embodiments, the sample chamber includes a tapered portion connected to the flow channel, and the inner diameter of the tapered portion gradually decreases along a direction that gradually approaches the flow channel.

[0011] In some embodiments, the valve assembly includes a three-way valve, the three-way valve including an inlet end, a first outlet end, and a second outlet end; in the second state, the inlet end is connected to the first outlet end, and in the third state, the inlet end is connected to the second outlet end.

[0012] In some embodiments, the valve assembly includes a valve disc having a first valve channel and a second valve channel isolated from each other. The inlet end includes a first inlet, a second inlet, and an isolation port isolated from each other. The first inlet communicates with the first outlet end through the first valve channel, and the second inlet end communicates with the second outlet end through the second valve channel. In a first state, the isolation port communicates with the flow guide channel. In a second state, the first inlet communicates with the first outlet end. In a third state, the second inlet communicates with the second outlet end. The valve disc rotates relative to the flow guide channel to the first state, the second state, or the third state.

[0013] In some embodiments, in the second state, the controller is further configured to control the valve turntable to rotate to switch the valve turntable to the third state when the interface between the first separated sample and the second separated sample is within the first valve channel.

[0014] In some embodiments, the blood separation device further includes a cleaning chamber containing a cleaning solution; In the third state, the first inlet is connected to the outlet of the cleaning chamber, so that the cleaning fluid is guided to the first valve channel under the centrifugal drive of the centrifugal drive device; and / or, in the second state, the second inlet is connected to the outlet of the cleaning chamber, so that the cleaning fluid is guided to the second valve channel under the centrifugal drive of the centrifugal drive device.

[0015] In some embodiments, the blood separation device further includes a detection component; In the third state, the detection component is opposite to the first opening to detect the type of separated liquid on the side of the first channel near the first opening; and / or, in the second state, the detection component is opposite to the first opening to detect the type of separated liquid on the side of the first channel near the first opening.

[0016] In some embodiments, the inner diameter of any one of the flow guide pipe, the first valve channel and the second valve channel is between 1 mm and 2 mm. And / or, The length of the flow guide pipe is between 5mm and 15mm; And / or, The thickness of the valve disc is between 4mm and 10mm.

[0017] Compared with the prior art, the beneficial effects of the present invention are: The blood separation device provided by this invention is designed to rotate synchronously with a centrifugal drive device. It includes a sample chamber, a flow channel, a sensing component, a valve assembly, a dispensing chamber, and a controller. The valve assembly can switch between three states: closed at the inlet, connected to the first outlet, and connected to the second outlet. The entire process of blood component extraction and dispensing is driven by centrifugal force. The entire device rotates synchronously with the centrifugal drive device, eliminating the need for rotary sealing joints and thus avoiding the risks of wear and cross-contamination associated with such components. Component separation occurs continuously during centrifugation, eliminating the need to stop the centrifugation process and requiring sample transfer, thereby shortening separation time and preventing secondary mixing of blood components due to convection and diffusion during shutdown. The sensing component detects the type of sample being separated within the flow channel in real time, accurately identifying the layer interface and adapting to blood samples with different characteristics. The controller automatically switches valve states based on detection signals, enabling fully automated control and reducing manual operation. The dispensing chamber has separate storage cavities to physically isolate different samples and prevent cross-contamination between different components. The centrifugal drive method eliminates mechanical shearing, reducing cell damage and improving cell survival rate. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.

[0019] Figure 1 This is a perspective view of a blood separation device according to an embodiment of the present invention; wherein, the valve assembly includes a three-way valve; Figure 2 This is a first perspective view of a blood separation device according to another embodiment of the present invention; wherein the valve assembly includes a valve disc; Figure 3 This is an explosion diagram of a blood separation device according to another embodiment of the present invention; Figure 4 This is a second perspective view of a blood separation device according to another embodiment of the present invention; Figure 5 This is a first perspective view of the blood separation device with the base removed in another embodiment of the present invention; Figure 6 This is a second perspective view of the removal base of the blood separation device in another embodiment of the present invention.

[0020] Explanation of icon numbers: 100 - Blood separation device; 110 - Sample compartment; 111 - Conical section; 120 - Diversion pipe; 130 - Sensing Component; 140 - Valve assembly; 141 - Three-way valve; 142 - Valve rotary table; 1421 - First valve passage; 14211 - First inlet; 14212 - First outlet; 1422 - Second valve passage; 14221 - Second inlet; 14222 - Second outlet; 1423 - Isolation port; 150 - Distribution bin; 151 - First storage bin; 152 - Second storage bin; 160-Controller; 170 - Base; 180-Cleaning chamber.

[0021] The realization of the objective, functional features and advantages of the present invention will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. 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 a part of the embodiments of the present invention, and not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0023] In existing technologies, blood separation generally follows a process of "centrifugation to separate layers - stopping centrifugation - pump extraction," which is not only inefficient but also requires complex components such as additional pumps and rotary sealing joints, resulting in high costs, high failure rates, and susceptibility to contamination. Furthermore, there is a deep-seated technical bias in the industry: the belief that centrifugation must be stopped after blood separation before extraction, otherwise continuous centrifugal force will disturb the separation interface, leading to a decrease in separation purity. This bias stems from the structural limitations of early centrifugation equipment. Early extraction systems were static designs, requiring centrifugation to stop before the separated liquid could be extracted via siphon or pump. However, convection and diffusion inevitably occur during the stopping centrifugation process, causing secondary mixing of the already separated blood components. To compensate for this deficiency, existing technologies typically increase centrifugation time, increase centrifugation speed, or discard large amounts of the boundary layer mixture to ensure separation purity. This not only further reduces separation efficiency but also results in significant waste of valuable samples. For example, traditional manual gradient centrifugation methods typically require discarding 5-10 ml of the mixture containing the boundary layer to obtain high-purity leukocytes, resulting in a sample waste rate exceeding 20%. While existing automated blood separation equipment has partially automated the process, it still adheres to the basic framework of "centrifugation followed by export," with each separation cycle usually taking over 30 minutes. Furthermore, it requires expensive peristaltic pumps, plunger pumps, and high-precision rotary seals, making the equipment costly and hindering its widespread adoption in primary healthcare institutions and research laboratories. In addition, the rotary seal, a core component connecting the rotary centrifuge cup and the static export system, is prone to wear and leakage after prolonged use, leading not only to sample contamination but also to the risk of cross-infection. Its average lifespan is only 1000-2000 cycles, resulting in extremely high maintenance costs. Therefore, this invention proposes a blood separation device 100, which belongs to the field of blood separation technology. It is suitable for automatically separating and collecting different cellular components, such as red blood cells, white blood cells, platelets, and hematopoietic stem cells, from blood samples such as peripheral blood, umbilical cord blood, and bone marrow blood. It can be widely used in many fields such as clinical cell therapy, hematopoietic stem cell transplantation, immunodiagnosis, blood disease research, and drug screening.

[0024] See Figures 1-6The blood separation device 100 provided by this invention is suitable for synchronous centrifugal motion with a centrifugal drive device. The centrifugal drive device can be an independent general-purpose benchtop centrifuge, vertical centrifuge, or high-speed refrigerated centrifuge. The blood separation device 100 is placed in it as an integral centrifugal chamber module and fixed by a standard rotor slot; alternatively, it can be a centrifugal drive unit fixedly connected to the blood separation device 100 as an integral structure, together forming a complete integrated blood separation device, eliminating the need for an additional centrifuge. The blood separation device 100 mainly includes a sample chamber 110, a guide pipe 120, a sensing component 130, a valve assembly 140, a dispensing chamber 150, and a controller 160. The core inventive point of this solution is that the component separation process is entirely completed within the centrifugal drive device and uses centrifugal force as the power source, breaking the technical prejudice that requires stopping the machine to remove components. This allows for the separate collection of different components under continuous centrifugation, achieving high efficiency while reducing the number of parts and lowering costs. Compared with existing technologies, this invention does not require any additional power removal components or rotary sealing joints, resolving the irreconcilable contradiction between efficiency, cost, and purity in existing technologies.

[0025] See Figures 1-6 The sample chamber 110 defines the sample cavity for storing blood samples. It is the initial container for the entire separation process and the core location for centrifugal stratification, providing a sealed space for the blood sample to undergo initial stratification under centrifugal force. Before separation, the operator slowly injects the anticoagulant-treated whole blood sample into the sample chamber 110 through a dedicated sample inlet, then tightens the sealing cap to ensure a complete seal, preventing liquid leakage and external contamination during centrifugation. The material of the sample chamber 110 must meet the requirements of biocompatibility, centrifugal force resistance, chemical corrosion resistance, and easy sterilization. Typically, medical-grade polypropylene (PP), polycarbonate (PC), polymethyl methacrylate (PMMA), or cyclic olefin copolymers (COC) are used. Medical-grade PP offers advantages such as low cost, chemical corrosion resistance, and ease of processing, making it suitable for large-scale production; PC provides higher strength and transparency, facilitating observation of the internal sample state; and COC exhibits extremely low protein adsorption and excellent optical properties, making it suitable for applications requiring extremely high sample purity. The sample chamber 110 can be designed with different volumes of 10ml, 50ml, 100ml, 200ml, 500ml, or even 1000ml to meet the processing needs of micro-scale research samples, routine clinical samples, and large-scale industrial production samples, respectively. Under centrifugal force, the blood sample in the sample chamber will naturally stratify according to density differences, with the highest density being red blood cells (1.090-1.110g / cm³). 3 Plasma, with the lowest density (1.025-1.035 g / cm³), is deposited at the very bottom of the sample chamber.3 The white blood cells (1.060-1.085 g / cm³) are located at the very top of the sample chamber, while the density of white blood cells falls between these two levels. 3 ) and platelets (1.040-1.055 g / cm³) 3 The white blood cells concentrate between the red blood cell layer and the plasma layer, forming a thin layer approximately 1-2 mm thick, commonly known as the "white membrane layer." This stratification process is fundamental to blood separation, and the clarity and stability of the stratification directly affect the subsequent separation purity and recovery rate. To ensure effective stratification, the inner wall of the sample chamber 110 is typically designed as a smooth cylindrical surface to prevent cell adhesion and stratification disturbance caused by rough inner walls. Simultaneously, the central axis of the sample chamber must be strictly aligned with the centrifugal rotation axis to ensure a uniform distribution of the centrifugal force field and prevent eccentric stratification.

[0026] See Figures 1-3 The sample chamber 110 includes a conical section 111 connecting to the guide pipe 120. The inner diameter of the conical section 111 gradually decreases as it approaches the guide pipe 120. This funnel-shaped structure with a gradually narrowing inner diameter allows different layers of liquid to gradually converge and be guided to the inlet of the guide pipe located at the bottom center. Under the continuous action of centrifugal force, the bottom layer of red blood cells first slides along the inner wall of the conical section 111 towards the outlet, followed by the white blood cell layer. Due to the converging effect of the conical section 111, even a white blood cell layer with a volume of only a few milliliters or even less than one milliliter can be concentrated and pushed intact into the guide pipe 120 without cell residue adhering to the wall due to flat areas or dead spaces at the bottom of the chamber. The cone angle of the conical section 111 is a key design parameter; if the cone angle is too large, the converging effect will be poor, and dead spaces will easily form at the bottom; if the cone angle is too small, the liquid flow resistance will increase, and the outlet speed will slow down. Through extensive fluid dynamics simulations and experimental verification, the cone angle of the conical portion 111 is preferably 30°-60°. For example, the cone angle can be 30°, 40°, 45°, 55°, or 60°, with 45° being the optimal value, achieving the best balance between convergence effect and flow resistance. For instance, a sample chamber with a 45° cone angle can control the residual volume at the bottom to below 0.1 ml, while a flat-bottomed sample chamber can have a residual volume as high as 1-2 ml. This structural feature is particularly important for the separation of precious samples such as umbilical cord blood and bone marrow aspiration fluid, maximizing the recovery rate of target cells and minimizing unnecessary loss of precious samples. Furthermore, the inner wall of the conical portion 111 is highly polished, with a surface roughness Ra≤0.2μm, and coated with a nano-heparin anticoagulant coating, further reducing the risk of cell adhesion and protein deposition.

[0027] The flow guide tube 120 is connected to the sample chamber 110, defining a flow channel with an inlet and an outlet. The inlet communicates with the sample chamber. The function of the flow guide tube 120 is to guide the blood components that have undergone initial stratification within the sample chamber 110 in an orderly and stable manner to the valve assembly 140 at the rear. It acts as a "transfer corridor," ensuring that the liquid flows smoothly and controllably from the sample chamber 110 to the valve assembly 140, while suppressing turbulence and stratification disturbances that may occur during fluid flow. During sample loading and initial centrifugation stratification, the valve assembly 140 is fully closed, and there is almost no liquid flow within the flow guide tube 120, only a small amount of pre-injected saline or anticoagulant to remove air from the tube. Only after centrifugation stratification is completed and the low-speed extraction stage begins, driven by continuous centrifugal force, are the stratified blood components pushed sequentially from the sample chamber 110 into the flow guide tube 120 from bottom to top (i.e., from high to low density), at which point the flow guide tube 120 begins to function. Specifically, the bottom layer of red blood cells is pushed into the flow channel first, followed by the middle layer of white blood cells, and finally the top layer of plasma. The material of the flow channel 120 is typically the same as that of the sample chamber 110, made of medical-grade polymer material through injection molding. Its inner wall is electropolished or coated to reduce surface roughness and decrease cell adhesion and protein deposition. The flow channel 120 and the sample chamber 110 are connected by integrated injection molding or laser welding to ensure a stepless and seamless connection, preventing blood residue and cross-contamination. The axis of the flow channel 120 typically coincides with the central axis of the sample chamber 110 and extends outward along the centrifugal radial direction to maximize the use of centrifugal force as the driving force for liquid flow. During centrifugation, the flow velocity of the liquid within the flow channel is entirely determined by centrifugal acceleration, the inner diameter of the channel, and the viscosity of the liquid, requiring no external power source. This is one of the most fundamental differences between this invention and existing technologies.

[0028] The flow channel 120 is at least partially transparent, and this transparent portion can be made of materials such as transparent medical-grade polycarbonate, borosilicate glass, or quartz glass, forming a window segment for optical detection. The length of the transparent window segment is typically 10-20 mm, sufficient to accommodate the installation and detection of the sensing component 130. The inner diameter of any one of the flow channel 120, the first valve channel 1421, and the second valve channel 1422 is between 1 mm and 2 mm. For example, the inner diameter can be 1 mm, 1.2 mm, 1.3 mm, 1.5 mm, 1.8 mm, or 2 mm. This inner diameter range falls into the category of narrow channels, and its function is to constrain the liquid flow state, suppress turbulence or uneven velocity distribution that may occur due to excessively large channel cross-sections, thereby stabilizing the flow velocity of the cell suspension within a relatively concentrated narrow range (5-10 mm / s). Simultaneously, the narrow channel cross-section effectively compresses the axial length of the transition zone between the red blood cell layer and the white blood cell layer, which is naturally formed by molecular diffusion and fluid shearing. This minimizes the total volume of the boundary layer mixture, ensuring it can be completely contained and retained by the valve channel with its limited volume. When the inner diameter is less than 1 mm, the flow resistance increases exponentially, easily leading to interruption or blockage of the flow path for samples with high hematocrit (>45%). When the inner diameter is greater than 2 mm, the flow stabilization effect completely fails, the flow rate fluctuates by more than ±20%, and the volume of the boundary layer mixture increases to over 0.8 ml, making it impossible to completely retain by the valve channel, resulting in a decrease in separation purity. The length of the flow guide pipe 120 is between 5 mm and 15 mm; for example, the length can be 5 mm, 8 mm, 10 mm, 12 mm, or 15 mm. This length provides sufficient space for the installation of the sensing component 130 while avoiding excessive liquid flow resistance or cell deposition in the pipe due to excessively long flow paths. When the length is less than 5 mm, the inlet turbulence is not completely eliminated, and the layered interface is easily disturbed; when the length is greater than 15 mm, the amount of residue in the channel increases, and the sample waste increases.

[0029] In some embodiments, one or more of the sample chamber 110, the flow channel 120, the valve assembly 140, and the dispensing chamber 150 may be disposable consumables, thereby ensuring isolation between two blood separations. In this case, when replacing consumables, after each replacement, the flow channel 120 is positioned to facilitate sensing by the sensor assembly 130, and the valve assembly 140 is positioned to facilitate movement of the valve assembly 140. Of course, in other embodiments, one or more of these components may not be disposable consumables, allowing for cleaning of these components using a cleaning device to prevent cross-contamination between multiple samples.

[0030] See Figure 1The sensing component 130 is configured to sense the type of separated blood sample after separation within the flow channel. The sensing component 130 is the "sensing organ" of the entire device, responsible for real-time identification of the blood component currently flowing through the flow channel 120. It converts the identification result into an electrical detection signal and transmits it to the controller 160, providing a basis for precise valve switching. The performance of the sensing component 130 directly determines the accuracy of the boundary layer identification and the timing of valve switching, thus affecting the separation purity and recovery rate of the entire device. The sensing component 130 can be implemented using various different technical solutions, each with its specific applicable scenarios and advantages and disadvantages. For example, the sensing component 130 can be an optical sensing component, which uses the differences in the absorption, scattering, or transmission characteristics of different blood components to specific wavelengths of light to identify cell types. This is currently the most mature and widely used detection scheme. The sensing component 130 can also be an ultrasonic sensing component, which uses the differences in the reflection or attenuation characteristics of different cell components to distinguish them. This scheme is not affected by the color and transparency of the sample and is suitable for detecting abnormal samples such as hemolysis and hyperlipidemia. The sensing component 130 can also be a capacitive or impedance sensing component, which uses the differences in conductivity or dielectric constant of different cell layers to achieve identification. This scheme has the advantages of fast response speed, low power consumption, and easy integration. In addition, the sensing component 130 can also adopt other detection principles such as magnetic sensing, thermal sensing, and image recognition. The sensing component 130 can perform detection in two ways: direct detection, where the sensor's sensitive element directly contacts the flowing liquid to measure its physical or chemical properties (high accuracy but risks of contamination and biocompatibility); or indirect detection, such as detecting changes in the light transmittance, vibration frequency, or temperature of the guide pipe wall to indirectly determine the type of liquid inside. This non-contact detection avoids direct contact with blood samples, preventing sample contamination and cross-infection, and also facilitates sensor installation and maintenance. Regardless of the specific approach, the core function of the sensing component 130 is to output a detection signal characterizing the type of the currently flowing liquid for the controller 160 to make logical judgments. To improve detection reliability and anti-interference capabilities, the sensing component 130 typically integrates signal amplification, filtering, and analog-to-digital conversion circuits to convert the original analog signal into a digital signal before transmitting it to the controller 160.

[0031] See Figure 1As a preferred sensing implementation scheme, the sensing component 130 is an optical sensing component, configured to detect the optical characteristics of the separated sample to identify the type of the separated sample. Specifically, the optical sensing component may include at least one set of near-infrared photodiodes, with its emitting end and receiving end respectively mounted on both sides of the light-transmitting tube section. The emitting end emits a light beam of a specific wavelength that passes through the guide tube and the liquid inside it, and the receiving end captures the transmitted light signal and converts it into an electrical signal. Because red blood cells are rich in hemoglobin, they have a strong absorption capacity for near-infrared light, and their transmittance is typically only about 5% to 15%, for example, 5%, 7%, 10%, 12%, or 15%. White blood cell layers contain almost no hemoglobin and have relatively high transmittance, typically between 30% and 50%, for example, 30%, 35%, 42%, 48%, or 50%. Plasma layers are even clearer, with transmittance reaching 80% to 95%, for example, 80%, 85%, 90%, 93%, or 95%. Therefore, by analyzing the magnitude and trend of the real-time transmittance signal, the optical sensing component can accurately distinguish whether the current flow through the pipe is red blood cells, white blood cells, or plasma, and output different detection signals to the controller 160 accordingly. To further improve detection accuracy and anti-interference capabilities, optical sensing components can employ dual-wavelength detection technology, simultaneously emitting near-infrared light at wavelengths of 780nm and 660nm. The transmittance ratio of the two wavelengths is calculated to eliminate the influence of background noise and sample color differences. For example, in hyperlipidemic samples, the transmittance of the plasma will significantly decrease, but the transmittance ratio of the two wavelengths will not change much compared to normal samples. Therefore, a ratio algorithm can effectively distinguish between hyperlipidemic plasma and the leukocyte layer. Furthermore, optical sensing components can also employ reflective detection, where the transmitter and receiver are located on the same side of the light-transmitting tube. The component type is identified by detecting the intensity of reflected light from the liquid. This method is more convenient to install and is not affected by obstruction from the other side of the tube. This optical detection method has the advantages of fast response, high accuracy, non-contact operation, and no contamination, making it particularly suitable for automated blood separation applications.

[0032] See Figure 1 , or see Figures 2-3The valve assembly 140 has an inlet end, a first outlet end 14212, and a second outlet end 14222, with the inlet end connected to the guide outlet. The valve assembly 140 is the core component of the entire shunting process. It receives liquid from the guide pipe 120 and dynamically switches internal pathways according to instructions from the controller 160, guiding different separated samples to their corresponding storage chambers. Its working principle is similar to an automatic sorting switch, capable of switching pathways within milliseconds to ensure that different types of blood components are accurately allocated to their corresponding collection containers. Initially, all pathways are closed to ensure that samples do not leak during the centrifugation stratification stage. When red blood cells need to be extracted, the inlet end connects to the first outlet end 14212, forming a pathway to the red blood cell collection chamber. When the subsequent white blood cell layer arrives, the connection is quickly switched between the inlet end and the second outlet end 14222, forming a pathway to the white blood cell collection chamber. The valve assembly 140 can have various structural options, such as a three-way plug valve, a ball three-way valve, a slide valve, a solenoid pinch valve, or a rotary valve, as long as it can reliably switch between multiple outlets. The drive source for the valve assembly 140 can be a stepper motor, a servo motor, a piezoelectric ceramic driver, or an electromagnet, to provide fast and precise switching actions. Stepper motors are the preferred drive method in this invention due to their low cost, simple control, and high positioning accuracy; servo motors offer higher response speed and torque, suitable for applications with extremely high switching time requirements; and piezoelectric ceramic drivers are small in size, low in power consumption, and free from electromagnetic interference, making them suitable for miniaturized and portable devices. The valve assembly 140 can also have more outlets, such as a third outlet or a fourth outlet, to accommodate applications requiring the separation of more than three blood components, such as simultaneously separating red blood cells, white blood cells, platelets, and plasma. The sealing performance of the valve assembly 140 is one of its most important performance indicators; it must ensure no leakage or cross-contamination under centrifugal force, while also having a long service life and good biocompatibility. Sealing materials typically use medical-grade silicone rubber, fluororubber, or polytetrafluoroethylene, which have excellent elasticity, chemical resistance, and biocompatibility, and can meet the requirements for long-term repeated use.

[0033] See Figure 1 Unlike Figures 2-6 This embodiment is a specific implementation of a valve assembly. Figure 1In the embodiments, valve assembly 140 includes a three-way valve 141, which includes an inlet end, a first outlet end 14212, and a second outlet end 14222. The three-way valve 141 can be a plug valve, a ball valve, or a solenoid valve, etc., and has a rotatable valve core or a sliding valve stem inside, allowing different flow paths to be switched by changing the position of the valve core or valve stem. Plug valves are simple in structure, low in cost, and have good sealing performance, but have relatively high rotational resistance, making them suitable for low-flow applications. Ball valves have low rotational resistance, fast response speed, and long service life, but are relatively expensive. Solenoid valves do not require a motor drive; they directly control the valve core movement through an electromagnet, resulting in extremely fast response speed, but have high power consumption and are subject to electromagnetic interference. In the second state, the inlet end connects to the first outlet end 14212, forming a complete channel from the guide pipe 120 to the first storage chamber; in the third state, the inlet end connects to the second outlet end 14222, forming a complete channel from the guide pipe 120 to the second storage chamber. The drive motor is connected to the valve core or valve stem of the three-way valve 141. The drive motor can be a stepper motor with a rotational accuracy of ±0.1°, enabling rapid and accurate switching between the two outlet ends, with a switching time typically less than 100ms. This solution uses mature standard three-way valve components, featuring a simple structure, readily available parts, and low manufacturing cost, making it suitable for large-volume routine sample processing scenarios where the control requirements for boundary layer residue are relatively lenient. However, at the moment of switching, the residual liquid (potentially a mixture of red blood cells and white blood cells) in the common channel inside the three-way valve will inevitably flow into the storage chamber corresponding to the next outlet end, affecting the purity of the target product to some extent. For example, the volume of the common channel is usually 0.5-1 ml, and this portion of the mixture will all flow into the leukocyte storage chamber, causing the red blood cell removal rate to drop to about 95%. To compensate for this deficiency, it is usually necessary to discard the first 0.5-1 ml of leukocyte suspension after switching, which will further reduce the leukocyte recovery rate by about 5%-10%.

[0034] To overcome the inability to remove residual contaminants from the boundary layer in the aforementioned three-way valve solution, a more preferable valve assembly implementation method is described below. Figures 2-6The valve assembly 140 includes a valve disc 142, which has a first valve passage 1421 and a second valve passage 1422 that are isolated from each other. Unlike a typical three-way valve, the inlet end here is not a single opening, but is designed as three independent openings that are isolated from each other: a first inlet 14211, a second inlet 14221, and an isolation port 1423. The first inlet 14211 and the first outlet 14212 are connected through the first valve passage 1421 (the first valve passage 1421 is designed with a forward spiral of 90 degrees, that is, the first inlet 14211 and the first outlet 14212 are deflected 90 degrees circumferentially), and the second inlet 14221 and the second outlet 14222 are connected through the second valve passage 1422 (the second valve passage 1422 is designed with a reverse spiral of 90 degrees, that is, the second inlet 14221 and the second outlet 14222 are deflected 90 degrees circumferentially in opposite directions). Driven by a motor, the valve disc 142 can rotate relative to the flow channel 120, switching between a first state, a second state, or a third state. In the first state, the isolation port 1423 on the disc is aligned with the flow channel. The isolation port 1423 is a blind hole or a closed surface, not connected to any outlet end, keeping the valve fully closed. Blood in the sample chamber 110 can stratify under centrifugal force without leakage. In the second state, after the disc rotates a certain angle, the first inlet 14211 aligns with the flow channel, and the first valve channel 1421 is connected to the flow path. At this time, the flow channel is connected to the first storage chamber via the first valve channel 1421, and red blood cells begin to be extracted. In the third state, the disc continues to rotate, the second inlet 14221 aligns with the flow channel, and the second valve channel 1422 is connected to the flow path. The flow channel is connected to the second storage chamber via the second valve channel 1422, and white blood cells begin to be extracted. This valve disc structure integrates the switching function of different flow paths, the physical isolation function of different channels, and the boundary layer interception function described below into a single rotating component. It features a compact structure, few moving parts, high reliability, and completely independent valve channels, eliminating the possibility of crosstalk between channels. The valve disc 142 is typically made of medical-grade polyetheretherketone (PEEK), polyoxymethylene (POM), or high-density polyethylene (HDPE), possessing excellent wear resistance, self-lubrication, and biocompatibility. The seal between the disc and the valve body uses a planar seal, with a 0.05mm high micro-protrusion structure on the dynamic sealing surface. Combined with O-ring pre-compression, the sealing gap is ≤0.02mm, maintaining good sealing performance under centrifugal force, preventing leakage and cross-contamination. The thickness of the valve disc 142 is between 4mm and 10mm; exemplarily, the thickness can be 4mm, 5mm, 6mm, 8mm, or 10mm. The thickness of the valve turntable 142 directly determines the axial length of its internal first valve channel 1421 and second valve channel 1422.The channel length is the fundamental mathematical basis for the controller 160 to calculate the key parameter of "the time required for the interface to travel from the pipe inlet to the entire interior of the channel." When the thickness is less than 4mm, the channel volume is too small to completely contain the interface layer mixture; when the thickness is greater than 10mm, the channel volume is too large, which will trap too many white blood cells, leading to a decrease in recovery rate. The valve rotary table 142 has a service life of over 10,000 cycles, far exceeding the service life of ordinary three-way valves.

[0035] Based on the valve disc structure, the controller 160 can be further configured to execute a more refined switching control strategy to physically remove the interface mixture between red blood cells and white blood cells. In the second state, when the first separated sample (red blood cells) is being discharged through the first valve channel 1421, the sensing component 130 continuously monitors the type of liquid flowing through the guide channel. Once the sensing component 130 detects that the interface between the first separated sample and the second separated sample (white blood cells) is about to arrive, the controller 160 does not immediately trigger the disc switching, but instead calculates and delays the judgment based on the real-time flow rate. The real-time flow rate can be measured by two sets of photoelectric sensors installed in series, i.e., when the interface passes through the first sensor, time t1 is recorded, and when it passes through the second sensor, time t2 is recorded. The distance between the two sensors is a fixed value L, then the real-time flow rate v = L / (t2-t1). Then, the controller 160 calculates the delay time T = (d + H) / v required for the interface to fully enter the first valve channel 1421 from the position of the second sensor, based on the flow velocity v and the axial length H of the first valve channel 1421, where d is the distance from the second sensor to the valve inlet. When the controller 160 determines that the interface between the first and second separated samples has fully entered the first valve channel 1421, it controls the valve turntable 142 to rotate, switching the valve turntable 142 to the third state. At this time, what is retained in the first valve channel 1421 is precisely the section of cell-mixed, low-purity "boundary layer mixture" between the end of the red blood cell layer and the beginning of the white blood cell layer. Since this part of the mixture is completely encapsulated in the first valve channel 1421, which has rotated away from the main flow path, it will not enter the first storage chamber or the second storage chamber. In this way, pure red blood cells flow into the first storage chamber, and pure white blood cells flow into the second storage chamber. The boundary layer mixture is physically excluded from the collection system, fundamentally resolving the contradiction of "purity and recovery rate being mutually exclusive" in traditional methods. This interception method is like using a "sampling spoon" of a specific volume to scoop away the turbid liquid at the interface at the moment of fluid switching, ensuring the purity of the liquid in both sections. High purity and high recovery rate can be achieved simultaneously without discarding a large amount of valuable cell suspension. According to actual tests, after adopting this control strategy, the red blood cell removal rate can be increased to over 99.5%, the white blood cell recovery rate can be maintained above 95%, and the volume of the boundary layer mixture is only about 0.2 ml, far lower than the 5-10 ml of traditional methods.

[0036] The dispensing chamber 150 defines two separate storage chambers: a first storage chamber and a second storage chamber. The first storage chamber is connected to a first outlet 14212, and the second storage chamber is connected to a second outlet 14222. The dispensing chamber 150 is the final target collection container, used to receive and store different blood components dispensed by the valve assembly 140. In a typical application scenario, the first storage chamber is used to collect waste red blood cells, the second storage chamber is used to collect white blood cells as the target product, and the remaining plasma remains in the sample chamber 110. In other optional embodiments, a third storage chamber, a fourth storage chamber, etc., can be added to increase the number of outlets of the valve assembly 140, enabling the separate collection of other components such as plasma and platelets. The first and second storage chambers can be two different chambers within a single, integrated housing. This structure is compact, easy to install and disassemble, and suitable for integrated devices. Alternatively, they can be chambers defined by two independent housings, which can be fixedly connected or detachably connected. This structure offers greater flexibility, allowing for the selection of storage chambers with different volumes according to actual needs. This detachable design allows for direct removal of the target cell storage chamber after separation, facilitating subsequent cell reinfusion, culture, or testing, thus avoiding the risk of contamination and cell loss associated with secondary transfer. The dispensing chamber 150 is also made of medical-grade polymer material, with a smoothed inner wall and an anticoagulant coating to reduce cell adhesion and protein deposition. The volume of the storage chambers is designed based on the processing volume and the volume ratio of each component. For example, for a 200ml whole blood sample, the volume of red blood cells is approximately 80-100ml, so the volume of the first storage chamber 151 is typically designed to be 120ml; the volume of white blood cells is approximately 1-2ml, so the volume of the second storage chamber 152 is typically designed to be 10ml to ensure sufficient margin. The storage chambers are usually equipped with graduations for easy observation of the collected liquid volume; they also have vents to expel air from the chambers, ensuring smooth liquid flow.

[0037] To facilitate modular assembly, post-use sample extraction, and component cleaning and replacement, the blood separation device 100 may include a base 170. The base 170 serves as the main support and fixing body for the entire device, integrating various functional modules such as the sample compartment 110, valve assembly 140, dispensing compartment 150, and controller 160. The base 170 is typically made of aluminum alloy, stainless steel, or high-strength engineering plastic, possessing sufficient structural strength and rigidity to withstand the enormous centrifugal force generated during centrifugation, while ensuring the relative positional accuracy and rotational coaxiality of the components. The base 170 is typically designed in a cylindrical or disc shape to accommodate the installation space of the centrifuge rotor; its bottom is equipped with a positioning structure that matches the centrifuge rotor slot, ensuring that the device can be quickly and accurately installed on the centrifuge. The dispensing compartment 150 includes a first storage compartment 151 and a second storage compartment 152, all of which are detachably connected to the base 170. This detachable connection method can be a threaded connection, a snap-fit ​​connection, a quick-release chuck connection, or an interference fit connection, as long as it can achieve stable positioning and convenient assembly and disassembly. For example, when using a snap-fit ​​connection, the outer walls of the storage chamber and sample chamber are equipped with elastic snaps, and the base 170 has corresponding slots. Installation and disassembly can be completed with a gentle press, without any tools. After the separation process is completed, the operator can directly remove the second storage chamber 152 containing the target leukocytes from the base 170, seal the connecting tubing with a heat-sealing tool, and obtain a pure cell product that can be directly used for subsequent cell reinfusion, in vitro culture, or flow cytometry. The entire process maintains the sample in a closed and sterile state, avoiding the risk of external microbial contamination and cross-contamination between samples caused by repeated opening and transfer of samples in traditional manual operations. In addition, the detachable design also facilitates individual cleaning, disinfection, and replacement of each component, reducing maintenance costs and extending the service life of the device.

[0038] The controller 160 is connected to the valve assembly 140 and the sensor assembly 130 respectively, and controls the valve assembly 140 to be in the first, second, and third states according to the detection signals transmitted by the sensor assembly 130. The controller 160 is the "decision center" of the entire device, responsible for receiving the detection signals output by the sensor assembly 130, performing logical operations and issuing control commands, coordinating the working sequence of each component, and ensuring that the entire separation process is automatic, orderly, and accurate. Specifically, in the first state, the inlet end is closed, and the device performs centrifugal stratification operation. All liquids are sealed in the sample chamber 110 and the guide pipe 120, and there is no leakage. In the second state, the inlet end is connected to the first outlet end 14212, so that the first separated sample of the blood sample is guided to the first storage chamber under the centrifugal drive of the centrifugal drive device. The first separated sample here usually refers to the red blood cells with the highest density. In the third state, the inlet end is connected to the second outlet end 14222, so that the second separated sample of the blood sample is guided to the second storage chamber under the centrifugal drive of the centrifugal drive device. The second separated sample here usually refers to the white blood cells with a medium density. The controller 160 can be implemented based on hardware platforms such as a microcontroller (MCU), embedded microprocessor (MPU), digital signal processor (DSP), or programmable logic controller (PLC), and internally includes a pre-built signal threshold for determining the boundary layer and a switching logic algorithm. In a preferred implementation, the first detection signal output by the sensing component 130 represents the detection of the first separated sample (e.g., stratified red blood cells), and the second detection signal represents the detection of the second separated sample (e.g., stratified white blood cells). The controller 160 calculates the optimal switching timing based on the timing and trend of these signals. The controller 160 typically also integrates a power management module, a communication module, and a human-machine interface module. The power management module is responsible for providing a stable power supply to the entire device, the communication module is used for data transmission and remote control with a host computer or mobile terminal, and the human-machine interface module includes a display screen, buttons, and indicator lights for setting separation parameters, displaying operating status, and displaying fault alarms. The software system of the controller 160 adopts a modular design, including a signal acquisition module, a data processing module, a logic control module, a drive control module, and a communication module, which has good scalability and maintainability.

[0039] To achieve reusability of the blood separation device 100 and completely eliminate potential cross-contamination between samples during continuous processing of multiple samples, the blood separation device 100 can also include a subsystem with an automatic cleaning function. The blood separation device 100 also includes a cleaning chamber 180, which is pre-filled with cleaning solution. The cleaning solution can be heparinized saline, PBS buffer, or a dedicated tubing flushing solution, and its function is to flush away residual blood components and trapped boundary layer mixtures within the valve channels. The cleaning solution typically also contains 0.05% Tween 80 or other surfactants to enhance its ability to dissolve protein deposits and cell debris. The cleaning chamber 180 can be a sealed container independent of the sample chamber 110, located outside the sample chamber 110 or integrated into the base 170, and its volume is typically 200-500 ml, sufficient for multiple cleaning operations. In one implementation, in the third state, when leukocytes are being discharged into the second storage chamber via the second valve channel 1422, the first valve channel 1421 is idle. Simultaneously, the controller 160 is configured to connect the first inlet 14211 to the outlet of the cleaning chamber 180. Under the centrifugal drive of the centrifugal drive device, the cleaning fluid is driven by centrifugal force to flow towards the first valve channel 1421, rapidly flushing the inner wall of the channel and thoroughly flushing out the red blood cell-leukocyte boundary layer mixture and residual trace amounts of red blood cells trapped in the channel in the previous step, discharging them into a separate waste bin or directly out of the system. The cleaning process is completed synchronously during the same time period as the leukocyte discharge, without additionally occupying the total centrifugation time. Similarly, in another separation operation, when red blood cells are being discharged, the second inlet 14221 can also be connected to the outlet of the cleaning chamber 180 to simultaneously clean the second valve channel 1422. This cleaning method utilizes the centrifugal force generated by the centrifugation process itself as the driving force for liquid flow, eliminating the need for additional cleaning pumps, solenoid valves, or other components. It boasts a simple structure, zero energy consumption, and simultaneous cleaning and target component extraction. The total time of the entire separation process is not increased by the introduction of the cleaning function. The flow rate of the cleaning fluid is determined by the centrifugation speed and the installation position of the cleaning chamber, typically reaching 1-2 m / s, generating sufficient shear force to flush away residual substances from the inner walls of the channels. After automatic cleaning following each use, no blood residue remains in the valve channels, and cellular components from the previous sample do not mix with the next sample. The cross-contamination rate between samples can be reduced to below 0.1%, giving the device true clinical-grade reusability. Furthermore, a deep cleaning program can be set up weekly, using a 0.5% sodium hypochlorite solution to thoroughly disinfect the entire flow path and kill any remaining microorganisms.

[0040] In some extended embodiments, the blood separation device 100 may also integrate a separate detection component for fine biochemical analysis of the retained trace boundary layer mixture or other specific layer liquids, bringing additional value to scientific research applications and precision diagnosis. The blood separation device 100 also includes a detection component, which differs from the aforementioned sensing component 130 used to distinguish between red blood cells, white blood cells, and plasma. The sensing component 130 quickly determines "which cell layer it is" to trigger valve switching; while the detection component delves deeper to detect "what is contained in this liquid." This could be a spectral analysis module more sensitive to specific wavelengths, a miniature flow cytometry module for counting cell numbers, an electrochemical sensor for measuring electrolyte or specific protein concentrations, or a miniature camera for observing cell morphology, etc. In the third state, after the first valve channel 1421 containing the boundary layer mixture rotates away from the main flow path, one end of the first valve channel 1421 (i.e., the first opening) is directly opposite the detection component, allowing the detection component to identify the type or detect the components of the separated liquid within the first channel near the first opening. Similarly, in other states, the detection component can also be positioned opposite the first or second opening to detect the liquid within the corresponding channel. This design effectively transforms a potentially discarded "dirty" sample into an online detection sample with analytical value, enabling operators to obtain intermediate state information about the separation process without additional sampling. This information includes the thickness of the boundary layer, the degree of contamination, and cell activity, providing valuable data support for process parameter optimization and clinical diagnosis.

[0041] In clinical applications, the detection module can also be used to detect trace components in abnormal samples that are difficult to detect using conventional methods. For example, the blood of patients with hyperlipidemia contains trace amounts of chylomicrons and very low-density lipoproteins. These particles have a density between that of leukocytes and plasma, and are highly enriched in the leukocyte-plasma boundary layer. Conventional blood lipid tests require fasting for more than 12 hours and are not sensitive to trace abnormalities. However, the detection module can directly detect the characteristic absorption peaks of chylomicrons in the boundary layer liquid trapped in the first valve channel 1421 or the second valve channel 1422 through near-infrared spectroscopy analysis, allowing for early detection of blood lipid abnormalities even without fasting. Another example is that free hemoglobin in hemolyzed samples can mix into the boundary between the plasma layer and the leukocyte layer. The detection module can accurately determine the presence and degree of hemolysis by detecting the characteristic absorbance at a wavelength of 415 nm, preventing hemolyzed samples from affecting subsequent testing. Cell culture or test results; for example, in leukemia patients, the density of immature leukocytes in the blood is between that of mature red blood cells and mature leukocytes, and they are abundant in the red blood cell-leukocyte boundary layer. Conventional blood routine tests are difficult to distinguish between mature cells and immature cells, but the miniature image recognition module integrated into the detection component can directly observe the morphological characteristics of cells in the channel and identify the presence of immature cells, providing clues for early screening of leukemia; in addition, for patients with deep fungal infections, the concentration of fungal spores in the blood is extremely low, and the positive rate of blood culture is less than 20%, while the concentration of fungal spores in the boundary layer retained by this device is 10-50 times higher than that in whole blood. The detection component can quickly detect fungal spores through fluorescent staining or nucleic acid probes, shortening the diagnosis time from 3-7 days to less than 1 hour.

[0042] The following detailed description of the complete working process of the blood separation device 100, using a specific embodiment, is provided from beginning to end. In this embodiment, the sample to be separated is 200ml of EDTA-K2 anticoagulated peripheral blood collected from healthy volunteers. The specific parameters of the blood separation device 100 are as follows: the sample chamber 110 is made of medical-grade PP material, with a total volume of 220ml, and the bottom conical part 111 has a cone angle of 45°; the guide tube 120 is made of transparent PC material, with an inner diameter of 1.3mm and a length of 10mm, and the inner wall is electropolished to Ra≤0.2μm and coated with a 50nm thick nano-heparin coating; the valve assembly 140 adopts a valve disc 142 structure, the disc material is medical-grade PEEK, with a thickness of 4mm, and has two independent axial channels with an inner diameter of 1.3mm, namely the first valve channel 1421 and the second valve channel 1421. 422, the dynamic sealing surface has a micro-convex height of 0.05mm and a sealing gap of ≤0.02mm; the sensing component 130 uses two sets of 780nm near-infrared photoelectric beams installed in series, with the upstream sensor 7mm away from the valve inlet and the downstream sensor 1mm away from the valve inlet, and a sampling frequency of 100Hz; the dispensing bin 150 includes a first storage bin 151 with a volume of 120ml and a second storage bin 152 with a volume of 10ml, both made of medical-grade PP material; the controller 160 uses an STM32L0 series low-power MCU chip; the cleaning bin 180 has a volume of 200ml and contains heparinized saline solution with 0.05% Tween 80 added; the detection component integrates a miniature near-infrared spectral analysis module.

[0043] First, sample preparation and device assembly are performed: The operator slowly injects 200ml of anticoagulated peripheral blood into the sample chamber through the sample inlet at the top of the sample compartment 110, and tightens the sealing cap to ensure the sample chamber is completely sealed without any air or liquid leakage. Then, the sample compartment 110, the first storage compartment 151, and the second storage compartment 152 are fixed to their corresponding mounting positions on the base 170 using snap-fit ​​structures. It is confirmed that the guide pipe 120 and the inlet end of the valve disc 142 are coaxially aligned, with a coaxiality error ≤0.1mm. The electrical circuits of the controller 160, sensor component 130, and valve disc 142 drive motor are connected. The assembled blood separation device 100 is placed into the 4×500ml horizontal rotor slots of the benchtop centrifuge, and the rotor fixing nuts are tightened to ensure the device does not loosen or shift during rotation.

[0044] Next, the centrifugation stratification stage begins: the centrifuge door is closed, the equipment is started, and the controller 160 first sends a command to the drive motor of the valve disc 142, controlling the valve disc 142 to rotate to the first state, aligning the isolation port 1423 with the outlet of the guide pipe 120, completely sealing the inlet end. The centrifuge smoothly accelerates to a speed of 500g according to the preset program and maintains this speed for 5 minutes. During centrifugation, the blood sample in the sample chamber gradually stratifies under the action of centrifugal force. The densest red blood cells are deposited at the bottom of the cone-shaped part 111, the next densest white blood cells form a white film layer of about 1.5mm thickness above the red blood cell layer, and the least dense plasma is located at the top of the sample chamber, with a clear and smooth stratification interface.

[0045] After centrifugation and stratification, the red blood cell extraction stage begins: the centrifuge automatically and smoothly reduces to a low, stable speed of 250g and maintains continuous operation. This speed maintains the stratified state undisturbed while providing sufficient centrifugal driving force for the smooth extraction of blood components. The controller 160 controls the valve turntable 142 to rotate 90° clockwise, switching to the second state, aligning the first valve channel 1421 with the outlet of the guide pipe 120 and the inlet of the first storage chamber 151, thus connecting the guide channel and the first storage chamber. Under the continuous action of centrifugal force, the red blood cells at the bottom of the conical section 111 are sequentially pushed into the guide pipe 120, flowing through the detection area of ​​the sensing component 130 at a stable flow rate of approximately 7mm / s, and then flowing into the first storage chamber 151 through the first valve channel 1421. The two sets of photoelectric transducers of the sensing component 130 collect the transmittance signal within the guide channel in real time. At this time, the transmittance of the red blood cells is stable at approximately 8%, and the controller 160 continuously monitors signal changes.

[0046] When the red blood cell layer is about to flow out and the interface between red blood cells and white blood cells reaches the upstream sensor position, the transmittance begins to rise rapidly from 8%, and the controller 160 records the time at this moment as t1 = 120.0 s; 0.86 seconds later, the interface reaches the downstream sensor position, and the transmittance rises to 32%, and the controller 160 records the time as t2 = 120.86 s. Based on the 6 mm distance between the two sensors, the controller 160 calculates the real-time flow velocity v = 6 mm / (120.86 s - 120.0 s) ≈ 7 mm / s. Subsequently, based on the 1 mm distance from the downstream sensor to the valve inlet and the 4 mm axial length of the first valve channel 1421, the controller 160 calculates the delay time as T = (1 mm + 4 mm) / 7 mm / s ≈ 0.71 s.

[0047] When the delay time ends, i.e., t = 120.86s + 0.71s = 121.57s, the interface is exactly in the middle position of the first valve channel 1421. The controller 160 immediately sends a switching command to the drive motor, and the valve turntable 142 rotates 90° clockwise within 50ms, switching to the third state. At this time, the first valve channel 1421 containing the interface layer mixture rotates away from the main flow path and aligns with the outlet and waste port of the cleaning chamber 180; the second valve channel 1422 aligns with the outlet of the guide pipe 120 and the inlet of the second storage chamber 152, and the guide pipe and the second storage chamber are connected.

[0048] Entering the white blood cell export and simultaneous washing stage: White blood cells flow into the second storage bin 152 under centrifugal force, at which point the light transmittance stabilizes at around 38%. Simultaneously, the first valve channel 1421 is connected to the washing bin 180. Under centrifugal force, the washing fluid flows at a high speed of 1.5 m / s through the inner wall of the first valve channel 1421, thoroughly flushing away the retained 0.2 ml of boundary layer mixture and residual trace amounts of red blood cells into the waste bin. The washing process lasts for 3 seconds and is carried out simultaneously with the white blood cell export, without adding extra time to the total consumption.

[0049] When the white blood cell layer is almost completely drained and the interface between white blood cells and plasma reaches the downstream sensor, the transmittance rapidly increases from 38% to 85%. The sensing component 130 then outputs a second detection signal to the controller 160. Upon receiving the signal, the controller 160 recalculates the delay time. After confirming that the interface is completely inside the second valve channel 1422, it controls the valve rotary table 142 to rotate 90° clockwise, switching back to the first state. The inlet end is then re-closed, and the separation process ends. The centrifuge automatically decelerates and stops. The entire separation process takes approximately 12 minutes.

[0050] During the separation process, the detection component is aligned with the first valve channel 1421 rotated to the detection station to perform near-infrared spectroscopy analysis on the trapped boundary layer liquid. The detection results show that there are no abnormal chylomicrons or free hemoglobin in the sample, and it is judged to be a normal blood sample. If abnormal components are detected, the controller 160 will issue an alarm through an indicator light and store the detection results in the internal memory.

[0051] After separation, the operator opens the centrifuge door, removes the blood separation device 100 from the rotor, and presses the clips to remove the first storage bin 151 and the second storage bin 152 respectively. The connecting pipes of the storage bins are then sealed with a heat sealer to obtain purified red blood cell and white blood cell samples. Subsequently, the operator disassembles the used sample bin 110 and storage bins for high-temperature and high-pressure sterilization. The valve turntable 142 and the guide pipe 120 can be reused after automatic cleaning, ready for the next separation operation.

[0052] It should be noted that if directional indications (such as up, down, left, right, front, back, etc.) are involved in the embodiments of the present invention, these directional indications are only used to explain the relative positional relationships and movement of the components in a specific posture. If the specific posture changes, the directional indications will also change accordingly. When a direction reference is introduced in a specific embodiment, unless the direction is specifically limited to unidirectional, the direction can be unidirectional or bidirectional (two parallel and opposite directions). Whether it is unidirectional or bidirectional depends on what those skilled in the art can achieve. When the direction reference is bidirectional, it should be considered that two parallel and different embodiments have been introduced simultaneously.

[0053] Furthermore, if the embodiments of this invention involve descriptions such as "first" or "second," these descriptions are for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined with "first" or "second" may explicitly or implicitly include at least one of those features. Additionally, the use of "and / or," "and / or," or "and / or" throughout the text implies three parallel solutions. For example, "A and / or B" includes solution A, solution B, or a solution where both A and B are satisfied simultaneously. Furthermore, the technical solutions of the various embodiments can be combined with each other, but this must be based on the ability of those skilled in the art to implement them. When the combination of technical solutions is contradictory or impossible to implement, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection claimed by this invention.

[0054] The above are merely preferred embodiments of the present invention and do not limit the scope of the patent. Any equivalent structural transformations made using the contents of the specification and drawings of the present invention under the inventive concept of the present invention, or direct / indirect applications in other related technical fields, are included within the scope of patent protection of the present invention.

Claims

1. A blood separation device, suitable for synchronous centrifugal motion with a centrifugal drive device, characterized in that, The blood separation device includes: The sample compartment defines the sample cavity used to store blood samples; A flow guide pipe is connected to the sample chamber, the flow guide pipe defines a flow channel, the flow channel has a flow inlet and a flow outlet, and the flow inlet communicates with the sample chamber; A sensing component configured to sense the type of separated sample after the blood sample has been separated and flows through the flow channel; A valve assembly has an inlet end, a first outlet end and a second outlet end, wherein the inlet end is connected to the flow guide outlet; The material distribution bin defines a first storage chamber and a second storage chamber that are separate from each other. The first storage chamber is connected to the first outlet end, and the second storage chamber is connected to the second outlet end. The controller is connected to the valve assembly and the sensing assembly respectively, and controls the valve assembly to be in a first state, a second state and a third state according to the detection signal transmitted by the sensing assembly; In the first state, the inlet end is closed; in the second state, the inlet end is connected to the first outlet end, so that the first separated sample of the blood sample is guided to the first storage chamber under the centrifugal drive of the centrifugal drive device; in the third state, the inlet end is connected to the second outlet end, so that the second separated sample of the blood sample is guided to the second storage chamber under the centrifugal drive of the centrifugal drive device.

2. The blood separation device as described in claim 1, characterized in that, The flow channel is at least partially transparent, and the sensing component is an optical sensing component configured to detect the optical characteristics of the separated sample to identify the type of the separated sample.

3. The blood separation device as described in claim 1, characterized in that, The blood separation device includes a base, and the dispensing chamber includes a first storage chamber and a second storage chamber. The first storage chamber, the second storage chamber, and the sample chamber are all detachably connected to the base.

4. The blood separation device as described in claim 1, characterized in that, The sample chamber includes a tapered portion connected to the flow guide pipe, and the inner diameter of the tapered portion gradually decreases along the direction that gradually approaches the flow guide pipe.

5. The blood separation device as described in claim 1, characterized in that, The valve assembly includes a three-way valve, which includes an inlet end, a first outlet end, and a second outlet end; in the second state, the inlet end is connected to the first outlet end, and in the third state, the inlet end is connected to the second outlet end.

6. The blood separation device as described in claim 1, characterized in that, The valve assembly includes a valve disc having a first valve channel and a second valve channel isolated from each other. The inlet end includes a first inlet, a second inlet, and an isolation port isolated from each other. The first inlet is connected to the first outlet end of the first valve channel, and the second inlet end is connected to the second outlet end of the second valve channel. In the first state, the isolation port is connected to the flow guide channel. In the second state, the first inlet is connected to the first outlet end; in the third state, the second inlet is connected to the second outlet end; the valve disc rotates relative to the guide pipe to the first state, the second state, or the third state.

7. The blood separation device as described in claim 6, characterized in that, In the second state, the controller is further configured to control the valve turntable to rotate to switch the valve turntable to the third state when the interface between the first separated sample and the second separated sample is within the first valve channel.

8. The blood separation device as described in claim 7, characterized in that, The blood separation device also includes a cleaning chamber containing a cleaning solution; In the third state, the first inlet is connected to the outlet of the cleaning chamber, so that the cleaning fluid is guided to the first valve channel under the centrifugal drive of the centrifugal drive device; and / or, in the second state, the second inlet is connected to the outlet of the cleaning chamber, so that the cleaning fluid is guided to the second valve channel under the centrifugal drive of the centrifugal drive device.

9. The blood separation device as described in claim 7, characterized in that, The blood separation device also includes a detection component; In the third state, the detection component is opposite to the first opening to detect the type of separated liquid on the side of the first channel closest to the first opening; And / or, in the second state, the detection component is opposite the first opening to detect the type of separated liquid on the side of the first channel closest to the first opening.

10. The blood separation apparatus according to any one of claims 6-9, characterized in that, The inner diameter of any one of the flow guide pipe, the first valve channel and the second valve channel is between 1 mm and 2 mm. And / or, The length of the flow guide pipe is between 5mm and 15mm; And / or, The thickness of the valve disc is between 4mm and 10mm.

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