Circulating Tumor Cell Screening and Isolation Device and Circulating Tumor Cell Detection Method

Abstract

The present invention provides a circulating tumor cell screening and separation device and a circulating tumor cell detection method, belonging to the technical field of medical detection, including: a chamber module, the chamber module is provided with a mixing chamber, a screening chamber and a waste liquid chamber, and the mixing chamber, the screening chamber and the waste liquid chamber are communicated in sequence; a control module, the control module is installed on the chamber module, and the control module is configured to be able to control whether the liquid drains from the mixing chamber to the screening chamber according to its own motion state; a temperature control module, the temperature control module is installed on the chamber module, and the temperature control module is configured to be able to control the temperature in the mixing chamber; a magnetic enrichment module, the magnetic enrichment module is configured to be able to form a magnetic field in the mixing chamber; the beneficial effect of the present invention is: a device for screening and separating CTCs based on immunomagnetic bead separation technology is provided, the device has a compact structure, a small volume, is convenient to operate, and has the function of simulating the human body's constant temperature environment to assist reaction cultivation, ensuring the reliability and detection accuracy during detection.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical detection, and relates to a circulating tumor cell screening and separation device and a circulating tumor cell detection method. Background Art

[0002] Circulating Tumor Cells (CTCs) refer to tumor cells that shed from primary or metastatic tumors and enter the blood circulation system. The detection of CTCs is of great significance for the early diagnosis, disease monitoring, efficacy evaluation, and prognosis judgment of cancer. CTCs are extremely rare in the blood (only 0 - 100 CTCs in 1 mL of blood), and the key problem is how to enrich and detect CTCs from the blood. Among many enrichment methods, the immunomagnetic bead method is widely used due to its rapid and non-destructive separation. This method is based on the binding of specific antigens on the surface of CTCs to antibodies on the magnetic beads, and enrichment is achieved by applying an external magnetic field. Then, the enriched cells are detected by surface-enhanced Raman scattering (SERS) technology.

[0003] In the past, the screening and separation of CTCs in blood usually relied on manual operation, which was rather troublesome and had low efficiency. Although there are currently some devices for screening and separating CTCs based on immunomagnetic bead separation technology, such devices are usually large in size, troublesome to operate, and their structures and functions are not perfect. They do not have a constant temperature cultivation function, which may lead to a decrease in detection accuracy. Summary of the Invention

[0004] The purpose of the present invention is to provide a circulating tumor cell screening and separation device and a circulating tumor cell detection method for the above problems existing in the prior art.

[0005] The purpose of the present invention can be achieved by the following technical solutions: A circulating tumor cell screening and separation device, comprising:

[0006] A chamber module, the chamber module is provided with a mixing chamber, a screening chamber, and a waste liquid chamber, and the mixing chamber, the screening chamber, and the waste liquid chamber are connected in sequence;

[0007] A control module, the control module is installed on the chamber module, and the control module is configured to be able to control whether the liquid drains from the mixing chamber to the screening chamber according to its own motion state;

[0008] A temperature control module, the temperature control module is installed on the chamber module, and the temperature control module is configured to be able to control the temperature in the mixing chamber;

[0009] A magnetic enrichment module, the magnetic enrichment module is configured to be able to form a magnetic field in the mixing chamber.

[0010] Preferably, the chamber module includes a mixing chamber, a screening chamber, and a waste liquid chamber. The mixing cavity is disposed in the mixing chamber, the screening cavity is disposed in the screening chamber, the waste liquid cavity is disposed in the waste liquid chamber. The screening chamber is detachably connected to the waste liquid chamber, and the mixing chamber is detachably connected to the screening chamber.

[0011] Preferably, the mixing chamber, the screening chamber, and the waste liquid chamber are arranged in sequence from top to bottom. The bottom of the mixing cavity communicates with the top of the screening cavity, and the bottom of the screening cavity communicates with the top of the waste liquid chamber.

[0012] Preferably, the screening chamber is provided with at least one fixing component. The fixing component includes a filter membrane fixing ring which is detachably connected to the screening chamber. A detachable filter membrane is installed between the filter membrane fixing ring and the screening chamber, and the filter membrane is located in the screening cavity.

[0013] Preferably, a detachable baffle is further installed between the filter membrane fixing ring and the screening chamber. The baffle is located in the screening cavity, and a plurality of small holes are formed in the baffle, and the filter membrane is closely attached to the baffle.

[0014] Preferably, the fixing component further includes a window fixing ring which is detachably connected to the filter membrane fixing ring. A detachable glass window is installed between the window fixing ring and the filter membrane fixing ring.

[0015] Preferably, the control module includes a piston block which is movably disposed in the mixing cavity. The outer peripheral surface of the piston block is in sealing fit with the cavity wall of the mixing cavity, thereby dividing the mixing cavity into an upper cavity and a lower cavity. The upper cavity is the part between the top of the mixing cavity and the upper surface of the piston block, and the lower cavity is the part between the lower surface of the piston block and the bottom of the mixing cavity. The top of the upper cavity is closed, and the bottom of the lower cavity communicates with the screening cavity;

[0016] When the piston block is stationary, the flow path between the upper cavity and the lower cavity is in a closed state; when the piston block moves in a direction that reduces the volume of the upper cavity and increases the volume of the lower cavity, the flow path between the upper cavity and the lower cavity is in an open state.

[0017] Preferably, a first connector and a second connector are provided on the outer wall of the mixing chamber. The first connector and the second connector are respectively communicated with two different regions of the mixing cavity, and the first connector and the second connector are communicated through a liquid guide pipe. The moving stroke range of the piston block includes a liquid discharge stroke interval. When the piston block is located in the liquid discharge stroke interval, the first connector is communicated with the upper cavity and the second connector is communicated with the lower cavity. When the piston block moves in a direction to reduce the volume of the upper cavity and increase the volume of the lower cavity, the upper cavity and the lower cavity are communicated through the liquid guide pipe.

[0018] Preferably, a valve hole is provided in the piston block, and the upper cavity and the lower cavity are communicated through the valve hole. A first one-way valve is installed in the valve hole. When the piston block is stationary or moves in a direction to increase the volume of the upper cavity and decrease the volume of the lower cavity, the first one-way valve is in a closed state. When the piston block moves in a direction to reduce the volume of the upper cavity and increase the volume of the lower cavity, the first one-way valve is in an open state.

[0019] Preferably, the mixing chamber is provided with a top cover, the top cover seals the top of the upper cavity, and an air hole is provided in the top cover. A second one-way valve is installed in the air hole. When the piston block moves in a direction to increase the volume of the upper cavity and decrease the volume of the lower cavity, the second one-way valve is in an open state. When the piston block moves in a direction to reduce the volume of the upper cavity and increase the volume of the lower cavity, the second one-way valve is in a closed state.

[0020] Preferably, the control module further includes a driving rod, and the driving rod penetrates into the upper cavity and is connected to the piston block.

[0021] Preferably, the control module further includes a driving element, the driving element is connected to the driving rod, and the driving element is configured to be able to drive the piston block to move through the driving rod.

[0022] Preferably, the temperature control module includes a heating element, a temperature measuring element and a controller. The heating element and the temperature measuring element are both electrically connected to the controller. The heating element and the temperature measuring element are both installed in the mixing chamber. The temperature measuring element is configured to be able to measure the temperature in the mixing cavity and feedback it to the controller. The controller is configured to be able to control the heating element to work according to the temperature signal fed back by the temperature measuring element so as to maintain the set temperature in the mixing cavity.

[0023] Preferably, the mixing chamber is provided with a sandwich cavity, the sandwich cavity surrounds the outer periphery of the mixing cavity, and the heating element is fixedly arranged in the sandwich cavity.

[0024] Preferably, the magnetic enrichment module includes an electromagnet which is configured to generate a magnetic field when powered on and remove the magnetic field when powered off, and the electromagnet is installed on the part of the driving rod located in the upper cavity.

[0025] Preferably, an installation hole is formed inside the driving rod, and the electromagnet is fixedly arranged in the installation hole.

[0026] Preferably, it further includes an ultrasonic module which is inserted into the mixing cavity and is configured to be able to generate high-frequency vibration in the mixing cavity.

[0027] A circulating tumor cell detection method includes the following steps:

[0028] S1: Adjust the circulating tumor cell screening and separation device to the initial state, ensure that the mixing cavity is clean and dry, and drive the piston block to move to the bottom of the mixing cavity through the driving element;

[0029] S2: Inject the blood sample and the nano magnetic probe into the upper cavity of the mixing cavity for reaction cultivation, and then start the temperature control module to simulate the human body constant temperature environment in the mixing cavity. During the reaction cultivation of the blood sample and the nano magnetic probe, the CTCs in the blood sample combine with the nano magnetic probe to form CTCs-magnetic bead complexes;

[0030] S3: After the reaction cultivation process reaches the set time, start the electromagnet, and the magnetic field generated by the electromagnet captures the CTCs-magnetic bead complexes;

[0031] S4: The driving element drives the piston block to move upward, the waste liquid in the upper cavity is discharged into the lower cavity, and then the waste liquid enters the waste liquid cavity through the screening cavity;

[0032] S5: Remove the screening chamber, then install the filter membrane on the screening chamber to seal the screening cavity with the filter membrane, install the screening chamber between the mixing chamber and the waste liquid chamber, and then drive the piston block to move downward to the bottom of the mixing cavity;

[0033] S6: Inject the cleaning liquid into the upper cavity, then turn off the electromagnet to remove the magnetic field, start the ultrasonic module to clean the upper cavity, and then drive the piston block to move upward to discharge the cleaning liquid in the upper cavity into the lower cavity. The cleaning liquid enters the waste liquid cavity through the screening cavity, and the CTCs-magnetic bead complexes in the cleaning liquid are blocked by the filter membrane;

[0034] S7: Remove the screening chamber again, then install the glass window on the screening chamber, and then place the screening chamber under the Raman spectrometer for detection.

[0035] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0036] 1. A device for screening and separating CTCs based on immunomagnetic bead separation technology is provided. This device has a compact structure, small volume, convenient operation, and has the function of simulating the human body's constant temperature environment to assist in reaction cultivation, ensuring the reliability and detection accuracy during detection;

[0037] 2. During the cleaning stage, the screening chamber can be separately disassembled to install a filter membrane, and then the screening chamber with the filter membrane is reassembled between the mixing chamber and the waste liquid chamber to ensure that the filter membrane can intercept the CTCs-magnetic bead complex during the cleaning process;

[0038] 3. The detachable screening chamber design realizes the effect of in-situ Raman detection. After the cleaning stage, instead of taking out the filter membrane or the CTCs-magnetic bead complex from the screening chamber, the screening chamber is cleverly disassembled separately from the device. After installing a glass window, the screening chamber can be directly placed on the detection platform of the Raman spectrometer, avoiding possible contamination introduced during the transfer process and improving the accuracy and reliability of the detection results;

[0039] 4. The presence of the piston block enables the mixing chamber to achieve liquid transfer in a limited space without additional waste liquid removal operation. The drainage function is realized by controlling the movement of the piston block, greatly improving the automation degree and convenience of the device; this design can automatically control the drainage after reaction cultivation and can automatically perform cleaning during the cleaning stage, simplifying the operation process;

[0040] 5. During the enrichment stage, the electromagnet can be energized to generate a magnetic field, which can attract and fix the CTCs-magnetic bead complex; during the cleaning stage, the electromagnet can be de-energized to remove the magnetic field, enabling the cleaning liquid to wash and collect the CTCs-magnetic bead complex. This design makes the device more flexible and convenient to use and greatly improves the automation degree. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Figure 1 It is a schematic structural diagram of the circulating tumor cell screening and separation device of the present invention.

[0042] Figure 2 It is an exploded view of the structure of the circulating tumor cell screening and separation device of the present invention.

[0043] Figure 3 It is a schematic structural diagram of Embodiment 1 of the present invention.

[0044] Figure 4 It is a schematic structural diagram of the mixing chamber and the piston block of Embodiment 1 of the present invention.

[0045] Figure 5Schematic diagram of the structure of Embodiment 2 of the present invention.

[0046] Figure 6 Schematic diagram of the structure of the mixing chamber and the piston block of Embodiment 2 of the present invention.

[0047] Figure 7 Schematic diagram of the connection relationship between the electromagnet and the drive rod of the present invention.

[0048] Figure 8 Axonometric view of the screening chamber of the present invention.

[0049] Figure 9 Exploded view of the structure of the screening chamber of the present invention.

[0050] In the figure, 100, mixing chamber; 110, mixing cavity; 111, upper cavity; 112, lower cavity; 120, first joint; 130, second joint; 140, liquid guide tube; 150, top cover; 151, air hole; 152, second one-way valve; 160, interlayer cavity; 200, screening chamber; 210, screening cavity; 220, fixing assembly; 221, filter membrane fixing ring; 222, window fixing ring; 230, filter membrane; 240, baffle; 250, glass window; 300, waste liquid chamber; 310, waste liquid cavity; 410, piston block; 411, valve hole; 412, first one-way valve; 420, drive rod; 421, mounting hole; 430, drive element; 510, heating element; 520, temperature measuring element; 600, electromagnet; 700, ultrasonic module. Detailed implementation manners

[0051] The following are specific embodiments of the present invention in combination with the accompanying drawings to further describe the technical solutions of the present invention, but the present invention is not limited to these embodiments.

[0052] As Figures 1 to 9 shown, a circulating tumor cell screening and separation device includes: a chamber module, the chamber module is provided with a mixing cavity 110, a screening cavity 210 and a waste liquid cavity 310, and the mixing cavity 110, the screening cavity 210 and the waste liquid cavity 310 are communicated in sequence; a control module, the control module is installed on the chamber module, and the control module is configured to be able to control whether the liquid drains from the mixing cavity 110 to the screening cavity 210 according to its own movement state; a temperature control module, the temperature control module is installed on the chamber module, and the temperature control module is configured to be able to control the temperature in the mixing cavity 110; a magnetic enrichment module, the magnetic enrichment module is configured to be able to form a magnetic field in the mixing cavity 110.

[0053] This screening and separation device is a device for screening and separating circulating tumor cells (CTCs) based on the immunomagnetic beads separation technology (Immunomagnetic Beads Separation, IMS). The target cells (circulating tumor cells) separated and screened by using this device can be detected by surface-enhanced Raman scattering (SERS) technology. This device can provide a reaction cultivation space for the binding of nano-magnetic probes (magnetic SERS probes) to circulating tumor cells, and attract and fix these nano-magnetic probes bound to the target cells through an externally applied magnetic field, while other unbound components can be eluted from the solution, thus realizing the effective separation of the target cells from other components.

[0054] The chamber module is the core part of the whole device, which is provided with a mixing chamber 110, a screening chamber 210 and a waste liquid chamber 310 that are connected in sequence. The mixing chamber 110 plays multiple roles in different operation stages. The mixing chamber 110 acts as a reaction chamber in the reaction cultivation stage and as a cleaning chamber in the cleaning stage. The screening chamber 210 is located on the path of the liquid flowing from the mixing chamber 110 to the waste liquid chamber 310. The screening chamber 210 is used to install a filter membrane 230, and the filter membrane 230 can intercept and collect the target cells (CTCs), while allowing the liquid or other components to pass through. The waste liquid chamber 310 is used to collect the waste liquid generated during the screening and separation process, and the waste liquid in the waste liquid chamber 310 can be discharged through the drain port. This highly integrated design greatly reduces the volume of the device, making the overall design more compact and portable, and very convenient to use.

[0055] The main function of the control module is to be responsible for the liquid flow in the mixing chamber 110 and control the on-off between the mixing chamber 110 and the screening chamber 210. The control module cuts off the connection between the mixing chamber 110 and the screening chamber 210 in the reaction cultivation stage, discharges the waste liquid to the screening chamber 210 in the enrichment stage, and discharges the cleaning liquid to the screening chamber 210 in the cleaning stage. The temperature control module can heat the mixing chamber 110 and maintain the temperature in the mixing chamber 110 at a set value. The temperature control module usually sets the temperature to 37 °C to simulate the human body's constant temperature environment and ensure that the cells react under the most suitable conditions. The magnetic enrichment module can generate a magnetic field in the mixing chamber 110 to adsorb the target cells (CTCs) with nano-magnetic probes. By adjusting the magnetic field intensity, the enrichment effect can also be optimized. Through the above-mentioned various modules, the whole process operations of constant temperature cultivation, automatic enrichment, waste liquid discharge and cleaning can be realized, which is more comprehensive and perfect in function, and greatly improves the reliability and detection accuracy during detection.

[0056] It should be noted that without the temperature control module, it is impossible to provide a suitable reaction environment in the mixing chamber 110, which may lead to an unsatisfactory reaction cultivation effect. In addition, the lack of a temperature control module means that the temperature in the mixing chamber 110 may fluctuate with the change of the external environment, resulting in inconsistent reaction cultivation conditions, thereby affecting the reliability of the detection results.

[0057] As Figures 1 to 6 , Figure 8 , Figure 9 shown, on the basis of the above embodiments, the chamber module includes a mixing chamber 100, a screening chamber 200, and a waste liquid chamber 300. The mixing chamber 110 is disposed in the mixing chamber 100, the screening chamber 210 is disposed in the screening chamber 200, and the waste liquid chamber 310 is disposed in the waste liquid chamber 300. The screening chamber 200 is detachably connected to the waste liquid chamber 300, and the mixing chamber 100 is detachably connected to the screening chamber 200.

[0058] The top of the mixing chamber 100 has a top cover 150, through which the top of the mixing chamber 110 can be closed. An inlet hole is provided on the outer wall of the mixing chamber 100 or the top cover 150, and the inlet hole communicates with the mixing chamber 110. A blood sample, a nano magnetic probe, and a cleaning solution (PBS buffer solution) can enter the mixing chamber 110 through the inlet hole. The screening chamber 200 is a flange structure, which is detachably installed between the mixing chamber 100 and the waste liquid chamber 300. Sealing rings are installed between the screening chamber 200 and the mixing chamber 100 and the waste liquid chamber 300.

[0059] Before the cleaning stage, the filter membrane 230 and the glass window 250 are not installed in the screening chamber 200, which can ensure that the waste liquid passes through the screening chamber 210 smoothly. If the filter membrane 230 is installed before the cleaning stage, other components in the waste liquid may block or damage the filter membrane 230, or the unreacted and bound nano magnetic probes in the waste liquid may adhere to the surface of the filter membrane 230, resulting in a false positive situation. During the cleaning stage, the screening chamber 200 can be detached separately and the filter membrane 230 can be installed, and then the screening chamber 200 with the filter membrane 230 is reassembled between the mixing chamber 100 and the waste liquid chamber 300 to ensure that the filter membrane 230 can intercept the CTCs-magnetic bead complex during the cleaning process.

[0060] After cleaning, the screening chamber 200 is disassembled again, and a glass window 250 is installed on the screening chamber 200. Then, the screening chamber 200 can be directly taken to the Raman spectrometer for detection. This detachable design realizes the effect of in-situ Raman detection. After the cleaning stage, instead of removing the filter membrane 230 or the CTCs-magnetic bead complex from the screening chamber 200, the screening chamber 200 is cleverly disassembled separately from the device. After installing the glass window 250, the screening chamber 200 can be directly placed on the detection platform of the Raman spectrometer, avoiding possible contamination during the transfer process and improving the accuracy and reliability of the detection results.

[0061] Based on the above embodiments, the mixing chamber 100, the screening chamber 200, and the waste liquid chamber 300 are arranged in sequence from top to bottom. The bottom of the mixing cavity 110 is communicated with the top of the screening cavity 210, and the bottom of the screening cavity 210 is communicated with the top of the waste liquid cavity 310.

[0062] In this embodiment, the liquid can directly flow from the mixing cavity 110 into the screening cavity 210 and then into the waste liquid cavity 310, forming a simple linear flow path. Utilizing the gravitational force, the liquid can flow naturally from top to bottom, reducing the dependence on pumps and other power equipment. And this vertically arranged design makes the whole device more compact, which is beneficial to the miniaturization of this device.

[0063] As Figures 1 to 6 、 Figure 8 、 Figure 9 shown, based on the above embodiments, the screening chamber 200 is provided with at least one fixing component 220. The fixing component 220 includes a filter membrane fixing ring 221. The filter membrane fixing ring 221 is detachably connected to the screening chamber 200. A detachable filter membrane 230 is installed between the filter membrane fixing ring 221 and the screening chamber 200. The filter membrane 230 is located in the screening cavity 210.

[0064] The filter membrane fixing ring 221 is used to fix the filter membrane 230 at the port of the screening chamber 200. In the example, the filter membrane fixing ring 221 is threadedly connected to the port of the screening chamber 200. The user can easily unscrew the filter membrane fixing ring 221, then install the filter membrane 230 at the port of the screening chamber 200, and then screw in the filter membrane fixing ring 221 to fix the filter membrane 230, ensuring that the filter membrane 230 will not shift or deform during the screening process.

[0065] Based on the above embodiments, a detachable baffle 240 is also installed between the filter membrane fixing ring 221 and the screening chamber 200. The baffle 240 is located in the screening cavity 210. The baffle 240 is provided with a number of small holes, and the filter membrane 230 is closely attached to the baffle 240.

[0066] The baffle 240 is used to support the filter membrane 230. The small holes formed thereon are relatively large in size, allowing liquids and other components to pass through. In the example, the filter membrane 230 is attached to the baffle 240 to form an integral structure. During installation, first remove the filter membrane fixing ring 221, then install the integral structure composed of the filter membrane 230 and the baffle 240 onto the screening chamber 200, and finally install the filter membrane fixing ring 221 for fixation.

[0067] Based on the above-described embodiment, the fixing assembly 220 further includes a window fixing ring 222. The window fixing ring 222 is detachably connected to the filter membrane fixing ring 221, and a detachable glass window 250 is installed between the window fixing ring 222 and the filter membrane fixing ring 221.

[0068] Since the screening chamber 200 needs to be transferred to the detection platform of the Raman spectrometer for in-situ Raman detection, the glass window 250 needs to be installed before detection. The glass window 250 is located above the filter membrane 230, and a quartz sheet with a high light transmittance is usually selected. The glass window 250 serves as an additional physical barrier, which can reduce the influence of the external environment on the interior of the screening chamber 210 and protect the sample and internal components from damage.

[0069] In the example, fixing assemblies 220 are installed at both the upper and lower ports of the screening chamber 200. In this way, two groups of filter membranes 230 can be installed, and the two groups of filter membranes 230 can form a double barrier, improving the effect of collecting CTCs-magnetic bead complexes and further enhancing the accuracy of detection.

[0070] As Figures 1 to 6 shown, based on the above-described embodiment, the control module includes a piston block 410. The piston block 410 is movably disposed in the mixing chamber 110. The outer peripheral surface of the piston block 410 is sealingly attached to the inner wall of the mixing chamber 110, thereby dividing the mixing chamber 110 into an upper cavity 111 and a lower cavity 112. The upper cavity 111 is defined as the part between the top of the mixing chamber 110 and the upper surface of the piston block 410, and the lower cavity 112 is defined as the part between the lower surface of the piston block 410 and the bottom of the mixing chamber 110. The top of the upper cavity 111 is closed, and the bottom of the lower cavity 112 communicates with the screening chamber 210. When the piston block 410 is stationary, the flow path between the upper cavity 111 and the lower cavity 112 is in a closed state. When the piston block 410 moves in a direction that reduces the volume of the upper cavity 111 and increases the volume of the lower cavity 112, the flow path between the upper cavity 111 and the lower cavity 112 is in an open state.

[0071] The mixing chamber 110 is separated by a piston block 410 into an upper chamber 111 and a lower chamber 112. Since the top of the upper chamber 111 is closed, the liquid in the upper chamber 111 can only flow into the lower chamber 112. The bottom of the lower chamber 112 is connected to the screening chamber 210, which means that the liquid in the lower chamber 112 can directly flow into the screening chamber 210, thereby discharging the liquid in the mixing chamber 110. The stroke position of the piston block 410 determines the volume sizes of the upper chamber 111 and the lower chamber 112; when the volume of the upper chamber 111 increases, the volume of the lower chamber 112 decreases; when the volume of the upper chamber 111 decreases, the volume of the lower chamber 112 increases. That is, when the piston block 410 moves, the volume of the upper chamber 111 and the volume of the lower chamber 112 are in an inverse proportion relationship.

[0072] It should be noted that the direction in which the volume of the upper chamber 111 decreases and the volume of the lower chamber 112 increases refers to the direction in which the piston block 410 moves upward (i.e., the direction in which the piston block 410 moves toward the top of the mixing chamber 110), and the direction in which the volume of the upper chamber 111 increases and the volume of the lower chamber 112 decreases refers to the direction in which the piston block 410 moves downward (i.e., the direction in which the piston block 410 moves toward the screening chamber 210).

[0073] The main function of the piston block 410 is to control the flow path from the upper chamber 111 to the lower chamber 112 and force the liquid transfer through its own motion state. When the piston block 410 is stationary, the flow path between the upper chamber 111 and the lower chamber 112 is in a closed state. At this time, the upper chamber 111 can retain liquid, and the liquid cannot flow into the lower chamber 112. Therefore, during the reaction cultivation stage, the piston block 410 remains stationary, and the nano magnetic probe and the blood sample can react and cultivate in the upper chamber 111. During the enrichment stage and the cleaning stage, the piston block 410 moves in the direction in which the volume of the upper chamber 111 decreases and the volume of the lower chamber 112 increases (the piston block 410 moves upward), the flow path from the upper chamber 111 to the lower chamber 112 is unblocked, and the liquid in the upper chamber 111 is oppressed, so as to transfer the liquid in the upper chamber 111 into the lower chamber 112; then let the piston block 410 move in the direction in which the volume of the upper chamber 111 increases and the volume of the lower chamber 112 decreases (the piston block 410 moves downward), so as to transfer the liquid in the lower chamber 112 to the screening chamber 210.

[0074] In actual use, the piston block 410 generally makes a reciprocating motion, that is, the piston block 410 moves up and down. When the piston block 410 moves upward, the liquid in the upper chamber 111 can flow into the lower chamber 112; when the piston block 410 moves downward, the liquid in the lower chamber 112 can flow into the screening chamber 210. Therefore, through the reciprocating motion of the piston block 410, the liquid transfer function can be better realized, that is, the liquid is transferred from the upper chamber 111 to the lower chamber 112, and then from the lower chamber 112 to the screening chamber 210.

[0075] The presence of the piston block 410 enables the mixing chamber 110 to achieve liquid transfer within a limited space without the need for additional waste liquid removal operations. By controlling the movement of the piston block 410 to achieve the liquid discharge function, the automation degree and convenience of the device are greatly improved. This design can automatically control the liquid discharge after reaction cultivation and can automatically perform cleaning during the cleaning stage, simplifying the operation process. Example 1:

[0076] As Figure 1 、 Figure 3 、 Figure 4 、 Figure 8 、 Figure 9 shown, the outer wall of the mixing chamber 100 is provided with a first joint 120 and a second joint 130. The first joint 120 and the second joint 130 are respectively communicated with two different regions of the mixing chamber 110, and the first joint 120 and the second joint 130 are communicated through a liquid guiding pipe 140; the moving stroke range of the piston block 410 includes a liquid discharge stroke interval. When the piston block 410 is located in the liquid discharge stroke interval, the first joint 120 is communicated with the upper cavity 111 and the second joint 130 is communicated with the lower cavity 112. When the piston block 410 moves in the direction of reducing the volume of the upper cavity 111 and increasing the volume of the lower cavity 112, the upper cavity 111 and the lower cavity 112 are communicated through the liquid guiding pipe 140.

[0077] In this embodiment, a liquid guiding pipe 140 is designed as the flow path between the upper cavity 111 and the lower cavity 112, and the piston block 410 can control whether the liquid is transferred through this flow path through its own motion state. When the piston block 410 moves upward, the pressure in the upper cavity 111 increases, so the liquid in the upper cavity 111 enters the lower cavity 112 through the liquid guiding pipe 140; when the piston block 410 moves downward, the pressure in the lower cavity 112 increases, so the liquid in the lower cavity 112 enters the screening chamber 210. During the downward movement of the piston block 410, the interface between the second joint 130 and the lower cavity 112 will be gradually sealed by the piston block 410 to prevent liquid backflow.

[0078] The specific working process of the first embodiment is as follows: In the initial state, the piston block 410 is at the bottom of the mixing chamber 110, thus sealing the intersection of the mixing chamber 110 and the screening chamber 210 and the interface between the second joint 130 and the lower cavity 112. At this time, the blood sample and the nano-magnetic probe can be put into the upper cavity 111 for reaction cultivation; when the device needs to perform a liquid discharge operation, the piston block 410 is pulled upward. When the piston block 410 enters the liquid discharge stroke interval, the upper cavity 111 and the lower cavity 112 are connected through the liquid guide pipe 140. As the piston block 410 continues to move upward, the liquid in the upper cavity 111 enters the lower cavity 112 through the liquid guide pipe 140; after the piston block 410 moves upward to a predetermined position, it can move downward. When the piston block 410 moves downward, it can cause the liquid in the lower cavity 112 to flow into the screening chamber 210; the piston block 410 can be pulled repeatedly to achieve the purpose of liquid discharge or cleaning. Embodiment Two:

[0079] As Figure 1 , Figure 2 , Figures 5 to 9 shown, the piston block 410 is provided with a valve hole 411, and the upper cavity 111 and the lower cavity 112 are connected through the valve hole 411. A first one-way valve 412 is installed in the valve hole 411; when the piston block 410 is stationary or moves in the direction that increases the volume of the upper cavity 111 and decreases the volume of the lower cavity 112, the first one-way valve 412 is in a closed state; when the piston block 410 moves in the direction that decreases the volume of the upper cavity 111 and increases the volume of the lower cavity 112, the first one-way valve 412 is in an open state.

[0080] In this embodiment, a valve hole 411 is designed in the piston block 410 as the flow path between the upper cavity 111 and the lower cavity 112, and a first one-way valve 412 is designed to control the on-off of the valve hole 411. The opening and closing state of the first one-way valve 412 can be controlled by the movement state of the piston block 410. The first one-way valve 412 ensures that the liquid can only flow from the upper cavity 111 to the lower cavity 112; when the piston block 410 is stationary or moves downward, the valve core of the first one-way valve 412 is in a closed state under the action of the spring, thus sealing the valve hole 411 and ensuring the isolation between the upper cavity 111 and the lower cavity 112; when the piston block 410 moves upward, the pressure in the upper cavity 111 increases, and the liquid in the upper cavity 111 can push open the valve core of the first one-way valve 412 and enter the lower cavity 112 through the valve hole 411.

[0081] The specific working process of the second embodiment is as follows: In the initial state, the piston block 410 is at the bottom of the mixing chamber 110, thus sealing the intersection of the mixing chamber 110 and the screening chamber 210. The first one-way valve 412 is in the closed state to seal the valve hole 411. At this time, the blood sample and the nano-magnetic probe can be put into the upper cavity 111 for reaction cultivation. When the device needs to perform a liquid discharge operation, the piston block 410 is pulled upward, and the first one-way valve 412 is in the open state. The liquid in the upper cavity 111 enters the lower cavity 112 through the valve hole 411. When the piston block 410 moves downward, the first one-way valve 412 is in the closed state. The piston block 410 can apply pressure to the liquid in the lower cavity 112, and the liquid in the lower cavity 112 cannot flow back into the upper cavity 111. In actual operation, the piston block 410 can be pulled repeatedly to achieve the purpose of liquid discharge or cleaning.

[0082] As Figures 1 to 6 shown, compared with the first embodiment, the second embodiment does not require installing a liquid guiding pipe 140 on the outer wall of the mixing chamber 100, reducing the complexity of the device, making the overall structure more concise, and also reducing the leakage risk. Moreover, the liquid transfer control logic of the second embodiment is more concise, the liquid transfer speed is faster, the response time is shorter, and the liquid does not need to pass through the external liquid guiding pipe 140, which can reduce the possibility of CTCs-magnetic bead complexes adhering to the inside of the liquid guiding pipe 140.

[0083] As Figure 1 、 Figure 2 、 Figures 5 to 9 shown, on the basis of the second embodiment, the mixing chamber 100 is provided with a top cover 150. The top cover 150 seals the top of the upper cavity 111. The top cover 150 is provided with an air hole 151, and a second one-way valve 152 is installed in the air hole 151. When the piston block 410 moves in the direction of increasing the volume of the upper cavity 111 and decreasing the volume of the lower cavity 112, the second one-way valve 152 is in the open state. When the piston block 410 moves in the direction of decreasing the volume of the upper cavity 111 and increasing the volume of the lower cavity 112, the second one-way valve 152 is in the closed state.

[0084] The top cover 150 seals the top of the upper cavity 111 to ensure that the liquid and gas in the upper cavity 111 will not leak from the top. The air hole 151 of the top cover 150 is used for allowing external gas to enter the upper cavity 111 to balance the internal and external pressure differences. Since the second one-way valve 152 is installed in the air hole 151, the second one-way valve 152 ensures that the gas can only enter the upper cavity 111 from the outside, and the liquid in the upper cavity 111 cannot push open the valve core of the second one-way valve 152 and flow out. Only when the pressure in the upper cavity 111 decreases to a certain extent, the external gas can push open the valve core of the second one-way valve 152 and enter the upper cavity 111.

[0085] In the second embodiment, when the piston block 410 moves downward, the volume of the upper cavity 111 increases. At this time, the upper cavity 111 is in a vacuum state, which makes it difficult for the piston block 410 to move downward. Therefore, an air hole 151 and a second one-way valve 152 are provided to balance the pressure difference. During the specific operation process, when the piston block 410 moves downward, the first one-way valve 412 is in a closed state, and the second one-way valve 152 is pushed open by the external gas and enters the upper cavity 111, enabling the piston block 410 to move downward smoothly; when the piston block 410 moves upward, the first one-way valve 412 is in an open state, and the second one-way valve 152 is in a closed state. The liquid in the upper cavity 111 cannot flow out through the air hole 151 and can only flow into the lower cavity 112 through the valve hole 411.

[0086] As Figures 1 to 9 shown, on the basis of the above-mentioned implementation manner, the control module further includes a driving rod 420, and the driving rod 420 penetrates into the upper cavity 111 and is connected to the piston block 410.

[0087] The driving rod 420 can accurately control the movement of the piston block 410. The piston block 410 can be driven to move upward or downward through the driving rod 420, so as to realize the reciprocating movement of the piston block 410.

[0088] On the basis of the above-mentioned implementation manner, the control module further includes a driving element 430, and the driving element 430 is connected to the driving rod 420. The driving element 430 is configured to be able to drive the piston block 410 to move through the driving rod 420.

[0089] The driving element 430 is the power source of the control module. It is preferably an electric push rod. A support frame is provided at the top of the mixing chamber 100, and the driving element 430 is fixedly installed on the support frame. The driving element 430 is connected to the piston block 410 through the driving rod 420, and transmits power to the piston block 410, enabling it to move up and down according to a preset program or operation instruction. Through the driving element 430, the device can automatically realize the transfer of liquid from the upper cavity 111 to the lower cavity 112 and then to the screening chamber 210, without additional manual operation, significantly improving the automation degree of the device.

[0090] As Figures 1 to 6 shown, on the basis of the above-mentioned implementation manner, the temperature control module includes a heating element 510, a temperature measuring element 520 and a controller. The heating element 510 and the temperature measuring element 520 are both electrically connected to the controller. The heating element 510 and the temperature measuring element 520 are both installed in the mixing chamber 100. The temperature measuring element 520 is configured to be able to measure the temperature in the mixing chamber 110 and feedback it to the controller. The controller is configured to be able to control the heating element 510 to work according to the temperature signal feedback by the temperature measuring element 520 so as to maintain the set temperature in the mixing chamber 110.

[0091] The heating element 510 is installed inside the mixing chamber 100 for heating the mixing cavity 110. The heating element 510 is preferably a heating jacket, and a resistance wire is arranged inside the heating jacket; the temperature measuring element 520 is used to measure the actual temperature inside the mixing cavity 110; the temperature measuring element 520 is preferably a thermocouple or a thermistor. The temperature measuring element 520 can monitor the temperature change in real time and feedback the temperature signal to the controller. The controller is responsible for receiving the temperature signal feedback by the temperature measuring element 520 and controlling the operation of the heating element 510 according to the temperature signal, so as to ensure that the temperature inside the mixing cavity 110 is stable at the set value.

[0092] Through the coordinated operation of the heating element 510, the temperature measuring element 520 and the controller, the temperature control module can simulate a constant temperature cultivation environment and realize fully automated temperature management. The user only needs to set the temperature value, and the subsequent temperature control is automatically completed by the system, making the device very convenient to use.

[0093] On the basis of the above embodiment, the mixing chamber 100 is provided with a sandwich cavity 160, and the sandwich cavity 160 surrounds the outer periphery of the mixing cavity 110. The heating element 510 is fixedly arranged inside the sandwich cavity 160.

[0094] The mixing chamber 100 is actually composed of a housing and an inner container. The inner container is arranged inside the housing, and a sandwich cavity 160 is formed between the two. The mixing cavity 110 is located inside the inner container. This design ensures that the heating element 510 can heat the mixing cavity 110 through the wall of the inner container, ensuring that heat can be efficiently transferred into the mixing cavity 110, and the user cannot directly touch the heating element 510, avoiding accidental burns. In addition, arranging the heating element 510 inside the sandwich cavity 160 also has a heat preservation effect to reduce heat dissipation to the outside world and improve the heating efficiency and energy utilization rate.

[0095] As Figures 1 to 7 shown, on the basis of the above embodiment, the magnetic enrichment module includes an electromagnet 600. The electromagnet 600 is configured to generate a magnetic field when energized and remove the magnetic field when de-energized. The electromagnet 600 is installed on the part of the driving rod 420 located inside the upper cavity 111.

[0096] During the enrichment stage, the electromagnet 600 can be energized to generate a magnetic field, which can attract and fix the CTCs-magnetic bead complex; during the cleaning stage, the electromagnet 600 can be de-energized to remove the magnetic field, so that the cleaning liquid can wash and collect the CTCs-magnetic bead complex. This design makes the device more flexible and convenient to use and greatly improves the degree of automation. In addition, the magnetic field intensity of the electromagnet 600 can be controlled by adjusting the current magnitude, so as to optimize the enrichment effect. Therefore, during actual operation, the device can select an appropriate magnetic field intensity according to the detection requirements and conditions to ensure the best enrichment effect.

[0097] On the basis of the above - mentioned embodiments, an installation hole 421 is formed inside the driving rod 420, and the electromagnet 600 is fixedly arranged in the installation hole 421.

[0098] The installation position of the electromagnet 600 has a great influence on the enrichment effect. If the electromagnet 600 is installed outside the mixing chamber 110, since the magnetic field strength decays rapidly with distance, some CTCs - magnetic bead complexes close to the electromagnet 600 can be effectively adsorbed together, while some CTCs - magnetic bead complexes far from the electromagnet 600 cannot be effectively enriched due to the too - weak magnetic field strength. If the electromagnet 600 is directly inserted into the mixing chamber 110, since the driving rod 420 is located at the central position of the mixing chamber 110, the electromagnet 600 cannot be located at the central position of the mixing chamber 110 due to interference, resulting in uneven distribution of the magnetic field strength. More importantly, if the electromagnet 600 is directly arranged in the mixing chamber 110, it will directly contact the liquid or sample in the mixing chamber 110, increasing the risk of contamination; moreover, since the piston block 410 needs to move up and down, the piston block 410 may collide with or interfere with the electromagnet 600.

[0099] For the above - mentioned reasons, in this embodiment, the electromagnet 600 is specifically arranged inside the driving rod 420. Since the driving rod 420 is located at the central position of the mixing chamber 110, the electromagnet 600 is also located at the central position of the mixing chamber 110, making the magnetic field strength in the mixing chamber 110 evenly distributed. And arranging the electromagnet 600 inside the driving rod 420 can completely solve the problem of collision or interference between the piston block 410 and the electromagnet 600 during the movement of the piston block 410, while ensuring that the electromagnet 600 does not contact the liquid in the mixing chamber 110.

[0100] As Figures 1 to 7 shown, on the basis of the above - mentioned embodiments, it further includes an ultrasonic module 700. The ultrasonic module 700 is inserted into the mixing chamber 110, and the ultrasonic module 700 is configured to be able to generate high - frequency vibrations in the mixing chamber 110.

[0101] The main function of the ultrasonic module 700 is to improve the cleaning effect during the cleaning stage. Since the magnetic field generated by the electromagnet 600 inside the driving rod 420 adsorbs and fixes the CTCs - magnetic bead complexes on the surface of the driving rod 420, even after the magnetic field is removed, there will still be some CTCs - magnetic bead complexes attached to the surface of the driving rod 420. And the ultrasonic module 700 can generate high - frequency vibrations in the cleaning liquid, loosening these CTCs - magnetic bead complexes adsorbed on the driving rod 420, so that the cleaning liquid can more effectively rinse and collect these CTCs - magnetic bead complexes.

[0102] It should also be noted here that the ultrasonic module 700 not only improves the cleaning effect during the cleaning stage, but also plays an important role during the reaction cultivation stage. During the reaction cultivation stage, the nano-magnetic probes introduced into the mixing chamber 110 may fall onto other components in the blood, causing the nano-magnetic probes to adhere to other components, which may lead to false positives during subsequent detection. The ultrasonic module 700 can separate the nano-magnetic probes from other components through high-frequency vibration, that is, shake the nano-magnetic probes off other components (non-target cells) through high-frequency vibration, thus avoiding false positives.

[0103] As Figures 1 to 9 shown, it should be emphasized that since this device has relatively comprehensive functions, it has the function of executing the entire operation step with one key. Only need to introduce the blood sample and nano-magnetic probes, and then start this device. The heating element 510, the temperature measuring element 520 and the controller can work together to simulate a constant temperature cultivation environment in the mixing chamber 110, and the ultrasonic module 700 is started to disperse the nano-magnetic probes; after the cultivation is completed, the heating element 510 is automatically powered off, and the electromagnet 600 is automatically powered on to adsorb the CTCs-magnetic bead complex onto the surface of the driving rod 420. Then the driving element 430 drives the piston block 410 to move up and down through the driving rod 420, so as to discharge the waste liquid from the mixing chamber 110. Then install the filter membrane 230 and the baffle 240 on the screening chamber 200, and then the system controls the electromagnet 600 to power off to remove the magnetic field. The cleaning liquid is injected into the upper cavity 111, and the ultrasonic module 700 is started to assist in cleaning. At the same time, the driving element 430 drives the piston block 410 to move up and down through the driving rod 420, so as to achieve the effect of automatic cleaning; after the cleaning is completed, the system turns off the ultrasonic module 700 and the driving element 430, and prompts the user to take out the screening chamber 200 for in-situ Raman detection. During the whole operation process, the number of manual operation steps is very small, and most steps can be automatically operated.

[0104] As Figures 1 to 9 shown, a circulating tumor cell detection method includes the following steps:

[0105] S1: Adjust the circulating tumor cell screening and separation device to the initial state, ensure that the mixing chamber 110 is clean and dry, and drive the piston block 410 to move to the bottom of the mixing chamber 110 through the driving element 430;

[0106] S2: Inject the blood sample and nano-magnetic probes into the upper cavity 111 of the mixing chamber 110 for reaction cultivation, and then start the temperature control module to simulate the human body constant temperature environment in the mixing chamber 110. During the reaction cultivation of the blood sample and the nano-magnetic probes, the CTCs in the blood sample combine with the nano-magnetic probes to form a CTCs-magnetic bead complex;

[0107] S3: After the reaction and cultivation process reaches the set time, activate the electromagnet 600, and the magnetic field generated by the electromagnet 600 captures the CTCs-magnetic bead complex;

[0108] S4: The driving element 430 drives the piston block 410 to move upward, and the waste liquid in the upper cavity 111 is discharged into the lower cavity 112, and then the waste liquid enters the waste liquid cavity 310 through the screening cavity 210;

[0109] S5: Remove the screening chamber 200, then install the filter membrane 230 on the screening chamber 200 so that the filter membrane 230 seals the screening cavity 210, install the screening chamber 200 between the mixing chamber 100 and the waste liquid chamber 300, and then drive the piston block 410 to move downward to the bottom of the mixing cavity 110;

[0110] S6: Inject cleaning liquid into the upper cavity 111, then turn off the electromagnet 600 to remove the magnetic field, activate the ultrasonic module 700 to clean the upper cavity 111, and then drive the piston block 410 to move upward so that the cleaning liquid in the upper cavity 111 is discharged into the lower cavity 112, and the cleaning liquid enters the waste liquid cavity 310 through the screening cavity 210, and the CTCs-magnetic bead complex in the cleaning liquid is blocked by the filter membrane 230;

[0111] S7: Remove the screening chamber 200 again, then install the glass window 250 on the screening chamber 200, and then place the screening chamber 200 under the Raman spectrometer for detection.

[0112] This method actually uses the circulating tumor cell screening and separation device to automatically perform cultivation, enrichment, separation, cleaning, and screening operations, and then places the screening chamber 200 under the Raman spectrometer for in-situ detection. This method improves the accuracy and reliability of detection, reduces the steps of manual operation, and greatly improves the detection efficiency.

[0113] In step S1, the piston block 410 is at the bottom of the mixing chamber 110, creating space for subsequent injection of the blood sample and the nano-magnetic probe. The electromagnet 600 is powered off to ensure that the nano-magnetic probe is not attracted at the initial stage. The filter membrane 230 and the baffle 240 are not installed in the screening chamber 200 to ensure that the waste liquid can pass through the screening chamber 210. In step S2, a human body constant temperature environment (usually 37°C) is simulated in the mixing chamber 110 to promote the effective binding of CTCs and the nano-magnetic probe, thus forming CTCs-magnetic bead complexes. Step S3 is to capture the CTCs-magnetic bead complexes using the magnetic field generated by the electromagnet 600. In step S4, the driving element 430 drives the piston block 410 to move up and down repeatedly, thereby discharging the waste liquid in the upper cavity 111 and reducing the influence of non-target components. Step S5 is to install the filter membrane 230 on the screening chamber 200 to facilitate the screening of CTCs-magnetic bead complexes. Step S6 is the cleaning step. In this step, the cleaning liquid needs to be injected into the upper cavity 111 first and the electromagnet 600 is turned off. With the assistance of ultrasonic vibration, the cleaning liquid flushes and collects the CTCs-magnetic bead complexes. The driving element 430 drives the piston block 410 to move up and down repeatedly, enabling the cleaning liquid to enter the screening chamber 210. The cleaning liquid can pass through the filter membrane 230 and enter the waste liquid chamber 310, while the CTCs-magnetic bead complexes are blocked by the filter membrane 230. Step S7 is actually the detection step. The screening chamber 200 is disassembled and placed under a Raman spectrometer for detection.

[0114] This method has a high degree of automation. The entire operation process can be run with one key, reducing manual intervention and improving operation efficiency. Moreover, this method simulates a constant temperature cultivation environment (usually 37°C) in the mixing chamber 110 through the heating element 510, the temperature measuring element 520, and the controller, promoting the effective binding of the nano-magnetic probe and CTCs and improving the accuracy of detection. The design of the multi-functional mixing chamber 110 integrates various functions such as reaction cultivation, enrichment, and cleaning, ensuring that all operations are completed in a closed environment, avoiding cross-contamination, and improving operation efficiency. The detachable design enables the screening chamber 200 to be directly placed under a Raman spectrometer for detection without additional sample transfer, achieving true in-situ detection, avoiding sample transfer between different containers, and reducing the possibility of contamination.

[0115] It should be noted that all directional indications (such as up, down, left, right, front, back...) in the embodiments of the present invention are only used to explain the relative positional relationship and movement conditions between components in a specific posture. If the specific posture changes, the directional indication will also change accordingly.

[0116] In addition, in the present invention, descriptions such as "first", "second", "one", etc. are for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include at least one such feature.

[0117] In the present invention, unless otherwise clearly defined and limited, terms such as "connection" and "fixation" shall be understood in a broad sense. For example, "fixation" may be a fixed connection, a detachable connection, or integrated; it may be a mechanical connection or an electrical connection; it may be directly connected or indirectly connected through an intermediate medium, and it may be the communication inside two elements or the interaction relationship between two elements, unless otherwise clearly limited.

[0118] In addition, the technical solutions between various embodiments of the present invention may be combined with each other, but it must be based on the ability of those of ordinary skill in the art to implement. When the combination of technical solutions results in contradictions or cannot be implemented, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

Claims

1. A circulating tumor cell screening and separation device, characterized in that: include: A chamber module, wherein the chamber module is provided with a mixing chamber (110), a screening chamber (210) and a waste liquid chamber (310), wherein the mixing chamber (110), the screening chamber (210) and the waste liquid chamber (310) are connected in sequence; a control module, the control module being mounted on the chamber module, the control module being configured to control whether liquid is discharged from the mixing chamber (110) to the screening chamber (210) according to its own motion state; a temperature control module, the temperature control module being installed on the chamber module, the temperature control module being configured to be able to control the temperature in the mixing chamber (110); a magnetic enrichment module, the magnetic enrichment module being configured to form a magnetic field in the mixing chamber (110); The chamber module comprises a mixing chamber (100), a screening chamber (200) and a waste liquid chamber (300); the mixing chamber (110) is arranged in the mixing chamber (100); the screening chamber (210) is arranged in the screening chamber (200); the waste liquid chamber (310) is arranged in the waste liquid chamber (300); the screening chamber (200) and the waste liquid chamber (300) are detachably connected; and the mixing chamber (100) and the screening chamber (200) are detachably connected; The mixing chamber (100), the screening chamber (200) and the waste liquid chamber (300) are arranged in sequence from top to bottom, the bottom of the mixing chamber (110) is connected to the top of the screening chamber (210), and the bottom of the screening chamber (210) is connected to the top of the waste liquid chamber (310); The control module comprises a piston block (410), the piston block (410) is movably arranged in the mixing chamber (110), the outer peripheral surface of the piston block (410) is sealed and fitted with the chamber wall of the mixing chamber (110), so as to separate the mixing chamber (110) into an upper chamber (111) and a lower chamber (112), the upper chamber (111) is arranged as the part between the top of the mixing chamber (110) and the upper surface of the piston block (410), and the lower chamber (112) is arranged as the part between the lower surface of the piston block (410) and the bottom of the mixing chamber (110), the top of the upper chamber (111) is closed, and the bottom of the lower chamber (112) is communicated with the screening chamber (210); When the piston block (410) is stationary, the flow path between the upper cavity (111) and the lower cavity (112) is in a closed state; when the piston block (410) moves in a direction that reduces the volume of the upper cavity (111) and increases the volume of the lower cavity (112), the flow path between the upper cavity (111) and the lower cavity (112) is in an open state; The piston block (410) is provided with a valve hole (411), the upper cavity (111) and the lower cavity (112) are communicated through the valve hole (411), and a first one-way valve (412) is installed in the valve hole (411); when the piston block (410) is stationary or moves in a direction that increases the volume of the upper cavity (111) and decreases the volume of the lower cavity (112), the first one-way valve (412) is in a closed state; when the piston block (410) moves in a direction that decreases the volume of the upper cavity (111) and increases the volume of the lower cavity (112), the first one-way valve (412) is in an open state; The mixing chamber (100) is provided with a top cover (150), the top cover (150) seals the top of the upper cavity (111), the top cover (150) is provided with an air hole (151), and a second one-way valve (152) is installed in the air hole (151); when the piston block (410) moves in a direction to increase the volume of the upper cavity (111) and reduce the volume of the lower cavity (112), the second one-way valve (152) is in an open state; when the piston block (410) moves in a direction to reduce the volume of the upper cavity (111) and increase the volume of the lower cavity (112), the second one-way valve (152) is in a closed state; The control module further comprises a driving rod (420), wherein the driving rod (420) penetrates into the upper cavity (111) and is connected to the piston block (410); The control module further comprises a driving element (430), wherein the driving element (430) is connected to the driving rod (420), and the driving element (430) is configured to be able to drive the piston block (410) to move through the driving rod (420); The magnetic enrichment module comprises an electromagnet (600), wherein the electromagnet (600) is configured to generate a magnetic field when powered on and remove the magnetic field when powered off, and the electromagnet (600) is installed at a portion of the driving rod (420) located in the upper cavity (111); The driving rod (420) is provided with a mounting hole (421) inside, and the electromagnet (600) is fixedly disposed in the mounting hole (421).

2. A circulating tumor cell screening and separation device as claimed in claim 1, characterized in that: The screening chamber (200) is provided with at least one fixing component (220), the fixing component (220) comprising a filter membrane fixing ring (221), the filter membrane fixing ring (221) being detachably connected to the screening chamber (200), a detachable filter membrane (230) being installed between the filter membrane fixing ring (221) and the screening chamber (200), and the filter membrane (230) being located in the screening cavity (210).

3. A circulating tumor cell screening and separation device as claimed in claim 2, characterized in that: A detachable baffle (240) is also installed between the filter membrane fixing ring (221) and the screening chamber (200). The baffle (240) is located in the screening chamber (210). The baffle (240) is provided with a plurality of small holes, and the filter membrane (230) is closely attached to the baffle (240).

4. A circulating tumor cell screening and separation device as claimed in claim 2, characterized in that: The fixing assembly (220) further comprises a window fixing ring (222), wherein the window fixing ring (222) is detachably connected to the filter membrane fixing ring (221), and a detachable glass window (250) is installed between the window fixing ring (222) and the filter membrane fixing ring (221).

5. A circulating tumor cell screening and separation device as claimed in claim 1, characterized in that: The temperature control module comprises a heating element (510), a temperature measuring element (520) and a controller; the heating element (510) and the temperature measuring element (520) are both electrically connected to the controller; the heating element (510) and the temperature measuring element (520) are both installed in the mixing chamber (100); the temperature measuring element (520) is configured to measure the temperature in the mixing chamber (110) and feed back the temperature to the controller; and the controller is configured to control the heating element (510) to operate according to a temperature signal fed back by the temperature measuring element (520) so that the mixing chamber (110) maintains a set temperature.

6. A circulating tumor cell screening and separation device as claimed in claim 5, characterized in that: The mixing chamber (100) is provided with an interlayer cavity (160), the interlayer cavity (160) surrounds the outer circumference of the mixing cavity (110), and the heating element (510) is fixedly arranged in the interlayer cavity (160).

7. A circulating tumor cell screening and separation device as claimed in claim 1, characterized in that: It also includes an ultrasonic module (700), which is inserted into the mixing chamber (110), and the ultrasonic module (700) is configured to generate high-frequency vibrations in the mixing chamber (110).

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