A portable detection device for assessing the risk of urothelial carcinoma tumor progression

Abstract

The utility model relates to urine detection technical field, concretely is a kind of portable detection device of urothelial carcinoma tumor progression risk assessment, including detector, display screen, disposable detection card box card joint groove and pluggable disposable detection card box, disposable detection card box is equipped with microfluidic chip, the sample processing area top of microfluidic chip is equipped with elastomer valve, sample tube is set up in directly above elastic lifting type, sample input channel is equipped with through in sample tube, sample is directly entered sample processing area from top to bottom through sample input channel, sample input channel top can be magnetically connected with detector sample input port and can be detached and cleaned.By the combination of disposable card box and detachable sample channel, the device avoids urine leakage and odor dispersion, reduces dependence on the built-in pump and simplifies manufacturing cost, facilitating on-site rapid detection and sample isolation.

Description

Technical Field

[0001] This invention relates to the field of urine detection technology, specifically a portable detection device for assessing the risk of urothelial carcinoma progression. Background Technology

[0002] A portable detection device for assessing the risk of urothelial carcinoma progression automatically captures, lyses, amplifies at an isothermal temperature, and detects multiple biomarker signals in urine samples using its core components, including a disposable microfluidic chip, a microfluidic-driven pump valve, a temperature control system, and optical / electrochemical sensors. The built-in processor integrates the data and generates a quantitative tumor progression risk report in real time through a risk assessment algorithm.

[0003] In the initial stage of processing, a small amount of fresh urine (10-20 mL) needs to be poured into a disposable test cartridge. After the cartridge is inserted into the device, the built-in micropump drives the urine to the sample processing area of ​​the microfluidic chip. This process requires the built-in micropump to transfer the urine and pre-placement in the disposable test cartridge. This method of urine sample input presents problems such as urine leakage and odor generation. Furthermore, the inclusion of a built-in micropump increases manufacturing difficulty and cost. In view of this problem, this technical solution designs a portable detection device for assessing the risk of urothelial carcinoma tumor progression. Utility Model Content

[0004] The purpose of this invention is to provide a portable detection device for assessing the risk of urothelial carcinoma progression, in order to solve the problems mentioned in the background art.

[0005] To achieve the above objectives, this utility model provides the following technical solution: A portable testing device for assessing the risk of urothelial carcinoma progression includes a testing instrument, a display screen, and a disposable test card holder slot. A disposable test card holder with a microfluidic chip is inserted into the slot. The microfluidic chip in the disposable test card holder is connected to the testing module inside the testing instrument. The disposable test card holder has a sample processing area for the microfluidic chip. A sample tube is elastically and liftably positioned above the sample processing area of ​​the microfluidic chip. An elastic valve is positioned at the top of the sample processing area of ​​the microfluidic chip. The elastic valve opens to both sides when subjected to conical pressure from the bottom of the sample tube, and automatically closes when the pressure is released. The sample processing area of ​​the chip is closed at the top, and a vertically penetrating sample input channel is provided in the middle of the sample tube. This channel is inserted into the sample tube inside the sample processing area of ​​the microfluidic chip. At this time, the bottom end of the sample input channel is connected to the sample processing area of ​​the microfluidic chip. Then, the urine sample to be tested is input along the top of the sample input channel, directly inputting the urine sample into the sample processing area of ​​the microfluidic chip for testing. After the input is complete, the pressure on the top of the sample tube is released, and the sample input channel automatically moves upward from the sample processing area of ​​the microfluidic chip. Then, the elastic valve closes the top of the sample processing area of ​​the microfluidic chip to ensure that the sample does not leak and that odor does not spread. When removing the sample, the disposable test cartridge can be directly removed from the disposable test cartridge slot.

[0006] Compared with the prior art, the beneficial effects of this utility model are: by directly injecting the sample into the microfluidic chip through the sample input channel and sealing it with an elastic valve, the chip automatically closes after the sample input is completed, preventing urine leakage and odor diffusion.

[0007] By employing disposable cartridges and passive actuation, samples are transferred via release, reducing the need for built-in fluid drive hardware.

[0008] The sample input channel and sample input port are magnetically detachably connected, and the sample channel can be removed for cleaning or replacement, reducing the risk of cross-contamination and improving detection accuracy. Attached Figure Description

[0009] Figure 1 A schematic diagram of a portable detection device for assessing the risk of urothelial carcinoma progression.

[0010] Figure 2 This is a second-view structural schematic diagram of a portable detection device for assessing the risk of urothelial carcinoma progression.

[0011] Figure 3 This is a front view schematic diagram of the internal structure of a portable detection device for assessing the risk of urothelial carcinoma progression.

[0012] Figure 4 This is a schematic diagram of the tube end cap in a portable detection device for assessing the risk of urothelial carcinoma progression.

[0013] Figure 5 for Figure 3 A magnified structural diagram of A in the middle.

[0014] Figure 6 for Figure 3 A magnified structural diagram of B in the diagram.

[0015] The components include: a detector 10, a display screen 11, a disposable test card holder slot 12, a sample input port 13, a positioning slide 14, a disposable test card holder 15, a sample processing area of ​​a microfluidic chip 16, an elastomer valve 17, a sample tube 18, a tube end cap 19, a positioning slider 20, a first magnet 21, a second magnet 22, a reset spring 23, a sample input channel 24, and a detection module 25. Detailed Implementation

[0016] It should be noted that, unless otherwise specified, the embodiments and features described in these embodiments can be combined with each other.

[0017] In the description of this utility model, it should be understood that the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicating orientation or positional relationships based on the orientation or positional relationships shown in the accompanying drawings, are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model. Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, features defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this utility model, unless otherwise stated, "a plurality of" means two or more.

[0018] In the description of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0019] The present invention will now be described in detail with reference to the accompanying drawings and embodiments.

[0020] Please see Figures 1-6 A portable detection device for assessing the risk of urothelial carcinoma progression includes a detector 10, a display screen 11, and a disposable test card holder slot 12. A disposable test card holder 15 is inserted into the slot 12. A microfluidic chip is mounted on the disposable test card holder 15. The microfluidic chip in the disposable test card holder 15 is connected to the detection module 25 inside the detector 10. The disposable test card holder 15 has a sample processing area 16 for the microfluidic chip. A sample tube 18 is elastically and liftably mounted directly above the sample processing area 16 of the microfluidic chip. An elastic valve 17 is mounted on the top of the sample processing area 16 of the microfluidic chip. The elastic valve 17 opens to both sides when subjected to conical pressure from the bottom of the sample tube 18, and automatically closes when the pressure is released. The top of the sample processing area 16 of the microfluidic chip is closed, and a vertically penetrating sample input channel 24 is provided in the middle of the sample tube 18, which is inserted into the sample tube 18 inside the sample processing area 16 of the microfluidic chip. At this time, the bottom end of the sample input channel 24 is connected to the inside of the sample processing area 16 of the microfluidic chip. Then, the urine sample to be tested is input along the top of the sample input channel 24, directly inputting the urine sample into the sample processing area 16 of the microfluidic chip for testing. After the input is complete, the pressure on the top of the sample tube 18 is released, and the sample input channel 24 automatically moves upward from the sample processing area 16 of the microfluidic chip. Then, the elastic valve 17 closes the top of the sample processing area 16 of the microfluidic chip to ensure that the sample does not leak and that odor does not spread. At the same time, when removing it, the disposable test card cassette 15 can be directly taken out from the disposable test card cassette slot 12.

[0021] In this embodiment of the present invention, a hole cover is embedded in the top of the sample input channel 24 to control the opening and closing of the top of the sample input channel 24. At the same time, a sample input port 13 is opened in the detector 10 corresponding to the sample tube 18. The sample input channel 24 is inserted vertically into the sample input port 13 for magnetic connection. At the same time, an upward pulling force greater than the magnetic connection is applied to remove the sample input channel 24 from the sample input port 13, which facilitates the cleaning of the inside of the sample input channel 24 and prevents interference between different urine samples, which would affect the accuracy of the detection. Specifically, a circular end cap 19 is installed on the outer side of the top of the sample tube 18. The end cap 19 is fitted with the top opening of the sample inlet 13 with a clearance. At the same time, multiple radially distributed positioning sliders 20 are evenly installed on the outer wall of the end cap 19. The inner wall of the sample inlet 13 corresponding to the positioning slider 20 has a positioning groove 14 with a top opening. The positioning slider 20 is longitudinally inserted into the positioning groove 14. A magnet 21 is installed at the bottom of the positioning slider 20. A magnet 22 is elastically connected inside the positioning groove 14 through a return spring 23. The magnet 21 and the magnet 22 are magnetically connected to maintain the stability of the sample tube 18 after it is inserted into the sample inlet 13. When controlling the rise and fall of the sample tube 18, downward pressure is directly applied to the sample tube 18, and then the bottom of the sample tube 18 is controlled to contact and connect or separate from the elastic valve 17. The magnetic connection between the magnet 21 and the magnet 22 is used to control the insertion and removal of the sample tube 18 inside the sample inlet 13.

[0022] In one embodiment of this utility model, the detector 10 has a display screen 11 and operation buttons on one side of its top. It works in conjunction with the detection module 25, disposable test card cassette 15, and microfluidic chip to detect urine samples placed inside the sample processing area 16 of the microfluidic chip. The specific detection principle is as follows: The microfluidic chip has a pre-filtration / enrichment unit in the sample processing area 16, which is used to retain detached cells and allow the supernatant to flow downstream. Pre-placed buffer or powdered reagents are in the corresponding reservoirs and are released and mixed with the sample through a predetermined capillary structure or valve control in the chip to achieve supernatant washing and enrichment. Specifically, the pre-filtration / enrichment unit contains built-in chemical lysis reagents or trace enzyme reagents to react with captured cells and release nucleic acids. If the magnetic bead method is used, nucleic acid binding magnetic beads are pre-placed in the chip or a mixture of magnetic beads is injected after lysis. The detection module 25 is equipped with a movable magnet or electromagnet to capture, wash and resolubilize the magnetic beads under the action of the chip, thereby completing nucleic acid purification and ensuring that upstream impurities are removed to improve amplification sensitivity. At the same time, the microfluidic chip is equipped with one or more amplification reaction chambers, pre-loaded with corresponding amplification reagents. The detection module 25 includes a temperature control unit, such as a heating element and a temperature sensor, and a constant temperature / programmed temperature controller, to accurately control the temperature of the amplification chamber and maintain the required temperature curve to complete the amplification of the target nucleic acid. For fluorescently labeled multiplex nucleic acid detection, the detection module 25 is equipped with multiple sets of light-emitting diodes (different wavelengths) and photodetectors (photodiodes / photosensitive sensors). The amplification process is monitored in real time through different fluorescence channels to quantify each target. The optical path and the chip optical window are precisely aligned between the disposable cartridge and the detection module to ensure stable signal acquisition. At the same time, positive / negative control areas are provided in the chip for real-time comparison to determine the validity of the detection. The detection process is displayed on the screen 11, and the operation process is controlled by operation buttons. The above is only a brief description of the operating principle of this detector. For details, please refer to existing related technologies. Since the focus of this technical solution is on the entry of urine sample, the completeness of this technical solution is not affected even if the above process is not described in detail.

[0023] The working principle of this utility model is as follows: In the idle position of this device, all the aforementioned driving components (representing power elements, electrical devices, and compatible power supplies) are connected via wires. The electrical connections are completed in sequence between the working components. The detailed connection methods are well-known in the field. The following mainly describes the working principle and process, without further explanation of the electrical control. Power on and initialize the detector 10, insert the disposable test card cassette 15 into the card slot 12, and ensure that the sample processing area 16 of the microfluidic chip is aligned with the detection module 25; The sample tube 18, which is equipped with the sample input channel 24, is inserted into the sample input port 13 of the detector from top to bottom. The positioning slider 20 is embedded in the positioning groove 14. The first magnet 21 and the second magnet 22 are magnetically connected. The reset spring 23 is in the standby position. The tube end cap 19 is matched with the top opening of the sample input port 13. Apply downward pressure to the sample tube 18 to push the elastic valve 17 open at the bottom of the sample tube 18, so that the bottom of the sample input channel 24 is connected to the sample processing area 16 of the microfluidic chip. 10–20 mL of fresh urine to be tested is introduced from top to bottom through sample input channel 24 to complete sample transfer. The pre-filtration / enrichment unit retains exfoliated cells and allows the supernatant to flow downstream.

[0024] After sample injection is complete, the downward pressure on sample tube 18 is released, and sample input channel 24 automatically moves out from microfluidic chip 16. Elastomer valve 17 closes, sealing the sample within the chip to prevent leakage and odor. The microfluidic chip performs pre-buffering / lysis, nucleic acid binding / magnetic bead purification in the sample processing area 16. If the magnetic bead method is used, the detection module 25 is equipped with an external magnet / electromagnet and amplification reaction. The detection module 25 provides a temperature control heating plate and temperature sensor, as well as optical / electrochemical detection multi-wavelength LEDs and photodetectors to realize multiple nucleic acid detection, and generates a quantitative tumor progression risk report through the built-in algorithm. After the test is completed, the test results and risk assessment are displayed on the screen 11 and can be exported through device storage or external interface.

[0025] It should be understood that in this application, all rotating, sliding, meshing, belt-driven and other moving parts are well lubricated and not prone to slippage or wear, and each part is provided with a corresponding protective shell. However, in the accompanying drawings of this application, the connection state of each moving part is not shown. It should also be understood that all parts in this application are made of metal or plastic materials with suitable strength in the relevant field to ensure that their structural rigidity meets the actual requirements.

[0026] The preferred embodiments of the present invention have been described in detail above. However, the present invention is not limited to the above embodiments. Within the scope of knowledge possessed by those skilled in the art, various changes can be made without departing from the spirit of the present invention.

Claims

1. A portable detection device for assessing the risk of urothelial carcinoma progression, characterized in that, include: The detector (10) and the display screen (11); A disposable test card slot (12) is provided on the detector (10). A disposable test card (15) can be inserted into the disposable test card slot (12). A microfluidic chip is provided on the disposable test card (15). The microfluidic chip is provided with a sample processing area (16). The sample processing area (16) is connected to the detection module (25) in the detector (10). The sample tube (18) is elastically and liftably installed directly above the sample processing area (16). The bottom end of the sample tube (18) is engaged with the elastomer valve (17) at the top of the sample processing area (16). When the sample tube (18) applies conical pressure, it pushes the elastomer valve (17) to open to connect the sample passage. When the pressure is lost, the elastomer valve (17) closes. A sample input channel (24) is located in the middle of the sample tube (18) and extends through the top and bottom. The bottom end of the sample input channel (24) is connected to the sample processing area (16) of the microfluidic chip.

2. The portable detection device for assessing the risk of urothelial carcinoma progression according to claim 1, characterized in that, The sample input channel (24) has an embedded cover at the top.

3. The portable detection device for assessing the risk of urothelial carcinoma progression according to claim 2, characterized in that, The sample input channel (24) is longitudinally inserted into the sample input port (13) inside the detector (10) and is detachably magnetically connected by a magnetic component. The sample input channel (24) can be removed for cleaning or replacement when an upward pulling force greater than the magnetic attraction force is applied.

4. The portable detection device for assessing the risk of urothelial carcinoma progression according to claim 3, characterized in that, The sample tube (18) is fitted with a tube end cap (19) on the outer side of the top. The outer wall of the tube end cap (19) is provided with multiple radially distributed positioning sliders (20). The inner wall of the detector (10) is provided with a positioning groove (14) with a top opening at the corresponding position. The positioning sliders (20) and the positioning grooves (14) are longitudinally inserted and matched.

5. The portable detection device for assessing the risk of urothelial carcinoma progression according to claim 4, characterized in that, The bottom of the positioning slider (20) is equipped with a magnet plate 1 (21), and the positioning groove (14) is elastically connected to a magnet plate 2 (22) through a reset spring (23). The magnet plate 1 (21) and the magnet plate 2 (22) are magnetically connected to maintain the stability of the sample tube (18) after insertion and to cooperate with the lifting and lowering action.

Images