A multi-chamber biological detection device containing a conducting structure

Abstract

The application discloses a multi-chamber biological detection device containing a conducting structure and belongs to the technical field of biological detection. The device comprises a handle, an outer shell, at least one storage tube, a reaction tube, a rod body, a sampling part and a conducting structure. The storage tube and the reaction tube are sequentially connected along the outer shell in the axial direction, and the upper and lower ends of each storage tube are sealed by a sealing film. The conducting structure comprises a conducting part or a conducting part integrated at the bottom of the storage tube. For any storage tube, if the storage tube is not integrated with the conducting part, a conducting part is arranged between the storage tube and the adjacent part below. When the adjacent part below is a switching part, the conducting part can not be arranged and the lower end surface of the storage tube directly abuts against the adjacent part in the axial direction. If the storage tube is integrated with the conducting part, no conducting part is arranged between the storage tube and the adjacent part below, or one conducting part is arranged. Through the cooperation of the layered conducting logic and the gas-liquid shunt gap, the application solves the problem of liquid splashing in the piercing instant of the existing device and supports the multi-chamber stacking expansion.

Description

Technical Field

[0001] This invention relates to the field of biological detection technology, and more specifically to a multi-chamber biological detection device. Background Technology

[0002] In the field of biomonitoring and rapid detection technology, especially in ATP fluorescence detection swabs and related biosampling devices, how to achieve stable storage, accurate release and efficient reaction of reagents has always been a key focus of the industry.

[0003] International patent WO99 / 19709A1 (authorization publication numbers US6524530B1 and EP1024354A1) discloses a swab testing device. The device includes a tube, a removable swab, an extraction liquid container, and a reaction reagent container. The device includes a reaction tube and a piercing structure located above it. This piercing structure (i.e., the first breaker in the claims) is typically implemented as a fixed acute-angled portion at the lower end of a splash-proofing member, which pierces the aluminum foil seal by moving the reaction tube upwards. The device employs a time-division multiplexing architecture of "upward piercing, downward sampling." The reaction tube must first move upwards to pierce the aluminum foil using the fixed acute-angled portion at the lower end of the splash-proofing member; only then can the swab move downwards for sampling. This sequential design prevents the conduction process from being completed continuously in one step. For rapid testing scenarios requiring liquid conduction within 10 seconds, this step-by-step operation severely hinders testing efficiency. More importantly, because the splash-proof component itself has a hollow channel, if a swab is inserted prematurely before the reaction tube is punctured and the internal pressure is released, the upper and lower chambers will form a direct gas-liquid connection through the hollow channel. This structural connectivity can easily lead to high-pressure gas instantly entraining liquid and being ejected. In addition, the design of the reaction tube carrying the reagent as a moving part increases the uncontrollability of liquid spillage, making it difficult to meet the needs of rapid, one-handed operation on site.

[0004] In existing technologies, multi-chamber detection devices, exemplified by US Patent 5965453A, employ a "coaxial stacking" reagent storage scheme. This device stacks multiple storage chambers containing different reagents sequentially along the tube's axial direction, with each chamber separated and pre-sealed by a puncturable membrane. Its conduction mechanism relies entirely on the axial puncture of a probe: the user pushes the probe, using its tip to puncture each layer of the sealing membrane sequentially, thereby releasing and mixing the reagents. Although this scheme uses helical guidance or indicator lines to control the probe's advancement speed to some extent, attempting to achieve a step-by-step reaction, it is essentially a rigid puncture logic of "dynamic braking." More importantly, this scheme does not truly solve the structural problems of gas-liquid separation and pressure balance. Because each storage chamber is separated only by a single-layer membrane, and there is a gap between the probe and the inner wall of the tube, when the puncture occurs, the upper and lower chambers can easily form a direct gas-liquid connection channel instantly through the periphery of the probe. In high-pressure operating environments for rapid detection (5-10 seconds), this structure cannot avoid the sudden pressure change at the moment of puncture, causing high-pressure gas to spray out entrained liquid. Furthermore, it cannot dynamically adjust the conduction cross section according to the reagent viscosity, posing an inherent gas-liquid dynamic risk.

[0005] In summary, both the "reaction tube upward puncture" and the "rod puncture of the stacked membrane" rely on the axial displacement of components to achieve conduction, essentially a passive design of "using movement to control movement," leading to a severe disruption in the operational sequence. This time-sharing conduction mechanism forces users to perform step-by-step operations, which not only violates the requirement for rapid detection to complete liquid conduction within 5-10 seconds, but also causes gas-liquid dynamics to become uncontrollable due to the interaction between the moving component and the sealing membrane: at the moment of puncture, the gap between the moving structure and the tube can easily form a direct gas-liquid connection channel, causing high-pressure gas to carry liquid and splash.

[0006] Therefore, existing technologies have always failed to break free from the structural deadlock of "movement equals risk," and there is an urgent need for a new static conduction scheme to simultaneously solve the problems of operational continuity and splash prevention. Summary of the Invention

[0007] This invention aims to overcome the shortcomings of existing technologies and provide a biological detection device that is reliably sealed, effectively prevents reagent splashing, and supports multi-chamber liquid storage and on-demand conduction. By optimizing the conduction structure and stacking logic, this invention significantly improves the stability of detection and the feasibility of manufacturing processes.

[0008] To achieve the above objectives, the present invention adopts the following technical solution: a multi-chamber biological detection device with a conductive structure, comprising a handle, an outer shell, at least one storage tube, a reaction tube, a rod, a sampling section, and a conductive structure. The storage tube and the reaction tube are connected in series along the axial direction of the outer shell. The upper and lower ends of each storage tube are sealed with a sealing membrane, while the top of the reaction tube may or may not have a sealing membrane. The conductive structure includes any one or a combination of the following: an independently disposed conductive element, or a conductive portion integrated into the bottom of the storage tube.

[0009] The core of this invention lies in the design of an interlayer connection logic based on physical boundaries, which constitutes a substantial feature distinguishing it from existing technologies. For any of the aforementioned storage tubes, the connection relationship between it and its adjacent lower component is strictly defined: if the storage tube does not integrate a conductive part, then when the adjacent lower component has a sealing membrane, a conductive element is provided between the storage tube and the adjacent lower component; when the adjacent lower component does not have a sealing membrane, no conductive element is provided between the storage tube and the adjacent lower component, or a conductive element is provided; when no conductive element is provided, the lower end face of the storage tube directly abuts axially against the upper end face of the adjacent lower component; when a conductive element is provided, the conductive element is located between the storage tube and the adjacent lower component. If the storage tube integrates a conductive part, then no conductive element is provided between the storage tube and the adjacent lower component, or a conductive element is provided. This layered conductive logic, together with the non-tight fit gap between the outer wall of the storage tube and the outer shell, constitutes a gas-liquid separation system, fundamentally solving the problem of liquid splashing at the moment of puncture.

[0010] In terms of scenario adaptability, this invention demonstrates hierarchical throughput adaptability. The fully external conductive layout utilizes the radial dimensions of independent conductive components, which are not limited by the tube opening, to form a large-diameter opening. Combined with the annular gap between the outer wall of the storage tube and the outer shell, it serves as an exhaust channel, specifically designed for large-volume conventional reagents, completely eliminating the phenomenon of gas-liquid competition for channels. The fully internal conductive layout utilizes the bottom-integrated flap structure to powerfully scrape the sampling section, maximizing the solid recovery rate; however, due to the physical bottleneck of flow channel encroachment, this layout is generally suitable for conventional reagent stacks of two layers or less. If three layers or more are required, the inner diameter of the storage tube needs to be increased or an external conductive component needs to be introduced for assistance. The hybrid conductive layout adopts an asymmetrical design of "upper internal (anti-flow obstruction) + lower external (large diameter)", placing the internal component with a small flow channel occupation on the top layer for scraping, and placing the large-diameter external component on the bottom layer for pressure relief, thereby achieving stable release of multiple layers of conventional reagents within a limited space.

[0011] Regarding the configuration of sampling and mixing functions, this invention offers several flexible architectures. In the basic scheme, the sampling section at the lower end of the rod performs the sample collection function, while the rod also serves as a conductive thrust transmission component. In the preferred scheme, which adds an adapter and a second rod, the sampling function is transferred to the second sampling section at the lower end of the second rod inside the reaction tube, while the upper first rod focuses on transmitting axial thrust to pierce each layer of sealing membrane, achieving physical separation of sampling and mixing functions. This architecture is particularly suitable for scenarios involving multi-reagent stepwise release, high-viscosity sample collection, or time-separated sampling and detection, eliminating the need for samples to pass through any storage tubes above, thus completely eliminating the risk of wall adhesion loss and cross-contamination.

[0012] Furthermore, this invention constructs a robust static axial limiting and guiding system. By tightly fitting and fixing the upper outer wall of the storage tube and the top outer wall of the reaction tube to the inner wall of the outer shell, the instability risk caused by axial movement of the reaction tube in existing technologies is completely eliminated. The rod body possesses axial rigidity that increases with the number of stacked layers, ensuring efficient force transmission during the puncture process. In terms of process implementation, this invention specifies that only one conductive component is allowed to be integrally formed with the outer shell, solving the assembly deadlock problem of deep-hole undercut molds being unable to demold and parts being unable to be installed, significantly improving mass production feasibility. This structure supports both soft fiber sampling units and rigid plastic sampling units, and the assembly process does not require complex twisting operations, greatly improving production efficiency and yield. Attached Figure Description

[0013] Figure 1 This is a schematic diagram of the overall structure of the biological sampling swab of the present invention;

[0014] Figure 2 This is a partial structural diagram of two structures on the outer edge of the conductive element of the present invention (a flat sheet structure without protrusions and a structure with annular protrusions);

[0015] Figure 3 This is a schematic diagram of the outer edge structure when the storage tube of the present invention integrates the bottom conductive part;

[0016] Figure 4 This is a top view of the six-lobed and single-lobed conductive elements of the present invention (flat sheet structure without protrusions and structure with annular protrusions).

[0017] Figure 5 This is a schematic diagram of the structure of the conductive component with an annular convex ridge structure of the present invention (six-lobed and single-lobed types).

[0018] Figure 6 This is a schematic diagram of the structure of the conductive element with a flat, non-protruding sheet structure of the present invention (six-lobed and single-lobed types).

[0019] Figure 7 This is a partial cross-sectional view and a bottom view of the storage tube of the integrated conductive part of the present invention;

[0020] Figure 8 This is a partial structural schematic diagram of the rigid plastic sampling section of the present invention;

[0021] Figure 9 This is a schematic diagram of the multi-storage tube hybrid conductive stacking structure of the present invention;

[0022] Figure 10 This is a schematic diagram of the multi-storage tube fully externally connected stacked structure of the present invention;

[0023] Figure 11 This is a schematic diagram of the multi-storage tube fully internal conductive stacked structure of the present invention;

[0024] Figure 12 This is a schematic diagram of the structure of the integrated conductive part of the present invention, which combines the storage tube and the conductive element.

[0025] Figure 13 This is a schematic diagram of the sampling and mixing function separation structure of the present invention, including the adapter and the dual rods;

[0026] Figure 14 This is a partial cross-sectional view of the structure of the present invention, in which the storage tube is directly supported at the port of the adapter and the conductive component is omitted;

[0027] Figure 15 A partial cross-sectional view of the structure of the conductive element disposed above the topmost storage tube of the present invention;

[0028] In the diagram: 1. Handle; 2. Fastening plate; 3. Insertion hole; 4. First rod body; 5. Outer shell; 6. First sampling section; 7. First sealing membrane; 8. First storage tube; 9. Second sealing membrane; 10. First conductive element; 11. Third sealing membrane; 12. Reaction tube; 13. Annular protrusion; 14. Conductive part; 15. Indentation; 16. Protrusion; 17. Second storage tube; 18. Fourth sealing membrane; 19. Fifth sealing membrane; 20. Second conductive element; 21. Petal; 22. Second sampling section; 30. Adapter; 31. First mating section; 32. Second mating section; 33. Central guide hole; 34. Liquid outlet hole; 41. Second rod body Detailed Implementation

[0029] The specific embodiments of the present invention will be further described in detail below with reference to the accompanying drawings. It should be understood that the specific embodiments described herein are only for explaining the present invention and are not intended to limit the present invention.

[0030] Example 1: Single storage tube basic structure and universal assembly (corresponding to) Figure 1 ).

[0031] The "multi-chamber" mentioned in this application refers to a collection of independent chambers consisting of a reaction tube and at least one storage tube. Therefore, configurations including a single storage tube and a reaction tube (as in Examples 1 to 3) essentially constitute a dual-chamber structure, which also falls within the scope of the "multi-chamber" protected by this invention.

[0032] like Figure 1 As shown, the present invention provides a multi-chamber biological detection device with a conductive structure, including a handle 1, a housing 5, a first rod 4, a first storage tube 8, and a reaction tube 12. The lower end of the handle 1 is provided with an insertion hole 3, and the upper end of the first rod 4 is inserted into the insertion hole 3 for a tight fit; alternatively, the first rod 4 and the handle 1 are integrally injection molded. The lower end of the first rod 4 is connected to a first sampling section 6.

[0033] The first sampling section 6 is made of a soft material, specifically selected from one or more of flocking, polyester fiber, or rayon; or it is a rigid structure with the function of accommodating samples, preferably a rigid plastic structure with grooves. Figure 8 In one type of rigid structure shown, the first sampling section 6 and the first rod 4 are integrally formed. The area within the dashed circle is defined as the first sampling section 6, and its annular groove is designed to accommodate and transfer samples when collecting liquid samples. In specific applications, such as when the sample is added directly through a detachable reaction tube (rather than through the rod), the sampling section 6 at the lower end of the rod 4 does not need to perform sample collection. It can be simplified to a blunt end, a flat cross-section (including the natural end face of the rod end), or other non-sampling structure at the lower end of the rod 4, which only needs to have the ability to transmit axial thrust to pierce the sealing membranes. In such cases, this end structure is still literally interpreted as a "sampling section," and its protection range is not limited by whether it actually performs a sampling function.

[0034] Several fastening plates 2 are provided on the lower outer periphery of the handle 1 to form a moderate tight fit with the inner wall of the outer shell 5 and prevent accidental slippage.

[0035] In the general assembly process, the upper and lower ends of the first storage tube 8 are sealed by the first sealing film 7 and the second sealing film 9, respectively, and the reaction tube 12 is sealed by the third sealing film 11. If the first conductive element 10 is provided, the first storage tube 8, the first conductive element 10, and the reaction tube 12 are stacked in sequence; if the first conductive element 10 is not provided, the first storage tube 8 and the reaction tube 12 are stacked vertically. Then, the entire stack is pushed into place from the lower opening of the outer shell 5. The upper outer wall of the first storage tube 8 is tightly fitted and fixed to the inner wall of the outer shell 5; the first conductive element 10 is located between the reaction tube 12 and the first storage tube 8 and is in close contact. If the first conductive element 10 contains an annular protrusion 13, it can enhance the tightness of the fit with the outer shell 5; if it is a flat sheet structure, it is clamped and fixed by the reaction tube 12 and the first storage tube 8; the upper section of the reaction tube 12 is inserted into the outer shell 5 and tightly fitted therewith.

[0036] For different application scenarios, this embodiment provides the following two fixing methods to construct a stable guiding system: Normally, only the top outer wall of the reaction tube 12 needs to be fixed with adhesive at the junction with the inner wall of the outer casing 5. In this case, the upper outer wall of the first storage tube 8 only needs to be tightly fitted with the inner wall of the outer casing 5, and the combination of "tight fitting of storage tube + adhesive application of reaction tube" can withstand the axial thrust during puncture. If the reaction tube 12 is configured as a detachable structure, adhesive needs to be applied at the junction of the upper outer wall of the lowest storage tube (the first storage tube 8 in this embodiment) adjacent to the reaction tube 12 and the inner wall of the outer casing 5, and / or at the junction of the outer edge of the conductive element (the first conductive element 10 in this embodiment) between the lowest storage tube and the reaction tube 12 and the inner wall of the outer casing 5. The upper storage tubes and conductive elements only need to be conventionally tightly fitted or axially abutted, without additional bonding. In this configuration, the reaction tube 12 and the outer casing 5 only need to be fitted tightly. Pulling out the reaction tube 12 will not cause the upper stacked structure to loosen, and the force exerted when the first rod 4 is pushed axially downward will not cause the reaction tube 12 to loosen.

[0037] In particular, the cross-sectional design of the lower section of the first storage tube 8 (adjacent to the second sealing membrane 9) is flexible. Its outer wall can be designed as a smooth cylindrical surface or a non-smooth structure (such as with axial ribs, local protrusions, etc.), and the inner wall can also be designed as a circle or an irregular structure adapted to the sampling part. Regardless of the specific shape, the core purpose of this section design is to create a gap channel for gas discharge by utilizing the non-tight contact between the outer wall of the first storage tube 8 and the inner wall of the outer casing 5.

[0038] Furthermore, when this device is used in scenarios where only reagent mixing or subsequent addition of culture medium is required without the need to collect external samples, the sampling unit 6 can be simplified to any structure at the lower end of the rod 4, which only needs to have the function of transmitting axial thrust to pierce the sealing membrane. Meanwhile, when the reaction tube 12 is not pre-filled with liquid reagents, the sealing membrane at its top can still be retained to maintain cleanliness, and the user can selectively remove it before use, all without departing from the scope of protection of this invention.

[0039] Example 2: Single storage tube external conductive component solution (corresponding to) Figure 1 , Figure 2 ).

[0040] This embodiment adopts an external design, meaning the first conductive element 10 is located outside the first storage tube 8. This external structure expands the opening area, making it specifically designed for storing large-volume reagents (such as lysis buffers and cleaning solutions), ensuring smooth venting and strong splash prevention.

[0041] like Figure 2 The diagram shows two structures for the outer edge of the first conductive element 10: a flat, unprotruding structure on the left and a structure with annular protrusions on the right. Unlike the general structure, this embodiment adds an independent first conductive element 10 between the first storage tube 8 and the reaction tube 12. The first conductive element 10 is independently disposed between the reaction tube 12 and the first storage tube 8, specifically between the second sealing membrane 9 and the third sealing membrane 11.

[0042] like Figure 4 As shown, the groove 15 can be selectively provided at the connection between the petal 21 and the edge of the first conductive element 10, depending on the structural characteristics (e.g., Figure 4-6 As shown). Specifically, for the single-lobe first conductive element 10 ( Figure 4-6 (Right side), due to the wider radial width of its petal 21 connecting section, the recess 15 can utilize the stress concentration effect to reduce the overturning resistance, ensuring that the petal 21 flips down smoothly; while for the six-petal first conductive element 10 ( Figure 4-6 (On the left side), its connecting section is narrow and made of highly flexible material, and the indentation 15 is usually omitted to simplify the mold structure. This principle also applies to the conductive part 14 integrated at the bottom of the first storage tube 8.

[0043] The number and distribution of the petals of the first conductive element 10 can be flexibly adjusted according to the manufacturing process. The figure shows two typical forms: a six-petal structure on the left and a single-petal structure on the right. It should be understood that the number of petals 21 is not limited to the six or single petals shown in the figure; it can also be two, three, or other numbers, as long as it can pierce the sealing membrane. The outer edge of the conductive element can be designed as a ring-shaped structure with annular protrusions 13. The cylindrical surface of the outer edge of this structure is press-fitted with the inner wall of the outer shell 5 to achieve pre-positioning; alternatively, a flat sheet without protrusions can be used, relying on the extrusion of the upper and lower film layers or adhesive application for fixation.

[0044] When in use, press down on the handle 1. The first rod 4 drives the first sampling part 6 to apply a pushing force, first piercing the first sealing membrane 7. Since the first storage tube 8 is tightly fitted with the outer shell 5 and the reaction tube 12 is tightly fitted and fixed with the outer shell 5, the first storage tube 8 and the reaction tube 12 are axially stationary, and only the handle 1 and the first rod 4 undergo axial displacement.

[0045] Subsequently, the first rod 4 drives the first sampling part 6 through the reagent chamber inside the first storage tube 8 and punctures the second sealing membrane 9 at the lower end of the first storage tube 8. The handle 1 continues to press down, and the first rod 4 pushes the first conductive member 10. Under the combined action of the flap 21 of the first conductive member 10 and the first rod 4, the third sealing membrane 11 at the top of the reaction tube 12 is punctured. The flap 21 of the first conductive member 10 bends downward under force, expanding the puncture area of ​​the third sealing membrane 11. The reagent in the first storage tube 8 then flows into the reaction tube 12 along its inner cavity. The gas in the reaction tube 12 is diverted and guided through the annular gap between the outer wall of the first storage tube 8 and the outer shell 5, achieving a smooth buffer for the downward flow of liquid.

[0046] This embodiment employs an external venting method. Its core design lies in constructing a "large-diameter vent + multi-stage buffer" venting structure, specifically designed for storing large-volume, high-flow-rate reagents, completely eliminating the phenomenon of gas-liquid competition for channels. For example... Figure 1 and Figure 2 As shown, the first conductive element 10 is independently disposed between the reaction tube 12 and the first storage tube 8. Unlike the built-in conductive part, which is limited by the inner diameter of the tube opening, the biggest advantage of the external structure lies in its decoupled radial dimension design. Through fluid simulation and experimental verification, the effective break area after the first conductive element 10 is flipped must be greater than the flow area of ​​the tube opening at the lower end of the first storage tube 8; in the preferred embodiment, this break area is further greater than the bottom outer diameter cross-sectional area of ​​the first storage tube 8. This ultra-large break design ensures that the gas has a sufficient escape cross-section when the liquid flows downward.

[0047] More importantly, this solution utilizes a non-tightly fitted gap to construct a multi-stage buffer exhaust system. When the first rod 4 pushes the first conductive element 10 to pierce the third sealing membrane 11, the compressed gas in the reaction tube 12 does not rush directly to the liquid inlet, but preferentially enters the buffer area defined by the "annular gap between the outer wall of the first storage tube 8 and the inner wall of the outer shell 5" and the "fitting gap between the annular protrusion 13 of the first conductive element 10 and the inner wall of the outer shell 5". This buffer area has flow adaptability; that is, for large-volume reagents, the cross-sectional area of ​​the aforementioned fitting gap can be appropriately increased by adjusting the outer diameter of the annular protrusion 13 of the first conductive element 10 or the outer diameter tolerance of the first storage tube 8 to provide a low-resistance exhaust path; for small-volume reagents, the gap can be correspondingly reduced. This adjustable gap design ensures that regardless of changes in liquid load, the gas can be quickly depressurized within the buffer area, avoiding back-pushing of liquid or the formation of a gas-liquid contention channel, ultimately achieving physical isolation and smooth flow of gas and liquid through the annular gap upwards and liquid flowing into the reaction tube 12 through the central channel.

[0048] As a preferred implementation of this solution, the conductive component can also be integrated with the outer casing 5 into a single structure. Given that the outer casing is typically quite long (approximately 10-15 cm), if multiple conductive components are integrally formed with the outer casing, it will lead to an insurmountable assembly deadlock: while the undercut structure within the deep hole can be achieved through forced release, this results in extremely complex molds and prevents parts from being installed. Therefore, in actual mass production, it is strictly limited to allowing only one conductive component to be integrated with the outer casing; the rest must be assembled separately, to balance structural simplification and assembly feasibility.

[0049] With the conductive component integrally formed, the upper-level storage tube and conductive component must be pushed into the assembly from the top opening of the outer shell to ensure a smooth assembly path. The lower storage tube and conductive component are assembled according to the general assembly method of Example 1.

[0050] It should be noted that the various functional additives and their concentration ranges mentioned in this specification are merely exemplary examples from the perspective of improving fluid dynamics and preventing wall adhesion, intended to illustrate how to ensure smooth conduction of reagents in the specific multi-chamber structure described in this invention. The core of this invention lies in the mechanical structure and conduction logic of the device. The complete formulation and precise components of the specific biochemical reaction reagent system (e.g., extractant, specific buffer pairs, stabilizer, and signal enhancer) carried in the storage tube are not considered key points of protection in this invention. Those skilled in the art can optimize the design according to specific detection projects (e.g., ATP detection, immunochromatography, or molecular diagnostics), which does not affect the independent implementation and scope of protection of the structural scheme of this invention.

[0051] Example 3: Single storage tube with built-in conductive section (corresponding to) Figure 3 , Figure 7 , Figure 12 ).

[0052] This implementation employs a built-in approach, where the conductive part 14 is directly integrated into the bottom of the first storage tube 8. This method results in a compact structure, specifically designed for storing trace amounts of reagents, and its high integration improves product assembly efficiency. For example... Figure 3 As shown, in this embodiment, the external first conductive element 10 is eliminated, and instead the conductive part 14 is directly integrated at the bottom of the first storage tube 8.

[0053] In the heat-sealing process of the first storage tube 8, if the conductive part 14 is tightly attached to the bottom of the tube, the high temperature will cause deformation of the bottom opening's heat capacity. Therefore, the conductive part 14 needs to maintain a safe distance of 0.5-1mm from the bottom of the first storage tube 8. The protrusion 16 is mainly used to compensate for insufficient puncture depth caused by this manufacturing error, ensuring sufficient force when puncturing the third sealing film 11. Figure 4 As shown, the number and distribution of the lobes in the conductive section 14 can be flexibly adjusted according to the production process. Figure 7 The diagram shows a six-petal structure. It should be understood that the number of petals 21 is not limited to the six petals or a single petal shown in the diagram; it can also be two petals, three petals, or other numbers, as long as it can achieve the function of piercing the sealing membrane.

[0054] In use, pressing down on handle 1 applies a pushing force to the first rod 4, piercing the first sealing membrane 7. Then, the first rod 4 passes through the reagent chamber inside the first storage tube 8, directly contacting the conductive part 14 at the bottom of the first storage tube 8. The flaps 21 of the conductive part 14 and the first sampling part 6 work together to successively pierce the second sealing membrane 9 at the bottom of the first storage tube 8 and the third sealing membrane 11 at the top of the reaction tube 12. Subsequently, the reagent in the first storage tube 8 flows into the reaction tube 12 along the inner cavity, and the gas is discharged through the fitting gap at the bottom of the first storage tube 8, maintaining unobstructed exhaust.

[0055] Due to the limited internal space occupied by the conductive part 14, the effective capacity of the storage tube of this scheme is relatively small, making it suitable for storing small amounts of reagents. At the same time, the flap 21 of the built-in conductive part 14 exerts a greater squeezing force on the sampling part, which can improve the release rate of the sample on the sampling part.

[0056] like Figure 12As shown, as an extreme working condition extension application of this embodiment 3, although the conductive part 14 is integrated into the bottom of the first storage tube 8, an auxiliary first conductive element 10 can still be selectively added between the first storage tube 8 and the reaction tube 12. In use, the first rod 4 drives the first sampling part 6 to first pierce the first sealing membrane 7. Then, the reagent in the first storage tube 8 is squeezed by the first rod 4, and the petals 21 of the conductive part 14 at its bottom and the first rod 4 work together to pierce the second sealing membrane 9. Subsequently, the petals 21 pressed down by the first rod 4 and the conductive part 14 work together to act on the first conductive element 10, causing its petals 21 to further flip and work together to pierce the third sealing membrane 11 at the top of the reaction tube 12.

[0057] In this application, whether an additional connecting element 10 is provided below the storage tube 8 with the integrated connecting part 14 depends on the physical balance between the cross-sectional area of ​​the flow channel and the venting requirements. If the inner diameter of the storage tube 8 is large, and the remaining cross-sectional area of ​​the flow channel after integrating the connecting part 14 is still greater than or equal to a preset threshold (e.g., 40% of the tube opening area), and the reagent venting requirements are low (e.g., for trace reagents), then the connecting element 10 below can be omitted, and smooth conduction can be achieved using a single-stage membrane rupture. If a large volume of conventional reagent needs to be stored, resulting in a flow channel cross-sectional area less than the preset threshold, or if the venting requirements are high, then an auxiliary connecting element 10 must be added. By using two-stage flaps to expand the rupture area, venting obstruction and back pressure accumulation caused by narrow flow channels are prevented, thereby ensuring the scraping recovery rate while also taking into account the stability of large-flow release.

[0058] It should be noted that the outer edge structure of the first conductive element 10 in this embodiment can refer to that in embodiment 2. Figure 2 As shown, a ring structure with annular protrusions 13 or a flat sheet structure without protrusions can be selected. The fixing method and applicable scenarios have been described in detail in Example 2, and will not be repeated here.

[0059] Example 4: Multi-storage tube built-in and external conduction hybrid scheme (corresponding to) Figure 9 ).

[0060] This embodiment is suitable for high-level detection scenarios that require the stepwise release of multiple reagents or a significant increase in reagent load. For example... Figure 9 As shown, this embodiment provides a dual-storage-tube stacked structure, which includes a reaction tube 12, a first storage tube 8, and a second storage tube 17 from bottom to top. The chambers are axially connected in series through the outer shell 5, and the tubes are axially abutted against each other. They are coaxially fixed by the tight fit between the outer wall of each tube and the inner wall of the outer shell 5.

[0061] This embodiment employs an asymmetric conductive layout of "built-in at the top and external at the bottom," meaning the second storage tube 17 at the top uses a built-in conductive section 14, while the first storage tube 8 at the bottom uses an external conductive section 10. This layout is based on a deep synergistic design of fluid dynamics and sampling efficiency. Since the built-in conductive section 14 is integrated into the bottom of the tube, its flaps 21 inevitably occupy the flow cross-section inside the tube cavity. Simultaneously, the flap structure of the built-in conductive section 14 significantly increases the local resistance coefficient of the fluid. If it were placed at the bottom near the reaction tube 12, the reagent would experience a cumulative pressure drop as it flows through the multi-layer stack, leading to a sudden decrease in flow rate or even obstruction of venting. Therefore, placing the built-in conductive section 14 at the very top of the stack ensures that the fluid undergoes only one contraction-expansion cycle, effectively maintaining low flow resistance characteristics in laminar flow. Simultaneously, the rigid conductive section at the top can also create a strong scraping effect on the first sampling section 6 as the rod descends, significantly improving the elution recovery rate of solid samples, thus achieving an optimal balance between eliminating flow resistance and improving sampling performance.

[0062] In use, press down on handle 1. The first rod 4 drives the first sampling part 6 to pierce the fourth sealing membrane 18, then through the second storage tube 17, press down on the flap 21 of the conductive part 14, and together with the first sampling part 6, continuously pierce the fifth sealing membrane 19 at the bottom of the second storage tube 17 and the first sealing membrane 7 at the top of the first storage tube 8. At this time, the liquid will flow down into the first storage tube 8 and mix with the liquid therein. Continue pressing down, the first rod 4 drives the first sampling part 6 to pierce the second sealing membrane 9, and then pushes the independent first conductive part 10. The flap 21 of the independent first conductive part 10 and the first sampling part 6 together pierce the third sealing membrane 11 at the top of the reaction tube 12. The flap 21 of the first conductive part 10 presses down and expands the rupture area of ​​the third sealing membrane 11; finally, all the reagents in the chambers flow into the reaction tube 12 along the diversion channel formed by the gap between the inner wall of the outer shell 5 and the outer wall of the storage tube, completing the multi-component mixing reaction.

[0063] It should be noted that the outer edge structure of the first conductive element 10 in this embodiment can refer to that in embodiment 2. Figure 2 As shown, a ring structure with annular protrusions 13 or a flat sheet structure without protrusions can be selected. The fixing method and applicable scenarios have been described in detail in Example 2, and will not be repeated here.

[0064] In the general assembly process of multi-storage tube stacking, unlike the method of pushing a single storage tube into the outer shell 5 as a whole in Embodiment 1, this embodiment provides the following two optional assembly paths due to the significant increase in the total stacking height. The first method is bottom-by-bottom pushing: First, push the second storage tube 17 from the bottom of the outer shell 5 to the top, then push in the second conductor 20, the first storage tube 8, and the first conductor 10 in sequence, and finally push the reaction tube 12 into the bottom of the outer shell 5 and tighten it. The second method is top-by-top pushing: First, fix the reaction tube 12 to the bottom of the outer shell 5, then invert the outer shell 5 or keep it vertical, and put in the first conductor 10, the first storage tube 8, the second conductor 20, the second storage tube 17, etc. in sequence from the opening at the top of the outer shell 5. Each component falls by its own weight and is positioned step by step with the outer wall annular protrusion or tight-fitting structure to the inner wall of the outer shell 5. Finally, install the handle 1 and the first rod 4. The two paths can be flexibly selected according to the level of automation of the production line and the tooling configuration, and neither will affect the axial contact relationship between the tubes or the integrity of the sealing film.

[0065] Example 5: Multi-channel external conduction scheme (corresponding to) Figure 10 )

[0066] This embodiment provides a stacked structure of purely external conductive components, designed to simplify mold development and maximize the break area, suitable for the rapid release of high-flow-rate reagents.

[0067] like Figure 10 As shown, this embodiment includes, from bottom to top, a reaction tube 12, a first storage tube 8, and a second storage tube 17. The difference is that this embodiment does not include any storage tubes with integrated conductive parts.

[0068] Specifically, a first conductive element 10 is provided between the reaction tube 12 and the first storage tube 8, and a second conductive element 20 is provided between the first storage tube 8 and the second storage tube 17. Both the first conductive element 10 and the second conductive element 20 adopt an annular structure with annular protrusions 13, and pre-positioning is achieved by interference fit between the outer cylindrical surface and the inner wall of the outer shell 5.

[0069] Pressing down on handle 1 causes the first rod 4 to drive the first sampling part 6 to pierce the fourth sealing membrane 18 and the fifth sealing membrane 19 in sequence. The first rod 4 continues to push the second conductive element 20. The flaps 21 of the second conductive element 20 and the first sampling part 6 work together to pierce the first sealing membrane 7, and the liquid in the second storage tube 17 flows into the first storage tube 8. The first rod 4 continues to push and pierce the second sealing membrane 9, and pushes the first conductive element 10. The flaps 21 of the first conductive element 10 and the first sampling part 6 work together to pierce the third sealing membrane 11, and the flaps 21 of the first conductive element 10 press down to expand the rupture area. Since the interlayer components are all independent external conductive elements, their radial dimensions are not limited by the opening of the storage tube, which can form a very large rupture area. The sealed gas in the reaction tube 12 is discharged upward through the gap between the outer wall of the first storage tube 8 and the second storage tube 17 and the inner wall of the outer shell 5. This fully external layout completely eliminates the loss of liquid storage caused by the space occupied by the built-in conductive parts, and all conductive parts can be produced in a standardized manner, which significantly reduces the manufacturing cost of multi-chamber swabs.

[0070] It should be noted that the outer edge structure of the first conductive element 10 and the second conductive element 20 in this embodiment can refer to that in Embodiment 2. Figure 2 As shown, a ring structure with annular protrusions 13 or a flat sheet structure without protrusions can be selected. The fixing method and applicable scenarios have been described in detail in Example 2, and will not be repeated here.

[0071] Example 6: Multi-storage tube fully integrated conduction scheme (corresponding to) Figure 11 )

[0072] This embodiment provides a stacked structure with purely built-in conductive parts, which aims to maximize device integration, reduce the number of parts, and is suitable for automated assembly lines.

[0073] like Figure 11 As shown, from bottom to top, it includes a reaction tube 12, a first storage tube 8, and a second storage tube 17. The difference is that this embodiment omits the independent external conductive components between layers.

[0074] Specifically, the bottom of the first storage tube 8 and the second storage tube 17 are integrated with a conductive part 14. To avoid deformation of the conductive part due to the heat sealing process, the conductive part 14 is kept at a safe distance of 0.5-1mm from the bottom of the first storage tube 8, and a protrusion 16 is provided at the tip of the petal 21 to compensate for the puncture amplitude.

[0075] In fully integrated designs, the conductive section 14 occupies the flow cross-section inside the tube. As the number of stacked layers increases, the cumulative narrowing effect of the interlayer flow channels significantly increases the resistance to liquid flow. Experiments have shown that for conventional water-based reagents, the number of stacked layers in a fully integrated design should not be too many (generally, no more than two layers are recommended). If three or more fully integrated stacks are necessary, the inner diameters of the storage tubes 8 and 17 must be enlarged accordingly to offset the volume occupied by the conductive section 14, ensuring sufficient fluid channels and venting gaps. Furthermore, the protrusion 16 on the tip of the flap 21 of the conductive section 14 prevents the flap from completely adhering to the membrane surface after flipping, forming a "vacuum suction cup," thus helping to maintain a small venting gap and ensuring that the liquid flows smoothly down by gravity.

[0076] Pressing down the handle 1 causes the first rod 4 to move the first sampling section 6 downwards, first piercing the fourth sealing membrane 18. Then, the first sampling section 6 contacts the conductive section 14 at the bottom of the second storage tube 17. The flaps 21 of the conductive section 14 press down, successively piercing the fifth sealing membrane 19 and the first sealing membrane 7 at the top of the first storage tube 8. Subsequently, the first rod 4 continues to move downwards to the conductive section 14, where the flaps 21 press down, piercing the second sealing membrane 9 and the third sealing membrane 11, ultimately allowing the liquid to flow into the reaction tube 12. This fully integrated design eliminates the assembly process of the intermediate conductive component, minimizing assembly steps. Furthermore, the conductive section exerts a greater scraping force on the sampling section, effectively improving the recovery rate of solid samples.

[0077] Examples 4-6 use two storage tubes stacked as an example. In practical applications, the number of stacked tubes can be expanded to any number greater than or equal to two, such as three or four storage tubes. The rules are exactly the same as described above. Only the axial rigidity of the rod needs to be increased synchronously with the number of stacked layers, and the handle length needs to be increased to ensure that the rod can pierce the sealing membrane at the opening of the reaction tube. However, due to the ergonomic grip limit of the handle and manufacturing assembly tolerances, the handle length cannot be extended indefinitely, resulting in a theoretical upper limit to the number of stacked layers. Nevertheless, for mainstream complex detections such as immunochromatography, multiplex PCR, or cell culture, it is usually only necessary to independently store 3 to 5 components such as lysis buffer, washing buffer, enzyme label, and chromogenic substrate. The stacking capability of this solution is sufficient to cover most application scenarios.

[0078] Example 7: Adapter solution for separating sampling and mixing functions (corresponding to) Figure 13 )

[0079] This embodiment provides a detection device structure that physically separates the sample collection function from the reagent mixing function, and is particularly suitable for scenarios involving stepwise release of multiple reagents, collection of high-viscosity samples, or time-separated sampling and detection.

[0080] like Figure 13As shown, in this embodiment, an adapter 30 is added between the reaction tube 12 and the outer casing 5. The outer wall of the adapter 30 has a first mating section 31 and a second mating section 32 arranged sequentially from top to bottom. The first mating section 31 is tightly fitted and fixed to the inner wall of the outer casing 5, and the second mating section 32 mates with the top inner wall of the reaction tube 12. A central guide hole 33 is provided within the second mating section 32. The upper end of the second rod 41 is inserted and fixed within the central guide hole 33, and the lower end of the second rod 41 has a second sampling section 22.

[0081] A first conductive element 10 is provided between the storage tube 8 and the adapter 30. Since no sealing membrane is provided above the adapter 30, the conductive element 10 does not need to perform a puncture function at this location. Its main function is to isolate the second sealing membrane 9 at the bottom of the storage tube 8 from the upper end face of the adapter 30, preventing the second sealing membrane 9 from being accidentally damaged due to direct contact and friction with the adapter 30 during assembly or transportation. The outer edge of the conductive element 10 can be radially positioned by an interference fit between the annular protrusion 13 and the inner wall of the outer casing 5, or by adhesive bonding. The axial support of the storage tube 8 is provided independently by the tight fit or adhesive bonding between its upper outer wall and the inner wall of the outer casing 5. The conductive element 10 does not bear the axial support function of the storage tube 8.

[0082] Unlike embodiments 1 to 6, in this embodiment, the upper first rod 4 and its first sampling section 6 no longer perform sample collection functions, but instead focus on transmitting axial thrust to pierce the sealing membranes and assist in reagent mixing. Specifically, the lower end of the first rod 4 can be simplified to a blunt end, a flat cross-section, or a piercing column structure, only needing the ability to pierce the sealing membrane; even if the shape of the first sampling section 6 is retained, it is only used as a pushing component in this embodiment and does not perform sample collection tasks from the external environment. To maintain consistency in the reference numerals of the various embodiments, Figure 13 The end structure at the lower end of the first rod 4 is still indicated by reference numeral '6' in the attached drawing. However, it should be understood that the specific shape of this end structure can be set to a blunt head, a piercing post, or retain the shape of the sampling head without performing the sampling function, depending on the actual use requirements. All of these fall within the equivalent scope of the first sampling part 6 of the present invention.

[0083] The actual sample collection function is transferred to the second sampling section 22 located at the lower end of the second rod 41 inside the reaction tube 12. In use, the reaction tube 12 can be pulled out from the lower end of the outer shell 5 first, and the second sampling section 22 can be used to directly dip into or wipe the sample to be tested, such as semi-solid secretions, high-viscosity biological samples, etc. Then the reaction tube 12 can be reinserted into the lower end of the outer shell 5 to complete the combination of sampling and device.

[0084] This "upper mixing, lower sampling" functional separation architecture has the following significant technical effects. First, it avoids contamination of the storage tube wall by high-viscosity samples. When there are many storage tubes, such as two or more, or when the sample is semi-solid or high-viscosity human secretions, if the sample is passed through the storage tube with the first rod in the traditional way, the sample is very likely to stick to the inner wall of the storage tube or the edge of the sealing membrane, resulting in sample loss, cross-contamination, or increased puncture resistance. In this embodiment, the sample is placed directly in the reaction tube 12, and the sample does not need to pass through any storage tube above, completely eliminating the risk of wall-attachment loss and contamination. Second, it optimizes the fluid path and venting. The central guide hole 33 of the adapter 30 is connected to the hollow flow channel of the second rod 41. After the first rod 4 punctures each layer of sealing membrane, the reagent in the storage tube flows through the adapter 30 and into the reaction tube 12, mixing with the sample pre-placed in the reaction tube. The second rod 41 adopts a hollow design and has a liquid outlet hole 34 on the side wall, from which liquid can flow out and evenly wet the second sampling section 22. Third, assembly flexibility and compatibility: In this embodiment, the adapter 30 is tightly fitted and fixed to the outer casing 5, and the reaction tube 12 is detachable. When the sampling function is not required, the second sampling part 22 at the lower end of the second rod 41 can be replaced with a blunt tip without sampling capability or omitted entirely, retaining only the guide rod. This allows the same set of molds to produce both sampling and non-sampling product variants, significantly reducing production costs.

[0085] During operation, the reaction tube 12 is pulled out, the sample is collected by the second sampling section 22, and then inserted back in; the handle 1 is pressed down, and the first rod 4 punctures the first sealing membrane 7, the second sealing membrane 9, etc. in sequence. The sample flows into the reaction tube 12 through the adapter 30 and mixes with the sample.

[0086] It should be noted that in this embodiment, no additional sealing membrane is provided above the adapter 30; the second sealing membrane 9 at the lower end of the storage tube 8 already serves as the isolation membrane. The introduction of the adapter 30 does not increase the number of puncture layers, maintaining operational continuity. Through the above design, this embodiment decouples the two actions of "sampling" and "reagent mixing," significantly expanding the application boundaries of the detection device, especially suitable for complex scenarios such as multi-sample testing, high-viscosity samples, and time-sharing operations, while maintaining complete compatibility with the aforementioned embodiments in terms of conductive structure and venting logic.

[0087] As a preferred alternative to this embodiment, when the top of the reaction tube 12 is not sealed, the conductive part between the storage tube 8 and the adapter 30 can be omitted. Figure 14As shown, the outer diameter D1 of the bottom end of the storage tube 8 is set to be greater than the inner diameter D2 of the upper end of the adapter 30, and less than the outer diameter D3 of the upper end of the adapter 30. During assembly, the lower end face of the storage tube 8 directly abuts axially against the upper end face of the adapter 30, providing stable support through end-face contact. The upper outer wall of the storage tube 8 remains tightly fitted and fixed to the inner wall of the outer casing 5, ensuring that the storage tube 8 does not undergo axial displacement during puncture. At the same time, since D1 > D2, an annular gap is naturally formed between the lower outer wall of the storage tube 8 and the inner wall of the adapter 30, providing a smooth exhaust channel for the gas in the reaction tube 12. This solution completely eliminates the need for a connecting component, further simplifying the number of parts and assembly process, while improving the axial support stability of the storage tube through rigid end-face contact. Figure 14 The remaining unmentioned structures and operating methods are all related to Figure 13 The scheme shown is the same.

[0088] When the adapter 30 is integrally formed with the outer shell 5, the "upper end surface of the adapter" should be understood as the supporting surface on the inner wall of the outer shell 5 for receiving the lower end surface of the storage tube 8. The supporting surface can be a continuous annular surface or a raised top surface spaced along the circumference.

[0089] Example 8: Top Auxiliary Conductor Solution (corresponding to) Figure 15 )

[0090] This embodiment addresses the special case where the sealing film at the top of the uppermost storage tube is made of a non-punctureable material (such as PET composite film), and provides an auxiliary puncture solution using a pre-installed top conductive element. In the multi-storage tube stacked structure of embodiments 4 to 6, if the top sealing film (such as the fourth sealing film 18) of the uppermost storage tube (such as the second storage tube 17) is replaced with a non-punctureable composite film from easily puncturable aluminum foil, the reliability of direct puncture of the soft sampling section 6 will significantly decrease. Therefore, this embodiment adds an independent top conductive element 10 above the top sealing film of the uppermost storage tube, and by changing the puncture action from "direct puncture by the soft sampling section" to "rigid flap shearing", the reliability and consistency of the puncture are ensured.

[0091] like Figure 15 As shown, from bottom to top, the components are a reaction tube 12, a first conductive element 10, a first storage tube 8, and a second conductive element 20. The top of the first storage tube 8 is sealed with a first sealing film 7, and the top second conductive element 20 is disposed above the first sealing film 7. The structure of the first conductive element 10 and the second conductive element 20 is consistent with the aforementioned conductive elements, having at least one petal 21. The connection between the petal 21 and the edge can be provided with a groove 15 as needed, and the outer edge can adopt a ring-shaped structure with an annular protrusion 13 or a flat plate structure. Figure 15The first conductive element 10 and the second conductive element 20 are structures with annular protrusions, but in practical applications, they can also be flat sheet structures. The top second conductive element 20 is located between the first sampling section 6 and the first sealing membrane 7. During assembly, the top second conductive element 20 is first inserted from the top of the outer shell 5 and pushed onto the upper surface of the first sealing membrane 7. Alternatively, the top second conductive element 20 can be placed on top of the first storage tube 8 and pushed into place from the bottom of the outer shell 5 together with the first storage tube 8. The outer edge of the top second conductive element 20 is pre-positioned by an interference fit between the annular protrusion 13 and the inner wall of the outer shell 5, or it can be fixed with adhesive to the top edge of the lower storage tube using a flat sheet structure.

[0092] In use, pressing down on handle 1 causes the first rod 4 to move the first sampling part 6 downwards, initially contacting the upper surface of the top second conductive element 20. The axial thrust of the first rod 4 causes the petals 21 of the top second conductive element 20 to flip over, with the sharp edge of the petal 21 piercing the first sealing membrane 7, forming an initial rupture. As the petal 21 continues to flip downwards, the rupture area expands, and the first sampling part 6 then smoothly passes through the ruptured first sealing membrane 7 into the first storage tube 8. The logic for subsequently piercing the second sealing membrane 9 and the third sealing membrane 11 is completely consistent with embodiments 1, 2, or 3, and will not be repeated here. The gas in the reaction tube 12 still escapes upwards through the non-tightly fitted gap between the lower outer wall of the first storage tube 8 and the inner wall of the outer shell 5.

[0093] In addition, the top second conductor 20 of the single storage tube structure is also applicable to the multi-storage tube stacking scenario. When the top sealing film of the storage tube located at the top of the multi-storage tube is a puncture-resistant composite film, it is only necessary to add a top second conductor 20 at the top of the top storage tube, and the conduction logic between each storage tube remains unchanged.

[0094] In summary, this invention significantly improves the product's adaptability to various scenarios by providing external conductive components, internal conductive parts, or a combination thereof. The external conductive component solution utilizes an independently designed external conductive component to create a larger opening area, completely eliminating liquid splashing. The internal solution offers high integration and simple assembly, while its flap structure provides greater scraping capability for solids, meeting specific sampling and recovery needs. Furthermore, storage tubes and conductive components can be stacked to achieve multi-chamber storage. In multi-chamber storage, the liquid conduction method in the storage tube can be flexibly adjusted according to injection molding production costs. Pure external or pure internal conductive components reduce the types and costs of assembled parts, while the hybrid "internal + external" layout can adapt to different throughputs and meet a full range of detection needs, from simple to complex, greatly expanding the product's application boundaries.

[0095] Regarding the configuration of sampling and mixing functions, this invention offers several flexible architectures. In the basic scheme, the sampling section at the lower end of the rod performs the sample collection function, while the rod also serves as a conductive thrust transmission component. In the preferred scheme, which adds an adapter and a second rod, the sampling function is transferred to the second sampling section at the lower end of the second rod inside the reaction tube, while the upper first rod focuses on transmitting axial thrust to pierce each layer of sealing membrane, achieving physical separation of sampling and mixing functions. This architecture is particularly suitable for scenarios involving multi-reagent stepwise release, high-viscosity sample collection, or time-separated sampling and detection, eliminating the need for samples to pass through any storage tubes above, thus completely eliminating the risk of wall adhesion loss and cross-contamination.

[0096] The above description is merely a preferred embodiment of the present invention and is not intended to limit the scope of protection of the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention. The embodiments in this specification are only used to explain the present invention and do not constitute a limitation on the scope of protection of the present invention. Those skilled in the art should understand that modifications can still be made to the specific embodiments of the present invention or equivalent substitutions can be made to some technical features without departing from the spirit and scope of the technical solution of the present invention, and all such modifications and substitutions should be covered within the scope of protection of the present invention.

Claims

1. A multi-chamber biological detection device containing a conductive structure, characterized in that, include: The device comprises a handle (1), a housing (5), at least one storage tube, a reaction tube (12), a rod (4), a sampling section (6), and a conductive structure; the conductive structure includes any one or a combination thereof: a conductive element or a conductive section (14) integrated into the bottom of the storage tube. The at least one storage tube and the reaction tube (12) are connected in series along the axial direction of the outer shell (5), and the two adjacent components are axially abutted; the upper and lower ends of each storage tube are sealed by a sealing film, and the top end of the reaction tube (12) is provided with a sealing film or is not provided with a sealing film. For any of the aforementioned storage tubes, its connection relationship with the adjacent component below satisfies the following condition: a) If the storage tube does not integrate the conductive part (14), then: (i) When the lower adjacent component of the storage tube has a sealing membrane, a conductive element is provided between the storage tube and the lower adjacent component; (ii) When the lower adjacent component of the storage tube does not have a sealing film, no conductive element is provided between the storage tube and the lower adjacent component, or a conductive element is provided; wherein, when no conductive element is provided, the lower end face of the storage tube directly abuts axially against the upper end face of the lower adjacent component; when a conductive element is provided, the conductive element is located between the storage tube and the lower adjacent component. b) If the storage tube integrates a conductive part (14), then no conductive part is provided between the storage tube and the adjacent component below, or a conductive part is provided; The top outer wall of the storage tube and the top outer wall of the reaction tube (12) are both tightly fitted and fixed to the inner wall of the outer shell (5); The lower outer wall of the at least one storage tube has a non-tight fit gap with the inner wall of the outer casing (5) to form a gas discharge channel.

2. The biological detection device according to claim 1, characterized in that, The conductive member has at least one flap (21), which is configured to flip when subjected to axial thrust to increase the opening area of ​​the lower sealing membrane; optionally, the flap (21) is provided with a groove (15) at the connection with the edge; the conductive part (14) has at least one flap (21), which is configured to flip when subjected to axial thrust to increase the opening area of ​​the lower sealing membrane, and the tip of the flap (21) is provided with a protrusion (16); optionally, the flap (21) of the conductive part (14) is provided with a groove (15) at the connection with the edge.

3. The biological detection device according to claim 1, characterized in that, The dimensions of the non-tight fit gap are configured to match the liquid volume within the storage tube to provide an appropriate venting flow.

4. The biological detection device according to claim 1, characterized in that, The number of storage tubes is two or more; each storage tube adopts any one of the following: a hybrid conductive layout, a fully external conductive layout, or a fully internal conductive layout; The hybrid conductive layout refers to at least one storage tube having a conductive part (14) integrated at the bottom and at least one other storage tube having a conductive element below it; The fully external conductive layout means that all storage tubes are connected to the adjacent components below by the conductive element; The fully built-in conductive layout means that the conductive part (14) is integrated at the bottom of all storage tubes.

5. The biological detection device according to claim 1, characterized in that, It also includes an adapter (30), which is located between the lowest storage tube and the reaction tube (12); the upper end face of the adapter (30) axially abuts against the lower end face of the storage tube, and the lower end of the adapter (30) is engaged with the reaction tube (12); the reaction tube (12) and the adapter (30) are detachably and tightly fitted; the adapter (30) and the outer shell (5) are fixed by bonding, tight fitting or integral molding.

6. The biological detection device according to claim 5, characterized in that, The adapter (30) is provided with a central guide hole (33), and a second rod (41) extending downward is fixed in the central guide hole (33). The lower end of the second rod (41) is provided with a second sampling part (22). The second sampling part (22) is made of soft material or hard plastic structure. The soft material is selected from one or more of flocking, polyester fiber or rayon. The hard plastic structure is a hard plastic structure with grooves.

7. The biological detection device according to claim 5, characterized in that, When no conductive part is provided between the lowermost storage tube and the adapter (30), the outer diameter of the bottom end of the lowermost storage tube is greater than the inner diameter of the upper end of the adapter (30) and less than the outer diameter of the upper end of the adapter (30), so that the lower end face of the lowermost storage tube axially abuts against the upper end face of the adapter (30), and at the same time forms an annular exhaust gap.

8. The biological detection device according to claim 1, characterized in that, One of the conductive components is integrally formed with the outer shell (5), while the remaining conductive components are independent assembly parts.

9. The biological detection device according to claim 1, characterized in that, The sampling unit (6) can be any of the following forms: (a) A soft material, wherein the soft material is selected from one or more of flocking, polyester fiber or rayon; (b) A rigid plastic structure with grooves; (c) The blunt end, flat section or piercing column structure at the lower end of the rod (4), which is still literally interpreted as the sampling part (6), and its protection range is not limited by whether the sampling function is actually performed.

10. The biological detection device according to claim 1, characterized in that, When the top sealing film of the uppermost storage tube is made of a non-punctureable material, a top guide is provided above the top sealing film; the top guide has at least one flap (21), which is configured to flip over to puncture the lower sealing film when subjected to axial thrust; the outer edge of the top guide is pre-positioned by an annular protrusion (13) and the inner wall of the outer shell (5) through interference fit, or is fixed with the top edge of the lower storage tube by adhesive in a flat sheet structure.

11. A method for biological detection using the apparatus according to any one of claims 1 to 10, characterized in that, Includes the following steps: S1. Assembly and Fixing: Connect the reaction tube (12) and at least one storage tube in series along the axial direction, and construct a statically fixed chamber structure by using the tight fit between the outer wall of the top of each tube and the inner wall of the outer shell (5); S2. Sample introduction: The sample to be tested is introduced into the reaction tube (12) by any of the following methods: (a) After collecting a sample using the sampling part (6) at the lower end of the rod (4), insert the rod (4) into the outer shell (5); (b) When the device further includes a second rod (41) and a second sampling section (22), the reaction tube (12) is pulled out from the lower end of the outer shell (5), and after the sample is collected by the second sampling section (22), the reaction tube (12) is reinserted into the lower end of the outer shell (5); (c) When the sampling section (6) at the lower end of the rod (4) is simplified to a non-sampling structure, the sample to be tested is added to the removed reaction tube (12) by means of a pipetting device, and then the reaction tube (12) is inserted back into the lower end of the outer shell (5); S3. Layered conduction: Press down on the rod (4) and use the axial thrust of the rod (4) to puncture each layer of sealing film in sequence, so that the reagent in the storage tube is released and flows downward; S4. Mixing and detection: After the reagent is mixed with the sample in the reaction tube (12), the detection is performed; during the puncture process, the compressed gas in the reaction tube (12) is discharged upward through the non-tight fit gap between the lower section of the storage tube and the inner wall of the outer shell (5), and the liquid flows downward into the reaction tube (12) by gravity, thus realizing the physical isolation and smooth flow of the gas-liquid path.

12. The method according to claim 11, characterized in that, In step S3, the logic of the layered conduction includes: if the storage tube does not integrate a conduction part (14), when the lower adjacent component of the storage tube is another storage tube or reaction tube (12), a conduction part is provided between the storage tube and the lower adjacent component, and the flaps (21) of the conduction part are used to flip and expand the opening area; when the lower adjacent component of the storage tube is a connector (30), a conduction part is provided between the storage tube and the connector (30) to provide axial support and radial positioning, or no conduction part is provided and the lower end face of the storage tube directly axially abuts against the upper end face of the connector (30); if the storage tube integrates a conduction part (14), no conduction part is provided between the storage tube and the lower adjacent component, or a conduction part is provided.

13. The method according to claim 11, characterized in that, When the device includes a connector (30) and no conductive part is provided between the lowermost storage tube and the connector (30), the lower end face of the storage tube directly abuts the upper end face of the connector (30) axially, and the gas in the reaction tube (12) is discharged upward through the annular gap between the outer wall of the bottom end of the storage tube and the inner wall of the connector (30).

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