Medical automation module, amplification system preparation module and sample treatment system

By setting up an automated transmission channel and negative pressure generator in the medical automation module, combining the staggered flow structure and module partition design, cross-contamination and complex flow problems in existing molecular diagnostic equipment are solved, and efficient and stable large batch sample processing and detection.

CN119144436APending Publication Date: 2024-12-17XIAN TIANLONG SCI & TECH +1
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Patent Information

Application Number
CN202411248110.X
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-09-06
Publication Date
2024-12-17

AI Technical Summary

Technical Problem

Existing batch molecular diagnostic equipment has problems such as huge size, complex modular design, many interactive ports, complex flow of reagents and consumables and detection objects, and the risk of pollution during flow, which leads to difficulty in expanding the detection project and the stability and reliability of the detection results. It is less capable and difficult to achieve a general design of detection equipment, and cannot effectively reduce the risk of cross-contamination.

Method used

Design a medical automation module with built-in automatic transmission channel with independent negative pressure, transporting the transfer object to other modules through the automated transmission channel, achieving isolation between the transfer object and the module functional area, and forming interlaced flow with the first and second negative pressure generating parts The flow field structure reduces the risk of pollution and ensures module independence through module partitions and interlocking designs.

Benefits of technology

Minimize the risk of cross-contamination, improve biological sample processing capabilities, meet the needs of large-scale sample processing, simplify the transmission process, improve detection efficiency, and ensure the stability and reliability of the detection results.

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Abstract

The invention discloses a medical automation module, an amplification system preparation module and a sample treatment system, and relates to the technical field of low-pollution-risk automatic medical examination, and provides the medical automation module, the amplification system preparation module and the sample treatment system. An automatic conveying channel with independent negative pressure is arranged in the medical automation module, and the conveyed objects are conveyed to other medical automation modules through the automatic conveying channel or the conveyed objects conveyed from other modules are collected through the automatic conveying channel. Therefore, the isolation between the transferred object and other functional areas or storage positions of the medical automation module is realized, which is similar to one-way transfer window transfer between traditional modularized laboratories, and the risk of cross contamination is reduced to the greatest extent. In addition, a first negative pressure generation part is arranged in the medical automation module, the automatic transmission channel is connected with a second negative pressure generation part, the first negative pressure generation part and the second negative pressure generation part are matched with each other for space purification, and the pollution risk is further reduced.
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Description

Technical Field

[0001] The present invention relates to the technical field of automated medical testing with low contamination risk, and belongs to optimized and improved medical devices or equipment, and specifically to a medical automation module, an amplification system preparation module and a sample processing system. Background Art

[0002] The development of modern biology has provided important guarantees for human health, greatly increased the average life expectancy of humans, and achieved remarkable results in the fields of animal husbandry and breeding. This includes the basic technologies of biology: gene recombination technology, extracting specific genetic information from organisms and inserting it into the genes of fast-growing microorganisms (such as Colon Bacillus); cell fusion technology, which is often used in the development of monoclonal antibodies and vaccine preparation; large-scale culture technology, which is used for the industrial preparation of antibody drugs; bioreactor technology, which uses biocatalysts to provide a good reaction environment for cell culture; molecular diagnostic technology with specific genetic material as the detection object, etc. Among them, the operation objects of molecular diagnosis and gene recombination technology are nucleic acid fragments, so their processing operations are relatively complicated. For molecular diagnosis, the traditional molecular diagnosis sample processing scheme divides the entire process into multiple physically isolated areas, and realizes the full process quantitative processing from sample processing, extraction, amplification, and result output with the participation of a large number of people. This scheme has problems such as high probability of human subjective interpretation errors and high risk of operator contamination and infection. In addition, taking nucleic acid fragment amplification technologies such as polymerase chain reaction as an example, the target fragment grows exponentially in multiple amplification cycles. The existence of such a long process and contamination risks may lead to competitive amplification of unwanted by-products, significantly reducing the efficiency and specificity of the entire reaction. At the same time, the contamination risk may also lead to false positive conclusions.

[0003] Therefore, compared with other types of biological tests, molecular diagnostic equipment may have a higher risk of cross-contamination, which also restricts the industry's development of integrated batch automated sample processing systems. Currently, only foreign giants have relatively stable automated equipment, and domestic manufacturers have adopted more strategies to increase processing space to reduce contamination risks, and rarely develop highly integrated molecular diagnostic equipment. Among foreign equipment, Roche's Cobas8000 molecular diagnostic system is the most classic system. In recent years, with the expansion of molecular diagnostic testing projects, more and more diseases can be diagnosed and treated as early as possible through molecular diagnostic solutions. Domestic large hospitals such as tertiary and secondary hospitals have an increasingly strong demand for integrated and batch processing of molecular diagnostic projects. To maximize the application scenarios of molecular diagnostic systems, it is necessary to rely on the underlying layout and structural design foundation of the system, and the primary consideration is to minimize the risk of contamination.

[0004] The patent with publication number CN112694970A discloses an amplification detection device that is more inclined to integration. On the one hand, this system has the problem of complex overall transportation, and on the other hand, the sample processing, extraction and amplification chambers are basically shared, making it difficult to achieve stable and continuous detection of epidemic diseases and projects with high transmission risks; the solution disclosed in the patent with publication number CN111902213A separates the sample tube cover and subsequent sample transfer processing and extraction amplification modules. Although it can reduce the contamination risk to a certain extent, the overall cross-contamination risk is still relatively large, and the transportation of the instrument also has certain problems; the solution disclosed in the patent with publication number US20210011039A1 independently configures different functional units into multiple medical automation modules. The size of each medical automation module is not too large, thus solving the problem of transportation and can be flexibly assembled on site, but from the perspective of the solution, how many openings are opened between each module? There are interactive ports for different samples or reagents, and there are many types of interactive ports. Therefore, the flow design of various consumables and reagents in the detection system is relatively complicated, and the large number of interactive ports between modules makes the risk of cross contamination between modules also high. Correspondingly, the structural design to reduce the risk of cross contamination is relatively difficult; some patents submitted by other domestic manufacturers also disclose integrated molecular detection equipment, but the overall design mostly follows the overall layout design similar to Antu. For example, the solution disclosed in the patent with publication number CN212894763U adopts a pre-packaged type test kit or a small bottle reagent configuration, which cannot continuously batch process samples and is applicable to relatively few detection objects. The solution disclosed in the patent with publication number CN112300911A arranges large-volume reagents and extraction and amplification modules in parallel. Although it can increase the sample processing capacity to a certain extent, the space occupied by the whole machine will be very large, and there are difficulties in modular disassembly, transportation and installation.

[0005] From the above analysis, it can be seen that the current batch molecular diagnostic equipment has problems such as huge size, complex modular design, multiple interactive ports, complex circulation of reagents, consumables and test objects, and the risk of contamination during circulation, which makes it difficult to expand the test items and the stability and reliability of the test results are low. Various companies are trying to design diagnostic equipment and systems with greater processing capabilities and basically no human participation in the test process. However, the actual situation is that there are more and more molecular diagnostic test items. Infectious diseases and non-infectious diseases are tested using the same system. There is a risk of cross-contamination caused by factors such as aerosols. It is difficult to achieve the universal design of the test equipment. The universal platform design that is compatible with more test items needs to be planned and laid out early from the aspects of structural layout, etc., to minimize or even eliminate the possible contamination risks. At present, there are few mature batch molecular diagnostic platforms. The processing of hundreds or even thousands of daily samples still requires a lot of reliance on labor. However, this is completely inconsistent with the concept of developing high-quality medical equipment in my country. Therefore, it is urgent to design a processing module or even an automated sample processing system with simple transmission and low cross-contamination risk. Summary of the invention

[0006] The purpose of the present invention is: In view of the above-mentioned problems, the present invention provides a medical automation module and a sample processing system, in which an automated transmission channel with independent negative pressure is set in the medical automation module, and the transfer objects are transported to other medical automation modules through the automated transmission channel or collected from other modules through the automated transmission channel. This achieves the isolation of the transfer objects from other functional areas or storage locations of the medical automation module, which is similar to the one-way transfer window transfer between traditional modular laboratories, and minimizes the risk of cross contamination. In addition, a first negative pressure generating part is configured in the medical automation module, and the automated transmission channel is connected to the second negative pressure generating part. The first negative pressure generating part and the second negative pressure generating part cooperate with each other to purify the space, further reducing the risk of contamination.

[0007] The technical solution adopted by the present invention is as follows:

[0008] A medical automation module comprises a module shell, wherein a first negative pressure generating part, a second negative pressure generating part, an automated transmission channel and an operating part are arranged in the module shell, wherein the automated transmission channel is fluidically connected to the second negative pressure generating part, wherein the first negative pressure generating part can act on the module shell to generate a first negative pressure, wherein the second negative pressure generating part can act on the automated transmission channel to generate a second negative pressure in the automated transmission channel, wherein the first negative pressure and the second negative pressure are independent of each other; wherein at least one of the two ends of the automated transmission channel along the Y-axis direction is provided with a transmission interaction port for matching other medical automation modules, wherein the transmission interaction port passes through the module shell, wherein the transmission interaction port can receive or transmit a transfer object, wherein a transfer port is arranged on a non-through side of the automated transmission channel, wherein a transmission partition door for opening and closing the transfer port is arranged at the transfer port, wherein the operating part can act on the transfer object and drive the transfer object to move, wherein the operating part can enter and exit the automated transmission channel through the opened transmission partition door, wherein the automated transmission channel can be relatively closed to the module shell through the closing of the transmission partition door.

[0009] Furthermore, the first negative pressure can drive a longitudinal airflow flowing from bottom to top, and the second negative pressure can drive a transverse airflow whose flow direction matches the Y-axis direction.

[0010] Furthermore, the automated transmission channel is arranged along the Y-axis direction of the module housing, and a negative pressure port is provided at the side wall end of the automated transmission channel arranged along the Y-axis direction. The negative pressure port is fluidically connected to a second negative pressure generating part through a transmission pipeline, and the transfer port is spaced apart from the negative pressure port in the Y-axis direction.

[0011] Furthermore, the automated transmission channel is provided with a transmission object driving component capable of driving the transmission object to move relative to the automated transmission channel.

[0012] Furthermore, the transfer object driving assembly includes a transmission substrate, a blocking part and a transmission belt assembly; the transmission belt assembly includes a pair of transmission belts and a transmission belt driving device, the pair of transmission belts are arranged at both ends of the transmission substrate along the X-axis direction, and the transmission belt driving device can drive the transmission belt to rotate and drive the transfer object received on the transmission belt to move along the Y-axis direction; the blocking part can be raised and lowered and connected to the transmission substrate, when the blocking part is raised, it can limit the displacement of the transfer object on the transmission belt, and when the blocking part is lowered, the displacement restriction on the transfer object can be released.

[0013] Furthermore, the automated transport channel also includes a detection unit for detecting the state of the transferred object and / or for controlling the operation of the conveyor belt.

[0014] An amplification system preparation module uses the above-mentioned medical automation module, the module shell includes an operation area located at the top, a preparation area located in the middle and a processing area located at the bottom, the operation part is arranged in the operation area, the operation part includes a transfer unit that can be detachably connected to a target object and drive the target object to move, and a pipetting unit that can perform pipetting operations; the automated transmission channel is arranged in the preparation area, the preparation area also includes an amplification system preparation module and a consumables storage position; a consumables lifting assembly is arranged between the processing area and the consumables storage position, and the processing area is provided with a consumables recovery assembly that can recycle consumables.

[0015] Furthermore, the consumables recovery component includes a reagent kit recovery tray, a suction cup unit, a consumables clamp and a heat-sealing film assembly, the consumables clamp can match with the reagent kit and move the reagent kit, the suction cup unit can transfer the film to be packaged, the reagent kit covered with the film to be packaged can be heat-sealed in the heat-sealing film assembly, and the reagent kit recovery tray can accommodate the reagent kit with the heat-sealed film.

[0016] A sample processing system comprises a plurality of the above-mentioned medical automation modules, wherein a medical automation module equipped with a sample extraction component forms an extraction module, a medical automation module equipped with a sample amplification system preparation component forms an amplification system preparation module, and a medical automation module equipped with a sample amplification detection component forms an amplification detection module; it also comprises an instant extraction kit configuration module equipped with an extraction kit preparation component; a plurality of instant extraction kit configuration modules are connected in series through an automated transmission channel to form an instant extraction kit configuration unit, a plurality of extraction modules are connected in series through an automated transmission channel to form an extraction unit, a plurality of amplification system preparation modules are connected in series through an automated transmission channel to form an amplification system preparation unit, and a plurality of amplification detection modules are connected in series through an automated transmission channel to form an amplification detection unit, wherein the instant extraction kit configuration unit, the extraction unit, the amplification system preparation unit, and the amplification detection unit are connected in series through the automated transmission channel in sequence.

[0017] Furthermore, a module partition door is provided between two adjacent automated transmission channels; the first negative pressure generated by the first negative pressure generating part of the amplification detection module is the lowest; and the second negative pressure generated by the second negative pressure generating parts of all medical automation modules is consistent in magnitude.

[0018] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are:

[0019] 1. The present invention sets up an automated transmission channel with independent negative pressure in the medical automation module, and transports the transfer objects to other medical automation modules through the automated transmission channel or collects the transfer objects transported from other modules through the automated transmission channel, thereby isolating the transfer objects from other functional areas or storage locations of the medical automation module and minimizing the risk of cross contamination.

[0020] 2. The first negative pressure generating part of the present invention generates a longitudinal airflow for the medical automation module, and the second negative pressure generating part generates a transverse airflow for the automated transmission channel, thereby forming a flow field structure with staggered flow. Even when the automated transmission channel is partially open, the flow fields in the medical automation module and the automated transmission channel are less affected. The first negative pressure and the second negative pressure cooperate with each other to purify the space, further reducing the risk of contamination.

[0021] 3. The medical automation modules with different functions of the present invention can be connected through the automated transmission channels in each module, so that the transferred objects can flow between the medical automation modules with different functions, which can ensure that consumables and samples can be added in a centralized manner and improve processing efficiency.

[0022] 4. The module partition doors and interlocking design provided between adjacent medical automation modules of the present invention ensure the independence of each medical automation module and further reduce the risk of contamination.

[0023] 5. The present invention can improve the biological sample processing capacity and meet the needs of large-scale sample processing through effectively configured medical automation modules and negative pressure systems. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 It is a schematic diagram of the structure of the amplification system preparation module based on the medical automation module design of the present invention;

[0025] Figure 2 It is a schematic diagram of the airflow direction in the medical automation module of the present invention;

[0026] Figure 3 It is a schematic diagram of the structure of the automated transmission channel of the present invention;

[0027] Figure 4 is a schematic structural diagram of the transmission door assembly of the present invention in a closed state;

[0028] Figure 5 is a schematic structural diagram of the transmission door assembly of the present invention in a partially opened state;

[0029] Figure 6 It is a schematic structural diagram of the reagent storage portion of the present invention;

[0030] Figure 7 It is a structural schematic diagram of the configuration module of the instant extraction kit of the present invention;

[0031] Figure 8 It is a schematic diagram of the structure of the extraction module designed based on the medical automation module of the present invention;

[0032] Fig. 9It is a structural schematic diagram of the amplification detection module designed based on the medical automation module of the present invention.

[0033] Markings in the figure: 10-first moving cross beam, 101-tubular clamping unit, 102-first pipetting unit, 11-first negative pressure generating part, 12-second moving cross beam, 121-second pipetting unit, 122-consumable clamping and transferring unit, 20-automatic transmission channel, 201-transmission pipeline, 202-transmission port, 203-transmission partition door, 2031-connecting plate, 2051-belt driving motor, 204-sterilization lamp, 2052-belt driving gear, 2053-belt driven gear, 2054-belt driving wheel, 2055-transmission belt, 2056-blocking part, 2057-detection unit, 206-transmission interaction port, 2061-outer ring connecting ring, 2062- Inner connecting ring, 21-reagent storage part, 211-reagent bottle, 212-air inlet, 213-refrigeration assembly, 221-first consumable temporary storage position, 222-reagent kit temporary storage position, 223-second consumable temporary storage position, 224-amplification consumable temporary storage position, 225-reagent switch cover assembly, 226-pipetting operation area, 23-amplification consumable switch cover assembly, 24-centrifugal mixing module, 25-consumable recovery drawer, 251-drawer connecting pipe, 30-reagent kit recovery plate, 31-suction cup unit, 32-third moving cross beam, 33-heat sealing film assembly, 40-instant extraction kit configuration module, 50-extraction module, 60-amplification system preparation module, 70-amplification detection module. DETAILED DESCRIPTION

[0034] The present invention will be described in detail below in conjunction with the accompanying drawings.

[0035] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0036] Example 1

[0037] A medical automation module, such as Figure 1-5As shown, in order to ensure that there is enough space for operation, the medical automation module includes a module shell, which is configured as a rectangular cylinder structure. The module shell is provided with a first negative pressure generating part 11, a second negative pressure generating part, an automated transmission channel 20 and an operating part capable of performing sample preparation related operations. The sample preparation related operations include the transfer of consumables and the transfer of liquids, etc. The automated transmission channel 20 is fluidically connected to the second negative pressure generating part. The first negative pressure generating part 11 can act on the module shell and generate a first negative pressure in the module shell. The second negative pressure generating part can act on the automated transmission channel 20 and generate a second negative pressure in the automated transmission channel 20. The first negative pressure and the second negative pressure are independent of each other. At least one of the two ends along the Y-axis direction is provided with a transmission interaction port for matching other medical automation modules, and the transmission interaction port can receive or transmit the transfer object. The upper part of the automated transmission channel 20 is provided with a transfer port, and the transfer port 202 is provided with a transmission partition door 203 for opening and closing the transfer port 202. The operating part can act on the transfer object and drive the transfer object to move. The operating part can enter and exit the automated transmission channel 20 through the opened transmission partition door 203, and the automated transmission channel 20 can be relatively closed with the module shell by closing the transmission partition door 203; the first negative pressure can drive the generation of a longitudinal airflow F01 flowing from bottom to top, and the second negative pressure can drive the generation of a transverse airflow F02 whose flow direction matches the Y-axis direction. The automated transmission channel 20 is arranged along the Y-axis direction of the medical automation module. A negative pressure port is provided at the side wall end of the automated transmission channel 20 arranged along the Y-axis direction. The negative pressure port is fluidically connected to the second negative pressure generating part through the transmission pipe 201. The transfer port 202 is arranged on the upper wall of the automated transmission channel 20 and is spaced apart from the negative pressure port in the Y-axis direction.

[0038] The automatic transmission channel 20 is provided with a transmission object driving component which can drive the transmission object to move relative to the automatic transmission channel 20 .

[0039] The transfer object driving component includes a transfer substrate, a blocking portion 2056 and a conveyor belt 2055 component; the conveyor belt 2055 component includes a pair of conveyor belts 2055 and a conveyor belt 2055 driving device, the pair of conveyor belts 2055 are arranged at both ends of the transfer substrate along the X-axis direction, and the conveyor belt 2055 driving device can drive the conveyor belt 2055 to rotate and drive the transfer object received on the conveyor belt 2055 to move along the Y-axis direction; the blocking portion 2056 can be raised and lowered and connected to the transfer substrate. When the blocking portion 2056 is raised, the displacement of the transfer object on the conveyor belt 2055 can be limited. When the blocking portion 2056 is lowered, the displacement restriction on the transfer object can be released.

[0040] Figure 2It is a schematic diagram of the airflow direction in the medical automation module provided by the present invention; the top of the module shell includes a first negative pressure generating part 11, and the automated transmission channel 20 is fluidically connected to the second negative pressure generating part, so that an independent negative pressure can be generated in the automated transmission channel 20, and the airflow in the medical automation module can generate a longitudinal airflow F01 with a flow direction from bottom to top under the drive of the first negative pressure generating part 11, and the airflow in the automated transmission channel 20 can generate a transverse airflow F02 with a flow direction along the extension direction of the transmission channel under the drive of the second negative pressure generating part, that is, the longitudinal airflow F01 is along the Z-axis direction, and the transverse airflow F02 is along the Y-axis direction, so that a staggered flow can be formed. The negative pressure airflow has little effect on the flow field in the medical automation module and the automated transmission channel 20 even when the automated transmission channel 20 is in an open state. In this embodiment, the first negative pressure generating part 11 and / or the second negative pressure generating part include an air filter component, and the air filter component here includes a HEPA filter unit. The filtration level here is not limited. In this way, the air in the medical automation module can be filtered and discharged, which minimizes the risk of pollution. Since the medical automation module is configured with an independent automated transmission channel 20, the airflow in the automated transmission channel 20 can be replaced faster, which reduces the risk of each transfer process.

[0041] Figure 3201. It is a schematic diagram of the structure of the automated transmission channel 20 provided by the present invention; here, one end of the length direction of the side wall of the automated transmission channel 20 includes a negative pressure port, and the negative pressure port is connected to the transmission pipeline 201. Here, the negative pressure port is arranged below the height center line of the automated transmission channel 20. The automated transmission channel 20 extends along the Y-axis direction and both ends penetrate the module shell to form two through ends. A transmission interaction port 206 is arranged at the through end of the automated transmission channel 20. Both through ends include a transmission interaction port 206. Only the transmission interaction port 206 at one end is shown in the figure. The transmission interaction port 206 is not shown in the figure. 06 also includes an outer ring connecting ring 2061 and an inner ring connecting ring 2062, and flexible materials such as rubber pads are arranged between the outer ring connecting ring 2061 and the inner ring connecting ring 2062 to achieve sealing, so as to ensure that the automated transmission channel 20 can be reliably connected with the corresponding automated transmission channels 20 of other medical automation modules. The automated transmission channel 20 includes a belt drive motor 2051, whose output shaft is connected to a belt drive gear 2052, and the belt drive gear 2052 is meshed with a belt driven gear 2053, and the belt driven gear 2053 is coaxially fixedly connected with the belt drive wheel 2054. The other end of the automated transmission channel 20 along the Y-axis direction is provided with a driven wheel, the driving wheel 2054 and the driven wheel are arranged at intervals, and a transmission belt 2055 is wound between the two. Here, there are two transmission belts 2055, which are arranged side by side in the automated transmission channel 20 along the X-axis direction. In this way, when the belt driving motor 2051 rotates clockwise or counterclockwise, it can drive the transmission object received on the transmission belt 2055 to move along the Y-axis direction to complete the transmission and conveying. A transmission substrate is arranged between the two transmission belts 2055, and a liftable barrier is arranged on the transmission substrate. Part 2056, when the blocking part 2056 is raised, it can limit the displacement of the transfer object 2055 on the conveyor belt, and when the blocking part 2056 is lowered, the displacement restriction on the transfer object can be released. In this way, the function of adjusting the timing of the transfer object transportation through the automated transmission channel 20 can be realized, thereby optimizing the overall transportation of the system. A plurality of detection units 2057 are arranged at intervals along the length direction of the automated transmission channel 20 for detecting the status of consumables and / or for monitoring the operation of the conveyor belt 2055, and can also serve as a control signal of the blocking part 2056 to restrict the displacement of at least part of the transfer object. A transmission door assembly that can be driven to open and close automatically is arranged at the top of the automated transmission channel 20. The door driving mechanism is not shown here. The door driving mechanism is connected to the transmission partition door 203 by driving the connecting plate 2031, so that the partition door 203 can be driven to move along the Y-axis direction to open or block the transfer port 202 of the automated transmission channel 20. In order to further reduce the risk of contamination in the automated transmission channel 20, a sterilization lamp 204 is also arranged at the top of the automated transmission channel 20. The optimal wavelength of the sterilization lamp is 405nm or other similar wavelengths, which are not limited here.

[0042] Figure 4is a schematic diagram of the structure of the transmission door assembly of the present invention in a closed state, Figure 5 Schematic diagram of the transmission gate assembly in a partially open state. Figure 4 , Figure 5 In order to clearly display the operating status of the transmission partition door 203, the top plate corresponding to the transmission partition door 203 in the open state is hidden; when it is necessary to transfer the object out of the automated transmission channel 20 or into the automated transmission channel 20, the door driving mechanism can drive the transmission partition door 203 to retract gradually, exposing the transfer port 202. When the transmission partition door 203 completely covers the transfer port 202, the automated transmission channel 20 can be in an independent relatively closed state. When the transfer port 202 is opened, the consumable clamping transfer unit 122 can be driven to descend and enter and exit the automated transmission channel 20 from the transfer port 202, thereby realizing the unobstructed and low-disturbance placement or removal of various consumables or reagent kits. A flexible sealing unit, such as a rubber strip, can also be configured between the transmission partition door 203 and the transfer port 202.

[0043] Example 2

[0044] An amplification system preparation module, an amplification system preparation module designed based on the medical automation module provided in Example 1, Example 2 is a further improvement of Example 1; further explanation, the same components are not repeated here, such as Figure 1As shown, it is a schematic diagram of the structure of the amplification system preparation module designed based on the medical automation module. The module shell includes an operation area located at the upper part, a preparation area located in the middle part and a processing area located at the lower part, wherein the operation area includes an operation part, and the operation part can drive the transfer objects such as the pipetting consumables box and the deep well plate reagent kit to move within a part of the range in the module shell, and the operation part can enter and exit the automated transmission channel 20 through the opened transmission partition door 203, and the operation part includes a moving beam that can be driven to slide along the X-axis direction of the medical automation module. In this embodiment, in order to ensure that the operation area has perfect operation functions for various types of reagents and consumables, two moving beams that can be independently driven along the X-axis direction are configured, wherein the first moving beam 10 is arranged on the left side of the figure, and this side is defined as the front end of the amplification system preparation module, and the second moving beam 12 is arranged on the right side of the figure, and this side is defined as the end of the amplification system preparation module. In order to ensure reliable movement and simplify drive, one end of the two moving beams in the length direction is slidably connected to the common slide rail, and the other end is rollingly connected to the common guide rod by relying on two roller groups. In the present invention, the first moving span beam 10 is respectively provided with a tubular clamping unit 101 and a first pipetting unit 102 along the Y-axis direction, and the second moving span beam 12 is respectively provided with a second pipetting unit 121 and a consumable clamping and transferring unit 122 along the Y-axis direction. Here, a first connecting member is arranged between the tubular clamping unit 101 and the first pipetting unit 102, so that the two can be driven together to slide synchronously along the length direction of the first moving span beam 10, that is, to slide synchronously along the Y-axis direction. Similarly, a second connecting member is arranged between the second pipetting unit 121 and the consumable clamping and transferring unit 122, so that the two can be driven together to slide synchronously along the length direction of the second moving span beam 12, that is, to slide synchronously along the Y-axis direction. The tubular clamping unit 101, the first pipetting unit 102, the second pipetting unit 121 and the consumable clamping and transferring unit 122 can be driven along the Z-axis direction by their own independent lifting drive mechanisms, so that they can match the preparation area in the middle within two different travel ranges to perform various operations such as consumable transfer and reagent pipetting. The preparation area in the middle includes a reagent storage section 21, a consumables storage section and an automated transmission channel 20. The consumables storage section includes a first consumables temporary storage position 221, a reagent box lifting position for lifting the reagent box, a reagent box temporary storage position 222, a second consumables temporary storage position 223 and an amplification consumables temporary storage position 224. The preparation area is also configured with a reagent switch cover assembly 225, a centrifugal mixing module 24 and an amplification consumables switch cover assembly 23.The front end of the preparation area is configured as a reagent storage section 21, and toward the end of the medical automation module, there are sequentially arranged a first consumable temporary storage position 221, a reagent switch cover assembly 225 and an automated transmission channel 20; on the right side of the automated transmission channel 20, a consumable storage area and an amplification processing area are arranged side by side along the Y-axis direction; the consumable storage area is sequentially configured with a reagent cartridge lifting position, a reagent cartridge temporary storage position 222, a second consumable temporary storage position 223 and an amplification consumable temporary storage position 224; the amplification processing area is sequentially configured with a centrifugal mixing module 24 and an amplification consumable switch cover assembly 23; here, since the reagent part related to the amplification system needs to be refrigerated, as shown. Figure 6 As shown, the reagent storage part 21 includes a refrigeration component 213, and the air inlet 212 and the air outlet of the refrigeration component 213 are located on the two side walls of the medical automation module in the Y-axis direction, and form a through air duct in the Y-axis direction of the medical automation module, so that the airflow of the refrigeration component 213 will not affect the airflow in the medical automation module. Similarly, the automated transmission channel 20 extends along the Y-axis direction of the medical automation module and forms a through structure, and a transmission door component that can be driven to open and close automatically is arranged at the top of the automated transmission channel 20, and a negative pressure port is also arranged on the side wall near the end of the automated transmission channel 20, and the negative pressure port is fluidically connected to the second negative pressure generating part located at the bottom through the transmission pipeline 201, and the negative pressure port and the transmission door component are arranged at intervals in the projection of the Y-axis direction, and the developmental flow of the airflow over a certain distance reduces the turbulence of the airflow in the automated transmission channel 20, so that the opening and closing of the transmission door component has little effect on the flow field in the automated transmission channel 20, and even if the transmission door component is opened, the automated transmission channel 20 can maintain a negative pressure state. Since the automated transmission channel 20 is arranged at a position closer to the front end of the medical automation module, the automated transmission channel 20 can be away from the terminal amplification consumables temporary storage position 224. When the amplification tube consumables in the amplification consumables temporary storage position 224 are in an open state, the target-containing sample liquid carried therein has a risk of contamination. The automated transmission channel 20 is closer to the front end reagent storage portion 21, so that the overall layout has a lower risk of contamination. The lower processing area is provided with a reagent kit recovery tray 30 at the front end, and a consumables recovery drawer 25 which can be pulled out and opened along the X-axis direction is provided above the reagent kit recovery tray 30. In order to reduce the risk of contamination in the consumables recovery drawer 25, its end near the end along the X-axis direction is fluidically connected to the drawer exhaust part by means of a drawer connecting pipe 251; along the front end of the medical automation module toward the end of the medical automation module, there is a film sealing area adjacent to the reagent kit recovery tray 30, and a third moving beam 32 which can move along the X-axis direction is provided above the film sealing area, and suction cup units 31 and consumables clamps are respectively provided on both sides of the third moving beam 32 along the X-axis direction, and a heat sealing film assembly 33 is provided below the film sealing area, as well as a consumables lifting assembly vertically connected to the reagent kit lifting position in the preparation area.

[0045] The various reagent kits and consumables of the present invention adopt a centralized configuration layout. During operation, the automated transmission channel 20 can receive the transfer objects delivered from other medical automation modules. These transfer objects include first-type consumables, second-type consumables, amplification tube consumables and reagent kits, and use the consumable clamping and transferring unit 122 to transfer the transfer objects to the corresponding position of the preparation area, wherein the first-type consumables can be first-type pipetting consumables, and the second-type consumables can be second-type pipetting consumables. The pipetting accuracy and capacity of the two may be different, and the centralized management goal of centralized addition of consumables and unified allocation can also be achieved. The tubular clamping unit 101 transfers various reagent bottles 211 from the reagent storage part 21 to the reagent switch cover assembly 225 and performs the opening operation. The consumable clamping and transferring unit 122 transfers an amplification tube consumable to the amplification consumable switch cover assembly 23 to perform the opening operation. , then the first pipetting unit 102 and / or the second pipetting unit 121 are driven to pick up pipetting consumables from the first consumables temporary storage position 221 and / or the second reagent temporary storage position. Here, the number of the first pipetting unit 102 and / or the second pipetting unit 121 can be set as needed and is not limited to 1. After picking up the pipetting consumables, the first pipetting unit 102 and / or the second pipetting unit 121 can aspirate the reagent from the reagent bottle 211 in the open state into the amplification tube consumables, and can also aspirate the eluent in the reagent kit into the amplification tube consumables. After completion, the pipetting consumables can be delivered to the consumables recovery drawer 25. The amplification tube consumables can be pipetted at the carrying position of the amplification consumables switch cover assembly 23, or can be transferred by the consumable clamping transfer unit 122 to the pipetting operation area 226 for pipetting. The pipetting operation area can be set at the adjacent reagent storage part 21 to facilitate the transfer of reagents. The amplification tube consumables that have completed the transfer of various reagents and eluents can be sent back to the amplification consumables switch cover assembly 23 to complete the cover closing operation. The amplification tube consumables that have completed the cover closing can be transferred to the centrifugal mixing module 24 for centrifugal treatment. After completion, they can be placed back in the amplification consumables temporary storage position 224. The amplification tube consumables that have completed the preparation of a specific number of amplification systems can be transferred to the automated transmission channel 20 by the consumables clamping and transferring unit 122, and then transferred to other medical automation modules to perform subsequent amplification detection and other operations. The used reagent kit is transferred to the reagent kit lifting position by the consumables clamping and transferring unit 122. The reagent kit lifting position drives the reagent kit on it to descend to the processing area under the drive of the consumables lifting assembly. The reagent kit descending to the processing area can be transferred to the heat sealing film assembly 33 by the consumables clamping claws. The suction cup unit 31 can transfer the film to be packaged and cover it above the reagent kit. The reagent kit completes the heat sealing film in the heat sealing film assembly 33. Finally, the suction cup unit 31 can transfer the heat-sealed reagent kit to the reagent kit recovery tray 30 to complete the recovery.The entire amplification system preparation module can prepare the amplification reaction system in a timely manner, and can recycle the reagent kits, pipetting consumables, etc. in a timely manner, and uniformly use the automated transmission channel 20 to interact with other medical automation modules to transfer objects. The path is simpler and the interaction efficiency is higher, eliminating the risk of contamination between the medical automation modules.

[0046] Example 3

[0047] A sample processing system includes a plurality of medical automation modules of the medical automation module design provided in Embodiment 1, wherein, Figure 8 As shown, the medical automation module configured with the sample extraction component forms an extraction module 50, such as Figure 1 As shown, the medical automation module configured with the sample amplification system preparation component forms an amplification system preparation module 60, such as Fig. 9 As shown, the medical automation module equipped with the sample amplification detection component forms an amplification detection module 70, as shown in FIG. Figure 7 As shown, it also includes an instant extraction kit configuration module 40 configured with an extraction kit preparation component.

[0048] Several instant extraction kit configuration modules 40 are connected in series through the automated transmission channel 20 to form an instant extraction kit configuration unit, several extraction modules 50 are connected in series through the automated transmission channel 20 to form an extraction unit, several amplification system preparation modules 60 are connected in series through the automated transmission channel 20 to form an amplification system preparation unit, and several amplification detection modules 70 are connected in series through the automated transmission channel 20 to form an amplification detection unit 2057. The instant extraction kit configuration unit, extraction unit, amplification system preparation unit, and amplification detection unit 2057 are connected in series through their respective automated transmission channels 20 in sequence.

[0049] The structure of the instant extraction kit configuration module 40 is based on the medical automation module design, but because the instant extraction kit configuration module 40 does not participate in any sample processing in the open state, the possibility of contamination of the instant extraction kit configuration module 40 is almost zero. Therefore, the instant extraction kit configuration module 40 is not configured with a second negative pressure generating part of the connected automated transmission channel 20. The automated transmission channel 20 within the instant extraction kit configuration module 40 eliminates the design of the negative pressure port in the automated transmission channel 20 of other medical automation modules, thereby simplifying the overall structure and improving the transmission efficiency under the premise of adaptive configuration. The instant extraction kit configuration module 40 can automatically construct an extraction reaction system and output the extraction kit to the adjacent extraction module 50. In addition, in order to ensure that consumables and samples can be added centrally, the instant extraction kit configuration module 40 is provided with various consumable loading drawers and sample loading drawers for receiving sample tubes to be processed. The consumables and samples are transferred to other designated medical automation modules through the instant extraction kit configuration module 40. The extraction module 50 can obtain the extraction kit in its corresponding automated transmission channel 20, add samples and / or quality control internal standards to the extraction kit, and then send it to the extraction and purification area. After the extraction and purification of the nucleic acid fragments are completed, they are output to the amplification system preparation module 60 through the corresponding automatic transmission channel 20. The amplification system preparation module 60 transfers the eluate in the extraction kit to the amplification strip consumables, and heat-seals the extraction kit in the amplification system preparation module 60 to recover it. After the amplification strip consumables receive various reagents to complete the configuration of the amplification system, they are centrifuged and output to the amplification detection module 70 through the automatic transmission channel 20 in the amplification system preparation module 60. The amplification strip consumables are sent to the amplification equipment to perform amplification and amplification detection, and the empty consumable boxes and the amplification consumables that have completed the detection are recovered. In this embodiment, the medical automation module provided in Example 1 can be further designed as an extraction module 50, an amplification system preparation module 60 and an amplification detection module 70, which ensures that the design of different medical automation modules in the entire system has simple and standard characteristics. The first negative pressure generating part 11 of the amplification detection module 70 generates the lowest first negative pressure, so that the amplification detection module 70 can rely on its lowest negative pressure to achieve faster internal airflow circulation and update, and also minimize the risk of contamination during the detection process to ensure that the detection results are stable and reliable. The second negative pressure generated by the second negative pressure generating parts of all medical automation modules is consistent in size, which ensures that the risk of contamination that may be generated during the transfer process is also small.

[0050] A module partition door is arranged between two adjacent automated transmission channels 20, a first module partition door is arranged between the instant extraction reagent kit configuration module 40 and the extraction module 50, a second module partition door is arranged between the extraction module 50 and the amplification system preparation module 60, and a third module partition door is arranged between the amplification system preparation module 60 and the amplification detection module 70. In the specific implementation process, the first module partition door, the second module partition door and the third module partition door are optimally configured as an interlocking type, so that the basic independence of each automated transmission channel 20 can be achieved, which reduces the overall contamination risk. In some scenarios, the module partition door and the transmission partition door 203 of each medical automation module are also configured as an interlocking type, so that the mutual influence between the automated transmission channel 20 and the airflow in the medical automation module can also be greatly reduced.

[0051] In other special scenarios, for example, in order to increase the processing capacity and processing speed of the sample processing system, no less than two extraction modules 50 can be arranged in series in the extraction unit, and no less than two amplification detection modules 70 can be arranged in series in the amplification detection. Of course, module partition doors can also be configured between the same type of medical automation modules to make the automated transmission channels 20 of the same type of medical automation modules relatively independent. Such an arrangement can also enable the sample processing system to adapt to the changing detection flux, and the interaction between the medical automation modules will not be repeated here.

[0052] The principles and implementation methods of the present invention are described in this article using specific embodiments. The description of the above embodiments is only used to help understand the method and core ideas of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made to the present invention without departing from the principles of the present invention, and these improvements and modifications also fall within the scope of protection of the claims of the present invention.

[0053] In the description of the present invention, it should be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside", etc. indicate directions or positional relationships based on the directions or positional relationships shown in the accompanying drawings, or are the directions or positional relationships in which the inventive product is usually placed when in use. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and therefore should not be understood as a limitation on the present invention.

[0054] In the description of the present invention, it is also necessary to explain that, unless otherwise clearly specified and limited, the terms "set", "install", "connect", and "connect" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

Claims

1. A medical automation module, characterized in that: The invention comprises a module shell, wherein a first negative pressure generating part, a second negative pressure generating part, an automated transmission channel and an operating part are arranged in the module shell, wherein the automated transmission channel is fluidically connected to the second negative pressure generating part, wherein the first negative pressure generating part can act on the module shell to generate a first negative pressure, wherein the second negative pressure generating part can act on the automated transmission channel to generate a second negative pressure in the automated transmission channel, wherein the first negative pressure and the second negative pressure are independent of each other; wherein at least one of the two ends of the automated transmission channel along the Y-axis direction is provided with a transmission interaction port for matching other medical automation modules, wherein the transmission interaction port passes through the module shell, wherein the transmission interaction port can receive or transmit a transfer object, wherein a transfer port is arranged on a non-through side of the automated transmission channel, wherein a transmission partition door for opening and closing the transfer port is arranged at the transfer port, wherein the operating part can act on the transfer object and drive the transfer object to move, wherein the operating part can enter and exit the automated transmission channel through the opened transmission partition door, and wherein the automated transmission channel can be relatively closed to the module shell through the closing of the transmission partition door.

2. The medical automation module according to claim 1, characterized in that: The first negative pressure can drive a longitudinal airflow flowing from bottom to top, and the second negative pressure can drive a transverse airflow flowing in a direction matching the Y-axis direction.

3. The medical automation module according to claim 1, characterized in that: The automated transmission channel is arranged along the Y-axis direction of the module shell, and a negative pressure port is provided at the side wall end of the automated transmission channel arranged along the Y-axis direction. The negative pressure port is fluidically connected to the second negative pressure generating part through a transmission pipeline, and the transfer port is spaced apart from the negative pressure port in the Y-axis direction.

4. The medical automation module according to claim 1, characterized in that: The automatic transmission channel is provided with a transmission object driving component which can drive the transmission object to move relative to the automatic transmission channel.

5. The medical automation module according to claim 4, characterized in that: The transfer object driving assembly includes a transmission substrate, a blocking part and a transmission belt assembly; the transmission belt assembly includes a pair of transmission belts and a transmission belt driving device, the pair of transmission belts are arranged at both ends of the transmission substrate along the X-axis direction, and the transmission belt driving device can drive the transmission belt to rotate and drive the transfer object received on the transmission belt to move along the Y-axis direction; the blocking part can be raised and lowered and connected to the transmission substrate, when the blocking part is raised, it can limit the displacement of the transfer object on the transmission belt, and when the blocking part is lowered, the displacement restriction on the transfer object can be released.

6. The medical automation module according to any one of claims 1 to 5, characterized in that: The automated transport channel further comprises a detection unit for detecting the status of the transferred object and / or for controlling the operation of the conveyor belt.

7. An amplification system preparation module, characterized in that: Using the medical automation module as described in any one of claims 1-6, the module shell includes an operation area located at the top, a preparation area located in the middle and a processing area located at the bottom, the operation part is arranged in the operation area, the operation part includes a transfer unit that can be detachably connected to a target object and drive the target object to move, and a pipetting unit that can perform pipetting operations; the automated transmission channel is arranged in the preparation area, the preparation area also includes an amplification system preparation module and a consumables storage position; a consumables lifting assembly is arranged between the processing area and the consumables storage position, and the processing area is provided with a consumables recovery assembly that can recycle consumables.

8. The amplification system preparation module according to claim 7, characterized in that: The consumables recovery component includes a reagent kit recovery tray, a suction cup unit, a consumables clamp and a heat-sealing film assembly. The consumables clamp can match with the reagent kit and move the reagent kit, the suction cup unit can transfer the film to be packaged, the reagent kit covered with the film to be packaged can be heat-sealed in the heat-sealing film assembly, and the reagent kit recovery tray can accommodate the reagent kit with the heat-sealed film.

9. A sample processing system, characterized in that: The invention comprises a plurality of medical automation modules as claimed in any one of claims 1 to 6, wherein a medical automation module equipped with a sample extraction component forms an extraction module, a medical automation module equipped with a sample amplification system preparation component forms an amplification system preparation module, and a medical automation module equipped with a sample amplification detection component forms an amplification detection module; it also comprises an instant extraction kit configuration module equipped with an extraction kit preparation component; a plurality of instant extraction kit configuration modules are connected in series through an automated transmission channel to form an instant extraction kit configuration unit, a plurality of extraction modules are connected in series through an automated transmission channel to form an extraction unit, a plurality of amplification system preparation modules are connected in series through an automated transmission channel to form an amplification system preparation unit, and a plurality of amplification detection modules are connected in series through an automated transmission channel to form an amplification detection unit, wherein the instant extraction kit configuration unit, the extraction unit, the amplification system preparation unit, and the amplification detection unit are connected in series through the automated transmission channel in sequence.

10. The sample processing system according to claim 9, characterized in that: A module partition door is arranged between two adjacent automated transmission channels; the first negative pressure generated by the first negative pressure generating part of the amplification detection module is the lowest; and the second negative pressure generated by the second negative pressure generating parts of all medical automation modules is consistent in magnitude.

Citation Information

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