WO2023122973A1 - Dispositif d'analyse d'échantillon multifonctionnel - Google Patents

Dispositif d'analyse d'échantillon multifonctionnel Download PDF

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Publication number
WO2023122973A1
WO2023122973A1 PCT/CN2021/142128 CN2021142128W WO2023122973A1 WO 2023122973 A1 WO2023122973 A1 WO 2023122973A1 CN 2021142128 W CN2021142128 W CN 2021142128W WO 2023122973 A1 WO2023122973 A1 WO 2023122973A1
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WO
WIPO (PCT)
Prior art keywords
sample
detection
module
detection module
instant
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PCT/CN2021/142128
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English (en)
Chinese (zh)
Inventor
杨翥翔
马勇
王胜昔
Original Assignee
深圳迈瑞动物医疗科技股份有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Application filed by 深圳迈瑞动物医疗科技股份有限公司 filed Critical 深圳迈瑞动物医疗科技股份有限公司
Priority to PCT/CN2021/142128 priority Critical patent/WO2023122973A1/fr
Priority to CN202180099242.9A priority patent/CN117460957A/zh
Publication of WO2023122973A1 publication Critical patent/WO2023122973A1/fr

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices

Definitions

  • the invention relates to a medical device, in particular to a multifunctional sample analysis device.
  • Wet blood analysis equipment is a commonly used blood sample analysis device, which can complete blood routine tests such as blood cell count and classification; it can also complete tests such as hemoglobin concentration and inflammatory factors.
  • Point-of-care testing (POCT) as a subdivision of in vitro diagnostics, has been widely used in clinical testing, personal health management, disease prevention and monitoring, and other fields due to its features of miniaturized instruments, rapid detection, and simple operation.
  • Instant testing can involve blood analysis, biochemical analysis, immune analysis, molecular analysis, coagulation analysis and other testing items. Realization methods of instant detection include but are not limited to microfluidic technology, dry biochemical analysis technology, colloidal gold detection technology, etc.
  • the present invention mainly provides a new multifunctional sample analysis device to demonstrate a multifunctional sample analysis device with both blood analysis and detection functions and instant detection functions.
  • an embodiment of the present application provides a multifunctional sample analysis device, including:
  • a machine base the machine base plays a supporting role
  • a sample adding module the sample adding module is installed on the base, the sample adding module includes a sampling needle for sampling and sample delivery and a sampling driving device for driving the sampling needle;
  • a blood analysis module is installed on the base, it includes a sample preparation device and a detection device, the sample preparation device has at least one reaction pool and a reagent supply assembly, and the reaction pool is used to receive the The sample sent by the sampling needle, the reagent supply component is used to provide processing reagents to the sample in the reaction pool to prepare the sample liquid to be tested; the detection device is used to detect the sample liquid to be tested, to obtain blood parameters of the sample;
  • At least one real-time detection module the real-time detection module is used for real-time detection of samples, and the real-time detection module is installed on the base;
  • the sample adding module, the blood analysis module and the instant detection module are all connected to the control unit by signals, and the control unit controls the sample adding module, the blood analysis module and the Real-time detection of module work;
  • the sample delivery range of the sampling needle covers the reaction pool and the instant detection module, so that samples can be distributed to the reaction pool and the instant detection module, and the control unit, according to the detection items of the sample, Controlling the sampling needle to send the sample into the reaction pool and/or real-time detection module corresponding to the detection item, and controlling the blood analysis module and/or the real-time detection module corresponding to the detection item
  • the detection module detects and analyzes the sample.
  • the instant detection module is distributed on at least one side of the blood analysis module.
  • each of the instant detection modules has a sample loading area
  • the moving track of the sampling needle covers all the sample loading areas of the instant detection modules, and can divide samples to all the sample analysis and detection modules.
  • the type of the instant detection module includes one or more of a dry blood analysis instant detection module, a biochemical analysis instant detection module, an immune analysis instant detection module, a molecular analysis instant detection module and a coagulation analysis instant detection module. Two or more.
  • both the blood analysis module and the real-time detection module are detection modules
  • the control unit receives the identity information of the current sample, and determines the detection items and the sample size to be collected according to the identity information ;
  • the control unit controls the sampling needle to collect samples of the sample size, and sends them to the detection modules corresponding to each detection item.
  • control unit determines the sample size
  • control unit judges the detection cycle of each detection module corresponding to the sample, and preferentially sends the sample to the detection module with a long detection cycle, and the detection cycle includes the time length or module time for the detection module to complete the detection. The time to complete the test plus the preparation time.
  • the control unit determines the detection items and the sample size to be collected according to the identity information of the next sample, and controls the sampling needle to collect the sample. For the next sample, the collected next sample is sent to the idle detection module corresponding to the detection item.
  • control unit when the control unit detects that one of the detection modules has completed the detection, it judges whether the sample currently corresponding to the sampling needle has a detection item corresponding to the detection module that has completed the detection; The sampling needle sends its current corresponding sample into the detection module that has completed the detection; if there is no detection module, control the detection module to be idle and wait for the next sample.
  • the machine base is preset with a plurality of module installation positions, and the module installation positions have an assembly structure for assembling the corresponding instant detection module
  • the instant detection module is a modular structure, which has an assembly structure for A docking structure connected to the assembly structure, the real-time detection module is detachably installed on the module installation position, and the docking structure is detachably connected to the assembly structure.
  • the instant detection modules are arranged horizontally or vertically.
  • the horizontal arrangement includes arranging in one or more rows in the horizontal direction, or arranging in an array in the horizontal direction.
  • the vertical arrangement includes being arranged in one or more columns in the vertical direction, or arranged in an array in the vertical direction.
  • the multifunctional sample analysis device has a sampling area, the sampling area has a sampling position and an emergency position, and the moving track of the sampling needle covers the sampling position and the emergency position.
  • the instant detection module includes a holding position for placing a sample carrying device and a detection device for cooperating with the sample carrying device, and the detection device is used for when the sample is added to the After being mounted on the sample carrying device, cooperate with the sample carrying device to complete the corresponding testing items.
  • the machine base includes a housing, and the housing encloses an accommodating cavity, the blood analysis module and the instant detection module are placed in the accommodating cavity, and the housing has a The dismounting port corresponding to the real-time detection module is used for replacing the sample carrying device corresponding to the real-time detection module.
  • the multifunctional sample analysis device includes a base, a sample adding module, a blood analysis module, at least one real-time detection module, and a control unit. Both the blood analysis module and the instant detection module are installed on the frame and integrated into a whole to realize multi-function and integration. At the same time, the blood analysis module and the real-time detection module share a sample adding module. The sample delivery range of the sampling needle of the sample adding module covers the blood analysis module and the real-time detection module. Send samples.
  • the overall structure of the equipment can be made more compact while realizing multiple functions, and a set of sample adding modules can be shared, which can further simplify the structure, reduce equipment operations and occupy less space.
  • FIG. 1 is a schematic diagram of each module of a multifunctional sample analysis device in an embodiment of the present application
  • Fig. 2 is a schematic structural diagram of a multifunctional sample analysis device in an embodiment of the present application
  • Fig. 3 is an enlarged view of part A in Fig. 2;
  • Fig. 4 is a schematic structural diagram of a multifunctional sample analysis device in another embodiment of the present application.
  • Fig. 5 is a schematic structural diagram of a sample adding module in an embodiment of the present application.
  • FIG. 6 is a schematic structural diagram of a sample adding module in another embodiment of the present application.
  • Fig. 7 is a schematic diagram of the cooperation structure between the suspension turret and the guide in one embodiment of the present application.
  • Fig. 8 is a schematic diagram of the sampling needle offset angle in an embodiment of the present application.
  • Fig. 9 is a schematic diagram of each sample position on the sampling module of the multifunctional sample analysis device in an embodiment of the present application.
  • Fig. 10 is a schematic structural diagram of a sampling module of a multifunctional sample analysis device in an embodiment of the present application.
  • Fig. 11 is a schematic diagram of each sample position on the sample rack in an embodiment of the present application.
  • Fig. 12 is a schematic diagram of the structure of a sample holder in an embodiment of the present application.
  • connection and “connection” mentioned in this application include direct and indirect connection (connection) unless otherwise specified.
  • This embodiment provides a multifunctional sample analysis device. Please refer to FIGS. 1-4.
  • the machine base 100 plays a supporting role, and other components are directly or indirectly connected to the machine base 100 .
  • the stand 100 may have a housing 110 , and the housing 110 has a closed or semi-closed cavity.
  • the base 100 can also be designed as other non-housing structures.
  • the blood analysis module 310 is installed on the base 100, and the blood analysis module 310 may be a wet blood analysis module.
  • the blood analysis module 310 includes a sample preparation device 311 and a detection device 312 .
  • the sample preparation device 311 has at least one reaction pool 3111 and a reagent supply assembly 3112 .
  • the reaction pool 3111 is used to receive the sample sent by the sampling needle 210 .
  • the reagent supply component 3112 is used to provide processing reagents to the samples in the reaction pool 3111, so as to prepare a sample solution to be tested.
  • the detection device 312 is used to detect the sample fluid to be tested to obtain blood parameters of the sample.
  • the point-of-care detection module 320 (POCT) 300 is a miniaturized and rapid detection module, which can involve blood analysis, biochemical analysis, immune analysis, molecular analysis, coagulation analysis and other detection items.
  • Instant detection methods include but are not limited to microfluidic technology, dry biochemical analysis technology, colloidal gold detection technology, etc.
  • the type of the point-of-care detection module 320 includes one of a dry blood analysis point-of-care detection module, a biochemical analysis point-of-care detection module, an immune analysis point-of-care detection module, a molecular analysis point-of-care detection module and a coagulation analysis point-of-care detection module species or two or more.
  • the blood analysis module 310 and the real-time detection module 320 are installed on the base 100, and can be arranged in a set order, with reasonable planning overall arrangement.
  • the sample adding module 200 is used to complete the sampling of the sample to be tested and deliver the collected sample to the corresponding blood analysis module 310 and real-time detection module 320 .
  • the sample adding module 200 is installed on the machine base 100 , and the sample adding module 200 includes a sampling needle 210 for sampling and sending a sample, a sampling driving device 220 for driving the sampling needle 210 and other related structures (such as a sample suction syringe 230 ).
  • the blood analysis module 310 , sample adding module 200 and real-time detection module 320 are all signally connected to the control unit 800 , and the control unit 800 is used to control the work of the blood analysis module 310 , sample adding module 200 and real-time detection module 320 .
  • the control unit controls the sampling needle to send the sample into the reaction pool 3111 and/or the real-time detection module 320 corresponding to the test item according to the test item of the sample, and controls the blood analysis module 310 and/or the real-time test module 320 corresponding to the test item Analyze samples.
  • the sampling range of the sampling needle 210 covers all blood analysis modules 310 and real-time detection modules 320 , therefore, the sampling needle 210 can distribute samples to all the blood analysis modules 310 and real-time detection modules 320 when needed.
  • the blood analysis module 310 and the real-time detection module 320 both have a sample loading area, and the moving track of the sampling needle 210 does not have to cover all the areas of the blood analysis module 310 and the real-time detection module 320, but only needs to cover the blood analysis module 310, real-time detection
  • the sample loading area of the module 320 is enough to simplify the travel of the sampling needle 210 and also help to make the whole device more compact, and at the same time, it can achieve the purpose of dividing samples to all the instant detection modules 320 .
  • the blood analysis module 310 and the real-time detection module 320 are installed on the machine base and integrated into a whole to realize multi-function and integration. Simultaneously, the blood analysis module 310 and the real-time detection module 320 share a sample adding module, and the sample feeding range of the sampling needle 210 of the sample adding module covers the blood analysis module 310 and the real-time detection module 320, and under the control of the control unit 800, sampling Needle 210 dispenses samples into each module.
  • the overall structure of the equipment can be made more compact while realizing multiple functions, and a set of sample adding modules can be shared, which can further simplify the structure, reduce equipment operations and occupy less space.
  • the sample filling of the blood analysis module 310 and each real-time detection module 320 is completed by the sampling needle 210 in the shared sampling module 200, and a set of sampling modules 200 can meet the use of multiple modules without separately targeting each
  • the blood analysis module 310 and the real-time detection module 320 design the sample adding module 200 separately, which further simplifies the structure of the device and enables the device to be more miniaturized.
  • the sampling needle 210 can realize the effect of accurate quantitative and fast filling speed.
  • the multifunctional sample analysis device 1 can also be provided with display screen 120 (as shown in Figures 2 and 4 ), report printing module (such as a printer), network interface and other hardware usually required by detection equipment, especially each The general-purpose hardware of the modules allows each module to share one or more general-purpose hardware, thereby saving equipment placement space and equipment purchase costs.
  • the machine base 100 includes a housing 110, the housing 110 encloses an accommodating chamber, a blood analysis module 310 and an instant detection module 320 placed in the holding chamber.
  • the casing 110 can protect the blood analysis module 310 and the real-time detection module 320 , and can also prevent external factors of the equipment from interfering with the detection and affecting the detection structure.
  • the detection process of the point-of-care detection module 320 needs to be realized by means of a sample carrying device 400 (also referred to as a consumable). Chips or discs, test strips, capillary tubes, test cards, etc.
  • the instant detection module 320 includes a holding position for placing the sample carrying device 400 and a detection device for cooperating with the sample carrying device 400 .
  • the holding position is mainly used to place the sample carrying device 400 , and according to different real-time detection principles, the holding position also has the function of fixing or implementing certain actions on the sample carrying device 400 when necessary. For example, as shown in FIG.
  • the supporting position may have a fixing structure 321 for fixing the microfluidic chip and a driving motor 322 for driving the microfluidic chip 40 to perform centrifugal movement.
  • the detection device is used to cooperate with the sample carrying device 400 after the sample is loaded on the sample carrying device 400 to complete the corresponding detection items.
  • the detection means can be but not limited to optical detection (such as colorimetry, etc.), chemical reaction detection (such as color reaction, etc.), physical property detection, etc.
  • the housing 110 has a disassembly port 111 corresponding to the instant detection module 320, from which the disassembly port 111 can be quickly and timely
  • the sample carrying device 400 corresponding to the real-time detection module 320 is replaced.
  • the types of the point-of-care detection module 320 include but not limited to dry blood analysis point-of-care detection module, biochemical analysis point-of-care detection module, immune analysis point-of-care detection module, molecular analysis point-of-care detection module and coagulation analysis point-of-care detection module.
  • the instant detection module for dry blood analysis uses a light source of a specific wavelength to irradiate the centrifuged blood sample in a special capillary, analyze and collect images.
  • Routine blood analysis is a well-developed technology at present, and a variety of analysis methods are integrated by the analysis module. For example: using the principle of electrical impedance to detect the number and volume distribution of white blood cells/basophils, red blood cells and platelets; using colorimetry to detect the concentration of hemoglobin; Immunoturbidimetry was used to detect inflammatory factors such as CRP and SAA.
  • the biochemical analysis real-time detection module can complete the detection of liver function, kidney function, pancreas, myocardium, blood sugar, blood lipids, electrolytes, etc., and is often used in health checkups, disease screening, and preoperative sign monitoring.
  • the different test packages of the biochemical analysis instant detection module based on the principle of centrifugal microfluidics are realized by the combination of different reagents packaged in the detection disc.
  • the instant detection module of immune analysis can carry out disease diagnosis and immune function monitoring through the detection and screening of inflammatory factors, tumor markers, antigens, antibodies and other items.
  • the different test packages of the immunoassay instant detection module based on the principle of centrifugal microfluidics are realized by different reagents or antibodies encapsulated in the detection disc.
  • the coagulation analysis real-time detection module can detect the status of the coagulation system and hemostatic function in the patient's body through the detection of thrombin time, prothrombin time, activated partial thromboplastin time, and fibrinogen. It is a must-check item before surgery.
  • the initial samples of the above-mentioned detection modules are whole blood, and for the detection modules that require serum, the separation of serum is realized by the centrifugal motor inside the module.
  • the diluent is needed for each detection module, it can be provided by the prepackaged diluent box in the sample carrying device 400 .
  • At least some of the immediate detection modules 320 in the multifunctional sample analysis device 1 are of different types, or all the immediate detection modules 320 are of the same type. That is, when the multifunctional sample analysis device 1 has at least two instant detection modules 320, the at least two instant detection modules 320 can be the same type of instant detection modules 320, or different types of instant detection modules 320, or one of them A part of the real-time detection modules 320 are of the same type, and another part of the real-time detection modules 320 are of different types.
  • the multifunctional sample analysis device 1 shown in this embodiment can realize multiple detection items (including blood detection items and various real-time detection items) in one device, thereby realizing centralized detection and centralized operation, improving detection efficiency and convenient operation Spend.
  • the multifunctional sample analysis device 1 can integrate POCT detection functions such as biochemistry, immunity, and molecular coagulation with blood test functions into a quick inspection all-in-one machine, which is applicable to but not limited to primary health systems, emergency treatment, pet hospitals and other places.
  • the machine base 100 is preset with a plurality of module installation positions 114 , and the module installation positions 114 have an assembly structure for assembling corresponding instant detection modules 320 .
  • the module installation position 114 may be a cavity structure, or other non-cavity structure, as long as it can accommodate and fix the corresponding real-time detection module 320 .
  • the real-time detection modules 320 are integral modules that can independently complete the corresponding real-time detection functions, that is, after the detected sample is added to each real-time detection module 320, the real-time detection module 320 is equipped with instructions from the control unit 800 or Under the control of the control unit possessed by the real-time detection module 320, it can independently complete the real-time detection function.
  • the real-time detection module 320 has a connection structure, the real-time detection module 320 is installed on the module installation position 114, and the connection structure and the assembly structure are detachably connected.
  • the detachable connection includes, but is not limited to, commonly used snap-fit fixation, screw-fit fixation, adhesive fixation, magnetic fixation, interference fit fixation, and the like.
  • the electrical connection can be realized through various conventional electrical connection structures, such as plug-in connection of connection terminals, contact connection, cable connection and the like.
  • these real-time detection modules 320 can be disassembled directly on the machine base 100 as a whole, and the operator can selectively configure the real-time detection modules 320 according to his own needs, so that the device has a corresponding real-time detection function, and the use of the device is more flexible.
  • the modular assembly of the real-time detection module 320 also facilitates the manufacturer to flexibly increase or decrease the real-time detection function according to the needs of operators.
  • the at least two real-time detection modules 320 share one sample adding module 200, which makes the structure more compact.
  • These instant detection modules 320 that can be disassembled as a whole can have fixed installation positions, that is, a certain installation position is only used to dock a certain instant detection module 320, and when the instant detection module 320 is not needed, the installation position can be idle .
  • the assembly structure on at least one module installation position 114 is a common structure that can be docked with at least two different types of instant detection modules 320, therefore, the operator can selectively install a kind of instant detection module 320 Installed on the module installation position 114.
  • the base has two assembly structures with a common structure, which can respectively be docked with more than three kinds of real-time detection modules 320. Therefore, the two module installation positions 114 can selectively assemble three different The instant detection module 320 further improves the flexibility of device function selection and use.
  • the real-time detection module 320 can also be installed in a non-integral modular form, that is, the real-time detection module 320 cannot be installed as an independent module when it is disassembled.
  • the advantage is that the real-time detection module 320 is firmly assembled on the base 100, and there is no need to set too many detachable structures for the modular structure, which is simpler in terms of structural design, and the simpler structure It also means that the difficulty of assembly is reduced, and it is also convenient to simplify the structure and make the volume of the whole machine smaller.
  • each instant detection module 320 can be arranged on the base in any manner, of course, a more reasonable arrangement can further make the structure of the device more compact or facilitate the movement of the sampling needle 210, so please refer to Figure 1, a
  • the instant detection module 320 is distributed on at least one side of the blood analysis module 310.
  • the multiple instant detection modules 320 may also be distributed on the vertical side (Z direction) of the blood analysis module 310 .
  • a plurality of instant detection modules 320 may also be arranged around the blood analysis module 310 horizontally and/or vertically.
  • the instant detection modules 320 are arranged horizontally or vertically.
  • the horizontal arrangement includes being arranged in one or more rows in the horizontal direction, or arranged in an array in the horizontal direction.
  • the vertical arrangement includes being arranged in one or more columns in the vertical direction, or arranged in an array in the vertical direction.
  • these instant detection modules 320 are arranged sequentially along the Y direction (X and Y in the figure are both horizontal and Z is vertical), and the sampling area is located at the sampling needle 210 on the Y-direction motion path. The sample dividing and pipetting operations are realized through the Y-direction reciprocating movement of the sampling needle 210 .
  • these instant detection modules 320 can also be arranged along the X direction or the Z direction.
  • the blood analysis module 310 and the real-time detection module 320 are collectively referred to as detection modules in this application.
  • the principle of arrangement of the detection modules may be: the detection modules with a long detection period are arranged first, so as to realize the earliest addition of samples and the earliest start of detection.
  • the detection modules with a total time-consuming time are placed in the front row, saving the time for replacing consumables and ensuring the consistency of detection.
  • At least one detection module is a dry-type blood analysis instant detection module
  • the dry-type blood analysis instant detection module involves multiple links such as centrifugation, cell staining, photoelectric detection, etc., capillary centrifugation Tube replacement, etc., therefore, put the dry blood analysis point-of-care module in the first place.
  • the control unit 800 judges the detection cycle of each detection module corresponding to the sample (that is, the time from the start of detection to the end of detection), and preferentially sends samples to the detection module with a long detection cycle, and the detection cycle includes the completion of the detection module.
  • the duration of the detection or the duration of the detection module to complete the detection plus the preparation time that is, the duration of consumable replacement.
  • the order of input samples of each detection module can also be implemented according to other principles, for example, to send samples to idle detection modules first, or to judge comprehensively based on factors such as the idle state and working hours of the detection modules .
  • each instant detection module 320 is related to colloidal gold test paper, detection card, capillary centrifuge tube, microfluidic detection
  • an in/out mechanism along the X direction can be designed (such as provided at the disassembly port 111), so that the instant detection module 320 can be inserted or taken out along the X direction.
  • the entering/exiting mechanism can also be omitted, and the operator installs it manually.
  • the sample loading module 200 can adopt various sample loading structures in the field of detection and analysis. Please refer to FIG. 5 , in one embodiment, the sampling needle 210 of the sampling needle communicates with a sample suction syringe 230 , and the sample suction syringe 230 provides the power to suck and discharge the sample.
  • the sample suction syringe 230 is a precise quantitative mechanism, which is connected to the sampling needle 210 through a pipeline, so as to ensure the accuracy of the sampling volume, sample dividing volume, and liquid transfer volume.
  • the sampling driving device 220 can be a device driven by at least one motor, cylinder, liquid cylinder, electromagnet, etc., and the sampling needle 210 is connected to the sampling driving device 220 to drive the sampling needle 210 to move at a desired position, for example The sampling needle 210 is driven to translate, lift and/or rotate as needed.
  • the sampling driving device 220 can also be provided with a guide mechanism to guide the movement of the sampling needle 210 .
  • the guiding mechanism can adopt all kinds of feasible guiding. Please refer to FIG. 6.
  • the sampling needle 210 is guided by the linear guide rail 221 in the Y direction movement. Because the linear guide rail 221 has high dimensional accuracy, the X-direction deflection of the sampling needle 210 is almost equal to the straightness deviation of the sampling needle 210, which can Control the deflection of the sampling needle 210 in the X direction within 0.6mm.
  • the Y-direction movement of the sampling needle 210 adopts a guide structure of "guide rod + guide sheet metal".
  • the Y-direction movement position is determined by the initial position optocoupler and the number of steps of the stepper motor, which can be adjusted in combination with the sampling position before leaving the factory.
  • the sampling needle 210 can rotate slightly around the guide structure, thereby causing the sampling needle 210 to deflect in a small range in the X direction. Therefore, please refer to FIGS. 7 and 8 , a detent 222 can be set on the guide sheet metal 223 , and the deflection of the sampling needle 210 can be reduced by adjusting the gap between the detent 222 and the guide sheet metal 223 .
  • B1 is the gap between the stop block 222 and the guide sheet metal 2
  • B2 is the offset of the sampling needle 210 in the X direction. In this way, the X-direction deflection of the sampling needle 210 can be controlled within 1 mm (including the straightness of the sampling needle 210 itself).
  • the sample loading module 200 completes operations such as sample suction, sample division, pipetting, cleaning the sampling needle 210, etc. All samples share at least one sampling position, and the sample loading area of each instant detection module 320 is fixed. The Y-direction movement of the sampling needle 210 reaches the sampling position, the sample adding area and other positions respectively. At the above position, the sampling needle 210 can be moved up and down along Z through the motor and the screw rod to complete the suction and injection operations. The height of the sampling needle 210 is jointly determined by the sample volume, the liquid absorption volume, the height of the test tube, and the height of the sample loading area.
  • each instant detection module 320 The sample loading area of each instant detection module 320 is located on the detection consumables, therefore, the consumables need to be positioned when they are loaded into the detection modules.
  • the detection module entry/exit mechanism also needs to involve position detection.
  • the sampling needle 210 absorbs different samples or liquids, the sampling needle 210 needs to be cleaned to avoid cross-contamination of samples and affect test results. Washing is done within the closed swab of the sample loading module 200 .
  • the sample to be detected can be injected manually by the operator, or an additional sampling module can be provided.
  • the sampling module is provided with a sampling position, and the moving track of the sampling needle 210 covers the sampling position, so that samples located on the sampling position can be sampled.
  • the sampling module is also provided with a retest waiting position and/or an unloading position, the sampling module is connected to the control unit 800 by signal, and the control unit 800 controls the sampling module to move the sample to be detected to the sampling position, and The sample injection module is controlled to send the sample that has been sampled to the retest waiting position and/or the unloading position.
  • the sample injection module can also have an emergency position, and the movement track of the sampling needle covers the emergency position, so that when an emergency order is received, samples from the emergency position are preferentially sampled.
  • the sampling module 500 is a rotary sampling device, which has a rotating base 510 and a driving mechanism 513 that drives the rotating base 510 to rotate.
  • the rotating base 510 has sample positions 511 for placing samples.
  • the sample positions 511 are arranged in an arc or a circle.
  • the driving mechanism 513 drives the rotating base 510 to move the samples on the sample positions 511 to the sampling positions.
  • the sampling position is a virtual position, which is located on the rotation path of the sample position 511. Driven by the driving mechanism 513, all the sample positions 511 can be moved to the sampling position for sampling.
  • the swivel seat 510 can specially reserve an urgent sample position 512 for storing urgent samples, and when an emergency order is received, the samples on the urgent sample position 512 are preferentially rotated to the sampling position for sampling.
  • the rotating base 510 transports all the test tubes 600 to the sampling position to complete the sample suction through a predetermined rotational movement.
  • the entire device is moved upwards (at this time, the sampling module 500 can be regarded as being in the unloading position), which is convenient for removing the measured sample and placing a new sample.
  • the rotation of the rotating base 510 can be directly driven by a motor, and the movement of the rotating base 510 in the Y direction or in other directions can be realized by means of motor+screw, motor+synchronous belt, motor+gear+rack, etc.
  • the sample injection module 500 can also be a sample injector, which is suitable for occasions with a large amount of samples.
  • the sampling module 500 has three positions: a loading position 521 , a sampling position (located below the sampling needle 210 in the figure), and a retest waiting position/unloading position 522 .
  • the test tube rack 700 placed on the loading position 521 is transported to the sampling position by the loading mechanism, and the movement of the test tube rack 700 depends on the lateral feed mechanism to move according to the set action to ensure that all samples on the test tube rack 700 are sucked.
  • test tube rack 700 after sample suction is removed from the sampling position by the transverse feed mechanism, and reaches the re-inspection waiting position/unloading position 522, waiting for re-inspection or unloading.
  • the tested test tube rack 700 can be removed by the unloading mechanism, which is convenient for the operator to take off the test tube rack 700, or the operator can directly take out the test tube rack 700 from the re-examination waiting position/unloading position 522.
  • the test tube rack 700 is provided with a test tube rack serial number 410 and a test tube serial number 720, etc., through which the identity information of the test tube rack 700 and/or the position of the sample on the test tube rack 700 can be determined.
  • the test tube 600 can also be provided with units such as the exclusive label 610 that can further determine the identity information of the sample.
  • the control unit 800 receives the identity information of the current sample, and determines the test items and the sample size to be collected (ie the total sample size) according to the identity information or the received instruction.
  • the control unit 800 receives the identity information of the sample, which can be obtained by automatically identifying the identity information of the sample (such as scanning the label 610 on the test tube 600 or other information carrying units), can also receive the identity information sent by other components, and can also directly receive the identity information of the operator. Input command information, etc.
  • the control unit 800 controls the sampling needle 210 to collect the sample with the determined sample size, and sends it to the idle instant test module 320 corresponding to each test item.
  • control unit 800 determines the sample size, it controls the sampling needle 210 to collect samples of the sample size at one time, and sends them to the detection modules corresponding to each detection item in sequence. Especially when multiple testing items are required, all samples with the required sample size can be obtained through one sampling. This operation can save operation steps and simplify the control stroke of the sampling needle 210 .
  • the sample adding module 200 can also collect more than two times, and then send it to the corresponding detection module.
  • the samples are sequentially distributed to the corresponding multiple detection modules. If the corresponding detection module is in a non-idle state, it can be divided into the detection module after waiting for the detection module to be idle.
  • the control unit 800 determines the detection items and the samples to be collected according to the identity information of the next sample or the received instruction. and control the sampling needle 210 to collect the next sample, and send the next sample to an idle detection module corresponding to the detection item. If there is a detection module that is not idle, wait for it to be idle before sending in samples. And so on, so as to complete the detection of multiple samples.
  • control unit 800 when the control unit 800 detects that a detection module has completed the detection, it judges whether the sample currently corresponding to the sampling needle 210 has a detection item corresponding to the detection module that has completed the detection; The current corresponding sample is sent to the detection module that has completed the detection; if there is no detection module, control the detection module that has completed the detection to be idle, or determine whether the subsequent samples have detection items corresponding to the detection module that has completed the detection.
  • the samples currently corresponding to the sampling needle 210 include samples currently collected by the sampling needle 210 and samples to be collected by the sampling needle 210 .
  • an embodiment of the present application also provides a multifunctional sample analysis device 1, which includes a base 100, a sample adding module 200, a blood analysis module 310, at least one type of instant detection module 320, and a control Unit 800.
  • the multifunctional sample analysis device 1 has at least one single-class detection mode and at least one multi-class detection mode.
  • Each single-category detection mode corresponds to one type of detection module, and can complete at least one detection item, that is, one type of single-category detection mode can complete at least one detection item.
  • Each multi-category detection mode corresponds to at least two types of detection modules (which can be a blood detection module 310 and at least one instant detection module 320, or two instant detection modules 320), and this multi-category detection mode can complete at least two Test items.
  • control unit 800 controls the sample adding module 200 to inject samples into the corresponding detection module, and controls the corresponding detection module to work.
  • the control unit 800 controls the sampling module 200 to inject samples into the detection module corresponding to the multi-category detection mode, and controls the detection module corresponding to the multi-category detection mode to work.
  • the control unit 800 receives the identity information of the current sample, and determines to execute the single-class detection mode or the multi-class detection mode according to the identity information or the received instruction.
  • the control unit 800 receives the identity information of the sample, which can be obtained by automatically identifying the identity information of the sample (such as scanning the label 610 on the test tube 600 or other information carrying units), can also receive the identity information sent by other components, and can also directly receive the identity information of the operator. Input command information, etc.
  • the control unit 800 determines the detection items and the required sample size, and controls the sampling needle 210 to collect the samples with the determined sample size, and sends them to the free corresponding to each detection item. detection module. If there is a detection module that is not idle, wait for it to be idle before sending in samples. And so on, so as to complete the detection of multiple samples.
  • the control unit 800 determines the sample volume to be collected according to the identity information or the received instruction.
  • the control unit 800 controls the sampling needle 210 to collect samples of the sample size, and sends them to the corresponding and idle detection modules corresponding to the multi-category detection mode.
  • control unit 800 determines the sample size, it controls the sampling needle 210 to collect samples of the sample size at one time, and sends them sequentially to the idle detection modules corresponding to the multi-category detection mode.
  • the sample adding module 200 can also collect more than two times, and then send it to the corresponding detection module.
  • the control unit 800 judges the detection cycle of each detection module corresponding to the sample, and preferentially sends the sample to the detection module with a long detection cycle, and the detection cycle includes the time for the detection module to complete the detection Or the length of time for the detection module to complete the detection plus the preparation time.
  • the order of input samples of each detection module can also be implemented according to other principles, for example, to send samples to idle detection modules first, or to judge comprehensively based on factors such as the idle state and working hours of the detection modules .
  • control unit 800 receives the identity information of the next sample, and determines to execute the single-category detection mode or the multi-category detection mode according to the identity information or the received instruction . Thereafter, subsequent steps may be performed according to the foregoing embodiments.
  • the test tube label 610 includes patient information, test item information, and blood drawing order.
  • the real-time detection module 320 performs the out-of-warehouse operation, prompting to put in the first sample detection consumables
  • the sampling module 500 transports the first sample to the sampling position, and the sampling needle 210 performs operations such as sampling and dividing according to the total sampling volume and the divided sample volume information.
  • the test process starts, and the test time is monitored (the completion of the sample injection can be confirmed by detecting the height position of the sampling needle 210 through the optocoupler).
  • the sampling module 500 transports the next sample to the sampling position; the sampling needle 210 also returns to the sampling position after dividing the sample and transferring the liquid, and performs cleaning operations to prepare for the next sample suction .
  • the operation interface prompts to prepare the consumables for the next sample.
  • the real-time detection module 320 performs an out-of-warehouse operation to replace the consumables (this step can be omitted if there is no real-time test item). This cycle continues until all the test tubes 600 on the test tube rack 700 are tested, then the test tubes 600 are taken out, or the tested test tube rack 700 is sent to the unloading area, and the next batch of sample testing is restarted.
  • the expedited sample scans the code, and the sample information is inserted into the original test information; after the test of the previous sample of the expedited sample is completed, the system prompts to release The urgent sample and urgent sample test consumables are loaded, and the test tube rack 700 or the sample injector directly sends the urgent sample to the sampling position or the sampling needle 210 moves to the emergency position to perform the urgent test.
  • the code scanning operation can be implemented through an external code scanning gun or a built-in code scanning module of the device.
  • the test tube label 610 includes patient information, test item information, and blood drawing order.
  • the device retrieves the detected item information, generates the first batch of consumables list, and displays it on the corresponding operation interface: the information of the consumables put in is displayed on the corresponding function bit icon; the real-time detection module 320 performs the out-of-warehouse operation, and puts in the corresponding consumables.
  • Retrieval principle Cover the first sample first, the idle module continues to retrieve the next sample, and so on.
  • the sampling module 500 will transport the first sample to the sampling position, and the real-time detection module 320 will perform the loading operation, and the detection consumables will reach the sampling area (if there is no real-time detection item, this step can be omitted) .
  • the sampling needle 210 performs operations such as sampling and dividing according to the information of the total sampling volume and the dividing volume. The principle is that after all the detection items of the first sample are divided and the pipetting operation is completed, the other sample detection items are sucked and sample injected. After the sampling needle 210 completes the operation, it immediately returns to the sampling position and waits.
  • the test process starts, and the test time is monitored (the completion of the sample injection can be confirmed by detecting the height position of the sampling needle 210 through an optocoupler).
  • the device automatically retrieves the sample test item information according to the order in which the samples are placed. If subsequent samples contain the module test item, the operation interface prompts to prepare corresponding test materials.
  • the device contains a wet blood analysis module 310, and the first sample contains blood analysis items, in order to reduce the number of cleanings of the sampling needle 210 due to the liquid transfer operation involved, first perform the blood separation of other instant detection modules 320, Finally, the blood analysis module 310 is executed to divide blood and transfer liquid.
  • the expedited sample scans the code, and the sample information is inserted into the original test item information; after the module of any test item in the expedited sample is free, the system prompts Put in urgent samples and urgent sample test consumables (if there is no immediate detection item, the step of putting in test consumables can be omitted), the sampling module 500 directly sends the urgent samples to the sampling position or the sampling needle 210 moves to the emergency position, Execute the expedited test; until all the test items of the expedited sample are completed, you can click "Exit Expedited” to continue the original test; you can also click "Temporary Expedited” to repeat the expedited test.
  • each instant detection module 320 test process is as follows:
  • Centrifugal dry blood analysis point-of-care detection module
  • Centrifugal disk microfluidic biochemical, immunological, coagulation analysis real-time detection module
  • Centrifugal disc dry biochemical and immunoassay instant detection module
  • Colloidal gold immunoassay instant detection module :

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  • Investigating Or Analysing Biological Materials (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

L'invention concerne un dispositif d'analyse d'échantillon multifonctionnel (1), comprenant une base (100), un module de chargement d'échantillon (200), un module d'analyse de sang (310), au moins un module de test de point d'intervention (320) et une unité de commande (800). Le module d'analyse de sang (310) et le module de test de point d'intervention (320) sont tous deux montés sur la base (100) et sont intégrés dans un ensemble pour obtenir de multiples fonctions et intégration. De plus, le module d'analyse de sang (310) et le module de test de point d'intervention (320) partagent un module de chargement d'échantillon (200). Une plage de distribution d'échantillon d'une aiguille d'échantillonnage (210) du module de chargement d'échantillon (200) recouvre le module d'analyse de sang (310) et le module de test de point d'intervention (320). Sous la commande de l'unité de commande (800), l'aiguille d'échantillonnage (210) délivre un échantillon à chaque module. Au moyen d'une structure intégrée, la structure globale du dispositif peut être plus compacte tout en obtenant de multiples fonctions et le partage d'un module de chargement d'échantillon (200) peut également simplifier davantage la structure, ce qui permet de réduire l'espace occupé du dispositif.
PCT/CN2021/142128 2021-12-28 2021-12-28 Dispositif d'analyse d'échantillon multifonctionnel WO2023122973A1 (fr)

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PCT/CN2021/142128 WO2023122973A1 (fr) 2021-12-28 2021-12-28 Dispositif d'analyse d'échantillon multifonctionnel
CN202180099242.9A CN117460957A (zh) 2021-12-28 2021-12-28 多功能样本分析设备

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