WO2023122973A1

WO2023122973A1 - Multifunctional sample analysis device

Info

Publication number: WO2023122973A1
Application number: PCT/CN2021/142128
Authority: WO
Inventors: 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: 2021-12-28
Filing date: 2021-12-28
Publication date: 2023-07-06
Also published as: CN117460957A

Abstract

Provided is a multifunctional sample analysis device (1), comprising a base (100), a sample loading module (200), a blood analysis module (310), at least one point-of-care testing module (320), and a control unit (800). The blood analysis module (310) and the point-of-care testing module (320) are both mounted on the base (100) and are integrated into a whole to achieve multiple functions and integration. In addition, the blood analysis module (310) and the point-of-care testing module (320) share one sample loading module (200). A sample delivery range of a sampling needle (210) of the sample loading module (200) covers the blood analysis module (310) and the point-of-care testing module (320). Under the control of the control unit (800), the sampling needle (210) delivers a sample to each module. By means of an integrated structure, the overall structure of the device can be more compact while achieving multiple functions, and the sharing of one sample loading module (200) can also further simplify the structure, thereby reducing occupied space of the device.

Description

Multifunctional sample analysis equipment

technical field

The invention relates to a medical device, in particular to a multifunctional sample analysis device.

Background technique

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.

Usually, in order to meet the needs of more comprehensive testing and analysis, doctors expect wet blood analysis equipment to be used together with various other point-of-care testing equipment, so as to obtain the results of various types of testing items more quickly, and help doctors to treat patients. Better diagnosis and treatment. However, under the coexistence of many testing equipment, it will inevitably occupy a lot of space, making the space in the workplace more and more tense.

technical problem

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.

technical solution

Based on the above purpose, 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, the 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;

and a control unit, 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.

In one embodiment, the instant detection module is distributed on at least one side of the blood analysis module.

In one embodiment, each of the instant detection modules has a sample loading area, and 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.

In one embodiment, there are at least two immediate detection modules, at least some of which are of different types.

In one embodiment, there are at least two instant detection modules, all of which are of the same type.

In one embodiment, 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.

In one embodiment, both the blood analysis module and the real-time detection module are detection modules, and 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.

In one embodiment, after the control unit determines the sample size, it controls the sampling needle to collect samples of the sample size at one time, and sends them to the detection modules corresponding to each detection item in sequence.

In one embodiment, the 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.

In one embodiment, after the sampling needle finishes sending the previous sample, 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.

In one embodiment, 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.

In one embodiment, 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, and 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.

In one embodiment, the instant detection modules are arranged horizontally or vertically.

In one embodiment, the horizontal arrangement includes arranging in one or more rows in the horizontal direction, or arranging in an array in the horizontal direction.

In one embodiment, the vertical arrangement includes being arranged in one or more columns in the vertical direction, or arranged in an array in the vertical direction.

In one embodiment, 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.

In one embodiment, 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.

In one embodiment, 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.

Beneficial effect

The multifunctional sample analysis device according to the above-mentioned embodiment 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. Through this integrated structure, 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.

Description of drawings

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.

Embodiments of the present invention

The present invention will be further described in detail below through specific embodiments in conjunction with the accompanying drawings. Wherein, similar elements in different implementations adopt associated similar element numbers. In the following implementation manners, many details are described for better understanding of the present application. However, those skilled in the art can readily recognize that some of the features can be omitted in different situations, or can be replaced by other elements, materials, and methods. In some cases, some operations related to the application are not shown or described in the description, this is to avoid the core part of the application being overwhelmed by too many descriptions, and for those skilled in the art, it is necessary to describe these operations in detail Relevant operations are not necessary, and they can fully understand the relevant operations according to the description in the specification and general technical knowledge in the field.

In addition, the characteristics, operations or characteristics described in the specification can be combined in any appropriate manner to form various embodiments. At the same time, the steps or actions in the method description can also be exchanged or adjusted in a manner obvious to those skilled in the art. Therefore, the various sequences in the specification and drawings are only for clearly describing a certain embodiment, and do not mean a necessary sequence, unless otherwise stated that a certain sequence must be followed.

The serial numbers assigned to components in this document, such as "first", "second", etc., are only used to distinguish the described objects, and do not have any sequence or technical meaning. The "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 detection module 320 and the control unit 800 and other related components.

Wherein, the machine base 100 plays a supporting role, and other components are directly or indirectly connected to the machine base 100 . Please refer to FIGS. 2 and 4 . In one embodiment, 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.

For example, in one embodiment, 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.

Different from setting the blood analysis equipment and real-time detection equipment separately, in this embodiment, 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.

Please refer to FIGS. 1-5 , 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.

Wherein, 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.

Among them, 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 .

Compared with the side-by-side arrangement of various blood analysis devices and real-time detection devices, in this device, 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. Through this integrated structure, 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.

At the same time, 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. Moreover, through the control of the control unit 800, the sampling needle 210 can realize the effect of accurate quantitative and fast filling speed.

In addition, 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.

Please refer to Figures 1-4, in order to make the whole machine more compact and simple in appearance, in one embodiment, 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.

Please refer to FIG. 3 , 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. Considering that the sample carrying device 400 is a consumable, in one embodiment, 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. 3 , in the microfluidic chip, 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.

Please refer to Figures 2 and 4, in one embodiment, in order to replace the sample carrying device 400 more conveniently, 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.

In one embodiment, 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. For example, 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. For example, 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.

In one embodiment, 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. When the diluent is needed for each detection module, it can be provided by the prepackaged diluent box in the sample carrying device 400 .

In one embodiment, 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.

Further, in one embodiment, please refer to FIGS. 2 and 4 , 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 . Some or all of 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. When installing these instant detection modules 320, it is only necessary to complete mechanical fixing, or mechanical fixing and simple electrical connection. For example, 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.

Therefore, 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. Moreover, 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. At the same time, 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 . In another embodiment, 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. For example, 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.

Of course, in addition to assembling the real-time detection module 320 in an integral modular form, 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.

Furthermore, 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 In one embodiment, the instant detection module 320 is distributed on at least one side of the blood analysis module 310. For example, in FIG. X direction). Of course, in other embodiments, the multiple instant detection modules 320 may also be distributed on the vertical side (Z direction) of the blood analysis module 310 . Alternatively, a plurality of instant detection modules 320 may also be arranged around the blood analysis module 310 horizontally and/or vertically.

In one embodiment, the instant detection modules 320 are arranged horizontally or vertically. Wherein, 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.

Please refer to Figures 1, 2 and 4. In one embodiment, 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 . In addition, these instant detection modules 320 can also be arranged along the X direction or the Z direction.

For the convenience of description, the blood analysis module 310 and the real-time detection module 320 are collectively referred to as detection modules in this application. In one embodiment, 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. Alternatively, in one embodiment, taking into account the time-consuming detection cycle and the difficulty in replacing consumables, 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. For example, in one embodiment, when at least one detection module is a dry-type blood analysis instant detection module, since 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.

Of course, it is not limited that the detection modules are arranged according to a certain rule, or the detection modules are arranged in other ways. Then, adjust the order of starting work from the order of sample delivery. In one embodiment, 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). However, in other embodiments, 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 .

Please refer to FIGS. 2 and 4. In one embodiment, when the instant detection modules 320 are arranged sequentially along the Y direction, each instant detection module 320 is related to colloidal gold test paper, detection card, capillary centrifuge tube, microfluidic detection For the replacement of disks and other consumables, 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. Of course, the entering/exiting mechanism can also be omitted, and the operator installs it manually.

Further, 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. In one embodiment, 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.

In one embodiment, based on cost considerations, 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. In this structure, 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 . As shown in FIG. 8 , B1 is the gap between the stop block 222 and the guide sheet metal 2 , and 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).

Further, 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. 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. When 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 .

Furthermore, the sample to be detected can be injected manually by the operator, or an additional sampling module can be provided. In one embodiment, 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.

In one embodiment, 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.

In one embodiment, 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.

Please refer to FIGS. 2 , 9 and 10 . In one embodiment, 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. In the rotary sampling device, 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. In addition, 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.

Please refer to Figures 2, 9 and 10. In one embodiment, 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.

Please refer to FIG. 4 , in an embodiment, the sample injection module 500 can also be a sample injector, which is suitable for occasions with a large amount of samples. As shown in FIG. 4 , 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. The 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. When 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. As shown in Figures 9 and 10, 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. In addition, 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.

Further, when the sample to be tested is tested, 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. After determining the test item and the sample size to be collected, 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.

In one embodiment, after the 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 . Certainly, in other embodiments, for the same sample, the sample adding module 200 can also collect more than two times, and then send it to the corresponding detection module.

In one embodiment, when a sample requires multiple real-time detections, after the sampling is completed, 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.

In one embodiment, when there are more than two samples to be detected, after the sampling needle 210 finishes sending the sample to the previous sample, 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.

In one embodiment, 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 .

On the other hand, 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.

Wherein, 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.

In the single-category detection mode, the 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. In the multi-category detection mode, 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.

In one embodiment, 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. When determining the single-category detection mode or the multi-category detection mode, 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.

In one embodiment, in the multi-category detection mode, 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.

In one embodiment, after the 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. Certainly, in other embodiments, for the same sample, the sample adding module 200 can also collect more than two times, and then send it to the corresponding detection module.

In one embodiment, in the multi-category detection mode, 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. However, in other embodiments, 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 .

In one embodiment, after the sampling needle 210 finishes sending the previous sample, the 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.

In the following, part of the workflow of the multifunctional sample analysis device 1 will be described in conjunction with the specific operation steps of an embodiment.

A workflow for single-sample detection:

(1) Blood sample preparation;

(2) Printing and pasting of the test tube label 610;

The test tube label 610 includes patient information, test item information, and blood drawing order.

(3) Sample code scanning;

Scan the code according to the order of blood drawing on the test tube label 610, and put it into the corresponding position of the test tube rack 700; you can use an external code scanning gun or a built-in code scanning module to scan the code. After scanning the code, the device will generate information about the testing items, the total sampling volume and the sub-sample volume.

(4) Preparation of POCT consumables (if there is no immediate detection item, this step can be omitted);

The real-time detection module 320 performs the out-of-warehouse operation, prompting to put in the first sample detection consumables

(5) Start the test;

Click the "single-sample detection mode" button on the operation interface, 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. After the sample injection of a single detection module is completed, 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).

During the detection process of the first sample, 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 . When the test of the last detection module is about to be terminated, the operation interface prompts to prepare the consumables for the next sample.

After the first sample test is completed, 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.

For temporary expedited test items, click the "temporary expedited" button on the operation interface; 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. After the test is completed, you can click "Exit Expedited" to continue the original test; you can also continue to click "Temporary Expedited" to repeat the expedited test.

During the whole process, all consumables for testing samples are put in sequentially. To detect discs, test cards, etc., you need to scan the code to obtain consumable information (if there is no real-time detection item, this step can be omitted). The code scanning operation can be implemented through an external code scanning gun or a built-in code scanning module of the device.

A workflow for multi-sample detection:

(1) Blood sample preparation;

(2) Printing and pasting of the test tube label 610;

(3) Sample code scanning;

Scan the code according to the order of blood drawing on the test tube label 610, and put it into the corresponding position of the test tube rack 700; you can use an external code scanning gun or a built-in code scanning module to scan the code. After the code scanning is completed, the device will generate information on the testing items, the total sampling volume of the first sample, the sampling volume and sub-sample volume information of each testing item in other samples.

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.

(5) Start the test;

Click the "multi-sample detection mode" button on the operation interface, 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.

After the sample injection of a single module is completed, 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). When a module test is about to be terminated, 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.

After the module test is completed, perform the out-of-warehouse operation and replace the consumables (this step can be omitted if there is no immediate detection item). After the replacement of consumables is completed, click the button of this module on the operation interface. When the equipment detects that the sampling needle 210 is waiting, this module performs the operation of entering the warehouse (if there is no immediate detection item, this step can be omitted), and the test tube rack 700 transports the corresponding samples to the sampling position. to start a new test.

If multiple modules are detected almost at the same time, after the replacement of consumables, click the corresponding module button on the operation interface, and when the equipment detects the sampling needle 210, it will be sorted according to the test time of these modules, and the warehouse-in operation will be performed sequentially (the warehouse with the longest time) , the corresponding samples are also sequentially transported to the sampling position (if there is no immediate detection item, this step can be omitted).

This cycle continues until all detection items of all samples are detected, and the next batch of samples is replaced. During the test, if 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.

For temporary expedited test items, click the "Temporary Expedited" button on the operation interface; 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.

Wherein, in an embodiment, each instant detection module 320 test process is as follows:

Centrifugal dry blood analysis point-of-care detection module:

Sample injection→sample centrifugation, staining-→optical detection.

Centrifugal disk microfluidic biochemical, immunological, coagulation analysis real-time detection module:

Sample injection→sample centrifugation, quantification/diluent quantification→mixing→colorimetric hole filling→reaction color development→optical detection.

Centrifugal disc dry biochemical and immunoassay instant detection module:

Sample injection→sample centrifugation, quantification→colorimetric hole filling→reaction color development→optical detection.

Colloidal gold immunoassay instant detection module:

Sample injection→antibody binding→reaction color development.

This document is described with reference to various exemplary embodiments. However, those skilled in the art will recognize that changes and modifications can be made to the exemplary embodiments without departing from the scope herein. For example, the various operational steps, as well as the components used to perform the operational steps, may be implemented in different ways depending on the particular application or considering any number of cost functions associated with the operation of the system (e.g., one or more steps may be deleted, modified or incorporated into other steps).

Claims

A multifunctional sample analysis device, characterized in that it includes:

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, the 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;

and a control unit, 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 multifunctional sample analysis device according to claim 1, wherein the instant detection module is distributed on at least one side of the blood analysis module.
The multifunctional sample analysis device according to claim 1 or 2, wherein the instant detection modules all have a sample loading area, and the moving track of the sampling needle covers all the sample loading areas of the instant detection modules, which can A sample is distributed to all said sample analysis and detection modules.
The multifunctional sample analysis device according to any one of claims 1-3, wherein there are at least two immediate detection modules, and at least some of the instant detection modules are of different types.
The multi-functional sample analysis device according to any one of claims 1-3, characterized in that there are at least two immediate detection modules, all of which are of the same type.
The multifunctional sample analysis device according to any one of claims 1-5, characterized in that, the types of the instant detection module include dry blood analysis instant detection module, biochemical analysis instant detection module, immune analysis instant detection module, One or more of the instant detection modules for molecular analysis and instant detection modules for coagulation analysis.
The multifunctional sample analysis device according to any one of claims 1-6, wherein the blood analysis module and the instant detection module are both detection modules, and the control unit receives the identity information of the current sample , and determine the testing items and 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 testing modules corresponding to each testing item.
The multifunctional sample analysis device according to claim 7, characterized in that, after the control unit determines the sample volume, it controls the sampling needle to collect the samples of the sample volume at one time, and sends them into the In the detection module corresponding to each detection item.
The multifunctional sample analysis device according to claim 7 or 8, wherein the control unit judges the detection period of each detection module corresponding to the sample, and preferentially sends the sample to the detection module with a long detection period, The detection period includes the time period for the detection module to complete the detection or the time period for the module to complete the detection plus the preparation time.
The multifunctional sample analysis device according to any one of claims 7-9, characterized in that, after the sampling needle finishes sending the previous sample, the control unit determines the detection status according to the identity information of the next sample. item and the amount of sample to be collected, controlling the sampling needle to collect the next sample, and sending the collected next sample into the idle detection module corresponding to the detection item.
The multifunctional sample analysis device according to any one of claims 7-10, characterized in that, 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 The detection item corresponding to the detection module that has completed the detection; if there is, control the sampling needle to send its current corresponding sample into the detection module that has completed the detection; if not, control the detection module to be idle, Waiting for the next sample.
The multi-functional sample analysis device according to any one of claims 1-11, wherein the base is preset with a plurality of module installation positions, and the module installation positions have holes for assembling corresponding instant detection modules. Assembly structure, the instant detection module is a modular structure, which has a docking structure for connecting with the assembly structure, the instant detection module is detachably installed on the module installation position, the docking structure It is detachably connected with the assembly structure.
The multifunctional sample analysis device according to any one of claims 1-12, wherein the instant detection modules are arranged horizontally or vertically.
The multifunctional sample analysis device according to claim 13, wherein the horizontal arrangement includes one or more rows arranged in the horizontal direction, or arranged in an array in the horizontal direction.
The multi-functional sample analysis device according to claim 13, wherein 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 according to any one of claims 1-15, characterized in that the multifunctional sample analysis device has a sample introduction area, the sample introduction area has a sampling position and an emergency position, and the sampling The moving track of the needle covers the sampling position and the emergency position.
The multifunctional sample analysis device according to any one of claims 1-16, characterized in that, 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. The detection device is used to cooperate with the sample carrying device to complete the corresponding detection items after the sample is loaded on the sample carrying device.
The multi-functional sample analysis device according to any one of claims 1-17, characterized in that, the base includes a casing, the casing encloses an accommodating cavity, and the blood analysis module and the instant The detection module is placed in the accommodating cavity, and the housing has a disassembly port corresponding to the instant detection module, and the disassembly port is used to replace the sample carrying device corresponding to the instant detection module.