CN117460957A - Multifunctional sample analysis equipment - Google Patents

Abstract

The multifunctional sample analysis equipment (1) comprises a machine base (100), a sampling module (200), a blood analysis module (310), at least one instant detection module (320) and a control unit (800), wherein the blood analysis module (310) and the instant detection module (320) are all installed on the machine base (100) and integrated into a whole, so that the multifunctional and integrated structure is realized. Simultaneously, the blood analysis module (310) and the instant detection module (320) share one sampling module (200), the sampling range of the sampling needle (210) of the sampling module (200) covers the blood analysis module (310) and the instant detection module (320), and the sampling needle (210) distributes samples to all the modules under the control of the control unit (800). Through the integrated structure, the whole structure of the equipment can be more compact under the condition of realizing multiple functions, and the structure can be further simplified by sharing one set of sampling modules (200), so that the occupied space of the equipment is reduced.

Description

Multifunctional sample analysis equipment Technical Field

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

Background

The wet blood analysis device is a common blood sample analysis device, which can complete routine blood detection such as blood cell count, classification and the like; detection of hemoglobin concentration, inflammatory factors, etc. can also be accomplished. In addition, point of care testing (POCT) is used as a subdivision in the field of in-vitro diagnosis, and is widely applied to the fields of clinical examination, personal health management, disease prevention and monitoring and the like by virtue of the characteristics of miniaturization of instruments, rapidness in detection, simplicity in operation and the like. The instant detection can relate to detection items such as blood analysis, biochemical analysis, immunoassay, molecular analysis, coagulation analysis and the like. Implementations of the instant detection include, but are not limited to, by microfluidic techniques, dry biochemical analysis techniques, colloidal gold detection techniques, and the like.

Generally, in order to meet the more comprehensive requirements of detection and analysis, doctors are more expected to put wet blood analysis equipment together with other various instant detection equipment so as to more quickly acquire the results of various types of detection items and help doctors to better diagnose and treat patients. However, many detection devices coexist, which inevitably occupy a large amount of space, so that the space of a workplace is increasingly strained.

Technical problem

The invention mainly provides a novel multifunctional sample analysis device for displaying the multifunctional sample analysis device with the blood analysis and detection functions and the instant detection functions.

Technical solution

In view of the above object, there is provided in one embodiment of the present application a multifunctional sample analysis apparatus including:

the machine base plays a supporting role;

the sample adding module is arranged on the machine base and comprises a sampling needle for sampling and sample feeding and a sampling driving device for driving the sampling needle to move;

a blood analysis module mounted on the housing and including a sample preparation device having at least one reaction cell for receiving a sample fed by the sampling needle and a reagent supply assembly for providing a processing reagent to the sample in the reaction cell to prepare a sample fluid to be tested; the detection device is used for detecting the sample liquid to be detected so as to obtain the blood parameters of the sample;

the instant detection module is used for detecting samples in real time and is arranged on the base;

The sample adding module, the blood analysis module and the instant detection module are connected with the control unit in a signal manner, and the control unit controls the sample adding module, the blood analysis module and the instant detection module to work;

the sample sending range of the sampling needle covers the reaction tank and the instant detection module so as to be capable of sending samples into the reaction tank and the instant detection module, and the control unit controls the sampling needle to send the samples into the reaction tank and/or the instant detection module corresponding to the detection items according to the detection items of the samples and controls the blood analysis module and/or the instant detection module corresponding to the detection items to carry out detection analysis on the samples.

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

In an embodiment, the instant detection modules are all provided with sample adding areas, the moving track of the sampling needle covers the sample adding areas of all the instant detection modules, and samples can be separated from all the sample analysis detection modules.

In one embodiment, the number of the instant detection modules is at least two, and at least part of the instant detection modules are different in type.

In one embodiment, the number of the instant detection modules is at least two, and all the instant detection modules are of the same type.

In one embodiment, the type of the instant detection module comprises one or more than two of a dry blood analysis instant detection module, a biochemical analysis instant detection module, an immunoassay instant detection module, a molecular analysis instant detection module and a blood coagulation analysis instant detection module.

In one embodiment, the blood analysis module and the instant detection module are both detection modules, and the control unit receives identity information of a current sample and determines a detection item and a sample quantity to be acquired according to the identity information; the control unit controls the sampling needle to collect the samples of the sample quantity and sends the samples into the detection modules corresponding to the detection items respectively.

In one embodiment, after the control unit determines the sample size, the sampling needle is controlled to collect the sample of the sample size at one time, and the sample is sequentially sent to the detection modules corresponding to the detection items.

In one embodiment, the control unit determines a detection period of each detection module corresponding to the sample, and sends the sample to the detection module with a long detection period preferentially, where the detection period includes a period of time for the detection module to complete detection or a period of time for the detection module to complete detection plus a preparation period.

In one embodiment, after the sampling needle finishes the sample feeding of the previous sample, the control unit determines a detection item and the sample quantity to be collected according to the identity information of the next sample, controls the sampling needle to collect the next sample, and sends the collected next sample into the idle detection module corresponding to the detection item.

In one embodiment, after the control unit detects that one of the detection modules completes detection, it is determined whether a sample corresponding to the sampling needle currently has a detection item corresponding to the detection module that has completed detection; if yes, the sampling needle is controlled to send the current corresponding sample into the detection module after detection; and if not, controlling the detection module to be idle, and waiting for the next sample.

In an embodiment, the base is preset with a plurality of module mounting positions, the module mounting positions are provided with assembling structures for assembling corresponding instant detection modules, the instant detection modules are of modularized structures and are provided with abutting structures for being connected with the assembling structures, the instant detection modules are detachably mounted on the module mounting positions, and the abutting structures are detachably connected with the assembling structures.

In one embodiment, the instant detection modules are arranged along the transverse direction or along the vertical direction.

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

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

In one embodiment, the multifunctional sample analysis device has a sample injection zone with a sampling site and an emergency site, the movement track of the sampling needle covering the sampling site and the emergency site.

In one embodiment, the instant detection module comprises a carrying position for placing a sample carrying device and a detection device matched with the sample carrying device, wherein the detection device is used for being matched with the sample carrying device after the sample is loaded on the sample carrying device so as to complete a corresponding detection project.

In one embodiment, the stand includes a housing, the housing encloses a receiving cavity, the blood analysis module and the instant detection module are disposed in the receiving cavity, the housing has a disassembly opening corresponding to the instant detection module, and the disassembly opening is used for replacing a sample carrying device corresponding to the instant detection module.

Advantageous effects

The multifunctional sample analysis device according to the above embodiment includes a base, a sample loading module, a blood analysis module, at least one instant detection module, and a control unit. The blood analysis module and the instant detection module are both arranged on the machine base and integrated into a whole, so that the multifunctional and integrated structure is realized. Simultaneously, the blood analysis module and the instant detection module share one sample adding module, the sample sending range of the sampling needle of the sample adding module covers the blood analysis module and the instant detection module, and under the control of the control unit, the sampling needle distributes samples to all the modules. Through this integrated structure, can be under the multi-functional circumstances of realization, make equipment overall structure compacter, share a set in addition and add the appearance module moreover, also can further simplify the structure, reduce equipment and make occupation space littleer.

Drawings

FIG. 1 is a schematic diagram of each module of a multifunctional sample analysis device according to an embodiment of the present application;

FIG. 2 is a schematic diagram of a multifunctional sample analyzer according to one embodiment of the present application;

FIG. 3 is an enlarged view of portion A of FIG. 2;

FIG. 4 is a schematic diagram of a multifunctional sample analyzer according to another embodiment of the present application;

FIG. 5 is a schematic structural diagram of a sample loading module according to an embodiment of the present application;

FIG. 6 is a schematic structural diagram of a sample loading module according to another embodiment of the present application;

FIG. 7 is a schematic view of the configuration of the engagement of the stop turret with the guide according to one embodiment of the present disclosure;

FIG. 8 is a schematic view of the offset angle of the sampling needle according to one embodiment of the present application;

FIG. 9 is a schematic diagram of sample positions on a sample injection module of a multifunctional sample analysis device according to an embodiment of the present disclosure;

FIG. 10 is a schematic diagram of a sample injection module of a multifunctional sample analysis device according to an embodiment of the present disclosure;

FIG. 11 is a schematic view of sample positions on a sample rack according to one embodiment of the present application;

FIG. 12 is a schematic view of a sample rack according to an embodiment of the present application.

Embodiments of the invention

The invention will be described in further detail below with reference to the drawings by means of specific embodiments. Wherein like elements in different embodiments are numbered alike in association. In the following embodiments, numerous specific details are set forth in order to provide a better understanding of the present application. However, one skilled in the art will readily recognize that some of the features may be omitted, or replaced by other elements, materials, or methods in different situations. In some instances, some operations associated with the present application have not been shown or described in the specification to avoid obscuring the core portions of the present application, and may not be necessary for a person skilled in the art to describe in detail the relevant operations based on the description herein and the general knowledge of one skilled in the art.

Furthermore, the described features, operations, or characteristics of the description may be combined in any suitable manner in various embodiments. Also, various steps or acts in the method descriptions may be interchanged or modified in a manner apparent to those of ordinary skill in the art. Thus, the various orders in the description and drawings are for clarity of description of only certain embodiments, and are not meant to be required orders unless otherwise indicated.

The numbering of the components itself, e.g. "first", "second", etc., is used herein merely to distinguish between the described objects and does not have any sequential or technical meaning. The terms "coupled" and "connected," as used herein, are intended to encompass both direct and indirect coupling (coupling), unless otherwise indicated.

Referring to fig. 1-4, in one embodiment, the multifunctional sample analysis apparatus 1 includes a base 100, a sampling module 200, a blood analysis module 310, at least one instant detection module 320, a control unit 800, and other related components.

Wherein, the stand 100 plays a supporting role, and other components are directly or indirectly connected to the stand 100. Referring to fig. 2 and 4, in one embodiment, the stand 100 may have a housing 110, where the housing 110 has a closed or semi-closed cavity. The housing 100 may be designed in other non-housing configurations.

The blood analysis module 310 is mounted on the housing 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 cell 3111 and a reagent supply assembly 3112. The reaction cell 3111 is for receiving a sample fed by the sampling needle 210. The reagent supply assembly 3112 is used to supply a processing reagent to a sample in the reaction cell 3111 to prepare a sample liquid to be measured. The detecting device 312 is used for detecting a sample fluid to be detected to obtain a blood parameter of the sample.

The point-of-care testing module 320 (POCT) 300 is a miniaturized and rapid testing module, and may be used for blood analysis, biochemical analysis, immunoassay, molecular analysis, blood coagulation analysis, etc. The manner of detection in real time includes, but is not limited to, microfluidic technology, dry biochemical analysis technology, colloidal gold detection technology, etc.

For example, in one embodiment, the types of instant detection modules 320 include one or more of a dry blood analysis instant detection module, a biochemical analysis instant detection module, an immunoassay instant detection module, a molecular analysis instant detection module, and a coagulation analysis instant detection module.

Unlike the case where the blood analysis device and the instant detection device are separately disposed, in this embodiment, the blood analysis module 310 and the instant detection module 320 are both mounted on the stand 100 and can be arranged in a set order to reasonably plan the overall layout.

Referring to fig. 1-5, the sample application module 200 is used for completing sampling of a sample to be tested and delivering the collected sample to the corresponding blood analysis module 310 and the instant detection module 320. The loading module 200 is mounted on the housing 100, and the loading module 200 includes a sampling needle 210 for sampling and feeding samples, a sampling drive 220 for driving the sampling needle 210 to move, and other related structures (e.g., a sample injector 230).

The blood analysis module 310, the sample application module 200 and the instant detection module 320 are all in signal connection with a control unit 800, and the control unit 800 is used for controlling the operations of the blood analysis module 310, the sample application module 200 and the instant detection module 320. The control unit controls the sampling needle to send the sample into the reaction tank 3111 and/or the instant detection module 320 corresponding to the detection item according to the detection item of the sample, and controls the blood analysis module 310 and/or the instant detection module 320 corresponding to the detection item to perform detection analysis on the sample.

The sample-feeding range of the sampling needle 210 covers all the blood analysis modules 310 and the instant detection modules 320, and thus, the sampling needle 210 can distribute samples to all the blood analysis modules 310 and the instant detection modules 320 when needed.

The blood analysis module 310 and the instant detection module 320 have sample adding areas, the moving track of the sampling needle 210 does not have to cover all areas of the blood analysis module 310 and the instant detection module 320, and only the sample adding areas of the blood analysis module 310 and the instant detection module 320 need to be covered, so that the stroke of the sampling needle 210 is simplified, the whole device is more compact, and the purpose of separating samples from all the instant detection modules 320 can be realized.

Compared with the parallel arrangement of the blood analysis equipment and the instant detection equipment, in the device, the blood analysis module 310 and the instant detection module 320 are all arranged on the machine base and integrated into a whole, so that the multifunctional and integrated device is realized. Meanwhile, the blood analysis module 310 and the instant detection module 320 share a sample application module, and a sample application range of the sampling needle 210 of the sample application module covers the blood analysis module 310 and the instant detection module 320, and the sampling needle 210 distributes samples to each module under the control of the control unit 800. Through this integrated structure, can be under the multi-functional circumstances of realization, make equipment overall structure compacter, share a set in addition and add the appearance module moreover, also can further simplify the structure, reduce equipment and make occupation space littleer.

Meanwhile, sample filling of the blood analysis module 310 and each instant detection module 320 is completed by the sampling needle 210 in the shared sample filling module 200, one set of sample filling module 200 can meet the use of a plurality of modules, and the sample filling module 200 does not need to be designed separately for each blood analysis module 310 and each instant detection module 320, so that the structure of the device is further simplified, and the device can be miniaturized. Moreover, the sampling needle 210 can realize the effects of accurate quantification and high filling speed under the control of the control unit 800.

In addition, the multifunctional sample analysis device 1 may further set hardware generally required by the detection device, such as the display screen 120 (as shown in fig. 2 and 4), the report printing module (such as a printer), the network interface, and the like, especially general hardware of each module, so that each module may share one or more general hardware, thereby saving a device placement space and a device purchase cost.

Referring to fig. 1 to 4, in order to make the whole apparatus more compact and compact in appearance, in one embodiment, the stand 100 includes a housing 110, the housing 110 encloses a receiving cavity, and the blood analysis module 310 and the instant detection module 320 are disposed in the receiving cavity. The housing 110 can protect the blood analysis module 310 and the instant detection module 320, and also can prevent the interference of external factors of the device to the detection, affecting the detection structure.

Referring to fig. 3, the detection process of the instant detection module 320 is implemented by a sample carrier 400 (also referred to as a consumable material), and for example, the sample carrier 400 may include, but is not limited to, a microfluidic chip or a disc, a test strip, a capillary tube, a detection card, etc. which can be applied to the instant detection technology. Considering that the sample carrier 400 is a consumable, in one embodiment, the instant detection module 320 includes a carrier location for placement of the sample carrier 400 and a detection device for cooperation with the sample carrier 400. The carrying bit is mainly used for placing the sample carrying device 400, and has the function of fixing or realizing certain actions on the sample carrying device 400 according to the difference of the instant detection principle when necessary. For example, as shown in fig. 3, in the microfluidic chip, the carrier may have a fixing structure 321 for fixing the microfluidic chip, a driving motor 322 for driving the microfluidic chip 40 to perform centrifugal motion, and the like. The detection device is used for being matched with the sample bearing device 400 after the sample is loaded on the sample bearing device 400 so as to complete corresponding detection items. The detection means may employ, but is not limited to, optical detection (e.g., colorimetry, etc.), chemical reaction detection (e.g., chromogenic reaction, etc.), physical property detection, etc.

Referring to fig. 2 and 4, in order to replace the sample carrier 400 more conveniently, the housing 110 has a detachable opening 111 corresponding to the instant detection module 320, and the sample carrier 400 corresponding to the instant detection module 320 can be replaced quickly and timely from the detachable opening 111.

In one embodiment, the types of on-line detection modules 320 include, but are not limited to, a dry blood analysis on-line detection module, a biochemical analysis on-line detection module, an immunoassay on-line detection module, a molecular analysis on-line detection module, and a coagulation analysis on-line detection module.

The dry blood analysis instant detection module irradiates and analyzes the blood sample after centrifugation in the special capillary tube by adopting a light source with specific wavelength to collect images. Conventional blood analysis is a well-developed technology, and various analysis methods are integrated by an analysis module. For example: detecting the quantity and volume distribution of white blood cells/basophils, erythrocytes and platelets by adopting an electrical impedance principle; detecting the concentration of hemoglobin by adopting a colorimetric method; acquiring a four-classification/five-classification statistical technique of the leucocytes by adopting a semiconductor laser flow type cell technique; and detecting inflammatory factors such as CRP, SAA and the like by adopting a latex immunoturbidimetry.

The biochemical analysis instant detection module can complete detection of liver function, kidney function, pancreas, cardiac muscle, blood sugar, blood fat, electrolyte and the like, and is commonly used for health examination, disease screening, preoperative sign monitoring and the like. For example, different test packages of the biochemical analysis instant detection module based on the centrifugal microfluidic principle are realized by different reagent combinations packaged in the detection disc.

The immunoassay instant detection module can be used for diagnosing diseases and monitoring immune functions through detection and screening of inflammatory factors, tumor markers, antigens, antibodies and other projects. For example, different test packages of immunoassay instant detection modules based on the principle of centrifugation microfluidic are realized by different reagents or antibodies encapsulated within the detection disc.

The blood coagulation analysis instant detection module can detect the blood coagulation system condition and the hemostatic function of a patient by detecting thrombin time, prothrombin time, activated partial thromboplastin time and fibrinogen, and is a necessary examination item before operation.

In one embodiment, the initial sample of each detection module is whole blood, and for the detection module requiring serum, the serum separation is realized by a centrifugal motor in the module. When a diluent is required for each detection module, it may be provided by a pre-packaged diluent cartridge within the sample carrier 400.

In one embodiment, at least some of the instant detection modules 320 in the multi-functional sample analysis device 1 are different in type, or all of the instant detection modules 320 are the same type of instant detection module 320. That is, when the multifunctional sample analysis apparatus 1 has at least two instant detection modules 320, the at least two instant detection modules 320 may be the same type of instant detection module 320, or may be different types of instant detection modules 320, or some of the instant detection modules 320 may be the same type, and some of the instant detection modules 320 may be different types.

The multifunctional sample analysis device 1 shown in this embodiment can realize a plurality of detection items (including blood detection items and various instant detection items) by one device, thereby realizing centralized detection and centralized operation, and improving detection efficiency and operation convenience. The multifunctional sample analysis device 1 can integrate POCT detection functions such as biochemistry, immunity, molecular coagulation and the like and blood detection functions into a quick-detection integrated machine, and is applicable to but not limited to occasions such as basic sanitation systems, emergency treatment, pet hospitals and the like.

Further, referring to fig. 2 and 4, the base 100 is provided with a plurality of module mounting positions 114, and the module mounting positions 114 have an assembling structure for assembling the corresponding instant detection module 320. The module mounting location 114 may be a cavity structure, or may be other non-cavity structures, so long as the corresponding instant detection module 320 can be accommodated and fixed. The instant detection modules 320 are all modules capable of independently completing the corresponding instant detection function, i.e., when a detected sample is added to each instant detection module 320, the instant detection module 320 has the capability of independently completing the instant detection function under the control of the control unit of the receiving control unit 800 or the control unit of the instant detection module 320 itself. The instant detection modules 320 may be installed by simply mechanically fastening, or mechanically fastening and simply electrically interfacing. For example, the instant detection module 320 has a connection structure, and the instant detection module 320 is mounted on the module mounting location 114, and the connection structure is detachably connected with the assembly structure. The releasable connection includes, but is not limited to, commonly used snap-fit, screw-fit, adhesive, magnetic, interference fit, etc. The electrical interfacing may be accomplished by conventional various electrical connection structures, such as plugging of connection terminals, contact connections, cable connections, and the like.

Therefore, the instant detection modules 320 can be directly assembled and disassembled on the stand 100, and an operator can selectively configure the instant detection modules 320 according to the needs of the operator, so that the device has a corresponding instant detection function, and the device is more flexible to use. Moreover, the modular assembly of the instant detection module 320 also facilitates the manufacturer to flexibly add or subtract instant detection functionality depending on the operator's needs. Meanwhile, the at least two instant detection modules 320 share one sample adding module 200, so that the structure is more compact.

The detachable instant detection modules 320 may have a fixed mounting position, i.e. a certain mounting position is only used for docking with a certain instant detection module 320, and the mounting position may be idle if the instant detection module 320 is not needed. In another embodiment, the mounting structure on at least one module mounting location 114 is a universal structure capable of interfacing with at least two different types of instant detection modules 320, so that an operator can selectively mount one instant detection module 320 on that module mounting location 114. For example, the base has two assembling structures with general structures, and the assembling structures can respectively realize the butt joint with more than three kinds of instant detection modules 320, so that the two module mounting positions 114 can respectively and selectively assemble three different kinds of instant detection modules 320, thereby further improving the flexibility of the function selection and the use of the equipment.

Of course, besides the instant detection module 320 is assembled in an integral modularized form, the instant detection module 320 can also be installed in a non-integral modularized form, that is, the instant detection module 320 cannot be integrally assembled and disassembled in an independent module when being assembled and disassembled, which has the advantages that the instant detection module 320 is firmly assembled on the stand 100, too many detachable structures are not required to be arranged for the modularized structure, the structure is simpler in terms of structural design, the simpler structure also means the reduction of assembly difficulty, and the structure is also convenient to simplify, so that the whole equipment is smaller in size.

Further, the instant detection modules 320 may be arranged on the base in any manner, and of course, a more reasonable arrangement may further make the device structure more compact or facilitate the movement of the sampling needle 210, so, referring to fig. 1, in one embodiment, the instant detection modules 320 are distributed on at least one side of the blood analysis module 310, for example, in fig. 1, a plurality of instant detection modules 320 are distributed in a row or a column on a lateral side (such as an X direction) of the blood analysis module 310. Of course, in other embodiments, the plurality of 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 disposed around the blood analysis module 310 in a lateral and/or vertical direction.

In one embodiment, the instant detection modules 320 are arranged in a lateral direction or in a vertical direction. Wherein the transverse arrangement comprises one or more rows arranged in the horizontal direction or an array arrangement in the horizontal direction. The vertical arrangement comprises one or more columns arranged in the vertical direction or arranged in an array in the vertical direction.

Referring to fig. 1, 2 and 4, in one embodiment, the instant detection modules 320 are sequentially arranged along the Y direction (X, Y is transversal and Z is vertical), and the sample application area is located on the Y direction movement path of the sampling needle 210. The sample separation and pipetting operations are realized by the Y-direction reciprocating motion of the sampling needle 210. In addition, the instant detection modules 320 may be arranged along the X-direction or the Z-direction.

For convenience of description, the blood analysis module 310 and the instant detection module 320 are collectively referred to herein as detection modules. In one embodiment, the detection module arrangement principle may be: and the detection module with long detection period is arranged at the forefront, so that the earliest sample adding and the earliest detection start are realized. Or in one embodiment, the time consumption of the detection period and the difficulty in consumable replacement are combined, the detection module with the total time consumption is arranged in front, the consumable replacement time is saved, and the detection consistency is ensured. For example, when at least one of the detection modules is a dry blood analysis instant detection module, the dry blood analysis instant detection module is placed in the first place because the dry blood analysis instant detection module involves multiple steps such as centrifugation, cell staining, photoelectric detection, and the like, while considering capillary tube replacement, and the like.

Of course, the detection modules may not be limited to be arranged according to a certain rule, or may be arranged in other manners. Then, the order of starting the work is adjusted from the sample transport order. In one embodiment, the control unit 800 determines a detection period (i.e., a period from start to end of detection) of each detection module corresponding to the sample, and sends the sample to the detection module with a long detection period preferentially, where the detection period includes a period of time for the detection module to complete detection or a period of time for the detection module to complete detection plus a preparation period (i.e., a period of time for consumable replacement). However, in other embodiments, the order of inputting the samples by each detection module may be implemented according to other principles, for example, sending samples into the idle detection module preferentially, or comprehensively determining factors such as the idle state and the working time of the detection module.

Referring to fig. 2 and 4, in an embodiment, when the instant detection modules 320 are all sequentially arranged along the Y direction, the instant detection modules 320 can be designed to be a feeding/discharging mechanism along the X direction (e.g. disposed at the mounting/dismounting port 111) because of the replacement of consumables such as colloidal gold test paper, detection card, capillary centrifuge tube, microfluidic detection disk, etc., so that the instant detection modules 320 can be inserted or removed along the X direction. Of course, the loading/unloading mechanism may be omitted and installed manually by an operator.

Further, the loading module 200 may employ various loading structures in the field of detection analysis. Referring to fig. 5, in one embodiment, the sampling needle 210 of the sampling needle communicates with a sample injector 230, and the sample injector 230 provides the motive force for aspirating and discharging the sample. The sample injector 230 is a precise and quantitative mechanism, and is connected with the sampling needle 210 through a pipeline, so that the accuracy of sampling, sample separation and liquid transfer can be ensured. The sampling driving device 220 may be a device driven by at least one power element such as a motor, a cylinder, a hydraulic cylinder, an 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, to drive the movement of translation, lifting and/or rotation of the sampling needle 210, etc., as required.

The sampling drive 220 may also be provided with a guide mechanism to guide the movement of the sampling needle 210. The guide mechanism can adopt various feasible guides. Referring to fig. 6, in one embodiment, the sampling needle 210 is guided by the linear guide 221 in the Y direction, and because the dimensional accuracy of the linear guide 221 is high, the sampling needle 210X-direction deflection is almost equal to the deviation from the straightness of the sampling needle 210, and the sampling needle 210X-direction deflection can be controlled within 0.6 mm.

In one embodiment, the Y-direction motion of the sampling needle 210 employs a "guide bar + guide plate" guide structure based on cost considerations. The Y-direction movement position is determined by the initial position optocoupler and the running step number of the stepping motor, and can be combined with the sample dividing position to be adjusted before leaving a factory. In this configuration, the sampling needle 210 can rotate slightly about the guide structure, thereby causing the sampling needle 210 to deflect in a small range in the X-direction. Therefore, referring to fig. 7 and 8, a rotation stop block 222 may be disposed on the guiding metal plate 223, so as to reduce the deflection of the sampling needle 210 by adjusting the gap between the rotation stop block 222 and the guiding metal plate 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 1mm (including the straightness of the sampling needle 210 itself).

Further, the sample application module 200 performs operations of sample suction, sample separation, pipetting, and cleaning of the sampling needle 210, and all samples share at least one sampling position, and the sample application area of each instant detection module 320 is fixed. The Y-direction movement of the sampling needle 210 reaches the sampling position, the sample application region, and the like, respectively. In the above position, the sampling needle 210 can be driven by a motor and a screw rod to move up and down along Z, so as to complete the operations of sucking and injecting. The height of the sampling needle 210 is determined by the sample amount, the liquid suction amount, the test tube height, the sample application area height, and the like. The sample loading area of each instant detection module 320 is located on the detection consumable, so that the consumable needs to be positioned when it is loaded into the detection module. The detection module in/out mechanism also needs to be related to position detection. When the sampling needle 210 absorbs different samples or liquids, the sampling needle 210 needs to be cleaned, so that cross contamination of the samples is avoided, and the test result is influenced. The washing is done within the closed swab of the loading module 200.

Further, the sample to be detected may be manually sampled by an operator, or a sample sampling module may be additionally provided. In one embodiment, the sample injection module is provided with sampling bits, and the movement track of the sampling needle 210 covers the sampling bits so as to sample from the sample located on the sampling bits.

In one embodiment, the sample injection module is further provided with a rechecking waiting position and/or an unloading position, the sample injection module is in signal connection with the control unit 800, the control unit 800 controls the sample injection module to move the sample to be detected to the sampling position, and controls the sample injection module to send the sample after the sampling to the rechecking waiting position and/or the unloading position.

In one embodiment, the sample injection module may further have an emergency department, and the movement track of the sampling needle covers the emergency department, so as to preferentially sample from the samples on the emergency department when the emergency department instruction is received.

Referring to fig. 2, 9 and 10, in one embodiment, the sample injection module 500 is a rotary sample injection device, which has a rotary base 510 and a driving mechanism 513 for driving the rotary base 510 to rotate. The rotary base 510 is provided with sample positions 511 for placing samples, the sample positions 511 are arranged in an arc shape or an annular shape, and the driving mechanism 513 drives the rotary base 510 to move the samples on the sample positions 511 to the sampling positions. In the rotary sample injection device, the sampling position belongs to a virtual position, and is located on the rotation path of the sampling position 511, and all the sampling positions 511 can be moved to the sampling position for sampling under the driving of the driving mechanism 513. In addition, the rotating base 510 may specifically reserve an urgent sample position 512 for placing an urgent sample, and when an urgent instruction is received, the sample on the urgent sample position 512 is preferentially rotated to a sampling position for sampling.

Referring to fig. 2, 9 and 10, in one embodiment, the rotating base 510 conveys all test tubes 600 to the sampling position through a predetermined rotation movement to complete the sample suction, and after all test tubes 600 are completely sucked, the rotating base 510 is moved out of the whole device in the Y direction (the sample injection module 500 can be regarded as being in the unloading position at this time), so as to be convenient for taking down the tested samples and placing new samples. The rotation of the rotating seat 510 can be directly driven by a motor, and the movement of the rotating seat 510 in the Y direction or other directions can be realized by a motor+screw rod, a motor+synchronous belt, a motor+gear+rack and the like.

Referring to fig. 4, in an embodiment, the sample injection module 500 may also be a sample injector, which is suitable for applications with a large sample size. As shown in fig. 4, the sample injection module 500 has three positions, namely a loading position 521, a sampling position (located below the sampling needle 210 in the figure), and a review waiting/unloading position 522. The test tube rack 700 placed at the loading position 521 is transported to the sampling position by the loading mechanism, and the movement of the test tube rack 700 is moved according to a set action by means of the infeed mechanism, so that all samples on the test tube rack 700 are sucked. The rack 700 with the sample sucked is removed from the sampling position by the infeed mechanism, and reaches the review waiting/unloading position 522, waiting for review or unloading. During unloading, the unloading mechanism can move out the tested test tube rack 700, so that an operator can conveniently take down the test tube rack 700, or the operator can directly take out the test tube rack 700 from the recheck waiting position/unloading position 522. As shown in fig. 9 and 10, the test tube rack 700 is provided with a test tube rack serial number 410, a test tube serial number 720, and the like, and identity information of the test tube rack 700 and/or a position of a sample on the test tube rack 700 can be determined according to the serial numbers. In addition, a dedicated label 610 and other units that can further determine the identity information of the sample may be disposed on the test tube 600.

Further, when detecting a sample to be detected, the control unit 800 receives identity information of the current sample, and determines a detection item and a sample amount to be collected (i.e., a total sample amount) according to the identity information or the received instruction. The control unit 800 receives identity information of a sample, and may be known by automatically identifying the identity information of the sample (such as a label 610 or other information carrying unit on the scan tube 600), or may receive identity information sent by other components, or may directly receive instruction information input by an operator, or the like. After determining the detection items and the sample amount to be collected, the control unit 800 controls the sampling needle 210 to collect the sample of the determined sample amount, and sends the sample to the corresponding idle instant detection module 320 of each detection item.

In one embodiment, after the control unit 800 determines the sample size, the sampling needle 210 is controlled to collect the sample of the sample size at a time, and sequentially send the sample to the detection module corresponding to each detection item. Especially when multiple test items are required, all samples of the required sample size can be obtained by one sampling. This operation can save operational steps and simplify the control stroke of the sampling needle 210. Of course, in other embodiments, the sampling module 200 may also collect more than two samples for the same sample, and then send the samples to the corresponding detection modules.

In one embodiment, when a sample requires multiple simultaneous assays, the samples are sequentially distributed to a corresponding plurality of assay modules after sampling is completed. If the corresponding detection module is in a non-idle state, the detection module can be separated into the detection modules after waiting for the detection module to be idle.

In one embodiment, when more than two samples need to be detected, after the sampling needle 210 finishes sample feeding of the previous sample, the control unit 800 determines a detection item and a sample amount to be collected according to identity information or a received instruction of the next sample, controls the sampling needle 210 to collect the next sample, and sends the next sample to a detection module corresponding to the detection item and free. If the detection module is not idle, the detection module can be sent into the sample after being idle. And so on, thereby completing the detection of multiple samples.

In one embodiment, after the control unit 800 detects that one detection module completes detection, it determines whether the sample currently corresponding to the sampling needle 210 has a detection item corresponding to the detection module that has completed detection; if yes, the sampling needle 210 is controlled to send the current corresponding sample into the detection module which has completed detection; if not, the detection module which has completed detection is controlled to be idle, or whether the subsequent sample has detection items corresponding to the detection module which has completed detection is judged. The current corresponding sample of the sampling needle 210 includes the sample that the current sampling needle 210 has collected and the sample that the sampling needle 210 is about to collect.

On the other hand, in one embodiment of the present application, there is also provided a multifunctional sample analysis device 1, which includes a housing 100, a sampling 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 is capable of completing at least one detection item, i.e. 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 (either a blood detection module 310 and at least one instant detection module 320 or two instant detection modules 320), and is capable of performing at least two detection items.

In the single-class detection mode, the control unit 800 controls the sample feeding module 200 to sample the corresponding detection module and controls the corresponding detection module to work. In the multi-class detection mode, the control unit 800 controls the sample feeding module 200 to sample the detection module corresponding to the multi-class detection mode, and controls the detection module corresponding to the multi-class detection mode to work.

In one embodiment, the control unit 800 receives identity information of a current sample and determines to perform a single-class detection mode or a multi-class detection mode based on the identity information or the received instruction. The control unit 800 receives identity information of a sample, and may be known by automatically identifying the identity information of the sample (such as a label 610 or other information carrying unit on the scan tube 600), or may receive identity information sent by other components, or may directly receive instruction information input by an operator, or the like. When determining the single-class detection mode or the multi-class detection mode, the control unit 800 determines the detection items and the required sample size, and controls the sampling needle 210 to collect the sample with the determined sample size, and sends the sample to the detection modules corresponding to the detection items and free. If the detection module is not idle, the detection module can be sent into the sample after being idle. And so on, thereby completing the detection of multiple samples.

In one embodiment, in the multi-category detection mode, the control unit 800 determines the amount of sample to be collected based on the identity information or the received instructions. The control unit 800 controls the sampling needle 210 to collect samples of the sample size, and sends the samples to the idle detection modules corresponding to the multi-class detection modes respectively.

In one embodiment, after the control unit 800 determines the sample size, the sampling needle 210 is controlled to collect the samples of the sample size at a time, and sequentially send the samples to the detection modules corresponding to the multi-category detection mode and being idle. Of course, in other embodiments, the sampling module 200 may also collect more than two samples for the same sample, and then send the samples to the corresponding detection modules.

In one embodiment, in the multi-class detection mode, the control unit 800 determines a detection period of each detection module corresponding to the sample, and sends the sample to the detection module with a long detection period preferentially, where the detection period includes a period of time for the detection module to complete detection or a period of time for the detection module to complete detection plus a preparation period. However, in other embodiments, the order of inputting the samples by each detection module may be implemented according to other principles, for example, sending samples into the idle detection module preferentially, or comprehensively determining factors such as the idle state and the working time of the detection module.

In one embodiment, after the sampling needle 210 completes the sample feeding of the previous sample, the control unit 800 receives the identity information of the next sample, and determines to execute the single-type detection mode or the multi-type detection mode according to the identity information or the received instruction. Thereafter, subsequent steps may be performed in accordance with the foregoing embodiments.

In the following, a part of the workflow of the multifunctional sample analyzing apparatus 1 is described in connection with the specific operation steps of an embodiment.

A workflow in single sample detection:

(1) Drawing blood and preparing samples;

(2) Printing and pasting test tube labels 610;

the tube label 610 contains patient information, test item information, and blood drawing sequences.

(3) Sample code scanning;

the test tube label 610 is scanned according to the blood drawing sequence and is put into the corresponding position of the test tube rack 700; the code scanning mode of an external code scanning gun or a code scanning module arranged in the equipment can be adopted. After the code scanning is completed, detection item information, total sampling amount and sample dividing amount information are generated in the equipment.

(4) POCT consumable preparation (this step may be omitted if no immediate detection item is available);

the immediate detection module 320 performs a discharging operation to prompt the placement of the first sample detection consumable

(5) Starting the test;

clicking the button of the operation interface "single sample detection mode", the sample injection module 500 conveys the first sample to the sampling position, and the sampling needle 210 performs operations of sample suction, sample separation and the like according to the total sampling amount and the sample separation amount information. After the sample injection of the single detection module is completed, the test process is started, 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).

In the first sample detection process, the sample injection module 500 conveys the next sample to a sampling position; after the sample separation and pipetting of the sampling needle 210 are completed, the sampling needle is returned to the sampling position, and the cleaning operation is performed to prepare the next sample for sample suction. And when the test of the last detection module is about to be terminated, the operation interface prompts the preparation of the next sample consumable.

After the initial sample test is completed, the instant detection module 320 performs a discharging operation to replace consumables (if there is no instant detection item, this step may be omitted). The cycle is performed until all test tubes 600 on the test tube rack 700 are completely tested, and the test tubes 600 are taken out, or the test tube rack 700 is sent to an unloading area, so that the next batch of sample testing is restarted.

For the temporary emergency test item, clicking a key of an operation interface 'temporary emergency'; the code scanning of the sample is accelerated, and the sample information is inserted into the original test information; after the test of the previous sample of the emergency sample is completed, the system prompts to put the emergency sample and the test consumable of the emergency sample, and the test tube rack 700 or the sample injector directly sends the emergency sample to the sampling position or the sampling needle 210 moves to the emergency position to execute the emergency test. After the test is finished, clicking the 'exit emergency', and continuing to execute the original test; the "temporary emergency" may also be clicked on and the emergency test repeated.

In the whole process, all consumables for detecting samples are sequentially put in. Detecting a disc, a detecting card, etc. requires performing a code scanning operation to acquire consumable information (if no instant detecting item is available, this step may be omitted). The code scanning operation can be implemented through an external code scanning gun or a code scanning module arranged in the equipment.

A workflow at the time of multi-sample detection:

(1) Drawing blood and preparing samples;

(2) Printing and pasting test tube labels 610;

the tube label 610 contains patient information, test item information, and blood drawing sequences.

(3) Sample code scanning;

the test tube label 610 is scanned according to the blood drawing sequence and is put into the corresponding position of the test tube rack 700; the code scanning mode of an external code scanning gun or a code scanning module arranged in the equipment can be adopted. After the code scanning is completed, detection item information, the total sampling amount of the first sample and the sampling amount and sample dividing amount information of each detection item of other samples are generated in the equipment.

(4) POCT consumable preparation (this step may be omitted if no immediate detection item is available);

the equipment retrieves the detection item information, generates a first consumable list, and displays the first consumable list on a corresponding operation interface: displaying the placed consumable information on the corresponding function bit icon; the instant detection module 320 performs the discharging operation and puts the corresponding consumable.

Searching principle: the first sample is covered first, the idle module continues to retrieve the next sample, and so on.

(5) Starting the test;

clicking the "multiple sample detection mode" button of the operation interface, the sample injection module 500 carries the first sample to the sampling position, the immediate detection module 320 performs the operation of advancing the cartridge, and detects that the consumable arrives at the sample application area (this step may be omitted if there is no immediate detection item). The sampling needle 210 performs sampling, sample separation, and the like according to the total sampling amount and sample separation amount information. The principle is that after the sample separation and pipetting operations of all the first samples are completed, the sample suction and sample injection operations of other sample detection items are performed, and the sampling needle 210 returns to the sampling position to wait immediately after the operation is completed.

After the single module sample injection is completed, the test process is started 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). When a module test is about to terminate, the device automatically retrieves sample test item information according to the sample placement sequence, and if a subsequent sample contains the module test item, the operation interface prompts preparation of corresponding detection materials.

After the module test is completed, the unloading operation is performed, and the consumable is replaced (if no instant detection item is available, this step may be omitted). After the consumable replacement is completed, the module button of the operation interface is clicked, and when the equipment detects that the sampling needle 210 waits, the module performs the operation of advancing the cartridge (if no instant detection item exists, the step can be omitted), the test tube rack 700 conveys the corresponding sample to the sampling position, and the new detection is restarted.

If a plurality of modules are detected almost simultaneously, after consumable replacement is completed, a button of a corresponding module of an operation interface is clicked, when the equipment detects that the sampling needle 210 waits, the operation of advancing a bin (advanced bin with long time) is sequentially executed according to the sequence of the test time of the modules, and the corresponding samples are also sequentially conveyed to a sampling position (if no instant detection item exists, the step can be omitted).

This cycle is performed until all detection items of all samples are detected, and the next sample is replaced. In the testing process, if the apparatus includes the wet blood analysis module 310 and the first sample includes the blood analysis items, the pipetting operation is involved, so as to reduce the number of times of cleaning the sampling needle 210, the other real-time detection modules 320 are first used to perform the blood separation, and finally the blood analysis module 310 is used to perform the blood separation and pipetting.

For the temporary emergency test item, clicking a key of an operation interface 'temporary emergency'; the method comprises the steps of urgent sample scanning, and inserting sample information into original test item information; after the module of any test item in the emergency sample is idle, the system prompts to put the emergency sample and the test consumable of the emergency sample (if no instant test item exists, the step of putting the test consumable can be omitted), and the sample injection module 500 directly sends the emergency sample to the sampling position or the sampling needle 210 moves to the emergency position to execute the emergency test; clicking the 'exit from the emergency' until all test items of the emergency sample are completed, and continuing to execute the original test; the "temporary emergency" may also be clicked again, and the emergency test repeatedly performed.

In one embodiment, the testing process of each instant detection module 320 is as follows:

centrifugal dry blood analysis instant detection module:

sample injection, sample centrifugation, staining, optical detection.

The centrifugal disc type microfluidic biochemical, immunological and blood coagulation analysis instant detection module comprises:

sample injection, sample centrifugal separation, quantitative/diluent quantification, uniform mixing, colorimetric hole filling, reaction color development and optical detection.

A centrifugal disc type dry biochemical and immune analysis instant detection module:

sample injection, sample centrifugal separation, quantification, colorimetric hole filling, reaction color development and optical detection.

Colloidal gold immunoassay instant detection module:

sample injection, antibody binding, reaction development.

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

Claims (18)

1. A multi-functional sample analysis device, comprising:

   the machine base plays a supporting role;

   the sample adding module is arranged on the machine base and comprises a sampling needle for sampling and sample feeding and a sampling driving device for driving the sampling needle to move;

   a blood analysis module mounted on the housing and including a sample preparation device having at least one reaction cell for receiving a sample fed by the sampling needle and a reagent supply assembly for providing a processing reagent to the sample in the reaction cell to prepare a sample fluid to be tested; the detection device is used for detecting the sample liquid to be detected so as to obtain the blood parameters of the sample;

   the instant detection module is used for detecting samples in real time and is arranged on the base;

   the sample adding module, the blood analysis module and the instant detection module are connected with the control unit in a signal manner, and the control unit controls the sample adding module, the blood analysis module and the instant detection module to work;

   The sample sending range of the sampling needle covers the reaction tank and the instant detection module so as to be capable of sending samples into the reaction tank and the instant detection module, and the control unit controls the sampling needle to send the samples into the reaction tank and/or the instant detection module corresponding to the detection items according to the detection items of the samples and controls the blood analysis module and/or the instant detection module corresponding to the detection items to carry out detection analysis on the samples.
2. The multi-functional sample analysis device of claim 1, wherein the point-of-care detection module is distributed on at least one side of the blood analysis module.
3. The multifunctional sample analysis device of claim 1 or 2, wherein the instant detection modules each have a sample application region, and the movement track of the sampling needle covers the sample application regions of all the instant detection modules, and can divide samples into all the sample analysis detection modules.
4. A multi-functional sample analysis device as claimed in any one of claims 1 to 3, wherein there are at least two of said on-line detection modules, at least some of said on-line detection modules being of different types.
5. A multi-functional sample analysis device as claimed in any one of claims 1 to 3, wherein there are at least two of said on-line detection modules, all of said on-line detection modules being of the same type.
6. The multifunctional sample analysis device of any one of claims 1-5, wherein the types of the instant detection module include one or more of a dry blood analysis instant detection module, a biochemical analysis instant detection module, an immunoassay instant detection module, a molecular analysis instant detection module, and a blood coagulation analysis instant detection module.
7. The multifunctional sample analysis device of 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 identity information of a current sample and determines a detection item and a sample size to be collected according to the identity information; the control unit controls the sampling needle to collect the samples of the sample quantity and sends the samples into the detection modules corresponding to the detection items respectively.
8. The apparatus according to claim 7, wherein after the control unit determines the sample size, the sampling needle is controlled to collect the sample of the sample size at one time and sequentially feed the sample into the detection module corresponding to each detection item.
9. The apparatus according to claim 7 or 8, wherein the control unit judges a detection period of each detection module to which the sample corresponds, and preferentially feeds the sample into the detection module having a long detection period, the detection period including a period of time during which the detection module completes detection or a period of time during which the detection module completes detection plus a preparation period.
10. The apparatus according to any one of claims 7 to 9, wherein after the sampling needle finishes feeding the previous sample, the control unit determines a detection item and a sample amount to be collected according to identity information of a next sample, controls the sampling needle to collect the next sample, and feeds the collected next sample into the detection module which is free and corresponds to the detection item.
11. The apparatus according to any one of claims 7 to 10, wherein when the control unit detects that one of the detection modules has completed detection, it is determined whether or not the sample currently corresponding to the sampling needle has a detection item corresponding to the detection module for which detection has completed; if yes, the sampling needle is controlled to send the current corresponding sample into the detection module after detection; and if not, controlling the detection module to be idle, and waiting for the next sample.
12. The apparatus according to any one of claims 1 to 11, wherein the housing is provided with a plurality of module mounting positions, the module mounting positions having thereon an assembling structure for assembling a corresponding instant detection module, the instant detection module being of a modular structure having a docking structure for connection with the assembling structure, the instant detection module being detachably mounted on the module mounting positions, the docking structure being detachably connected with the assembling structure.
13. The multifunctional sample analysis device of any one of claims 1-12, wherein each instant detection module is arranged laterally or vertically between each instant detection module.
14. The multifunctional sample analysis device of claim 13, wherein the lateral arrangement comprises one or more rows arranged in a horizontal direction or an array arrangement in a horizontal direction.
15. The multifunctional sample analysis device of claim 13, wherein the vertical arrangement comprises one or more columns arranged in a vertical direction or an array arrangement in a vertical direction.
16. The multifunctional sample analysis device of any one of claims 1-15, wherein the multifunctional sample analysis device has a sample injection zone having a sampling location and an emergency location, the movement track of the sampling needle overlaying the sampling location and the emergency location.
17. The multifunctional sample analysis device of any one of claims 1-16, wherein the point-of-care detection module comprises a carrier location for placement of a sample carrier and detection means for cooperation with the sample carrier after the sample is applied to the sample carrier to complete a corresponding detection project.
18. The multifunctional sample analysis device of any one of claims 1-17, wherein the housing comprises a housing that encloses a receiving cavity, the blood analysis module and the instant detection module being disposed within the receiving cavity, the housing having a disassembly opening corresponding to the instant detection module for replacing a sample carrier corresponding to the instant detection module.