Patent Publication Number: US-2022221479-A1

Title: Piercing condition selection method

Description:
RELATED APPLICATIONS 
     The present application is a continuation of International Application No. PCT/JP2020/035943, filed Sep. 24, 2020, which claims priority from Japanese Patent Application No. 2019-180786, filed Sep. 30, 2019, the disclosures of which applications are hereby incorporated by reference here in their entirety. 
    
    
     TECHNICAL FIELD 
     The present invention relates to an automatic analysis apparatus capable of obtaining measurement information on various test items by causing a reaction between a sample (specimen) such as blood or urine and various reagents to measure a reaction process thereof, and a piercing condition selection method therefor. 
     BACKGROUND ART 
     Conventionally, there have been various types of known automatic analysis apparatuses that can obtain measurement information on various test items by causing a reaction between various reagents and biological samples such as blood and urine to measure a reaction process thereof, such as a blood coagulation analysis apparatus and an analysis apparatus using an immunoassay method. For example, a specimen as a biological sample is dispensed from a specimen vessel (blood sample tube) to a reaction vessel, and a reagent according to a test item is dispensed and mixed with the dispensed specimen to perform various measurements and analyzes. 
     In such an analysis apparatus, when a specimen is sucked from a specimen vessel having a stopper (cap), CTS (Closed Tube Sampling: specimen dispensation from the specimen vessel having the stopper), which samples a specimen with the stopper attached, may be adopted. In this CTS, for example, a needle-shaped piercer having a hollow tube inside is used, and after the stopper is punctured by this piercer (stopper is pierced), a nozzle (specimen probe) is inserted into the specimen vessel through the inside of the piercer to suck the specimen (for example, see Patent Document 1). 
     In addition, in an automatic analysis apparatus adopting such a CTS method, despite the existence of stoppers of various materials and specimen vessels of various shapes, at present, the number of operation conditions of a piercing operation of puncturing a stopper of a specimen vessel by a piercer is fixed to one (for example, see Patent Document 2). 
     CITATION LIST 
     Patent Document 
     
         
         Patent Document 1: JP 2015-155925 A 
         Patent Document 2: WO/2016/084462 
       
    
     SUMMARY OF THE INVENTION 
     Problem to be Solved by the Invention 
     However, considering that an influence of puncturing (piercing) on the specimen vessel differs depending on the shape of the specimen vessel and the material of the stopper, when the piercing operation condition is uniform, the specimen vessel may be damaged in some cases. In addition, since most of the stoppers of the specimen vessels to be pierced are made of rubber, depending on the piercing conditions (piercing operation conditions) such as a piercing speed, a piercing force, a piercer withdrawal speed after piercing, and a piercing distance of the piercer with respect to the specimen vessel, the rubber stopper may be pushed into the specimen vessel and cannot be pierced, rubber fragments may adhere to the inside of the piercer when the piercer is hollow, or an inner hole of the piercer may be blocked with the rubber stopper. 
     The invention has been made by paying attention to the above-mentioned problems, and an object of the invention to provide an automatic analysis apparatus capable of realizing a piercing operation under an appropriate piercing condition according to a type of a specimen vessel having a stopper, and a piercing condition selection method therefor. 
     Means for Solving Problem 
     To achieve the object, the invention is an automatic analysis apparatus for obtaining measurement information on a predetermined test item by causing a reaction between a specimen and a reagent to measure a reaction process thereof, including a specimen supply portion, a specimen rack loaded with the same type of one or more specimen vessels having stoppers being arranged in the specimen supply portion, a rack identification information reading unit for reading rack identification information assigned to the specimen rack, a drive unit for executing a piercing operation of piercing the stopper of the specimen vessel having the stopper at a specimen suction position by a piercer and sucking a specimen in the specimen vessel having the stopper by a specimen suction nozzle passing through a hole formed by the piercer, a piercing condition setting unit for setting a piercing operation condition by the piercer for the specimen vessel having the stopper loaded in the specimen rack based on the rack identification information read by the rack identification information reading unit, and a controller for controlling an operation of the drive unit based on a piercing operation condition set by the piercing condition setting unit. 
     In addition, the invention is a piercing condition selection method for an automatic analysis apparatus including a specimen supply portion, a specimen rack loaded with the same type of one or more specimen vessels having stoppers being arranged in the specimen supply portion, and a drive unit for executing a piercing operation of piercing the stopper of the specimen vessel having the stopper at a specimen suction position by a piercer and sucking a specimen in the specimen vessel having the stopper by a specimen suction nozzle passing through a hole formed by the piercer, and obtaining measurement information on a predetermined test item by causing a reaction between a reagent and the specimen sucked by the specimen suction nozzle to measure a reaction process thereof, the method including a rack identification information reading step of reading rack identification information assigned to the specimen rack, a piercing condition setting step of setting a piercing operation condition by the piercer for the specimen vessel having the stopper loaded in the specimen rack based on rack identification information read in the rack identification information reading step, and an operation control step of controlling an operation of the drive unit based on a piercing operation condition set in the piercing condition setting step. 
     According to the automatic analysis apparatus and the piercing condition selection method therefor having the above configuration, since the piercing operation condition by the piercer for the specimen vessel having the stopper is set based on the rack identification information assigned to the specimen rack loaded with the same type of one or more specimen vessels having stoppers, it is possible to realize the piercing operation under an appropriate (optimal) piercing condition according to the type of the specimen vessel having the stopper. For this reason, it is possible to reduce the above-mentioned piercing problems in the past, prevent a long analysis time, and reduce the amount of specimen loss. Allowing setting of the piercing condition in such specimen rack units is particularly beneficial for a micro blood collection tube (which is a dedicated tube and aligns the height on the rack) to which identification information such as a specimen ID label cannot be affixed. That is, when the micro blood collection tube is used without using an adapter, etc., the optimum piercing condition can be set even if the specimen ID is not provided, as long as the information unique to the rack is added. 
     Effect of the Invention 
     According to the invention, there is provided an automatic analysis apparatus capable of realizing a piercing operation (CTS operation) under an appropriate piercing condition according to a type of a specimen vessel having a stopper, and a piercing condition selection method therefor. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         FIG. 1  is a schematic overall external view of an automatic analysis apparatus according to an embodiment of the invention; 
         FIG. 2  is a block diagram illustrating a schematic configuration of the automatic analysis apparatus of  FIG. 1 ; 
         FIG. 3  is a block diagram illustrating a configuration for setting an appropriate piercing operation condition for each specimen rack; 
         FIG. 4  is a flowchart illustrating a flow of a method for setting an appropriate piercing operation condition for each specimen rack; and 
         FIG. 5  is a schematic view illustrating an example of a piercing operation when a piercer is hollow. 
     
    
    
     MODE(S) FOR CARRYING OUT THE INVENTION 
     Hereinafter, an embodiment of the invention will be described with reference to the drawings. 
       FIG. 1  is a schematic overall external view of an automatic analysis apparatus according to the present embodiment, and  FIG. 2  is a block diagram illustrating a schematic configuration of the automatic analysis apparatus of  FIG. 1 . As illustrated in  FIG. 2 , the automatic analysis apparatus  1  of the present embodiment includes a specimen supply portion  50  for supplying a specimen, a reaction portion  40  for holding a reaction vessel  54  into which a specimen is dispensed, and a reagent supply portion  30  for supplying a reagent to the reaction vessel  54 , and obtains measurement information on a predetermined test item by causing a reaction between a specimen and a reagent supplied from the reagent supply portion  30  to the reaction vessel  54  to measure a reaction process. 
     Specifically, an outer frame of the automatic analysis apparatus  1  of the present embodiment is formed by a housing  100 , and the automatic analysis apparatus  1  is configured by forming a specimen processing space in an upper part of the housing  100  (see  FIG. 1 ). 
     As clearly illustrated in  FIG. 2 , the automatic analysis apparatus  1  includes a control unit (controller)  10 , a measurement unit  30 , and a touch screen  190 . 
     The control unit  10  controls the overall operation of the automatic analysis apparatus  1 . The control unit  10  includes, for example, a personal computer (PC). The control unit  10  includes a Central Processing Unit (CPU)  12 , a Random Access Memory (RAM)  14 , a Read Only Memory (ROM)  16 , a storage  18 , and a communication interface (I/F)  20  connected to each other via a bus line  22 . The CPU  12  performs various signal processing, etc. The RAM  14  functions as a main storage device of the CPU  12 . As the RAM  14 , for example, a Dynamic RAM (DRAM), a Static RAM (SRAM), etc. can be used. The ROM  16  records various boot programs, etc. For the storage  18 , for example, a Hard Disk Drive (HDD), a Solid State Drive (SSD), etc. can be used. Various types of information such as programs and parameters used by the CPU  12  are recorded in the storage  18 . Further, data acquired by the measurement unit  30  is recorded in the storage  18 . The RAM  14  and the storage  18  are not limited thereto, and can be replaced with various storage devices. The control unit  10  communicates with an external device, for example, the measurement unit  30  and the touch screen  190  via the communication I/F  20 . 
     The touch screen  190  includes a display device  192  and a touch panel  194 . The display device  192  may include, for example, a liquid crystal display (LCD), an organic EL display, etc. The display device  192  displays various screens under the control of the control unit  10 . This screen may include various screens such as an operation screen of the automatic analysis apparatus  1 , a screen showing a measurement result, and a screen showing an analysis result. The touch panel  194  is provided on the display device  192 . The touch panel  194  acquires an input from a user and transmits the obtained input information to the control unit  10 . 
     The control unit  10  may be connected to other devices such as a printer, a handy code reader, and a host computer via the communication I/F  20 . 
     The measurement unit  30  includes a control circuit  42 , a data processing circuit  44 , a constant temperature bath  52 , the reaction vessel  54 , a light source  62 , a scattered light detector  64 , a transmitted light detector  66 , a specimen vessel (blood sample tube)  72 , a reagent vessel  74 , a specimen probe  76 , and a reagent probe  78 . In this case, the reaction vessel  54 , the scattered light detector  64 , and the transmitted light detector  66  are provided in the constant temperature bath  52 . In addition, the specimen vessel  72  is a specimen vessel having a stopper, and a specimen rack loaded with the same type of one or more specimen vessels  72  having stoppers is arranged in the specimen supply portion  50 . 
     The control circuit  42  controls an operation of each part of the measurement unit  30  based on a command from the control unit  10 . Although not illustrated, the control circuit  42  is connected to the data processing circuit  44 , the constant temperature bath  52 , the light source  62 , the scattered light detector  64 , the transmitted light detector  66 , the specimen probe  76 , the reagent probe  78 , etc., and controls an operation of each part. 
     The data processing circuit  44  is connected to the scattered light detector  64  and the transmitted light detector  66 , and acquires a detection result from the scattered light detector  64  and the transmitted light detector  66 . The data processing circuit  44  performs various processes on the acquired detection result and outputs a processing result. The processes performed by the data processing circuit  44  may include, for example, an A/D conversion process for converting a format of data output from the scattered light detector  64  and the transmitted light detector  66  into a format that can be processed by the control unit  10 . 
     The control circuit  42  and the data processing circuit  44  may include, for example, a CPU, an Application Specific Integrated Circuit (ASIC), a Field Programmable Gate Array (FPGA), etc. Each of the control circuit  42  and the data processing circuit  44  may be configured by one integrated circuit, etc., or may be configured by combining a plurality of integrated circuits, etc. Further, the control circuit  42  and the data processing circuit  44  may include one integrated circuit, etc. The operation of the control circuit  42  and the data processing circuit  44  may be performed according to, for example, a program recorded in a storage device or a recording area in the circuit. 
     The specimen vessel  72  contains, for example, a specimen obtained from blood collected from a patient. The reagent vessel  74  contains various reagents used for measurement. Any number of specimen vessels  72  and reagent vessels  74  may be provided. Since there is usually a plurality of types of reagents used for analysis, there is generally a plurality of reagent vessels  74 . The specimen probe  76  dispenses the specimen contained in the specimen vessel  72  into the reaction vessel  54  under the control of the control circuit  42 . The reagent probe  78  dispenses the reagent contained in the reagent vessel  74  into the reaction vessel  54  under the control of the control circuit  42 . Any number of specimen probes  76  and reagent probes  78  may be used. 
     The constant temperature bath  52  maintains the temperature of the reaction vessel  54  at a predetermined temperature under the control of the control circuit  42 . In the reaction vessel  54 , a mixed solution obtained by mixing the specimen dispensed by the specimen probe  76  and the reagent dispensed by the reagent probe  78  reacts. Note that any number of reaction vessels  54  may be used. 
     The light source  62  emits light having a predetermined wavelength under the control of the control circuit  42 . The light source  62  may be configured to emit light having a different wavelength depending on the measurement condition. Therefore, the light source  62  may have a plurality of light source elements. The light emitted from the light source  62  is guided by, for example, an optical fiber, and is applied to the reaction vessel  54 . The light applied to the reaction vessel  54  is partially scattered and partially transmitted depending on the reaction process state of the mixed solution in the reaction vessel  54 . The scattered light detector  64  detects the light scattered in the reaction vessel  54 , and detects, for example, the amount of the scattered light. The transmitted light detector  66  detects the light transmitted through the reaction vessel  54 , and detects, for example, the amount of transmitted light. The data processing circuit  44  processes information on the amount of scattered light detected by the scattered light detector  64 , and processes information on the amount of transmitted light detected by the transmitted light detector  66 . Any one of the scattered light detector  64  and the transmitted light detector  66  may operate depending on the measurement condition. Therefore, the data processing circuit  44  may process any one of the information on the amount of scattered light detected by the scattered light detector  64  or the information on the amount of transmitted light detected by the transmitted light detector  66  according to the measurement condition. The data processing circuit  44  transmits processed data to the control unit  10 . Note that even though the measurement unit  30  illustrated in  FIG. 3  includes two light detectors, the scattered light detector  64  and the transmitted light detector  66 , the measurement unit  30  may include any one of the light detectors. 
     The control unit  10  performs various calculations based on the data acquired from the measurement unit  30 . These calculations include calculation of the reaction amount of the mixed solution, quantitative calculation of the substance amount or an activity value of a substance to be measured in a subject based on the reaction amount, etc. The data processing circuit  44  may perform some or all of these calculations. 
     Note that here, even though the case where a PC that controls the operation of the measurement unit  30  and a PC that performs data calculation and quantitative calculation are the same control unit  10  is illustrated, the PCs may be separate bodies. In other words, the PC that performs the data calculation and the quantitative calculation may exist as each. 
     Next, a description will be given of characteristic functional units of the automatic analysis apparatus  1  having the above configuration allowing setting of an appropriate piercing operation condition for each specimen rack, and a piercing condition selection method with reference to  FIGS. 3 to 5 . 
     As illustrated in  FIG. 3 , the automatic analysis apparatus  1  of the present embodiment includes a rack identification information reading unit  84  that reads rack identification information C assigned to a specimen rack  70  loaded with the same type of one or more specimen vessels  72  having stoppers, a CTS drive unit  80  that executes a piercing operation of piercing the stopper of the specimen vessel  72  having the stopper by a piercer at a specimen suction position and sucks a specimen in the specimen vessel  72  having the stopper by a specimen suction nozzle included in the specimen probe  76  passing through a hole formed by the piercer, a piercing condition setting unit  82  that sets a piercing operation condition by the piercer for the specimen vessel  72  having the stopper loaded in the specimen rack  70  based on the rack identification information C read by the rack identification information reading unit  84 , and the control unit  10  that controls an operation of the CTS drive unit  80  based on the piercing operation condition set by the piercing condition setting unit  82 . The automatic analysis apparatus  1  can use a plurality of specimen racks  70 , and can identify the type of the specimen vessel  72  mounted on the specimen rack  70  by identifying the rack identification information C. Note that the rack identification information C assigned to the specimen rack  70  may be a coded display (bar code or a  2 D code, for example, a rack ID label or a rack number) printed on or affixed to the specimen rack  70 , or may be formed by a shape peculiar to the specimen rack  70  (for example, a notch or a hole for ID is included in a bit) and/or a physical element used for reading the shape. As a physical element used for reading the shape, a magnet, etc. can be mentioned. In particular, when a large amount of information can be assigned to the  2 D code, etc., it is possible to set a piercing operation condition for each position on the specimen rack  70 . 
     Here,  FIG. 5  illustrates an example of a piercing operation using a tubular (hollow) piercer. As illustrated in the figure, a needle-shaped piercer  74 , which is a hollow tube inside, is used, and after the stopper  73  closing an opening of the specimen vessel  72  is punctured (the stopper is pierced) by the piercer  74 , the specimen suction nozzle (specimen probe)  76  is inserted into the specimen vessel  72  through the inside of the piercer  74  to suck a specimen  75 . Note that the piercer does not have to be tubular in this way. When the piercer is not tubular, after the stopper is pierced by the piercer, the specimen suction nozzle sucks the specimen in the specimen vessel having the stopper through the hole of the stopper formed by the piercer without intervention of the piercer. 
     Next, a description will be given of a method of setting an appropriate piercing operation condition for each specimen rack  70  using the functional units illustrated in  FIG. 3  described above with reference to  FIG. 4 . 
     First, in a state where the specimen rack  70  is set in the specimen supply portion  50  (step S 1 ; also see  FIG. 3 ), the rack identification information reading unit  84  reads the rack identification information C assigned to the specimen rack  70  (rack identification information reading step S 2 ). Thereafter, the piercing condition setting unit  82  sets a piercing operation condition by the piercer for the specimen vessel  72  having the stopper loaded in the specimen rack  70  based on the rack identification information C read by the rack identification information reading unit  84  (piercing condition setting step S 3 ). In this case, the piercing condition setting unit  82  sets the piercing operation condition (in rack units) based on an operation condition table in which the rack identification information C and the piercing operation condition are associated with each other and stored. 
     Note that examples of the piercing operation condition may include a lower limit of descent, a descent speed, a piercing force of the piercer, a descent speed pattern of the piercer during descent (two-step descent, etc.), inner and outer diameters of piercers (in the case of having a plurality of piercers), an upper limit point of the detection area for detecting the liquid level of the specimen with insertion of the suction nozzle (specimen probe) into the specimen vessel  72  having the stopper, the cumulative number of times of piercing, etc. Here, the cumulative number of times of piercing is useful when the stopper is damaged by a plurality of number of times of piercing by the piercer due to a characteristic of the stopper, and by cumulatively counting the number of times of piercing for each specimen ID, for example, a counting result may be fed back to the piercing condition setting unit  82  or the control unit  10 . 
     Thereafter, when the specimen vessel  72  having the stopper is positioned at the specimen suction position, the control unit  10  controls an operation of the CTS drive unit  80  based on the piercing operation condition set by the piercing condition setting unit  82  (operation control step S 4 ). In this way, at the specimen suction position, the stopper of the specimen vessel  72  having the stopper can be pierced by the piercer under an appropriate piercing operation condition according to the type of the specimen vessel  72  having the stopper, and then the specimen in the specimen vessel  72  having the stopper can be sucked by the specimen probe  76  passing through the hole formed by the piercer. 
     As described above, according to the present embodiment, since the piercing operation condition by the piercer for the specimen vessel  72  having the stopper can be set based on the rack identification information C assigned to the specimen rack  70  loaded with the same type of one or more specimen vessels  72  having stoppers, it is possible to realize the piercing operation under an appropriate (optimal) piercing condition according to the type of the specimen vessel  72  having the stopper. For this reason, it is possible to reduce the above-mentioned problems during piercing occurring in the past, prevent a long analysis time, and reduce the amount of specimen loss. In addition, allowing setting of the piercing condition in such specimen rack units is particularly beneficial for a micro blood collection tube (which is a dedicated tube and aligns the height on the rack) to which identification information such as a specimen ID label cannot be affixed. That is, when the micro blood collection tube is used without using an adapter, etc., the optimum piercing condition can be set even if the specimen ID is not provided, as long as the rack identification information C unique to the specimen rack  70  is added. 
     Note that the invention is not limited to the above-described embodiment, and can be variously modified and implemented without departing from the gist thereof. For example, in the invention, the form of the rack identification information, the configuration form of the automatic analysis apparatus, etc. can be arbitrarily set. In addition, some or all of the above-described embodiments may be combined, or a part of a configuration may be omitted from one of the above-mentioned embodiments.