JP7514710B2 - Automated Analysis Equipment - Google Patents

Description

The embodiments disclosed in this specification and the drawings relate to an automated analyzer.

The automated analyzer adds reagents corresponding to various test items to a test sample, such as a patient's blood, that contains the components to be analyzed, and causes the reagents to react with specific components contained in the test sample. The automated analyzer analyzes the components of the test sample that correspond to the test items by measuring this reaction, for example optically.

In such an automatic analyzer, the stirrer stirs the sample and reagent contained in the reaction vessel. Specifically, the stirrer attached to the stirrer is inserted into the mixture of the sample and reagent, and the stirrer is driven to stir the sample and reagent. For example, if the stirrer is made of a vibrating member such as a piezoelectric element, the vibrating member is vibrated back and forth to stir the sample and reagent. Also, if the stirrer is made of a rotating member that is a stirring plate attached to a stirring rod, the stirrer is rotated by a motor to stir the sample and reagent.

Generally, automated analyzers are designed on the assumption that mixing will occur when the stirring position where the stirrer is used is in the correct position (e.g., near the center of the reaction vessel), but it is difficult to confirm whether stirring is occurring in the correct position during actual stirring. Therefore, even if the automated analyzer detects a serious error, such as the stirrer colliding with the reaction vessel, the sample and reagent may not be mixed sufficiently due to a shift in the stirring position, affecting the accuracy of the measurement results.

Furthermore, if the stirrer collides with the reaction vessel, it may cause damage to both the stirrer and the reaction vessel, which is undesirable. For this reason, it is desirable to be able to detect the amount of deviation between the stirring position of the stirrer and the appropriate position where the stirrer should be performing stirring. Furthermore, if it is possible to calculate the amount of deviation between the actual stirring position of the stirrer and the appropriate position, not only can it be possible to prevent collisions between the stirrer and the reaction vessel, but it can also be possible to make adjustments to the amount of deviation.

JP 2018-091743 A JP 2016-133425 A JP 2003-057249 A JP 2019-174215 A

One of the problems that the embodiments disclosed in this specification and the drawings aim to solve is to calculate the amount of deviation of the stirring position, where stirring is performed by the stirrer of a stirring device in an automatic analyzer, from the appropriate position, and to improve the accuracy of stirring samples and reagents. However, the problems that the embodiments disclosed in this specification and the drawings aim to solve are not limited to the above problem. Problems corresponding to the effects of each configuration shown in the embodiments described below can also be positioned as other problems.

The automated analyzer according to the embodiment includes a holding unit that holds a plurality of reaction vessels, a stirring means having a stirrer for stirring the mixture of sample and reagent contained in the reaction vessel, a generating unit that emits light or ultrasound for detection, and a receiving unit that receives the light or ultrasound emitted by the generating unit, and includes a detecting unit that detects the behavior of the stirrer in the stirring means, and a deviation amount calculating unit that calculates the deviation amount of the stirring position, which is the position where stirring is performed by the stirrer, from the appropriate position based on the detection result by the detecting unit.

FIG. 1 is a block diagram showing the functional configuration of an automatic analyzer according to a first embodiment. FIG. 2 is a diagram showing an example of the configuration of an analysis mechanism in the automatic analyzer shown in FIG. 1 . 3A and 3B are diagrams illustrating the stirring principle of the first stirrer of the automatic analyzer according to the first embodiment. 13 is a diagram illustrating an example of a pattern of a detection result signal when the stirring position of the first stirrer is in an appropriate position. FIG. 13 is a diagram illustrating an example of a pattern of a detection result signal when the stirring position of a first stirrer is deviated from an appropriate position. FIG. FIG. 2 is a diagram for explaining an example of the positional relationship between reaction vessels and a detection device in a state in which the reaction vessels are accommodated in a reaction disk. 13A and 13B are diagrams illustrating another example of the positional relationship between the reaction vessels and the detection device when the reaction vessels are accommodated in the reaction disk. FIG. 4 is a flowchart illustrating the process contents of a deviation amount calculation process executed by a deviation amount calculation function of the control circuit in the automatic analyzer according to the first embodiment. FIG. 11 is a diagram illustrating an example of the structure of a first stirrer of an automatic analyzer according to a second embodiment. FIG. 11 is a diagram illustrating another example of the structure of the first stirrer of the automatic analyzer according to the second embodiment. FIG. 11 is a schematic diagram showing a rotating first stirrer as viewed from above in an automatic analyzer according to a second embodiment. FIG. 13 is a schematic diagram showing the positional relationship between the first cutting plate and the detection device when viewed from above (a state in which the detection signal is blocked by the first cutting plate). FIG. 13 is a schematic diagram showing the positional relationship between the first cutting plate and the detection device when viewed from above (a state in which the detection signal is not blocked by the first cutting plate). FIG. 13 is a diagram showing an example of a detection result signal generated by a detection device in the automatic analyzer according to the second embodiment (when the stirring position is at the appropriate position). FIG. 13 is a diagram showing an example of a detection result signal generated by a detection device in the automatic analyzer according to the second embodiment (in a state where the stirring position is shifted toward the outer periphery of the rotating first cutting plate). FIG. 13 is a diagram showing an example of a detection result signal generated by a detection device in the automatic analyzer according to the second embodiment (in a state where the stirring position is shifted toward the inner periphery of the rotating first cutting plate). FIG. 11 is a block diagram showing the functional configuration of an automatic analyzer according to a third embodiment. FIG. 11 is a flowchart illustrating the processing contents of a stirring position adjustment process executed by a stirring position adjustment function of a control circuit in an automatic analyzer according to a third embodiment. 19 is a plan view showing an example of different stirring positions for obtaining the amount of deviation from the appropriate position in the stirring position adjustment process shown in FIG. 18 . 19 is a plan view showing another example of different stirring positions for obtaining the amount of deviation from the appropriate position in the stirring position adjustment process shown in FIG. 18 . FIG. 13 is a block diagram showing the functional configuration of an automatic analyzer according to a fourth embodiment. FIG. 13 is a flowchart illustrating the processing contents of an agitation operation determination process executed by an agitation operation determination function of a control circuit in an automatic analyzer according to a fourth embodiment.

The automated analyzer according to this embodiment will be described below with reference to the drawings. In the following description, components having substantially the same functions and configurations will be given the same reference numerals, and duplicate descriptions will be given only when necessary.

First Embodiment
(Automatic analyzer)
Fig. 1 is a block diagram showing an example of the functional configuration of an automatic analyzer 1 according to this embodiment. The automatic analyzer 1 shown in Fig. 1 is configured to include, for example, an analysis mechanism 2, an analysis circuit 3, a drive mechanism 4, an input interface 5, an output interface 6, a communication interface 7, a memory circuit 8, and a control circuit 9.

The automatic analyzer 1 is an apparatus that measures the concentration of a sample, etc., using, for example, the latex agglutination method, and various carrier particles can be used as the insoluble carrier added to the reagent. For example, latex particles, polystyrene, polystyrene latex, silica particles, etc. can be used as the carrier particles. Of course, the method of measuring the concentration of a sample, etc. in the automatic analyzer 1 is not limited to this.

The analysis mechanism 2 adds reagents to a sample, such as a standard sample or a test sample, that are used for each test item set for the sample. The analysis mechanism 2 measures the reaction liquid obtained by adding the reagents to the sample, and generates, for example, standard data and test data. In this embodiment, the standard data represents absorbance measurement data for a standard sample containing a known concentration of the target substance. The test data represents absorbance measurement data for the test sample.

The analysis circuit 3 is a processor that analyzes the standard data and test data generated by the analysis mechanism 2, and generates calibration data, analytical data, etc. The calibration data includes, for example, information about a calibration curve generated based on the standard data. The analytical data includes, for example, information about the concentration of the target substance contained in the test sample, which is obtained by analyzing the test data based on the calibration data.

The analysis circuit 3 executes an operation program stored in the memory circuit 8, and realizes a function corresponding to this operation program to generate calibration data, analysis data, etc. For example, the analysis circuit 3 generates a calibration curve based on 1) standard data obtained for a standard sample with a known absorbance and a concentration of 0 and one or more standard samples with known concentrations, 2) preset concentrations for these standard samples, and 3) preset photometric timing, etc., and calculates calibration data including information about this calibration curve. The analysis circuit 3 also generates analysis data based on test data, calibration data including a calibration curve for a test item corresponding to this test data, and preset photometric timing, etc. The analysis circuit 3 outputs the generated calibration data, analysis data, etc. to the control circuit 9.

The drive mechanism 4 drives the analysis mechanism 2 under the control of the control circuit 9. For example, the drive mechanism 4 is realized by a gear, a stepping motor, a belt conveyor, a lead screw, etc.

The input interface 5 accepts settings such as analysis parameters for each test item related to the sample requested to be measured, for example, from the user or via the hospital network NW. The input interface 5 is realized by, for example, a mouse, a keyboard, and a touchpad where instructions are input by touching the operation surface. The input interface 5 is connected to the control circuit 9, converts operation instructions input by the user into electrical signals, and outputs these electrical signals to the control circuit 9. Note that in this embodiment, the input interface 5 is not limited to only those having physical operation parts such as a mouse and a keyboard. For example, an electrical signal processing circuit that receives electrical signals corresponding to operation instructions input from an external input device provided separately from the automatic analyzer 1 and outputs these electrical signals to the control circuit 9 is also included as an example of the input interface 5.

The output interface 6 is connected to the control circuit 9 and outputs a signal supplied from the control circuit 9. The output interface 6 is realized, for example, by a display circuit and a printed circuit. The display circuit includes, for example, a CRT display, a liquid crystal display, an organic EL display, an LED display, and a plasma display. In this embodiment, the display circuit also includes a processing circuit that converts data representing the display object into a video signal and outputs the video signal to the outside. The printed circuit includes, for example, a printer. In this embodiment, the printed circuit also includes an output circuit that outputs data representing the print object to the outside.

The communication interface 7 is connected, for example, to an intra-hospital network NW, and connects the automatic analyzer 1 to the intra-hospital network NW. The communication interface 7 performs data communication with a Hospital Information System (HIS) via the intra-hospital network NW. Note that the communication interface 7 may also perform data communication with the HIS via a laboratory department system (Laboratory Information System: LIS) connected to the intra-hospital network NW.

The memory circuit 8 is composed of a processor-readable recording medium, such as a magnetic or optical recording medium, or a semiconductor memory. Note that the memory circuit 8 does not necessarily have to be realized by a single storage device. For example, the memory circuit 8 can be realized by multiple storage devices.

The memory circuitry 8 also stores an operating program executed by the analysis circuitry 3 and an operating program executed by the control circuitry 9. The memory circuitry 8 stores information related to calibration curves for reagents held in the analysis mechanism 2. As will be described in detail later, calibration curves for reagents used in the analysis mechanism 2 are generated by the automatic analyzer 1 and stored in the memory circuitry 8 as calibration data. The calibration data stored in the memory circuitry 8 also includes, for example, data related to the photometry timing preset for the reagent for each test item.

The photometric timing represents the time at which information such as absorbance used in generating calibration data including a calibration curve is acquired. That is, the photometric timing represents, for example, the time that has elapsed since a reagent containing carrier particles, which are insoluble carriers to which a component that binds to the detection target is immobilized, is added to a standard sample. The photometric timing also represents the time at which information such as absorbance used in generating analytical data is acquired. That is, the photometric timing represents, for example, the time that has elapsed since a reagent containing insoluble carrier particles is added to a test sample.

That is, the memory circuitry 8 stores the calibration data generated by the analysis circuitry 3 for each test item. The memory circuitry 8 also stores the analysis data generated by the analysis circuitry 3 for each test sample.

The control circuit 9 is a processor that functions as the core of the automatic analyzer 1. The control circuit 9 executes an operating program stored in the memory circuit 8, thereby realizing a function corresponding to the operating program. The control circuit 9 may also include a memory area that stores at least a portion of the data stored in the memory circuit 8.

Figure 2 is a schematic diagram showing an example of the configuration of the analysis mechanism 2 shown in Figure 1. As shown in Figure 2, the analysis mechanism 2 of the automatic analyzer 1 according to this embodiment is configured to include a reaction disk 201, a constant temperature unit 202, a sample disk 203, a first reagent storage 204, and a second reagent storage 205.

The reaction disk 201 transports the reaction vessels 2011 along a predetermined path. Specifically, the reaction disk 201 holds a plurality of reaction vessels 2011 in a circular arrangement. Therefore, the reaction disk 201 constitutes a holding section in this embodiment. The reaction disk 201 is alternately rotated and stopped at predetermined time intervals by the drive mechanism 4.

The reaction vessel 2011 is made of, for example, glass. The reaction vessel 2011 is in the shape of a rectangular prism and has an opening at the top. Of the first to fourth side walls forming the rectangular prism, light irradiated from a light source provided in the photometric unit 214 is incident from the outer surface of the first side wall. Of the first to fourth side walls, the light incident from the outer surface of the first side wall is emitted from the outer surface of the second side wall facing the first side wall.

The thermostatic unit 202 stores a heat medium set to a predetermined temperature. The thermostatic unit 202 heats the reaction liquid contained in the reaction vessel 2011 to a predetermined temperature and keeps it warm by immersing the reaction vessel 2011 in the stored heat medium.

The sample disk 203 holds multiple sample containers that contain samples. The sample disk 203 is rotated by the drive mechanism 4. In this embodiment, a sample that contains the components to be detected is appropriately referred to as a test sample.

The first reagent storage 204 keeps a number of reagent containers refrigerated, each containing a first reagent that reacts with a specific component contained in the standard sample and the test sample. The first reagent is, for example, a buffer solution containing bovine serum albumin (BSA) or the like. A reagent label is affixed to the reagent container. An optical mark representing reagent information is printed on the reagent label. The optical mark may be any pixel code, such as a one-dimensional pixel code or a two-dimensional pixel code. The reagent information is information about the reagent contained in the reagent container, and includes, for example, the reagent name, reagent manufacturer code, reagent item code, bottle type, bottle size, capacity, manufacturing lot number, and validity period.

The first reagent storage 204 also keeps a number of standard sample containers that contain standard samples cool. Each of the standard sample containers contains a standard sample of the same component but with a different concentration. The standard sample containers may be held on the sample disk 203.

A reagent rack 2041 is provided in the first reagent storage 204 so as to be freely rotatable. The reagent rack 2041 holds a plurality of reagent containers and a plurality of standard sample containers arranged in a circular ring shape. The reagent rack 2041 is rotated by the drive mechanism 4. In addition, a reader (not shown) is provided in the first reagent storage 204 to read reagent information from the reagent labels affixed to the reagent containers. The read reagent information is stored in the memory circuit 8.

A first reagent aspirating position is set at a predetermined position on the first reagent storage 204. The first reagent aspirating position is provided, for example, at a position where the rotational trajectory of the first reagent dispensing probe 209 intersects with the movement trajectory of the openings of the reagent containers and standard sample containers arranged in a circular ring shape on the reagent rack 2041.

The second reagent storage 205 keeps multiple reagent containers refrigerated, each containing a second reagent that pairs with a first reagent in a two-reagent system. The second reagent is a solution containing an insoluble carrier, such as carrier particles, on which a specific antigen or antibody contained in the sample is immobilized, which binds to or dissociates from the antigen or antibody through a specific antigen-antibody reaction. The substance that binds to or dissociates from the antigen or antibody through a specific reaction may be an enzyme, a substrate, an aptamer, or a receptor. A reagent rack 2051 is provided in the second reagent storage 205 so as to be freely rotatable.

The reagent rack 2051 holds multiple reagent containers arranged in a circular ring shape. Note that a standard sample container that contains a standard sample may be kept cold in the second reagent storage 205. The reagent rack 2051 is rotated by the drive mechanism 4. Also, a reader (not shown) is provided in the second reagent storage 205 to read reagent information from the reagent label affixed to the reagent container. The read reagent information is stored in the memory circuit 8.

A second reagent aspirating position is set at a predetermined position on the second reagent storage 205. The second reagent aspirating position is provided, for example, at a position where the rotational trajectory of the second reagent dispensing probe 211 intersects with the movement trajectory of the openings of the reagent containers arranged in a circular ring shape on the reagent rack 2051.

The analysis mechanism 2 of the automatic analyzer 1 shown in FIG. 2 is further configured to include a sample dispensing arm 206, a sample dispensing probe 207, a first reagent dispensing arm 208, a first reagent dispensing probe 209, a second reagent dispensing arm 210, a second reagent dispensing probe 211, a first stirring device 212, a second stirring device 213, a photometry unit 214, and a cleaning unit 215.

The sample dispensing arm 206 is provided between the reaction disk 201 and the sample disk 203. The sample dispensing arm 206 is provided so as to be movable up and down in the vertical direction and rotatable in the horizontal direction by the drive mechanism 4. The sample dispensing arm 206 holds a sample dispensing probe 207 at one end.

The sample dispensing probe 207 rotates along an arc-shaped rotational orbit in association with the rotation of the sample dispensing arm 206. The opening of the sample container held by the sample disk 203 is positioned on this rotational orbit. In addition, a sample discharge position for discharging the sample aspirated by the sample dispensing probe 207 into the reaction container 2011 is provided on the rotational orbit of the sample dispensing probe 207. The sample discharge position is provided at a position where the rotational orbit of the sample dispensing probe 207 and the movement orbit of the reaction container 2011 held on the reaction disk 201 intersect.

The sample dispensing probe 207 is driven by the drive mechanism 4 and moves vertically either directly above the opening of the sample container held by the sample disk 203 or at the sample discharge position. The sample dispensing probe 207 also aspirates sample from the sample container located directly below it under the control of the control circuit 9. The sample dispensing probe 207 also aspirates the aspirated sample into the reaction container 2011 located directly below the sample discharge position under the control of the control circuit 9. As can be seen from this, the sample dispensing arm 206 and the sample dispensing probe 207 constitute the sample dispensing device of this embodiment.

The first reagent dispensing arm 208 is provided near the outer periphery of the first reagent storage 204. The first reagent dispensing arm 208 is provided so as to be movable up and down in the vertical direction and rotatable in the horizontal direction by the drive mechanism 4. The first reagent dispensing arm 208 holds a first reagent dispensing probe 209 at one end.

The first reagent dispensing probe 209 rotates along an arc-shaped rotational orbit in association with the rotation of the first reagent dispensing arm 208. A first reagent aspirating position is provided on this rotational orbit. Also, a first reagent dispensing position is set on the rotational orbit of the first reagent dispensing probe 209 for dispensing the first reagent or standard sample aspirated by the first reagent dispensing probe 209 into the reaction vessel 2011. The first reagent dispensing position is provided at a position where the rotational orbit of the first reagent dispensing probe 209 and the movement orbit of the reaction vessel 2011 held on the reaction disk 201 intersect.

The first reagent dispensing probe 209 is driven by the drive mechanism 4 and moves up and down at the first reagent aspirating position or the first reagent dispensing position on the rotation orbit. The first reagent dispensing probe 209 also aspirates the first reagent or standard sample from a reagent container located directly below the first reagent aspirating position under the control of the control circuit 9. The first reagent dispensing probe 209 also discharges the aspirated first reagent or standard sample into a reaction container 2011 located directly below the first reagent dispensing position under the control of the control circuit 9. As can be seen from this, the first reagent dispensing arm 208 and the first reagent dispensing probe 209 constitute the first reagent dispensing device according to this embodiment.

The second reagent dispensing arm 210 is provided near the outer periphery of the first reagent storage 204. The second reagent dispensing arm 210 is provided so as to be movable up and down in the vertical direction and rotatable in the horizontal direction by the drive mechanism 4. The second reagent dispensing arm 210 holds a second reagent dispensing probe 211 at one end.

The second reagent dispensing probe 211 rotates along an arc-shaped rotational orbit in association with the rotation of the second reagent dispensing arm 210. A second reagent aspirating position is provided on this rotational orbit. In addition, a second reagent ejection position is set on the rotational orbit of the second reagent dispensing probe 211 for ejecting the second reagent aspirated by the second reagent dispensing probe 211 into the reaction vessel 2011. The second reagent ejection position is provided at a position where the rotational orbit of the second reagent dispensing probe 211 and the movement orbit of the reaction vessel 2011 held on the reaction disk 201 intersect.

The second reagent dispensing probe 211 is driven by the drive mechanism 4 and moves up and down at a second reagent aspirating position or a second reagent dispensing position on the rotation orbit. The second reagent dispensing probe 211 also aspirates the second reagent from a reagent container located directly below the second reagent aspirating position under the control of the control circuit 9. The second reagent dispensing probe 211 also discharges the aspirated second reagent into a reaction container 2011 located directly below the second reagent dispensing position under the control of the control circuit 9. As can be seen from this, the second reagent dispensing arm 210 and the second reagent dispensing probe 211 constitute the second reagent dispensing device of this embodiment.

The first stirrer 212 is provided near the outer periphery of the reaction disk 201. The first stirrer 212 has a first stirring arm 2121 and a first stirrer provided at the tip of the first stirring arm 2121. The first stirrer 212 stirs the mixture of the standard sample and the first reagent contained in the reaction vessel 2011 located at the first stirring position on the reaction disk 201 with the first stirrer. The first stirrer 212 also stirs the mixture of the test sample and the first reagent contained in the reaction vessel 2011 located at the first stirring position on the reaction disk 201 with the first stirrer.

The second stirrer 213 is provided near the outer periphery of the reaction disk 201. The second stirrer 213 has a second stirring arm 2131 and also has a second stirrer provided at the tip of the second stirring arm 2131. The second stirrer 213 stirs the mixture of the standard sample, the first reagent, and the second reagent contained in the reaction vessel 2011 located at the second stirring position on the reaction disk 201 with the second stirrer. The second stirrer 213 also stirs the mixture of the test sample, the first reagent, and the second reagent contained in the reaction vessel 2011 located at the second stirring position with the second stirrer.

The photometry unit 214 optically measures the reaction liquid of the sample, the first reagent, and the second reagent dispensed into the reaction vessel 2011. The photometry unit 214 has a light source and a photodetector. The photometry unit 214 irradiates light from the light source according to the control of the control circuit 9. The irradiated light enters the first side wall of the reaction vessel 2011 and exits from the second side wall opposite the first side wall. The photometry unit 214 detects the light exiting from the reaction vessel 2011 using the photodetector.

Specifically, for example, the photodetector is disposed at a position on the optical axis of light irradiated from the light source to the reaction vessel 2011. The photodetector detects light that has passed through the reaction solution of the standard sample, the first reagent, and the second reagent in the reaction vessel 2011, and generates standard data represented by absorbance based on the intensity of the detected light. The photodetector also detects light that has passed through the reaction solution of the test sample, the first reagent, and the second reagent in the reaction vessel 2011, and generates test data represented by absorbance based on the intensity of the detected light. The photometric unit 214 outputs the generated standard data and test data to the analysis circuit 3 as measurement results.

The cleaning unit 215 cleans the inside of the reaction vessel 2011 after the measurement of the reaction liquid has been completed by the photometry unit 214.

As shown in FIG. 1, the control circuit 9 executes an operation program stored in the memory circuit 8 to realize a function corresponding to the program. For example, the control circuit 9 executes an operation program to realize a system control function 91, a calibration control function 92, and a measurement control function 93. Note that in this embodiment, a case where the system control function 91, the calibration control function 92, and the measurement control function 93 are realized by a single processor is described, but this is not limited to this. For example, the control circuit may be configured by combining multiple independent processors, and each processor may execute an operation program to realize the system control function 91, the calibration control function 92, and the measurement control function 93.

The system control function 91 is a function that controls each part of the automatic analyzer 1 based on the input information input from the input interface 5.

The calibration control function 92 is a function that controls the analysis mechanism 2 and the drive mechanism 4 so as to generate standard data. Specifically, the control circuit 9 executes the calibration control function 92 at a predetermined timing. Examples of the predetermined timing include during initial setup, when the device is started up, during maintenance, and when a user inputs an instruction to start a calibration operation.

When the calibration control function 92 is executed, the control circuit 9 controls the analysis mechanism 2 and the drive mechanism 4. By controlling the analysis mechanism 2 and the drive mechanism 4, standard data is generated in the analysis mechanism 2. Specifically, for example, by being driven by the drive mechanism 4, the first reagent dispensing probe 209 of the analysis mechanism 2 aspirates the standard sample from the first reagent storage 204 and ejects the aspirated standard sample into the reaction vessel 2011. Next, the first reagent dispensing probe 209 aspirates the first reagent from the first reagent storage 204 and ejects the aspirated first reagent into the reaction vessel 2011 from which the standard sample was ejected. Next, the first stirring device 212 stirs the solution in which the first reagent has been added to the standard sample.

Next, the second reagent dispensing probe 211 aspirates the second reagent from the second reagent storage 205 and dispenses the aspirated second reagent into the mixed liquid in which the standard sample and the first reagent are mixed. Next, the second mixing device 213 mixes the solution in which the second reagent is added to the mixed liquid. The photometric unit 214 generates standard data by optically measuring the reaction liquid in which the standard sample, the first reagent, and the second reagent are mixed. The photometric unit 214 outputs the generated standard data to the analysis circuit 3. The photometric unit 214 repeats the measurement of the reaction liquid a preset number of times at a preset cycle, and outputs the generated standard data to the analysis circuit 3. The analysis mechanism 2 repeats the above operation for standard samples of multiple preset concentrations, and outputs the generated standard data to the analysis circuit 3.

The measurement control function 93 is a function that controls the analysis mechanism 2 and the drive mechanism 4 so as to generate test data. Specifically, the control circuit 9 executes the measurement control function 93 in response to a predetermined instruction. The predetermined instruction is, for example, an instruction to start a measurement operation input by a user, and an instruction indicating that a preset time has been reached.

When the measurement control function 93 is executed, the control circuit 9 controls the analysis mechanism 2 and the drive mechanism 4. By controlling the analysis mechanism 2 and the drive mechanism 4, the analysis mechanism 2 generates test data. Specifically, by being driven by the drive mechanism 4, the sample dispensing probe 207 of the analysis mechanism 2 aspirates the test sample from the sample disk 203 and ejects the aspirated test sample into the reaction vessel 2011. Next, the first reagent dispensing probe 209 aspirates the first reagent from the first reagent storage 204 and ejects the aspirated first reagent into the reaction vessel 2011 into which the test sample was ejected. Next, the first stirring device 212 stirs the solution to which the first reagent has been added to the test sample.

The second reagent dispensing probe 211 then aspirates the second reagent from the second reagent storage 205 and dispenses the aspirated second reagent into the mixed liquid in which the test sample and the first reagent are mixed. Next, the second mixing device 213 mixes the solution in which the second reagent has been added to the mixed liquid. Next, the photometry unit 214 optically measures the reaction liquid in which the test sample, the first reagent, and the second reagent are mixed, thereby generating test data. The photometry unit 214 outputs the generated test data to the analysis circuit 3. The photometry unit 214 repeats the measurement of the reaction liquid a preset number of times at a preset cycle, and outputs the generated test data to the analysis circuit 3.

The analysis circuit 3 shown in FIG. 1 executes an operation program stored in the memory circuit 8 to realize a function corresponding to the program. For example, the analysis circuit 3 executes an operation program to realize a calibration data generation function 31 and an analysis data generation function 32. Note that, in this embodiment, a case where the calibration data generation function 31 and the analysis data generation function 32 are realized by a single processor will be described, but this is not limited to this. For example, the analysis circuit may be configured by combining multiple independent processors, and the calibration data generation function 31 and the analysis data generation function 32 may be realized by each processor executing an operation program.

The calibration data generation function 31 is a function that generates calibration data based on the standard data generated by the analysis mechanism 2. Specifically, when the analysis circuit 3 receives the standard data generated by the analysis mechanism 2, it executes the calibration data generation function 31. When the calibration data generation function 31 is executed, the analysis circuit 3 generates a calibration curve based on the standard data, which is measurement data including absorbance for standard samples of multiple different concentrations. This generated calibration curve is stored in the memory circuit 8 as calibration data.

The analytical data generation function 32 is a function that generates analytical data by analyzing the test data generated by the analysis mechanism 2. Specifically, when the analysis circuit 3 receives the test data generated by the analysis mechanism 2, it executes the analytical data generation function 32. When the analytical data generation function 32 is executed, the analysis circuit 3 reads out calibration data including information about the calibration curve from the memory circuit 8. Based on the test data and calibration data, the analysis circuit 3 generates analytical data including information about the concentration of the target to be detected in the test sample.

(Mixing device)
Next, the stirring operation by the first stirrer 212 and the second stirrer 213 included in the automated analyzer 1 according to this embodiment will be described in detail. Fig. 3 is a schematic perspective view explaining the stirring principle of the first stirrer 212. The following explanation will focus on the stirring principle and operation of the first stirrer 212, but the stirring principle and operation of the second stirrer 213 are also similar to those of the first stirrer 212.

As shown in FIG. 3, in this embodiment, the first stirrer 2122 of the first stirrer 212 is composed of a vibrating member such as a piezoelectric element. For example, by applying an AC voltage of a specific frequency as a drive signal to this piezoelectric element, the piezoelectric element vibrates and can stir the mixture of the sample and reagent. In this embodiment, for example, under the control of the control circuit 9, a drive signal is applied to the vibrating member such as the piezoelectric element at a predetermined timing.

When a drive signal is applied to the piezoelectric element, the piezoelectric element repeats a reciprocating motion back and forth like a pendulum. In other words, when a mixture of sample and reagent is contained in a reaction vessel, the piezoelectric element, which is the first stirrer 2122, is inserted into the mixture and a drive signal is applied to the piezoelectric element, the piezoelectric element reciprocates as shown in FIG. 3, and the mixture can be stirred. In this embodiment, the pendulum-like reciprocating motion of the piezoelectric element is detected by the detection device 300. Note that the piezoelectric element is an example of a vibrating member that vibrates to stir the mixture of sample and reagent, and the first stirrer 2122 in this embodiment may be constructed using another member that vibrates in response to a drive signal.

The detection device 300 is configured with a generating unit 301 and a receiving unit 302. The generating unit 301 transmits a detection signal DS toward the receiving unit 302. The detection signal DS emits, for example, light or ultrasonic waves for detection. The receiving unit 302 receives the detection signal DS transmitted by the generating unit 301. If there is no obstacle between the generating unit 301 and the receiving unit 302, that is, if there is no piezoelectric element that is the first stirrer 2122, the detection signal DS is received by the receiving unit 302. This state is, for example, the off state of the detection device 300. On the other hand, if there is an obstacle between the generating unit 301 and the receiving unit 302, that is, if there is a piezoelectric element that is the first stirrer 2122, the detection signal DS is blocked by the piezoelectric element and is not received by the receiving unit 302. This state is, for example, the on state of the detection device 300. Therefore, when the piezoelectric element that is the first stirrer 2122 vibrates, this vibration can be detected by the detection device 300.

Figure 4 is a diagram showing the on/off state of the detection result signal generated by the detection device 300 when the stirring position of the first stirrer 2122 is not deviated from the appropriate position, which is the design position. As shown in this figure, in this embodiment, the detection signal DS emitted by the generating unit 301 in the detection device 300 is set to pass through the center of the reciprocating motion of the piezoelectric element, which is the first stirrer 2122. In other words, when the piezoelectric element, which is the first stirrer 2122, vibrates, the generating unit 301 and receiving unit 302 of the detection device 300 are positioned so that the detection signal DS emitted by the generating unit 301 is blocked by the piezoelectric element when the piezoelectric element reaches a position where it extends directly downward. This is the design appropriate position where the first stirrer 2122 should perform stirring.

For this reason, when the stirring position where the piezoelectric element of the first stirrer 2122 vibrates to stir is in the position as designed, the detection result signal generated by the detection device 300 is in the ON state regularly. In other words, the center of the amplitude of the piezoelectric element of the first stirrer 2122 is equal to the position where the detection signal DS of the detection device 300 is blocked, and the pattern of the detection result signal generated by the detection device 300 is such that the detection device 300 is in the ON state at equal intervals.

Figure 5 is a diagram showing the on/off state of the detection result signal generated by the detection device 300 when the stirring position, where the piezoelectric element, which is the first stirrer 2122, stirs, is shifted from the appropriate position, which is the design position. In such a case, as shown in Figure 5, the detection signal DS emitted by the generating unit 301 in the detection device 300 does not pass through the center of the reciprocating motion of the piezoelectric element, which is the first stirrer 2122. In other words, when the piezoelectric element, which is the first stirrer 2122, vibrates, when the piezoelectric element comes to a position shifted from the position where it extends directly downward, the detection signal DS emitted by the generating unit 301 is blocked by the piezoelectric element. For this reason, a bias occurs in the timing at which the detection result signal generated by the detection device 300 becomes in the on state. In other words, the position where the detection signal DS of the detection device 300 is blocked becomes a position shifted from the amplitude of the piezoelectric element, and the pattern of the detection result signal generated by the detection device 300 is such that the detection device 300 becomes in the on state in a biased period.

As can be seen from the explanation using Figures 4 and 5, in this embodiment, the detection result signal of the detection device 300 is expressed as a timing signal when the detection signal DS transmitted from the generating unit 301 is interrupted by the piezoelectric element which is the first stirrer 2122. In other words, the detection result signal is a timing signal that turns on at the timing when the piezoelectric element which is the first stirrer 2122 interrupts the detection signal DS.

The deviation amount of the stirring position where stirring is performed by the first stirrer 2122 from the appropriate position is calculated by the deviation amount calculation function 94 in the control circuit 9 shown in FIG. 1. That is, the deviation amount calculation function 94 calculates the deviation amount between the stirring position where stirring is actually performed and the designed appropriate position based on the detection result signal generated by the detection device 300.

For example, in this embodiment, the relationship between the periodicity pattern of the detection result signal and the amount of deviation of the stirring position where stirring was performed from the appropriate position is registered in advance in the deviation amount calculation function 94 in the control circuit 9. For example, the detection result signal pattern for when the stirring position is in the appropriate position, the detection result signal pattern for when the stirring position is deviated 1 mm to the right from the appropriate position, the detection result signal pattern for when the stirring position is deviated 2 mm to the right from the appropriate position, etc. are registered in advance as registered patterns for each amount of deviation.

The deviation amount calculation function 94 compares the periodic pattern of the actually measured detection result signal with a registered pattern that has been registered in advance, and determines the deviation amount from the appropriate position of the stirring position where stirring was performed by the piezoelectric element that is the first stirrer 2122. In other words, it performs pattern matching between the detection result signal pattern and the registered registered pattern, and determines the deviation amount represented by the most similar registered pattern as the deviation amount from the appropriate position.

Alternatively, the deviation calculation function 94 may calculate the deviation of the stirring position from the in-phase of the pattern of the detection result signal by calculation. That is, the deviation calculation function 94 calculates the deviation of the stirring position where stirring was performed from the appropriate position based on the degree of periodic bias in the pattern of the detection result signal generated by the detection device 300. Specifically, when the stirring position where stirring was performed is the center of the vibration amplitude of the piezoelectric element that is the first stirrer 2122, the bias of the period when the detection result signal is on is zero. However, as the deviation of the stirring position where stirring was performed increases, the bias of the period when the detection result signal is on also increases. Therefore, for example, the deviation calculation function 94 calculates the difference between the length of time related to the longer period and the length of time related to the shorter period in the period when the detection result signal is on, and determines that the deviation of the stirring position increases as this difference increases.

Figure 6 is a diagram explaining the positional relationship between the reaction vessel 2011 and the detection device 300 when the reaction vessel 2011 is housed in the reaction disk 201. In the example shown in Figure 6, the detection device 300 detects the vibration of the first stirrer 2122, which is immersed in the mixture of the sample and the reagent. For this reason, the generating unit 301 and the receiving unit 302 of the detection device 300 are provided inside the reaction disk 201.

The detection signal DS emitted by the generating unit 301 passes through the heat medium in the constant temperature unit 202 of the reaction disk 201 and the mixed liquid in the reaction vessel 2011, and is received by the receiving unit 302. During this time, if the piezoelectric element that is the first stirrer 2122 blocks this detection signal, the detection signal is no longer received by the receiving unit 302, and the detection result signal generated by the detection device 300 becomes ON.

Figure 7 shows another example of the placement position of the detection device 300. In this figure, the detection device 300 detects the vibration of the first stirrer 2122 in the portion that is not immersed in the mixture of the sample and the reagent. For this reason, the generating unit 301 and the receiving unit 302 of the detection device 300 are provided outside the reaction disk 201.

The detection signal DS emitted by the generating unit 301 passes through the atmosphere and is received by the receiving unit 302. During this time, if the piezoelectric element that is the first stirrer 2122 blocks this detection signal, the receiving unit 302 will no longer receive the detection signal, and the detection result signal generated by the detection device 300 will be in the ON state.

The calculation of the deviation of the stirring position using this detection device 300 can be performed constantly, for example, when the automatic analyzer 1 is actually analyzing a test sample such as a patient's blood. This makes it possible to constantly monitor the stirring position where the first stirrer 2122 stirs while the automatic analyzer 1 is operating.

Calculation of the amount of deviation of the stirring position using the detection device 300 can also be performed, for example, during an operational inspection of the automatic analyzer 1. In this case, the stirring position can be inspected by operating the automatic analyzer 1 using, for example, a standard sample and having the first stirrer 212 stir the mixture of the standard sample and the reagent. This makes it possible to check the stirring position at which the first stirrer 2122 stirs before the automatic analyzer 1 starts the actual analysis operation.

Next, the deviation amount calculation process executed by the deviation amount calculation function 94 in the control circuit 9 will be described with reference to FIG. 8. This deviation amount calculation process is, for example, a process that is routinely executed while the automatic analyzer 1 is performing an analysis operation on a test sample collected from a patient. The deviation amount calculation process executed for the first stirrer 212 will be described below as well, but in the automatic analyzer 1 according to this embodiment, a similar process is also executed for the second stirrer 213.

As shown in FIG. 8, the deviation amount calculation function 94 of the control circuit 9 first determines whether stirring has been performed by the first stirrer 212 (step S10). That is, during the analysis operation of the automatic analyzer 1, the reaction vessels 2011 are arranged in a ring shape on the reaction disk 201, and are alternately rotated and stopped at predetermined time intervals. Then, when the reaction vessels 2011 are stopped at the operating position of the first stirrer 212, the mixed liquid is stirred by the first stirrer 2122.

If stirring is not being performed by the first stirrer 2122 (step S10: No), the deviation amount calculation function 94 in the control circuit 9 waits until stirring is actually performed. On the other hand, if stirring is being performed by the first stirrer 2122 (step S10: Yes), the deviation amount calculation function 94 in the control circuit 9 uses the detection device 300 to detect and calculate the deviation amount of the stirring position (step S12). That is, using the method described above, the deviation amount from the appropriate stirring position where stirring is performed by the first stirrer 2122 is calculated based on the detection result signal generated by the detection device 300.

Next, the deviation amount calculation function 94 in the control circuit 9 determines whether the deviation amount calculated in step S12 is equal to or greater than a predetermined value (step S14). For example, the predetermined value is a numerical value such as 0.5 mm or 1 mm. This predetermined value is preregistered in the deviation amount calculation function 94 in the control circuit 9, and the deviation amount calculated in step S12 is compared with this registered predetermined value. If the deviation amount calculated in step S12 is not equal to or greater than the predetermined value (step S14: No), the process returns to step S10 described above, and agitation by the first agitator 212 for the next reaction vessel 2011 is awaited.

On the other hand, if the deviation calculated in step S12 is equal to or greater than the predetermined value (step S14: Yes), the deviation calculation function 94 in the control circuit 9 issues a warning to the user of the automatic analyzer 1 (step S16). This warning can be issued, for example, by outputting a text display of the warning on the display of the output interface 6. Also, if the output interface 6 has a voice output function, the warning can be output by voice output. Based on this warning, the user of the automatic analyzer 1 can inspect or adjust the automatic analyzer 1. Then, the process returns to step S10 described above, and the process waits for the first stirrer 212 to stir the next reaction vessel 2011.

The deviation amount of the stirring position calculated in step S12 may be output as a numerical value. For example, in step S12, the calculated deviation amount may be displayed and output on the display of the output interface 6 as 0.5 mm, 1 mm, etc. Furthermore, in the warning in step S16, the deviation amount of the stirring position may be output as a numerical value together with the warning. For example, the deviation amount of the stirring position may be displayed and output on the display of the output interface 6 as 1 mm, 1.5 mm, etc., or numerical values such as 1 mm, 1.5 mm may be output as audio together with the warning.

As described above, the automatic analyzer 1 according to this embodiment can calculate the amount of deviation of the stirring position where stirring is performed by the first stirrer 2122 from the appropriate position based on the detection result signal detected by the detection device 300, so the user can determine whether stirring is being performed at the appropriate position based on this calculated amount of deviation. In addition, based on the magnitude of the deviation of the stirring position from the appropriate position, it can be determined whether the analysis of the automatic analyzer 1 in operation should be continued or some adjustment should be made. In addition, when the automatic analyzer 1 is undergoing inspection work, the positions of the first stirrer 212 and the first stirrer 2122, and the position of the reaction vessel 2011 that contains the reaction vessel 2011 can also be adjusted based on the amount of deviation of the stirring position from the appropriate position.

As already mentioned, in the automated analyzer 1 according to this embodiment, the configuration and operation of the second stirrer 213 are equivalent to the configuration and operation of the first stirrer 212. Therefore, the contents described for the first stirrer 212 also apply directly to the second stirrer 213.

Second Embodiment
In the automated analyzer 1 according to the first embodiment described above, the stirrer is composed of a vibration member such as a piezoelectric element, but in the automated analyzer 1 according to the second embodiment, the stirrer is composed of a rotating stirring rod and a rotating member that is a stirring plate attached to the stirring rod, which is different. Below, the automated analyzer 1 according to the second embodiment will be described in terms of the differences from the first embodiment described above.

Figure 9 is a diagram illustrating the structure of the first stirrer 2122 in the first stirrer 212 of the automated analyzer 1 according to the second embodiment. The following description will also focus on the structure and operation of the first stirrer 212, but the structure and operation of the second stirrer 213 are similar to those of the first stirrer 212.

As shown in FIG. 9, in this embodiment, the first stirrer 2122 of the first stirrer 212 is composed of a first stirring rod 2123 and a first rotating member 2124, which is a stirring plate provided at the tip of the first stirring rod 2123. The first stirring rod 2123 is inserted into the mixture of the sample and the reagent, and rotates around the central axis in the longitudinal direction of the first stirring rod 2123. When the first stirring rod 2123 rotates, the first rotating member 2124, which is a stirring plate attached to the first stirring rod 2123, also rotates accordingly, stirring the mixture. The rotation operation of the first stirring rod 2123 is performed under the operational control of the first stirring device 212.

The shape of the stirring plate of the first rotating member 2124 is arbitrary as long as the purpose of stirring the mixed liquid is achieved. For example, the stirring plate may be spatula-shaped or may be rectangular. The number of stirring plates of the first rotating member 2124 is also arbitrary, and may be one, three, or four, instead of two.

A first cutting plate 2125 is provided on the top of the first stirring rod 2123. When the first stirring rod 2123 rotates, the first cutting plate 2125 attached to the first stirring rod 2123 also rotates accordingly. For example, the first stirring rod 2123 and the first rotating member 2124 alternately rotate in a clockwise direction and a counterclockwise direction when viewed from above. In this embodiment, the rotation of the first cutting plate 2125 is detected by the detection device 300, and the amount of deviation of the stirring position where the first stirrer 2122 performs stirring from the appropriate position is calculated.

The first cut plate 2125 of the first stirrer 2122 illustrated in FIG. 9 is not immersed in the mixture when stirring the mixture of the sample and the reagent contained in the reaction vessel 2011, but the first cut plate 2125 may be immersed in the mixture. In this case, as shown in FIG. 10, the mounting position of the first cut plate 2125 on the first stirring rod 2123 moves downward. That is, the first cut plate 2125 rotates in the mixture of the sample and the reagent together with the first rotating member 2124. Therefore, when the first cut plate 2125 is immersed in the mixture of the sample and the reagent, it can be said that the first cut plate 2125 also contributes to stirring the mixture.

Figure 11 shows a plan view of the first cutting plate 2125 seen from above. As can be seen from Figure 11, the first cutting plate 2125 rotates together with the rotation of the first stirring rod 2123. In this embodiment, the generating unit 301 of the detection device 300 transmits a detection signal DS to this first cutting plate 2125, and the detection result signal is switched on/off depending on whether or not it can be received by the receiving unit 302.

Figures 12 and 13 are schematic diagrams showing the positional relationship between the first cut plate 2125 and the detection device 300 when viewed from above. Figure 12 illustrates a case where the first cut plate 2125 blocks the detection signal DS emitted from the generation unit 301 of the detection device 300, and Figure 13 illustrates a case where the detection signal DS emitted from the generation unit 301 of the detection device 300 is not blocked by the first cut plate 2125 and is received by the receiving unit 302.

As can be seen from Figures 12 and 13, when the first cutter plate 2125 rotates, a state in which the detection signal DS is blocked by the first cutter plate 2125 and cannot be received by the receiver unit 302, as shown in Figure 12, and a state in which the detection signal DS is not blocked by the first cutter plate 2125 and can be received by the receiver unit 302, as shown in Figure 13, are alternately repeated.

Also, as can be seen from FIG. 11, the time (period) during which the detection signal DS transmitted from the generating unit 301 is blocked by the first cutting plate 2125 varies depending on the position to which the first cutting plate 2125 rotates. For example, when the detection signal DS transmitted from the generating unit 301 is blocked by the outer periphery of the first cutting plate 2125, the time during which the detection signal DS is blocked by the first cutting plate 2125 is short. On the other hand, when the detection signal DS transmitted from the generating unit 301 is blocked by the inner periphery of the first cutting plate 2125, the time during which the detection signal DS is blocked by the first cutting plate 2125 is long. In this embodiment, this characteristic is utilized to detect the amount of deviation of the first stirring rod 2123, that is, the amount of deviation of the stirring position of the first stirring bar 2122 from the appropriate position.

In this embodiment, for example, when the stirring position of the first stirrer 2122 is the appropriate position, the time when the detection signal DS is blocked by the first cutter plate 2125 and the detection device 300 is turned on is set to be equal to the time when the detection signal DS is received by the receiving unit 302 and the detection device 300 is turned off. In this case, as shown in FIG. 14, the detection result signal generated by the detection device 300 has equal on and off times, and the periods of both are aligned.

On the other hand, if the stirring position of the first stirrer 2122 is shifted from the appropriate position toward the outer periphery in the rotational direction of the first cutter plate 2125, the on time in the detection result signal generated by the detection device 300 becomes shorter than the off time, as shown in FIG. 15. Also, as the stirring position shifts further toward the outer periphery, the on time in the detection result signal becomes shorter.

In contrast, if the stirring position of the first stirrer 2122 is shifted from the appropriate position toward the inner circumference in the rotation direction of the first cutter plate 2125, the on time in the detection result signal generated by the detection device 300 will be longer than the off time, as shown in FIG. 16. Also, as the stirring position shifts further toward the inner circumference, the on time in the detection result signal will be longer.

For this reason, the deviation calculation function 94 in the control circuit 9 of the automatic analyzer 1 according to this embodiment calculates the deviation of the stirring position at which the first stirrer 2122 stirs from the appropriate position based on the ratio of on time to off time in one period of the detection result signal generated by the detection device 300.

As in the first embodiment described above, for example, the relationship between the pattern of the detection result signal and the amount of deviation of the stirring position where stirring was performed from the appropriate position is registered in advance in the deviation amount calculation function 94 in the control circuit 9. For example, the pattern of the detection result signal when the stirring position is in the appropriate position, the pattern of the detection result signal when the stirring position is deviated 1 mm to the right from the appropriate position, the pattern of the detection result signal when the stirring position is deviated 2 mm to the right from the appropriate position, etc., is registered in advance as a registered pattern for each amount of deviation.

The deviation amount calculation function 94 compares the pattern of the actually measured detection result signal with a registered pattern that has been registered in advance, and determines the amount of deviation from the appropriate position of the stirring position where stirring was performed by the first rotating member 2124 of the first stirrer 2122. In other words, it performs pattern matching between the pattern of the detection result signal and the registered registered pattern, and determines the amount of deviation represented by the most similar registered pattern as the amount of deviation from the appropriate position.

Alternatively, the deviation calculation function 94 may calculate the deviation of the stirring position from the ratio of on time to off time in the detection result signal. In other words, the deviation of the stirring position where the first stirrer 2122 stirs is estimated based on the ratio of on time in one cycle.

For example, the deviation calculation function 94 calculates the deviation amount assuming that the stirring position where stirring was performed has shifted from the appropriate position toward the inner circumference in proportion to the increase in the on-time in the pattern of the detection result signal generated by the detection device 300. Conversely, the deviation amount is calculated assuming that the stirring position where stirring was performed has shifted from the appropriate position toward the outer circumference in proportion to the decrease in the on-time in the pattern of the detection result signal generated by the detection device 300.

The deviation amount calculation process executed by the deviation amount calculation function 94 in the control circuit 9 of the automatic analyzer 1 according to this embodiment is the same as that of the first embodiment described above. That is, the automatic analyzer 1 according to this embodiment also executes the deviation amount calculation process shown in FIG. 8. However, the method of calculating the deviation amount of the stirring position from the appropriate position in step S12 is configured and operates as described above. By executing this deviation amount calculation process, the user can know the deviation amount of the stirring position where stirring was performed from the appropriate position, or can receive a warning if a deviation amount equal to or greater than a predetermined value occurs.

In this embodiment, the first agitator 2122 is provided with a first cutter 2125 in addition to the first rotating member 2124, and the detection signal DS is sent toward the first cutter 2125. However, the detection signal DS may be sent toward the first rotating member 2124 without additionally providing the first cutter 2125. In other words, the first cutter 2125 may be omitted. In this case, the amount of deviation of the agitation position where agitation is performed by the first agitator 2122 from the appropriate position is calculated using the detection result signal detected based on the rotation of the first rotating member 2124. In this way, the first rotating member 2124 that performs agitation can be used instead of the first cutter 2125.

As described above, even in the automatic analyzer 1 in which the first stirrer 2122 is configured as the first rotating member 2124 that rotates in the mixed liquid, the amount of deviation of the stirring position where the first stirrer 2122 stirs from the appropriate position can be calculated based on the detection result signal detected by the detection device 300, so the user can determine whether stirring is being performed at the appropriate position based on the calculated amount of deviation. In addition, based on the magnitude of the amount of deviation of the stirring position from the appropriate position, it can be determined whether the analysis of the automatic analyzer 1 in operation should be continued or some adjustment should be made. In addition, when the automatic analyzer 1 is being inspected, the positions of the first stirrer 212 and the first stirrer 2122, and the position of the reaction vessel 2011 that contains the reaction vessel 2011 can be adjusted based on the amount of deviation of the stirring position from the appropriate position.

As already mentioned, in the automated analyzer 1 according to this embodiment, the configuration and operation of the second stirrer 213 are equivalent to the configuration and operation of the first stirrer 212. Therefore, the contents described for the first stirrer 212 also apply directly to the second stirrer 213.

Third Embodiment
In the automatic analyzer 1 according to the third embodiment, an agitation position adjustment function for adjusting the agitation positions where the first agitator 212 and the second agitator 213 perform agitation is additionally provided to the automatic analyzer 1 according to the first and second embodiments described above. Below, the differences from the first and second embodiments described above will be described.

Fig. 17 is a block diagram showing an example of the functional configuration of the automatic analyzer 1 according to the third embodiment, and corresponds to Fig. 1 described above. As shown in Fig. 17, the automatic analyzer 1 according to this embodiment is configured by adding a stirring position adjustment function 95 to the control circuit 9 of the automatic analyzer 1 according to the first and second embodiments described above.

This stirring position adjustment function 95 is a function that is executed based on a stirring position adjustment instruction from the user input via the input interface 5. For example, when the user starts up the automatic analyzer 1 in the morning, the user causes the automatic analyzer 1 to execute the stirring position adjustment function 95 and adjust the stirring positions of the first stirrer 212 and the second stirrer 213. Alternatively, during an inspection operation of the automatic analyzer 1, the user causes the automatic analyzer 1 to execute the stirring position adjustment function 95 and adjust the stirring positions of the first stirrer 212 and the second stirrer 213. This stirring position adjustment function 95 constitutes the stirring position adjustment unit in this embodiment.

Figure 18 is a diagram showing a flowchart explaining the contents of the stirring position adjustment process executed by the control circuit 9 of the automatic analyzer 1 according to this embodiment. The following mainly explains the operation of the first stirring device 212, but the operation of the second stirring device 213 is similar to that of the first stirring device 212. Specifically, the stirring position adjustment process executed for the first stirring device 212 will be explained based on this Figure 18, but a similar stirring position adjustment process is also executed for the second stirring device 213.

As shown in FIG. 18, when the stirring position adjustment process is started, the stirring position adjustment function 95 in the control circuit 9 first drives the first stirring device 212 at the stirring position for which the stirring position adjustment command has been received, to perform stirring (step S30). That is, the first stirrer 2122 is operated to stir the mixture of the sample and the reagent, and a detection result signal is generated using the detection device 300.

Next, the stirring position adjustment function 95 in the control circuit 9 calculates the deviation amount of the stirring position where stirring is performed by the first stirrer 2122 from the appropriate position based on the detection result signal generated in step S30 (step S32). The method for calculating this deviation amount may be any of the methods in the first and second embodiments described above.

Next, the stirring position adjustment function 95 in the control circuit 9 executes steps S30 and S32 a predetermined number of times and determines whether or not the amount of deviation has been acquired a predetermined number of times (step S34). Here, the predetermined number of times is a number of times such as 4 times, 6 times, or 9 times.

If the amount of deviation of the stirring position for a predetermined number of times has not been acquired (step S34: No), the stirring position adjustment function 95 in the control circuit 9 changes the stirring position of the first stirring bar 2122 (step S36). In other words, the stirring position of the first stirring bar 2122 in the first stirring device 212 is changed to a different stirring position from the previous one.

The position to which the stirring position is moved can be determined arbitrarily. For example, the stirring position may be moved randomly. Alternatively, as shown in FIG. 19, the stirring position may be changed in order, with the initial stirring position P1 at the center, and the amount of deviation of the stirring position at each of the eight surrounding stirring positions P2 to P9 is obtained. In this case, the predetermined number of times in step S34 is nine.

Also, as shown in FIG. 20, the stirring position may be changed in order so that the amount of deviation of the stirring position is obtained at each of the four surrounding stirring positions P2 to P5, centered around the initial stirring position P1. In this case, the predetermined number of times in step S34 is five.

Next, as shown in FIG. 18, the stirring position adjustment function 95 in the control circuit 9 returns to step S30 described above, and calculates the amount of deviation from the appropriate position for the stirring position changed in step S36. That is, in this stirring position adjustment process, the amount of deviation from the appropriate position for each of the different stirring positions is calculated.

On the other hand, if it is determined in step S34 that the deviation amount of the stirring position has been acquired a predetermined number of times (step S34: Yes), the stirring position adjustment function 95 in the control circuit 9 determines and stores the optimal stirring position (step S38). For example, in this embodiment, the stirring position with the smallest deviation amount is determined as the optimal stirring position and stored in the system control function 91. The system control function 91 then controls the first stirring device 212 so that stirring is performed by the first stirring bar 2122 at this newly stored stirring position. This ends the stirring position adjustment process for the first stirring device 212.

As already mentioned, in the automated analyzer 1 according to this embodiment, the configuration and operation of the second stirrer 213 are equivalent to the configuration and operation of the first stirrer 212. Therefore, the contents described for the first stirrer 212 also apply directly to the second stirrer 213.

As described above, in the automated analyzer 1 according to this embodiment, the stirring position adjustment function 95 is additionally provided, so that the user can have the automated analyzer 1 automatically adjust the stirring positions of the first stirrer 212 and the second stirrer 213. This makes it possible to minimize the deviation in the stirring positions of the first stirrer 212 and the second stirrer 213, thereby improving the stirring accuracy of the mixture of the sample and the reagent.

Fourth Embodiment
In the automatic analyzer 1 according to the fourth embodiment, an agitation operation determination function is additionally provided to the automatic analyzer 1 according to the first to third embodiments described above, which determines whether the mixed liquid is being properly agitated by the first agitator 212 and the second agitator 213. In the following, differences from the third embodiment described above will be additionally described, but the fourth embodiment can be similarly applied to the first and second embodiments described above.

Fig. 21 is a block diagram showing an example of the functional configuration of the automatic analyzer 1 according to the fourth embodiment, and corresponds to Fig. 1 and Fig. 17 described above. As shown in Fig. 21, the automatic analyzer 1 according to this embodiment is configured by adding a stirring operation determination function 96 to the control circuit 9 of the automatic analyzer 1 according to the third embodiment described above.

This stirring operation determination function 96, like the deviation amount calculation function 94, is constantly executed to determine whether the first stirring device 212 and the second stirring device 213 are performing the stirring operation properly while the automatic analyzer 1 is performing an analysis operation on a test sample collected from a patient. Alternatively, during an inspection operation of the automatic analyzer 1, a user may cause the automatic analyzer 1 to execute the stirring operation determination function 96 to determine whether the stirring operations of the first stirring device 212 and the second stirring device 213 are being performed properly. This stirring operation determination function 96 constitutes the stirring operation determination unit in this embodiment.

Figure 22 is a diagram showing a flowchart explaining the contents of the stirring operation determination process executed by the control circuit 9 of the automatic analyzer 1 according to this embodiment. The following mainly explains the operation of the first stirring device 212, but the operation of the second stirring device 213 is similar to that of the first stirring device 212. Specifically, the stirring operation determination process executed for the first stirring device 212 will be explained based on Figure 22, but a similar stirring operation determination process is also executed for the second stirring device 213.

As shown in FIG. 22, in the stirring operation determination process, first, the stirring operation determination function 96 in the control circuit 9 determines whether stirring has been performed by the first stirrer 212 (step S10). That is, during the analysis operation of the automatic analyzer 1, the reaction vessels 2011 are arranged in a ring shape on the reaction disk 201, and are alternately rotated and stopped at predetermined time intervals. Then, when the reaction vessels 2011 are stopped at the operating position of the first stirrer 212, the mixed liquid is stirred by the first stirrer 2122.

If stirring is not being performed by the first stirrer 2122 (step S50: No), the stirring operation determination function 96 in the control circuit 9 waits until stirring is actually performed. On the other hand, if stirring is being performed by the first stirrer 2122 (step S50: Yes), the stirring operation determination function 96 in the control circuit 9 acquires a detection result signal from the detection device 300 (step S52). That is, in order for the detection device 300 to detect the stirring position of the first stirrer 2122 of the first stirrer 212, the detection device 300 constantly transmits a detection signal DS and generates a detection result signal. The stirring operation determination function 96 acquires this detection result signal.

Next, the stirring operation determination function 96 in the control circuit 9 determines whether stirring by the first stirrer 2122 is being performed properly based on the detection result signal acquired in step S52 (step S54). That is, the detection result signal generated by the detection device 300 represents the behavior of the stirring operation by the first stirrer 2122 as a detection result signal pattern. Therefore, in this embodiment, by analyzing the pattern of this detection result signal, it is determined whether stirring by the first stirrer 2122 is being performed properly.

For example, by analyzing the pattern of the detection result signal, if the number of times the signal is on within a specified time is less than a predetermined threshold, the stirring operation determination function 96 determines that the stirring operation by the first stirrer 2122 is not being performed properly. Alternatively, if the detection result signal does not turn on at all within a specified time, the stirring operation determination function 96 determines that the stirring operation by the first stirrer 2122 is not being performed properly. This can occur, for example, when the first stirrer 2122 is broken and missing, or bent. In the automated analyzer 1 according to this embodiment, such a condition can be detected based on the detection result signal generated by the detection device 300.

If it is determined in step S54 that the stirring operation by the first stirrer 2122 is being performed properly (step S54: Yes), the stirring operation determination function 96 in the control circuit 9 returns to the above-mentioned step S50 and waits until the next stirring by the first stirrer 212.

On the other hand, if it is determined that the stirring operation by the first stirrer 2122 is not being performed properly (step S54: No), the stirring operation determination function 96 in the control circuit 9 issues a warning to the user of the automatic analyzer 1 (step S56). This warning can be issued, for example, by outputting a text display of the warning on the display of the output interface 6. Also, if the output interface 6 has a voice output function, the warning can be output by voice output. Based on this warning, the user of the automatic analyzer 1 can inspect or adjust the first stirrer 212. Then, the process returns to step S50 described above, and the process waits for the first stirrer 212 to stir the next reaction vessel 2011.

As already mentioned, in the automated analyzer 1 according to this embodiment, the configuration and operation of the second stirrer 213 are equivalent to the configuration and operation of the first stirrer 212. Therefore, the contents described for the first stirrer 212 also apply directly to the second stirrer 213.

As described above, in the automated analyzer 1 according to this embodiment, the stirring operation determination function 96 is additionally provided, so that even if a malfunction occurs in the stirring operation of the first stirrer 212 and the second stirrer 213, this can be detected quickly. This makes it possible to further improve the reliability of the stirring operation by the first stirrer 212 and the second stirrer 213.

In the above description, an example was described in which the "processor" reads out and executes a program corresponding to each function from the storage circuit 8, but the embodiment is not limited to this. The term "processor" refers to circuits such as a CPU (central processing unit), a GPU (Graphics Processing Unit), an Application Specific Integrated Circuit (ASIC), a programmable logic device (e.g., a Simple Programmable Logic Device (SPLD), a Complex Programmable Logic Device (CPLD), and a Field Programmable Gate Array (FPGA)). When the processor is, for example, a CPU, the processor realizes the function by reading out and executing a program stored in the storage circuit 8. On the other hand, when the processor is, for example, an ASIC, instead of storing the program in the storage circuit 8, the function is directly incorporated as a logic circuit in the circuit of the processor. Note that each processor in this embodiment is not limited to being configured as a single circuit for each processor, and may be configured as a single processor by combining multiple independent circuits to realize the function. Furthermore, multiple components in FIG. 1 may be integrated into a single processor to achieve the functions.

Although several embodiments have been described above, these embodiments are presented only as examples and are not intended to limit the scope of the invention. The novel apparatus and method described in this specification can be embodied in various other forms. In addition, various omissions, substitutions, and modifications can be made to the forms of the apparatus and method described in this specification without departing from the spirit of the invention. The appended claims and their equivalents are intended to include such forms and modifications that fall within the scope and spirit of the invention.

1...automatic analyzer, 2...analysis mechanism, 3...analysis circuit, 4...drive mechanism, 5...input interface, 6...output interface, 7...communication interface, 8...memory circuit, 9...control circuit, 31...calibration data generation function, 32...analysis data generation function, 91...system control function, 92...calibration control function, 93...measurement control function, 201...reaction disk, 202...thermostatic section, 203...sample disk, 204...first reagent storage, 205...second reagent storage, 206...sample dispensing arm, 207...sample dispensing probe, 208...first reagent dispensing arm, 209...first reagent dispensing probe, 210...second reagent dispensing arm, 211...second reagent dispensing probe, 212...first stirring device, 213...second stirring device, 214...photometric unit, 215...cleaning unit, 300...detection device, 301...generation unit, 302...reception unit

Claims (10)

A holder that holds a plurality of reaction vessels;
a stirring means having a stirrer for stirring the mixture of the sample and the reagent contained in the reaction vessel;
A detection means including a generating unit that generates light or ultrasonic waves for detection and a receiving unit that receives the light or ultrasonic waves generated by the generating unit, and detects the behavior of the stirrer in the stirring means;
a deviation amount calculation unit that calculates a deviation amount of a stirring position, which is a position where stirring is performed by the stirrer, from an appropriate position based on a detection result by the detection means;
Equipped with
The detection means detects the behavior of the stirrer as a pattern of a detection result signal,
The deviation amount calculation unit calculates the deviation amount of the stirring position based on a pattern of the detection result signal,
An automatic analyzer, wherein the pattern of the detection result signal is represented as a timing signal at which the detection signal emitted by the generating unit is interrupted by the stirrer. 2. The automatic analyzer according to claim 1, wherein the stirrer is composed of a vibrating member that vibrates to stir the mixed liquid, and the generating unit and receiving unit of the detection means are positioned such that, when the vibrating member stirs the mixed liquid, the detection signal emitted by the generating unit is blocked by the vibrating member when the vibrating member is at the center of the amplitude of vibration of the vibrating member. The automatic analyzer according to claim 2 , wherein the deviation amount calculation unit calculates the deviation amount of the stirring position by comparing a periodic pattern in the detection result signal with a registered pattern that is registered in advance. The automatic analyzer according to claim 2 , wherein the deviation amount calculation unit calculates the deviation amount of the stirring position based on a degree of deviation in periodicity in a pattern of the detection result signal. 2. The automated analyzer according to claim 1, wherein the stirrer comprises a stirring rod that rotates about a central axis in the longitudinal direction , and a rotating member that is attached to the stirring rod and rotates in conjunction with the rotation of the stirring rod to stir the mixed liquid. The stirring bar further includes a cutting plate attached to the stirring rod and rotating in association with the rotation of the stirring rod,
The automatic analyzer of claim 5, wherein the generating unit and the receiving unit are arranged so that, in the detection result signal, the detection signal emitted by the generating unit alternates between periods when it is blocked by the cutting plate that rotates in conjunction with the rotation of the stirring rod and periods when it is not blocked. The automatic analyzer according to claim 6 , wherein the deviation amount calculation section calculates the deviation amount of the stirring position from a ratio of an on time to an off time in the detection result signal. A holder that holds a plurality of reaction vessels;
a stirring means having a stirrer for stirring the mixture of the sample and the reagent contained in the reaction vessel;
A detection means including a generating unit that generates light or ultrasonic waves for detection and a receiving unit that receives the light or ultrasonic waves generated by the generating unit, and detects the behavior of the stirrer in the stirring means;
a deviation amount calculation unit that calculates a deviation amount of a stirring position, which is a position where stirring is performed by the stirrer, from an appropriate position based on a detection result by the detection means;
an agitation position adjustment unit that adjusts the agitation position, which is a position where agitation is performed by the agitator, based on the deviation amount of the agitation position with respect to the appropriate position calculated by the deviation amount calculation unit;
Equipped with
The stirring position adjustment unit calculates the amount of deviation of the stirring position from the appropriate position at different stirring positions a predetermined number of times, and determines the stirring position with the smallest amount of deviation as the optimal stirring position. 9. The automatic analyzer according to claim 1 , further comprising a stirring operation determination unit that determines whether the stirring operation of the stirrer is properly performed on the mixed liquid based on a detection result of the detection means. The automated analyzer according to claim 9 , further comprising a first warning unit that issues a warning to a user when the stirring operation determination unit determines that stirring by the stirrer is not being performed properly.