Automated analysis device

By using limiters and an RFID tag system in the automated analysis device, the problem of incorrect reagent replacement is solved, preventing the reagent suction nozzle from being inserted into the wrong reagent bottle. This results in reagent management with less space and a simplified structure.

CN115398242BActive Publication Date: 2026-06-02HITACHI HIGH TECH CORP

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
HITACHI HIGH TECH CORP
Filing Date
2021-02-03
Publication Date
2026-06-02

AI Technical Summary

Technical Problem

Existing automated analysis devices are prone to errors when changing system reagents, causing the device to stop operating. In addition, the need for an additional cover structure increases the complexity of the device and the space occupied.

Method used

A limiting element is placed on the moving path of the reagent suction nozzle of the nozzle unit to prevent the reagent suction nozzle from being inserted. Combined with RFID tags and a drive control system, this ensures the correct reagent type and prevents erroneous operation.

Benefits of technology

It effectively prevents incorrect placement of reagents and removal at the wrong time, reduces device space and number of components, and ensures stable analysis.

✦ Generated by Eureka AI based on patent content.

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Abstract

Provided is an automatic analysis device (1) including: a reagent bottle setting portion (200) that sets a reagent bottle (301) that contains a reagent used for analysis; and a nozzle unit (210) that connects a portion where the reagent is used and a supply flow path (220) provided in the reagent bottle (301) set in the reagent bottle setting portion (200) to the reagent bottle (301), wherein a stopper (202) is provided on a movement path of a reagent suction nozzle (400) of the nozzle unit (210) to prevent the reagent suction nozzle (400) from being inserted into the reagent bottle (301). Thus, an automatic analysis device is provided that prevents placement errors of reagent types and prevents reagent removal at the wrong time with fewer spaces and components.
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Description

Technical Field

[0001] This invention relates to an automated analytical device for analyzing the concentration of predetermined components in biological samples such as blood and urine (hereinafter referred to as specimens) using reagents. Background Technology

[0002] As an example of a sample analysis device that allows for smoother replacement of reagent bottles compared to the past, Patent Document 1 describes the following technology, which includes: a container setting section for setting reagent bottles; an openable and closable cap set in the reagent bottle setting section; a solenoid for locking the cap in the open position; and an information processing unit that controls the locking and unlocking of the cap in the open position by the solenoid, and locks the cap in the open position when the reagent is replaced.

[0003] Existing technical documents

[0004] Patent documents

[0005] Patent Document 1: Japanese Patent Application Publication No. 2011-209207 Summary of the Invention

[0006] The problem that the invention aims to solve

[0007] An automated analysis device is known that uses reagents housed within the device to analyze samples.

[0008] For reagents used in automated analytical devices, most reagents are either individually prepared according to the test items (hereinafter referred to as test reagents) or commonly used in various test items (hereinafter referred to as system reagents).

[0009] Among them, the system reagents are mostly loaded in multiple quantities according to the measurement principle of the device, the cleaning method of the device, etc.

[0010] Here, we assume the user mistakenly removes the system reagent while it is in use. In this case, the device cannot continue the measurement due to the lack of system reagent supply and stops. The user needs to reset the reagent and repeat the measurement, which prolongs the time required to obtain the analytical results.

[0011] The automatic analysis apparatus disclosed in the aforementioned Patent Document 1 describes a method that includes: providing a container setting part capable of setting a reagent bottle containing the reagents used for analysis and a lid for opening or closing the container setting part, and locking or unlocking the lid.

[0012] Furthermore, a structure is adopted in which the cap and the nozzle for inserting reagents are linked. When placing reagents, the type of reagent is identified. If the correct reagent type is identified, the cap and nozzle are allowed to descend; if the correct reagent type is not identified, the nozzle is prohibited from descending to prevent incorrect setting. After the reagent is set, the cap and nozzle are prohibited from rising except when the reagent should be replaced, thereby preventing the user from accidentally removing the reagent.

[0013] However, the automated analysis device disclosed in Patent Document 1 requires a cover that is not needed for the purpose of placing reagents in the device. Therefore, there is a problem of the reagent placement section becoming large and complex.

[0014] The present invention was made to solve the above-mentioned problems and provides an automatic analysis device that can prevent incorrect placement of reagent types and incorrect removal of reagents at the wrong time with less space and fewer components.

[0015] Solution for solving the problem

[0016] The present invention includes multiple solutions to the above-mentioned problems. One example is an automatic analysis device, characterized in that it has a limiting member disposed on the moving path of the reagent aspiration nozzle of the nozzle unit, which prevents the reagent aspiration nozzle from being inserted into the reagent bottle.

[0017] Invention Effects

[0018] According to the present invention, it is possible to prevent incorrect placement of reagent types and incorrect removal of reagents at less time with less space and fewer components. Other issues, structures, and effects beyond those described above will become clear through the following description of embodiments. Attached Figure Description

[0019] Figure 1 This is a diagram showing the overall structure of the automatic analysis device according to an embodiment of the present invention.

[0020] Figure 2 This is a diagram illustrating an example of a reagent bottle containing system reagents used in the automated analytical apparatus of the present invention.

[0021] Figure 3 This is a diagram showing a schematic structure of the reagent bottle mounting section and nozzle unit of the automatic analysis device of the present invention.

[0022] Figure 4 This is a diagram showing a schematic structure of the reagent bottle mounting section and nozzle unit of the automatic analysis device of the present invention.

[0023] Figure 5 This is a flowchart illustrating the reagent bottle setup process of the automatic analysis device of the present invention.

[0024] Figure 6 It means Figure 5 The diagram shows the positional relationship between the reagent bottle and the limiting component during step S4.

[0025] Figure 7 It means Figure 5 A diagram showing the positional relationship between the reagent bottle and the limiting component during step S6.

[0026] Figure 8 It means Figure 5 The diagram shows the positional relationship between the reagent bottle and the limiting component during step S7.

[0027] Figure 9 It means Figure 5 A diagram showing the positional relationship between the reagent bottle and the limiting component after step S8.

[0028] Figure 10 This is a flowchart of the reagent bottle removal process of the automatic analysis device of the present invention.

[0029] Figure 11 It means Figure 10 A diagram showing the positional relationship between the reagent bottle and the limiting component during step S11.

[0030] Figure 12 It means Figure 10 A diagram showing the positional relationship between the reagent bottle and the limiting component during step S12. Detailed Implementation

[0031] use Figures 1 to 12 An embodiment of the automatic analysis apparatus of the present invention will be described.

[0032] Here, in the following embodiments, an immunoassay apparatus is used as an example for description. However, the automated analysis apparatus using the reagent bottle configuration structure disclosed in this invention is not limited to immunoassay apparatuses, but can be applied to all automated analysis apparatuses that use system reagents, such as automated biochemical analysis apparatuses, hematological examination apparatuses, liquid chromatography quality analysis apparatuses, etc.

[0033] First, use Figure 1 The overall structure of the automated immune analyzer in this embodiment will be described. Figure 1 This is a diagram showing the overall structure of the automated immune analysis device in this embodiment.

[0034] Figure 1The automated immunoassay analyzer 1 shown is a device for reacting a sample and reagents and measuring the reaction solution. It includes a conveyor line 100, a sample dispensing mechanism 103, a constant temperature chamber 109, a container 108, a conveying mechanism 113, a reagent tray 102, a reagent dispensing mechanism 104, a magnetic particle stirring mechanism 105, a magnetic separation unit 114, a BF separation conveying mechanism 115, a reaction solution suction mechanism 116, a washing solution A dispensing mechanism 117, a washing solution B dispensing mechanism 118, a detection unit conveying mechanism 121, a detection solution dispensing mechanism 119, a detection unit 120, a control unit 131, a storage device 132, a display device 133, and an input device 134.

[0035] The transfer line 100 is used to transport a support 100A capable of holding multiple specimen containers 100B containing specimens to a specimen dispensing position, etc.

[0036] The sample dispensing mechanism 103 is used to attract the sample contained in the sample container 100B and dispense it into the nozzle of the reaction vessel 106 on the constant temperature chamber 109.

[0037] The incubator 109 is a tray used to react the sample and reagent at a constant temperature. Its temperature is maintained at a predetermined temperature by a heater (not shown), thus promoting the reaction between the sample and reagent. Multiple reaction vessels 106 are held within the incubator 109, serving as sites for mixing and reacting the sample and reagent.

[0038] The storage box 108 holds a disposable dispensing pipette 107 installed at the front end of the sample dispensing mechanism 103 during sample collection and dispensing, and a reaction container 106 into which the sample collected by the sample dispensing mechanism 103 and reagents are placed for reaction.

[0039] The conveying mechanism 113 transports the unused reaction container 106 held in the bin 108 to the constant temperature chamber 109. In addition, it transports the used reaction container 106 to the reaction container disposal section 110, transports the unused dispensing pipette tip 107 held in the bin 108 to the dispensing pipette tip installation position 111, and transports the used dispensing pipette tip 107 to the dispensing pipette tip disposal site 112.

[0040] The reagent tray 102 is a tray for storing reagent bottles 101 containing test reagents and is kept cold in order to prevent the deterioration of the test reagents.

[0041] The reagent dispensing mechanism 104 is a nozzle used to draw the reagent stored in the reagent bottle 101 in the reagent tray 102 and dispense it into the reaction vessel 106.

[0042] The magnetic particle stirring mechanism 105 stirs the magnetic particle solution in the reagent tray 102.

[0043] The BF separation conveying mechanism 115 moves the reaction vessel 106, which has been dispensed with magnetic particle solution, from the constant temperature chamber 109 to the magnetic separation section 114.

[0044] The magnetic separation unit 114 performs magnetic separation processing on the reaction vessel 106, which has been dispensed with a solution of magnetic particles.

[0045] The reaction solution suction mechanism 116 draws the reaction solution from the reaction vessel 106, which is being transported to the magnetic separation section 114. The cleaning solution A discharge mechanism 117 discharges cleaning solution A into the reaction vessel 106, which is being transported to the magnetic separation section 114. The cleaning solution B discharge mechanism 118 discharges cleaning solution B into the reaction vessel 106, which is being transported to the magnetic separation section 114.

[0046] The testing department conveying mechanism 121 conveys the reaction vessel 106 from the constant temperature chamber 109 to the testing department 120, or from the testing department 120 to the constant temperature chamber 109.

[0047] The detection solution dispensing mechanism 119 dispenses the reagents for detection into the reaction vessel 106, which is conveyed to the detection section 120 by the detection section conveying mechanism 121.

[0048] The detection unit 120 performs the detection of the target substance in the reaction container 106, in which the reaction solution of the detection reagent is discharged by the detection solution discharge mechanism 119.

[0049] The cleaning process performed in the magnetic separation unit 114 is to remove substances from the sample that remain in the reaction solution. Two cleaning solutions are used sequentially. Cleaning solution A is an aqueous solution, primarily removing coexisting substances such as inorganic salts. Cleaning solution B is a solution containing an organic solvent, primarily removing coexisting substances such as lipids and proteins.

[0050] The test reagent dispensed from the test solution dispensing mechanism 119 is used to adjust the pH and other parameters after the cleaning process to prepare a liquid suitable for testing.

[0051] The cleaning solutions A and B, along with the detection solution, are collectively referred to as the system reagents.

[0052] The control unit 131 is a computer that controls the various operations of the aforementioned components and performs calculations to determine the concentration of a predetermined component in the sample based on the detection results from the detection unit 120. It consists of one or more processors, CPUs, etc. The control unit 131 controls the operations of each device through various programs. These programs are stored in storage devices such as storage devices 132 and are read and executed by the CPU.

[0053] Furthermore, the control processing of actions performed by the control unit 131 can be centralized in one program, distributed among multiple programs, or a combination thereof. Additionally, part or all of the program can be implemented using dedicated hardware, or it can be modularized.

[0054] The storage device 132 is a storage medium that stores data and analysis results related to the samples inserted into the automated immunoassay analyzer 1, and is composed of semiconductor memory such as flash memory, disks such as HDDs, etc. The storage device 132 also stores various computer programs for controlling the operation of the devices within the automated immunoassay analyzer 1, as well as various display processing procedures described later.

[0055] Display device 133 is a display device such as a liquid crystal display that displays information related to analysis results and the progress of the analysis.

[0056] The input device 134 consists of a keyboard and a mouse for inputting data.

[0057] Next, regarding Figure 1 The overall analysis process of the automated immunoassay analyzer 1 of this embodiment will be briefly described. Furthermore, before analysis, consumables such as reagent bottles 101, dispensing pipette tips 107, and reaction containers 106 required for analysis are respectively placed in the reagent tray 102 and the compartment 108 within the device.

[0058] First, with the blood, urine, or other samples of the subject to be analyzed placed in the sample container 100B, the user inserts the holder 100A into the automated analysis device. Here, the unused reaction container 106 and the dispensing pipette tip 107 are transported to the incubator 109 and the dispensing pipette tip mounting position 111 by the transfer mechanism 113.

[0059] Then, the reagent dispensing mechanism 104 accesses the reagent tray 102, thereby dispensing the reagent stored in the reagent bottle 101 into the reaction vessel 106 on the thermostat 109.

[0060] Then, when the stent 100A reaches the sample dispensing position via the conveyor line 100, the sample dispensing mechanism 103 dispenses the sample into the reaction container 106, and the reaction between the sample and the reagent begins. This reaction, for example, refers to using a luminescently labeled antibody that reacts only with a specific antigen of the sample as a reagent, and binding the sample and the luminescently labeled substance through an antigen-antibody reaction.

[0061] After this action is completed, the used dispensing pipette 107 is transported by the conveying mechanism 113 to the dispensing pipette disposal site 112 and discarded.

[0062] After the reaction between the sample and the reagent is initiated by stirring, other reagents are sometimes added at specific times to further induce the reaction. For example, there is a process that further binds the aforementioned antigen to magnetic microspheres on which antibodies are bound to the surface. Therefore, the reaction vessel 106, which is placed in the constant temperature chamber 109 for a predetermined time, is transported to the magnetic separation section 114 by the BF separation conveyor 115.

[0063] In the magnetic separation section 114, the magnetic separation of the sample is performed, and then the unwanted solution is discharged from the reaction solution suction mechanism 116, and the system reagent, referred to as the cleaning solution, is further discharged from the cleaning solution A discharge mechanism 117 and the cleaning solution B discharge mechanism 118.

[0064] After the magnetic separation process is completed, the reaction vessel 106 is transferred from the magnetic separation section 114 to the constant temperature chamber 109 by the BF separation conveying mechanism 115.

[0065] Regardless of whether there is magnetic separation, the reaction vessel 106, which has been in a constant temperature chamber 109 for a predetermined time, is transported to the detection unit 120 by the detection unit conveying mechanism 121. After the detection reagent is discharged by the detection solution discharge mechanism 119, the detection unit 120 detects the signal from the reaction solution and outputs the detection result to the control unit 131.

[0066] In the control unit 131, the concentration of a predetermined component in the sample is determined, the result is displayed on the display device 133 and notified to the user, and stored in the storage device 132.

[0067] After the testing is completed, the reaction vessel 106 is transported by the testing department conveying mechanism 121 and the conveying mechanism 113 to the reaction vessel disposal section 110 for disposal.

[0068] Next, use Figure 2 This section describes the reagent bottle containing the system reagents used in the automated immunoassay analyzer 1 of this embodiment. Figure 2 It means to contain. Figure 1 A diagram showing an example of a schematic representation of the reagent bottles used in the automated analytical apparatus.

[0069] Figure 2 The reagent bottle 301 shown is a plastic container with a depth greater than its width.

[0070] Place the reagent bottle 301 in the middle Figure 2 The surfaces shown are defined as the front surface 302, side surface 303, top surface 304, and bottom surface 305 in the insertion direction.

[0071] A cylindrical threaded cap 306 is provided on the upper surface 304 of the reagent bottle 301 at a position where the reagent suction nozzle 400 of the nozzle unit 210 of the reagent bottle setting part 200 (described later) can be inserted.

[0072] A label 308, indicating the type of reagent, expiration date, etc., is affixed to the front surface 302 of the reagent bottle 301 in the insertion direction. Additionally, an RFID tag 309 is affixed to the label 308. The RFID tag 309 stores reagent-related information such as reagent type, batch number, expiration date, whether it has been used, and remaining uses.

[0073] Next, use Figure 3 and Figure 4 The reagent bottle setting section 200 and the nozzle unit 210, which are the main parts of the automated immunoassay analyzer 1 in this embodiment, will be described in detail. Figure 3 and Figure 4 This is a diagram showing the schematic structure of the reagent bottle mounting section 200 and the nozzle unit 210.

[0074] In the automated immunoassay analyzer 1 of this embodiment, multiple locations are provided on the back side of the front cover. Figure 3 The reagent bottle setting section 200 is shown.

[0075] The system reagents can have multiple reagent bottles placed in each location. Therefore, if one reagent bottle is empty, another bottle can be used automatically, allowing for continuous operation without stopping the system for reagent setup.

[0076] like Figure 3 and Figure 4 As shown, the reagent bottle setting section 200 is a part that houses a reagent bottle 301 containing reagents for analysis, and includes a limiting member 202, a limiting member drive section 250, a nozzle unit 210, and an RFID reader 350. Furthermore, as a part of the control section 131 related to the reagent bottle setting section 200, the control section 131 includes a reagent judgment section 131a, a limiting member drive control section 131b, and a nozzle drive control section 131c.

[0077] The nozzle unit 210 is a unit for connecting the part that connects to the reagent and the supply flow path 220 provided in the reagent bottle 301 of the reagent bottle setting part 200 to the reagent bottle 301, and is composed of a reagent suction nozzle 400 and a nozzle drive part 450.

[0078] The reagent suction nozzle 400 is a device for connecting the part that connects to the reagent and the supply flow path 220 of the reagent bottle 301 provided in the reagent bottle setting part 200 to the reagent bottle 301. It is configured such that, according to the control of the nozzle drive control unit 131c, the nozzle drive unit 450 such as the motor is driven, so that the reagent suction nozzle 400 is inserted into the reagent provided in the reagent bottle 301 of the reagent bottle setting part 200, or removed from the reagent bottle 301.

[0079] The reagent suction nozzle 400 is connected to the supply flow path 220, a syringe (not shown), or other liquid driving devices, and can supply reagents from the reagent bottle 301 to the application site on the device.

[0080] The limiting member 202 serves as a barrier on the moving path of the reagent suction nozzle 400, preventing the reagent suction nozzle 400 from being inserted into the reagent bottle 301. It is positioned in the space between the lower end 402 of the reagent suction nozzle 400 and the reagent bottle 301.

[0081] In this embodiment, as Figure 3 and Figure 4 As shown, the limiting member 202 is positioned at the contact point between the lower end 402 of the reagent suction nozzle 400 and the upper surface of the limiting member 202, to prevent the reagent in the reagent suction nozzle 400 from accidentally adhering to the hands of the operator performing the replacement operation when changing the reagent bottle 301. In particular, the limiting member 202 is preferably positioned such that the length L1 of the reagent suction nozzle 400 from the upper end 404 to the lower end 402 and the travel distance L2 of the reagent suction nozzle 400 are equal, but it is not particularly limited to this position, and a structure in which L1 is shorter than L2 may also be used.

[0082] Furthermore, its configuration is such that when the reagent suction nozzle 400 is engaged with the reagent bottle 301 and it is determined that the reagent is being used, even if the reagent suction nozzle 400 is to be removed, it will interfere with and prevent removal.

[0083] The material of the limiting member 202 is not particularly limited, but a material with poor reactivity with the reagent is preferred. Furthermore, there are no particular limitations on rigidity, but when the lower end 402 of the reagent suction nozzle 400 is in contact with the upper surface of the limiting member 202, a flexible material is sometimes preferred to reliably prevent deformation of the reagent suction nozzle 400. There are also no particular limitations on the shape; various shapes such as a flat plate can be used.

[0084] The limiting member 202 is configured such that, under the control of the limiting member drive control unit 131b, the limiting member drive unit 250, such as a motor, is driven to protrude from the side of the reagent bottle setting unit 200 or to move backward to the side, thereby preventing the reagent suction nozzle 400 from being set onto or removed from the reagent bottle 301.

[0085] The reagent judgment unit 131a determines whether the reagent bottle 301 set in the reagent bottle setting unit 200 is appropriate based on the reagent information read by the RFID reader 350, and outputs the judgment result to the limit member drive control unit 131b and the nozzle drive control unit 131c.

[0086] Preferably, the limit member drive control unit 131b drives and controls the limit member drive unit 250 to fix the limit member 202 except when the reagent bottle 301 is being replaced, thereby preventing the movement of the reagent suction nozzle 400.

[0087] In particular, in this embodiment, it is preferable that when the reagent bottle 301 set in the reagent bottle setting section 200 is determined to be correct based on the reagent information, the limiting member drive control section 131b drives the limiting member 202 to avoid obstructing the reagent suction nozzle 400 from accessing the reagent bottle 301. Furthermore, when the reagent bottle 301 is not determined to be correct, it is preferable not to drive the limiting member 202 to avoid obstructing the movement of the reagent suction nozzle 400.

[0088] Similarly, the nozzle drive control unit 131c is a part that controls the rising and falling movements of the reagent suction nozzle 400. It is preferable to drive and control the nozzle drive unit 450 to fix the reagent suction nozzle 400 except when changing the reagent bottle 301.

[0089] In particular, in this embodiment, it is preferred that the nozzle drive control unit 131c drives the reagent suction nozzle 400 when it is determined that the reagent bottle 301 set in the reagent bottle setting unit 200 is correct according to the reagent information, and does not drive the reagent suction nozzle 400 when it is not determined that the reagent bottle 301 is correct, and keeps it fixed.

[0090] The RFID reader 350 is a device for reading reagent information stored in the RFID tag 309 installed on the label 308 of the reagent bottle 301. It is located in the reagent bottle setting section 200 at a position where the RFID tag 309 can be read when the front surface 302 of the reagent bottle 301 is inserted and stops.

[0091] Next, use Figures 5 to 12 The process of setting and unloading system reagents in the reagent bottle setting unit 200 of the automatic analysis device of the present invention will be described.

[0092] First, use Figures 5 to 9 The process of setting up the system reagents is explained. Figure 5 This is a flowchart of the reagent bottle setup process. Figure 6 It means Figure 5 The diagram shows the positional relationship between the reagent bottle and the limiting component during step S4. Figure 7 It means Figure 5 A diagram showing the positional relationship between the reagent bottle and the limiting component during step S6. Figure 8 It means Figure 5 The diagram shows the positional relationship between the reagent bottle and the limiting component during step S7. Figure 9 It means Figure 5 A diagram showing the positional relationship between the reagent bottle and the limiting component after step S8.

[0093] In the initial setup of reagent bottle 301 ( Figure 5 In step S1), firstly, the control unit 131 determines, based on information from the RFID reader 350, whether the reagent bottle setting section 200 to which the user wants to set the reagent bottle 301 is empty (step S2). If it is determined that the reagent bottle setting section 200 is empty, the process proceeds to step S3. Conversely, if it is determined that the reagent bottle 301 is not empty, meaning that a reagent bottle 301 is already in use, the user cannot set the reagent bottle 301. In this case, the process proceeds to step S9.

[0094] After that, as Figure 6 As shown, the reagent bottle 301 that the user wants to set is placed in the reagent bottle setting section 200. At this time, the limit member drive control section 131b fixes the limit member 202 in the locked position, and the nozzle drive section 450 fixes the reagent suction nozzle 400 in the raised position.

[0095] Thus, the reagent suction nozzle 400 is kept in a state where there is a limiting member 202 between the lower end 402 of the reagent suction nozzle 400 and the reagent bottle 301 until the correctness of the reagent setting is confirmed, so that the reagent suction nozzle 400 cannot descend, thereby suppressing the incorrectly set reagent bottle 301 and preventing liquid from dripping from the lower end 402 of the reagent suction nozzle 400.

[0096] When the user places the reagent bottle 301 on the reagent bottle setting unit 200, the RFID reader 350 can read the information of the RFID tag 309. Therefore, the RFID reader 350 attempts to read the RFID tag 309 at constant intervals (step S3).

[0097] Next, the control unit 131 determines whether the information of the RFID tag 309 can be read by the RFID reader 350, that is, whether the reagent bottle 301 has been configured in the reagent bottle setting unit 200 (step S4). If it is determined that the reagent bottle 301 is configured in the reagent bottle setting unit 200, the process proceeds to step S5. Conversely, if it is determined that it is not configured, the process returns to step S3 until it is configured.

[0098] In addition, in step S2 or step S3, the determination is not limited to reading the RFID tag 309 by the RFID reader 350, but can also be based on information from the reagent bottle detection sensor.

[0099] After identifying the information of the RFID tag 309 of the reagent bottle 301 read by the RFID tag 309, the reagent judgment unit 131a judges whether the reagent bottle 301 set by the user is correct (step S5).

[0100] If in step S5 it is determined that the reagent bottle 301 set by the user can be configured, then... Figure 7 As shown, the limit member drive control unit 131b moves the limit member 202 to the standby position and fixes it (step S6).

[0101] When the limiting member 202 is fixed in the standby position, the nozzle drive control unit 131c begins to lower the reagent suction nozzle 400 (step S7), as... Figure 8 As shown, after being connected to reagent bottle 301, the descent stops. When it reaches this state, it becomes capable of attracting reagents.

[0102] After that, as Figure 9 As shown, the limit member drive control unit 131b moves the limit member 202 to the locked position and fixes it (step S8). By fixing the limit member 202 in the locked position, even if the user attempts to remove the reagent bottle 301, the reagent suction nozzle 400 will interfere with the limit member 202, thus preventing the reagent suction nozzle 400 from being removed from the reagent bottle 301. Therefore, it is possible to prevent the user from accidentally removing the reagent bottle 301 during use.

[0103] Returning to step S5, the determination that a reagent bottle should not be installed refers to any of the following: a different type of reagent, an expired reagent, or a reagent bottle 301 already in use in another device. Additionally, if the information read from the RFID tag 309 differs from what should be read, it is also determined that the reagent bottle should not be installed. These determinations are made by the reagent determination unit 131a of the control unit 131 based on the information read from the RFID tag 309 by the RFID reader 350. If the reagent determination unit 131a determines that the reagent bottle 301 to be installed by the user is not the correct reagent bottle, the process proceeds to step S9.

[0104] If it is determined that the reagent bottle 301 that the user wants to set is not the reagent bottle that should be set, it is preferable to inform the user. Therefore, if it is determined in step S2 that the reagent bottle setting unit 200 is not empty, or in step S5 that the reagent information is incorrect, the reagent determination unit 131a issues an alarm (step S9) to inform the user.

[0105] Methods of notification include illuminating indicator lights and displaying alarms on the user interface.

[0106] For example, indicator lights are mostly located on the upper part of the reagent bottle setting section 200, and are composed of buttons with built-in LEDs. Depending on how the indicator light illuminates, it is often used to notify the user that a slot for a reagent bottle that needs replacing has been placed, or to notify the user that an inappropriate reagent has been placed. In addition, as mentioned above, the indicator light also functions as a button; when the user presses it after placing the reagent bottle 301 in the reagent bottle setting section 200, the device can recognize that the reagent bottle 301 has been placed.

[0107] Afterwards, the limit member drive control unit 131b holds the limit member 202 in the locked position (step S10), ending the process. Therefore, the limit member 202 interferes with the reagent suction nozzle 400, preventing the movement to the connection position with the reagent bottle 301 from being blocked. This prevents the user from setting the reagent bottle 301 in a position it shouldn't be. Furthermore, the order of steps S9 and S10 can be reversed.

[0108] It is preferable to confirm whether the settings of the reagent bottle 301 that the user wants to set are feasible before the reagent suction nozzle 400 is connected to the reagent bottle 301.

[0109] When the reagent suction nozzle 400 descends to the connected position, it is already in contact with the reagent in the reagent bottle 301. Therefore, even if the user notices an error in the reagent bottle 301 through notification from the device, reagent mixing occurs through the reagent suction nozzle 400 or the supply flow path 220 at its tip. This mixing with the wrong reagent can affect analytical performance, therefore, complicated additional operations such as cleaning the reagent suction nozzle 400 and the supply flow path 220 must be performed before replacing it with the correct reagent.

[0110] To prevent this, before the reagent suction nozzle 400 descends, it is determined whether the reagent bottle 301 can be set. If it is determined that it cannot be set, the reagent suction nozzle 400 and the reagent will not come into contact. This structure is very useful.

[0111] Furthermore, if the reagent information is not read within the predetermined time in steps S3 and S4, some undesirable situation may occur, such as the reagent bottle 301 not being set to the proper orientation, forgetting to replace the reagent bottle, or setting a completely different reagent bottle. Therefore, the preferred reagent determination unit 131a will also issue an alarm in this situation.

[0112] Next, use Figures 10 to 12 The process of unloading system reagents from reagent bottle setting section 200 is described.

[0113] Figure 10 This is a flowchart of the reagent bottle removal process. Figure 11It means Figure 10 A diagram showing the positional relationship between the reagent bottle and the limiting component during step S11. Figure 12 It means Figure 10 A diagram showing the positional relationship between the reagent bottle and the limiting component during step S12.

[0114] The reagent bottle 301 needs to be replaced in the following situations: when the reagent bottle 301 is empty, when the reagent has expired, when the user has explicitly instructed the device to replace the reagent, and when the device determines, based on accuracy management results, that the set reagent is unusable. These determinations are made by the reagent determination unit 131a of the control unit 131.

[0115] When it is determined that a replacement is needed, the control unit 131 notifies the user of reagent replacement via flashing indicator lights, etc., and if... Figure 11 As shown, the limit member drive control unit 131b moves the limit member 202 to the standby position and fixes it (step S11).

[0116] When this state is reached, the reagent suction nozzle 400 can be raised. Therefore, the nozzle drive unit 450 raises the reagent suction nozzle 400 and stops and fixes it after completion.

[0117] After the scheduled time has elapsed, such as Figure 12 As shown, the limit member drive control unit 131b moves the limit member 202 to the locked position and fixes it (step S12). This allows the user to remove the reagent bottle 301. The user can easily determine whether the reagent bottle 301 can be removed by observing whether the reagent suction nozzle 400 has risen and whether the limit member 202 is located between the lower end 402 of the reagent suction nozzle and the reagent bottle 301.

[0118] In this state, prepare the setup for the next reagent bottle 301 as described earlier.

[0119] In addition, if the reagent bottle 301 is kept connected in the connection position for a predetermined time after step S12, there is a possibility of failure such as forgetting to replace the reagent bottle 301. Therefore, it is preferable for the control unit 131 to issue an alarm.

[0120] Next, the effects of this embodiment will be explained.

[0121] The automatic analysis device 1 of the above embodiment includes a limiting member 202, which is disposed on the moving path of the reagent suction nozzle 400 of the nozzle unit 210 and prevents the reagent suction nozzle 400 from being inserted into the reagent bottle 301.

[0122] Therefore, by means of the structure and operation of the limiting member 202 located between the reagent suction nozzle 400 and the reagent bottle 301 and its driving mechanism, the two purposes of preventing the incorrect setting of the reagent bottle 301 and preventing the reagent bottle 301 from being accidentally removed during reagent use can be achieved. Compared with the past, it can save space and form a simple device structure.

[0123] Furthermore, it also has the following effect: when changing reagent bottle 301, even if dripping occurs from the lower end 402 of reagent suction nozzle 400, the limiting member 202 blocks the liquid, thereby preventing contact with the user. This structure is particularly preferred in parts where containers containing organic solvents are used as reagents.

[0124] In addition, the limiting member 202 is positioned such that the length L1 of the reagent suction nozzle 400 from the upper end 404 to the lower end 402 is equal to the moving distance L2 of the reagent suction nozzle 400. Therefore, when changing the reagent bottle 301, it can suppress any dripping from the lower end 402 of the reagent suction nozzle 400, and can more reliably prevent the reagent from contacting the user.

[0125] Furthermore, a limit member drive control unit 131b is provided to drive and control the limit member 202. The limit member drive control unit 131b fixes the limit member 202 except when the reagent bottle 301 is being replaced, thereby preventing the movement of the reagent suction nozzle 400. This reliably prevents the incorrectly set reagent bottle 301 and enables more stable sample analysis.

[0126] In addition, it also has an RFID reader 350 that reads the reagent information stored in the RFID tag 309 installed on the reagent bottle 301. When the limit member drive control unit 131b determines that the reagent bottle 301 is correct, it drives the limit member 202 to not obstruct the movement of the reagent suction nozzle 400. When it does not determine that the reagent bottle 301 is correct, it does not drive the limit member 202 to obstruct the movement of the reagent suction nozzle 400. In this way, it can automatically determine whether the reagent set when the reagent bottle 301 is set in the reagent bottle setting unit 200 is appropriate and notify the user, which can further reduce the burden on the user.

[0127] Furthermore, it also includes a nozzle drive control unit 131c that controls the rising and falling motion of the reagent aspiration nozzle 400. The nozzle drive control unit 131c fixes the reagent aspiration nozzle 400 except when the reagent bottle 301 is being replaced, thereby reliably preventing the reagent bottle 301 from being set incorrectly and enabling more stable sample analysis.

[0128] In addition, it also has an RFID reader 350 that reads the reagent information stored in the RFID tag 309 installed on the reagent bottle 301. The nozzle drive control unit 131c drives the reagent suction nozzle 400 when it determines that the reagent bottle 301 is correct, and does not drive the reagent suction nozzle 400 when it does not determine that the reagent bottle 301 is correct. This also enables it to automatically determine whether the reagent set when the reagent bottle 301 is set in the reagent bottle setting unit 200 is appropriate and notify the user, which can further reduce the burden on the user.

[0129] <Other>

[0130] Furthermore, the present invention is not limited to the embodiments described above, and various modifications and applications are possible. The embodiments described above are examples provided for easy understanding and illustration of the present invention, and are not limited to having all the structures described.

[0131] Symbol Explanation

[0132] 1—Automated Immunoassay Analyzer, 100—Transfer Line, 100A—Stabilizer, 100B—Specimen Container, 101—Reagent Bottle, 102—Reagent Tray, 103—Specimen Dispensing Mechanism, 104—Reagent Dispensing Mechanism, 105—Magnetic Particle Stirring Mechanism, 106—Reaction Container, 107—Dispensing Pipette Tip, 108—Container, 109—Incubator, 110—Reaction Container Disposal Section, 111—Dispensing Pipette Tip Installation Position, 112—Dispensing Pipette Tip Disposal Location, 113—Transfer Mechanism, 114—Magnetic Separation Section, 115—BF Separation Transfer Mechanism, 116—Reaction Solution Suction Mechanism, 117—Washing Solution A Dispensing Mechanism, 118—Washing Solution B Dispensing Mechanism, 119—Detection Solution Dispensing Mechanism, 120—Detection Section, 121— The testing department conveying mechanism includes: 131—control unit; 131a—reagent judgment unit; 131b—limiting element drive control unit (limiting element control unit); 131c—nozzle drive control unit (nozzle control unit); 132—storage device; 133—display device; 134—input device; 200—reagent bottle setting unit; 202—limiting element; 210—nozzle unit; 220—supply flow path; 250—limiting element drive unit; 301—reagent bottle; 302—front surface in insertion direction; 303—side; 304—upper surface; 305—bottom surface; 306—cap; 308—label; 309—RFID tag; 350—RFID reader; 400—reagent suction nozzle; 402—lower end; 404—upper end; 450—nozzle drive unit.

Claims

1. An automatic analysis device, comprising: A reagent bottle holder, which contains reagent bottles for use in the analysis; and A nozzle unit is used to connect the part that uses the reagent and the supply flow path provided inside the reagent bottle in the reagent bottle mounting section to the reagent bottle. The automatic analysis device is characterized in that... The nozzle unit is equipped with a limiting member disposed on the movement path of the nozzle of the nozzle unit and movable between a locked position and a standby position. In the locked position, the lower end of the nozzle unit is in direct contact with the upper surface of the limiting member, which prevents the nozzle from being inserted into the reagent bottle.

2. The automatic analysis device according to claim 1, characterized in that, The limiting member is positioned such that the length of the nozzle from the top to the bottom is equal to the distance the nozzle moves.

3. The automatic analysis device according to claim 1, characterized in that, It also includes a limit member control unit, which drives and controls the limit member. The limiting member control unit fixes the limiting member except when the reagent bottle is being replaced, thus preventing the nozzle from moving.

4. The automatic analysis device according to claim 3, characterized in that, It also includes an RFID reader that reads reagent information stored in the RFID tags attached to the reagent bottles. Regarding the limiting member control unit, when it determines that the reagent bottle is correct, it drives the limiting member to not obstruct the movement of the nozzle; when it does not determine that the reagent bottle is correct, it does not drive the limiting member to obstruct the movement of the nozzle.

5. The automatic analysis device according to claim 1, characterized in that, It also includes a nozzle control unit that controls the raising and lowering movements of the nozzle. The nozzle control unit fixes the nozzle except when the reagent bottle is being replaced.

6. The automatic analysis device according to claim 5, characterized in that, It also includes an RFID reader that reads reagent information stored in the RFID tags attached to the reagent bottles. Regarding the nozzle control unit, it drives the nozzle when it determines that the reagent bottle is correct, and does not drive the nozzle when it does not determine that the reagent bottle is correct.

7. The automatic analysis apparatus according to any one of claims 1-6, characterized in that, The limiting member is flexible and is flat.