Automatic analysis device

Abstract

This invention provides an automatic analysis device that can efficiently transfer to the analysis action without prior preparation for discarding the reaction container on the device. Therefore, in the reaction promotion unit (108), the holding position of the reaction container at the discard position (202) during the first operation cycle moves to the setting position (201) of the reaction container after n (n: an integer) operation cycles. The consumable delivery unit (112) performs the discarding action of discarding the reaction container from the discard position in each operation cycle up to the nth operation cycle, without performing the setting action of setting the reaction container at the setting position. After the (n+1)th operation cycle, in each operation cycle, it performs the setting action of setting the reaction container at the setting position and the discarding action of discarding the reaction container from the discard position.

Description

Technical Field

[0001] This invention relates to an automated analysis device. Background Technology

[0002] In automated analytical devices that use disposable reaction containers to hold the sample and reagent mixture, the reaction containers used for analysis are discarded when the analysis is completed, leaving no reaction container residue in the device. However, if the analysis is interrupted without proper completion, reaction containers that should have been discarded upon device shutdown may sometimes remain inside the device. Therefore, in automated analytical devices using disposable reaction containers, the analysis preparation process, from the user's request to start the analysis until the device begins measuring the sample, involves discarding any reaction containers that should have been discarded but remain in the device. Consequently, the preparation time for samples measured immediately after device startup is longer than the analysis preparation time for continuous analysis.

[0003] In response, Patent Document 1 discloses that the inspection and disposal of the reaction vessel for the presence or absence of residue is performed only at the location used to check the initial sample after the operation begins, while at other locations, the inspection and disposal are performed after the operation has begun, thereby shortening the preparation time.

[0004] Existing technical documents

[0005] Patent documents

[0006] Patent Document 1: International Publication No. 2011 / 078118 Summary of the Invention

[0007] The technical problem that the invention aims to solve

[0008] In Patent Document 1, the presence or absence of a reaction container at a location on the reaction container setting mechanism is determined by opening and closing the gripping mechanism of the reaction container conveying mechanism. If a reaction container is detected, it is discarded even if it remains on the device. By implementing the above procedure at all locations on the reaction container setting mechanism, reaction containers that would otherwise be discarded are not used for inspection while remaining. In this case, by starting operation without waiting for confirmation of all locations, the initial inspection of the specimen can be substantially accelerated after operation begins.

[0009] However, in this structure, in the overlapping action cycles of preparation and operation, the number of actions these mechanisms must perform within a single action cycle increases compared to action cycles not in this state. This may necessitate, for example, extending the cycle length, or requiring the mechanisms to be multiplied or increased in speed. The former leads to increased inspection time, while the latter results in higher equipment costs.

[0010] Technical solutions adopted to solve technical problems

[0011] An automatic analysis apparatus according to one embodiment of the present invention includes: a reaction facilitation unit having a plurality of holding positions for configuring a reaction vessel; and a consumable delivery unit accessing a first position and a second position of the reaction facilitation unit. The reaction facilitation unit performs operations correctly according to a rule in each operation cycle. In the first operation cycle, the holding position at the second position moves to the first position after n (n: an integer) operation cycles. The first position is the position where the consumable delivery unit sets the reaction vessel in the reaction facilitation unit, and the second position is the position where the consumable delivery unit discards the reaction vessel from the reaction facilitation unit. From the first operation cycle to the nth operation cycle, in each operation cycle, the consumable delivery unit performs a discarding operation of the reaction vessel from the second position without setting the reaction vessel at the first position. After the (n+1)th operation cycle, in each operation cycle, it performs a setting operation of the reaction vessel at the first position and a discarding operation of the reaction vessel from the second position.

[0012] Invention Effects

[0013] By analyzing preparation actions, the reaction vessel on the device can be efficiently transferred to the analysis action without prior disposal.

[0014] Other technical issues, structures, and effects not mentioned above will be further clarified through the following description of the implementation methods. Attached Figure Description

[0015] Figure 1 This is a diagram showing the basic structure of an automatic analysis device.

[0016] Figure 2 This is a schematic diagram of the consumables delivery unit and the reaction facilitation unit.

[0017] Figure 3 This is a diagram showing the timing of the disposal and setup of the reaction vessel.

[0018] Figure 4 This is a timing diagram showing the actions of the consumable delivery unit at the start of the analysis action.

[0019] Figure 5 This is a flowchart of the reaction vessel setup and disposal action determination for the consumables transfer unit.

[0020] Figure 6 It is a diagram showing the transition of the positional states of the reaction promoting unit at each holding position.

[0021] Figure 7 It is a diagram that indicates whether the setting, use, or obsolescence of each position status is possible. Detailed Implementation

[0022] Examples of automated analytical devices to which this invention is applicable include automated biochemical analyzers, automated immunoassay analyzers, and automated gene analyzers. However, it is not limited to the embodiments described below, but broadly includes devices that react samples with reagents and analyze the samples based on the results of the reaction. For example, it also includes quality analysis devices for clinical examinations and coagulation analysis devices for measuring blood clotting time. Furthermore, it is applicable to composite systems consisting of these devices and automated biochemical analyzers, automated immunoassay analyzers, etc., or automated analytical systems that utilize these devices.

[0023] Figure 1 This diagram illustrates the basic structure of an automated analysis device. As its main components, the automated analysis device 100 includes: a sample transfer unit 102 that transfers a sample container 101, such as a blood collection tube, containing the sample to be analyzed, to a sample aspiration position 110; a reagent storage unit 104 that controls the temperature of a reagent container 103 containing reagents for analysis to bring the reagent temperature within a certain temperature range; a sample dispensing unit 105 that dispenses the sample from the sample container 101 into a reaction vessel; a reagent dispensing unit 106 that dispenses the reagent from the reagent container 103 into the reaction vessel; a stirring unit 107 that stirs particles or the like in the liquid within the reagent container 103; a reaction promotion unit 108 that houses a reaction vessel containing a reaction solution after the sample and reagents have been mixed, and controls the temperature of the reaction solution to bring it within a certain temperature range; and a measurement unit 109 that optically measures the amount of substance in the reaction solution after the reaction has been promoted by the reaction promotion unit 108. In addition, an ambient temperature measurement sensor is provided to measure the temperature of the surrounding environment equipped with an automatic analysis device. These units are controlled by the control unit 115.

[0024] The specimen transfer unit 102 may be, for example, a specimen holder on which one or more specimen containers 101 are mounted, or a specimen tray mounted on the circumference of a tray. In the case of a specimen holder, the specimen holder is transferred to the specimen suction position 110 of the specimen dispensing unit 105 by a conveyor belt mechanism or a robotic arm or other conveying device.

[0025] The reagent storage unit 104 may be, for example, a structure in which multiple reagent containers 103 are arranged on a circumference and any reagent container is transferred to a desired location by rotating them, or a structure in which reagent containers are arranged in a row or multiple rows in both directions.

[0026] The measurement unit 109 performs optical measurements on the reaction liquid within the measurement flow path. During this measurement, the temperature of the reaction liquid within the flow path is maintained within a specific temperature range. Examples of measurements include the absorbance of the reaction liquid, the amount of light emitted when reagents are added to the reaction liquid or a voltage is applied, the number of particles in the reaction liquid, and the current and voltage changes when the reaction liquid contacts the electrode film. Therefore, the measurement unit 109 is equipped with a photometer such as a photomultiplier tube or photometer, an imaging element such as a CCD, and an ammeter and voltmeter for measuring changes in current or voltage.

[0027] The reaction facilitation unit 108 ensures a stable reaction by maintaining the temperature of the reaction vessel within a predetermined temperature range. For example, it can be an incubator where multiple reaction vessels are arranged circumferentially and the temperature is controlled by heating the surrounding area using a heater, or it can be a thermostat where the reaction vessels are immersed in a tank with a liquid circulating within a controlled temperature range. The reaction facilitation unit 108 has multiple holding positions for arranging the reaction vessels.

[0028] Based on the analytical performance requirements of the analytical apparatus and considering the carryover effect between samples, the following situations may occur when dispensing samples in the sample dispensing unit 105: a dispensing needle that can be replaced whenever the sample changes is used in the part in contact with the sample, or an unused reaction container is used as the reaction container for reacting the sample with the reagent each time. The dispensing needle and reaction container are discarded after one use. In this case, new dispensing needles or reaction containers required for an analysis period are stored in the consumable storage unit 111, and are transferred to the usage site or from the used site to the disposal site by the consumable transfer unit 112 as needed for disposal. Even in the reagent dispensing unit 106 and the stirring unit 107, considering the carryover effect, a reagent dispensing nozzle cleaning unit 113 and a stirring rod cleaning unit 114 are provided for cleaning the immersed parts in the reagent.

[0029] Example 1

[0030] In Embodiment 1, relative to the holding positions on the reaction facilitator unit 108 which operates regularly, the consumable delivery unit 112 has at least one setting position for setting up the reaction container and one disposal position for disposing of the reaction container. In the automatic analysis apparatus of Embodiment 1, instead of performing a preparatory operation to check whether there are reaction containers that should be disposed of at all holding positions, the reaction containers that should be disposed of are disposed of by utilizing the setting up and disposal operations of the reaction containers performed in the normal analysis operation.

[0031] Figure 2This is a schematic diagram of the consumable delivery unit 112 and the reaction accelerator unit 108. The reaction accelerator unit 108 has multiple holding positions for holding the reaction vessel. These holding positions are indicated by solid circles in the diagram. For the reaction accelerator unit 108, the consumable delivery unit 112 can access the set position 201 and the discard position 202 of the reaction vessel, indicated by dashed circles. The consumable delivery unit 112 sets the reaction vessel at the holding position reaching the set position 201 and removes and discards the reaction vessel from the holding position reaching the discard position 202. According to... Figure 2 As explained, the holding position on the reaction facilitator unit 108 is determined based on the value in the circle indicating the holding position. In the example in the attached figure, the holding position reaching the set position 201 is location 1, and the holding position reaching the discard position 202 is location 4.

[0032] The holding positions of the set position 201 and the abandoned position 202 are updated by the action of the reaction facilitator 108. For example, if one action of the reaction facilitator 108 is a clockwise rotation that increases the number of holding positions on the reaction facilitator 108 by 1, then with one action of the reaction facilitator 108, the holding positions reaching the same position increase by one location. For example, in Figure 2 In the example, after one action of the reaction facilitator 108, the holding position that reaches the set position 201 becomes location 2, and the holding position that reaches the discard position 202 becomes location 5.

[0033] Furthermore, the number of locations the reaction facilitator 108 moves to in a single operation, and the number or locations of the consumable delivery unit 112 that can access the holding position of the reaction facilitator 108, are not limited. Additionally, although... Figure 2 An example of a disc-shaped reaction promoting unit 108 is shown, but this does not limit the shape of the reaction promoting unit 108. For example, it could be a rack shape.

[0034] In the analysis operation, the consumable delivery unit 112 sets an unused reaction container in the holding position upon reaching the setting position 201 during one operation cycle, and discards the reaction container from the holding position upon reaching the discard position 202. The consumable delivery unit 112 repeats the regular operation, and the holding position at the discard position 202 reaches the setting position 201 after a few seconds.

[0035] Figure 3Figure (301) illustrates the timing of reaction vessel disposal and setup. Assuming the reaction facilitator 108 has 64 holding positions, the timing of reaction vessel disposal and setup for each holding position (location 1 to 64) within the device's operation cycle is shown. In operation cycle 1, the consumable delivery unit 112 performs a reaction vessel disposal operation at location 1, which is located at disposal position 202. In operation cycle 4, three cycles later, the consumable delivery unit 112 performs a reaction vessel setup operation at location 1, which has moved to setup position 201. By repeatedly performing regular operations according to the operation cycle by the reaction facilitator 108 and the consumable delivery unit 112, the holding position reaching the setup position necessarily indicates that the reaction vessel disposal operation has been performed before the specified cycle.

[0036] In this embodiment, this relationship is used to perform the disposal of a reaction vessel that should have been discarded. Figure 4 This timing diagram illustrates the operation of the consumable delivery unit 112 at the start of the analysis. Figure 3 This is based on an automatic analysis device where moving from the holding position at discarded position 202 to the setting position 201 requires three operation cycles. During the first three operation cycles of the analysis operation, the consumable delivery unit 112 does not set the reaction container. The setting of the reaction container begins in operation cycle 4. At this time, location 1 at setting position 201 has undergone a discarding operation three operation cycles ago. Therefore, even if the reaction container is still at location 1 after the previous analysis operation, it is discarded in stage 4. In this way, even if the reaction container that should have been discarded at the end of the previous analysis operation remains on the device, by performing the discarding of the reaction container at its holding position a few seconds before setting the reaction container, it is not necessary to check all the holding positions of the reaction facilitator unit one by one before the analysis operation, thus enabling efficient transition to the analysis operation.

[0037] Furthermore, in this example, within the same operation cycle, the consumable transfer unit 112 continuously sets up and discards reaction containers. For example, in operation cycle 4, the reaction container is set up at location 1, and the reaction container is discarded at location 4. To efficiently perform these two operations, the consumable transfer unit 112 first transfers a new reaction container and sets it to the holding position at the setting position 201. Then, without returning to the starting position, it moves directly to the discarding position 202, removes the reaction container set at the holding position at the discarding position 202, and transfers it to the discarding section for disposal. Thus, within one operation cycle, the setting up and discarding of reaction containers can be easily performed using a single consumable transfer unit. Therefore, it is not necessary to install separate consumable transfer units for setting up and discarding reaction containers, thereby optimizing the mechanism configuration and reducing equipment costs.

[0038] Example 2

[0039] In this embodiment, in addition to continuously performing reaction container disposal and setup actions, the state of each holding position on the reaction promotion unit is defined and managed, thereby enabling the determination of reaction containers that cannot be disposed of, such as reaction containers under measurement.

[0040] In the case of the automatic analysis device of Example 1, in order to regularly perform the setting and discarding actions of the reaction vessels in each operation cycle, the reaction vessels holding the reaction liquid in the measurement and the reaction vessels holding the sample and reagent to raise the temperature of the sample and reagent reach the discarding position 202 immediately after the prescribed operation cycle. Although the analysis has not yet ended, if these reaction vessels are discarded, problems such as measurement interruption and loss of the sample and reagent in the analysis will occur. Therefore, in this embodiment, an automatic analysis device is proposed that can determine the reaction vessels that cannot be discarded, such as the reaction vessels in the measurement, by defining the state of each holding position of the reaction promotion unit 108.

[0041] Figure 5 This is a flowchart illustrating the determination of reaction vessel setup and disposal actions by the consumable delivery unit 112, executed by the control device 115. If the operator of the automatic analysis device instructs the start of the analysis action (step 501), the control device 115 sets the status (referred to as "position status") of all holding positions on the reaction promotion unit 108 to "unclear" (step 502). The position status "unclear" indicates that it is unclear whether the reaction vessel is configured in the holding position. If the reaction promotion unit 108 performs an action (step 503), the holding positions accessed by the consumable delivery unit 112 are updated. First, the consumable delivery unit 112 confirms the position status of the holding position located in the updated setup position 201 (step 504). If the reaction vessel is not configured in the holding position (position status = "none"), the consumable delivery unit 112 sets the reaction vessel in the holding position located in the setup position 201 (step 505) and changes the position status of the holding position to "yes" (step 506). The position status "yes" indicates that the reaction vessel set in the holding position is the reaction vessel set in this analysis action.

[0042] On the other hand, when confirming the position status of setting position 201 (step 504), if the position status is other than "none," i.e., "unclear," "present," "in use," or "disposable," no operation is performed on setting position 201, and consumable delivery unit 112 moves to disposal position (step 507). Similarly to step 504, consumable delivery unit 112 confirms the position status of holding position located at disposal position 202 (step 508). If the position status of holding position reaching disposal position 202 is "unclear" or "disposable," consumable delivery unit 112 discards the reaction vessel from disposal position 202 (step 509) and changes the position status of holding position to "none" (step 510). On the other hand, when confirming the position status of disposal position 202 (step 508), if the position status is other than "unclear" or "disposable," i.e., "none," "present," or "in use," no operation is performed on disposal position 202, and the process moves to analysis completion determination (step 511). In the analysis end determination (step 511), it is determined whether to continue the analysis or end the analysis. If the analysis is to continue, the action of the reaction facilitation unit 108 is returned (step 503). If the analysis is to end, the analysis end action is executed (step 512), and the analysis action is ended.

[0043] Figure 6 This is a transition diagram of the position states at each holding position of the reaction facilitation unit 108. Regardless of the actual position state when the automatic analysis device is started or when the analysis operation begins, the position state of all holding positions is set to "undefined" (601). When the consumable transfer unit 112 performs a reaction container disposal operation for a certain holding position, the position state transitions to "none" (602). In addition, in the case of "undefined", the consumable transfer unit 112 performs the reaction container disposal operation regardless of whether there is actually a reaction container at the holding position. When the consumable transfer unit 112 performs a reaction container setting operation for the holding position whose position state has changed to "none" (602), the position state changes to "present" (603). When the position state is "present", the consumable transfer unit 112 cannot perform the reaction container setting operation or disposal operation for that holding position.

[0044] The sample or reagent is dispensed into the reaction vessel in the "present" holding position via the sample dispensing unit 105 or the reagent dispensing unit 106, and the position status changes to "in use" (604). In the "in use" holding position, the consumable delivery unit 112 cannot perform the setting or disposal actions of the reaction vessel. It can be confirmed that the sample dispensing unit or reagent dispensing unit performs the necessary dispensing actions.

[0045] After the holding period at the reaction promotion unit 108 ends, such as after measurement or heating, the position status of the reaction container in the "in use" (604) position changes to "disposable" (605). For the reaction container in the "disposable" (605) position, the consumable delivery unit 112 can perform the disposal action of the reaction container, but it cannot perform the setting action of the reaction container or the dispensing action of the dispensing unit. By disposing of the reaction container in the "disposable" (605) position, the position status changes to "none" (602).

[0046] Figure 7 This is a diagram (701) summarizing the status of each position, indicating whether it can be set up, used, or discarded. The position status is categorized into five types: "Unclear," "None," "Yes," "In Use," and "Discardable," which respectively define whether the reaction container can be set up, used, or discarded. The control device 115 confirms the position status of the holding position accessed by the consumable delivery unit 112 and determines whether the reaction container can be discarded, used, or set up. If the determination is incorrect, the action is controlled to skip that action.

[0047] By defining the position state at the holding position of the reaction promoting unit 108, it is possible not only to achieve the effect shown in Example 1. Figure 4 The consumable delivery unit 112 can determine the actions permitted for the holding position, thereby reducing, for example, the risk of resetting the reaction vessel in a holding position where the reaction vessel has already been set, the risk of discarding the reaction vessel holding the reaction liquid during the measurement midway through the measurement, or the risk of performing an incorrect dispensing action.

[0048] This embodiment is a particularly effective structure for composite automated analysis devices that perform multiple measurements on a single device. In composite automated analysis devices, to optimize the mechanism configuration and reduce device costs, a single mechanism is sometimes shared among multiple measurement systems. For example, when the reaction facilitation unit 108 is shared by multiple measurement systems, the risk of erroneous processing due to the sequence of actions increases.

[0049] Furthermore, the present invention is not limited to the above embodiments and includes various modifications. The above embodiments have been described in detail for ease of understanding, but are not limited to having all the described structures. Additionally, a part of the structure of one embodiment may be added to the structure of other embodiments, and for a part of the structure of each embodiment, other structures may be added, deleted, or replaced.

[0050] Label Explanation

[0051] 100…Automatic analysis device, 101…Specimen container, 102…Specimen transfer unit, 103…Reagent container, 104…Reagent storage unit, 105…Specimen dispensing unit, 106…Reagent dispensing unit, 107…Stirring unit, 108…Reaction promotion unit, 109…Measurement unit, 110…Specimen aspiration position, 111…Consumable storage unit, 112…Consumable transfer unit, 113…Reagent dispensing nozzle cleaning unit, 114…Stirring rod cleaning unit, 115…Control device, 201…Setting position, 202…Disposal position.

Claims

1. An automatic analysis device, characterized in that, include: A reaction facilitating unit having multiple holding positions for configuring the reaction vessel; as well as A consumable delivery unit that accesses the first and second positions of the reaction facilitating unit. The reaction facilitation unit performs its actions flawlessly according to the rules in each action cycle. During the first action cycle, the unit remains in the second position and moves to the first position after n action cycles, where n is an integer. The first position is the location where the consumable delivery unit places the reaction vessel in the reaction facilitating unit, and the second position is the location where the consumable delivery unit discards the reaction vessel from the reaction facilitating unit. The consumable delivery unit performs a disposal action of discarding the reaction container from the second position in each action cycle up to the nth action cycle, without performing a setting action of setting the reaction container at the first position. After the (n+1)th action cycle, it performs a setting action of setting the reaction container at the first position and a disposal action of discarding the reaction container from the second position in each action cycle.

2. The automatic analysis device as described in claim 1, characterized in that, After the (n+1)th action cycle, the consumable delivery unit, in each action cycle, delivers a new reaction container to the first position, sets the new reaction container to the holding position located at the first position, then moves to the second position, removes the reaction container set to the holding position located at the second position, and delivers it to the disposal section for disposal.

3. The automatic analysis device as described in claim 1, characterized in that, The reaction facilitation unit has a reaction container arranged on the circumference, and performs a predetermined amount of rotation in each action cycle.

4. An automatic analysis device, characterized in that, include: A reaction facilitating unit having multiple holding positions for configuring the reaction vessel; A consumable delivery unit that accesses a first position and a second position of the reaction facilitating unit; as well as A control device that manages the position state of each holding position of the reaction facilitator unit. The reaction facilitation unit performs its actions flawlessly according to the rules in each action cycle. During the first action cycle, the unit remains in the second position and moves to the first position after n action cycles, where n is an integer. The location status includes a first state indicating that the configuration of the reaction vessel is unclear, and a second state indicating that no reaction vessel is configured. The first position is the location where the consumable delivery unit places the reaction vessel in the reaction facilitating unit, and the second position is the location where the consumable delivery unit discards the reaction vessel from the reaction facilitating unit. The consumable delivery unit, from the first action cycle to the nth action cycle, performs a disposal action of discarding the reaction container from the second position in each action cycle, without performing a setting action of setting the reaction container at the first position. After the (n+1)th action cycle, in each action cycle, it performs both the setting action of setting the reaction container at the first position and the disposal action of discarding the reaction container from the second position. The consumable delivery unit performs a reaction container setting operation when the position state of the holding position in the first position is the second state, and performs a reaction container disposal operation when the position state of the holding position in the second position is the first state.

5. The automatic analysis device as described in claim 4, characterized in that, When the analysis action begins, the control device sets the position state of all the holding positions of the reaction promotion unit to the first state.

6. The automatic analysis device as described in claim 5, characterized in that, In each operation cycle, the consumable delivery unit delivers a new reaction container to the first position when the holding position at the first position is in the second state, sets the new reaction container in the holding position at the first position, and then moves to the second position. When the holding position at the second position is in the first state, the reaction container set in the holding position at the second position is taken out and delivered to the disposal section for disposal.

7. The automatic analysis device as described in claim 6, characterized in that, The control device switches the position state of the consumable conveying unit from the second state to the third state when it has performed the action of setting up the reaction container, and switches the position state of the consumable conveying unit from the second state when it has performed the action of discarding the reaction container.

8. The automatic analysis device as described in claim 7, characterized in that, The control device performs a dispensing action on the set reaction vessel according to the dispensing unit, causing the position state of the holding position in the third state to change to the fourth state, and according to the end of the holding period in the reaction promotion unit, causes the position state of the holding position in the fourth state to change to the fifth state.

9. The automatic analysis device as described in claim 8, characterized in that, When the consumable delivery unit is in the fifth state while still in the second position, it performs the disposal action of the reaction container.

Images