Automatic analysis device and water leakage determination method thereof

Abstract

The purpose of the present invention is to provide an automatic analysis device capable of determining water leakage without adding a new component and a control mode thereof. To this end, this automatic analysis device is provided with: a dispensing nozzle that dispenses a sample or a reagent; a pressure generation source that generates pressure within the dispensing nozzle; a flow path that connects the pressure generation source and the dispensing nozzle; a pressure sensor that detects the pressure in the flow path; a solenoid valve which is provided in the flow path and opens and closes the flow path; and a control unit that determines the presence or absence of water leakage on the basis of a change in pressure data associated with suction or discharge of air by the dispensing nozzle.

Description

Technical Field

[0001] The invention relates to an automatic analyzing device and a water leakage judging method thereof. Background Art

[0002] The dispensing mechanism of an automatic analysis device for quantitative / qualitative analysis of blood, urine, etc. is equipped with a solenoid valve for adjusting the pressure of the dispensing syringe when sucking or discharging specimens and reagents, a pressure sensor for detecting the pressure in the dispensing flow path, etc. If foreign matter is mixed in the solenoid valve or the dispensing flow path deteriorates over the years, water leakage from the dispensing mechanism may be caused by poor operation of the solenoid valve or poor flow path state. Therefore, an automatic analysis device having a function of determining whether there is water leakage from the dispensing mechanism is proposed. For example, Patent Document 1 discloses the following: a pressure sensor and at least two solenoid valves arranged in a manner separated by the pressure sensor are provided in the flow path, and the pressure waveform data of the pressure is obtained using the pressure sensor in a state where each solenoid valve is closed, and the obtained data is compared with the data in the normal state, thereby determining water leakage in the flow path.

[0003] Prior art literature

[0004] Patent Literature

[0005] Patent Document 1: Japanese Patent Application Publication No. 2020-16449 Summary of the invention

[0006] Problems to be solved by the invention

[0007] However, the technology described in Patent Document 1 has a problem that not only new components such as solenoid valves need to be added, but also control modes for these components need to be added.

[0008] An object of the present invention is to provide an automatic analysis device capable of determining water leakage without adding new components and control modes.

[0009] Means for solving problems

[0010] In order to solve the above-mentioned problems, the automatic analysis device of the present invention comprises: a dispensing nozzle, which dispenses a specimen or a reagent; a pressure generating source, which generates pressure in the dispensing nozzle; a flow path, which connects the pressure generating source with the dispensing nozzle; a pressure sensor, which detects the pressure in the flow path; an electromagnetic valve, which is arranged in the flow path and opens and closes the flow path; and a control unit, which determines whether there is a water leakage based on the change of pressure data associated with the suction or discharge of air by the dispensing nozzle.

[0011] Effects of the Invention

[0012] According to the present invention, an automatic analysis device capable of determining water leakage can be provided without adding new components and their control modes. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 is a schematic structural diagram of the automatic analysis device.

[0014] Figure 2 is a schematic diagram showing the structure of the dispensing mechanism.

[0015] Figure 3 is a block diagram of the structure related to the water leakage determination process using the pressure data detected by the pressure sensor.

[0016] Figure 4 is a graph of the pressure waveform obtained by the feature quantity extraction unit when the dispensing nozzle sucks and discharges air (the solid line is an example of an abnormal state with water leakage caused by a solenoid valve defect, and the dashed line is an example of a normal state without water leakage).

[0017] Figure 5 is a graph of the vibration frequency distribution obtained by the feature quantity extraction unit when the dispensing nozzle sucks and discharges air (the solid line is an example of an abnormal state with water leakage caused by a solenoid valve defect, and the dashed line is an example of a normal state without water leakage).

[0018] Figure 6 is a flowchart showing the operation of the automatic analysis device during water leakage determination in Example 1.

[0019] Figure 7 is a graph of the pressure waveform obtained by the feature quantity extraction unit when the dispensing nozzle sucks and discharges air (the solid line is an example of an abnormal state with water leakage caused by a flow path defect, and the dashed line is an example of a normal state without water leakage).

[0020] Figure 8 is related to Figure 4 the same pressure waveform graph (with a predetermined threshold further added to Figure 4 it).

[0021] Figure 9 is a flowchart showing the operation of the automatic analysis device during water leakage determination in Example 2. DETAILED DESCRIPTION OF THE INVENTION

[0022] Hereinafter, the automatic analysis device and its water leakage determination method according to the embodiments of the present invention will be described with reference to the drawings.

[0023] Example 1

[0024] Use Figures 1 to 6 to illustrate the structure and operation of the automatic analysis device in Example 1. First, based on Figure 1Describe the structure of the automatic analysis device of Example 1. Figure 1 It is a schematic structural diagram of the automatic analysis device.

[0025] As Figure 1 shown, the automatic analysis device 100 is composed of a conveyor line 101, a reagent tray 103, a reaction tray 104, a dispensing mechanism 105, a stirring mechanism 106, a spectroscope 107, a control unit 115, an input unit 123, a display unit 124, etc.

[0026] The conveyor line 101 transfers the specimen rack 111 holding the specimen container 110 containing the specimen (sample) to the specimen dispensing position 121. The dispensing mechanism 105 dispenses the specimen from the specimen container 110 to the reaction unit 112 (reaction container) at the specimen dispensing position 121. The conveyor line 101 is also connected to the rotor 102. By rotating the rotor 102, the specimen rack 111 is exchanged with other conveyor lines 101.

[0027] The reagent tray 103 holds the reagent container 113 containing the reagent, and rotates the reagent container 113 to the reagent dispensing position 122. The dispensing mechanism 105 dispenses the reagent from the reagent container 113 to the reaction unit 112 at the reagent dispensing position 122. In addition, the reagent is dispensed into the reaction unit 112 in an amount required for colorimetric analysis, and reacts with the components in the specimen to be analyzed.

[0028] The reaction tray 104 holds the reaction unit 112, and rotates the reaction unit 112, which is the object of each operation, to the positions where the spectroscope 107 for colorimetric analysis, the stirring mechanism 106, the reaction unit cleaning mechanism 108, etc. respectively operate. In addition, the periphery of the reaction unit 112 is filled with water or the like and maintained at a fixed temperature. Thereby, in the reaction solution, which is a mixture of the specimen and the reagent, the chemical reaction between the components in the specimen and the reagent is promoted.

[0029] The dispensing mechanism 105 sucks the specimen to be subjected to colorimetric analysis from the specimen container 110 and discharges it to the reaction unit 112, and sucks the reagent corresponding to the analysis target from the reagent container 113 and discharges it to the reaction unit 112. The dispensing mechanism 105 includes an arm 118, a dispensing mechanism motor 119, a dispensing nozzle 116, a dispensing flow path 125, a pressure sensor 126, a dispensing syringe 127, a solenoid valve 128, etc. The arm 118 holds the dispensing nozzle 116 and the liquid level sensor 117. The liquid level sensor 117 detects the presence or absence of liquid based on the change in capacitance. A shielding portion 114 is provided near the position where the dispensing mechanism 105 performs the dispensing operation. In addition, the dispensing mechanism motor 119, the pressure sensor 126, the dispensing syringe 127, the solenoid valve 128, etc. are electrically connected to the control unit 115. The dispensing mechanism motor 119 moves the dispensing mechanism 105 in the vertical direction or the rotational direction. In addition, regarding the dispensing nozzle 116, the dispensing flow path 125, the pressure sensor 126, the dispensing syringe 127, and the solenoid valve 128, Figure 2 will be described later.

[0030] The stirring mechanism 106 stirs the reaction liquid in the reaction unit 112 in order to promote the reaction between the component to be analyzed in the specimen dispensed from the specimen container 110 to the reaction unit 112 and the reagent dispensed from the reagent container 113 to the reaction unit 112.

[0031] The LED light source 120 irradiates the reaction liquid that has been stirred by the stirring mechanism 106 and has undergone a chemical reaction with output light. The spectroscope 107 spectroscopes the transmitted light that has passed through the reaction liquid. Based on the spectroscoped transmitted light, colorimetric analysis based on absorbance measurement is performed.

[0032] The reaction unit cleaning mechanism 108 sucks the reaction liquid from the reaction unit 112 after the colorimetric analysis is completed, discharges the sucked detergent, etc., thereby cleaning the reaction unit 112.

[0033] The nozzle cleaning mechanism 109 cleans the front end of the dispensing nozzle 116 of the dispensing mechanism 105 that has dispensed the specimen or the reagent. Thereby, the residue attached to the dispensing nozzle 116 is removed, and it will not affect the next analysis target.

[0034] The input unit 123 is composed of a keyboard, a mouse, a touch panel, etc., and inputs an instruction from the user to the control unit 115. The display unit 124 is composed of an LCD (Liquid Crystal Display, liquid crystal display), etc., and displays an operation screen, etc.

[0035] The control unit 115 is composed of a processor, a memory, etc., controls the operations of the respective mechanisms within the automatic analysis device 100, and performs arithmetic processing for obtaining the concentrations of predetermined components in specimens (liquids) such as blood and urine. Additionally, as will be described later, based on changes in the pressure data accompanying the suction or discharge of air by the dispensing nozzle 116, the control unit 115 also determines whether there is water leakage in the dispensing mechanism 105.

[0036] Furthermore, the structure of the above-described automatic analysis device 100 is merely an example, and it is possible to not have the conveyor line 101 and the rotor 102 and instead provide a specimen disk for holding specimens, or to provide a specimen pretreatment system for performing various pretreatments on specimens.

[0037] In addition, in Figure 1 , as the automatic analysis device 100, an example of a device for measuring biochemical items is given, but the present invention can also be applied to an automatic analysis device that performs different analyses such as immunoassay items in addition to biochemical items.

[0038] Next, based on Figure 2 and Figure 3 the structure of the dispensing mechanism 105 and the process for determining water leakage in the dispensing mechanism 105 will be described. Additionally, the dispensing mechanism 105 that is the object of water leakage determination can be for specimens or for reagents.

[0039] Figure 2 is a schematic diagram showing the structure of the dispensing mechanism. As Figure 2 shown, the dispensing mechanism 105 includes a dispensing nozzle 116, a dispensing flow path 125, a dispensing syringe 127, a pump 132, a solenoid valve 128, a pressure sensor 126, etc. The dispensing nozzle 116 dispenses specimens or reagents. The dispensing flow path 125 connects the dispensing nozzle 116, the pressure sensor 126, the dispensing syringe 127, the solenoid valve 128, etc. The dispensing syringe 127 (pressure generating source) is driven in the vertical direction in a state where the solenoid valve 128 is closed, thereby generating a pressure for suction or discharge of specimens and reagents within the dispensing nozzle 116. The pump 132 generates a pressure for supplying internal cleaning water for cleaning the inside of the dispensing nozzle 116. The solenoid valve 128 is provided in the dispensing flow path 125 between the pump 132 and the dispensing syringe 127, and opens and closes the dispensing flow path 125. The solenoid valve 128 is in an open state only at the timing of supplying internal cleaning water, and is in a closed state during suction or discharge of specimens and reagents other than this, during standby, etc. The pressure sensor 126 detects the pressure within the dispensing flow path 125. Additionally, the opening and closing of the solenoid valve 128, the operation of the dispensing syringe 127, etc. are performed by the control unit 115 (in Figure 2(omitted in the figure) control. In addition, when the automatic analysis device 100 operates, the pump 132 is basically always driven. Therefore, the control unit 115 can adjust the state of the fluid and pressure in the dispensing flow path 125 by controlling the opening and closing of the solenoid valve 128.

[0040] Figure 3 is a block diagram of a structure related to a water leakage determination process using pressure data detected by a pressure sensor. As Figure 3 shown, the water leakage determination system is composed of a pressure sensor 126, an amplifier 129, an A / D converter 130, a feature quantity extraction unit 131, a control unit 115, a display unit 124, etc. The amplifier 129 amplifies the data of the pressure waveform obtained by the pressure sensor 126 and outputs it to the A / D converter 130. The A / D converter 130 converts the pressure data amplified by the amplifier 129 into a digital signal and outputs it to the feature quantity extraction unit 131.

[0041] After receiving the pressure data converted into a digital signal from the A / D converter 130, the feature quantity extraction unit 131 extracts a feature quantity (determination value) for water leakage determination and sends the extracted feature quantity to the control unit 115. Here, the extraction of the feature quantity means calculating feature quantities such as the average pressure (hereinafter, simply referred to as "average pressure") during a predetermined period (a period corresponding to the peak or trough of the pressure waveform), the vibration time width of the pressure waveform, and the vibration frequency of the pressure waveform based on the acquired pressure data.

[0042] In addition, the details of the extraction method of each feature quantity in the feature quantity extraction unit 131 will be described later.

[0043] As Figure 3 shown, the control unit 115 includes a storage unit 115a, a feature quantity comparison unit 115b, and an abnormality determination unit 115c. The storage unit 115a stores the pressure data converted into a digital signal by the A / D converter 130, the feature quantity extracted by the feature quantity extraction unit 131, various thresholds set for each solenoid valve 128 or each dispensing mechanism 105, etc. The threshold is used to determine whether there is water leakage and is determined in advance based on the pressure data obtained in the normal state where there is no water leakage in the dispensing mechanism 105. The feature quantity comparison unit 115b compares the feature quantity extracted by the feature quantity extraction unit 131 with the threshold stored in the storage unit 115a and sends the comparison result to the abnormality determination unit. The abnormality determination unit 115c uses the comparison result of the feature quantity comparison unit 115b to determine whether there is water leakage in the dispensing mechanism 105.

[0044] In the abnormality determination unit 115c, when it is determined that there is water leakage (abnormality), an alarm display signal is output to the display unit 124, and a warning screen is displayed on the display unit 124. Thereby, the operator can be prompted to take measures such as replacing the seal. In addition, the control unit 115 stops the analysis operation of the specimen. The displayed warning screen may include various methods such as displaying statements like "There is water leakage" and displaying a warning lamp for water leakage. On the other hand, when it is determined in the abnormality determination unit 115c that there is no water leakage (normal), the pressure data converted into a digital signal by the A / D converter 130 and the feature amounts extracted by the feature amount extraction unit 131 are stored in the storage unit 115a, and the analysis operation is started or continued.

[0045] In addition, Figure 2 and Figure 3 The structure shown is merely an example. For example, the feature amount extraction unit 131 may be provided within the control unit 115 or regarded as part of a generalized control unit. In addition, a control unit for controlling the operation of each mechanism or obtaining the component concentration and a control unit for the water leakage determination system may be provided separately.

[0046] Here, based on Figure 4 and Figure 5 the method for extracting each feature amount in the feature amount extraction unit 131 and the comparison method in the feature amount comparison unit 115b are described. Figure 4 is a graph of the pressure waveform obtained by the feature amount extraction unit when the dispensing nozzle attracts and discharges air. The solid line represents an example of an abnormal state with water leakage caused by a solenoid valve defect, and the dashed line represents an example of a normal state without water leakage. In addition, the reason for attracting and discharging air instead of liquid is that the difference between normal and abnormal states is small during the attraction and discharge of liquid, making it difficult to perform high-precision determination.

[0047] Before the dispensing nozzle 116 starts to attract air, the pressure is near 0 kPa (atmospheric pressure) regardless of whether there is water leakage. During the period from the start to the end of the air attraction (the first period), the pressure first vibrates in the negative (negative pressure) direction and then returns to near the atmospheric pressure. During this first period, there is no significant difference between the pressure waveforms in the case of a solenoid valve abnormality such as foreign matter mixed in the solenoid valve 128 and the normal case. This is because the drive of the dispensing syringe 127 has a greater influence on the pressure change than the state of the solenoid valve 128.

[0048] Next, during the period from the end of air suction to the start of air discharge (the second period), the pressure repeatedly vibrates in the positive (positive pressure) direction and the negative (negative pressure) direction, gradually approaching the behavior near the atmospheric pressure. Especially in the case of an abnormal solenoid valve, due to water leakage from the front end of the dispensing nozzle 116, a pressure loss is generated inside the dispensing flow path 125. Therefore, compared with the normal situation, the attenuation of the pressure becomes larger and the amplitude of the pressure waveform becomes smaller.

[0049] After that, during the period from the start to the end of air discharge (the third period), the pressure vibrates in the positive (positive pressure) direction and then returns near the atmospheric pressure. During this third period, there is no significant difference between the pressure waveforms in the case of an abnormal solenoid valve and the normal case. This is because the driving of the dispensing syringe 127 has a greater influence on the pressure change than the state of the solenoid valve 128.

[0050] Next, during the period from the end of air discharge to the movement of the dispensing mechanism 105 (the fourth period), the pressure repeatedly vibrates in the negative (negative pressure) direction and the positive (positive pressure) direction, gradually approaching the behavior near the atmospheric pressure. Especially in the case of an abnormal solenoid valve, due to water leakage from the front end of the dispensing nozzle 116, a pressure loss is generated inside the dispensing flow path 125. Therefore, compared with the normal situation, the attenuation of the pressure becomes larger and the amplitude of the pressure waveform becomes smaller. That is, in the case of an abnormal solenoid valve, the vibration time width, which is the time from the end of air discharge until the pressure attenuates to near the atmospheric pressure and stabilizes, is shorter than that in the normal case.

[0051] In this specification, for example, the vibration time width of the pressure waveform after the end of air discharge is defined as "the time required from the start point, which is the end of air discharge, to the end point, which is the moment when the state where the pressure change relative to the reference pressure value is within ±0.5 kPa continues for a predetermined time or more". In addition, the reference pressure value can be 0 kPa or the pressure value obtained at the start of air suction. Also, the predetermined time can be set to any time such as 30 ms. For example, in Figure 4 it, Δt0 represents the vibration time width in the normal case, and Δt1 represents the vibration time width in the case of an abnormal solenoid valve. And the extraction period of the vibration time width is not limited to the fourth period. When the pressure change also converges sufficiently during the second period, the vibration time width can also be extracted from the pressure waveform of the second period.

[0052] As described above, the pressure waveform varies depending on whether there is water leakage. Therefore, as one of the characteristic quantities for determining the presence or absence of water leakage, the characteristic quantity extraction unit 131 extracts the average value of the pressure at the peak or trough portion in the pressure waveform existing in any one of the first period to the fourth period from the pressure waveform, that is, the average pressure. In addition, the peak or trough portion (the time period when the peak or trough appears) of each period can be determined based on the drive mode of the dispensing syringe 127 pre-stored in the storage unit 115a, or can be determined based on the pressure waveform under normal conditions. Also, as described above, in the first period and the third period, there is no significant difference in the pressure waveform between the case of solenoid valve abnormality and the normal case. Therefore, the characteristic quantity extraction unit 131 can also extract the average pressure corresponding to the peak or trough only in the second period and the fourth period.

[0053] On the other hand, the average pressure threshold value serving as a reference for determining the presence or absence of water leakage is stored in the storage unit 115a. In Figure 4 wherein, P2 represents the average pressure threshold value corresponding to the first peak in the pressure waveform of the second period, and P4 represents the average pressure threshold value corresponding to the first trough in the pressure waveform of the fourth period. For example, a value smaller than the peak value of the peak or trough under normal conditions by a specified amount is set as the average pressure threshold value. Then, the characteristic quantity comparison unit 115b compares the characteristic quantity, that is, the average pressure, extracted by the characteristic quantity extraction unit 131 with the average pressure threshold value stored in the storage unit 115a.

[0054] In addition, the characteristic quantity extraction unit 131 can also extract the above-mentioned vibration time width as another characteristic quantity for determining the presence or absence of water leakage. In this case, the characteristic quantity comparison unit 115b compares the vibration time width extracted by the characteristic quantity extraction unit 131 with the vibration time width threshold value stored in the storage unit 115a to determine the presence or absence of water leakage. For example, a value shorter than the vibration time width under normal conditions, that is, Δt0, by a predetermined time is set as the vibration time width threshold value.

[0055] Moreover, the characteristic quantity extraction unit 131 can also extract the vibration frequency of the pressure waveform as another characteristic quantity for determining the presence or absence of water leakage. Figure 5 is a graph of the vibration frequency distribution obtained by the characteristic quantity extraction unit when the dispensing nozzle attracts and discharges air. The solid line represents an example of an abnormal state with water leakage caused by a defective solenoid valve, and the dashed line represents an example of a normal state without water leakage.

[0056] Figure 5 The vibration frequency distribution shown in the figure is calculated by applying operations such as Fourier transform to the pressure data obtained by the characteristic quantity extraction unit 131 from the A / D converter 130. The pressure data used for the operation can also be normalized with respect to the atmospheric pressure or with respect to the data of the first point.

[0057] As Figure 5 shown, under normal conditions, a peak is observed in the predetermined low-frequency component. However, in the case of an abnormal solenoid valve, the pressure decay is large and the amplitude of the pressure waveform is small, so a peak is observed at 0 Hz (DC component). Therefore, a value smaller than the frequency at which a peak occurs under normal conditions by a predetermined amount can also be stored as the vibration frequency threshold in the storage unit 115a, and the presence or absence of water leakage can be determined based on whether a peak exists in the high-frequency region higher than this threshold. In addition, when the peak of the vibration frequency extracted by the feature quantity extraction unit 131 is 0 Hz, it can also be determined that there is water leakage without comparing with the threshold value.

[0058] As described above, feature quantities such as the average pressure, the vibration time width of the pressure waveform, and the vibration frequency of the pressure waveform are extracted in the feature quantity extraction unit 131, and comparisons using these feature quantities are performed in the feature quantity comparison unit 115b. However, the comparison method is not limited to comparing with the absolute value of the threshold. For example, the feature quantity comparison unit 115b can also compare whether the difference between the feature quantity in the normal state and the extracted feature quantity is within a predetermined range (threshold). In addition, only the difference can be calculated in the feature quantity comparison unit 115b, and the abnormality determination unit 115c determines the presence or absence of water leakage based on whether the difference is within the predetermined range.

[0059] In addition, the abnormality determination unit 115c can also periodically monitor the time-series change of the feature quantity, etc. (for example, the change amount per unit time) based on the feature quantity and the data of the pressure waveform stored in the storage unit 115a. When there is a change exceeding a predetermined allowable value, it is diagnosed that there is a sign of water leakage. As a result of such sign diagnosis, when there is a sign of water leakage, the abnormality determination unit 115c outputs a preventive alarm to the display unit 124. In addition, the abnormality determination unit 115c can also calculate an approximate curve based on the time-series change to predict the water leakage period, etc., and output the recommended period for maintenance, etc. to the display unit 124.

[0060] Moreover, the determination result of the abnormality determination unit 115c can also be periodically sent to the server of the service center connected to the control unit 115 through a network or the like. As a result, the service center can also confirm the recommended period for maintenance, etc., and can perform maintenance countermeasures at an accurate timing. In addition, by collecting the data of multiple automatic analysis devices by the server of the service center for machine learning, etc., the accuracy of the threshold value used in water leakage determination can also be improved.

[0061] The acquisition of the above-mentioned pressure data and the determination of water leakage are performed at least at any timing during the analysis preparation operation, the analysis operation, and the standby time. For example, it can be set once within 1 hour at any timing such as morning, noon, and evening. However, in order to prevent waste of specimens and reagents, it is preferable to perform the water leakage determination during the analysis preparation operation. In addition, "during the analysis preparation operation" refers to the period during which various startup processes are performed after the automatic analyzer 100 is started, "during the analysis operation" refers to the period during which the automatic analyzer 100 analyzes the specimen, and "during the standby time" refers to the idle state period during which the automatic analyzer 100 does not analyze the specimen.

[0062] In particular, during the analysis operation of the automatic analyzer 100, in order to prevent the pressure transmission medium (system water) filled in the dispensing flow path 125 from mixing with the specimen or reagent to be dispensed and the concentration from changing, before aspirating the specimen or the like, the segmented air that separates the pressure transmission medium from the specimen or the like is aspirated. Therefore, when acquiring the pressure data and determining the water leakage during the analysis operation, it is preferable to utilize the timing of aspirating the segmented air. The segmented air is aspirated each time a specimen or reagent is dispensed, so there is an advantage that the water leakage determination can also be performed at a high frequency. As a result, even if water leakage occurs during the analysis operation, it can be immediately determined as water leakage.

[0063] Next, based on Figure 6 The processing flow of the automatic analyzer 100 at the time of water leakage determination will be described. Figure 6 It is a flowchart showing the operation of the automatic analyzer at the time of water leakage discrimination in the first embodiment.

[0064] First, the control unit 115 supplies internal washing water to the dispensing flow path 125 with the solenoid valve 128 open to clean the inside of the dispensing nozzle 116 (step S601). By performing such internal cleaning before aspirating air using the dispensing nozzle 116 for water leakage determination, even when the water leakage determination is performed multiple times, the conditions of the dispensing nozzle 116 and the dispensing flow path 125 can be made to conform to the same conditions each time, and the accuracy of the water leakage determination is improved.

[0065] After that, the control unit 115 drives the pressure sensor 126 to start acquiring the pressure data in the dispensing flow path 125 (step S602). Then, the control unit 115 drives the dispensing syringe 127 with the solenoid valve 128 closed to aspirate air into the dispensing nozzle 116 (step S603). After that, the control unit 115 drives the dispensing syringe 127 with the solenoid valve 128 closed to discharge the air from the dispensing nozzle 116 (step S604). When the discharge of the air is completed, the control unit 115 ends the acquisition of the pressure data by the pressure sensor 126 (step S605).

[0066] Next, the feature quantity extraction unit 131 extracts at least one of the average pressure, the vibration time width of the pressure waveform, and the vibration frequency of the pressure waveform from the acquired pressure data as a feature quantity (step S606). After that, the feature quantity comparison unit 115b reads out the threshold value stored in the storage unit 115a in advance, and compares the feature quantity extracted in step S606 with the read threshold value (step S607).

[0067] When the comparison result in step S607 is within the range of the threshold value (when the feature quantity is equal to or greater than the threshold value), the abnormality determination unit 115c determines that there is no water leakage (normal), and stores data such as the feature quantity and the pressure waveform in the storage unit 115a (step S608). In addition, if it is a water leakage determination during the analysis preparation operation, the analysis is started. If it is a water leakage determination during the analysis operation, the analysis is continued or restarted. If it is a water leakage determination during standby, the device returns to the standby state (step S609).

[0068] On the other hand, when the comparison result in step S607 is outside the range of the threshold value (when the feature quantity is less than the threshold value), the abnormality determination unit 115c determines that there is water leakage (abnormal), and outputs a water leakage alarm to the display unit 124 (step S610). In addition, if it is a water leakage determination during the analysis operation, the analysis operation is stopped (step S611).

[0069] Embodiment 2

[0070] Based on Figures 7 to 9 Embodiment 2 will be described. The automatic analysis device of Embodiment 2 is basically the same in structure as the automatic analysis device of Embodiment 1, but different from Embodiment 1, it not only determines the presence or absence of water leakage, but also determines the cause location of the water leakage.

[0071] According to Embodiment 1, when it is determined that there is water leakage, an alarm is output to stop the automatic analysis device 100, thereby avoiding waste of specimens, reagents, and time. However, during subsequent maintenance, it is necessary to investigate the cause location of the water leakage. The cause of the water leakage from the dispensing mechanism 105 is not only the malfunction of the solenoid valve caused by foreign matter mixing, etc., but there is also a possibility of flow path malfunction caused by damage to the dispensing flow path 125 or loosening of the flow path connection part. Therefore, in Embodiment 2, a threshold value is further added to Embodiment 1, and the feature quantity is compared more carefully.

[0072] Next, use Figure 7 and Figure 8 to illustrate the determination method of the presence or absence of water leakage and the cause location in Embodiment 2. Figure 7 is a chart of the pressure waveform obtained by the feature quantity extraction unit when the dispensing nozzle sucks and discharges air. The solid line represents an example of an abnormal state with water leakage caused by a flow path malfunction, and the dotted line represents an example of a normal state without water leakage.Figure 8 is a chart of the same pressure waveform, that is, the solid line represents an example of an abnormal state where water leakage is caused by a malfunction of the solenoid valve. However, Figure 4 predetermined thresholds (P3, P4’, ΔTa, ΔTb) are further added. Figure 4

[0073] Comparing Figure 7 and Figure 8 it can be seen that in the case of water leakage due to a malfunction of the flow path, compared with the case of water leakage due to a malfunction of the solenoid valve, the amplitude of the pressure waveform becomes smaller as a whole. This is because if there is a flow path abnormality, in addition to the pressure loss caused by water leakage from the tip of the dispensing nozzle 116, a pressure loss is also generated due to water leakage from the abnormal part of the dispensing flow path 125. In addition, in the case of a flow path abnormality, the vibration time width, that is, the time from the end of air suction and discharge to when the pressure decays to near atmospheric pressure and stabilizes, is further shorter compared with the case of a solenoid valve abnormality. Hereinafter, three examples will be given to illustrate representative determination methods based on such tendencies.

[0074] The first determination method is a method of extracting the average pressure of the peak or trough of the pressure waveform from the pressure data in the first period or the third period, which has a small difference from the normal case, in the case of a solenoid valve abnormality, and comparing it with the average pressure threshold of these periods. In Figure 7 and Figure 8 example, P3 is added as the average pressure threshold corresponding to the peak part in the third period. It can be seen that in Figure 7 the case of the flow path abnormality shown, the average pressure of the peak part in the third period is less than the threshold P3 and is regarded as abnormal. On the other hand, in Figure 8 the case of the solenoid valve abnormality shown, the average pressure of the peak part in the third period exceeds the threshold P3 and is not regarded as abnormal. In addition, regarding the first period, as long as the average pressure threshold corresponding to the trough part is set, the presence or absence of a flow path abnormality can be distinguished in the same way as in the third period.

[0075] Therefore, even if the average pressure extracted in the second period and the fourth period is less than the threshold and is regarded as abnormal, and the average pressure extracted in the first period and the third period is greater than the threshold and is not regarded as abnormal, it can be determined that the water leakage is caused by a malfunction of the solenoid valve. On the other hand, in any period, if the average pressure extracted is less than the threshold and is regarded as abnormal, it can be determined that the water leakage is caused by a malfunction of the flow path.

[0076] Next, the second determination method will be described. The second determination method is a method of setting two thresholds, a large one and a small one, within the second period or the fourth period, and comparing the average pressure extracted in this period with these thresholds. In Figure 7and Figure 8 In the example of Figure 8 , as the pressure average value threshold corresponding to the trough part in the fourth period, in addition to P4, P4' is added. It can be seen that in Figure 7 in the case of the flow path abnormality shown in Figure 7 , the average pressure value of the trough part in the fourth period is less than the threshold P4 and less than the threshold P4'. On the other hand, in Figure 8 in the case of the solenoid valve abnormality shown in Figure 8 , the average pressure value of the trough part in the fourth period is less than the threshold P4 but exceeds the threshold P4'. Therefore, when the average pressure value extracted in the fourth period is between the two thresholds, it can be determined that the solenoid valve is abnormal, and when it is less than the two thresholds, it can be determined that the flow path is abnormal. In addition, regarding the second period, if a threshold smaller than the amplitude ratio threshold P2 is set differently from the threshold P2, it is also possible to distinguish whether it is a flow path abnormality or a solenoid valve abnormality in the same way as in the fourth period.

[0077] Next, the third determination method will be described. The third determination method is as follows: Instead of the average pressure value, two thresholds of large and small are set for the vibration time width, and the extracted vibration time width is compared with these thresholds. In Figure 7 and Figure 8 in the example of Figure 7 and Figure 8 , as the vibration time width thresholds in the fourth period, a smaller threshold ΔTa and a larger threshold ΔTb are added. It can be seen that in Figure 7 in the case of the flow path abnormality shown in Figure 7 , the vibration time width in the fourth period, that is, Δt2, is less than the threshold ΔTb and less than the threshold ΔTa. On the other hand, in Figure 8 in the case of the solenoid valve abnormality shown in Figure 8 , the vibration time width Δt1 in the fourth period is less than the threshold Δb but exceeds the threshold Ta. Therefore, when the vibration time width extracted in the fourth period is between the two thresholds, it can be determined that the solenoid valve is abnormal, and when it is less than the two thresholds, it can be determined that the flow path is abnormal. In addition, according to the pressure waveform, in the second period, by setting two thresholds of large and small, it is also possible to distinguish whether it is a flow path abnormality or a solenoid valve abnormality in the same way as in the fourth period.

[0078] Next, based on Figure 9 the processing flow of the automatic analysis device 100 at the time of leakage determination will be described. Figure 9 is a flowchart showing the operation of the automatic analysis device at the time of leakage determination in Embodiment 2. Here, the case of the first determination method among the above three determination methods will be taken as an example for explanation.

[0079] First, Figure 9 Steps S901 to S909 in Figure 9 are the same as those in the above-mentioned Figure 6Steps S601 to S609 are the same. However, in this embodiment, when the determination result in step S907 is outside (less than) the range of the threshold for the second period or the fourth period, the feature quantity comparison unit 115b reads out the threshold for the first period or the third period pre-stored in the storage unit 115a, and compares the feature quantity extracted during this period with the read threshold (step S910).

[0080] When the comparison result in step S910 is within the range of the threshold (when the feature quantity is equal to or greater than the threshold), that is, only when the second period and the fourth period among the first period to the fourth period are outside the range of the threshold, the abnormality determination unit 115c determines that the solenoid valve is abnormal and outputs a solenoid valve failure alarm to the display unit 124 (step S911). In addition, if it is a water leakage determination during the analysis operation, the analysis operation stops (step S912).

[0081] On the other hand, when the determination result in step S910 is outside the range of the threshold (when the feature quantity is less than the threshold), that is, when all of the first period to the fourth period are outside the range of the threshold, the abnormality determination unit 115c determines that the flow path is abnormal and outputs a flow path failure alarm to the display unit 124 (step S913). In addition, if it is a water leakage determination during the analysis operation, the analysis operation stops (step S914).

[0082] In addition, in the case of the second determination method and the third determination method in which multiple thresholds are set within the same period, the comparison method in step S910 in the above steps is different, but the other steps are the same as those in the case of the first determination method.

[0083] The present invention is not limited to the above-described embodiments and includes various modification examples. For example, as the negative pressure generation source, in addition to the syringe, a diaphragm, a micropump, etc. can also be used. In addition, the determination method using the aforementioned threshold is merely an example, and other methods can be appropriately used according to the structure of the dispensing mechanism, etc.

[0084] Symbol Explanation

[0085] 101 ··· Conveyor line, 102 ··· Rotor, 103 ··· Reagent tray, 104 ··· Reaction plate, 105 ··· Dispensing mechanism, 106 ··· Stirring mechanism, 107 ··· Spectrophotometer, 108 ··· Reaction unit cleaning mechanism, 109 ··· Nozzle cleaning mechanism, 110 ··· Specimen container, 111 ··· Specimen rack, 112 ··· Reaction unit, 113 ··· Reagent container, 114 ··· Shielding part, 115 ··· Control unit, 115a ··· Storage part, 115b ··· Feature quantity comparison part, 115c ··· Abnormality determination part, 116 ··· Dispensing nozzle, 117 ··· Liquid level sensor, 118 ··· Arm, 119 ··· Motor for dispensing mechanism, 120 ··· LED light source, 121 ··· Specimen dispensing position, 122 ··· Reagent dispensing position, 123 ··· Input part, 124 ··· Display part, 125 ··· Dispensing flow path, 126 ··· Pressure sensor, 127 ··· Dispensing syringe, 128 ··· Solenoid valve, 129 ··· Amplifier, 130 ··· A / D converter, 131 ··· Feature quantity extraction part, 132 ··· Pump.

Claims

1. An automatic analysis device, characterized in that, Comprising: A dispensing nozzle that dispenses a specimen or a reagent; A pressure generating source that generates pressure inside the dispensing nozzle; A flow path that connects the pressure generating source and the dispensing nozzle; A pressure sensor that detects the pressure inside the flow path; A solenoid valve that is provided in the flow path and opens and closes the flow path; and A control unit that determines whether there is a water leak based on a change in pressure data associated with the suction or discharge of air by the dispensing nozzle.

2. The automatic analysis device according to claim 1, wherein: The control unit extracts the average pressure of the peak or trough of the pressure waveform from the pressure data, and compares the extracted average pressure with a predetermined average pressure threshold to determine whether there is a water leak.

3. The automatic analysis device according to claim 2, wherein: The control unit extracts the average pressure of the peak or trough of the pressure waveform from the pressure data in a second period from the end of the air suction to the start of the air discharge or the pressure data in a fourth period after the end of the air discharge.

4. The automatic analysis device according to claim 3, wherein: The control unit performs the following control: It also extracts the average pressure of the peak or trough of the pressure waveform from the pressure data in a first period during the air suction or the pressure data in a third period during the air discharge. When the average pressure extracted in the second period and the fourth period is smaller than their respective average pressure thresholds, and the average pressure extracted in the first period and the third period is larger than their respective average pressure thresholds, it is determined that the solenoid valve is abnormal. When the average pressure extracted in any one of the first period, the second period, the third period, and the fourth period is smaller than their respective average pressure thresholds, it is determined that the flow path is abnormal.

5. The automatic analysis device according to claim 1, wherein: The control unit extracts the vibration time width of the pressure waveform from the pressure data in a fourth period after the end of the air discharge, and compares the extracted vibration time width with a predetermined vibration time width threshold to determine whether there is a water leak.

6. The automatic analysis device according to claim 3 or 5, wherein: The average pressure threshold or the vibration time width threshold has two thresholds, a larger one and a smaller one, within one period. When the extracted average pressure or vibration time width is between the two thresholds, the control unit determines that the solenoid valve is abnormal; when the extracted average pressure or vibration time width is smaller than any one of the thresholds, the control unit determines that the flow path is abnormal.

7. The automatic analysis device according to claim 1, wherein: The control unit extracts the vibration frequency of the pressure waveform from the pressure data, and compares the extracted vibration frequency with a predetermined vibration frequency threshold to determine whether there is a water leak.

8. The automatic analysis device according to claim 1, wherein: Before attracting the air using the dispensing nozzle, the control unit cleans the interior of the dispensing nozzle.

9. The automatic analysis device according to claim 2, wherein when acquiring the pressure data and determining water leakage during the analysis operation, the air is segmented air that is attracted before attracting the specimen or the reagent to separate the system water in the dispensing nozzle from the specimen or the reagent.

10. A method for determining water leakage of an automatic analysis device, the automatic analysis device comprising: a dispensing nozzle that dispenses a specimen or a reagent; a pressure generating source that generates pressure inside the dispensing nozzle; a flow path that connects the pressure generating source to the dispensing nozzle; a pressure sensor that detects the pressure inside the flow path; and a control unit that determines whether there is water leakage based on pressure data obtained from the pressure sensor, characterized in that, The method for determining water leakage includes the following steps: the dispensing nozzle attracts or discharges air; the pressure sensor detects a change in the pressure data in the flow path associated with the attraction or discharge of the air; and the control unit extracts at least one of the average pressure of the peak or trough of the pressure waveform, the vibration time width of the pressure waveform, and the vibration frequency of the pressure waveform from the pressure data and compares it with a predetermined threshold.

11. The method for determining water leakage of the automatic analysis device according to claim 10, wherein before the step of the dispensing nozzle attracting or discharging air, there is a step of the control unit cleaning the interior of the flow path and the dispensing nozzle.

12. The method for determining water leakage of the automatic analysis device according to claim 10, wherein when acquiring the pressure data and determining water leakage during the analysis operation, the air is segmented air that is attracted before attracting the specimen or the reagent to separate the system water in the dispensing nozzle from the specimen or the reagent.

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