Puncture condition selection method

Abstract

Provided are an automatic analysis device capable of performing a specimen dispensing (CTS) action of a stoppered specimen container under appropriate piercing conditions corresponding to the category of the stoppered specimen container, and a piercing condition selection method thereof. The automatic analysis device (1) of the present invention includes: a rack identification information reading section (84) that reads rack identification information (C) imparted to a specimen rack (70); a CTS drive section (80) that performs a piercing action of piercing a stopper of a stoppered specimen container at a specimen suction position by a piercer, and sucks a specimen in the stoppered specimen container using a specimen suction nozzle that passes through a hole formed by the piercing by the piercer; a piercing condition setting section (82) that sets a piercing action condition of the piercer for the stoppered specimen container loaded in the specimen rack (70) based on the rack identification information (C) read by the rack identification information reading section (84); and a control unit (10) that controls the action of the CTS drive section (80) based on the set piercing action condition.

Description

TECHNICAL FIELD

[0001] The present application relates to an automatic analysis device capable of obtaining measurement information for various test items by reacting a sample (specimen) of blood, urine, or the like with various reagents and measuring the reaction process, and a puncture condition selection method thereof. BACKGROUND

[0002] Various forms of automatic analysis devices, such as blood coagulation analysis devices and analysis devices using immunoassay, capable of obtaining measurement information for various test items by reacting a biological sample of blood, urine, or the like with various reagents and measuring the reaction process, have been known for a long time, and for example, a specimen (test object) as a biological sample is dispensed from a specimen container to a reaction container, a reagent corresponding to a test item is dispensed to the dispensed specimen and mixed, and various measurements and analyses are performed.

[0003] In such an analysis device, when a specimen is aspirated from a specimen container with a stopper (cap), CTS (Closed Tube Sampling) in which the specimen is sampled with the stopper is sometimes used. In this CTS, for example, a needle-shaped puncture device in which the inside is a hollow tube is used, and after the puncture device bores a hole in the stopper (punctures the stopper), a nozzle (specimen probe) is inserted into the specimen container through the inside of the puncture device to aspirate the specimen (for example, refer to Japanese Patent Document 1).

[0004] In addition, in an automatic analysis device using such a CTS method, although there are various materials of stoppers and various shapes of specimen containers, the present situation is that the action condition of the puncture action of the puncture device that punctures the stopper of the specimen container is fixed to one (for example, refer to Japanese Patent Document 2).

[0005]

Prior Art Documents

[0006]

Patent Documents

[0007]

Japanese Patent Document 1

[0008]

Japanese Patent Document 2

[0009] However, considering that the effect of perforation (piercing) on the specimen container varies depending on the shape of the specimen container and the material of the plug, if the piercing operation conditions are uniform, there is a risk of breakage of the specimen container depending on the situation. In addition, the plug of the specimen container to be perforated is mostly made of rubber, and thus, depending on the perforation conditions (piercing operation conditions) such as the perforation speed, the perforation force, the extraction speed of the piercer after perforation, and the perforation distance of the piercer with respect to the specimen container, there are cases where the rubber plug is pressed into the specimen container and cannot be perforated, or cases where pieces of rubber are attached to the inside of the piercer in the hollow state of the piercer, and the inner hole of the piercer is blocked by the rubber plug.

[0010] The present application is made in view of the above-described problems, and aims to provide an automatic analysis device capable of performing a piercing operation with appropriate perforation conditions corresponding to the category of a plug-equipped specimen container, and a piercing condition selection method thereof.

[0011] To achieve the above-described object, the present application is an automatic analysis device that obtains measurement information for a prescribed inspection item by reacting a specimen with a reagent and measuring the reaction process, characterized by comprising: a specimen supply section in which a specimen rack in which one or more plug-equipped specimen containers of the same category are loaded is arranged; a rack identification information reading section that reads rack identification information given to the specimen rack; a drive section that performs a piercing operation of perforating the plug of the plug-equipped specimen container by a piercer at a specimen suction position, and that sucks a specimen in the plug-equipped specimen container using a specimen suction nozzle that passes through a hole perforated by the piercer; a piercing condition setting section that sets the piercing operation conditions of the piercer with respect to the plug-equipped specimen container loaded in the specimen rack based on the rack identification information read by the rack identification information reading section; and a control section that controls the operation of the drive section based on the piercing operation conditions set by the piercing condition setting section.

[0012] Further, the present application is a method for selecting a piercing condition of an automatic analysis device, the automatic analysis device including: a sample supply section in which a sample rack in which one or more of the same type of stoppered sample containers are loaded is arranged; and a drive section that performs a piercing action in which a stopper of the stoppered sample container is perforated by a piercer, and that sucks a sample in the stoppered sample container using a sample suction nozzle that passes through the hole perforated by the piercer, the automatic analysis device obtaining measurement information for a prescribed test item by causing the sample sucked by the sample suction nozzle to react with a reagent and measuring the reaction process, the method for selecting a piercing condition characterized by including: a rack identification information reading step of reading rack identification information given to the sample rack; a piercing condition setting step of setting a piercing action condition of the piercer for the stoppered sample container loaded in the sample rack based on the rack identification information read in the rack identification information reading step; and an action control step of controlling an action of the drive section based on the piercing action condition set in the piercing condition setting step.

[0013] According to the automatic analysis device and the method for selecting a piercing condition thereof according to the above-described configuration, the piercing action condition of the piercer is set for the stoppered sample container based on the rack identification information given to the sample rack in which one or more of the same type of stoppered sample containers are loaded, and thus the piercing action can be performed with an appropriate (optimal) perforation condition corresponding to the type of the stoppered sample container. Therefore, the aforementioned defect at the time of piercing that has occurred in the past can be reduced, the lengthening of the analysis time can be prevented, and the amount of sample loss can be reduced. This is particularly advantageous in the case where the piercing condition is set for each sample rack, and in the case of a micro blood collection tube (height alignment on the rack is performed by a dedicated tube) to which identification information such as a sample ID label cannot be attached. That is, in the case where a micro blood collection tube is used without using an adapter or the like, the optimal piercing condition can be set even if a sample ID is not attached, as long as information inherent to the sample rack is attached.

[0014] According to the present application, an automatic analysis device and a method for selecting a piercing condition thereof are provided, in which a piercing action (CTS action) can be performed with an appropriate perforation condition corresponding to the type of a stoppered sample container. BRIEF DESCRIPTION OF DRAWINGS

[0015] Figure 1 is a schematic overall appearance view of an automatic analysis device according to an embodiment of the present application.

[0016] Figure 2 is a block diagram showing a schematic configuration of an automatic analysis device according to Figure 1 .

[0017] Figure 3 is a block diagram showing a configuration for setting an appropriate piercing action condition for each sample rack.

[0018] Figure 4 It is a flowchart illustrating the method for setting appropriate puncture action conditions for each specimen rack.

[0019] Figure 5 This is a schematic diagram illustrating an example of a puncture procedure when the puncture instrument is hollow. Detailed Implementation

[0020] Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings.

[0021] Figure 1 This is a schematic overall appearance view of the automatic analysis device according to this embodiment. Figure 2 It means Figure 1 A block diagram outlining the basic structure of an automated analysis device. (See attached diagram.) Figure 2 As shown, the automatic analysis device 1 of this embodiment includes a specimen supply unit 50 for supplying specimens, a reaction unit 40 for holding a reaction container 54 containing a sample, and a reagent supply unit 30 for supplying reagents to the reaction container 54. By causing the reagents supplied from the reagent supply unit 30 to the reaction container 54 to react with the specimens and measuring the reaction process, measurement information is obtained for the specified test items.

[0022] Specifically, the automatic analysis device 1 of this embodiment consists of a housing 100 forming its outer frame, and a specimen processing space formed in the upper part of the housing 100 (see reference). Figure 1 ).

[0023] like Figure 2 As clearly shown, the automatic analysis device 1 includes a control unit (control section) 10, a measurement unit 30, and a touch screen 190.

[0024] The control unit 10 controls the overall operation of the automatic analysis device 1. The control unit 10 is, for example, a personal computer (PC). The control unit 10 includes a central processing unit (CPU) 12, random access memory (RAM) 14, read-only memory (ROM) 16, storage medium 18, and communication interface (I / F) 20, all interconnected via a bus 22. The CPU 12 performs various signal processing tasks. The RAM 14 functions as the main storage device for the CPU 12. The RAM 14 can be, for example, dynamic RAM (DRAM) or static RAM (SRAM). The ROM 16 stores various startup programs. The storage medium 18 can be, for example, a hard disk drive (HDD) or a solid-state drive (SSD). The storage medium 18 stores various information such as programs and parameters used by the CPU 12. Additionally, the storage medium 18 stores data acquired by the measurement unit 30. The RAM 14 and storage medium 18 are not limited to these and can be replaced with various storage devices. The control unit 10 communicates with external devices such as the measurement unit 30 and the touchscreen 190 via the communication I / F 20.

[0025] The touch panel 194 is provided on the display device 192. The touch panel 194 acquires an input from a user, and transmits the acquired input information to the control unit 10.

[0026] The control unit 10 can also be connected to other devices such as a printer, a hand-held code reader, a host computer, and the like via the communication I / F 20.

[0027] The measurement unit 30 includes a control circuit 42, a data processing circuit 44, a thermostat 52, a reaction container 54, a light source 62, a scattered light detector 64, a transmitted light detector 66, a specimen container 72, a reagent container 74, a specimen probe 76, and a reagent probe 78. In this case, the reaction container 54, the scattered light detector 64, and the transmitted light detector 66 are provided in the thermostat 52. In addition, the specimen container 72 is a stoppered specimen container, and a specimen rack in which one or more of the same type of stoppered specimen container 72 is loaded is arranged in the specimen supply section 50.

[0028] The control circuit 42 controls the operation of each part of the measurement unit 30 based on an instruction from the control unit 10. The control circuit 42, although not shown, is connected to the data processing circuit 44, the thermostat 52, the light source 62, the scattered light detector 64, the transmitted light detector 66, the specimen probe 76, the reagent probe 78, and the like, and controls the operation of each part.

[0029] The data processing circuit 44 is connected to the scattered light detector 64 and the transmitted light detector 66, and acquires a detection result from the scattered light detector 64 and the transmitted light detector 66. The data processing circuit 44 performs various processes on the acquired detection result, and outputs a processed result. The process performed by the data processing circuit 44 can include, for example, an A / D conversion process of converting the format of data output from the scattered light detector 64 and the transmitted light detector 66 into a format that can be processed by the control unit 10, and the like.

[0030] The control circuit 42 and the data processing circuit 44, for example, can include a CPU, an application specific integrated circuit (ASIC), or a field programmable gate array (FPGA). The control circuit 42 and the data processing circuit 44 can each be configured from one integrated circuit or the like, or can be configured in combination from a plurality of integrated circuits or the like. Also, the control circuit 42 and the data processing circuit 44 can be configured from one integrated circuit or the like. The operations of the control circuit 42 and the data processing circuit 44 can be performed in accordance with a program recorded in a storage device or a recording region in the circuit.

[0031] The specimen container 72 accommodates a specimen obtained from blood collected from a patient, for example. The reagent container 74 accommodates various reagents used for the assay. The specimen container 72 and the reagent container 74 can each be provided as a plurality of containers. Since the reagents used for the analysis are generally a plurality of kinds, the reagent container 74 is generally a plurality of containers. The specimen probe 76 dispenses the specimen accommodated in the specimen container 72 toward the reaction container 54 under the control of the control circuit 42. The reagent probe 78 dispenses the reagent accommodated in the reagent container 74 toward the reaction container 54 under the control of the control circuit 42. The number of the specimen probe 76 and the reagent probe 78 can also be a plurality.

[0032] The thermostat 52 maintains the temperature of the reaction container 54 at a prescribed temperature under the control of the control circuit 42. In the reaction container 54, a mixed solution of the specimen dispensed by the specimen probe 76 and the reagent dispensed by the reagent probe 78 is caused to react. Also, the reaction container 54 can be a plurality of containers.

[0033] The light source 62 irradiates light of a prescribed wavelength under the control of the control circuit 42. The light source 62 can be configured to irradiate light having different wavelengths according to the conditions of the assay. Therefore, the light source 62 can be provided with a plurality of light source elements. The light irradiated from the light source 62 is guided by an optical fiber, for example, and is irradiated to the reaction container 54. The light irradiated to the reaction container 54 is scattered in part and transmitted in part according to the reaction process state of the mixed solution in the reaction container 54. The scattered light detector 64 detects the light scattered by the reaction container 54, for example, the amount of the scattered light. The transmitted light detector 66 detects the light transmitted through the reaction container 54, for example, the amount of the transmitted light. The data processing circuit 44 processes the information on the amount of the scattered light detected by the scattered light detector 64, or the information on the amount of the transmitted light detected by the transmitted light detector 66. The scattered light detector 64 and the transmitted light detector 66 can be caused to operate either one according to the conditions of the assay. Therefore, the data processing circuit 44 can be caused to process either one of the information on the amount of the scattered light detected by the scattered light detector 64 and the information on the amount of the transmitted light detected by the transmitted light detector 66 according to the conditions of the assay. The data processing circuit 44 transmits the data processed to the control unit 10. Also, Figure 3The illustrated measurement unit 30 has both a scattered light detector 64 and a transmitted light detector 66, but can have only one of them.

[0034] The control unit 10 performs various operations based on data acquired from the measurement unit 30. The operations include calculation of the reaction amount of the mixed solution, quantitative operation of the amount of the measurement target substance in the subject based on the reaction amount, and the like. Part or all of these operations can also be performed by the data processing circuit 44.

[0035] Note that, here, the case where the PC that controls the operation of the measurement unit 30 and the PC that performs data operation and quantitative operation are the same control unit 10 is described, but they can be independent. In other words, the PC that performs data operation and quantitative operation can exist as a single body.

[0036] Next, the characteristic functional units of the automatic analysis device 1 of the above-described configuration that can set appropriate puncture operation conditions for each specimen rack and the puncture condition selection method will be described with reference to Figures 3-5

[0037] As shown in Figure 3 The automatic analysis device 1 of the present embodiment has a rack identification information reading unit 84 that reads rack identification information C given to a specimen rack 70 in which one or more specimen containers 72 of the same type are loaded, a CTS drive unit 80 that performs a puncture operation in which a plug of the specimen container 72 is punctured by a puncture needle and that sucks a specimen in the specimen container 72 using a specimen suction nozzle of a specimen probe 76 that passes through the hole formed by the puncture operation, a puncture condition setting unit 82 that sets a puncture operation condition of the puncture needle for the specimen container 72 loaded in the specimen rack 70 based on the rack identification information C read by the rack identification information reading unit 84, and the aforementioned control unit 10 that controls the operation of the CTS drive unit 80 based on the puncture operation condition set by the puncture condition setting unit 82. The automatic analysis device 1 can use a plurality of specimen racks 70, and can identify the type of the specimen container 72 mounted on the specimen rack 70 by recognizing the rack identification information C. Note that the rack identification information C given to the specimen rack 70 can be a coded display (bar code or two-dimensional code, such as a rack ID label or rack number) printed or attached to the specimen rack 70, or can be formed by a shape (for example, a notch, a hole, or the like for an ID) unique to the specimen rack 70 and / or a physical element for reading the shape. As the physical element for reading the shape, a magnet or the like can be cited. In particular, if a large amount of information can be given by a two-dimensional code or the like, the puncture operation condition can be set for each position on the specimen rack 70.

[0038] Here, Figure 5 ​An example of a puncture operation using a tubular (hollow) puncture device is shown. As shown, a puncture device 74 having a needle shape with a hollow tube on the inside is used, and after the puncture device 74 perforates (perforates the plug) a plug 73 that blocks the opening of a specimen container 72, a specimen suction nozzle (specimen probe) 76 is inserted through the inside of the puncture device 74 into the specimen container 72 to suction a specimen 75. In addition, the puncture device does not have to be tubular, and in the case of a non-tubular puncture device, after the puncture device perforates the plug, the specimen suction nozzle suctions the specimen in the specimen container with the plug without passing through the puncture device.

[0039] Next, a method of setting appropriate puncture operation conditions for each specimen rack 70 using such a function section as shown in the foregoing will be described with reference to Figure 4 Figure 3

[0040] First, in a state in which the specimen rack 70 is placed on the specimen supply section 50 (step S1; also refer to Figure 3 ), the rack identification information reading section 84 reads the rack identification information C imparted to the specimen rack 70 (rack identification information reading step S2). Then, the puncture condition setting section 82 sets the puncture operation conditions of the puncture device for the specimen container 72 with a plug filled in the specimen rack 70 based on the rack identification information C read by the rack identification information reading section 84 (puncture condition setting step S3). In this case, the puncture condition setting section 82 sets the puncture operation conditions (in units of racks) based on an operation condition table in which the rack identification information C is associated with the puncture operation conditions.

[0041] In addition, as the puncture operation conditions, the lower limit point of the descent of the puncture device, the descent speed, the perforation force, the descent speed pattern of the puncture device at the time of descent (2-stage descent, etc.), the inner and outer diameters of the puncture device (when there are a plurality of puncture devices), the upper limit point of the detection range of the specimen liquid level detected in conjunction with the insertion of the suction nozzle (specimen probe) into the specimen container 72 with a plug, the cumulative number of perforations, etc. can be cited. Here, the cumulative number of perforations is effective in the case in which the plug is broken due to the characteristics of the plug and the perforation by the puncture device is performed a plurality of times, and by, for example, counting the number of perforations cumulatively for each specimen ID, the count result can be fed back to the puncture condition setting section 82 or the control unit 10.

[0042] Then, when the specimen container 72 with a plug is located at the specimen suction position, the control unit 10 controls the operation of the CTS drive section 80 based on the puncture operation conditions set by the puncture condition setting section 82 (operation control step S4). Thus, at the specimen suction position, the plug of the specimen container 72 with a plug is perforated by the puncture device with appropriate puncture operation conditions corresponding to the category of the specimen container 72 with a plug, and then the specimen in the specimen container 72 with a plug can be suctioned by the specimen probe 76 through the hole perforated by the puncture device. ​​

[0043] As described above, according to the present embodiment, the piercing action condition of the piercer is set for the stopper-equipped specimen container 72 based on the rack identification information C imparted to the specimen rack 70 formed by loading one or more of the same type of stopper-equipped specimen container 72, and thus the piercing action can be performed with the appropriate (optimal) perforation condition corresponding to the type of the stopper-equipped specimen container 72. Therefore, the aforementioned defects at the time of piercing that have occurred in the past can be reduced, the lengthening of the analysis time can be prevented, and the amount of specimen loss can be reduced. In addition, the case where the piercing condition is set in units of specimen racks is particularly advantageous in a micro blood collection tube (height alignment on the rack is performed by a dedicated tube) to which identification information such as a specimen ID label cannot be attached. That is, in the case where a micro blood collection tube is used without using an adapter or the like, the optimal piercing condition can be set even without a specimen ID as long as the information C inherent to the specimen rack 70 is attached.

[0044] In addition, the present application is not limited to the aforementioned embodiments, and various modifications can be made to implement the present application without departing from the gist thereof. For example, in the present application, the form of the rack identification information, the configuration of the automatic analysis device, and the like can be arbitrarily set. In addition, a part or all of the aforementioned embodiments can be combined, or a part of the configuration can be omitted from one of the aforementioned embodiments.

[0045] [Legend of Reference Numerals]

[0046] 1 Automatic analysis device

[0047] 10 Control unit (control section)

[0048] 50 Specimen supply section

[0049] 70 Specimen rack

[0050] 72 Specimen container

[0051] 80 CTS drive section

[0052] 82 Piercing condition setting section

[0053] 84 Rack identification information reading section

[0054] C Rack identification information

Claims

1. An automated analytical apparatus, which obtains measurement information for specified test items by reacting a sample with a reagent and measuring the reaction process, characterized in that, Possessing: a specimen supply section in which one or more racks are arranged, each of the racks being filled with one or more stoppered specimen containers of the same type; a rack identification information reading section that reads rack identification information imparted to the racks; a drive section that performs a puncture action by a puncture device on a stopper of the stoppered specimen container at a specimen suction position, and causes a specimen suction nozzle that operates independently of the puncture device to suction a specimen in the stoppered specimen container through a hole punctured by the puncture device; a puncture condition setting section that sets a puncture action condition of the puncture device for the stoppered specimen container filled in the rack based on the rack identification information read by the rack identification information reading section; and a control section that controls the puncture action of the drive section based on the puncture action condition set by the puncture condition setting section.

2. The automatic analysis device according to claim 1, wherein the puncture action condition includes at least one of a lower limit point of descent of the puncture device, a descent speed, a puncture force, a descent speed pattern of the puncture device at the time of descent, an inner and outer diameter of the puncture device, an upper limit point of a detection range of a liquid surface of the specimen detected in conjunction with insertion of the specimen suction nozzle into the stoppered specimen container, and a cumulative puncture number.

3. The automatic analysis device according to claim 1 or 2, wherein the rack identification information is a coded display printed or attached to the rack.

4. The automatic analysis device according to claim 1 or 2, wherein the rack identification information is formed by a shape inherent to the rack and / or a physical element for reading the shape.

5. The automatic analysis device according to claim 1 or 2, wherein the puncture condition setting section sets the puncture action condition based on an action condition table in which the rack identification information is associated with the puncture action condition.

6. A puncture condition selection method for an automatic analysis device, the automatic analysis device possessing: a specimen supply section in which one or more racks are arranged, each of the racks being filled with one or more stoppered specimen containers of the same type; and a drive section that performs a puncture action by a puncture device on a stopper of the stoppered specimen container at a specimen suction position, and causes a specimen suction nozzle that operates independently of the puncture device to suction a specimen in the stoppered specimen container through a hole punctured by the puncture device; the automatic analysis device obtaining measurement information for a prescribed inspection item by causing the specimen suctioned by the specimen suction nozzle to react with a reagent and measuring the reaction process, the puncture condition selection method characterized by comprising: a rack identification information reading step that reads rack identification information imparted to the racks; a puncture condition setting step that sets a puncture action condition of the puncture device for the stoppered specimen container filled in the rack based on the rack identification information read by the rack identification information reading step; and an action control step that controls the puncture action of the drive section based on the puncture action condition set by the puncture condition setting step.

7. The puncture condition selection method according to claim 6, wherein The above piercing operation condition includes at least one of a lower limit point of lowering of the above piercing device, a lowering speed, a piercing force, a lowering speed pattern of the above piercing device at the time of lowering, an inner diameter and an outer diameter of the above piercing device, an upper limit point of a detection range for detecting a liquid level of the specimen accompanying with insertion of the above specimen suction nozzle into the above stoppered specimen container, and a cumulative number of times of piercing.

8. The piercing condition selection method according to claim 6 or 7, wherein The above rack identification information is a coded display printed or attached to the above specimen rack.

9. The piercing condition selection method according to claim 6 or 7, wherein The above rack identification information is formed by a shape inherent to the above specimen rack and / or a physical element for reading of the shape.

10. The piercing condition selection method according to claim 6 or 7, wherein The above piercing operation condition setting step sets the piercing operation condition based on an operation condition table in which the above rack identification information is associated with the piercing operation condition.

Images