Patent Description:
Conventionally, there have been various types of known automatic analysis apparatuses that can obtain measurement information on various test items by causing a reaction between various reagents and biological samples such as blood and urine to measure a reaction process thereof, such as a blood coagulation analysis apparatus and an analysis apparatus using an immunoassay method. For example, a specimen as a biological sample is dispensed from a specimen vessel (blood sample tube) to a reaction vessel, and a reagent according to a test item is dispensed and mixed with the dispensed specimen to perform various measurements and analyzes.

In such an analysis apparatus, when a specimen is sucked from a specimen vessel having a stopper (cap), CTS (Closed Tube Sampling: specimen dispensation from the specimen vessel having the stopper), which samples a specimen with the stopper attached, may be adopted. In this CTS, for example, a needle-shaped piercer having a hollow tube inside is used, and after the stopper is punctured by this piercer (stopper is pierced), a nozzle (specimen probe) is inserted into the specimen vessel through the inside of the piercer to suck the specimen (for example, see Patent Document <NUM>).

In addition, in an automatic analysis apparatus adopting such a CTS method, despite the existence of stoppers of various materials and specimen vessels of various shapes, at present, the number of operation conditions of a piercing operation of puncturing a stopper of a specimen vessel by a piercer is fixed to one (for example, see Patent Document <NUM>).

However, considering that an influence of puncturing (piercing) on the specimen vessel differs depending on the shape of the specimen vessel and the material of the stopper, when the piercing operation condition is uniform, the specimen vessel may be damaged in some cases. In addition, since most of the stoppers of the specimen vessels to be pierced are made of rubber, depending on the piercing conditions (piercing operation conditions) such as a piercing speed, a piercing force, a piercer withdrawal speed after piercing, and a piercing distance of the piercer with respect to the specimen vessel, the rubber stopper may be pushed into the specimen vessel and cannot be pierced, rubber fragments may adhere to the inside of the piercer when the piercer is hollow, or an inner hole of the piercer may be blocked with the rubber stopper.

The invention has been made by paying attention to the above-mentioned problems, and an object of the invention to provide an automatic analysis apparatus capable of realizing a piercing operation under an appropriate piercing condition according to a type of a specimen vessel having a stopper, and a piercing condition selection method therefor.

To achieve the object, the invention provides for an automatic analysis apparatus according to claim <NUM>.

In addition, the invention provides for a piercing condition selection method according to claim <NUM>.

According to the automatic analysis apparatus and the piercing condition selection method therefor having the above configuration, since the piercing operation condition by the piercer for the specimen vessel having the stopper is set based on the rack identification information assigned to the specimen rack loaded with the same type of one or more specimen vessels having stoppers, it is possible to realize the piercing operation under an appropriate (optimal) piercing condition according to the type of the specimen vessel having the stopper. For this reason, it is possible to reduce the above-mentioned piercing problems in the past, prevent a long analysis time, and reduce the amount of specimen loss. Allowing setting of the piercing condition in such specimen rack units is particularly beneficial for a micro blood collection tube (which is a dedicated tube and aligns the height on the rack) to which identification information such as a specimen ID label cannot be affixed. That is, when the micro blood collection tube is used without using an adapter, etc., the optimum piercing condition can be set even if the specimen ID is not provided, as long as the information unique to the rack is added.

According to the invention, there is provided an automatic analysis apparatus capable of realizing a piercing operation (CTS operation) under an appropriate piercing condition according to a type of a specimen vessel having a stopper, and a piercing condition selection method therefor.

Hereinafter, an embodiment of the invention will be described with reference to the drawings.

<FIG> is a schematic overall external view of an automatic analysis apparatus according to the present embodiment, and <FIG> is a block diagram illustrating a schematic configuration of the automatic analysis apparatus of <FIG>. As illustrated in <FIG>, the automatic analysis apparatus <NUM> of the present embodiment includes a specimen supply portion <NUM> for supplying a specimen, a reaction portion <NUM> for holding a reaction vessel <NUM> into which a specimen is dispensed, and a reagent supply portion <NUM> for supplying a reagent to the reaction vessel <NUM>, and obtains measurement information on a predetermined test item by causing a reaction between a specimen and a reagent supplied from the reagent supply portion <NUM> to the reaction vessel <NUM> to measure a reaction process.

Specifically, an outer frame of the automatic analysis apparatus <NUM> of the present embodiment is formed by a housing <NUM>, and the automatic analysis apparatus <NUM> is configured by forming a specimen processing space in an upper part of the housing <NUM> (see <FIG>).

As clearly illustrated in <FIG>, the automatic analysis apparatus <NUM> includes a control unit (controller) <NUM>, a measurement unit <NUM>, and a touch screen <NUM>.

The control unit <NUM> controls the overall operation of the automatic analysis apparatus <NUM>. The control unit <NUM> includes, for example, a personal computer (PC). The control unit <NUM> includes a Central Processing Unit (CPU) <NUM>, a Random Access Memory (RAM) <NUM>, a Read Only Memory (ROM) <NUM>, a storage <NUM>, and a communication interface (I/F) <NUM> connected to each other via a bus line <NUM>. The CPU <NUM> performs various signal processing, etc. The RAM <NUM> functions as a main storage device of the CPU <NUM>. As the RAM <NUM>, for example, a Dynamic RAM (DRAM), a Static RAM (SRAM), etc. can be used. The ROM <NUM> records various boot programs, etc. For the storage <NUM>, for example, a Hard Disk Drive (HDD), a Solid State Drive (SSD), etc. can be used. Various types of information such as programs and parameters used by the CPU <NUM> are recorded in the storage <NUM>. Further, data acquired by the measurement unit <NUM> is recorded in the storage <NUM>. The RAM <NUM> and the storage <NUM> are not limited thereto, and can be replaced with various storage devices. The control unit <NUM> communicates with an external device, for example, the measurement unit <NUM> and the touch screen <NUM> via the communication I/F <NUM>.

The touch screen <NUM> includes a display device <NUM> and a touch panel <NUM>. The display device <NUM> may include, for example, a liquid crystal display (LCD), an organic EL display, etc. The display device <NUM> displays various screens under the control of the control unit <NUM>. This screen may include various screens such as an operation screen of the automatic analysis apparatus <NUM>, a screen showing a measurement result, and a screen showing an analysis result. The touch panel <NUM> is provided on the display device <NUM>. The touch panel <NUM> acquires an input from a user and transmits the obtained input information to the control unit <NUM>.

The control unit <NUM> may be connected to other devices such as a printer, a handy code reader, and a host computer via the communication I/F <NUM>.

The measurement unit <NUM> includes a control circuit <NUM>, a data processing circuit <NUM>, a constant temperature bath <NUM>, the reaction vessel <NUM>, a light source <NUM>, a scattered light detector <NUM>, a transmitted light detector <NUM>, a specimen vessel <NUM>, a reagent vessel <NUM>, a specimen probe <NUM>, and a reagent probe <NUM>. In this case, the reaction vessel <NUM>, the scattered light detector <NUM>, and the transmitted light detector <NUM> are provided in the constant temperature bath <NUM>. In addition, the specimen vessel <NUM> is a specimen vessel having a stopper, and a specimen rack loaded with the same type of one or more specimen vessels <NUM> having stoppers is arranged in the specimen supply portion <NUM>.

The control circuit <NUM> controls an operation of each part of the measurement unit <NUM> based on a command from the control unit <NUM>. Although not illustrated, the control circuit <NUM> is connected to the data processing circuit <NUM>, the constant temperature bath <NUM>, the light source <NUM>, the scattered light detector <NUM>, the transmitted light detector <NUM>, the specimen probe <NUM>, the reagent probe <NUM>, etc., and controls an operation of each part.

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

The control circuit <NUM> and the data processing circuit <NUM> may include, for example, a CPU, an Application Specific Integrated Circuit (ASIC), a Field Programmable Gate Array (FPGA), etc. Each of the control circuit <NUM> and the data processing circuit <NUM> may be configured by one integrated circuit, etc., or may be configured by combining a plurality of integrated circuits, etc. Further, the control circuit <NUM> and the data processing circuit <NUM> may include one integrated circuit, etc. The operation of the control circuit <NUM> and the data processing circuit <NUM> may be performed according to, for example, a program recorded in a storage device or a recording area in the circuit.

The specimen vessel <NUM> contains, for example, a specimen obtained from blood collected from a patient. The reagent vessel <NUM> contains various reagents used for measurement. Any number of specimen vessels <NUM> and reagent vessels <NUM> may be provided. Since there is usually a plurality of types of reagents used for analysis, there is generally a plurality of reagent vessels <NUM>. The specimen probe <NUM> dispenses the specimen contained in the specimen vessel <NUM> into the reaction vessel <NUM> under the control of the control circuit <NUM>. The reagent probe <NUM> dispenses the reagent contained in the reagent vessel <NUM> into the reaction vessel <NUM> under the control of the control circuit <NUM>. Any number of specimen probes <NUM> and reagent probes <NUM> may be used.

The constant temperature bath <NUM> maintains the temperature of the reaction vessel <NUM> at a predetermined temperature under the control of the control circuit <NUM>. In the reaction vessel <NUM>, a mixed solution obtained by mixing the specimen dispensed by the specimen probe <NUM> and the reagent dispensed by the reagent probe <NUM> reacts. Note that any number of reaction vessels <NUM> may be used.

The light source <NUM> emits light having a predetermined wavelength under the control of the control circuit <NUM>. The light source <NUM> may be configured to emit light having a different wavelength depending on the measurement condition. Therefore, the light source <NUM> may have a plurality of light source elements. The light emitted from the light source <NUM> is guided by, for example, an optical fiber, and is applied to the reaction vessel <NUM>. The light applied to the reaction vessel <NUM> is partially scattered and partially transmitted depending on the reaction process state of the mixed solution in the reaction vessel <NUM>. The scattered light detector <NUM> detects the light scattered in the reaction vessel <NUM>, and detects, for example, the amount of the scattered light. The transmitted light detector <NUM> detects the light transmitted through the reaction vessel <NUM>, and detects, for example, the amount of transmitted light. The data processing circuit <NUM> processes information on the amount of scattered light detected by the scattered light detector <NUM>, and processes information on the amount of transmitted light detected by the transmitted light detector <NUM>. Any one of the scattered light detector <NUM> and the transmitted light detector <NUM> may operate depending on the measurement condition. Therefore, the data processing circuit <NUM> may process any one of the information on the amount of scattered light detected by the scattered light detector <NUM> or the information on the amount of transmitted light detected by the transmitted light detector <NUM> according to the measurement condition. The data processing circuit <NUM> transmits processed data to the control unit <NUM>. Note that even though the measurement unit <NUM> illustrated in <FIG> includes two light detectors, the scattered light detector <NUM> and the transmitted light detector <NUM>, the measurement unit <NUM> may include any one of the light detectors.

The control unit <NUM> performs various calculations based on the data acquired from the measurement unit <NUM>. These calculations include calculation of the reaction amount of the mixed solution, quantitative calculation of the substance amount or an activity value of a substance to be measured in a subject based on the reaction amount, etc. The data processing circuit <NUM> may perform some or all of these calculations.

Note that here, even though the case where a PC that controls the operation of the measurement unit <NUM> and a PC that performs data calculation and quantitative calculation are the same control unit <NUM> is illustrated, the PCs may be separate bodies. In other words, the PC that performs the data calculation and the quantitative calculation may exist as each.

Next, a description will be given of characteristic functional units of the automatic analysis apparatus <NUM> having the above configuration allowing setting of an appropriate piercing operation condition for each specimen rack, and a piercing condition selection method with reference to <FIG>.

As illustrated in <FIG>, the automatic analysis apparatus <NUM> of the present embodiment includes a rack identification information reading unit <NUM> that reads rack identification information C assigned to a specimen rack <NUM> loaded with the same type of one or more specimen vessels <NUM> having stoppers, a CTS drive unit <NUM> that executes a piercing operation of piercing the stopper of the specimen vessel <NUM> having the stopper by a piercer at a specimen suction position and sucks a specimen in the specimen vessel <NUM> having the stopper by a specimen suction nozzle included in the specimen probe <NUM> passing through a hole formed by the piercer, a piercing condition setting unit <NUM> that sets a piercing operation condition by the piercer for the specimen vessel <NUM> having the stopper loaded in the specimen rack <NUM> based on the rack identification information C read by the rack identification information reading unit <NUM>, and the control unit <NUM> that controls an operation of the CTS drive unit <NUM> based on the piercing operation condition set by the piercing condition setting unit <NUM>. The automatic analysis apparatus <NUM> can use a plurality of specimen racks <NUM>, and can identify the type of the specimen vessel <NUM> mounted on the specimen rack <NUM> by identifying the rack identification information C. Note that the rack identification information C assigned to the specimen rack <NUM> may be a coded display (bar code or a 2D code, for example, a rack ID label or a rack number) printed on or affixed to the specimen rack <NUM>, or may be formed by a shape peculiar to the specimen rack <NUM> (for example, a notch or a hole for ID is included in a bit) and/or a physical element used for reading the shape. As a physical element used for reading the shape, a magnet, etc. can be mentioned. In particular, when a large amount of information can be assigned to the 2D code, etc., it is possible to set a piercing operation condition for each position on the specimen rack <NUM>.

Here, <FIG> illustrates an example of a piercing operation using a tubular (hollow) piercer. As illustrated in the figure, a needle-shaped piercer <NUM>, which is a hollow tube inside, is used, and after the stopper <NUM> closing an opening of the specimen vessel <NUM> is punctured (the stopper is pierced) by the piercer <NUM>, the specimen suction nozzle (specimen probe) <NUM> is inserted into the specimen vessel <NUM> through the inside of the piercer <NUM> to suck a specimen <NUM>. Note that the piercer does not have to be tubular in this way. When the piercer is not tubular, after the stopper is pierced by the piercer, the specimen suction nozzle sucks the specimen in the specimen vessel having the stopper through the hole of the stopper formed by the piercer without intervention of the piercer.

Next, a description will be given of a method of setting an appropriate piercing operation condition for each specimen rack <NUM> using the functional units illustrated in <FIG> described above with reference to <FIG>.

First, in a state where the specimen rack <NUM> is set in the specimen supply portion <NUM> (step S1; also see <FIG>), the rack identification information reading unit <NUM> reads the rack identification information C assigned to the specimen rack <NUM> (rack identification information reading step S2). Thereafter, the piercing condition setting unit <NUM> sets a piercing operation condition by the piercer for the specimen vessel <NUM> having the stopper loaded in the specimen rack <NUM> based on the rack identification information C read by the rack identification information reading unit <NUM> (piercing condition setting step S3). In this case, the piercing condition setting unit <NUM> sets the piercing operation condition (in rack units) based on an operation condition table in which the rack identification information C and the piercing operation condition are associated with each other and stored.

Note that examples of the piercing operation condition may include a lower limit of descent, a descent speed, a piercing force of the piercer, a descent speed pattern of the piercer during descent (two-step descent, etc.), inner and outer diameters of piercers (in the case of having a plurality of piercers), an upper limit of a stop position of the detection area for detecting the liquid level of the specimen with insertion of the suction nozzle (specimen probe) into the specimen vessel <NUM> having the stopper, the cumulative number of times of piercing, etc. Here, the cumulative number of times of piercing is useful when the stopper is damaged by a plurality of number of times of piercing by the piercer due to a characteristic of the stopper, and by cumulatively counting the number of times of piercing for each specimen ID, for example, a counting result may be fed back to the piercing condition setting unit <NUM> or the control unit <NUM>.

Thereafter, when the specimen vessel <NUM> having the stopper is positioned at the specimen suction position, the control unit <NUM> controls an operation of the CTS drive unit <NUM> based on the piercing operation condition set by the piercing condition setting unit <NUM> (operation control step S4). In this way, at the specimen suction position, the stopper of the specimen vessel <NUM> having the stopper can be pierced by the piercer under an appropriate piercing operation condition according to the type of the specimen vessel <NUM> having the stopper, and then the specimen in the specimen vessel <NUM> having the stopper can be sucked by the specimen probe <NUM> passing through the hole formed by the piercer.

Claim 1:
An automatic analysis apparatus (<NUM>) for obtaining measurement information on a predetermined test item by causing a reaction between a specimen and a reagent to measure a reaction process thereof, the apparatus comprising:
a specimen supply portion (<NUM>), a specimen rack (<NUM>) loaded with the same type of one or more specimen vessels (<NUM>) having stoppers being arranged in the specimen supply portion (<NUM>);
a rack identification information reading unit (<NUM>) configured to read rack identification information assigned to the specimen rack (<NUM>);
a drive unit (<NUM>) configured to execute a piercing operation of piercing the stopper (<NUM>) of the specimen vessel (<NUM>) having the stopper (<NUM>) at a specimen suction position by a piercer (<NUM>), and configured to execute a sucking operation of sucking a specimen in the specimen vessel (<NUM>) having the stopper (<NUM>) by a specimen suction nozzle (<NUM>) passing through a hole formed by the piercer (<NUM>);
characterised in that
a piercing condition setting unit (<NUM>) configured to set a piercing operation condition selected from a number of piercing operation conditions by the piercer (<NUM>) for the specimen vessel (<NUM>) having the stopper (<NUM>) loaded in the specimen rack (<NUM>) based on the rack identification information (C) read by the rack identification information reading unit (<NUM>); and
a controller (<NUM>) configured to control the piercing operation of the drive unit (<NUM>) based on a piercing operation condition set by the piercing condition setting unit (<NUM>).