Blood analysis device, blood analysis method, and program

Abstract

A blood analyzer that comprises: a container information acquiring unit that acquires container information relating to the type of a specimen container to be used; a needle for aspirating a blood specimen contained in the specimen container and discharging the same; a blood analysis unit provided with a chamber for receiving the blood specimen that is aspirated from the specimen container and discharged by the needle; and a control unit that controls the aspiration and discharge of the blood specimen by the needle on the basis of the container information. The control unit sets the amount of the blood specimen to be aspirated by the needle on the basis of the container information.

Description

[Technical Field]

[0001] The present invention relates to a blood analyzer, a blood analysis method, and a program for analyzing a blood sample contained in a sample container. [Background technology]

[0002] Conventionally, blood collection devices have been proposed that collect blood by reducing the pressure in a vacuum blood collection chamber in a housing and applying a predetermined negative pressure to a blood bag (see, for example, Patent Document 1). In recent years, devices have also been proposed that analyze blood by setting a blood collection tube with its lid closed in the device body (see, for example, Non-Patent Document 1). [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Publication number 6-28112 [Non-patent literature]

[0004] [Non-Patent Document 1] Photoelectric Partners Vol.6, published by Nihon Kohden Corporation Summary of the Invention [Problem to be solved by the invention]

[0005] A blood collection tube that can be inserted into the device with its lid closed is referred to here as a closed-type sample container. When a closed-type sample container is used, a needle is inserted into the lid of the sample container, allowing the blood sample contained in the sample container to be aspirated through the needle. Once the blood sample has been aspirated, the needle is removed from the sample container. The blood sample is then ejected from the needle into a container (chamber) in a blood analysis unit, such as a blood cell counter. This allows the blood to be analyzed in the blood analysis unit (e.g., counting red blood cells, etc.).

[0006] However, when a closed-type sample container is used, when the needle is removed from the sample container after aspirating the blood sample, the blood sample inside the needle may be pushed back into the needle due to the pressure difference (pressure fluctuation) between the inside and outside of the sample container. For example, if the pressure inside the sample container is relatively high compared to the outside pressure, the blood sample inside the needle may be pushed back into the needle.

[0007] In this case, even if you intend to push out the specified amount of blood sample from the needle, the air trapped at the tip of the needle will be pushed out before the blood sample, resulting in a smaller amount of blood sample being ejected than the specified amount by the amount of air pushed out. As a result, the blood analysis unit will not be able to accurately analyze the blood sample ejected into the chamber.

[0008] On the other hand, blood collection tubes that are inserted into the device body with their lids removed are referred to here as open-type sample containers. When using open-type sample containers, there is no lid to close the sample container, so no pressure difference occurs between the inside and outside of the sample container. Therefore, after aspirating the blood sample and removing the needle from the sample container, the blood sample does not move within the needle due to the pressure difference. Therefore, when using open-type sample containers, it is not appropriate to use the same method as when using closed-type sample containers to accurately analyze the blood sample.

[0009] The present invention has been made to solve the above problems, and its purpose is to provide a blood analysis device, a blood analysis method, and a program that can accurately analyze blood samples regardless of the type of sample container used (closed type, open type). [Means for solving the problem]

[0010] A blood analysis device according to one aspect of the present invention comprises a container information acquisition unit that acquires container information regarding the type of specimen container used, a needle that aspirates and discharges a blood specimen contained in the specimen container, a blood analysis unit having a chamber that receives the blood specimen aspirated from the specimen container and discharged by the needle, and a control unit that controls the aspirating and discharging of the blood specimen by the needle based on the container information, and the control unit sets the amount of blood specimen to be aspirated by the needle based on the container information.

[0011] A blood analysis method according to another aspect of the present invention includes an aspiration volume setting step of setting the volume of the blood sample to be aspirated by a needle based on container information relating to the type of sample container used; an aspiration step of causing the needle to aspirate the blood sample from the sample container by the set aspiration volume; an ejection step of ejecting at least a portion of the aspirated blood sample from the needle into a chamber of a blood analysis unit; and an analysis step of analyzing the blood sample ejected into the chamber.

[0012] A program according to yet another aspect of the present invention is a program for causing a computer to execute the above-described blood analysis method.

[0013] A program according to yet another aspect of the present invention is a program for causing a computer to execute an aspiration volume setting step of setting the amount of blood sample to be aspirated by the needle based on container information relating to the type of sample container used, and an output step of outputting information about the set aspiration volume to a blood analyzer. [Effects of the Invention]

[0014] According to the present invention, blood samples can be analyzed with high accuracy regardless of the type of sample container used (closed type, open type). [Brief explanation of the drawings]

[0015] [Figure 1]1 is a perspective view showing the external configuration of a blood analyzer according to an embodiment of the present invention. [Figure 2] FIG. 2 is an explanatory diagram schematically illustrating the internal configuration of the blood analyzer. [Figure 3] FIG. 1 is a side view of a closed-type (first type) specimen container. [Figure 4] FIG. 1 is a perspective view of an open-type (second type) specimen container. [Figure 5] FIG. 1 is a perspective view of an adapter into which a first type of sample container is inserted. [Figure 6] FIG. 10 is a perspective view of an adapter into which a second type of sample container is inserted. [Figure 7] FIG. 10 is a perspective view showing a step in loading a first type of specimen container into the device body. [Figure 8] FIG. 2 is a plan view of the inside of the specimen container loading section when a first type of specimen container is loaded into the device body. [Figure 9] 6 is inserted into the adapter of FIG. 5.

[0023] FIG. [Figure 10] 10 is a plan view of the inside of the specimen container loading section when a second type specimen container is loaded into the device body using the adapter of FIG. 9. FIG. [Figure 11] 10 is a flowchart showing a processing flow in the blood analyzer. [Figure 12] FIG. 1 is an explanatory diagram schematically showing the fluctuation of a blood sample collected from a first type of sample container within a needle. [Figure 13] FIG. 10 is an explanatory diagram schematically showing the fluctuation of a blood sample collected from a second type of sample container within a needle. [Figure 14] FIG. 10 is a perspective view showing another configuration of the blood analyzer. [Figure 15] 1 is a block diagram showing a schematic configuration of a blood analysis system. DETAILED DESCRIPTION OF THE INVENTION

[0016] Hereinafter, exemplary embodiments of the present invention will be described with reference to the drawings.

[0017] [1. Overview of the blood analyzer] 1 is a perspective view showing the external configuration of a blood analyzer 1 of this embodiment. Blood analyzer 1 has a display unit 3 on the upper front surface of device main body 2. Display unit 3 is configured, for example, with a liquid crystal display device with a touch panel, and displays blood analysis results and the like, as well as accepts input of various information by an operator (for example, a medical professional).

[0018] A specimen container loading section 4 is provided at the bottom of the device main body 2. The specimen container 10 can be loaded into the device main body 2 by opening the cover 4a of the specimen container loading section 4, setting a specimen container 10 containing a blood specimen, and closing the cover 4a. The specimen container 10 is loaded into the device main body 2 with an adapter attached that corresponds to the type of specimen container 10. Details of the types of specimen container 10 and the adapters used will be described later.

[0019] A reagent container loading section 5 is provided on the side of the device main body 2. By opening the opening / closing door 5a of the reagent container loading section 5, it is possible to replenish the reagents used in blood analysis (for example, reagents for immunoassay).

[0020] 2. Internal structure of the blood analyzer 2 is an explanatory diagram showing a schematic diagram of the internal configuration of blood analyzer 1. Blood analyzer 1 includes needle 20, blood analysis unit 30, and control unit 40. Control unit 40 is configured by a central processing unit (computer), for example, called a CPU (Central Processing Unit), and controls the operation of each unit of blood analyzer 1.

[0021] The needle 20 aspirates and dispenses the blood sample contained in the sample container 10. The needle 20 pierces the lid of the sample container 10 as needed to aspirate and dispense the blood sample. The rear end of the needle 20 is connected to a metered dose syringe 22 via a first pipe 21 shown by a dashed line and an electromagnetic valve device (not shown). The control unit 40 drives the metered dose syringe 22 and the electromagnetic valve device, causing the needle 20 to aspirate and dispense the blood sample.

[0022] The needle 20 is moved horizontally and vertically by the probe unit 23. The probe unit 23 includes a horizontal movement mechanism 24 and a vertical movement mechanism 25. The horizontal movement mechanism 24 and the vertical movement mechanism 25 include, for example, an endless belt, and a drive roller and a driven roller that move the endless belt. When the control unit 40 drives the drive rollers of the horizontal movement mechanism 24 and the vertical movement mechanism 25, the endless belt of the horizontal movement mechanism 24 moves horizontally and the endless belt of the vertical movement mechanism 25 moves vertically. This allows the needle 20 supported by the vertical movement mechanism 25 to move horizontally and vertically.

[0023] The horizontal movement mechanism 24 and the vertical movement mechanism 25 may be configured as a feed screw mechanism. The feed screw mechanism rotates the feed screw with a stepping motor, thereby moving an engagement portion that engages with the feed screw in the horizontal or vertical direction. Therefore, by connecting the vertical movement mechanism 25 to the engagement portion of the horizontal movement mechanism 24 and holding the needle 20 in the engagement portion of the vertical movement mechanism 25, the needle 20 can be moved in the horizontal and vertical directions.

[0024] The blood analysis unit 30 performs blood analysis, such as counting blood cells and measuring immunity. The blood analysis unit 30 has a chamber 31 (container) that receives blood samples aspirated and discharged from the specimen container 10 by the needle 20. A counting device is provided within the chamber 31 for blood cell counting. The counting device can perform measurement methods such as impedance analysis, flow cytometry, and focusing flow impedance analysis, depending on the blood cells to be counted. The control unit 40 can create frequency distributions and the like by processing the measurement data acquired by the counting device. The counting device may also be provided outside the chamber 31 and connected to it.

[0025] The chambers 31 are provided according to the blood cells to be counted. For example, an RBC chamber and a WBC chamber are separately provided as the chambers 31. The RBC chamber is provided for counting red blood cells. The WBC chamber is provided for counting white blood cells and analyzing hemoglobin (HGB).

[0026] A BASO chamber and an LMNE chamber may further be provided as chambers 31. The BASO chamber is a chamber provided for counting basophils, which are included in white blood cells. The LMNE chamber is a chamber provided for counting lymphocytes, monocytes, neutrophils, and eosinophils, which are included in white blood cells. The "LMNE" in the LMNE chamber is an abbreviation of the initials of lymphocyte, monocyte, neutrophil, and eosinophil.

[0027] A CRP measurement chamber may be further provided as chamber 31. The CRP measurement chamber is configured so that the CRP value can be optically measured according to the latex agglutination method. CRP is an abbreviation for C-reactive protein. The CRP measurement chamber is provided with a light irradiator and a light detector for CRP measurement on the lower wall surface of the chamber, and is configured so that the liquid contained therein can be appropriately stirred.

[0028] A plurality of reagent containers (not shown) are provided near the CRP measurement chamber. Each reagent container contains a hemolysis reagent, a buffer solution, an anti-human CRP-sensitized latex immunoreagent, etc. When measuring CRP, the reagent is aspirated from each reagent container by the needle 20 at an appropriate timing and dispensed into the CRP measurement chamber.

[0029] The blood analysis section 30 has a washing container 32. The washing container 32 is provided to wash away blood adhering to the needle 20 and to discard excess blood sample in the needle 20.

[0030] A discharge pipe 33 shown by a dashed line is connected to the lower end of the chamber 31 and the washing container 32. The waste liquid in the chamber 31 and the washing container 32 is sent to the waste liquid container 50 through an electromagnetic valve device (not shown) by driving a discharge part (not shown). The discharge part is composed of a discharge syringe or a discharge pump.

[0031] When a specimen container 10 containing a blood specimen is loaded into the specimen container loading section 4 (see FIG. 1) of the device main body 2, the control section 40 drives the probe unit 23 to move the needle 20 horizontally and vertically. This allows the needle 20 to advance into and retreat from the specimen container 10, chamber 31, and reagent container, respectively. In addition, the control section 40 drives the metering syringe 22 to aspirate the blood specimen or reagent through the needle 20 and eject the blood specimen or reagent from the needle 20. Through these operations, blood analysis (blood cell counting, immunoassay) is performed in the blood analysis section 30.

[0032] The blood analyzer 1 further includes a temperature adjustment unit 41. The temperature adjustment unit 41 is connected to, for example, a second pipe 26 branching off from the first pipe 21. A switching valve 27 for switching the flow path is provided at the branch point between the first pipe 21 and the second pipe 26. The temperature adjustment unit 41 uses the heater to warm the diluent filled in a tank (also called a buffer tank) wrapped around a heater. The heated diluent merges with the first pipe 21 via the second pipe 26 and the switching valve 27 and is discharged into the chamber 31 through the needle 20. At this time, the blood sample previously aspirated by the needle 20 from the sample container 10 is also discharged into the chamber 31 simultaneously with the heated diluent. Therefore, in the chamber 31, the blood sample is heated to a desired temperature by being mixed with the heated diluent. The temperature adjustment unit 41 may be configured to directly heat the chamber 31 using a heater or the like, thereby warming the blood sample in the chamber 31. By warming the blood sample to a desired temperature in this manner, it is possible to prevent coagulation in blood samples that tend to coagulate in cold temperatures.

[0033] [3. Types of specimen containers] Next, we will explain the specimen containers 10 that are to be used with the blood analyzer 1. In this embodiment, both closed type (first type) and open type (second type) specimen containers 10 can be used. In the following explanation, when it is necessary to particularly distinguish between closed type and open type, closed type specimen containers will be referred to as specimen container 10P, and open type specimen containers will be referred to as specimen container 10Q.

[0034] FIG. 3 is a side view of a closed-type specimen container 10P. The specimen container 10P is a container from which blood can be collected with the lid 10b still attached to the container body 10a. The specimen container 10P is also called a vacuum blood collection tube because its interior is set to a negative pressure. When a syringe needle attached to a container holder (not shown) is inserted into a patient's vein, the specimen container 10 is inserted into the container holder, and the needle inside the container holder pierces and penetrates the lid 10b, the negative pressure causes the patient's blood to be drawn into and stored in the specimen container 10P. The specimen container 10P can hold, for example, 1 to 5 mL of blood.

[0035] When performing blood analysis using the specimen container 10P, the specimen container 10P is loaded into the device main body 2 (specimen container loading section 4) with the lid 10b still attached to the container body 10a. Then, a needle 20 (see FIG. 2) is inserted into the lid 10b to aspirate the blood inside. That is, the needle 20 penetrates the lid 10b of the specimen container 10P and aspirates the blood specimen contained in the specimen container 10P. Therefore, since the operator does not come into contact with the patient's blood when performing blood analysis, closed-type specimen containers 10P are effective in preventing infection.

[0036] FIG. 4 is a perspective view of an open-type specimen container 10Q. The specimen container 10Q is a container into which blood collected from a patient is sent directly into the container body 10a with the lid 10b removed. After the blood is stored, the lid 10b is fitted onto the container body 10a. The specimen container 10Q holds, for example, 0.2 to 0.5 mL of blood. For example, if the subject of blood collection is elderly, an infant, or a patient from whom normal blood collection is difficult, only a small amount of blood can be collected. In such cases, the specimen container 10Q is used for blood collection.

[0037] When performing blood analysis using the specimen container 10Q, the specimen container 10Q is loaded into the device main body 2 (specimen container loading section 4) with the lid 10b removed (only the container body 10a). The needle 20 is inserted into the container body 10a and aspirates the blood inside. Therefore, the open-type specimen container 10Q can also be said to be a container in which the needle 20 is inserted into the specimen container 10Q with the lid 10b of the specimen container 10Q removed, and the blood specimen is directly aspirated.

[0038] As shown in FIGS. 3 and 4, a label L may be affixed to the surface of the container body 10a. Peripheral information about the specimen container 10 is printed on the label L. The peripheral information includes registration information including the registration number of the patient from whom blood was drawn, information about the reagent in the specimen container 10 (e.g., information about the presence or absence of an anticoagulant), and identification information unique to each specimen container 10 for distinguishing individual specimen containers 10. The identification information includes manufacturing information such as the serial number and manufacturer of the specimen container 10, as well as information about the type of specimen container 10 (whether it is a closed type or an open type). At least a portion of the peripheral information is represented, for example, by a barcode (one-dimensional code), but may also be represented by a two-dimensional code such as a QR code (registered trademark) instead of a barcode.

[0039] [4. Detection of adapters and sample containers] A closed-type specimen container 10P is inserted into an adapter 61 shown in Figure 5 and loaded into the device body 2. The adapter 61 includes a cylindrical body 61a, a support portion 61b, a protrusion 61c, and a plurality of ribs 61d. The specimen container 10P is inserted into the body 61a.

[0040] The support portion 61b is provided to protrude radially from the outer peripheral surface of the main body 61a. When the axial direction of the cylindrical main body 61a is the X direction, the support portion 61b is formed in a U shape when viewed from the X direction, but the shape of the support portion 61b is not particularly limited. When the protruding direction of the support portion 61b from the outer peripheral surface of the main body 61a is the Y direction, the protrusion portion 61c is provided to protrude from the support portion 61b in the Z direction perpendicular to the XY plane.

[0041] A plurality of ribs 61d are provided on the inner peripheral surface of the main body 61a, extending in the X direction, and spaced apart circumferentially. When the sample container 10P is inserted into the main body 61a, it comes into contact with the plurality of ribs 61d, thereby holding the sample container 10P in the main body 61a. A protrusion 61e is provided on the top surface of the main body 61a, located at the end in the X direction, for alignment with an adapter 62 (see FIG. 6), which will be described later.

[0042] On the other hand, an open-type specimen container 10Q is loaded into the device main body 2 using both the adapter 62 shown in Fig. 6 and the adapter 61 shown in Fig. 5. The adapter 62 is configured to have a main body 62a with a cylindrical inner circumferential surface, a support portion 62b, and a protrusion 62c. The specimen container 10Q is inserted into and held inside the main body 62a.

[0043] In this embodiment, the main body 62a has a shape in which the outer diameter changes in two stages, but is not limited to this shape. When the axial direction of the cylindrical main body 62a is the same X direction as the coordinate system of the adapter 61, a mark 62d for alignment with the adapter 61 (see FIG. 5) is provided on the upper part of the main body 62a in the X direction.

[0044] The support portion 62b is provided to protrude radially from the outer peripheral surface of the main body 62a. The protruding direction of the support portion 62b relative to the main body 62a is perpendicular to the X direction, but is opposite to the protruding direction of the support portion 61b of the adapter 61 (-Y direction). The support portion 62b is formed in a shape combining multiple members such as flat plates, but the shape of the support portion 62b is not particularly limited. The protruding portion 62c is provided to protrude from the support portion 62b, but the protruding direction is the same direction (Z direction) as the protruding direction of the protruding portion 61c of the adapter 61.

[0045] When loading a closed-type specimen container 10P into the device main body 2, the specimen container 10P is inserted into the adapter 61 and placed on the support base 4b inside the cover 4a, as shown in Figure 7. Then, the cover 4a is closed.

[0046] 8 is a plan view of the inside of the sample container loading unit 4 when the cover 4a is closed and a sample container 10P is loaded. The sample container loading unit 4 is provided with an adapter detection unit 70. The adapter detection unit 70 is configured to have a first switch 71 and a second switch 72 arranged spaced apart from each other in the horizontal direction.

[0047] When the cover 4a is closed with the sample container 10P placed on the support base 4b, the protrusion 61c of the adapter 61 presses the first switch 71. On the other hand, the second switch 72 is not pressed at all. This allows the adapter detection unit 70 to detect that the adapter 61 is being used and that a closed-type sample container 10P has been loaded.

[0048] On the other hand, when loading an open-type sample container 10Q into the device main body 2, first, as shown in FIG. 9, the main body 62a of the adapter 62 is inserted into the main body 61a of the adapter 61. At this time, the position of the convex portion 61e of the adapter 61 is aligned with the position of the mark 62d of the adapter 62. In this state, the protrusions 61c and 62c are offset in the Y direction and parallel in the Z direction. Then, the sample container 10Q is inserted into the main body 62a of the adapter 62. Alternatively, the sample container 10Q may be inserted into the adapter 62 first, and then the adapter 62 may be inserted into the adapter 61. Then, the sample container 10Q, adapters 61, and 62 are placed as a set on the support base 4b inside the cover 4a, and the cover 4a is closed.

[0049] 10 is a plan view of the inside of the specimen container loading unit 4 when the cover 4a is closed and the specimen container 10Q is loaded. When the cover 4a is closed with the specimen container 10Q placed on the support base 4b, the protrusion 61c of the adapter 61 presses the first switch 71, and the protrusion 62c of the adapter 62 presses the second switch 72. This allows the adapter detection unit 70 to detect that the adapters 61 and 62 are being used, and also to detect that an open-type specimen container 10Q has been loaded.

[0050] In this way, the adapter detection unit 70 detects whether the sample container 10 to be used is a closed type or an open type, and acquires this information (information on the type of sample container 10). From this, it can be said that the adapter detection unit 70 constitutes a container information acquisition unit 100 that acquires container information related to the type of sample container 10 to be used. The blood analyzer 1 is equipped with such a container information acquisition unit 100.

[0051] Furthermore, when the specimen container 10P is a closed-type specimen container, the adapter 61 is used alone, and when the specimen container 10Q is an open-type specimen container, the adapters 61 and 62 are used in combination. From this, it can be said that when the specimen container 10 is attached to at least one adapter determined according to the type of specimen container 10 and loaded into the apparatus main body 2, the adapter detection unit 70 acquires container information regarding the type of specimen container 10 by detecting the adapter. In this way, by using the adapter detection unit 70 as the container information acquisition unit 100, it is possible to reliably acquire container information regarding the type of specimen container 10 used based on the detection of the adapter used.

[0052] 5. Controlling the aspiration and discharge of blood samples using a needle In this embodiment, the control unit 40 controls the suction and discharge of the blood sample by the needle 20 based on the container information acquired by the container information acquisition unit 100 (adapter detection unit 70). The processing performed by such control will be described below.

[0053] 11 is a flowchart showing the processing flow in the blood analyzer 1. First, when a sample container 10 (closed type or open type) is inserted into a corresponding adapter and loaded into the sample container loading section 4 of the device main body 2 (S1), the adapter detection section 70 detects whether the loaded sample container 10 is a closed type or an open type by detecting the adapter, and acquires container information regarding the type of the loaded sample container 10 (S2; information acquisition step).

[0054] Next, the control unit 40 determines whether the amount of blood sample to be aspirated by the needle 20 needs to be deviated from a predetermined amount (e.g., 10 μL) based on the container information (type of specimen container 10) acquired in S2 (S3).The control unit 40 then sets the aspirated amount based on the determination result in S3 (S4-1, S4-2; aspirated amount setting step).

[0055] For example, if the control unit 40 recognizes from the container information that the sample container 10 is a closed-type sample container 10P, it determines that the volume V of the blood sample aspirated by the needle 20 needs to be deviated from the specified volume Vs (S3). The control unit 40 then sets the volume V to be greater than the specified volume Vs by a predetermined volume Vm (S4-1). The specified volume Vs and the predetermined volume Vm can be set arbitrarily. For example, the specified volume Vs may be set as appropriate as the volume required for blood analysis (e.g., counting red blood cells and white blood cells (5-partition), measuring CRP levels, etc.). The specified volume Vm may also be set as appropriate based on the operator's (e.g., medical professional's) experience using the blood analyzer 1 or based on predictions based on that experience.

[0056] On the other hand, if the control unit 40 recognizes from the container information that the specimen container 10 is an open-type specimen container 10Q, it determines that there is no need to deviate the amount V of blood specimen aspirated by the needle 20 from the specified amount Vs (S3).Then, the control unit 40 sets the amount V of aspirated blood specimen to the same amount as the specified amount Vs (S4-2).

[0057] Next, the control unit 40 drives the metering syringe 22 (see FIG. 2) to cause the needle 20 to aspirate the blood sample from the sample container 10 by the aspirate volume V set in S4-1 or S4-2 (S5-1, S5-2; aspirating process).

[0058] That is, if the specimen container 10 is a closed type, the needle 20 is caused to aspirate the blood specimen from the specimen container 10P by the aspiration volume V = Vs + Vm set in S4-1 (S5-1). On the other hand, if the specimen container 10 is an open type, the needle 20 is caused to aspirate the blood specimen from the specimen container 10Q by the aspiration volume V = Vs set in S4-2 (S5-2). The aspiration volume V can be easily controlled, for example, by the control unit 40 controlling the time for which the metering syringe 22 is driven. When the aspiration of the blood specimen is completed in S5-1 and S5-2, the control unit 40 drives the probe unit 23 (see FIG. 2) to withdraw the needle 20 from the specimen container 10.

[0059] Next, the control unit 40 drives the metering syringe 22 to eject at least a portion of the aspirated blood sample from the needle 20 into a predetermined chamber 31 of the blood analysis unit 30 (S6, S7; ejection step).

[0060] For example, if the specimen container 10 is a closed type, the control unit 40 drives the metering syringe 22 to push out the blood specimen from the needle 20 into the cleaning container 32 (see FIG. 2) in an amount equal to or less than the predetermined amount Vm (S6). In other words, a portion of the blood specimen is discharged. The control unit 40 then causes the needle 20 to eject the blood specimen in a specified amount Vs into the chamber 31 (S7). On the other hand, if the specimen container 10 is an open type, the control unit 40 drives the metering syringe 22 to eject the blood specimen from the needle 20 in a specified amount Vs (= suction amount V) into the chamber 31 (S7). The amount of blood specimen ejected from the needle 20 can be easily controlled by controlling the time the control unit 40 drives the metering syringe 22.

[0061] Finally, the blood analysis unit 30 analyzes the blood sample discharged into the chamber 31 (S8; analysis step).

[0062] As described above, the control unit 40 determines, based on the container information, whether or not the volume V of blood sample aspirated by the needle 20 needs to be deviated from the preset volume Vs, and sets the volume of aspirated blood sample based on the result of that determination (S2, S3, S4-1, S4-2). This allows the specified volume Vs of blood sample to be discharged from the needle 20 into the chamber 31 of the blood analysis unit 30, regardless of the type of sample container 10 (closed type, open type), thereby enabling accurate analysis of the blood sample. The effect of this will be described in more detail below.

[0063] Figure 12 schematically shows the movement of a blood sample SA collected from a closed-type sample container 10P within the needle 20. Figure 13 also schematically shows the movement of a blood sample SA collected from an open-type sample container 10Q within the needle 20. In Figures 12 and 13, the upper side is the rear end of the needle and the lower side is the front end of the needle.

[0064] As shown in FIG. 12, after the needle 20 is removed from the sample container 10P, the blood sample SA is aspirated into the needle 20 by an aspirated volume V (= Vs + Vm). This volume is then pushed toward the rear end of the needle by pressure fluctuations inside and outside the sample container 10P. This causes air to enter the tip of the needle (the amount of air contained at this time is referred to as Vair). In this state, if the metered syringe 22 is driven for a time period corresponding to the discharge of the specified volume Vs to discharge the blood sample SA from the needle 20 into the chamber 31, the volume of blood sample SA discharged from the needle 20 will be reduced by the amount of air that entered the tip of the needle, Vair, resulting in an amount Vs' that is less than the specified volume Vs (Vs = Vs' + Vair). Therefore, the blood analysis unit 30 is unable to supply the amount of blood sample SA required for blood analysis, making it difficult to perform accurate blood analysis.

[0065] However, in this embodiment, in S6, the blood sample SA is pushed out and discarded from the needle 20 by an amount equal to or less than the predetermined amount Vm, thereby pushing out any air that has entered the tip of the needle and positioning the blood sample SA at the tip of the needle. Therefore, by driving the metering syringe 22 in this state for a time equivalent to the discharge of the predetermined amount Vs, the blood sample SA of the predetermined amount Vs can be discharged from the needle 20 into the chamber 31. As a result, the blood analysis unit 30 can accurately analyze the blood using the blood sample SA of the predetermined amount Vs. Note that any blood sample SA remaining in the needle 20 after the discharge of the predetermined amount Vs of blood sample SA is then discarded in the waste liquid container 50 (see FIG. 2) by washing the inside of the needle 20.

[0066] 13, when the blood sample SA is aspirated into the needle 20 from the open-type sample container 10Q by an aspirated volume V (=Vs), no pressure fluctuation occurs as in the closed-type sample container, and the blood sample SA contained in the needle 20 does not displace even when the needle 20 is removed from the sample container 10Q. Therefore, by driving the metering syringe 22 in this state for a time equivalent to the discharge of the specified volume Vs, the specified volume Vs of the blood sample SA can be discharged from the needle 20 into the chamber 31. As a result, the blood analysis unit 30 can accurately analyze the blood using the specified volume Vs of the blood sample SA.

[0067] If the specimen container 10 is of the closed type (first type), the control unit 40 determines that the aspiration volume V needs to be deviated from the specified volume Vs, and sets the aspiration volume V to an amount that is a predetermined volume Vm greater than the specified volume Vs (S3, S4-1). If the specimen container 10 is of the closed type, as described above, a situation may occur in which the specified volume of blood specimen is not dispensed into the chamber 31 of the blood analysis unit 30 due to the pressure difference that occurs after the needle 20 is removed from the specimen container 10P after the blood specimen has been aspirationed. Therefore, the control by the control unit 40 described above is particularly effective when a closed type specimen container 10P is used.

[0068] The control unit 40 removes the needle 20 from the sample container 10, pushes out the blood sample inside the needle 20 from the tip of the needle by an amount equal to or less than a predetermined amount Vm, and then discharges the blood sample from the needle 20 by a specified amount Vs into the chamber 31 (S5-1, S6). In this case, with the blood sample positioned at the tip of the needle, the blood sample can be discharged from the needle 20 by the specified amount Vs into the chamber 31.

[0069] If the specimen container 10 is an open type (second type), the control unit 40 determines that there is no need to deviate the aspiration volume V from the specified volume Vs, and sets the aspiration volume V to the same volume as the specified volume Vs (S3, S4-2). When the specimen container 10 is an open type, the problems described above associated with the use of a closed-type specimen container 10P do not occur. Therefore, when an open-type specimen container 10Q is used, the aspiration volume V is set to the specified volume Vs, and the aspirated blood specimen of the specified volume Vs is discharged from the needle 20 into the chamber 31 of the blood analysis unit 30, enabling accurate analysis of the blood specimen in the blood analysis unit 30.

[0070] In the above, the control unit 40 determines whether or not the amount of blood sample aspirated by the needle 20 needs to be deviated from a specified amount based on the container information acquired in S2 (S3), and sets the aspirate amount based on the result of that determination (S4-1, S4-2), but this control is not limited to this. For example, a table that presets the relationship between the type of sample container 10 (open type, closed type) and the aspirate amount may be stored in the memory unit 43 (see FIG. 15), and the control unit 40 may read out from the memory unit 43 and set the aspirate amount corresponding to the type of sample container 10 based on the container information acquired in S2 (S4-1, S4-2).

[0071] 6. Other Configurations of the Blood Analyzer FIG. 14 is a perspective view showing another configuration of the blood analyzer 1 of this embodiment. An information reading unit 80 may be provided on the front of the device main body 2, between the display unit 3 and the sample container loading unit 4. The information reading unit 80 is configured, for example, as a barcode reader, and optically reads identification information printed on a label L (see FIGS. 3 and 4) attached to the side of the sample container 10. As mentioned above, the identification information includes information regarding the type of sample container 10 (closed type, open type). The information reading unit 80 may also be configured to read two-dimensional codes.

[0072] In the information acquisition step S2 described above, the information reading unit 80 may acquire container information regarding the type of specimen container 10 by reading identification information unique to the specimen container 10. Reading the identification information by the information reading unit 80 also ensures that the container information can be acquired. Therefore, in this case, it can be said that the information reading unit 80 functions as the container information acquisition unit 100.

[0073] Furthermore, because the blood analysis device 1 has a built-in information reading unit 80, unlike when an external barcode reader is used, it is possible to have the information reading unit 80 read information even in a small space, or to hold the sample container 10 in one hand and read information.

[0074] [7. Blood Analysis System] 15 is a block diagram showing the schematic configuration of blood analysis system 300 of this embodiment. Blood analysis system 300 is configured by connecting terminal device 200 and the above-mentioned blood analysis device 1 so that they can communicate with each other via a communication line. The communication line may be wired or wireless.

[0075] In addition to the configuration of the present embodiment described above, blood analyzer 1 is configured to include a storage unit 43 and a communication unit 44. Storage unit 43 is a memory that stores the operating program of control unit 40 and various types of information, and is configured to include a ROM (Read Only Memory), a RAM (Random Access Memory), a non-volatile memory, etc. Communication unit 44 is an interface for communicating with the outside (e.g., terminal device 200), and is configured to include an antenna, a transmission / reception circuit, a modulation circuit, a demodulation circuit, etc.

[0076] The terminal device 200 is a type of computer such as a smartphone, tablet, etc. The terminal device 200 is configured to include an imaging unit 201, an input unit 202, a terminal display unit 203, a terminal storage unit 204, a terminal communication unit 205, an image recognition unit 206, and a terminal control unit 207.

[0077] The imaging unit 201 is, for example, a camera, and acquires an image by capturing an image. The imaging unit 201 can also read identification information, such as a barcode, by capturing an image of the identification information. In this case, the imaging unit 201 functions as a terminal-side reader that reads the identification information. The input unit 202 is, for example, composed of switches, buttons, etc., and accepts various information input by the owner of the terminal device 200. The terminal display unit 203 is, for example, composed of a liquid crystal display device, and displays various information. The terminal display unit 203 may also be composed of a display device with a touch panel. In this case, the terminal display unit 203 can also serve as the input unit 202. The terminal storage unit 204 is a memory that stores the operating program of the terminal control unit 207 and various information, and is composed of a ROM, a RAM, a non-volatile memory, etc. The terminal communication unit 205 is an interface for communicating with an external device (e.g., the blood analyzer 1) and is composed of an antenna, a transmission / reception circuit, a modulation circuit, a demodulation circuit, etc.

[0078] The image recognition unit 206 recognizes the shape of the object (e.g., adapters 61, 62) that is the subject of the image captured by the imaging unit 201. The shape recognition can be performed by, for example, pattern matching. The terminal control unit 207 is a CPU that controls the operation of each unit of the terminal device 200 in accordance with the operating program stored in the terminal storage unit 204.

[0079] Next, the processing in the blood analysis system 300 will be described. First, a predetermined program (application software) is downloaded to the terminal device 200 and stored in the terminal storage unit 204. Next, the terminal control unit 207 sets the amount of blood sample to be aspirated by the needle 20 based on container information related to the type of specimen container 10 to be used (aspirate amount setting step). At this time, the container information may be acquired by the image recognition unit 206 recognizing the shape of at least one adapter (e.g., adapter 61 or 62) determined according to the type of specimen container 10 from an image acquired by the imaging unit 201. Alternatively, the container information may be acquired by the imaging unit 201, serving as a terminal-side reader, capturing and reading identification information (e.g., a barcode) attached to the specimen container 10.

[0080] For example, when the image recognition unit 206 recognizes the shape of the adapter 61, the terminal control unit 207 determines that the specimen container 10 to be used is a closed-type specimen container 10P. The terminal control unit 207 then sets the amount V of the blood specimen to be aspirated by the needle 20 to a predetermined amount Vm greater than the specified amount Vs. Furthermore, when the image recognition unit 206 recognizes the shape of the adapter 62, the terminal control unit 207 determines that the specimen container 10 to be used is an open-type specimen container 10Q. The terminal control unit 207 then sets the amount V of the blood specimen to be aspirated by the needle 20 to the same amount as the specified amount Vs.

[0081] Next, terminal device 200 outputs information about suction volume V set by terminal control unit 207 to the blood analyzer via terminal communication unit 205 (output step). This allows blood analyzer 1 to aspirate the blood sample from needle 20 by the set suction volume V, and discharge at least a portion of the aspirated blood sample into a predetermined chamber 31 of blood analysis unit 30, thereby performing blood analysis.

[0082] In this way, even if the suction volume V by the needle 20 is set on the terminal device 200 side and information on the set suction volume V is output from the terminal device 200 to the blood analysis device 1, the blood analysis device 1 can aspirate the blood sample by the set suction volume V depending on the type of sample container 10 used, so as in this embodiment, blood samples can be analyzed accurately regardless of the type of sample container 10 used.

[0083] [8. Program] The control unit 40 of the blood analyzer 1 can be configured as a computer on which an operating program is installed. By having the computer read and execute the program, each unit of the blood analyzer 1 can be operated to execute each of the processes (steps) described above. Such a program is acquired, for example, by downloading it from an external source via a network and stored in the storage unit 43. Note that the program may also be read by a reading unit (not shown) from a computer-readable recording medium such as a CD-ROM (Compact Disk-Read Only Memory), and the read program may be stored in the storage unit 43. In other words, the program of this embodiment is a program for causing a computer to execute the blood analysis method described above.

[0084] Similarly, the terminal control unit 207 of the terminal device 200 can also be configured by a computer on which an operating program is installed. The computer reads and executes the program, thereby operating each unit of the terminal device 200 to execute each of the processes (steps) described above. Such a program is obtained by downloading it from an external source via a network, for example, and stored in the terminal storage unit 204.

[0085] Although the embodiments of the present invention have been described above, the scope of the present invention is not limited to these, and the invention can be expanded or modified without departing from the spirit of the invention. [Industrial Applicability]

[0086] The present invention can be used, for example, in an apparatus for performing blood analysis using closed-type and open-type sample containers. [Explanation of symbols]

[0087] 1 Blood analyzer 10, 10P, 10Q specimen containers 10b Lid 20 needles 30 Blood Analysis Department 31 Chamber 40 Control Unit 61 Adapter 62 Adapter 70 Adapter detector 80 Information reading unit 100 Information acquisition department 201 Imaging unit (terminal side reading unit)

Claims

1. a container information acquisition unit that acquires container information relating to the type of specimen container used; a needle for aspirating and discharging the blood sample contained in the sample container; a blood analysis unit having a chamber for receiving the blood sample aspirated from the sample container by the needle and discharged; a control unit that controls the suction and discharge of the blood sample by the needle based on the container information, the control unit sets the amount of the blood sample to be aspirated by the needle based on the container information; the control unit determines whether the suction amount needs to be deviated from a predetermined specified amount based on the container information, and sets the suction amount based on the determination result; the control unit determines that the aspirated amount needs to be deviated from the specified amount when the specimen container is of a first type, and sets the aspirated amount to an amount that is larger than the specified amount by a predetermined amount; The first type is a closed type blood analyzer in which the needle penetrates a lid of the sample container to aspirate the blood sample contained in the sample container.

2. The blood analysis apparatus of claim 1, wherein the control unit removes the needle from the sample container, pushes out the blood sample inside the needle from the tip of the needle in an amount equal to or less than the predetermined amount, and then ejects the blood sample from the needle into the chamber in the specified amount.

3. When the specimen container is of a second type, the control unit determines that there is no need to deviate the suction amount from the specified amount, and sets the suction amount to the same amount as the specified amount; 3. The blood analyzer according to claim 1, wherein the second type is an open type in which the needle is inserted into the sample container with the lid of the sample container removed to directly aspirate the blood sample.

4. A blood analysis device as described in any of claims 1 to 3, wherein the container information acquisition unit includes an adapter detection unit that acquires the container information by detecting at least one adapter determined depending on the type of the sample container when the sample container is attached to the adapter and loaded into the device main body.

5. A blood analysis apparatus described in any one of claims 1 to 4, wherein the container information acquisition unit includes an information reading unit that acquires the container information by reading identification information unique to the specimen container attached to the specimen container.

6. A container information acquisition unit that acquires container information regarding the type of specimen container used; a needle for aspirating and discharging the blood sample contained in the sample container; a blood analysis unit having a chamber for receiving the blood sample aspirated from the sample container by the needle and discharged; a control unit that controls the suction and discharge of the blood sample by the needle based on the container information, the control unit sets the amount of the blood sample to be aspirated by the needle based on the container information; The blood analysis device includes an adapter detection unit, wherein the container information acquisition unit acquires the container information by detecting at least one adapter determined according to the type of the sample container when the sample container is attached to the adapter and loaded into the device main body.

7. The adapter an adapter corresponding to the first type that is attached to the sample container when the sample container is of the first type; an adapter corresponding to the second type that is attached to the sample container when the sample container is of the second type; The adapter detection unit detecting an adapter corresponding to the first type, thereby detecting that the sample container of the first type is loaded in the device body; The blood analyzer according to claim 6, wherein the blood analyzer detects that the sample container of the second type is loaded in the device body by detecting an adapter corresponding to the second type.

8. The adapter detection unit has a first switch and a second switch, detecting that the specimen container of the first type is loaded in the device body by the adapter corresponding to the first type pressing the first switch; The blood analyzer of claim 7, wherein an adapter corresponding to the second type presses the first switch and the second switch to detect that the sample container of the second type is loaded in the device body.

9. A blood analysis device described in any of claims 6 to 8, wherein the control unit determines whether or not the suction volume needs to be deviated from a predetermined specified volume based on the container information, and sets the suction volume based on the determination result.

10. A suction volume setting step of setting the volume of blood sample to be suctioned by the needle based on container information relating to the type of sample container to be used; a suction step of aspirating the blood sample from the sample container by the needle by the set suction amount; a discharging step of discharging at least a portion of the aspirated blood sample from the needle into a chamber of a blood analysis unit; an analyzing step of analyzing the blood sample discharged into the chamber, In the suction volume setting step, it is determined whether or not it is necessary to deviate the suction volume from a predetermined specified volume based on the container information, and the suction volume is set based on the determination result. In the aspiration volume setting step, if the specimen container is of a first type, it is determined that the aspiration volume needs to be deviated from the specified volume, and the aspiration volume is set to an amount that is larger than the specified volume by a predetermined amount; The first type is a closed type in which the needle penetrates the lid of the sample container and aspirates the blood sample contained in the sample container.

11. In the aspirating step, after aspirating the blood sample, the needle is removed from the sample container; The blood analysis method according to claim 10 , wherein the ejection step includes pushing out the blood sample from the needle by an amount equal to or less than the predetermined amount, and then ejecting the blood sample from the needle into the chamber by the specified amount.

12. In the aspiration volume setting step, if the specimen container is of a second type, it is determined that there is no need to deviate the aspiration volume from the specified volume, and the aspiration volume is set to the same volume as the specified volume; 12. The blood analysis method according to claim 10, wherein the second type is an open type in which the needle is inserted into the sample container with the lid of the sample container removed to directly aspirate the blood sample.

13. 13. The blood analysis method according to claim 10, wherein the container information is acquired by a detection unit detecting at least one adapter determined according to the type of the sample container when the sample container is attached to the adapter and loaded into the device body.

14. A suction volume setting step of setting the volume of blood sample to be suctioned by the needle based on container information relating to the type of sample container to be used; a suction step of aspirating the blood sample from the sample container by the needle by the set suction amount; a discharging step of discharging at least a portion of the aspirated blood sample from the needle into a chamber of a blood analysis unit; an analyzing step of analyzing the blood sample discharged into the chamber; an information acquisition step of acquiring the container information, A blood analysis method in which the container information is obtained by an adapter detection unit detecting the adapter when the sample container is attached to at least one adapter determined according to the type of the sample container and loaded into the device main body.

15. The adapter an adapter corresponding to the first type that is attached to the sample container when the sample container is of the first type; an adapter corresponding to the second type that is attached to the sample container when the sample container is of the second type; In the information acquisition step, the adapter detection unit detects the adapter corresponding to the first type, thereby detecting that the sample container of the first type is loaded in the device body; The blood analysis method according to claim 14, wherein the adapter detection unit detects an adapter corresponding to the second type, thereby detecting that the sample container of the second type is loaded in the device body.

16. The adapter detection unit has a first switch and a second switch, In the information acquisition step, detecting that the specimen container of the first type is loaded in the device body by the adapter corresponding to the first type pressing the first switch; The blood analysis method of claim 15, wherein an adapter corresponding to the second type presses the first switch and the second switch to detect that the sample container of the second type is loaded into the device body.

17. A blood analysis method described in any of claims 14 to 16, wherein in the suction volume setting process, it is determined based on the container information whether or not it is necessary to deviate the suction volume from a predetermined specified volume, and the suction volume is set based on the determination result.

18. A program for causing a computer to execute the blood analysis method described in any one of claims 10 to 17.

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