Reagent containers, reagent container kits, method for installing reagent containers, reagent container frames, and analytical instruments.
Patent Information
- Application Number
- JP2022042985
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2022-03-17
- Publication Date
- 2026-10-16
- Estimated Expiration
- 2042-03-17
AI Technical Summary
【0025】 本発明によれば、試薬容器を分析装置へ容易に設置できる。
Smart Images

Figure 0007936672000001 
Figure 0007936672000002 
Figure 0007936672000003
Abstract
Description
TECHNICAL FIELD
[0001] The present invention relates to a reagent container for storing a reagent used in an analyzer, a reagent container kit, a method for installing a reagent container, a frame for a reagent container, a method for assembling a reagent container, and an analyzer for analyzing a specimen using the reagent container.
BACKGROUND ART
[0002] Patent Document 1 discloses a reagent container including a flexible soft bag having a cylindrical lid mounting portion provided at an upper end portion, and a lid member for closing an opening of the lid mounting portion. A flange portion is provided on the lid mounting portion of the reagent container, and the reagent container is suspended from a bracket by engaging the flange portion with a notch portion formed in the bracket of the analyzer. A communication hole is formed in the lid member, and by screwing a connection member connected to the analyzer into the communication hole, inflow of air into the soft bag is suppressed, and the liquid inside the reagent container can be supplied to the analyzer via the connection member.
PRIOR ART DOCUMENTS
PATENT DOCUMENTS
[0003]
PATENT DOCUMENT 1
SUMMARY OF THE INVENTION
PROBLEMS TO BE SOLVED BY THE INVENTION
[0004] The method for installing the reagent container of Patent Document 1 is complicated because an operator is required to perform an operation of inserting the connection member into the communication hole of the lid member when attaching the reagent container to the analyzer.
[0005] Accordingly, it is desired that the reagent container can be easily installed in the analyzer.
[0006] The present invention is directed to enabling a reagent container to be easily installed in an analyzer.
MEANS FOR SOLVING THE PROBLEMS
[0007] To achieve the above objective, the reagent container (100) of the present invention, as shown in Figures 1 and 2, is a reagent container (100) for containing reagents drawn in by a suction tube (252) provided on an analyzer (300), comprising a bag-shaped reagent storage section (10) for containing reagents, and an opening (21a) attached to the reagent storage section (10) that is configured such that the inside of the reagent storage section (10) is sealed when the suction tube (252) is inserted from above in conjunction with a predetermined operation on the analyzer (300). Opening (21) A frame (20) containing and also containing. The opening (21) has a sealing surface (21b) that contacts a sealing body (252a) provided on the suction tube (252) to seal the opening (21a).
[0008] As shown in Figures 1 and 2, the reagent container (100) of the present invention is configured such that the inside of the reagent storage section (10) is sealed when a suction tube (252) is inserted from above in conjunction with a predetermined operation on the analyzer (300), and includes a frame (20) with an opening (21a) attached to the reagent storage section (10). This eliminates the need for the user to insert the suction tube (252) into the opening (21a) of the reagent container (100) before installation, allowing the reagent container (100) to be easily installed on the analyzer (300). Furthermore, since the inside of the reagent storage section (10) is sealed when the suction tube (252) is inserted, contact between the reagent inside the reagent storage section (10) and the outside air can be suppressed. Therefore, deterioration of the reagent after installation on the analyzer (300) can be suppressed.
[0009] The reagent container kit (450) of the present invention, as shown in Figure 27, is a reagent container kit (450) for assembling a reagent container (100) that contains a reagent to be aspirated by a suction tube (252) provided on an analyzer (300), and comprises a bag-shaped reagent storage section (10) for containing the reagent, and a frame (20) that includes an opening (21a) and can be attached to the reagent storage section (10), wherein the frame (20) is attached to the reagent storage section (10) and when the suction tube (252) is inserted from above in conjunction with a predetermined operation on the analyzer (300) The suction tube (252) has a sealing surface (21b) that contacts the sealing body (252a) and seals the opening (21a), and the contact between the sealing body (252a) and the sealing surface (21b) The reagent storage section (10) is configured to be airtight inside.
[0010] As shown in Figure 27, the reagent container kit (450) of the present invention is configured such that when the frame (20) is attached to the reagent container (10) and a suction tube (252) is inserted from above in conjunction with a predetermined operation on the analyzer (300), the inside of the reagent container (10) is sealed. This eliminates the need for the user to insert the suction tube (252) into the opening (21a) of the reagent container (100) before installation, allowing the reagent container (100) to be easily installed on the analyzer (300). Furthermore, since the inside of the reagent container (10) is sealed when the suction tube (252) is inserted, contact between the reagent inside the reagent container (10) and the outside air can be suppressed. Therefore, deterioration of the reagent after installation on the analyzer (300) can be suppressed.
[0011] The method for installing a reagent container of the present invention, as shown in Figure 1, is a method for installing a reagent container (100) into an analyzer (300) having a suction tube (252), wherein the reagent container (100), which includes a bag-shaped reagent storage section (10) for containing reagents to be aspirated by the suction tube (252) and a frame (20) having an opening (21a), is moved into the analyzer (300), and the frame (20) is brought into contact with a part of the analyzer (300) so that the opening (21a) is positioned below the suction tube (252) (see Figure 1(B)), and the suction tube (252) is moved downward while the frame (20) is in contact with a part of the analyzer (300) so that the suction tube (252) is inserted into the opening (21a) from above the reagent container (100), and when the suction tube (252) is inserted into the opening (21a) By contact between the sealing body (252a) provided on the suction tube (252) and the sealing surface (21b) placed on the frame (20), The inside of the reagent container (10) is sealed (see Figure 1(C)).
[0012] As shown in Figure 1, the method for installing the reagent container of the present invention involves moving the reagent container (100) into the analyzer (300) until it contacts the frame (20), and then moving the suction tube (252) downwards, thereby allowing the suction tube (252) to be inserted into the opening (21a). Therefore, the user does not need to insert the suction tube (252) into the opening (21a) of the reagent container (100) before installation, making it easy to install the reagent container (100) into the analyzer (300). Furthermore, since the inside of the reagent storage section (10) is sealed when the suction tube (252) is inserted, contact between the reagent inside the reagent storage section (10) and the outside air can be suppressed. Therefore, deterioration of the reagent after installation in the analyzer (300) can be suppressed.
[0017] The reagent container frame (20) of the present invention, as shown in Figures 1 and 2, is a frame (20) attached to a bag-shaped reagent container (100) that contains reagents aspirated by a suction tube (252) provided on an analyzer (300), and has a movement restricting portion (23) having connecting portions (26, 27) that connect to the reagent container (100) which is provided with an opening (21a). And a sealing surface (21b) for sealing the opening (21a), The movement restricting unit (23) comes into contact with a part of the analyzer (300), so that when a predetermined operation on the analyzer (300) is performed, the suction tube (252) is inserted into the reagent container (100) from above. By contact between the sealing body (252a) and the sealing surface (21b) provided on the suction tube (252), The movement of the opening (21a) is restricted so that the inside of the reagent container (100) is sealed.
[0018] As shown in Figures 1 and 2, the frame (20) of the reagent container of the present invention has a movement restricting section (23) that contacts a part of the analyzer (300), thereby restricting the movement of the opening (21a) so that the inside of the reagent container (100) is sealed when a suction tube (252) is inserted into the reagent container (100) from above in conjunction with a predetermined operation on the analyzer (300). This eliminates the need for the user to insert the suction tube (252) into the opening (21a) of the reagent container (100) before installation, allowing the reagent container (100) to be easily installed in the analyzer (300). Furthermore, since the inside of the reagent storage section (10) is sealed when the suction tube (252) is inserted, contact between the reagent inside the reagent storage section (10) and the outside air can be suppressed. Therefore, deterioration of the reagent after installation in the analyzer (300) can be suppressed.
[0023] As shown in Figure 14, the analytical apparatus (300) of the present invention comprises a sample aspiration unit (220) for aspirating a sample, a reagent aspiration unit (250) for aspirating a reagent from a reagent container (100), a sample preparation unit (230) for mixing the sample and reagent to prepare a measurement sample, a detection unit (240) for detecting components in the measurement sample, and an analysis unit (203) for analyzing the detection signal from the detection unit (240). The reagent aspiration unit (250) includes a container holding unit (251) for holding a reagent container (100) which includes a reagent holding unit (10) for containing the reagent and a frame (20) which includes an opening (21a), and is inserted into the opening (21a) from above the reagent container (100) held by the container holding unit (251), and when inserted into the opening (21a) By contacting the opening (21a), the opening (21a) is sealed. The inside of the reagent container (10) is sealed. Having a sealing body (252a) The device comprises a suction tube (252), an operating unit (253) that accepts a predetermined operation for moving the suction tube (252), and a moving mechanism (254) that, in conjunction with the predetermined operation, moves the reagent container (100) and the suction tube (252) relative to each other, thereby allowing the suction tube (252) to enter the reagent container (100) held by the container holding unit (251) and retracting the suction tube (252) outside the reagent container (100).
[0024] In the analyzer (300) of the present invention, as shown in FIG. 14, since a user does not need to perform the operation of inserting the suction tube (252) into the opening (21a) of the reagent container (100) before installing the reagent container (100), the reagent container (100) can be easily installed in the analyzer (300). Furthermore, since the interior of the reagent storage section (10) is hermetically sealed when the suction tube (252) is inserted into the opening (21a), the hermetic sealing can prevent the reagent in the reagent container (100) from coming into contact with the outside air. Accordingly, deterioration of the reagent after installation in the analyzer (300) can be suppressed. Effects of the Invention
[0025] According to the present invention, the reagent container can be easily installed in the analyzer. Brief Description of the Drawings
[0026] [Figure 1] They are a schematic view (A) showing the configuration of the reagent container, a schematic view (B) before insertion of the suction tube into the reagent container installed in the analyzer, and a schematic view (C) after insertion of the suction tube. [Figure 2] It is a perspective view for explaining an example of the reagent container. [Figure 3] It is an exploded perspective view of the reagent container of FIG. 2. [Figure 4] It is a perspective view of the mounting member viewed from the lower surface side. [Figure 5] It is a schematic cross-sectional view of the reagent container. [Figure 6] It is a top view of the reagent container. [Figure 7] It is a view of the movement restricting portion viewed from one end side along the first direction. [Figure 8] It is an enlarged perspective view of the reagent container for explaining the fixing portion and the supporting portion. [Figure 9] It is a perspective view showing an example of a small-capacity reagent container. [Figure 10] It is a view of the large-capacity reagent container (A) and the small-capacity reagent container (B) viewed along the first direction. [Figure 11] It is a view of the large-capacity reagent container (A) and the small-capacity reagent container (B) viewed along the second direction. [Figure 12] This is a perspective view showing an example of an analytical instrument. [Figure 13] Figure 12 is a schematic plan view illustrating the configuration of the analytical apparatus. [Figure 14] This is a schematic diagram illustrating the sample aspiration unit, reagent preparation unit, and detection unit. [Figure 15] This is a perspective view showing an example of a reagent aspiration section. [Figure 16] This is a schematic perspective view illustrating the structure of the containment area. [Figure 17] This diagram shows the reagent containers placed inside the storage compartment. [Figure 18] This is a diagram showing the second insertion section. [Figure 19] This diagram shows the state in which the movement restricting part has been inserted into the second insertion part. [Figure 20] This is a schematic cross-sectional view from above showing the state in which the movement restricting part is inserted into the second insertion part. [Figure 21] This figure shows the state before (A) the protruding member engages with the notch in the movement restricting section, and the state after (B) the member engages with it. [Figure 22] This is a schematic longitudinal cross-sectional view of the reagent container holder when the suction tube is in the raised position. [Figure 23] This figure shows the reagent containers placed in the reagent container holder shown in Figure 22. [Figure 24] Figure 23 shows the suction tube in the lowered position. [Figure 25] This is a schematic cross-sectional view of a reagent container with a suction tube inserted, seen from above. [Figure 26] This is an enlarged cross-sectional view of the opening, showing the state before (A) the opening is sealed and the sealed state (B). [Figure 27] This is a perspective view showing an example of a reagent container kit. [Figure 28] This is a perspective view showing modified versions (A) to (D) of the reagent container. [Figure 29] This is a schematic diagram showing other variations of the reagent container. [Figure 30] This figure shows modified versions of a reagent container, with the reagent storage section and the movement-restricting section separated (A) and the reagent storage section housed within the movement-restricting section (B). [Figure 31] This is a schematic diagram showing a first modified example of a suction tube seal. [Figure 32] This is a schematic diagram showing a second modified example of the suction tube seal. [Figure 33] This is a schematic diagram (A) and a perspective view (B) of the seal, showing an example of a reagent container with an opening that is sealed. [Figure 34] This diagram shows a modified example of the contact area. [Figure 35] Figure 34 shows the reagent containers in their set positions. [Figure 36] This diagram shows the state in which the engagement pin of the switching mechanism is in the second part of the guide groove (A) and the state in which it is in the first part (B). [Figure 37] This diagram illustrates the state before the suction tube is inserted into the opening (A), the state when the sealing switching mechanism seals the opening (B), and the state when the sealing switching mechanism releases the seal (C). [Figure 38] This figure shows a modified version of the analytical apparatus with a mounting member, illustrating the state before the suction tube is inserted into the opening (A) and the state after the suction tube has been inserted into the opening (B). [Figure 39] This figure shows a modified version of the analytical apparatus in which a drive unit for the suction tube is provided, and illustrates the state before the suction tube is inserted into the opening (A) and the state after the suction tube has been inserted into the opening (B). [Modes for carrying out the invention]
[0027] The following explanation is based on the drawings. [Reagent container] First, with reference to Figure 1, an overview of a reagent container 100 according to one embodiment will be described.
[0028] The reagent container 100 is a container that houses reagents 12 used for analyzing samples by the analyzer 300. As shown in Figure 1(A), the reagent container 100 comprises a reagent storage section 10 and a frame 20.
[0029] The reagent container 10 is a container capable of holding liquids, and the reagent 12 is contained within it. In the example shown in Figure 1, the reagent container 10 is a bag-shaped member. The reagent container 10 is flexible and deformable. The reagent container 10 may also be a rigid container that does not deform.
[0030] The frame 20 is a component attached to the reagent storage section 10. The frame 20 includes an opening 21a that connects the inside of the reagent storage section 10 to the outside of the reagent storage section 10.
[0031] In the example shown in Figure 1, the frame 20 includes an opening 21 attached to the top of the reagent storage section 10 and a movement restricting section 23 fixed to the opening 21. The opening 21a is a through hole formed in the opening 21. The opening 21a has a circular shape. The opening 21a is provided at the top of the reagent storage section 10. The opening 21a is located on one end of the reagent storage section 10 in the longitudinal direction in the horizontal direction. The movement restricting section 23 has a rectangular flat plate shape. The movement restricting section 23 is attached to the opening 21 by a fixing section 26. The fixing section 26 is a through hole corresponding to the outer shape of the opening 21. The fixing section 26 is located in the center of the movement restricting section 23 and penetrates through the movement restricting section 23 in the thickness direction. The movement restricting section 23 is fixed to the opening 21 by inserting the opening 21 into the fixing section 26. Note that Figure 1(A) shows the movement restricting section 23 separated from the opening 21. The frame 20 is made of a harder material than the reagent container 10. The opening 21 and movement restricting portion 23 that make up the frame 20 have the rigidity necessary to maintain their shape under normal use conditions of the reagent container 100.
[0032] The reagent container 100 is installed in the analyzer 300 as shown in Figure 1(B). The reagent container 100 is installed by the user inside the analyzer 300 in a predetermined orientation and is held in place by the analyzer 300. The reagent container 100 is inserted horizontally into the analyzer 300 with one end in the longitudinal direction, where the opening 21a is located, leading. The reagent container 100 is positioned at set position Ps with the opening 21a facing upwards, such that the central axis of the opening 21a of the frame 20 coincides with the central axis of the suction tube 252.
[0033] The analyzer 300 includes a container holder 251 for holding the reagent container 100, and a suction tube 252 for aspirating the reagent from the reagent container 100 held in the container holder 251. The suction tube 252 is positioned directly above the container holder 251 and is movable in the vertical direction. The reagent container 100 is held in the set position Ps in the container holder 251. The container holder 251 is a space that accommodates the reagent container 100.
[0034] The movement restricting section 23 is configured to restrict the movement of the opening 21a by contacting a part of the analyzer 300 when the reagent container 100 is inserted into the container holding section 251. That is, the analyzer 300 includes a contact section 270 that contacts the movement restricting section 23 to restrict the movement of the opening 21a. The contact section 270 includes the inner surface of the container holding section 251. When the reagent container 100 is inserted into the container holding section 251, the end face of the movement restricting section 23 located on the leading side in the insertion direction contacts the contact section 270, which is the inner surface of the container holding section 251, thereby determining the position of the opening 21a in the insertion direction to be the set position Ps.
[0035] Furthermore, the contact portions 270 are also provided on both the upper and lower sides of the movement restricting portion 23 at both ends in the width direction of the movement restricting portion 23. When the reagent container 100 is placed in the container holding portion 251, the movement restricting portion 23 is inserted between the contact portions 270 provided on both sides in the width direction, both above and below. As a result, the contact portions 270 abut against the movement restricting portion 23 in the vertical direction, thereby restricting the vertical movement of the opening 21a. By abutting the movement restricting portion 23, the contact portions 270 fix the movement restricting portion 23 so that the opening 21a does not move from the set position Ps.
[0036] The analyzer 300 is equipped with an operating unit 253 that receives a predetermined operation from the user of the analyzer 300 to move the suction tube 252. As shown in Figure 1(C), the suction tube 252 is inserted into the reagent container 100 from above in conjunction with the predetermined operation on the analyzer 300.
[0037] Here, the frame 20 is configured such that the inside of the reagent storage section 10 is sealed when the suction tube 252 is inserted from above in conjunction with a predetermined operation on the analyzer 300. In the example shown in Figure 1(C), the opening 21a of the frame 20 is closed by the sealant 252a provided on the suction tube 252 when the suction tube 252 is inserted into the opening 21a. With the inside of the reagent storage section 10 sealed, the reagent 12 inside the reagent storage section 10 is drawn in by the suction tube 252.
[0038] Thus, the reagent container 100 is a reagent container that holds reagent 12 that is aspirated by a suction tube 252 provided on the analyzer 300. The reagent container 100 holds reagent 12 that is repeatedly aspirated with the suction tube 252 inserted. When the suction tube 252 is inserted into the opening 21a of an unused reagent container 100 and the inside of the reagent storage section 10 is sealed, the suction tube 252 can remain inserted until all of the reagent 12 in the reagent storage section 10 is consumed. During that time, the inside of the reagent storage section 10 remains sealed by the sealant 252a.
[0039] As described above, the reagent container 100 of this embodiment is configured such that the inside of the reagent storage section 10 is sealed when the suction tube 252 is inserted from above in conjunction with a predetermined operation on the analyzer 300, and includes a frame 20 that includes an opening 21a attached to the reagent storage section 10. As a result, the user does not need to insert the suction tube 252 into the opening 21a of the reagent container 100 before installation, so the reagent container 100 can be easily installed on the analyzer 300. In addition, since the inside of the reagent storage section 10 is sealed when the suction tube 252 is inserted, contact between the reagent 12 inside the reagent storage section 10 and the outside air can be suppressed. Therefore, deterioration of the reagent 12 after installation on the analyzer 300 can be suppressed.
[0040] Thus, the reagent container 100 of this embodiment is configured to suppress the deterioration of the quality of the reagent 12 after installation in the analyzer 300, and to allow it to be used for a longer period of time while remaining attached to the analyzer 300. One of the main means of suppressing quality deterioration is to prevent contact between the reagent 12 and air.
[0041] In the case of a rigid reagent container that does not deform, if reagents are aspirated in a sealed state, the internal pressure of the reagent container decreases as the amount of reagent decreases, and it becomes impossible to aspirate the reagent once it reaches equilibrium with the suction pressure. Therefore, the inside of the container must be open to the atmosphere. The reagent inside the reagent container deteriorates due to contact with air. In contrast, in this embodiment, a deformable bag-shaped reagent storage section 10 is provided, so the reagent storage section 10 itself can contract and deform, thereby avoiding a decrease in internal pressure, and as a result, reagents 12 can be aspirated even in a sealed state. Therefore, the reagent container 100 is configured so that the inside of the reagent storage section 10 is sealed by suppressing the inflow of air into the opening 21a. By suppressing the inflow of air into the opening 21a, deterioration of the reagent 12 inside the reagent storage section 10 due to contact with air can be suppressed.
[0042] Since the deterioration of reagent 12 can be suppressed, the reagents in reagent container 100 can be used for a longer period of time while the reagent container 100 is installed in the analyzer 300. Therefore, by increasing the capacity of the reagent storage section 10 and enabling more reagent aspirations from a single reagent container 100, the frequency of replacing reagent container 100 during the operation of the analyzer 300 can be reduced. This is preferable for the user because it reduces the number of times the reagent container 100 needs to be replaced over a certain period of time.
[0043] On the other hand, if a bag-shaped reagent container 10 that is easily deformable is used, the position of the opening 21a when inserting the suction tube 252 into the reagent container 10, and the position of the opening 21a with the suction tube 252 inserted, can easily change due to external forces. In particular, in this embodiment, the suction tube 252 is inserted into the opening 21a by the operation of the analyzer 300 rather than by the user manually inserting it, so positioning the opening 21a and preventing displacement of the opening 21a are important for sealing the reagent container 10.
[0044] Therefore, the reagent container 100 of this embodiment is equipped with a frame structure that ensures the positioning of the opening 21a and prevents misalignment of the opening 21a when it is installed in the analyzer 300. Specifically, the movement restricting portion 23 of the frame 20 comes into contact with a part of the analyzer 300 (a contact portion 270 described later), thereby ensuring that the reagent container 100 is reliably positioned at the set position Ps of the container holding portion 251. As a result, the relative position between the opening 21a and the sealing body 252a is accurately determined, and the opening 21a can be reliably closed.
[0045] Furthermore, at the set position Ps, the movement restricting part 23 contacts a part of the analyzer 300, thereby holding the movement restricting part 23, which is fixed to the opening 21, in place. As a result, the movement of the opening 21a is restricted so that the opening 21a, which is sealed by the sealant 252a, does not shift position. This prevents the sealant 252a from releasing the seal of the reagent storage section 10 due to unintended shifting of the opening 21a while the suction tube 252 is inserted into the reagent storage section 10.
[0046] The frame 20 is configured to maintain a sealed state inside the reagent container 10 while the reagent 12 is repeatedly aspirated by the suction tube 252. This allows the reagent in the reagent container 100 to be used for a longer period of time without the reagent 12 degrading due to contact with air, even while the reagent container 100 is installed in the analyzer 300.
[0047] [How to set up reagent containers] The method for setting up the reagent container in this embodiment will now be described. First, the reagent container 100, which includes a reagent storage section 10 for containing the reagent to be aspirated by the suction tube 252 and a frame 20 having an opening 21a, is moved into the analyzer 300 as shown in Figure 1(B).
[0048] By bringing the frame 20 into contact with a part of the analyzer 300 within the analyzer 300, the opening 21a is positioned directly below the suction tube 252. In other words, when the reagent container 100 is moved to the set position Ps within the analyzer 300, the movement restricting part 23 comes into contact with a part of the analyzer 300, thereby positioning the opening 21a directly below the suction tube 252.
[0049] Then, as shown in Figure 1(C), by moving the suction tube 252 downward while the frame 20 is in contact with a part of the analyzer 300, the suction tube 252 is inserted into the opening 21a from above the reagent container 100, and the inside of the reagent storage section 10 is sealed when the suction tube 252 is inserted into the opening 21a. Specifically, the suction tube 252 moves downward in conjunction with a predetermined operation on the analyzer 300. As a result, the suction tube 252 is inserted into the opening 21a. When the suction tube 252 is inserted into the opening 21a, the opening 21a is closed by the sealant 252a of the suction tube 252, and the inside of the reagent storage section 10 is sealed.
[0050] In this embodiment of the reagent container installation method, the reagent container 100 is moved into the analyzer 300 until it comes into contact with the frame 20, and the suction tube 252 is moved downward, allowing it to be inserted into the opening 21a. Therefore, the user does not need to insert the suction tube 252 into the opening 21a of the reagent container 100 before installation, making it easy to install the reagent container 100 into the analyzer 300. Furthermore, since the inside of the reagent storage section 10 is sealed when the suction tube 252 is inserted, contact between the reagent inside the reagent storage section 10 and the outside air can be suppressed. Therefore, deterioration of the reagent after installation in the analyzer 300 can be suppressed.
[0051] (Detailed configuration of reagent containers) In the following, the configuration of the reagent container 100 in other embodiments will be described in detail with reference to Figures 2 to 12. In the following, as shown in Figure 2, the longitudinal direction of the reagent container 100 will be referred to as the first direction A, and the short direction of the reagent container 100 will be referred to as the second direction B. The vertical direction will be referred to as the Z direction.
[0052] (Reagent storage section) The reagent container 10 contains the reagent 12 (see Figure 5). As shown in Figure 2, the reagent container 10 is a bag-shaped component.
[0053] The reagent storage section 10 is formed in a bag shape from a film-like material. As shown in Figure 3, the reagent storage section 10 is formed in a hollow bag shape by overlapping multiple sheet-like members and joining the outer edges of the overlapping film materials.
[0054] The reagent container 10 is made of a laminated film material 11 having gas barrier properties and light-shielding properties. Gas barrier properties refer to the property of being impermeable to gases. In this specification, gas barrier properties refer to being impermeable to air, especially oxygen. Light-shielding properties refer to the property of being impermeable to light. As a result, it is possible to suppress the deterioration of the reagent 12 contained in the reagent container 100 by external air and the deterioration of the reagent 12 contained in the reagent container 100 by external light such as sunlight. As a result, the deterioration of the reagent can be effectively suppressed over a long period of time.
[0055] The laminated film material 11 may include at least one base layer and at least one gas barrier layer. The laminated film material 11 may further include a protective layer that protects the outer surface of the gas barrier layer. The laminated film material 11 may also have a light-shielding layer made of a light-shielding material. When a material having both gas barrier and light-shielding properties is used for the gas barrier layer, the gas barrier layer and the light-shielding layer may be the same layer. The number of layers in the laminated film material is two or more, but may be 3 to 9 or 10 or more, and is not particularly limited.
[0056] The laminated film material 11 used in the reagent storage section 10 may have the following configuration, for example: (outside of bag) / nylon (15 μm) / aluminum foil (9 μm) / polyethylene (9 μm) / (inside of bag). In this configuration, the reagent storage section 10 has nylon functioning as a protective layer, aluminum foil functioning as a gas barrier layer and light shielding layer, and polyethylene as the base layer. The base layers made of polyethylene in the reagent storage section 10 are joined together by heat welding. The laminated film material 11 with this configuration is a metal foil laminate film with a structure in which a gas barrier layer made of metal foil is laminated on a resin base layer.
[0057] In addition, the laminated film material 11 can be, for example, a resin-based multilayer barrier film, a coated film, a vapor-deposited film, or an organic-inorganic composite film. A resin-based multilayer barrier film is a film with a structure in which gas barrier layers of resin material are laminated. Examples of resin materials with excellent gas barrier properties include PVDC (polyvinylidene chloride), PVA (polyvinyl alcohol), and EVOH (ethylene-vinyl alcohol copolymer). A coated film is a film with a structure in which a gas barrier material is coated (film-formed) onto a substrate layer. Examples of gas barrier materials that are film-formed include PVDC, PVA, and EVOH. A vapor-deposited film is a film with a structure in which a gas barrier material is vapor-deposited onto a substrate layer. Examples of vapor-deposited gas barrier materials include metals such as aluminum and steel, or inorganic oxides such as alumina and silica. Organic-inorganic composite films include laminated films with a structure in which a gas barrier layer of organic material (resin material) and a gas barrier layer of inorganic material are laminated separately, and films equipped with a gas barrier layer in which an inorganic material is dispersed in an organic binder.
[0058] (frame) As shown in Figure 2, the frame 20 includes an opening 21 having an opening 21a, and a movement restricting portion 23 configured to contact a part of the analyzer 300 and restrict the movement of the opening 21a.
[0059] The movement restricting section 23 contacts a part of the analyzer 300, thereby suppressing the movement of the opening 21a. This suppresses misalignment between the suction tube 252 and the opening 21a when the suction tube 252 is inserted. Furthermore, since misalignment between the suction tube 252 and the opening 21a is suppressed when the suction tube 252 is inserted into the reagent storage section 10 through the opening 21a, the sealed state inside the reagent storage section 10 can be effectively maintained.
[0060] <Opening> The opening 21 is a cylindrical portion in which the opening 21a is formed. The lower end of the opening 21a connects to the inside of the reagent storage section 10, and the upper end connects to the outside of the reagent storage section 10. The opening 21 is located at the top of the reagent storage section 10.
[0061] The opening 21 has a sealing surface 21b that contacts the sealing body 252a (see Figure 26) provided on the suction tube 252 to seal the opening 21a. As a result, the reagent container 10 can be easily and effectively sealed by the contact between the sealing body 252a and the sealing surface 21b.
[0062] The sealing surface 21b can be the upper end surface of the opening 21, the inner circumferential surface of the opening 21, or the outer circumferential surface of the opening 21. In the example in Figure 2, the sealing surface 21b is the annular upper end surface of the opening 21 surrounding the opening 21a (i.e., the edge of the opening 21a), and is in contact with the sealing body 252a (see Figure 26) provided on the suction tube 252 from above and below.
[0063] Furthermore, a removable cap may be fitted to the opening 21, for example. In that case, the reagent container 100 is provided to the user with the opening 21a sealed by the cap, and the cap is removed before it is placed in the analyzer 300.
[0064] Furthermore, for example, a punctureable sealing film may be welded to the upper surface of the opening 21 so as to cover the opening 21a. The reagent container 100 is provided to the user with the opening 21a sealed by the sealing film, and after being placed in the analyzer 300, it can be opened by puncturing the sealing film with a suction tube 252.
[0065] As shown in Figure 3, the opening 21 is formed in the mounting member 22 attached to the reagent container 10. The opening 21 is integrally formed with the mounting member 22 so as to protrude upward from the upper surface of the mounting member 22.
[0066] The mounting member 22 is made of a resin material formed separately from the reagent storage section 10. The resin material constituting the mounting member 22 is, for example, a thermoplastic resin, specifically polyethylene (PE). The resin material constituting the mounting member 22 may also be polypropylene (PP), polyethylene terephthalate (PET), or the like.
[0067] The outer periphery of the mounting member 22 is welded to the inner periphery of the reagent storage section 10. The mounting member 22 is provided at the upper end of the reagent storage section 10 so as to be sandwiched between the outer edges of the two laminated film materials 11 that constitute the reagent storage section 10, and is welded to the inner surfaces of the two laminated film materials 11. The space between the outer periphery of the mounting member 22 and the reagent storage section 10 is sealed by welding. This makes it easy to attach the mounting member 22, which has rigidity for connecting with the movement restricting section 23, to the flexible bag-shaped reagent storage section 10, and also makes it easy to achieve sealing between the mounting member 22 and the reagent storage section 10.
[0068] The mounting member 22 has a supported portion 22a that is spaced horizontally from the opening 21. The mounting member 22 has an elongated hexagonal shape, with the opening 21 located at one end in the longitudinal direction of the mounting member 22 and the supported portion 22a located at the other end. The supported portion 22a is a projection integrally formed on the mounting member 22 so as to protrude upward from the upper surface of the mounting member 22. When viewed from the first direction A, the supported portion 22a has a T-shape, with the base being narrower than the upper part.
[0069] Here, the opening 21 is located near the end of the reagent storage section 10 in the horizontal direction. Even when the reagent storage section 10 is expanded by accommodating the reagent 12 (see Figure 5), the opening 21 of the mounting member 22 is located relatively close to the inner surface of the reagent storage section 10. Therefore, if the suction tube 252 is inserted at an angle with respect to the central axis of the opening 21, there is a possibility that the tip of the suction tube 252 will come into contact with the inner surface of the reagent storage section 10.
[0070] Therefore, the opening 21 has a suction tube guide portion 21c that protrudes downward from the lower end of the opening 21a toward the interior of the reagent storage portion 10. The suction tube guide portion 21c is integrally formed with the mounting member 22 and has a shape that partially extends downward from the lower end of the cylindrical opening 21. The suction tube guide portion 21c is formed in a wall shape so as to separate the suction tube 252 inserted into the opening 21a from the inner surface of the reagent storage portion 10. As a result, even if the suction tube 252 is inserted into the interior of the reagent storage portion 10 at an angle with respect to the central axis of the opening 21a, the tip of the suction tube 252 can be guided so as to suppress contact between the tip of the suction tube 252 and the inner surface of the reagent storage portion 10.
[0071] As shown in Figures 4 and 5, the suction tube guide portion 21c is provided to separate the suction tube 252 inserted into the opening 21a from the inner surface of the reagent storage portion 10. On the other hand, since there is no risk of the tip of the suction tube 252 coming into contact with the inner surface of the reagent storage portion 10 on the central side of the reagent storage portion 10 (see Figure 5), the suction tube guide portion 21c is not formed in the portion of the reagent storage portion 10 that faces the center in the horizontal plane. For this reason, the suction tube guide portion 21c has a C-shaped cross-sectional shape (see Figure 4) that surrounds the suction tube 252 inserted into the opening 21a in the horizontal plane.
[0072] (Mobility Control Department) Returning to Figure 2, the movement restricting unit 23 has the function of positioning the opening 21a relative to the suction tube 252 of the analyzer 300. The movement restricting unit 23 also has the function of preventing misalignment of the opening 21a.
[0073] The movement restricting portion 23 is fixed to the opening 21 so as to protrude horizontally from the opening 21. This allows the relative position of the movement restricting portion 23 and the opening 21a to be fixed. Furthermore, the portion of the movement restricting portion 23 that protrudes horizontally from the opening 21 makes it easy to implement a configuration in which it contacts a part of the analytical device 300 to restrict its movement, and the contact area necessary to prevent misalignment of the opening 21a can be easily obtained through this contact.
[0074] As shown in Figure 3, the movement restricting section 23 has a generally flat plate shape. The movement restricting section 23 has a shape that extends along a first direction A in the horizontal plane. In plan view (see Figure 6), the movement restricting section 23 has a rectangular shape including a pair of long sides extending in the first direction A and a pair of short sides extending in the second direction B. As will be described later, the reagent container 100 is installed in the container holding section 251 of the analyzer 300 by inserting it into the container holding section 251 along the first direction A, with one end 23a of the movement restricting section 23, where the opening 21 is located, as the leading edge.
[0075] The movement restricting section 23 is made of a resin material. The resin material constituting the movement restricting section 23 is, for example, a thermoplastic resin, specifically polyethylene (PE). The resin material constituting the movement restricting section 23 may also be polypropylene (PP) or polyethylene terephthalate (PET).
[0076] As shown in Figure 6, the movement restricting part 23 is fixed to the opening 21 between one end 23a and the central part in the first direction A of the movement restricting part 23. In other words, the opening 21 is positioned closer to the one end 23a of the movement restricting part 23 than to the other end 23b. This allows the opening 21a formed in the opening 21 on the one end 23a side to be positioned directly below the suction tube 252 by gripping the other end 23b of the movement restricting part 23 and moving the reagent container 100 in the first direction A. In this case, since the opening 21 is far from the other end 23b of the movement restricting part 23, it is possible to prevent the user's fingers from coming into contact with the suction tube 252 when attaching the reagent container 100.
[0077] <Restrictions on horizontal movement> The movement restricting unit 23 is configured to restrict the horizontal movement of the opening 21a by contacting a part of the analyzer 300 in the horizontal direction. This prevents the horizontal positional relationship between the opening 21a and the suction tube 252 from shifting.
[0078] The movement restricting portion 23 includes a horizontal contact surface 24 which is made up of the inner surface of a hole formed in the movement restricting portion 23, the inner surface of a notch formed in the movement restricting portion 23, or the side surface of the movement restricting portion 23. This allows a horizontal contact surface 24 for restricting the horizontal movement of the opening 21a to be provided on the movement restricting portion 23 with a simple configuration.
[0079] Specifically, the horizontal contact surface 24 includes a first surface 24a which is the side surface (i.e., the front end surface) formed at one end 23a of the movement restricting portion 23 in the first direction A. This makes it easy to achieve both alignment of the opening 21a in the first direction A and movement restriction when attaching the reagent container 100 to the analyzer 300, simply by advancing the reagent container 100 in the first direction A until one end 23a of the movement restricting portion 23 abuts against the inner surface of the container holding portion 251.
[0080] The horizontal contact surface 24 includes second surfaces 24b and 24c, which are sides extending along the first direction A of the movement restricting section 23. The second surfaces 24b and 24c are a pair of sides that constitute the long side of the movement restricting section 23 in a plan view, and are provided on one side and the other side of the movement restricting section 23 in the second direction B. This makes it easy to achieve both alignment and movement restriction of the opening 21a in the second direction B by the sides of the movement restricting section 23. In Figure 6, the second surfaces 24b and 24c are located on the outermost side of the movement restricting section 23 in the second direction B.
[0081] As will be described later, the movement restricting portion 23 is formed to face the inner surface of the container holding portion 251 of the analyzer 300 (see Figure 20) in both the first direction A and the second direction B, which are mutually orthogonal in the horizontal plane. As a result, the movement restricting portion 23 comes into contact with the inner surface of the container holding portion 251, thereby suppressing misalignment of the opening 21a in both the first direction A and the second direction B. Furthermore, as will be described later, by setting the distance between the movement restricting portion 23 and the opposing surface (inner surface of the container holding portion 251) within the allowable range of misalignment, it is possible to prevent misalignment exceeding the allowable range of the opening 21a while allowing slight misalignment, thereby facilitating the installation of the reagent container 100.
[0082] Furthermore, as shown in Figure 6, the movement restricting section 23 has a notch 23c formed on its side surface. The horizontal contact surface 24 includes a third surface 24d which is the inner surface of the notch 23c. The third surface 24d contacts a part of the analyzer 300 that enters the notch 23c. As a result, the movement restricting section 23 and the analyzer 300 can be brought into contact by the contact between the third surface 24d inside the notch 23c and a part of the analyzer 300. This contact effectively prevents the opening 21a from shifting position. In addition, when attaching the reagent container 100 to the analyzer 300, the movement restricting section 23 contacts a part of the analyzer 300 and becomes immobile, so the user can perceive by touch that the reagent container 100 has been placed in the correct position without having to visually confirm it.
[0083] The notch 23c is formed in a V-shape on the second surfaces 24b and 24c, and the third surface 24d consists of a V-shaped bent inclined surface. Therefore, when the third surface 24d comes into contact with a part of the analytical instrument 300, the part of the analytical instrument 300 can be guided toward the bending point (the most recessed part) of the third surface 24d. In other words, the contact position on the third surface 24d can be determined with high precision.
[0084] Furthermore, the movement restricting section 23 has a hole 23d formed on its upper surface. The horizontal contact surface 24 includes a fourth surface 24e which is the inner surface of the hole 23d. The fourth surface 24e contacts a part of the analysis device 300 (see entry member 281, described later, Figure 22) that enters the interior of the hole 23d. As a result, the movement restricting section 23 and the analysis device 300 can be brought into contact by a part of the analysis device 300 entering the hole 23d formed in the movement restricting section 23. This contact effectively suppresses displacement of the opening 21a.
[0085] In Figure 6, the hole 23d is a through-hole that penetrates the movement restricting section 23 in the thickness direction (Z direction). The hole 23d is provided in the movement restricting section 23 between one end 23a in the first direction A and the opening 21. By providing the hole 23d close to the opening 21, the horizontal position of the opening 21 can be positioned more accurately and the opening 21 can be fixed when the analyzer 300 comes into contact with the hole 23d. In Figure 6, there are two holes 23d. The two holes 23d are aligned along the second direction B. There may be only one hole 23d.
[0086] The movement restricting section 23 has a guide section 23e that guides the movement of the opening 21a when it is positioned below the suction tube 252 of the analyzer 300. The guide section 23e extends along a first direction A in the horizontal plane. The guide section 23e slides while in contact with a part of the analyzer 300, thereby aligning the movement direction of the movement restricting section 23 with the first direction A. This makes it possible to easily and accurately position the opening 21a in the correct position for insertion of the suction tube 252 when the reagent container 100 is placed in the container holding section 251 of the analyzer 300.
[0087] The guide portion 23e is provided to extend linearly from one end 23a of the movement restricting portion 23 to the gripping portion 25 on the other end 23b. In the example of Figure 6, the guide portion 23e is the side surface of the movement restricting portion 23 that extends along the first direction A. That is, the guide portion 23e is composed of second surfaces 24b and 24c. Since notches 23c are provided on the second surfaces 24b and 24c, the guide portion 23e is provided intermittently in the range from one end 23a to the gripping portion 25. The guide portion 23e is provided on both sides of the movement restricting portion 23 in the second direction B.
[0088] <Restrictions on vertical movement> The movement restricting section 23 is configured to restrict the vertical movement of the opening 21a by contacting a part of the analyzer 300 in the vertical direction (Z direction). This makes it possible to suppress the vertical movement of the opening 21a when inserting the suction tube 252 into the reagent storage section 10 and when withdrawing the suction tube 252 from the reagent storage section 10, even in a reagent container 100 equipped with a bag-shaped reagent storage section 10 that is easily deformable.
[0089] As shown in Figure 7, the movement restricting section 23 includes an upper surface 23f and a lower surface 23g that contact a part of the analyzer 300 in the vertical direction (Z direction). This allows for restricting the vertical movement of the opening 21a with a simple configuration.
[0090] The movement restricting section 23 is formed to face the inner surface of the container holding section 251 of the analyzer 300 (see Figure 19) in both the upward and downward directions. As a result, the movement restricting section 23 contacts the inner surface of the container holding section 251, thereby suppressing the movement of the opening 21a in both the upward and downward directions. Furthermore, by setting the distance between the movement restricting section 23 and the opposing surface (inner surface of the container holding section 251) within the allowable range of misalignment, it is possible to prevent movement of the opening 21a beyond the allowable range while allowing slight movement, thereby facilitating the installation of the reagent container 100.
[0091] <Gripping part> As shown in Figure 6, the movement restricting section 23 has a gripping section 25 at the other end 23b in the first direction A of the movement restricting section 23 for gripping the movement restricting section 23. This makes it easy to grip the other end 23b of the movement restricting section 23. In addition, since the bag-shaped reagent container 10 is easily deformed and difficult to grip, providing the gripping section 25 on the movement restricting section 23 makes it easier to carry the reagent container 100.
[0092] The gripping portion 25 has a flat plate shape extending along the horizontal or vertical direction. In the example shown in Figure 6, the gripping portion 25 is the other end 23b of the movement restricting portion 23 and has a flat plate shape extending along the vertical direction. The gripping portion 25 has a pair of gripping sides 25a that extend along the first direction A and the vertical direction (Z direction). This allows the gripping portion 25 to be gripped by being held between the left and right sides. The gripping form, which is held between the fingers, makes it easy for the user to apply force even in a relatively small area, and allows for stable gripping of the reagent container 100.
[0093] The gripping portion 25 is positioned at the other end 23b of the movement restricting portion 23, in the center of the second direction B. The width of the gripping portion 25 (the distance between the pair of gripping sides 25a) is smaller than the distance between the pair of second surfaces 24b and 24c, which are the sides of the movement restricting portion 23. As shown in Figure 6, a wall portion 25b is provided on the other end 23b side of the pair of gripping sides 25a. As shown in Figure 5, the inner space enclosed by the pair of gripping sides 25a and the wall portion 25b is hollow, and the corner of the reagent storage portion 10 (the corner on the other end 23b side of the upper part of the reagent storage portion 10) is housed in this inner space. Therefore, the corner of the reagent storage portion 10 is not exposed near the gripping portion 25, and the user does not come into contact with the corner of the reagent storage portion 10 when gripping the gripping portion 25.
[0094] <Mounting structure between the movement restriction section and the reagent storage section> The movement restricting section 23 is fixed to the opening 21 as described above. Since the mounting member 22, which has the opening 21 formed thereon, is joined to the reagent storage section 10, the movement restricting section 23 is connected to the reagent storage section 10 at the portion of the opening 21. The movement restricting section 23 also functions as a support member to support the weight of the reagent storage section 10 containing the reagent when carrying the reagent container 100.
[0095] As shown in Figures 3 and 8, the movement restricting section 23 includes a fixing section 26 fixed to the opening 21 and a support section 27 that supports the upper part of the reagent container 10 at a position away from the opening 21. This allows the reagent container 10 to be supported by being suspended from the movement restricting section 23 at multiple points on the fixing section 26 and the support section 27 when carrying the reagent container 100. Because the weight of the reagent container 10 is distributed and acted upon at multiple points on the movement restricting section 23, the reagent container 10 can be stably supported even if its capacity is large. In addition, the user does not have to grasp the easily deformable bag-like part, making it easier to handle the reagent container 100.
[0096] The fixing portion 26 is provided between the central portion and one end 23a of the movement restricting portion 23 in the first direction A. The fixing portion 26 includes a through hole 26a that penetrates the movement restricting portion 23 in the thickness direction (vertical direction) and an engaging piece 26b that engages with the neck portion 21d of the opening 21. The through hole 26a is formed to a size that allows the opening 21 to pass through. A pair of engaging pieces 26b are provided inside the through hole 26a, and the neck portion 21d is sandwiched between the pair of engaging pieces 26b.
[0097] The support portion 27 is provided in the central part of the movement restricting portion 23 in the first direction A. The support portion 27 includes a first penetration portion 27a that penetrates the movement restricting portion 23 in the thickness direction (vertical direction), and a slit-shaped second penetration portion 27b that extends from the first penetration portion 27a in the first direction A. The first penetration portion 27a is formed to be large enough for the entire supported portion 22a of the reagent container portion 10 to pass through. The second penetration portion 27b is formed to be large (width) enough for the base of the supported portion 22a to pass through, but not for the wider upper portion to pass through.
[0098] As described above, the opening 21 and the supported portion 22a are arranged on the upper surface of the mounting member 22 with a gap between them in the first direction A. The fixing portion 26 and the support portion 27 of the movement restricting portion 23 are arranged along the first direction A at a distance equal to the distance between the opening 21 and the supported portion 22a of the mounting member 22. As shown in Figure 8, the fixing portion 26 is fixed to the opening 21, and the support portion 27 is fixed to the supported portion 22a.
[0099] As a result, even when the bag-shaped reagent container 10 has multiple fixing points, such as an opening 21 to which the movement restricting part 23 is fixed and a supported part 22a, both the opening 21 and the supported part 22a can be formed on a single mounting member 22, thus simplifying the structure of the reagent container 100.
[0100] A method for attaching the movement restricting part 23 to the reagent storage section 10 will be described. As shown in Figure 3, with the horizontal positions of the through hole 26a of the fixing part 26 and the first through hole 27a of the support part 27 aligned with the upper opening 21 and supported part 22a of the reagent storage section 10, the movement restricting part 23 is brought close to the reagent storage section 10 from above. As a result, the opening 21 is inserted into the through hole 26a and the supported part 22a is inserted into the first through hole 27a. Then, the movement restricting part 23 is moved relative to the opening 21 in the first direction A. As a result, as shown in Figure 8, the neck part 21d is sandwiched in the gap between the pair of engaging pieces 26b, fixing the fixing part 26 and the opening 21. In addition, the base of the supported part 22a enters the second through hole 27b from the first through hole 27a, and the supported part 22a engages with the second through hole 27b (support part 27) in the vertical direction.
[0101] <Information recording medium> As shown in Figure 2, the frame 20 includes an information recording medium 28 that records reagent information. The information recording medium 28 is an RFID (radio frequency identifier) tag. This allows the analyzer 300 to read the reagent information from the information recording medium 28 when the reagent container 100 is attached to the analyzer 300. If the information recording medium 28 is provided in a deformable bag-shaped reagent storage section 10, it may be difficult to attach the information recording medium 28 or the information recording medium 28 may be difficult to read. However, by providing the information recording medium 28 in the movement restriction section 23, the information recording medium 28 can be easily attached and read reliably.
[0102] The information recording medium 28 has a flat plate shape and is located in the center of the upper surface 23f (see Figure 5) of the movement restricting section 23. In Figure 2, the information recording medium 28 is positioned to cover the support section 27 (see Figure 3) of the movement restricting section 23.
[0103] <reagent> The reagent 12 contained in the reagent container 10 is a liquid. Reagent 12 is an aqueous solution containing components corresponding to the analytical items obtained from the sample analysis. The reagent container 100 contains a staining solution for staining specific cells as a reagent. The staining solution contains various fluorescent dyes for staining, for example, white blood cells, red blood cells, organelles, platelets, etc., in the blood.
[0104] The storage period for the reagent is 75 days to 1 year from the time the suction tube 252 is inserted into the opening 21a. The storage period is the length of time during which the measurement accuracy using the reagent by the analyzer 300 can be guaranteed. In this embodiment, with the suction tube 252 inserted into the opening 21a and the inside of the reagent storage section 10 sealed, the measurement accuracy is maintained for a period of 75 days to 1 year. Since the deterioration of the reagent can be suppressed by sealing the reagent storage section 10, the reagent quality can be maintained stably for a longer period of time. As a result, the frequency of reagent (reagent container 100) replacement can be reduced, thereby reducing the burden on the user involved in the replacement work.
[0105] <Types of reagent containers> The reagent container 100 may have different shapes depending on the volume of reagent it contains.
[0106] For example, Figures 2 to 6 show a large-capacity reagent container 100. The reagent storage section 10 of the reagent container 100 can hold 200 mL to 500 mL of reagent. This allows for a relatively large-capacity reagent container 100 with a capacity of 200 mL to 500 mL. As a result, the frequency of reagent (reagent container 100) replacement in the analytical instrument 300 can be reduced. On the other hand, because the reagent storage capacity is large, the period until the reagent is completely consumed is extended. In this embodiment, the deterioration of the reagent can be suppressed by sealing the reagent storage section 10, so even if the reagent storage capacity is increased and the shelf life of the reagent is extended, the reagent quality can be maintained.
[0107] Figure 9 shows a small-capacity reagent container 200. The reagent storage section 110 of the reagent container 200 can hold 20 mL to 100 mL of reagent. Thus, even with a relatively small-capacity reagent container 100, the deterioration of the reagent can be suppressed by sealing the reagent storage section 10, which is preferable.
[0108] Figures 10 and 11 show reagent container 100 and reagent container 200 side by side. Comparing reagent container 10 and reagent container 110, the length L1 in the first direction A, the thickness W1 in the second direction B, and the vertical length H1 of reagent container 10 are all larger than the length L2 in the first direction A, the thickness W2 in the second direction B, and the vertical length H2 of reagent container 110.
[0109] The large-capacity reagent container 100 and the small-capacity reagent container 200 share a partially common structure. That is, the large-capacity reagent container 100 and the small-capacity reagent container 200 are equipped with frames 20 of the same shape. On the other hand, the large-capacity reagent container 100 and the small-capacity reagent container 200 have different shapes in their reagent storage sections (10, 110). It is preferable to make the shape of the frame 20 having the opening 21 and the movement restricting section 23 the same for both the reagent container 100 and the reagent container 200, as this allows the structure for inserting the suction tube 252 in the analyzer 300, the positioning of the opening 21a, and the structure for suppressing misalignment to be applied to both the reagent container 100 and the reagent container 200 in common.
[0110] [Analyzer] Next, the analyzer 300 of this embodiment will be described. The analyzer 300 shown in Figure 12 is an automated measurement unit that aspirates reagent 12 (see Figure 5) from the reagent container 100 and uses the aspirated reagent 12 to analyze the sample. Hereinafter, in the horizontal plane, the left-right direction of the analyzer 300 will be defined as the X direction, and the front-back direction (depth direction) of the analyzer 300 will be defined as the Y direction.
[0111] As shown in Figure 12, the analyzer 300 comprises a measurement unit 201, a sample transport device 202 positioned on the front side (direction of arrow Y1) of the measurement unit 201, and an analysis unit 203 consisting of a PC (personal computer) electrically connected to each measurement unit 201 and the sample transport device 202.
[0112] Figure 12 shows an example in which the analyzer 300 is equipped with two measuring units 201 aligned in the X direction. Each measuring unit 201 includes a unit cover 206 that houses the measuring mechanism inside. The two measuring units 201 are designated as the first measuring unit 201a and the second measuring unit 201b. The second measuring unit 201b may perform analysis of different measurement items than the first measuring unit 201a.
[0113] As shown in Figure 13, the sample transport device 202 includes a pre-analysis rack holding unit 202a capable of holding a plurality of racks 2 containing sample containers 1 for samples before analysis, a post-analysis rack holding unit 202b capable of holding a plurality of racks 2 containing sample containers 1 for samples after analysis, a rack transport unit 202c that moves the racks 2 horizontally in the X direction, and a barcode reading unit 205.
[0114] The sample transport device 202 is configured to move the racks 2, which are held in the pre-analysis rack holding section 202a, one by one onto the rack transport section 202c.
[0115] The sample transport device 202 is configured to transport the rack 2 on the rack transport section 202c in the X direction, thereby positioning a predetermined sample container 1 held in the rack at the intake position 4b where the first measurement unit 201a takes in the sample, the intake position 4a where the second measurement unit 201b takes in the sample, and the reading position 4c where the barcode reader 205 reads the barcode of the sample container 1. The sample transport device 202 is configured to move the rack 2 after analysis from the rack transport section 202c to the post-analysis rack holding section 202b.
[0116] As shown in Figures 12 and 13, the analysis unit 203 consists of a personal computer (PC) and is mainly composed of a control unit 203a (see Figure 13) consisting of a CPU, ROM, RAM, etc., a display unit 203b, and an input device 203c. The display unit 203b is provided to display the analysis results obtained by analyzing the digital signal data transmitted from the first measurement unit 201a and the second measurement unit 201b. The analysis unit 203 is connected to the host computer 204.
[0117] The control unit 203a includes a CPU, ROM, RAM, hard disk, input / output interface, and communication interface. The CPU executes application programs, allowing the computer to function as the analysis unit 203. The control unit 203a controls the operation of the first measurement unit 201a, the second measurement unit 201b, and the sample transport device 202. A measurement results database is also installed on the hard disk of the control unit 203a.
[0118] The control unit 203a is configured to analyze the components to be analyzed using the measurement results transmitted from the first measurement unit 201a and the second measurement unit 201b, and to acquire the analysis results (red blood cell count, platelet count, hemoglobin amount, white blood cell count, etc.). Thus, the analyzer 300 of this embodiment is a blood cell counter that counts formed elements in a sample.
[0119] As shown in Figure 13, each measurement unit 201 (201a, 201b) includes a measurement control unit 210, a sample aspiration unit 220 for aspirating a sample, a sample preparation unit 230 for mixing the sample and reagents to prepare a measurement sample, and a detection unit 240 for detecting components in the measurement sample.
[0120] The measurement control unit 210 includes a processor, memory, driver circuitry, input / output interface, and communication interface. The measurement control unit 210 communicates with the control unit 203a of the analysis unit 203. Based on measurement instructions from the control unit 203a, the measurement control unit 210 controls the operation of each part in the measurement unit 201, such as the sample aspiration unit 220, sample preparation unit 230, and detection unit 240. The measurement control unit 210 outputs reagent information obtained from the reading unit 256 (described later) and measurement results obtained from the detection unit 240 to the control unit 203a.
[0121] As shown in Figure 14, the sample aspiration unit 220 includes a piercer 221, which is a suction tube through which the sample passes, and a quantitative unit 222. The piercer 221 is formed so that its tip can penetrate (puncture) the sealed lid 1a of the sample container 1. The piercer 221 is also configured to be movable by a motor between the sample aspiration position from the sample container 1 and the reaction chamber 231, which will be described later. The quantitative unit 222 consists of a syringe pump and has the function of aspirating a predetermined amount of sample from the sample container 1 via the piercer 221 and discharging it into the reaction chamber 231.
[0122] The sample preparation unit 230 has a reagent aspiration unit 250 that aspirates reagents from the reagent container 100. The sample preparation unit 230 also includes a reaction chamber 231. The reaction chamber 231 is configured to mix and react the sample (blood) aspirated by the sample aspiration unit 220 with the reagent supplied from the reagent aspiration unit 250. Although only one is shown in Figure 14, multiple reaction chambers 231 are provided depending on the type of measurement. Multiple types of reagents (staining solutions) according to the measurement item are supplied to each reaction chamber 231, and measurement samples according to various measurement items are prepared through the mixing and reaction process of the sample and reagent. The prepared measurement samples are then supplied to the detection unit 240.
[0123] The sample preparation unit 230 includes a quantitative unit 232 connected to the suction tube 252 of the reagent aspiration unit 250 for quantitatively aspirating reagents, and electromagnetic valves 233a and 233b for opening and closing the flow path when transferring the aspirated reagents to the quantitative unit 232 and the reaction chamber 231. The quantitative unit 232 consists of a syringe pump and a diaphragm pump, etc. The sample preparation unit 230 also includes a quantitative unit 234 and electromagnetic valves 235a and 235b for transferring reagents (hemolytic agents) from a large-capacity reagent container 3 located outside the measurement unit.
[0124] The quantitative analysis unit 232 is configured to draw a predetermined amount of reagent from the reagent container 100 (or 200) into the quantitative analysis unit 232 via the suction tube 252 by opening the electromagnetic valve 233a and closing the electromagnetic valve 233b while the suction tube 252 is inserted into the reagent container 100 (or 200). The quantitative analysis unit 232 is configured to transfer the reagent quantified inside the quantitative analysis unit 232 to the reaction chamber 231 by closing the electromagnetic valve 233a and opening the electromagnetic valve 233b.
[0125] The detection unit 240 includes an FCM measurement unit 241 that detects formed elements such as leukocytes (WBCs) in the sample using a flow cytometry method with a semiconductor laser. The measurement results obtained by the detection unit 240 are transmitted to the analysis unit 203 as measurement data (measurement results) of the sample by the measurement control unit 210 (see Figure 13).
[0126] The analysis unit 203 analyzes the detection signal from the detection unit 240. The analysis unit 203 analyzes individual particles based on the light detected by the FCM measurement unit 241. The analysis unit 203 creates a scattergram by combining scattered light intensity and fluorescence intensity as parameters, classifies the formed elements in the sample based on the distribution of the scattergram, and counts each classified type. Measurement items by flow cytometry include NEUT (neutrophils), LYMPH (lymphocytes), MONO (monocytes), EO (eosinophils), and BASO (basophils).
[0127] Furthermore, the detection unit 240 performs detection using the sheath flow DC detection method. Specifically, the detection unit 240 flows particles such as cells into a flow of sheath fluid passing through a micro-opening, and applies a direct current between a pair of electrodes positioned opposite each other on either side of the micro-opening. As a result of detection using the sheath flow DC detection method, the detection unit 240 outputs the pulsed current change as the particles pass through the micro-opening. The analysis unit 203 counts individual particles based on the current change. One of the measurement items using the sheath flow DC detection method is the number of red blood cells (RBCs).
[0128] Furthermore, the detection unit 240 performs HGB detection (detection of hemoglobin in blood) using the SLS-hemoglobin method. The measurement sample, which is a mixture of a hemolytic agent and the sample, is irradiated with measurement light from a light source, and the amount of transmitted light to the measurement sample is acquired by the light receiving unit. The detection unit 240 outputs the change in the amount of transmitted light during the process of SLS-hemoglobin formation as the detection result of the SLS-hemoglobin method. The analysis unit 203 calculates the hemoglobin concentration (HGB) in the measurement sample based on the change in the amount of transmitted light.
[0129] As shown in Figure 14, the reagent aspiration unit 250 comprises a container holding unit 251, a suction tube 252, an operating unit 253, and a moving mechanism 254.
[0130] The container holding section 251 holds the reagent container 100 (200), which includes a reagent storage section 10 (110) and a frame 20 (see Figure 2) including an opening 21a.
[0131] The suction tube 252 draws in the reagent container 100 (200) held in the container holding section 251. The suction tube 252 is inserted into the opening 21a from above the reagent container 100 (200) held in the container holding section 251. The suction tube 252 is configured to seal the inside of the reagent storage section 10 when inserted into the opening 21a. The upper end of the suction tube 252 is connected to a flow path leading to the quantitative section 232 and the reaction chamber 231.
[0132] The control unit 253 is configured to receive a predetermined operation from the user of the analyzer 300 to move the suction tube 252. The movement mechanism 254 moves the reagent container 100 (200) and the suction tube 252 relative to each other in conjunction with the predetermined operation received by the control unit 253. The movement mechanism 254 is configured to move the suction tube 252 into the reagent container 100 (200) held by the container holding unit 251 and to retract the suction tube 252 to the outside of the reagent container 100 (200) by relative movement.
[0133] In the analytical apparatus 300 of this embodiment, the user does not need to insert the suction tube 252 into the opening 21a of the reagent container 100 (200) before installing the reagent container 100 (200), so the reagent container 100 (200) can be easily installed in the analytical apparatus 300. In addition, when the suction tube 252 is inserted into the opening 21a, the inside of the reagent storage section 10 (110) is sealed, so that the reagent inside the reagent container 100 (200) does not come into contact with the outside air. Therefore, deterioration of the reagent after installation in the analytical apparatus 300 can be suppressed.
[0134] The suction tube 252 is configured to seal the inside of the reagent storage section 10 (110) by suppressing the inflow of air into the opening 21a. This suppresses the deterioration of the reagent inside the reagent storage section 10 (110) due to contact with air. As a result, the quality of the reagent can be maintained for a longer period of time while the inside of the reagent storage section 10 (110) is sealed with the suction tube 252 inserted.
[0135] (Structure of the reagent aspiration section) Next, the detailed structure of the reagent aspiration section 250 will be described.
[0136] As shown in Figure 12, the reagent aspiration unit 250 is located inside the unit cover 206. The front side of the unit cover 206 is provided with an openable and closable front cover 206a. The reagent aspiration unit 250 is located at the upper front of the measurement unit 201 and is exposed to the outside by opening the front cover 206a. This allows the user to easily replace the reagent containers 100 and 200.
[0137] As shown in Figure 15, the reagent suction unit 250 includes a plurality of reagent container holders, each capable of holding one reagent container 100 (or 200). The reagent suction unit 250 includes, for example, a total of five reagent container holders, but for convenience, only three reagent container holders 250a, 250b, and 250c are shown in Figure 15. The plurality of reagent container holders 250a to 250c are arranged side by side in the lateral direction.
[0138] Reagent container holders 250a, 250b, and 250c are each equipped with reagent containers 100 (or 200) containing different types of reagents (staining solutions) for measuring multiple parameters. Depending on the type of reagent, large (approximately 300 mL) reagent containers 100 and small (approximately 30 mL) reagent containers 200 are used, but each reagent container holder 250a to 250c is equipped with a predetermined type of reagent container. In Figure 15, reagent container holders 250a and 250b are equipped with large reagent containers 100, while reagent container holder 250c is equipped with small reagent containers 200.
[0139] Each reagent container holder 250a to 250c comprises a lower chassis 255a and an upper chassis 255b, a container holding section 251, a suction tube 252, an operating section 253, and a moving mechanism 254 (see Figure 22). Below, the structure of reagent container holder 250a will be described as a representative example of reagent container holders 250a to 250c.
[0140] <Container holding part> The container holding section 251 is provided on the lower chassis 255a. The container holding section 251 is located at the very bottom of the reagent container holder 250a. The container holding section 251 is configured to hold a reagent container 100 which includes a bag-shaped reagent storage section 10 for containing reagents and a frame 20 including an opening 21a.
[0141] The container holding section 251 has a box-shaped or cylindrical housing section 260 that can accommodate the reagent container 100 inside and has an opening formed horizontally. The housing section 260 has an opening at its Y1 end and is provided to extend from the opening toward the Y2 direction.
[0142] As shown in Figure 16, the housing section 260 includes a first insertion section 261 into which the reagent housing section 10 of the reagent container 100 is inserted, and a second insertion section 262 located above the first insertion section 261 into which the movement restricting section 23 of the reagent container 100 is inserted.
[0143] The first insertion section 261 is a space partitioned by a pair of side sections 261a facing both sides of the reagent storage section 10 in the width direction (X direction), and a bottom section 261b facing the bottom surface of the reagent storage section 10 in the vertical direction (Z direction). The upper part of the first insertion section 261 and the second insertion section 262 are connected by a connecting passage 263.
[0144] The connecting passage 263 is a space for allowing the connection portion (the portion where the mounting member 22 is located) of the reagent container 100, between the movement restricting portion 23 and the reagent storage portion 10, to pass through in the Y direction.
[0145] The second insertion section 262 extends from the entrance of the housing section 260 toward the set position Ps directly below the suction tube 252 and is configured to guide the reagent container 100 to the set position Ps (see Figure 17) by contacting the movement restricting section 23. This allows the reagent container 100 to be guided from the entrance of the housing section 260 to the set position Ps using the movement restricting section 23. As a result, even a reagent container 100 equipped with a reagent housing section 10 that is easily deformed can be accurately guided to the set position Ps with a simple operation by the user, which is to insert the reagent container 100 from the entrance of the housing section 260.
[0146] As shown in Figure 18, the second insertion portion 262 has a convex cross-sectional shape. That is, the second insertion portion 262 has a convex cross-sectional shape due to a wide lower part into which the flat plate-shaped movement restricting portion 23 is inserted, and a narrow upper part into which the opening 21 protruding above the movement restricting portion 23 is inserted.
[0147] <Abutment part> The reagent suction section 250 (see Figure 15) is equipped with a contact section 270 (see Figure 18). The contact section 270 shown in Figure 18 contacts a movement restricting section 23 (see Figure 19) provided on the frame 20 of the reagent container 100, which is placed in the container holding section 251, thereby restricting the movement of the opening 21a. As a result, the contact section 270 contacts the movement restricting section 23, which suppresses misalignment between the suction tube 252 and the opening 21a when the suction tube 252 is inserted. Furthermore, since misalignment between the suction tube 252 and the opening 21a is suppressed when the suction tube 252 is inserted into the reagent storage section 10 through the opening 21a, the sealed state inside the reagent storage section 10 can be effectively maintained.
[0148] The contact portion 270 is configured to restrict the movement of the opening 21a of the reagent container 100 by coming into contact with the movement restricting portion 23, which is fixed to the opening 21a. This fixes the relative position between the movement restricting portion 23 and the opening 21a, so that by bringing the contact portion 270 into contact with the movement restricting portion 23, the opening 21a can be reliably and accurately positioned and its movement restricted.
[0149] At least a portion of the contact portion 270 is provided in the housing portion 260 (see Figure 16). This allows the contact portion 270 and the movement restricting portion 23 to come into contact when the reagent container 100 is inserted into the housing portion 260 from the entrance, thereby restricting the movement of the opening 21a within the housing portion 260.
[0150] Specifically, the contact portion 270 (see Figure 18) is located in the second insertion portion 262. By providing the contact portion 270 in the second insertion portion 262, which corresponds to the movement restricting portion 23 of the reagent container 100, even a reagent container 100 equipped with a easily deformable reagent storage portion 10 can have the contact portion 270 and the movement restricting portion 23 come into contact in a preset relative positional relationship. As a result, the positioning and movement restriction of the opening 21a can be accurately performed.
[0151] <Horizontal positioning restrictions> As shown in Figures 18 and 19, the contact portion 270 is configured to restrict the horizontal movement of the opening 21a by contacting the movement restricting portion 23 in the horizontal direction. This prevents the horizontal positional relationship between the opening 21a and the suction pipe 252 from shifting due to the contact portion 270.
[0152] The contact portion 270 includes the inner surface of the container holding portion 251 and is configured to face the movement restricting portion 23 in both the first direction A and the second direction B, which are mutually orthogonal in the horizontal plane. As a result, the movement restricting portion 23 contacts the inner surface of the container holding portion 251, thereby suppressing misalignment of the opening 21a in both the first direction A and the second direction B. Furthermore, by setting the distance between the movement restricting portion 23 and the contact portion 270 (inner surface of the container holding portion 251) within the allowable range of misalignment, it is possible to prevent misalignment exceeding the allowable range of the opening 21a while allowing slight misalignment, thereby facilitating the installation of the reagent container 100.
[0153] The contact portion 270 is configured to contact either a hole formed in the movement restricting portion 23, a notch formed in the movement restricting portion 23, or a side surface of the movement restricting portion 23. This allows the contact portion 270 to contact the movement restricting portion 23 and effectively restrict the horizontal movement of the opening 21a with a simple configuration.
[0154] Specifically, as shown in Figure 20, the contact portion 270 includes a first contact surface 271 that contacts the side surface of the movement restricting portion 23 in a first direction A in the horizontal plane. The first contact surface 271 is the inner wall surface of the Y1 direction end of the housing portion 260 (see Figure 16). When the reagent container 100 is inserted into the housing portion 260 from the entrance in the Y2 direction, the first surface 24a of the movement restricting portion 23 contacts the first contact surface 271. The position where the first surface 24a of the movement restricting portion 23 contacts the first contact surface 271 is the set position Ps of the reagent container 100 (200). This makes it easy to achieve both alignment of the opening 21a in the first direction A and movement restriction simply by abutting the side surface of the movement restricting portion 23 against the inner surface of the container holding portion 251.
[0155] The contact portion 270 includes a second contact surface 272 that contacts the side surface of the movement restricting portion 23 in a second direction B perpendicular to the first direction A in the horizontal plane. Specifically, as shown in Figure 18, a pair of groove-shaped portions 262a recessed in the X direction are provided on both sides of the second insertion portion 262 in the X direction, so as to receive both ends of the movement restricting portion 23 in the second direction B. The second contact surface 272 is the inner surface of the pair of groove-shaped portions 262a. As shown in Figure 19, when the movement restricting portion 23 is inserted into the second insertion portion 262, both ends of the movement restricting portion 23 in the X direction (second direction B) are positioned inside the groove-shaped portions 262a. As a result, the pair of second contact surfaces 272 face the pair of second surfaces 24b and 24c of the movement restricting portion 23 in the second direction B. When the movement restricting portion 23 moves in the width direction, it comes into contact with one of the pair of second contact surfaces 272, thereby restricting the movement of the movement restricting portion 23. This makes it easy to achieve both alignment and movement restriction of the opening 21a in the second direction B using the side surface of the movement restricting portion 23.
[0156] The distance between the pair of second contact surfaces 272 is slightly greater than the distance between the pair of second surfaces 24b and 24c of the movement restricting portion 23 (i.e., the width of the movement restricting portion 23 in the second direction B). The pair of second contact surfaces 272 are provided to restrict the movement of the movement restricting portion 23 in the width direction X of the second insertion portion 262 to within an acceptable range.
[0157] Furthermore, as shown in Figure 20, the contact portion 270 includes a third contact surface 273a that contacts a notch formed on the side surface of the movement restricting portion 23. This allows the notch formed on the side surface of the movement restricting portion 23 and the third contact surface 273a to come into contact. This contact effectively suppresses displacement of the opening 21a.
[0158] The third contact surface 273a of the contact portion 270 is biased to move back and forth toward the inside of the second insertion portion 262 and is configured to contact the movement restricting portion 23 on the inside of the second insertion portion 262 when the reagent container 100 is placed in the set position Ps. Specifically, the second insertion portion 262 is provided with a protruding member 273 that protrudes in the X direction from the second contact surface 272 toward the inside of the second contact surface 272 of the second insertion portion 262. One protruding member 273 is provided on each side of the second insertion portion 262 in the X direction. Each protruding member 273 consists of a V-shaped leaf spring and protrudes from the space portion 262b into the interior of the second insertion portion 262 through a gap 272a formed in each of the pair of second contact surfaces 272. The surface of these protruding members 273 is the third contact surface 273a.
[0159] As shown in Figure 21(A), when the movement restricting section 23 is inserted into the second insertion section 262, the third contact surface 273a of each protruding member 273 comes into contact with the pair of second surfaces 24b and 24c, pushing it outward in the X direction from the second insertion section 262. The third contact surface 273a of each protruding member 273 biases the movement restricting section 23 toward the center of the second insertion section 262 in the X direction by the elastic force of the leaf spring. As shown in Figure 20(B), when the reagent container 100 is placed in the set position Ps, the notches 23c formed in the second surfaces 24b and 24c of the movement restricting section 23 reach the position of each protruding member 273. As a result, the third contact surface 273a of each protruding member 273 enters the inside of the notch 23c by the elastic force F of the leaf spring, in accordance with the recess of the notch 23c. As a result, the third contact surface 273a comes into contact with the third surface 24d, which is the inner surface of the notch 23c. The movement restricting portion 23 is restricted from moving in the Y direction as the third contact surface 273a and the third surface 24d come into contact, unless an external force is applied that overcomes the elastic force F of the protruding member 273.
[0160] The contact between the contact portion 270 (third contact surface 273a) and the movement restricting portion 23 allows the movement restricting portion 23 to be held so that the opening 21a of the reagent container 100 does not move from the set position Ps. Furthermore, when the reagent container 100 is inserted into the housing portion 260, the movement restricting portion 23 does not move at the set position Ps, so the user can perceive by touch that the reagent container 100 has been placed in the correct position without having to visually check its position. In addition, since the movement restricting portion 23 receives elastic force F from both sides in the X direction by each protruding member 273, the movement restricting portion 23 is positioned in the center of the second insertion portion 262 in the X direction.
[0161] <Vertical position restriction> The contact portion 270 is configured to restrict the vertical movement of the opening 21a by contacting the movement restricting portion 23 in the vertical direction. This makes it possible to suppress the vertical movement of the opening 21a when inserting the suction tube 252 into the reagent storage portion 10 and when withdrawing the suction tube 252 from the reagent storage portion 10, even in a reagent container 100 equipped with a bag-shaped reagent storage portion 10 that is easily deformable.
[0162] Specifically, as shown in Figure 18, the contact portion 270 includes an upper contact surface 274 and a lower contact surface 275. The upper contact surface 274 and the lower contact surface 275 are configured to contact the upper surface 23f and lower surface 23g (see Figure 19) of the movement restricting portion 23, respectively. The upper contact surface 274 constitutes the upper surface of the groove-shaped portion 262a. The lower contact surface 275 constitutes the lower surface of the groove-shaped portion 262a. Therefore, a pair of upper contact surfaces 274 and lower contact surfaces 275 are provided, one on each side of the second insertion portion 262 in the X direction.
[0163] The lower contact surface 275 contacts the lower surfaces 23g at both ends of the movement restricting portion 23 in the second direction B, determining the vertical position of the movement restricting portion 23. The lower contact surface 275 and the upper contact surface 274 face each other in the Z direction at a distance greater than a predetermined allowable range than the thickness of the movement restricting portion 23. Therefore, the upper contact surface 274 normally faces the upper surfaces 23f at both ends of the movement restricting portion 23 in the second direction B without contact. When the movement restricting portion 23 is lifted upward, the upper contact surface 274 contacts the upper surfaces 23f of the movement restricting portion 23, restricting the movement of the movement restricting portion 23 so that it does not move upward beyond a predetermined allowable range. This allows for the restriction of vertical movement of the opening 21a with a simple configuration.
[0164] Thus, the contact portion 270 is positioned to face the movement restricting portion 23 in both the upward and downward directions. As a result, the contact portion 270 contacts the upper surface 23f and lower surface 23g of the movement restricting portion 23, thereby suppressing the movement of the opening 21a in both the upward and downward directions. Furthermore, by setting the distance between the movement restricting portion 23 and the contact portion 270 within the allowable range of misalignment, it is possible to prevent movement of the opening 21a beyond the allowable range while allowing slight movement, thereby facilitating the installation of the reagent container 100.
[0165] When the movement restricting portion 23 is inserted into the second insertion portion 262, the lower contact surface 275 contacts the lower surface 23g of the movement restricting portion 23 to support it. In other words, the container holding portion 251 supports the reagent container 100 by suspending it by supporting both ends of the movement restricting portion 23 in the second direction B with the lower contact surfaces 275 on both sides in the X direction. Since the reagent storage portion 10 (110) is deformable, the bottom surface 261b of the first insertion portion 261 (see Figure 22) contributes very little to supporting the reagent container 100. In other words, the container holding portion 251 has a pair of groove-shaped portions 262a into which both ends of the movement restricting portion 23 in the second direction B are inserted, and the entire reagent container 100 is supported by the pair of groove-shaped portions 262a via the movement restricting portion 23.
[0166] <Reading Section> As shown in Figure 17, the container holding unit 251 includes a reading unit 256 that acquires information about the reagent from an information recording medium 28 provided in the reagent container 100 located within the storage unit 260. This allows the reagent information to be read from the information recording medium 28 when the reagent container 100 is attached to the analyzer 300.
[0167] The reading unit 256 is individually provided on the top of each of the storage sections 260 of the multiple reagent container holders 250a. This allows for the individual reading of reagent information from each reagent container 100 installed in the multiple storage sections 260.
[0168] Specifically, as shown in Figure 22, the reading unit 256 is provided on the upper part of the second insertion section 262 of the storage section 260, covering the upper part of the second insertion section 262. The reading unit 256 consists of an RFID reader that performs wireless communication with the information recording medium 28, which is made up of an RFID tag, and reads information from the information recording medium 28.
[0169] As shown in Figure 17, the reading unit 256 is located in the space enclosed by the peripheral wall 264 above the second insertion unit 262. The reading unit 256 has a flat plate shape extending along the Y direction. The reading unit 256 is positioned opposite the information recording medium 28 located on the upper surface of the movement restricting unit 23 in the vertical direction (Z direction) when the reagent container 100 is placed in the set position Ps. As a result, the reading unit 256 reads reagent information from the information recording medium 28 located directly below it via contactless wireless communication. The space between the reading unit 256 located in one of the reagent container holders (for example, reagent container holder 250b) and the information recording medium 28 of the reagent container 100 installed in the reagent container holders 250a and 250c adjacent to that reagent container holder 250b is separated by the peripheral wall 264 surrounding the reading unit 256 and the lower chassis 255a. Therefore, interference with the information recording medium 28 of the reagent container 100 installed in the adjacent reagent container holder is prevented.
[0170] The reagent information includes various details such as the reagent type, lot number, and storage period. The analysis unit 203 (see Figure 13) acquires the reagent information read from the information recording medium 28 by the reading unit 256 via the measurement control unit 210, and performs processing based on the acquired reagent information. For example, the analysis unit 203 manages the storage period of the reagents.
[0171] <Suction tube and moving mechanism> As shown in Figure 22, the suction tube 252 is positioned above the innermost part (Y2 direction end) of the housing section 260 of the container holding section 251, with its tip facing downwards. The suction tube 252 is held by a moving mechanism 254 and is configured to be moved vertically (Z direction) by the moving mechanism 254. As a result, the suction tube 252 enters the inside of the reagent housing section 10 (110) through the opening 21a of the reagent container 100 (200) inserted into the inner side of the container holding section 251, and is configured to aspirate the reagent inside the reagent container 100 (200).
[0172] The suction tube 252 has a sealant 252a that seals the opening 21a by coming into contact with the opening 21a when the suction tube 252 is inserted into the opening 21a. This allows the reagent container 10 to be easily and effectively sealed by the sealant 252a.
[0173] The sealing body 252a is provided so as to surround the outer circumference of the suction tube 252 and is configured to elastically deform upon contact with the edge of the opening 21a (i.e., the sealing surface 21b of the opening 21) to seal the opening 21a. This allows the reagent container 10 to be reliably sealed by the sealing body 252a by utilizing the downward movement of the suction tube 252 when it is inserted into the opening 21a.
[0174] The sealant 252a is made of an elastically deformable rubber material. The sealant 252a is made of a solid material that does not allow air to pass through. The sealant 252a does not have any ventilation holes that allow the opening 21a to communicate with the outside when the opening 21a is sealed. A biasing member 252b is provided between the sealant 252a and the suction tube holder 254a that holds the suction tube 252, for biasing the sealant 252a toward the opening 21a. The biasing member 252b is made of a compression spring.
[0175] The moving mechanism 254 holds the suction tube 252 so that it can move vertically (in the Z direction) between an elevated position P1 and a lowered position P2 (see Figure 24). The moving mechanism 254 includes a suction tube holder 254a and a linear motion mechanism consisting of a linear rail 254b and a fixed slider 254c. The suction tube 252 is attached to the suction tube holder 254a, which is connected to the upper end of the linear rail 254b via a connecting portion 254d that extends in the Y direction. The linear rail 254b is located on the front surface (side surface in the Y1 direction) of the reagent container holder 250a and extends in the Z direction. The fixed slider 254c is fixed to the lower chassis 255a and holds the linear rail 254b so that it can move along the Z direction. This causes the linear rail 254b to move in the Z direction relative to the fixed slider 254c. As the linear rail 254b moves in the Z direction, the suction tube 252 moves integrally with the linear rail 254b in the Z direction.
[0176] As shown in Figure 23, the raised position P1 is the position where the entire suction tube 252 is retracted above the reagent container 100 which is placed in the set position Ps. In the raised position P1, the reagent container 100 (200) can be removed from the reagent container holder 250a (reagent container holder 250b, reagent container holder 250c) or placed back into the reagent container holder 250a (reagent container holder 250b, reagent container holder 250c).
[0177] As shown in Figure 24, the lowered position P2 is the position in which the suction tube 252 is inserted into the reagent container 10(110) through the opening 21a of the reagent container 100(200). At the lowered position P2, the tip of the suction tube 252 is positioned near the inner bottom of the reagent container 10(110) directly below the opening 21a.
[0178] Thus, the moving mechanism 254 supports the suction tube 252 so that it can move vertically, and is configured to move the suction tube 252 in conjunction with a predetermined operation on the operating unit 253, thereby allowing the suction tube 252 to enter the reagent container 100 held in the container holding unit 251 and to retract the suction tube 252 outside the reagent container 100. As a result, the suction tube 252 can be moved into the reagent container 100 and retracted outside the reagent container 100 simply by moving the suction tube 252 up and down. The less freedom of movement the suction tube 252 has in its direction, the more accurately and reproducibly the suction tube 252 can be operated, so that the operation of sealing the reagent container 10 when the suction tube 252 is inserted can be performed with greater precision by simple vertical movement.
[0179] Furthermore, as shown in Figure 22, the moving mechanism 254 holds the operating unit 253 so that the suction tube 252 and the operating unit 253 move in conjunction. The operating unit 253 is provided on the front surface (side surface in the Y1 direction) of the reagent container holder 250a, and the back surface (side surface in the Y2 direction) of the operating unit 253 is attached to the linear rail 254b. As a result, the linear rail 254b, the suction tube 252, and the operating unit 253 move together in the Z direction.
[0180] <Operation section> As shown in Figure 15, the operating section 253 is located on the front surface (in the direction of arrow Y1) of each of the reagent container holders 250a to 250c (lower chassis 255a). The operating section 253 is configured as a cover that can be opened and closed to cover the front surface of the container holding section 251 of the reagent container holder 250a.
[0181] As shown in Figure 22, the operating unit 253 is configured to be movable between an extraction position Q1 that allows the reagent container 100 to be extracted from the container holding unit 251 and an extraction prevention position Q2 that prevents the reagent container 100 from being extracted from the container holding unit 251. In other words, the operating unit 253 is configured to be movable by a movement mechanism 254 between an extraction position Q1 (see Figures 22 and 23) that opens the container holding unit 251 and an extraction prevention position Q2 (see Figure 24) that covers (closes) the container holding unit 251. The extraction position Q1 is the raised position of the operating unit 253 when the suction tube 252 is in the raised position P1. The extraction prevention position Q2 is the lowered position of the operating unit 253 when the suction tube 252 is in the lowered position P2.
[0182] The operating unit 253 is configured to be grasped and moved by the user. The operating unit 253 has an operating grip portion 253a that protrudes forward (in the Y1 direction) from the front surface of the operating unit 253. The user can move the operating unit 253 in the Z direction by grasping this operating grip portion 253a and moving it in the Z direction.
[0183] The moving mechanism 254 inserts the suction tube 252 into the opening 21a in conjunction with the operation of moving the operating unit 253 to the removal prevention position Q2 (see Figure 24). The moving mechanism 254 retracts the suction tube 252 outside the reagent container 100 in conjunction with the operation of moving the operating unit 253 to the removal position Q1 (see Figure 23).
[0184] As a result, the suction tube 252 can be automatically retracted outside the reagent container 100 simply by moving the operating unit 253 to the removal position Q1 in order to remove the reagent container 100, and after the reagent container 100 is placed, the suction tube 252 can be automatically inserted into the opening 21a simply by moving the operating unit 253 to the removal prevention position Q2.
[0185] Furthermore, if the reagent container 100 does not reach the set position Ps (i.e., if the reagent container 100 is positioned on the Y1 side of the set position Ps), the gripping portion 25 of the movement restricting portion 23 will be positioned directly below the operating portion 253 from the housing portion 260. Therefore, if the user attempts to move the operating portion 253 downward without correctly inserting the reagent container 100 to the set position Ps, the gripping portion 25 will come into contact with the operating portion 253, thereby preventing the operating portion 253 from moving downward.
[0186] <Abutment part> In this embodiment, in addition to the contact portion 270 provided inside the container holding portion 251, a contact portion 280 is provided outside the container holding portion 251. The contact portion 280 is configured to contact the movement restricting portion 23 of the reagent container 100 and fix the opening 21a, at least when the suction tube 252 is inserted into the opening 21a. This prevents the reagent container 100 from moving unintentionally when the suction tube 252 is inserted into the opening 21a. Therefore, it is possible to prevent the seal of the reagent storage portion 10 from being released or the reagent from spilling out of the reagent storage portion 10 due to displacement of the opening 21a.
[0187] The contact portion 280 includes an entry member 281 that enters a recess formed in the movement restricting portion 23 of the reagent container 100 in conjunction with the movement of the suction tube 252 by the movement mechanism 254. As shown in Figure 22, the suction tube holding portion 254a of the movement mechanism 254 is provided with a columnar entry member 281 extending in the Z direction, in addition to the suction tube 252. Therefore, the entry member 281 moves integrally in the Z direction with the suction tube 252, the suction tube holding portion 254a, the connecting portion 254d, and the linear rail 254b. When the reagent container 100 is placed in the set position Ps (i.e., when the opening 21a is placed directly below the suction tube 252), the entry member 281 is located directly above the hole 23d formed in the movement restricting portion 23. The recess formed in the movement restricting portion 23 is this hole 23d.
[0188] When the suction tube 252 is in the raised position P1, the entry member 281 is positioned above the hole 23d (see Figure 6) of the movement restricting section 23, and is not in contact with the reagent container 100. In the raised position P1, the distance between the tip of the entry member 281 and the movement restricting section 23 is smaller than the distance between the suction tube 252 and the opening 21a.
[0189] As the suction tube 252 moves downward, the entry member 281 also moves downward with the suction tube 252 and enters the hole 23d (see Figure 6) of the movement restricting section 23. As a result, as shown in Figure 25, the outer surface of the entry member 281 and the fourth surface 24e, which is the inner surface of the hole 23d, come into contact. Note that the tip of the entry member 281 enters the hole 23d first, and then the tip of the suction tube 252 is inserted into the opening 21a. Therefore, at the time the tip of the suction tube 252 is inserted into the opening 21a, the entry member 281 is in contact with the movement restricting section 23. As a result, even if an external force causing displacement occurs on the movement restricting member 23 for some reason, such as the suction tube 252 coming into contact with the inner surface of the opening 21a at the time the suction tube 252 is inserted into the opening 21a, the insertion member 281 inserted into the hole 23d will suppress the movement of the movement restricting member 23.
[0190] As shown in Figure 24, when the suction tube 252 is in the lowered position P2, the entry member 281 passes through the hole 23d of the movement restricting part 23, and the tip of the entry member 281 is inserted into the fixing hole 261c formed in the bottom surface 261b of the container holding part 251. In this state, the upper end of the entry member 281 is held by the suction tube holding part 254a, and the lower end (tip) of the entry member 281 abuts against the housing part 260 through the fixing hole 261c, so that both ends of the entry member 281 are firmly held in place so that they do not move. As a result, while the suction tube 252 is in the lowered position P2, the movement restricting part 23 that abuts against the entry member 281 at the hole 23d is immobile in the horizontal direction. This ensures that the opening 21a is securely fixed by the contact between the contact part 280 (entry member 281) and the hole 23d formed in the movement restricting part 23.
[0191] (Differences between reagent container holders) The structure of the reagent container holder 250a, which accommodates a large reagent container 100, has been described above. As shown in Figure 15, the reagent container holder 250b also accommodates a large reagent container 100, and therefore has the same structure as the reagent container holder 250a. The reagent container holder 250c, which accommodates a small reagent container 200, has structural differences from the reagent container holders 250a and 250b, as it is designed to accommodate a small reagent container 200.
[0192] Specifically, because the small reagent container 200 has a smaller height (vertical dimension) compared to the large reagent container 100, the reagent container holder 250c is provided with a spacer 290 to raise the bottom position of the container holding part 251. The reagent container holder 250c is configured such that the height position of the opening 21a of the reagent container 200 is equal to the height position of the opening 21a of the reagent container 100 installed in the reagent container holder 250a (250b) due to the spacer 290. As a result, the insertion height of the large reagent container 100 in the reagent container holders 250a and 250b is the same as the insertion height of the small reagent container 200 in the reagent container holder 250c. Specifically, the height position of the movement restricting section 23 for reagent container 100 in reagent container holders 250a and 250b (the height position of the second insertion section 262) is the same as the height position of the movement restricting section 23 for reagent container 200 in reagent container holder 250c (the height position of the second insertion section 262). This allows the user to ensure that the insertion height of each reagent container 100 and 200 is the same when installing them, thus facilitating the installation process.
[0193] Furthermore, in the reagent container holder 250c, the travel distance of the suction tube 252 between the raised position P1 and the lowered position P2 is set to be short to accommodate the small reagent container 200, which has a smaller height. Reflecting this short travel distance, the vertical dimension of the reagent container holder 250c is smaller than that of the reagent container holder 250a (250b).
[0194] The rest of the structure of reagent container holder 250c is the same as that of reagent container holder 250a (250b).
[0195] (Setting up reagent containers) Next, the procedure for installing the reagent container 100 into the reagent container holder 250a of the measurement unit 201 will be described. Since the installation procedure is the same for reagent containers 100 and 200, only the installation procedure for reagent container 100 will be described, and the installation procedure for reagent container 200 will be omitted. Similarly, only the installation procedure for reagent container 100 into reagent container holder 250a will be described here, and the installation procedures for the other reagent container holders 250b and 250c will be omitted.
[0196] First, the user opens the front cover 206a (see Figure 12), grasps the operating grip 253a of the reagent container holder 250a, moves the operating unit 253 to the removal position Q1 (see Figure 22), and opens the inlet of the container holding unit 251. The suction tube 252 is moved to the raised position P1 as the operating unit 253 is positioned at the removal position Q1.
[0197] Next, the user inserts the reagent container 100 into the housing section 260 of the container holding section 251, as shown in Figure 23. As shown in Figure 16, the user grasps the gripping section 25 of the movement restricting section 23 and inserts one end 23a of the movement restricting section 23 in the first direction A into the second insertion section 262 of the housing section 260 in the Y2 direction. At this time, the guide sections 23e (see Figure 6), which are both ends of the movement restricting section 23 in the second direction B, are positioned within the pair of groove-shaped sections 262a of the second insertion section 262, thereby guiding the movement restricting section 23 to move in the Y direction within the second insertion section 262. As the movement restricting section 23 moves in the Y2 direction within the second insertion section 262, the reagent housing section 10 enters the first insertion section 261 in the Y2 direction.
[0198] As shown in Figure 21, when the movement restricting section 23 reaches the installation position of the protruding member 273, the second surfaces 24b and 24c on both sides of the movement restricting section 23 push the third contact surfaces 273a of the pair of protruding members 273 outward in the X direction. Since the movement restricting section 23 is biased from both sides by the pair of protruding members 273, the center position of the movement restricting section 23 is aligned with the center of the second insertion section 262 in the X direction.
[0199] As shown in Figure 20, the first surface 24a at one end 23a of the movement restricting portion 23 comes into contact with the first contact surface 271, thereby positioning the reagent container 100 at the set position Ps where the opening 21a is located directly below the suction tube 252. At this time, the third contact surfaces 273a of each of the pair of protruding members 273 of the second insertion portion 262 come into contact with the third surfaces 24d in the notches 23c on both sides of the movement restricting portion 23, thereby restricting the movement of the movement restricting portion 23 in the Y direction.
[0200] Furthermore, as shown in Figure 19, at both ends of the movement restricting portion 23 in the second direction B, the lower surface 23g of the movement restricting portion 23 is supported by the lower contact surface 275 of the second insertion portion 262. As a result, the entire reagent container 100 is supported by the pair of lower contact surfaces 275. At both ends of the movement restricting portion 23 in the second direction B, the upper surface 23f of the movement restricting portion 23 faces the upper contact surface 274, thereby restricting upward movement of the movement restricting portion 23 beyond the allowable range.
[0201] Subsequently, as shown in Figures 23 and 24, the user moves the operating section 253 of the reagent container holder 250a downward from the removal position Q1 to the removal prevention position Q2. This causes the suction tube 252 and the entry member 281 to move downward. First, the entry member 281 is inserted into the hole 23d (see Figure 25) of the movement restricting section 23, and then the suction tube 252 is inserted into the opening 21a. Note that a suction tube guide section 21c is provided inside the reagent storage section 10 below the opening 21a. Therefore, even if the entry angle of the suction tube 252 is slightly inclined with respect to the central axis of the opening 21a, the tip of the suction tube 252 is guided by the suction tube guide section 21c towards the inner bottom of the reagent storage section 10 without contacting the inner surface of the reagent storage section 10.
[0202] As shown in Figure 26(A), during the downward movement of the suction tube 252, the sealing body 252a provided on the suction tube 252 comes into contact with the sealing surface 21b of the opening 21a from above. After the suction tube 252 moves downward by the movement mechanism 254 and the sealing body 252a comes into contact with the sealing surface 21b of the opening 21a, the suction tube 252 is moved further downward to a predetermined lowered position P2. The suction tube 252 moves downward while compressing the biasing member 252b. Note that Figure 26(A) shows the state just before the sealing body 252a comes into contact with the sealing surface 21b of the opening 21a.
[0203] As shown in Figure 24, when the operating unit 253 moves to the removal prevention position Q2, the tip of the suction tube 252, which is in the lowered position P2, is positioned near the inner bottom of the reagent storage unit 10.
[0204] As shown in Figure 26(B), at the lowered position P2, the biasing member 252b is compressed, thereby biasing the sealant 252a toward the opening 21a. As a result, the sealant 252a elastically deforms and comes into close contact with the sealing surface 21b of the opening 21a, and the opening 21a is reliably sealed by the sealant 252a. The horizontal and vertical positioning of the opening 21a is controlled by the contact between the movement restricting portion 23 and the contact portion 270, and the sealant 252a is biased toward the edge of the opening 21a by the biasing member 252b, so the opening 21a is reliably sealed by the sealant 252a.
[0205] Furthermore, when the operating unit 253 moves to the removal prevention position Q2, the entry member 281 comes into contact with the fixing hole 261c (see Figure 24) of the housing unit 260, thereby suppressing misalignment of the opening 21a via the contacting entry member 281 and the movement restricting unit 23. The operating unit 253 is positioned in front of the entrance of the housing unit 260 when the reagent container 100 is housed in the removal prevention position Q2 (towards the Y1 direction), and covers the entrance of the housing unit 260. This prevents the user from accidentally pulling out the reagent container 100 from the housing unit 260.
[0206] With the above steps completed, the process of placing the reagent container 100 into the reagent container holder 250a is finished.
[0207] (Replacement of reagent container) Next, the procedure for replacing reagent container 100 will be described. Since the replacement procedure is the same for reagent containers 100 and 200, only the procedure for replacing reagent container 100 will be described, and the procedure for replacing reagent container 200 will be omitted. Similarly, only the procedure for replacing reagent container 100 in reagent container holder 250a will be described here, and the procedures for replacing reagent container 100 in the other reagent container holders 250b and 250c will be omitted.
[0208] First, the user opens the front cover 206a (see Figure 12), grasps the operating grip 253a of the operating unit 253, and moves the operating unit 253 to the removal position Q1 (see Figure 23), thereby opening the entrance to the container holding unit 251. As shown in Figure 23, the suction tube 252 is pulled out from the opening 21a as the operating unit 253 is positioned at the removal position Q1, and is positioned at the raised position P1 above the container holding unit 251. The entry member 281 also retracts above the hole 23d of the movement restricting unit 23.
[0209] Next, the user removes the reagent container 100, which is positioned at set position Ps, from the storage section 260. As shown in Figure 17, the user grasps the gripping portion 25 of the movement restricting portion 23 and pulls the movement restricting portion 23 out in the Y1 direction. Since the movement restricting portion 23 is in contact with the protruding member 273 at the notch 23c (see Figure 20), the user pulls the movement restricting portion 23 in the Y1 direction against the elastic force of the protruding member 273. This releases the contact between the notch 23c and the protruding member 273.
[0210] The user continues to pull the movement restricting section 23 in the Y1 direction, thereby removing the movement restricting section 23 from the second insertion section 262 in the Y1 direction, and simultaneously removing the reagent storage section 10 from the first insertion section 261 in the Y1 direction.
[0211] Subsequently, the user performs an installation operation to set the new reagent container 100 into the container holding unit 251. The details of the installation operation are as described above. In this way, the suction tube 252, the sealant 252a, and the entry member 281 move up and down in conjunction with the operating unit 253, so the user can retract the suction tube 252, release the seal provided by the sealant 252a, and release the contact between the entry member 281 and the movement restricting unit 23 in a single action simply by lifting the operating unit 253.
[0212] (Operation of the analytical instrument) Next, the measurement processing operation of the analytical apparatus 300 according to the first embodiment will be described with reference to Figures 13 and 14. Since the components to be analyzed are measured similarly in both the first measurement unit 201a and the second measurement unit 201b, the following description will focus on the case where the components to be analyzed are measured using the second measurement unit 201b, and the description of the measurement processing operation of the first measurement unit 201a will be omitted. The measurement processing operation of the second measurement unit 201b is controlled by the measurement control unit 210 based on the control of the analysis unit 203. Here, only the FCM measurement unit 241 will be described, and the other measurement methods will be omitted.
[0213] First, as shown in Figure 13, after the barcode is read at reading position 4c, the sample container 1 is transported to intake position 4a and then taken into the second measurement unit 201b by the container transfer mechanism 211. From the sample container 1, which has been transported to aspiration position 4d by the container transfer mechanism 211, the sample is aspirated by the sample aspiration unit 220, as shown in Figure 14, and the quantified sample is supplied to the reaction chamber 231 of the sample preparation unit 230. Then, the sample preparation unit 230 prepares the measurement sample from the aspirated sample.
[0214] Specifically, the quantitative unit 232 and the electromagnetic valve 233a (233b) operate to supply reagents contained in each reagent container 100 (or 200) set in the reagent suction unit 250 to a predetermined reaction chamber 231 corresponding to the measurement item. Furthermore, the quantitative unit 234 and the electromagnetic valve 235a (235b) operate to supply reagents (hemolytic agents) contained in an external large-capacity reagent container 3 to a predetermined reaction chamber 231. Then, the sample and reagent are mixed in the reaction chamber 231 and the measurement sample is prepared through the reaction process.
[0215] Next, the component to be analyzed is detected from the sample by the detection unit 240. The sample prepared using the reagent contained in the reagent container 100 (or 200) is supplied to the FCM measurement unit 241 of the detection unit 240, where various measurement items are measured by flow cytometry. After the measurement is complete, the measured sample in the reaction chamber 231 is discarded into the waste liquid chamber 246 via the electromagnetic valve 245. The measurement data is then transmitted from the measurement control unit 210 of the second measurement unit 201b to the analysis unit 203.
[0216] Subsequently, the control unit 203a analyzes the target components based on the measurement results transmitted from the second measurement unit 201b. This completes the analysis of the sample, and the operation ends.
[0217] [Second form of reagent container] A reagent container 100 according to a second aspect of the present invention, as shown in Figures 1, 2, 22 to 24, and 26, is a reagent container 100 for containing a reagent that is drawn in by a suction tube 252 provided on an analyzer 300, and comprises a reagent storage section 10 for containing the reagent and a frame 20 provided on the reagent storage section 10, which includes an opening 21a. As shown in Figures 23, 24, and 26, the frame 20 is configured such that the opening 21a is closed by a sealing body 252a that moves together with the suction tube 252 when the suction tube 252 is inserted from above in conjunction with a predetermined operation on the analyzer 300.
[0218] As a result, the user does not need to insert the suction tube 252 into the opening 21a of the reagent container 100 before installation, so the reagent container 100 can be easily installed in the analyzer 300. In addition, since the opening 21a is closed by the sealing body 252a that moves together with the suction tube 252, contact between the reagent in the reagent storage section 10 and the outside air can be suppressed. Therefore, deterioration of the reagent after installation in the analyzer 300 can be suppressed.
[0219] [Third form of reagent container] A reagent container 100 according to a third aspect of the present invention, as shown in Figures 1, 2, 22 to 24, and 26, is a reagent container 100 for containing reagents drawn in by a suction tube 252 that is vertically movable on an analyzer 300, and comprises a reagent storage section 10 for containing reagents, a mounting member 22 provided on the reagent storage section 10 and having an opening 21a, and a movement restricting section 23 attached to the mounting member 22. As shown in Figures 19 and 20, the movement restricting section 23 is configured to support the reagent storage section 10 via the mounting member 22 by contacting a part of the analyzer 300 (see Figure 20), thereby positioning the opening 21a directly below the suction tube 252 (set position Ps, see Figure 23) and contacting a part of the analyzer 300.
[0220] In the reagent container 100 according to the third embodiment, the movement restricting part 23 (see Figures 19 and 20) contacts a part of the analyzer 300, thereby positioning the opening 21a directly below the suction tube 252 and supporting the reagent storage part 10 via the mounting member 22. As a result, when installing the reagent container 100 into the analyzer 300, as shown in Figures 23 to 24, the movement restricting part 23 contacts the contact part 270 of the analyzer 300, and then the suction tube 252 is inserted into the opening 21a simply by moving the suction tube 252 downward. Therefore, since the user does not need to insert the suction tube 252 into the opening 21a of the reagent container 100 before installation, the reagent container 100 can be easily installed into the analyzer 300.
[0221] [Reagent container kit] Next, with reference to Figure 27, the reagent container kit 450 of this embodiment will be described. The reagent container kit 450 is a reagent container kit for assembling a reagent container 100 that contains reagents that are repeatedly aspirated while the suction tube 252 provided in the analyzer 300 is inserted.
[0222] The reagent container kit 450 comprises a bag-shaped reagent storage section 10 for containing reagents, and a frame 20 that includes an opening 21a and can be attached to the reagent storage section 10. In the reagent container kit 450, the container body 451, which consists of the reagent storage section 10 and a mounting member 22 attached to the reagent storage section 10, and the movement restricting section 23 are provided to the user in a separate state. The reagent container 100 is assembled by the user attaching the movement restricting section 23 to the opening 21 and supported portion 22a of the mounting member 22.
[0223] As described above, the frame 20 is attached to the reagent storage section 10 and is configured such that the inside of the reagent storage section 10 is sealed when the suction tube 252 is inserted from above in conjunction with a predetermined operation on the analyzer 300.
[0224] As a result, with the reagent container kit 450 of this embodiment, the user does not need to insert the suction tube 252 into the opening 21a of the reagent container 100 before installation, so the reagent container 100 can be easily installed in the analyzer 300. In addition, since the inside of the reagent storage section 10 is sealed when the suction tube 252 is inserted, contact between the reagent inside the reagent storage section 10 and the outside air can be suppressed. Therefore, deterioration of the reagent after installation in the analyzer 300 can be suppressed.
[0225] [Method for assembling reagent containers] The assembly method for assembling the reagent container 100 from the reagent container kit 450 of this embodiment will now be described. The assembly method for the reagent container 100 of this embodiment is as shown in Figure 27 and comprises a container body 451 including a reagent storage section 10 for storing reagents and a mounting member 22 having an opening 21a and provided on the reagent storage section 10, and a movement restricting section 23 that contacts a part of the analyzer 300 and restricts the movement of the opening 21a so that the inside of the reagent storage section 10 is sealed when a suction tube 252 is inserted into the reagent storage section 10 from above in conjunction with a predetermined operation on the analyzer 300.
[0226] In the assembly method of the reagent container 100 of this embodiment, firstly, the movement restricting part 23 is placed on the mounting member 22 of the reagent container 100. Specifically, the connection part (fixing part 26, support part 27) of the movement restricting part 23 is placed directly above the mounting portion (opening 21, supported part 22a) of the mounting member 22. Then, the movement restricting part 23 is placed on the mounting member 22 such that the opening 21 and the supported part 22a are located inside the through hole 26a of the fixing part 26 and inside the first through hole 27a of the support part 27, respectively.
[0227] Secondly, the mounting member 22 and the movement restricting part 23 are engaged with each other by moving the movement restricting part 23 relative to the mounting member 22. That is, with the opening 21 positioned inside the through hole 26a of the fixing part 26 and the supported part 22a positioned inside the first through hole 27a of the support part 27, the movement restricting part 23 is moved toward one end 23a in the first direction A. As a result, the neck portion 21d of the opening 21 is sandwiched between the pair of engaging pieces 26b, causing the fixing part 26 to engage with the opening 21. Also, as the supported part 22a moves from the first through hole 27a to the second through hole 27b, the supported part 22a engages with the support part 27. This completes the assembly of the reagent container 100.
[0228] When the assembled reagent container 100 is placed in the analyzer 300, the movement restricting unit 23 contacts a part of the analyzer 300, thereby restricting the movement of the opening 21a so that the inside of the reagent storage section 10 is sealed when the suction tube 252 is inserted into the reagent storage section 10 from above in conjunction with a predetermined operation on the analyzer 300. As a result, the user does not need to insert the suction tube 252 into the opening 21a of the reagent container 100 before placing the reagent container 100, so the reagent container 100 can be easily placed in the analyzer 300. In addition, since the inside of the reagent storage section 10 is sealed when the suction tube 252 is inserted, contact between the reagent inside the reagent storage section 10 and the outside air can be suppressed. Therefore, deterioration of the reagent after placement in the analyzer 300 can be suppressed.
[0229] [Container body] As shown in Figure 27, the reagent container 100 of this embodiment comprises a container body 451 including a reagent storage section 10 for storing reagents and a mounting member 22 having an opening 21a and provided on the reagent storage section 10. The mounting member 22 has a mounting portion (opening 21, supported portion 22a) to which a frame 20 that restricts the movement of the opening 21a is attached so that the inside of the reagent storage section 10 is sealed when a suction tube 252 is inserted from above in conjunction with a predetermined operation of the analyzer 300 is attached.
[0230] As a result, by attaching the frame 20 to the mounting member 22 and installing the reagent container 100 in the analyzer 300, the suction tube 252 can be inserted in conjunction with predetermined operations on the analyzer 300. This eliminates the need for the user to insert the suction tube 252 into the opening 21a of the reagent container 100 before installation, making it easy to install the reagent container 100 into the analyzer 300. Furthermore, since the inside of the reagent storage section 10 is sealed when the suction tube 252 is inserted, contact between the reagent inside the reagent storage section 10 and the outside air can be suppressed. Therefore, deterioration of the reagent after installation in the analyzer 300 can be suppressed.
[0231] Furthermore, in this embodiment, the mounting member 22 has multiple mounting portions (openings 21, supported portions 22a) arranged at intervals from each other. As a result, when carrying the reagent container 100, the reagent storage section 10 is supported by being suspended from the frame 20 at multiple points between the openings 21 and the supported portions 22a. Since the weight of the reagent storage section 10 is distributed and acted upon at multiple points of the movement restricting section 23, the reagent storage section 10 can be stably supported even if its capacity is large.
[0232] [frame] As shown in Figures 3 and 27, the frame 20 of this embodiment is attached to a reagent container 100 that contains reagents drawn in by a suction tube 252 provided on the analyzer 300, and includes a movement restricting part 23 having a connecting part (fixing part 26 and support part 27) that connects to the reagent container 100 which is provided with an opening 21a. As shown in Figures 18 to 20 and 23 to 24, the movement restricting part 23 contacts a part of the analyzer 300 (contact part 270) to restrict the movement of the opening 21a so that the inside of the reagent container 100 is sealed when the suction tube 252 is inserted into the reagent container 100 from above in conjunction with a predetermined operation on the analyzer 300.
[0233] As a result, as shown in Figures 22 and 23, the user does not need to insert the suction tube 252 into the opening 21a of the reagent container 100 before installation, so the reagent container 100 can be easily installed in the analyzer 300. Also, as shown in Figure 24, the inside of the reagent storage section 10 is sealed when the suction tube 252 is inserted, so that the reagent inside the reagent storage section 10 does not come into contact with the outside air. Therefore, the deterioration of the reagent after installation in the analyzer 300 can be suppressed.
[0234] (Other forms of reagent containers) In the present invention, the reagent container may have various configurations, for example, as shown in Figure 28.
[0235] Figures 28(A) to (D) show various modified versions of the reagent container. In the reagent container 400a of Figure 28(A), the width of the movement restricting portion 23 is larger than that of the reagent container 100 in Figure 2. Near one end 23a of the movement restricting portion 23, there is no hole 23d that engages with the entry member 281. In each of the reagent containers 400a to 400d in Figures 28(A) to (D), the amount of protrusion of the opening 21 from the movement restricting portion 23 is smaller compared to the reagent container 100 in Figure 2. The movement restricting portion 23 is fixed to the opening 21 by inserting the opening 21 from below into a hole formed in the movement restricting portion 23.
[0236] In the reagent container 400a in Figure 28(A) and the reagent container 400b in Figure 28(B), the gripping portion 401 has a flat plate shape that extends horizontally. In the reagent container 400c in Figure 28(C) and the reagent container 400d in Figure 28(D), a gripping portion 402a extending horizontally is provided, allowing the gripping portion 402a to be held between the top and bottom, and a pair of gripping portions 402b extending vertically are provided on both sides of the movement restricting portion 23, allowing the gripping portion 401b to be held between the left and right.
[0237] As shown in Figures 28(A) to (D), the movement restricting portion 23 is not limited to the shape shown in Figures 2 and 3. The shape of the movement restricting portion 23 is not limited to a plate shape, but may be a rod shape, a tubular shape, etc. The movement restricting portion 23 does not have to have a constant width. The movement restricting portion 23 does not have to have a constant thickness. The movement restricting portion 23 may have a shape in which either or both of its thickness and / or width change along the first direction A. The movement restricting portion 23 may have a shape in which either or both of its thickness and / or width change along the second direction B. The longitudinal direction of the movement restricting portion 23 and the longitudinal direction of the reagent storage portion 10 (110, 403, 404) may be different. The movement restricting portion 23 may have the same shape at one end 23a and the other end 23b in the first direction A, or they may have different shapes. Each side surface of the movement restricting portion 23 does not have to be formed in a straight line. Each side of the movement restricting section 23 may be curved or bent. The movement restricting section 23 does not necessarily have to be provided with gripping sections 25 (401, 402a, 402b).
[0238] In the reagent container 400b shown in Figure 28(B), a vertically elongated reagent storage section 404 is provided, with a shorter length in the first direction A and extending vertically. As shown in Figure 29, in the reagent container 400a, the lower end portion 403a of the reagent storage section 403 is provided such that it slopes downward from the other end 23b side to the one end 23a side in the first direction A. Therefore, the inner bottom surface of the reagent storage section 403 also slopes downward from the other end 23b side to the one end 23a side in the first direction A, making it easier for the reagent to accumulate directly below the opening 21a into which the suction tube 252 is inserted. As a result, the dead volume of the reagent can be reduced.
[0239] In the reagent container 400e shown in Figures 30(A) and (B), the movement restricting section 410 includes a fixing section 411a fixed to the opening 21 and a bottom support section 412 that supports the bottom of the reagent storage section 10. This allows the relative positions of the movement restricting section 410 and the opening 21a to be fixed. Furthermore, since the movement restricting section 410 supports the bottom of the reagent storage section 10, deformation of the easily deformable bag-shaped reagent storage section 10 is prevented, allowing the user to easily handle the reagent container 100.
[0240] The movement restricting section 410 includes a flat plate-shaped portion 411 having a fixed portion 411a, a bottom support portion 412, and a connecting portion 413 connecting the flat plate-shaped portion 411 and the bottom support portion 412. The flat plate-shaped portion 411 extends horizontally along the upper part of the reagent storage section 10, the bottom support portion 412 extends horizontally along the bottom of the reagent storage section 10, and the connecting portion 413 extends vertically along the end face on the other end 23b side of the reagent storage section 10. The movement restricting section 410 has a box-like shape with one side open. The one end 23a side in the first direction A of the movement restricting section 410 is open and serves as an entrance for inserting the reagent storage section 10. When the reagent container 10 is placed inside the movement restricting section 410, the reagent container 10 is surrounded by the flat plate portion 411, the bottom support portion 412, the connecting portion 413, and the side portion 414 of the movement restricting section 410, except for the one end 23a which is the entrance.
[0241] (Other embodiments of the sealed structure of the reagent container) Figure 26 shows an example in which a sealing body 252a provided on the suction tube 252 abuts against the sealing surface 21b, which is the upper surface of the opening 21, thereby sealing the opening 21a. However, Figures 31 and 32 show examples in which the position of the sealing surface 21b is different.
[0242] In Figure 31, the sealant 501 provided on the suction tube 252 has a shape that tapers downwards. The total width (diameter) of the lower end of the sealant 501 is smaller than the diameter of the opening 21a. The total width (diameter) of the upper end of the sealant 501 is larger than the diameter of the opening 21a. The outer circumference between the lower and upper ends of the sealant 501 is inclined.
[0243] As a result, when the suction tube 252 is inserted into the reagent container 10 through the opening 21a, the lower end of the sealant 501 enters the interior of the opening 21a, and the inclined surface between the lower and upper ends of the sealant 501 fits tightly into the inner circumferential surface of the opening 21, thereby sealing the opening 21a. In this configuration, the opening 21 has a sealing surface 421 which is the inner circumferential surface of the opening 21.
[0244] In Figure 32, the sealing body 502 provided on the suction tube 252 has a recess 502a on its lower surface into which the opening 21 is fitted. The recess 502a opens on the lower surface of the sealing body 502 and is tapered upwards. The inner diameter of the lower end of the recess 502a is larger than the outer diameter of the opening 21. The inner diameter of the upper end of the recess 502a is smaller than the outer diameter of the opening 21. The inner circumference between the lower and upper ends of the recess 502a is an inclined surface. Note that the upper end of the recess 502a does not reach the upper surface of the sealing body 502, and the recess 502a is a non-penetrating recess.
[0245] As a result, when the suction tube 252 is inserted into the reagent container 10 through the opening 21a, the opening 21 enters the interior of the recess 502a of the sealant 502, and the outer surface of the opening 21 fits tightly against the inclined surface between the lower and upper ends of the recess 502a, thereby sealing the opening 21a. In this configuration, the opening 21 has a sealing surface 422 made up of the outer surface of the opening 21.
[0246] <Example of a reagent container with a sealing section> Figures 31 and 32 show an example in which the opening 21a is sealed by sealing bodies 501 and 502 provided on the suction tube 252, while Figure 33 shows an example in which the reagent container 100 is provided with a structure to seal the opening 21a.
[0247] The frame 20 of the reagent container 100 includes an elastically deformable sealing portion 430 that covers the opening 21a. The sealing portion 430 is a cap that fits into the opening 21a formed in the opening 21 of the frame 20. The sealing portion 430 is made of an elastically deformable rubber material such as silicone rubber.
[0248] The sealing portion 430 is configured to deform as the suction tube 252 is inserted, thereby sealing the gap between the suction tube 252 and the opening 21a. Specifically, the sealing portion 430 has a membrane-like portion 431 that covers the opening 21a, and a through-hole 431a is provided in the center of the membrane-like portion 431 through which the suction tube 252 passes. On the lower surface of the membrane-like portion 431, a plurality of downward-facing, protruding contact portions 432 are arranged in an annular pattern surrounding the through-hole 431a.
[0249] As shown in Figure 33(B), when the suction tube 252 is inserted into the through hole 431a, the membrane portion 431, which is pulled by friction with the suction tube 252, elastically deforms downward into a convex shape, and the distance between the tips of the multiple contact portions 432 provided on the lower surface of the membrane portion 431 is widened.
[0250] On the other hand, as shown in Figure 33(A), when the suction tube 252 moves upward from the through hole 431a, the membrane portion 431 elastically deforms upward into a convex shape, reducing the distance between the tips of the multiple contact portions 432 provided on the lower surface of the membrane portion 431, and causing it to adhere tightly to the outer surface of the suction tube 252. As a result, the outer surface of the suction tube 252 adheres tightly to each contact portion 432 around its entire circumference, sealing the gap between the suction tube 252 and the sealing portion 430.
[0251] The suction tube 252 is configured to apply an upward biasing force to the sealing portion 430 to such an extent that a sealed state is maintained by the multiple contact portions 432 while it is inserted into the reagent storage portion 10 of the reagent container 100. In this configuration, the suction tube 252 is not provided with a sealing body 252a. This makes it possible to achieve a structure in which the opening 21a is sealed by the elastic deformation of the sealing portion 430 provided in the reagent container 100, even without providing a sealing body 252a in the suction tube 252.
[0252] (Other forms of analytical instruments) In the present invention, the analytical apparatus 300 may be configured as shown in Figures 34 to 39, for example.
[0253] <Other examples of entry components> Figure 22 shows an example in which the contact portion 280 of the analyzer 300 includes an entry member 281 that enters a recess formed in the movement restricting portion 23 of the reagent container 100 in conjunction with the movement of the suction tube 252 by the movement mechanism 254. However, in Figures 34 and 35, the contact portion 280 of the analyzer 300 includes an entry member 511 that enters a recess formed in the movement restricting portion 23 of the reagent container 100 in conjunction with the placement of the reagent container 100 into the container holding portion 251.
[0254] In Figure 34, the entry member 511 is provided on a movable member 510 on which a contact piece 512 is formed. The movable member 510 is provided on the lower chassis 255a (see Figure 15), is rotatably supported by a rotating shaft 513, and is biased by a biasing member 514 toward the disengagement position 516a shown in Figure 34. In the disengagement position 516a, the entry member 511 is retracted above the movement restricting portion 23 of the reagent container 100.
[0255] As the reagent container 100 is moved toward the set position Ps of the container holding section 251, one end 23a of the movement restricting section 23 of the reagent container 100 comes into contact with the contact piece 512. As the reagent container 100 reaches the set position Ps, the movement restricting section 23 moves against the biasing force of the biasing member 514, pushing away the contact piece 512. As the contact piece 512 is pushed, the movable member 510 rotates around the rotation axis 513 from the disengaged position 516a to the engaged position 516b (see Figure 35). As the movable member 510 rotates, the entry member 511 enters the hole 23d (see Figure 6) of the movement restricting section 23.
[0256] As a result, as shown in Figure 35, when the reagent container 100 is placed in the set position Ps, the movable member 510 is placed in the engagement position 516b, and the entry member 511 comes into contact with the fourth surface 24e, which is the inner surface of the hole 23d, thereby engaging the entry member 511 with the movement restricting part 23. This engagement between the entry member 511 and the movement restricting part 23 allows the position of the opening 21a to be fixed in advance before the suction tube 252 is moved.
[0257] In the examples shown in Figures 34 and 35, the analyzer 300 is further provided with a switching mechanism 520 that switches between a state in which the movement mechanism 254 allows the suction tube 252 to move and a state in which the movement mechanism 254 prohibits the suction tube 252 from moving, in conjunction with the engagement of the entry member 511 and the movement restricting part 23.
[0258] The switching mechanism 520 includes a moving member 521 capable of reciprocating in the Y direction, and an engagement pin 522 provided on the moving member 521. The moving member 521 has an engagement hole 523 that engages with an engagement shaft 515 provided on the movable member 510. The engagement hole 523 is an elongated hole extending in the Z direction, and when the engagement shaft 515 moves in an arc shape as the movable member 510 rotates about the rotation shaft 513, the engagement shaft 515 moves the moving member 521 in the Y direction while changing its position in the Z direction within the engagement hole 523. That is, the moving member 521 is a cam mechanism that converts the rotational motion of the movable member 510 into reciprocating motion in the Y direction. The engagement pin 522 of the moving member 521 is disposed in a guide groove 530 formed in an upper chassis 255b (see FIG. 36) attached to the moving mechanism 254 (linear rail 254b, see FIG. 22). The guide groove 530 shown in FIG. 36 includes a first portion 531 extending in the Z direction, and a second portion 532 extending in the Y direction at the lower end of the first portion 531.
[0259] When the movable member 510 is at the disengagement position 516a (see FIG. 34), the engagement pin 522 of the moving member 521 is disposed inside the second portion 532 of the guide groove 530 in FIG. 36(A). When the engagement pin 522 is in the second portion 532, if the upper chassis 255b attempts to move downward, the inner peripheral surface of the second portion 532 comes into contact with the engagement pin 522, so that the upper chassis 255b cannot move downward. Therefore, the operation unit 253, the suction tube 252, and the upper chassis 255b, which move integrally with the linear rail 254b, are prohibited from moving from the raised position to the lowered position. That is, the user cannot move the operation unit 253 and the suction tube 252 downward until the reagent container 100 is properly placed at the set position Ps.
[0260] When the movable member 510 moves from the disengagement position 516a to the engagement position 516b (see FIG. 35), the moving member 521 moves in the Y1 direction, and the engagement pin 522 moves from the second portion 532 to the lower end portion of the first portion 531 (see FIG. 36(B)). Since the first portion 531 extends in the Z direction, when the engagement pin 522 is at the lower end portion of the first portion 531, the upper chassis 255b is movable downward. Therefore, the operation portion 253, the suction tube 252, and the upper chassis 255b that move integrally with the linear rail 254b are allowed to move from the raised position to the lowered position. That is, in a state where the reagent container 100 is properly arranged at the set position Ps, the user is allowed to move the operation portion 253 and the suction tube 252 downward.
[0261] According to this configuration, since the suction tube 252 cannot move downward when the reagent container 100 has not reached the set position Ps, it is possible to prevent the user from erroneously moving the suction tube 252.
[0262] <Sealing Switching Mechanism for Sealing Body> In the example shown in FIG. 23, since the suction tube 252 is provided with the sealing body 252a, the sealing body 252a seals or unseals the opening 21a as the suction tube 252 moves up and down. In contrast, in FIG. 37, the analyzer 300 includes a sealing switching mechanism 540 that operates the sealing portion 440 provided on the reagent container 100 to switch between sealing and unsealing the opening 21a.
[0263] As shown in FIG. 37(A), the opening 21 of the reagent container 100 is provided with a packing 441 covering the opening 21a, a caulking member 442 arranged on the packing 441, and a disengagement member 443 arranged on the caulking member 442. The opening 21 is further provided with a locking claw 444 that engages with the outer peripheral portion of the caulking member 442. The packing 441, the caulking member 442, and the disengagement member 443 are each provided with an insertion hole for inserting the suction tube 252 therethrough.
[0264] The sealing switching mechanism 540 includes a release part 541 that operates the release member 443 and a sealing part 542 that operates the crimping member 442. As shown in Figure 37(B), the suction tube 252 is inserted into the opening 21a from above the reagent container 100, passing through the insertion holes of the packing 441, the crimping member 442, and the release member 443. After the suction tube 252 is inserted, the sealing switching mechanism 540 uses the sealing part 542 to press the crimping member 442 downward toward the packing 441. The pressure from the sealing part 542 causes the crimping member 442 to compress and deform the packing 441 inward toward the insertion hole. As a result, the packing 441 comes into close contact with the suction tube 252 in the insertion hole, sealing the opening 21a. At this time, the locking claw 444 engages with the groove on the outer circumference of the crimping member 442, maintaining the sealed state by the crimping member 442 against the repulsive force of the packing 441.
[0265] When the suction tube 252 is withdrawn from the reagent container 10, as shown in Figure 37(C), the sealing switching mechanism 540 uses the release part 541 to press the release member 443 downward toward the locking claw 444. The release member 443 pushes down the locking claw 444, thereby releasing the engagement between the crimping member 442 and the locking claw 444. As a result, the compressed packing 441 pushes the crimping member 442 upward and returns to its uncompressed state as shown in Figure 37(A). As a result, the tight seal between the suction tube 252 and the packing 441 in the insertion hole is released, the sealing of the opening 21a is released, and the suction tube 252 becomes movable.
[0266] <Example of configuration of the operating section and moving mechanism> In the examples shown in Figures 22 to 24, the moving mechanism 254 is configured to move the suction tube 252, but in Figure 38, the moving mechanism 254 moves the mounting member 550 on which the reagent container 100 is placed relative to the suction tube 252.
[0267] The operating section 253 includes a mounting member 550 on which the bottom of the reagent container 100 is placed. The moving mechanism 254 movably supports the mounting member 550. The moving mechanism 254 consists of a linear rail into which the mounting member 550 slidably engages, and supports the mounting member 550 so that it can move in the Z direction between a lowered position P12 shown in Figure 38(A) and an raised position P11 shown in Figure 38(B). In Figure 38, the suction tube 252 is fixed to the chassis 551 and does not move.
[0268] The moving mechanism 254 is configured to move the mounting member 550 in conjunction with a predetermined operation on the mounting member 550, thereby allowing the suction tube 252 to enter the reagent container 100 placed on the mounting member 550 and retracting the suction tube 252 outside the reagent container 100. Specifically, as shown in Figure 38(A), after the user places the reagent container 100 at the set position Ps on the mounting member 550 at the lowered position P12, the user pushes the mounting member 550 upward, as shown in Figure 38(B). This causes the reagent container 100 on the mounting member 550 to move upward toward the suction tube 252, and the suction tube 252 is inserted into the opening 21a. At the raised position P11 shown in Figure 38(B), the opening 21a is sealed by the sealant 252a.
[0269] Thus, instead of moving the suction tube 252, the reagent container 100 may be moved toward the suction tube 252 by the mounting member 550, thereby inserting the suction tube 252 into the reagent container 100. Alternatively, both the suction tube 252 and the mounting member 550 may be moved.
[0270] Furthermore, while Figures 22 to 24 show an example where the operating section 253 is configured as a cover for the reagent container holders 250a to 250c, as shown in Figure 38, the operating section 253 may also be configured as a mounting member 550 for the reagent container 100, other than a cover.
[0271] In addition, in Figure 39, the operation unit 253 includes a switch 560 that accepts predetermined operations. The switch 560 accepts operation input and outputs a signal to operate the moving mechanism 254. The switch 560 may be a mechanical hardware switch or a switch displayed on the display unit 203b as a GUI (Graphical User Interface).
[0272] The moving mechanism 254 includes a drive unit 561 and a moving mechanism 562 that move the reagent container 100 and the suction tube 252 relative to each other in conjunction with a predetermined operation on the operating unit 253. The drive unit 561 is, for example, an electric motor. The moving mechanism 562 is a screw shaft that engages with the nut portion of the suction tube holder 254a, and is rotated by the drive unit 561 to move the suction tube holder 254a and the suction tube 252 up and down.
[0273] The user places the reagent container 100 in the container holding unit 251 and then performs an input operation on the operation unit 253. When the operation unit 253 receives the input operation, it outputs a signal to the measurement control unit 210. The measurement control unit 210 operates the drive unit 561 in response to the signal from the operation unit 253. In Figure 39(B), the drive unit 561 moves the suction tube 252 downward and inserts the suction tube 252 into the opening 21a. In this way, the suction tube 252 may be moved by the drive unit 561 in response to the operation of the switch 560.
[0274] (Other examples of analytical instruments) In this embodiment, the analyzer 300 is shown as a blood cell counter, but it is not limited to this. The analyzer 300 can be any device that measures a sample using reagent 12. Reagent 12 contains components corresponding to the measurement principle of the sample by the analyzer 300, and is not limited to staining solutions.
[0275] <Coagulation analyzer> The analyzer 300 may be, for example, a coagulation analyzer that performs blood coagulation analysis. In this case, the sample is plasma or serum separated from blood. The detection unit 240 performs optical measurements of the sample using coagulation methods, synthetic substrate methods, immunoturbidimetry, and / or agglutination methods. The analysis unit 203 analyzes the sample based on the detected light.
[0276] In the coagulation method, the sample is irradiated with light, and the coagulation time, during which fibrinogen in the sample is converted to fibrin, is measured based on the electrical signal of the transmitted or scattered light from the sample. Reagent 12 is a coagulation reagent containing coagulation factors. Measurement items in the coagulation method include PT (prothrombin time), APTT (activated partial thromboplastin time), and Fbg (fibrinogen amount).
[0277] In the synthetic substrate method, the sample is irradiated with light, and the degree of color development due to the action of a chromogenic synthetic substrate on the enzyme in the sample is measured based on the electrical signal of the transmitted light from the sample. Reagent 12 contains a chromogenic synthetic substrate. Measurement items in the synthetic substrate method include ATIII (antithrombin III), α2-PI (α2-plasmin inhibitor), and PLG (plasminogen).
[0278] In immunoturbidimetry, an antibody-sensitizing reagent that elicits an antigen-antibody reaction with coagulation and fibrinolytic factors in the sample is added to the sample, and the substance contained in reagent 12 agglutinates as a result of the antigen-antibody reaction. Reagent 12 is an antibody-sensitizing reagent. In immunoturbidimetry, the sample to be measured is irradiated with light, and the agglutination rate of the reagent-containing substance in the sample is measured based on the electrical signal of the transmitted or scattered light from the sample. Measurement items in immunoturbidimetry include D-dimer and FDP (fibrin degradation products).
[0279] In the agglutination method, a measurement sample is irradiated with light, and a change in absorbance during the agglutination reaction process of platelets and the like in the measurement sample is measured based on an electrical signal of transmitted light from the sample. Reagent 12 contains a substance that induces a platelet agglutination reaction or immobilized platelets. Measurement items of the agglutination method include vWF:RCo (von Willebrand ristocetin cofactor) and platelet agglutination ability, and the like.
[0280] <Immunoassay Device> Further, for example, the analyzer 300 may be an immunoassay device. The analyzer 300 detects a target component by utilizing an antigen-antibody reaction between the target component in blood and a component in a reagent. As the target component, for example, an antigen or antibody, a protein, a peptide and the like contained in blood are detected. The immunoassay device acquires serum or plasma as a specimen, and performs quantitative measurement or qualitative measurement of an antigen, an antibody or the like contained in the specimen. The antigen-antibody reaction includes not only a reaction between an antigen and an antibody, but also a reaction using a specific binding substance such as an aptamer. An aptamer is a nucleic acid molecule or peptide synthesized to specifically bind to a specific substance.
[0281] The detection unit 240 measures light generated from the sample, that is, chemiluminescence based on the test substance contained in the specimen. The analysis unit 203 performs analysis based on the light detected by the detection unit 240. The reagent 12 can include a reagent containing a component that specifically binds to the target component to form an immune complex, a reagent containing a simple substance of the immune complex, a reagent containing a labeling substance, an enzyme reagent for generating chemiluminescence, and the like.
[0282] Here, chemiluminescence is light emitted by utilizing energy from a chemical reaction. Chemiluminescence is, for example, light emitted when a molecule is excited to an excited state by a chemical reaction and returns from the excited state to the ground state. The chemiluminescence detected by the detection unit is based on, for example, the enzyme immunochemiluminescence assay (CLEIA), and is light generated by a reaction between an enzyme and a substrate. Measurement items of the enzyme immunochemiluminescence assay include HBsAb, FT3, FT4, TSH and the like.
[0283] The chemiluminescence detected by the detection unit may be light obtained from methods such as chemiluminescence analysis (CLIA), electrochemiluminescence analysis (ECLIA), fluorescence enzyme analysis (FEIA), LOCI (Luminescent Oxygen Channeling Immunoassay), or BLEIA (Bioluminescent Enzyme Immunoassay).
[0284] It should be noted that the embodiments disclosed herein are illustrative and not restrictive in all respects. The scope of the present invention is indicated by the claims rather than by the description of the embodiments above, and further includes all modifications within the meaning and scope equivalent to the claims. [Explanation of symbols]
[0285] 10, 110, 403: Reagent storage section, 11: Laminated film material, 12: Reagent, 20: Frame, 21: Opening, 21a: Opening, 21b, 421, 422: Sealing surface, 21c: Suction tube guide section, 22: Mounting member, 22a: Supported section, 23, 410: Movement restricting section, 23a: One end, 23b: Other end, 23c: Notch, 23d: Hole, 23e: Guide section, 23f: Top surface, 23g: Bottom surface, 24: horizontal contact surface, 24a: first surface, 24b, 24c: second surface, 24d: third surface, 24e: fourth surface, 25, 401, 402a, 402b: gripping part, 26, 411a: fixing part, 27: support part, 28: information recording medium, 100, 200, 400a~400e: reagent container, 110: reagent storage part, 203: analysis part, 220: sample aspiration part, 230: sample preparation part, 240: Detection unit, 250: Reagent suction unit, 250a~c: Reagent container holder, 251: Container holding unit, 252: Suction tube, 252a, 501, 502: Sealing unit, 253: Operation unit, 254, 562: Moving mechanism, 256: Reading unit, 260: Storage unit, 261: First insertion unit, 262: Second insertion unit, 270, 280: Contact unit, 271: First contact surface, 272: Second contact surface, 273a: Third contact surface , 274: Upper contact surface, 275: Lower contact surface, 281, 511: Entry member, 300: Analytical device, 412: Bottom support part, 430, 440: Sealing part, 450: Reagent container kit, 451: Container body, 511: Entry member, 550: Mounting member, 560: Switch, 561: Drive unit, A: First direction, B: Second direction, Ps: Set position, Q1: Removal position, Q2: Removal prevention position
Claims
1. A reagent container for containing reagents drawn in by a suction tube provided in an analytical instrument, A bag-shaped reagent container for containing the aforementioned reagent, The device is configured such that the inside of the reagent storage section is sealed when the suction tube is inserted from above in conjunction with a predetermined operation of the analyzer, and includes a frame with an opening attached to the reagent storage section, A reagent container wherein the opening has a sealing surface that contacts a sealing body provided on the suction tube to seal the opening.
2. The reagent container according to claim 1, wherein the frame further includes a movement restricting portion configured to contact a part of the analyzer and restrict the movement of the opening.
3. The reagent container according to claim 2, wherein the movement restricting portion is configured to restrict the horizontal movement of the opening by contacting a part of the analyzer in the horizontal direction.
4. The reagent container according to claim 3, wherein the movement restricting portion is formed to face the inner surface of the container holding portion of the analyzer in each of the first and second directions which are mutually orthogonal in the horizontal plane.
5. The reagent container according to claim 3 or 4, wherein the movement restricting portion includes a horizontal contact surface consisting of the inner surface of a hole formed in the movement restricting portion, the inner surface of a notch formed in the movement restricting portion, and the side surface of the movement restricting portion.
6. The movement restricting portion has a shape that extends along a first direction in the horizontal plane, The reagent container according to claim 5, wherein the horizontal contact surface includes a first surface consisting of the side surface formed at the end of the movement restricting portion in the first direction.
7. The movement restricting portion has a shape that extends along a first direction in the horizontal plane, The reagent container according to claim 5, wherein the horizontal contact surface includes a second surface which is the side surface extending along the first direction of the movement restricting portion.
8. The aforementioned movement restricting portion has a notch formed on its side, The reagent container according to claim 5, wherein the horizontal contact surface is the inner surface of the notch and includes a third surface that contacts a part of the analyzer that enters the notch.
9. The aforementioned movement restricting portion has a hole formed on its upper surface, The reagent container according to claim 5, wherein the horizontal contact surface is the inner surface of the hole and includes a fourth surface that contacts a part of the analytical device that enters the inside of the hole.
10. The reagent container according to any one of claims 2 to 9, wherein the movement restricting portion is configured to restrict the vertical movement of the opening by contacting a part of the analyzer in the vertical direction.
11. The reagent container according to claim 10, wherein the movement restricting portion is formed to face the inner surface of the container holding portion of the analyzer in both the upward and downward directions.
12. The reagent container according to claim 10 or 11, wherein the movement restricting portion includes an upper surface and a lower surface that abut a part of the analyzer in the vertical direction.
13. The reagent container according to any one of claims 2 to 12, wherein the movement restricting portion is fixed to the opening so as to protrude horizontally from the opening.
14. The reagent container according to claim 13, wherein the movement restricting portion includes a fixing portion fixed to the opening and a support portion that supports the upper part of the reagent storage portion at a position away from the opening.
15. The aforementioned opening is formed in the mounting member provided on the upper part of the reagent storage section. The mounting member has a supported portion that is positioned horizontally apart from the opening, The reagent container according to claim 14, wherein the fixing portion is fixed to the opening and the support portion is fixed to the supported portion.
16. The mounting member is made of a resin material and is formed separately from the reagent storage section. The reagent container according to claim 15, wherein the outer periphery of the mounting member is welded to the inner periphery of the reagent storage portion.
17. The reagent container according to claim 13, wherein the movement restricting portion includes a fixing portion fixed to the opening and a bottom support portion that supports the bottom of the reagent storage portion.
18. The reagent container according to any one of claims 2 to 17, wherein the movement restricting portion extends along a first direction in the horizontal plane and has a guide portion that guides the movement when the opening is positioned below the suction tube of the analyzer.
19. The reagent container according to claim 18, wherein the movement restricting portion is fixed to the opening between one end of the movement restricting portion in the first direction and the central portion of the movement restricting portion.
20. The reagent container according to claim 18 or 19, wherein the movement restricting portion has a gripping portion at the other end of the movement restricting portion in the first direction for gripping the movement restricting portion.
21. The reagent container according to claim 20, wherein the gripping portion has a flat plate shape extending along the horizontal or vertical direction.
22. The reagent container according to any one of claims 1 to 21, wherein the frame includes an information recording medium that records information about the reagent.
23. The reagent container according to any one of claims 1 to 22, wherein the sealing surface is one of the upper end surface of the opening, the inner circumferential surface of the opening, or the outer circumferential surface of the opening.
24. The reagent container according to any one of claims 1 to 23, wherein the opening has a suction tube guide portion that protrudes downward from the lower end of the opening toward the interior of the reagent storage portion.
25. The reagent container according to any one of claims 1 to 24, wherein the frame is configured to maintain a sealed state inside the reagent storage section while the reagent is repeatedly aspirated by the suction tube.
26. The reagent container according to any one of claims 1 to 25, wherein the reagent storage section is made of a laminated film material having gas barrier properties and light-shielding properties.
27. The reagent container according to any one of claims 1 to 26, wherein the reagent storage section contains 200 mL or more and 500 mL or less of the reagent.
28. The reagent container according to any one of claims 1 to 26, wherein the reagent storage section contains 20 mL or more and 100 mL or less of the reagent.
29. The reagent container according to any one of claims 1 to 28, wherein the storage period of the reagent is 75 days or more and 1 year or less after the suction tube is inserted into the opening.
30. The reagent container according to any one of claims 1 to 29, wherein the reagent contains a staining solution for staining a predetermined cell.
31. A reagent container kit for assembling a reagent container that contains reagents drawn in by a suction tube provided in an analytical instrument, A bag-shaped reagent container for containing the aforementioned reagent, A frame including an opening and attachable to the reagent storage section, The reagent container kit wherein the frame, when attached to the reagent storage section, has a sealing surface that contacts a sealing body provided on the suction tube to seal the opening when the suction tube is inserted from above in conjunction with a predetermined operation on the analyzer, and the inside of the reagent storage section is sealed by the contact between the sealing body and the sealing surface.
32. A method for installing a reagent container into an analytical instrument having a suction tube, The reagent container, which includes a bag-shaped reagent container for containing the reagent to be aspirated by the suction tube and a frame having an opening, is moved into the analyzer. By bringing the frame into contact with a part of the analyzer within the analyzer, the opening is positioned below the suction tube. A method for installing a reagent container, wherein the suction tube is moved downward while the frame is in contact with a part of the analyzer, thereby inserting the suction tube into the opening from above the reagent container, and when the suction tube is inserted into the opening, the inside of the reagent storage section is sealed by the contact between the sealing body provided on the suction tube and the sealing surface arranged on the frame.
33. A frame attached to a bag-shaped reagent container that holds reagents aspirated by a suction tube provided in an analytical instrument, A movement restricting unit having a connecting portion for connecting the reagent container having an opening, It comprises a sealing surface for sealing the opening, The movement restricting portion is a frame for a reagent container, which, by contacting a part of the analyzer, restricts the movement of the opening so that when the suction tube is inserted into the reagent container from above in conjunction with a predetermined operation of the analyzer, the inside of the reagent container is sealed by contact between the sealing body provided on the suction tube and the sealing surface.
34. The apparatus comprises a sample aspiration unit for aspirating a sample, a reagent aspiration unit for aspirating a reagent from a reagent container, a sample preparation unit for mixing the sample and the reagent to prepare a measurement sample, a detection unit for detecting components in the measurement sample, and an analysis unit for analyzing the detection signal from the detection unit. The reagent suction unit is, A container holding section for holding the reagent container includes a reagent holding section for containing the reagent and a frame including an opening, A suction tube having a sealing body that is inserted into the opening from above the reagent container held in the container holding part, and which, when inserted into the opening, seals the opening by coming into contact with it, thereby sealing the inside of the reagent storage part, An operating unit that accepts a predetermined operation for moving the suction tube, An analytical apparatus comprising a moving mechanism that, in conjunction with the predetermined operation, moves the reagent container and the suction tube relative to each other, thereby causing the suction tube to enter the reagent container held in the container holding section and to retract the suction tube outside the reagent container.
35. The analytical apparatus according to claim 34, further comprising a contact portion that contacts a movement restricting portion provided on the frame of the reagent container arranged in the container holding portion to restrict the movement of the opening.
36. The analytical apparatus according to claim 35, wherein the contact portion is configured to restrict the horizontal movement of the opening by contacting the movement restricting portion in the horizontal direction.
37. The analytical apparatus according to claim 36, wherein the contact portion includes the inner surface of the container holding portion and is configured to face the movement restricting portion in each of the first and second directions which are mutually orthogonal in the horizontal plane.
38. The analytical apparatus according to claim 36 or 37, wherein the contact portion is configured to contact any of the holes formed in the movement restricting portion, the notches formed in the movement restricting portion, and the side surface of the movement restricting portion.
39. The analytical apparatus according to claim 38, wherein the contact portion includes a first contact surface that contacts the side surface of the movement restricting portion in a first direction in the horizontal plane.
40. The analytical apparatus according to claim 39, wherein the contact portion includes a second contact surface that contacts the side surface of the movement restricting portion in a second direction perpendicular to the first direction in the horizontal plane.
41. The analytical apparatus according to claim 38, wherein the contact portion includes a third contact surface that contacts a notch formed on the side surface of the movement restricting portion.
42. The analytical apparatus according to any one of claims 35 to 41, wherein the contact portion is configured to restrict the vertical movement of the opening by contacting the movement restricting portion in the vertical direction.
43. The analytical apparatus according to claim 42, wherein the contact portion is provided so as to face the movement restricting portion in both the upward and downward directions.
44. The analytical apparatus according to claim 43, wherein the contact portion includes an upper contact surface and a lower contact surface that contact the upper surface and lower surface of the movement restricting portion, respectively.
45. The analytical apparatus according to any one of claims 35 to 44, wherein the contact portion is configured to restrict the movement of the opening by contacting the movement restricting portion fixed to the opening of the reagent container.
46. The container holding portion has a box-shaped or cylindrical housing portion that can accommodate the reagent container inside and has an opening formed horizontally. The analytical apparatus according to any one of claims 35 to 45, wherein at least a portion of the contact portion is provided in the housing portion.
47. The housing portion includes a first insertion portion into which the reagent housing portion of the reagent container is inserted, and a second insertion portion positioned above the first insertion portion into which the movement restricting portion of the reagent container is inserted. The analytical apparatus according to claim 46, wherein the contact portion is located in the second insertion portion.
48. The analytical apparatus according to claim 47, wherein the second insertion portion extends from the entrance of the housing portion toward a set position directly below the suction tube and is configured to guide the reagent container to the set position by contacting the movement restricting portion.
49. The analytical apparatus according to claim 48, wherein the contact portion is biased to move back and forth toward the inside of the second insertion portion, and is configured to contact the movement restricting portion inside the second insertion portion when the reagent container is placed in the set position.
50. The analytical apparatus according to any one of claims 46 to 49, wherein the container holding unit includes a reading unit that acquires information about the reagent from an information recording medium provided in the reagent container disposed within the storage unit.
51. The reagent suction unit includes the container holding unit, the suction tube, and the moving mechanism, and comprises a plurality of reagent container holders arranged laterally. The analytical apparatus according to claim 50, wherein the reading unit is individually provided on the upper part of the housing portion of each of the plurality of reagent container holders.
52. The analytical apparatus according to any one of claims 35 to 51, wherein the sealing body is provided so as to surround the outer circumference of the suction tube and is configured to elastically deform upon contact with the edge of the opening to seal the opening.
53. The analytical apparatus according to any one of claims 35 to 52, wherein the contact portion is configured to contact the movement restricting portion of the reagent container and fix the opening when the suction tube is inserted into the opening.
54. The aforementioned contact portion is, An entry member that enters into a recess formed in the movement restricting portion of the reagent container in conjunction with the movement of the suction tube by the aforementioned movement mechanism, or The analytical apparatus according to claim 53, further comprising an entry member that enters a recess formed in the movement restricting portion of the reagent container in conjunction with the placement of the reagent container into the container holding portion.
55. The analytical apparatus according to any one of claims 35 to 54, wherein the moving mechanism is configured to support the suction tube so that it can move in the vertical direction, and to move the suction tube in conjunction with the predetermined operation, thereby causing the suction tube to enter the reagent container held in the container holding part and to retract the suction tube outside the reagent container.
56. The operating unit is movable between a removal position that allows the removal of the reagent container from the container holding unit and a removal prevention position that prevents the removal of the reagent container from the container holding unit. The analytical apparatus according to claim 55, wherein the moving mechanism inserts the suction tube into the opening in conjunction with an operation to move the operating unit to the removal prevention position, and retracts the suction tube outside the reagent container in conjunction with an operation to move the operating unit to the removal position.
57. The operating section includes a mounting member on which the bottom of the reagent container is placed, The analytical apparatus according to any one of claims 35 to 54, wherein the moving mechanism is configured to support the aforementioned mounting member so as to be movable, and to move the aforementioned mounting member in conjunction with the predetermined operation, thereby causing the suction tube to enter the reagent container installed on the aforementioned mounting member and to retract the suction tube outside the reagent container.
58. The operation unit includes a switch that accepts the predetermined operation, The analytical apparatus according to any one of claims 35 to 54, wherein the moving mechanism includes a drive unit that moves the reagent container and the suction tube relative to each other in conjunction with the predetermined operation.
Citation Information
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