Patent Description:
<CIT> (hereinafter, Patent Document <NUM>) discloses a reagent container <NUM> including a reagent storage pouch <NUM>, as illustrated in <FIG>. The reagent storage pouch <NUM> has a bag-shaped member <NUM> storing a reagent therein, and a tubular reagent takeout member <NUM> attached to the bag-shaped member <NUM>. The reagent takeout member <NUM> includes a nozzle insertion port <NUM>, and the nozzle insertion port <NUM> is used to insert the sample aspiration nozzle of the automatic analyzer into the bag-shaped member <NUM>. Further, <CIT> is concerned with a liquid suction tool. <CIT> is concerned with a sequencing device and describes a method of preparing reagents.

In Patent Document <NUM> mentioned above, the bag-shaped member <NUM> is configured to have flexibility by a synthetic resin film such as nylon or polypropylene in order to suppress the oxidation of the reagent stored therein. In this case, when the aspiration tube (nozzle) of the analyzer is inserted through the nozzle insertion port <NUM> into the reagent container <NUM>, the tip of the aspiration tube having passed through the reagent takeout member <NUM> may come into contact with the inner bottom of the bag-shaped member <NUM>. When the tip of the aspiration tube comes into contact with the inner bottom of the bag-shaped member <NUM>, the tip of the aspiration tube may penetrate the bag-shaped member <NUM>. If the tip of the aspiration tube penetrates the bag-shaped member <NUM>, it may cause liquid leakage of the reagent.

In particular, in the analyzer, there may be a case where the reagent container has a nozzle insertion port covered with a sealing material, and the aspiration tube pierces the sealing material so that the aspiration tube is inserted into the reagent container. In that case, a hard tube member with a sharp tip may be employed for the aspiration tube in order to ensure the piercing performance, and the contact between the tip of the aspiration tube and the inner bottom of the bag-shaped member increases the risk that the tip of the aspiration tube could penetrate the bag-shaped member.

An object of the present invention is to provide a reagent container capable of suppressing the tip of the aspiration tube from penetrating the container body due to contact with the tip of the aspiration tube of the analyzer.

A reagent container according to the present invention is defined in claim <NUM>. As a result, when the tip (<NUM>) of the aspiration tube (<NUM>) inserted into the container body (<NUM>) through the opening comes into contact with the inner bottom of the container body (<NUM>), the tip (<NUM>) of the aspiration tube (<NUM>) comes into contact with and is received by the penetration prevention member (<NUM>) instead of the flexible bag-shaped liquid container(<NUM>). As a result, even in the case of using a reagent container (<NUM>) including a flexible bag-shaped liquid container (<NUM>) storing a reagent (<NUM>), it is possible to avoid contact between the tip (<NUM>) of the aspiration tube (<NUM>) and the flexible bag-shaped liquid container(<NUM>). Therefore, it is possible to suppress the tip (<NUM>) of the aspiration tube (<NUM>) of the analyzer from penetrating the container body (<NUM>).

In the reagent container according to an embodiment of the present invention, the inner bottom of the flexible bag-shaped liquid container (<NUM>) is arranged at a position off the lower side where the tip (<NUM>) of the aspiration tube (<NUM>) inserted through the opening is arranged. As a result, even in the case of using a reagent container (<NUM>) including a flexible bag-shaped liquid container (<NUM>) storing a reagent (<NUM>), it is possible to avoid contact between the tip (<NUM>) of the aspiration tube (<NUM>) and the flexible bag-shaped liquid container (<NUM>). Therefore, it is possible to suppress the tip (<NUM>) of the aspiration tube (<NUM>) of the analyzer (<NUM>) from penetrating the container body (<NUM>).

The present invention makes it possible to suppress the tip of the aspiration tube from penetrating the container body due to contact with the aspiration tube of the analyzer.

Hereinafter, embodiments are described with reference to the drawings.

First, the outline of a reagent container <NUM> according to an embodiment is described with reference to <FIG>.

<FIG> is a schematic cross-sectional diagram illustrating an outline of the reagent container <NUM> installed in an analyzer <NUM>. The reagent container <NUM> is a reagent container that internally stores the reagent <NUM> used for sample analysis. The reagent container <NUM> is a container capable of storing a liquid. The reagent container <NUM> is a reagent container that is installed in the analyzer <NUM> and stores the reagent <NUM> supplied to the analyzer <NUM> via the aspiration tube <NUM>. The analyzer <NUM> includes a reagent placement unit 221A on which the reagent container <NUM> can be placed. The reagent container <NUM> is placed on and held by the reagent placement unit in a predetermined placement posture. The analyzer <NUM> is an automatic analyzer that acquires the reagent <NUM> in the reagent container <NUM> and analyzes a sample using the acquired reagent <NUM>.

The sample can be a substance of biological origin. The sample contains a test substance. When the sample is added and reacted with a reagent, a specimen for measuring the test substance is prepared. The subject is mainly human, but may be an animal other than human. The analyzer <NUM> performs analysis for clinical examination or medical research of, for example, a sample collected from a patient. The sample of biological origin is, for example, a liquid collected from the subject such as blood (whole blood, serum, or plasma) or urine, a liquid obtained by subjecting the collected liquid to a predetermined pretreatment, or the like. In addition, the sample may be, for example, a part of the tissue of the subject or cells other than the liquid. The analyzer <NUM> detects a test substance contained in the sample. The test substance may contain, for example, a predetermined component, cells, or formed components in a blood or urine sample. The test substance may be a nucleic acid such as DNA (deoxyribonucleic acid), a cell or intracellular substance, an antigen or an antibody, a protein, a peptide, or the like.

The analyzer <NUM> can aspirate the reagent <NUM> from the inside of the reagent container <NUM> by using an aspiration tube <NUM> or the like. The reagent container <NUM> stores the reagent <NUM> in an amount that allows a predetermined number of sample analyses. The reagent container <NUM> can be a disposable container that is discarded when almost the entire amount of the reagent <NUM> being stored is aspirated.

The reagent <NUM> is a liquid. The reagent <NUM> is, for example, an aqueous solution containing components corresponding to the analysis items by sample analysis. When mixed with a sample in the analyzer <NUM>, the reagent <NUM> contains, for example, a component that reacts with a component contained in the sample. The reagent <NUM> contains, for example, a component that labels a test substance contained in the sample.

The reagent container <NUM> includes at least a container body <NUM> including a tubular member <NUM>, a bag-shaped member <NUM>, and a penetration prevention member <NUM>. The tubular member <NUM>, the bag-shaped member <NUM>, and the penetration prevention member <NUM> are separate parts formed separately from each other. The tubular member <NUM> and the bag-shaped member <NUM> are integrated by being joined. In addition, the penetration prevention member <NUM> and the bag-shaped member <NUM> are integrated by being joined.

The tubular member <NUM> includes a tubular shape with a hollow inside. The tubular member <NUM> is a member that communicates the inside and the outside of the container body <NUM> and serves as an entrance/exit of the aspiration tube <NUM>.

The tubular member <NUM> includes openings into which the aspiration tube <NUM> is inserted. In the example of <FIG>, the openings communicate with each other inside the tubular member <NUM>. The tubular member <NUM> includes a peripheral wall portion <NUM> that partitions the openings. In the example of <FIG>, the tubular member <NUM> extends linearly in the vertical direction. The tubular member <NUM> has, for example, a cylindrical shape (see <FIG>). The tubular member <NUM> may have a square tubular shape other than a cylindrical shape. Here, the term "from above" indicates a position above the upper end surface of the tubular member <NUM> having openings into which the aspiration tube <NUM> is inserted. In other words, "from above" includes a region X just above the opening into which the tip <NUM> of the aspiration tube <NUM> is inserted.

The bag-shaped member <NUM> is a bag-shaped container portion that stores the reagent <NUM>. The bag-shaped member <NUM> is formed in a bag shape by a sheet-shaped or film-shaped material. The bag-shaped member <NUM> is a flexible bag-shaped liquid container. The bag-shaped member <NUM> is formed in a bag shape, for example, by joining the inner surfaces of the outer peripheral portions of one folded sheet-shaped member <NUM> to each other. In addition, as illustrated in <FIG>, for example, the bag-shaped member <NUM> is formed in a bag shape by stacking sheet-shaped members <NUM> and joining the region BR1 along the peripheral edge of the stacked sheet-shaped members <NUM> to each other.

In addition, the bag-shaped member <NUM> is joined to the tubular member <NUM>. In the examples of <FIG>, the bag-shaped member <NUM> is joined in a region BR2 that surrounds the periphery of the tubular member <NUM> along the outer peripheral surface of the tubular member <NUM>. By joining, the openings of the tubular member <NUM> and the internal space of the bag-shaped member <NUM> communicate with each other. The internal space of the bag-shaped member <NUM> communicates with the outside of the container body <NUM> through the openings of the tubular member <NUM>. By joining, the container body <NUM> communicates with the outside only at the openings of the tubular member <NUM>.

The opening of the tubular member <NUM> can be sealed by the sealing material <NUM> (see <FIG>). When penetrated by the aspiration tube <NUM>, the sealing material <NUM> allows aspiration of the reagent <NUM> from the inside of the reagent container <NUM> through the openings. The sealing material <NUM> may be removed from the container body <NUM> when, for example, the reagent container <NUM> is used. The sealing material <NUM> may be repeatedly attached and detached at a position covering the opening of the tubular member <NUM>.

The bag-shaped member <NUM> may include a reagent identification member <NUM> on the outer surface thereof (see <FIG>), such as an RFID (radio frequency identifier) tag or a display label that stores information about the reagent.

As illustrated in <FIG>, when the analyzer <NUM> aspirates the reagent <NUM>, the aspiration tube <NUM> is inserted through the opening of the tubular member <NUM> to access the reagent <NUM> inside the container body <NUM> from the outside of the container body <NUM>. The aspiration tube <NUM> is, for example, a thin hollow tubular member extending linearly. The upper end of the aspiration tube <NUM> is connected to the fluid circuit of the analyzer <NUM> and is held by the analyzer <NUM>. The aspiration tube <NUM> enters the inside of the opening of the tubular member <NUM> from the outside of the container body <NUM> along the central axis CA of the tubular member <NUM>. The aspiration tube <NUM> aspirates the reagent <NUM> from the tip <NUM> by being supplied with an aspiration force by the analyzer <NUM>.

In order to reduce the dead volume of the reagent <NUM>, the dimensions of the container body <NUM> suitable for the analyzer <NUM> are designed so that the tip <NUM> of the aspiration tube <NUM> having penetrated into the container body <NUM> is as close as possible to the inner bottom of the container body <NUM>. Note that the dead volume is the residual amount of the reagent <NUM> that cannot be aspirated by the aspiration tube <NUM> and remains in the reagent container <NUM>. The tip <NUM> of the aspiration tube <NUM> is designed so as not to come into contact with the bottom portion of the container body <NUM>, but the tip <NUM> may come into contact with the bottom portion in consideration of dimensional error and the like.

Therefore, in the present embodiment, the container body <NUM> includes a penetration prevention member <NUM> that prevents the tip <NUM> of the aspiration tube <NUM> from penetrating the container body <NUM>. The penetration prevention member <NUM> is arranged below the tip <NUM> of the aspiration tube <NUM> inserted through the opening of the tubular member <NUM>. Here, "below the tip of the aspiration tube" means below the tip <NUM> of the aspiration tube <NUM> having moved to the inner bottom side of the container body <NUM> along the central axis CA of the tubular member <NUM>.

In the example of <FIG>, the penetration prevention member <NUM> constitutes a part of the inner surface <NUM> of the container body <NUM>. The container body <NUM> includes the penetration prevention member <NUM> in a bottom portion region including an intersection CP between the central axis CA of the opening of the tubular member <NUM> and the inner surface <NUM> of the container body <NUM>. The shape of the penetration prevention member <NUM> is not particularly limited. In the example of <FIG>, the penetration prevention member <NUM> has a flat plate shape. In the example of <FIG>, the penetration prevention member <NUM> has a disk shape corresponding to the shape of the opening of the tubular member <NUM>. In the example of <FIG>, the bag-shaped member <NUM> is joined in a region BR3 (see <FIG>) that surrounds the periphery of the penetration prevention member <NUM> along the outer peripheral surface of the penetration prevention member <NUM>. Therefore, the lower surface portion of the penetration prevention member <NUM> forms a part of the outer surface of the container body <NUM>. The penetration prevention member <NUM> may be joined to the inner bottom of the bag-shaped member <NUM> inside the bag-shaped member <NUM>.

In the example of <FIG>, the width of the penetration prevention member <NUM> in the direction intersecting the moving direction of the aspiration tube <NUM> is larger than the width of the opening of the tubular member <NUM> in consideration of the movement of the aspiration tube <NUM> and the variation in the position of the tip <NUM>. The penetration prevention member <NUM> may be formed over a larger area, for example, the entire inner bottom of the bag-shaped member <NUM>.

When the aspiration tube <NUM> enters the inside of the container body <NUM> via the tubular member <NUM>, the tip <NUM> of the aspiration tube <NUM> may come into contact with the penetration prevention member <NUM>. Therefore, the tip <NUM> of the aspiration tube <NUM> is suppressed from penetrating the bag-shaped member <NUM>. The penetration prevention member <NUM> is configured so that it does not penetrate even if it comes into contact with the tip <NUM> of the aspiration tube <NUM>. Therefore, even if the tip <NUM> of the aspiration tube <NUM> comes into contact, the reagent container <NUM> is prevented from penetrating.

As described above, in the reagent container <NUM> according to the present embodiment, the container body <NUM> includes a penetration prevention member <NUM> that prevents the tip <NUM> of the aspiration tube <NUM> inserted from above the opening of the tubular member <NUM> from penetrating the container body <NUM>. As a result, when the tip <NUM> of the aspiration tube <NUM> inserted into the container body <NUM> through the opening of the tubular member <NUM> is about to come into contact with the inner surface <NUM> of the container body <NUM>, the tip <NUM> of the aspiration tube <NUM> comes into contact with the penetration prevention member <NUM> instead of the bag-shaped member <NUM> and is received. As a result, even in the case of using the reagent container <NUM> including the bag-shaped member <NUM> storing the reagent <NUM>, it is possible to avoid contact between the tip <NUM> of the aspiration tube <NUM> and the bag-shaped member <NUM>.

Further, as illustrated in <FIG>, in the configuration in which the penetration prevention member <NUM> is provided in the bottom portion region including the intersection CP between the central axis CA of the opening of the tubular member <NUM> and the inner surface <NUM> of the container body <NUM>, the aspiration tube <NUM> entering the inside of the container body <NUM> along the central axis CA is more reliably received by the penetration prevention member <NUM>. In addition, since the penetration prevention member <NUM> is arranged in the bottom portion region, the tip <NUM> of the aspiration tube <NUM> can be arranged at a position as close as possible to the inner bottom of the container body <NUM>. Therefore, it is possible to reduce the dead volume of the reagent <NUM>.

In addition, in the example of <FIG>, the penetration prevention member <NUM> is locally formed in the bottom portion region including the intersection CP on the inner surface <NUM> of the container body <NUM>. Therefore, it is not necessary to provide the penetration prevention member <NUM> in a large area of the inner surface <NUM> of the container body <NUM>. Hence, it is possible to prevent the tip <NUM> of the aspiration tube <NUM> from penetrating the container body <NUM> while maintaining the flexibility of the bag-shaped member <NUM>.

Note that, in the manufacture of the reagent container <NUM>, a predetermined amount of the reagent <NUM> is dispensed into the container body <NUM>, the air layer inside is eliminated, and the sealing material <NUM> is joined to the upper surface of the opening of the tubular member <NUM>. In order to eliminate the air in the container body <NUM>, preferably, the air in the container body <NUM> is replaced with an inert gas. That is, the gas phase region inside the container body <NUM> can be filled with an inert gas. As the inert gas, for example, argon, helium, neon, nitrogen, or the like can be employed.

In the present embodiment, the reagent container <NUM> may have the following configuration.

The reagent container <NUM> illustrated in <FIG> is a reagent container that is installed in the analyzer <NUM> and stores the reagent <NUM> supplied to the analyzer <NUM> via the aspiration tube <NUM>, including the container body <NUM> that includes the tubular member <NUM> with an opening into which the aspiration tube <NUM> is inserted, and that includes the bag-shaped member <NUM> joined to the tubular member <NUM> and storing the reagent <NUM>. The inner bottom of the bag-shaped member <NUM> is arranged at a position off the lower side where the tip <NUM> of the aspiration tube <NUM> inserted through the opening is arranged.

That is, in the example of <FIG>, the bag-shaped member <NUM> is not arranged below the tip <NUM> of the aspiration tube <NUM> inserted through the opening of the tubular member <NUM>. The bag-shaped member <NUM> is arranged in a region other than the lower position where the tip <NUM> of the aspiration tube <NUM> inserted through the opening of the tubular member <NUM> is arranged.

As described above, in a reagent container <NUM> according to another embodiment, the inner bottom of the bag-shaped member <NUM> is arranged at a position off the lower side where the tip <NUM> of the aspiration tube <NUM> inserted through the opening of the tubular member <NUM> is arranged. As a result, even in the case of using the reagent container <NUM> including the bag-shaped member <NUM> storing the reagent <NUM>, it is possible to avoid contact between the tip <NUM> of the aspiration tube <NUM> and the bag-shaped member <NUM>. Therefore, it is possible to suppress the tip <NUM> of the aspiration tube <NUM> of the analyzer <NUM> from penetrating the container body <NUM>.

The container body <NUM> has a gas barrier property as a whole. The gas barrier property is a property that makes it difficult for gas to permeate. As used herein, the gas barrier property refers to how difficult it is for air, especially oxygen, to permeate. As a result, it is possible to prevent the reagent <NUM> stored in the reagent container <NUM> from being deteriorated by the outside air. The container body <NUM> has a light-shielding property. The light-shielding property is a property that makes it difficult for light to transmit. As a result, it is possible to suppress the reagent <NUM> stored in the reagent container <NUM> from being deteriorated by external light such as sunlight.

The tubular member <NUM> has a gas barrier property and a light-shielding property. The tubular member <NUM> is a molded product made of a resin material. The resin material constituting the tubular member <NUM> is, for example, a thermoplastic resin, specifically polyethylene (PE). The resin material constituting the tubular member <NUM> may be polypropylene (PP), polyethylene terephthalate (PET), or the like.

The bag-shaped member <NUM> has a gas barrier property. The bag-shaped member <NUM> has a higher gas barrier property than the tubular member <NUM>. The bag-shaped member <NUM> has a light-shielding property. The bag-shaped member <NUM> is formed of, for example, a sheet-shaped member <NUM> with a gas barrier property and a light-shielding property. Specifically, the bag-shaped member <NUM> is made of a laminated structure film material with a gas barrier property and a light-shielding property as the sheet-shaped member <NUM>. This makes it possible to suppress the deterioration of the reagent <NUM> due to the outside air, and suppress the deterioration of the reagent <NUM> due to the external light. Therefore, the quality of the reagent <NUM> can be maintained for a longer period of time.

The laminated structure film material includes various film materials so-called "gas barrier films". As illustrated in <FIG>, the laminated structure film material may typically include at least one base material layer 31A and at least one gas barrier layer 31B. As illustrated in <FIG>, the laminated structure film material may further include a protective layer 31C that protects the outer surface of the gas barrier layer 31B. The laminated structure film material may have a light-shielding layer made of a light-shielding material. When a material with both a gas barrier property and a light-shielding property is used for the gas barrier layer 31B, the gas barrier layer 31B and the light-shielding layer can be the same layer. The number of layers of the laminated structure film material is <NUM> or more, but may be <NUM> to <NUM> or <NUM> or more, and is not particularly limited.

Examples of the laminated structure film material include a metal foil laminated film, a resin-based multilayer barrier film, a coating-based film, a vapor-deposited film, and an organic-inorganic composite film. The metal foil laminated film is a film having a structure in which a gas barrier layer made of a metal foil such as an aluminum foil is laminated on a resin base material layer. The resin-based multilayer barrier film is a film having a structure in which resin material layers with an excellent gas barrier property are laminated. The resin material with an excellent gas barrier property may be, for example, PVDC (polyvinylidene chloride), PVA (polyvinyl alcohol), EVOH (ethylene-vinyl alcohol copolymer), and the like. The coating-based film is a film having a structure in which a base material layer is coated (film-formed) with a gas barrier material. The gas barrier material to be film-formed is PVDC, PVA, EVOH, or the like, and can be formed by a wet process such as coating. The vapor-deposited film is a film having a structure in which a gas barrier material is vapor-deposited on a base material layer. The gas barrier material to be vapor-deposited is a metal such as aluminum, or an inorganic oxide such as alumina or silica. The gas barrier material can also be formed by a dry process in which a deposition treatment other than vapor deposition is performed. The organic-inorganic composite film includes a laminated film having a structure in which a gas barrier layer made of an organic (resin) material and a gas barrier layer made of an inorganic material are separately laminated, a film including a gas barrier layer in which an inorganic material is dispersed in an organic binder, and the like.

The laminated structure film material used as the sheet-shaped member <NUM> of the bag-shaped member <NUM> includes an inner surface on which a base material layer 31A made of a material that can be joined to the tubular member <NUM> or a joint layer separate from the base material layer 31A is formed. The material that can be joined to the tubular member <NUM> is, for example, the same resin material as the tubular member <NUM>. For example, both the tubular member <NUM> and the base material layer/joint layer are made of a thermoplastic resin such as polyethylene, and the tubular member <NUM> and the base material layer/joint layer are joined by heat welding.

The constituent material of the penetration prevention member <NUM> is not particularly limited. The penetration prevention member <NUM> may be a molded product made of, for example, a resin material, as long as it is more resistant to penetration than the inner bottom of the bag-shaped member <NUM>. The penetration prevention member <NUM> may be of a material or shape having a mechanical strength so that it is not penetrated even if it comes into contact with the tip <NUM> of the aspiration tube <NUM>. The penetration prevention member <NUM> is made of a material harder than the bag-shaped member <NUM>. In this case, after comparison of the material constituting the penetration prevention member <NUM> with the material of the laminated structure film material constituting the bag-shaped member <NUM>, the material constituting the penetration prevention member <NUM> is preferably the harder material. As a method of comparing the hardness of constituent materials, it is preferable to compare by a Vickers hardness test using Vickers hardness, which is one of the measures for expressing hardness. Note that, when the laminated structure film material constituting the bag-shaped member <NUM> is formed of a single layer, comparison is made with the Vickers hardness of the single layer, and in the case of a composite layer, comparison is made with the Vickers hardness of the layer having the maximum hardness in the composite layer. In addition, the penetration prevention member <NUM> may be made of a resin material having a higher density than the bag-shaped member <NUM>. In this case, after comparison of the density of the resin material constituting the penetration prevention member <NUM> with the density of the resin material of the laminated structure film material constituting the bag-shaped member <NUM>, the resin material constituting the penetration prevention member <NUM> is preferably the higher-density resin material. As a method of comparing the densities of resin materials, it is preferable to compare by the dimensional method, which is a method of measuring the bulk density. Note that, when the laminated structure film material constituting the bag-shaped member <NUM> is formed of a single layer, comparison is made with the density of the single layer, and in the case of a composite layer, comparison is made with the density of the resin material having the maximum density in the composite layer. As an example, the penetration prevention member <NUM> may be made of a resin material, a rubber material, or an elastomer other than rubber that does not cause mutual adverse effects against the reagent <NUM> stored in the bag-shaped member <NUM>, and the penetration prevention member <NUM> is made of, for example, the same material as the base material layer 31A of the sheet-shaped member <NUM>. In addition, the penetration prevention member <NUM> is made of, for example, the same material as the tubular member <NUM>.

According to the invention as illustrated in <FIG>, the penetration prevention member <NUM> has a thickness t1 larger than that of the bag-shaped member <NUM>. As a result, the mechanical strength of the penetration prevention member <NUM> can be increased so that it does not penetrate even if it comes into contact with the aspiration tube <NUM>. As a result, it is possible to more reliably suppress the tip <NUM> of the aspiration tube <NUM> from penetrating the container body <NUM>. The bag-shaped member <NUM> has a thickness t2. The thickness t2 is the thickness of the sheet-shaped member <NUM>. The thickness t1 is twice or more, preferably four times or more, and more preferably eight times or more the thickness t2.

In the example illustrated in <FIG>, the penetration prevention member <NUM> and the tubular member <NUM> are provided separately, and are separately joined to the bag-shaped member <NUM>. The penetration prevention member <NUM> and the tubular member <NUM> may be formed as one part.

In the example illustrated in <FIG>, the penetration prevention member <NUM> is integrally formed with the tubular member <NUM>. As a result, it is possible to suppress an increase in the number of parts of the reagent container <NUM> even when the penetration prevention member <NUM> is provided. In addition, even if the flexible bag-shaped member <NUM> is provided, it is possible to suppress the positional relationship between the penetration prevention member <NUM> and the tubular member <NUM> from being displaced. Moreover, the bag-shaped member <NUM> can be easily joined as compared with the case where the penetration prevention member <NUM> and the tubular member <NUM> are provided separately.

In <FIG>, the tubular member <NUM> has an opening at the upper end portion and not at the lower end portion. The penetration prevention member <NUM> constitutes a closed bottom portion <NUM> of the tubular member <NUM>. As a result, the tip <NUM> of the aspiration tube <NUM> can be reliably received by the penetration prevention member <NUM> simply by inserting the aspiration tube <NUM> through the opening of the tubular member <NUM> and moving the aspiration tube <NUM> downward as it is.

The lower end portion of the tubular member <NUM> is arranged at a position near the inner bottom <NUM> of the bag-shaped member <NUM>. The penetration prevention member <NUM> is provided to close the lower end portion of the tubular member <NUM> arranged at a position near the inner bottom <NUM> of the bag-shaped member <NUM>. The penetration prevention member <NUM> is arranged inside the bag-shaped member <NUM> at an upper position away from the inner bottom <NUM> of the bag-shaped member <NUM>. Even when the tip <NUM> of the aspiration tube <NUM> enters the opening of the tubular member <NUM> and moves as much as possible downward inside the tubular member <NUM>, the tip <NUM> of the aspiration tube <NUM> is received by the penetration prevention member <NUM> before coming into contact with the bag-shaped member <NUM>.

In the example of <FIG>, instead of the opening formed at the lower end portion of the tubular member <NUM> in <FIG>, a side opening <NUM> is formed on the side surface of the tubular member <NUM>. That is, the tubular member <NUM> includes a tubular peripheral wall portion <NUM> with an opening formed at the upper end portion, and a side opening <NUM> that penetrates the peripheral wall portion <NUM> and communicates between the opening at the upper end portion of the tubular member <NUM> and the inside of the bag-shaped member <NUM>. The bag-shaped member <NUM> is joined to the tubular member <NUM> at a position closer to the upper end portion than the side opening <NUM> in a state where the formed portion of the side opening <NUM> of the tubular member <NUM> is housed inside.

The reagent <NUM> in the bag-shaped member <NUM> can flow into the inside of the tubular member <NUM> through the side opening <NUM>. The reagent <NUM> is aspirated inside the tubular member <NUM> with the tip <NUM> of the aspiration tube <NUM> arranged near the upper surface <NUM> of the penetration prevention member <NUM>, that is, the bottom portion <NUM> of the tubular member <NUM>. In this way, the tubular member <NUM> having the penetration prevention member <NUM> at the bottom portion can aspirate the reagent <NUM> in a state where the tip <NUM> of the aspiration tube <NUM> is arranged in the internal space of the tubular member <NUM>.

In the example of <FIG>, wince the penetration prevention member <NUM> is arranged above the inner bottom <NUM> of the bag-shaped member <NUM>, the tip <NUM> of the aspiration tube <NUM> is also arranged above the inner bottom <NUM> of the bag-shaped member <NUM>. Therefore, when the reagent <NUM> is aspirated to the maximum, a dead volume corresponding to the height from the inner bottom <NUM> to the upper surface <NUM> of the penetration prevention member <NUM> is generated.

In light of the above, in the example illustrated in <FIG>, the upper surface <NUM> of the penetration prevention member <NUM> is arranged at a position lower than the inner bottom <NUM> of the bag-shaped member <NUM>. As a result, the tip <NUM> of the aspiration tube <NUM> can reach a position lower than the inner bottom <NUM> of the bag-shaped member <NUM> without coming into contact with the bag-shaped member <NUM>. Therefore, the reagent <NUM> stored inside the bag-shaped member <NUM> can be easily collected up to the position of the upper surface <NUM> of the penetration prevention member <NUM>. This makes it possible to reduce the dead volume of the reagent <NUM> even if the bag-shaped member <NUM> is joined to the tubular member <NUM> from the side.

In the example of <FIG>, similarly to <FIG>, the tubular member <NUM> includes a tubular peripheral wall portion <NUM> with an opening formed at the upper end portion, and a side opening <NUM> that penetrates the peripheral wall portion <NUM> and communicates between the opening at the upper end portion and the inside of the bag-shaped member <NUM>. Plus, in the configuration example of <FIG>, the bag-shaped member <NUM> is joined to the outer surface 23A of the peripheral wall portion <NUM> to cover the periphery of the side opening <NUM>. That is, unlike <FIG> where the tubular member <NUM> is inserted into the bag-shaped member <NUM>, <FIG> is such that the bag-shaped member <NUM> is joined to the tubular member <NUM> to project laterally from the outer peripheral surface (that is, the outer surface 23A) of the tubular member <NUM>.

As a result, the bag-shaped member <NUM> is joined to the vertically extending tubular member <NUM> from the side. Therefore, when the aspiration tube <NUM> enters the inside of the tubular member <NUM>, the tip <NUM> of the aspiration tube <NUM> is not arranged inside the bag-shaped member <NUM>. Therefore, it is possible to more reliably prevent the tip <NUM> of the aspiration tube <NUM> from coming into contact with the bag-shaped member <NUM>.

As described above, in the example of <FIG>, the inner bottom <NUM> of the bag-shaped member <NUM> is arranged at a position off the lower side where the tip <NUM> of the aspiration tube <NUM> inserted through the opening of the tubular member <NUM> is arranged. The inner bottom <NUM> of the bag-shaped member <NUM> is arranged in a region other than the intersection CP between the central axis CA of the opening of the tubular member <NUM> and the inner surface <NUM> of the container body <NUM>. The inner bottom <NUM> of the bag-shaped member <NUM> is arranged at a position of the outer surface 23A of the tubular member <NUM> and a position outside the outer surface 23A of the tubular member <NUM> in the radial direction.

In <FIG>, the penetration prevention member <NUM> is provided to close the lower end portion of the peripheral wall portion <NUM>. As a result, the tip <NUM> of the aspiration tube <NUM> can be reliably received by the penetration prevention member <NUM> simply by inserting the aspiration tube <NUM> through the opening of the tubular member <NUM> and moving the aspiration tube <NUM> downward as it is. In addition, even when the aspiration tube <NUM> enters in a tilted manner, the tip <NUM> of the aspiration tube <NUM> is guided by the inner surface of the peripheral wall portion <NUM>, and the tip <NUM> can be prevented from coming into contact with the bag-shaped member <NUM>. The lower surface portion <NUM> of the penetration prevention member <NUM> is the outer surface of the tubular member <NUM> and is exposed to the outside of the container body <NUM>.

The upper joint region BR2 between the bag-shaped member <NUM> and the tubular member <NUM> is arranged at a position between the upper end portion of the side opening <NUM> and the opening (that is, the upper end portion of the tubular member <NUM>). The lower joint region BR2 between the bag-shaped member <NUM> and the tubular member <NUM> is arranged at a position between the lower end portion of the side opening <NUM> and the penetration prevention member <NUM>.

Therefore, in the example of <FIG>, the upper end portion of the tubular member <NUM> protrudes higher than the bag-shaped member <NUM>, and the lower end portion of the tubular member <NUM> protrudes toward a position lower than the bag-shaped member <NUM>. The upper surface <NUM> of the penetration prevention member <NUM> is provided on the tubular member <NUM> to protrude toward a position lower than the inner bottom <NUM> of the bag-shaped member <NUM>. The penetration prevention member <NUM> is arranged at the lowermost part of the container body <NUM>.

In the example illustrated in <FIG>, the inner bottom <NUM> of the bag-shaped member <NUM> extends laterally from the tubular member <NUM> in a direction orthogonal to the central axis CA of the tubular member <NUM>. On the other hand, in the example illustrated in <FIG>, the inner bottom <NUM> of the bag-shaped member <NUM> is inclined toward the tubular member <NUM> side and is connected to the lower end portion of the side opening <NUM>.

This allows the reagent <NUM> in the bag-shaped member <NUM> to easily flow along the inclined inner bottom <NUM> to the upper surface <NUM> of the penetration prevention member <NUM>. As a result, the dead volume of the reagent <NUM> can be reduced more effectively.

In <FIG>, the lower side portion of the bag-shaped member <NUM> is inclined at an angle θ with respect to the upper side portion of the bag-shaped member <NUM>. Note that the auxiliary line AL indicating the angle θ is a line parallel to the upper side portion of the bag-shaped member <NUM>. The lower side portion of the bag-shaped member <NUM> is inclined toward the tubular member <NUM> side. As a result, the inner bottom <NUM> of the bag-shaped member <NUM> is inclined toward the tubular member <NUM> side. The inner bottom <NUM> of the bag-shaped member <NUM> is formed so that the position in the vertical direction at the end portion on the tubular member <NUM> side substantially coincides with the lower end portion of the side opening <NUM> of the tubular member <NUM>. As a result, the inner bottom <NUM> of the bag-shaped member <NUM> is connected to the lower end portion of the side opening <NUM>. The upper surface <NUM> of the penetration prevention member <NUM> is arranged at a position lower than the lower end portion of the side opening <NUM>.

In <FIG>, when the reagent <NUM> is aspirated from the tip <NUM> of the aspiration tube <NUM> arranged near the upper surface <NUM> of the penetration prevention member <NUM> and the amount of the reagent in the bag-shaped member <NUM> decreases, the action of gravity causes the reagent <NUM> to flow toward the side opening <NUM> side along the inclined inner bottom <NUM> (see the arrow in <FIG>). Therefore, the reagent <NUM> remaining in the bag-shaped member <NUM> is reduced as much as possible.

In <FIG>, the penetration prevention member <NUM> is integrally formed with the tubular member <NUM> as the bottom portion <NUM> of the tubular member <NUM>, but for example, the bottom portion <NUM> of the tubular member <NUM> may be configured as an opening, and the penetration prevention member <NUM> as a cap attached to close the opening at the bottom portion.

A more specific configuration example of the reagent container <NUM> is described with reference to <FIG> illustrate specific examples of the reagent container <NUM> employing the structure illustrated in <FIG>.

As illustrated in <FIG>, the reagent container <NUM> includes a container body <NUM> that includes a tubular member <NUM> and a bag-shaped member <NUM> joined to the tubular member <NUM> and storing the reagent <NUM>. The penetration prevention member <NUM> is integrally formed with the tubular member <NUM> to close the lower end portion of the tubular member <NUM>.

In the example of <FIG>, the reagent container <NUM> includes a holding member <NUM> that holds the tubular member <NUM> at an upper position of the container body <NUM>. Since the container body <NUM> has a structure in which the reagent <NUM> is stored in the flexible bag-shaped member <NUM>, the bag-shaped member <NUM> is easily deformed when the container body <NUM> is installed alone. The holding member <NUM> has a function of determining the position of the tubular member <NUM> by supporting at least a part of the container body <NUM>.

As a result, even when the reagent container <NUM> includes the flexible bag-shaped member <NUM>, it is possible to stably hold the position of the tubular member <NUM> serving as the entrance/exit of the aspiration tube <NUM>.

As illustrated in <FIG>, the tubular member <NUM> is, for example, a molded product made of polyethylene. The tubular member <NUM> includes a substantially cylindrical peripheral wall portion <NUM>. The peripheral wall portion <NUM> has a circular outer shape when viewed from the direction in which the central axis CA extends. An opening is formed at the upper end portion of the peripheral wall portion <NUM>. Note that a flange portion 21A projecting outward in the radial direction is formed at the upper end portion of the tubular member <NUM>. The lower end portion of the peripheral wall portion <NUM> is closed by the penetration prevention member <NUM>. The penetration prevention member <NUM> constitutes the bottom portion <NUM> of the tubular member <NUM>. The tubular member <NUM> includes a cylindrical internal space partitioned by an inner peripheral surface of the tubular member <NUM> and an upper surface <NUM> (see <FIG>) of the penetration prevention member <NUM>, and the upper end portion of this internal space is opened to the outside of the tubular member <NUM> through the opening.

The tubular member <NUM> includes a side opening <NUM> that penetrates the peripheral wall portion <NUM> and opens laterally. The side opening <NUM> extends from the vicinity of the upper end portion to the vicinity of the lower end portion of the peripheral wall portion <NUM>. The side opening <NUM> is formed between the protrusion 26A and the protrusion 26B to be described later.

The tubular member <NUM> includes a protrusion <NUM> that protrudes from the edge portion of the side opening <NUM> toward the inside of the bag-shaped member <NUM>. The protrusion <NUM> protrudes from the outer peripheral surface of the peripheral wall portion <NUM> to the side orthogonal to the central axis CA of the tubular member <NUM>. The protrusion <NUM> protrudes toward front of the side opening <NUM>. Therefore, the protrusion <NUM> protrudes toward the inside of the bag-shaped member <NUM> (see <FIG>) and is covered with the bag-shaped member <NUM>. Here, when the bag-shaped member <NUM> is joined so that the bag-shaped member <NUM> is in close contact with the side opening <NUM>, the volume of the bag-shaped member <NUM> is reduced. Therefore, according to the configuration including the protrusion <NUM>, the bag-shaped member <NUM> can be joined in a state where the internal space of the bag-shaped member <NUM> is expanded by the protrusion <NUM>, so that the volume of the bag-shaped member <NUM> can be stably secured.

The protrusion <NUM> is formed at the upper end portion and the lower end portion of the side opening <NUM>. That is, the protrusion <NUM> includes a protrusion 26A formed at the upper end portion of the side opening <NUM> and a protrusion 26B formed at the lower end portion of the side opening <NUM>.

The protrusion <NUM> is also provided at a position between the upper end portion and the lower end portion of the side opening <NUM>. In the example of <FIG>, a protrusion 26C, a protrusion 26D, and a protrusion 26E are provided between the upper end portion and the lower end portion of the side opening <NUM>. A total of five protrusions 26A to 26E are arranged spaced apart from each other in the vertical direction. In the example of <FIG>, the five protrusions 26A to 26E are arranged at positions at substantially equal intervals along the vertical direction. Each of the protrusions 26A to 26E has a flat plate shape.

The protrusion <NUM> is formed to connect one edge portion and the other edge portion in the width direction of the side opening <NUM>. Specifically, as illustrated in <FIG>, the protrusion 26C, the protrusion 26D, and the protrusion 26E straddle and cross the side opening <NUM> to connect one edge portion and the other edge portion of the side opening <NUM>. As a result, the protrusion <NUM> has a beam-like structure straddling both edge portions of the side opening <NUM>. The side opening <NUM> formed in the tubular member <NUM> is divided into four small regions arranged in the vertical direction by the protrusion 26C, the protrusion 26D, and the protrusion 26E. Note that, in <FIG>, hatching is provided in the area of the side opening <NUM> for convenience of explanation.

As a result, the protrusion <NUM> functions as a reinforcing structure for the side opening <NUM>, making it possible to improve the mechanical strength of the tubular member <NUM>. As a result, when the bag-shaped member <NUM> is joined around the edge portion of the side opening <NUM>, it is possible to suppress deformation of the tubular member <NUM> due to pressure. In addition, even if the aspiration tube <NUM> enters the tubular member <NUM> at an angle toward the side opening <NUM>, the tip <NUM> of the aspiration tube <NUM> can be brought into contact with the protrusion <NUM>. Therefore, it is possible to effectively suppress the tip <NUM> of the aspiration tube <NUM> from coming into contact with the bag-shaped member <NUM>.

Moreover, in the examples of <FIG> and <FIG>, the tubular member <NUM> includes connecting portions <NUM> that connect the protrusions <NUM> adjacent to each other in the vertical direction. The connecting portions <NUM> are provided at four locations to connect the protrusion 26A and the protrusion 26C, the protrusion 26C and the protrusion 26D, the protrusion 26D and the protrusion 26D, and the protrusion 26E and the protrusion 26B. The connecting portions <NUM> extend along the vertical direction, which is the longitudinal direction of the side opening <NUM>. The connecting portions <NUM> have a flat plate shape extending in the vertical direction. The connecting portions <NUM> connect the five protrusions 26A to 26E to each other to integrate them in a grid pattern, effectively improving the mechanical strength of the tubular member <NUM>.

The connecting portions <NUM> are arranged at an intermediate position between one edge portion and the other edge portion of the side opening <NUM>. For this reason, the connecting portions <NUM> are formed to divide the side opening <NUM> into a portion on one edge portion side and a portion on the other edge portion side. Therefore, as illustrated in <FIG>, since each of the four opening portions divided into four in the vertical direction by the protrusions 26C to 26E is further divided into two in the width direction by the connecting portion <NUM>, the side opening <NUM> is divided into a total of eight opening portions 25A to <NUM>.

The width W2 of the protrusion 26A to protrusion 26E is substantially equal to or larger than the width W1 of the side opening <NUM>. Therefore, as illustrated in <FIG>, even when the reagent <NUM> is not contained in the bag-shaped member <NUM>, a bulge <NUM> widened and bulged outward is formed in the formation region of the protrusions 26A to 26E. That is, formed in the bag-shaped member <NUM> is a hollow internal space in which the inner surfaces of the sheet-shaped member <NUM> are separated from each other by the protrusion <NUM>. Since the bag-shaped member <NUM> is joined to the tubular member <NUM> in a state where the internal space is formed in advance, the internal volume that can store the reagent <NUM> is increased by that amount.

Further, as illustrated in <FIG>, the protrusion length L of the protrusion 26D located at the center of the side opening <NUM> in the vertical direction, among the protrusions 26A to 26E, is larger than the protrusion lengths of the other protrusions 26A, 26B, 26C, and 26E. This makes it possible to increase the internal space (that is, the volume of the reagent <NUM>) of the bag-shaped member <NUM> in the bulge <NUM> (see <FIG>) without making longer than necessary the protrusions 26A and 26B at both ends, where external force is likely to be applied.

In addition, the protrusion 26A at the upper end portion and the protrusion 26B at the lower end portion each form a joint region BR2 (see <FIG>) serving as a boundary portion separating the inside and the outside of the container body <NUM>. That is, the bag-shaped member <NUM> is joined along the outer peripheral surfaces of the protrusion 26A and the protrusion 26B. As a result, the tubular member <NUM> and the bag-shaped member <NUM> can be joined at the portion of the protrusion <NUM>. Unlike the tubular member <NUM>, the protrusion <NUM> does not need to have a hollow structure, so that deformation due to pressure at the time of joining can be effectively suppressed. As a result, the tubular member <NUM> and the bag-shaped member <NUM> can be joined more easily.

The protrusion 26A and the tip end portion <NUM> of the protrusion 26B have a tapered shape. Therefore, formation of a gap is avoided at the boundary portion from the location where the sheet-shaped members <NUM> of the bag-shaped member <NUM> are joined to each other to the location where the sheet-shaped member <NUM>, the protrusion 26A, and the protrusion 26B are joined.

As illustrated in <FIG>, the penetration prevention member <NUM> at the lower end portion of the tubular member <NUM> has a rounded shape and is formed to protrude at a position lower than that of the bag-shaped member <NUM>. The upper surface <NUM> of the penetration prevention member <NUM> is formed in a substantially spherical concave shape. The tubular member <NUM> including the penetration prevention member <NUM> is formed of, for example, polyethylene, and the thickness t1 of the penetration prevention member <NUM> is, for example, about <NUM>. A recessed portion <NUM> for engaging with the holding member <NUM> is formed on the outer surface of the peripheral wall portion <NUM> and at a position between the penetration prevention member <NUM> and the side opening <NUM>. Specifically, the recessed portion <NUM> is formed to be adjacent to the lower side of the protrusion 26B.

As illustrated in <FIG>, as an example of the sheet-shaped member <NUM>, the bag-shaped member <NUM> is made up of a three-layer laminated structure film material (see <FIG>) including (polyethylene/aluminum/nylon) from the inside. The bag-shaped member <NUM> is joined to the tubular member <NUM> when the inner polyethylene base material layer 31A is welded to the surface of the polyethylene tubular member <NUM>. The gas barrier layer 31B is made of aluminum. A nylon protective layer 31C is formed on the surface side of the gas barrier layer 31B. The thickness t1 of the sheet-shaped member <NUM> is, for example, in the range of <NUM> or more and <NUM> or less. Therefore, the thickness t1 of the penetration prevention member <NUM> is larger than the thickness t2 of the bag-shaped member <NUM>.

The bag-shaped member <NUM> is joined from the side to the tubular member <NUM> extending in the vertical direction. The bag-shaped member <NUM> is joined to the tubular member <NUM> to cover the side opening <NUM> inside. The upper end portion of the bag-shaped member <NUM> is joined along the outer periphery of the protrusion 26A (see <FIG>) of the tubular member <NUM>. The lower end portion of the bag-shaped member <NUM> is joined along the outer periphery of the protrusion 26B (see <FIG>) of the tubular member <NUM>. The bag-shaped member <NUM> is provided to store the protrusion 26C, the protrusion 26D, and the protrusion 26E (see <FIG>). The bag-shaped member <NUM> is also joined to the outer peripheral surfaces of the protrusion 26C, the protrusion 26D, and the protrusion 26E.

In addition, the bag-shaped member <NUM> is joined so that the laminated film is wound around the outer surface of the peripheral wall portion <NUM>. That is, the bag-shaped member <NUM> is joined to the tubular member <NUM> to cover the outer surface excluding the upper end portion of the tubular member <NUM> and the lower end portion of the tubular member <NUM>. With these configurations, the internal space of the bag-shaped member <NUM> communicates only with the side opening <NUM> of the tubular member <NUM>, and the side opening <NUM> communicates only with the opening at the upper end portion of the tubular member <NUM>. Note that the flange portion 21A at the upper end portion of the tubular member <NUM> protrudes upward from the bag-shaped member <NUM>. The upper surface <NUM> of the penetration prevention member <NUM> constituting the bottom portion <NUM> of the tubular member <NUM> protrudes at a position lower than the inner bottom <NUM> of the bag-shaped member <NUM>.

In addition, as illustrated in <FIG>, the container body <NUM> includes a sealing material <NUM> that seals the opening of the tubular member <NUM> and is puncturable by the aspiration tube <NUM>.

This makes it possible to store the unused reagent <NUM> for a long time in a sealed state without the risk of erroneous opening. In addition, when the sealing material <NUM> for the opening of the tubular member <NUM> is punctured by the aspiration tube <NUM>, a hard tube member having a sharp tip <NUM> is employed for the aspiration tube <NUM>, so that the bag-shaped member <NUM> is easily damaged. On the other hand, in the present embodiment, since the penetration prevention member <NUM> of the container body <NUM> can receive the sharp tip <NUM>, it is possible to particularly effectively suppress damage to the bag-shaped member <NUM>.

The sealing material <NUM> is made of, for example, a laminated film with a gas barrier property and a light-shielding property, and is welded to the upper end portion of the tubular member <NUM> to cover the opening at the upper end portion of the tubular member <NUM>. The laminated film constituting the sealing material <NUM> may be the same as the laminated film constituting the bag-shaped member <NUM>, but may be different. Preferably, the sealing material <NUM> has a property of being easily broken as compared with the bag-shaped member <NUM>. As a result, the sealing material <NUM> can be easily punctured by the tip <NUM> of the aspiration tube <NUM>. As an example, the sealing material <NUM> is made up of a four-layer laminated structure film material including (polyethylene/aluminum/polyethylene/PET) from the inside. PET as a protective layer has the property of being harder and less stretchable than, for example, nylon of the sheet-shaped member <NUM> constituting the bag-shaped member <NUM>. Therefore, the sealing material <NUM> is more easily punctured than the sheet-shaped member <NUM>.

The holding member <NUM> illustrated in <FIG> is configured as a case for storing the container body <NUM>. The holding member <NUM> is made of a material that is less likely to be deformed than the bag-shaped member <NUM>. The holding member <NUM> is, for example, a molded product made of a resin material. The resin material is, for example, polyethylene.

The holding member <NUM> includes a peripheral wall <NUM> formed with an open upper portion to surround the periphery of the container body <NUM>, and a bottom surface portion <NUM> formed at the bottom portion of the peripheral wall <NUM>. The holding member <NUM> stores and holds the container body <NUM> by inserting the container body <NUM> into the peripheral wall <NUM> from the open upper part.

The holding member <NUM> includes a support portion <NUM> that supports the bag-shaped member <NUM>. This makes it possible to stably hold the posture of the reagent container <NUM> even when the reagent container <NUM> includes the flexible bag-shaped member <NUM>.

The support portion <NUM> includes an inner peripheral surface of the peripheral wall <NUM> and an upper surface of the bottom surface portion <NUM>. The inner peripheral surface of the peripheral wall <NUM> supports the periphery of the bag-shaped member <NUM>, and the bag-shaped member <NUM> is mounted on the bottom surface portion <NUM>, so that the lower end portion of the bag-shaped member <NUM> is supported by the bottom surface portion <NUM>.

The holding member <NUM> includes a first engaging portion <NUM> that engages with the container body <NUM> to determine the position of the opening of the tubular member <NUM>, and a second engaging portion <NUM> that engages with the container body <NUM> to determine the position of the penetration prevention member <NUM>.

This allows the first engaging portion <NUM> to determine the position of the opening of the tubular member <NUM> serving as the entrance/exit of the aspiration tube <NUM>, and allows the second engaging portion <NUM> to determine the position of the penetration prevention member <NUM> that receives the tip <NUM> of the aspiration tube <NUM>. Therefore, since the penetration prevention member <NUM> can more reliably receive the tip <NUM> of the aspiration tube <NUM>, it is possible to effectively suppress the aspiration tube <NUM> from coming into contact with the bag-shaped member <NUM>.

As illustrated in <FIG>, the first engaging portion <NUM> includes an inner peripheral surface of the peripheral wall <NUM>. Specifically, the peripheral wall <NUM> includes an insertion portion <NUM> having a substantially cylindrical shape with an inner diameter d1 corresponding to the outer shape of the tubular member <NUM>. In addition, in the portion of the support portion <NUM> on the outer side of the insertion portion <NUM>, the distance d2 between the inner peripheral surfaces of the peripheral wall <NUM> is formed to be smaller than the inner diameter d1. The first engaging portion <NUM> includes an edge portion at the boundary between the insertion portion <NUM> and the support portion <NUM>. Therefore, when the tubular member <NUM> of the container body <NUM> is inserted into the insertion portion <NUM>, the first engaging portion <NUM> determines the position of the opening of the tubular member <NUM> with respect to the holding member <NUM> in the horizontal direction. In addition, the first engaging portion <NUM> restricts the movement of the tubular member <NUM> toward the support portion <NUM>. The first engaging portion <NUM> also has a function of guiding the tubular member <NUM> so that the tubular member <NUM> is inserted straight into the insertion portion <NUM> without being inclined.

As illustrated in <FIG>, the second engaging portion <NUM> includes the end portion of the bottom surface portion <NUM>. The bottom surface portion <NUM> extends from the region of the support portion <NUM> to the insertion portion <NUM> in which the tubular member <NUM> is arranged, and the second engaging portion <NUM> is formed at a position adjacent to the insertion portion <NUM>. When the tubular member <NUM> is inserted into the insertion portion <NUM>, the penetration prevention member <NUM> at the bottom portion of the tubular member <NUM> passes through the second engaging portion <NUM> and is arranged at a position lower than the bottom surface portion <NUM>. Then, the second engaging portion <NUM> engages with the tubular member <NUM> by fitting into the recessed portion <NUM> (see <FIG>) formed in the vicinity of the penetration prevention member <NUM>. As a result, the position of the penetration prevention member <NUM> with respect to the holding member <NUM> in the vertical direction is determined. When the holding member <NUM> storing the container body <NUM> is installed in the analyzer <NUM>, the second engaging portion <NUM> makes it possible to mechanically position the depth position of the penetration prevention member <NUM> in the reagent container <NUM> (that is, the insertion depth of the aspiration tube <NUM>). Note that the second engaging portion <NUM> and the recessed portion <NUM> form a snap-fit type engaging structure. The second engaging portion <NUM> also functions as a retaining portion that locks the container body <NUM> from the holding member <NUM> by fitting it into the recessed portion <NUM> to prevent accidental pullout.

At the time of manufacturing the reagent container <NUM>, first, the tubular member <NUM> and the bag-shaped member <NUM> are joined by heat welding to form the container body <NUM>. A predetermined amount of reagent <NUM> is injected into the container body <NUM>, and the air inside is removed or replaced with an inert gas. Then, the sealing material <NUM> is joined by heat welding to the opening at the upper end portion of the tubular member <NUM>, sealing the internal reagent <NUM>. Then, the container body <NUM> is inserted into the holding member <NUM>, and the tubular member <NUM> is engaged with the first engaging portion <NUM> and the second engaging portion <NUM> to be fixed to the holding member <NUM>.

As illustrated in <FIG>, the configuration storing the container body <NUM> in the case-shaped holding member <NUM> can include a reagent identification member <NUM>, such as an RFID or a display label storing information about a drug, attached to the outer surface of the holding member <NUM>.

Note that the volume of the reagent <NUM> in the reagent container <NUM> is arbitrary. The shapes of the bag-shaped member <NUM> and the holding member <NUM> of the reagent container <NUM> can be appropriately changed according to the volume of the reagent <NUM> that can be stored.

For example, <FIG> illustrates an example of a large-capacity type reagent container 100A having a capacity larger than that of the reagent container <NUM> illustrated in <FIG>. In the reagent container 100A, the shape of the tubular member <NUM> is the same as that of the example of <FIG> (length L10), but the length L12 of the bag-shaped member <NUM> is larger. In addition, the width W12 of the bag-shaped member <NUM> is enlarged from the middle, and is larger than the example (width W10) of <FIG>. Similarly, in the holding member <NUM> of the reagent container 100A, the shape in the vicinity of the insertion portion <NUM> into which the tubular member <NUM> is inserted is the same as that of <FIG>, but the shape of the support portion <NUM> of the holding member <NUM> is deformed according to the bag-shaped member <NUM>. The support portion <NUM> of the reagent container 100A has a length L13 larger than that of the example of <FIG> (length L11), and the width W13 of the support portion <NUM> is enlarged from the middle, and is larger than the example of <FIG> (width W11).

Next, a configuration example of the analyzer <NUM> that uses the reagent container <NUM> is described with reference to <FIG>.

The analyzer <NUM> illustrated in <FIG> is a blood cell counter. The blood cell counter is a device that measures a blood sample using the reagent <NUM> and detects cells such as blood cells and solid components contained in the blood sample.

The analyzer <NUM> includes a sample aspirator <NUM> that aspirates blood being a sample <NUM> from a sample container (test tube) <NUM>, a reagent aspirator <NUM> that aspirates the reagent <NUM> from the reagent container <NUM>, a specimen preparation unit <NUM> that prepares a measurement specimen using the aspirated sample <NUM> and reagent <NUM>, and a detection unit <NUM> that detects a test substance from the measurement specimen prepared by the specimen preparation unit <NUM>. The analyzer <NUM> is communicably connected to the control device <NUM> that analyzes the measurement results.

The sample aspirator <NUM> includes an aspiration tube <NUM> through which the sample passes, and a quantification unit <NUM>. The sample aspirator <NUM> aspirates the sample from the sample container <NUM> by the aspiration tube <NUM> and the quantification unit <NUM>. The quantification unit <NUM> includes a syringe pump and the like connected to the aspiration tube <NUM>. The sample aspirator <NUM> supplies a predetermined amount of sample required for sample measurement to the reaction chamber <NUM> of the specimen preparation unit <NUM> by the quantification unit <NUM>.

The reagent aspirator <NUM> is provided inside the analyzer <NUM>, and includes a container storage unit <NUM> in which the reagent container <NUM> is installed, an aspiration tube <NUM>, and a quantification unit <NUM>. Multiple sets of the container storage unit <NUM>, the aspiration tube <NUM>, and the quantification unit <NUM> may be provided so that multiple reagent containers <NUM> can be installed in order to supply different reagents <NUM> for each measurement item of the sample.

The container storage unit <NUM> can store the reagent container <NUM>, and is configured to hold the stored reagent container <NUM> in a predetermined position and a predetermined posture. The container storage unit <NUM> includes a reagent placement unit 221A configured to position and support the reagent container <NUM> in contact with the lower surface, the front surface on which the tubular member <NUM> is arranged, and both side surfaces of the reagent container <NUM>. The reagent container <NUM> is installed on the reagent placement unit 221A by the user.

The aspiration tube <NUM> is made of a hard material of stainless steel, and the tip <NUM> is formed in a sharp shape so that the sealing material <NUM> of the reagent container <NUM> can be punctured (that is, penetrated). The aspiration tube <NUM> is arranged at a position directly above the opening of the reagent container <NUM> installed in the container storage unit <NUM> so that the tip <NUM> faces downward, and is attached to an aspiration tube holder <NUM> that can move up and down. The aspiration tube holder <NUM> is configured to move up and down in conjunction with a cover <NUM> that covers the inlet of the container storage unit <NUM>. The cover <NUM> is configured to be movable in the vertical direction, and can be moved to a closed position Z1 that covers the inlet of the container storage unit <NUM> and an open position Z2 that opens the inlet of the container storage unit <NUM>.

When installing the reagent container <NUM>, the user moves the cover <NUM> upward to the opening position Z2 to open the inlet of the container storage unit <NUM>. The user installs the reagent container <NUM> (or the reagent container 100A) in the opened container storage unit <NUM>. The reagent container <NUM> is supported by the reagent placement unit 221A at a position where an opening is arranged directly below the aspiration tube <NUM>. After installing the reagent container <NUM>, the user moves the cover <NUM> downward to the closing position Z1 to close the inlet of the container storage unit <NUM>. At this time, the aspiration tube <NUM> moves downward in conjunction with the downward movement of the cover <NUM>, and the tip <NUM> of the aspiration tube <NUM> penetrates the sealing material <NUM> and enters the inside of the reagent container <NUM> through the opening.

The quantification unit <NUM> includes a pump 222A including a syringe pump, a diaphragm pump, and the like, electromagnetic valves 222B and 222C for switching the transfer path of the aspirated reagent <NUM>, and a flow path 222D. By opening the electromagnetic valve 222B and aspirating the pump 222A, the reagent <NUM> is quantitatively aspirated from the inside of the reagent container <NUM> through the aspiration tube <NUM> and the flow path 222D. By opening the electromagnetic valve 222C and discharging the pump 222A, the quantified reagent <NUM> is transferred to the reaction chamber <NUM> through the flow path 222D.

The specimen preparation unit <NUM> includes a reaction chamber <NUM>. The reaction chamber <NUM> is configured to mix the sample (blood) <NUM> aspirated by the sample aspirator <NUM> and the reagent <NUM> supplied from the reagent aspirator <NUM>. Multiple reaction chambers <NUM> may be provided depending on the number of measurement items. The reaction chamber <NUM> is supplied with the reagent <NUM> according to the measurement item, and a measurement specimen according to the measurement item is prepared by mixing the sample <NUM> and the reagent <NUM>. Then, the prepared measurement specimen is supplied to the detection unit <NUM>. The excess measurement specimen is discharged to the waste liquid chamber <NUM> by opening the valve <NUM>. The reagent <NUM> contains a staining solution for specifically staining specific type of particles or cells in a biological sample such as blood, urine or body fluid. Body fluid may be any one of cerebrospinal fluid, thoracic fluid, abdominal fluid, fluid of the cardiac sac, synovial fluid, dialysate from peritoneal dialysis, and intraperitoneal rinse. The staining solution contains, for example, at least one fluorescent dye for staining cells. The fluorescent dye may be fluorescent dye for staining at least one of white blood cells, red blood cells, reticulocytes, nucleated red blood cells, organelles, platelets, and other blood cells in blood. The fluorescent dye may be fluorescent dye for staining white blood cells, red blood cells, bacteria, epithelial cells and other formed elements in urine. The fluorescent dye may be fluorescent dye for staining white blood cells, red blood cells, epithelial cells and other cells in body fluid.

The detection unit <NUM> detects blood cell components contained in a blood sample. The detection unit <NUM> classifies and detects the stained blood cell components contained in the measurement specimen by a flow cytometry method using a semiconductor laser. In addition, the detection result obtained by the detection unit <NUM> is transmitted to the control device <NUM> as measurement data (measurement result) of the sample.

The detection unit <NUM> causes particles such as cells to flow into the flow of the sheath liquid formed in the flow path portion, irradiates the flowing particles with laser light from the light transmitting unit, and detects scattered light and fluorescence by the light receiving unit. The control device <NUM> analyzes individual particles based on the light detected by the detection unit <NUM>. For example, a scattergram that combines scattered light intensity and fluorescence intensity as parameters is created, and the specimen is analyzed based on the distribution and the like of the scattergram. Measurement items by the flow cytometry method include NEUT (neutrophil), LYMPH (lymphocyte), MONO (monocyte), EO (eosinophil), BASO (basophil) and the like.

In addition, the detection unit <NUM> performs detection by, for example, a sheath flow DC detection method. That is, the detection unit <NUM> detects an electrical change between a flow path portion provided with an opening portion through which a specimen flows and a pair of electrodes arranged to face each other with the opening portion in between. The detection unit <NUM> causes particles such as cells to flow in the flow of the sheath liquid passing through the opening portion, and causes a direct current to flow between the electrodes. The detection unit <NUM> detects individual particles based on the pulsed current change as the particles pass through the opening portion. Measurement items by the sheath flow DC detection method include WBC (white blood cell) count, RBC (hemoglobin) count, HGB (hemoglobin amount), HCT (hematocrit value), MCV (mean corpuscular volume), MCH (mean corpuscular hemoglobin), MCHC (mean corpuscular hemoglobin concentration), PLT (platelet count), and the like.

Here, an example has been provided in which the analyzer <NUM> is a blood cell counter, but the present invention is not limited to this. The analyzer <NUM> may be any device that measures a sample using the reagent <NUM>. The reagent <NUM> contains components according to the measurement principle of the sample by the analyzer <NUM>, and is not limited to the staining solution.

The analyzer <NUM> can be, for example, a blood coagulation analyzer that performs blood coagulation analysis. In this case, the sample is plasma or serum isolated from blood. The analyzer <NUM> analyzes the sample using a coagulation method, a synthetic substrate method, immunonephelometry, and/or an agglutination method.

In the coagulation method, the measurement specimen is irradiated with light to measure the coagulation time of converting fibrinogen in the sample to fibrin based on the electric signal of the transmitted light or scattered light from the specimen. As the reagent <NUM>, a coagulation reagent containing a coagulation factor is used. Measurement items of the coagulation method include PT (prothrombin time), APTT (activated partial thromboplastin time), Fbg (fibrinogen amount), and the like.

In the synthetic substrate method, the measurement specimen is irradiated with light to measure the degree of color development due to the action of the chromogenic synthetic substrate with respect to the enzyme in the measurement specimen based on the electric signal of the transmitted light from the specimen. The reagent <NUM> contains a chromogenic synthetic substrate. Measurement items of the synthetic substrate method include ATIII (antithrombin III), α2-PI (α2-plasmin inhibitor), PLG (plasminogen), and the like.

In immunonephelometry, an antibody-sensitizing reagent that causes an antigen-antibody reaction against coagulation·fibrinolytic factors in the sample is added to the sample, and the substance contained in the reagent <NUM> agglutinates as a result of the antigen-antibody reaction. The reagent <NUM> is an antibody-sensitizing reagent. In immunonephelometry, the measurement specimen is irradiated with light to measure the agglutination rate of the reagent-containing substance in the measurement specimen based on the electric signal of the transmitted light or scattered light from the specimen. Measurement items of immunonephelometry include D-dimer, FDP (fibrin degradation product), and the like.

In the agglutination method, the measurement specimen is irradiated with light to measure the change in absorbance in the process of agglutination of platelets and the like in the measurement specimen based on the electric signal of the transmitted light from the specimen. The reagent <NUM> 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), platelet agglutination ability, and the like.

The analyzer <NUM> can be, for example, a blood coagulation analyzer that performs blood coagulation analysis. In this case, the sample is plasma or serum isolated from blood. The analyzer <NUM> analyzes the sample using a coagulation method, a synthetic substrate method, immunonephelometry, or an agglutination method. The control device <NUM> analyzes the sample based on the detected light.

In addition, for example, the analyzer <NUM> may be an immunoassay device. The analyzer <NUM> detects the target component by using the antigen-antibody reaction between the target component in blood and the component in the reagent. As a target component, for example, an antigen or antibody, a protein, a peptide, or the like contained in blood is detected. The immunoassay device acquires serum or plasma as a sample, and quantitatively or qualitatively measures an antigen or antibody contained in the sample. Note that 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. Aptamers are nucleic acid molecules or peptides synthesized to specifically bind to a particular substance.

The analyzer <NUM> measures the light generated from the specimen, that is, the chemiluminescence based on the test substance contained in the sample. The analyzer <NUM> generates measurement data based on the light detected by the detection unit. The reagent <NUM> may 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 an immune complex, a reagent containing a labeling substance, an enzyme reagent for generating chemical luminescence, and the like.

Here, chemiluminescence is light emitted by utilizing energy generated by a chemical reaction. Chemiluminescence is, for example, light emitted when a molecule is excited by a chemical reaction to an excited state and returns from the excited state to the ground state. The chemiluminescence detected by the detection unit is, for example, based on chemiluminescence enzyme immunoassay (CLEIA), and is the light generated by the reaction between the enzyme and the substrate. Measurement items of chemiluminescence enzyme immunoassay include HBsAb, FT3, FT4, TSH, and the like.

Note that the chemiluminescence detected by the detection unit may be, for example, light based on chemiluminescence immunoassay (CLIA), electrochemiluminescence immunoassay (ECLIA), fluorescence enzyme immunoassay (FEIA method), LOCI method (Luminescent Oxygen Channeling Immunoassay), BLEIA method (bioluminescent enzyme immunoassay), and the like.

Claim 1:
A reagent container that is installed in an analyzer for use, and that stores a reagent supplied to the analyzer via an aspiration tube, the reagent container (<NUM>) comprising:
a container body (<NUM>) comprising
a tubular member (<NUM>) with an opening into which the aspiration tube is inserted from above, and
a flexible bag-shaped liquid container (<NUM>) joined to the tubular member (<NUM>) and storing the reagent,
characterized in that
the container body (<NUM>) comprises a penetration prevention member (<NUM>) for preventing a tip of the aspiration tube inserted through the opening from penetrating the container body (<NUM>),
wherein the penetration prevention member (<NUM>) has a thickness larger than that of the flexible bag-shaped liquid container (<NUM>), and
comprises a material harder than the flexible bag-shaped liquid container (<NUM>), and
wherein the container body (<NUM>) comprises the penetration prevention member (<NUM>) in a bottom portion region including an intersection between a central axis of the opening of the tubular member (<NUM>) and an inner surface of the container body (<NUM>).