WO2015012390A1 - 検体調製用容器 - Google Patents
検体調製用容器 Download PDFInfo
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- WO2015012390A1 WO2015012390A1 PCT/JP2014/069703 JP2014069703W WO2015012390A1 WO 2015012390 A1 WO2015012390 A1 WO 2015012390A1 JP 2014069703 W JP2014069703 W JP 2014069703W WO 2015012390 A1 WO2015012390 A1 WO 2015012390A1
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- container
- capillary
- wall
- sample
- biological sample
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/38—Diluting, dispersing or mixing samples
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150015—Source of blood
- A61B5/150022—Source of blood for capillary blood or interstitial fluid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150343—Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F31/00—Mixers with shaking, oscillating, or vibrating mechanisms
- B01F31/65—Mixers with shaking, oscillating, or vibrating mechanisms the materials to be mixed being directly submitted to a pulsating movement, e.g. by means of an oscillating piston or air column
- B01F31/651—Mixing by successively aspirating a part of the mixture in a conduit, e.g. a piston, and reinjecting it through the same conduit into the receptacle
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
- B01F35/50—Mixing receptacles
- B01F35/53—Mixing receptacles characterised by the configuration of the interior, e.g. baffles for facilitating the mixing of components
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
- B01F35/50—Mixing receptacles
- B01F35/53—Mixing receptacles characterised by the configuration of the interior, e.g. baffles for facilitating the mixing of components
- B01F35/531—Mixing receptacles characterised by the configuration of the interior, e.g. baffles for facilitating the mixing of components with baffles, plates or bars on the wall or the bottom
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
- B01L3/508—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
- B01L3/508—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
- B01L3/5082—Test tubes per se
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
- B01L3/508—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
- B01L3/5082—Test tubes per se
- B01L3/50825—Closing or opening means, corks, bungs
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/02—Devices for withdrawing samples
- G01N1/10—Devices for withdrawing samples in the liquid or fluent state
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
- B01L2200/02—Adapting objects or devices to another
- B01L2200/025—Align devices or objects to ensure defined positions relative to each other
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
- B01L2200/02—Adapting objects or devices to another
- B01L2200/026—Fluid interfacing between devices or objects, e.g. connectors, inlet details
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/04—Closures and closing means
- B01L2300/041—Connecting closures to device or container
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/04—Closures and closing means
- B01L2300/041—Connecting closures to device or container
- B01L2300/044—Connecting closures to device or container pierceable, e.g. films, membranes
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/04—Closures and closing means
- B01L2300/046—Function or devices integrated in the closure
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/04—Closures and closing means
- B01L2300/046—Function or devices integrated in the closure
- B01L2300/047—Additional chamber, reservoir
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/06—Auxiliary integrated devices, integrated components
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/06—Auxiliary integrated devices, integrated components
- B01L2300/0609—Holders integrated in container to position an object
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/08—Geometry, shape and general structure
- B01L2300/0832—Geometry, shape and general structure cylindrical, tube shaped
- B01L2300/0838—Capillaries
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/08—Geometry, shape and general structure
- B01L2300/0848—Specific forms of parts of containers
- B01L2300/0851—Bottom walls
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/08—Geometry, shape and general structure
- B01L2300/0848—Specific forms of parts of containers
- B01L2300/0858—Side walls
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2400/00—Moving or stopping fluids
- B01L2400/08—Regulating or influencing the flow resistance
- B01L2400/084—Passive control of flow resistance
- B01L2400/086—Passive control of flow resistance using baffles or other fixed flow obstructions
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/38—Diluting, dispersing or mixing samples
- G01N2001/383—Diluting, dispersing or mixing samples collecting and diluting in a flow of liquid
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N2035/00465—Separating and mixing arrangements
- G01N2035/00514—Stationary mixing elements
Definitions
- the present invention relates to a specimen preparation container for biological sample analysis.
- Patent Document 1 includes an inlet for supplying a dilution solution at the top for diluting a blood sample, and an inlet for injecting air for stirring the liquid at the bottom.
- a liquid mixing container having a roughened surface is disclosed.
- Patent Document 2 discloses a system for diluting and mixing a specimen by discharging a specimen such as blood and a diluent into a container, and repeatedly aspirating and discharging the liquid in the container using a liquid dispensing means. ing.
- An object of the present invention is to provide a means for collecting a small amount of biological sample used for biological sample analysis and preparing a diluted solution of the sample.
- the present invention provides a device for collecting a small amount of a liquid biological sample, a sample dilution container capable of easily mixing a liquid biological sample and a diluting solution, and a combination thereof.
- a container assembly for specimen preparation is provided.
- the present invention is a sample preparation container, A biological sample collection device and a sample dilution container;
- the biological sample collection device comprises: A capillary having openings at both ends, and a support member for supporting the capillary,
- the sample dilution container is: An opening, A swirl flow generating member formed on the inner wall of the container,
- the capillary of the biological sample collection device is disposed inside the sample dilution container by the support member.
- a container for sample preparation is provided.
- the present invention provides a biological sample collection device having a capillary having openings at both ends and a support member for supporting the capillary.
- the present invention provides a sample dilution container having an opening and a swirl flow generating member formed on the inner wall of the container.
- a trace amount of a biological sample can be collected. Further, according to the present invention, it is possible to dilute the minute sample to a desired concentration by a simple means. Therefore, according to the present invention, a highly accurate analysis result can be obtained even from a small amount of biological sample.
- INDUSTRIAL APPLICABILITY The present invention is useful for the preparation of a specimen for a simple test at home or bedside, or a blood test for a patient who is difficult to collect blood by a conventional method such as infants, the elderly, and the sick, or a large amount of blood.
- FIG. 4 is a partial side view of an exemplary embodiment of a biological sampling device 2 having a capillary tube 21 and a support member 22.
- An exemplary embodiment of a biological sample collection device 2. (A): Front view, (b): Cross-sectional view along line AA in (a), (c): Plan view.
- FIG. 4 is a cross-sectional view of an exemplary embodiment of a swirl flow generating member 32 formed in the sample dilution container 3.
- FIG. 3 is a plan view of an exemplary embodiment of a swirl flow generating member 32 formed in the sample dilution container 3.
- the sample preparation container of the present invention is a device for preparing a sample for biological sample analysis such as a blood test.
- the biological sample that is the source of the specimen prepared in the specimen preparation container of the present invention includes body fluids such as blood, serum, plasma, saliva, urine, stool and vomit solution or suspension, animal and plant tissues, Examples include lysates or suspensions of cells.
- the sample preparation container of the present invention includes a biological sample collection device for collecting a small amount of the above-described biological sample and a sample dilution container for diluting the collected biological sample with a diluting solution.
- the biological sample collecting device has a capillary for collecting and holding a biological sample.
- the biological sample collection device has a shape that can be combined with the sample dilution container so that the capillary is disposed inside the sample dilution container.
- the biological sample is collected and held by the capillary of the biological sample collection device, and is placed in the sample dilution container when the device is set in the sample dilution container.
- the device and the sample dilution container may be provided or used in combination, or may be provided or used alone.
- the sample dilution container has a swirl flow generating member on its inner wall.
- the swirling flow generating member has a function of swirling the liquid in the container when the liquid is injected into the sample dilution container.
- the “swirl flow” means, for example, a flow swirling in a horizontal direction generally along the inner peripheral surface of the container, a flow swirling in a vertical direction generally along the inner peripheral surface of the container, or a generally swirling flow of the container. This means a flow that spirally swirls along the inner peripheral surface.
- the swirl flow generating member is a concave portion or a convex portion formed on the inner wall of the sample dilution container, such as an inclined surface, a protrusion, or a depression.
- the swirling flow generating member is provided on the inner wall of the container, so that a swirling flow of the diluting solution is generated inside the container.
- the biological sample in the capillary tube arranged inside the container flows out of the capillary tube and is sufficiently mixed with the diluting solution.
- the sample preparation container of the present invention makes it possible to easily prepare a homogeneous diluted solution of a small amount of biological sample.
- the setting of the biological sample collection device in the sample dilution container and the injection of the dilution solution into the sample dilution container may be performed manually or automatically.
- the device When setting a biological sample collection device automatically, the device may be carried by a device transfer device and attached to a sample dilution container. Alternatively, the device transfer apparatus may continue to hold the device in its position after transferring the device so that the capillary is disposed inside the sample dilution container.
- the device transfer device or dilution device is placed in the device or container or a rack containing them. It is preferable that a label for recognition by the solution injection device is provided.
- Specimens prepared in the specimen preparation container of the present invention can be directly set in a normal analyzer for analysis. More preferably, the specimen preparation container of the present invention is set in an analyzer with a biological sample placed therein, and a series of steps from preparation of a diluted sample to analysis is performed automatically or semi-automatically in the analyzer. Samples prepared by the sample preparation container of the present invention are applied to various biological sample analysis such as high performance liquid chromatography devices, biochemical automatic analyzers, blood cell counters, flow cytometry, flow injection devices, particle size measuring devices, etc. can do.
- the specimen preparation container 1 of the present invention includes a biological sample collection device 2 and a sample dilution container 3. Furthermore, the specimen preparation container 1 may include a lid 4 for closing the opening of the sample dilution container 2.
- 1a, b and c show a side view, a sectional view and a perspective view, respectively, of an exemplary embodiment of a sample preparation container 1 of the present invention.
- a specimen preparation container 1 shown in FIG. 1 a includes a biological sample collection device 2, a sample dilution container 3, and a lid 4.
- FIG. 1c further shows an injection tube 5 for injecting a sample dilution solution. The injection tube 5 passes through the lid 4 in the direction of the arrow in FIG.
- the biological sample collection device 2 In the sample preparation container 1 shown in FIG. 1, the biological sample collection device 2, the sample dilution container 3, and the lid 4 are manufactured as separate parts as shown in FIGS. 2a to 2c.
- the sample preparation container 1 When the sample preparation container 1 is configured by combining the biological sample collection device 2 with the lid portion 4 as shown in FIG. 2 d, the device 2 is covered with the lid portion 4. Is disposed inside the container 3.
- the biological sample collection device 2 and the sample dilution container 3 may be used in combination as described above, but may be used alone.
- the biological sample collection device 2 includes a capillary tube 21 having openings at both ends for collecting a small amount of a biological sample, and one or a plurality of support members 22 for supporting the capillary tube 21.
- the capillary 21 takes in a biological sample inside by capillary action. For example, if a lancet or the like is used to slightly bleed from a fingertip and the capillary 21 is brought into contact with the bleeding site, a necessary amount of blood is taken into the capillary 21 by capillary action. Therefore, by using the biological sample collection device 2, it is possible to collect a blood sample without invading the living body with a blood collection needle or the like.
- the inner diameter of the capillary tube 21 may be any size necessary to cause capillary action, and the inner diameter is preferably about 0.1 to 3 mm, more preferably about 0.5 mm to 1.5 mm.
- the length of the capillary tube 21 may be a size that can hold a biological sample in an amount necessary for analysis, preferably about 1 to 5 ⁇ L, more preferably 2 to 4 ⁇ L.
- the support member 22 supports the capillary 21 so that the capillary 21 can hold its position inside the sample dilution container 3. Since the sample in the capillary 21 is held inside by capillary action, the direction of the opening of the capillary 21 in a state of being supported in the container 3 is not limited, and can be arranged in any direction from the horizontal direction to the vertical direction. .
- FIG. 3 illustrates a partial side view of an exemplary embodiment of the device 2 arranged such that the opening of the capillary 21 inside the container 3 is oriented vertically and horizontally.
- the capillary 21 is preferably arranged so as not to contact the inner wall of the container 3 so that the sample can be easily released after the dilution solution is injected.
- the capillary 21 is supported by two support members 22.
- Each of the support members 22 is connected to a capillary 21 at one end and a fixing member 23 for fixing the device 2 to the lid portion 4 at another end.
- the fixing member 23 shown in FIG. 4 is annular and has a structure that can be fitted inside the cylindrical lid portion 4.
- FIG. 5 shows a structure in which the biological sample collection device 2 shown in FIG. 4 is fixed to the lid 4 by the fixing member 23. In this way, when the device 2 is fixed to the lid portion 4, when the container 3 is covered with the lid portion 4, the capillary 21 has an opening portion by cooperation of the support member 22, the fixing member 23, and the lid portion 4.
- the sample is inserted and held in the sample dilution container 3 in a state of being directed in a prescribed direction (vertical direction in FIG. 5).
- the biological sample collecting device 2 and the lid portion 4 may be integrally formed from the beginning to manufacture a lid portion with a capillary as shown in FIG.
- the fixing member 23 has a structure that can be directly fixed to the opening edge of the container 3, and the device 2 is fixed to the container 3 by the fixing member 23.
- the capillary 21 is held inside the container 3 by the cooperation of the support member 22 and the fixing member 23.
- the biological sample collection device 2 does not have the fixing member 23, and instead, one end of the support member 22 is connected to the device transfer apparatus. By driving the device transfer device, the capillary 21 is transferred to a desired position in the container 3 and held.
- the shape of the fixing member 23 may be any structure as long as the biological sample collection device 2 can be fixed to the sample dilution container 3 or the lid 4, and examples thereof include an annular shape, a U shape, and a hook shape, but are not limited thereto. There is no need to
- polymethyl methacrylate resin, polystyrene, ASA resin, cycloolefin, polycarbonate, polyethylene terephthalate, etc. are preferable, and polymethyl methacrylate resin and polystyrene are more preferable in terms of transparency and hydrophilicity.
- the device 2 is preferably formed by injection molding, hot press molding, cast molding, 3D lamination, or the like. More preferably, the capillary tube 21, the support member 22, and the fixing member 23 are integrally formed by injection molding.
- sample Dilution Container 3 has an opening 31 through which the capillary 21 and the injection pipe 5 for injecting dilution solution are inserted into the container 3.
- the shape of the bottom of the container 3 is not particularly limited.
- the container 3 is a cylindrical tube having a round bottom, a flat bottom, or an intermediate shape bottom.
- the container 3 may also have a leg for self-supporting.
- the size of the container 3 can be appropriately changed according to the amount of the dilution solution to be injected.
- the dilution solution is injected into the container 3 from the injection tube 5.
- the injected dilution solution dilutes the biological sample held in the capillary 21.
- the diluting solution is preferably injected into the container 3 in such an amount that the water surface after injection is at least above the upper end of the capillary 21.
- a swirling flow generating member 32 is formed on the inner wall of the container 3, and the swirling flow of the solution is generated when the solution comes into contact with the swirling flow generating member 32 when the diluting solution is injected.
- the swirling flow plays a role of causing the biological sample to flow out of the capillary tube 21 and a role of sufficiently mixing the flowed biological sample with the diluting solution. Further, the sample and the solution can be stirred more efficiently by repeatedly sucking and discharging the solution in the container 3 using the injection tube 5 or the like.
- the swirl flow generating member 32 is basically composed of one or a plurality of convex portions or concave portions formed on the bottom or side wall of the inner wall of the container 3.
- Preferred examples of the one or more protrusions include one or more inclined surfaces, one or more shelf-like protrusions, one cone-like protrusion, one windmill-like, radial or S-shaped.
- Protrusions can include one, two, three, four or more than five wing or spiral protrusions, or combinations thereof.
- Preferable examples of the one or more recesses include one or more recesses formed in a part of the bottom.
- FIGS. 6 a to e and FIGS. 7 a to e illustrate a cross-sectional view and a plan view, respectively, of an exemplary embodiment of the swirl flow generating member 32 formed in the sample dilution container 3.
- the swirl flow generating member 32 is one inclined surface formed from the side surface of the inner wall of the container 3 to the bottom.
- FIGS. 6 a and 7 a illustrate a cross-sectional view and a plan view, respectively, of an exemplary embodiment of the swirl flow generating member 32 formed in the sample dilution container 3.
- the swirl flow generating member 32 is one inclined surface formed from the side surface of the inner wall of the container 3 to the bottom.
- the swirl flow generating member 32 is one conical protrusion formed at the center of the bottom of the container 3.
- the swirl flow generating member 32 is a plurality of blade-like protrusions formed on the bottom of the inner wall of the container 3.
- the swirl flow generating member 32 is one spiral protrusion formed from the side surface to the bottom of the container 3.
- the swirl flow generating member 32 is one recess formed at a position eccentric with respect to the bottom of the container 3, whereby the container 3 forms a two-stage bottom. .
- FIGS. 8a to 8e show conceptual diagrams of swirling flow (arrows) of the solution generated in the container 3 when the dilution solution is discharged from the injection tube 5 to the container 3 shown in FIGS. 6a to 6e.
- the capillary 21 has the upper end position equal to or higher than the upper end position of the swirling flow generating member 32 formed on the inner wall of the sample dilution container 3. It is desirable that it is disposed inside the container 3 so as to be lower.
- the sample dilution container 3 is preferably formed by injection molding or the like from polypropylene, polyethylene, polystyrene, polymethyl methacrylate resin, polyethylene terephthalate, polyamide, polybutylene terephthalate, polyacetal, or the like. More preferably, the swirl flow generating member 32 is formed integrally with the container 3.
- Lid portion The lid portion 4 can be a cap, a screw cap, a lid, or the like for closing the opening of the sample dilution container 3.
- the lid 4 may have a shape that covers the opening of the container 3 by covering the container 3 to which the biological sample collection device 2 is fixed.
- the lid 4 is connected to or integrally formed with the biological sampling device 2 (see, for example, FIG. 5), and simultaneously seals the container 3 with the lid 4.
- the biological sample collecting device 2 is fixed to the container 3, and the capillary tube 21 is held inside the container 3.
- the lid portion 4 can also serve as the fixing member 23 of the device 2.
- the lid 4 can also serve as a handle for operating the device 2 when the biological sample is collected using the biological sample collection device 2.
- the lid 4 may also have a hole 42 in the wall 41 of the surface through which the injection tube passes so that the injection tube 5 can be inserted into the sample dilution container 3.
- the lid 4 may have a membrane 43 through which the injection tube can be punctured, instead of the wall 41 having the hole 42.
- the hole 42 in the wall 41 may be any size and shape that allows the injection tube 5 to pass through, and may be a hole, a straight, curved, cross, or radial slit.
- the hole 42 is usually closed and can be opened only when the injection tube 5 passes, for example, a slit having a linear shape, a curved shape, a cross shape or a radial shape.
- the slit may be opened to such an extent that the solution inside does not jump out of the container 3 due to its surface tension.
- the slit width is preferably 0.2 mm to 0.6 mm, and more preferably 0.3 mm to 0.5 mm.
- the slit width is larger than 0.6 mm, the sample solution passes through the slit. It may leak out of the container.
- FIG. 9 shows an exemplary embodiment of the wall 41 of the lid 4.
- the wall 41 has radial slits 42a
- the wall 41 has cross-shaped slits 42b.
- the wall 41 is always provided with a hole 42c for passage of the injection tube 5.
- the wall 41 is a membrane 43 through which the injection tube 5 can be punctured.
- the lid 4 is preferably formed from linear low density polyethylene, polypropylene, high density polyethylene, low density polyethylene, polyamide, polyacetal, or the like.
- the wall 41 is preferably formed from linear low density polyethylene, polypropylene, high density polyethylene, low density polyethylene, polyamide, polyacetal, or the like.
- the membrane 43 is preferably formed from linear low density polyethylene, polypropylene, high density polyethylene, low density polyethylene, polyamide, polyacetal, or the like, and is preferably a thin layer that can be easily punctured by an injection tube.
- membrane 43 are formed by injection molding.
- the injection tube 5 has a discharge port 51 for discharging the dilution solution.
- the discharge port 51 is opened in a direction in which the swirling flow generating member 32 inside the sample dilution container 3 can discharge the diluting solution in a direction in which the swirling flow can be generated.
- the discharge port opens to the side surface near the tip of the injection tube 5 and discharges the dilution solution toward the side wall facing the swirling flow generating member 32 in the sample dilution container 3 (FIG. 8a).
- the discharge port opens at the tip of the injection tube 5 and discharges the dilution solution toward the swirl flow generating member 32 at the bottom of the sample dilution container 3 (see FIG. 8b).
- the injection tube 5 may be provided in a manual injection member, or may be provided as a part of an automatic dispensing device or an analyzer.
- the guide 6 indicates a position where the device 2 and the container 3 are connected to hold the capillary 21 of the biological sample collection device 2 in an appropriate position in the sample dilution container 3.
- the guide 6 is a pair of engaging members provided on the device 2 and the container 3, whereby the device 2 is fixed to the container 3 in a predetermined positional relationship.
- the capillary tube 21 can always be arranged at a fixed position.
- the guide 6 is a pair of engaging members provided on the lid 4 and the container 3 connected to the device 2.
- the container 3 has an asymmetrical shape, for example, a circular opening having a part of a flat wall, and the device 2 has an arcuate fixing member corresponding to the shape of the opening.
- the device 2 and the container 3 are always fixed in a predetermined positional relationship, and the capillary 21 is placed at a fixed position in the container 3.
- the guide 6 may be an indicator such as a line, groove, or protrusion displayed on the device 2 and the container 3.
- the guide 6 is a pair of engaging members provided on the lid portion 4 and the container 3.
- Engaging member 7 plays a role of arranging the container 1 in a predetermined direction with respect to the rack when the specimen preparation containers 1 of the present invention are arranged in the rack. Further, if the rack in which the containers 1 are arranged is set in the dispensing or analyzing apparatus, the arrangement of the containers 1 with respect to the apparatus is fixed. Therefore, the containers 1 are arranged in a position suitable for dispensing or analyzing in the apparatus. It becomes possible.
- the engaging member 7 only needs to be configured and shaped so that the container 1 can be stably fixed to the rack. Therefore, the engaging member 7 can be provided at any position of the sample dilution container 3 or the lid 4.
- the engaging member 7 is an engaging member such as a protrusion or a hook provided on the sample dilution container 3, and engages with a pair of members provided on the rack, so that the container 1 is placed on the rack. Fix it.
- the engaging member 7 is an elongated protrusion provided on the outer wall of the sample dilution container 3 along the long axis.
- the engaging member 7 may be formed integrally with the sample dilution container 3 or may be formed and connected as a separate member, but is preferably formed integrally.
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Abstract
Description
生体試料採取用デバイスと、試料希釈用容器とを備え、
該生体試料採取用デバイスは、
両端に開口部を有する毛細管と
該毛細管を支持するための支持部材と
を有し、
該試料希釈用容器は、
開口部と、
該容器の内壁に形成された旋回流発生部材と
を有し、
該生体試料採取用デバイスの毛細管は、該支持部材により、該試料希釈用容器の内部に配置される、
検体調製用容器を提供する。
本発明の検体調製用容器1は、生体試料採取用デバイス2と、試料希釈用容器3とを備える。さらに検体調製用容器1は、試料希釈用容器2の開口部を閉じるための蓋部4を備えていてもよい。図1a、bおよびcは、それぞれ、本発明の検体調製用容器1の例示的実施形態の側面図、断面図および斜視図を示す。図1aに示される検体調製用容器1は、生体試料採取用デバイス2と、試料希釈用容器3と、蓋部4とを備えている。参考として、図1cにはさらに、試料希釈用溶液を注入するための注入管5が図示されている。注入管5は、図1c中の矢印の方向に、蓋部4を通過して、容器3の開口部から内部に挿入される。図1に示される検体調製用容器1においては、生体試料採取用デバイス2、試料希釈用容器3および蓋部4は、図2a~cに示すようにそれぞれ別個の部品として製造されるが、これらを組み合わせて検体調製用容器1を構成するときは、図2dに示されるように生体試料採取用デバイス2は蓋部4と一体化しており、容器3を蓋部4で蓋をすると、デバイス2が容器3の内部に配置される。なお、生体試料採取用デバイス2と試料希釈用容器3とは、上記のように組み合わせて使用されてもよいが、各々単独で使用されてもよい。
生体試料採取用デバイス2は、生体試料を微量採取するための、両端に開口部を有する毛細管21と、該毛細管21を支持するための1つまたは複数の支持部材22とを有する。毛細管21は、毛細管現象によって内部に生体試料を取り込む。例えば、ランセットなどにより指先等から僅かに出血させ、該出血部位に毛細管21を接触させると、毛細管現象によって、必要な量の血液が毛細管21に取り込まれる。したがって、生体試料採取用デバイス2を用いることにより、生体に採血針などによる侵襲を与えることなく血液試料の採取が可能となる。毛細管21の内径は、毛細管現象を引き起こすのに必要なサイズであればよく、内径約0.1~3mmが好ましく、約0.5mm~1.5mmがより好ましい。毛細管21の長さは、分析に必要な量、好ましくは約1~5μL、より好ましくは2~4μLの生体試料を保持できるサイズであればよい。
試料希釈用容器3は開口部31を有し、この開口部から前述した毛細管21、および希釈用溶液注入用の注入管5が容器3内部に挿入される。容器3の底部の形状は特に限定されないが、好ましくは、容器3は、丸底、平底、またはその中間の形状の底部を有する円筒形の管である。容器3はまた、自立するための脚部を有していてもよい。容器3の大きさは、注入する希釈用溶液の量に応じて適宜変更することができる。
蓋部4は、試料希釈用容器3の開口部を閉じるためのキャップ、スクリューキャップ、リッドなどであり得る。一実施形態において、蓋部4は、生体試料採取用デバイス2が固定された容器3に被せて容器3の開口部を封鎖する形状であり得る。別の実施形態において、蓋部4は、生体試料採取用デバイス2と連結されているかまたは一体成形されており(例えば、図5を参照)、蓋部4で容器3を封鎖することにより、同時に生体試料採取用デバイス2が容器3に固定され、毛細管21が容器3内部に保持される。後者の実施形態の場合、蓋部4は、デバイス2の固定部材23の役割を兼ね備え得る。また後者の実施形態の場合、蓋部4は、生体試料採取用デバイス2を用いて生体試料の採取するときに、デバイス2を操作するためのハンドルの役割を兼ね備えることができる。
注入管5は、希釈用溶液を排出するための排出口51を有する。好ましくは、排出口51は、試料希釈用容器3の内部の旋回流発生部材32が旋回流を発生できる方向に希釈用溶液を排出できる向きに開口している。一実施形態において、排出口は注入管5の先端部近傍の側面に開口しており、試料希釈用容器3にある旋回流発生部材32に対面する側壁に向かって希釈用溶液を排出する(図8aを参照)。別の実施形態において、排出口は注入管5の先端に開口しており、試料希釈用容器3の底部にある旋回流発生部材32に向かって希釈用溶液を排出する(図8bを参照)。なお、注入管5は、手動の注入部材に具備されていてもよいし、自動分注装置または分析装置の一部として具備されていてもよい。
ガイド6は、生体試料採取用デバイス2の毛細管21を試料希釈用容器3内で適切な位置に保持するために、デバイス2と容器3とを連結する位置を指示する。一実施形態において、ガイド6は、デバイス2と容器3とに設けられた対をなす係合部材であり、これによりデバイス2が容器3に所定の位置関係で固定されるので、容器3内で常に一定の位置に毛細管21を配置することができる。別の実施形態においては、ガイド6は、デバイス2に連結された蓋部4と容器3とに設けられた対をなす係合部材である。さらに別の実施形態においては、容器3が非対称な形状、例えば一部に平面状の壁を有する円形状の開口部を有し、デバイス2が該開口部の形状に対応する円弧状の固定部材を有するか、または該開口部の形状に対応する形状のキャップに連結されていれば、デバイス2と容器3とが常に所定の位置関係で固定され、容器3内で一定の位置に毛細管21を配置することができる。なお別の実施形態においては、ガイド6は、デバイス2と容器3とに表示されたライン、溝、突起などの指標であり得る。前述の図1においては、ガイド6は、蓋部4と容器3とに設けられた対をなす係合部材であり、デバイス2と連結された蓋部4を容器3に装着することにより、デバイス2の毛細管21が容器3内部の所定の位置に保持される。
係合部材7は、本発明の検体調製用容器1をラックに並べる場合に、容器1をラックに対して所定の向きに配置する役割を果たす。さらに容器1を並べたラックを分注または分析装置にセットすれば、該装置に対する容器1の配置が固定されるので、該装置中で、分注または分析に好適な位置に容器1を配置することが可能になる。係合部材7は、容器1をラックに安定に固定できる形状および配置に構成されていればよいので、試料希釈用容器3または蓋部4の任意の位置に設けることができる。好ましくは、係合部材7は、試料希釈用容器3に設けられた突起やフックなどの係合部材であり、ラックに設けられた対をなす部材と係合して、容器1をラック上に固定する。前述の図1においては、係合部材7は、試料希釈用容器3の外壁に長軸に沿って設けられた細長い突起である。なお係合部材7は、試料希釈用容器3と一体的に形成されても、別々の部材として成形し連結させてもよいが、一体的に形成されるのが好ましい。
2 生体試料採取用デバイス
3 試料希釈用容器
4 蓋部
5 注入管
6 ガイド
7 係合部材
21 毛細管
22 支持部材
23 固定部材
31 開口部
32 旋回流発生部材
41 壁
42a 放射状スリット
42b 十字状スリット
42c 穴
43 膜
51 排出口
Claims (12)
- 検体調製用容器であって、
生体試料採取用デバイスと、試料希釈用容器とを備え、
該生体試料採取用デバイスは、
両端に開口部を有する毛細管と
該毛細管を支持するための支持部材と
を有し、
該試料希釈用容器は、
開口部と、
該容器の内壁に形成された旋回流発生部材と
を有し、
該生体試料採取用デバイスの毛細管は、該支持部材により、該試料希釈用容器の内部に配置される、
検体調製用容器。 - 前記生体試料採取用デバイスが、前記デバイスの毛細管が前記試料希釈用容器内に配置されるように、該デバイスを該試料希釈用容器に固定するための固定部材をさらに有する、請求項1記載の検体調製用容器。
- 前記試料希釈用容器の開口部を閉じるための蓋部を備える、請求項1又は2記載の検体調製用容器。
- 前記固定部材が前記蓋部である、請求項3記載の検体調製用容器。
- 前記蓋部が、前記試料希釈用容器に液体を注入するための注入管が通過するための孔、または該注入管が穿刺可能な膜を有する、請求項3又は4記載の検体調製用容器。
- 前記デバイスの毛細管の上端の位置が前記試料希釈用容器の内壁に形成された旋回流発生部材の上端の位置と同じ高さかまたはそれより下になるように、該毛細管が該試料希釈用容器内に配置される、請求項1~5のいずれか1項記載の検体調製用容器。
- 前記デバイスの毛細管を前記試料希釈用容器中の所望の位置に配置するためのガイドをさらに有する、請求項1~6のいずれか1項記載の検体調製用容器。
- 検体調製用容器をラックに留めるための係合部材をさらに備える、請求項1~7のいずれか1項記載の検体調製用容器。
- 両端に開口部を有する毛細管と、該毛細管を支持するための支持部材とを有する、生体試料採取用デバイス。
- 開口部と、容器の内壁に形成された旋回流発生部材とを有する、試料希釈用容器。
- 前記旋回流発生部材が、
容器内壁の側面から底部にかけて形成された傾斜面、
容器内壁の側面または底部中央に形成された錐体状突起、
容器内壁の底部に形成された複数の羽根状突起、
容器内壁の側面から底部にかけて形成されたらせん状突起、
容器底部に対して偏心した位置に形成された凹部、
のいずれか1以上である、請求項1~8のいずれか1項記載の検体調製用容器。 - 前記旋回流発生部材が、
容器内壁の側面から底部にかけて形成された傾斜面、
容器内壁の側面または底部中央に形成された錐体状突起、
容器内壁の底部に形成された複数の羽根状突起、
容器内壁の側面から底部にかけて形成されたらせん状突起、
容器底部に対して偏心した位置に形成された凹部、
のいずれか1以上である、請求項10記載の試料希釈用容器。
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EP14830243.3A EP3026417B1 (en) | 2013-07-26 | 2014-07-25 | Container for specimen preparation |
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JP2015528355A JP6474347B2 (ja) | 2013-07-26 | 2014-07-25 | 検体調製用容器 |
CN201480042008.2A CN105452838B (zh) | 2013-07-26 | 2014-07-25 | 检体调制用容器 |
ES14830243T ES2793200T3 (es) | 2013-07-26 | 2014-07-25 | Recipiente para preparación de espécimen |
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CN108603872A (zh) * | 2015-11-26 | 2018-09-28 | 诺凡麦有限公司 | 化验设备 |
JP2019502103A (ja) * | 2015-11-26 | 2019-01-24 | ノヴァメッド リミティッド | アッセイ装置 |
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Also Published As
Publication number | Publication date |
---|---|
JP6474347B2 (ja) | 2019-02-27 |
EP3026417A1 (en) | 2016-06-01 |
US10386277B2 (en) | 2019-08-20 |
EP3026417A4 (en) | 2017-07-12 |
EP3026417B1 (en) | 2020-05-13 |
ES2793200T3 (es) | 2020-11-13 |
PT3026417T (pt) | 2020-06-02 |
US20160169779A1 (en) | 2016-06-16 |
CN105452838A (zh) | 2016-03-30 |
CN105452838B (zh) | 2019-06-25 |
JPWO2015012390A1 (ja) | 2017-03-02 |
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