WO2022065342A1 - Récipient de collecte d'échantillon - Google Patents

Récipient de collecte d'échantillon Download PDF

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Publication number
WO2022065342A1
WO2022065342A1 PCT/JP2021/034711 JP2021034711W WO2022065342A1 WO 2022065342 A1 WO2022065342 A1 WO 2022065342A1 JP 2021034711 W JP2021034711 W JP 2021034711W WO 2022065342 A1 WO2022065342 A1 WO 2022065342A1
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WO
WIPO (PCT)
Prior art keywords
film
barrier film
collection container
sample collection
container body
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Application number
PCT/JP2021/034711
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English (en)
Japanese (ja)
Inventor
嵩也 内山
邦哉 駒井
雅敏 丹生谷
浩信 五十川
Original Assignee
積水メディカル株式会社
徳山積水工業株式会社
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Publication date
Application filed by 積水メディカル株式会社, 徳山積水工業株式会社 filed Critical 積水メディカル株式会社
Publication of WO2022065342A1 publication Critical patent/WO2022065342A1/fr

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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
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154—Devices using pre-evacuated means
    • 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

Definitions

  • the present invention relates to a sample collection container.
  • sample collection containers from which samples are collected are widely used.
  • An example of the sample collection container is a blood collection tube from which blood is collected.
  • the blood collection tube is designed so that a specified amount of blood can be collected by reducing the pressure inside (for example, Patent Document 1).
  • sample collection container When using the sample collection container, customer information and sample information such as the sample number may be entered on the outer surface of the sample collection container with a pen or the like. Further, a sample collection container to which a paper label for writing sample information with a pencil or a pen is attached is also known.
  • a sample collection container containing an internal substance such as a vacuum collection tube containing a liquid containing an anticoagulant.
  • the conventional sample collection container in which the liquid is housed has a problem that the liquid gradually evaporates.
  • a barrier film to the outer peripheral surface of the container.
  • the surface of the barrier film is a smooth surface, so that the sample information cannot be entered with a pencil or pen, or the entered sample information is touched. And rubbing occurs.
  • An object of the present invention is to provide a sample collection container in which sample information can be entered on the surface of a barrier film and the entered sample information is less likely to be rubbed.
  • the container body and the barrier film arranged on the outer surface of the container body are provided, and the water vapor permeability of the barrier film at 40 ° C. and 90% RH is 0.8 g / g.
  • the outer surface of the barrier film is (m 2 ⁇ day) or less, and has a rough surface region having an arithmetic mean roughness Ra of 1.5 ⁇ m or more, and the rough surface region of the barrier film is a sample collection container.
  • a sample collection container is provided that constitutes at least a portion of the outer surface of the.
  • the maximum height Rz of the rough surface region of the barrier film is 10.0 ⁇ m or more.
  • the arithmetic average roughness Ra of the rough surface region of the barrier film is 2.4 ⁇ m or more.
  • the water vapor transmission rate of the sample collection container at 40 ° C. and 0% RH is 1.1 g / (m 2 ⁇ day) or less.
  • the barrier film has a first film, a first adhesive layer, a second film, and a second adhesive layer in this order.
  • the outer surface of the first film has the rough surface region, and the second adhesive layer is arranged on the outer surface of the container body.
  • the first film is a barrier film main body
  • the second film is a polyethylene terephthalate film
  • the sample collection container includes a stopper attached to an opening of the container body and a liquid contained in the container body.
  • the sample collected in the sample collection container is blood
  • the liquid is a liquid containing an anticoagulant.
  • the sample collection container according to the present invention includes a container body and a barrier film arranged on the outer surface of the container body, and the water vapor permeability of the barrier film at 40 ° C. and 90% RH is 0.8 g / g.
  • the outer surface of the barrier film is (m 2 ⁇ day) or less, and has a rough surface region having an arithmetic mean roughness Ra of 1.5 ⁇ m or more.
  • the rough surface region of the barrier film constitutes at least a part of the outer surface of the sample collection container. Since the sample collection container according to the present invention has the above configuration, the sample information can be written on the surface of the barrier film, and the written sample information is less likely to be rubbed.
  • FIG. 1 is a front sectional view schematically showing a sample collection container according to the first embodiment of the present invention.
  • FIG. 2 is a front sectional view schematically showing a sample collection container according to a second embodiment of the present invention.
  • the sample collection container according to the present invention includes a container body and a barrier film arranged on the outer surface of the container body, and the water vapor permeability of the barrier film at 40 ° C. and 90% RH is 0.8 g / g.
  • the outer surface of the barrier film is (m 2 ⁇ day) or less, and has a rough surface region having an arithmetic mean roughness Ra of 1.5 ⁇ m or more.
  • the rough surface region of the barrier film constitutes at least a part of the outer surface of the sample collection container.
  • the sample information can be entered on the surface of the barrier film, and the entered sample information is less likely to be rubbed.
  • the sample information can be entered with a pencil or a pen in the rough surface region, and the entered sample information can be entered. Even if you touch, the sample information is not easily faded. Therefore, in the sample collection container according to the present invention, the barrier performance can be enhanced, the sample information can be satisfactorily entered, and the entered sample information can be less likely to be rubbed.
  • the barrier film is arranged on the outer surface of the container body.
  • the barrier film is preferably attached on the outer surface of the container body, and is preferably wrapped.
  • the barrier film is preferably a water vapor barrier film.
  • the barrier film is preferably transparent. In the sample collection container, it is preferable that the collected sample can be visually recognized through the barrier film when the sample is collected.
  • the barrier film is preferably a transparent barrier film, and preferably a transparent water vapor barrier film.
  • the water vapor transmission rate of the barrier film at 40 ° C. and 90% RH is 0.8 g / (m 2 ⁇ day) or less.
  • the water vapor transmission rate of the barrier film at 40 ° C. and 90% RH is preferably 0.6 g / (m 2 ⁇ day) or less, more preferably 0.3 g / (m). 2. Day) or less, more preferably 0.1 g / (m 2 ⁇ day) or less, and particularly preferably 0.05 g / (m 2 ⁇ day) or less.
  • the water vapor transmission rate of the barrier film at 40 ° C. and 90% RH is measured according to the B method of JIS K7129.
  • the outer surface of the barrier film has a rough surface region having an arithmetic average roughness Ra of 1.5 ⁇ m or more.
  • the rough surface region constitutes at least a part of the outer surface of the sample collection container.
  • the arithmetic average roughness Ra of the rough surface region is preferably 2.0 ⁇ m or more, more preferably 2.4 ⁇ m or more, still more preferably 3.0 ⁇ m or more, and particularly preferably 5.0 ⁇ m or more.
  • the arithmetic average roughness Ra of the rough surface region is preferably 10.0 ⁇ m or less, more preferably 9.0 ⁇ m or less, still more preferably 8.0 ⁇ m or less, particularly preferably 7.0 ⁇ m or less, and most preferably 6.0 ⁇ m or less. Is.
  • the arithmetic average roughness Ra of the rough surface region is at least the above lower limit, the effect of the present invention can be exhibited even more effectively.
  • the sample information can be satisfactorily entered with a pencil.
  • the arithmetic average roughness Ra of the rough surface region is not more than the above upper limit, the sample information can be satisfactorily entered with a pencil and a pen, and the water vapor barrier performance can be maintained high.
  • the arithmetic average roughness Ra of the outer surface of the barrier film can be measured according to JIS B0601: 2001.
  • the maximum height Rz of the rough surface region is preferably 10.0 ⁇ m or more, more preferably 15.0 ⁇ m or more, still more preferably 20.0 ⁇ m or more, particularly preferably 25.0 ⁇ m or more, and most preferably 30.0 ⁇ m or more. be.
  • the maximum height Rz of the rough surface region is preferably 70.0 ⁇ m or less, more preferably 60.0 ⁇ m or less, still more preferably 55.0 ⁇ m or less, particularly preferably 50.0 ⁇ m or less, and most preferably 45.0 ⁇ m or less. be.
  • the maximum height Rz of the rough surface region is at least the above lower limit, the effect of the present invention can be exhibited even more effectively.
  • the maximum height Rz of the rough surface region is not more than the upper limit, the sample information can be satisfactorily entered with a pencil and a pen, and the water vapor barrier performance can be maintained high.
  • the maximum height Rz of the outer surface of the barrier film can be measured according to JIS B0601: 2001.
  • the arithmetic average roughness Ra of the rough surface region is 2.0 ⁇ m or more and the maximum height Rz is 20.0 ⁇ m or more. In this case, the sample information can be entered even better with a pencil and a pen.
  • Examples of the method for forming the rough surface region by adjusting the arithmetic average roughness Ra and the maximum height Rz of the outer surface of the barrier film include a method of rubbing with sandpaper and a method of projecting fine sand. Be done.
  • a sample collection container can be produced by arranging the barrier film having the rough surface region on the outer surface of the container body.
  • the thickness of the barrier film is preferably 5 ⁇ m or more, more preferably 30 ⁇ m or more, preferably 300 ⁇ m or less, and more preferably 200 ⁇ m or less.
  • the thickness of the barrier film is the thickness of the barrier film itself.
  • the barrier film is preferably arranged at 0.2 laps or more, more preferably 0.5 laps or more, and more preferably 3 laps or less in the circumferential direction of the outer surface of the container body. It is preferable that it is arranged, and it is more preferable that it is arranged in 1.5 laps or less. In this case, the barrier performance can be further improved.
  • the surface area of the portion where the barrier film is arranged is preferably 15% or more, more preferably 30% or more, still more preferably 70% or more.
  • the barrier performance can be further improved.
  • sample information can be easily entered.
  • the surface area of the portion where the barrier film is arranged may be 100%, 100% or less, or 90% or less. It may be 80% or less.
  • the surface area of the rough surface region is preferably 2% or more, more preferably 10% or more, still more preferably 20% or more. It is preferably 95% or less, more preferably 70% or less, still more preferably 40% or less.
  • the surface area of the rough surface region is at least the above lower limit, sample information can be easily entered.
  • the surface area of the rough surface region is not more than the upper limit, the visibility inside the container at the time of sample collection can be improved, and the water vapor barrier performance can be maintained high.
  • the rough surface region constitutes at least a part of the outer surface of the sample collection container.
  • the surface area is preferably 5% or more, more preferably 15% or more, still more preferably 25% or more, preferably 90% or less, more preferably 65% or less, still more preferably 45% or less.
  • the barrier film preferably has a barrier film main body and an adhesive layer.
  • the adhesive layer is arranged on the outer surface of the container body, and the barrier film body is arranged outside the adhesive layer.
  • the barrier film main body may be arranged on the outer surface of the adhesive layer.
  • the barrier film includes a first film, a first adhesive layer, a second film, and a second adhesive layer. It is more preferable to have them in order.
  • the outer surface of the first film has the rough surface region, and it is preferable that the second adhesive layer is arranged on the outer surface of the container body.
  • the first film may be the barrier film main body, and the second film may be the barrier film main body.
  • the barrier film has a portion having a first film, a first adhesive layer, a second film, and a second adhesive layer in this order.
  • the outer surface of the first film and the outer surface of the second film constitute the outer surface of the barrier film, and the outer surface of the second film has the rough surface region. You may be doing it.
  • the outer surface of the first film and the outer surface of the second film constitute the outer surface of the barrier film, and the outer surface of the first film has the rough surface region. You may be doing it.
  • the second adhesive layer is arranged on the outer surface of the container body.
  • the first film may be the barrier film main body
  • the second film may be the barrier film main body.
  • the first film and the first adhesive layer may be directly laminated or may be laminated via another layer.
  • the first adhesive layer and the second film may be directly laminated or may be laminated via another layer.
  • the second film and the second adhesive layer may be directly laminated or may be laminated via another layer.
  • the first film and the first adhesive layer are directly laminated, and the first adhesive layer and the second film are directly laminated. It is preferable that the second film and the second adhesive layer are directly laminated.
  • the barrier film preferably has a barrier film body.
  • the water vapor transmission rate of the barrier film body at 40 ° C. and 90% RH is preferably 0.8 g / (m 2 ⁇ day) or less, more preferably 0.6 g / (m 2 ⁇ day) or less, still more preferably. It is 0.3 g / (m 2 ⁇ day) or less, particularly preferably 0.1 g / (m 2 ⁇ day) or less, and most preferably 0.05 g / (m 2 ⁇ day) or less.
  • the water vapor transmission rate of the barrier film body at 40 ° C. and 90% RH is measured according to the B method of JIS K7129.
  • the barrier film main body preferably includes a base film, an inorganic oxide layer, and more preferably a base film, an inorganic oxide layer, and a barrier coat layer in this order.
  • the base film and the inorganic oxide layer may be directly laminated or may be laminated via another layer.
  • the inorganic oxide layer and the barrier coat layer may be directly laminated or may be laminated via another layer.
  • the base film examples include polyethylene terephthalate film, polyethylene naphthalate film, nylon film, polyethylene film, polypropylene film, polystyrene film, polyamide film, polycarbonate film, polyacrylic nitrile film, and polyimide film.
  • the base film is preferably transparent.
  • the inorganic oxide layer is preferably a layer having a gas barrier property or a water vapor barrier property.
  • the inorganic oxide layer is preferably an inorganic oxide-deposited layer in which an inorganic oxide is vapor-deposited on the surface of the base film.
  • Examples of the inorganic oxide contained in the inorganic oxide layer include aluminum oxide, silicon oxide, tin oxide, magnesium oxide and the like. Only one kind of the above-mentioned inorganic oxide may be used, or two or more kinds thereof may be used in combination.
  • the inorganic oxide is preferably aluminum oxide or silicon oxide.
  • the barrier coat layer is a layer having a gas barrier property. Further, by having the barrier coat layer, oxidation of the inorganic oxide can be effectively suppressed, and damage to the inorganic oxide layer due to an external impact or the like can be suppressed.
  • the material of the barrier coat layer a conventionally known material used as the barrier coat layer can be used.
  • the material of the barrier coat layer include a composition containing a hydrolysis product of alkoxysilane and a water-soluble polymer, polyethylene terephthalate, nylon and the like.
  • the material of the barrier coat layer only one kind may be used, or two or more kinds may be used in combination.
  • water-soluble polymer examples include polyvinyl alcohol-based resins and ethylene-vinyl alcohol copolymers. Only one kind of the water-soluble polymer may be used, or two or more kinds thereof may be used in combination.
  • the base film and the inorganic oxide layer it is preferable that the base film is arranged on the container body side.
  • the base film and the barrier coat layer it is preferable that the base film is arranged on the container body side.
  • the outer surface of the barrier film body is the outer surface of the barrier film. Therefore, it is preferable that the outer surface of the barrier film body has the rough surface region.
  • the first film is the barrier film main body.
  • the outer surface of the first film is the outer surface of the barrier film. Therefore, it is preferable that the outer surface of the first film has the rough surface region.
  • the above-mentioned commercial products include “GX-PF” and “GL-AEC-F” manufactured by Toppan Printing Co., Ltd., “IB-PET-PXB2” manufactured by Dai Nippon Printing Co., Ltd., and “Barrier Rocks 1011 SBR2” manufactured by Toray Film Processing Co., Ltd. , "V Barrier” manufactured by Mitsui Chemicals Tocello Co., Ltd., “Tech Barrier” manufactured by Mitsubishi Chemical Corporation, and the like.
  • a barrier film main body having the rough surface region can be obtained.
  • the second film may be the barrier film main body or not the barrier film main body.
  • the first film is a barrier film main body
  • the second film is preferably not a barrier film main body, and is preferably a resin film.
  • Examples of the second film include polyethylene terephthalate film, polyethylene naphthalate film, nylon film, polyethylene film, polypropylene film, polystyrene film, polyamide film, polycarbonate film, polyacrylic nitrile film, and polyimide film.
  • the second film is preferably a polyethylene terephthalate film.
  • the adhesive can be applied satisfactorily and the laminating workability can be improved.
  • the thickness of the second film is preferably 1 ⁇ m or more, more preferably 10 ⁇ m or more, preferably 80 ⁇ m or less, and more preferably 50 ⁇ m or less.
  • the thickness of the second film is the thickness of the second film itself.
  • the barrier film preferably has an adhesive layer.
  • the adhesive layer is a layer formed by an adhesive.
  • the first adhesive layer is arranged between the first film and the second film.
  • the second adhesive layer is arranged between the second film and the outer surface of the container body.
  • the second adhesive layer is preferably arranged on the outer surface of the container body.
  • the material of the pressure-sensitive adhesive layer is not particularly limited, and a conventionally known pressure-sensitive adhesive can be used.
  • the pressure-sensitive adhesive include silicone-based pressure-sensitive adhesives, urethane-based pressure-sensitive adhesives, acrylic-based pressure-sensitive adhesives, and the like. Only one kind of the above-mentioned pressure-sensitive adhesive may be used, or two or more kinds thereof may be used in combination.
  • the pressure-sensitive adhesive is preferably an acrylic pressure-sensitive adhesive or a silicone-based pressure-sensitive adhesive.
  • the thickness of the first adhesive layer is preferably 1 ⁇ m or more, more preferably 10 ⁇ m or more, preferably 80 ⁇ m or less, and more preferably 50 ⁇ m or less.
  • the thickness of the first adhesive layer is the thickness of the first adhesive layer itself. When the thickness of the first adhesive layer is at least the above lower limit and at least the above upper limit, the adhesive strength can be enhanced.
  • the thickness of the second adhesive layer is preferably 1 ⁇ m or more, more preferably 10 ⁇ m or more, preferably 80 ⁇ m or less, and more preferably 50 ⁇ m or less.
  • the thickness of the second adhesive layer is the thickness of the second adhesive layer itself. When the thickness of the second adhesive layer is at least the above lower limit and at least the above upper limit, the adhesive strength can be enhanced.
  • the container body preferably has an opening.
  • the shape of the container body is not particularly limited.
  • the container body is preferably a bottomed container, and more preferably a bottomed tubular container.
  • the material of the container body is not particularly limited.
  • thermoplastic resins such as polyethylene, polypropylene, polystyrene, polyethylene terephthalate, polyethylene naphthalate, polymethylmethacrylate, and polyacrylonitrile; and thermocurable resins such as unsaturated polyester resin, epoxy resin, and epoxy-acrylate resin.
  • Resins Modified natural resins such as cellulose acetate, cellulose propionate, ethyl cellulose, ethylchitin, etc .; Examples thereof include silicate glass such as soda lime glass, phosphoric acid glass and borosilicate glass, and glass such as quartz glass. Only one of these components may be used, or two or more of these components may be used in combination.
  • the material of the container body is preferably resin, more preferably polyethylene terephthalate or polyethylene naphthalate, and even more preferably polyethylene terephthalate.
  • the water vapor transmission rate of the barrier film at 40 ° C. and 90% RH is preferably 0.5 g / (m 2 ⁇ day) or less, more preferably 0. It is 2 g / (m 2 ⁇ day) or less, more preferably 0.05 g / (m 2 ⁇ day) or less.
  • the sample collection container preferably includes a stopper attached to the opening of the container body.
  • a conventionally known stopper can be used.
  • the stopper is preferably a stopper having a material and shape that can be attached to the opening of the container body in an airtight and liquidtight manner. From the viewpoint of easily collecting the sample in the sample collection container, it is preferable that the stopper is configured so that the needle can be pierced.
  • plug body examples include a plug body having a shape that fits into the opening of the container body, a sheet-shaped seal plug body, and the like.
  • the stopper body may be a stopper body including a stopper body such as a rubber stopper and a cap member made of plastic or the like. In this case, it is possible to reduce the risk of the body fluid coming into contact with the human body when the plug is pulled out from the opening of the container body after collecting the body fluid such as blood.
  • the material of the stopper body examples include synthetic resin, elastomer, rubber, metal leaf and the like.
  • Examples of the rubber include butyl rubber and halogenated butyl rubber.
  • Examples of the metal foil include aluminum foil and the like.
  • the material of the stopper body (or the stopper body) is preferably butyl rubber or halogenated butyl rubber.
  • the stopper (or the main body of the stopper) is preferably a butyl rubber stopper or a halogenated butyl rubber stopper.
  • the sample collection container may include an container contained in the container body.
  • the type and amount of the contained substance and the type and amount of the sample to be collected are not particularly limited.
  • sample examples include biological samples and the like. Specific examples of the sample include blood, plasma, urine, and cerebrospinal fluid.
  • Examples of the components contained in the contained substance include anticoagulants, enzymes, enzyme stabilizers, organic compounds, and inorganic compounds.
  • anticoagulant examples include citric acid, oxalic acid, EDTA (ethylenediaminetetraacetic acid), heparin and the like.
  • citric acid oxalic acid
  • EDTA ethylenediaminetetraacetic acid
  • heparin heparin
  • the anticoagulant only one kind may be used, or two or more kinds may be used in combination.
  • the enzyme examples include serine proteases such as trypsin, chymotrypsin, elastase, trombine, plasmin, serpentine trombine-like enzyme, subtilisin and acidic carboxypeptidase; thiol proteases such as catepsin B and phycin; carboxypeptidase A, carboxypeptidase B and leucine amino. Examples thereof include metal proteases such as peptidase and quininase I. Only one type of the above enzyme may be used, or two or more types may be used in combination.
  • the stabilizer for the enzyme examples include sugars such as dextran, peptides, and proteins such as albumin and globulin.
  • examples of the stabilizer for the enzyme include ⁇ -alanine, glycine, D-mannitol, gelatin, albumin and the like.
  • the stabilizer of the above enzyme only one kind may be used, or two or more kinds may be used in combination.
  • organic compound examples include sugar, formaldehyde free substance, citric acid and the like.
  • sugar examples include glucose, fructose, galactose, maltose, cyclodextrin and the like.
  • Examples of the inorganic compound include phosphoric acid, sodium chloride, potassium chloride, boric acid, trisphosphate and the like.
  • the contained substance may be a liquid, a dried product, or a freeze-dried product.
  • the sample collection container preferably includes a liquid contained in the container body.
  • the solvent of the liquid is preferably water. Since the sample collection container is provided with a barrier film, evaporation of the liquid can be effectively suppressed as compared with a sample collection container without a barrier film.
  • the liquid is preferably a liquid containing the anticoagulant, and more preferably a liquid containing the anticoagulant and water.
  • the anticoagulant preferably contains citric acid, EDTA, or heparin, and more preferably citric acid, EDTA, or heparin.
  • the liquid preferably contains at least one of citric acid, EDTA and heparin.
  • the amount of liquid contained in the container body may be 0.1 mL or more, or 5 mL or less.
  • the sample collection container is preferably provided with the enzyme contained in the container body, and is preferably provided with the enzyme housed in the container body and a stabilizer for the enzyme.
  • the enzyme may be contained in the container body in a liquid state mixed with a solvent, in a dry state, or in a freeze-dried state. May be.
  • the stabilizer of the enzyme may be contained in the container body in a liquid state mixed with a solvent, in a dry state, or in a freeze-dried state. May be.
  • the enzyme and the stabilizer of the enzyme may be contained in the container body in the state of a mixed solution containing the enzyme, the stabilizer of the enzyme and a solvent, and the enzyme and the stabilizer of the enzyme may be stabilized.
  • sample collection container is provided with a barrier film, it is possible to effectively suppress a decrease in enzyme activity as compared with a sample collection container without a barrier film.
  • the enzyme is preferably thrombin-like enzyme or thrombin.
  • the sample collection container is a blood collection container.
  • the sample collection container is preferably a blood collection tube, and more preferably a vacuum blood collection tube.
  • the sample collection container may contain components other than the components described above in the container body.
  • the other components include serum or plasma separating agents, serum or plasma separating jigs, Ficoll, magnetic beads and the like.
  • the amount of sample collected in the above sample collection container is not particularly limited.
  • the amount of the sample collected in the sample collection container may be 0.5 mL or more, 4.5 mL or more, or 7.6 mL or more.
  • the amount of the sample collected in the sample collection container may be 10 mL or less, 5.5 mL or less, or 2.0 mL or less.
  • FIG. 1 is a front sectional view schematically showing a sample collection container according to the first embodiment of the present invention.
  • the sample collection container 11 shown in FIG. 1 includes a container body 1, a stopper 2, a barrier film 3, and a liquid 4.
  • the inside of the sample collection container 11 is depressurized.
  • the container body 1 is a tubular container body.
  • the container body 1 has an opening at one end and a closed bottom at the other end.
  • the stopper 2 is attached to the opening of the container body 1.
  • the barrier film 3 is arranged in the circumferential direction on the outer surface 1a of the container body 1.
  • the barrier film 3 is arranged on a part of the outer surface 1a of the container body 1.
  • the barrier film 3 is wound on the outer surface 1a of the container body 1.
  • the liquid 4 is housed in the container body 1.
  • the barrier film 3 has a first film 31, a first adhesive layer 33, a second film 32, and a second adhesive layer 34 in this order from the outside to the inside of the sample collection container 11. ..
  • a second adhesive layer 34 is arranged on the outer surface 1a of the container body 1.
  • the second film 32 is arranged on the surface of the second adhesive layer 34 opposite to the container body 1.
  • the first adhesive layer 33 is arranged on the surface of the second film 32 opposite to the second adhesive layer 34.
  • the first film 31 is arranged on the surface of the first adhesive layer 33 opposite to the second film 32.
  • the first film 31 is the barrier film body
  • the second film 32 is the polyethylene terephthalate film.
  • the outer surface 3a of the barrier film 3 and the outer surface of the first film 31 have a rough surface region R.
  • the rough surface region R exists on the outer surface 3a of the barrier film 3 and a part of the outer surface of the first film 31.
  • the outer surface 3a of the barrier film 3 and the outer surface of the first film 31 have a rough surface region R and a smooth surface region having an arithmetic mean roughness Ra of less than 1.5 ⁇ m.
  • the rough surface region R of the barrier film 3 constitutes a part of the outer surface of the sample collection container 11.
  • FIG. 2 is a front sectional view schematically showing a sample collection container according to a second embodiment of the present invention.
  • the sample collection container 11A shown in FIG. 2 includes a container body 1, a stopper 2, a barrier film 3A, and a liquid 4.
  • the inside of the sample collection container 11A is depressurized.
  • the container body 1 is a tubular container body.
  • the container body 1 has an opening at one end and a closed bottom at the other end.
  • the stopper 2 is attached to the opening of the container body 1.
  • the barrier film 3A is arranged in the circumferential direction on the outer surface 1a of the container body 1.
  • the barrier film 3A is arranged on a part of the outer surface 1a of the container body 1.
  • the barrier film 3A is wound on the outer surface 1a of the container body 1.
  • the liquid 4 is housed in the container body 1.
  • the barrier film 3A has a first film 31A, a first adhesive layer 33A, a second film 32A, and a second adhesive layer 34A in this order from the outside to the inside of the sample collection container 11A. There is a part.
  • the barrier film 3A has a first film 31A, a first adhesive layer 33A, a second film 32A, and a second adhesive layer 34A in this order from the outside to the inside of the sample collection container 11A. It has a portion and a portion having a second film 32A and a second adhesive layer 34A in this order.
  • the second adhesive layer 34A is arranged on the outer surface 1a of the container body 1.
  • the second film 32A is arranged on the surface of the second adhesive layer 34A opposite to the container body 1.
  • the first adhesive layer 33A is partially arranged on the surface of the second film 32A opposite to the second adhesive layer 34A. On the surface of the second film 32A opposite to the second adhesive layer 34A, there are a portion where the first adhesive layer 33A is arranged and a portion where the first adhesive layer 33A is not arranged. exist.
  • the first film 31A is arranged on the surface of the first adhesive layer 33A opposite to the second film 32A.
  • the outer surface of the first film 31A and the outer surface of the second film 32A constitute the outer surface 3Aa of the barrier film 3A.
  • the rough surface region R exists on a part of the outer surface 3Aa of the barrier film 3A and the outer surface of the second film 32A.
  • the outer surface 3Aa of the barrier film 3A and the outer surface of the second film 32A have a rough surface region R and a smooth surface region having an arithmetic mean roughness Ra of less than 1.5 ⁇ m.
  • the rough surface region R of the barrier film 3A constitutes a part of the outer surface of the sample collection container 11A.
  • the water vapor transmission rate of the sample collection container at 40 ° C. and 0% RH is preferably 1.1 g / (m 2 ⁇ day) or less, more preferably 0.9 g / (m 2 ⁇ day) or less, still more preferably. It is 0.6 g / (m 2 ⁇ day) or less. When the water vapor transmission rate is not more than the upper limit, the barrier performance can be exhibited more effectively.
  • the water vapor transmission rate of the sample collection container at 40 ° C. and 0% RH may be 0.2 g / (m 2 ⁇ day) or more, and 0.4 g / (m 2 ⁇ day) or more. You may.
  • the water vapor transmission rate of the sample collection container at 40 ° C. and 0% RH is measured as follows.
  • a sample collection container (the inside is not decompressed and the inside is not decompressed) in which water is stored in the container body that does not contain liquid inside, sealed with a stopper, and a barrier film is placed on the outer surface of the container body.
  • the obtained sample collection container is stored at 40 ° C. and 0% RH.
  • the water vapor transmission rate is calculated by using the amount of attenuation of the weight of the sample collection container before and after storage as the amount of water evaporation.
  • the air permeability of the sample collection container at 40 ° C. and 0% RH is preferably 0.5 cc / (m 2 ⁇ day ⁇ atm) or less, more preferably 0.4 cc / (m 2 ⁇ day ⁇ atm) or less. , More preferably 0.3 cc / ( m2 ⁇ day ⁇ atm) or less.
  • the air permeability of the sample collection container at 40 ° C. and 0% RH may be 0.1 cc / (m 2 ⁇ day ⁇ atm) or more, and 0.2 cc / (m 2 ⁇ day ⁇ atm). ) Or more.
  • the air permeability of the sample collection container at 40 ° C. and 0% RH is measured as follows.
  • the obtained sample collection container is stored at 40 ° C. and 0% RH. Water is sucked into the sample collection container, and the amount of increase in internal pressure due to storage is calculated from the calibration curve of the collected amount and internal pressure, and the air permeability is calculated.
  • the inside of the sample collection container is sterilized according to the standards described in ISO and JIS.
  • Container body The following container body having the shape shown in FIG. 1 was prepared.
  • a rubber stopper (butyl rubber stopper) having the shape shown in FIG. 1 and which can be attached to the opening of the container body was prepared.
  • Example 1 Preparation of barrier film The following materials were prepared.
  • Film X "GX-PF” manufactured by Toppan Printing Co., Ltd. (thickness 12 ⁇ m) Polyethylene terephthalate film (PET film) (thickness 25 ⁇ m) Adhesive release paper
  • the film X, the adhesive, the PET film, the adhesive, and the release paper are laminated in this order and laminated to form a film X (thickness 12 ⁇ m) / first adhesive layer / PET film (thickness 25 ⁇ m) / second adhesive.
  • a laminated film having a layer structure of a layer / release paper was obtained.
  • the obtained barrier film has a barrier film main body (first film) having a rough surface region, a first adhesive layer, a PET film (second film), and a second adhesive layer in this order. ..
  • the obtained barrier film has the following dimensions.
  • Examples 2 to 19 A barrier film and a sample collection container were prepared in the same manner as in Example 1 except that the time and area of rubbing with sandpaper were changed.
  • Example 1 The barrier was the same as in Example 1 except that the surface of the film X of the obtained laminated film was not rubbed with sandpaper (# 40) and the film X was used as the barrier film main body (first film). A film and a sample collection container were prepared.
  • Arithmetic mean roughness Ra and maximum height Rz of the barrier film In Examples 1 to 19, the arithmetic mean roughness Ra and the maximum height Rz of the portion rubbed with sandpaper were measured. In Comparative Example 1, the arithmetic mean roughness Ra and the maximum height Rz of the surface of the barrier film were measured. Arithmetic mean roughness Ra and maximum height Rz were measured according to JIS B0601: 2001. As a measuring device, a 3D measuring microscope (“VR-3100” manufactured by KEYENCE CORPORATION) was used.
  • the obtained sample collection container was stored in a constant temperature and humidity device at 40 ° C. and 0% RH.
  • the water vapor transmission rate was calculated by using the amount of attenuation of the weight of the sample collection container before and after storage as the amount of water evaporation.

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Abstract

L'invention concerne un récipient de collecte d'échantillon qui permet d'écrire des informations d'échantillon sur la surface d'un film barrière et rend difficile le grattage des informations d'échantillon écrites.　Un récipient de collecte d'échantillon selon la présente invention comprend un corps de récipient et un film barrière disposé sur la surface externe du corps de récipient. Le taux de transmission de vapeur d'eau du film barrière à 40° et 90 % de HR est inférieur ou égal à 0,8 g/(m2/jour). La surface externe du film barrière a une surface rugueuse où la rugosité moyenne arithmétique Ra est supérieure ou égale à 1,5 µm. La surface rugueuse du film barrière constitue au moins une portion de la surface externe du récipient de collecte d'échantillon.
PCT/JP2021/034711 2020-09-23 2021-09-22 Récipient de collecte d'échantillon WO2022065342A1 (fr)

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JP2020-158429 2020-09-23
JP2020158429 2020-09-23

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH091732A (ja) * 1995-06-16 1997-01-07 Yodogawa Steel Works Ltd ふっ化ビニリデンフィルムのラミネート金属板の製造方法
JPH09299356A (ja) * 1996-05-02 1997-11-25 Becton Dickinson & Co 血液採集用試験管アセンブリー
JP2000023949A (ja) * 1998-07-14 2000-01-25 Terumo Corp 採血管
JP2005305856A (ja) * 2004-04-22 2005-11-04 Dainippon Printing Co Ltd 透明バリアフィルム、それを用いた積層材および包装用容器
JP2013140172A (ja) * 2006-09-08 2013-07-18 Becton Dickinson & Co 物理的な充填ライン指標を備える試料容器
JP2018154694A (ja) * 2017-03-16 2018-10-04 東洋インキＳｃホールディングス株式会社 ラミネート用ホットメルト接着剤及びそれを用いたラミネートフィルム積層体

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH091732A (ja) * 1995-06-16 1997-01-07 Yodogawa Steel Works Ltd ふっ化ビニリデンフィルムのラミネート金属板の製造方法
JPH09299356A (ja) * 1996-05-02 1997-11-25 Becton Dickinson & Co 血液採集用試験管アセンブリー
JP2000023949A (ja) * 1998-07-14 2000-01-25 Terumo Corp 採血管
JP2005305856A (ja) * 2004-04-22 2005-11-04 Dainippon Printing Co Ltd 透明バリアフィルム、それを用いた積層材および包装用容器
JP2013140172A (ja) * 2006-09-08 2013-07-18 Becton Dickinson & Co 物理的な充填ライン指標を備える試料容器
JP2018154694A (ja) * 2017-03-16 2018-10-04 東洋インキＳｃホールディングス株式会社 ラミネート用ホットメルト接着剤及びそれを用いたラミネートフィルム積層体

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