WO2023073767A1 - Liquid collection container and method for manufacturing liquid collection container - Google Patents

Liquid collection container and method for manufacturing liquid collection container Download PDF

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Publication number
WO2023073767A1
WO2023073767A1 PCT/JP2021/039322 JP2021039322W WO2023073767A1 WO 2023073767 A1 WO2023073767 A1 WO 2023073767A1 JP 2021039322 W JP2021039322 W JP 2021039322W WO 2023073767 A1 WO2023073767 A1 WO 2023073767A1
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WIPO (PCT)
Prior art keywords
space
plug
state
outside
container
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PCT/JP2021/039322
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French (fr)
Japanese (ja)
Inventor
学司 加藤
順一 桑原
Original Assignee
株式会社サンプラテック
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Application filed by 株式会社サンプラテック filed Critical 株式会社サンプラテック
Priority to PCT/JP2021/039322 priority Critical patent/WO2023073767A1/en
Priority to PCT/JP2022/037374 priority patent/WO2023074303A1/en
Publication of WO2023073767A1 publication Critical patent/WO2023073767A1/en

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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
    • 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
    • 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

Definitions

  • the present disclosure relates to a liquid collection container for collecting liquid and a method of manufacturing the liquid collection container.
  • a container called a so-called vacuum blood collection tube is widely used to collect blood for testing.
  • a vacuum blood collection tube consists of a main body consisting of a conical bottom wall made of plastic or glass, a cylindrical side wall rising from the periphery of the bottom wall, and a rubber-like plug that closes the opening of the main body. (See Patent Document 1, for example).
  • the stopper may be a sheet containing aluminum, and only the needle sticking portion may be made of rubber.
  • the inside of the vacuum blood collection tube is maintained in a decompressed state, and blood can flow directly from another container or from a vein of the body by connecting the rubber-like portion of the stopper with a needle.
  • the standard vacuum blood collection tubes as described above are mainly used for blood testing purposes, and in most cases test results are obtained by mixing the blood that has flowed into the pre-loaded reagents.
  • the stopper is opened and the blood is sucked using an instrument.
  • the main body of the vacuum blood collection tube is made of a hard material because of its structure that maintains a decompressed state until the blood collection process. Therefore, even if it is sucked from a tube that is communicated by sticking a needle into the stopper, the contained liquid cannot be recovered due to pressure resistance. Therefore, it is necessary to open at least a part of the stopper and then use an instrument to aspirate. Equipment maintenance costs, labor costs, etc., eventually lead to an increase in the price of the product.
  • the present disclosure has been conceived under such circumstances, and the main object thereof is to provide a liquid collection container that separates the components of the collected liquid and allows necessary components to be taken out in a closed state. do.
  • a liquid-sampling container provided by the first aspect of the present disclosure has a container body having a cylindrical portion extending in a first direction, and is in close contact with the inner peripheral surface of the cylindrical portion in the circumferential direction without a gap.
  • a gasket that partitions the inner space of the container body into a first space and a second space and is slidable in the first direction; a first switching part capable of switching between a state in which the space communicates with the outside and a state in which the first space does not communicate with the outside; and a second switching part capable of switching between a state in which the second space communicates with the outside and a state in which the second space does not communicate with the outside, and the first space is in a decompressed state.
  • the first switching section includes a first plug, a second plug, and a channel tube
  • the first plug is one end of the cylindrical section in the first direction. and has a communication hole penetrating in the first direction
  • the second plug includes a gas-impermeable and liquid-tight first elastic portion
  • the flow path has a first end connected to the first plug body in a state of communicating with the communication hole, and a second end closed by the first elastic portion.
  • the first switching portion includes a third plug that closes an opening on one side of the tubular portion in the first direction, and the third plug is gas impermeable. and is liquid-tight, and by piercing the third plug with a puncture needle, the first space can be communicated with the outside.
  • the container body has a bottom wall portion closing the other side end in the first direction of the cylindrical portion, and a hole connected to the bottom wall portion and penetrating in the first direction. and a tip tube portion, wherein the second switching portion includes a sealing body attached to the tip tube portion, and by opening the sealing body, the second space can communicate with the outside. is.
  • the first space of the container contains a gelling agent and a blood anticoagulant.
  • a method for manufacturing a liquid-sampling container provided by the second aspect of the present disclosure is a method for manufacturing a liquid-sampling container according to the first aspect of the present disclosure, wherein the first space does not communicate with the outside, connecting a suction means to the other side end of the container body in the first direction, and sucking and moving the gasket to the other side in the first direction by the suction means; closing the end and retaining the gasket in the suction-moved position to maintain a reduced pressure in the first space.
  • FIG. 1 is a perspective view showing a liquid collection container according to a first embodiment of the present disclosure
  • FIG. FIG. 2 is a longitudinal sectional view of the liquid collection container shown in FIG. 1
  • 3 shows a state in which a gel-like agent and a blood anticoagulant are accommodated in the liquid collection container shown in FIG. 2
  • FIG. 4 is a vertical cross-sectional view showing one step of an example of a method for manufacturing a liquid-sampling container according to the first embodiment of the present disclosure
  • FIG. 5 is a longitudinal sectional view showing a step following FIG. 4
  • 1 is a vertical cross-sectional view showing a usage state of a liquid collection container according to a first embodiment of the present disclosure
  • FIG. 1 is a vertical cross-sectional view showing a usage state of a liquid collection container according to a first embodiment of the present disclosure
  • FIG. 1 is a vertical cross-sectional view showing a usage state of a liquid collection container according to a first embodiment of the present disclosure
  • FIG. 1 is a vertical cross-sectional view showing a usage state of a liquid collection container according to a first embodiment of the present disclosure
  • FIG. 1 is a vertical cross-sectional view showing a usage state of a liquid collection container according to a first embodiment of the present disclosure
  • FIG. 1 is a vertical cross-sectional view showing a usage state of a liquid collection container according to a first embodiment of the present disclosure
  • FIG. 3 is a longitudinal cross-sectional view similar to FIG. 2 showing a liquid collection container according to a second embodiment of the present disclosure
  • FIG. FIG. 13 shows a state in which a gel-like agent and a blood anticoagulant are accommodated in the liquid collection container shown in FIG. 12;
  • FIG. 1 is a perspective view of the liquid collection container A1.
  • FIG. 2 is a longitudinal sectional view of the liquid collection container A1.
  • the container body 1 includes a tubular portion 11 , a bottom wall portion 12 and a tip tubular portion 13 .
  • the tubular portion 11 has a substantially cylindrical shape and extends in the first direction x.
  • the tubular portion 11 has an opening 111 at one end in the first direction x (hereinafter referred to as “first direction one side x1 end”).
  • first direction one side x1 end In the tubular portion 11, the end portion on the one side x1 in the first direction (the portion where the opening portion 111 is formed) has a slightly larger diameter than the other portions.
  • the bottom wall portion 12 closes the other side end of the cylindrical portion 11 in the first direction x (hereinafter referred to as "first direction other side x2 end").
  • the bottom wall portion 12 is generally disc-shaped.
  • the tip tubular portion 13 is connected to the radial center of the bottom wall portion 12 and protrudes to the other side x2 in the first direction.
  • the tip tubular portion 13 has a hole 131 penetrating in the first direction x and communicating with the inner space S of the tubular portion 11 (container body 1).
  • a general-purpose syringe syringe
  • the gasket 2 is fitted inside the tubular portion 11 and closely adheres to the inner peripheral surface of the tubular portion 11 in the circumferential direction without a gap.
  • the gasket 2 is made of a rubber material having moderate elasticity, and has a configuration in which two semi-circular ring-shaped protruding portions are connected to the outer periphery of the cylindrical portion in a manner aligned in the first direction x.
  • the constituent material of the gasket 2 is not particularly limited, and examples thereof include TPE (thermoplastic elastomer).
  • the gasket 2 divides the inner space S of the tubular portion 11 (container body 1) into a first space S1 and a second space S2.
  • the first space S1 is positioned on one side x1 in the first direction with respect to the gasket 2, and the second space S2 is positioned on the other side x2 in the first direction with respect to the gasket 2.
  • the gasket 2 can slide in the first direction x while tightly adhering to the inner peripheral surface of the cylindrical portion 11 .
  • the first plug 3, the second plug 4 and the channel tube 5 are arranged at the first direction one side x1 end of the container 1.
  • the first plug 3 is made of, for example, a rubber material, and is press-fitted into the first direction one side x1 end of the tubular portion 11 . Thereby, the first plug 3 closes the opening 111 of the cylindrical portion 11 .
  • the first plug body 3 has a communication hole 31 and a convex tubular portion 32 .
  • the communication hole 31 is a hole that penetrates in the first direction x and is formed in the center of the first plug 3 in the radial direction.
  • the convex tubular portion 32 has a substantially cylindrical shape and protrudes toward the one side x1 in the first direction.
  • a constituent material of the first plug body 3 is not particularly limited, and examples thereof include butyl rubber.
  • the second plug 4 has a support portion 41 and a first elastic portion 42.
  • the support portion 41 is a portion that surrounds and supports the first elastic portion 42 and has a substantially cylindrical shape.
  • a constituent material of the support portion 41 is not particularly limited, and examples thereof include a resin material such as polyethylene.
  • the first elastic portion 42 is made of a rubber material that can be punctured by a puncture needle, and is press-fitted into the support portion 41 .
  • the first elastic portion 42 is gas-impermeable and liquid-tight.
  • the space between the support portion 41 and the first elastic portion 42 is hermetically sealed by an appropriate means such as adhesion.
  • the tip of the first elastic portion 42 (the lower end in FIG. 2) extends beyond the support portion 41 .
  • the first elastic portion 42 has an appropriate elastic restoring force. Thereby, the first elastic portion 42 has a resealing property to close the puncture hole of the puncture needle.
  • a constituent material of the first elastic portion 42 is not particularly limited, and examples thereof include butyl rubber.
  • the channel tube 5 is a fluid channel that connects the first plug 3 and the second plug 4, and is made of, for example, a flexible material.
  • the flow tube 5 has a first end 51 and a second end 52 at both ends.
  • the first end portion 51 is fitted onto the convex cylindrical portion 32, and the convex cylindrical portion 32 and the first end portion 51 are connected in a sealed state by appropriate means such as adhesion.
  • the first end portion 51 is connected to the first plug body 3 in a state of being communicated with the communication hole 31 , and the interior of the flow path tube 5 is connected to the tubular portion 11 (container body 1 ) via the communication hole 31 . ) communicates with the first space S1.
  • the second end portion 52 is fitted onto the tip of the first elastic portion 42 of the second plug 4, and the first elastic portion 42 and the second end portion 52 are connected in a sealed state by an appropriate means such as adhesion. ing. Thereby, the second end portion 52 is closed by the first elastic portion 42 . Moreover, the inside of the channel tube 5 is cut off from the outside and does not communicate with the outside.
  • the first space S1 of the container body 1 does not communicate with the outside due to the first plug 3, the second plug 4 and the channel tube 5 configured as described above.
  • a puncture needle for example, a puncture needle 91 of a blood collection tool 9A, which will be described later with reference to FIG. 7
  • the first space S1 of the container body 1 passes through the flow path tube 5 can communicate with the outside.
  • the first plug body 3, the second plug body 4 and the channel tube 5 can be handled as one assembly part.
  • the first plug 3, the second plug 4, and the channel tube 5 are examples of the "first switching section.”
  • the sealing body 6 is attached to the tip cylindrical portion 13 of the container body 1 .
  • the sealing body 6 is composed of, for example, a flexible cylindrical tube.
  • the sealing body 6 is made of a heat-sealable material.
  • a seal portion 61 is formed at the tip of the sealing body 6 (the lower end in FIG. 2). This seal portion 61 is a heat-sealed portion that is closed by thermal welding at the tip cylindrical portion of the sealing body 6, for example.
  • the sealing body 6 described above is an example of the "second switching part".
  • the first space S1 of the container body 1 contains a specific gravity liquid 80, a gelling agent 81, and a blood anticoagulant 82. Also, the first space S1 is in a decompressed state.
  • the specific gravity liquid 80, the gelling agent 81, and the blood anticoagulant 82 are arranged on one side x1 in the first direction of the gasket 2, and are laminated on the gasket 2 in this order from the other side x2 in the first direction.
  • a specific gravity liquid 80 suitable for separating mononuclear cells in blood is used.
  • the gelatinous agent 81 has an appropriate density and temporarily functions as a barrier layer until centrifugation is performed.
  • the blood anticoagulant 82 contains an ingredient that prevents blood from clotting (for example, sodium citrate) at an appropriate concentration.
  • FIGS. 4 and 5 are cross-sectional views showing one step of the manufacturing method of the liquid-sampling container A1, and are longitudinal cross-sectional views similar to FIG.
  • the specific gravity liquid 80, the gelling agent 81 and the blood anticoagulant 82 are stacked on the gasket 2 with the opening 111 of the container body 1 opened.
  • the sealing body 6 does not have the sealing portion 61, and the tip of the sealing body 6 (first direction other side x2 end) is open.
  • the first stopper 3 is attached to the container 1 so as to close the opening 111 .
  • the first space S1 of the container 1 is not communicated with the outside.
  • a pump P is connected to the tip of the sealing body 6, and the air in the second space S2 of the container body 1 is sucked by the operation of the pump P to move the gasket 2 toward the other side x2 in the first direction. aspirate to move.
  • the gasket 2 is suction-moved to a position where it abuts against the bottom wall portion 12 (the other end in the first direction x2 in the cylindrical portion 11).
  • the first space S1 of the container body 1 does not communicate with the outside, the first space S1 is in a decompressed state.
  • the pump P described above is an example of the "suction means".
  • the intermediate portion of the sealing body 6 is sealed by heat welding to form a seal portion 61 .
  • the end of the container body 1 on the other side x2 in the first direction is closed by the sealing body 6 .
  • the gasket 2 stays at the position where it has been moved by suction, and the decompressed state of the first space S1 is maintained.
  • the liquid collection container A1 shown in FIG. 3 is manufactured.
  • the decompression level gradually decreases after manufacturing, but it is impossible to visually judge whether it is appropriate at the time of use. Therefore, from the viewpoint of risk avoidance, an early expiration date is set, but this leads to early disposal loss.
  • the position of the gasket determines whether or not the decompression level at the time of use is appropriate. There is an advantage that it can be determined by visual confirmation.
  • FIG. 6 the usage method and action of the liquid collection container A1 will be described with reference to FIGS. 6 to 11.
  • the liquid collection container A1 is used to collect blood in the container body 1, separate and collect mononuclear cells in the blood from other components by centrifugation.
  • FIGS. 6 and 7 when collecting blood into the container body 1 of the liquid collection container A1, for example, the puncture needle 91 of the blood collection tool 9A is pierced into the first elastic portion 42 of the second plug 4. Also, the blood collection needle (not shown) of the blood collection tool 9A is pierced into the vein of the body. Here, the pressure-reduced state is maintained in the first space S1 of the container body 1 . Therefore, by piercing the first elastic portion 42 with the puncture needle 91, for example, blood directly flows into the first space S1 from the body (outside), and the blood can be collected.
  • FIG. 7 shows blood 83 collected inside container body 1 (first space S1).
  • the puncture needle 91 of the blood collection tool 9A is removed from the first elastic portion 42. As shown in FIG. The puncture hole of the puncture needle 91 is blocked by the first elastic portion 42, and the first space S1 does not communicate with the outside.
  • the channel tube 5 is heat-sealed to form a closed seal portion 53, and the second plug 4 is removed (see FIG. 8).
  • the liquid collection container A1 is set in a centrifuge, for example, and centrifuged. Centrifugation of the liquid-collecting container A1 separates blood components, and as shown in FIG. 2 in this order from the other side x2 in the first direction.
  • a collection container 9B is used to collect some of the blood components in the container body 1.
  • the mononuclear cells 85 are raw materials for regenerative medicine products.
  • the collection container 9B has, for example, multiple ports 93, discharge ports 94, filters 95, and multiple tubes 96.
  • the filter 95 is set inside the collection container 9B.
  • a plurality of ports 93 and a discharge port 94 are arranged on opposite sides of the filter 95 .
  • Filter 95 has the property that plasma 86 can pass through and mononuclear cells 85 cannot pass through.
  • a suction device (not shown) such as a pump is connected to the discharge port 94 .
  • a tube 96 is connected to one of the ports 93 .
  • the tubes 96 are made of a heat-sealable material, and the ends of the tubes 96 are heat-sealed to form a seal portion 961 .
  • the tip of the channel tube 5 and the tip of the tube 96 in the liquid collection container A1 are connected using, for example, an aseptic connecting device (not shown), and the sealing portion 61 of the sealing body 6 is cut. do.
  • An opening 62 is formed at the tip of the sealing body 6, and the tip of the sealing body 6 is open to the outside.
  • the first space S1 on the one side x1 in the first direction from the gasket 2 communicates with the collection container 9B (outside).
  • the operation of the pump causes plasma 86 and mononuclear cells on the one side x1 in the first direction in the first space S1. 85 are aspirated in turn.
  • the second space S2 on the other side x2 in the first direction than the gasket 2 communicates with the outside, and the gasket 2 smoothly slides to the one side x1 in the first direction without receiving pressure resistance.
  • Plasma 86 and mononuclear cells 85 are sucked and moved into collection container 9B, and plasma 86 passes through filter 95 and is discharged from discharge port 94 . As shown in FIG. 11, mononuclear cells 85 are captured by filter 95 and remain in collection container 9B.
  • the tube 96 is cut and sealed by heat welding. After that, other ports 93 are used to wash the inside of the collection container 9B and to inject the culture solution into the collection container 9B, if necessary.
  • the gasket 2 is fitted inside the cylindrical portion 11 of the container body 1.
  • the gasket 2 is in close contact with the inner peripheral surface of the cylindrical portion 11 in the circumferential direction without gaps, thereby dividing the inner space S of the container body 1 into a first space S1 on one side x1 in the first direction and a first space S1 on the other side in the first direction. It is partitioned into a second space S2 of x2.
  • a first stopper 3, a second stopper 4, and a channel tube 5 (first switching portion) are arranged at the first direction one side x1 end of the container body 1, and the first direction other side of the container body 1 is arranged.
  • a sealing body 6 (second switching portion) is arranged on the side x2.
  • the first plug 3, the second plug 4, and the channel tube 5 can be switched between a state in which the first space S1 communicates with the outside and a state in which the first space S1 does not communicate with the outside.
  • the sealing body 6 can be switched between a state in which the second space S2 communicates with the outside and a state in which the second space S2 does not communicate with the outside.
  • the first space S1 is in a decompressed state (see FIG. 3).
  • the gasket 2 smoothly slides in the first direction one side x1 without being subjected to pressure resistance, and the necessary components in the first space S1 are sucked and moved to the collection container 9B different from the liquid collection container A1. can be done. Therefore, according to this embodiment, even when the necessary components in the first space S1 are transferred to another container, it is possible to take them out in a closed state without opening the container body 1 .
  • the first space S1 of the container body 1 contains a gelling agent 81 and a blood anticoagulant 82 .
  • the mononuclear cells 85 (required components) in the blood collected in the container body 1 can be separated from other components by centrifugation and recovered.
  • ⁇ Second embodiment> 12 and 13 show a liquid collection container according to a second embodiment of the present disclosure.
  • the liquid-sampling container A2 of this embodiment includes a third plug 7 instead of the first plug 3, the second plug 4, and the channel tube 5 of the liquid-sampling container A1 of the above embodiment.
  • 12 and subsequent drawings elements identical or similar to those of the liquid collection container A1 of the above embodiment are assigned the same reference numerals as those of the above embodiment, and description thereof will be omitted as appropriate.
  • the third plug 7 is arranged at the first direction one side x1 end of the container body 1 .
  • the third plug 7 is made of, for example, a rubber material that can be punctured by a puncture needle, and has gas impermeability and liquid tightness.
  • the third plug 7 has an appropriate elastic restoring force and a resealing property to block the puncture hole of the puncture needle.
  • the third plug body 7 is press-fitted into the first direction one side x1 end of the tubular portion 11 . Thereby, the third plug 7 closes the opening 111 of the cylindrical portion 11 .
  • the constituent material of the third plug 7 is not limited to the above, and examples thereof include butyl rubber.
  • the first space S1 of the container body 1 does not communicate with the outside due to the third plug body 7 configured as described above.
  • the third plug body 7 configured as described above.
  • the first space S1 of the container body 1 can communicate with the outside.
  • the third plug 7 described above is an example of the "first switching part".
  • the first space S1 of the container body 1 contains a specific gravity liquid 80, a gelling agent 81 and a blood anticoagulant 82. Also, the first space S1 is in a decompressed state.
  • the specific gravity liquid 80, the gelling agent 81 and the blood anticoagulant 82 are the same as those described with reference to FIG. 3 for the liquid collection container A1 of the first embodiment.
  • the liquid-sampling container A2 of this embodiment can be manufactured by the same manufacturing method as that of the liquid-sampling container A1 of the first embodiment.
  • the gasket 2 is fitted inside the cylindrical portion 11 of the container body 1.
  • the gasket 2 is in close contact with the inner peripheral surface of the cylindrical portion 11 in the circumferential direction without gaps, thereby dividing the inner space S of the container body 1 into a first space S1 on one side x1 in the first direction and a first space S1 on the other side in the first direction. It is partitioned into a second space S2 of x2.
  • a third plug 7 (first switching portion) is arranged at the end of the container body 1 on one side x1 in the first direction, and a sealing body 6 (second switching part) is arranged.
  • the third plug 7 can be switched between a state in which the first space S1 communicates with the outside and a state in which the first space S1 does not communicate with the outside.
  • the sealing body 6 can be switched between a state in which the second space S2 communicates with the outside and a state in which the second space S2 does not communicate with the outside.
  • the first space S1 is in a decompressed state (see FIG. 13).
  • the first space S1 of the container body 1 contains a gelling agent 81 and a blood anticoagulant 82 .
  • the mononuclear cells 85 (required components) in the blood collected in the container body 1 can be separated from other components by centrifugation and recovered.
  • liquid collection container according to the present disclosure is not limited to the above embodiments.
  • the specific configuration of each part of the liquid collection container of the present disclosure can be modified in various ways.
  • the second switching unit may have a configuration including a tubular member connected to the other end of the container body in the first direction, and an on-off valve capable of switching the internal flow rate of the tubular member. good. Further, a configuration may be adopted in which a vent filter is provided in the second switching portion to prevent contamination by outside air flowing in when the second space communicates with the outside.
  • the application of the liquid collection container of the present disclosure is not particularly limited, and it may be used for applications other than the application of separating and collecting mononuclear cells from blood. be.
  • the liquid to be collected inside the container body is not limited to blood either.

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Abstract

Provided is a liquid collection container which separates components of a collected liquid and with which it is possible to extract required components in a closed state. The present invention comprises: a container body 1 having a tubular part 11 extending in a first direction x; a gasket 2 that is slidable in the first direction x and closely adheres to the inner circumferential surface of the tubular part 11 with no gap therebetween in the circumferential direction, thereby partitioning an inner space S of the container body 1 into a first space S1 and a second space S2; a first plug 3, a second plug 4, and a flow path tube 5 (first switching part) that are disposed on an end on one side x1 in the first direction in the container body 1 and can switch between a state where the first space S1 communicates with the outside and a state where the first space does not communicate with the outside; and a sealing body 6 (second switching part) that is disposed on an end on the other side x2 in the first direction in the container body 1 and can switch between a state where the second space S2 communicates with the outside and a state where the second space S2 does not communicate with the outside. The first space S1 is in a reduced pressure state.

Description

液体採取容器、および液体採取容器の製造方法Liquid collection container and method for manufacturing liquid collection container
　本開示は、液体を採取するための液体採取容器、および液体採取容器の製造方法に関する。 The present disclosure relates to a liquid collection container for collecting liquid and a method of manufacturing the liquid collection container.
　検査用の血液の採取には、いわゆる真空採血管と呼ばれる容器が広く用いられている。真空採血管は、プラスチックまたはガラスで成形されたコニカル形状の底壁と当該底壁の周縁から立ち上がる円筒状の側壁から成る本体部と、当該本体部の開口を塞ぐゴム状の栓体で構成される（例えば、特許文献１を参照）。栓体は、アルミニウムを含むシートであって針刺し部のみがゴム状に構成されている場合もある。真空採血管の内部は、減圧状態が維持されており、栓体のゴム状部に針刺し連通することによって他容器、あるいは身体の静脈から直接血液を流入させることができる。 A container called a so-called vacuum blood collection tube is widely used to collect blood for testing. A vacuum blood collection tube consists of a main body consisting of a conical bottom wall made of plastic or glass, a cylindrical side wall rising from the periphery of the bottom wall, and a rubber-like plug that closes the opening of the main body. (See Patent Document 1, for example). The stopper may be a sheet containing aluminum, and only the needle sticking portion may be made of rubber. The inside of the vacuum blood collection tube is maintained in a decompressed state, and blood can flow directly from another container or from a vein of the body by connecting the rubber-like portion of the stopper with a needle.
　上記のような標準的な真空採血管は、主に血液検査目的に使用されており、あらかじめ内蔵した試薬に流入させた血液を混和させて検査結果を出す場合がほとんどである。採取した血液を別の容器に移す必要がある場合には、栓体を開放して器具を用いて吸引することになる。 The standard vacuum blood collection tubes as described above are mainly used for blood testing purposes, and in most cases test results are obtained by mixing the blood that has flowed into the pre-loaded reagents. When the collected blood needs to be transferred to another container, the stopper is opened and the blood is sucked using an instrument.
　特に血液成分の一部を再生医療等製品の原料とすることを目的にする場合、全血試料を採取した真空採血管を遠心分離にかけ血液成分を分離し、必要成分のみを吸引回収する方法が採られている。しかしながら真空採血管は、採血工程までは減圧状態を維持する構造上、本体部は硬質素材である。そのため栓体への針刺しで連通させたチューブから吸引しても圧力抵抗によって収容した液体を回収することができない。そこで、栓体の少なくとも一部を開放した上で器具を用いて吸引せざるを得ないが、そうなると原料の無菌性を確保するために高レベルの無菌設備や専門技術が必要になり、その高額な設備維持費、人件費等が結果的に製品の高額化につながってしまう。 Especially when the purpose is to use some of the blood components as a raw material for regenerative medicine products, a method of centrifuging a vacuum blood collection tube containing a whole blood sample to separate the blood components and aspirating and recovering only the necessary components is recommended. being taken. However, the main body of the vacuum blood collection tube is made of a hard material because of its structure that maintains a decompressed state until the blood collection process. Therefore, even if it is sucked from a tube that is communicated by sticking a needle into the stopper, the contained liquid cannot be recovered due to pressure resistance. Therefore, it is necessary to open at least a part of the stopper and then use an instrument to aspirate. Equipment maintenance costs, labor costs, etc., eventually lead to an increase in the price of the product.
特開２００８－２６４０６６号公報JP 2008-264066 A
　本開示は、このような事情のもとで考え出されたものであって、採取した液体を成分分離し、且つ閉鎖状態で必要成分を取り出し可能な液体採取容器を提供することを主たる課題とする。 The present disclosure has been conceived under such circumstances, and the main object thereof is to provide a liquid collection container that separates the components of the collected liquid and allows necessary components to be taken out in a closed state. do.
　上記の課題を解決するため、本開示では、次の技術的手段を採用した。 In order to solve the above problems, the following technical measures are adopted in this disclosure.
　本開示の第１の側面によって提供される液体採取容器は、第１方向に延びる筒状部を有する容器体と、前記筒状部の内周面に対して周方向に隙間なく密着することで前記容器体の内側空間を第１空間および第２空間に区画し、且つ前記第１方向に摺動可能なガスケットと、前記容器体における前記第１方向の一方側端に配置され、前記第１空間が外部と連通する状態と、前記第１空間が外部と連通しない状態とに切換え可能な第１切換部と、前記容器体における前記第１方向の他方側端に配置され、前記第２空間が外部と連通する状態と、前記第２空間が外部と連通しない状態とに切換え可能な第２切換部と、を備え、前記第１空間は、減圧状態である。 A liquid-sampling container provided by the first aspect of the present disclosure has a container body having a cylindrical portion extending in a first direction, and is in close contact with the inner peripheral surface of the cylindrical portion in the circumferential direction without a gap. a gasket that partitions the inner space of the container body into a first space and a second space and is slidable in the first direction; a first switching part capable of switching between a state in which the space communicates with the outside and a state in which the first space does not communicate with the outside; and a second switching part capable of switching between a state in which the second space communicates with the outside and a state in which the second space does not communicate with the outside, and the first space is in a decompressed state.
　好ましい実施の形態においては、前記第１切換部は、第１栓体、第２栓体および流路チューブを含み、前記第１栓体は、前記筒状部における前記第１方向の一方側端の開口部を塞いでおり、且つ前記第１方向に貫通する連通孔を有し、前記第２栓体は、ガス非透過性、且つ液密性を有する第１弾性部を備え、前記流路チューブは、前記連通孔に通じる状態で前記第１栓体に接続された第１端部と、前記第１弾性部で閉鎖された第２端部と、を有する。 In a preferred embodiment, the first switching section includes a first plug, a second plug, and a channel tube, and the first plug is one end of the cylindrical section in the first direction. and has a communication hole penetrating in the first direction, the second plug includes a gas-impermeable and liquid-tight first elastic portion, and the flow path The tube has a first end connected to the first plug body in a state of communicating with the communication hole, and a second end closed by the first elastic portion.
　好ましい実施の形態においては、前記第１切換部は、前記筒状部における前記第１方向の一方側端の開口部を塞ぐ第３栓体を含み、前記第３栓体は、ガス非透過性、且つ液密性を有し、前記第３栓体へ穿刺針を刺すことで、前記第１空間と外部とが連通可能である。 In a preferred embodiment, the first switching portion includes a third plug that closes an opening on one side of the tubular portion in the first direction, and the third plug is gas impermeable. and is liquid-tight, and by piercing the third plug with a puncture needle, the first space can be communicated with the outside.
　好ましい実施の形態においては、前記容器体は、前記筒状部における前記第１方向の他方側端を塞ぐ底壁部と、前記底壁部につながり、且つ前記第１方向に貫通する孔を有する先端筒部と、を有し、前記第２切換部は、前記先端筒部に取り付けられた封止体を含み、前記封止体を開放することで、前記第２空間と外部とが連通可能である。 In a preferred embodiment, the container body has a bottom wall portion closing the other side end in the first direction of the cylindrical portion, and a hole connected to the bottom wall portion and penetrating in the first direction. and a tip tube portion, wherein the second switching portion includes a sealing body attached to the tip tube portion, and by opening the sealing body, the second space can communicate with the outside. is.
　好ましい実施の形態においては、前記容器体の前記第１空間には、ゲル状剤および血液抗凝固剤が収容されている。 In a preferred embodiment, the first space of the container contains a gelling agent and a blood anticoagulant.
　本開示の第２の側面によって提供される液体採取容器の製造方法は、本開示の第１の側面に係る液体採取容器の製造方法であって、前記第１空間が外部と連通しない状態で、前記容器体における前記第１方向の他方側端に吸引手段を連通させ、当該吸引手段により前記ガスケットを前記第１方向の他方側に吸引移動させる工程と、前記容器体における前記第１方向の他方端を閉塞し、前記ガスケットを吸引移動した位置に留めて前記第１空間の減圧維持を行う工程と、を含む。 A method for manufacturing a liquid-sampling container provided by the second aspect of the present disclosure is a method for manufacturing a liquid-sampling container according to the first aspect of the present disclosure, wherein the first space does not communicate with the outside, connecting a suction means to the other side end of the container body in the first direction, and sucking and moving the gasket to the other side in the first direction by the suction means; closing the end and retaining the gasket in the suction-moved position to maintain a reduced pressure in the first space.
　本開示のその他の特徴および利点は、添付図面を参照して以下に行う詳細な説明によって、より明らかとなろう。 Other features and advantages of the present disclosure will become clearer from the detailed description given below with reference to the accompanying drawings.
本開示の第１実施形態に係る液体採取容器を示す斜視図である。1 is a perspective view showing a liquid collection container according to a first embodiment of the present disclosure; FIG. 図１に示す液体採取容器の縦断面図である。FIG. 2 is a longitudinal sectional view of the liquid collection container shown in FIG. 1; 図２に示す液体採取容器において、ゲル状剤および血液抗凝固剤が収容された状態を表す。3 shows a state in which a gel-like agent and a blood anticoagulant are accommodated in the liquid collection container shown in FIG. 2; 本開示の第１実施形態に係る液体採取容器の製造方法の一例の一工程を示す縦断面図である。FIG. 4 is a vertical cross-sectional view showing one step of an example of a method for manufacturing a liquid-sampling container according to the first embodiment of the present disclosure; 図４に続く工程を示す縦断面図である。FIG. 5 is a longitudinal sectional view showing a step following FIG. 4; 本開示の第１実施形態に係る液体採取容器の使用状態を示す縦断面図である。1 is a vertical cross-sectional view showing a usage state of a liquid collection container according to a first embodiment of the present disclosure; FIG. 本開示の第１実施形態に係る液体採取容器の使用状態を示す縦断面図である。1 is a vertical cross-sectional view showing a usage state of a liquid collection container according to a first embodiment of the present disclosure; FIG. 本開示の第１実施形態に係る液体採取容器の使用状態を示す縦断面図である。1 is a vertical cross-sectional view showing a usage state of a liquid collection container according to a first embodiment of the present disclosure; FIG. 本開示の第１実施形態に係る液体採取容器の使用状態を示す縦断面図である。1 is a vertical cross-sectional view showing a usage state of a liquid collection container according to a first embodiment of the present disclosure; FIG. 本開示の第１実施形態に係る液体採取容器の使用状態を示す縦断面図である。1 is a vertical cross-sectional view showing a usage state of a liquid collection container according to a first embodiment of the present disclosure; FIG. 本開示の第１実施形態に係る液体採取容器の使用状態を示す縦断面図である。1 is a vertical cross-sectional view showing a usage state of a liquid collection container according to a first embodiment of the present disclosure; FIG. 本開示の第２実施形態に係る液体採取容器を示す、図２と同様の縦断面図である。3 is a longitudinal cross-sectional view similar to FIG. 2 showing a liquid collection container according to a second embodiment of the present disclosure; FIG. 図１２に示す液体採取容器において、ゲル状剤および血液抗凝固剤が収容された状態を表す。FIG. 13 shows a state in which a gel-like agent and a blood anticoagulant are accommodated in the liquid collection container shown in FIG. 12;
　以下、本開示の好ましい実施の形態を図面を参照しつつ具体的に説明する。 Hereinafter, preferred embodiments of the present disclosure will be specifically described with reference to the drawings.
　本開示における「第１」、「第２」、「第３」等の用語は、単にラベルとして用いたものであり、必ずしもそれらの対象物に順列を付することを意図していない。 The terms "first", "second", "third", etc. in the present disclosure are merely used as labels and are not necessarily intended to give permutations to those objects.
＜第１実施形態＞
　図１～図３は、本開示の第１実施形態に係る液体採取容器を示している。本実施形態の液体採取容器Ａ１は、容器体１、ガスケット２、第１栓体３、第２栓体４、流路チューブ５および封止体６を備えている。本実施形態の液体採取容器Ａ１は、例えば血液を採取し、当該血液中の単核球を遠心分離によって他の成分から分離して回収する際に用いられる。図１は、液体採取容器Ａ１の斜視図である。図２は、液体採取容器Ａ１の縦断面図である。 <First Embodiment>
1 to 3 show a liquid collection container according to a first embodiment of the present disclosure. A liquid-sampling container A1 of this embodiment includes a container body 1, a gasket 2, a first plug 3, a second plug 4, a channel tube 5, and a sealing body 6. As shown in FIG. The liquid collection container A1 of the present embodiment is used, for example, when blood is collected and mononuclear cells in the blood are separated from other components by centrifugation and collected. FIG. 1 is a perspective view of the liquid collection container A1. FIG. 2 is a longitudinal sectional view of the liquid collection container A1.
　本実施形態においては、容器体１は、筒状部１１、底壁部１２および先端筒部１３を備えている。筒状部１１は、概略円筒状とされており、第１方向ｘに延びている。筒状部１１は、第１方向ｘの一方側端（以下、適宜「第１方向一方側ｘ１端」という。）において開口部１１１を有する。筒状部１１において、第１方向一方側ｘ１の端部（開口部１１１の形成部位）は、他の部位よりも少し大径である。 In this embodiment, the container body 1 includes a tubular portion 11 , a bottom wall portion 12 and a tip tubular portion 13 . The tubular portion 11 has a substantially cylindrical shape and extends in the first direction x. The tubular portion 11 has an opening 111 at one end in the first direction x (hereinafter referred to as “first direction one side x1 end”). In the tubular portion 11, the end portion on the one side x1 in the first direction (the portion where the opening portion 111 is formed) has a slightly larger diameter than the other portions.
　底壁部１２は、筒状部１１における第１方向ｘの他方側端（以下、適宜「第１方向他方側ｘ２端」という。）を塞いでいる。底壁部１２は、概略円板状である。先端筒部１３は、底壁部１２の径方向中央につながって第１方向他方側ｘ２に突出している。先端筒部１３は、第１方向ｘに貫通して筒状部１１（容器体１）の内側空間Ｓに通じる孔１３１を有する。このような構成の容器体１としては、例えば汎用品である注射器のシリンジ（注射筒）を用いることができる。 The bottom wall portion 12 closes the other side end of the cylindrical portion 11 in the first direction x (hereinafter referred to as "first direction other side x2 end"). The bottom wall portion 12 is generally disc-shaped. The tip tubular portion 13 is connected to the radial center of the bottom wall portion 12 and protrudes to the other side x2 in the first direction. The tip tubular portion 13 has a hole 131 penetrating in the first direction x and communicating with the inner space S of the tubular portion 11 (container body 1). As the container body 1 having such a configuration, for example, a general-purpose syringe (syringe) can be used.
　ガスケット２は、筒状部１１に内嵌されており、筒状部１１の内周面に対して周方向に隙間なく密着している。ガスケット２は、適度な弾性を有するゴム材料によって形成されており、円柱状部分の外周に半円リング状の２つの突起部分が第１方向ｘに並ぶ態様でつながる構成とされている。ガスケット２の構成材料は特に限定されず、例えばＴＰＥ（熱可塑性エラストマー）などが挙げられる。このガスケット２は、筒状部１１（容器体１）の内側空間Ｓを第１空間Ｓ１および第２空間Ｓ２に区画する。第１空間Ｓ１はガスケット２に対して第１方向一方側ｘ１に位置し、第２空間Ｓ２はガスケット２に対して第１方向他方側ｘ２に位置する。ガスケット２は、筒状部１１の内周面に隙間なく密着しつつ、第１方向ｘに摺動可能である。 The gasket 2 is fitted inside the tubular portion 11 and closely adheres to the inner peripheral surface of the tubular portion 11 in the circumferential direction without a gap. The gasket 2 is made of a rubber material having moderate elasticity, and has a configuration in which two semi-circular ring-shaped protruding portions are connected to the outer periphery of the cylindrical portion in a manner aligned in the first direction x. The constituent material of the gasket 2 is not particularly limited, and examples thereof include TPE (thermoplastic elastomer). The gasket 2 divides the inner space S of the tubular portion 11 (container body 1) into a first space S1 and a second space S2. The first space S1 is positioned on one side x1 in the first direction with respect to the gasket 2, and the second space S2 is positioned on the other side x2 in the first direction with respect to the gasket 2. As shown in FIG. The gasket 2 can slide in the first direction x while tightly adhering to the inner peripheral surface of the cylindrical portion 11 .
　第１栓体３、第２栓体４および流路チューブ５は、容器体１の第１方向一方側ｘ１端に配置されている。 The first plug 3, the second plug 4 and the channel tube 5 are arranged at the first direction one side x1 end of the container 1.
　第１栓体３は、例えばゴム材料によって構成されており、筒状部１１の第１方向一方側ｘ１端に圧入されている。これにより、第１栓体３は、筒状部１１の開口部１１１を塞いでいる。第１栓体３は、連通孔３１および凸状筒部３２を有する。連通孔３１は、第１方向ｘに貫通する孔であり、第１栓体３の径方向中央に形成されている。凸状筒部３２は、概略円筒状であり、第１方向一方側ｘ１側に突出している。第１栓体３の構成材料は特に限定されず、例えばブチルゴムなどが挙げられる。 The first plug 3 is made of, for example, a rubber material, and is press-fitted into the first direction one side x1 end of the tubular portion 11 . Thereby, the first plug 3 closes the opening 111 of the cylindrical portion 11 . The first plug body 3 has a communication hole 31 and a convex tubular portion 32 . The communication hole 31 is a hole that penetrates in the first direction x and is formed in the center of the first plug 3 in the radial direction. The convex tubular portion 32 has a substantially cylindrical shape and protrudes toward the one side x1 in the first direction. A constituent material of the first plug body 3 is not particularly limited, and examples thereof include butyl rubber.
　本実施形態において、第２栓体４は、支持部４１および第１弾性部４２を有する。支持部４１は、第１弾性部４２を包囲しつつ支持する部分であり、略筒状とされている。支持部４１の構成材料は特に限定されず、例えばポリエチレンなどの樹脂材料が挙げられる。 In this embodiment, the second plug 4 has a support portion 41 and a first elastic portion 42. The support portion 41 is a portion that surrounds and supports the first elastic portion 42 and has a substantially cylindrical shape. A constituent material of the support portion 41 is not particularly limited, and examples thereof include a resin material such as polyethylene.
　第１弾性部４２は、穿刺針を穿刺可能なゴム材料によって構成されており、支持部４１に圧入されている。第１弾性部４２は、ガス非透過性および液密性を有する。支持部４１および第１弾性部４２の間は接着等の適宜手段により密閉状態とされている。例えば第１弾性部４２の先端（図２における下方側端）は、支持部４１よりも延出している。この第１弾性部４２は、適度な弾性復元力を有する。これにより、第１弾性部４２は、穿刺針の突き刺し孔を塞ぐ再シール性を有する。第１弾性部４２の構成材料は特に限定されず、例えばブチルゴムなどが挙げられる。 The first elastic portion 42 is made of a rubber material that can be punctured by a puncture needle, and is press-fitted into the support portion 41 . The first elastic portion 42 is gas-impermeable and liquid-tight. The space between the support portion 41 and the first elastic portion 42 is hermetically sealed by an appropriate means such as adhesion. For example, the tip of the first elastic portion 42 (the lower end in FIG. 2) extends beyond the support portion 41 . The first elastic portion 42 has an appropriate elastic restoring force. Thereby, the first elastic portion 42 has a resealing property to close the puncture hole of the puncture needle. A constituent material of the first elastic portion 42 is not particularly limited, and examples thereof include butyl rubber.
　流路チューブ５は、第１栓体３と第２栓体４との間をつなぐ流体流路であり、例えば可撓性を有する材料により構成される。流路チューブ５は、その両端に第１端部５１および第２端部５２を有する。第１端部５１は、凸状筒部３２に外嵌されており、凸状筒部３２および第１端部５１は接着等の適宜手段により密閉状態で接続されている。これにより、第１端部５１は、連通孔３１に通じる状態で第１栓体３に接続されており、流路チューブ５の内部は、連通孔３１を介して筒状部１１（容器体１）の第１空間Ｓ１に連通している。 The channel tube 5 is a fluid channel that connects the first plug 3 and the second plug 4, and is made of, for example, a flexible material. The flow tube 5 has a first end 51 and a second end 52 at both ends. The first end portion 51 is fitted onto the convex cylindrical portion 32, and the convex cylindrical portion 32 and the first end portion 51 are connected in a sealed state by appropriate means such as adhesion. As a result, the first end portion 51 is connected to the first plug body 3 in a state of being communicated with the communication hole 31 , and the interior of the flow path tube 5 is connected to the tubular portion 11 (container body 1 ) via the communication hole 31 . ) communicates with the first space S1.
　第２端部５２は、第２栓体４の第１弾性部４２の先端に外嵌されており、第１弾性部４２および第２端部５２は接着等の適宜手段により密閉状態で接続されている。これにより、第２端部５２は、第１弾性部４２により閉鎖されている。また、流路チューブ５の内部は、外部と遮断されており、外部と連通しない。 The second end portion 52 is fitted onto the tip of the first elastic portion 42 of the second plug 4, and the first elastic portion 42 and the second end portion 52 are connected in a sealed state by an appropriate means such as adhesion. ing. Thereby, the second end portion 52 is closed by the first elastic portion 42 . Moreover, the inside of the channel tube 5 is cut off from the outside and does not communicate with the outside.
　図２に示す状態において、上記構成の第１栓体３、第２栓体４および流路チューブ５により、容器体１の第１空間Ｓ１は外部と連通しない。その一方、例えば第１弾性部４２に穿刺針（例えば図７を参照して後述する採血具９Ａの穿刺針９１）を刺すことで、容器体１の第１空間Ｓ１は流路チューブ５を介して外部と連通可能である。第１栓体３、第２栓体４および流路チューブ５は、一つのアセンブリ部品として取り扱うことが可能である。上記の第１栓体３、第２栓体４および流路チューブ５は、「第１切換部」の一例である。 In the state shown in FIG. 2, the first space S1 of the container body 1 does not communicate with the outside due to the first plug 3, the second plug 4 and the channel tube 5 configured as described above. On the other hand, for example, by piercing the first elastic portion 42 with a puncture needle (for example, a puncture needle 91 of a blood collection tool 9A, which will be described later with reference to FIG. 7), the first space S1 of the container body 1 passes through the flow path tube 5 can communicate with the outside. The first plug body 3, the second plug body 4 and the channel tube 5 can be handled as one assembly part. The first plug 3, the second plug 4, and the channel tube 5 are examples of the "first switching section."
　封止体６は、容器体１の先端筒部１３に取り付けられている。封止体６は、例えば可撓性を有する筒状チューブにより構成されている。封止体６は、熱溶着可能な材料により構成される。封止体６の先端（図２における下方側端）には、シール部６１が形成されている。このシール部６１は、例えば封止体６の先端筒状部分において熱溶着によって閉塞されたヒートシール部である。上記の封止体６は、「第２切換部」の一例である。 The sealing body 6 is attached to the tip cylindrical portion 13 of the container body 1 . The sealing body 6 is composed of, for example, a flexible cylindrical tube. The sealing body 6 is made of a heat-sealable material. A seal portion 61 is formed at the tip of the sealing body 6 (the lower end in FIG. 2). This seal portion 61 is a heat-sealed portion that is closed by thermal welding at the tip cylindrical portion of the sealing body 6, for example. The sealing body 6 described above is an example of the "second switching part".
　本実施形態の液体採取容器Ａ１においては、図３に示すように、容器体１の第１空間Ｓ１には比重液８０、ゲル状剤８１および血液抗凝固剤８２が収容されている。また、第１空間Ｓ１は、減圧状態である。比重液８０、ゲル状剤８１および血液抗凝固剤８２は、ガスケット２の第１方向一方側ｘ１に配置されており、ガスケット２に対して第１方向他方側ｘ２からこの順に積層されている。比重液８０は、血液中の単核球を分離するのに適したものが用いられる。ゲル状剤８１は、適度な密度を有し、遠心分離を行うまでの間、一時的にバリア層として機能する。血液抗凝固剤８２は、血液の凝固を防止する成分（例えばクエン酸ナトリウム）を適度な濃度で含む。 In the liquid collection container A1 of the present embodiment, as shown in FIG. 3, the first space S1 of the container body 1 contains a specific gravity liquid 80, a gelling agent 81, and a blood anticoagulant 82. Also, the first space S1 is in a decompressed state. The specific gravity liquid 80, the gelling agent 81, and the blood anticoagulant 82 are arranged on one side x1 in the first direction of the gasket 2, and are laminated on the gasket 2 in this order from the other side x2 in the first direction. A specific gravity liquid 80 suitable for separating mononuclear cells in blood is used. The gelatinous agent 81 has an appropriate density and temporarily functions as a barrier layer until centrifugation is performed. The blood anticoagulant 82 contains an ingredient that prevents blood from clotting (for example, sodium citrate) at an appropriate concentration.
　次に、液体採取容器Ａ１の製造方法の一例について、図４および図５を参照して以下に説明する。図４および図５はそれぞれ、液体採取容器Ａ１の製造方法の一工程を示す断面図であって、図３と同様の縦断面図である。 Next, an example of a method for manufacturing the liquid collection container A1 will be described below with reference to FIGS. 4 and 5. 4 and 5 are cross-sectional views showing one step of the manufacturing method of the liquid-sampling container A1, and are longitudinal cross-sectional views similar to FIG.
　まず、図４に示すように、容器体１の開口部１１１が開放した状態にて、ガスケット２上に比重液８０、ゲル状剤８１および血液抗凝固剤８２を積層配置する。ここで、封止体６は、シール部６１を有しておらず、封止体６の先端（第１方向他方側ｘ２端）が開放している。次に、開口部１１１を塞ぐように容器体１に第１栓体３を取り付ける。これにより、容器体１の第１空間Ｓ１は外部と連通しない状態となる。 First, as shown in FIG. 4, the specific gravity liquid 80, the gelling agent 81 and the blood anticoagulant 82 are stacked on the gasket 2 with the opening 111 of the container body 1 opened. Here, the sealing body 6 does not have the sealing portion 61, and the tip of the sealing body 6 (first direction other side x2 end) is open. Next, the first stopper 3 is attached to the container 1 so as to close the opening 111 . As a result, the first space S1 of the container 1 is not communicated with the outside.
　次いで、図５に示すように、封止体６の先端にポンプＰを接続し、ポンプＰの作動により容器体１の第２空間Ｓ２の空気を吸引してガスケット２を第１方向他方側ｘ２に吸引移動させる。ガスケット２は、底壁部１２に当接する位置（筒状部１１内の第１方向他方側ｘ２端）まで吸引移動させられる。ここで、容器体１の第１空間Ｓ１は外部と連通しないため、第１空間Ｓ１は減圧状態となる。上記のポンプＰは、「吸引手段」の一例である。 Next, as shown in FIG. 5, a pump P is connected to the tip of the sealing body 6, and the air in the second space S2 of the container body 1 is sucked by the operation of the pump P to move the gasket 2 toward the other side x2 in the first direction. aspirate to move. The gasket 2 is suction-moved to a position where it abuts against the bottom wall portion 12 (the other end in the first direction x2 in the cylindrical portion 11). Here, since the first space S1 of the container body 1 does not communicate with the outside, the first space S1 is in a decompressed state. The pump P described above is an example of the "suction means".
　次いで、封止体６の中間部を熱溶着により封止し、シール部６１を形成する。このとき、封止体６によって容器体１の第１方向他方側ｘ２端が閉塞した状態にある。そして、ガスケット２は、吸引移動した位置に留まって第１空間Ｓ１の減圧状態が維持される。このようにして、図３に示した液体採取容器Ａ１が製造される。 Next, the intermediate portion of the sealing body 6 is sealed by heat welding to form a seal portion 61 . At this time, the end of the container body 1 on the other side x2 in the first direction is closed by the sealing body 6 . Then, the gasket 2 stays at the position where it has been moved by suction, and the decompressed state of the first space S1 is maintained. Thus, the liquid collection container A1 shown in FIG. 3 is manufactured.
　なお、一般的な真空採血管においては、製造後徐々に減圧レベルが下がっていくが、使用時点で適正か否かの判断は目視では不可能である。そのため、リスク回避の観点から早めの使用期限を設けているが、早期の廃棄ロスに繋がっている。本開示の液体採取容器であれば、以下に説明するような作用により、閉鎖状態で容器内の必要成分を取り出し可能である利点に加え、使用時点の減圧レベルが適正か否かについてガスケット位置の目視確認で判断できる、という利点がある。 In addition, in general vacuum blood collection tubes, the decompression level gradually decreases after manufacturing, but it is impossible to visually judge whether it is appropriate at the time of use. Therefore, from the viewpoint of risk avoidance, an early expiration date is set, but this leads to early disposal loss. With the liquid-sampling container of the present disclosure, in addition to the advantage of being able to take out the necessary components from the container in a closed state due to the action described below, the position of the gasket determines whether or not the decompression level at the time of use is appropriate. There is an advantage that it can be determined by visual confirmation.
　次に、液体採取容器Ａ１の使用方法および作用について、図６～図１１を参照しつつ説明する。 Next, the usage method and action of the liquid collection container A1 will be described with reference to FIGS. 6 to 11. FIG.
　液体採取容器Ａ１は、容器体１内に血液を採取し、当該血液中の単核球を遠心分離によって他の成分から分離し、且つ回収するのに使用される。 The liquid collection container A1 is used to collect blood in the container body 1, separate and collect mononuclear cells in the blood from other components by centrifugation.
　図６および図７に示すように、液体採取容器Ａ１の容器体１内に血液を採取する際、例えば採血具９Ａの穿刺針９１を第２栓体４の第１弾性部４２へ刺す。また、採血具９Ａの採血針（図示せず）を身体の静脈に刺す。ここで、容器体１の第１空間Ｓ１は減圧状態が維持されている。このため、第１弾性部４２に穿刺針９１を突き刺すことで例えば身体（外部）から直接血液が第１空間Ｓ１に流入し、血液を採取することができる。図７は、容器体１の内部（第１空間Ｓ１）に採取した血液８３を示す。容器体１に血液８３を採取した後、採血具９Ａの穿刺針９１を第１弾性部４２から抜き去る。第１弾性部４２において穿刺針９１の突き刺し孔は塞がれ、第１空間Ｓ１が外部と連通しない状態となる。 As shown in FIGS. 6 and 7, when collecting blood into the container body 1 of the liquid collection container A1, for example, the puncture needle 91 of the blood collection tool 9A is pierced into the first elastic portion 42 of the second plug 4. Also, the blood collection needle (not shown) of the blood collection tool 9A is pierced into the vein of the body. Here, the pressure-reduced state is maintained in the first space S1 of the container body 1 . Therefore, by piercing the first elastic portion 42 with the puncture needle 91, for example, blood directly flows into the first space S1 from the body (outside), and the blood can be collected. FIG. 7 shows blood 83 collected inside container body 1 (first space S1). After the blood 83 is collected in the container body 1, the puncture needle 91 of the blood collection tool 9A is removed from the first elastic portion 42. As shown in FIG. The puncture hole of the puncture needle 91 is blocked by the first elastic portion 42, and the first space S1 does not communicate with the outside.
　次に、流路チューブ５をヒートシールして閉じたシール部５３を形成し、第２栓体４を除去する（図８参照）。その後、液体採取容器Ａ１を例えば遠心分離機にセットし、遠心分離を行う。液体採取容器Ａ１を遠心分離すると血液成分が分離し、図８に示すように、液体採取容器Ａ１の第１空間Ｓ１には、赤血球８４、ゲル状剤８１、単核球８５および血漿８６がガスケット２に対して第１方向他方側ｘ２からこの順に積層された状態となる。 Next, the channel tube 5 is heat-sealed to form a closed seal portion 53, and the second plug 4 is removed (see FIG. 8). After that, the liquid collection container A1 is set in a centrifuge, for example, and centrifuged. Centrifugation of the liquid-collecting container A1 separates blood components, and as shown in FIG. 2 in this order from the other side x2 in the first direction.
　次いで、図９に示すように、回収容器９Ｂを用いて容器体１内の血液成分の一部を回収する。本実施形態では、容器体１内の単核球８５を回収する場合について説明する。単核球８５は、再生医療等製品の原料となる。 Then, as shown in FIG. 9, a collection container 9B is used to collect some of the blood components in the container body 1. In this embodiment, a case of recovering the mononuclear cells 85 in the container body 1 will be described. The mononuclear cells 85 are raw materials for regenerative medicine products.
　回収容器９Ｂは、例えば複数のポート９３、排出ポート９４、フィルター９５、複数のチューブ９６を有する。フィルター９５は、回収容器９Ｂの内部にセットされている。複数のポート９３と、排出ポート９４とは、フィルター９５を挟んで反対側に配置されている。フィルター９５は、血漿８６が通過でき、且つ単核球８５が通過できない性質を有する。排出ポート９４には、ポンプなどの吸引装置（図示せず）が接続されている。チューブ９６は、複数のポート９３のいずれかに接続されている。チューブ９６は、熱溶着可能な材料により構成され、各チューブ９６の先端はヒートシールにより閉じたシール部９６１とされている。 The collection container 9B has, for example, multiple ports 93, discharge ports 94, filters 95, and multiple tubes 96. The filter 95 is set inside the collection container 9B. A plurality of ports 93 and a discharge port 94 are arranged on opposite sides of the filter 95 . Filter 95 has the property that plasma 86 can pass through and mononuclear cells 85 cannot pass through. A suction device (not shown) such as a pump is connected to the discharge port 94 . A tube 96 is connected to one of the ports 93 . The tubes 96 are made of a heat-sealable material, and the ends of the tubes 96 are heat-sealed to form a seal portion 961 .
　図１０に示すように、液体採取容器Ａ１における流路チューブ５の先端とチューブ９６の先端とを例えば無菌接続装置（図示せず）を用いて接続し、封止体６のシール部６１を切断する。封止体６の先端には開口６２が形成され、封止体６の先端が外部に開放した状態となる。ここで、ガスケット２よりも第１方向一方側ｘ１の第１空間Ｓ１は回収容器９Ｂ（外部）に連通する。また、ガスケット２よりも第１方向他方側ｘ２が外部に連通する状態にあるので、図外の上記ポンプの作動により、第１空間Ｓ１において第１方向一方側ｘ１にある血漿８６および単核球８５が順に吸引される。このとき、ガスケット２よりも第１方向他方側ｘ２の第２空間Ｓ２は外部に連通しており、ガスケット２は圧力抵抗を受けることなくスムーズに第１方向一方側ｘ１に摺動する。血漿８６および単核球８５は、回収容器９Ｂ内に吸引移動し、血漿８６についてはフィルター９５を通過して排出ポート９４から排出される。図１１に示すように、単核球８５は、フィルター９５により捕捉され、回収容器９Ｂ内に留まる。 As shown in FIG. 10, the tip of the channel tube 5 and the tip of the tube 96 in the liquid collection container A1 are connected using, for example, an aseptic connecting device (not shown), and the sealing portion 61 of the sealing body 6 is cut. do. An opening 62 is formed at the tip of the sealing body 6, and the tip of the sealing body 6 is open to the outside. Here, the first space S1 on the one side x1 in the first direction from the gasket 2 communicates with the collection container 9B (outside). Further, since the other side x2 in the first direction communicates with the outside rather than the gasket 2, the operation of the pump (not shown) causes plasma 86 and mononuclear cells on the one side x1 in the first direction in the first space S1. 85 are aspirated in turn. At this time, the second space S2 on the other side x2 in the first direction than the gasket 2 communicates with the outside, and the gasket 2 smoothly slides to the one side x1 in the first direction without receiving pressure resistance. Plasma 86 and mononuclear cells 85 are sucked and moved into collection container 9B, and plasma 86 passes through filter 95 and is discharged from discharge port 94 . As shown in FIG. 11, mononuclear cells 85 are captured by filter 95 and remain in collection container 9B.
　次いで、チューブ９６を熱溶着により切断および封止する。その後、必要に応じて、他のポート９３を利用して回収容器９Ｂ内の洗浄や回収容器９Ｂ内への培養液の注入等を行う。 Then, the tube 96 is cut and sealed by heat welding. After that, other ports 93 are used to wash the inside of the collection container 9B and to inject the culture solution into the collection container 9B, if necessary.
　液体採取容器Ａ１においては、図２、図３に示すように、容器体１の筒状部１１には、ガスケット２が内嵌されている。ガスケット２は、筒状部１１の内周面に対して周方向に隙間なく密着することで、容器体１の内側空間Ｓを第１方向一方側ｘ１の第１空間Ｓ１および第１方向他方側ｘ２の第２空間Ｓ２に区画している。容器体１の第１方向一方側ｘ１端には、第１栓体３、第２栓体４および流路チューブ５（第１切換部）が配置されており、容器体１の第１方向他方側ｘ２には封止体６（第２切換部）が配置されている。第１栓体３、第２栓体４および流路チューブ５は、第１空間Ｓ１が外部と連通する状態と、第１空間Ｓ１が外部と連通しない状態とに切換え可能である。封止体６は、第２空間Ｓ２が外部と連通する状態と、第２空間Ｓ２が外部と連通しない状態とに切換え可能である。第１空間Ｓ１は、減圧状態とされている（図３参照）。 As shown in FIGS. 2 and 3, in the liquid-sampling container A1, the gasket 2 is fitted inside the cylindrical portion 11 of the container body 1. As shown in FIGS. The gasket 2 is in close contact with the inner peripheral surface of the cylindrical portion 11 in the circumferential direction without gaps, thereby dividing the inner space S of the container body 1 into a first space S1 on one side x1 in the first direction and a first space S1 on the other side in the first direction. It is partitioned into a second space S2 of x2. A first stopper 3, a second stopper 4, and a channel tube 5 (first switching portion) are arranged at the first direction one side x1 end of the container body 1, and the first direction other side of the container body 1 is arranged. A sealing body 6 (second switching portion) is arranged on the side x2. The first plug 3, the second plug 4, and the channel tube 5 can be switched between a state in which the first space S1 communicates with the outside and a state in which the first space S1 does not communicate with the outside. The sealing body 6 can be switched between a state in which the second space S2 communicates with the outside and a state in which the second space S2 does not communicate with the outside. The first space S1 is in a decompressed state (see FIG. 3).
　このような構成によれば、図６、図７等を参照して説明したように、例えば第１弾性部４２に穿刺針９１を突き刺すことで、身体（外部）から直接血液（液体）を第１空間Ｓ１に流入させることができる。 According to such a configuration, as described with reference to FIGS. 6 and 7, for example, by piercing the first elastic portion 42 with the puncture needle 91, blood (liquid) is directly injected from the body (outside). It can be made to flow into 1 space S1.
　第１空間Ｓ１の血液成分を分離した後においては、図９～図１１等を参照して説明したように、例えば第１空間Ｓ１を外部の吸引装置と連通させ、且つ第２空間Ｓ２を外部と連通する状態とする。これにより、ガスケット２は圧力抵抗を受けることなくスムーズに第１方向一方側ｘ１に摺動し、第１空間Ｓ１にある必要成分を液体採取容器Ａ１とは別の回収容器９Ｂに吸引移動させることができる。したがって、本実施形態によれば、第１空間Ｓ１にある必要成分を別の容器に移す場合においても、容器体１を開放することなく閉鎖状態で取り出すことが可能である。 After separating the blood components in the first space S1, as described with reference to FIGS. and communicate with. As a result, the gasket 2 smoothly slides in the first direction one side x1 without being subjected to pressure resistance, and the necessary components in the first space S1 are sucked and moved to the collection container 9B different from the liquid collection container A1. can be done. Therefore, according to this embodiment, even when the necessary components in the first space S1 are transferred to another container, it is possible to take them out in a closed state without opening the container body 1 .
　本実施形態において、容器体１の第１空間Ｓ１には、ゲル状剤８１および血液抗凝固剤８２が収容されている。これにより、容器体１に採取した血液中の単核球８５（必要成分）を、遠心分離により他の成分から分離して回収することができる。 In this embodiment, the first space S1 of the container body 1 contains a gelling agent 81 and a blood anticoagulant 82 . As a result, the mononuclear cells 85 (required components) in the blood collected in the container body 1 can be separated from other components by centrifugation and recovered.
＜第２実施形態＞
　図１２および図１３は、本開示の第２実施形態に係る液体採取容器を示している。本実施形態の液体採取容器Ａ２は、上記実施形態の液体採取容器Ａ１における第１栓体３、第２栓体４および流路チューブ５に代えて、第３栓体７を備えている。なお、図１２以降の図面において、上記実施形態の液体採取容器Ａ１と同一または類似の要素には、上記実施形態と同一の符号を付しており、適宜説明を省略する。 <Second embodiment>
12 and 13 show a liquid collection container according to a second embodiment of the present disclosure. The liquid-sampling container A2 of this embodiment includes a third plug 7 instead of the first plug 3, the second plug 4, and the channel tube 5 of the liquid-sampling container A1 of the above embodiment. 12 and subsequent drawings, elements identical or similar to those of the liquid collection container A1 of the above embodiment are assigned the same reference numerals as those of the above embodiment, and description thereof will be omitted as appropriate.
　第３栓体７は、容器体１の第１方向一方側ｘ１端に配置されている。第３栓体７は、例えば穿刺針を穿刺可能なゴム材料によって構成されており、ガス非透過性および液密性を有する。第３栓体７は、適度な弾性復元力を有し、穿刺針の突き刺し孔を塞ぐ再シール性を有する。第３栓体７は、筒状部１１の第１方向一方側ｘ１端に圧入されている。これにより、第３栓体７は、筒状部１１の開口部１１１を塞いでいる。第３栓体７の構成材料は等に限定されず、例えばブチルゴムなどが挙げられる。 The third plug 7 is arranged at the first direction one side x1 end of the container body 1 . The third plug 7 is made of, for example, a rubber material that can be punctured by a puncture needle, and has gas impermeability and liquid tightness. The third plug 7 has an appropriate elastic restoring force and a resealing property to block the puncture hole of the puncture needle. The third plug body 7 is press-fitted into the first direction one side x1 end of the tubular portion 11 . Thereby, the third plug 7 closes the opening 111 of the cylindrical portion 11 . The constituent material of the third plug 7 is not limited to the above, and examples thereof include butyl rubber.
　図１２に示す状態において、上記構成の第３栓体７により、容器体１の第１空間Ｓ１は外部と連通しない。その一方、例えば第３栓体７に穿刺針を刺すことで、容器体１の第１空間Ｓ１は外部と連通可能である。上記の第３栓体７は、「第１切換部」の一例である。 In the state shown in FIG. 12, the first space S1 of the container body 1 does not communicate with the outside due to the third plug body 7 configured as described above. On the other hand, for example, by piercing the third plug 7 with a puncture needle, the first space S1 of the container body 1 can communicate with the outside. The third plug 7 described above is an example of the "first switching part".
　本実施形態の液体採取容器Ａ２においては、図１３に示すように、容器体１の第１空間Ｓ１には比重液８０、ゲル状剤８１および血液抗凝固剤８２が収容されている。また、第１空間Ｓ１は、減圧状態である。比重液８０、ゲル状剤８１および血液抗凝固剤８２は、上記第１実施形態の液体採取容器Ａ１において図３を参照して説明したのと同様である。また、本実施形態の液体採取容器Ａ２は、上記第１実施形態の液体採取容器Ａ１と同様の製造方法によって製造することができる。 In the liquid collection container A2 of the present embodiment, as shown in FIG. 13, the first space S1 of the container body 1 contains a specific gravity liquid 80, a gelling agent 81 and a blood anticoagulant 82. Also, the first space S1 is in a decompressed state. The specific gravity liquid 80, the gelling agent 81 and the blood anticoagulant 82 are the same as those described with reference to FIG. 3 for the liquid collection container A1 of the first embodiment. Further, the liquid-sampling container A2 of this embodiment can be manufactured by the same manufacturing method as that of the liquid-sampling container A1 of the first embodiment.
　液体採取容器Ａ２においては、容器体１の筒状部１１には、ガスケット２が内嵌されている。ガスケット２は、筒状部１１の内周面に対して周方向に隙間なく密着することで、容器体１の内側空間Ｓを第１方向一方側ｘ１の第１空間Ｓ１および第１方向他方側ｘ２の第２空間Ｓ２に区画している。容器体１の第１方向一方側ｘ１端には、第３栓体７（第１切換部）が配置されており、容器体１の第１方向他方側ｘ２には封止体６（第２切換部）が配置されている。第３栓体７は、第１空間Ｓ１が外部と連通する状態と、第１空間Ｓ１が外部と連通しない状態とに切換え可能である。封止体６は、第２空間Ｓ２が外部と連通する状態と、第２空間Ｓ２が外部と連通しない状態とに切換え可能である。第１空間Ｓ１は、減圧状態とされている（図１３参照）。 In the liquid collection container A2, the gasket 2 is fitted inside the cylindrical portion 11 of the container body 1. The gasket 2 is in close contact with the inner peripheral surface of the cylindrical portion 11 in the circumferential direction without gaps, thereby dividing the inner space S of the container body 1 into a first space S1 on one side x1 in the first direction and a first space S1 on the other side in the first direction. It is partitioned into a second space S2 of x2. A third plug 7 (first switching portion) is arranged at the end of the container body 1 on one side x1 in the first direction, and a sealing body 6 (second switching part) is arranged. The third plug 7 can be switched between a state in which the first space S1 communicates with the outside and a state in which the first space S1 does not communicate with the outside. The sealing body 6 can be switched between a state in which the second space S2 communicates with the outside and a state in which the second space S2 does not communicate with the outside. The first space S1 is in a decompressed state (see FIG. 13).
　このような構成によれば、例えば第３栓体７に穿刺針を突き刺すことで、身体（外部）から直接血液（液体）を第１空間Ｓ１に流入させることができる。第１空間Ｓ１の血液成分を分離した後においては、例えば第１空間Ｓ１を外部の吸引装置と連通させ、且つ第２空間Ｓ２を外部と連通する状態とする。これにより、ガスケット２は圧力抵抗を受けることなくスムーズに第１方向一方側ｘ１に摺動し、第１空間Ｓ１にある必要成分を液体採取容器Ａ２とは別の容器に吸引移動させることができる。したがって、本実施形態によれば、第１空間Ｓ１にある必要成分を別の容器に移す場合においても、容器体１を開放することなく閉鎖状態で取り出すことが可能である。 With such a configuration, for example, by piercing the third plug 7 with a puncture needle, blood (liquid) can flow directly from the body (outside) into the first space S1. After separating the blood components in the first space S1, for example, the first space S1 is brought into communication with an external suction device, and the second space S2 is brought into communication with the outside. As a result, the gasket 2 smoothly slides in the first direction one side x1 without receiving pressure resistance, and the necessary component in the first space S1 can be sucked and moved to a container other than the liquid collection container A2. . Therefore, according to this embodiment, even when the necessary components in the first space S1 are transferred to another container, it is possible to take them out in a closed state without opening the container body 1 .
　本実施形態において、容器体１の第１空間Ｓ１には、ゲル状剤８１および血液抗凝固剤８２が収容されている。これにより、容器体１に採取した血液中の単核球８５（必要成分）を、遠心分離により他の成分から分離して回収することができる。 In this embodiment, the first space S1 of the container body 1 contains a gelling agent 81 and a blood anticoagulant 82 . As a result, the mononuclear cells 85 (required components) in the blood collected in the container body 1 can be separated from other components by centrifugation and recovered.
　以上、本開示の具体的な実施形態を説明したが、本開示にかかる液体採取容器は、上記実施形態に限定されるものではない。本開示の液体採取容器の各部の具体的な構成は、種々に設計変更自在である。 Although specific embodiments of the present disclosure have been described above, the liquid collection container according to the present disclosure is not limited to the above embodiments. The specific configuration of each part of the liquid collection container of the present disclosure can be modified in various ways.
　上記実施形態において、第２切換部が封止体６により構成される場合について説明したが、本開示はこれに限定されない。第２切換部は、例えば容器体の第１方向の他方側端に接続された筒状部材と、この筒状部材の内部流量を開閉切換え可能な開閉弁と、を備えた構成であってもよい。また、第２切換部にベントフィルターを設けて、第２空間と外部とが連通する際に流入する外気による汚染を防ぐ構成であってもよい。 Although the case where the second switching portion is configured by the sealing body 6 has been described in the above embodiment, the present disclosure is not limited to this. For example, the second switching unit may have a configuration including a tubular member connected to the other end of the container body in the first direction, and an on-off valve capable of switching the internal flow rate of the tubular member. good. Further, a configuration may be adopted in which a vent filter is provided in the second switching portion to prevent contamination by outside air flowing in when the second space communicates with the outside.
　本開示の液体採取容器の使用用途は特に限定されず、血液から単核球を分離採取する用途以外に使用してもよく、例えば血漿、ＰＲＰ（多血小板血漿）の分離採取などにも好適である。容器体の内部に採取する液体についても血液に限定されない。 The application of the liquid collection container of the present disclosure is not particularly limited, and it may be used for applications other than the application of separating and collecting mononuclear cells from blood. be. The liquid to be collected inside the container body is not limited to blood either.
　Ａ１，Ａ２：液体採取容器、１：容器体、１１：筒状部、１１１：開口部、１２：底壁部、１３：先端筒部、１３１：孔、２：ガスケット、３：第１栓体（第１切換部）、３１：連通孔、３２：凸状筒部、４：第２栓体（第１切換部）、４１：支持部、４２：第１弾性部、５：流路チューブ（第１切換部）、５１：第１端部、５２：第２端部、５３：シール部、６：封止体（第２切換部）、６１：シール部、６２：開口、７：第３栓体（第１切換部）、８０：比重液、８１：ゲル状剤、８２：血液抗凝固剤、８３：血液、８４：赤血球、８５：単核球、８６：血漿、９Ａ：採血具、９Ｂ：回収容器、９１：穿刺針、９３：ポート、９４：排出ポート、９５：フィルター、９６：チューブ、９６１：シール部、Ｐ：ポンプ、Ｓ：内側空間、Ｓ１：第１空間、Ｓ２：第２空間、ｘ：第１方向、ｘ１：第１方向一方側、ｘ２：第１方向他方側 A1, A2: liquid collection container, 1: container body, 11: tubular portion, 111: opening, 12: bottom wall portion, 13: tip tubular portion, 131: hole, 2: gasket, 3: first stopper (first switching portion), 31: communication hole, 32: convex cylindrical portion, 4: second plug (first switching portion), 41: support portion, 42: first elastic portion, 5: flow path tube ( 51: first end portion; 52: second end portion; 53: sealing portion; 6: sealing body (second switching portion); 61: sealing portion; Plug body (first switching unit), 80: Specific gravity liquid, 81: Gel agent, 82: Blood anticoagulant, 83: Blood, 84: Red blood cells, 85: Mononuclear cells, 86: Plasma, 9A: Blood collection tool, 9B: collection container, 91: puncture needle, 93: port, 94: discharge port, 95: filter, 96: tube, 961: sealing portion, P: pump, S: inner space, S1: first space, S2: second 2 spaces, x: first direction, x1: one side of first direction, x2: other side of first direction

Claims (6)

  1. 　第１方向に延びる筒状部を有する容器体と、
    　前記筒状部の内周面に対して周方向に隙間なく密着することで前記容器体の内側空間を第１空間および第２空間に区画し、且つ前記第１方向に摺動可能なガスケットと、
    　前記容器体における前記第１方向の一方側端に配置され、前記第１空間が外部と連通する状態と、前記第１空間が外部と連通しない状態とに切換え可能な第１切換部と、
    　前記容器体における前記第１方向の他方側端に配置され、前記第２空間が外部と連通する状態と、前記第２空間が外部と連通しない状態とに切換え可能な第２切換部と、を備え、
    　前記第１空間は、減圧状態である、液体採取容器。     a container body having a tubular portion extending in a first direction;
    and a gasket that divides the inner space of the container body into a first space and a second space by closely adhering to the inner peripheral surface of the tubular portion in the circumferential direction without gaps, and is slidable in the first direction. ,
    a first switching portion disposed at one end of the container body in the first direction and capable of switching between a state in which the first space communicates with the outside and a state in which the first space does not communicate with the outside;
    a second switching part disposed at the other end of the container body in the first direction and capable of switching between a state in which the second space communicates with the outside and a state in which the second space does not communicate with the outside; prepared,
    The liquid collection container, wherein the first space is in a decompressed state.
  2. 　前記第１切換部は、第１栓体、第２栓体および流路チューブを含み、
    　前記第１栓体は、前記筒状部における前記第１方向の一方側端の開口部を塞いでおり、且つ前記第１方向に貫通する連通孔を有し、
    　前記第２栓体は、ガス非透過性、且つ液密性を有する第１弾性部を備え、
    　前記流路チューブは、前記連通孔に通じる状態で前記第１栓体に接続された第１端部と、前記第１弾性部で閉鎖された第２端部と、を有する、請求項１に記載の液体採取容器。     The first switching unit includes a first plug, a second plug and a flow path tube,
    The first plug closes an opening on one side of the cylindrical portion in the first direction and has a communication hole penetrating in the first direction,
    The second plug has a gas-impermeable and liquid-tight first elastic portion,
    2. The flow tube according to claim 1, wherein the channel tube has a first end connected to the first plug body in a state of communicating with the communication hole, and a second end closed by the first elastic portion. A liquid collection container as described.
  3. 　前記第１切換部は、前記筒状部における前記第１方向の一方側端の開口部を塞ぐ第３栓体を含み、
    　前記第３栓体は、ガス非透過性、且つ液密性を有し、
    　前記第３栓体へ穿刺針を刺すことで、前記第１空間と外部とが連通可能である、請求項１に記載の液体採取容器。     The first switching part includes a third plug that closes an opening on one side of the tubular part in the first direction,
    the third plug is gas-impermeable and liquid-tight;
    2. The liquid-collecting container according to claim 1, wherein said first space can communicate with the outside by piercing said third plug with a puncture needle.
  4. 　前記容器体は、前記筒状部における前記第１方向の他方側端を塞ぐ底壁部と、前記底壁部につながり、且つ前記第１方向に貫通する孔を有する先端筒部と、を有し、
    　前記第２切換部は、前記先端筒部に取り付けられた封止体を含み、
    　前記封止体を開放することで、前記第２空間と外部とが連通可能である、請求項１ないし３のいずれかに記載の液体採取容器。     The container body has a bottom wall portion that closes the other end of the cylindrical portion in the first direction, and a distal end cylindrical portion that is connected to the bottom wall portion and has a hole penetrating in the first direction. death,
    The second switching section includes a sealing body attached to the tip tube section,
    4. The liquid-sampling container according to any one of claims 1 to 3, wherein the second space can communicate with the outside by opening the sealing body.
  5. 　前記容器体の前記第１空間には、ゲル状剤および血液抗凝固剤が収容されている、請求項１ないし４のいずれかに記載の液体採取容器。 The liquid collection container according to any one of claims 1 to 4, wherein the first space of the container body contains a gelling agent and a blood anticoagulant.
  6. 　請求項１ないし５のいずれかに記載の液体採取容器の製造方法であって、
    　前記第１空間が外部と連通しない状態で、前記容器体における前記第１方向の他方側端に吸引手段を連通させ、当該吸引手段により前記ガスケットを前記第１方向の他方側に吸引移動させる工程と、
    　前記容器体における前記第１方向の他方端を閉塞し、前記ガスケットを吸引移動した位置に留めて前記第１空間の減圧維持を行う工程と、を含む、液体採取容器の製造方法。     A method for manufacturing a liquid-sampling container according to any one of claims 1 to 5,
    A step of connecting a suction means to the other side end of the container body in the first direction in a state where the first space does not communicate with the outside, and sucking and moving the gasket to the other side in the first direction by the suction means. and,
    a step of closing the other end of the container body in the first direction and keeping the gasket at the suction-moved position to keep the first space under reduced pressure.
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JPS4849888U (en) * 1971-10-09 1973-06-29
JPS4853595A (en) * 1971-11-05 1973-07-27
JP2007006973A (en) * 2005-06-28 2007-01-18 Sekisui Chem Co Ltd Blood sampling and separating apparatus
JP2013132240A (en) * 2011-12-26 2013-07-08 Otsuka Pharmaceut Factory Inc Cell separation device and centrifugal separation method
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