WO2020004174A1 - Récipient de collecte de sang - Google Patents

Récipient de collecte de sang Download PDF

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Publication number
WO2020004174A1
WO2020004174A1 PCT/JP2019/024292 JP2019024292W WO2020004174A1 WO 2020004174 A1 WO2020004174 A1 WO 2020004174A1 JP 2019024292 W JP2019024292 W JP 2019024292W WO 2020004174 A1 WO2020004174 A1 WO 2020004174A1
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WO
WIPO (PCT)
Prior art keywords
blood collection
collection container
main body
blood
thickness
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2019/024292
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English (en)
Japanese (ja)
Inventor
雅敏 丹生谷
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Tokuyama Sekisui Co Ltd
Sekisui Medical Co Ltd
Original Assignee
Tokuyama Sekisui Co Ltd
Sekisui Medical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Tokuyama Sekisui Co Ltd, Sekisui Medical Co Ltd filed Critical Tokuyama Sekisui Co Ltd
Priority to JP2020527440A priority Critical patent/JP7244162B2/ja
Priority to CN201980037695.1A priority patent/CN112219118B/zh
Publication of WO2020004174A1 publication Critical patent/WO2020004174A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61B5/154—Devices using pre-evacuated means
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers

Definitions

  • the present invention relates to a blood collection container.
  • Blood collection containers such as blood collection tubes are widely used for collecting blood in clinical tests.
  • serum or plasma separation composition is housed, serum or plasma can be separated from the collected blood (whole blood).
  • Patent Document 1 listed below discloses a tube body having an opened first end, a sheet joined to the first end of the tube body to close the opening, and a tube body formed by elastic deformation. And a hemostatic valve openable in the longitudinal direction of the blood collection container.
  • the hemostasis valve is arranged in the tube body so as to partition the first end side and the side opposite to the longitudinal direction of the tube body.
  • the blood collection container after blood collection is centrifuged to separate serum or plasma from blood, and then placed in a low-temperature environment (eg, -20 ° C or lower) by placing dry ice or the like on the blood collection container. May be transported. In this case, freezing starts from a blood-derived sample such as serum or plasma located above the blood collection container due to the influence of dry ice or the like.
  • a low-temperature environment eg, -20 ° C or lower
  • An object of the present invention is to provide a blood collection container that can prevent cracks or cracks in the bottom portion even when the blood collection container after blood collection is exposed to a low-temperature environment.
  • the blood collection container main body having an open end, a side surface, and a bottom surface, and a plug inserted into the open end, wherein the bottom surface portion with respect to the average thickness of the side surface portion
  • a blood collection container wherein the ratio of the thickness of the tip is 1.25 or more and 1.75 or less, and the material of the blood collection container main body contains polyethylene terephthalate having an intrinsic viscosity of 0.75 dL / g or more and 0.79 dL / g or less.
  • the thickness of the tip of the bottom portion is 1.25 mm or more and 1.75 mm or less.
  • the blood collection container includes a serum or plasma separation composition, and the serum or plasma separation composition is contained in the blood collection container main body.
  • the blood collection container includes a clot release agent, and the clot release agent is attached to an inner wall surface of the blood collection container main body.
  • a blood collection container includes a blood collection container main body having an open end, a side surface, and a bottom surface, and a plug inserted into the open end.
  • the ratio of the thickness of the tip of the bottom portion to the average thickness of the side portion is 1.25 or more and 1.75 or less.
  • the material of the blood collection container main body includes polyethylene terephthalate having an intrinsic viscosity of 0.75 dL / g or more and 0.79 dL / g or less.
  • FIG. 1 is a front sectional view of a blood collection container main body according to one embodiment of the present invention.
  • 2A and 2B are a front view and a front sectional view of a plug according to an embodiment of the present invention.
  • FIG. 3 is a front sectional view of the blood collection container according to one embodiment of the present invention.
  • a blood collection container includes a blood collection container main body having an open end, a side surface, and a bottom surface, and a plug inserted into the open end.
  • the ratio of the thickness of the tip of the bottom portion to the average thickness of the side portion is 1.25 or more and 1.75 or less.
  • the material of the blood collection container main body includes polyethylene terephthalate having an intrinsic viscosity of 0.75 dL / g or more and 0.79 dL / g or less.
  • the blood collection container according to the present invention since the above-described configuration is provided, even if the blood collection container after blood collection is exposed to a low-temperature environment, it is possible to prevent cracks or cracks in the bottom portion.
  • the bottom surface of the blood collection container main body has a rounded shape.
  • the outer shape of the bottom surface of the blood collection container has an arc shape or an elliptical arc shape when the blood collection container body is viewed from the front.
  • a resin having a low intrinsic viscosity for example, polyethylene terephthalate having an intrinsic viscosity of about 0.6 dL / g
  • the thickness of the side surface portion and the thickness of the bottom surface portion of the blood collection container main body are substantially the same. For this reason, in the conventional blood collection container, the strength of the bottom portion of the blood collection container main body is low, and the bottom surface portion may be cracked or cracked due to freezing and expansion of the blood-derived sample.
  • the material of the blood collection container main body a material containing polyethylene terephthalate having a specific intrinsic viscosity is used, and since the blood collection container main body has a specific shape, the bottom surface is The strength of the part can be increased. Therefore, even if the blood collection container is exposed to a low-temperature environment (eg, -20 ° C or lower) by placing dry ice or the like on top of the blood collection container centrifuged to separate serum or plasma from blood, Cracks or cracks in the part can be prevented.
  • a low-temperature environment eg, -20 ° C or lower
  • the thickness of the bottom surface portion is not changed by increasing the thickness of the entire blood collection container main body (the thickness of the side surface portion and the thickness of the bottom surface portion). It is relatively large compared to. Therefore, the blood collection container can be used for a commonly used transfer device of an automatic analyzer, and the manufacturing cost can be reduced as compared with a blood collection container in which the entire thickness of the blood collection container body is increased.
  • FIG. 1 is a front sectional view of a blood collection container main body according to one embodiment of the present invention.
  • the blood collection container main body 1 has an open end 1a, a side surface 1b, and a bottom surface 1c. One end of the blood collection container main body 1 is open, and the other end opposite to the one end is closed. The side surface portion 1b and the bottom surface portion 1c are continuous.
  • the blood collection container main body 1 has an open end 1a at one end and a tip 11c of the bottom surface 1c at the other end.
  • the bottom surface 1c has a roundness.
  • the outer shape of the bottom surface portion 1c has an arc shape or an elliptical arc shape when the blood collection container main body 1 is viewed from the front.
  • the outer shape of the side surface portion 1b is not an arc shape or an elliptical arc shape when the blood collection container main body 1 is viewed from the front.
  • the ratio of the thickness of the tip 11c of the bottom portion 1c to the average thickness of the side portion 1b of the blood collection container body 1 (the thickness of the tip 11c of the bottom portion 1c / the average thickness of the side portion 1b) is 1.25 or more and 1.75 or less. is there. If the ratio (thickness of the tip 11c of the bottom portion 1c / average thickness of the side portion 1b) is less than 1.25, the strength of the bottom portion may be poor, and the blood collection container after blood collection is exposed to a low-temperature environment. In this case, cracks or cracks may occur in the bottom surface. If the above ratio (the thickness of the tip 11c of the bottom portion 1c / the average thickness of the side portion 1b) exceeds 1.75, sink marks may occur during molding.
  • the ratio of the thickness of the tip 11c of the bottom portion 1c to the average thickness of the side portion 1b is preferably 1.3 or more, and preferably 1.6 or less. is there.
  • the above ratio thickness of the tip 11c of the bottom portion 1c / average thickness of the side portion 1b
  • the strength of the bottom portion can be further increased, and the blood collection container after blood collection is exposed to a low-temperature environment. In this case, cracks or cracks in the bottom surface can be more effectively prevented.
  • the ratio (the thickness of the tip 11c of the bottom portion 1c / the average thickness of the side portion 1b) is equal to or less than the upper limit, molding defects can be reduced.
  • the average thickness of the side portion is obtained by calculating the thickness of the side portion at five or more points selected at intervals of 10 mm from a position lowered 10 mm from the opening end of the blood collection container main body toward the bottom portion, and averaging the thickness of each point.
  • the average thickness of the side surface portion 1b is preferably 0.8 mm or more, more preferably 0.9 mm or more, preferably 1.5 mm or less, and more preferably 1.3 mm or less.
  • the strength of the blood collection container main body can be further increased.
  • the thickness of the tip 11c of the bottom portion 1c is preferably 1.25 mm or more, more preferably 1.3 mm or more, preferably 1.75 mm or less, and more preferably 1.6 mm or less.
  • the thickness of the tip 11c of the bottom portion 1c is equal to or greater than the lower limit and equal to or less than the upper limit, the strength of the bottom portion can be further increased, and even when the blood collection container after blood collection is exposed to a low-temperature environment, the bottom portion can be reduced. Cracks or cracks can be more effectively prevented.
  • the side surface portion 1b may be inclined inward from the opening end side to the bottom surface side, or may not be inclined.
  • the material of the blood collection container main body 1 includes polyethylene terephthalate having an intrinsic viscosity of 0.75 dL / g or more and 0.79 dL / g or less. If the intrinsic viscosity is less than 0.75 dL / g or more than 0.79 dL / g, the blood collection container main body is inferior in moldability, and a bottom part having a specific shape may not be formed. In addition, as the material of the blood collection container main body 1, only one kind may be used, or two or more kinds may be used in combination.
  • the intrinsic viscosity of the polyethylene terephthalate is preferably 0.76 dL / g or more, more preferably 0.78 dL / g or less.
  • the moldability can be further improved, and the bottom portion can be formed more favorably.
  • the intrinsic viscosity is determined in accordance with JIS K7390: 2003.
  • the material of the blood collection container main body 1 may include, for example, polyester other than polyethylene terephthalate having the intrinsic viscosity of 0.75 dL / g or more and 0.79 dL / g or less.
  • the content of polyethylene terephthalate whose intrinsic viscosity is 0.75 dL / g or more and 0.79 dL / g or less in 100% by weight of the material of the blood collection container main body is preferably 85% by weight or more, more preferably 90% by weight or more, It is more preferably at least 95% by weight, particularly preferably at least 99% by weight, most preferably 100% by weight (total amount). Therefore, it is most preferable that the material of the blood collection container main body is polyethylene terephthalate having the intrinsic viscosity of 0.75 dL / g or more and 0.79 dL / g or less.
  • FIG. 2A is a front view of the plug according to the embodiment of the present invention.
  • FIG. 2B is a front sectional view of the plug according to the embodiment of the present invention.
  • the plug 2 includes a cap member 21 and a plug main body 22.
  • the cap member 21 is provided so as to cover the outer surface of the plug body 22.
  • the outer surface of the plug body 22 and the inner surface of the cap member 21 are in contact.
  • the cap member 21 has a plurality of ribs 21a protruding radially outward of the cap member.
  • the cap member may or may not include the rib.
  • the member comprises a rib.
  • the plug body 22 has a large diameter portion on the upper end side and a small diameter portion on the lower end side.
  • the plug main body 22 has a step formed by the large diameter portion and the small diameter portion.
  • the material of the plug body 22 is preferably an elastomer. As the material of the plug body 22, only one kind may be used, or two or more kinds may be used in combination.
  • Examples of the elastomer include a thermosetting elastomer and a thermoplastic elastomer.
  • examples of the thermosetting elastomer include isoprene rubber, butyl rubber, butadiene rubber, and styrene-butadiene copolymer rubber.
  • examples of the thermoplastic elastomer include a styrene-based elastomer.
  • the plug body 22 is a rubber stopper.
  • the plug body 22 is preferably a rubber plug.
  • the stopper body is a rubber stopper, the stopper body can be deformed favorably, so that the stopper body can be effectively prevented from coming off from the cap member.
  • the maximum inner diameter of the cap member 21 is preferably 12 mm or more, more preferably 13 mm or more, preferably 18 mm or less, more preferably 17 mm or less. is there.
  • the length of the cap member 21 is preferably 11 mm or more, more preferably 15 mm or more, preferably 25 mm or less, and more preferably 20 mm or less.
  • FIG. 3 is a front sectional view of the blood collection container according to one embodiment of the present invention.
  • the blood collection container 4 includes the blood collection container main body 1 illustrated in FIG. 1, the stopper 2 illustrated in FIG. 2, and the serum or plasma separation composition 3.
  • the plug 2 is inserted into the open end 1 a of the blood collection container main body 1.
  • the small diameter portion of the stopper body 22 is inserted into the blood collection container body 1.
  • the step portion of the stopper body 22 is in contact with the upper end of the blood collection container body 1.
  • the serum or plasma separation composition 3 is contained in the blood collection container main body 1.
  • the blood collection container according to the present invention preferably includes a composition for separating serum or plasma.
  • the above composition for separating serum or plasma is used for separating serum or plasma from blood.
  • separating serum from blood blood is collected inside a blood collection container containing a serum or plasma separation composition, and then centrifuged by a centrifuge. By centrifugation, cellular components and blood coagulation components and the like in blood sediment downward (blood clot), and serum is separated into the supernatant.
  • the composition for separating serum or plasma is located in the intermediate layer, and forms a partition wall for separating the blood clot from the serum.
  • the serum or plasma separation composition a conventionally known serum or plasma separation composition can be used.
  • the composition for separating serum or plasma include the composition for separating serum or plasma described in WO2011 / 105151A1 and the like.
  • the blood collection container according to the present invention preferably includes a clot release agent.
  • the blood clot release agent is preferably attached to the inner wall surface of the blood collection container main body 1. Since the blood collection container 4 is provided with the above clot release agent, it is possible to prevent the blood clot from adhering to the inner wall surface of the blood collection container main body 1 after the blood has clotted, and to separate the blood clot and the serum well. can do.
  • clot release agent a conventionally known clot release agent can be used.
  • examples of the clot release agent include the clot release agents described in JP-A-2008-304207 and JP-B-5-10095.
  • the internal pressure of the blood collection container is not particularly limited.
  • the blood collection container may be a vacuum blood collection container (vacuum blood collection tube) whose inside is evacuated and sealed with the plug.
  • a vacuum blood collection container vacuum blood collection tube
  • a fixed amount of blood can be easily collected regardless of the skill of the blood collector.
  • the inside of the blood collection container is preferably sterilized according to the standards described in ISO and JIS.
  • the blood collection container contains a blood coagulation promoter such as silica and thrombin, and an anticoagulant such as heparin, ethylenediaminetetraacetic acid (EDTA) and citric acid, depending on the purpose of the blood coagulation promoter or blood anticoagulation.
  • a blood coagulation promoter such as silica and thrombin
  • an anticoagulant such as heparin, ethylenediaminetetraacetic acid (EDTA) and citric acid, depending on the purpose of the blood coagulation promoter or blood anticoagulation.
  • EDTA ethylenediaminetetraacetic acid
  • citric acid citric acid
  • the blood collection container main body can be manufactured by injecting the material of the blood collection container main body into a mold corresponding to the shape of the blood collection container main body and molding the same. If necessary, a clot release agent is attached to the inner wall surface of the obtained blood collection container main body, and the obtained blood collection container main body contains the serum or plasma separation composition, and the open end of the blood collection container main body A blood collection container can be prepared by inserting a plug into the blood collection container.
  • Step 1) Insert the tip of one end of the blood collection needle into a blood vessel.
  • Step 2) Insert the blood collection container into the blood collection holder so that the tip of the other end of the blood collection needle penetrates the plug of the blood collection container.
  • Step 3) Since the pressure inside the blood collection container is reduced, blood is sucked into the blood collection container via the blood collection needle.
  • Plug body rubber stopper (material: butyl rubber)
  • Cap member length 20 mm, maximum inner diameter 14 mm, material: polyethylene
  • composition for separating serum or plasma was prepared as follows.
  • a liquid resin component is prepared by dissolving a cyclopentadiene-based oligomer (manufactured by ExxonMobil, trade name: ESCOREZ5690) and trimellitic acid ester (manufactured by Dainippon Ink and Chemicals, trade name: Monosizer W700) at 130 ° C. did.
  • Polypropylene glycol manufactured by NOF CORPORATION, trade name: Uniol D700 was dissolved as a polyalkylene glycol in the liquid resin component, and cooled to about 30 ° C.
  • hydrophilic fine powder silica manufactured by Nippon Aerosil Co., Ltd., trade name: Aerosil 200CF
  • hydrophobic fine powder silica manufactured by Nippon Aerosil Co., Ltd., trade name: Aerosil R974
  • the mixing ratio of each component was 52.3% by weight of cyclopentadiene-based oligomer, 44.2% by weight of trimellitate, and 0.8% of polypropylene glycol based on 100% by weight of the obtained composition for separating serum or plasma.
  • a clot release agent containing silica (coagulation accelerator) was prepared as follows.
  • Carbinol-modified silicone oil in which hydroxyl groups have been introduced into polydimethylsiloxane in methyl alcohol, polyvinylpyrrolidone, and finely divided silica (average particle size: 40 ⁇ m, linseed oil oil absorption: 30 ml / 100 g, BET specific surface area: 12,000 cm 2 / g, ratio Resistance value 26 ⁇ ⁇ cm).
  • a clot release agent containing silica was prepared.
  • the mixing ratio of each component was 0.1% by weight of carbinol-modified silicone oil, 0.1% by weight of polyvinylpyrrolidone, and 1% by weight of fine powdered silica based on 100% by weight of the obtained clot release agent containing silica. 0% by weight.
  • Example 1 Preparation of the blood collection container body: Polyethylene terephthalate having an intrinsic viscosity of 0.77 dL / g was prepared as a material for the blood collection container body. The polyethylene terephthalate was poured into a mold and molded at a heating temperature of 300 ° C. to produce a blood collection container main body having the shape shown in FIG. The dimensions of the obtained blood collection container main body are shown below. The intrinsic viscosity of polyethylene terephthalate was determined in accordance with JIS K7390: 2003.
  • the average thickness of the side portion is obtained by determining the thickness of the side portion at five or more points selected at intervals of 10 mm from a position 10 mm lower from the opening end of the blood collection container body toward the bottom portion, and averaging the thickness of each point. I asked for it.
  • the thickness of the portion other than the tip of the bottom portion is also thicker than the average thickness of the side portion.
  • Preparation of blood collection container The obtained clot release agent containing silica was sprayed on the inner wall surface of the blood collection container main body and air-dried. Next, 0.9 g of the obtained composition for separating serum or plasma was accommodated in a blood collection container main body, the pressure inside the blood collection container was reduced to 12 kPa, and the blood collection container was sealed with a stopper to prepare a blood collection container. In addition, ten blood collection containers were prepared.
  • Example 2 A blood collection container body and a blood collection container were produced in the same manner as in Example 1, except that the mold dimensions were changed and the thickness of the tip of the bottom portion of the blood collection container body was 1.5 mm.
  • Example 3 A blood collection container body and a blood collection container were produced in the same manner as in Example 1, except that the mold dimensions were changed and the thickness of the tip of the bottom portion of the blood collection container body was 1.75 mm.
  • Comparative Example 1 The procedure was performed except that polyethylene terephthalate having an intrinsic viscosity of 0.61 dL / g was used as the material of the blood collection container main body, the mold size was changed, and the thickness of the tip of the bottom portion of the blood collection container main body was set to 1.0 mm.
  • a blood collection container main body and a blood collection container were prepared.
  • the thickness of the portion other than the tip of the bottom portion is also the same as the average thickness of the side portion.
  • this blood collection container was set up in a test tube stand so that the bottom surface of the blood collection container body faced downward, and dry ice was placed on the upper end (plug) of the blood collection container, and stored in a styrofoam box. It was allowed to stand for 24 hours with the temperature inside the styrofoam box kept at -40 ° C or lower.
  • the blood collection container After standing, the blood collection container was left at room temperature and thawed. Thereafter, the bottom of the blood collection container body was visually observed. The number of cracks or cracks on the bottom surface of the 10 blood collection containers was determined.
  • Table 1 below shows the structure and results of the blood collection container.
  • the blood collection container body 1a Open end 1b ... side surface 1c ... Bottom part 2 ... stopper 3.
  • Composition for separating serum or plasma 4 Blood collection container 11c ... tip 21 ... Cap member 21a ... rib 22 ... stopper body

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Abstract

L'objectif de la présente invention est de fournir un récipient de collecte de sang permettant d'empêcher une partie inférieure de se fissurer ou de se rompre même lorsque le récipient de collecte de sang est exposé à un environnement à basse température après la collecte de sang. L'invention concerne un récipient de collecte de sang qui comprend un corps de récipient de collecte de sang possédant une extrémité ouverte, une partie latérale et une partie inférieure, et un corps de bouchon inséré dans l'extrémité ouverte, le rapport de l'épaisseur de l'extrémité distale de la partie inférieure à l'épaisseur moyenne de la partie latérale étant de 1,25 à 1,75, et le matériau du corps de récipient de collecte de sang comprenant du polyéthylène téréphtalate présentant une viscosité intrinsèque de 0,75 à 0,79 dL/g.
PCT/JP2019/024292 2018-06-26 2019-06-19 Récipient de collecte de sang Ceased WO2020004174A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2020527440A JP7244162B2 (ja) 2018-06-26 2019-06-19 採血容器
CN201980037695.1A CN112219118B (zh) 2018-06-26 2019-06-19 采血容器

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JP2018-120854 2018-06-26
JP2018120854 2018-06-26

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WO2020004174A1 true WO2020004174A1 (fr) 2020-01-02

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JPS5993330A (ja) * 1982-11-19 1984-05-29 Dainippon Ink & Chem Inc 熱可塑性ポリエステル製耐熱容器の成形法およびブロ−ユニツト
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JP7244162B2 (ja) 2023-03-22
JPWO2020004174A1 (ja) 2021-07-15
CN112219118A (zh) 2021-01-12

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