JP5915659B2 - Blood collection tube - Google Patents

Blood collection tube Download PDF

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JP5915659B2
JP5915659B2 JP2013534769A JP2013534769A JP5915659B2 JP 5915659 B2 JP5915659 B2 JP 5915659B2 JP 2013534769 A JP2013534769 A JP 2013534769A JP 2013534769 A JP2013534769 A JP 2013534769A JP 5915659 B2 JP5915659 B2 JP 5915659B2
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rubber
blood
blood collection
tube
collection tube
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JPWO2013042772A1 (en
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竜夫 海老原
竜夫 海老原
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Nipro Corp
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154—Devices using pre-evacuated means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/15003—Source of blood for venous or arterial 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
    • A61B5/150007—Details
    • A61B5/150351—Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150755—Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5021—Test tubes specially adapted for centrifugation purposes
    • B01L3/50215—Test tubes specially adapted for centrifugation purposes using a float to separate phases

Description

本発明は、採血管に関する。   The present invention relates to a blood collection tube.

近年、ＮＡＴ（ＰＣＲ）検査が普及し、エイズや肝炎の検査がなされている。ＮＡＴ（ＰＣＲ）検査は、ウイルスを構成する核酸を増幅・検出する検査である。ＮＡＴ（ＰＣＲ）検査は、従来の抗原・抗体検査と比較して、迅速な検査である。ＮＡＴ（ＰＣＲ）検査にあたっては、被験者の血液を市販の採血管に採血し、遠心分離をする。この際用いる採血管として、採取された血液への抗凝固剤の溶解性が改良された採血管が公知である（特許文献１参照）。   In recent years, NAT (PCR) testing has become widespread, and AIDS and hepatitis have been tested. The NAT (PCR) test is a test that amplifies and detects a nucleic acid constituting a virus. The NAT (PCR) test is a rapid test compared to the conventional antigen / antibody test. In the NAT (PCR) test, the blood of the subject is collected in a commercially available blood collection tube and centrifuged. As a blood collection tube used at this time, a blood collection tube in which the solubility of the anticoagulant in the collected blood is improved is known (see Patent Document 1).

ところで、採血管中の遠心分離された血液は、−２０℃以下に急速冷凍して保存される。しかしながら、この急速冷凍により市販の採血管が脆化し、さらに血液（主に血餅）が膨張する。このため、搬送時における振動等によって、採血管が破損しやすい。この破損により、感染症の検査に用いる血液が飛散するため非常に危険である。   By the way, the centrifuged blood in the blood collection tube is rapidly frozen and stored at -20 ° C or lower. However, this quick freezing causes a commercially available blood collection tube to become brittle, and blood (mainly blood clot) expands. For this reason, the blood collection tube is liable to be damaged due to vibration or the like during conveyance. This damage is very dangerous because blood used for infectious diseases is scattered.

特開２０００−１７６００６号公報JP 2000-176006 A

本発明は、主にＮＡＴ（ＰＣＲ）検査のために、分離・急速冷凍された血液を収容する管体の破損を防止することができる採血管を提供することを課題とする。   An object of the present invention is to provide a blood collection tube capable of preventing damage to a tubular body that contains separated and rapidly frozen blood mainly for NAT (PCR) inspection.

本発明者は、上記課題を解決するために鋭意検討した結果、採血管に血液分離剤よりも比重が大きい対寒性の弾性体からなる円筒状スリーブを収容することにより、当該スリーブが血液（主に血餅）の膨張を緩和させることによって、本発明を完成させた。   As a result of intensive studies to solve the above-mentioned problems, the present inventor has accommodated a cylindrical sleeve made of an elastic body against cold having a higher specific gravity than a blood separating agent in a blood collection tube, so that the sleeve is blood ( The present invention was completed mainly by relieving the expansion of blood clots).

本発明は、有底の管体と、前記管体の開口を閉鎖する蓋体とを備え、前記管体内部に血液分離剤が収容されてなり、かつ前記管体内部が減圧されてなる採血管であって、さらに前記管体内部に円筒状スリーブを収容してなり、前記円筒状スリーブは、その比重が前記血液分離剤よりも大きい耐寒性の弾性体を含む材料からなることを特徴とする採血管を提供する。   The present invention includes a bottomed tube body and a lid body that closes the opening of the tube body, the blood separating agent is accommodated in the tube body, and the inside of the tube body is decompressed. A blood vessel, further comprising a cylindrical sleeve housed inside the tubular body, wherein the cylindrical sleeve is made of a material including a cold-resistant elastic body having a specific gravity greater than that of the blood separating agent. Provide a blood collection tube.

１つの実施態様では、耐寒性の弾性体は、ニトリルゴム、シリコンゴム、フッ素ゴム、エチレンプロピレンゴム、クロロプレンゴム、ブチルゴム、ウレタンゴム、ポリ塩化ビニル系エラストマー、スチレン系エラストマー、シリコン系エラストマー、およびウレタンエラストマーからなる群より選択されるいずれか１である。   In one embodiment, the cold-resistant elastic body includes nitrile rubber, silicon rubber, fluorine rubber, ethylene propylene rubber, chloroprene rubber, butyl rubber, urethane rubber, polyvinyl chloride elastomer, styrene elastomer, silicon elastomer, and urethane. Any one selected from the group consisting of elastomers.

本発明によれば、主にＮＡＴ（ＰＣＲ）検査のために、分離・急速冷凍された血液を収容する採血管の破損を防止することができる。   According to the present invention, it is possible to prevent damage to a blood collection tube containing blood that has been separated and snap frozen, mainly for NAT (PCR) testing.

本発明の採血管の一実施例を示す説明図である。It is explanatory drawing which shows one Example of the blood collection tube of this invention.

１ 管体
２ 蓋体
３ 血液分離剤
４ 円筒状スリーブ1 Tube 2 Lid 3 Blood Separating Agent 4 Cylindrical Sleeve

以下、本発明の実施例について図面に基づいて説明する。図１は本発明の採血管の一実施例を示す説明図である。本発明の採血管は、有底の管体１と、前記管体の開口を閉鎖する蓋体２とを備え、かつ管体内部が減圧されてなる、いわゆる「真空採血管」または「減圧採血管」と称されるものである。本発明において、管体１および蓋体２の形状、材料等は限定されるものではない。例えば、採血管としては、蓋体２としてゴム栓を採用したタイプのもの（特許文献１、特開２０００−１７１４６２号公報、特開２００５−２９６１２２等参照）や、ゴムとラミネートシールを組み合わせたもの（特開平０６−１８９９４４号公報、特開平１１−３１８８６５号公報および特開２０００−０８３９３４号公報等参照）を採用したタイプのものが挙げられ、いずれも採用することができる。また、管体１の材料は、透明な樹脂を採用することができ、例えば、ポリプロピレン、ポリエチレンテレフタレート等のポリエステル、アクリル樹脂およびポリカーボーネート等を挙げることができるが、市販品は主にポリエチレンテレフタレートが主に用いられている。また、蓋体２の材料も、医療用に用いられるゴムおよびエラストマーを採用することができ、例えば、天然ゴム、イソプレンゴム、ブチルゴム、クロロプレンゴム、シリコンゴム、ブタジエンゴムまたはスチレン−ブタジエン−スチレンブロック共重合体（ＳＢＳ）エラストマー等が挙げられる。   Embodiments of the present invention will be described below with reference to the drawings. FIG. 1 is an explanatory view showing an embodiment of the blood collection tube of the present invention. The blood collection tube of the present invention comprises a so-called “vacuum blood collection tube” or “reduced-pressure collection” comprising a tube body 1 with a bottom and a lid body 2 that closes the opening of the tube body, and the inside of the tube body is decompressed. It is called “blood vessel”. In the present invention, the shapes and materials of the tube body 1 and the lid body 2 are not limited. For example, as a blood collection tube, a type using a rubber stopper as the lid 2 (see Patent Document 1, Japanese Patent Laid-Open No. 2000-171462, Japanese Patent Laid-Open No. 2005-296122, etc.), or a combination of rubber and a laminate seal (See JP-A-06-189944, JP-A-11-318865, JP-A-2000-083934, etc.), and any of them can be used. The material of the tube 1 can employ a transparent resin, and examples thereof include polyesters such as polypropylene and polyethylene terephthalate, acrylic resins, and polycarbonates, but commercially available products are mainly polyethylene terephthalate. Is mainly used. The lid 2 may be made of rubber or elastomer used for medical purposes, for example, natural rubber, isoprene rubber, butyl rubber, chloroprene rubber, silicon rubber, butadiene rubber, or styrene-butadiene-styrene block. A polymer (SBS) elastomer etc. are mentioned.

また、管体１内部に血液分離剤３が収容されてなる。本発明においては、血液分離剤３の材料等にも限定されるものではないが、例えば、シリコン、α−オレフィン−マレイン酸エステル、ポリエステル系重合体、アクリル系重合体、塩素化ポリブテン、シクロペンタジエン樹脂、およびシクロペンタジエン樹脂に水酸基、エステル基、エーテル基ならびにエポシキ基等を導入した変性シクロペンタジエン樹脂を主成分とするもの等が挙げられる。   Further, the blood separating agent 3 is accommodated in the tube body 1. In the present invention, the material of the blood separating agent 3 is not limited, but for example, silicon, α-olefin-maleic acid ester, polyester polymer, acrylic polymer, chlorinated polybutene, cyclopentadiene. Examples thereof include a resin, and a cyclopentadiene resin whose main component is a modified cyclopentadiene resin in which a hydroxyl group, an ester group, an ether group, an epoxy group or the like is introduced.

さらに、本発明の採血管は、管体１内部に抗凝固剤を収容してもよい。本発明においては、抗凝固剤の材料等に限定されるものではないが、例えば、抗凝固剤としては、エチレンジアミン四酢酸（ＥＤＴＡ）のアルカリ金属塩、ヘパリンのアルカリ金属塩、およびクエン酸ナトリウム等が挙げられる。   Furthermore, the blood collection tube of the present invention may contain an anticoagulant inside the tube 1. In the present invention, the anticoagulant is not limited to materials such as an anticoagulant, but examples of the anticoagulant include an alkali metal salt of ethylenediaminetetraacetic acid (EDTA), an alkali metal salt of heparin, and sodium citrate. Is mentioned.

本発明は、以上に説明した内容に加え、さらに採血管の管体１内部に円筒状スリーブ４を収容してなる。円筒状スリーブ４の形状は、少なくとも内腔を有する円筒形状であり、その内腔の方向が管体の長軸方向と略平行となるように、採血管の管体内部に収容できるものであればよい。円筒状スリーブ４の外径については、収容する管体の大きさに従って適宜設計することができる。また、円筒状スリーブ４の内腔の容積は、採血される血液、少なくとも当該血液を遠心分離して得た血餅を当該内腔に収容できる程度の大きさであればよく、例えば、１〜４０ｃｍ３、好ましくは５〜３０ｃｍ３程度である。円筒状スリーブ４の長軸方向の長さ（高さ）、外径、内径（肉厚）は、この内腔の容積と採血管の管体２の内径に応じて適宜決定される。In addition to the contents described above, the present invention further includes a cylindrical sleeve 4 housed inside the tube 1 of the blood collection tube. The cylindrical sleeve 4 has a cylindrical shape having at least a lumen, and can be accommodated inside the tube of the blood collection tube so that the direction of the lumen is substantially parallel to the long axis direction of the tube. That's fine. About the outer diameter of the cylindrical sleeve 4, it can design suitably according to the magnitude | size of the tubular body to accommodate. Further, the volume of the lumen of the cylindrical sleeve 4 may be large enough to accommodate the blood to be collected, at least the blood clot obtained by centrifuging the blood, in the lumen. It is about 40 cm 3 , preferably about 5 to 30 cm 3 . The length (height), outer diameter, and inner diameter (thickness) of the cylindrical sleeve 4 in the major axis direction are appropriately determined according to the volume of the lumen and the inner diameter of the tube 2 of the blood collection tube.

円筒状スリーブ４の材料は、耐寒性の弾性体を含む材料からなる。耐寒性の弾性体は、低温においても弾性体としての機能を維持できる材料であれば特に限定されるものではなく、その材料耐寒限界温度が−３０℃以下、好ましくは−４０℃以下、さらに好ましくは−５０℃以下のものをいう。このような耐寒性の弾性体としては、例えば、ニトリルゴム、シリコンゴム、フッ素ゴム、エチレンプロピレンゴム、クロロプレンゴム、ブチルゴム、ウレタンゴム、ポリ塩化ビニル系エラストマー、スチレン系エラストマー、シリコン系エラストマー、およびウレタンエラストマー等が挙げられる。円筒状スリーブ４の材料としてこれら耐寒性の弾性体を含む材料を選択することにより、急速冷凍時の血液（主に血餅）の膨張を緩和することができ、採血管の管体１の破損がしにくくなる。   The material of the cylindrical sleeve 4 is made of a material including a cold-resistant elastic body. The cold resistant elastic body is not particularly limited as long as it is a material that can maintain its function as an elastic body even at a low temperature, and the material cold resistance limit temperature is −30 ° C. or lower, preferably −40 ° C. or lower, and more preferably. Means -50 ° C or lower. Examples of such cold-resistant elastic bodies include nitrile rubber, silicon rubber, fluorine rubber, ethylene propylene rubber, chloroprene rubber, butyl rubber, urethane rubber, polyvinyl chloride elastomer, styrene elastomer, silicon elastomer, and urethane. An elastomer etc. are mentioned. By selecting a material containing these cold-resistant elastic bodies as the material of the cylindrical sleeve 4, the expansion of blood (mainly blood clot) at the time of quick freezing can be reduced, and the tube 1 of the blood collection tube is damaged. It becomes difficult to rub.

そして、本発明において、上記耐寒性の弾性体を含む材料は、その比重が血液分離剤３よりも大きいものである。これは、採血後の遠心分離において、円筒状スリーブ４が採血管の管体１の下方に移動することができるようにするためである。したがって、血液分離剤３の比重を考慮しながら、適切な比重の耐寒性の弾性体を選択することになる。血液文理剤３の比重は、一般には１．０４０〜１．０４５の範囲であるが、本発明は必ずもこの比重の値に限定されるものではない。なお、血液分離剤３の比重よりも低い比重を有する耐寒性の弾性体であったとしても、その耐寒性の弾性体の材料に炭酸カルシウムまたは酸化マグネシウム等を添加することにより、その材料としての比重を増加させることもできる。   In the present invention, the material containing the cold-resistant elastic body has a specific gravity greater than that of the blood separating agent 3. This is to allow the cylindrical sleeve 4 to move below the tube 1 of the blood collection tube during centrifugation after blood collection. Therefore, a cold-resistant elastic body having an appropriate specific gravity is selected in consideration of the specific gravity of the blood separating agent 3. The specific gravity of the blood writing agent 3 is generally in the range of 1.040 to 1.045, but the present invention is not necessarily limited to this specific gravity value. In addition, even if it is a cold-resistant elastic body having a specific gravity lower than that of blood separating agent 3, by adding calcium carbonate or magnesium oxide to the material of the cold-resistant elastic body, Specific gravity can also be increased.

本発明は、主にＮＡＴ（ＰＣＲ）検査用の採血管として採用され得る。   The present invention can be mainly employed as a blood collection tube for NAT (PCR) examination.

Claims (2)

有底の管体と、前記管体の開口を閉鎖する蓋体とを備え、前記管体内部に血液分離剤が収容されてなり、かつ前記管体内部が減圧されてなる採血管であって、さらに前記管体内部に円筒状スリーブを収容してなり、前記円筒状スリーブは、その比重が前記血液分離剤よりも大きい耐寒性の弾性体を含む材料からなることを特徴とする採血管。   A blood collection tube comprising a bottomed tube body and a lid for closing the opening of the tube body, wherein a blood separating agent is accommodated inside the tube body, and the inside of the tube body is decompressed. Furthermore, a cylindrical sleeve is accommodated inside the tubular body, and the cylindrical sleeve is made of a material including a cold-resistant elastic body whose specific gravity is larger than that of the blood separating agent. 前記耐寒性の弾性体が、ニトリルゴム、シリコンゴム、フッ素ゴム、エチレンプロピレンゴム、クロロプレンゴム、ブチルゴム、ウレタンゴム、ポリ塩化ビニル系エラストマー、スチレン系エラストマー、シリコン系エラストマー、およびウレタンエラストマーからなる群より選択されるいずれか１である、請求項１に記載の採血管。   The cold-resistant elastic body is a group consisting of nitrile rubber, silicon rubber, fluorine rubber, ethylene propylene rubber, chloroprene rubber, butyl rubber, urethane rubber, polyvinyl chloride elastomer, styrene elastomer, silicon elastomer, and urethane elastomer. The blood collection tube according to claim 1, which is any one selected.
JP2013534769A 2011-09-22 2012-09-21 Blood collection tube Active JP5915659B2 (en)

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JP3248501B2 (en) * 1998-12-07 2002-01-21 ニプロ株式会社 Blood coagulation tube with blood separation agent
JP3704982B2 (en) * 1998-12-17 2005-10-12 ニプロ株式会社 Nucleic acid amplification blood collection tube
US20080017577A1 (en) * 2006-07-21 2008-01-24 Becton, Dickinson And Company Membrane-based Double-layer Tube for Sample Collections
WO2008078808A1 (en) * 2006-12-27 2008-07-03 Medibic Vacuum blood collection tube
CN101353453B (en) * 2007-07-27 2012-10-10 中国铁道科学研究院金属及化学研究所 Chloroprene rubber composition having improved cold tolerance
CN201356558Y (en) * 2009-01-21 2009-12-09 威海鸿宇医疗器械有限公司 Hollow gel-filling vacuum blood taking tube
CN101602866B (en) * 2009-07-09 2011-09-14 四机赛瓦石油钻采设备有限公司 Cold-resistant rubber material suitable for preparing air sac and preparation method thereof
CN101724213A (en) * 2009-12-16 2010-06-09 天津鹏翎胶管股份有限公司 Formula of inner rubber layer of low-temperature resistant fuel oil rubber tube

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