JP2004223115A

JP2004223115A - Humor collecting device

Info

Publication number: JP2004223115A
Application number: JP2003016998A
Authority: JP
Inventors: Koichi Sonoda; 耕一園田; Hiroshi Yazaki; 宏史矢崎
Original assignee: Terumo Corp
Current assignee: Terumo Corp
Priority date: 2003-01-27
Filing date: 2003-01-27
Publication date: 2004-08-12
Anticipated expiration: 2023-01-27
Also published as: JP4138512B2

Abstract

<P>PROBLEM TO BE SOLVED: To provide a humor collecting device having a simple constitution which can feed a humor credibly and rapidly to a detecting part. <P>SOLUTION: The humor collecting device comprises a base, a groove-like humor supply channel formed on the base and having a humor inlet on one end, and a detecting member for detecting the ingredients of the humor. The humor collecting device is characterized by that the humor supply channel has a certain width and a height, the detecting member has a width wider than the width of the humor supply channel and covers at least part of the humor supply channel on the base, and the height of the part of the humor supply channel covered by the detecting member is smaller than the height of the other part of the humor supply channel. <P>COPYRIGHT: (C)2004,JPO&NCIPI

Description

【０００１】
【発明が属する技術分野】
本発明は、血液や尿、汗などの体液中の成分を測定するための体液採取具に関する。特に、検出部材を有し、毛管作用により体液を移送する送液路を有する体液採取具に関する。
【０００２】
【従来の技術】
従来、血液や尿、汗、皮膚からの滲出液を採取し、グルコース、コレステロール、ヘモグロビンなどの成分を簡易に測定する試験器具が多用されている。特に血液中のグルコース濃度を測定することは、糖尿病患者の状態をモニターするため重要であり、日常的な測定が求められている。
【０００３】
血糖測定は、グルコースに特異的に反応するグルコースオキシダーゼやグルコースデヒドロゲナーゼ等の酵素が用いられており、このグルコースの酵素反応生成物や反応生成物によりさらに生成されるものを、呈色反応として光学的に測定する方法や、電荷の移動として電気的に測定する方法により行われている。
【０００４】
このような測定は、多くの場合、測定機構を備えた成分測定装置と１回使い捨ての試験片により行われる。穿刺具により指、腕等を穿刺し、少量の出血を得、１回使用の使い捨て試験片に血液を点着することによって、試験片上の測定部に血液が到達する。成分測定装置は、光学的に測定する場合には、試験片上の測定部の位置に合わせて発光素子と受光素子が備えられており、また、電気的に測定する場合には、試験片に設けられた電気的な接点に接触する電気的は測定回路が備えられており、光学的あるいは電気的な測定値を血液中のグルコース濃度を算出するものが用いられている。
【０００５】
従って、成分測定を簡便確実に行うためには、試験片に点着した血液が速やかに測定部に到達することが必要であり、毛管作用を発現する細長い空間を有する支持体に試薬層を設け、細長い空間の端部に血液を点着し、試薬層を有する測定部まで毛管作用により血液を到達させるものが考案されている。（例えば、特許文献１を参照のこと）
しかしながら、毛管作用による上記の血液等の体液の移送は、大変不安定であり、表面状態の科学的、物理的な変化により、移送路の途中で血液の進入が止まってしまい、測定部まで到達しない場合がある。特に体液の流れる空間の断面形状が変化しているような個所や、試験具の本体材料と測定部分の試験紙材料が異なり、表面性状が変化しているような個所では、体液の滞留が起こり易い。
【０００６】
このような体液流路内で血液等の体液が滞留してしまうような不安定さを解決するため、様々な提案がなされている。例えば、体液流路内に体液の移送方向に沿って糸を設け、この糸に振動エネルギーを加えることにより体液の移動が円滑に行われるようにした試験具（例えば、特許文献２を参照のこと）や、体液流路の体液入口から測定部（検出部）まで体液流路が連続的に狭窄化することにより、体液入口から遠ざかるほど毛管作用が強くなるので上記滞留を防止することができるようにすることが提案されている（例えば、特許文献３参照のこと）、あるいは、２部材からなる体液流路部材表面をフォイルで覆うことによって、部材の境界で体液の進入が停止してしまうデバイス（例えば、特許文献４を参照のこと）などである。
【０００７】
しかしながら、体液の流路形状の変化と表面性状の変化が合わせて起こった場合など、体液の滞留が起こり易い状況を十分に改善する試験具は依然として求められている。
【０００８】
【特許文献１】
特開平８−２４７９４６号公報
【特許文献２】
特開平９−６１３１０号公報
【特許文献３】
特表２００１−５２６３９１公報
【特許文献４】
特表２００１−５２５５５３公報
【０００９】
【発明が解決しようとする課題】
本発明の目的は、体液をより確実かつ迅速に検出部へ移送することことができる簡便な構成の体液採取具を提供することにある。
【００１０】
【課題を解決するための手段】
このような目的は、下記の（１）〜（１１）の構成により達成される。
【００１１】
（１）基板、基板上に形成された一端に体液入口を有する溝状の体液送液路、および体液中の成分を検出する検出部材とを有する体液採取具において、該検出部材は該体液送液路の幅よりも広い幅を有し該基板上において該体液送液路の少なくとも一部を覆ってなり、該検出部材に覆われてなる部分の該体液送液路の高さが該体液送液路の他の部分の高さよりも低いことを特徴とする体液採取具。
【００１２】
（２）前記体液送液路の前記検出部材に覆われてなる部分において、前記基板上の該検出部材に対応する部分が凹部とされ、該検出部材が該凹部に嵌め込まれてなり、該体液送液路および該体液送液路を覆う検出部材がカバー材により覆われてなることを特徴とする上記（１）に記載の体液採取具。
【００１３】
（３）前記体液送液路に前記検出部材の端面部が露出してなることを特徴とする上記（１）または（２）に記載の体液採取具。
【００１４】
（４）前記検出部材は、検出部と固定部を有し、該検出部は体液中の成分を検出するための検出試薬を有し、該固定部は前記基板と該検出部材とを固定するものであり、該検出部と該基板との間に空間部を有し、前記体液送液路と該空間部が連続していることを特徴とする上記（１）ないし（３）に記載の体液採取具。
【００１５】
（５）前記空間部は幅と高さを有し、該空間部の幅が、前記体液送液路の幅よりも大きいことを特徴とする上記（１）ないし（４）に記載の体液採取具。
【００１６】
（６）前記基板または前記カバー材が通気孔を有し、前記空間部が前記体液送液路とは異なる開口より該通気孔に連通してなることを特徴とする上記（１）ないし（５）に記載の体液採取具。
【００１７】
（７）前記基板が、平板材、該平板材上に該体液送液路を形成するための送液路形成部材からなることを特徴とする上記（１）ないし（６）に記載の体液採取具。
【００１８】
（８）前記検出部材が体液の前記成分と反応して光学的測定可能な物質に変化する物質を含有する試験紙であって、前記検出部と前記固定部が同一材料であることを特徴とする上記（１）ないし（７）に記載の体液採取具。
【００１９】
（９）前記送液路形成部材が印刷により形成されてなることを特徴とする上記（６）ないし（８）に記載の体液採取具。
【００２０】
（１０）前記送液路形成部材が前記基板と一体に予め成形されてなることを特徴とする上記（７）または（８）に記載の体液採取具。
【００２１】
（１１）前記送液路形成部材が粘着テープにより形成されてなることを特徴とする上記（６）ないし（８）に記載の体液採取具。
【００２２】
【発明の実施の形態】
本発明の１実施形態について、図を用いて説明する。図１は本発明の１実施形態の平面図、図２は、図１中のＡ−Ａ’線断面図、図３は図１に示す体液採取具の分解図である。
【００２３】
図１〜図３に示す体液採取具１は、体液送液路７、空間部８、通気孔１０、凹部２０１および凹部２０２が形成された基板２１と第１カバー２３、および第２カバー２４と、凹部２０１、２０２の形状に適合した検出部材３からなり、該検出部材３は、基板２１の凹部２０１、２０２に嵌め込まれ、第１カバー２３と第２カバー２４により覆われている。
【００２４】
基板２１は、細長い平板状の形状をしており、成分測定装置への装着しやすく、また、体液採取具自体を持ち易くなっている。本実施形態においては、基板２１の長軸方向の一端から他端まで溝が形成されており、該溝の途中に該溝の幅より大きな幅を有する略円形状の空間部８が形成されている。該溝の一端である体液入口５１と開口部５２の間の溝により形成される体液送液路７は、第１カバー２３を積層することにより覆われ、さらに空間部８から該溝の他端までの部分は通気孔１０となっている。さらに、基板２１には、空間部８を含む凹部２０１が形成されている。また、開口部５２近傍には、凹部２０１よりも浅い凹部２０２が形成されている。
【００２５】
体液送液路７は、体液入口５１と開口部５２を有し、基板２１の長軸方向に平行にほぼ直線状に形成されている。体液入口５１は、基板２１の１端部に開口し、体液送液路７の多端である開口部５２は、検出部材３が嵌め込まれる空間部８、凹部２０１、凹部２０２に開口している。凹部２０１、２０２は、体液送液路７の幅よりも大きな幅を有する検出部材３の大きさと厚さに対応した幅と深さを有し、検出部材３が嵌め込まれ、体液送液路７の溝の高さ（深さ）と比べ、空間部８の空間の高さが低くされてなる。また、凹部２０２は、検出部材３の一部が嵌め込まれることにより、体液送液路７の開口部５２近傍の高さが体液送液路７の他の部分よりも低くされてなる。また、検出部材３の端部面３５が体液送液路７に露出している。体液送液路７は、体液入口５１に供給されら血液等の体液が、毛管作用により体液送液路７内に進入し、検出部材３まで運ばれるようにされている。
【００２６】
通気孔１０は、体液送液路７の開口部５２と異なる個所で、空間部８に開口している。本実施形態においては体液送液路７の延長上に溝状に形成されている。
【００２７】
検出部材３は、凹部２０１、２０２と適合する形状をしており、凹部２０１、２０２に嵌め込まれ、凹部２０２に嵌め込まれた検出部材３の上面の高さが、基板２１の上面の高さと略一致し、カバー２３を積層したときにカバー２３の基板２１側の面と基板２１のカバー２３側の面が前面に亘って密着するようにされている。検出部材３には、空間部８に面し、測定対象物質と反応する物質が配された検出部３１と凹部２０１，２０２に面する固定部３２、および体液送液路７に露出する端面部３５を有する。本実施形態では、光学的に測定する方法に用いられるものであって、グルコースオキシダーゼ、パーオキシダーゼおよび呈色試薬を含有する多孔質膜の空間部に対応する部分（図３の検出部材３において破線で示された円の内側部分）を検出部として用い、その他の周辺部分を固定部分として用いている。
【００２８】
カバー２３は、基板２１の幅と同一の幅と体液送液路７（検出部材３に覆われた開口部５２近傍を含む）を覆うために足りる長さを有する形状の平板部材で構成されている。基板２１に検出部材３が嵌め込まれたものに、カバー２３を積層し、体液送液路７を形成するとともに、開口部５２近傍において、検出部材３の固定部３２を基板２１との間に挟み込んでいる。また、カバー２４は凹部２０１に嵌め込まれた検出部材３を基板２１との間に挟み込んでいる。カバー２４は、検出部３１に対応する部分が切り取られた測定孔９を有しており、体液採取具１が図示しない成分測定装置に装着された時に、発光素子や受光素子を有する成分測定装置の測定機構部による検出部への発光素子による測定光の照射と受光素子による反射光の計測を可能としている。カバー２４は、検出部３１の汚れ、破損の防止、検出部材３の基板２１への固定という効果を有するが、無くてもよい。また、本実施形態では、カバー２３とカバー２４とを別に設けたが、連続した１枚の部材の一部に測定孔９が設けられてもよい。
【００２９】
基材２１、検出部材３およびカバー２３で形成される体液送液路７の開口部５２近傍において、凹部２０２を設けることにより、カバー２３の基板２１側面と基板２１のカバー２３側面を密着させることができる。カバー２３と基板２１の間に、検出部材３が挟み込まれて密着しない場合、体液送液路７の検出部材３の端部近傍においてカバー２３が基板２１から浮き上がり、体液送液路７の横断面積が拡大し、毛管作用が消失する可能性が高くなるので、検出部材３の固定部３２の端部面３５の全厚みが凹部２０２に嵌め込まれることが好ましい。また、検出部材３が多孔性膜等の多孔質基材の場合、カバー２３と基板２１を接合する際、該多孔質基材を圧縮することにより、カバー２３と基板２１を密着させることができる。検出部材３の固定部３２が硬質材料の場合には、端部面３５の厚みを圧縮することができないので、凹部２０２を設けることに大きな効果がある。
【００３０】
基板２１およびカバー２３、２４の構成材料としては、特に限定されないが、例えば、ＡＢＳ樹脂、ポリエチレン、ポリプロピレン、ポリスチレン、ポリ塩化ビニル、ポリ塩化ビニリデン樹脂、ポリフェニレンオキサイド、熱可塑性ポリウレタン、ポリメチルメタクリレート、ポリオキシエチレン、フッ素樹脂、ポリカーボネート、ポリアミド、ポリエチレンテレフタレート等の熱可塑性樹脂や、フェノール樹脂、エポキシ樹脂、シリコーン樹脂、不飽和ポリエステル樹脂等の熱硬化性樹脂等が挙げられる。さらに、アルミナ、ジルコニア等のセラミックス、ステンレス、アルミニウム、チタン等の金属を用いることもできる。
【００３１】
本実施形態の基板２１は体液送液路７等が形成されているが、これは、平板状の基材に溝や凹部を機械的な切削により形成する方法や射出成形により一体として作製することができる。また、平板上の基板に印刷や、両面テープなどにより、所定形状の材料を積層して送液路形成部材とし、体液送液路７、空間部８、凹部２０１、２０２、通気孔１０を形成することもできる。これらの製造方法に限定されないことは言うまでもない。
【００３２】
検出部材３は、検出部３１と固定部３２を異なる構成としてもよいし、同一の構成材料としてもよい。体液成分の検出を呈色試薬のによる発色の光学的な測定で行う場合には、検出部３１として呈色試薬を含有するシート状多孔質基材を用いることが多く、検出部材３を呈色試薬を含有するシート状多孔質基材で構成すると、簡単な構成で製造することができるので、検出部３１と固定部３２は同一の材料で構成することが好ましい。
【００３３】
検出部３は、血液中の所定成分を検出し得るものであり、例えば、血液を吸収可能なシート状多孔質基材に呈色試薬を担持してなるものがある。このシート状多孔質基材しては、多孔性膜、不織布、織布等が挙げられる。特に多孔性膜は、孔径や表面性状等の高い均一性が得られるので好ましい。また、該シート状多孔質基材は、少なくともその一面で赤血球の透過を阻止できるものが好ましい。該シート状多孔質基材の赤血球の透過を阻止する面から血液を吸収させ、該シート状多孔質基材の他面で該呈色試薬の呈色を測定することにより、赤血球による呈色測定の妨害を抑制することができるからである。
【００３４】
検出部３に用いられるシート状多孔質基材の構成材料としては、ポリエステル、ポリアミド、ポリオレフィン、ポリスルホンあるいはセルロース等の樹脂が挙げられるが、血液の良好な吸収を得るために、親水性を有する材料、または親水化処理されたものが好ましい。親水化方法としては、呈色反応に影響の少ない方法を採用することができ、例えば、プラズマ処理、グロー放電、コロナ放電、紫外線照射等の物理活性化処理のほか、界面活性剤、水溶性シリコン、ヒドロキシプロピルセルロース、ポリエチレングリコール、ポリプロピレングリコール等の被覆等により行うことができる。検出部３をこのようなシート状多孔質基材で構成する場合、固定部３２も同一材料で構成することが好ましい。また、検出部３を構成するシート状多孔質基材は単層のシートでもよく、複数枚のシートを積層した多層構成であってもよい。
【００３５】
呈色試薬としては、血糖値測定用の場合、グルコースオキシダーゼとパーオキシダーゼ等の酵素と、４−アミノアンチピリンとＮ−エチル−Ｎ−（２−ヒドロキシ−３−スルホプロピル）−ｍ−トルイジン等の発色剤との組合わせが挙げられる。その他、測定成分に応じて、例えばアスコルビン酸オキシダーゼ、アルコールオキシダーゼ、アルコールデヒドロゲナーゼ、ガラクトースオキシダーゼ、フルクトースデヒドロゲナーゼ、コレステロールデヒドロゲナーゼ、コレステロールオキシダーゼ、乳酸オキシダーゼ、乳酸デヒドロゲナーゼ、ビリルビンオキシダーゼ、キサンチンオキシダーゼ等の血液成分と反応する酵素と、前記の発色剤の他の発色剤との組み合わせも可能である。さらに、ｐＨを調節する緩衝剤を含ませることもできる。
【００３６】
検出部材３がグルコース濃度を電気的に測定するものである場合には、例えば、特開昭６０−１７３４４号公報や特開平２−２４５６５０号公報に記載の電極検出具が挙げられる。これらの電極検出具は、少なくとも二つの極を有し、電極上で血液成分と反応する前記酵素と、フェリシアン化カリウム、フェロセン等のメディエータとを組合わせた試薬と血液中の所定成分が反応することにより、メディエータを通じて電子が電極に移動し、電気的な測定が可能となる。このような場合には、検出部３１は前記電極および測定試薬により構成される。固定部３２は前記電極や試薬を支持する基材で構成することができる。
【００３７】
基板２１とカバー２３、２４、および基板２１と検出部材３との固着方法としては、例えば、熱融着、超音波融着、接着剤による接着、両面テープなどの粘着剤による粘着等が挙げられる。
【００３８】
体液送液路７は、体液採取具１の長軸方向端部に体液入口５１、検出部材３近傍に開口部５２を有し、体液入口５１から採取した血液は、毛管作用により開口部５２に向かって進入する。以下、体液送液路７の血液が進入する方向に垂直な方向での断面を「横断面」とする。体液送液路７の横断面積は、特に限定されないが、０．０５〜３０ｍｍ^２程度でることが好ましく、０．１〜１０ｍｍ^２程度であるのがより好ましい。体液送液路７の横断面積が小さすぎると、血液の供給速度が遅く、十分な量の血液を得るのに長時間を要し、一方、体液送液路７の横断面積が大きすぎると、毛管作用による血液の進入が困難となる。また、体液入口５１から開口部５２に向かって、体液送液路７の横断面積がしだいに小さくなっていてもよい。断面積が小さくなっていることにより、毛管作用が大きくなり、血液が進入するのに好ましい。
【００３９】
体液送液路７の横断面形状は、円形、Ｖ字形、方形など特に限定されないが、体液送液路７内に体液の残存量を少なくするために、薄型の方形が好ましい。この場合、好ましくは、その高さが０．０５〜０．５ｍｍ、好ましくは０．１〜０．３ｍｍであり、その幅が０．５〜３ｍｍ、好ましくは０．８〜２ｍｍである。体液送液路７の長さは、１〜２５ｍｍであるのが好ましく、５〜２０ｍｍであるのがより好ましい。また、体液送液路７の内面は、前記したような親水化処理を施されていることが好ましい。
【００４０】
体液送液路７の開口部５２近傍まで進入した血液は、体液送液路７に露出した検出部材３の端面部３５に接触する。端面部３５は、体液送液路７に露出し、親水性を有するものであるので、毛管作用を持続させることができる。開口部５２近傍では、進入した血液は、端面部３５に接触により材料の差異を乗り越えた後、体液送液路７よりも幅（体液送液路７の体液の流れ方向に垂直であって、前記検出部材面に平行な部分の長さ）の広がった空間部８に進入するので、材料の連続性により、毛管作用が消失することなく、血液の空間部８への進入を継続させることができる。
【００４１】
空間部８は、体液送液路７を進入してきた血液が進入し、同時に検出部３１と接触する。検出部３が多孔性基材である場合、血液は多孔性基材に吸収される一方空間部８に進入し、検出部３全面にほぼ均一に吸収される。また、検出部３が電極で有る場合には、空間部８に速やかに血液が満たされ、検出部３に接触する血液量が不足することがない。
【００４２】
この空間部８の容積は、特に限定されないが、０．１〜５μＬであるのが好ましく、０．５〜１μＬであるのがより好ましい。空間部８の容積が大きすぎると、必要以上の血液が採取され、患者の負担が大きくなる。また、空間部８の幅を体液送液路８の幅よりも大きくし、高さを低くすることにより、検出部３１を大きく設けることが可能となる。空間部８の最大幅は、特に限定されるものではないが、体液送液路７の開口部５２の幅の１〜１０倍が好ましく、１．５〜８倍がより好ましい。この幅の比が小さすぎると検知部が小さくなってしまい、測定精度が低下し、大きすぎると毛管作用が消失してしまう可能性がある。また、体液送液路７の最小断面積に対する空間部８の横断面の最大断面積の比は、特に限定されるものではないが、０．３〜２．０が好ましく、０．５〜１．２がより好ましい。
【００４３】
通気孔１０は、体液送液路７とは異なる個所で空間部８に連通し、体液送液路７に血液が進入する際、体液送液路７および空間部８の圧力を大気圧としている。これにより、血液の進入が内圧により阻害されることを防止することができる。
【００４４】
次に、本発明の体液採取具の第２の実施形態について説明する。図４は、本発明の体液採取具の第２の実施形態を示す平面図、図５は図４中Ｂ−Ｂ’線断面図、図６は図４の体液採取具に用いられるカバー２３１の平面図、図７は図６中Ｃ−Ｃ’線断面図、図８は図４の体液採取具に用いられる検出部材３の平面図、図９は図８中Ｄ−Ｄ’線断面図、図１０は図４の体液採取具に用いられる基板２２の平面図、図１１は図１０中Ｅ−Ｅ’線断面図である。
【００４５】
以下、第２の実施形態の体液採取具１０１について説明するが、前記第１の実施形態との相違点を中心に説明し、第１の実施形態と同様の事項については、説明を省略する。
【００４６】
本実施形態の基板２２は検出部材３０１が嵌め込まれる凹部２０３を有する。また、基板２２は平板材２１１の上に数回のシルクスクリーン印刷を行いインク樹脂層２２３、２２２、２２１を積層し、体液送液路７、空間部８、凹部２０３、通気孔１０を設けている。
【００４７】
本実施形態においても、体液送液路７の開口部５２近傍まで進入した血液は、体液送液路７に露出した検出部材３０１の端面部３５に接触する。端面部３５は、体液送液路７に露出し、毛管作用を持続させることができる。開口部近傍では、進入した血液は、端面部３５に接触により材料の差異を乗り越えた後、体液送液路７よりも幅（体液送液路７の体液の流れ方向に垂直であって、前記検出部材面に平行な部分の長さ）の広がった空間部８に進入するので、材料の連続性により、毛管作用が消失することなく、血液の空間部８への進入を継続させることができる。
【００４８】
次に、本発明の体液採取具の第３の実施形態について説明する。図１２は、本発明の体液採取具の第３の実施形態を示す平面図、図１３は、図１２中Ｆ−Ｆ’線断面図、図１４は図１２の体液採取具に用いられる基板２５の平面図、図１５は図１４中Ｇ−Ｇ線断面図である。
【００４９】
以下、第３の実施形態の体液採取具１０２について説明するが、前記第２の実施形態との相違点を中心に説明し、第１、第２の実施形態と同様の事項については、説明を省略する。
【００５０】
本実施形態の基板２５は、第２の実施形態の基板２２とほぼ同様の形状をしているが、検出部材３０２の通気孔１１側端部が、基板２５の端部２３０と一致しているので、基板２５の凹部２０４は、通気孔１１側端部まで切りかかれている。また、カバー２３２には測定孔を有していない。
【００５１】
本実施形態の検出部材３０２の検知部は、電気的に体液成分を測定する測定極９３、対極９４からなり、測定極９３の表面には測定試薬３２２が付着している。また、検出部材３２１の通気孔１１側端部９７は、カバー２３２から露出しており、二つの電気接続部９１，９２を有している。電気接続部９１、９２と測定極９３、対極９４は、それぞれ導電材料９５、９６により、それぞれ接続されている。これらの電極構成としては、例えば、前記の特開昭６０−１７３４４号公報や特開平２−２４５６５０号公報、およびその他の従来技術を用いることができる。
【００５２】
以上、本発明の体液採取具を各実施形態に基づいて説明したが、本発明はこれらに限定されるものではなく、例えば、各部の構成は、同様の機能を発揮し得る任意の構成のものに置換することができ、また、任意の他の構成を追加することもできる。
【００５３】
前記の各実施形態では、採取する体液として、血液を代表に説明したが、本発明では、採取する体液は、これらに限らず、例えば、尿、汗、リンパ液、唾液等であってもよい。また、測定の目的とする所定成分は、グルコースの他、例えば各種糖類、コレステロール、乳酸、クレアチニン、ヘモグロビン、各種蛋白質等であってもよい。
【００５４】
【発明の効果】
本発明の体液採取具は、基板、基板上に形成された一端に体液入口を有する溝状の体液送液路、および体液中の成分を検出する検出部材とを有する体液採取具において、該検出部材は該体液送液路の幅よりも広い幅を有し該基板上において該体液送液路の少なくとも一部を覆ってなり、該検出部材に覆われてなる部分の該体液送液路の高さが該体液送液路の他の部分の高さよりも低いことを特徴とするので、」体液送液路等における毛管作用による体液の移送が促進され、例えば体液移送路の表面性状が変化した場合でも体液をより確実にかつ迅速に検出部に移送することができ、また、簡便は構成で行うことができる。
また、前記体液送液路の前記検出部材に覆われてなる部分において、前記基板上の該検出部材に対応する部分が凹部とされ、該検出部材が該凹部に嵌め込まれてなり、該体液送液路および該体液送液路を覆う検出部材がカバー材により覆われてなるので、上記効果をさらに高めることができる。
【００５５】
また、本発明は、前記体液送液路に前記検出部材の端面部が露出してなるので、上記効果を高めることができる。
【００５６】
また、前記検出部材は、検出部と固定部を有し、該検出部は体液中の成分を検出するための検出試薬を有し、該固定部は前記基板と該検出部材とを固定するものであり、該検出部と該基板との間に空間部を有し、前記体液送液路と該空間部が連続しているので、体液が検出部に均一に接触すので、測定精度が向上する。
【００５７】
また、前記空間部は幅と高さを有し、該空間部の幅が、前記体液送液路の幅よりも大きいので、検出部が大きくなり、測定精度が向上する。
【００５８】
また、前記基板または前記カバー材が通気孔を有し、前記空間部が前記体液送液路とは異なる開口より該通気孔に連通してなるので、迅速に体液を採取することができる。
【００５９】
また、前記基板が、平板材、該平板材上に該体液送液路を形成するための送液路形成部材からなるので、体液採取具の組立てがさらに容易となる。
【００６０】
また、前記検出部材が体液の前記成分と反応して光学的測定可能な物質に変化する物質を含有する試験紙であって、前記検出部と前記固定部が同一材料であるので、体液採取具の組立てがさらに容易となる。
【００６１】
また、前記送液路形成部材が印刷により形成されてなるので、複雑な形状であっても作製が容易である。
【００６２】
また、前記送液路形成部材が前記基板と一体に予め成形されてなるので、大量生産が容易である。
【００６３】
また、前記送液路形成部材が粘着テープにより形成されてなるので、組み立ての際、他の接着剤を必要としないので、簡便に組立てることができる。
【図面の簡単な説明】
【図１】本発明の１実施形態の平面図である。
【図２】図１中のＡ−Ａ’線断面図である。
【図３】図１に示す体液採取具の分解図である。
【図４】本発明の体液採取具の第２の実施形態を示す平面図である。
【図５】図４中Ｂ−Ｂ’線断面図である。
【図６】図４の体液採取具に用いられるカバー２３１の平面図である。
【図７】図６中Ｃ−Ｃ’線断面図である。
【図８】図４の体液採取具に用いられる検出部材３の平面図である。
【図９】図８中Ｄ−Ｄ’線断面図である。
【図１０】図４の体液採取具に用いられる基板２２の平面図である。
【図１１】図１０中Ｅ−Ｅ’線断面図である。
【図１２】本発明の体液採取具の第３の実施形態を示す平面図である。
【図１３】図１２中Ｆ−Ｆ’線断面図である。
【図１４】図１２の体液採取具に用いられる基板２５の平面図である。
【図１５】図１４中Ｇ−Ｇ’線断面図である。
【符号の説明】
１、１０１、１０２体液採取具
１０通気口
２、２１、２１１、２５基板
２０１、２０２、２０３、２０４凹部
２２送液路形成部材
２２１、２２２、２２３インク樹脂層
２３、２４、２３１、２３２カバー
２３０端部
３、３０１、３２１検出部材
３１、３０２検出部
３２固定部
３２２測定試薬
３５端部面
５１体液入口
５２開口部
７体液送液路
８空間部
９測定孔
９１、９２電気接続部
９３、９４測定電極（測定極、対極）
９５、９６導電材料[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to a body fluid sampling device for measuring components in body fluid such as blood, urine, and sweat. In particular, the present invention relates to a bodily fluid sampling tool having a detecting member and having a liquid feeding path for transferring bodily fluid by capillary action.
[0002]
[Prior art]
2. Description of the Related Art Conventionally, test instruments that collect blood, urine, sweat, and exudate from skin and easily measure components such as glucose, cholesterol, and hemoglobin have been frequently used. In particular, measuring the glucose concentration in blood is important for monitoring the condition of a diabetic patient, and daily measurement is required.
[0003]
In blood glucose measurement, enzymes such as glucose oxidase and glucose dehydrogenase that specifically react with glucose are used, and the products further generated by the enzyme reaction products and reaction products of glucose are optically detected as a color reaction. This method is performed by a method of measuring the electric charge or a method of measuring the electric charge electrically.
[0004]
Such measurements are often made with a component measuring device equipped with a measuring mechanism and a single-use disposable test piece. A finger, an arm, or the like is punctured with a puncture device, a small amount of bleeding is obtained, and blood is spotted on a single-use disposable test piece, so that the blood reaches a measurement portion on the test piece. The component measuring device is provided with a light emitting element and a light receiving element in accordance with the position of the measuring section on the test piece when measuring optically, and is provided on the test piece when measuring electrically. An electrical measurement circuit is provided for contacting the electrical contact provided, and an optical or electrical measurement value is used to calculate the glucose concentration in blood.
[0005]
Therefore, in order to easily and reliably perform the component measurement, it is necessary that blood spotted on the test piece quickly reach the measurement part, and a reagent layer is provided on a support having a long and narrow space that exhibits a capillary action. A device has been devised in which blood is spotted on the end of an elongated space, and the blood reaches the measuring section having a reagent layer by capillary action. (For example, see Patent Document 1)
However, the transfer of bodily fluids such as blood due to capillary action is very unstable, and due to scientific and physical changes in the surface state, the blood stops flowing in the middle of the transfer path and reaches the measurement section. May not. In particular, in places where the cross-sectional shape of the space in which the body fluid flows changes, or where the surface properties of the test device differ from the body material of the test device and the test paper material of the measurement part, the retention of body fluid occurs. easy.
[0006]
Various proposals have been made to solve such instability that body fluid such as blood stays in such a body fluid channel. For example, a test device in which a yarn is provided in a bodily fluid flow path in a body fluid transfer direction and vibration energy is applied to the yarn so that movement of the bodily fluid is performed smoothly (for example, see Patent Document 2) ) And the continuous narrowing of the body fluid channel from the body fluid inlet of the body fluid channel to the measurement unit (detection unit), so that the capillary action becomes stronger as the body fluid channel is further away from the body fluid channel, so that the above-mentioned stagnation can be prevented. (For example, refer to Patent Document 3), or a device in which penetration of body fluid stops at a boundary between members by covering the surface of a body fluid flow channel member composed of two members with a foil. (See, for example, Patent Document 4).
[0007]
However, there is still a need for a test device that sufficiently improves the situation in which stagnation of bodily fluids is likely to occur, such as when the change in the shape of the flow path of the bodily fluids and the change in surface properties occur together.
[0008]
[Patent Document 1]
JP-A-8-247946
[Patent Document 2]
JP-A-9-61310
[Patent Document 3]
JP 2001-526391 A
[Patent Document 4]
JP 2001-525553 Gazette
[0009]
[Problems to be solved by the invention]
An object of the present invention is to provide a bodily fluid sampling device having a simple configuration that can transfer a bodily fluid to a detection unit more reliably and quickly.
[0010]
[Means for Solving the Problems]
Such an object is achieved by the following configurations (1) to (11).
[0011]
(1) In a bodily fluid collection tool including a substrate, a groove-shaped bodily fluid feeding path having a bodily fluid inlet at one end formed on the substrate, and a detecting member for detecting a component in the bodily fluid, the detecting member is configured to transmit the bodily fluid. The body fluid feeding path has a width wider than the width of the fluid path and covers at least a part of the body fluid feeding path on the substrate, and the height of the body fluid feeding path at a portion covered by the detection member is the height of the body fluid. A bodily fluid sampling device characterized by being lower than the height of the other part of the liquid feeding path.
[0012]
(2) In a portion of the body fluid feeding path covered by the detection member, a portion corresponding to the detection member on the substrate is formed as a recess, and the detection member is fitted into the recess, and the body fluid is formed. The bodily fluid collection device according to (1), wherein the liquid feeding path and a detection member that covers the bodily fluid feeding path are covered with a cover material.
[0013]
(3) The bodily fluid sampling device according to (1) or (2), wherein an end surface of the detection member is exposed in the bodily fluid feeding passage.
[0014]
(4) The detection member has a detection portion and a fixing portion, and the detection portion has a detection reagent for detecting a component in a body fluid, and the fixing portion fixes the substrate and the detection member. (1) to (3), wherein a space is provided between the detection unit and the substrate, and the body fluid supply passage is continuous with the space. Body fluid collection tool.
[0015]
(5) The body fluid collection according to any one of (1) to (4), wherein the space has a width and a height, and the width of the space is larger than the width of the body fluid feeding passage. Utensils.
[0016]
(6) The above (1) to (5), wherein the substrate or the cover member has a vent, and the space portion communicates with the vent through an opening different from the body fluid passage. The body fluid sampling device according to (1).
[0017]
(7) The bodily fluid collection according to any one of (1) to (6), wherein the substrate is made of a flat plate member and a liquid feed path forming member for forming the body liquid feed path on the flat plate member. Utensils.
[0018]
(8) A test paper containing a substance in which the detection member reacts with the component of the body fluid to change into a substance that can be optically measured, wherein the detection unit and the fixing unit are made of the same material. The body fluid sampling device according to any one of the above (1) to (7).
[0019]
(9) The bodily fluid collection device according to any one of (6) to (8), wherein the liquid supply path forming member is formed by printing.
[0020]
(10) The bodily fluid sampling device according to the above (7) or (8), wherein the liquid supply path forming member is formed in advance integrally with the substrate.
[0021]
(11) The bodily fluid collection device according to any one of (6) to (8), wherein the liquid supply path forming member is formed of an adhesive tape.
[0022]
BEST MODE FOR CARRYING OUT THE INVENTION
One embodiment of the present invention will be described with reference to the drawings. 1 is a plan view of one embodiment of the present invention, FIG. 2 is a cross-sectional view taken along line AA ′ in FIG. 1, and FIG. 3 is an exploded view of the bodily fluid sampling device shown in FIG.
[0023]
The bodily fluid collection device 1 shown in FIGS. 1 to 3 includes a substrate 21 having a bodily fluid feeding path 7, a space 8, a vent 10, a concave portion 201 and a concave portion 202, a first cover 23, and a second cover 24. The detection member 3 is fitted into the depressions 201 and 202 of the substrate 21 and is covered by the first cover 23 and the second cover 24.
[0024]
The substrate 21 has an elongated flat plate shape, is easily mounted on the component measuring device, and is easy to hold the body fluid sampling tool itself. In the present embodiment, a groove is formed from one end to the other end of the substrate 21 in the long axis direction, and a substantially circular space 8 having a width larger than the width of the groove is formed in the middle of the groove. I have. The bodily fluid passage 7 formed by the groove between the bodily fluid inlet 51 and the opening 52, which is one end of the groove, is covered by laminating the first cover 23, and further from the space 8 to the other end of the groove. The portion up to this is a ventilation hole 10. Further, a recess 201 including the space 8 is formed in the substrate 21. In the vicinity of the opening 52, a concave portion 202 shallower than the concave portion 201 is formed.
[0025]
The bodily fluid feeding passage 7 has a bodily fluid inlet 51 and an opening 52 and is formed substantially linearly in parallel with the long axis direction of the substrate 21. The bodily fluid inlet 51 opens at one end of the substrate 21, and the opening 52, which is a multi-end of the bodily fluid feeding passage 7, opens into the space 8 into which the detection member 3 is fitted, the recess 201, and the recess 202. The recesses 201 and 202 have a width and a depth corresponding to the size and thickness of the detection member 3 having a width larger than the width of the body fluid passage 7, and the detection member 3 is fitted therein. The height of the space in the space 8 is made lower than the height (depth) of the groove. In addition, the recess 202 is configured such that the height of the vicinity of the opening 52 of the body fluid passage 7 is made lower than other portions of the body fluid passage 7 by fitting a part of the detection member 3. Further, the end surface 35 of the detection member 3 is exposed to the bodily fluid feeding passage 7. The bodily fluid feeding path 7 is configured such that bodily fluid such as blood supplied to the bodily fluid inlet 51 enters the bodily fluid feeding path 7 by capillary action and is carried to the detection member 3.
[0026]
The ventilation hole 10 is open to the space 8 at a location different from the opening 52 of the bodily fluid supply channel 7. In the present embodiment, it is formed in a groove shape on the extension of the body fluid feeding path 7.
[0027]
The detecting member 3 has a shape compatible with the concave portions 201 and 202. The detecting member 3 is fitted in the concave portions 201 and 202, and the height of the upper surface of the detecting member 3 fitted in the concave portion 202 is substantially equal to the height of the upper surface of the substrate 21. When the covers 23 are stacked, the surface of the cover 23 on the substrate 21 side and the surface of the substrate 21 on the cover 23 side are in close contact with each other over the front surface. The detection member 3 includes a detection unit 31 facing the space 8 and provided with a substance that reacts with the substance to be measured, a fixing unit 32 facing the recesses 201 and 202, and an end surface exposed to the body fluid supply passage 7. 35. In the present embodiment, a portion corresponding to the space portion of the porous membrane containing glucose oxidase, peroxidase, and the color reagent (broken line in the detection member 3 in FIG. 3) is used for an optical measurement method. Are used as the detection unit, and the other peripheral parts are used as fixed parts.
[0028]
The cover 23 is formed of a flat plate member having the same width as the width of the substrate 21 and a length sufficient to cover the bodily fluid passage 7 (including the vicinity of the opening 52 covered by the detection member 3). I have. The cover 23 is laminated on the substrate 21 in which the detection member 3 is fitted to form the bodily fluid passage 7, and the fixing portion 32 of the detection member 3 is sandwiched between the substrate 21 and the opening 52. In. The cover 24 sandwiches the detection member 3 fitted in the recess 201 between the cover 21 and the substrate 21. The cover 24 has a measurement hole 9 in which a portion corresponding to the detection unit 31 is cut out. When the body fluid sampling tool 1 is mounted on a component measurement device (not shown), a component measurement device having a light emitting element and a light receiving element is provided. It is possible to irradiate the detecting unit with the measuring light by the light emitting element and measure the reflected light by the light receiving element. The cover 24 has an effect of preventing the detection unit 31 from being stained or damaged and fixing the detection member 3 to the substrate 21, but may be omitted. Further, in this embodiment, the cover 23 and the cover 24 are provided separately, but the measurement hole 9 may be provided in a part of one continuous member.
[0029]
By providing a concave portion 202 in the vicinity of the opening 52 of the bodily fluid passage 7 formed by the base member 21, the detecting member 3 and the cover 23, the side surface of the substrate 21 of the cover 23 and the side surface of the cover 21 of the substrate 21 are brought into close contact Can be. If the detection member 3 is sandwiched between the cover 23 and the substrate 21 and does not adhere, the cover 23 floats up from the substrate 21 in the vicinity of the end of the detection member 3 in the body fluid passage 7, and a cross-sectional area of the body fluid passage 7. Therefore, it is preferable that the entire thickness of the end surface 35 of the fixing portion 32 of the detection member 3 be fitted into the concave portion 202 since the possibility that the capillary action is lost increases. Further, when the detection member 3 is a porous substrate such as a porous film, the cover 23 and the substrate 21 can be brought into close contact with each other by compressing the porous substrate when joining the cover 23 and the substrate 21. . When the fixing portion 32 of the detection member 3 is made of a hard material, the thickness of the end surface 35 cannot be reduced, so that providing the concave portion 202 has a great effect.
[0030]
The constituent materials of the substrate 21 and the covers 23 and 24 are not particularly limited. For example, ABS resin, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride resin, polyphenylene oxide, thermoplastic polyurethane, polymethyl methacrylate, polymethyl methacrylate Thermoplastic resins such as oxyethylene, fluororesin, polycarbonate, polyamide, and polyethylene terephthalate; and thermosetting resins such as phenolic resin, epoxy resin, silicone resin, and unsaturated polyester resin. Further, ceramics such as alumina and zirconia, and metals such as stainless steel, aluminum and titanium can also be used.
[0031]
The substrate 21 of the present embodiment is formed with the bodily fluid passage 7 and the like, which is formed integrally with a flat base material by a method of forming grooves and recesses by mechanical cutting or by injection molding. Can be. In addition, a material having a predetermined shape is laminated on a substrate on a flat plate by printing, double-sided tape, or the like to form a liquid sending path forming member, and a body fluid sending path 7, space portions 8, concave portions 201 and 202, and vent holes 10 are formed. You can also. It goes without saying that the present invention is not limited to these manufacturing methods.
[0032]
In the detection member 3, the detection unit 31 and the fixing unit 32 may have different configurations, or may have the same configuration material. In the case where the detection of the body fluid component is performed by optical measurement of color development using a coloring reagent, a sheet-like porous base material containing a coloring reagent is often used as the detecting unit 31, and the detecting member 3 is colored. If the detection section 31 and the fixing section 32 are made of a sheet-like porous base material containing a reagent, they can be manufactured with a simple structure.
[0033]
The detection unit 3 is capable of detecting a predetermined component in blood, and includes, for example, a device in which a coloring reagent is carried on a sheet-like porous substrate capable of absorbing blood. Examples of the sheet-like porous substrate include a porous film, a nonwoven fabric, and a woven fabric. In particular, a porous membrane is preferable because high uniformity such as pore diameter and surface properties can be obtained. Further, it is preferable that the sheet-like porous base material can prevent permeation of red blood cells on at least one surface thereof. The blood is absorbed from the surface of the sheet-shaped porous substrate that blocks the transmission of red blood cells, and the color of the color reagent is measured on the other surface of the sheet-shaped porous substrate, whereby color measurement by red blood cells is performed. This is because it is possible to suppress the disturbance of the image.
[0034]
Examples of the constituent material of the sheet-like porous substrate used in the detection unit 3 include resins such as polyester, polyamide, polyolefin, polysulfone, and cellulose. In order to obtain good blood absorption, a material having hydrophilicity is used. Or those subjected to a hydrophilic treatment. As the hydrophilization method, a method having little effect on the color reaction can be employed. For example, in addition to a physical activation treatment such as a plasma treatment, a glow discharge, a corona discharge, and ultraviolet irradiation, a surfactant, a water-soluble silicon , Hydroxypropylcellulose, polyethylene glycol, polypropylene glycol or the like. When the detecting section 3 is made of such a sheet-like porous substrate, it is preferable that the fixing section 32 is also made of the same material. Further, the sheet-like porous base material constituting the detection section 3 may be a single-layer sheet or a multilayer structure in which a plurality of sheets are stacked.
[0035]
Examples of the coloring reagent include enzymes such as glucose oxidase and peroxidase, and enzymes such as 4-aminoantipyrine and N-ethyl-N- (2-hydroxy-3-sulfopropyl) -m-toluidine in the case of measuring a blood glucose level. Combinations with color formers can be mentioned. In addition, enzymes that react with blood components such as, for example, ascorbate oxidase, alcohol oxidase, alcohol dehydrogenase, galactose oxidase, fructose dehydrogenase, cholesterol dehydrogenase, cholesterol oxidase, lactate oxidase, lactate dehydrogenase, bilirubin oxidase, and xanthine oxidase. It is also possible to combine the above-described color former with another color former. Further, a buffer for adjusting pH can be included.
[0036]
When the detection member 3 electrically measures the glucose concentration, for example, an electrode detector described in JP-A-60-17344 and JP-A-2-245650 is mentioned. These electrode detectors have at least two poles, and a predetermined component in the blood reacts with a reagent in which the enzyme reacting with blood components on the electrodes and a mediator such as potassium ferricyanide or ferrocene are combined. Thereby, electrons move to the electrode through the mediator, and electrical measurement becomes possible. In such a case, the detection unit 31 is configured by the electrodes and the measurement reagent. The fixing part 32 can be composed of a substrate that supports the electrodes and the reagent.
[0037]
Examples of a method of fixing the substrate 21 and the covers 23 and 24 and the substrate 21 and the detection member 3 include heat fusion, ultrasonic fusion, adhesion with an adhesive, and adhesion with an adhesive such as a double-sided tape. .
[0038]
The bodily fluid feeding passage 7 has a bodily fluid inlet 51 at the longitudinal end of the bodily fluid collection device 1 and an opening 52 near the detection member 3, and blood collected from the bodily fluid inlet 51 flows into the opening 52 by capillary action. Approaching. Hereinafter, a cross section of the body fluid supply path 7 in a direction perpendicular to the direction in which blood enters is referred to as a “cross section”. The cross-sectional area of the body fluid passage 7 is not particularly limited, but is 0.05 to 30 mm. ² About 0.1 to 10 mm ² More preferably, it is about If the cross-sectional area of the bodily fluid passage 7 is too small, the blood supply rate is slow, and it takes a long time to obtain a sufficient amount of blood. On the other hand, if the cross-sectional area of the bodily fluid passage 7 is too large, Blood entry by capillary action becomes difficult. Further, the cross-sectional area of the bodily fluid feeding passage 7 may be gradually reduced from the bodily fluid inlet 51 toward the opening 52. The reduced cross-sectional area increases capillary action and is preferred for blood entry.
[0039]
The cross-sectional shape of the body fluid passage 7 is not particularly limited, such as a circular shape, a V-shape, and a square, but a thin rectangular shape is preferable in order to reduce the remaining amount of the body fluid in the body fluid passage 7. In this case, preferably, the height is 0.05 to 0.5 mm, preferably 0.1 to 0.3 mm, and the width is 0.5 to 3 mm, preferably 0.8 to 2 mm. The length of the bodily fluid feeding passage 7 is preferably 1 to 25 mm, more preferably 5 to 20 mm. Further, it is preferable that the inner surface of the bodily fluid supply passage 7 has been subjected to the above-mentioned hydrophilic treatment.
[0040]
The blood that has entered the vicinity of the opening 52 of the bodily fluid delivery channel 7 contacts the end surface 35 of the detection member 3 exposed to the body fluid delivery channel 7. The end surface 35 is exposed to the body fluid passage 7 and has a hydrophilic property, so that the capillary action can be maintained. In the vicinity of the opening 52, the blood that has entered enters the end face 35 and, after having overcome the difference in material, is wider than the body fluid passage 7 (perpendicular to the flow direction of the body fluid in the body fluid passage 7, Since it enters the space 8 where the length (the length of the portion parallel to the detection member surface) is widened, the continuity of the material allows the blood to continue to enter the space 8 without losing the capillary action. it can.
[0041]
The blood that has entered the body fluid feeding path 7 enters the space 8, and at the same time comes into contact with the detection unit 31. When the detection unit 3 is a porous substrate, blood enters the space 8 while being absorbed by the porous substrate, and is almost uniformly absorbed over the entire surface of the detection unit 3. When the detection unit 3 is an electrode, the space 8 is quickly filled with blood, and the amount of blood in contact with the detection unit 3 does not run short.
[0042]
The volume of the space 8 is not particularly limited, but is preferably 0.1 to 5 μL, more preferably 0.5 to 1 μL. If the volume of the space 8 is too large, more blood is collected than necessary, and the burden on the patient increases. In addition, by making the width of the space 8 larger than the width of the body fluid passage 8 and lowering the height, the detection unit 31 can be provided with a large size. Although the maximum width of the space 8 is not particularly limited, it is preferably 1 to 10 times, more preferably 1.5 to 8 times the width of the opening 52 of the bodily fluid passage 7. If the ratio of the widths is too small, the detection unit becomes small, and the measurement accuracy is reduced. If the ratio is too large, the capillary action may be lost. Further, the ratio of the maximum cross-sectional area of the transverse section of the space portion 8 to the minimum cross-sectional area of the bodily fluid feeding path 7 is not particularly limited, but is preferably 0.3 to 2.0, and 0.5 to 1 .2 is more preferred.
[0043]
The ventilation hole 10 communicates with the space portion 8 at a location different from the body fluid passage 7, and when blood enters the body fluid passage 7, the pressure in the body fluid passage 7 and the space 8 is set to the atmospheric pressure. . Thereby, it is possible to prevent the entry of blood from being hindered by the internal pressure.
[0044]
Next, a second embodiment of the bodily fluid sampling device of the present invention will be described. FIG. 4 is a plan view showing a second embodiment of the bodily fluid collecting device of the present invention, FIG. 5 is a cross-sectional view taken along line BB ′ in FIG. 4, and FIG. 6 shows a cover 231 used in the bodily fluid collecting device of FIG. 7, FIG. 7 is a cross-sectional view taken along the line CC ′ in FIG. 6, FIG. 8 is a plan view of the detection member 3 used in the bodily fluid sampling device of FIG. 4, FIG. 9 is a cross-sectional view taken along the line DD ′ in FIG. FIG. 10 is a plan view of a substrate 22 used in the body fluid sampling device of FIG. 4, and FIG. 11 is a sectional view taken along line EE 'in FIG.
[0045]
Hereinafter, the bodily fluid collection device 101 of the second embodiment will be described, but the description will focus on differences from the first embodiment, and description of the same items as in the first embodiment will be omitted.
[0046]
The substrate 22 of the present embodiment has a concave portion 203 into which the detection member 301 is fitted. In addition, the substrate 22 is formed by performing silk screen printing several times on the flat plate member 211 and laminating the ink resin layers 223, 222, and 221, and providing the body fluid delivery path 7, the space 8, the recess 203, and the ventilation hole 10. I have.
[0047]
Also in the present embodiment, the blood that has entered the vicinity of the opening 52 of the bodily fluid feeding channel 7 comes into contact with the end surface 35 of the detection member 301 exposed to the bodily fluid feeding channel 7. The end face portion 35 is exposed to the bodily fluid passage 7 and can maintain the capillary action. In the vicinity of the opening, the entered blood, after having overcome the difference in material by contacting the end face portion 35, is wider than the body fluid passage 7 (perpendicular to the body fluid flow direction of the body fluid passage 7; The blood enters the space 8 where the length of the portion parallel to the detection member surface is widened, so that the continuity of the material allows the blood to continue to enter the space 8 without losing the capillary action. .
[0048]
Next, a third embodiment of the body fluid sampling device of the present invention will be described. 12 is a plan view showing a third embodiment of the bodily fluid collecting device of the present invention, FIG. 13 is a sectional view taken along line FF ′ in FIG. 12, and FIG. 14 is a substrate 25 used in the bodily fluid collecting device of FIG. 15 is a sectional view taken along line GG in FIG.
[0049]
Hereinafter, the bodily fluid collection device 102 according to the third embodiment will be described, but the description will focus on differences from the second embodiment, and the same items as those in the first and second embodiments will be described. Omitted.
[0050]
The substrate 25 of the present embodiment has substantially the same shape as the substrate 22 of the second embodiment, but the end of the detection member 302 on the side of the ventilation hole 11 coincides with the end 230 of the substrate 25. Therefore, the concave portion 204 of the substrate 25 is cut to the end on the side of the ventilation hole 11. Further, the cover 232 has no measurement hole.
[0051]
The detection section of the detection member 302 of the present embodiment includes a measurement electrode 93 and a counter electrode 94 for electrically measuring a body fluid component, and a measurement reagent 322 is attached to the surface of the measurement electrode 93. Further, the end 97 of the detection member 321 on the side of the ventilation hole 11 is exposed from the cover 232 and has two electric connection portions 91 and 92. The electrical connection portions 91 and 92 are connected to the measurement electrode 93 and the counter electrode 94 by conductive materials 95 and 96, respectively. As these electrode configurations, for example, the above-mentioned JP-A-60-17344 and JP-A-2-245650, and other conventional techniques can be used.
[0052]
As described above, the bodily fluid collection device of the present invention has been described based on each embodiment. However, the present invention is not limited to these. For example, the configuration of each unit is an arbitrary configuration that can exhibit the same function. And any other configuration can be added.
[0053]
In the above embodiments, blood is representatively described as a body fluid to be collected. However, in the present invention, the body fluid to be collected is not limited to these, and may be, for example, urine, sweat, lymph, saliva, or the like. In addition, the predetermined component to be measured may be, for example, various sugars, cholesterol, lactic acid, creatinine, hemoglobin, various proteins, and the like, in addition to glucose.
[0054]
【The invention's effect】
The bodily fluid collecting device of the present invention is a bodily fluid collecting device having a substrate, a groove-shaped bodily fluid feeding path having a bodily fluid inlet at one end formed on the substrate, and a detection member for detecting a component in the bodily fluid. The member has a width wider than the width of the bodily fluid passage, covers at least a part of the bodily fluid passage on the substrate, and covers a portion of the bodily fluid passage that is covered by the detection member. Since the height is lower than the height of the other part of the bodily fluid feeding passage, the transfer of bodily fluid by capillary action in the bodily fluid feeding passage or the like is promoted, for example, the surface property of the bodily fluid transferring passage changes. In this case, the body fluid can be more reliably and quickly transferred to the detection unit, and the configuration can be simply performed.
In a portion of the bodily fluid supply passage covered by the detection member, a portion corresponding to the detection member on the substrate is formed as a concave portion, and the detection member is fitted into the concave portion. Since the detection member that covers the fluid passage and the bodily fluid delivery passage is covered with the cover material, the above effect can be further enhanced.
[0055]
In addition, according to the present invention, since the end surface of the detection member is exposed in the body fluid feeding passage, the above-described effect can be enhanced.
[0056]
Further, the detection member has a detection portion and a fixing portion, the detection portion has a detection reagent for detecting a component in a body fluid, and the fixing portion fixes the substrate and the detection member. Since there is a space between the detection unit and the substrate, and the body fluid supply passage and the space are continuous, the body fluid comes into uniform contact with the detection unit, so that the measurement accuracy is improved. I do.
[0057]
Further, the space has a width and a height, and the width of the space is larger than the width of the bodily fluid passage, so that the detection unit becomes large, and the measurement accuracy is improved.
[0058]
In addition, since the substrate or the cover member has a ventilation hole, and the space communicates with the ventilation hole through an opening different from the body fluid feeding passage, the body fluid can be collected quickly.
[0059]
In addition, since the substrate is formed of a flat plate member and a liquid passage forming member for forming the body liquid passage on the flat plate member, assembly of the bodily fluid sampling tool is further facilitated.
[0060]
In addition, the detection member is a test paper containing a substance that changes into a substance that can be optically measured by reacting with the component of the body fluid, and the detection unit and the fixing unit are the same material. Is easier to assemble.
[0061]
Further, since the liquid supply path forming member is formed by printing, it is easy to manufacture even a complicated shape.
[0062]
Further, since the liquid supply path forming member is formed in advance integrally with the substrate, mass production is easy.
[0063]
In addition, since the liquid supply path forming member is formed of an adhesive tape, no other adhesive is required at the time of assembly, so that the assembly can be easily performed.
[Brief description of the drawings]
FIG. 1 is a plan view of one embodiment of the present invention.
FIG. 2 is a sectional view taken along line AA 'in FIG.
FIG. 3 is an exploded view of the bodily fluid sampling device shown in FIG. 1;
FIG. 4 is a plan view showing a second embodiment of the body fluid sampling device of the present invention.
FIG. 5 is a sectional view taken along line BB ′ in FIG. 4;
6 is a plan view of a cover 231 used in the bodily fluid sampling device of FIG.
FIG. 7 is a sectional view taken along line CC ′ in FIG. 6;
8 is a plan view of a detection member 3 used in the bodily fluid sampling device of FIG.
FIG. 9 is a sectional view taken along line DD ′ in FIG. 8;
FIG. 10 is a plan view of a substrate 22 used for the bodily fluid sampling device of FIG. 4;
FIG. 11 is a sectional view taken along line EE ′ in FIG. 10;
FIG. 12 is a plan view showing a third embodiment of the bodily fluid sampling device of the present invention.
FIG. 13 is a sectional view taken along line FF ′ in FIG. 12;
14 is a plan view of a substrate 25 used in the bodily fluid sampling device of FIG.
FIG. 15 is a sectional view taken along line GG ′ in FIG. 14;
[Explanation of symbols]
1,101,102 Body fluid sampling tool
10 Vent
2, 21, 211, 25 substrates
201, 202, 203, 204 recess
22 Liquid supply path forming member
221, 222, 223 Ink resin layer
23, 24, 231, 232 cover
230 end
3,301,321 Detection member
31, 302 detector
32 fixing part
322 measuring reagent
35 end face
51 Body fluid inlet
52 opening
7 Body fluid feeding path
8 space
9 Measurement hole
91, 92 Electrical connection
93, 94 measuring electrode (measuring electrode, counter electrode)
95, 96 conductive material

Claims

In the body fluid collecting tool having a substrate, a groove-shaped body fluid feeding path having a body fluid inlet at one end formed on the substrate, and a detection member for detecting a component in the body fluid, the detection member is provided in the body fluid feeding path. The body fluid passage having a width wider than the width and covering at least a part of the body fluid passage on the substrate, and a height of the body fluid passage at a portion covered by the detection member; A bodily fluid sampling device characterized by being lower than the height of the other part of the body.

In a portion of the body fluid feeding passage covered by the detection member, a portion corresponding to the detection member on the substrate is formed as a recess, and the detection member is fitted into the recess, and the body fluid feeding passage is formed. The body fluid sampling device according to claim 1, wherein the detection member that covers the body fluid feeding path is covered with a cover material.

The bodily fluid sampling tool according to claim 1 or 2, wherein an end surface of the detection member is exposed in the bodily fluid feeding passage.

The detection member has a detection unit and a fixing unit, the detection unit has a detection reagent for detecting a component in a body fluid, and the fixing unit fixes the substrate and the detection member. 4. The body fluid sampling device according to claim 1, further comprising a space between the detection unit and the substrate, wherein the body fluid supply passage is continuous with the space.

The body fluid collection device according to claim 1, wherein the space has a width and a height, and the width of the space is larger than the width of the body fluid passage.

The bodily fluid collection according to any one of claims 1 to 5, wherein the substrate or the cover member has a vent, and the space portion communicates with the vent through an opening different from the bodily fluid feeding passage. Utensils.

7. The bodily fluid collecting device according to claim 1, wherein the substrate comprises a flat plate member and a liquid feed path forming member for forming the bodily fluid feed path on the flat plate member.

The said detection member is a test paper containing the substance which changes into the substance which can be optically measured by reacting with the said component of a bodily fluid, The said detection part and the said fixing part are the same materials, The Claims characterized by the above-mentioned. 8. The body fluid sampling device according to any one of 1 to 7.

9. The body fluid sampling device according to claim 6, wherein the liquid supply path forming member is formed by printing.

The bodily fluid sampling device according to claim 7 or 8, wherein the liquid feeding path forming member is formed in advance integrally with the substrate.

The bodily fluid sampling device according to claim 6 or 8, wherein the liquid feeding path forming member is formed of an adhesive tape.