JP4250692B2 - Body fluid measuring device and wearing body - Google Patents

Description

【００２７】
【数２】

【００２８】
このように、本願発明に係る体液測定装置によれば、使い捨て用として提供される装着体を本体に装着した上で、この装着体の皮膚当接部を患者の指先や耳たぶに押し当てた状態を保持しつつ、あたかも従来のランセットを扱うようにして穿刺体を突出させるという操作をするだけで、それ以上の操作、あるいは動作を要することなく、血糖値等の体液測定を適正に行うことができる。また、測定に必要な検体量が少なくてすむので、患者の負担が軽減される。加えて、血液採取に失敗して測定不能となることがなく、１回の穿刺で確実に測定を行うことができる。
【００２９】
本願発明のその他の特徴および利点は、図面を参照して以下に行う詳細な説明から、明らかとなろう。
【００３０】
【発明の実施の形態】
以下、本願発明の好ましい実施の形態を図面を参照しつつ、説明する。図１は、本願発明に係る体液測定装置の全体外観図、図２、図３は、装着体の詳細を示す拡大縦断面図、図４は、センサ構成部分の平面図、図５は、センサを完成させた状態の縦断面図である。
【００３１】
図１ないし図３に示されるように、本願発明に係る体液測定装置10は、本体20と装着体30とを組み合わせて使用される。本体20は、その上面にスイッチボタン類、ＬＣＤ表示器22などが配置されている。この本体20の前部には筒状部21が延出形成されており、その先端部には、後に詳しく説明するキャップ状の装着体30が装着されている。また、この本体20の内部には、装着体30が備える穿刺体31を前進駆動するための駆動機構（23，32）、および、マイクロコンピュータ等の回路等が内蔵される。図１において符号23は、上記駆動機構の一部を構成し、使用者が手動によって押圧するための押圧部を示している。
【００３２】
図２および図３に装着体30の一例の詳細を示す。この装着体30は、円筒部34と、この円筒部34の先端を塞ぐように位置する底壁部35とを備える大略キャップ状をしており、その主要部分は樹脂成形によって作製される。円筒部34の内径は、本体20の前部筒状部24の外径と対応させられており、この前部筒状部24に被せるようにして簡便に装着することができる。
【００３３】
このキャップ状の装着体30の底壁部35には、穿刺体31と、バイオセンサ36とが一体に組み込まれる。底壁部35には、円筒壁35ｂと底壁35ｃとを有する円筒状の陥没部35Ａがこの装着体30の中心位置に形成され、この陥没部35Ａの底壁35ｃには、中心孔35ｄが開けられている。
【００３４】
一方、穿刺体31は、上記中心孔35ｄにスライド可能に嵌合するガイド軸部31ａとこのガイド軸部31ａの一端に一体形成されたフランジ部31ｂとを有する樹脂製のガイド体31Ａに金属製の穿刺針31ｃを一体にインサートした形態をもっており、フランジ部31ｂと後述する板状バイオセンサ36の上面との間に介装された弾性体31ｄにより、常時図２に示す退避位置、すなわち、フランジ部31ｂが陥没部35Ａの底壁35ｃに当接する位置に向けて付勢されている。この退避位置において、ガイド軸部31ａの後端は底壁35ｃの内側に突出した状態となり、穿刺針31ｃは、後述する板状バイオセンサ36の裏側に退避した状態となる。上記のように穿刺体31を退避位置に向けて付勢する弾性体31ｄの態様としては、図２および図３に示されるように金属あるいは樹脂でできた圧縮コイルバネを用いるほか、発泡ウレタン等の形態とすることができる。このように弾性体31ｄ を発泡ウレタンの形態とし、穿刺体31が退避位置をとるとき穿刺針31ｃがこの発泡ウレタンの内部に埋没するようにしておくと、この穿刺針が外物に触れる機会を少なくすることができるので、衛生的である。また、上記弾性体31ｄ は、樹脂製のガイド体31Ａと一体成形された板状バネの形態とすることができる。
【００３５】
図２に示す実施の態様においては、板状バイオセンサ36は皮膚当接部37のみを介して皮膚40に接することができるように、皮膚40に対して角度をもって配置される。また、皮膚当接部37は穿刺体31の進出位置、すなわち穿刺箇所の近傍へ配置される。
【００３６】
図３に示す実施の態様においては、板状バイオセンサ36は皮膚当接部37のみを介して皮膚40に接することができるように、皮膚40に負圧を作用させるための開口35ｅ近傍に配置される。また、皮膚当接部37は穿刺体31の進出位置、すなわち穿刺箇所の近傍へ配置される。尚、図中点線で示される貫通孔35ｆは皮膚へ負圧を作用させるためのものである。
【００３７】
板状バイオセンサ36は、上面に作用極36ｃおよび対極36ｄが膜形成された絶縁ベース板36Ａと、作用極36ｃおよび対極36ｄの一部を露出させる溝36ｅを形成するように絶縁ベース板36Ａ上に積層された板状スペーサ36Ｂ，36Ｂと、この板状スペーサ36Ｂ，36Ｂにさらに積層された板状カバー36Ｃとを備えている。以下、この板状バイオセンサ36の作製工程を説明する。
【００３８】
図４に示すように、たとえば０．２ｍｍの厚みをもつ樹脂製絶縁シートからなる平面視長矩形状のベース板36Ａが準備される。このベース板36Ａの上面には、グラファイトインクを用いたスクリーン印刷の手法により、作用極36ｃと対極36ｄとが膜状に形成される。作用極36ｃは、端子部となるべき端部領域36ｆから電極として機能する領域36ｇが延出形成された平面形態をもち、一方、対極36ｄは、端子部となるべき端部領域36ｈから電極として機能する領域36ｉをもつ平面形態をもっている。なお、上記作用極36ｃおよび対極36ｄは、金や白金などの貴金属を蒸着するとともにエッチング処理して所定のパターンを作ることによって形成することもできる。
【００３９】
次に、作用極36ｃおよび対極36ｄの各突出部36ｇ，36ｉが縦方向に並ぶ帯状領域と、作用極36ｃおよび対極36ｄの各端部領域36ｆ，36ｈを残してレジスト層36ｊを印刷形成する。
【００４０】
続いて、上記レジスト層36ｊに重ねるようにして、レジスト層36ｊと同等の平面形状を有するスペーサ板36Ｂを配置する。このスペーサ板36Ｂとしては、たとえば厚み０．２ｍｍの樹脂製の板が採用され、表裏面に粘着剤層を設けた両面テープ態様のものが使用される。これにより、スペーサ板36Ｂで挟まれる凹溝36ｅが形成され（図５参照）、かつこの凹溝36ｅの底部の帯状の領域に上記作用極36ｃと対極36ｄの各突出部36ｇ，36ｉが並んで露出する格好となる。なお、上記凹溝36ｅの幅は、たとえば１．５ｍｍ、長さはたとえば３ｍｍに設定される。
【００４１】
次に、上記凹溝36ｅの底部の帯状の領域に、図５に良く表れているような反応試薬層36ｋを形成する。血糖値測定用のセンサとして構成する場合、この反応試薬は、酸化酵素であるグルコースオキシターゼおよびメディエータとしてのフェリシアン化カリウムを含むものが採用される。反応試薬層36ｋはたとえば分注法により形成される。
【００４２】
次に、図５に示したようにスペーサ板36Ｂに重ねるようにして、貫通孔36ｍを有する平面視矩形状のカバー板36Ｃを重ね合わせてこのバイオセンサ36が完成する。すなわち、図５に表れているように、上記ベース板36Ａとスペーサ板36Ｂ，36Ｂとで形成された凹溝36ｅをカバー板36Ｃで塞ぐことによって縦方向に延びる断面横長矩形状の体液通路36ｂが形成され、かつ、この体液通路36ｂの内面に、作用極36ｃおよび対極36ｄに接触する試薬層36ｋ（反応部）が形成される。この体液通路36ｂの容積は、前述した凹溝36ｅの幅、長さ、およびスペーサ板36Ｂ，36Ｂの厚み寸法から、１．５ｍｍ×３ｍｍ×０．２ｍｍ＝０．９μｌとなるが、試薬層36ｋの固形分体積約０．２μｌを差し引くと、この体液通路36ｂの実質容積は約０．7 μｌというきわめて小さなものとなる。
【００４３】
板状バイオセンサ36のベース板36Ａの端部に露出する作用極36ｃおよび対極36ｄ用の端子部36ｆ，36ｈと本体20は、コネクタピン25 ａの先端を上記端子部36ｆ，36ｈに接触させることによって電気的に接続される。
【００４４】
一方、本体20の筒状部21には、コネクタピン25 ａの先端がこの筒状部21の前面に弾性的に突出するようにして、一対のピンコネクタ25が組み込まれている。このピンコネクタ25は、図８に示したように電子回路33に接続されている。この電子回路33は、マイクロコンピュータなどで構成され、後述するようにバイオセンサ36内で生じる酵素反応および電気化学反応によって生じる作用電流から検量線を用いて血糖値等の被検知物質の測定値を決定するとともに、これを本体20の表面に配した表示器22に表示する機能をもたせてある。さらに、本体20には、図２および図３に示したように上記押圧部23によって押圧駆動される押圧ロッド32がその軸線方向（図中に矢印で示した方向）に移動可能であり、かつバネによって常時後方側に付勢されながら組み込まれて駆動機構23，32が構成されている。なお、駆動機構23，32としては、これに限らず、軸方向移動可能であってしかも軸方向の中立位置に弾性復帰するように押圧ロッド32を設け、この押圧ロッド32を後方に引き絞ってラッチ保持し、ラッチ解除ボタンを押すことでこの押圧ロッド32を勢い良く前方発射させ、この押圧ロッド32が穿刺体31のガイド軸部31ａの後端を勢いよく打ちつけ、これにともなって穿刺針31ｃが瞬間的に皮膚当接面35ａから突出するように構成することも可能である。また、図示しない吸引シリンダ機構を本体20に内蔵させることにより、筒状部21の先端に負圧を作用させることができるようにすることもできる。また、装着体30を本体20に装着したときにバイオセンサ36の端子部と導通接触するべく本体20に設ける端子は、前述したように常時ピンが弾性的に突出するピンコネクタの形態とするほか、たとえば、装着体30の本体20への装着と連動して、装着体30が装着されていないときには端子ピンが本体内に退動しており、装着体30が装着されると端子ピンが本体から突出してバイオセンサの端子部との適切な導通接触が図られるように構成することも可能である。
【００４５】
次に、上記構成を備える体液測定装置10の使用方法ないし動作を図１ないし図３を参照しつつ説明する。
【００４６】
装着体30は、使い捨て消耗品として提供され、体液測定装置10の使用にあたって使用者はこの装着体30を本体20の筒状部21に装着する（図１参照）。上記実施形態において装着体30はキャップ状をしているので、このような装着作業は容易に行える。装着体30が装着されると、図２に表れているように本体側のコネクタピン25 ａの先端がバイオセンサ36のベース板36Ａ両端上面に配置された電極部36ｆ，36ｈに自動的に接触する。
【００４７】
装着体30の底壁部35の端面 35 ′、およびバイオセンサ 36 の皮膚当接部 37を患者の皮膚の適当な部位、たとえば指先や耳たぶに押し当てた状態で、押圧部23を押下する。そうすると、本体20の内部の押圧ロッド32の先端が穿刺体31のガイド軸部31ａの後端部を押し、押圧ロッド32が装着体30の陥没部35Ａの裏側に当接するまでのストロークをもって穿刺体31を弾性体37の弾力に抗して前方に押し出す。このとき、穿刺体31の穿刺針31ｃは、バイオセンサ36の皮膚当接部37の近傍を穿刺して皮膚に傷を付け、血液を出液させる。押圧部23への押圧を解除すると、押圧ロッド32はバネの弾力によって元の位置まで復帰動し、また、穿刺体31もまた弾性体37の弾力によって穿刺針31ｃが皮膚当接部37から没入する退避位置まで復帰する。
【００４８】
穿刺針31ｃの突出により、皮膚に適度な傷がつけられ、この傷から出液した血液が、毛管現象により、皮膚当接部37を介してバイオセンサ36内の体液通路36ｂに導入させられる。皮膚当接部37は穿刺針31ｃ進出位置、つまり皮膚の傷、したがって出液部にきわめて近傍に位置している。そうして、前述したように、バイオセンサ36内の体液通路36ｂの実質容積はきわめて小さいため、少量の血液で体液通路36ｂを充満させることが可能である。したがって、出液部の血液量をいちいち黙視確認するまでもなく、皮膚当接部37を皮膚に押し付けたまま上記の操作をし、かつ皮膚当接部37を皮膚に押し付けた状態を所定時間保持するだけで、測定に必要十分な血液をセンサ中の体液通路36ｂに導入することができる。なお、前述したように、吸引シリンダ機構を本体に付加し、開口35ｅ（および貫通孔35ｆ）を介して皮膚に負圧を作用させながら上述した操作をすると、鬱血状態の皮膚に穿刺針31ｃで傷を付けることができるため、より充分な量の血液を出液させることができる。
【００４９】
バイオセンサ36内の体液通路36ｂ内において、反応試薬（反応部36ｋ）が血液によって溶解されると、以下の数３に示される酵素反応が開始される結果、反応部36ｋに共存させているフェリシアン化カリウムが還元され、還元型の電子伝達体であるフェロシアン化カリウムが蓄積される。
【００５０】
【数３】

【００５１】
フェロシアン化カリウムの蓄積量は、基質濃度、すなわち血液中のグルコース濃度に比例する。一定時間蓄積された還元型の電子伝達体は、以下の数４に示される電気化学反応により、酸化される。
【００５２】
【数４】

【００５３】
測定装置本体20 の内の電子回路33は、このとき測定される作用極電流から、グルコース濃度（血糖値）を演算・決定し、好ましくはたとえば本体20 の表面に配置されたＬＣＤ表示器22に表示する。
【００５４】
このように、上記体液測定装置10によれば、装着体30を本体20の所定部位に装着するという簡単な前準備をした後、装着体30の端面 35 ′およびバイオセンサ 36の皮膚当接部 37を患者の指先や耳たぶ等に押し当てた状態を保持しつつ、あたかも従来のランセットを扱うようにして穿刺針31ｃを突出させるという操作をするだけで、それ以上の操作、あるいは動作を要することなく、血糖値等の体液測定を適正に行うことができる。
【００５５】
図６ないし図１１は、バイオセンサ36の他の構造例を示す。このバイオセンサ36は、ベース板36Ａと、スペーサ板36Ｂ，36Ｂと、カバー板36Ｃとを備える点では前述のバイオセンサ36と同様であるが、ベース板36Ａには作用極36ｃのみが形成され、カバー板36Ｃとして導電性金属を用いることにより、このカバー板36Ｃの内面を対極36ｄとして機能させている。より具体的には、ベース板36Ａには、図４に示すようなパターンの作用極36ｃが形成される。そして、図１０および図１１に示すように、この作用極36ｃの内方の一部を露出させるようにして、所定の間隔をあけて２枚のスペーサ板36Ｂ，36Ｂが重ねられる。これにより、作用極36ｃの一部が底面に露出する凹溝36ｅが形成される。作用極36ｃの外方部は露出させられ、コネクタピン25ａ，25ａと接触する電極部36ｆとして機能する。凹溝36ｅの幅、長さ、深さは、それぞれ、前述の実施形態のものと同等に設定され、この凹溝36ｅとカバー体36Ｃとにより、体液通路36ｂが形成される。凹溝36ｅの底部には、反応試薬が塗布された反応部36ｋが形成される。このセンサ36を血糖値測定用に構成する場合、反応試薬として、前述したのと同様のものを用いることができる。カバー体36Ｃの上面適部は、コネクタピン25ａと接触する電極部36ｈとして機能させられる。
【００５６】
なお、図６ないし図１１の構造のバイオセンサ36において、図 に示したようにベース板36Ａに形成する作用極36ｃに接触するようにしてフェリシアン化カリウムを含む反応試薬層361k（第１反応部）を形成する一方、カバー体36Ｃの内面に酸化酵素であるグルコースオキシターゼおよびメディエータとしてのフェリシアン化カリウムを含む反応試薬層362k（第２反応部）を形成することによって反応部36ｋを形成する態様とすることも可能である。このようにすれば、酵素反応および電気化学反応を介して作用極電流を検出するこの種のバイオセンサ36において、アスコルビン酸の影響を除去したより正確な測定が可能となる。
【００５７】
もちろん、この発明の範囲は上述した実施形態に限定されることはない。実施形態では、血糖値を測定するためのものとして説明されているが、測定対象は血糖値に限定されない。また、装着体の具体的形状およびバイオセンサの具体的構造は、種々変更可能である。本願発明の最も重要なポイントは、本体に装着して使用される好ましくは使い捨ての装着体に穿刺体とバイオセンサとが一体的に組み込まれている点である。また、更に重要なポイントは、バイオセンサが皮膚当接部のみを介して皮膚と接している点である。
【図面の簡単な説明】
【図１】 本発明に係る体液測定装置の全体外観図である。
【図２】 装着体の詳細を示す拡大縦断面図である。
【図３】 他の態様の装着体の詳細を示す拡大縦断面図である。
【図４】 センサを分解した状態の平面図である。
【図５】 センサの縦断面図である。
【図６】 センサの縦断面図である。
【図７】 センサの縦断面図である。
【図８】 電気的な構成を説明するための概略構成図である。
【図９】 センサの縦断面図である。
【図１０】 センサの縦断面図である。
【図１１】 センサの縦断面図である。
【符号の説明】
１０ 体液測定装置
２０ 本体
２３ 押圧部（駆動機構を構成する）
２５ａ コネクタピン（本体の端子としての）
３０ 装着体
３１ 穿刺体
３１ｄ 弾性体
３２ 押圧ロッド（駆動機構を構成する）
３３ 電子回路
３６ センサ
３６Ａ ベース板（センサを構成する）
３６Ｂ スペーサ（センサを構成する）
３６Ｃ カバー板（センサを構成する）
３６ｂ 体液流路（センサの）
３６ｃ 作用極（センサの）
３６ｄ 対極（センサの）
３６ｅ 溝（センサの）
３６ｋ 反応部（センサの反応試薬層）
３６ｆ，３６ｈ 端子部（センサの電極としての）
３６１ｋ 第１反応部（センサの反応試薬層）
３６２ｋ 第２反応部（センサの反応試薬層）
３７ 皮膚当接部（センサの（体液吸引口）） [0001]
BACKGROUND OF THE INVENTION
The present invention can measure a substance to be detected contained in a body fluid such as blood glucose concentration (hereinafter referred to as “blood glucose level”), and collects and measures body fluid from the skin by an integrated operation. The present invention relates to a lancet-integrated bodily fluid measuring device configured to be able to perform such operations.
[0002]
BACKGROUND OF THE INVENTION
In order to treat diabetes, it is necessary to keep the blood glucose level of the patient in a normal range, and blood glucose level management by the patient himself is an important treatment method. In particular, when the blood glucose level is maintained in a normal range by insulin injection by the patient himself, appropriate blood glucose level measurement by the patient himself is indispensable.
[0003]
Portable blood glucose level measuring devices used for such a purpose are already on the market, and an example thereof is disclosed in, for example, Japanese Patent Publication No. 8-20412. This blood glucose level measuring apparatus is used by inserting a disposable test piece having an enzyme electrode into a main body. When blood as a specimen is brought into contact with the test piece, a part of the blood is drawn into the reaction part by capillary action, and an anodic current is generated through an enzyme reaction and an electrochemical reaction. This anode current is converted into a blood glucose level in the apparatus body and displayed.
[0004]
By the way, a sample to be brought into contact with a test piece of the measuring apparatus as described above, that is, blood is generally collected using an instrument called a lancet as disclosed in, for example, Japanese Patent Laid-Open No. 9-266898. It is. This lancet is a device for making a small hole (scratching) in the skin of a patient's fingertip, etc., and letting the blood discharged from the hole thus opened touch a predetermined part of the above-mentioned test piece Therefore, the blood glucose level can be measured relatively easily.
[0005]
However, in the conventional general blood sugar level self-measuring method described above, since the lancet for collecting blood as a sample and the measuring device are separate, the lancet is combined with the inconvenience of having to carry both. Therefore, it is necessary to perform two operations, that is, the operation of scratching the skin and the operation of causing blood drawn from the wound to touch the test piece, and there is still room for improvement in terms of convenience. In particular, with regard to the action of touching the test piece with blood, it is necessary to bring the required amount of blood into contact with the specified part of the test piece, and this is done for patients who are unfamiliar or who have poor vision. Alternatively, when blood is collected from an earlobe that is not directly visible to the person, it is extremely difficult to quickly and appropriately touch the blood drawn from the wound as described above.
[0006]
In addition, since the test piece is configured to draw blood by capillary action from a hole at the tip to a planar enzyme electrode provided in the reaction part, in order to allow a necessary amount of blood to reach the reaction part, 3 to 5 μl of blood needs to touch the specimen. If this amount of blood is insufficient, or if this amount of blood is not properly attached to a small area surrounding the tip hole of the test piece, accurate measurement may not be possible. Such a situation can occur frequently when the amount of blood discharged from a wound is insufficient, such as an infant or an elderly person.
[0007]
In order to solve the above problems, Japanese Patent Laid-Open No. 10-28683 discloses that a sensor incorporated in a device is simply skinned with a lancet incorporated in the device. There has been proposed a lancet-integrated blood glucose level measuring device that measures blood discharged from the lancet. However, in the device disclosed in the publication, the lancet needle and the sensor have to be set separately at predetermined positions in the apparatus, and there is still room for improvement in terms of usability.
[0008]
In order to improve usability, a lancet-integrated body fluid measuring device that uses a lancet and a sensor integrally is disclosed in Japanese Patent Application No. 10-166894. This lancet-integrated body fluid measuring device has the following configuration. That is, a body fluid measuring device including a main body and a mounting body mounted on the main body for use, wherein the mounting body includes a skin contact surface and a sensor disposed along the skin contact surface. A puncture body that is movable between an advancing position in which the tip protrudes from the skin contact surface and a retracted position in which the tip is recessed from the skin contact surface and is biased toward the retracted position by an elastic body; The main body has a terminal that contacts each electrode of the sensor included in the mounting body when the mounting body is mounted and conducts to the electrode, and is measured based on an electrical signal obtained through the terminal. An electronic circuit for determining a value and a drive mechanism for driving the puncture body forward so that the puncture body takes an advanced position are provided. Further, the sensor in the wearing body has a plate shape extending along the skin contact surface as a whole, and a body fluid passage is formed inside the thickness direction so that the reaction portion faces the inner surface, and In addition, there is provided a configuration in which a through hole is formed which communicates with the body fluid passage and allows the tip of the puncture body to pass therethrough.
[0009]
Since the through-hole through which the puncture body passes and the body fluid passage in the sensor communicate with each other, blood discharged from the wound on the skin directly enters the through-hole, and subsequently fills the body fluid passage where the reaction part faces. It is done. Therefore, the distance from the skin wound to the reaction part is remarkably shortened. Further, since the sensor itself has a plate shape, the volume of the body fluid passage can be reduced. For this reason, the blood volume required for measurement can be significantly reduced.
[0010]
However, in the bodily fluid measuring device described in Japanese Patent Application No. 10-166894, the plate-like sensor of the mounting body used by being mounted on the bodily fluid measuring device is arranged substantially in parallel with the skin and serves as a blood introduction port. Since the sensor and the skin are in contact with the part other than the through hole, the blood discharged from the wound on the skin directly enters the through hole, and the contact part between the sensor and the sensor other than the through hole and the skin There was a problem that it entered into the gap that could be made between. In this case, the discharged blood does not reach the reaction part inside the sensor, and measurement is impossible. That is, blood collection for measurement fails. Therefore, the user has to redo the measurement. By doing so, the user suffers from the pain of being forced to puncture twice or more in one measurement, and also suffers from the pain that the skin is contaminated with blood. In addition, it is necessary to use two or more attachments for one measurement, which is a problem from the viewpoint of cost.
[0011]
The essence of the above problem from the technical aspect is that the flow path of the discharged blood exists other than the blood inlet of the sensor. That is, the discharged blood is guided to the body fluid passage of the sensor as a capillary phenomenon from the body fluid introduction port, but since there is a contact point between the sensor and the skin other than the body fluid introduction port, the blood is interposed between the sensor and the skin. There is room to enter the gaps that can be created as capillary action. This is because the gap formed between the sensor and the skin is usually narrow enough to cause capillary action, that is, the surface area per volume is sufficiently large. In other words, the capillary phenomenon to the blood inlet and the capillary phenomenon to the other are competing.
[0012]
The invention of the present application has been conceived under such circumstances, and it is possible to further improve the usability by further simplifying the operation required of the patient for measurement and to significantly increase the necessary sample amount. An object of the present invention is to provide a lancet-integrated bodily fluid measuring device that can reduce blood pressure and reliably collect blood and can improve measurement reliability.
[0013]
DISCLOSURE OF THE INVENTION
In order to solve the above problems, the present invention takes the following technical means.
[0014]
  The body fluid measuring device provided by the present invention is:A body fluid measuring device comprising a main body and a mounting body to be used by being mounted on the main body, wherein the main body contacts each electrode of a sensor included in the mounting body when the mounting body is mounted. And an electronic circuit for determining a measurement value based on an electric signal obtained through the terminal, and a drive mechanism for driving the puncture body forward so that the puncture body takes an advanced position. The wearable body is a puncture that is movable between a sensor having a skin contact portion and a position where the tip protrudes to the vicinity of the skin contact portion and a retreat position where the tip is recessed from the skin contact portion. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a body fluid measuring device including a body and a mounting body in such a body fluid measuring device, and the gist thereof is to bring a sensor into contact with the skin only through the skin contact portion. By arranging the sensor in this way, there is no room for blood to enter between the skin and the portion other than the skin contact portion, and the flow path of the discharged blood is limited to the body fluid passage of the sensor. Can do.
[0015]
  The wearing body is provided as a disposable consumable, for example. In the measurement, the user wears the wearing body on the main body. Operate the drive mechanism of the main unit while pressing the skin contact part against the skin of the fingertip or earlobe.SetThen, the puncture body in the retracted position is advanced, and the tip of the puncture body protrudes from the skin contact surface, thereby damaging the skin. The puncture body returns to the retracted position by the action of the next instantaneous elastic body. If the apparatus is kept as it is, blood discharged from the skin permeates the sensor, and the sensor outputs a reaction current. This electric current is converted into a specific component concentration in the blood by an electronic circuit and displayed on, for example, a display arranged on the surface of the main body.
[0016]
Thus, in the body fluid measurement device of the present invention, since the puncture body and the sensor are integrated in advance in the mounting body, the user only needs to mount the mounting body on the main body for measurement. Compared with the case where the measuring device and the measuring device are used separately, as compared with the conventional lancet-integrated blood measuring device in which the lancet needle and the sensor need to be set separately at a predetermined part of the device, Its usability is significantly improved.
[0017]
  The skin contact portion of the sensor incorporated in the wearing body simultaneously constitutes a body fluid suction port. And the skin contact part is arrange | positioned so that it may become the advance position of the puncture body. The vicinity mentioned here refers to a degree of proximity so that blood discharged from the puncture body injuries the skin immediately contacts the body fluid suction port when blood drops are formed. For example, if the blood required for measurement is 1 μl, (1μ lThe body fluid suction port needs to be arranged at least within 1 mm from the advancement position of the puncture body.
[0018]
As a means for arranging the sensor so as to come into contact with the skin only through the skin contact portion, the sensor is preferably arranged at an angle of 5 to 90 degrees with respect to the skin. By doing so, the part other than the skin contact part is detached from the skin, and blood can be prevented from entering the gap formed between the skin and the part other than the skin contact part. If the angle between the sensor and the skin is 5 degrees or less, the gap between the skin and the portion other than the skin contact portion is not sufficient, and blood may enter the gap, which is not preferable. Even if the angle between the sensor and the skin is 90 degrees or more, if the angle from the opposite direction is measured, it is less than 90 degrees, and there is no difference from the case where the angle is less than 90 degrees.
[0019]
As another means for arranging the sensor so as to be in contact with the skin only through the skin contact portion, the skin contact portion is arranged in the vicinity of the advancement position of the puncture body and in the vicinity of the opening for applying negative pressure to the skin. It is. The skin swells by applying a negative pressure, and becomes a protrusion near the opening. By disposing the skin contact portion of the sensor so as to be in contact with the protruding skin, the sensor can be disposed so as to be in contact with the skin only through the skin contact portion. That is, a negative pressure is applied to the skin that is essentially flat to give a three-dimensional shape (protrusion), and contact with the skin only through the skin contact portion without taking measures such as tilting the sensor. It is arranged. Even in this case, the portion other than the skin contact portion is detached from the skin, and blood can be prevented from entering the gap formed between the skin and the portion other than the skin contact portion.
[0020]
In a preferred embodiment, the wearing body has an opening for applying a negative pressure to the skin. If comprised in this way, since the skin surface can be congested and can be injured by the puncture body, a sufficient amount of blood can be discharged, and the measurement can be made more reliable.
[0021]
In a preferred embodiment, the sensor in the mounting body further includes a base plate having a working electrode and a counter electrode formed on an upper surface, and a groove formed so as to face a part of each of the working electrode and the counter electrode. The spacer includes a spacer superimposed on the base plate, a reaction part in which a reaction reagent layer is formed on a part or all of the groove, and a cover plate superimposed on the spacer. A space surrounded by the plate forms a body fluid passage, and a terminal portion that is electrically connected to the working electrode and the counter electrode and is brought into contact with the terminal of the main body is disposed at an appropriate upper surface of the base plate.
[0022]
In another preferred embodiment, the sensor in the mounting body includes a base plate having a working electrode formed on an upper surface thereof, and a groove on the base plate so that a part of the working electrode is faced to form a groove. A first electrode layer formed on the groove so as to be in contact with the working electrode, and a spacer plate overlaid on the spacer and having a counter electrode facing the groove on the lower surface. A reaction part and a second reaction part having a second reagent layer formed on the lower surface of the cover plate so as to be in contact with the counter electrode, and a space surrounded by the groove and the cover plate is formed. While the body fluid passage is formed, the first terminal portion that is electrically connected to the working electrode and is brought into contact with the terminal of the main body is disposed at an appropriate portion of the upper surface of the base plate, and is electrically connected to the counter electrode. 2nd terminal part made to contact with the terminal of It is disposed on the upper surface of the cover plate.
[0023]
  With this configuration, the base plate is printed by, for example, screen printing.PoleAlternatively, a counter electrode can be easily formed, and a plate sensor in which a body fluid passage is properly formed in the thickness direction can be easily manufactured by a simple method of stacking plate components.
[0024]
When the body fluid measuring device of the present invention is configured for blood glucose level measurement, for example, a reagent containing glucose oxidase as an oxidase and potassium ferricyanide as a mediator is employed as a reaction reagent disposed in the reaction part of the sensor. The
[0025]
When the reaction part is dissolved by blood, the enzyme reaction shown in Equation 1 is started, and as a result, potassium ferricyanide coexisting in the reaction layer is reduced, and reduced type electron carrier potassium ferrocyanide is accumulated. The The amount is proportional to the substrate concentration, ie the glucose concentration in the blood. The reduced electron carrier accumulated for a certain period of time is oxidized by an electrochemical reaction expressed by Equation 2. The electronic circuit in the measuring apparatus main body calculates and determines the glucose concentration (blood glucose level) from the anode current measured at this time, and displays it on the display device arranged on the main body surface as described above.
[0026]
[Expression 1]

[0027]
[Expression 2]

[0028]
Thus, according to the bodily fluid measurement device according to the present invention, after the mounting body provided for disposable use is mounted on the main body, the skin contact portion of this mounting body is pressed against the patient's fingertip or earlobe. It is possible to properly measure body fluids such as blood sugar level without requiring any further operation or operation, just by operating the lancet as if handling a conventional lancet it can. In addition, since the amount of specimen required for measurement is small, the burden on the patient is reduced. In addition, it is possible to reliably perform measurement with one puncture without failing to collect blood and making measurement impossible.
[0029]
Other features and advantages of the present invention will become apparent from the detailed description given below with reference to the drawings.
[0030]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, preferred embodiments of the present invention will be described with reference to the drawings. FIG. 1 is an overall external view of a body fluid measuring device according to the present invention, FIGS. 2 and 3 are enlarged longitudinal sectional views showing details of a mounted body, FIG. 4 is a plan view of sensor components, and FIG. It is a longitudinal cross-sectional view of the state which completed.
[0031]
As shown in FIGS. 1 to 3, the body fluid measuring device 10 according to the present invention is used in combination of a main body 20 and a mounting body 30. The main body 20 has switch buttons, an LCD display 22 and the like disposed on the upper surface thereof. A cylindrical portion 21 is formed to extend from the front portion of the main body 20, and a cap-like mounting body 30 which will be described in detail later is attached to the tip portion thereof. In addition, inside the main body 20, a drive mechanism (23, 32) for driving the puncture body 31 provided in the mounting body 30 forward, and a circuit such as a microcomputer are incorporated. In FIG. 1, the code | symbol 23 comprises a part of said drive mechanism, and has shown the press part for a user to press manually.
[0032]
2 and 3 show details of an example of the mounting body 30. FIG. The mounting body 30 has a generally cap shape including a cylindrical portion 34 and a bottom wall portion 35 positioned so as to close the tip of the cylindrical portion 34, and a main portion thereof is manufactured by resin molding. The inner diameter of the cylindrical portion 34 is made to correspond to the outer diameter of the front cylindrical portion 24 of the main body 20, and can be easily mounted so as to cover the front cylindrical portion 24.
[0033]
The puncture body 31 and the biosensor 36 are integrated into the bottom wall portion 35 of the cap-shaped mounting body 30. A cylindrical recess 35A having a cylindrical wall 35b and a bottom wall 35c is formed in the bottom wall 35 at the center position of the mounting body 30, and a center hole 35d is formed in the bottom wall 35c of the recess 35A. Opened.
[0034]
On the other hand, the puncture body 31 is made of metal on a resin guide body 31A having a guide shaft portion 31a slidably fitted in the center hole 35d and a flange portion 31b integrally formed at one end of the guide shaft portion 31a. The puncture needle 31c is integrally inserted, and the elastic body 31d interposed between the flange portion 31b and the upper surface of the plate-shaped biosensor 36 to be described later always has the retracted position shown in FIG. The portion 31b is biased toward a position where it abuts against the bottom wall 35c of the depressed portion 35A. At this retracted position, the rear end of the guide shaft portion 31a protrudes to the inside of the bottom wall 35c, and the puncture needle 31c retracts to the back side of the plate-like biosensor 36 described later. As described above, the elastic body 31d for urging the puncture body 31 toward the retracted position uses a compression coil spring made of metal or resin as shown in FIG. 2 and FIG. It can be in the form. If the elastic body 31d is in the form of urethane foam and the puncture needle 31c is buried in the foamed urethane when the puncture body 31 is in the retracted position, the opportunity for the puncture needle to touch an external object is obtained. Hygienic because it can be reduced. The elastic body 31d can be in the form of a plate spring integrally formed with the resin guide body 31A.
[0035]
In the embodiment shown in FIG. 2, the plate-like biosensor 36 is disposed at an angle with respect to the skin 40 so that the plate-like biosensor 36 can contact the skin 40 only through the skin contact portion 37. The skin contact portion 37 is disposed at the advance position of the puncture body 31, that is, in the vicinity of the puncture location.
[0036]
In the embodiment shown in FIG. 3, the plate-like biosensor 36 is disposed in the vicinity of the opening 35e for applying a negative pressure to the skin 40 so that the plate-like biosensor 36 can contact the skin 40 only through the skin contact portion 37. Is done. The skin contact portion 37 is disposed at the advance position of the puncture body 31, that is, in the vicinity of the puncture location. In addition, the through-hole 35f shown by the dotted line in the drawing is for applying a negative pressure to the skin.
[0037]
The plate-like biosensor 36 is formed on the insulating base plate 36A so as to form an insulating base plate 36A having a working electrode 36c and a counter electrode 36d formed on the upper surface, and a groove 36e exposing a part of the working electrode 36c and the counter electrode 36d. The plate-like spacers 36B and 36B are laminated, and the plate-like cover 36C is further laminated on the plate-like spacers 36B and 36B. Hereinafter, a manufacturing process of the plate-like biosensor 36 will be described.
[0038]
As shown in FIG. 4, a base plate 36A having a rectangular shape in plan view made of a resin insulating sheet having a thickness of 0.2 mm, for example, is prepared. A working electrode 36c and a counter electrode 36d are formed in a film shape on the upper surface of the base plate 36A by screen printing using graphite ink. The working electrode 36c has a planar form in which a region 36g functioning as an electrode is extended from an end region 36f to be a terminal portion, while the counter electrode 36d is an electrode from an end region 36h to be a terminal portion. It has a planar form with a functioning region 36i. The working electrode 36c and the counter electrode 36d can also be formed by depositing a noble metal such as gold or platinum and etching it to form a predetermined pattern.
[0039]
Next, a resist layer 36j is formed by printing while leaving the band-like regions in which the projecting portions 36g and 36i of the working electrode 36c and the counter electrode 36d are arranged in the vertical direction and the end regions 36f and 36h of the working electrode 36c and the counter electrode 36d.
[0040]
Subsequently, a spacer plate 36B having a planar shape equivalent to that of the resist layer 36j is disposed so as to overlap the resist layer 36j. As the spacer plate 36B, for example, a resin plate having a thickness of 0.2 mm is employed, and a double-sided tape type in which an adhesive layer is provided on the front and back surfaces is used. As a result, a concave groove 36e sandwiched between the spacer plates 36B is formed (see FIG. 5), and the projecting portions 36g and 36i of the working electrode 36c and the counter electrode 36d are arranged in a band-like region at the bottom of the concave groove 36e. It will be exposed. The width of the concave groove 36e is set to 1.5 mm, for example, and the length is set to 3 mm, for example.
[0041]
Next, a reaction reagent layer 36k that appears well in FIG. 5 is formed in a band-like region at the bottom of the concave groove 36e. When configured as a blood glucose level measurement sensor, this reaction reagent includes glucose oxidase which is an oxidase and potassium ferricyanide as a mediator. The reaction reagent layer 36k is formed by, for example, a dispensing method.
[0042]
Next, as shown in FIG. 5, the biosensor 36 is completed by overlapping the cover plate 36 </ b> C having a rectangular shape in plan view having the through hole 36 m so as to overlap the spacer plate 36 </ b> B. That is, as shown in FIG. 5, a body fluid passage 36b having a horizontally-long rectangular cross section extending in the longitudinal direction is formed by closing the groove 36e formed by the base plate 36A and the spacer plates 36B and 36B with the cover plate 36C. A reagent layer 36k (reaction part) that is formed and is in contact with the working electrode 36c and the counter electrode 36d is formed on the inner surface of the body fluid passage 36b. The volume of the body fluid passage 36b is 1.5 mm × 3 mm × 0.2 mm = 0.9 μl from the width and length of the concave groove 36e described above and the thickness dimension of the spacer plates 36B and 36B, but the reagent layer 36k When the solid volume of about 0.2 μl is subtracted, the substantial volume of the body fluid passage 36 b becomes extremely small, about 0.7 μl.
[0043]
  The terminal portions 36f and 36h for the working electrode 36c and the counter electrode 36d exposed at the end of the base plate 36A of the plate-like biosensor 36 and the body 20 are connector pins.twenty five aIs electrically connected by bringing the end of the terminal into contact with the terminal portions 36f and 36h.
[0044]
  On the other hand, the cylindrical portion 21 of the main body 20 has connector pins.twenty five aA pair of pin connectors 25 is incorporated such that the tip of the first elastically protrudes from the front surface of the cylindrical portion 21. This pin connector 25 is an electronic circuit as shown in FIG.33It is connected to the. This electronic circuit33Is composed of a microcomputer or the like, and determines a measured value of a substance to be detected such as a blood glucose level using a calibration curve from an action current generated by an enzyme reaction and an electrochemical reaction occurring in the biosensor 36 as described later, A function of displaying this on a display 22 arranged on the surface of the main body 20 is provided. Further, the main body 20 has a pressing rod 32 that is pressed and driven by the pressing portion 23 as shown in FIGS. 2 and 3, and is movable in the axial direction (direction indicated by an arrow in the drawing). The drive mechanisms 23 and 32 are configured by being always urged rearward by a spring. The drive mechanisms 23 and 32 are not limited to this, and a pressing rod 32 is provided so as to be movable in the axial direction and elastically return to the neutral position in the axial direction. By holding the latch and pushing the latch release button, this push rod 32 is vigorously fired forward, and this push rod 32 is guided by the guide shaft of the puncture body 31.PartIt is also possible to strike the rear end of 31a vigorously so that the puncture needle 31c momentarily protrudes from the skin contact surface 35a. Further, by incorporating a suction cylinder mechanism (not shown) in the main body 20, a negative pressure can be applied to the tip of the cylindrical portion 21. In addition, the terminal provided on the main body 20 so as to be in conductive contact with the terminal portion of the biosensor 36 when the mounting body 30 is mounted on the main body 20 is in the form of a pin connector in which the pins elastically protrude as described above. For example, in conjunction with the mounting of the mounting body 30 to the main body 20, when the mounting body 30 is not mounted, the terminal pin is retracted into the main body, and when the mounting body 30 is mounted, the terminal pin is It is also possible to configure such that proper conduction contact with the terminal portion of the biosensor is achieved by projecting from the terminal.
[0045]
Next, a usage method or operation of the body fluid measuring device 10 having the above configuration will be described with reference to FIGS.
[0046]
  The mounting body 30 is provided as a disposable consumable, and the user mounts the mounting body 30 on the cylindrical portion 21 of the main body 20 when using the body fluid measuring device 10 (see FIG. 1). Since the mounting body 30 has a cap shape in the above embodiment, such mounting work can be easily performed. When the mounting body 30 is mounted, as shown in FIG.twenty five aOf the base plate 36A of the biosensor 36 is automatically brought into contact with the electrode portions 36f and 36h arranged on both upper surfaces.
[0047]
  Of the bottom wall 35 of the mounting body 30End face 35 ′,And biosensors 36 ofSkin contactPart 37Is pressed against an appropriate part of the patient's skin, such as a fingertip or an earlobe. Then, the tip of the pressing rod 32 inside the main body 20 presses the rear end portion of the guide shaft portion 31a of the puncture body 31, and the puncture body has a stroke until the pressing rod 32 contacts the back side of the recessed portion 35A of the mounting body 30. 31 is pushed forward against the elasticity of the elastic body 37. At this time, the puncture needle 31c of the puncture body 31 punctures the vicinity of the skin contact portion 37 of the biosensor 36, damages the skin, and discharges blood. When the pressing to the pressing portion 23 is released, the pressing rod 32 returns to the original position by the elasticity of the spring, and the puncture body 31 is also inserted into the skin contact portion 37 by the elasticity of the elastic body 37. Return to the retracted position.
[0048]
  Due to the protrusion of the puncture needle 31c, the skin is moderately damaged, and blood discharged from the wound is introduced into the body fluid passage 36b in the biosensor 36 through the skin contact portion 37 by capillary action. The skin contact portion 37 is positioned very close to the advancement position of the puncture needle 31c, that is, the wound on the skin, and thus the liquid discharge portion. As described above, since the substantial volume of the body fluid passage 36b in the biosensor 36 is extremely small, the body fluid passage 36b can be filled with a small amount of blood. Therefore, it is not necessary to silently check the blood volume in the liquid discharge part, and the above operation is performed while the skin contact part 37 is pressed against the skin, and the state where the skin contact part 37 is pressed against the skin is maintained for a predetermined time. By doing so, blood necessary and sufficient for measurement can be introduced into the body fluid passage 36b in the sensor. As described above, if the suction cylinder mechanism is added to the main body and the above operation is performed while applying negative pressure to the skin through the opening 35e (and the through hole 35f), the congested skinTo wearSince the wound can be made with the puncture needle 31c, a more sufficient amount of blood can be discharged.
[0049]
In the body fluid passage 36b in the biosensor 36, when the reaction reagent (reaction part 36k) is dissolved by blood, the enzyme reaction shown in the following equation 3 is started. Potassium cyanide is reduced and potassium ferrocyanide, a reduced electron carrier, is accumulated.
[0050]
[Equation 3]

[0051]
The accumulated amount of potassium ferrocyanide is proportional to the substrate concentration, that is, the glucose concentration in blood. The reduced electron carrier accumulated for a certain period of time is oxidized by the electrochemical reaction shown in the following Equation 4.
[0052]
[Expression 4]

[0053]
  Measuring device body20 ofInside electronic circuit33Calculates and determines the glucose concentration (blood glucose level) from the working electrode current measured at this time.20 ofLCD display 22 placed on the surfaceInindicate.
[0054]
  As described above, according to the body fluid measuring device 10, after the simple preparation for mounting the mounting body 30 on the predetermined part of the main body 20,End face 35 ′ And biosensor 36Skin contactPart 37Without touching the patient's fingertip, earlobe, etc., as if handling the conventional lancet and protruding the puncture needle 31c without any further operation or action In addition, body fluid such as blood sugar level can be measured appropriately.
[0055]
6 to 11 show other structural examples of the biosensor 36. FIG. This biosensor 36 is the same as the biosensor 36 described above in that it includes a base plate 36A, spacer plates 36B and 36B, and a cover plate 36C, but only the working electrode 36c is formed on the base plate 36A. By using a conductive metal as the cover plate 36C, the inner surface of the cover plate 36C functions as a counter electrode 36d. More specifically, a working electrode 36c having a pattern as shown in FIG. 4 is formed on the base plate 36A. Then, as shown in FIGS. 10 and 11, the two spacer plates 36B and 36B are overlapped with a predetermined interval so as to expose a part of the inner side of the working electrode 36c. As a result, a concave groove 36e is formed in which a part of the working electrode 36c is exposed to the bottom surface. The outer portion of the working electrode 36c is exposed and functions as an electrode portion 36f that contacts the connector pins 25a and 25a. The width, length, and depth of the recessed groove 36e are set to be equal to those of the above-described embodiment, and the body fluid passage 36b is formed by the recessed groove 36e and the cover body 36C. A reaction portion 36k coated with a reaction reagent is formed at the bottom of the concave groove 36e. When this sensor 36 is configured for blood glucose level measurement, the same reaction reagent as described above can be used. An appropriate upper surface portion of the cover body 36C is caused to function as an electrode portion 36h that comes into contact with the connector pin 25a.
[0056]
  In the biosensor 36 having the structure shown in FIGS. 6 to 11, the reaction reagent layer 361k (first reaction part) containing potassium ferricyanide is brought into contact with the working electrode 36c formed on the base plate 36A as shown in the figure. On the other hand, the reaction part 36k is formed by forming the reaction reagent layer 362k (second reaction part) containing glucose oxidase as an oxidase and potassium ferricyanide as a mediator on the inner surface of the cover body 36C. Is also possible. In this way, it acts via enzymatic and electrochemical reactionsveryIn this type of biosensor 36 that detects electric current, more accurate measurement is possible without the influence of ascorbic acid.
[0057]
Of course, the scope of the present invention is not limited to the embodiment described above. In the embodiment, the blood glucose level is described as being measured, but the measurement target is not limited to the blood glucose level. The specific shape of the wearing body and the specific structure of the biosensor can be variously changed. The most important point of the present invention is that the puncture body and the biosensor are integrally incorporated in a preferably disposable mounting body that is used by being mounted on the main body. A more important point is that the biosensor is in contact with the skin only through the skin contact portion.
[Brief description of the drawings]
FIG. 1 is an overall external view of a body fluid measuring device according to the present invention.
FIG. 2 is an enlarged longitudinal sectional view showing details of the mounting body.
FIG. 3 is an enlarged longitudinal sectional view showing details of a mounting body according to another embodiment.
[Figure 4] SensorDisassembled stateFIG.
FIG. 5 is a longitudinal sectional view of a sensor.
FIG. 6 is a longitudinal sectional view of a sensor.
FIG. 7 is a longitudinal sectional view of a sensor.
FIG. 8 is a schematic configuration diagram for explaining an electrical configuration;
FIG. 9 is a longitudinal sectional view of a sensor.
FIG. 10 is a longitudinal sectional view of a sensor.
FIG. 11 is a longitudinal sectional view of a sensor.
[Explanation of symbols]
  10 Body fluid measuring device
  20 body
  23 Pressing part (constituting drive mechanism)
  25a Connector pin (as terminal of main body)
  30 Wearing body
  31 Puncture body
  31d elastic body
  32 Press rod (constitutes drive mechanism)
  33 Electronic circuit
  36 sensors
  36A Base plate (constituting sensor)
  36B Spacer (constituting sensor)
  36C Cover plate (constituting sensor)
  36b Body fluid flow path (for sensor)
  36c Working electrode (sensor)
  36d Counter electrode (sensor)
  36e Groove (sensor)
  36k reaction part (reaction reagent layer of sensor)
  36f, 36h terminal part (as sensor electrode)
  361k 1st reaction part (reaction reagent layer of sensor)
  362k 2nd reaction part (reaction reagent layer of sensor)
  37 Skin contact part(Sensor (Body fluid suction port))

Claims (10)

A body fluid measuring device comprising a main body and a mounting body to be used by mounting on the main body,
The main body is a terminal that contacts each electrode of the sensor included in the mounting body when the mounting body is mounted and conducts to the electrodes, and an electronic that determines a measured value based on an electrical signal obtained through the terminal. A circuit, and a drive mechanism for driving the puncture body forward so that the puncture body takes an advanced position,
The mounting body includes a sensor having a skin contact portion, and a puncture body that is movable between an advancing position in which the tip protrudes in the vicinity of the skin contact portion and a retracted position in which the tip is recessed from the skin contact portion. Has
The sensor has a plate-like shape as a whole, and a body fluid passage is formed on the inner surface in the thickness direction so that the reaction portion faces the inner surface, and contacts the skin only through the skin contact portion. And it is arranged at an angle of 5 to 90 degrees with respect to the tangential direction at the contact portion of the skin with the skin contact portion,
The sensor further includes a base plate having a working electrode formed on an upper surface thereof, a spacer superimposed on the base plate so as to form a groove so as to face a part of the working electrode, and the spacer. A cover plate having a counter electrode facing the groove formed on a lower surface; a first reaction part having a first reagent layer formed in the groove so as to contact the working electrode; and the cover so as to contact the counter electrode A second reaction portion having a second reagent layer formed on the lower surface of the plate, and a space surrounded by the groove and the cover plate forms a body fluid passage, A first terminal portion that is electrically connected and brought into contact with a terminal of the main body is disposed on an appropriate portion of the upper surface of the base plate, and a second terminal portion that is electrically connected to the counter electrode and brought into contact with the terminal of the main body is It is arranged on the upper surface of the cover plate,
The bodily fluid measuring device, wherein the skin contact portion constitutes a bodily fluid suction port communicating with the bodily fluid passage and is disposed in the vicinity of the advance position of the tip of the puncture body. A body fluid measuring device comprising a main body and a mounting body to be used by mounting on the main body,
The main body is a terminal that contacts each electrode of the sensor included in the mounting body when the mounting body is mounted and conducts to the electrodes, and an electronic that determines a measured value based on an electrical signal obtained through the terminal. A circuit and a drive mechanism for driving the puncture body forward so that the puncture body takes an advanced position, and the mounting body includes a sensor having a skin contact portion, and a tip having a skin contact portion. A puncture body that is movable between an advancing position that protrudes in the vicinity and a retreat position in which the tip is retracted from the skin contact portion;
The sensor is disposed at an angle of 5 to 90 degrees with respect to the skin through only the skin contact portion, and with respect to the tangential direction at the contact portion of the skin with the skin contact portion,
The terminal in the main body is movable between an advanced position where the tip protrudes from the main body and a retracted position retracted from the advanced position, and is always biased in the advanced direction by a spring. A body fluid measuring device. A body fluid measuring device comprising a main body and a mounting body to be used by mounting on the main body,
The main body is a terminal that contacts each electrode of the sensor included in the mounting body when the mounting body is mounted and conducts to the electrodes, and an electronic that determines a measured value based on an electrical signal obtained through the terminal. A circuit, and a drive mechanism for driving the puncture body forward so that the puncture body takes an advanced position,
The wearing body includes a sensor having a skin contact portion, a puncture body that is movable between an advancing position in which the tip protrudes in the vicinity of the skin contact portion and a retracted position in which the tip is recessed from the skin contact portion, An opening for applying negative pressure to the skin,
The sensor has a plate-like shape as a whole, a body fluid passage in which a reaction part faces the inner surface in the thickness direction, and a base plate with a working electrode formed on the upper surface, and the function described above. A spacer superimposed on the base plate so as to form a groove with a part of the pole facing, a cover plate superimposed on the spacer and formed with a counter electrode facing the groove on the lower surface, and the working electrode A first reaction part in which a first reagent layer is formed in the groove so as to be in contact; and a second reaction part in which a second reagent layer is formed on the lower surface of the cover plate so as to be in contact with the counter electrode. The space surrounded by the groove and the cover plate forms a body fluid passage, while the first terminal portion that is connected to the terminal of the main body through the working electrode is the base plate It is arranged in the appropriate part of the upper surface of the above and A second terminal portion that is brought into contact with the body of the terminal conducts To pole is disposed on an upper surface of the cover plate,
The skin contact portion is disposed in the vicinity of the opening that is in the vicinity of the advance position of the tip of the puncture body, and constitutes a body fluid suction port that communicates with the body fluid passage. measuring device. A body fluid measuring device comprising a main body and a mounting body to be used by mounting on the main body,
The main body is a terminal that contacts each electrode of the sensor included in the mounting body when the mounting body is mounted and conducts to the electrodes, and an electronic that determines a measured value based on an electrical signal obtained through the terminal. A circuit, and a drive mechanism for driving the puncture body forward so that the puncture body takes an advanced position,
The wearing body includes a sensor having a skin contact portion, a puncture body that is movable between an advancing position in which the tip protrudes in the vicinity of the skin contact portion and a retracted position in which the tip is recessed from the skin contact portion, An opening for applying negative pressure to the skin,
The skin contact portion is disposed in the vicinity of the opening,
The terminal in the main body is movable between an advanced position where the tip protrudes from the main body and a retracted position retracted from the advanced position, and is always biased in the advanced direction by a spring. A body fluid measuring device.   The terminal in the main body is movable between an advanced position where the tip protrudes from the main body and a retracted position retracted from the advanced position, and is always biased in the advanced direction by a spring. 4. The body fluid measuring device according to 1 or 3. The wearing body further includes an elastic body for biasing the puncture body toward the retracted position,
The body fluid measuring device according to claim 1, wherein the elastic body is integrally formed with the puncture body.   The mounting body further includes an elastic body for urging the puncture body toward the retracted position, and the puncture needle of the puncture body is placed in the elastic body when the puncture body is stationary at the retracted position side. The body fluid measuring device according to any one of claims 1 to 6, wherein the body fluid measuring device is configured to retreat and be protected.   The body fluid measuring device according to claim 1, wherein the wearing body has a cap shape as a whole.   The body fluid measuring device according to claim 1, wherein the cover plate is formed of a conductor plate, and a lower surface thereof functions as a counter electrode, and an appropriate upper surface portion functions as a second terminal portion.   The body fluid measuring device according to claim 1, wherein the body fluid measuring device is used by being mounted on a main body.

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