JP3742741B2

JP3742741B2 - Body fluid testing device

Info

Publication number: JP3742741B2
Application number: JP35765699A
Authority: JP
Inventors: 豊大杉; 栄次有田; 耕一園田; 尚穂西川
Original assignee: Terumo Corp
Current assignee: Terumo Corp
Priority date: 1999-12-16
Filing date: 1999-12-16
Publication date: 2006-02-08
Anticipated expiration: 2019-12-16
Also published as: JP2001170031A

Description

【０００１】
【発明の属する技術分野】
本発明は、体液、例えば血液の検査に際し、指先のような生体表面に穿刺針を穿刺して血液を採取し、検査を行う体液検査装置に関する。
【０００２】
【従来の技術】
近年、糖尿病患者の増加に伴い、日常の血糖値の変動を患者自身がモニターする自己血糖値測定が推奨されてきている。自己血糖値測定には、血中のブドウ糖量に応じて呈色する試験紙を装着し、試験紙に血液を供給させ、その呈色の度合いを光学的に測定（測色）して血糖値を定量化する血糖測定器が用いられている。この測定に先立ち、患者は、穿刺針や小刀を備えた穿刺具を用いて指先の皮膚を穿刺した後、その穿刺部周辺を指等で圧迫して血液を絞り出すことが必要である。そして、穿刺具と血糖測定器が別々となっているために、出血の状態のまま穿刺具から血糖測定器に持ち替える必要があり、操作性が悪く、衛生面から見ても好ましいものではない。
【０００３】
そこで、従来の穿刺具と血糖測定器が一体となっているものが特開平６−３３９４７３号公報に開示されている。この血糖測定器は、ハウジング内に、穿刺手段と、体液を体液用化学試薬に移送する手段と、体液用化学試薬の光学的な測定を行い結果を表示する手段を備える。しかしながら、この血糖測定器においては穿刺を行っても出血量が不十分なため、穿刺後に指等で圧迫して体液を絞り出す必要があり、従来のものと操作性にあまり相違がない。また、血糖測定器としては特開平９−２７６２３５号公報に開示されたものもある。この血糖測定器はハウジング内に穿刺手段と、指を圧迫する圧迫帯と、体液成分を測定し表示する手段を備える。しかしながら、この血糖測定器は圧迫帯の効果により必要量の体液採取は可能としたものの、使用後、圧迫帯から指を引き抜く際に、指先に残った体液が圧迫帯に付着してしまい感染等の危険性を有している。
【０００４】
【発明が解決しようとする課題】
本発明の目的は、上述した従来技術の問題点を鑑みて、穿刺、体液採取、測定を連続に行うことができ、かつ体液の付着のおそれの極めて少ない体液検査装置を提供するものである。
【０００５】
【課題を解決するための手段】
上述目的を達成するものは、皮膚を穿刺して微量の体液を採取し該体液の成分を測定するための体液検査装置であって、該体液検査装置は、ケースと、指先穿刺のために突出可能な穿刺針を備える穿刺部材と体液中の特定成分と反応する試薬を含む検出チップおよび該検出チップへの体液誘導路を備える検出チップ部材とが一体となったチップ穿刺針組立体と、前記チップ穿刺針組立体を着脱可能に装着する装着部と、前記チップ穿刺針組立体の前記装着部への装着を検知するチップ穿刺針組立体装着確認機構と、穿刺部材装着部と穿刺開始スイッチと前記穿刺部材装着部を付勢するための弾性部材とを備えるとともに穿刺針突出部を除き実質的に気密に形成された穿刺針の一時的な突出を行うための穿刺針駆動機構と、穿刺針突出部を除き実質的に気密に形成された穿刺針の一時的な突出を行うための穿刺針駆動機構と、電動ポンプを備え、前記穿刺針駆動機構内部を吸引することにより穿刺針による指先の穿刺部位を含む周辺部位を吸引するための吸引機構と、前記穿刺開始スイッチを含む穿刺針駆動機構の作動を検知し、該検知結果に基づいて吸引機構の作動を開始させる吸引機構作動機能ならびに吸引機構の作動停止を行う吸引機構制御機構と、該吸引機構による穿刺針駆動機構内の減圧状態を解除するための減圧状態解除機構と、体液接触後の前記検出チップの状態を検出するための検出機構と、該検出機構による検出結果より体液状態を評価する体液状態評価機構と、該体液状態評価機構による評価結果を表示する表示機構とを有することを特徴とする体液検査装置。
そして、前記チップ穿刺針組立体は、穿刺針の刃先の上方に指先に密着可能な環状開口部を備え、前記体液誘導路の一端開口部は該環状開口部内に突出し他端は前記チップまで延びているものであることが好ましい。
【０００６】
さらに、前記チップ穿刺針組立体装着確認機構は、前記穿刺部材が穿刺可能な位置まで押し込まれているかを検知するチップ穿刺針組立体装着監視センサであることが好ましい。さらに、前記チップ穿刺針組立体装着確認機構は、発光素子と受光素子により未使用チップ穿刺針組立体の反射光を受光することにより前記チップ穿刺針組立体の装着を確認するものであることが好ましい。さらに、前記吸引機構制御は、前記検出機構により検出される検出チップの状態変化信号を用いて、吸引機構の作動を停止するものであることが好ましい。また、前記減圧状態解除機構は、前記吸引機構により減圧される減圧形成空間と該減圧形成空間の外部とを連通する微量吸気口であることが好ましい。また、前記減圧状態解除機構は、前記吸引機構により減圧される減圧形成空間と該減圧形成空間の外部とを連通可能な弁であってもよい。そして、前記体液検査装置は、前記吸引機構により減圧される穿刺針駆動機構内の圧力を検知するための圧力検知部を備えていることが好ましい。そして、前記体液検査装置は、前記吸引機構制御機構および前記体液状態評価機構を備える制御部と、該制御部に電気的に接続された穿刺針駆動機構内部の圧力を検知するための圧力センサ、穿刺針による穿刺開始を検知するための穿刺開始検出センサおよび表示部を備えていることが好ましい。
【０００７】
【発明の実施の形態】
本発明の体液検査装置を図面に示す好適実施例に基づいて詳細に説明する。
図１は、本発明の体液検査装置の一実施例の外観図、図２は、図１に示した体液検査装置より保護カバーを取り外した状態の平面図、図３は図１に示す体液検査装置のケース部分を破断した内部構造説明図である。
本発明の体液検査装置１は、皮膚を穿刺して微量の体液を採取し体液の成分を測定するための体液検査装置である。体液検査装置１は、ケース２と、ケース２に着脱可能に装着されるとともに開口部８内に指先穿刺のために突出可能な穿刺針を備える穿刺部材１６と、ケース２に着脱可能に装着されるとともに、体液中の特定成分と反応する試薬を含む検出チップ２５および検出チップ２５への体液誘導路を備える検出チップ部材と、穿刺部材装着部と穿刺開始スイッチと穿刺部材装着部を付勢するための弾性部材１８とを備えるとともに、穿刺針突出部を除き実質的に気密に形成された穿刺針の一時的な突出を行うための穿刺針駆動機構１０と、電動ポンプ１２ａを備え、穿刺針駆動機構内部を吸引することにより穿刺針による指先の穿刺部位を含む周辺部位を吸引するための吸引機構１２と、穿刺開始スイッチを含む穿刺針駆動機構１０の作動を検知し、この検知結果に基づいて吸引機構１２を作動を開始させる吸引機構１２の作動開始ならびに吸引機構１２の作動停止を制御する吸引機構制御部と、吸引機構１２による減圧状態を解除するための減圧状態解除機構３１と、体液接触後の検出チップ２５の状態を検出するための検出機構と、検出機構１０４，１０５による検出結果より体液状態を評価する体液状態評価機構と、体液状態評価機構による評価結果を表示する表示機構５とを備えている。
【０００８】
この実施例の体液検査装置１は、ケース２とケース２内に収納された内部機構からなる。ケース２は、図１ないし図５に示す実施例では、ケース本体２ａとケース本体２ａに一端部が回動可能に取り付けられた蓋部材２ｂからなる。蓋部材２ｂは、指先を挿入可能な開口部８と、開口部８側面に装着されるカバー４を備えている。なお、蓋部材はなくてもよく、さらに、蓋部材としては、指先を挿入可能な開口部などを備えず、後述するチップ穿刺針組立体の装着部を単に被包可能に、ケース本体２ａに一端部が回動可能に取り付けられたものであってもよい。さらに、蓋部材としては、装着部に後述するチップ穿刺針組立体が装着された状態では、蓋部材を完全に閉じることができないようになっていてもよい。
ケース本体２ａ内に収納された内部機構は、穿刺針の一時的な突出を行うための穿刺針駆動機構１０と、穿刺針による指先の穿刺部位を含む周辺部位を吸引するための吸引機構１２と、吸引機構１２による減圧状態を解除するための減圧状態解除機構３１と、体液接触後の検出チップ２５の状態を検出するための検出機構１０４，１０５と、検出機構による検出結果より体液状態を評価する体液状態評価機構と、体液状態評価機構による評価結果を表示する表示機構５とを備えている。
【０００９】
そして、この体液検査装置１では、使用時には、開口部８内への指先穿刺のために突出可能な穿刺針を備える穿刺部材１６と、体液中の特定成分と反応する試薬を含む検出チップ２５および検出チップ２５への体液誘導路を備える検出チップ部材とが装着される。そして、この実施例では、穿刺部材１６と検出チップ部材とが一体となったチップ穿刺針組立体２２が用いられており、チップ穿刺針組立体２２は、体液検査装置の組立体装着部７に着脱可能に装着される。このチップ穿刺針組立体２２は、検査毎に交換される。また、図３に示すように、蓋部材２ｂ内部には、予備用のチップ穿刺針組立体２２を複数収納できる収納部１５を備えるとともに、蓋部材２ｂの上面には、図２に示すように未使用のチップ穿刺針組立体２２の残数確認用の小窓１７が設けられており、外部よりチップ穿刺針組立体残数を確認可能となっている。
【００１０】
チップ穿刺針組立体２２は、穿刺部材（ランセット）１６と、この穿刺部材１６を移動可能に収納する筒状部材と、筒状部材の先端部が固定された組立体本体部材を備える。組立体は、穿刺部材１６の穿刺針の刃先の上方に位置し、指先に密着可能な環状開口部２６と検出チップ２５を備え、さらに、一端開口部が環状開口部２６内に突出し他端がチップ２５付近まで延びる体液誘導路を備えている。このため、穿刺部材１６により穿刺されることにより生じた出血による血液は、誘導路を通り、検出チップ２５に送られる。
誘導路は、その断面形状および長さは測定に必要とする体液量により異なるが体液の残存量を少なくなるよう設計するのが望ましい。具体的には、断面形状としては管状、Ｖ字溝、長方形溝でも構わないが、体液の残存量を少なくできるため薄型の長方形が好ましい。厚みは０．０５〜０．５ｍｍ程度、幅は０．５〜３ｍｍ程度が好ましい。長さは、５ｍｍ〜１５ｍｍ程度が適当である。
【００１１】
チップ穿刺針組立体２２の環状開口部（吸引口）２６は、例えば指先、上腕、腹部、大腿部、耳たぶのような生体表面に接する部位である。この吸引口２６は性別、年齢等の個人差や穿刺部位にかかわらず良好に吸引採血が行えるように、その開口径（開口面積）が調整されている。具体的には吸引口２６の開口径は４〜１０ｍｍが好ましく、特に、穿刺部位が指や耳たぶの場合は４〜６ｍｍがより好ましい。チップ穿刺針組立体２２の吸引口２６部外周縁は、生体表面（皮膚）に押し当てたときに穿刺部周辺を刺激し穿刺時の痛みを和らげる効果を発揮するのに適した形状となっている。また、穿刺器具１１内が減圧状態であるときに、チップ穿刺針組立体２２と生体表面との間から空気が穿刺器具１１へ流入することを阻止するのに適した形状となっている。
環状開口部２６の誘導路の縁には、体液導入ガイド部を設けることが望ましい。体液導入ガイド部は、そこに体液が接触すると誘導路開口まで体液を導く機能を有する。体液誘導ガイド部としては、誘導路開口の周縁の左右両方にレール状のガイドを突出させるよう設けたものが好適である。体液導入ガイド部の大きさは、幅は１〜３ｍｍ程度、高さは０．５〜３ｍｍ程度、長さは１〜３ｍｍ程度が望ましい。
そして、チップ穿刺針組立体２２は内部の視認性を確保するため、特に穿刺後の出血状態を目視確認できるように、透明または着色透明な材料で構成されているのが望ましいが半透明または不透明であってもよい。
【００１２】
検出チップ２５は、目的とする体液検査に適したものが使用され、例えば、血液中のグルコースを測定する場合には、グルコースオキシダーゼ、ペルオキシダーゼと呈色試薬が担持されている。測定目的とする成分は、ブドウ糖（血糖値）に限らず、例えばたんぱく質、コレステロール、尿酸、クレアチニン、アルコール、ナトリウム等の無機イオン、ヘモグロビン（潜血）等であってもよい。また、検出チップ基材としては、吸液性（親水性）のある紙、膜、不織布などが用いられる。
そして、体液検査装置１の内部機構の蓋部材２ｂ内に露出する部分７は、上記のチップ穿刺針組立体２２の装着部７となっており、装着部７は側面の４つの角が面取りされ、かつ上面の中央部から斜めに削られた四角柱形状となっており、側面にチップ穿刺針組立体２２の内面に密着するガスケットが設けられている。
【００１３】
穿刺針の一時的な突出を行うための穿刺針駆動機構１０は、筒状ハウジング２７と、このハウジング２７内部を摺動するプランジャー２８と、プランジャー２８の後端に固定されたシャフト２１と、このシャフト２１の後端側を被包するようにハウジング２７の後端部に取り付けられた調整カバー３０と、弾性部材（ばね部材）１８と、ハウジング２７の側面開口部２７ａを覆う開口部カバー９と、穿刺開始スイッチ部材３を備える。プランジャー２８は、側面にハウジング２７の側面開口部２７ａ内に侵入する係止用爪部１９と、先端にチップ穿刺針組立体２２の筒状部材内に侵入可能かつ先端に穿刺部材１６の穿刺針ハブを保持可能な筒状の穿刺針ホルダー部２０を備えている。弾性部材１８は、一端（先端）がプランジャー２８の後端（シャフト２１との接続部）に固定され、シャフトの先端部分を被包し、後端は、ハウジング２７の中央部に形成された内側に突出する弾性部材固定部２９に固定されている。このため、図７に示すような、プランジャー２８の係止用爪部１９がハウジング２７の開口部と係合する状態では、弾性部材１８は、プランジャー２８の後端とハウジング２７の弾性部材固定部２９間により圧縮された状態となっている。また、シャフト２１には、後端部にリブ２１ａが、また調整カバー３０は、その中間部に上記リブ２１ａと当接可能に設けられたリブ３０ａを備えている。この調整カバーの位置を調整することにより穿刺針の突出量が調整される。
【００１４】
また、弾性部材１８は、図９に示すように、プランジャー２８の係止用爪部１９がハウジング２７の開口部と係合しない状態では、穿刺針の刃先がチップ穿刺針組立体２２の開口部より突出しないような長さのものとなっている。このため、穿刺終了後に指先を引き抜く際に、穿刺針が指先に引っかかることがない。プランジャー２８の係止用爪部１９は、一端（後端）がプランジャー２８に固定され、先端が自由端となっている所定長さの棒状形状を備え、かつ、先端は外方に若干突出している。このため、この爪部１９は、ハウジング２７に設けられた係合用爪侵入用開口部２７ａに容易に侵入し、侵入することにより両者（爪部の先端面と開口部の先端内面）が当接し、係合する。また、側面開口部２７ａは、外側が開口部カバー９により覆われており、さらに、その外側には穿刺開始スイッチ部材３が設けられている。スイッチ部材３は、押圧操作部３ａと係合解除用チップ部３ｂを備え、係合解除用チップ部３ｂは、ハウジング２７の側面開口部部分（開口部に侵入した爪部の先端部）を開口部カバー９の外側より押圧可能となっている。このため、スイッチ部材３を押圧することにより、穿刺針は、図８に示すように圧縮されたばねの圧縮解除により付勢され、組立体２２より突出し指２３を穿刺する。チップ穿刺針組立体２２は、穿刺部位を限定せずに穿刺が行える。
【００１５】
なお、このような構成に限定されるものではなく、例えば、穿刺の開始は、チップ穿刺針組立体２２が前後に可動できるように構成し、チップ穿刺針組立体２２と体液検査装置１（ケース２）の接合部にマイクロスイッチ等の機械式センサを備え、穿刺部位をチップ穿刺針組立体２２に当てた状態で少し押し込むことにより穿刺が開始されるようにしてもよい。
また、この実施例の体液検査装置１は、チップ穿刺針組立体２２の試薬部分や体液が点着した部分を触れることなくチップ穿刺針組立体２２を取り外すための機械式のチップ穿刺針組立体リリースレバー６を有している。リリースレバー６は露出する突起６ａを備えており、リリースレバー６を図４の矢印方向に移動させると突起６ａにより押されて、チップ穿刺針組立体２２は装着部７より離脱する。
【００１６】
次に、穿刺針による指先の穿刺部位を含む周辺部位を吸引するための吸引機構１２および吸引機構１２による減圧状態を解除するための減圧状態解除機構３１について説明する。
吸引機構１２は、吸引ポンプ（電動ポンプ）１２ａと、この吸引ポンプ１２ａと穿刺針駆動機構１０の筒状ハウジング２７とを接続するチューブ１２ｂと、吸引ポンプ１２ａに接続された排気管１２ｃとを備え、減圧状態解除機構３１は、チューブ１２ｂの途中に設けられた減圧解除弁により構成されている。このため、穿刺針駆動機構１０の筒状ハウジング２７内は、穿刺針１６が突出する開口部２６（使用時に指により閉鎖される部分）を除き実質的気密に構成されており、吸引手段により、穿刺針駆動機構１０の筒状ハウジング２７内が減圧されることにより、開口部に密着される指の部位を吸引可能となっている。吸引ポンプ（電動ポンプ）としては、直線運動式（ピストン形、ダイヤフラム形）、回転運動式、摺動運動式などの電動式吸引ポンプが用いられる。減圧状態解除機構３１は、吸引ポンプに直接もしくは穿刺針駆動機構１０の筒状ハウジング２７に設けてもよい。
【００１７】
減圧解除弁としては、機械式、電磁式、機構的に流量制御または圧力制御を行うことができるものであればどのようなものでもよい。例えば、絞り弁、流量調整弁、電磁弁などが挙げられる。また、絞り弁としては、微少細管を用いたものが好適であり、図示する実施例では、微少細管からなる絞り弁（低量吸気弁）が用いられている。この微少細管の口径（内径）は電動式ポンプの排気速度と細管からの気体の流量より決定される。なお、減圧状態解除機構としては、上記のような特別な構成を設けることなく、穿刺針駆動機構１０の筒状ハウジング２７の気密性の程度を若干低いものとすることにより達成してもよい。具体的には、ハウジング２７の側面に細孔を設けること、ハウジング２７と調整カバー３０の固定部間に僅かな隙間を設けることなどが考えられる。これらの細孔、低量吸気弁などが形成する微量吸気口により穿刺針駆動機構１０に減圧状態解除機構を付与することができる。
【００１８】
次に、穿刺開始スイッチを含む穿刺針駆動機構１０の作動を検知し、検知結果に基づいて吸引機構１２を作動を開始させる吸引機構作動機能ならびに吸引機構１２の作動停止を行う吸引機構制御部および体液接触後の検出チップ２５の状態を検出するための検出機構について説明する。
この実施例の体液検査装置１は、体液接触後の検出チップ２５の状態を検出するための検出機構として、検出チップ２５に光を当てるための発光素子１０４と発光素子１０４より照射され検出チップ２５にて反射される反射光を受光するための受光素子１０５を備え、受光素子からはその受光光量に応じたアナログ信号が出力され、増幅部１０６により増幅された後、ＡＤ変換器１０７にてデジタル信号に変換され、後述する制御部１００に入力される。発光素子および受光素子を用いた反射光量の測定（検出チップ２５の検出）は、制御部から測定終了の判断がなされるまで一定時間間隔（例えば、１秒ごと）で継続して行われる。
【００１９】
また、この実施例の体液検査装置１は、チップ穿刺針組立体装着監視センサ１０３、蓋開閉センサ１１５を備え、体液検査装置１の休止状態から測定可能な状態までを検知可能となっている。具体的には、蓋開閉センサ１１５により蓋部材２ｂの開放が検知され、かつ、チップ穿刺針組立体装着監視センサ１０３によりチップ穿刺針組立体の装着が確認されたことにより、測定可能な状態であることを検知する。
蓋開閉センサ１１５としては、機械式が好ましいが電気式、光式でもよい。体液検査装置１は、検出チップ２５での反応を光学的に測定する際、ケース２の蓋部材２ｂおよびこの蓋部材２ｂに設けられた保護カバー４により、検出チップ２５への外光の侵入を阻止し、測定精度を向上させている。
【００２０】
図１０に、この実施例の体液検査装置１の電気的構成部分のブロック図を示す。
体液検査装置１は、発光素子１０４、受光素子１０５と受光素子１０５のための増幅部１０６ならびに増幅部１０６より出力される信号を返還するＡＤ変換器１０７からなる受光信号形成部、電源部（電池）１１４、蓋開閉検出センサ１１５、穿刺針駆動機構内部の圧力を検知するための圧力センサ１０８、吸引ポンプ１２ａ、穿刺開始検出センサ１１０、チップ穿刺針組立体装着監視センサ１０３、表示部５、音声出力部１１３、メモリ１１２、外部出力部１１１を備えており、それらは、制御部１００に電気的に接続されている。そして、制御部１００、増幅部ならびに増幅部より出力される信号を返還するＡＤ変換器、メモリは、基板２４上に取り付けられている。
【００２１】
制御部１００は、マイクロコンピュータで構成され、受光素子１０５からの信号（正確には、受光信号形成部より出力される信号）に基づいて目的とする例えば血糖のような血中成分を算出する演算機能を有する。さらに、制御部１００は、発光素子、吸引ポンプ、表示部、音声出力部、メモリ、外部出力部を制御する。
表示部は、制御部１００からの信号に基づいて体液検査結果などを表示するためのものであり、液晶ディスプレイが好適に使用される。また、音声出力部は、制御部１００（体液状態評価機構）からの信号に基づいてブザー音または体液検査結果を音声により出力するものである。外部出力部１１１は、メモリ（記憶部）に記憶された体液検出結果（例えば、血糖値等のデータ）をパソコンのような外部装置へ出力するためのものである。この場合、外部出力部１１１は、例えばＲＳ２３２Ｃのような通信ドライバーを内蔵している。また、赤外線通信を行う場合には、外部出力部１１１は、赤外線発光素子およびその駆動回路が用いられる。メモリは、体液検出結果（例えば、血糖値等のデータ）を測定時間とともに記憶するためのものである。
【００２２】
チップ穿刺針組立体装着監視センサ１０３は、穿刺具が穿刺可能な位置まで、押し込まれているか検知するためのものであり、磁気式センサ、機械式センサ、光式センサいずれでもよいが、磁気センサが好適である。なお、このチップ穿刺針組立体装着監視センサ１０３を設けず、発光素子１０４と受光素子１０５により、未使用チップ穿刺針組立体の反射光を受光することにより、チップ穿刺針組立体の装着を確認するものでもよい。
穿刺開始検出センサは、穿刺が開始したことを検出するセンサであり、穿刺開始スイッチに直接もしくは穿刺針駆動機構１０の穿刺時に駆動する部位に設けられる。穿刺開始検出センサとしても、磁気式センサ、機械式センサ、光式センサいずれでもよい。また、圧力センサ１０８は、吸引ポンプと穿刺針駆動機構内部とを連通するチューブ内に設けられている。圧力センサとしては、例えば、半導体型圧力センサが好適に使用される。なお、圧力センサは、穿刺針駆動機構内部に設けてもよい。この圧力センサを設けることにより、ポンプ作動時の体液吸引が正しく行われているか監視することができる。具体的には、指２３とチップ穿刺針組立体２２の開口部との接触が正しく行われずリークが起きていることが検知でき、これを制御部１００により表示部による警告表示もしくは音声出力部によりエラーメッセージを出力することができる。
【００２３】
次に体液検査装置１を用いた体液の採取、測定をする際の各部の操作について説明する。
体液検査装置１のケース２の蓋部材２ｂが開かれると、蓋が開かれたことを蓋開閉センサ１１５が制御部１００に伝え、チップ穿刺針組立体２２取り付けの指示を表示部５に表示する。次にチップ穿刺針組立体２２をチップ穿刺針組立体装着部７にセットし、プランジャー２８の係止用爪部１９がハウジング２７の開口部と係合する状態まで押し込む。これにより、図７に示す状態となり、ばね１８は圧縮状態で保持される。この状態において、受光素子は作動しており、検出された信号は変換器で変換され制御部に入力され、チップ穿刺針組立体２２が取り付けられたことを制御部が判断する。同時にチップ穿刺針組立体装着監視センサ１０３により、穿刺具が穿刺可能な位置まで、押し込まれているか検知し、検知結果は制御部に入力される。チップ穿刺針組立体２２が穿刺可能な位置まで押し込まれたことが確認されると、表示部５に穿刺開始可能状態の表示を行う。
【００２４】
次に、図６のようにチップ穿刺針組立体２２先端の吸引口２６を指等の穿刺部位に押し当て穿刺開始スイッチ部材３を図７の矢印方向に押すと、開始ボタンの係合解除用チップ部３ｂにより、ハウジング２７の係合用爪侵入用開口部部分（開口部に侵入した爪部の先端部）を開口部カバー９を介して押圧し、プランジャー２８の係止用爪部１９のハウジング２７の開口部との係合を解除する。これにより、弾性部材１８が圧縮状態から解放されランセット１６と穿刺針ホルダー部２０は加速前進し、ランセット１６の刃先による皮膚への穿刺が行われる（図８）。穿刺後ランセット１６と穿刺針ホルダー部２０は、弾性部材１８の減衰運動によりケース２内に収納される（図９）。
【００２５】
また、穿刺開始センサにより穿刺開始が検知されると、制御部１００は、電動式ポンプ１２ａを動作させ、穿刺針による指先の穿刺部位を含む周辺部位を吸引するために穿刺針駆動機構内部を吸引する。なお、穿刺開始センサを設けることなく、穿刺開始スイッチにより、直接吸引手段が作動するようにしてもよい。また、吸引ポンプの作動開始のタイミングは穿刺が行われたと同時に行われても、若干遅れて作動するようにしてもよい。吸引ポンプによる圧力は陰圧で、２００ｍｍＨｇ〜６００ｍｍＨｇが好ましく、特に４００ｍｍＨｇ以上が好ましい。これにより、短時間で必要量の血液を穿刺部位より流出させることができる。皮膚上に出血した体液はチップ内壁の溝を伝って試験紙に染み込む。この状態で測定が開始し、その結果が表示部５に表示される（図６）。測定終了後はチップ穿刺針組立体リリースレバー６によりチップ穿刺針組立体２２を装着部７から外し、測定が終了する。
【００２６】
そして、この実施例の体液検査装置１では、制御部を備え、制御部は、検出機構により検出される検出チップ２５の状態変化信号を用いて、吸引機構１２の作動が停止するように制御するものである。このため、制御部１００は、デジタル信号として入力される受光素子の電圧変化により、検出チップ２５に体液が吸引されたことを判断可能であり、これを用いて吸引ポンプの作動終了を制御する。なお、このような方法に限らず、予め設定した時間により自動的に吸引ポンプを停止するように制御してもよい。
そして、検出チップ２５に体液が供給されると、体液中の成分（例えば、グルコース）と試験紙に含まれる試薬とが反応し、色の変化が生じこれを発光素子および受光素子を用いて変化程度を検知し、これより体液性状（例えば、血糖値）を演算する。
【００２７】
【発明の効果】
本発明の体液検査装置は、皮膚を穿刺して微量の体液を採取し該体液の成分を測定するための体液検査装置であって、該体液検査装置は、ケースと、該体液検査装置に着脱可能に装着されるとともに指先穿刺のために突出可能な穿刺針を備える穿刺部材と、該体液検査装置に着脱可能に装着されるとともに、体液中の特定成分と反応する試薬を含む検出チップおよび該検出チップへの体液誘導路を備える検出チップ部材と、穿刺部材装着部と穿刺開始スイッチと前記穿刺部材装着部を付勢するための弾性部材とを備えるとともに、穿刺針突出部を除き実質的に気密に形成された穿刺針の一時的な突出を行うための穿刺針駆動機構と、電動ポンプを備え、前記穿刺針駆動機構内部を吸引することにより穿刺針による指先の穿刺部位を含む周辺部位を吸引するための吸引機構と、前記穿刺開始スイッチを含む穿刺針駆動機構の作動を検知し、該検知結果に基づいて吸引機構を作動を開始させる吸引機構作動機能ならびに吸引機構の作動停止を行う吸引機構制御機構と、該吸引機構による穿刺針駆動機構内の減圧状態を解除するための減圧状態解除機構と、体液接触後の前記検出チップの状態を検出するための検出機構と、該検出機構による検出結果より体液状態を評価する体液状態評価機構と、該体液状態評価機構による評価結果を表示する表示機構とを有している。
特に吸引手段を備えるため体液採取を確実に行うことができ、かつ減圧状態解除機構を備えることにより、過剰な減圧状態の持続を防止でき穿刺部位への負担も少なく、さらに、体液の装置内部への付着も極めて少ない。
【図面の簡単な説明】
【図１】図１は、本発明の体液検査装置の一実施例の正面図である。
【図２】図２は、図１に示した体液検査装置より保護カバーを取り外した状態の平面図である。
【図３】図３は図１に示した体液検査装置のケース部分を破断した内部構造説明図である。
【図４】図４は、図１に示した体液検査装置へのチップ穿刺針組立体の装着過程を説明するための説明図である。
【図５】図５は、図１に示した体液検査装置にチップ穿刺針組立体を装着した状態を示す図である。
【図６】図６は、図５に示した体液検査装置に指を挿入した状態を示す図である。
【図７】図７は、図１に示した体液検査装置にチップ穿刺針組立体を装着した状態の断面図である。
【図８】図８は、図１に示した体液検査装置により指が穿刺された状態の断面図である。
【図９】図９は、図１に示した体液検査装置による検査が終了した状態の断面図である。
【図１０】図１０は、本発明の体液検査装置の回路構成を示すブロック図である。
【符号の説明】
１体液検査装置
２ケース
２ａケース本体
２ｂ蓋部材
３穿刺開始スイッチ部材
４カバー
５表示機構
７装着部
８開口部
１０穿刺針駆動機構
１１穿刺器具
１２吸引機構
１２ａ電動ポンプ（吸引ポンプ）
１２ｂチューブ
１６穿刺部材
１８弾性部材
２２チップ穿刺針組立体
３１減圧状態解除機構
１００制御部
１０３チップ穿刺針組立体装着監視センサ
１０４発光素子
１０５受光素子
１０８圧力センサ
１１０穿刺開始検出センサ[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a bodily fluid testing device that performs testing by puncturing a puncture needle on the surface of a living body such as a fingertip when testing bodily fluids such as blood.
[0002]
[Prior art]
In recent years, with the increase in the number of diabetic patients, self blood glucose level measurement in which patients themselves monitor fluctuations in daily blood glucose levels has been recommended. For self blood glucose level measurement, a test paper that is colored according to the amount of glucose in the blood is attached, blood is supplied to the test paper, and the degree of coloration is measured optically (color measurement) to determine the blood glucose level. A blood glucose meter that quantifies the blood glucose level is used. Prior to this measurement, the patient needs to squeeze out the blood by pressing the skin around the puncture portion with a finger or the like after puncturing the skin of the fingertip using a puncture tool equipped with a puncture needle or a knife. And since the puncture device and the blood glucose measuring device are separate, it is necessary to switch from the puncture device to the blood glucose measuring device in the state of bleeding, and the operability is poor, which is not preferable from the viewpoint of hygiene.
[0003]
Therefore, a device in which a conventional puncture device and a blood glucose measuring device are integrated is disclosed in Japanese Patent Laid-Open No. 6-339473. This blood glucose meter includes a puncturing means, a means for transferring body fluid to the chemical reagent for body fluid, and a means for optically measuring the chemical reagent for body fluid and displaying the result in the housing. However, in this blood glucose meter, since the amount of bleeding is insufficient even when puncturing is performed, it is necessary to squeeze the body fluid by squeezing with a finger or the like after puncturing, and there is not much difference in operability from the conventional one. Another blood glucose measuring device is disclosed in JP-A-9-276235. This blood glucose meter includes a puncturing means, a compression band for pressing a finger, and a means for measuring and displaying a body fluid component in the housing. However, although this blood glucose meter can collect a necessary amount of body fluid due to the effect of the compression band, when the finger is pulled out from the compression band after use, the body fluid remaining on the fingertip adheres to the compression band and causes infection, etc. Have the risk of
[0004]
[Problems to be solved by the invention]
An object of the present invention is to provide a bodily fluid test apparatus that can continuously perform puncture, bodily fluid collection, and measurement in view of the above-described problems of the prior art and that is extremely unlikely to cause bodily fluid adhesion.
[0005]
[Means for Solving the Problems]
What achieves the above-mentioned object is a bodily fluid testing device for puncturing the skin to collect a small amount of bodily fluid and measuring the components of the bodily fluid, the bodily fluid testing device comprising a case, Chip puncture in which a puncture member including a puncture needle that can be protruded for fingertip puncture, a detection chip including a reagent that reacts with a specific component in body fluid, and a detection chip member including a body fluid guiding path to the detection chip are integrated A needle assembly, a mounting portion for detachably mounting the chip puncture needle assembly, and a chip puncture needle assembly mounting confirmation mechanism for detecting mounting of the chip puncture needle assembly to the mounting portion; A puncture member mounting portion, a puncture start switch, and an elastic member for biasing the puncture member mounting portion, and for temporarily projecting a puncture needle formed substantially airtight except for the puncture needle projection portion A puncture needle drive mechanism, a puncture needle drive mechanism for temporarily projecting the puncture needle formed substantially air-tight except for the puncture needle protrusion, and an electric pump, and the inside of the puncture needle drive mechanism The operation of the suction mechanism for sucking the peripheral part including the puncture part of the fingertip by the puncture needle by suction and the operation of the puncture needle drive mechanism including the puncture start switch are detected, and the operation of the suction mechanism based on the detection result A suction mechanism operation function for starting the suction mechanism, a suction mechanism control mechanism for stopping the operation of the suction mechanism, a decompression state release mechanism for releasing the decompression state in the puncture needle drive mechanism by the suction mechanism, and a body fluid contact A detection mechanism for detecting the state of the detection chip, a body fluid state evaluation mechanism for evaluating a body fluid state from a detection result by the detection mechanism, and a display mechanism for displaying an evaluation result by the body fluid state evaluation mechanism A body fluid testing device.
And Said The tip puncture needle assembly includes an annular opening that can be in close contact with a fingertip above the cutting edge of the puncture needle, one end opening of the body fluid guiding path projects into the annular opening, and the other end extends to the tip It is preferable that
[0006]
Furthermore, it is preferable that the tip puncture needle assembly mounting confirmation mechanism is a tip puncture needle assembly mounting monitoring sensor that detects whether the puncturing member is pushed to a puncturable position. Furthermore, the chip puncture needle assembly mounting confirmation mechanism may be configured to confirm the mounting of the chip puncture needle assembly by receiving reflected light of the unused chip puncture needle assembly by a light emitting element and a light receiving element. preferable. Furthermore, it is preferable that the suction mechanism control is to stop the operation of the suction mechanism using a state change signal of the detection chip detected by the detection mechanism. Moreover, it is preferable that the said pressure reduction state cancellation | release mechanism is a micro intake port which connects the pressure reduction formation space decompressed by the said suction mechanism, and the exterior of this pressure reduction formation space. Further, the reduced pressure state release mechanism may be a valve capable of communicating a reduced pressure forming space decompressed by the suction mechanism and the outside of the reduced pressure forming space. And it is preferable that the said bodily fluid test | inspection apparatus is equipped with the pressure detection part for detecting the pressure in the puncture needle drive mechanism decompressed by the said suction mechanism. The bodily fluid testing device includes a control unit including the suction mechanism control mechanism and the bodily fluid state evaluation mechanism, and a pressure sensor for detecting the pressure inside the puncture needle drive mechanism electrically connected to the control unit, It is preferable to include a puncture start detection sensor and a display unit for detecting the puncture start by the puncture needle.
[0007]
DETAILED DESCRIPTION OF THE INVENTION
The bodily fluid test | inspection apparatus of this invention is demonstrated in detail based on the preferred Example shown on drawing.
FIG. 1 is an external view of an embodiment of a bodily fluid testing device of the present invention, FIG. 2 is a plan view with a protective cover removed from the bodily fluid testing device shown in FIG. 1, and FIG. 3 is a bodily fluid testing shown in FIG. It is internal structure explanatory drawing which fractured | ruptured the case part of the apparatus.
The body fluid testing device 1 of the present invention is a body fluid testing device for puncturing the skin to collect a small amount of body fluid and measuring the components of the body fluid. The body fluid testing device 1 is detachably attached to the case 2, the puncture member 16 that is detachably attached to the case 2 and includes a puncture needle that can protrude into the opening 8 for puncturing the fingertip, and the case 2. In addition, the detection chip 25 including a reagent that reacts with a specific component in the body fluid, the detection chip member including the body fluid guiding path to the detection chip 25, the puncture member mounting portion, the puncture start switch, and the puncture member mounting portion are energized. A puncture needle drive mechanism 10 for temporarily projecting the puncture needle formed substantially air-tight except for the puncture needle protrusion, and an electric pump 12a. By detecting the inside of the drive mechanism, the operation of the suction mechanism 12 for sucking the peripheral part including the puncture part of the fingertip by the puncture needle and the puncture needle drive mechanism 10 including the puncture start switch are detected. Based on this detection result, the suction mechanism 12 for starting the operation of the suction mechanism 12 and starting the operation of the suction mechanism 12 and stopping the operation of the suction mechanism 12, and the decompression state release for releasing the decompression state by the suction mechanism 12 The mechanism 31, a detection mechanism for detecting the state of the detection chip 25 after contact with the body fluid, a body fluid state evaluation mechanism for evaluating the body fluid state from the detection results of the detection mechanisms 104 and 105, and an evaluation result by the body fluid state evaluation mechanism And a display mechanism 5 for displaying.
[0008]
The body fluid testing device 1 according to this embodiment includes a case 2 and an internal mechanism housed in the case 2. In the embodiment shown in FIGS. 1 to 5, the case 2 includes a case main body 2a and a lid member 2b having one end portion rotatably attached to the case main body 2a. The lid member 2b includes an opening 8 into which a fingertip can be inserted, and a cover 4 attached to the side surface of the opening 8. The lid member may not be provided. Further, the lid member does not include an opening or the like into which a fingertip can be inserted, and the case body 2a can be simply encapsulated with a mounting portion of a chip puncture needle assembly to be described later. The one end part may be rotatably attached. Further, as the lid member, the lid member may not be completely closed in a state where a chip puncture needle assembly, which will be described later, is mounted on the mounting portion.
The internal mechanism housed in the case body 2a includes a puncture needle driving mechanism 10 for temporarily projecting the puncture needle, and a suction mechanism 12 for sucking a peripheral portion including a puncture portion of the fingertip by the puncture needle. The body fluid state is evaluated from the decompression state release mechanism 31 for releasing the decompression state by the suction mechanism 12, the detection mechanisms 104 and 105 for detecting the state of the detection chip 25 after the body fluid contact, and the detection result by the detection mechanism. A body fluid state evaluation mechanism and a display mechanism 5 for displaying an evaluation result by the body fluid state evaluation mechanism.
[0009]
And in this bodily fluid test | inspection apparatus 1, in use, the detection chip | tip 25 containing the puncture member 16 provided with the puncture needle which can protrude for the fingertip puncture in the opening part 8, and the reagent which reacts with the specific component in body fluid, A detection chip member having a body fluid guiding path to the detection chip 25 is attached. In this embodiment, a tip puncture needle assembly 22 in which the puncture member 16 and the detection tip member are integrated is used, and the tip puncture needle assembly 22 is attached to the assembly mounting portion 7 of the body fluid testing device. Removably mounted. The tip puncture needle assembly 22 is replaced for each inspection. Further, as shown in FIG. 3, the lid member 2b is provided with a storage portion 15 in which a plurality of spare tip puncture needle assemblies 22 can be stored, and the upper surface of the lid member 2b is provided with a top surface as shown in FIG. A small window 17 for confirming the remaining number of unused tip puncture needle assemblies 22 is provided, and the remaining number of tip puncture needle assemblies can be confirmed from the outside.
[0010]
The chip puncture needle assembly 22 includes a puncture member (lancet) 16, a cylindrical member that movably accommodates the puncture member 16, and an assembly body member to which the distal end portion of the cylindrical member is fixed. The assembly is located above the cutting edge of the puncture needle of the puncture member 16 and includes an annular opening 26 and a detection chip 25 that can be in close contact with the fingertip. Further, one end opening projects into the annular opening 26 and the other end is A body fluid guiding path extending to the vicinity of the chip 25 is provided. For this reason, blood due to bleeding generated by being punctured by the puncture member 16 passes through the guide path and is sent to the detection chip 25.
The guide path is desirably designed to reduce the remaining amount of body fluid, although its cross-sectional shape and length vary depending on the amount of body fluid required for measurement. Specifically, the cross-sectional shape may be a tubular shape, a V-shaped groove, or a rectangular groove, but a thin rectangular shape is preferable because the remaining amount of body fluid can be reduced. The thickness is preferably about 0.05 to 0.5 mm, and the width is preferably about 0.5 to 3 mm. A length of about 5 mm to 15 mm is appropriate.
[0011]
The annular opening (suction port) 26 of the tip puncture needle assembly 22 is a part that contacts a living body surface such as a fingertip, upper arm, abdomen, thigh, or earlobe. The opening diameter (opening area) of the suction port 26 is adjusted so that suction blood can be collected satisfactorily regardless of individual differences such as sex and age, and the puncture site. Specifically, the opening diameter of the suction port 26 is preferably 4 to 10 mm, and more preferably 4 to 6 mm when the puncture site is a finger or an earlobe. The outer peripheral edge of the suction port 26 of the tip puncture needle assembly 22 has a shape suitable for exerting an effect of stimulating the periphery of the puncture portion when pressed against the surface of the living body (skin) and relieving pain during puncture. Yes. Further, when the inside of the puncture device 11 is in a decompressed state, the shape is suitable for preventing air from flowing into the puncture device 11 from between the tip puncture needle assembly 22 and the living body surface.
It is desirable to provide a body fluid introduction guide part at the edge of the guide path of the annular opening 26. The body fluid introduction guide portion has a function of guiding the body fluid to the guide path opening when the body fluid comes into contact therewith. As the bodily fluid guide portion, it is preferable to provide a rail-like guide so as to protrude on both the left and right sides of the periphery of the guide passage opening. The body fluid introduction guide portion preferably has a width of about 1 to 3 mm, a height of about 0.5 to 3 mm, and a length of about 1 to 3 mm.
The tip puncture needle assembly 22 is preferably made of a transparent or colored transparent material so that the bleeding state after the puncture can be visually confirmed, in order to ensure the internal visibility. It may be.
[0012]
The detection chip 25 is suitable for a target body fluid test. For example, when measuring glucose in blood, glucose oxidase, peroxidase and a color reagent are carried. Ingredients for measurement are not limited to glucose (blood glucose level), but include, for example, protein, cholesterol, uric acid, creatinine, alcohol, sodium etc Inorganic ions, hemoglobin (occult blood) and the like may be used. In addition, as the detection chip substrate, liquid-absorbing (hydrophilic) paper, film, nonwoven fabric, or the like is used.
The portion 7 exposed in the lid member 2b of the internal mechanism of the body fluid test apparatus 1 is the mounting portion 7 of the tip puncture needle assembly 22, and the mounting portion 7 is chamfered at four corners. In addition, it has a quadrangular prism shape that is obliquely cut from the center of the upper surface, and a gasket that is in close contact with the inner surface of the tip puncture needle assembly 22 is provided on the side surface.
[0013]
The puncture needle drive mechanism 10 for temporarily projecting the puncture needle includes a cylindrical housing 27, a plunger 28 that slides inside the housing 27, and a shaft 21 that is fixed to the rear end of the plunger 28. The adjustment cover 30 attached to the rear end of the housing 27 so as to enclose the rear end of the shaft 21, the elastic member (spring member) 18, and the opening cover that covers the side opening 27 a of the housing 27 9 and a puncture start switch member 3. The plunger 28 has a locking claw portion 19 that penetrates into the side opening 27a of the housing 27 on the side surface, can penetrate into the cylindrical member of the tip puncture needle assembly 22 at the tip, and punctures the puncture member 16 at the tip. A cylindrical puncture needle holder portion 20 capable of holding a needle hub is provided. One end (front end) of the elastic member 18 is fixed to the rear end (connecting portion with the shaft 21) of the plunger 28, covers the front end portion of the shaft, and the rear end is formed at the center of the housing 27. It is fixed to an elastic member fixing portion 29 protruding inward. Therefore, in a state where the locking claw portion 19 of the plunger 28 is engaged with the opening portion of the housing 27 as shown in FIG. 7, the elastic member 18 has the rear end of the plunger 28 and the elastic member of the housing 27. It is in a compressed state between the fixed portions 29. Further, the shaft 21 includes a rib 21a at the rear end portion, and the adjustment cover 30 includes a rib 30a provided at an intermediate portion thereof so as to be able to contact the rib 21a. The amount of protrusion of the puncture needle is adjusted by adjusting the position of the adjustment cover.
[0014]
Further, as shown in FIG. 9, the elastic member 18 is configured so that the tip of the puncture needle is open to the tip puncture needle assembly 22 when the locking claw portion 19 of the plunger 28 is not engaged with the opening of the housing 27. The length is such that it does not protrude from the part. For this reason, when the fingertip is pulled out after the puncture is completed, the puncture needle is not caught on the fingertip. The locking claw portion 19 of the plunger 28 has a rod-like shape with a predetermined length, one end (rear end) being fixed to the plunger 28 and the tip being a free end, and the tip slightly outward. It protrudes. For this reason, the claw portion 19 easily enters the engaging claw intrusion opening portion 27a provided in the housing 27, and both of them come into contact with each other (the front end surface of the claw portion and the inner end surface of the opening portion). , Engage. The side opening 27a is covered with the opening cover 9, and the puncture start switch member 3 is provided on the outer side. The switch member 3 includes a pressing operation portion 3a and a disengaging tip portion 3b, and the disengaging tip portion 3b opens a side opening portion of the housing 27 (a tip portion of a claw that has entered the opening portion). The outer cover 9 can be pressed from the outside. For this reason, when the switch member 3 is pressed, the puncture needle is urged by the compression release of the compressed spring as shown in FIG. 8, protrudes from the assembly 22 and punctures the finger 23. The chip puncture needle assembly 22 can puncture without limiting the puncture site.
[0015]
Note that the present invention is not limited to such a configuration. For example, the start of puncture is configured such that the tip puncture needle assembly 22 can be moved back and forth, and the tip puncture needle assembly 22 and the body fluid testing device 1 (case) A mechanical sensor such as a micro switch may be provided in the joint portion of 2), and the puncture may be started by slightly pushing the puncture site with the tip puncture needle assembly 22 in contact.
In addition, the body fluid testing device 1 of this embodiment is a mechanical chip puncture needle assembly for removing the chip puncture needle assembly 22 without touching the reagent portion or the body fluid spotted portion of the chip puncture needle assembly 22. A release lever 6 is provided. The release lever 6 has an exposed protrusion 6a. When the release lever 6 is moved in the direction of the arrow in FIG. 4, the tip puncture needle assembly 22 is detached from the mounting portion 7 by being pushed by the protrusion 6a.
[0016]
Next, the suction mechanism 12 for sucking a peripheral part including the puncture part of the fingertip by the puncture needle and the reduced pressure state release mechanism 31 for releasing the reduced pressure state by the suction mechanism 12 will be described.
The suction mechanism 12 includes a suction pump (electric pump) 12a, a tube 12b connecting the suction pump 12a and the cylindrical housing 27 of the puncture needle drive mechanism 10, and an exhaust pipe 12c connected to the suction pump 12a. The decompression state release mechanism 31 is constituted by a decompression release valve provided in the middle of the tube 12b. For this reason, the inside of the cylindrical housing 27 of the puncture needle drive mechanism 10 is substantially airtight except for an opening 26 (a portion that is closed by a finger during use) from which the puncture needle 16 protrudes. By depressurizing the inside of the cylindrical housing 27 of the puncture needle drive mechanism 10, it is possible to suck a finger portion that is in close contact with the opening. As the suction pump (electric pump), an electric suction pump such as a linear motion type (piston type or diaphragm type), a rotary motion type, or a sliding motion type is used. The decompression state release mechanism 31 may be provided directly on the suction pump or on the cylindrical housing 27 of the puncture needle drive mechanism 10.
[0017]
Any decompression release valve may be used as long as it can perform flow control or pressure control mechanically, electromagnetically, or mechanically. For example, a throttle valve, a flow rate adjustment valve, a solenoid valve, etc. are mentioned. Further, as the throttle valve, one using a fine tube is suitable, and in the illustrated embodiment, a throttle valve (low intake valve) made up of a fine tube is used. The diameter (inner diameter) of the micro-thin tube is determined from the exhaust speed of the electric pump and the gas flow rate from the narrow tube. Note that the reduced pressure state release mechanism may be achieved by providing a slightly low degree of airtightness of the cylindrical housing 27 of the puncture needle drive mechanism 10 without providing a special configuration as described above. Specifically, it is conceivable to provide pores on the side surface of the housing 27 and to provide a slight gap between the housing 27 and the fixing portion of the adjustment cover 30. A reduced pressure release mechanism can be provided to the puncture needle drive mechanism 10 by a minute intake port formed by these pores, a low-volume intake valve, and the like.
[0018]
Next, the operation of the puncture needle drive mechanism 10 including the puncture start switch is detected, a suction mechanism operation function for starting the operation of the suction mechanism 12 based on the detection result, and a suction mechanism control unit for stopping the operation of the suction mechanism 12; A detection mechanism for detecting the state of the detection chip 25 after the body fluid contact will be described.
The body fluid testing device 1 of this embodiment is irradiated with light from the light emitting element 104 and the light emitting element 104 for applying light to the detection chip 25 as a detection mechanism for detecting the state of the detection chip 25 after the body fluid contact. The light receiving element 105 for receiving the reflected light reflected by the light is output from the light receiving element. An analog signal corresponding to the amount of received light is output from the light receiving element and amplified by the amplifying unit 106 and then digitally converted by the AD converter 107. It is converted into a signal and input to the control unit 100 described later. The measurement of the amount of reflected light using the light emitting element and the light receiving element (detection by the detection chip 25) is continuously performed at regular time intervals (for example, every second) until the control unit determines that the measurement is finished.
[0019]
In addition, the body fluid testing device 1 of this embodiment includes a chip puncture needle assembly mounting monitoring sensor 103 and a lid opening / closing sensor 115, and can detect from a resting state to a measurable state of the body fluid testing device 1. Specifically, when the lid opening / closing sensor 115 detects the opening of the lid member 2b and the chip puncture needle assembly mounting monitoring sensor 103 confirms the mounting of the chip puncture needle assembly, Measurement Detect that it can be determined.
The lid opening / closing sensor 115 is preferably a mechanical type, but may be an electric type or an optical type. When the body fluid test apparatus 1 optically measures the reaction at the detection chip 25, the cover member 2b of the case 2 and the protective cover 4 provided on the cover member 2b prevent external light from entering the detection chip 25. Prevents and improves measurement accuracy.
[0020]
In FIG. 10, the block diagram of the electrical component part of the bodily fluid test | inspection apparatus 1 of this Example is shown.
The body fluid testing device 1 includes a light-emitting element 104, a light-receiving element 105, an amplifier 106 for the light-receiving element 105, and a light-receiving signal forming unit including an AD converter 107 that returns a signal output from the amplifier 106. ) 114, lid open / close detection sensor 115, pressure sensor 108 for detecting the pressure inside the puncture needle drive mechanism, suction pump 12a, puncture start detection sensor 110, tip puncture needle assembly attachment monitoring sensor 103, display unit 5, sound An output unit 113, a memory 112, and an external output unit 111 are provided, and these are electrically connected to the control unit 100. An AD converter and a memory that return a signal output from the control unit 100, the amplification unit, and the amplification unit are mounted on the substrate 24.
[0021]
The control unit 100 is configured by a microcomputer, and calculates a target blood component such as blood glucose based on a signal from the light receiving element 105 (more precisely, a signal output from the light receiving signal forming unit). It has a function. Further, the control unit 100 controls the light emitting element, the suction pump, the display unit, the audio output unit, the memory, and the external output unit.
The display unit is for displaying a body fluid test result based on a signal from the control unit 100, and a liquid crystal display is preferably used. The sound output unit outputs a buzzer sound or a body fluid test result by sound based on a signal from the control unit 100 (body fluid state evaluation mechanism). The external output unit 111 is a memory (storage unit). In This is for outputting the stored body fluid detection result (for example, data such as blood glucose level) to an external device such as a personal computer. In this case, the external output unit 111 incorporates a communication driver such as RS232C. When performing infrared communication, the external output unit 111 uses an infrared light emitting element and its drive circuit. The memory is for storing a body fluid detection result (for example, data such as a blood glucose level) together with a measurement time.
[0022]
The chip puncture needle assembly mounting monitoring sensor 103 is for detecting whether or not the puncture tool has been pushed to a puncturable position, and may be any of a magnetic sensor, a mechanical sensor, and an optical sensor. Is preferred. The chip puncture needle assembly mounting monitoring sensor 103 is not provided, and the reflected light of the unused chip puncture needle assembly is received by the light emitting element 104 and the light receiving element 105, thereby confirming the mounting of the chip puncture needle assembly. You may do it.
The puncture start detection sensor is a sensor that detects that puncture has started, and is provided directly to the puncture start switch or at a site that is driven when the puncture needle drive mechanism 10 is punctured. The puncture start detection sensor may be any of a magnetic sensor, a mechanical sensor, and an optical sensor. The pressure sensor 108 is provided in a tube that communicates the suction pump and the inside of the puncture needle drive mechanism. As the pressure sensor, for example, a semiconductor type pressure sensor is preferably used. The pressure sensor may be provided inside the puncture needle drive mechanism. By providing this pressure sensor, it is possible to monitor whether or not the body fluid suction is correctly performed when the pump is operated. Specifically, it is possible to detect that the finger 23 and the opening of the tip puncture needle assembly 22 are not correctly contacted and that a leak has occurred, and this is detected by the control unit 100 by means of a warning display on the display unit or a voice output unit An error message can be output.
[0023]
Next, the operation of each part when collecting and measuring body fluid using the body fluid testing device 1 will be described.
When the lid member 2b of the case 2 of the body fluid testing device 1 is opened, the lid opening / closing sensor 115 notifies the control unit 100 that the lid has been opened, and displays an instruction to attach the chip puncture needle assembly 22 on the display unit 5. . Next, the tip puncture needle assembly 22 is set on the tip puncture needle assembly mounting portion 7 and pushed in until the locking claw portion 19 of the plunger 28 engages with the opening of the housing 27. Thereby, it will be in the state shown in FIG. 7, and the spring 18 will be hold | maintained in a compression state. In this state, the light receiving element is activated, and the detected signal is converted by the converter and input to the control unit, and the control unit determines that the tip puncture needle assembly 22 is attached. At the same time, the tip puncture needle assembly mounting monitoring sensor 103 detects whether or not the puncture tool has been pushed into a puncturable position, and the detection result is input to the control unit. When it is confirmed that the tip puncture needle assembly 22 has been pushed to a position where puncturing is possible, the display unit 5 displays a puncture startable state.
[0024]
Next, when the suction port 26 at the tip of the tip puncture needle assembly 22 is pressed against the puncture site such as a finger as shown in FIG. 6 and the puncture start switch member 3 is pushed in the direction of the arrow in FIG. By the tip portion 3b, the engaging claw intrusion opening portion of the housing 27 (the front end portion of the claw portion that has entered the opening portion) is pressed through the opening cover 9, and the locking claw portion 19 of the plunger 28 is pressed. The engagement with the opening of the housing 27 is released. As a result, the elastic member 18 is released from the compressed state, and the lancet 16 and the puncture needle holder portion 20 are accelerated and advanced, and puncture of the skin with the cutting edge of the lancet 16 is performed (FIG. 8). The post-puncture lancet 16 and the puncture needle holder 20 are housed in the case 2 by the damping movement of the elastic member 18 (FIG. 9).
[0025]
When the puncture start sensor detects the puncture start, the control unit 100 operates the electric pump 12a to suck the inside of the puncture needle drive mechanism in order to suck the peripheral part including the puncture part of the fingertip by the puncture needle. To do. Note that the suction means may be operated directly by the puncture start switch without providing the puncture start sensor. Moreover, the timing of starting the operation of the suction pump may be performed with a slight delay even if it is performed simultaneously with the puncture. The pressure by the suction pump is a negative pressure, preferably 200 mmHg to 600 mmHg, particularly preferably 400 mmHg or more. Thereby, a required amount of blood can be discharged from the puncture site in a short time. Body fluid that bleeds onto the skin penetrates the groove on the inner wall of the chip and soaks into the test paper. Measurement starts in this state, and the result is displayed on the display unit 5 (FIG. 6). After the measurement is completed, the tip puncture needle assembly 22 is removed from the mounting portion 7 by the tip puncture needle assembly release lever 6, and the measurement is completed.
[0026]
And the bodily fluid test | inspection apparatus 1 of this Example is provided with a control part, and a control part is controlled so that the action | operation of the suction mechanism 12 stops using the state change signal of the detection chip 25 detected by a detection mechanism. Is. For this reason, the control unit 100 can determine that the body fluid has been sucked into the detection chip 25 based on the voltage change of the light receiving element input as a digital signal, and uses this to control the end of the operation of the suction pump. Note that the present invention is not limited to such a method, and the suction pump may be automatically stopped at a preset time.
When the body fluid is supplied to the detection chip 25, a component (for example, glucose) in the body fluid reacts with the reagent contained in the test paper, and a color change occurs, which is changed using the light emitting element and the light receiving element. The degree of fluid is detected, and the body fluid property (for example, blood glucose level) is calculated from the degree.
[0027]
【The invention's effect】
The bodily fluid testing device of the present invention is a bodily fluid testing device for puncturing the skin, collecting a small amount of bodily fluid, and measuring the components of the bodily fluid, and the bodily fluid testing device is attached to and detached from the case and the bodily fluid testing device A puncture member comprising a puncture needle that is detachably mounted and projectable for fingertip puncture, a detection chip that is detachably mounted on the bodily fluid testing device and includes a reagent that reacts with a specific component in the bodily fluid, and the A detection chip member having a body fluid guiding path to the detection chip, a puncture member mounting portion, a puncture start switch, and an elastic member for biasing the puncture member mounting portion, and substantially excluding the puncture needle protruding portion A peripheral portion including a puncture needle drive mechanism for temporarily projecting an airtight puncture needle and an electric pump, and including a puncture site of a fingertip by a puncture needle by sucking the inside of the puncture needle drive mechanism Detecting the operation of the suction mechanism for sucking the puncture needle and the puncture needle drive mechanism including the puncture start switch, and based on the detection result, the suction mechanism operation function for starting the operation of the suction mechanism and the operation of the suction mechanism are stopped. A suction mechanism control mechanism, a decompression state release mechanism for releasing the decompression state in the puncture needle drive mechanism by the suction mechanism, a detection mechanism for detecting the state of the detection chip after contact with body fluid, and the detection mechanism A body fluid state evaluation mechanism that evaluates the body fluid state from the detection result obtained by, and a display mechanism that displays the evaluation result by the body fluid state evaluation mechanism.
In particular, since it is equipped with a suction means, it is possible to reliably collect body fluid, and by providing a decompression state release mechanism, it is possible to prevent excessive decompression state from being sustained and to reduce the burden on the puncture site, and further to the inside of the body fluid device There is also very little adhesion.
[Brief description of the drawings]
FIG. 1 is a front view of an embodiment of a body fluid testing device according to the present invention.
FIG. 2 is a plan view of a state in which a protective cover is removed from the body fluid test device shown in FIG.
FIG. 3 is an explanatory diagram of an internal structure in which a case portion of the body fluid testing device shown in FIG. 1 is broken.
4 is an explanatory view for explaining a process of mounting the tip puncture needle assembly to the body fluid testing device shown in FIG. 1; FIG.
FIG. 5 is a view showing a state in which a chip puncture needle assembly is mounted on the body fluid test apparatus shown in FIG. 1;
6 is a view showing a state where a finger is inserted into the body fluid testing device shown in FIG. 5. FIG.
7 is a cross-sectional view of a state in which the tip puncture needle assembly is mounted on the body fluid test apparatus shown in FIG. 1. FIG.
FIG. 8 is a cross-sectional view of a state where a finger is punctured by the body fluid testing device shown in FIG.
9 is a cross-sectional view of a state where the inspection by the body fluid inspection device shown in FIG. 1 has been completed.
FIG. 10 is a block diagram showing a circuit configuration of the body fluid testing device of the present invention.
[Explanation of symbols]
1 Body fluid testing device
2 cases
2a Case body
2b Lid member
3 Puncture start switch member
4 Cover
5. Display mechanism
7 Wearing part
8 opening
10 Puncture needle drive mechanism
11 Puncture device
12 Suction mechanism
12a Electric pump (suction pump)
12b tube
16 Puncture member
18 Elastic member
22 Tip puncture needle assembly
31 Depressurized state release mechanism
100 Control unit
103 Chip puncture needle assembly mounting monitoring sensor
104 Light emitting device
105 Light receiving element
108 Pressure sensor
110 Puncture start detection sensor

Claims

A body fluid testing device for puncturing the skin to collect a small amount of body fluid and measuring the components of the body fluid, the body fluid testing device comprising a case and a puncture needle that can project for fingertip puncture A chip puncture needle assembly in which a detection chip including a reagent that reacts with a specific component in body fluid and a detection chip member having a body fluid guiding path to the detection chip, and the chip puncture needle assembly are detachable A mounting portion to be mounted on the chip, a chip puncture needle assembly mounting confirmation mechanism for detecting mounting of the tip puncture needle assembly to the mounting portion , a puncture member mounting portion, a puncture start switch, and the puncture member mounting portion being energized A puncture needle drive mechanism for temporarily projecting the puncture needle formed substantially airtight except for the puncture needle protrusion and a substantially airtight except for the puncture needle protrusion Drilling formed on A puncture needle drive mechanism for temporarily projecting the needle and an electric pump, and a suction mechanism for sucking the inside of the puncture needle drive mechanism to suck a peripheral part including a puncture part of a fingertip by the puncture needle A suction mechanism operating function for detecting the operation of the puncture needle drive mechanism including the puncture start switch and starting the operation of the suction mechanism based on the detection result; and a suction mechanism control mechanism for stopping the operation of the suction mechanism; The reduced pressure state release mechanism for releasing the reduced pressure state in the puncture needle drive mechanism by the suction mechanism, the detection mechanism for detecting the state of the detection chip after contacting the body fluid, and the body fluid state from the detection result by the detection mechanism A bodily fluid test apparatus comprising: a bodily fluid state evaluating mechanism to be evaluated; and a display mechanism for displaying an evaluation result by the bodily fluid state evaluating mechanism.

The tip puncture needle assembly includes an annular opening that can be in close contact with a fingertip above the cutting edge of the puncture needle, one end opening of the body fluid guiding path projects into the annular opening, and the other end extends to the tip. The bodily fluid test | inspection apparatus of Claim 1 which is a thing.

3. The body fluid testing device according to claim 1, wherein the tip puncture needle assembly mounting confirmation mechanism is a tip puncture needle assembly mounting monitoring sensor that detects whether the puncture member is pushed to a puncturable position.

The chip puncture needle assembly mounting confirmation mechanism is configured to confirm the mounting of the chip puncture needle assembly by receiving reflected light of an unused chip puncture needle assembly with a light emitting element and a light receiving element. 4. The body fluid testing device according to any one of 3 above.

The body fluid testing device according to any one of claims 1 to 4, wherein the suction mechanism control mechanism is configured to stop the operation of the suction mechanism using a state change signal of the detection chip detected by the detection mechanism.

The reduced pressure release mechanism, the body fluid testing device according to any one of the claims 1 is very small intake port communicating with the outside of the vacuum forming space and the pressure reduction space formed is reduced by the suction mechanism 5.

The reduced pressure release mechanism, the body fluid testing device according to any one of claims 1 is capable of communicating valve and external vacuum forming space and the pressure reduction space formed is reduced by the suction mechanism 5.

The body fluid testing device according to any one of claims 1 to 7 , further comprising a pressure detection unit for detecting a pressure in the puncture needle drive mechanism that is decompressed by the suction mechanism.

The bodily fluid testing device includes a control unit including the suction mechanism control mechanism and the bodily fluid state evaluation mechanism, and a pressure sensor for detecting a pressure inside the puncture needle drive mechanism that is electrically connected to the control unit, humoral testing apparatus according to any one of puncturing starting detection sensor for detecting the puncturing initiation by the puncture needle, and claims 1 and a display unit 8.