JP2006091022A - 小体積生体外分析物センサおよび関連する方法 - Google Patents
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Abstract
【解決手段】センサは、作用電極および対向電極を含み、かつ、前記センサのコネクタ中における正しい位置を決めるための挿入用モニタリングトレースを含むことができる。一の実施形態においては、前記センサは、サンプル中に一定量の電荷を放電し、前記電荷を放電するのにかかった時間を測定し、前記一定量の電荷および一定量の時間を用いて分析物の一部を電解するために用いた電流を測定することによって分析物の濃度を決定する。
【選択図】図3
Description
したがって、小体積のサンプル中における分析物濃度の正確で感度の高い分析を行うことが可能で、痛みが比較的少なく、容易に使用できる血液分析物センサを開発することは、望ましいことであり、また非常に有用である。
極を形成することを含む。スペーサー層を前記第1の基板もしくは第2の基板のいずれかに配置する。前記スペーサー層は、センサが完成したとき、サンプルを抽出し、保持するチャンバを規定する。レドックスメディエーターおよび/または第2の電子移動剤を、センサが完成したときサンプルチャンバ内に露出されることになる領域にある前記第1の基板もしくは第2の基板の上に配置することができる。その後、前記第1および第2の基板を揃え、スペーサーによって、少なくとも1つの作用電極および少なくとも1つの対向電極もしくは対向/参照電極とのアクセスを提供するサンプルチャンバとの間隔をあける。いくつかの実施形態においては、前記第1および第2の基板は、単一のシートもしくは連続する材料ウェブの一部をなす。本発明は、これらのセンサを作製するための特に有効かつ確実な方法を含む。
(好ましい実施形態の詳細な説明)
本明細書で使用される用語を下記定義により定義づける。
「生体液」は、分析物の測定が可能なあらゆる体液であり、例えば、血液( 全血および血漿および血清のような無細胞成分を含む) 、間質液、皮膚液(dermal fluid)、汗、涙、尿および唾液である。
り低下した結果生じる。
「対向している電極(facing electrode)」という語は、作用電極の作用面が対向電極の表面とほぼ対向するように配置されているような、作用電極と対向電極の配置を表す。少なくともいくつかの例においては、作用電極と対向電極との間の距離が、作用電極の作用面の幅よりも短い。
「指示電極」は、サンプルチャンバおよび/または測定域が部分的または完全に満たされたことを検出する電極である。
「測定域」は、本明細書中では、分析物アッセイで調べるつもりのサンプルの部分のみを収容する大きさに形成された、サンプルチャンバの領域である。
「対向/参照電極の電位」とは、セル中の溶液がpH7の0.1MのNaCl溶液であるときのセルの参照電極または対向/参照電極の半電池(half cell) 電位である。
「参照電極」には、対向電極としても機能する参照電極(すなわち、対向/参照電極)が、「参照電極」には対向/参照電極を含まれない旨が記載されていない限り、含まれるものとする。
「サンプルチャンバ内の表面」とは、作用電極、対向電極、対向/参照電極、参照電極
、指示電極、スペーサーの各面、またはサンプルチャンバに結合しているその他のあらゆる面を含む。
「作用面」とは、非浸出性レドックスメディエーターで被覆され、かつサンプルに露出している作用電極の部分であるか、または前記レドックスメディエーターが拡散性の場合、「作用面」は、前記サンプルに露出している前記作用電極の部分である。
図面全般、特に図1および2を参照すると、本発明の小体積生体外電気化学的センサ20は、通常、第1の基板32上に作用電極22、第2の基板34上に対向電極(対向/参照電極)24、およびサンプルチャンバ26を備えている。サンプルチャンバ26は、サンプルがチャンバ内に供給されると、サンプルが作用電極22、対向電極24および存在し得る全ての参照電極または支持電極と電解的に接触するように構成されている。これにより、電流が電極間を流れることができ、分析物の電気分解(電気酸化または電気還元)が引き起こされる。スペーサー33は、第1の基板32と第2の基板34の間に配置され、電極22、24間に空間を形成し、評価するつもりのサンプルを収納するサンプルチャンバ26を形成する。
作用電極22は、成形された炭素繊維複合体で形成することもできるし、または、ポリエステルのような不活性の非導電性基剤であって、好適な導電層を堆積させた基材で構成することもできる。前記導電層は、一般に、比較的低い電気抵抗を有し、また作動中のセンサの電位範囲においては、一般に、電気化学的に不活性である。好適な導電層としては、金、炭素、白金、二酸化ルテニウム、パラジウム、および例えばECCOCOAT CT5079−3炭素充填導電性エポキシコーティング(ダブリュー.アール.グレース社、ウォーバン、マサチューセッツ州(W.R. Grace Company, Woburn, MA)より入手可能)のような導電性エポキシ類、ならびに当業者に公知の他の不腐食性材料が挙げられる。電極(例えば、前記導電層)は、蒸着または印刷といった方法で、不活性材料の表面上に堆積される。電極は、基材上に印刷されることが好ましい。
作用電極22に加え、分析物の分析を行う感知化学物質をサンプルチャンバ26に設ける。この感知化学物質は、レドックスメディエーターおよび第2の電子移動剤を含むことが好ましいが、場合によっては、いずれか一方または他方だけ用いてもよい。レドックスメディエーターおよび第2の電子移動剤は、それぞれ個別に拡散性または非浸出性(すなわち、不拡散性)とすることができ、例えば、いずれか一方もしくは両方が拡散性または非浸出性であってもよい。感知化学成分の配置は、各成分が拡散性か非浸出性かによって決まる。例えば、非浸出性および/または拡散性の成分は、一般に、作用電極上に感知層を形成する。あるいは、1以上の拡散性の成分を、サンプルの導入前に、サンプルチャンバ内のいずれかの面に配置してもよい。他の例として、1以上の拡散性の成分を、センサへのサンプルの導入前に、サンプル中に配してもよい。
物の濃度も測定できる。DNAおよび/またはRNAの濃度を測定するのに適したアッセイが、米国特許出願番号09/138,888および09/145,776に開示されており、また、PCT出願PCT/US99/14460に記載されている。
あらゆる有機または有機金属レドックス種がレドックスメディエーターとして使用可能であるが、好適なレドックスメディエーターの一種は、遷移金属化合物または錯体である。好適な遷移金属化合物または錯体としては、オスミウム、ルテニウム、鉄およびコバルトの化合物または錯体が挙げられる。これらの錯体においては、遷移金属は1以上のリガンドに配位結合している。前記リガンドは、一般に、一座、二座、三座、または四座リガンドである。最も好ましいリガンドは、例えば、ピリジンおよび/またはイミダゾール誘導体のような複素環式窒素化合物である。多座リガンドには、複数のピリジンおよび/またはイミダゾール環が含まれていてもよい。あるいは、例えば、フェロセンのようなメタロセン誘導体を用いることもできる。メディエーターの例として、[Os(4−(N−(6−アミノヘキシル)アミノビピリジン)(1,1' −ジメチルー2,2' −ビイミダゾル)2 )Cl3 が挙げられる。
本発明の好ましい実施形態においては、前記センサは、レドックスメディエーターならびに、レドックスメディエーターおよび分析物への、またはレドックスメディエーターおよび分析物からの電子移動を可能にする第2の電子移動剤とを含む。前記第2の電子移動剤は、拡散性または非浸出性(例えば、レドックスポリマーに取り込まれるか、あるいは配位結合、共有結合、またはイオン結合している)であってよい。好適な第2の電子移動剤の一例は、分析物の反応を触媒する酵素である。例えば、分析物がグルコースである場合、グルコースオキシダーゼ、またはピロロキノリンキノングルコースデヒドロゲナーゼ(PQQ)のようなグルコースデヒドロゲナーゼを使用する。分析物がラクテートである場合、ラクテートオキシダーゼがこの役割を果たす。その他の分析物に対しては、他の酵素を使用できる。
る可能性を低減することが好ましい。この非導電性材料は、着色されていてもよく、無着色でもよい。また、印刷またはその他の方法によって基板上に形成されていてもよい。前記非導電性材料は、対向電極の形成前または形成後に堆積することができる。一実施形態においては、非導電性インクを使用して複数の12.3マイクロメーター(0.5mil)の厚さの対向電極の間に充填する。また、別の実施形態においては、非導電性インクを使用して複数の6.4マイクロメーター(0.25mil)の厚さの対向電極の間に充填する。通常、約6.4マイクロメーター未満の厚さにはフィラーインクは必要でない。また、センサデザインによっては、6.4マイクロメーターの厚さの対向電極にフィラーインクは必要でない。
本発明の一実施形態においては、作用電極22および対向電極24は、図1および図2に示すように、互いに向かい合わせに配置され対向し、対向する電極対を形成している。この好ましい構成においては、サンプルチャンバ26は、一般に、これら2つの電極間に配置される。この対向する電極構成においては、電極同士が約0.2mm以下の距離をあけて離間し(すなわち、作用電極の少なくとも一部が、対向電極の一部から200μm以下の距離をあけて離間している)、好ましくは100μm以下、最も好ましくは50μm以下の距離をあけて離間していることが好ましい。
1以上の電極との接触を提供することができる。すなわち、多数の電極を組合せ、1つのコンタクトパッドを介して接続する。
サンプルチャンバ26は、図1、2に示すように、一般に、電極22、24、基板32,34、およびスペーサー33の組合せによって規定される。測定域は、このサンプルチャンバ内に含まれ、分析物アッセイで分析されるサンプルの部分のみを収容する前記サンプルチャンバの領域である。図1および2に示す本発明の実施形態においては、サンプルチャンバ26は、2つの電極22、24およびスペーサー33によって結合した、それらの非導電性基板32,34との間の空間である。この実施形態では、サンプルチャンバは、好ましくは約1μL以下、より好ましくは約0.32μL以下、最も好ましくは約0.25μL以下の体積を有する。
に対して拡散時間が長くなるため、分析物アッセイ中に分析物がサンプルチャンバの他の部分から測定域へと拡散することに起因する誤差が低減される。一般に、サンプルチャンバの厚さは、約50〜約200mmである。
サンプルチャンバは、チャンバ内にサンプルが配置される前は空であってもよい。または、いくつかの実施形態においては、サンプルチャンバは、測定過程において液体サンプルを吸収して保持するための吸収材(図3では、吸着材50として示している)。好適な吸収材としては、ポリエステル、ナイロン、セルロース、およびニトロセルロースのようなセルロース誘導体を含む。前記吸収材は、サンプルチャンバの毛管作用を補うか、または、好ましくはそれに取って代わる吸取り作用によって、小体積サンプルの吸取りを促進する。これに加えて、またはこの代わりとして、サンプルチャンバの壁の一部または全体を、液体サンプルの表面張力を低下させ、サンプルチャンバ内の液体の流れを高めることを意図して、界面活性剤を塗布してもよい。使用可能な界面活性剤の例としては、商標名ゾニルFSO(Zonyl FSO )でデュポン社、ウィルミントン、DE(Dupont of Wilmington)から入手可能である。
図4〜12は、先端充填と側面充填の双方の別のセンサデザインを示す。図4によれば、センサ320は、作用電極322、対向電極324、第2の対向電極344(下記に示すように、充填指示機能を有してもよい)、および、少なくともセンサ320の少なくとも一部に沿って伸びるサンプルチャンバ326を備え、および任意に吸収材350を含んでもよい。
電子機器と接続するためのコンタクトパッド503を含む。このコンタクトパッド503は、トレース552によって作用電極502と接続している。図6Bに示すように、粘着物の層や両面テープのようなスペーサー504がチャンネル506を規定し、センサのサンプルチャンバを形成する。図6C(図1Aを反転させ、電極側を上にして示した図)に示すように、2つの対向(もしくは対向/参照)電極510、512が第2の基板508に形成されている。この多数の対向電極の配置は、下記に述べるように、対向電極512を使用して、充填指示機能をも果たしている。各対向電極510,512は、外部電子機器と接続するための接触領域またはパッド511、513を有している。これらのコンタクトパッド511、513はトレース551、553によって対向電極と接続している。作用電極502および2つの対向電極510、512がチャンネル506の領域において対向するように第2の基板508を反転させて、スペーサー504を挟んで第1の基板500上に配置する。
る。この多数の対向電極の配置は、以下に述べるように、充填指示機能(fill indicator function) を提供することができる。通気孔574(図9Cに陰影領域として表示している)が、第2の基板を貫通して形成されている。図示している実施形態においては、この通気孔574は、対向電極、および任意にスペーサー564をもつ基板568のみを貫通している。本実施形態においては、通気孔は、例えば、基板の一部をダイカットすることによって形成してもよい。このダイカットにより、少なくとも1つの対向電極の一部分を除去することもできるが、チャンネル内でのサンプルとの接触のため、ならびにセンサの他端における接触部との電気的接続のために十分な量の前記対向電極を残しておくべきである。別の実施形態においては、通気孔574を、全ての層を貫通するか、または第1の基板を貫通し、第2の基板を貫通しないように形成してもよい。
側から導入された時のみ、正確な前記センサの読みが得られる場合に特に重要である。
様々な理由により、多電極センサを使用することができる。例えば、単一のサンプルを用いて種々の分析物を試験するために多電極を使用してもよい。多電極の一実施形態は、1以上のサンプルチャンバを有し、そのそれぞれは、1以上の作用電極を有し、各作用電極が異なる測定領域を規定している。レドックスメディエーターが非浸出性である場合、作用電極の1以上が、第1の分析物の試験に適切な試薬、例えば、適切な酵素を備えていても良く、残りの作用電極の1以上が、第2の分析物の試験に適切な試薬を備えていても良い。例えば、多電極センサは、グルコースオキシダーゼを備えた、グルコース濃度測定用の1以上の作用電極と、感知層にラクテートを備えた、ラクテート濃度測定用の1以上の作用電極とを含んでいることもある。
1μL以下の液体を充填したサンプルチャンバを用いる場合、サンプルチャンバが充填されたことを確認できることが望ましいことが多い。図6A〜6Cは、充填インジケータ構造を有するセンサの一例を示す。特に、図6Aは、作用電極502が印刷された第1の基板500を示している。例えば、粘着物の層または両面粘着テープといったスペーサー504(図6B)が第1の基板500と作用電極502の上方に形成され、層内に形成されたチャンネル506によりサンプルチャンバが提供される。図6C(図6Aおよび6Bを反転させ、電極側を上にして示した図)に示すように、第2の基板508には2つの対向電極510、512が印刷されている。好ましくは、チャンネル506の入口514に最も近い対向電極510は、他方の対向電極512の少なくとも2倍、好ましくは少なくとも5倍または10倍の表面積をサンプルチャンバ内に有する。
、単一の指示電極、および、好ましくは、いずれの側をサンプル液と接触させるべきか示す表示をさらに備えていてもよい。
図13A〜13Bは、図5A〜5Cに表示されたセンサの配置について示した一実施形態を記載したものである。この方法は、先に記載した様々な他のセンサの配置についても使用することができる。図5A〜5Cの3層を組み合わせるとき、センサ420が形成される。
、対向電極セクション1024を基板1000の他の半面上に作製する。いくつかの実施形態においては、基板1000を、切り目をつけて、折り曲げて、セクション1022,1024をセンサに一体形成することができる。いくつかの実施形態においては、図13Aに示したように、個別の作用電極セクション1022を、基板1000上に互いに近接、隣接させ、材料の無駄を減らしている。同様に、個別の対向電極セクション1024を互いに近接、隣接させて形成することもできる。他の形態においては、個別の作用電極セクション1022(および、同様に、対向電極セクション1024)を図13Bに示すように、スペースを空けて配置することもできる。プロセスの残りの部分は多数のセンサの作製のために記載するが、個別のセンサを形成するために容易に変形することもできる。
チャンネルに相当する粘着物の部分を除去することもできる。
満であることが好ましい。層構造のセンサ構造を作製するために「キスカット」法を使用することによって、サンプルチャンバ壁の完全性が保存される。それによってより確実で再現可能なサンプルチャンバ体積が提供される。
、整列および/または近接した電極の行または列に沿ったストリッピング等を含む種々の方法によって配置できる。また、他の成分を個別に、あるいはレドックスメディエーターおよび/または第2の電子移動剤と共に配置してもよい。これらの成分としては、例えば、界面活性剤、ポリマー、ポリマーフィルム、防腐剤、バインダー、緩衝剤、および架橋剤が挙げられる。
一般的に、図16Aおよび16B、図17Aおよび図17B、ならびに図18Aおよび図18Bを参照して、図5A〜図5Cの組合されたセンサ(センサ1420と称する)は、一般に、電気的コネクタ1500によって、メーターまたは他の電気的装置と接続する。そのコネクタは、センサ1420の末端において、コンタクトパッド423,425,443,444で結合および接続する構成となっている。センサメーターは、一般に、センサの電極に電位および/または電流を提供するため、ポテンシオスタットまたは他の構成部品を備えている。センサ読取装置はまた、分析物濃度をセンサ信号から測定するためのプロセッサ(例えば、マイクロプロセッサーまたはハードウェア)を備えていてもよい。前記センサメーターはまた、ディスプレイまたはディスプレイをセンサに結合させるためのポートを含む。前記ディスプレイは、センサ信号および/または、例えば、分析物濃度、分析物濃度の変化速度、および/または閾値分析物濃度の超過(例えば、低血糖または高血糖として示される)を含む、センサ信号より測定された結果を表示する。
的に接触することが重要である。
ドは、導電性インクのような導電材料によってそれぞれ接続されている。2以上のコンタクトパッド間の導電性経路の抵抗は符号化された情報と関連する。不連続の検量値の例としては、所与の範囲の抵抗値が1つの検量設定値に相当しうる。そして異なる範囲の抵抗値は、異なる検量設定値に相当しうる。連続する検量値の例としては、検量設定値は、抵抗の連続関数に相当する。コンタクトパッド間の好適な導電性経路は図19A〜19Lに示されている。
本発明の原理により構成された分析物測定装置は、これまでに述べたように、サンプル採取装置と組み合わされたセンサを一般に含み、一体型のサンプル採取および測定装置を提供する。サンプル採取装置は一般に、例えば、患者の皮膚に注射し、血液が流れるようにすることができるランセットのような皮膚穿孔部材を備えている。好ましい実施形態においては、一体型サンプル取得および分析物測定装置は、ランセットと測定ストリップを保持する切開器具を備えている。前記切開器具は活性型コッキング(active cocking)であることが好ましい。使用者に対して、使用前に前記装置をコックすることを要求することによって、ランセットを不注意にトリガするリスクを減少させる。前記切開器具はまた、使用者がランセットを皮膚に挿入する深さを調節することができることが好ましいだろう。そのような装置はすでに、ベーリンガーマンハイム(Boehringer Mannheim) やパルコ(Palco) のような会社から購入可能である。この特徴により、使用者が、身体の部位により、または使用者により異なる皮膚厚、皮膚耐久度、または痛覚感受性の違いに従って切開器具を調節することが可能になる。
切開中に患者が体験する痛みが軽減する。さらに、あざができる傾向が一般に減少する。
本発明の電気化学的センサは、電極に電位を印加して、または電位を印加せずに作動させることができる。一実施形態においては、電気化学反応が自然に起こり、作用電極と対向電極との間に電位を印加する必要はない。別の実施形態においては、作用電極および対向電極との間に電位を印加する。ただし、電位は一定であっても一定でなくてもよい。必要とされる電位の大きさは、使用されるレドックスメディエーターによって決まる。電極が自然に均衡状態となる電位、または外部バイアスの印加により均衡状態となる電位、および分析物が電気分解される電位は、一般に、電気化学反応を完了またはほぼ完了させるのに十分な大きさであるが、測定する信号に影響を及ぼす尿酸塩、アスコルビン酸塩、およびアセトアミノフェン等の妨害物質の電気化学反応を著しく誘発する程度の酸化を起こさない大きさであることが好ましい。非浸出性のレドックスメディエーターに関しては、電位は、一般に、標準カロメル電極(SCE)に対して約−350mV〜約+400mVである。好ましくは、前記レドックスメディエーターの電位は、SCEに対して約+100mVよりも負の電位、より好ましくは0mVよりも負の電位、最も好ましくは約−150mVよりも負の電位である。
博條ヤ の後、生じる。図15Aは、既に記載したセンサにおける、グルコースのような
分析物を電気分解するための電流と時間の関係を表すグラフの一例である。図15Bは、その同じデータについての電流の自然対数と時間との関係を示すグラフである。センサが平衡している間、図15Aおよび15Bに唐o 狽ナ 示すように、サンプルを完全にサン
プルチャンバに充填した後、電流をピーク電流値まで増加させる。ピーク電流は一般にシステムが、拡散というよりはむしろ、運動論的に制限されている間に生じる。一般に前記電流は、その後減少し始めるが、場合によっては拡散が制限される前にさらに上昇する場合もある。最終的に、電流値は図15Bに唐k 狽ナ 示された領域に入る。そこでは、電
流の自然対数と時間の間に直線的な関係がある。分析物の残りの部分を電気分解するために必要な非線形または好ましくは、線形の推定方法(estimation method) (例えば、線形最小二乗法)を用いて外挿することが好ましい。図15Bでは、外挿の領域を唐d 狽ナ
示し、外挿を実線で示している。
あるように注意を払わなければならない。システムが拡散制限状態であることを確認する1つの方法は、ピーク電流ipeak(“P”)が達成されるまで電流値を観察することである。電流値は、電流が通常ピーク電流の分数である閾値ithreash 以下に低下するまで、電流値の観察を続ける。例えば、前記閾値はピーク電流の2分の1、3分の1または4分の1である(例えば、ithreash =j*ipeak、ただし、jは例えば、0.5,0.33または0.25である)。前記閾値は、センサの特徴に基づいて選択される。それによって、システムが拡散制限となるとき高い信頼度を有する。
nt) を有するプロセッサを用いて行い、上述の式の完全もしくは部分的な結果を、所与の入力データの設定値に基づいて表す。
別の電流測定方法としては、既知の量の電荷をサンプルに放電すること(分析物の電気分解によって)および放電に必要な時間を測定することを含む。その後、電流を、電荷と放電時間の指数として計算する。例としては、メーター内の回路によってコンデンサを帯電し、その後作用電極もしくは対向電極に結合させ、分析物の電気分解によって放電することができる。閾値レベルまで放電するための時間は、例えば、メーターのプロセシング回路の一部であるクロック回路を使用して測定することができる。クロック回路を使用することによって、非常に正確に時間測定ができる。これは、電流もしくは電荷を直接測定し、高価なA/D(アナログ〜デジタル)コンバータを使用して、これらのアナログの測定値を処理可能なデジタル表示に換算しなければならない設計に比べて有利である。
CA =Q/nFV (3a)
ただし、nは、分析物を電気分解するのに必要な電子等量を表し、Fは、ファラデー定数(約96、500クーロン/ 等量)を表し、Vは、測定域のサンプルの体積を表す。拡散可能メディエーターを用いた場合、下記式から分析物の濃度を得ることができる。
ただし、Qtot は、測定中に移動する総電荷量を表し、Qbackは、分析物によらない、例えば、作用電極と対向電極の間の拡散可能なメディエーターの往復によって移動する電荷の量を表す。少なくとも、いくつかの例においては、バックグランド電荷がある量の分析物の電気分解によって生じる電荷の大きさの5倍を上回らないようにセンサは構成されている。好ましくは、バックグランド信号は、分析物の電気分解により生じる電荷の200%、100%、50%、25%、10%、または5%を上回らない。
ただし、Aは作用電極の面積、Fはファラデー定数(約96、500クーロン/ 等量)、DM はサンプル中のメディエーターの有効拡散係数、CM は測定域のレドックスメディエーターの濃度、dは離間した対向する電極関の距離、tは測定時間の合計、nM はレドックスメディエーターによって得られたもしくは失われた電子の数を表す。
QG =Ad(0.90)CG nG Fただし、Aは作用電極の面積、dは離間した対向する電極間の距離、CG はグルコース濃度、nは分析物の電気分解に要する電子数(例えば、グルコース分子当たり2個の電子)、Fはファラデー定数である。グルコースの場合、CG は、5mM(または5×10-6モル/cm3 )、tは60秒、nG は2、nM は1、レドックスメディエーターからの電荷と分析物の電解酸化による電荷との比率は下記式によって表される。
例えば、Qback/QG の比率が5の場合、(DM CM )/d2 は7.5×10-7モル/(cm3 秒)である。また、例えば、Qback/QG の比率が1の場合、(DM CM )/d2 は1.5×10-7モル/(cm3 秒)である。さらにまた別の例としては、上記比率が0.1の場合、(DM CM )/d2 は1.5×10-8モル/(cm3 秒)である。よって、所望の比率に従い、DM 、CM 、およびdを適切に選択することにより、所望の比率を有するようにセンサを構成できる。
ィエーターの反応速度が、作用電極よりも対向電極において著しく速いこと;レドックスメディエーターを作用電極上に固定化すること;対向電極または対向/参照電極における反応によりレドックスメディエーターを対向電極または対向/参照電極上に固定化させること;またはレドックスメディエーターの拡散を遅らせることが挙げられる。
定値に有意な誤差が生じる。一般に、分析物が5分未満でほぼ完全に電気分解されるよう、サンプル中の分析物の予測濃度に基づいて、特定のレドックスメディエーターおよび任意の第2の電子移動剤のみならず、電極間の電位も選択される。分析物は、好ましくは約2分以内、より好ましくは約1分以内にほぼ完全に電気分解されるようにする。
サンプルを加熱し、分析物の拡散、酸化、または還元の速度を速めることができる。この加熱は、加熱環境下へのセンサの配置またはセンサへの発熱体の適用を含む種々の方法により達成できる。
本発明を、以下の一般的な実施例によりさらに特徴付ける。これらの実施例は、これま
での記述により十分に説明された本発明の範囲を限定することを意図するものではない。本発明の概念の範囲内での変更は、当業者には明らかである。
Claims (10)
- 血液中のグルコース濃度を測定するための電気化学センサストリップにおいて、
第1の主面およびその第1の主面に対向する第2の主面を有する第1の基板と、同基板は前記ストリップの近位端と、遠位端と、前記近位端から遠位端まで伸びる第1および第2の側端とを画定することと、
第1の主面およびその第1の主面に対向する第2の主面を有する第2の基板と、前記第1および第2の基板は、前記第1の基板の第1の主面と前記第2の基板の第1の主面とが対向する関係になるように配置されていることと、
前記第1および第2の基板の間に配置されるスペーサ材料と、該スペーサ材料、および前記第1および第2の基板はさらに、
前記第1および第2の基板の間にて前記近位端または前記第1の側端に沿う第1の開口部と、
前記第1および第2の基板の間にて前記第2の側端に沿う第2の開口部と、
前記第1の開口部から第2の開口部に通じるチャンネルと、
前記チャンネルに沿って、前記第1の開口部の近傍に設けられる1μL以下の体積の測定領域を備えたサンプルチャンバとをさらに画定することと、
前記第1の基板の第1の主面に配置され、その上にグルコースに反応し得る触媒を備えた作用電極と、
前記第1の基板の第1の主面または前記第2の基板の第1の主面上に配置された対向電極と、前記作用電極および対向電極は、グルコースを含有するサンプルが前記測定領域に配置されたときにグルコースに反応する信号を生じるべく前記サンプルチャンバの箇所に存在することと、
前記第1の基板の第2の主面または前記第2の基板の第2の主面に配置され、前記センサストリップの幅を横切って伸びる導電性ストリップを有するとともに、センサが適切にメーターに挿入されたことを示すためのメーターの少なくとも2つのコンタクトリードの間に電流のための経路を提供する挿入モニターとを含むセンサストリップ。 - 前記挿入モニターが前記第1の基板の第2の主面上に配置された請求項1記載のセンサストリップ。
- 前記対向電極は前記第1の基板の第1の主面に配置された請求項1又は2に記載のセンサストリップ。
- 前記対向電極が前記第2の基板の第1の主面上に配置された請求項1〜3のいずれかに記載のセンサストリップ。
- 前記挿入モニターが、前記ストリップについての符号化された情報を提供するために構成および配置された請求項1〜4のいずれかに記載のセンサストリップ。
- 請求項1〜5のいずれかに記載の電気化学的グルコースセンサストリップとの着脱自在な接続のための複数の接触構造を含むコネクタであり、各接触構造は、
センサ接触部との電気的な接続のための近位端と、
電気的装置との電気的な接続のための遠位端とを含み、および
前記複数の接触構造は、
遠位端から近位端に長手方向に伸びる1以上の第1のコンタクトリードと、
遠位端から前記1以上の第1のコンタクトリードの近位端を通過して長手方向に伸び、前記センサの長手方向の中心線に向かって傾斜している、1以上の第2のコンタクトリードとを含む、コネクタ。 - 前記コネクタは、前記センサの単一の導電性の表面と電気的に接触するために、少なくとも2つの第2のコンタクトリードを含む請求項6記載のコネクタ。
- 前記第1のコンタクトリードは、センサの作用電極および対向電極のうちの少なくとも1つと接触するように構成および配置され、前記第2のコンタクトリードは、センサの挿入モニターと接触するように構成および配置された請求項7記載のコネクタ。
- (a)請求項1〜5のいずれかに記載の電気化学的センサと、
(b)前記電気化学的センサに接続されるとともに、
(i)作用電極と対向電極の間に電流を流すことによって、血液サンプル中のグルコースの少なくとも1部を電気分解し、
(ii)前記グルコースの電気分解中、複数の電流値を測定し、その電流値の少なくともいくつかは前記センサ中の前記分析物の電気分解が実質的に拡散制限されている間に得られ、
(iii)前記センサ中の前記グルコースの電気分解が実質的に拡散制限されているときに得られた電流値から、電流値と時間との間の関係の外挿のためのパラメータを測定し、
(iv)前記サンプル中の前記グルコースの部分的電気分解において消費された実際の電荷量を測定し、
(v)前記サンプル中に残っているグルコースを電気分解するのに必要な外挿された電荷を測定し、かつ
(vi)前記実際の電荷および外挿された電荷から、前記血液サンプル中のグルコースの濃度を測定するように構成および配置されたプロセッサとを備える電気化学的センサ装置。 - 請求項1〜5のいずれかに記載の電気化学的センサ内に配置された体液サンプル中の分析物の一部を電気分解するために使用される電流の量を測定する方法であり、
電気化学的センサ中に配置された体液サンプルに一定量の電荷を放電し、前記分析物を電気分解すること、
前記一定量の電荷を放電するのに必要な時間を測定すること、および
一定量の電荷および一定量の時間を用いて、前記分析物の一部を電気分解するために使用される電流を測定すること、を含む方法。
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JP2020099723A (ja) * | 2015-11-11 | 2020-07-02 | メドトロニック ミニメド インコーポレイテッド | コネクタシステム |
Also Published As
Publication number | Publication date |
---|---|
US20100126884A1 (en) | 2010-05-27 |
US6616819B1 (en) | 2003-09-09 |
AU776764B2 (en) | 2004-09-23 |
US20020157948A2 (en) | 2002-10-31 |
US6749740B2 (en) | 2004-06-15 |
US6942518B2 (en) | 2005-09-13 |
US8066858B2 (en) | 2011-11-29 |
AU1234701A (en) | 2001-05-14 |
EP1145000B8 (en) | 2005-09-14 |
CA2358993A1 (en) | 2001-05-10 |
WO2001033216A1 (en) | 2001-05-10 |
ATE295538T1 (de) | 2005-05-15 |
US20020084196A1 (en) | 2002-07-04 |
KR100495935B1 (ko) | 2005-06-16 |
US20080283396A1 (en) | 2008-11-20 |
EP1145000B1 (en) | 2005-05-11 |
US20090260985A1 (en) | 2009-10-22 |
US20040225230A1 (en) | 2004-11-11 |
CN1201149C (zh) | 2005-05-11 |
CA2358993C (en) | 2005-08-02 |
DE60020076T2 (de) | 2006-03-16 |
US20090260986A1 (en) | 2009-10-22 |
EP1145000A1 (en) | 2001-10-17 |
US20020053523A1 (en) | 2002-05-09 |
US20020148739A2 (en) | 2002-10-17 |
DE60020076D1 (de) | 2005-06-16 |
JP2003513279A (ja) | 2003-04-08 |
CN1322299A (zh) | 2001-11-14 |
JP4885508B2 (ja) | 2012-02-29 |
KR20010093785A (ko) | 2001-10-29 |
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