JP2008062072A - 検体監視装置、検体監視装置の製造方法、及びディジタル信号の伝達方法 - Google Patents
検体監視装置、検体監視装置の製造方法、及びディジタル信号の伝達方法 Download PDFInfo
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Abstract
【解決手段】検体監視装置は、その少なくとも一部分が、埋め込まれて体液と密に接触するように適合され、かつ前記体液中の検体のレベルを表す信号を生成する電気化学センサと、前記電気化学センサに結合されて、前記体液中の前記検体のレベルを表す信号を送信する送信器234、236、238と、該送信器234、236、238は拡散符号の組を使用して前記信号の送信を容易にするように構成および配置されていることとを有する。
【選択図】図30
Description
本発明は、さまざまな変形例および代替形態が可能であり、その詳細を図面によって例示し、以下で詳しく説明する。しかし、記載の特定の実施形態に本発明を限定しようとする意図はないことを理解されたい。これとは反対に、その意図は、添付の請求項によって定義される本発明の趣旨および範囲に含まれる全ての修正、等価物および代替物をカバーすることにある。
「対電極」は、作用電極と対をなす電極である。対電極には、作用電極を流れる電流と大きさが等しく、逆の極性の電流が流れる。本発明の文脈では、用語「対電極」は、参照電極としても機能する対電極(すなわち対電極/参照電極)を含む。
表面に捕捉され、または表面に化学的に結合したときに、化合物が表面に「固定化」されるという。
「作用電極」は、電子移動剤の媒介の有無にかかわらず、そこで検体(またはそのレベルが検体のレベルに依存する第2の化合物)が電解酸化または電解還元される電極である。
「検出層」は、検体の電解を促進する成分を含んだセンサの構成要素である。検出層は、電子移動剤、検体の反応を触媒して電極での応答を生み出す触媒、これらの組合せなどの成分を含んでもよい。センサの一部の実施形態では、検出層が、作用電極の近くに、または作用電極の表面に非浸出的に配置された層である。
検体センサ・システム
本発明の検体監視システムはさまざまな条件の下で利用することが可能である。検体監視システムで使用されるセンサおよび他のユニットの具体的な構成は例えば、意図する検体監視システムの用途、および検体監視システムが動作する条件によって決まる。検体監視システムの一実施形態は、患者または使用者に埋め込むように構成されたセンサを含む。センサの埋込みは例えば、血液中の検体のレベルを直接に検査するために、動脈または静脈系に実施することができる。あるいは、間質液中の検体のレベルを決定するために、センサを間質組織に埋め込むことができる。この間質液中の検体のレベルを、血液または他の流体中の検体のレベルに相関させ、かつ/または血液または他の流体中の検体のレベルに変換することができる。埋込み部位および埋込みの深さが、センサの具体的な形状、構成要素および構成に影響する場合がある。場合によっては、センサの埋込みの深さを制限するために皮下埋込みが好ましい場合がある。他の流体中の検体のレベルを決定するために、センサを体の他の領域に埋め込むこともできる。本発明の検体監視システムで使用するのに適したセンサの例が、本願明細書に援用する米国特許出願番号09/034,372に記載されている。
図2に示すように、センサ42は、基板50の表面に形成された少なくとも1つの作用電極58を含む。センサ42はさらに、少なくとも1つの対電極60(または対電極/参照電極)、および/または少なくとも1つの参照電極62(図8参照)を有してもよい。対電極60および/または参照電極62は基板50の表面に形成することができ、あるいは別個のユニットとすることができる。例えば、対電極および/または参照電極を、やはり患者に埋め込まれる第2の基板の表面に形成することができ、あるいは埋込み可能センサの一部の実施形態では、少なくとも1つの作用電極を患者に埋め込み、対電極および/または参照電極は患者の皮膚の表面に配置することができる。皮膚表面の対電極および/または参照電極を埋込み式作用電極とともに使用することは、本願明細書に援用する米国特許第5593852号に記載されている。
基板50は、例えばポリマーまたはプラスチック材料、およびセラミック材料を含む、さまざまな非電導性材料を使用して形成され得る。特定のセンサ42に適した材料は、少なくとも部分的には、センサ42の所望の用途および材料の特性に基づいて決定され得る。
作用電極58の構築に使用される少なくとも1つの導電性トレース52が基板の表面に形成される。基板50の表面にはさらに、電極(例えば追加の作用電極、対電極、対電極/参照電極、および/または参照電極)として、および温度プローブなどの他の構成要素として使用する別の導電性トレース52を形成され得る。導電性トレース52は、図2に示すように、センサ50の長さ57のほぼ全体に沿って延びてもよい。ただしこれは必須ではない。導電性トレース52の配置は例えば、検体監視システムの具体的な構成(例えばセンサ42に対する制御ユニットのコンタクトおよび/または試料室の相対配置)によって決まる。埋込み式センサ、特に皮下埋込み式センサでは、埋め込まれなければならないセンサの量をできるだけ小さくするために、導電性トレースが一般にセンサ42の先端近くまで延びる。
一般に、導電性トレース52はそれぞれコンタクト・パッド49を含む。コンタクト・パッド49は単純に、コンタクト・パッド49が制御ユニット(例えば図1のセンサ制御ユニット44)の導電性コンタクトと接触することを除いて、トレース52の残りの部分から区別できない導電性トレース52の一部分とすることができる。しかし、より一般的にはコンタクト・パッド49は、制御ユニットのコンタクトとの接続を容易にするためにトレース52の他の領域よりも大きな幅を有する導電性トレース52の領域である。導電性トレース52の幅に比べてコンタクト・パッド49を相対的に大きくすることによって、コンタクト・パッド49と制御ユニットのコンタクトとの間の正確な位置合せの必要性が、小さなコンタクト・パッドで求められるほどには重要でなくなる。
以下に、いくつかの例示的な電極構成を説明する。ただし他の構成も使用できることを理解されたい。図3Aに示した一実施形態においては、センサ42が、2つの作用電極58a,58b、および参照電極としても機能する1つの対電極60を含む。他の実施形態では、図3Bに示すように、センサが、1つの作用電極58a、1つの対電極60、および1つの参照電極62を有する。これらのそれぞれの実施形態では、全ての電極が基板50の同じ側に形成されて示されている。
酸素などのいくつかの検体は、作用電極58の表面で直接に電解酸化または電解還元させることが可能である。グルコース、乳酸などの他の検体では、検体の電解酸化または電解還元を容易にするために、少なくとも1種類の電子移動剤および/または少なくとも1種類の触媒が存在する必要がある。触媒は、作用電極58の表面で直接に電解酸化または電解還元させることが可能な酸素などの検体に対して使用してもよい。これらの検体に対しては、それぞれの作用電極58が、作用電極58の作用表面、または作用表面の近くに形成された検出層64を有する。検出層64は一般に、作用電極58の近くに、またはたいていはセンサ42の先端近くの作用電極58の小部分にだけに形成される。これによって、センサ42を形成するのに必要な材料の量が制限され、検体を含む流体(例えば体液、試料流体または担体流体)との接触に最良の位置に検出層64が置かれる。
多くの実施形態では、図3Aおよび3Bに示すように作用電極58の導電材料56と接触した検出層64が、1種以上の電子移動剤を含む。本発明の一部の実施形態では、センサ42が患者の体内に埋め込まれている間、電子移動剤が作用電極58からほとんど、または全く浸出しない。拡散性の、または浸出可能(すなわち放出可能)な電子移動剤は多くの場合に検体を含む流体中に拡散し、これによって時間が経つにつれてセンサの感度が低下することによって、電極の効果が低下する。さらに、埋込み可能センサ42中の拡散性または浸出性の電子移動剤は患者の損傷の原因になる可能性がある。これらの実施形態では、検体を含んだ流体に浸漬してから24時間、より好ましくは72時間の間、少なくとも90%、より好ましくは少なくとも95%、最も好ましくは少なくとも99%の電子移動剤がセンサの表面にとどまることが好ましい。特に埋込み可能センサでは、37℃の体液に浸漬してから24時間、より好ましくは72時間の間、少なくとも90%、より好ましくは少なくとも95%、最も好ましくは少なくとも99%の電子移動剤がセンサの表面にとどまることが好ましい。
別のタイプの非放出性電子移動剤はイオン結合した酸化還元種を含む。このタイプのメディエータは一般に、逆の極性に荷電した酸化還元種に結合した荷電ポリマーを含む。このタイプのメディエータの例には、オスミウムまたはルテニウムポリピリジルカチオンなどの正荷電酸化還元種に結合したNafion(登録商標)(デュポン社)などの負荷電ポリマーが含まれる。イオン結合メディエータの他の例が、フェリシアン化物、フェロシアン化物などの負荷電酸化還元種に結合した四級化されたポリ(4−ビニルピリジン)またはポリ(1−ビニルイミダゾール)などの正荷電ポリマーである。好ましいイオン結合酸化還元種は、逆の極性に荷電した酸化還元ポリマーに結合した高荷電酸化還元種である。
検出層64はさらに、検体の反応を触媒する能力を有する触媒を含んでもよい。一部の実施形態では触媒がさらに、電子移動剤の働きをする。適切な触媒の一例は検体の反応を触媒する酵素である。例えば、検体がグルコースであるときには、グルコースオキシダーゼ、グルコースデヒドロゲナーゼ(例えばピロロキノリンキノングルコースデヒドロゲナーゼ(PQQ))、オリゴ糖デヒドロゲナーゼなどの触媒を使用してもよい。検体が乳酸であるときには、乳酸オキシダーゼまたは乳酸デヒドロゲナーゼを使用してもよい。検体が酸素であるとき、あるいは検体の反応に応答して酸素が生成または消費されるときには、ラッカーゼを使用してもよい。
検体を電解するためには、作用電極58と対電極60の間に(参照電位に対する)電位を印加する。印加する電位の大きさの最小値は多くの場合、特定の電子移動剤、検体(検体が電極において直接に電極において直接に電解される場合)、または第2の化合物(そのレベルが検体のレベルに依存する酸素、過酸化水素などの第2の化合物が電極において直接に電解される場合)によって決まる。印加する電位は通常、所望の電気化学反応に応じて、電極において直接に電解される電子移動剤、検体または第2の化合物の酸化還元電位に等しいか、あるいはこれらよりも酸化的または還元的である。作用電極の電位は一般に、電気化学反応を完了まで、または完了近くまで駆動するのに十分な大きさである。
センサには、随意的にさまざまな個別要素を含めることができる。随意的な1つの個別要素が温度プローブ66(図8および11)である。温度プローブ66は、さまざまな周知の設計および材料を使用して製作することができる。例示的な1つの温度プローブ66は、温度依存特性を有する材料を使用して形成された温度依存要素72を介して互いに接続された2本のプローブ・リード68,70を使用して形成されている。適切な温度依存特性の一例は温度依存要素72の抵抗である。
少なくとも患者の皮下に挿入されるセンサ42の部分には、図9に示すように、随意的なフィルム層75が形成される。この随意的なフィルム層74は、1つ以上の機能を果たすことができる。フィルム層74は、大きな生体分子の電極への侵入を防ぐ。これは、排除しようとする生体分子よりも小さな孔径を有するフィルム層74を使用することによって達成される。このような生体分子は、電極および/または検出層64を汚損する可能性があり、これによってセンサ42の効果が低下し、所与の検体濃度に対して予想される信号振幅が変化する可能性がある。作用電極58の汚損はさらにセンサ42の有効寿命を短くする可能性がある。生体適合層74はさらに、センサ42へのタンパク質の付着、血餅の形成、およびセンサ42と身体の間の望ましくないその他の相互作用を防ぐことができる。
センサ42に、干渉剤排除層(図示せず)を含めることができる。干渉剤排除層は、生体適合層75または質量輸送制限層74(後述)に組み込み、あるいは別個の層とすることができる。干渉剤は、電極において直接に、または電子移動剤を介して間接的に電解還元または電解酸化されて、偽信号を生み出す分子または他の種である。一実施形態においては、フィルムまたは膜によって、作用電極58の周囲の領域への1種以上の干渉剤の侵入を防ぐ。このタイプの干渉剤排除層は、検体に比較して、1種以上の干渉剤に対してはるかに低い透過性を示すことが好ましい。
作用電極58の周囲の領域への検体、例えばグルコースまたは乳酸の質量輸送の速度を低減させる拡散制限障壁として作用する質量輸送制限層74をセンサに含めてもよい。検体の拡散を制限することによって、作用電極58の近くの検体の定常状態濃度(これは体液または試料流体中の検体の濃度に比例する)を低減することが可能である。これによって、正確に測定し得る検体濃度の上限が広がり、さらに、検体のレベルとともに電流がほぼ直線的に増大する範囲を広げることができる。
埋込み可能センサはさらに、随意的に、患者に埋め込まれる基板部分に配置された抗凝固剤を有することができる。この抗凝固剤は、特にセンサの挿入後に、センサの周囲の血液または他の体液の凝固を低減または排除することができる。血餅はセンサを汚損し、またはセンサ中に拡散する検体の量を再現不能なほどに減らす可能性がある。有用な抗凝固剤の例には、ヘパリンおよび組織プラスミノゲン賦活剤(TPA)、ならびに他の周知の抗凝固剤が含まれる。
センサ42は、生体内検体監視装置、特に埋込み式検体監視装置の交換可能な構成要素として設計することができる。センサ42は一般に数日間の動作が可能である。動作期間が少なくとも1日、より好ましくは少なくとも3日、最も好ましくは少なくとも1週間であることが好ましい。その後、センサ42は取り外し、新しいセンサと交換することが可能である。例えば電極の汚損、あるいは電子移動剤または触媒の浸出によって、センサ42の寿命は短縮される。センサ42の耐用寿命のこれらの制限条件はそれぞれ、先に説明した生体適合層75または非浸出性の電子移動剤および触媒の使用によって克服することが可能である。
患者の皮下にセンサ42を挿入するのに、図12に示す挿入装置120を使用することが可能である。挿入装置120は一般に、金属、硬質プラスチックなどの構造的に堅い材料を使用して形成される。好ましい材料には、ステンレス鋼およびABS(アクリロニトリル−ブタジエン−スチレン)プラスチックが含まれる。一部の実施形態では、患者の皮膚への侵入を容易にするために、挿入装置120の先端121が尖っており、かつ/または鋭くなっている。鋭く薄い挿入装置によって、センサ42の挿入時に患者が感じる痛みを低減することができる。他の実施形態では、挿入装置120の先端121が、鈍いまたは平らな形状を含む他の形状を有する。例えばこれらの実施形態は特に、センサ42を皮膚に押入するときに挿入装置120が皮膚に侵入せず、センサ42の構造支持として機能するするときに有用である。
皮膚表面取付けセンサ制御ユニット44は、患者の皮膚の表面に配置するように構成される。皮膚表面取付けセンサ制御ユニット44は、随意的に、患者にとって快適で、かつ例えば患者の着衣の下に隠すことができる形状に形成される。大腿、脚、上腕、肩または腹は、皮膚表面取付けセンサ制御ユニット44を覆い隠すのに都合のよい患者の体部分である。しかし、皮膚表面取付けセンサ制御ユニット44は患者の他の体部分に配置することもできる。皮膚表面取付けセンサ制御ユニット44の一実施形態は、覆い隠しやすいよう、図14〜16に示すような薄い楕円形の形状を有する。しかし他の形状およびサイズを使用することもできる。
皮膚表面取付けセンサ制御ユニット44は一般に、センサ42および検体監視装置システム40を動作させる電子構成要素の少なくとも一部分を含む。オンスキン制御ユニット44の電子回路の一実施形態を図18Aのブロック図に示す。皮膚表面取付けセンサ制御ユニット44の電子構成要素は一般に、オンスキン制御ユニット44およびセンサ42を動作させるための電源95と、センサ42から信号を取得し、センサ42を動作させるためのセンサ回路97と、センサ信号を所望の形式に変換する測定回路96と、少なくともセンサ回路97および/または測定回路96から信号を取得し、随意的な送信器98に信号を供給する処理回路109とを含む。一部の実施形態では、処理回路109がさらに、センサ42からの信号を部分的にまたは完全に評価し、その結果得られたデータを随意的な送信器98に送り、かつ/または検体のレベルが閾値を上回った場合に随意的な警報システム94(図18B参照)を作動することができる。処理回路109は多くの場合にディジタル論理回路を含む。
図30から分かるとおり、それぞれの送信器が、ビット「1」を表すチップ配列を同時に送信する場合、それらの送信は重ね合せの原理に従って結合される。これは、結果として生じる結合された送信が、それぞれの送信器のビット「1」を表すそれぞれのチップ配列の和に等しいということを意味する。
やはり図30から分かるとおり、CDMA受信器を、特定の送信器から発せられた送信だけを受信するように構成することが可能である。例えば図30では、受信器240が、送信器234からの送信だけを受信するように構成されている。受信器240は、送信器234が使用していると分かっている拡散符号に対して入力信号を相関させる相関器242,244を使用する。相関器242は、結合された送信に対して相関させたときに、送信器234から送信されたビット「0」が検出されなかったことを指示する出力「0」を生み出す。
=0+0+0
=0
相関器244は、結合された送信に対して相関させたときに、送信器234から送信されたビット「1」が検出されたことを指示する出力「1」を生み出す。
=1+0+0
=1
送信器236および238からの信号D1およびE1の存在は、受信器240が送信器234からの送信を識別するのを妨げないことに留意されたい。これは、拡散符号がそれぞれの送信器を識別する働きをするためである。それぞれの送信器をそれ自体の拡散符号セットに割り当て、それによって送信器を一意的に識別する製造方法を使用してもよい。しかし、製造業者はおそらく一意の拡散符号セットを使い切ってしまうため、これらのセットが必要に迫られて再使用される可能性がある。再使用方式の下では、拡散符号セットが、より小さな送信器集団から発せられた特定の送信を識別するだろうが、特定の送信器を一意的には識別しないであろう。
センサ42によって生成されたデータへのアクセスを容易にするために、検体監視装置40に、1つ以上の受信/表示ユニット46,48を含めることができ、一部の実施形態では、受信/表示ユニットが、皮膚表面取付けセンサ制御ユニット44からの信号を処理して皮下組織中の検体の濃度またはレベルを決定され得る。小型の受信/表示ユニット46は患者が携帯することができる。これらのユニット46は手のひらサイズのユニットとすることができ、かつ/あるいは、患者のベルトに取り付け、またはバッグまたは財布に入れるように適合させることができる。例えば使用者が医療機器の使用者であると分からないように、一実施形態では小型の受信/表示ユニット46がポケット・ベルの外観を呈する。このような受信/表示ユニットは、随意的に、単方向または双方向ページング機能を有することができる。
図25に、本発明に基づくセンサ・ベースの薬物送達システム250のブロック図を示す。このシステムは、1つ以上のセンサ252からの信号に応答して、高レベルまたは低レベルの検体の影響を打ち消す薬物を供給することができる。あるいは、このシステムは、薬物濃度を監視して、薬物が治療上の望ましい範囲の中に収まっているいることを保証する。この薬物送達システムは、皮下に埋め込まれた1つ以上のセンサ252(2つ以上であることが好ましい)、皮膚表面取付けセンサ制御ユニット254、受信/表示ユニット256、データ記憶/制御モジュール258、および薬物投与システム260を含む。いくつかのケースでは、受信/表示ユニット256、データ記憶/制御モジュール258および薬物投与システム260を単一のユニットとして統合することができる。センサ・ベースの薬物送達システム250は、データ記憶/制御モジュール252の制御アルゴリズム/機構に必要な入力を提供する1つ以上のセンサ252からのデータを使用して、薬物の投与を調整する。例えば、グルコース・センサを使用して、インスリンの投与を制御および調整することが可能である。
Claims (21)
- その少なくとも一部分が、埋め込まれて体液と密に接触するように適合され、かつ前記体液中の検体のレベルを表す信号を生成する電気化学センサと、
前記電気化学センサに結合されて、前記体液中の前記検体のレベルを表す信号を送信する送信器と、該送信器は拡散符号の組を使用して前記信号の送信を容易にするように構成および配置されていることと、
を有する検体監視装置。 - 前記電気化学センサは可撓性を有する基板を有する、請求項1に記載の検体監視装置。
- 前記電気化学センサは検体応答酵素がその少なくとも一部分の表面に配置された作用電極を有する、請求項1に記載の検体監視装置。
- 前記電気化学センサは前記体液中のグルコース・レベルを表す信号を生成するように構成および配置されている、請求項1に記載の検体監視装置。
- 前記送信器は第2の識別信号を送信するようにさらに構成および配置されている、請求項1に記載の検体監視装置。
- 前記送信器は、少なくとも2つの送信器が同じ領域で識別可能に送信できるだけの処理利得を使用するように構成および配置されている、請求項1に記載の検体監視装置。
- 前記送信器は、少なくとも4つの送信器が同じ領域で識別可能に送信できるだけの処理利得を使用するように構成および配置されている、請求項6に記載の検体監視装置。
- 前記送信器は、少なくとも8つの送信器が同じ領域で識別可能に送信できるだけの処理利得を使用するように構成および配置されている、請求項7に記載の検体監視装置。
- 前記送信器は、少なくとも16個の送信器が同じ領域で識別可能に送信できるだけの処理利得を使用するように構成および配置されている、請求項8に記載の検体監視装置。
- 各々が電気化学センサと送信器とからなる集団の検体監視装置を製造する方法であって、
前記集団の検体監視装置の第1の部分集団のうちの第1の送信器に第1の拡散符号セットを割り当てる工程と、
前記集団の検体監視装置の第2の部分集団のうちの第2の送信器に、前記第1の拡散符号セットを含まない第2の拡散符号セットを割り当てる工程と、
前記第1の送信器を前記電気化学センサに結合して、体液中の検体のレベルを表す信号を前記電気化学センサから受け取るための導電経路を前記第1の送信器に提供する工程と、
からなる方法。 - 前記送信器を前記電気化学センサに結合する工程は、前記送信器を前記電気化学センサに配置する工程からなる、請求項10に記載の方法。
- 前記送信器を前記電気化学センサに配置する工程は、前記送信器を、前記電気化学センサの可撓性を有する基板に配置することからなる、請求項11に記載の方法。
- 複数のデータ語の少なくとも1つは、体液中の検体のレベルを表すディジタル信号に由来するデータを含み、前記データ語はそれぞれビット・セットの組からなり、前記データ語の少なくとも2つについて、前記ビット・セットがデータ・ビット・セットの組および誤り訂正ビット・セットの組に編成されるように、前記複数のデータ語をデータ・メッセージに組み立てる工程と、
前記データ・メッセージに組み立てられた前記複数のデータ語のうちの1つのデータ語を構成するビットが続けて送信されないように、前記データ・メッセージを送信する工程と、
からなる体液中の検体のレベルを表すディジタル信号を伝達する方法。 - 前記複数のデータ語を前記データ・メッセージに組み立てる工程は、前記各データ語について、前記ビット・セットがデータ・ビット・セットの組および誤り訂正ビット・セットの組に編成されるように、前記複数のデータ語を前記データ・メッセージに組み立てる工程からなる、請求項13に記載の方法。
- 体液中の検体のレベルを表すアナログ信号を収集する工程と、
前記アナログ信号を体液中の検体のレベルを表すディジタル信号に変換する工程と、
からさらになる、請求項13に記載の方法。 - 前記データ・メッセージを送信する工程は、前記データ・メッセージに組み立てられたそれぞれのデータ語の第1のビットを送信し、続いて前記データ・メッセージに組み立てられたそれぞれのデータ語の第2のビットを送信し、さらに続けて前記データ・メッセージに組み立てられたそれぞれのデータ語の次のビットを、前記データ・メッセージ全体が送信されるまで送信する工程からなる、請求項15に記載の方法。
- その少なくとも一部分が、埋め込まれて体液と密に接触するように適合され、かつ前記体液中の検体のレベルを表す信号を生成する電気化学センサと、
前記電気化学センサに結合された送信器とを有し、前記送信器は、
前記体液中の前記検体のレベルを表す前記信号を、前記体液中の前記検体のレベルを表すディジタル信号に変換し、
複数のデータ語をデータ・メッセージに組み立て、その際に、少なくとも1つの前記データ語は前記体液中の前記検体のレベルを表す前記ディジタル信号に由来するデータを含み、前記データ語はそれぞれビット・セットの組からなり、少なくとも2つの前記データ語について、前記ビット・セットをデータ・ビット・セットの組および誤り訂正ビット・セットの組に編成し、
前記データ・メッセージに組み立てられた前記複数のデータ語のうちの1つのデータ語を構成するビットが続けて送信されないように、前記データ・メッセージを送信するように構成および配置されている、検体監視装置。 - 前記送信器は、前記データ・メッセージに組み立てられたそれぞれのデータ語の第1のビットを送信し、続いて前記データ・メッセージに組み立てられたそれぞれのデータ語の第2のビットを送信し、さらに続けて前記データ・メッセージに組み立てられたそれぞれのデータ語の次のビットを、前記データ・メッセージ全体が送信されるまで送信するように構成および配置された送信器を有する、請求項17に記載の検体監視装置。
- 前記電気化学センサに結合された前記送信器は、前記電気化学センサ上に配置された前記送信器を有する、請求項17に記載の検体監視装置。
- 前記電気化学センサ上に配置された前記送信器は、前記電気化学センサの可撓性を有する基板に配置された前記送信器を有する、請求項19に記載の検体監視装置。
- 前記電気化学センサは、前記体液中のグルコース・レベルを表す信号を生成するように構成および配置されている、請求項19に記載の検体監視装置。
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