JP2014514093A - 先進的な検体センサの較正及びエラー検出 - Google Patents
先進的な検体センサの較正及びエラー検出 Download PDFInfo
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Abstract
Description
この出願は、2011年4月15日に出願された米国特許仮出願第第61/476,145号の利益を主張する。上述した出願は、参照によってその全体が本願明細書に組み込まれ、明らかにこの明細書の一部をなす。
△S=(a*log(t)+b)*△I
ここで△Sは感度の変化、tは検体センサを較正してからの時間、△Iは決定されたインピーダンスの変化、且つa及びbは予め定められた係数である。
本願明細書において記載されている実施形態の理解を容易にするために、多くの用語は、以下に定められる。
従来の生体内連続検体センシング技術は典型的に、連続検体センサを較正するために、センサセッションの間に実行される基準測定に依存している。この基準測定は、実質的に時間に対応するセンサデータと組み合わされ、組み合わされたデータペアを生じさせる。続いて、組み合わせされたデータペア上で(例えば、最小自乗回帰を用いて)回帰が実行され、センサシグナルと推定されるグルコース濃度との関係を定める変換関数を生成する。
y=mx+b
ここで、yはセンサシグナル(カウント)を表し、xは推定されたグルコース濃度(mg/dL)を表し、mは検体濃度に対するセンサ感度(カウント/mg/dL)を表し、且つbはベースラインの信号(カウント)を表している。本願明細書の他の部分に記載されるように、ある実施形態においては、bの値(すなわち、ベースライン)を0或いはほぼ0とすることができる。その結果、これらの実施形態については、較正は方程式y=mxを解くことによって定めることができる。
本願明細書の他の部分に記載するように、ある実施形態においては、検体センサシステムの自己較正は、以下の方程式を解くことができるように、感度プロフィール(及び測定された或いは推定されたベースライン)に基づいてセンサ感度を決定することにより実行することができる。
y=mx+b
ここで、yはセンサシグナル(カウント)を表し、xは推定されたグルコース濃度(mg/dL)を表し、mは検体に対するセンサ感度(カウント/mg/dL)を表し、且つbはベースライン信号(カウント)を表す。この方程式から、変換関数を形成することができ、それによってセンサ信号は、推定されるグルコース濃度に変換される。
センサが受容者に植設されるときに、様々なタイプのノイズは生じる場合がある。いくつかの植設可能センサは、ベースライン信号及び検体信号の2つの構成要素から成る信号(例えば、カウント)を測定する。ベースライン信号は実質的に測定検体以外のファクタ(例えば、妨害化学種、非反応関連の過酸化水素、又は検体或いは補助検体(co-analyte)と重なる酸化電位を有する他の電気活性化学種)からの信号貢献から成る。検体信号(例えば、グルコース信号)は、実質的に検体からの信号貢献から成る。従って、信号がこれらの2つの構成要素を含むので、検体(例えば、グルコース)濃度を決定するべく、方程式y=mx+bを解くことによって較正を実行することができ、ここでbの値が信号のベースラインを表している。いくつかの状況においては、ベースラインは一定の及び一定でない非検体ファクタから成る。一般に、患者或いはヘルスケアの専門家により正確な検体濃度を与えるために、バックグラウンド信号を減少させ或いは取り除くことが望ましい。
連続検体センサを製造するプロセスは、時にはある程度のセンサロット間の変動に曝される場合がある。この変動を補償するために、センサ感度に影響を及ぼし或いは感度プロフィールに関する追加の情報を提供するパラメータを定めるべく、一つ又は複数の較正コードを各センサ或いはセンサの組に割り当てることができる。この較正コードは異なるセンサの変動を減らすことができ、差を調整するアルゴリズムを適用することにより、異なるセンサロットからのセンサを使用することから獲得される結果が全般的に等しく且つ一貫することを確かにする。一つの実施形態において、検体センサシステムは、一つ又は複数の較正コードがユーザによってシステムに手動で入力されるように構成することができる。他の実施形態においては、較正コードは、多数のセンサのパッケージに付着される(或いは、挿入される)較正が符合化されたラベルの一部とすることができる。この較正が符合化されたラベルそれ自身は、光学的技術、RFID(電波による個体識別)、その他、及びそれらの組み合わせを含むが、それらには限定されない様々な技術のいずれかによって読むことができ或いは問い合わせることができる。コードをセンサシステムに転送するためのこれらの技術は、より自動的で、正確で、且つ患者にとって便利で、また手動での入力に比較してエラーの傾向がより少ないものとすることができる。手動での入力には、例えば、間違ったコードを入力する患者或いは病院スタッフによって生じる、誤った較正、従って不正確なグルコース濃度表示につながるかもしれない、エラーの固有のリスクがある。その結果、このことは、患者或いは病院スタッフが不適切な措置(例えば、低血糖状態においてあると共に、インシュリンを注射する)を取ることに帰着する場合がある。
センサの属性を決定して及び/又はセンサデータを較正するために、いくつかの実施形態は、一つ又は複数の刺激信号をセンサに印加する。本願明細書で使用する「刺激信号」という用語は、広義の用語であり、この分野の当業者にとって通常の及び慣例的なその意味が与えられ(且つ特別な或いはカスタマイズされた意味に限定されず)、且つ応答を生じさせ或いは引き出すために使用されるシステム(例えば、検体センサ)に印加される信号(例えば、電圧、電流或いは電界強度といった時間で変化する或いは空間で変化する量)を指すがそれには限定されない。
Rmembrane=△v/△i
である。
本願明細書で議論するように、センサセッションの間の検体濃度に対するセンサの感度は、多くの場合に時間の関数として変化するであろう。感度のこの変化は、特定レベルの感度について電流の増加として現れ得る。いくつかの実施形態においては、感度は、最初の24〜48時間の間に、数十パーセントの相対変化として増加する。正確な検体濃度の測定値をユーザに提供するためには、基準測定(例えば、ストリップベースの血糖測定)を使用するシステム較正が必要となる場合がある。典型的に、較正の割合は、1日に1回、2回或いはそれ以上とすることができる。
いくつかの実施形態は、センサの温度を決定するために、信号処理技術を使用することができる。例えば、刺激信号はセンサに印加することができ、信号応答が測定され、且つ信号応答に基づいてセンサの温度を取り出すことができる。
いくつかの実施形態においては、センサエレクトロニクス内への湿気進入は、特定の周波数或いは周波数範囲においてセンサのインピーダンスを測定することに基づいて決定することができる。測定されたインピーダンスが予め定められたインピーダンス値と十分に対応しない場合、作動可能にセンサに接続されているセンサシステムは湿気進入エラールーチンを開始することができる。対応は、一つ又は複数の閾値、データ関連関数等を使用して決定することができる。更に、ここで留意されるべきことは、湿気放出を決定する際に、インピーダンスの位相情報が有益な情報を提供し得ることである。従って、いくつかの実施形態においては、インピーダンス測定は、別々のインピーダンスの大きさと位相成分に分けることができ、且つインピーダンスの成分の一方又は両方は、対応を決定するために、予め定められた値と比較することができる。
いくつかの実施形態においては、特定の周波数或いは周波数範囲においてインピーダンスを測定することに基づいて、膜損傷を検出することができる。測定されたインピーダンスが予め定められた一つ又は複数のインピーダンス値に十分に対応しない場合、センサに作動可能に接続されているセンサシステムは、続いて、膜損傷エラールーチンを開始することができる。対応は、データ関連関数を使用して決定することができる。
いくつかの実施形態では、センサの再利用を検出することができる。本願明細書に記載されているグルコースセンサの実施形態は信頼性の高いセンサデータをセンサが提供できる、定められた寿命を有し得る。定められた寿命の後、センサの信頼性はもはや高くなく、不正確なセンサデータを与える場合がある。予め定義された寿命を越えた使用を防止するために、いくつかの実施形態は、センサはもはや使用するべきでないと決定された後、センサの取り替えをユーザに通報する。センサをもはや使用するべきでないかどうかを決定するために、様々な方法を使用することができる。例えば、センサが最初に使用されて(例えば、最初にユーザに植設されたとき、又はセンサエレクトロニクスモジュールに最初に電気的に接続されたとき)から生じた予め定められた期間、又はセンサに欠陥(例えば、膜の破裂、不安定な感度等)があるという決定である。センサをもはや使用するべきでないと一旦決定されると、センサシステムは、例えば、新しいセンサの使用をユーザに聞こえるように及び/又は視覚的に促し、及び/又はディスプレイをシャットダウンし、又はディスプレイ上でのセンサデータの表示を中止することによって、新しいセンサの使用をユーザに通報することができる。しかしながら、ユーザは、新しいセンサを使用する代わりに同じセンサを再利用しようとする場合がある。このことは、ユーザとって危険であろう。センサが与えるであろう不正確なデータにユーザが依存するからである。
いくつかの実施形態は、センサ膜の一つ又は複数の測定されたインピーダンスに基づいて過剰電位ルーチンを適用する。検体センサのいくつかの実施形態に過剰電位(例えば、検体を連続的に検知するために使用するときにセンサに印加するバイアス電圧より高いボルテージ電圧)を印加することは検体センサの安定化を助け、それによってセンサの慣らし期間を短くすることが見出された。過剰電位は、センサが一旦十分に安定したら中断する必要があり、さもなければセンサの損傷が生じる場合がある。従って、センサの感度或いは感度の変化を決定するためにセンサの一つ又は複数のインピーダンス測定値を使用することができる。図11〜図14を参照して記載したようなものといった、本願明細書に記載されている技法のいずれかを、センサのインピーダンスを測定するために用いることができる。決定された感度或いは感度の変化は、次には、例えば測定されたインピーダンスと予め定められた感度とインピーダンスの関係との対応を決定することによってセンサが安定したか否か或いは決定された期間以内に安定するかを示すために、使用することができる。センサが安定した或いは決定された期間内に安定すると決定されると、過剰電位の印加を中断し或いは減少させることができる。加えて、過剰電位の大きさ及び/又は過剰電位をセンサに印加すべき延べ時間は、過剰電位を印加する前に或いは過剰電位を印加する間に取得された一つ又は複数のインピーダンス測定に基づいて、決定し或いは修正することができる。すなわち、いくつかの実施形態による、過剰電位ルーチンは、一つ又は複数のインピーダンス測定値に従って修正し或いは中断することができる。
センサシステムのいくつかの実施形態は、複数のセンサ電極を含む。例えば、上記したように、検体検知電極に加えて、いくつかの実施形態は検体+ベースライン信号からのベースライン信号の減算を可能にするための補助電極を含むことができる。いくつかの実施形態は、一つ又は複数の冗長な検体センサを含むこともできる。
いくつかの実施形態においては、スケーリングファクタは、二電極検体センサの応答における差を修正するために使用することができる。いくつかの実施形態においては、使用できる二電極検体センサは、基準センサ/システムであり、それによって、外部の(例えば、システムとは別々の)検体測定装置を用いること無しに、較正のために(例えば、内側からシステムに対して)基準データを提供することができる。いくつかの実施形態においては、二電極検体センサは、特定の検体と反応する酵素を含む第1の電極(ブラス酵素電極と呼ぶことができる)と、酵素を含まない第2の電極(マイナス酵素電極と呼ぶことができる)とを有する。
いくつかの実施形態による例示的な較正プロセスについて、図24を参照してここで述べる。較正プロセス2400は、変換関数2408を形成し或いは修正するために、一つ又は複数の植設前情報2402、内部診断情報2404、及び入力としての外部参照情報2406を使用することができる。変換関数2408は、(例えば、電流或いはカウントを単位と)センサデータを(例えば、検体濃度を単位にする)推定される検体値2410に変換するために使用することができる。推定される検体値を表す情報が、続いて、ユーザディスプレイ上に表示され、外部装置(例えば、インシュリンポンプ、PCコンピュータ、モバイルコンピューティング装置、その他)に送信されるといったように出力2412され、及び/又は更に処理される。検体は、例えば、グルコースとすることができる。
− 現在使用する(例えば、植設された)センサに関連付けられた、センサのある期間に亘る感度の変化の予測されるプロフィールといった予め定められた感度プロフィール;
− (例えば、センサのインピーダンス、静電容量或いは他の電気的或いは化学的な属性を表す出力である)特定の刺激信号の出力と、(例えば、先行する生体内での及び/又は生体外での研究から決定された)センサ感度との間の以前に決定された関係;
− (例えば、センサのインピーダンス、静電容量或いは他の電気的或いは化学的な属性を表す出力である)特定の刺激信号の出力と(例えば、先行する生体内で及び/又は生体外での研究から決定された)センサ温度との以前に決定された関係;
− 以前に植設された検体濃度センサから取得されたセンサデータ;
− 本願明細書に述べるように較正されるセンサに関連付けられた較正コード;
− センサと感度、ベースライン、ドリフト、インピーダンス、インピーダンス/温度関係との間の(例えば、患者或いは他の患者の先行研究から決定された、患者について共通する特性を有する)患者に特有な関係;
− センサ植設部位(腹部、腕、その他)に特定の関係(異なる部位は異なる脈管密度を有していてよい);
− センサ製造からの時間(例えば、センサが棚の上にあった時間、センサが製造され及び/又は出荷された日付、センサが製造され及び/又は出荷された時とセンサが植設された時との間の時間);及び
− 棚上げされたセンサの温度、湿度、外的因子に対する曝露。
− 本願明細書に記載される(刺激信号の出力がリアルタイムに取得され且つ処理され得る)刺激信号の技法のいずれかを使用するセンサの(例えば、その出力がセンサのインピーダンスを表す)刺激信号の出力;
− 植設されたセンサによって測定される検体濃度を表すセンサデータ(現在植設されたセンサを使用するリアルタイムデータ及び/又は以前に生成されたセンサデータ);
− 植設された検体センサと同じ位置に又は植設された検体センサとは別々に配置される、(サーミスタといった)植設されたセンサ又は補助センサを使用する温度の測定値;
− 例えばそのセンサの一つの電極が本願明細書に記載されるようにベースライン信号を決定するように設計されている、多電極センサからのセンサデータ;
− 冗長なセンサのうちの一つ又は複数が、他の冗長なセンサうちの全てではないにしても少なくともいくつかと実質的に同じであるように設計された(例えば、同じセンサ膜タイプを有する)冗長なセンサによって生成されるセンサデータ;
− (光学、熱、容量、その他といった)異なる様式を有すると共に検体センサと同じ位置に配置される或いは検体センサから離れて配置された、一つ又は複数の補助センサによって生成されるセンサデータ;
− センサが植設されてから及び/又はセンサシステムのセンサエレクトロニクスに(例えば、物理的に又は電子的に)接続されてからの時間;
− 例えば、圧力センサ(例えば、圧縮人工産物を検出するために)によって生成されるセンサ/センサシステムの上の圧力を表わすデータ;
− (例えば、受容者の運動/移動/活動を表す)加速度計によって生成されるデータ;
− (例えば、センサシステムの湿気シールの完全性を表す)一定量の湿気進入;及び
− (いくつかの実施形態において、生の信号とフィルタ処理された信号との間の残差と呼ぶことができる)検体濃度信号における一定量のノイズ。
− 基準モニタから取得されたリアルタイムの及び/又は先行する検体濃度情報(例えば、別々のセンサ、例えば指スティックグルコースメータから得られた検体濃度値);
− 基準メータのタイプ/ブランド(異なるメータは異なるバイアス/精度を有していてよい);
− 患者によって消費される炭水化物を表す情報;
− インスリン作用期間(insulin on board)、インシュリン感応性、グルカゴン作用期間(glucagon on board)といった薬剤ペン/ポンプからの情報;
− グルカゴン感度情報;及び
− (例えば、同じロットからのセンサといった類似した特性を有するセンサから集められたデータに基づく)母集団ベースのデータから集められた情報。
本発明の実施形態は、方法、装置及びコンピュータープログラム製品のフローチャートを参照しつつ上記及び以下に記載されている。ここで理解されることは、フローチャート図の各ブロック及びフローチャート図のブロックの組合せが、コンピュータープログラムの命令の実行によって実施できることである。これらのコンピュータープログラム命令は、機械を生産するために、センサエレクトロニクスシステムにおけるコンピュータ或いは他のプログラム可能なデータ処理機械(例えばコントローラ、マイクロコントローラ、マイクロプロセッサ或いはその他)上にロードすることができ、コンピュータ或いは他のプログラム可能なデータ処理機械上で実行される命令がフローチャートのブロックにおいて特定される機能を実施する命令を生じさせるようになっている。これらのコンピュータープログラム命令はまた、コンピュータ或いは他のプログラム可能なデータ処理機械が特定の仕方で機能するように命令するコンピュータ読取可能メモリに格納することができ、コンピュータ読取可能メモリに格納された命令が、フローチャートのブロックにおいて特定される機能を実行する命令を含む製品を生産するようになっている。コンピュータープログラム命令はまた、一連の機能を果たすステップがコンピュータ或いは他のプログラム可能な装置上で実行されるようにしてコンピュータ実行プロセスを生成するために、コンピュータ或いは他のプログラム可能なデータ処理機械上にロードすることができ、コンピュータ或いは他のプログラム可能である装置上で実行する命令が、本願明細書に示されているフローチャートのブロックにおいて特定される機能を実施するためのステップを提供するようになっている。
以下の実施例において実施形態を更に詳述するが、それらは実例として提供されるものであり、如何なる方法であっても発明を限定することを意図しない。本願明細書に開示するように、緩衝液内に配置されたグルコースセンサの複素インピーダンスを分析するべく、Gamry定電位装置システムを使用する研究が実行された。このGamry定電位装置システムは、Ref600のモデル名でGamry社から商業的に入手可能である。緩衝液は、公知のグルコース濃度を有する改質されたイソライト(等張電解質製剤)である。多くの実施例において、グルコース濃度は約100mg/dLである。公知のインピーダンスでのシステムのテストにより、実施例におけるインピーダンス測定エラーが約1〜5%であることが見いだされた。
感度とインピーダンスの関係
実施例1は、センサの感度とセンサのインピーダンスとの関係を示している。この実施例では、IVBGセンサがGamry定電位装置システムに接続され、且つ100mg/dLのグルコース濃度を有する改質イソライトの緩衝溶液中に配置された。実験の間の温度は37℃であった。インピーダンススペクトルは固定間隔の時間で取得された。この実験において分析されたインピーダンススペクトルは、1Hzから100kHzの範囲であり、且つセンサインピーダンス及びセンサ感度の測定値は約1200分の期間において15分間隔で取得された。
インピーダンスを使用しての感度ドリフトの過去に遡る補償
図27は、7つの異なるセンサ、センサA〜Gを使用して様々な期間に亘って測定された感度及びインピーダンスポイントのプロットである。センサA〜Gは経皮タイプのセンサであるが、いくつかの異なるセンサロットから選択されている。従って、センサA〜Gはすべてが経皮センサではあるが、異なるロットからのセンサは、わずかに異なる方法で又はわずかに異なる状態下で製造されるため、異なるロットからのセンサが異なる感度プロフィールを示す結果となる場合がある。この実施例では、センサA及びDは第1ロットから選択され、センサBは第2ロットから選択され、且つセンサC、E、F及びGは第3ロットから選択されている。
インピーダンス測定を使用するセンサデータの予測的な較正
実施例5は、予測的な較正に関する。更に、この実験における、センサデータの較正は、異なるセンサロットからのセンサから前もって導かれた感度の変化とインピーダンスの変化との関係に基づいている。すなわち、実施例3においては、評価曲線2802は、第4のセンサロットからそれぞれ選択されたセンサR〜Uを使用して取得されたデータを補償するために使用されたが、その第4のセンサロットは、評価曲線2802を導き出すために使用されたセンサのグループには含まれていない。実施例5は、較正されるセンサのタイプとは異なるタイプのセンサから導き出された感度の変化とインピーダンスの変化との関係を使用して、データを較正できることを示している。このことは、感度ドリフトを補償するためにセンサの工場較正コードを用いる必要はないことを示している。
温度の効果
図40は、センサのインピーダンス及び感度と温度の関係を示している。ポイント4002は3日の期間に亘って測定されたセンサの感度値であり、且つポイント4004は同じ期間に亘って測定されたセンサのインピーダンス値である。実施例4において、センサは経皮タイプのセンサである。図40に示すように、温度は最初に37℃に設定されて維持され、次いで45℃まで上昇し、最後に25℃まで低下する。
温度補償
図42は、実施例4のセンサによって測定された検体濃度データの補償の、センサ慣らしの後の温度の効果について示している。ここで、インピーダンスと温度の関係は、センサデータを補償するために使用された。この例では、その関係は図41のデータから導き出された評価曲線に基づいている。
湿気進入の検出
実施例6は、センサを駆動するために使用されるセンサエレクトロニクスの構成部分内の湿気進入の検出を含んでいる。この実施例では、100Hzから1kHzにわたる周波数の入力信号がセンサに印加される。信号の応答は、続いて、周波数の範囲に亘って測定され、インピーダンス及び位相の変化の両方がそこから導き出される。次に、センサエレクトロニクスモジュールの密封部分の内側に典型的に配置される接点が濡らされる。入力信号の周波数は、100Hzと1000Hzとの間で変更される。応答がもう一度測定され、インピーダンス及び位相の変化の両方が導き出される。
膜損傷の検出
実施例7は、インピーダンス測定を使用するセンサ膜の損傷の検出を含んでいる。この実施例では、検体センサのインピーダンスは、100から1kHzにわたる周波数の範囲上で測定された。センサ膜の一部は、続いて、膜損傷を生じさせるためにかみそりの刃を使用して切断された。センサのインピーダンスは、同じ周波数の範囲でもう一度測定された。膜損傷を検出するためにインピーダンスを用いることができるかどうかを決定するために、膜を切断する前のセンサのインピーダンス測定値は、続いて、膜を切断した後のセンサの測定値と比較された。
インピーダンスを計算するためにFFTを使用する研究
図46は、高速フーリエ変換(FFT:Fast Fourier Transform)を使用して計算されたインピーダンス、及び比較のためにGamryを使用して測定されたインピーダンスをプロットするグラフである。図46は、30分、1.5時間、3時間及び13時間の入力データについてのFFT及び対応するGamry測定値を示している。FFTデータは、約1kHzの周波数まで実質的にGamryデータを辿った。図33における周波数が1kHzより後の食い違いは、FFTを計算するために使用したシステムの公知の制限によるものと考えられる。従って、FFTの使用は、1kHzのスペクトルを過ぎてもなお正確なインピーダンスデータを提供でき、それによってGamryを使用して測定されたインピーダンスに対する良好な対応を提供すると考えられる。
生体内での感度変化の補償
図47〜図49は、生体内グルコースセンサを使用する、人間の内部における感度変化の補償に関する。
線形感度とインピーダンスの相関及び非線形感度とインピーダンスの相関との比較
研究室での実験は、センサ感度の変化(ドリフト)とインピーダンスの変化との間に逆の関係があることを示した。測定されたインピーダンスに基づき、線形或いは非線形のセンサ感度とインピーダンスとの相関を使用して、センサ感度のドリフトは補償することができる。
△S =(a*log(t)+b)*△I
として表すことができる。ここでa及びbは、類似するセンサの先行テストから決定される定数である。類似するセンサの先行テストは、生体外でのベンチテストを使用して実行され、且つ定数はこの実験において従来のコンピュータープロット技法を使用して導き出された。
△S=感度の%変化=(時間tにおける感度−Sc)/Sc*100%
ここで、Scは較正において決定される感度、且つtは最後の較正からの時間である。
△I=%インピーダンス変化=(時間tにおけるインピーダンス−Ic)/Ic*100%
ここで、Icは較正時のインピーダンスである。
△S=−4.807*△I−0.742
であった。この最良線形当てはめは、線形感度とインピーダンスの相関として使用された。
Claims (195)
- 連続検体センサにより生成されたセンサデータを較正する方法であって、
前記連続検体センサを使用してセンサデータを生成すること、
センサ感度情報を含む先験的な情報を適用することにより、前記連続検体センサの感度値を時間の関数として、電子的な装置により、反復的に決定すること、及び
前記決定された感度値に少なくとも部分的に基づいて前記センサデータを較正すること、
を含む方法。 - 前記センサデータを較正することは、センサセッションの実質的に全体に亘って反復的に実行される、請求項1に記載した方法。
- 感度値を反復的に決定することは、前記先験的な情報によって定まるように、定期的に実行され或いは不定期な間隔で実行される、請求項1に記載した方法。
- 感度値を反復的に決定することは、実質的にセンサセッションの全体に亘って実行される、請求項1に記載した方法。
- 感度値を決定することは、実質的にリアルタイムに実行される、請求項1に記載した方法。
- 前記先験的な情報は、センサセッションが開始した後の予め定められた時間に関連付けられている少なくとも一つの予め定められた感度値に関連付けられている、請求項1に記載した方法。
- 前記少なくとも一つの予め定められた感度値は、生体外での検体濃度測定から決定された感度と所定の時間における生体内での検体濃度測定から決定された感度との間の相関に関連付けられている、請求項6に記載した方法。
- 前記先験的な情報は、入力として時間を使用する予め定められた感度関数に関連付けられている、請求項1に記載した方法。
- 時間は、センサセッションが開始した後の時間に対応する、請求項8に記載した方法。
- 時間は、製造の時点或いは製造からの時間のうちの少なくとも一つに対応する、請求項8に記載した方法。
- 前記連続検体センサの前記感度値はまた、少なくとも一つの他のパラメータの関数である、請求項1に記載した方法。
- 前記少なくとも一つの他のパラメータは、温度、pH、水和作用のレベル或いは期間、硬化条件、センサを作動開始する間に前記連続検体センサを囲む流体の検体濃度、及びそれらの組み合わせより成るグループから選択される、請求項11に記載した方法。
- 前記センサデータを較正することは、基準血糖データを使用せずに実行される、請求項1に記載した方法。
- 前記電子装置は、少なくとも約3日のセンサセッションを通じて約10%を超えない平均絶対相対差に対応する精度レベルをもたらすべく構成され、
且つ前記平均絶対相対差の計算に関連付けられている基準測定は血液の分析により決定される、請求項1に記載した方法。 - 前記センサセッションは、少なくとも約4日である、請求項14に記載した方法。
- 前記センサセッションは、少なくとも約5日である、請求項14に記載した方法。
- 前記センサセッションは、少なくとも約6日である、請求項14に記載した方法。
- 前記センサセッションは、少なくとも約7日である、請求項14に記載した方法。
- 前記センサセッションは、少なくとも約10日である、請求項14に記載した方法。
- 前記平均絶対相対差は、前記センサセッションを通じて約7%を超えない、請求項14に記載した方法。
- 前記平均絶対相対差は、前記センサセッションを通じて約5%を超えない、請求項14に記載した方法。
- 前記平均絶対相対差は、前記センサセッションを通じて約3%を超えない、請求項14に記載した方法。
- 前記先験的な情報は、較正コードに関連付けられている、請求項1に記載した方法。
- 前記先験的な感度情報は、前記センサを使用する前に前記センサエレクトロニクスに格納される、請求項1に記載した方法。
- 連続検体センサにより生成されるセンサデータを較正する方法であって、
連続検体センサを使用してセンサデータを生成すること、
前記連続検体センサの複数の異なる感度値を、時間の関数及び先験的な情報に関連付けられている感度情報の関数として、電子装置により決定すること、
及び前記複数の異なる感度値のうちの少なくとも一つに少なくとも部分的に基づいて前記センサデータを較正すること、
を含む方法。 - 前記連続検体センサを較正することは、センサセッションの実質的に全体を通して反復的に実行される、請求項25に記載した方法。
- 前記複数の異なる感度値は、コンピュータメモリのルックアップテーブルに格納される、請求項25に記載した方法。
- 複数の異なる感度値を決定することは、センサセッションの実質的に全体を通して一度だけ実行される、請求項25に記載した方法。
- 前記先験的な情報は、センサセッションが開始した後の予め定められた時間に関連付けられている少なくとも一つの予め定められた感度値に関連付けられている、請求項25に記載した方法。
- 前記少なくとも一つの予め定められた感度値は、生体外での検体濃度測定から決定された感度と所定の時間において生体内での検体濃度測定から決定された感度との間の相関に関連付けられている、請求項29に記載した方法。
- 前記先験的な情報は、入力として時間を使用する予め定められた感度関数に関連付けられている、請求項25に記載した方法。
- 時間は、センサセッションが開始した後の時間に対応する、請求項25に記載した方法。
- 時間は、製造の時点或いは製造からの時間に対応する、請求項25に記載した方法。
- 前記複数の感度値はまた、時間以外の少なくとも一つのパラメータの関数である、請求項25に記載した方法。
- 前記少なくとも一つの他のパラメータは、温度、pH、水和作用のレベル或いは期間、硬化条件、センサを作動開始する間の連続検体センサを囲む流体の検体濃度、及びそれらの組み合わせより成るグループから選択される、請求項25に記載した方法。
- 前記連続検体センサを較正することは、基準血糖データを使用せずに実行される、請求項25に記載した方法。
- 前記電子装置は、少なくとも約3日のセンサセッションを通じて約10%を超えない平均絶対相対差に対応する精度レベルをもたらすべく構成され、
且つ前記平均絶対相対差の計算に関連付けられている基準測定値は血液の分析により決定される、請求項25に記載した方法。 - 前記センサセッションは、少なくとも約4日である、請求項37に記載した方法。
- 前記センサセッションは、少なくとも約5日である、請求項37に記載した方法。
- 前記センサセッションは、少なくとも約6日である、請求項37に記載した方法。
- 前記センサセッションは、少なくとも約7日である、請求項37に記載した方法。
- 前記センサセッションは、少なくとも約10日である、請求項37に記載した方法。
- 前記平均絶対相対差は、前記センサセッションを通じて約7%を超えない、請求項37に記載した方法。
- 前記平均絶対相対差は、前記センサセッションを通じて約5%を超えない、請求項37に記載した方法。
- 前記平均絶対相対差は、前記センサセッションを通じて約3%を超えない、請求項37に記載した方法。
- 前記先験的な情報は、較正コードに関連付けられている、請求項37に記載した方法。
- 連続検体センサからのデータを処理するための方法であって、
少なくとも一つのセンサデータポイントを含んでいる連続検体センサからのセンサデータを、電子装置によって、受け入れること、
前記連続検体センサの感度値を、時間の関数及びセンサセッションを開始した後の所定の時間に関連付けられている少なくとも一つの予め定められた感度値の関数として反復的に決定すること、
少なくとも部分的に前記感度値に基づいて変換関数を形成すること、
及び前記少なくとも一つのセンサデータポイントに前記変換関数を適用することによって、検体出力値を決定すること、
を含む方法。 - 前記連続検体センサの感度を反復的に決定することは、連続的に実行される、請求項47に記載した方法。
- 感度を反復的に決定することは、実質的にリアルタイムに実行される、請求項47に記載した方法。
- 前記連続検体センサのベースラインを決定することを更に含み、前記変換関数は少なくとも部分的に前記ベースラインに基づく、請求項47に記載した方法。
- 前記連続検体センサのベースラインを決定することは、連続的に実行される、請求項50に記載した方法。
- 前記連続検体センサの感度を決定すること、及び前記検体センサのベースラインを決定することは、実質的に同時に実行される、請求項51に記載した方法。
- 前記少なくとも一つの予め定められた感度値は、前記連続検体センサの製造施設において設定される、請求項47に記載した方法。
- 少なくとも一つの較正コードを受け入れること、及び
センサセッションが開始した後の所定の時間に少なくとも一つの較正コードを電子装置に適用すること、を更に含む請求項47に記載した方法。 - 感度を反復的に決定することは、前記少なくとも一つの較正コードによって定められるように、定期的な間隔で実行され或いは不定期な間隔で実行される、請求項54に記載した方法。
- 少なくとも一つの較正コードは、少なくとも一つの予め定められた感度に関連付けられている、請求項55に記載した方法。
- 前記少なくとも一つの較正コードは、入力として時間の関数における時間を使用する予め定められた感度関数に関連付けられている、請求項55に記載した方法。
- 時間は、センサセッションを開始した後の時間に対応する、請求項47に記載した方法。
- 時間は、製造の時点或いは製造からの時間に対応する、請求項47に記載した方法。
- 前記連続検体センサの感度値はまた、少なくとも一つの他のパラメータの関数である、請求項47に記載した方法。
- 前記少なくとも一つの他のパラメータは、温度、pH、水和作用のレベル或いは期間、硬化条件、センサを作動開始する間の連続検体センサを囲む流体の検体濃度、及びそれらの組み合わせより成るグループから選択される、請求項60に記載した方法。
- 連続検体センサを較正する方法であって、
連続検体センサからセンサデータを受け入れること、
センサセッションを開始した後の所定の時間に関連付けられている少なくとも一つの予め定められた感度値の関数である、実質的にセンサセッションの全体に亘っての検体に対するセンサ感度の変化に対応する予め定められた感度プロフィールを、形成し又は受け入れること、及び
リアルタイム較正において、電子装置により、前記感度プロフィールを適用すること、
を含む方法。 - 少なくとも一つの予め定められた感度値、予め定められた感度プロフィール、或いはその両方が前記連続検体センサの製造施設において設定される、請求項62に記載した方法。
- 少なくとも一つの較正コードを受け入れること、及び
前記センサセッションを開始した後の所定の時間に少なくとも一つの較正コードを前記電子装置に適用すること、を更に含む請求項62に記載した方法。 - 前記少なくとも一つの較正コードは、前記少なくとも一つの予め定められた感度に関連付けられている、請求項64に記載した方法。
- 前記少なくとも一つの較正コードは、入力として時間を使用する予め定められた感度関数に関連付けられている、請求項64に記載した方法。
- 前記感度プロフィールは、時間の関数である、請求項62に記載した方法。
- 時間は、センサセッションを開始した後の時間に対応する、請求項67に記載した方法。
- 時間は、製造の時点或いは製造からの時間に対応する、請求項67に記載した方法。
- 前記感度値は、時間と、予め定められた感度値と、温度、pH、水和作用のレベル或いは期間、硬化条件、センサを作動開始する間の連続検体センサを囲む流体の検体濃度、及びそれらの組み合わせより成るグループから選択される少なくとも一つのパラメータの関数である、請求項62に記載した方法。
- 連続検体センサからのデータを処理する方法であって、
少なくとも一つのセンサデータポイントを含んでいる連続検体センサからのセンサデータを、電子装置によって、受け入れること、
センサセッションの実質的に全体に亘ってのセンサ感度の変化に対応する、感度プロフィールを受け入れ又は形成すること、
前記感度プロフィールに少なくとも部分的に基づいて変換関数を形成すること、及び
前記少なくとも一つのセンサデータポイントに前記変換関数を適用することによって検体出力値を決定すること、
を含む方法。 - 前記感度プロフィールは、前記連続検体センサの製造施設において設定される、請求項71に記載した方法。
- 少なくとも一つの較正コードを受け入れること、
及びセンサセッションを開始した後の所定の時間に前記少なくとも一つの較正コードを前記電子装置に適用すること、を更に含む請求項71に記載した方法。 - 前記少なくとも一つの較正コードは、前記少なくとも一つの予め定められた感度に関連付けられている、請求項73に記載した方法。
- 前記少なくとも一つの較正コードは、前記感度プロフィールに関連付けられている、請求項73に記載した方法。
- 前記感度プロフィールは、時間の関数である、請求項71に記載した方法。
- 時間は、センサセッションを開始した後の時間に対応する、請求項76に記載した方法。
- 時間は、製造の時点或いは製造からの時間に対応する、請求項76に記載した方法。
- 前記感度が時間の関数であり、且つ少なくとも一つのパラメータが温度、pH、水和作用のレベル或いは期間、硬化条件、センサを作動開始する間の連続検体センサを囲む流体の検体濃度、及びそれらの組み合わせより成るグループから選択される、請求項71に記載した方法。
- 受容者の内部の検体濃度をモニタするためのシステムであって、
受容者の内部の検体濃度を測定すると共に工場較正されたセンサデータを提供するべく構成された連続検体センサであり、前記工場較正されたセンサデータが基準血糖データを使用せずに較正される連続検体センサを備え、
前記システムは、少なくとも約3日のセンサセッションを通じて約10%を超えない平均絶対相対差に対応する精度レベルをもたらすべく構成され、
前記平均絶対相対差の計算に関連付けられている基準測定は、血液の分析により決定される、
システム。 - 前記センサセッションは、少なくとも約4日である、請求項80に記載のシステム。
- 前記センサセッションは、少なくとも約5日である、請求項80に記載のシステム。
- 前記センサセッションは、少なくとも約6日である、請求項80に記載のシステム。
- 前記センサセッションは、少なくとも約7日である、請求項80に記載のシステム。
- 前記センサセッションは、少なくとも約10日である、請求項80に記載のシステム。
- 前記平均絶対相対差は、前記センサセッションを通じて約7%を超えない、請求項80に記載のシステム。
- 前記平均絶対相対差は、前記センサセッションを通じて約5%を超えない、請求項80に記載のシステム。
- 前記平均絶対相対差は、前記センサセッションを通じて約3%を超えない、請求項80に記載のシステム。
- 連続検体センサの属性を決定する方法であって、
バイアス電圧を前記検体センサに印加すること、
前記バイアス電圧を上回る電圧ステップを前記検体センサに印加すること、
センサエレクトロニクスを使用して、前記電圧ステップの信号応答を測定すること、
センサエレクトロニクスを使用して、前記信号応答のピーク電流を決定すること、及び
センサエレクトロニクスを使用して、前記ピーク電流を予め定められた関係に関連付けることにより前記センサの属性を決定すること、
を含む方法。 - 前記ピーク電流を前記予め定められた関係に関連づけることは、前記ピーク電流に基づいて前記センサのインピーダンスを計算すること、及び前記センサインピーダンスを前記予め定められた関係に関連づけること、を含む請求項89に記載した方法。
- 前記センサの属性は、前記センサの感度或いは前記センサの温度である、請求項89に記載した方法。
- 前記ピーク電流は、前記電圧ステップより前の応答の大きさと前記電圧ステップに起因する最も大きく測定された応答の大きさとの間の差である、請求項89に記載した方法。
- 前記予め定められた関係はインピーダンスとセンサ感度との関係であり、且つ前記センサの属性は前記センサの感度である、請求項89に記載した方法。
- 前記決定されたセンサの属性を使用してセンサデータを補償すること、を更に含む請求項89に記載した方法。
- 前記補償することは、前記ピーク電流の予め定められた関係をセンサ感度或いはセンサ感度の変化に関連付けること及び関連付けられたセンサ感度或いはセンサ感度の変化に応じてセンサデータの値を修正することを含む、請求項94に記載した方法。
- 前記予め定められた関係は、前記検体センサを使用する期間に亘って線形な関係である、請求項89に記載した方法。
- 前記予め定められた関係は、前記検体センサを使用する期間に亘って非線形な関係である、請求項89に記載した方法。
- 前記予め定められた関係は、前記検体センサに類似するセンサを先行テストすることにより決定される、請求項89に記載した方法。
- 請求項89〜98のいずれか一項に記載した方法を実施するべく構成されたセンサシステム。
- 前記センサシステムは、コンピュータメモリに格納された命令を備え、
前記命令は、前記センサシステムの一つ又は複数のプロセッサにより実行されるときに、請求項89〜98のうちの一つに記載した方法を前記センサシステムに実施させる、請求項99に記載のセンサシステム。 - 検体センサを較正する方法であって、
時間変化する信号を前記検体センサに印加すること、
印加された信号に対する信号応答を測定すること、
センサエレクトロニクスを使用し、前記信号応答の少なくとも一つの属性を予め定められた感度プロフィールに関連づけて、検体センサの感度を決定すること、
前記決定された感度及び前記検体センサにより生成されたセンサデータを使用して推定される検体濃度値を、センサエレクトロニクスを使用して生成すること、
を含む方法。 - 前記感度プロフィールは、前記センサを植設してからの期間に亘って変化する感度値を含む、請求項101に記載した方法。
- 前記予め定められた感度プロフィールは、複数の感度値を含む、請求項101に記載した方法。
- 前記予め定められた感度プロフィールは、前記検体センサに類似する検体センサの感度変化を研究することから生成されるセンサ感度データに基づく、請求項101に記載した方法。
- 前記センサにバイアス電圧を印加することを更に含み、
前記時間で変化する信号は、前記バイアス電圧を上回るステップ電圧或いは前記バイアス電圧に重なる正弦波電圧を含む、請求項101に記載した方法。 - 前記決定することは、
測定された信号応答に基づいてインピーダンス値を計算すること、
及び前記インピーダンス値を予め定められた感度プロフィールの感度値に関連づけること、を更に含む請求項101に記載した方法。 - DCバイアス電圧を前記センサに印加してセンサデータを生成し、
前記検体濃度値を推定することが前記決定された感度を使用して修正されたセンサデータを生成すること、を含む請求項101に記載した方法。 - 変換関数を前記修正されたセンサデータに適用して前記推定される検体濃度値を生成すること、を更に含む請求項107に記載した方法。
- 前記決定された感度の少なくとも一部分に基づいて変換関数を形成することを更に含み、
推定される検体濃度値を生成するために前記変換関数をセンサデータに適用する、請求項107に記載した方法。 - 前記属性は、前記信号応答のピーク電流値である、請求項101に記載した方法。
- 前記決定することは、
前記信号応答データについて高速フーリエ変換を実行すること、前記信号応答の曲線の少なくとも一部を組み込むこと、及び前記信号応答のピーク電流を決定することのうちの少なくとも一つを使用することを含む、請求項101に記載した方法。 - 前記決定することは、複数の異なる予め定められた感度プロフィールから決定されたセンサ属性に基づいて予め定められた感度プロフィールを選択することを更に含む、請求項101に記載した方法。
- 前記選択は、前記決定されたセンサ属性と前記複数の異なる予め定められた感度プロフィールのそれぞれとの間の相関を決定するべくデータ関連分析を実行することを含み、
且つ前記選択された予め定められた感度プロフィールが最も高い相関を有する、請求項112に記載した方法。 - 前記選択された感度プロフィールを使用して推定される検体濃度値を生成すること、を更に含む請求項111又は112に記載した方法。
- 前記選択された感度プロフィールを使用して第2の感度値を決定すること、
推定される検体濃度値の第1のセットは、前記決定された感度値及び第1の時間周期に関連付けられているセンサデータを使用して生成され、
且つ濃度値の第2のセットは、第2の感度値及び第2の時間周期に関連付けられているセンサデータを使用して生成される、請求項114に記載した方法。 - 請求項101〜115のいずれか一項に記載した方法を実施するべく構成されたセンサシステム。
- 前記センサシステムは、コンピュータメモリに格納された命令を備え、
前記命令は、前記センサシステムの一つ又は複数のプロセッサにより実行されるときに、請求項101〜115のいずれか一項に記載した方法を前記センサシステムに実施させる、請求項116に記載のセンサシステム。 - 検体センサシステムが適切に機能しているかどうかを決定する方法であって、
刺激信号を前記検体センサに印加すること、
前記刺激信号に対する応答を測定すること、
信号応答に基づいてセンサ属性の値を推定すること、
前記センサ属性を、前記センサ属性の予め定められた関係及び予め定められたセンサ感度プロフィールに関連づけること、
及び前記相関が予め定められた相関閾値を超えない場合にエラールーチンを開始すること、
を含む方法。 - 関連づけることは、データ関連分析を実行することを含む、請求項118に記載した方法。
- 前記エラールーチンは、前記検体センサが適切に機能していないことを示すメッセージをユーザに表示することを含む、請求項118に記載した方法。
- 前記センサ属性は、前記センサ膜のインピーダンスである、請求項118に記載した方法。
- 請求項118〜121のいずれか一項に記載した方法を実施するべく構成されたセンサシステム。
- 前記センサシステムは、コンピュータメモリに格納された命令を備え、
前記命令は、前記センサシステムの一つ又は複数のプロセッサにより実行されるときに、請求項118〜121のいずれか一項に記載した方法を前記センサシステムに実施させる、請求項122に記載のセンサシステム。 - 検体センサと関連付けられている温度を決定する方法であって、
刺激信号を前記検体センサに印加すること、
前記信号の信号応答を測定すること、
及び前記検体センサに関連付けられている温度を決定することであって、前記決定することが前記信号応答の少なくとも一つの属性を温度に対するセンサ属性の予め定められた関係に関連づけることを含む、方法。 - 前記決定された温度及び前記検体センサから生成されたセンサデータを使用して推定される検体濃度値を生成すること、を更に含む請求項124に記載した方法。
- 前記生成することは、前記決定された温度を使用して前記センサデータを補償すること、及び変換関数を使用して、前記補償されたセンサデータを生成される推定された検体値に変換することを含む、請求項125に記載した方法。
- 前記生成することは、前記決定された温度を使用して変換関数を形成し或いは修正すること、及び前記形成された或いは修正された変換関数を使用して前記センサデータを生成された推定される検体値に変換すること、を含む請求項125に記載した方法。
- 第2のセンサを使用して温度を測定することを更に含み、
前記決定することは、前記測定された温度を使用して前記検体センサに関連付けられる温度を決定することを更に含む、請求項124に記載した方法。 - 前記第2のセンサはサーミスタである、請求項128に記載した方法。
- 請求項124〜129のいずれか一項に記載した方法を実施するべく構成されたセンサシステム。
- 前記センサシステムは、コンピュータメモリに格納された命令を備え、
前記命令は、前記センサシステムの一つ又は複数のプロセッサによって実行されるときに、請求項124〜129のいずれか一項に記載した方法を前記センサシステムに実施させる、請求項130に記載のセンサシステム。 - 電子的なセンサシステム内への湿気進入を決定する方法であって、
特定の周波数を有する刺激信号或いは周波数スペクトルを含む信号を検体センサに印加すること、
前記刺激信号に対する応答を測定すること、
センサエレクトロニクスを使用し、前記測定された信号応答に基づいてインピーダンスを計算すること、
センサエレクトロニクスを使用して、前記インピーダンスが湿気進入に対応する予め定められたレベルに入るかどうかを決定すること、
及びインピーダンスがそれぞれの予め定められたレベルの一方又は両方を超過する場合、センサエレクトロニクスを使用してエラールーチンを開始すること、
を含む方法。 - 前記エラールーチンは、前記センサシステムが適切に機能できないかもしれないことをユーザに警告するべく、可聴の警報及び表示スクリーン上の視覚的な警報の起動を一つ又は複数含む、請求項132に記載した方法。
- 前記刺激信号は予め定められた周波数を有する、請求項132に記載した方法。
- 前記刺激信号は、周波数のスペクトルを有する、請求項132に記載した方法。
- 前記計算されるインピーダンスは、大きさの値と位相の値とを含み、
前記決定は、前記インピーダンスの大きさの値を予め定義されたインピーダンスの大きさ閾値と、且つ前記位相の値を予め定められた位相の閾値と、比較することを含む請求項132に記載した方法。 - 前記計算されるインピーダンスは複素インピーダンス値である、請求項132に記載した方法。
- 請求項132〜137のいずれか一項に記載した方法を実施するべく構成されたセンサシステム。
- 前記センサシステムは、コンピュータメモリに格納された命令を備え、
前記命令は、前記センサシステムの一つ又は複数のプロセッサによって実行されるときに、請求項132〜137のいずれか一項に記載した方法を前記センサシステムに実施させる、請求項138に記載のセンサシステム。 - センサシステムを使用する検体センサの膜損傷を決定する方法であって、
刺激信号を検体センサに印加すること、
前記刺激信号に対する応答を測定すること、
センサエレクトロニクスを使用し、前記信号応答に基づいてインピーダンスを計算すること、
センサエレクトロニクスを使用して、前記インピーダンスが膜損傷に対応する予め定義されたレベルに入るかどうかを決定すること、
センサエレクトロニクスを使用して、前記インピーダンスがあらかじめ定義されたレベルを超過する場合にエラールーチンを開始すること、
を含む方法。 - 前記エラールーチンは、可聴の警報及び表示スクリーン上の視覚的な警報を一つ又は複数起動させることを含む、請求項140に記載した方法。
- 前記刺激信号は予め定められた周波数を有する、請求項140に記載した方法。
- 前記刺激信号は、周波数のスペクトルを有する、請求項140に記載した方法。
- 前記計算されたインピーダンスは、大きさの値と位相の値とを含み、
前記決定は、前記インピーダンスの大きさの値を予め定義されたインピーダンスの大きさ閾値と、及び前記位相の値を予め定義された位相の閾値と比較することを含む、請求項140に記載した方法。 - 前記計算されるインピーダンスは、複素インピーダンス値である、請求項140に記載した方法。
- 請求項140〜145のいずれか一項に記載した方法を実施するべく構成されたセンサシステム。
- 前記センサシステムは、コンピュータメモリに格納された命令を備え、
前記命令は、前記センサシステムの一つ又は複数のプロセッサにより実行されるときに、請求項140〜145のうちの一つに記載した方法を前記センサシステムに実施させる、請求項146に記載のセンサシステム。 - 検体センサの再利用を決定する方法であって、
刺激信号を検体センサに印加すること、
前記刺激信号に対する応答を測定すること、
前記応答に基づいてインピーダンス応答を計算すること、
前記計算されたインピーダンスを予め定められた閾値と比較すること、
及び前記インピーダンスが閾値を越えると決定された場合にセンサ再利用ルーチンを開始すること、
を含む方法。 - 前記センサ再利用ルーチンは、不適切なセンサ再利用をユーザに通報する可聴の及び/又は視覚的な警報を起動させることを含む、請求項148に記載した方法。
- 前記センサを再利用する作業工程は、前記センサシステムを完全に又は部分的にシャットダウンさせること及び/又は前記センサシステムのユーザーインターフェース上へのセンサデータの表示を中止すること、を含む請求項148に記載した方法。
- 請求項148〜150のいずれか一項に記載した方法を実施するべく構成されたセンサシステム。
- 前記センサシステムは、コンピュータメモリに格納された命令を備え、
前記命令は、前記センサシステムの一つ又は複数のプロセッサにより実行されるときに、請求項148〜150のいずれか一項に記載した方法を前記センサシステムに実施させる、請求項151に記載のセンサシステム。 - 検体センサの再利用を決定する方法であって、
刺激信号を検体センサに印加すること、
前記刺激信号に対する応答を測定すること、
応答に基づいてインピーダンスを計算すること、
データ関連関数を使用して計算されたインピーダンスと、一つ又は複数の記録されたインピーダンス値との相関を決定すること、
及び前記相関が予め定められた閾値を越えると決定された場合にセンサ再利用ルーチンを開始すること、
を含む方法。 - 前記センサ再利用ルーチンは、不適切なセンサ再利用をユーザに通報する可聴の及び/又は視覚的な警報を起動させることを含む、請求項153に記載した方法。
- 前記センサを再利用する作業工程は、前記センサシステムを完全に又は部分的にシャットダウンさせること及び/又は前記センサシステムのユーザーインターフェース上へのセンサデータの表示を中止することを含む、請求項153に記載した方法。
- 請求項153〜155のいずれか一項に記載した方法を実施するべく構成されたセンサシステム。
- 前記センサシステムは、コンピュータメモリに格納された命令を備え、
前記命令は、前記センサシステムの一つ又は複数のプロセッサにより実行されるときに、請求項153〜155のいずれか一項に記載した方法を前記センサシステムに実施させる、請求項156に記載のセンサシステム。 - 過剰電位を検体センサに印加する方法であって、
刺激信号を検体センサに印加すること、
前記刺激信号に対する応答を測定すること、
前記応答に基づいてセンサの感度或いはセンサの感度の変化を決定すること、
及び前記決定された感度或いは感度の変化に基づいて過剰電位をセンサに印加すること、
を含む方法。 - 前記決定することは、応答に基づいてインピーダンスを計算すること、及びインピーダンスに基づいて感度或いは感度変化を決定することを含む、請求項158に記載した方法。
- 前記感度或いは感度の変化を決定することは、予め定められたインピーダンスに対するインピーダンスを感度の関係に関連づけることを更に含む、請求項159に記載した方法。
- 前記印加することは、過剰電位がセンサに印加された延べ時間を決定し或いは修正することを含む、請求項158に記載した方法。
- 前記印加することは、前記センサに印加された過剰電位の大きさを決定し或いは修正することを含む、請求項158に記載した方法。
- 請求項158〜162のいずれか一項に記載した方法を実施するべく構成されたセンサシステム。
- 前記センサシステムは、コンピュータメモリに格納された命令を備え、
前記命令は、前記センサシステムの一つ又は複数のプロセッサにより実行されるときに、請求項158〜162のいずれか一項に記載した方法を前記センサシステムに実施させる、請求項163に記載のセンサシステム。 - 連続検体センサの属性を決定する方法であって、
第1の作用電極及び第1の基準電極を有している第1の検体センサに刺激信号を印加すること、
第2の作用電極及び第2の基準電極を有している第2の検体センサを使用して前記刺激信号の信号応答を測定すること、
及び前記応答を予め定められた関係に関連づけることによって、前記第1のセンサの属性を決定すること、
を含む方法。 - 第1の作用電極にバイアス電圧を印加してセンサデータを生成すること、
及び前記バイアス電圧に対する応答を測定すること、を含む請求項165に記載した方法。 - 前記決定された属性を使用してセンサデータを較正すること、を更に含む請求項166に記載した方法。
- 前記決定された属性は、インピーダンス及び温度のうちの一つである、請求項165に記載した方法。
- 前記決定された属性を使用してセンサ膜の損傷を決定すること、を更に含む請求項165に記載した方法。
- 第1及び第2の検体センサを取り囲んでいるセンサシステム内への湿気侵入を、前記決定された属性を使用して決定すること、を更に含むことを特徴とする請求項165に記載した方法。
- 請求項165〜170のいずれか一項に記載した方法を実施するべく構成されたセンサシステム。
- 前記センサシステムは、コンピュータメモリに格納された命令を備え、
前記命令は、前記センサシステムの一つ又は複数のプロセッサにより実行されるときに、請求項165〜170のいずれか一項に記載した方法を前記センサシステムに実施させる、請求項171に記載のセンサシステム。 - 連続検体センサシステムにおいて使用されるスケーリングを決定する方法であって、
第1の刺激信号を検体センサの第1の作用電極に印加すること、
前記第1の刺激信号に対する応答を測定すること、
第2の刺激信号を検体センサの第2の作用電極に印加すること、
前記第2の刺激信号に対する応答を測定すること、
センサエレクトロニクスを使用して、前記第1及び第2の刺激信号に対する測定された応答に基づいてスケーリングファクタを決定すること、
及び検体センサにより生成されたセンサデータに基づいて推定される検体値を生成するべくスケーリングファクタを使用すること、
を含む方法。 - 前記方法が周期的に実行される、請求項173に記載した方法。
- 前記決定することは、
前記第1の刺激信号に対する応答を使用して第1のインピーダンスを計算すること、
前記第2の刺激信号に対する応答を使用して第2のインピーダンスを計算すること、を含み、
前記スケーリングファクタが前記第1のインピーダンスと前記第2のインピーダンスの比である、請求項173に記載した方法。 - 第1の作用電極は、前記検体と反応するように構成された酵素を含む薄膜を有し且つ第2の作用電極は前記酵素を含まない薄膜を有する、請求項173に記載した方法。
- 前記スケーリングファクタを決定することは、前記第1及び第2の刺激信号に対する測定された応答に基づいて以前のスケーリングファクタを更新することを含む、請求項173に記載した方法。
- スケーリングファクタがアセトアミノフェンのスケーリングファクタであり、
この方法は、前記アセトアミノフェンのスケーリングファクタに基づいて更なるスケーリングファクタを更新することを含み、
且つ前記更なるスケーリングファクタは、推定される検体値を生成するべくセンサデータに適用される、請求項173に記載した方法。 - 請求項173〜178のいずれか一項に記載した方法を実施するべく構成されたセンサシステム。
- 前記センサシステムは、コンピュータメモリに格納された命令を備え、
前記命令は、前記センサシステムの一つ又は複数のプロセッサにより実行されるときに、請求項173〜178のいずれか一項に記載した方法を前記センサシステムに実施させる、請求項179に記載のセンサシステム。 - 検体センサを較正する方法であって、
予め定められた信号を検体センサに印加すること、
印加された信号に対する応答を測定すること、
センサエレクトロニクスを使用し、前記測定された応答に基づいて前記検体センサの薄膜に関連付けられているインピーダンスの変化を決定すること、
前記決定されたインピーダンスに基づいて前記検体センサの感度の変化を計算すること、
前記計算された感度の変化及び前記検体センサの以前に使用された感度に基づいて修正された感度を計算すること、
及び前記修正された感度を使用して推定される検体値を生成すること、
を含む方法。 - 前記感度の変化を計算することは、非線形補償関数を適用することを含む、請求項181に記載した方法。
- 前記非線形補償関数は、以下の方程式として表され、
△S =(a*log(t)+b)*△I
ここで、△Sは感度の変化、tは検体センサを較正してからの時間、△Iは決定されたインピーダンスの変化、且つa及びbは予め定められた係数である、請求項182に記載した方法。 - a及びbは類似した検体センサを前もってテストすることにより決定される、請求項183に記載した方法。
- 請求項181〜184のいずれか一項に記載した方法を実施するべく構成されたセンサシステム。
- 前記センサシステムは、コンピュータメモリに格納された命令を備え、
前記命令は、前記センサシステムの一つ又は複数のプロセッサにより実行されるときに、請求項181〜184のいずれか一項に記載した方法を前記センサシステムに実施させる、請求項185に記載のセンサシステム。 - 検体センサを較正するための方法であって、
皮下検体センサを使用してセンサデータを生成すること、
植設前の情報、内部診断情報、及び/又は外部基準情報を入力として使用して、変換関数を形成し或いは修正すること、
前記変換関数を使用してセンサデータを較正すること、
を含む方法。 - 植設前の情報は、
検体センサに関連付けられている予め定められた感度プロフィール、測定されたセンサ属性とセンサ感度との間の予め決定された関係、測定されたセンサ属性とセンサ温度との間の一つ又は複数の予め決定された関係からなるグループより選択される情報、
以前に使用された検体センサから取得されるセンサデータ、
検体センサに関連付けられている較正コード、
検体センサと感度、ベースライン、ドリフト及びインピーダンスのうちの一つ又は複数との間の患者に特有の関係、
センサの植設部位を表す情報、
検体センサの製造からの時間、
及び温度或いは湿度に暴露されている検体を表す情報、を含む請求項187に記載した方法。 - 前記内部診断情報は、刺激信号の出力、前記センサにより測定された検体濃度を表すセンサデータ、センサ或いは別個のセンサを使用する温度測定、検体センサと実質的に同様に設計された冗長なセンサにより生成されるセンサデータ、検体センサとは異なる様式を有している補助センサにより生成されるセンサデータ、前記センサが植設されてから或いは前記センサに接続されるセンサエレクトロニクスに接続されてからの時間、センサ或いはセンサシステム上の圧力を表す圧力センサにより生成されるデータ、加速度計により生成されるデータ、湿気進入の基準、及び検体濃度信号のノイズ基準より成るグループから選択される、請求項187或いは188に記載した方法。
- 前記基準情報は、基準モニタから取得されたリアルタイムの及び/又は先行する検体濃度情報、基準データを提供するために使用される基準モニタのタイプ/ブランドに関する情報、ユーザによって消費される炭水化物の量に関する情報、薬剤送達装置から受け入れる情報、グルカゴン感度情報、及び集団ベースのデータから集まった情報より成るグループから選択される情報を含む、請求項187,188又は189に記載した方法。
- 請求項187〜190のいずれか一項に記載した方法を実施するべく構成されたセンサシステム。
- 前記センサシステムは、コンピュータメモリに格納された命令を備え、
前記命令は、前記センサシステムの一つ又は複数のプロセッサにより実行されるときに、請求項187〜190のうちの一つに記載した方法を前記センサシステムに実施させる、請求項191に記載のセンサシステム。 - 実質的に明細書及び/又は図面に示され及び/又は記載されている装置。
- 実質的に明細書及び/又は図面に示され及び/又は記載されている方法。
- 実質的に明細書及び/又は図面に示され及び/又は記載されているシステム。
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