JP2015186625A - 電気化学分析物センサ - Google Patents
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Abstract
【解決手段】患者のグルコース、ラクテートまたは酸素などの分析物レベルの持続的または自動的モニタ用に埋め込み可能センサを用いてもよい。電気化学分析物は、基板と基板に配された導電材料とを含み、導電材料が作用電極を形成する。導電材料がセンサの表面に形成された凹状溝に配されるセンサもある。分析物、またはレベルが分析物のレベルに依存する第2の化合物の電気分解を促進させるために電子移動剤および/または触媒を与えてもよい。作用電極と基準電極または対向/基準電極との間に電位を形成し、生じる電流は体液中の分析物の濃度の関数である。
【選択図】図1
Description
分析物センサ装置
本発明のセンサは、様々な条件下、各種装置に利用できる。センサの詳細な構造は、センサの用途および、センサの作動条件(例えば、生体内または生体外)により決定される。分析物センサの一実施形態は、生体内での作動を目的として、患者または使用者への埋め込み用に構成される。例えば、センサは、血中の分析物レベルを直接テストするために動脈系または静脈系に埋め込むこともできる。また、センサは、間質液中の分析物レベルを測定するために間質組織に埋め込むこともできる。このレベルは、血液または他の流体中の分析物レベルと相関関係を有し、および/または分析物レベルに換算することができる。埋め込みの部位およびその深さは、センサの特定の形状、構成要素、および構造に影響を及ぼすことがある。場合によっては、センサの埋め込み深さを制限するため、皮下埋め込みの方が好ましいことがある。センサは、他の流体中の分析物レベルを測定するために、身体の他の部位に埋め込むこともできる。
センサ
本発明に係るセンサ42は、図2に示しているように、基板50上に形成された少なくとも一つの作用電極58を有する。センサ42は、少なくとも一つの対向電極60(または対向/基準電極)および/または少なくとも一つの基準電極62(図8参照)も備えていてもよい。対向電極60および/または基準電極62は、基板50上に形成されていても、別個の装置であってもよい。例えば、対向電極および/または基準電極は、同様に患者に埋め込まれる第二の基板上に形成されるか、或いは、埋め込み可能なセンサの幾つかの実施形態では、作用電極または電極を患者に埋め込み、対向電極および/または基準電極は、患者の皮膚上に配置してもよい。埋め込み可能な作用電極を用いた皮膚上対向および/または基準電極の使用については、米国特許第5,593,852号明細書に記載されており、それらを参照し本明細書において援用する。
基板50は、例えば、ポリマまたはプラスチック材料、およびセラミック材料を含む各種非導電性材料を用いて形成することができる。特殊なセンサ42に適した材料は、少なくともある程度は、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る。
作用電極58を構成するために、基板上に少なくとも一つの導電トレース52を形成する。更に、電極(例えば、更なる作用電極、並びに、対向、対向/基準、および/または基準電極)および、温度プローブなどの、他の構成要素としての使用を目的として、基板50上に他の導電トレース52を形成してもよい。必須ではないが、導電トレース52は、図2に示されているように、センサ50の長手方向57に沿ってその距離の殆どに渡って延設されていてもよい。導電トレース52の配置は、分析物モニタ装置の特定の構造(例えば、制御装置のコンタクトの配置、および/またはサンプル室のセンサ42との関係)によって決められる。埋め込み可能なセンサ、特に皮下に埋め込み可能なセンサでは、導電トレースは一般に、センサの埋め込まれなければならない量を最小にするためセンサ42の先端近くまで延設されている。
コンタクトパッド
一般に、各導電トレース52はコンタクトパッド49を有する。コンタクトパッド49は、制御装置(例えば、図1のセンサ制御装置)の導電コンタクトと接触させられる以外は、トレース52の残りの部分と区別できない、単に導電トレース52の一部であってもよい。しかしながら、より一般的には、コンタクトパッド49は、制御装置のコンタクトとの接続を容易にするため、導電トレース52の他の部分よりも幅の広いトレース52の一部分である。導電トレース52の幅と比べて、コンタクトパッド49を比較的大きくすることにより、小さなコンタクトパッドを用いた場合よりも、コンタクトパッド49と制御装置のコンタクトとの間の精密な位置合わせの必要性における重要性が低下する。
典型的電極構造
以下、多くの典型的な電極構造を説明するが、他の構造も同様に使用できることは言うまでもない。図3Aに示されている一実施形態において、センサ42は、二つの作用電極58a、58bと、基準電極としても機能する一つの対向電極60とを備えている。別の実施形態において、センサは、図3Bに示されているように、一つの作用電極58aと、一つの対向電極60と、一つの基準電極62とを備えている。これらの各実施形態は、基板50の同一面上に全ての電極が形成された状態で図解されている。
酸素のような幾つかの分析物は、作用電極58上で直接電気酸化または電気還元される。グルコースや、ラクテートなどの他の分析物は、分析物の電気酸化または電気還元を容易にするため、少なくとも一つの電子移動剤および/または少なくとも一つの触媒の存在を必要とする。触媒は、作用電極58上で直接電気酸化または電気還元される、酸素などのそれら分析物に使用してもよい。これらの分析物に対して、各作用電極58は、作用電極58の作用面上または近傍に形成された感知層64を有する。一般に、感知層64は、作用電極58の小さな部分のみにまたはその近傍、しばしば、センサ42の先端部近傍に形成される。これにより、センサ42を形成するために必要とされる物質量が制限され、また分析物含有流体(例えば、体液、サンプル液、または担体液)との接触に最適な位置に感知層64が配置される。
図3Aおよび図3Bに示されているように、多くの実施形態において、感知層64は、作用電極58の導電材料56と接触している一以上の電子移動剤を含んでいる。幾つかの実施形態において、電子移動剤が拡散することまたは作用電極から浸出してしまうことは、特に一度しか使用されない生体外センサ42では許容される。他の生体外センサでは、電子移動剤を含む担体流体を利用することもできる。分析物は、例えば、微細孔膜等を通る浸透流により、オリジナルのサンプル流体から担体流体に移される。
感知層64は、分析物の反応に触媒作用を及ぼすことのできる触媒を含んでいてもよい。触媒はまた、幾つかの実施形態では、電子移動剤として機能することもできる。適した触媒の一例は、分析物の反応に触媒作用を及ぼす酵素である。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、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))、またはオリゴ糖デヒドロゲナーゼのような触媒が使用できる。分析物がラクテートである場合、乳酸オキシダーゼまたは乳酸デヒドロゲナーゼが使用できる。分析物が酸素である場合、または酸素が分析物の反応に応じて発生するかまたは消費される場合、ラッカーゼが使用できる。
分析物を電解するため、作用および対向電極58、60に渡って電位(対基準電位)を印可する。印可する電位の最低限の大きさは、しばしば、特定の電子移動剤、分析物(分析物が電極で直接電解される場合)、または第二の化合物(分析物レベルによってレベルが決まる酸素または過酸化水素のような第二の化合物が電極で直接電解される場合)によって決められる。印可する電位は、通常、所望の電気化学反応によって、電極で直接電解される電子移動剤、分析物、または第二の化合物のいずれかのレドックス電位と等しく、或いは、より酸化または還元するものである。作用電極の電位は、一般に、電気化学反応を完了または略完了させられるほど十分に高い。
センサには、様々な選択自由なアイテムが含まれていてもよい。選択自由な一アイテムが温度プローブ66(図8および図11)である。温度プローブ66は、様々な公知のデザインおよび材料を用いて作製される。典型的な一温度プローブ66は、温度依存特性を有する材料を使用して形成される、温度依存要素72により互いに接続されている二つのプローブリード68、70を用いて形成される。適した温度依存特性の一例は、温度依存要素72の抵抗性である。
図9に示されているように、任意のフィルム層75は、少なくともセンサ42の患者の皮下に挿入される部分上に形成される。この任意のフィルム層74は、一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浸透を防ぐ。これは、排除されるべき生体分子よりも孔径の小さいフィルム層74を使用することにより実現される。そのような生体分子は、電極および/または感知層64を汚染することがあり、それによりセンサ42の有効性を低下させ、一定の分析物濃度に対し予想される信号振幅を変化させることがある。作用電極58の汚染により、センサ42の有効寿命が短縮されることもある。生体親和性層74は、タンパク質のセンサ42への付着、凝血塊の形成、およびセンサ42と身体間の他の望ましくない相互作用を防ぐこともできる。
センサ42には、妨害物質排除層(図示なし)が含まれていてもよい。妨害物質排除層は、生体親和性層75または物質移動制限層74(後述)に組入れても、別個の層であってもよい。妨害物質とは、直接、または電子移動剤を介して電極で電気還元または電気酸化され疑似信号を発生させる分子または他の種である。一実施形態では、フィルムまたは膜は、作用電極58の周辺領域への一以上の妨害物質の浸透を防ぐ。この種の妨害物質排除層は、分析物質に対するよりも妨害物質の一つ以上に対する透過性がかなり低いのが好ましい。
物質移動制限層74は、作用電極58周辺領域への、分析物、例えば、グルコースまたはラクテートの物質移動率を低下させるため、拡散制限バリヤとして機能するようにセンサに備えられていてもよい。分析物の拡散を制限することにより、作用電極58近傍での分析物の定常状態濃度(体内またはサンプル流体内の分析物濃度に比例する)を低下させることができる。これにより、正確に測定できる分析物濃度の上限が広がり、電流が分析物レベルと共に略直線的に増加する範囲も拡大される。
埋め込み可能なセンサはまた、オプションとして、患者に埋め込まれる基板の部分に施された抗凝固剤を有していてもよい。この抗凝固剤は、特に、センサの挿入後、センサ周囲の血液または他の体液の凝固を減少させるか、または排除することができる。凝血塊は、センサを汚染したり、またはセンサ内に拡散する分析物の量を復元不可能に減少させる場合がある。有用な抗凝固剤の例としては、ヘパリンおよび組織プラスミノーゲン活性化因子(TPA)、および、他の公知の抗凝固剤が挙げられる。
センサ42は、生体内または生体外分析物モニタ、および、特に埋め込み可能な分析物モニタの、交換可能な部品となるように設計することもできる。一般に、センサ42は数日間に渡って機能することができる。機能する期間は、少なくとも一日であるのが好ましく、更に好ましくは、少なくとも三日、最も好ましくは、少なくとも一週間である。また、センサ42は、取り除き、新しいセンサと交換することができる。センサ42の寿命は、電極の汚染、或いは、電子移動剤または触媒の浸出により短縮される場合がある。センサ42の耐用年数に関するこれらの制約は、上述したように、生体親和性層75、または浸出不可電子移動剤および触媒をそれぞれ使用することにより克服できる。
Claims (14)
- 遠位領域および近位領域を有する基板であって、該基板が少なくとも第1の表面および第2の表面を含み;
前記基板の前記遠位領域上に配置された少なくとも1つの作用電極であって、該少なくとも1つの作用電極が前記基板の前記第1の表面上に形成され;
前記基板の前記遠位領域上に配置された少なくとも1つの対向電極であって、該少なくとも1つの対向電極が前記基板の前記第2の表面上に形成され;
前記基板の前記近位領域上および前記基板の前記第1の表面上に配置された複数の第1の導電コンタクトであって、該複数の第1の導電コンタクトの少なくとも第1が前記作用電極と電気的に連絡しており、前記複数の第1の導電コンタクトの少なくとも第2が前記対向電極と電気的に連絡しており;
前記対向電極を前記第1の導電コンタクトの第2に電気的に連結する、前記基板を通して形成される少なくとも1つの経路;
前記少なくとも1つの作用電極に近い感知層;および
前記少なくとも1つの作用電極に近い物質移動制限層;
を有する生体内グルコースセンサである、
ことを特徴とするグルコースセンサ。 - 前記センサが平面センサであることを特徴とする請求項1記載のグルコースセンサ。
- 遠位領域および近位領域を有する基板であって、該基板が少なくとも第1の表面および第2の表面を含み;
前記基板の前記遠位領域上に配置された少なくとも1つの作用電極であって、該少なくとも1つの作用電極が前記基板の前記第1の表面上に形成され;
前記基板の前記遠位領域上に配置された少なくとも1つの対向電極であって、該少なくとも1つの対向電極が前記基板の前記第2の表面上に形成され;
前記基板の前記近位領域上および前記基板の前記第1の表面上に配置された複数の第1の導電コンタクトであって、該複数の第1の導電コンタクトの少なくとも第1が前記作用電極と電気的に連絡しており、前記複数の第1の導電コンタクトの少なくとも第2が前記対向電極と電気的に連絡しており;
前記対向電極を前記第1の導電コンタクトの第2に電気的に連結する、前記基板を通して形成される少なくとも1つの経路;および
前記少なくとも1つの作用電極に近い感知層;
を有する生体内グルコースセンサであって、
該センサの長さが、0.3cmから5cmの間である、
ことを特徴とするグルコースセンサ。 - 前記センサが幅の狭い部分および幅の広い部分を含み、該幅の狭い部分が、皮下に配置され、0.25cmから2cmの間の長さを有することを特徴とする請求項3記載のグルコースセンサ。
- 前記センサが平面センサであることを特徴とする請求項3記載のグルコースセンサ。
- 遠位領域および近位領域を有する基板であって、該基板が少なくとも第1の表面および第2の表面を含み;
前記基板の前記遠位領域上に配置された少なくとも1つの作用電極であって、該少なくとも1つの作用電極が前記基板の前記第1の表面上に形成され;
前記基板の前記遠位領域上に配置された少なくとも1つの対向電極であって、該少なくとも1つの対向電極が前記基板の前記第2の表面上に形成され;
前記基板の前記近位領域上および前記基板の前記第1の表面上に配置された複数の第1の導電コンタクトであって、該複数の第1の導電コンタクトの少なくとも第1が前記作用電極と電気的に連絡しており、前記複数の第1の導電コンタクトの少なくとも第2が前記対向電極と電気的に連絡しており;
前記対向電極を前記第1の導電コンタクトの第2に電気的に連結する、前記基板を通して形成される少なくとも1つの経路;および
前記少なくとも1つの作用電極に近い感知層;
を有する生体内グルコースセンサである、
ことを特徴とするグルコースセンサ。 - 前記基板が、100μmから300μmまでの厚さを有することを特徴とする請求項6記載のグルコースセンサ。
- 前記センサが平面センサであることを特徴とする請求項6記載のグルコースセンサ。
- 前記基板が、非導電性プラスチックまたはポリマ材料を有することを特徴とする請求項1記載のグルコースセンサ。
- 前記非導電性プラスチックまたはポリマ材料が、熱可塑性物質であることを特徴とする請求項9記載のグルコースセンサ。
- 前記作用電極が、炭素材料を含むことを特徴とする請求項1記載のグルコースセンサ。
- 前記作用電極が、炭素材料を含むことを特徴とする請求項3記載のグルコースセンサ。
- 前記作用電極が、炭素材料を含むことを特徴とする請求項6記載のグルコースセンサ。
- 前記感知層が、グルコースオキシダーゼを含むことを特徴とする請求項1記載のグルコースセンサ。
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US09/034,372 US6134461A (en) | 1998-03-04 | 1998-03-04 | Electrochemical analyte |
US09/034,372 | 1998-03-04 |
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JP2011173021A Pending JP2012011208A (ja) | 1998-03-04 | 2011-08-08 | 電気化学分析物センサ |
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EP (2) | EP2308371A1 (ja) |
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US20030088166A1 (en) | 2003-05-08 |
US6484046B1 (en) | 2002-11-19 |
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JP2002506209A (ja) | 2002-02-26 |
JP5021115B2 (ja) | 2012-09-05 |
US6134461A (en) | 2000-10-17 |
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EP1060394B1 (en) | 2017-06-14 |
JP2012011208A (ja) | 2012-01-19 |
WO1999045387A2 (en) | 1999-09-10 |
EP1060394A2 (en) | 2000-12-20 |
AU2465999A (en) | 1999-09-20 |
JP6395055B2 (ja) | 2018-09-26 |
US20140221801A1 (en) | 2014-08-07 |
US7003340B2 (en) | 2006-02-21 |
US20100204554A1 (en) | 2010-08-12 |
US8706180B2 (en) | 2014-04-22 |
WO1999045387A3 (en) | 2000-04-13 |
US20130274574A1 (en) | 2013-10-17 |
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