JP2010227601A - 分析物モニタシステムおよびその使用方法 - Google Patents
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Abstract
【解決手段】 挿入キットは、一部が前記電気化学センサを挿入する間前記センサを支持するのに適合した鋭く堅い平面構造、または鋭く硬いUまたはV字型構造を有するインサータと、前記電気化学センサおよび前記インサータを受入れるように構成された開口部と、前記インサータおよび電気化学センサを患者の体内に推進する推進機構と、前記センサを前記患者の体内に残したまま前記インサータを前記患者の体内から除去するための引き戻し機構とを有する挿入銃とを備える。
【選択図】 図18A
Description
本発明の分析物モニタシステムは、様々な条件下で利用可能である。センサの詳細な構造、および分析物モニタシステムに使用される他の装置は、分析物モニタシステムの用途および、分析物モニタシステムの作動条件により決定される。分析物モニタシステムの一実施形態は、患者または使用者への埋め込み用に構成されたセンサを含む。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。本発明の分析物モニタシステムにおける使用に適したセンサの例は、特許文献1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。
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、埋込型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、特許文献2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、分析物モニタシステムの特定の構造(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。埋込型センサ、特に皮下に埋込型センサでは、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。
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。
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。本発明に係る幾つかの実施形態においては、センサ42が患者に埋め込まれている期間、作用電極58からの電子移動剤の浸出は殆どまたは全く生じない。拡散するまたは浸出可能な(つまり、放出可能な)電子移動剤は、しばしば、分析物含有流体中に拡散して、時間の経過とともにセンサの感度を低下させ、電極の有効性を低下させる。更に、埋込型センサ42における、拡散または浸出する電子移動剤は、患者に害をなすこともある。これらの実施形態においては、分析物含有流体に24時間、更に好ましくは、72時間浸漬した後、電子移動剤の好ましくは少なくとも90%、更に好ましくは、少なくとも95%、最も好ましくは、少なくとも99%がセンサ上に残る。特に、埋込型センサでは、37℃の体液中に24時間、更に好ましくは、72時間浸漬した後、電子移動剤の好ましくは少なくとも90%、更に好ましくは、少なくとも95%、最も好ましくは、少なくとも99%がセンサ上に残る。
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。
埋込型センサはまた、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、生体内分析物モニタ、および、特に埋込型分析物モニタの、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。
挿入装置120は、図12に示すように、センサ42を患者の皮下に挿入するために使用することができる。挿入装置120は一般的に、金属または硬質プラスチックのような、構造的硬質材料を使用し形成される。好ましい材料としては、ステンレス鋼やABS(アクリロニトリルブタジエンスチレン)プラスチックが挙げられる。幾つかの実施形態においては、挿入装置120は、患者の皮膚への侵入を容易にするよう先端部121を尖らせおよび/または鋭くする。鋭く薄い挿入装置により、センサ42の挿入に際して患者の感じる痛みが減少する場合もある。他の実施形態において、挿入装置120の先端部121は、他の形状を有し、鈍いまたは平らな形状がある。これらの実施形態は、挿入装置120が皮膚に侵入するのではなく、むしろセンサ42を皮膚に押し入れる際にセンサ42の構造上の支持体としての役割を果たす場合特に有用であり得る。
皮膚上センサ制御装置44は、患者の皮膚上に設置するように構成する。皮膚上センサ制御装置44は、オプションとして、患者にとって快適で、例えば、患者の衣服の下に隠せる形状に形成される。皮膚上センサ制御装置44を隠して設置するには、患者の体の部位では、大腿部、下脚、上腕、肩、または腹部が好都合である。しかしながら、皮膚上センサ制御装置44は、患者の体の他の部分に配置してもよい。皮膚上センサ制御装置44の一実施形態は、図14〜16に示しているように、より隠しやすくするため薄い楕円形状をしている。しかしながら、他の形状およびサイズを用いてもよい。
皮膚上センサ制御装置(on−skin sensor control unit)44はまた、一般に、センサ42および分析物モニタ装置システム40を作動させる電子部品の少なくとも一部を備えている。皮膚上制御装置44における電子機器回路の一実施形態を図18Aにおいてブロック図として示している。皮膚上センサ制御装置44の電子部品には、一般に、皮膚上制御装置44とセンサ42を作動させるための電源装置95と、センサ42から信号を得てセンサ42を作動させるセンサ回路97と、センサ信号を所望のフォーマットに変換する測定回路96と、最低限、センサ回路97および/または測定回路96から信号を得て、その信号を選択自由な送信機98に提供する処理回路109とが含まれる。幾つかの実施形態において、処理回路109は、センサ42からの信号を部分的または完全に評価し、その結果得られたデータを選択自由な送信機98に伝達し、および/または、分析物レベルが閾値を超える場合、選択自由な警報システム94(図18B参照)を始動させることもできる。処理回路109は、デジタル論理回路機構を有するものが多い。
一以上のレシーバ/表示装置46、48は、センサ42によって生成されるデータへのアクセスを容易にするため分析物モニタ装置40を備えることもでき、また、幾つかの実施形態においては、皮膚上センサ制御装置44からの信号を処理し、皮下組織中の分析物濃度またはレベルを測定することもできる。小型レシーバ/表示装置46は、患者が携帯することもできる。これらの装置46は、掌サイズとすることもでき、および/または、患者が携帯するベルト上、或いは、かばんまたはハンドバック内に納まるように適合させることもできる。小型レシーバ/表示装置46の一実施形態は、例えば、使用者が医療装置を使用している人であることがわからないように、ポケットベル(pager)の外観を有する。そのようなレシーバ/表示装置は、オプションとして、送信または受信可能、若しくは、送受信可能な呼び出し機能を有することもできる。
図25は、本発明に係る、センサを基礎とした(sensor based)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、薬物を供給し、一以上のセンサ252からの信号に応答して分析物の高レベルまたは低レベルに対し中和作用する。また、前記システムは、薬物を確実に所望の治療領域内に滞留させるように薬物濃度をモニターする。薬物送達システムは、一以上(好ましくは二以上)の皮下に埋め込まれたセンサ252と、皮膚上センサ制御装置254と、レシーバ/表示装置256と、データ記憶および制御装置モジュール258と、薬物投与システム260とを備えている。場合によって、レシーバ/表示装置256と、データ記憶および制御装置モジュール258と、薬物投与システム260とは、単一装置内に一体化してもよい。センサを基礎とした薬物送達システム250は、一以上のセンサ252からのデータを使用して、データ記憶および制御装置モジュール252のコントロールアルゴリズム/機構に必要な入力情報を提供し、薬物の投与を調節する。一例として、グルコースセンサを使用して、インシュリンの投与を制御および調節することができるであろう。
Claims (10)
- 患者に電気化学センサを挿入するための挿入キットであって、
その一部が、前記電気化学センサを挿入する間前記センサを支持するのに適合した鋭く堅い平面構造、または鋭く硬いUまたはV字型構造を有するインサータと、
前記電気化学センサおよび前記インサータを受入れるように構成された開口部と、前記インサータおよび電気化学センサを患者の体内に推進する推進機構と、前記センサを前記患者の体内に残したまま前記インサータを前記患者の体内から除去するための引き戻し機構とを有する挿入銃とを備えた挿入キット。 - 前記挿入銃が更に、前記患者への挿入に先立って、前記インサータおよび電気化学センサを挿入準備ポジション(cocked position)に保持する挿入準備機構(cocking mechanism)と、前記インサータおよび電気化学センサを前記挿入準備ポジションから解放し、前記推進機構に、前記インサータおよび電気化学センサを前記患者の体内に推進させる解放機構とを備えている請求項1に記載の挿入キット。
- 更に、前記インサータおよび挿入銃を使用して患者に挿入する電気化学センサを備えている請求項1に記載の挿入キット。
- 前記電気化学センサが、前記センサが患者の体内に容易に停留するように掛かり部を有する請求項3に記載の挿入キット。
- 前記電気化学センサが柔軟性を有する請求項3に記載の挿入キット。
- 前記挿入銃およびインサータが、前記電気化学センサを患者の体内の約2〜12mmの深さに挿入するよう構成されている請求項1に記載の挿入キット。
- 前記挿入銃およびインサータが、患者の体表面に対して約15°〜60°の角度で前記電気化学センサを患者の体内に挿入するよう構成されている請求項1に記載の挿入キット。
- 前記インサータの断面幅が、1mm以下である請求項1に記載の挿入キット。
- 前記インサータの断面高さが、1mm以下である請求項1に記載の挿入キット。
- 前記挿入銃が、センサ制御装置の取付け台と組み合わされるように構成されている請求項1に記載の挿入キット。
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WO2012124800A1 (ja) * | 2011-03-16 | 2012-09-20 | 学校法人 芝浦工業大学 | 抗凝固薬測定用センサ |
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2012124800A1 (ja) * | 2011-03-16 | 2012-09-20 | 学校法人 芝浦工業大学 | 抗凝固薬測定用センサ |
JP5946139B2 (ja) * | 2011-03-16 | 2016-07-05 | 学校法人 芝浦工業大学 | 抗凝固薬測定用センサ |
JP2020511240A (ja) * | 2017-03-21 | 2020-04-16 | エフ ホフマン−ラ ロッシュ アクチェン ゲゼルシャフト | 医療装置、および医療装置を製造するための方法 |
JP7142642B2 (ja) | 2017-03-21 | 2022-09-27 | エフ ホフマン-ラ ロッシュ アクチェン ゲゼルシャフト | 医療装置、および医療装置を製造するための方法 |
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