JP2014057885A - ヒドロゲルを使用した検体のモニタリングシステムのためのセンサアセンブリおよびセンサアセンブリを使用した検体のモニタリング方法 - Google Patents
ヒドロゲルを使用した検体のモニタリングシステムのためのセンサアセンブリおよびセンサアセンブリを使用した検体のモニタリング方法 Download PDFInfo
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Abstract
【解決手段】検体のモニタリングシステムのためのセンサアセンブリであって、センサアセンブリは、ヒドロゲルと、電極アセンブリとを含み、ヒドロゲルは検体と反応する酵素を含み、ヒドロゲルは酵素を封入し、および、ヒドロゲルは患者の浸透性にされた皮膚と接面し、皮膚を通して検体を受け取るように適合され、電極アセンブリはセンサアセンブリの表面上にあり、検体の値と相関する電気信号を検出する、ことを特徴とするセンサアセンブリである。
【選択図】図1
Description
式中、
Cは電流、
Ciはt=0の電流、
Cfは最終電流、
Sは感度定数、
t*は変曲点を達成するために必要な曝露時間、および
tは曝露時間を表す。
上記の式を再整理することができ、以下の通り一つの時点の較正プロトコルを使用して血中グルコース値を簡便に予測することができる:
X(t)=(Y−b)/m、およびm=(Yc−b)/Xrc(t)
センサ感度mの値は、センサの較正時点でのセンサの電流読取値Ycおよび標準的な基準血中グルコース値Xrc(t)を使用して、各ex vivo試験から得ることができる。その後の血中グルコース値X(t)を、対応する標準的な基準血中グルコース値Xr(t)と比較すると、様々な時点での変動因子D(t)を算出できることが明らかである:
D(t)=Xr(t)/X(t)
多数の成功したex vivo試験からD(t)対時間tをグラフ化することによって、D(t)対tのグラフの最良の組合せは、次の通り表すことのできる三次多項式関数となった:
D(t)=c*t3+d*t2+e*t+f
式中、c、d、e、fは、上記の三次多項式にD(t)対tのデータの最良の組合せを得るように計算された数値係数である。しかし、三次多項式の使用は例示的であり、変動データを指数関数に合わせる、またはダイレクトルックアップテーブル法を使用するアルゴリズムなどの変動因子を表す他の方法を使用することもできる。
Xp(t)=X(t)*D(t)=X(t)*(c*t3+d*t2+e*t+f)
この式はエラー訂正法を表し、その有用性は、アルゴリズムを適用しない場合(図16)に対して適用した場合(図17)のClark Error Gridを比較することによって理解することができる。図16中のデータ対の負のバイアスおよび広い分散は効果的に訂正され、結果として図17に示すように、すべてのデータ点はClark Error Grid内で臨床的に関連するAおよびB領域に入る。このエラー訂正法は、本発明の例示的な実施形態による、連続的な経皮的検体モニタリングシステムを使用して生成されるデータに適用することができる。
なお、本発明は、特許請求の範囲を含め、以下の発明を包含する。
1.生体膜と接面し、前記生体膜から検体を受け取るように適合された媒体であって、アガロースベースのヒドロゲル、ポリエチレングリコールジアクリレート(PEGDA)ベースのヒドロゲルおよびそれらの混合物からなる群から選択されるヒドロゲルを含む媒体と、
電極アセンブリとを含み、
前記媒体が前記検体と連続的に反応するように適合され、
前記電極アセンブリによって電気信号が検出され、前記電気信号が検体の値と相関することを特徴とする経皮的な検体のモニタリングシステム。
2.前記検体の値は前記生体膜を通る前記検体の流量であることを特徴とする1に記載の経皮的な検体のモニタリングシステム。
3.前記検体の値が患者の体液中の前記検体の濃度であることを特徴とする1に記載の経皮的な検体のモニタリングシステム。
4.前記電極アセンブリおよび前記媒体を支持するセンサ本体をさらに含むことを特徴とする1に記載の経皮的な検体のモニタリングシステム。
5.前記検体がグルコースを含むことを特徴とする1に記載の経皮的な検体のモニタリングシステム。
6.前記媒体がグルコースオキシダーゼを含むことを特徴とする5に記載の経皮的な検体のモニタリングシステム。
7.前記媒体がアガロースベースのヒドロゲルを含むことを特徴とする1に記載の経皮的な検体のモニタリングシステム。
8.前記媒体がポリエチレングリコールジアクリレート(PEGDA)ベースのヒドロゲルを含むことを特徴とする1に記載の経皮的な検体のモニタリングシステム。
9.前記ヒドロゲルに濃度1〜10%のグルコースオキシダーゼが添加されていることを特徴とする8に記載の経皮的な検体のモニタリングシステム。
10.前記ヒドロゲルが2000〜8000の分子量を有することを特徴とする8に記載の経皮的な検体のモニタリングシステム。
11.前記ヒドロゲルが約34,00の分子量を有することを特徴とする8に記載の経皮的な検体のモニタリングシステム。
12.前記ヒドロゲルが約200マイクロメーターの厚さを有することを特徴とする8に記載の経皮的な検体のモニタリングシステム。
13.前記ヒドロゲルがグルコースオキシダーゼに予め浸漬されたことを特徴とする8に記載の経皮的な検体のモニタリングシステム。
14.前記ヒドロゲルがグルコースオキシダーゼを予め添加されたことを特徴とする8に記載の経皮的な検体のモニタリングシステム。
15.前記ヒドロゲルがポリエチレングリコールジアクリレート/ポリエチレンイミン(PEGDA−PEI)ベースのヒドロゲルを含むことを特徴とする1に記載の経皮的な検体のモニタリングシステム。
16.前記ヒドロゲルがポリエチレングリコールジアクリレート−n−ビニルピロリドン(PEGDA−NVP)ヒドロゲルを含むことを特徴とする1に記載の経皮的な検体のモニタリングシステム。
17.媒体が生体膜から検体を受け取ることができるように前記媒体を前記生体膜に関して配置し、前記媒体がアガロースベースのヒドロゲル、ポリエチレングリコールジアクリレート(PEGDA)ベースのヒドロゲルおよびそれらの混合物からなる群から選択されるヒドロゲルを含み、前記媒体に電極アセンブリが接続されているステップと、
前記検体を前記媒体と連続的に反応させるステップと、
前記電極アセンブリで電気信号を検出するステップとを含み、
前記電気信号が検体の値と相関することを特徴とする検体をモニタリングするための方法。
18.前記生体膜の浸透性を増加させるために前記生体膜を予め処理することをさらに含むことを特徴とする17に記載の方法。
19.前記予め処理するステップが、前記生体膜に低周波数の超音波を適用することを特徴とする18に記載の方法。
20.前記媒体がアガロースベースのヒドロゲルを含むことを特徴とする17に記載の方法。
21.前記媒体がポリエチレングリコールジアクリレート(PEGDA)ベースのヒドロゲルを含むことを特徴とする17に記載の方法。
22.前記ヒドロゲルに濃度1〜10%のグルコースオキシダーゼが添加されていることを特徴とする21に記載の方法。
23.前記ヒドロゲルが2000〜80,00の分子量を有することを特徴とする21に記載の方法。
24.前記ヒドロゲルが約3,400の分子量を有することを特徴とする21に記載の方法。
25.前記ヒドロゲルが約200マイクロメーターの厚さを有することを特徴とする21に記載の方法。
26.前記ヒドロゲルがポリエチレングリコールジアクリレート/ポリエチレンイミン(PEGDA−PEI)ベースのヒドロゲルを含むことを特徴とする17に記載の方法。
27.前記ヒドロゲルがポリエチレングリコールジアクリレート−n−ビニルピロリドン(PEGDA−NVP)ヒドロゲルを含むことを特徴とする17に記載の方法。
Claims (15)
- 検体のモニタリングシステムのためのセンサアセンブリであって、前記センサアセンブリは、ヒドロゲルと、電極アセンブリとを含み、
前記ヒドロゲルは検体と反応する酵素を含み、前記ヒドロゲルは酵素を封入し、および、前記ヒドロゲルは患者の浸透性にされた皮膚と接面し、前記皮膚を通して検体を受け取るように適合され、
前記電極アセンブリはセンサアセンブリの表面上あり、前記検体の値と相関する電気信号を検出する、ことを特徴とするセンサアセンブリ。 - 前記ヒドロゲルが、アガロースベースのヒドロゲル、ビニルアセテートベースのヒドロゲル、ポリエチレングリコールジアクリレート/ポリエチレンイミン(PEGDA−PEI)ベースのヒドロゲル、およびポリエチレングリコールジアクリレート−n−ビニルピロリドン(PEGDA−NVP)のヒドロゲルからなる群から選択されることを特徴とする請求項1に記載のセンサアセンブリ。
- 前記酵素がグルコースオキシダーゼであることを特徴とする請求項1に記載のセンサアセンブリ。
- 前記ヒドロゲルに濃度1〜10%のグルコースオキシダーゼが添加されていることを特徴とする請求項3に記載のセンサアセンブリ。
- 前記検体の値は前記生体膜を通る前記検体の流量であることを特徴とする請求項1のセンサアセンブリ。
- 前記検体の値が患者の体液中の前記検体の濃度であることを特徴とする請求項1に記載のセンサアセンブリ。
- 前記検体がグルコースであることを特徴とする請求項1に記載のアセンブリ。
- 検体をモニタリングするための方法であって、
ヒドロゲルが生体膜から検体を受け取ることができるように、前記ヒドロゲルを前記生体膜に関して配置するステップであって、前記ヒドロゲルは酵素を封入し、電極アセンブリは電気的にセンサー体と接続されているステップと、
前記検体を前記封入された酵素に反応させるステップと、
前記電極アセンブリで電気信号を検出するステップと、を含み、
前記電気信号が検体の値と相関することを特徴とする方法。 - 前記検体と前記酵素が連続的に反応することを特徴とする請求項8に記載の方法。
- 前記ヒドロゲルが、アガロースベースのヒドロゲル、ビニルアセテートベースのヒドロゲル、ポリエチレングリコールジアクリレート/ポリエチレンイミン(PEGDA−PEI)ベースのヒドロゲル、およびポリエチレングリコールジアクリレート−n−ビニルピロリドン(PEGDA−NVP)のヒドロゲルからなる群から選択されることを特徴とする請求項8に記載の方法。
- 前記酵素が、グルコースオキシダーゼであることを特徴とする請求項8に記載の方法。
- 前記ヒドロゲルに濃度1〜10%のグルコースオキシダーゼが添加されていることを特徴とする請求項11に記載の方法。
- 前記生体膜が皮膚であることを特徴とする請求項8に記載の方法。
- 前記生体膜の浸透性を増加させるために前記生体膜を予め処理することをさらに含むことを特徴とする請求項8に記載の方法。
- 前記予め処理するステップが、角質の物理的な分断を含むことを特徴とする請求項14に記載の方法。
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US20060094946A1 (en) | 2006-05-04 |
NZ554624A (en) | 2010-11-26 |
JP5815652B2 (ja) | 2015-11-17 |
US8224414B2 (en) | 2012-07-17 |
US20060094944A1 (en) | 2006-05-04 |
US20160376431A1 (en) | 2016-12-29 |
US10196512B2 (en) | 2019-02-05 |
US9549697B2 (en) | 2017-01-24 |
US20170145203A1 (en) | 2017-05-25 |
US20080311670A1 (en) | 2008-12-18 |
US10655004B2 (en) | 2020-05-19 |
US20190136037A1 (en) | 2019-05-09 |
US10227485B2 (en) | 2019-03-12 |
BRPI0517255A (pt) | 2008-10-07 |
US20190136038A1 (en) | 2019-05-09 |
US20200362158A1 (en) | 2020-11-19 |
US20060094945A1 (en) | 2006-05-04 |
US10988610B2 (en) | 2021-04-27 |
US10647846B2 (en) | 2020-05-12 |
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