JP2021164475A - 連続センサー用双性イオン表面修飾 - Google Patents
連続センサー用双性イオン表面修飾 Download PDFInfo
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- JP2021164475A JP2021164475A JP2021113541A JP2021113541A JP2021164475A JP 2021164475 A JP2021164475 A JP 2021164475A JP 2021113541 A JP2021113541 A JP 2021113541A JP 2021113541 A JP2021113541 A JP 2021113541A JP 2021164475 A JP2021164475 A JP 2021164475A
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- A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
- A61B5/14865—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
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- A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
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- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
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- A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
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Abstract
【解決手段】分析物、例えば、宿主におけるグルコースの濃度の測定装置が提供される。その装置は分析物の濃度に関連する信号を発生するように構成されている連続分析物センサー34、基準電極30、および作用電極38上に位置する感応膜32を含むことができる。その感応膜は前記感応膜を通り抜ける前記分析物の流動を制御するように構成されている拡散抵抗ドメインを含む。その拡散抵抗ドメインは1種類以上の双性イオン性化合物および親水性領域と疎水性領域の両方を含む基礎重合体を含む。
【選択図】図1
Description
定義
大要
模範的なグルコースセンサー構成
センサー電子装置
ノイズ
干渉物質
ドリフト
好ましくは、スプレー、浸漬、流延、電界紡糸、蒸着、スピンコーティング、被覆などのような溶液ベースの技術によって好ましい実施形態の重合体を処理することができる。溶媒ベースの材料に用いられる方法と類似した方法によって水ベースの高分子エマルジョンを製作して膜を形成することができる。両方の場合で揮発性の液体(例えば、有機溶媒または水)の蒸発によりその重合体の膜が残される。当業者に周知の多数の方法により多機能性反応性成分を使用して被着した膜の架橋を実行することができる。その液体系は熱、蒸気、高エネルギー放射線、紫外線により、または鋳型中または被覆される基材上で最終重合体を作製する反応を完了することにより硬化することができる。
生体防御ドメイン
幾つかの実施形態では拡散抵抗層とも呼ばれる拡散抵抗ドメイン44を使用することができ、生体防御ドメインと比べて移植可能装置のより近くに配置する。幾つかの実施形態では表面活性基含有基礎重合体を含む生体防御ドメインに拡散抵抗ドメインの機能性を組み込むことができる。よって、拡散抵抗ドメインについての本明細書における記述は生体防御ドメインにも当てはまり得ることを留意すべきである。拡散抵抗ドメインは酸素および他の分析物(例えば、グルコース)の基底酵素ドメインへの流動を制御するように機能する。本明細書中の別の箇所でさらに詳細に記載されるように、血液中の酸素の量と比べてモル過剰量のグルコースが存在する、すなわち、細胞外液中の遊離酸素分子毎に通常は100個を超えるグルコース分子が存在する(Updike et al., Deabetes Care 5:207−21 (1982)を参照のこと)。しかしながら、酸素を補助因子として用いる固定化酵素ベースのセンサーが酸素分圧の変化には応答せずにグルコース濃度の変化に直線的に応答するために非律速的過剰量の酸素がそのセンサーに供給される。より具体的には、グルコースモニタリング反応が酸素により制限されるとき、グルコースの最小濃度の上では直線性が達成されない。グルコースと酸素の流動を制御するために酵素ドメインの上に配置される半透膜が無い場合では、最大でも約40mg/dLまでしかグルコースレベルに対する直線的応答を得ることができない。しかしながら、臨床背景ではグルコースレベルに対する直線的応答が最大で少なくとも約500mg/dLまで望ましい。
幾つかの実施形態では酵素層とも呼ばれる酵素ドメイン42を使用することができ、拡散抵抗ドメイン44よりも電気化学的反応性表面から遠くない位置に配置する。酵素ドメインは分析物と反応するように構成されている触媒を含む。1つの実施形態では酵素ドメインはグルコース酸化酵素を含む固定化酵素ドメイン42である。他の実施形態では酵素ドメイン42に他の酸化酵素、例えば、ガラクトース酸化酵素、コレステロール酸化酵素、アミノ酸酸化酵素、アルコール酸化酵素、乳酸酸化酵素、またはウリカーゼをしみ込ませることができる。例えば、酵素ベースの電気化学的グルコースセンサーが良く働くように、センサーの反応は酵素活性によっても補因子の濃度によっても制限されるべきではない。
干渉ドメイン
電極ドメイン
様々な生物活性(治療)剤のうちのいずれかを本明細書に記載される分析物センサーシステム、例えば、図1に示されている分析物センサーシステムと共に使用することができると考えられている。幾つかの実施形態ではその生物活性剤は抗凝血剤である。「抗凝血剤」という用語は、本明細書において使用される場合、広い意味を持つ用語であり、当業者にとってのその通常的、且つ、慣用的な意味が与えられ(且つ、特別な意味または特例的な意味に限定されず)、限定されないが、凝血を防止する(例えば、血液の凝固を最小化する、低減させる、または止める)物質を指す。これらの実施形態では分析物センサーシステムに含まれる抗凝血剤はセンサー内またはセンサー上で凝血を防止することができる。センサーシステムへの組込みに適切な抗凝血剤にはビタミンKアンタゴニスト(例えば、アセノクマロール、クロリンジオン、ジクマロール(Dicoumarol)、ジフェナジオン、エチルビスクムアセテート、フェンプロクモン、フェニンジオン、チオクロマロール、またはワーファリン)、ヘパリン系抗凝血剤(例えば、血小板凝集阻害薬:アンチトロンビンIII、ベミパリン、ダルテパリン、ダナパロイド、エノキサパリン、ヘパリン、ナドロパリン、パルナパリン、レビパリン、スロデキシド、チンザパリン)、他の血小板凝集阻害薬(例えば、アブシキシマブ、アセチルサリチル酸(アスピリン)、アロキシプリン、ベラプロスト、ジタゾール、カルシウムカルバサラート、クロリクロメン、クロピドグレル、ジピリダモール、エポプロステノール、エプチフィバチド、インドブフェン、イロプロスト、ピコタミド、チクロピジン、チロフィバン、トレプロスチニル、トリフルサル)、酵素(例えば、アルテプラーゼ、アンクロッド、アニストレプラーゼ、ブリナーゼ、ドロトレコギンα、フィブリノリシン、プロテインC、レテプラーゼ、サルプラーゼ、ストレプトキナーゼ、テネクテプラーゼ、ウロキナーゼ)、直接的トロンビン阻害剤(例えば、アルガトロバン、ビバリルジン(Bivalirudin)、デシルジン、レピルジン、メラガトラン、キシメラガトラン、他の抗血栓薬(例えば、ダビガトラン、デフィブロタイド、デルマタン硫酸、フォンダパリヌクス、リバロキサバン)などが含まれるが、これらに限定されない。
生物活性剤の放出
生物活性剤の負荷
「模範的なグルコースセンサー構成」という表題の節に記載されるようにセンサーを構築し、そのセンサーは2%ポリ(カルボキシル)ベタイン(pCB)を含んでなる一元的生体防御/拡散抵抗ドメインを含む。センサーの最も外側のドメインにおけるpCBの存在が表面の湿潤を促進し、水和に起因する重合体の再構成を速める。より速い重合体の再構成がセンサードリフトを減少させることによりセンサーの性能を向上させる。
「模範的なグルコースセンサー構成」という表題の節に記載されるようにセンサーを構築し、そのセンサーは一元的生体防御/拡散抵抗ドメインを含む。ほぼ等量の正に帯電した[2−(アクリロイルオキシ)エチル]トリメチルアンモニウムクロリド(TMA)モノマーと負に帯電した2−カルボキシエチルアクリレート(CAA)モノマーを含む約2重量%の共重合体を含む重合体の混合物から一元的生体防御/拡散抵抗ドメインが形成される。
「模範的なグルコースセンサー構成」という表題の節に記載されるようにセンサーを構築し、そのセンサーはpCBに結合可能である表面修飾末端基を含んでなる一元的生体防御/拡散抵抗ドメインを含む。
「模範的なグルコースセンサー構成」という表題の節に記載されるようにセンサーを構築し、そのセンサーはpCBに架橋可能である表面修飾末端基を含んでなる一元的生体防御/拡散抵抗ドメインを含む。
実施例5[加水分解性ベタインエステル]
43−A1号明細書;米国特許出願公開第2011−0024307−A1号明細書;米国特許出願公開第2011−0027127−A1号明細書;米国特許出願公開第2011−0027453−A1号明細書;米国特許出願公開第2011−0027458−A1号明細書;米国特許出願公開第2011−0028815−A1号明細書;米国特許出願公開第2011−0028816−A1号明細書;米国特許出願公開第2011−0046467−A1号明細書;米国特許出願公開第2011−0077490−A1号明細書;米国特許出願公開第2011−0118579−A1号明細書;米国特許出願公開第2011−0124992−A1号明細書;米国特許出願公開第2011−0125410−A1号明細書;米国特許出願公開第2011−0130970−A1号明細書;米国特許出願公開第2011−0130971−A1号明細書;米国特許出願公開第2011−0130998−A1号明細書;米国特許出願公開第2011−0144465−A1号明細書;米国特許出願公開第2011−0178378−A1号明細書;米国特許出願公開第2011−0190614−A1号明細書;米国特許出願公開第2011−0201910−A1号明細書;米国特許出願公開第2011−0201911−A1号明細書;米国特許出願公開第2011−0218414−A1号明細書;米国特許出願公開第2011−0231140−A1号明細書;米国特許出願公開第2011−0231141−A1号明細書;米国特許出願公開第2011−0231142−A1号明細書;米国特許出願公開第2011−0253533−A1号明細書;米国特許出願公開第2011−0263958−A1号明細書;米国特許出願公開第2011−0270062−A1号明細書;米国特許出願公開第2011−0270158−A1号明細書;米国特許出願公開第2011−0275919−A1号明細書;米国特許出願公開第2011−0290645−A1号明細書;米国特許出願公開第2011−0313543−A1号明細書;米国特許出願公開第2011−0320130−A1号明細書;米国特許出願公開第2012−0035445−A1号明細書;米国特許出願公開第2012−0040101−A1号明細書;米国特許出願公開第2012−0046534−A1号明細書;米国特許出願公開第2012−0078071−A1号明細書;米国特許出願公開第2012−0108934−A1号明細書;米国特許出願公開第2012−0130214−A1号明細書;米国特許出願公開第2012−0172691−A1号明細書;米国特許出願公開第2012−0179014−A1号明細書;米国特許出願公開第2012−0186581−A1号明細書;米国特許出願公開第2012−0190953−A1号明細書;米国特許出願公開第2012−0191063−A1号明細書;米国特許出願公開第2012−0203467−A1号明細書;米国特許出願公開第2012−0209098−A1号明細書;米国特許出願公開第2012−0215086−A1号明細書;米国特許出願公開第2012−0215087−A1号明細書;米国特許出願公開第2012−0215201−A1号明細書;米国特許出願公開第2012−0215461−A1号明細書;米国特許出願公開第2012−0215462−A1号明細書;米国特許出願公開第2012−0215496−A1号明細書;米国特許出願公開第2012−0220979−A1号明細書;米国特許出願公開第2012−0226121−A1号明細書;米国特許出願公開第2012−0228134−A1号明細書;米国特許出願公開第2012−0238852−A1号明細書;米国特許出願公開第2012−0245448−A1号明細書;米国特許出願公開第2012−0245855−A1号明細書;米国特許出願公開第2012−0255875−A1号明細書;米国特許出願公開第2012−0258748−A1号明細書;米国特許出願公開第2012−0259191−A1号明細書;米国特許出願公開第2012−0260323−A1号明細書;米国特許出願公開第2012−0262298−A1号明細書;米国特許出願公開第2012−0265035−A1号明細書;米国特許出願公開第2012−0265036−A1号明細書;米国特許出願公開第2012−0265037−A1号明細書;米国特許出願公開第2012−0277562−A1号明細書;米国特許出願公開第2012−0277566−A1号明細書;米国特許出願公開第2012−0283541−A1号明細書;米国特許出願公開第2012−0283543−A1号明細書;米国特許出願公開第2012−0296311−A1号明細書;米国特許出願公開第2012−0302854−A1号明細書;米国特許出願公開第2012−0302855−A1号明細書;米国特許出願公開第2012−0323100−A1号明細書;米国特許出願公開第2013−0012798−A1号明細書;米国特許出願公開第2013−0030273−A1号明細書;米国特許出願公開第2013−0035575−A1号明細書;米国特許出願公開第2013−0035865−A1号明細書;米国特許出願公開第2013−0035871−A1号明細書;米国特許出願公開第2005−0056552−A1号明細書;および米国特許出願公開第2005−0182451−A1号明細書において開示されている。
Claims (34)
- 分析物の濃度の測定装置であって、
分析物の濃度に関連する信号を発生するように構成されているセンサー、および
前記センサー上に位置する感応膜であって、前記感応膜を通り抜ける前記分析物の流動を制御するように構成されている拡散抵抗ドメインを含む前記感応膜
を含み、前記拡散抵抗ドメインが基礎重合体と1種類以上の双性イオン性化合物を含み、且つ、前記基礎重合体が親水性領域と疎水性領域の両方を含む、前記装置。 - 前記拡散抵抗ドメイン中の前記1種類以上の双性イオン性化合物の量が前記抵抗ドメインの約10重量%未満である、請求項1に記載の装置。
- 前記拡散抵抗ドメイン中の前記1種類以上の双性イオン性化合物の量が前記抵抗ドメインの約5重量%未満である、請求項1に記載の装置。
- 前記1種類以上の双性イオン性化合物がベタイン化合物またはその誘導体を含む、請求項1に記載の装置。
- 前記1種類以上の双性イオン性化合物が、カルボキシルベタイン化合物、スルホベタイン化合物、ホスホルベタイン化合物、およびそれらの誘導体からなる群より選択される少なくとも1種類の化合物を含む、請求項1に記載の装置。
- 前記1種類以上の双性イオン性化合物が、コカミドプロピルベタイン、オレアミドプロピルベタイン、オクチルスルホベタイン、カプリリルスルホベタイン、ラウリルスルホベタイン、ミリスチルスルホベタイン、パルミチルスルホベタイン、ステアリルスルホベタイン、ベタイン(トリメチルグリシン)、オクチルベタイン、ホスファチジルコリン、グリシンベタイン、ポリ(カルボキシベタイン)、ポリ(スルホベタイン)、およびそれらの誘導体からなる群より選択される少なくとも1種類の化合物を含む、請求項1に記載の装置。
- 前記1種類以上の双性イオン性化合物が、ポリ(カルボキシベタイン)、ポリ(スルホベタイン)、およびそれらの誘導体からなる群より選択される少なくとも1種類の化合物を含む、請求項1に記載の装置。
- 前記感応膜が、グルコース酸化酵素、グルコース脱水素酵素、ガラクトース酸化酵素、コレステロール酸化酵素、アミノ酸酸化酵素、アルコール酸化酵素、乳酸酸化酵素、およびウリカーゼからなる群より選択される酵素を含む酵素ドメインをさらに含む、請求項1に記載の装置。
- 前記酵素がグルコース酸化酵素である、請求項8に記載の装置。
- 前記基礎重合体が、エポキシ、ポリオレフィン、ポリシロキサン、ポリエーテル、ポリアクリレート、ポリエステル、ポリカーボネート、およびポリウレタンからなる群より選択される少なくとも1種類の重合体を含む、請求項1に記載の装置。
- 前記ポリウレタンがポリウレタン共重合体である、請求項10に記載の装置。
- 前記基礎重合体がポリウレタンである、請求項1に記載の装置。
- 前記センサーが電極を含む、請求項1に記載の装置。
- 前記装置が分析物濃度の連続測定用に構成されている、請求項1に記載の装置。
- 前記分析物がグルコースである、請求項1に記載の装置。
- 前記拡散抵抗ドメインが一元的生体防御/拡散抵抗ドメインである、請求項1に記載の装置。
- 分析物の濃度の測定装置であって、
分析物の濃度に関連する信号を発生するように構成されているセンサー、および
前記センサー上に位置する感応膜
を含み、前記センサーから最も遠位にある前記感応膜の表面が1種類以上の双性イオン性化合物を含む被覆で被覆されている、前記装置。 - 前記センサーから最も遠位にある前記感応膜の前記表面が前記1種類以上の双性イオン性化合物との架橋用に構成されている表面活性末端基を含み、且つ、前記1種類以上の双性イオン性化合物が前記表面活性末端基に架橋されている、請求項17に記載の装置。
- 前記センサー膜の前記表面上の前記被覆がヒドロゲルではない、請求項17に記載の装置。
- 前記1種類以上の双性イオン性化合物がベタイン化合物またはその誘導体を含む、請求項17に記載の装置。
- 前記1種類以上の双性イオン性化合物が、カルボキシルベタイン化合物、スルホベタイン化合物、ホスホルベタイン化合物、およびそれらの誘導体からなる群より選択される少なくとも1種類の化合物を含む、請求項17に記載の装置。
- 前記1種類以上の双性イオン性化合物が、コカミドプロピルベタイン、オレアミドプロピルベタイン、オクチルスルホベタイン、カプリリルスルホベタイン、ラウリルスルホベタイン、ミリスチルスルホベタイン、パルミチルスルホベタイン、ステアリルスルホベタイン、ベタイン(トリメチルグリシン)、オクチルベタイン、ホスファチジルコリン、グリシンベタイン、ポリ(カルボキシベタイン)、ポリ(スルホベタイン)、およびそれらの誘導体からなる群より選択される1種類以上の化合物を含む、請求項17に記載の装置。
- 前記1種類以上の双性イオン性化合物が、ポリ(カルボキシベタイン)、ポリ(スルホベタイン)、およびそれらの誘導体からなる群より選択される1種類以上の化合物を含む、請求項17に記載の装置。
- 前記ベタイン化合物またはその誘導体がベタインの加水分解性陽イオン性エステルである、請求項20に記載の装置。
- 前記ベタインの加水分解性陽イオン性エステルが陽イオン性ポリ(カルボキシベタイン)エステルである、請求項24に記載の装置。
- 前記感応膜が、グルコース酸化酵素、グルコース脱水素酵素、ガラクトース酸化酵素、コレステロール酸化酵素、アミノ酸酸化酵素、アルコール酸化酵素、乳酸酸化酵素、およびウリカーゼからなる群より選択される酵素を含む酵素ドメインをさらに含む、請求項17に記載の装置。
- 前記酵素がグルコース酸化酵素である、請求項26に記載の装置。
- 前記センサー膜が前記センサーの最も遠位に位置する生体防御ドメインを含み、且つ、前記生体防御ドメインが、エポキシ、ポリオレフィン、ポリシロキサン、ポリエーテル、ポリアクリレート、ポリエステル、ポリカーボネート、およびポリウレタンからなる群より選択される少なくとも1種類の重合体を含む、請求項17に記載の装置。
- 前記ポリウレタンがポリウレタン共重合体である、請求項28に記載の装置。
- 前記基礎重合体がポリウレタンである、請求項28に記載の装置。
- 前記センサー膜が、エポキシ、ポリオレフィン、ポリシロキサン、ポリエーテル、ポリアクリレート、ポリエステル、ポリカーボネート、およびポリウレタンからなる群より選択される少なくとも1種類の重合体を含む一元的生体防御/拡散抵抗ドメインを含む、請求項17に記載の装置。
- 前記センサーが電極を含む、請求項17に記載の装置。
- 前記装置が分析物濃度の連続測定用に構成されている、請求項17に記載の装置。
- 前記分析物がグルコースである、請求項17に記載の装置。
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WO2005005973A1 (en) * | 2003-07-09 | 2005-01-20 | University Of Brighton | Improved electrodes |
JP2009540889A (ja) * | 2006-06-19 | 2009-11-26 | エフ ホフマン−ラ ロッシュ アクチェン ゲゼルシャフト | 電流測定センサおよびその製造方法 |
JP2011517422A (ja) * | 2008-03-28 | 2011-06-09 | アボット ダイアベティス ケア インコーポレイテッド | 検体センサ較正管理 |
WO2011057219A2 (en) * | 2009-11-06 | 2011-05-12 | University Of Washington Through Its Center For Commercialization | Crosslinked zwitterionic hydrogels |
JP2011185744A (ja) * | 2010-03-09 | 2011-09-22 | Toray Ind Inc | バイオセンサに用いられるカバーフィルム |
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