JP2019504288A - 分析物センサのための酵素固定化接着層 - Google Patents
分析物センサのための酵素固定化接着層 Download PDFInfo
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- JP2019504288A JP2019504288A JP2018515510A JP2018515510A JP2019504288A JP 2019504288 A JP2019504288 A JP 2019504288A JP 2018515510 A JP2018515510 A JP 2018515510A JP 2018515510 A JP2018515510 A JP 2018515510A JP 2019504288 A JP2019504288 A JP 2019504288A
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Abstract
Description
出願データシートにおいて特定される任意かつ全ての優先権主張、またはそれに対するいかなる訂正も、37 CFR 1.57の下で参照により本明細書に組み込まれる。本出願は、2015年12月30日に出願された米国仮出願第62/273,155号、2015年12月30日に出願された米国仮出願第62/273,142号、及び2015年12月30日に出願された米国仮出願第62/273,219号の利益を主張する。前述の出願の各々は、参照によりその全体が本明細書に組み込まれ、各々が、これによって明示的に本明細書の一部となる。
第1の態様では、分析物濃度(例えば、グルコース)を決定するためのデバイスであって、分析物の濃度と関連した信号を生成するように構成されたセンサと、該センサ上に位置する検知膜と、を備える、デバイスを提供する。検知膜は、酵素層を含み、該酵素層は、酵素と、ポリウレタン及び/またはポリ尿素セグメント、ならびに1つ以上の双性イオン繰り返し単位を含むポリマーと、を含む。酵素層は、酵素を保護し、酵素の活性に悪影響を及ぼすことなく、それが検知膜から宿主に浸出するのを防止する。酵素層は、0.01μm〜約250μmの厚さであり得る。
本明細書において、及び以下の特許請求の範囲において、以下の意味を有すると定義される多くの用語を参照する。
図1は、宿主に取り付けられ、多くの他の例示的なデバイス110〜113と通信している、連続分析物センサシステム100の概略図である。使い捨て筐体(図示せず)を介して宿主の皮膚に固定される、オンスキン(on−skin)センサアセンブリ600を備える経皮分析物センサシステムが示される。このシステムには、経皮分析物センサ200、及び分析物情報を受信機に無線送信するための電子機器ユニット(「センサ電子機器」または「トランスミッタ」と交換可能に称される)500が含まれる。使用中、センサ200の検知部分は、宿主の皮膚の下にあり、センサ200の接触部分は、電子機器ユニット500に操作可能に接続されている(例えば、電気的に接続されている)。電子機器ユニット500は、宿主の皮膚に固定された接着パッチに取り付けられた筐体と係合される。
本明細書に開示される膜システムは、生体液と接触した埋め込み可能なデバイスと共に使用するのに好適である。例えば、膜システムは、生体液中の分析物レベルをモニタリングし、決定するためのデバイス、例えば、糖尿病を有する個体のグルコースレベルをモニタリングするためのデバイスなどの埋め込み可能なデバイスと共に利用され得る。いくつかの実施形態において、分析物測定デバイスは、連続デバイスである。分析物測定デバイスは、任意の好適な検知素子を用いて、限定されないが、酵素的、化学的、物理的、電気化学的、分光光度的、旋光分析的、熱量測定的、放射測定的、免疫化学的、または同様の素子を伴うものを含む未加工信号を提供する。
一般に、分析物センサシステムは、宿主における分析物レベルと関連したデータの測定及び処理を可能にするハードウェア、ファームウェア、またはソフトウェアを含み得る、「コンピュータシステム」とも称される、それと関連した電子機器を有する。電気化学センサの例示的な一実施形態において、電子機器は、ポテンショスタット、電力をセンサに提供するための電源、及び信号処理に有用な他のコンポーネントを含む。追加の実施形態において、電子機器のうちの一部または全ては、センサまたは電子機器の他の部分と有線または無線で通信し得る。例えば、デバイス上に配設されたポテンショスタットは、ベッドサイドにある残りの電子機器(例えば、プロセッサ、レコーダ、トランスミッタ、受信器など)に配線され得る。別の実施例において、電子機器のある部分が、例えば赤外線(IR)または無線周波数(RF)によって電子機器(例えば、受信器)の別の部分に無線接続される。電子機器の他の実施形態は、米国特許公開第US−2005−0192557−A1号、米国特許公開第US−2005−0245795−A1号、米国特許公開第US−2005−0245795−A1号、米国特許公開第US−2005−0245795−A1号、米国特許公開第US−2008−0119703−A1号、及び米国特許公開第US−2008−0108942−A1号(それぞれが参照によりその全体が本明細書に組み込まれる)に記載されるものなどのセンサデータ出力を提供するために有用であり得ることが企図される。
干渉物質は、センサに偽陽性または偽陰性の分析物信号(例えば、非分析関連信号)を生成させ得る分子または他の種である。いくつかの干渉物質は、センサの電気化学的反応表面において還元または酸化されるが、他の干渉物質は、使用される酵素(例えば、グルコースオキシダーゼ)が測定される分析物と反応する能力を干渉する。さらに他の干渉物質は、酵素(例えば、グルコースオキシダーゼ)と反応して、電気化学的に活性である副産物を生成する。干渉物質は、応答信号を誇張またはマスクする場合があり、それにより虚偽のまたは誤解を招く結果につながる。例えば、偽陽性信号は、宿主の分析物濃度(例えば、グルコース濃度)を真の分析濃度より高く見せ得る。偽陽性信号は、いくつかの従来センサにおいて臨床的に重要な問題をもたらし得る。例えば、宿主が干渉物質(例えば、アセトアミノフェン)を摂取した深刻な低血糖状況において、結果として生じる人工的に高いグルコース信号は、宿主に正常血糖または高血糖であると信じさせる可能性がある。それに応答して、宿主は、適切な一連の行動が食事を始めることである場合に、過剰なインスリンを注入することによって、または何もしないことによって、不適切な治療決定を下し得る。順に、この不適切な行動または行動しないことが、宿主にとって危険な低血糖エピソードにつながり得る。したがって、本明細書において企図されるある特定の実施形態は、分析物測定に対する干渉物質の効果を実質的に低減または排除する膜システムを含む。これらの膜システムは、電極の電気活性表面上への干渉物質の流れを遮断または実質的に低減することができる1つ以上のドメインを含み得、米国特許公開第US−2009−0247856−A1においてより詳細に記載されるように、ノイズを低減し、センサ精度を改善し得る。
本明細書で使用される場合、「ドリフト」という用語は、広義語であり、その通常の、かつ慣例的な意味が当業者に示されるものであり(かつ特別な、またはカスタマイズされた意味に限定されるものではなく)、経時的なセンサの感度の変化を指すが、これに限定されない。ドリフトは、ポリウレタン拡散抵抗ドメインを使用する実施形態において特に明らかであり得る、センサ膜システムの透過性の変化によって駆動され得る。理論に束縛されるものではないが、そのようなシステムにおける透過性の変化は、表面に対してより親水性のコンポーネントをもたらす拡散抵抗ドメインポリウレタンポリマー鎖の再配置、またはそうでなければ膜システムの水和中に親水性ポリマーコンポーネントへのより優れたアクセスを可能にするような再配置から生じると考えられる。このため、水和速度の増加または膜システムの湿潤性の増加は、システムドリフトを低減する。
好ましい実施形態のポリマーは、スプレー、浸漬、流延、電界紡糸、蒸着、スピンコーティング、コーティングなどの溶液系技法によって処理され得る。水系ポリマーエマルジョンは、溶媒系材料に使用されるものと同様の方法によって膜を形成するように製造され得る。両方の場合において、揮発性液体(例えば、有機溶媒または水)の蒸発は、ポリマーのフィルムを残す。堆積されたフィルムまたは層の架橋は、多くの方法によって多機能反応性成分の使用を通じて行われ得る。液体系は、熱、水分、高エネルギー照射、紫外線によって、またはコーティングされる型内もしくは基材上に最終ポリマーを生成する反応を完了させることによって硬化し得る。
バイオインターフェース層は、宿主に埋め込まれるかまたは宿主に接続されたときに(例えば、血管への対体アクセスを提供する血管内アクセスデバイスを介して)、生体液とインターフェースする(すなわち、接触する)ように構成された埋め込み可能なデバイスのドメインまたは層である。分析物センサ、例えば、宿主に埋め込まれた連続分析物センサ上に存在する場合、バイオインターフェース層は、生体材料関連炎症応答を低減することによってセンサの寿命を増加させ、センサの不正確性を減少させることができる。バイオインターフェース層の防汚性は、センサ上の細胞、タンパク質、及び他の生物学的種の蓄積を阻害し得る。いくつかの実施形態において、バイオインターフェースドメインは、参照によりその全体が本明細書に組み込まれる、2015年12月20日に出願された米国仮出願第62/273,142号に記載されるバイオインターフェースドメインで形成されてもよい。
アンモニオホスフェート(ホスホベタインもしくはレシチン類似体)、アンモニオホスホネート(ホスホノベタイン)、またはアンモニオホスフィネート(ホスフィノベタイン)が含まれ、それぞれ以下の構造を有し、
アンモニオカルボキシレートは、以下の構造を有し、
いくつかの実施形態において、拡散抵抗層とも称される拡散抵抗ドメイン46を使用することができ、バイオインターフェース層に対して埋め込み可能なデバイスのより近位に位置付けられる。いくつかの実施形態において、拡散抵抗ドメインの機能性は、ポリ双性イオンバイオインターフェースポリマーを含むバイオインターフェース層に組み込まれ得る。したがって、拡散抵抗ドメインに関する本明細書の記載は、バイオインターフェース層にも適用し得ることに留意されたい。拡散抵抗ドメインは、酸素及び他の分析物(例えば、グルコース)の、下にある酵素ドメインへの流動を制御するように機能する。本明細書の別の場所により詳細に記載されるように、血中の酸素量に対してモル過剰のグルコースが存在し、すなわち細胞外液中の遊離酸素分子毎に、典型的に100個超のグルコース分子が存在する(Updike et al.,Diabetes Care 5:207−21(1982)を参照されたい)。しかしながら、酸素を共因子として用いる固定化酵素系センサには、グルコース濃度の変化に線形的に応答するが、酸素分圧の変化に応答しないように、非レート制限過剰で酸素が供給される。より具体的には、グルコースモニタリング反応が酸素制限される場合、線形性は、最小より上のグルコース濃度で達成されない。グルコース及び酸素の流動を制御するために酵素ドメイン上に位置する半透過性膜なしに、グルコースレベルに対する線形応答は、わずか最大約40mg/dLで得ることができる。しかしながら、臨床設定において、グルコースレベルに対する線形応答は、少なくとも最大約500mg/dLが望ましい。いくつかの実施形態において、拡散抵抗ドメインは、参照によりその全体が本明細書に組み込まれる、2015年12月20日に出願された米国仮出願第62/273,219号に記載される拡散抵抗ドメインで形成され得る。
酵素ドメインとも称される酵素層は、活性酵素を固定化するように構成された埋め込み可能なデバイスのドメインまたは層であり、宿主に埋め込まれるかまたは宿主に接続されたときに(例えば、血管への体外アクセスを提供する血管内アクセスデバイスを介して)、分析物と反応する。一実施形態において、酵素ドメインは、グルコースオキシダーゼを含む。他の実施形態において、酵素ドメインに、他のオキシダーゼ、例えば、ガラクトースオキシダーゼ、コレステロールオキシダーゼ、アミノ酸オキシダーゼ、アルコールオキシダーゼ、乳酸オキシダーゼ、またはウリカーゼを含浸させることができる。例えば、酵素系電気化学グルコースセンサが良好に動作するために、センサの応答は、酵素活性によっても共因子濃度によっても制限されてはならない。他の実施形態において、酵素は、グルコースデヒドロゲナーゼなどのデヒドロゲナーゼであってもよい。
アンモニオホスフェート(ホスホベタインもしくはレシチン類似体)、アンモニオホスホネート(ホスホノベタイン)、またはアンモニオホスフィネート(ホスフィノベタイン)が含まれ、それぞれ以下の構造を有し、
構造i)〜vii)のうちのいずれかのポリ双性イオンを生成するために使用され得る好適な双性イオンモノマーのさらなる例には、アンモニオスルホネート(スルホベタイン)、アンモニオスルフェートが含まれ、それぞれ以下の構造を有し、
アンモニオカルボキシレートは、以下の構造を有し、
いくつかの実施形態において、例えば図2Bに示されるセンサ構成において、干渉層とも称される干渉ドメイン43は、バイオインターフェース層に加えて(またはその代わりに)提供され得ることが企図される。干渉ドメイン43は、電気化学的反応表面への1つ以上の干渉物質の透過を実質的に低減し得る。干渉ドメイン43は、測定した種より干渉物質のうちの1つ以上に対してはるかに低い透過性であるように構成され得る。干渉遮断がバイオインターフェース層によって(例えば、バイオインターフェース層の表面活性基含有ポリマーを介して)提供され得るいくつかの実施形態において、別個の干渉ドメインは存在しない。他の実施形態において、膜は、干渉ドメイン及びバイオインターフェース層の両方を含み、両方のドメインは、1つ以上の干渉物質の透過を低減するように構成される。さらなる実施形態において、干渉ドメイン及びバイオインターフェース層は、それぞれ異なる干渉種の透過を低減するように構成される。例えば、干渉ドメインは、ある種の干渉種の透過を低減することに関して、バイオインターフェース層より優れた特異性を有し得るが、バイオインターフェース層は、別種の干渉種の透過を低減することに関して、干渉ドメインより優れた特異性を有し得る。いくつかの実施形態において、干渉ドメイン及びバイオインターフェース層の両方は、透過低減のためにある特定の干渉種を標的とするように構成される。
いくつかの実施形態において、ある特定のポリマーフィルムを使用して、干渉ドメインを形成することができる。例えば、2,2′−ジメチル−4,4′−ジアミノビフェニルから調製されたある特定のポリイミド、及び対応する二無水物を、過酸化水素選択的膜として用いられ得るフィルムに流延することができる。例えば、Ekinci et al.,Turk.J.Chem.30(2006),277−285を参照されたい。一実施形態において、フィルムは、以下のステップを使用して調製される。第1に、n−メチル−2−ピロリデン(NMP)を、減圧下でCaH2上に蒸留し、約4Å分子篩上で保管する。試薬グレードピロメリト酸二無水物(PMDA)を、減圧下、約250℃で昇華させ、使用前に真空下、約120℃で乾燥させた。ジアミンを、再結晶化を介してエタノールから精製して光る結晶を得る。次に、2,20−ジメチル−4,40−ジアミノビフェニル(約1.06g、約5mmol)を、窒素ライン、オーバーヘッド撹拌器、キシレン充填したDean−Starkトラップ、及び凝縮器を備えた50mLのSchlenk管内でNMP(約15mL)に溶解する。次いで、PMDA(約1.09g、約5mmol)をアミン溶液に付加し、続いて一晩撹拌して粘性溶液を得る。約3時間撹拌した後、溶液を約200℃で約15時間、加熱還流する。重合プロセスの間に、イミド化から生成された水を、約1〜2mLのキシレンと一緒に反応混合液から蒸留させる。周囲温度に冷却した後、溶液をNMPで希釈し、次いで95%エタノールの激しく撹拌された溶液にゆっくり付加する。沈殿したポリマーを濾過を介して収集し、エタノールで洗浄し、減圧下150℃で乾燥させる。コーティング前に、基質(例えば、Pt電極)を清浄し、任意に水性アルミナスラリーで約0.05μmに研磨する。次いで、約70mgのポリイミドを約2mLのNMPに溶解することによって調製された約20μLのポリマー溶液を、Pt電極の表面上に滴下し、室温で約3日間乾燥させる。
自己組織化プロセスを用いて、連続して交互のアニオン及びカチオン高分子電解質を電荷表面上に含む、超薄多層フィルムを構築することができる。例えば、Decher et al.,Thin Solid Films,210−211(1992)831−835を参照されたい。逆電荷間のイオン誘引は、多層構築のための駆動力である。各層における表面機能的密度を維持するために約100%の反応収率を必要とする化学吸着技法とは反対に、共有結合が自己組織化プロセスで形成される必要はない。さらに、古典的なラングミュア・ブロジェット技法を超える利点は、溶液プロセスが、基質のサイズ及びトポロジーから独立していることである。そのようなプロセスにおける使用のための例示的な高分子電解質には、限定されないが、ポリスチレンスルホネートナトリウム塩、ポリビニルスルホネートカリウム塩、ポリ−4−ビニルベンジル−(N,N−ジエチル−N−メチル−)−ヨウ化アンモニウム、及びポリ(塩酸アリルアミン)が含まれる。多層フィルムの構築は、以下のように行われ得る。正電荷を帯びた平面表面を有する固体基質を、アニオン性高分子電解質を含有する溶液に浸漬させ、ポリアニオンの単層が吸着される。吸着は、比較的高い高分子電解質濃度で実行されるため、多数のイオン基は、溶液との界面に曝露されたままであり、故に表面電荷は逆転する。純水で洗浄した後、基質をカチオン性高分子電解質を含有する溶液に浸漬させる。再度、単層が吸着されるが、ここで元の表面電荷が回復される。両方のステップをサイクル様式で繰り返すことにより、両方のポリマーの交互の多層アセンブリが得られる。この多層形成のプロセスは、逆電荷の誘引に基づくため、最小2つの逆電荷分子を必要とする。結果として、電荷が層毎に逆になる限り、単に基質を所望されるだけ多くの高分子電解質溶液に浸漬させることによって、2つより多くの分子を多層に組み込むことができる。微振動多層アセンブリも容易に調製され得る。この点において、この技法は、むしろ周期的に交互する層系に限定されるラングミュア・ブロジェット技法よりも用途が広い。別の利点は、浸漬手順が、基質のサイズまたは連続プロセスにおける自動化に関して主たる制限を課さないことである。
図2Aに示される実施形態などのいくつかの実施形態において、電極層とも称される任意の電極ドメイン42は、バイオインターフェースドメイン及び酵素ドメインに加えて提供され得るが、他の実施形態において、電極ドメインの機能性は、バイオインターフェースドメイン、拡散抵抗ドメイン、酵素ドメイン、及び電極ドメインの機能性を含む一体ドメインに組み込まれ得る。
様々な生物活性(治療)剤のうちのいずれかが、本明細書に記載される分析物センサシステム、例えば図1に示される分析物センサシステムと共に使用され得ることが企図される。特定の実施形態において、生物活性剤は、開示されるデバイスのバイオインターフェース層中にあり得る。いくつかの実施形態において、生物活性剤は、抗凝固剤である。本明細書で使用される場合、「抗凝固剤」という用語は、広義語であり、その通常の、かつ慣例的な意味が当業者に示されるものであり(かつ特別な、またはカスタマイズされた意味に限定されるものではなく)、凝固を防止する(例えば、血液の塞栓を最小化、低減、または停止する)物質を指すが、これに限定されない。これらの実施形態において、分析物センサシステムに含まれる抗凝固剤は、センサ内またはセンサ上の凝固を防止することができる。センサシステムへの組み込みに好適な抗凝固剤には、限定されないが、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(Dicumarol、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、またはワルファリン)、ヘパリン基抗凝固剤(例えば、血小板凝集阻害剤: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、ソルデキシド、チンザパリン)、他の血小板凝集阻害剤(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、カルバサラートカルシウム、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、タンパク質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)、直接トロンビン阻害剤(例えば、アルガトロバン、ビバリルジン、デシルジン、レピルジン、メラガトラン、キシメラガトラン)、他の抗血栓剤(例えば、ダビガトラン、デフィブロチド、硫酸デルマタン、フォンダパリヌクス、リバロキサバン)などが含まれる。
多くの変数が、生物活性剤放出の薬物動態に影響を及ぼし得る。好ましい実施形態の生物活性剤は、短期または長期放出に最適であり得る。いくつかの実施形態において、好ましい実施形態の生物活性剤は、センサ挿入の短期効果と関連した因子(例えば、急性炎症または塞栓)を助けるまたは克服するように設計される。いくつかの実施形態において、好ましい実施形態の生物活性剤は、長期効果と関連した因子、例えば、慢性炎症または線維性組織もしくはプラーク材料の構築を助けるまたは克服するように設計される。いくつかの実施形態において、好ましい実施形態の生物活性剤は、短期及び長期放出を合わせて、両方の利益を利用する。
膜システムへの生物活性剤の負荷の量は、いくつかの因子に依存し得る。例えば、生物活性剤の投与量及び期間は、膜システムの意図される用途、例えば、意図されるデバイスの使用期間など、患者間の生物活性剤の有効用量の差異、生物活性剤を負荷する場所及び方法、ならびに生物活性剤及び任意にそれらの担体マトリックスと関連した放出速度によって異なり得る。そのため、当業者であれば、上記の理由で、生物活性剤を負荷するレベルの変動性を理解するであろう。
ベタイン含有ポリウレタン尿素ポリマーを、有機溶媒中の2ステップ重縮合反応を介して合成した。第1のステップにおいて、両方の鎖にイソシアネート末端基を有する均質ポリウレタンプレポリマーを調製した。第2のステップにおいて、小分子ジアミン(複数可)を、鎖延長剤(複数可)として使用した。これらのジアミンは、希釈有機溶液中でプレポリマーと反応して、線形構造及び狭い分子量分泌を有する十分に定義されたポリウレタン尿素を得る。
i.グルコース傾斜(pA/mg/dL)−漸増するグルコース濃度の緩衝溶液中に配置された場合のセンサの電気応答の通常最小二乗線形回帰分析。グルコース感度とも称される。
ii.ベースライン同等(mg/dL)−非グルコース関連信号のmg/dL同等
iii.MARD(%)−平均絶体相対差異、理想線から離れた変化の尺度
iv.低酸素応答−大気条件下で得られる信号と比較して、低減した酸素条件下での電気応答の変化率として定義される(すなわち、0.25±0.05mg O2/L)。酸素性能とも称される。
v.アセトアミノフェンバイアス−2mg/dL濃度のアセトアミノフェンからのmg/dL同等信号グルコース同等とも称される。
水性溶液中のベタイン含有ポリウレタン尿素ポリマーを、水中の2ステップ重縮合反応を介して合成した。第1のステップにおいて、両方の鎖にイソシアネート末端基を有する均質ポリウレタンプレポリマーを調製した。第2のステップにおいて、小分子ジアミン(複数可)を、鎖延長剤(複数可)として使用した。これらのジアミンは、希釈水性溶液中でプレポリマーと反応して、水媒介性ポリウレタン尿素溶液を得る。
、米国特許公開第2012−0046534−A1号、米国特許公開第2012−0078071−A1号、米国特許公開第2012−0108934−A1号、米国特許公開第2012−0130214−A1号、米国特許公開第2012−0172691−A1号、米国特許公開第2012−0179014−A1号、米国特許公開第2012−0186581−A1号、米国特許公開第2012−0190953−A1号、米国特許公開第2012−0191063−A1号、米国特許公開第2012−0203467−A1号、米国特許公開第2012−0209098−A1号、米国特許公開第2012−0215086−A1号、米国特許公開第2012−0215087−A1号、米国特許公開第2012−0215201−A1号、米国特許公開第2012−0215461−A1号、米国特許公開第2012−0215462−A1号、米国特許公開第2012−0215496−A1号、米国特許公開第2012−0220979−A1号、米国特許公開第2012−0226121−A1号、米国特許公開第2012−0228134−A1号、米国特許公開第2012−0238852−A1号、米国特許公開第2012−0245448−A1号、米国特許公開第2012−0245855−A1号、米国特許公開第2012−0255875−A1号、米国特許公開第2012−0258748−A1号、米国特許公開第2012−0259191−A1号、米国特許公開第2012−0260323−A1号、米国特許公開第2012−0262298−A1号、米国特許公開第2012−0265035−A1号、米国特許公開第2012−0265036−A1号、米国特許公開第2012−0265037−A1号、米国特許公開第2012−0277562−A1号、米国特許公開第2012−0277566−A1号、米国特許公開第2012−0283541−A1号、米国特許公開第2012−0283543−A1号、米国特許公開第2012−0296311−A1号、米国特許公開第2012−0302854−A1号、米国特許公開第2012−0302855−A1号、米国特許公開第2012−0323100−A1号、米国特許公開第2013−0012798−A1号、米国特許公開第2013−0030273−A1号、米国特許公開第2013−0035575−A1号、米国特許公開第2013−0035865−A1号、米国特許公開第2013−0035871−A1号、米国特許公開第2013−0053665−A1号、米国特許公開第2013−0053666−A1号、米国特許公開第2013−0060112−A1号、米国特許公開第2013−0078912−A1号、米国特許公開第2013−0076531−A1号、米国特許公開第2013−0076532−A1号、米国特許公開第2013−0131478−A1号、米国特許公開第2013−150692−A1号、米国特許公開第2014−0094671−A1号、米国特許公開第2014−0005508−A1号、米国特許公開第2014−0118166−A1号、米国特許公開第2014−0118138−A1号、米国特許公開第2014−0188402−A1号、米国特許公開第2014−0182350−A1号、及び米国特許公開第2014−0275896−A1号に開示されている。
Claims (39)
- 分析物濃度の測定のためのデバイスであって、前記デバイスが、
分析物の濃度と関連した信号を生成するように構成されたセンサと、
前記センサ上に位置する検知膜であって、酵素層を含む検知膜と、を備え、前記酵素層が、酵素と、水性条件に1時間、37℃で接触したときに、初期酵素負荷の少なくとも80%、より好ましくは少なくとも90%を保持することができる酵素層ポリマーと、を含み、前記ポリマーが、ポリウレタン及び/またはポリ尿素セグメント、ならびに1つ以上の双性イオン繰り返し単位を含む、デバイス。 - 前記ポリマーが、カルボン酸ジオール、ポリエチレンオキシドジオール、ポリオキサゾリンから選択される、1つ以上のイオン性または非イオン性エマルジョン安定化剤をさらに含む、請求項1に記載のデバイス。
- 前記1つ以上の双性イオン繰り返し単位が、ベタイン化合物またはその誘導体を含む、請求項1に記載のデバイス。
- 前記1つ以上の双性イオン繰り返し単位が、ベタイン化合物またはその前駆体を含む、請求項1に記載のデバイス。
- 前記1つ以上の双性イオン繰り返し単位が、カルボキシルベタイン、スルホベタイン、リンベタイン、及びそれらの誘導体からなる群から選択される少なくとも1つの部分を含む、請求項1に記載のデバイス。
- 前記1つ以上の双性イオン繰り返し単位が、以下からなる群から選択されるモノマーから誘導され、
- 前記1つ以上の双性イオン繰り返し単位が、以下からなる群から選択されるモノマーから誘導され、
- 前記1つ以上の双性イオン繰り返し単位が、以下からなる群から選択されるモノマーから誘導され、
- 前記重合基が、アルケン、アルキン、エポキシド、ラクトン、アミン、ヒドロキシル、イソシアネート、カルボン酸、無水物、シラン、ハロゲン化物、アルデヒド、及びカルボジイミドから選択される、請求項6〜9のいずれか1項に記載のデバイス。
- 前記1つ以上の双性イオン繰り返し単位が、前記ポリマーの総重量に基づいて少なくとも約1重量%である、請求項1に記載のデバイス。
- 双性イオン繰り返し単位を除く前記ポリウレタン及び/またはポリ尿素セグメントが、前記ポリマーの総重量に基づいて約15重量%〜約99重量%である、請求項1に記載のデバイス。
- 前記ポリマーが、ポリエチレンオキシドセグメントをさらに含む、請求項1に記載のデバイス。
- 前記ポリエチレンオキシドセグメントが、前記酵素層ポリマーの総重量に基づいて約5重量%〜約60重量%である、請求項12に記載のデバイス。
- 前記ポリマーが、約10kDa〜約500,000kDaの分子量を有する、請求項1に記載のデバイス。
- 前記酵素が、グルコースオキシダーゼである、請求項1に記載のデバイス。
- 前記酵素が、ガラクトースオキシダーゼ、コレステロールオキシダーゼ、アミノ酸オキシダーゼ、アルコールオキシダーゼ、乳酸オキシダーゼ、またはウリカーゼである、請求項1に記載のデバイス。
- ベースポリマーをさらに含み、前記ベースポリマーが、ポリウレタンを含む、請求項1に記載のデバイス。
- 前記ベースポリマーが、ポリエーテル−ウレタン−尿素、ポリカーボネート−ウレタン、ポリエーテル−ウレタン、シリコーン−ポリエーテル−ウレタン、シリコーン−ポリカーボネート−ウレタン、及びポリエステル−ウレタンから選択されるポリウレタンコポリマーである、請求項17に記載のデバイス。
- ベースポリマーをさらに含み、前記ベースポリマーが、シリコーン、エポキシ、ポリオレフィン、ポリスチレン、ポリオキシメチレン、ポリシロキサン、ポリエーテル、ポリアクリル酸、ポリメタクリル酸、ポリエステル、ポリカーボネート、ポリアミド、ポリ(エーテルケトン)、ポリ(エーテルイミド)から選択されるポリマーを含む、請求項1に記載のデバイス。
- 酵素安定化試薬をさらに含む、請求項1に記載のデバイス。
- 前記酵素安定化試薬が、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)、及びポリ(スルホベタイン)から選択される1つ以上の双性イオンを含む、請求項20に記載のデバイス。
- 前記酵素安定化試薬が、アルブミン、キトサン、ヒアルロン酸塩から選択される生体剤を含む、請求項20に記載のデバイス。
- 1つまたはいくつかの架橋剤をさらに含み、前記架橋剤中に、多官能性イソシアネート、多官能性アジリジン、多官能性カルボジイミドから選択されるポリマーまたはオリゴマーを含む、請求項1に記載のデバイス。
- 前記酵素層が、0.01μm〜約250μmの厚さである、請求項1に記載のデバイス。
- 前記センサが、電極を含む、請求項1に記載のデバイス。
- 前記デバイスが、分析物濃度の連続測定のために構成されている、請求項1に記載のデバイス。
- 前記分析物が、グルコースである、請求項1に記載のデバイス。
- 分析物濃度の測定のためのデバイスであって、前記デバイスが、分析物の濃度と関連した信号を生成するように構成されたセンサと、前記センサ上に位置する検知膜であって、酵素層を含む検知膜と、を備え、前記酵素層が、酵素と、最大24時間の処理の間、70℃及び90%相対湿度条件に曝露されたときに、初期センサ感度の少なくとも50%、より好ましくは少なくとも60%を保持することができる酵素層ポリマーと、を含み、前記ポリマーが、ポリウレタン及び/またはポリ尿素セグメント、ならびに1つ以上の双性イオン繰り返し単位を含む、デバイス。
- 分析物濃度の測定のためのデバイスであって、前記デバイスが、
分析物の濃度と関連した信号を生成するように構成された経皮センサと、
前記センサ上に位置する検知膜であって、酵素層を含む検知膜と、を備え、前記酵素層が、酵素及び酵素層ポリマーを含み、前記ポリマーが、1つ以上の双性イオン繰り返し単位を含む、デバイス。 - 前記酵素層ポリマーが、ポリウレタン及び/またはポリ尿素セグメントをさらに含む、請求項29に記載のデバイス。
- 前記1つ以上の双性イオン繰り返し単位が、ベタイン単位を含む、請求項29に記載のデバイス。
- 前記双性イオン繰り返し単位が、第1のベタイン単位及び第2のベタイン単位を含み、前記第1のベタイン単位が、前記第2のベタイン単位とは異なる、請求項29に記載のデバイス。
- 前記双性イオン繰り返し単位が、末端基に位置していない、請求項29に記載のデバイス。
- 前記酵素層ポリマーが、10kDa〜500,000kDaの分子量を有する、請求項29に記載のデバイス。
- 前記酵素層ポリマーが、10kDa〜100,000kDaの分子量を有する、請求項29に記載のデバイス。
- 前記酵素層ポリマーが、100,000kDa〜500,000kDaの分子量を有する、請求項29に記載のデバイス。
- 前記酵素層ポリマーが、約1.4〜約3.5の多分散性指数を有する、請求項29に記載のデバイス。
- 前記酵素層ポリマーが、約10°〜約90°の接触角を有する、請求項29に記載のデバイス。
- 前記1つ以上の双性イオン繰り返し単位が、前記ポリマーの総重量に基づいて少なくとも約1重量%である、請求項29に記載のデバイス。
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