JP7184643B2 - グルコース濃度の測定のためのデバイス - Google Patents
グルコース濃度の測定のためのデバイス Download PDFInfo
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- JP7184643B2 JP7184643B2 JP2018522996A JP2018522996A JP7184643B2 JP 7184643 B2 JP7184643 B2 JP 7184643B2 JP 2018522996 A JP2018522996 A JP 2018522996A JP 2018522996 A JP2018522996 A JP 2018522996A JP 7184643 B2 JP7184643 B2 JP 7184643B2
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Description
出願データシートに特定されるあらゆる優先権主張、またはそれに対する任意の訂正は、米国特許法施行規則第1.57条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日出願の米国仮出願第62/273,155号、2015年12月30日出願の米国仮出願第62/273,142号、及び2015年12月30日出願の米国仮出願第62/273,219号の利益を主張するものである。前述の出願は各々、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。
定義
センサシステム
膜系
センサ電子機器
干渉物質
ドリフト
膜製造
バイオインターフェースドメイン
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、
いくつかの現在の拡散抵抗層の欠点の1つは、それらが、インビトロ試験及びインビボデータの両方によって示されるように、センサ使用の数日以内に著しいセンサドリフトを引き起こす傾向があることである。理論に束縛されるものではないが、感度は、拡散抵抗層中の親水性ポリマーに部分的に関連する。親水性ポリマーが水和条件下にあるときに層から経時的に浸出する場合、感度の変化ならびに精度及び寿命の低下が生じ得る。
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。一実施形態では、酵素ドメインは、グルコースオキシダーゼを含む。他の実施形態では、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。いくつかの実施形態では、酵素ドメインは、2015年12月30日出願の米国仮出願第62/273,155号(参照によりその全体が本明細書に組み込まれる)に記載の酵素ドメインで形成され得る。
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、
干渉ドメイン
XY
YX
XYX
XYXYX
XYXYXY
XXYYXYXXYY
XXXYYYXXXYYYXXX
XYXYXYXYXYXYX
XYZXYZXYZX
XYXZXYXZXYXZ
ZYYXZZZXYYYXZ
CA
CAC
CACA
CACAC
CACACA
CACACAC
CACACACA
CACACACAC
CACACACACA
CACACACACAC
CACACACACACA
CACACACACACAC
CACACACACACACA
CACACACACACACAC
CACACACACACACACA
CACACACACACACACAC
CACACACACACACACACA
CACACACACACACACACAC
CACACACACACACACACACA
CACACACACACACACACACAC
CACACACACACACACACACACA
CACACACACACACACACACACAC
CACACACACACACACACACACACA
CACACACACACACACACACACACAC
CACACACACACACACACACACACACAC
CACACACACACACACACACACACACACAC
CACACACACACACACACACACACACACACAC
CACACACACACACACACACACACACACACACAC
AC
ACA
ACAC
ACACA
ACACAC
ACACACA
ACACACAC
ACACACACA
ACACACACAC
ACACACACACA
ACACACACACAC
ACACACACACACA
ACACACACACACAC
ACACACACACACACA
ACACACACACACACAC
ACACACACACACACACA
ACACACACACACACACAC
ACACACACACACACACACA
ACACACACACACACACACAC
ACACACACACACACACACACA
ACACACACACACACACACACAC
ACACACACACACACACACACACA
ACACACACACACACACACACACAC
ACACACACACACACACACACACACA
ACACACACACACACACACACACACACA
ACACACACACACACACACACACACACACA
ACACACACACACACACACACACACACACACA
ACACACACACACACACACACACACACACACACA
ポリイミンフィルム
自己組織化技法
電極ドメイン
生物活性剤
生物活性剤の放出
生物活性剤の負荷
PVPとシリコーンを有するか有しないかのいずれかのポリウレタン尿素-ポリカーボネートブロックコポリマーとのブレンドを含む拡散抵抗層を含んだセンサを調製した。シリコーンを有するブロックコポリマーは、図5に示すTgを有した。2つのブロックコポリマーの引張強度を図6Aに示し、穿刺抵抗を図6Bに示す。センサの感度をインビトロモデルで200時間にわたって測定し、結果を図4に示す。拡散抵抗層内の高Tg及び高引張強度のシリコーンを有しないポリマーを有するセンサは、より低いTg及び引張強度ならびにシリコーンを有するセンサと比較して、本実験にわたって最小ドリフト(10%未満)を有した。
PVPとシリコーンを有するか有しないかのいずれかのポリウレタン尿素-ポリカーボネートブロックコポリマーとのブレンドを含む拡散抵抗層を含んだセンサを調製した。センサの感度をインビボブタモデルで試験した。7日目及び14日目に、センサを除去し、分析して、破裂パーセントを決定した。データを図7に示す。センサの抵抗層機械的特性に関して、インビボ安定性試験は、機械的に頑強な高Tgのポリマーベースの抵抗層がより低い破裂率を有することを示す。
PVPとシリコーンを有しないポリウレタン尿素-ポリカーボネートブロックコポリマーとのブレンドを含む拡散抵抗層を有するセンサを調製した。1つの試料では、センサを50℃の蒸留水中に様々な時間間隔にわたって浸漬し、その後、硬化させた。別の試料では、浸漬なしにセンサを硬化させた。結果を図10に示す。浸漬硬化は、キャルチェックからドリフトを排除した。図10は、シリコーンを含むRLから調製された対照センサと図5に示す高TgのRLであるポリカーボネートウレタン-1で作製された試験センサとの間のセンサ感度ドリフトの比較である。センサを一定のグルコース濃度(300mg/dL)を有する緩衝溶液に曝露し、それらの感度を、バックグラウンド信号を差し引いた後に測定し、最大14日間にわたってモニタリングした。2時間時点にわたる感度変化を計算し、図10にプロットした。見られるように、高TgのRLから調製されたセンサは、シリコーンを含むRLから調製されたセンサと比較して、はるかにより小さい規模のドリフトを経験した。
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 (17)
- グルコース濃度の測定のためのデバイスであって、前記デバイスが、
生体液と接触してグルコース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、
前記センサの作用電極の周りに位置する検知膜と、を備え、前記検知膜が、-50℃を超えるASTM D3418を使用して測定された最低ガラス転移温度を有するベースポリマーを含む拡散抵抗層を含み、
前記ベースポリマーが、ポリウレタンセグメントと、1つ以上のポリカーボネートセグメントと、を含むセグメント化ブロックコポリマーであり、
前記ベースポリマーにおけるシリコーンの含有量は、1重量%未満であり、
前記拡散抵抗層が、親水性ポリマーをさらに含み、
前記親水性ポリマーは、ポリビニルピロリドンである、デバイス。 - 前記ベースポリマーの前記最低ガラス転移温度が、0℃を超える、請求項1に記載のデバイス。
- 前記ベースポリマーの前記最低ガラス転移温度が、0℃~66℃である、請求項1に記載のデバイス。
- 前記ベースポリマーの前記最低ガラス転移温度が、20℃~60℃である、請求項1に記載のデバイス。
- 前記ベースポリマーの前記最低ガラス転移温度が、0℃~30℃である、請求項1に記載のデバイス。
- 前記ベースポリマーの前記最低ガラス転移温度が、30℃~60℃である、請求項1に記載のデバイス。
- 前記ベースポリマーの最大引張強度が、7900psiから8750psiである、請求項1に記載のデバイス。
- 前記ベースポリマーが、ポリカーボネートを含む、請求項1に記載のデバイス。
- 前記親水性ポリマーが、前記ベースポリマーとブレンドされる、請求項1に記載のデバイス。
- 前記親水性ポリマーが、前記ベースポリマーに共有結合される、請求項1に記載のデバイス。
- 前記ベースポリマーまたは前記親水性ポリマーが、1つの架橋剤またはいくつかの架橋剤を含み、前記架橋剤が、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。
- 前記拡散抵抗層が、ポリカーボネート-ウレタンベースポリマーとポリビニルピロリドンとのブレンドを含む、請求項1に記載のデバイス。
- 前記拡散抵抗層が、0.01μm~250μmの厚さである、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。
- 前記ベースポリマーが、6000psiを超えるASTM D1708によって測定された最大引張強度を有する、請求項1に記載のデバイス。
- 前記ベースポリマーが、ASTM D3418を使用して測定された複数のガラス転移温度を有する、請求項1に記載のデバイス。
- グルコース濃度の測定のためのデバイスであって、前記デバイスが、
生体液と接触してグルコース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、
前記センサの作用電極の周りに位置する検知膜と、を備え、前記検知膜が、-50℃を超えるASTM D3418を使用して測定された最低ガラス転移温度を有するベースポリマーを含む拡散抵抗層を含み、
前記ベースポリマーが、ポリウレタンセグメントと、1つ以上のポリカーボネートセグメントと、を含むセグメント化ブロックコポリマーであり、
前記ベースポリマーにおけるシリコーンの含有量は、1重量%未満であり、
前記拡散抵抗層が、親水性ポリマーをさらに含み、
前記親水性ポリマーが、ポリビニルアルコール、ポリエチレングリコール、ポリアクリルアミド、ポリアセテート、ポリエチレンオキシド、ポリエチレンアミン、ポリビニルピロリドン、ポリオキサゾリン、及びそれらの混合物から選択される、デバイス。
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