JP2015198960A5 - - Google Patents
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- JP2015198960A5 JP2015198960A5 JP2015134307A JP2015134307A JP2015198960A5 JP 2015198960 A5 JP2015198960 A5 JP 2015198960A5 JP 2015134307 A JP2015134307 A JP 2015134307A JP 2015134307 A JP2015134307 A JP 2015134307A JP 2015198960 A5 JP2015198960 A5 JP 2015198960A5
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- analyte sensor
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- 239000012491 analyte Substances 0.000 claims 84
- 230000035945 sensitivity Effects 0.000 claims 12
- 238000004519 manufacturing process Methods 0.000 claims 6
- 239000000758 substrate Substances 0.000 claims 6
- 239000012528 membrane Substances 0.000 claims 5
- 102000004190 Enzymes Human genes 0.000 claims 4
- 108090000790 Enzymes Proteins 0.000 claims 4
- 210000003722 Extracellular Fluid Anatomy 0.000 claims 3
- 239000012530 fluid Substances 0.000 claims 3
- 238000000338 in vitro Methods 0.000 claims 3
- 238000005259 measurement Methods 0.000 claims 3
- 230000035699 permeability Effects 0.000 claims 3
- WQZGKKKJIJFFOK-GASJEMHNSA-N D-Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims 2
- OKTJSMMVPCPJKN-UHFFFAOYSA-N carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims 2
- 230000000875 corresponding Effects 0.000 claims 2
- 239000008103 glucose Substances 0.000 claims 2
- KDLHZDBZIXYQEI-UHFFFAOYSA-N palladium Chemical compound [Pd] KDLHZDBZIXYQEI-UHFFFAOYSA-N 0.000 claims 2
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 claims 2
- 229920000642 polymer Polymers 0.000 claims 2
- 238000005070 sampling Methods 0.000 claims 2
- 239000000126 substance Substances 0.000 claims 2
- 238000009827 uniform distribution Methods 0.000 claims 2
- HKZLPVFGJNLROG-UHFFFAOYSA-M Silver chloride Chemical compound [Cl-].[Ag+] HKZLPVFGJNLROG-UHFFFAOYSA-M 0.000 claims 1
- 229910021397 glassy carbon Inorganic materials 0.000 claims 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 claims 1
- 229910052737 gold Inorganic materials 0.000 claims 1
- 239000010931 gold Substances 0.000 claims 1
- 229910002804 graphite Inorganic materials 0.000 claims 1
- 239000010439 graphite Substances 0.000 claims 1
- GKOZUEZYRPOHIO-UHFFFAOYSA-N iridium Chemical compound [Ir] GKOZUEZYRPOHIO-UHFFFAOYSA-N 0.000 claims 1
- 229910052741 iridium Inorganic materials 0.000 claims 1
- 229910052760 oxygen Inorganic materials 0.000 claims 1
- MYMOFIZGZYHOMD-UHFFFAOYSA-N oxygen Chemical compound O=O MYMOFIZGZYHOMD-UHFFFAOYSA-N 0.000 claims 1
- 239000001301 oxygen Substances 0.000 claims 1
- 229910052763 palladium Inorganic materials 0.000 claims 1
- 229910052697 platinum Inorganic materials 0.000 claims 1
- -1 platinum iridium Chemical compound 0.000 claims 1
- 239000002861 polymer material Substances 0.000 claims 1
- 229910052709 silver Inorganic materials 0.000 claims 1
- 239000004332 silver Substances 0.000 claims 1
- BQCADISMDOOEFD-UHFFFAOYSA-N silver Chemical compound [Ag] BQCADISMDOOEFD-UHFFFAOYSA-N 0.000 claims 1
- RTAQQCXQSZGOHL-UHFFFAOYSA-N titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 claims 1
- 229910052719 titanium Inorganic materials 0.000 claims 1
- 239000010936 titanium Substances 0.000 claims 1
Claims (34)
- 検体センサであって、
基板;
前記基板の一部の上に1つ以上のストリップで形成された導電層;
前記導電層上に形成された誘電体層;および
前記導電層上に形成されたセンシング層であって、前記導電層の1つ以上のストリップに直交する1つ以上のストリップで形成され、3日〜30日の検体センサ使用期間中、間質液と流体接触し続けたときに、モニターされた検体レベルに対応する1つ以上の信号を検体センサが発生するように、1つ以上の所定の再現可能なパラメータを有する検体センサ活性領域を画成する、センシング層;
を備え、
前記発生される1つ以上の信号は、該信号に適用される所定の較正パラメータに基づき、前記モニターされた検体レベルと関連付けられ、該所定の較正パラメータは検体センサ使用期間の前に該検体センサと関連付けられ、さらに
発生される1つ以上の信号は、前記検体センサ使用期間中に検体センサによってモニターされた検体レベルを報告するのに、検体センサ使用期間中に得られたインビトロ基準測定値に基づく較正を必要としない、検体センサ。 - 前記センシング層上に形成された膜層をさらに備えた、請求項1記載の検体センサ。
- 前記膜層が、均一な厚さ、または均一な分布、あるいはその両方を有することを特徴とする請求項2記載の検体センサ。
- 前記膜層が、低い酸素透過性を有することを特徴とする請求項2記載の検体センサ。
- 前記センシング層をその上に有する前記導電層が、 作用電極の少なくとも一部を画成することを特徴とする請求項1記載の検体センサ。
- 前記導電層が、ガラス状炭素、グラファイト、銀、塩化銀、白金、パラジウム、白金イリジウム、チタニウム、金、またはイリジウムのうち1種類以上を含むことを特徴とする請求項発生される1つ以上の信号は、前記検体センサ使用期間中に検体センサによってモニターされた検体レベルを報告するのに、検体センサ使用期間中に得られたインビトロ基準測定値に基づく較正を必要としない、1記載の検体センサ。
- 前記誘電体層が、光画像形成性のポリマー材料を含むことを特徴とする請求項1記載の検体センサ。
- 前記誘電体層が、前記導電層上および前記基板の少なくとも一部の上に形成された光画像形成性のフィルムを含むことを特徴とする請求項1記載の検体センサ。
- 前記膜層が、前記センシング層上に形成された、グルコース流制限層、干渉物質除去層または生体適合層のうち1つ以上を含むことを特徴とする請求項2記載の検体センサ。
- 前記導電層上に形成された前記センシング層の表面積が、0.01mm2〜1.0mm2であることを特徴とする請求項1記載の検体センサ。
- 前記導電層上に形成された前記センシング層の表面積が、0.04mm2〜0.36mm2であることを特徴とする請求項1記載の検体センサ。
- 前記基板上の前記導電層上に形成された前記センシング層の表面積が一定であることを特徴とする請求項1記載の検体センサ。
- 検体センサであって、
3日〜30日の検体センサの使用期間中における間質液との流体接触用に構成された遠位部を有する基板;
前記基板の遠位部上に1つ以上のストリップで形成された導電層;および
前記導電層上に形成されたセンシング層であって、前記導電層の1つ以上のストリップに直交する1つ以上のストリップで形成され、前記検体センサ使用期間中、モニターされた検体レベルに対応する1つ以上の信号を検体センサが発生するように、1つ以上の所定の再現可能なパラメータを有する検体センサ活性領域を画成する、センシング層
を備え、
前記発生される1つ以上の信号は、該信号に適用される所定の較正パラメータに基づき、前記モニターされた検体レベルと関連付けられ、該所定の較正パラメータは検体センサ使用期間の前に該検体センサと関連づけられ、さらに
前記発生される1つ以上の信号は、前記センサ使用期間中に検体センサによってモニターされた検体レベルを報告するのに、検体センサ使用期間中に得られたインビトロ基準測定値に基づく較正を必要としない、検体センサ。 - 前記導電層上に形成された前記センシング層の表面積が、前記検体センサ使用期間中の間質液との流体接触用に構成されている前記検体センサの作用電極の少なくとも一部を画成することを特徴とする請求項13記載の検体センサ。
- 前記センシング層上に形成された膜層をさらに備えた、請求項13記載の検体センサ。
- 前記膜層が、均一な厚さ、または均一な分布、あるいはその両方を有することを特徴とする請求項15記載の検体センサ。
- 前記膜層が、前記センシング層上に形成された、グルコース流制限層、干渉物質除去層または生体適合層のうち1つ以上を含むことを特徴とする請求項15記載の検体センサ。
- 前記導電層の表面積が、0.01mm 2 〜1.0mm 2 であることを特徴とする請求項10記載の検体センサ。
- 前記導電層の表面積が、0.01mm 2 〜1.0mm 2 であることを特徴とする請求項13記載の検体センサ。
- 前記導電層上に形成されたセンシング層の表面積が、0.01mm 2 〜1.0mm 2 であることを特徴とする請求項19記載の検体センサ。
- 前記検体センサ活性領域の1つ以上の所定の再現可能なパラメータが、製造の間における所定のセンサバッチ内でのセンサ間の感度における5%未満の変動係数を有する活性領域の所定の寸法を含むことを特徴とする請求項1記載の検体センサ。
- 前記検体センサ活性領域の1つ以上の所定の再現可能なパラメータが、検体センサの膜ポリマーの粘度、透過性、厚さまたは組成特性、酵素安定性を含む検体センサの酵素特性、あるいは検体センサの生体適合性のうちの1つ以上に基づくことを特徴とする請求項1記載の検体センサ。
- 前記所定の較正パラメータは、検体センサと関連づけられかつ検体センサの製造中に決定されるセンサ感度を含むことを特徴とする請求項1記載の検体センサ。
- 前記センサ感度が、検体センサの膜の厚さに反比例し、かつ検体センサ活性領域に比例することを特徴とする請求項1記載の検体センサ。
- 前記センサ感度が、検体センサ製造中に、同じ検体センサロット中の複数のサンプリングされた検体センサから決定される平均センサ感度であることを特徴とする請求項23記載の検体センサ。
- センサ感度に関連する所定のドリフトプロファイルが、検体センサと関連付けられることを特徴とする請求項23記載の検体センサ。
- 前記所定のドリフトプロファイルが、センサ使用期間中にモニターされた検体レベルを報告するために、前記発生する1つ以上の信号に適用されることを特徴とする請求項26記載の検体センサ。
- 前記検体センサ活性領域の1つ以上の所定の再現可能なパラメータが、製造の間における所定のセンサバッチ内でのセンサ間の感度における5%未満の変動係数を有する活性領域の所定の寸法を含むことを特徴とする請求項13記載の検体センサ。
- 前記検体センサ活性領域の1つ以上の所定の再現可能なパラメータが、検体センサの膜ポリマーの粘度、透過性、厚さまたは組成特性、酵素安定性を含む検体センサの酵素特性、あるいは検体センサの生体適合性のうちの1つ以上に基づくことを特徴とする請求項13記載の検体センサ。
- 前記所定の較正パラメータは、検体センサと関連付けられかつ検体センサ製造中に決定されるセンサ感度を含むことを特徴とする請求項13記載の検体センサ。
- 前記センサ感度が、検体センサの膜の厚さに反比例し、かつ活性検体センサ活性領域に比例することを特徴とする請求項30記載の検体センサ。
- 前記センサ感度が、検体センサ製造中に、同じ検体センサロット中の複数のサンプリングされた検体センサから決定される平均センサ感度であることを特徴とする請求項30記載の検体センサ。
- センサ感度に関連する所定のドリフトプロファイルが、検体センサと関連付けられることを特徴とする請求項30記載の検体センサ。
- 前記事前に定義されるドリフトプロファイルが、センサ使用期間中にモニターされた検体レベルを報告するために、前記発生する1つ以上の信号に適用されることを特徴とする請求項33記載の検体センサ。
Applications Claiming Priority (12)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US15589109P | 2009-02-26 | 2009-02-26 | |
US15588909P | 2009-02-26 | 2009-02-26 | |
US15589309P | 2009-02-26 | 2009-02-26 | |
US61/155,891 | 2009-02-26 | ||
US61/155,889 | 2009-02-26 | ||
US61/155,893 | 2009-02-26 | ||
US16549909P | 2009-03-31 | 2009-03-31 | |
US61/165,499 | 2009-03-31 | ||
US23846109P | 2009-08-31 | 2009-08-31 | |
US61/238,461 | 2009-08-31 | ||
US29084709P | 2009-12-29 | 2009-12-29 | |
US61/290,847 | 2009-12-29 |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2011552211A Division JP2012519038A (ja) | 2009-02-26 | 2010-02-26 | 改良された検体センサおよびその製造および使用方法 |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2017184435A Division JP2018029983A (ja) | 2009-02-26 | 2017-09-26 | 改良された検体センサ |
Publications (2)
Publication Number | Publication Date |
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JP2015198960A JP2015198960A (ja) | 2015-11-12 |
JP2015198960A5 true JP2015198960A5 (ja) | 2016-08-04 |
Family
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Family Applications (6)
Application Number | Title | Priority Date | Filing Date |
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JP2011552211A Pending JP2012519038A (ja) | 2009-02-26 | 2010-02-26 | 改良された検体センサおよびその製造および使用方法 |
JP2015134307A Pending JP2015198960A (ja) | 2009-02-26 | 2015-07-03 | 改良された検体センサおよびその製造および使用方法 |
JP2017184435A Pending JP2018029983A (ja) | 2009-02-26 | 2017-09-26 | 改良された検体センサ |
JP2020198224A Active JP7043571B2 (ja) | 2009-02-26 | 2020-11-30 | 検体センサおよびセンサ制御装置を含むシステム |
JP2022041667A Active JP7295298B2 (ja) | 2009-02-26 | 2022-03-16 | 改良された検体センサおよびその製造および使用方法 |
JP2023094655A Pending JP2023118735A (ja) | 2009-02-26 | 2023-06-08 | 改良された検体センサおよびその製造および使用方法 |
Family Applications Before (1)
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JP2011552211A Pending JP2012519038A (ja) | 2009-02-26 | 2010-02-26 | 改良された検体センサおよびその製造および使用方法 |
Family Applications After (4)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2017184435A Pending JP2018029983A (ja) | 2009-02-26 | 2017-09-26 | 改良された検体センサ |
JP2020198224A Active JP7043571B2 (ja) | 2009-02-26 | 2020-11-30 | 検体センサおよびセンサ制御装置を含むシステム |
JP2022041667A Active JP7295298B2 (ja) | 2009-02-26 | 2022-03-16 | 改良された検体センサおよびその製造および使用方法 |
JP2023094655A Pending JP2023118735A (ja) | 2009-02-26 | 2023-06-08 | 改良された検体センサおよびその製造および使用方法 |
Country Status (9)
Country | Link |
---|---|
US (3) | US20100230285A1 (ja) |
EP (5) | EP4252639A3 (ja) |
JP (6) | JP2012519038A (ja) |
CN (1) | CN102438517B (ja) |
DK (2) | DK3912551T3 (ja) |
ES (1) | ES2967456T3 (ja) |
FI (2) | FI3714788T3 (ja) |
LT (2) | LT3912551T (ja) |
WO (1) | WO2010099507A1 (ja) |
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