JP6407715B2 - 薬剤用量レジメンを経時的に最適化するためのシステム - Google Patents
薬剤用量レジメンを経時的に最適化するためのシステム Download PDFInfo
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Description
Claims (10)
- 患者の基本インスリン用量レジメンを経時的に最適化するためのシステムであって、
前記患者の血液サンプルを受承し、前記患者の血液サンプルの血糖値を測定し、測定した前記血糖値及び測定時間の情報を含む血糖データセットを生成するための血糖メータ(110、210);
患者作動型操作であって、インスリン含有薬剤の1用量の投与の指標である操作が実施されたことを検知する検知手段(250);
(a)複数の前記血糖データセット、(b)時間の関数として、検知された前記患者作動型操作を表すデータ、及び(c)初期の基本インスリン用量レジメンを表すデータ、を記憶するよう適合された、記憶手段;
前記記憶手段に作動可能に接続されたプロセッサ(240)であって、前記プロセッサは、前記患者の将来の血糖レベル測定値を所定の範囲内に維持するために、前記患者の現在のインスリン用量レジメンの構成要素を変化させるかどうか及びどの程度変化させるかを、複数の前記血糖データセットに基づいて決定するようプログラムされている、プロセッサ(240);並びに
前記患者のインスリン用量レジメンの構成要素を前記患者に伝達するための出力手段(260)
を備える、システムにおいて、
第2の所定の時間帯に前記患者作動型操作が検知されない場合、前記第2の所定の時間帯後の次の時間帯の第1の所定の時間帯に生成された所与の血糖データセットは、前記プロセッサによって無視される、
システム。 - (a)薬剤用リザーバ、
前記薬剤用流出口、及び
前記リザーバから薬剤を前記流出口を通じて吐出するための薬剤吐出機構を備える、薬剤送達デバイス(20);並びに
(b)前記薬剤送達デバイスに取り外し可能に設置でき、設置位置において前記流出口を覆うように適合されたキャップデバイス(10)であって、
(b1)前記血糖メータ、
(b2)前記記憶手段及び前記プロセッサ、
(b3)前記出力手段、並びに
(b4)前記検知手段
を備えるキャップデバイス(10)
を備える、薬剤送達アセンブリの形態のシステムであって、
前記検知手段は、前記キャップを少なくとも部分的に前記薬剤送達デバイスから所定の期間取り外した際にキャップ取り外しイベントを検知するよう適合され、前記キャップ取り外しイベントは前記インスリン含有薬剤の1用量の投与の指標である、請求項1に記載のシステム。 - (a)薬剤用リザーバ、
前記薬剤用流出口、及び
作動時に前記リザーバから所望の量の薬剤を前記流出口を通じて吐出するよう設定できる薬剤吐出機構、
1回分の吐出量を表す用量データを検出し、記憶し、転送する手段であって、前記吐出は前記インスリン含有薬剤の1用量の投与の指標である、手段
を備える、薬剤送達デバイス(502);並びに
(b)前記薬剤送達デバイスに取り外し可能に設置でき、設置位置において前記流出口を覆うように適合されたキャップデバイスであって、
(b1)前記血糖メータ、
(b2)前記記憶手段及び前記プロセッサ、
(b3)前記出力手段、並びに
(b4)前記検知手段
を備えるキャップデバイス
を備える、薬剤送達アセンブリの形態のシステムであって、
前記検知手段は前記薬剤送達デバイスから用量データを受信するよう適合される、請求項1に記載のシステム。 - (a)薬剤用リザーバ、
前記薬剤用流出口、
前記リザーバから薬剤を前記流出口を通じて吐出するための薬剤吐出機構、
前記血糖メータ、
前記記憶手段及び前記プロセッサ、
前記出力手段、並びに
前記検知手段
を備える、薬剤送達デバイスであって、
前記検知手段は前記薬剤吐出機構が作動したことを検知するよう適合され、前記吐出は前記インスリン含有薬剤の1用量の投与の指標である、薬剤送達デバイス;並びに
(b)前記薬剤送達デバイスに取り外し可能に設置でき、設置位置において前記流出口を覆うよう適合されたキャップデバイス
を備える薬剤送達アセンブリの形態の、請求項1に記載のシステム。 - 前記血糖データセットに含まれる血糖値が所定の範囲外の場合、前記プロセッサによって当該血糖データセットは無視される、請求項1〜4のいずれか1項に記載のシステム。
- 血糖メータ、検知手段、並びに、患者の将来の血糖レベル測定値を所定の範囲内に維持するために、前記患者のインスリン用量レジメンの構成要素を変化させるかどうか及びどの程度変化させるかを、血糖値に基づいて決定するよう構成されたプロセッサを備えるアセンブリを用いて、患者の基本インスリン用量レジメンを経時的に最適化するための方法であって、
前記血糖メータにおいて、血糖値を経時的に複数回測定するステップ;
前記血糖メータにおいて、測定した前記血糖値及び測定時間の情報を含む血糖データセットを生成するステップ;
前記検知手段において、患者作動型操作であって、インスリン含有薬剤の1用量の投与の指標である操作が実施されたことを検知するステップ;並びに
前記プロセッサにおいて、前記患者の将来の血糖レベル測定値を所定の範囲内に維持するために、前記患者の現在のインスリン用量レジメンの構成要素を変化させるかどうか及びどの程度変化させるかを、複数の前記血糖データセットに基づいて決定するステップ
を含み、
前記プロセッサにおいて、第2の所定の時間帯に前記患者作動型操作が検知されない場合、前記第2の所定の時間帯後の次の時間帯の第1の所定の時間帯に生成された所与の血糖データセットは、無視される、方法。 - 前記アセンブリが、薬剤送達デバイスを更に備える、請求項6に記載の方法。
- 前記患者作動型操作は、前記薬剤送達デバイスから薬剤の1用量を吐出させることである、請求項7に記載の方法。
- 前記薬剤送達デバイスは、薬剤吐出機構を有する主部、及び前記主部に取り外し可能に設置できるよう適合されたキャップを備え、
前記患者作動型操作は、前記キャップを少なくとも部分的に前記薬剤送達デバイスから所定の期間だけ取り外すことである、請求項7に記載の方法。 - 前記血糖メータは前記キャップ内に配設される、請求項9に記載の方法。
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EP11165063.6 | 2011-05-06 | ||
EP11165063 | 2011-05-06 | ||
US201161485291P | 2011-05-12 | 2011-05-12 | |
US61/485,291 | 2011-05-12 | ||
PCT/EP2012/058035 WO2012152628A1 (en) | 2011-05-06 | 2012-05-02 | System for optimizing a drug dosage regimen over time |
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JP2014514120A JP2014514120A (ja) | 2014-06-19 |
JP6407715B2 true JP6407715B2 (ja) | 2018-10-17 |
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EP (1) | EP2705453B1 (ja) |
JP (1) | JP6407715B2 (ja) |
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US20150246179A1 (en) * | 2014-03-02 | 2015-09-03 | Nissim Zur | Device and method for drug dosing with administration monitoring, in particular for insulin pen integrated with smart phone apps. |
AU2015271767B2 (en) | 2014-06-03 | 2020-04-02 | Amgen Inc. | Controllable drug delivery system and method of use |
WO2016026679A1 (en) * | 2014-08-19 | 2016-02-25 | Carebay Europe Ltd | Medicament injection device or injection mock-up demo device with motion detector to log and track user behaviour |
CN107073220B (zh) * | 2014-10-23 | 2021-05-14 | 诺和诺德股份有限公司 | 具有在夹子构件上的电子显示器的笔型药物输送装置 |
US10258745B2 (en) | 2015-01-23 | 2019-04-16 | Becton, Dickinson And Company | Method and device for capturing a dose dialing event |
EP3132821B1 (en) | 2015-03-03 | 2018-12-19 | Innovative Precision Instruments Limited | Drug information detection apparatus and drug information detection type injection apparatus |
CN108136136B (zh) | 2015-09-30 | 2021-03-16 | 诺和诺德股份有限公司 | 低功耗的附加装置 |
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EP2705453B1 (en) | 2018-12-19 |
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