JP2013519451A - 生物学的因子又は薬物を被検者に送達するためのシステム、装置及び方法 - Google Patents
生物学的因子又は薬物を被検者に送達するためのシステム、装置及び方法 Download PDFInfo
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/48—Other medical applications
- A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
- A61B5/4839—Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
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- G—PHYSICS
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- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
- G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
Abstract
【選択図】図10C
Description
を含んでいる線形差分モデルを作ること;被検者に関する予め定めた血糖ゾーンを得ること;線形差分モデルと予め定めた血糖ゾーンを用いて予測される血糖値に基づいて次のインスリン投与を計算すること;及び、計算された次のインスリン投与に基づいて被検者にインスリンを送達すること;を含んでいる。一実施形態では、インスリンの送達は、時間的に変動し、及び、投与量によって変わる。別の実施形態では、インスリンの送達は、持続注入であるか、又は、不連続注入である。一実施形態では、該インスリンは、ヒトインスリン、哺乳動物インスリン又はインスリン類似体である。グルコースデータは、一時的な(episotic)グルコース測定値又はセルフモニタリング測定値を包含し得る。グルコース測定値は、皮下で、静脈内で、腹腔内で、又は、非侵襲的に、得ることができる。CGMデータは、埋込グルコースセンサー、光学的グルコースセンサー、酵素的グルコースセンサー及びフィンガースティックグルコースセンサーから本質的になるセンサーの群から選択されるセンサーで得る。
1. 安定性に関して、以下の固有多項式
実験1: 予め調整したビルトインオープンループ処理を名目食事値で適用する。
実験2: Zone-MPCの限界を80mg/dL〜140mg/dLの間に設定し、及び、食事はアナウンスしない。
実験3: Zone-MPCの限界を100mg/dL〜120mg/dLの間に設定し、及び、食事はアナウンスしない。
実験4: MPCの設定値110mg/dL、及び、食事はアナウンスしない。
実験5: Zone-MPCの限界を80mg/dL〜140mg/dLの間に設定し、及び、名目食事をアナウンスする。
実験6: Zone-MPCの限界を100mg/dL〜120mg/dLの間に設定し、及び、名目食事をアナウンスする。
実験7: MPCの設定値110mg/dL、及び、名目食事をアナウンスする。
実験8: 予め調整したビルトインオープンループ処理について、摂られた食事の値と-40%のミスマッチでアナウンスされた食事を用いて試験する。
実験9: Zone-MPCの限界を80mg/dL〜140mg/dLの間に設定し、摂られた食事の値と-40%のミスマッチでアナウンスされた食事を用いる。
Claims (19)
- 被検者に対して薬物又は生物学的作用因子を連続的にモニター及び送達する方法であって、
被検者に関する薬物又は生物学的作用因子の血中濃度に関連する値を得ること;
そのデータを伝達関数を用いてマッピングすること;
複数の状態を含んでいる線形差分モデルを作ること;
被検者体内の薬物又は生物学的作用因子に関する規定値ゾーンを得ること;
線形差分モデルと規定ゾーンを用いて予測される薬物又は生物学的作用因子の値に基づいて薬物又は生物学的作用因子の次の投与薬量及び/又は送達の時間を計算すること;
計算された次の投与に基づいて被検者に薬物又は生物学的作用因子を送達すること;
を含んでいる、前記方法。 - 前記薬物又は生物学的作用因子がインスリンである、請求項1の方法。
- 前記数値データが、インスリン濃度及び血糖値を含んでいる、請求項2の方法。
- 前記方法が、糖尿病を治療する、請求項1の方法。
- 値を得ることが、被検者に関するインスリン及び食事のデータ値並びに連続グルコースモニタリング(CGM)データ値を得ることを含んでいることを含み;
伝達関数:
を用いてインスリン(I)データ値と食事(M)データ値をマッピングして、新しい状態Imap及びMmapを得ること;
線形差分モデルを作ることが、
を含んでいる線形差分モデルを作ることを含み;
規定値ゾーンを得ることが、被検者に関する所定の血糖ゾーンを得ることを含み;
線形差分モデルと所定の血糖ゾーンを用いて予測される血糖値に基づいて次のインスリン投与を計算すること;
計算された次のインスリン投与に基づいて被検者にインスリンを送達すること;
を含む、請求項2、3又は4の方法。 - 前記インスリンの送達が、時間的に変動し、及び、投与量によって変わる、請求項5の方法。
- 前記インスリンの送達が、持続注入であるか、又は、不連続注入である、請求項5の方法。
- 前記次の投与が、薬物又はインスリンを送達するポンプ又は装置で実施される、請求項1〜5の方法。
- 前記次の投与が、コンピューター制御されている埋込型の薬物ポンプ又はインスリンポンプで実施される、請求項1〜5の方法。
- 前記インスリンが、インスリン又はインスリン類似体を含んでいる、請求項5の方法。
- 各食事の後の最大血糖値が、血糖ゾーンの範囲内に維持される、請求項5の方法。
- 前記CGMデータが、一時的なグルコース測定値又はセルフモニタリング測定値である、請求項5の方法。
- 前記グルコース測定値が、皮下で、静脈内で、腹腔内で、又は、非侵襲的に得られる、請求項5の方法。
- 前記CGMデータが、埋込グルコースセンサー、光学的グルコースセンサー、酵素的グルコースセンサー及びフィンガースティックグルコースセンサーから本質的になるセンサーの群から選択されるセンサーで得られる、請求項5の方法。
- 前記薬物、生物学的作用因子又はインスリンが被検者に自動化ポンプで送達される、コンピューターによって実施される請求項1〜14のいずれか1項の方法。
- 前記薬物、生物学的作用因子又はインスリンが被検者に自動化ポンプで送達される、請求項1〜14のいずれか1項の自動化された方法。
- 請求項5〜14の自動化された方法を実施する制御器を含んでいるインスリンポンプシステムであって、インスリン又はインスリン類似体が被検者にポンプで送達される、前記インスリンポンプシステム。
- 請求項15〜17のいずれかのコンピューターで実施される方法、自動化された方法又はポンプシステムであって、前記コンピューター又はシステムが、請求項1〜14の方法に従ってポンプを機能させるための命令を含んでいるコンピューターが読み取り可能な記憶媒体を含んでいる、前記コンピューターで実施される方法、自動化された方法又はポンプシステム。
- センサー、ポンプ若しくはPDAで実施されるか、又は、ウェブベースアプリケーションを介して実施される、請求項1〜14の方法。
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