JP2005509465A - ドラッグデリバリを滴定する装置および方法 - Google Patents
ドラッグデリバリを滴定する装置および方法 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
- A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
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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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- 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
- 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
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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
- A61B5/4821—Determining level or depth of anaesthesia
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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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M2005/14208—Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/04—Liquids
- A61M2202/0468—Liquids non-physiological
- A61M2202/048—Anaesthetics
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Abstract
Description
本発明は包括的に、特定の事象に応答して患者に対するドラッグデリバリ速度、時間プロファイルおよび/または効果部位濃度を変化させる装置および方法に関する。本発明は特に、患者の1つまたは複数の生理学的状態の電子監視信号および/またはユーザによる観察と入力に応じた1つまたは複数の薬物(例えば、鎮静剤(sedatives)、鎮痛剤(analgesics)、または健忘薬(amnestics)であり得る)の滴定を、薬物状態モデルの要素となる従来からある安全性を重視したソフトウェアにより電子的に統合する。
薬物の滴定は、所望の効果を得るために臨床医によって広く用いられる。一般に、同一量の薬物でも患者によって幅広く異なる効果が生じ得るため、滴定した薬物に対する患者の応答にはばらつきが見込まれる。したがって、通常の滴定で臨床医は、初回用量の薬物を与えて患者の反応を観察する場合がある。予想した時間フレームで所望の結果が得られない場合(例えば用量が少なすぎる場合)、追加分の薬物を投与することができる。追加投与をする度に観察期間を置き、最終的に所望の効果が得られるまで続ける。薬物に対する患者の応答の当然のばらつきのために、滴定は、臨床医が取りうる全ての措置(armamentarium)の中で昔から確立されているプロセスとされてきた。しかしながら、この従来の滴定プロセスには時間も労力もかかり、人為ミスが起こりやすい。
[発明の概要]
「臨床医が最もよく知っている」というパラダイムを実現し、それによって反復的で労力のかかる作業はコンピュータで行いながらも臨床医であるユーザが常に責任を持ち続けられるようにするために、本発明は、コンピュータ制御のドラッグデリバリではなくコンピュータ支援によるドラッグデリバリを利用する。本発明によるコンピュータ支援によるドラッグデリバリシステムおよびドラッグデリバリ方法は、自動アクション(例えば薬物レベルの低減)が総じて安全な効果をもたらす場合、臨床的ヒューリスティックスに基づき、臨床医による入力なしで、明確な事前にプログラムされたアクションを開始することができる。事前にプログラムされたアクションは、臨床的ヒューリスティックスに基づき、トランスペアレントな有限状態アルゴリズムとして実施することができる。この有限状態アルゴリズムでは、明確な事象(特定の(患者の生理学的反応、またはドラッグデリバリ装置の状態に基づく)警戒または警告アラーム、ユーザ入力、あるいは刺激に対する応答性がなくなりつつある、など)がシステムをトリガして、あるドラッグデリバリ状態(すなわち「薬物状態」)から別のドラッグデリバリ状態へ移行させることにより、完全な薬物状態モデルを提供する。臨床医の負担を減らすためのコンピュータおよび/またはソフトウェアによって開始される自動アクションは通常、薬物レベルの維持や低減といった本質的に「安全な」アクションに制限される。本発明の特定の実施形態において、システムの制御ソフトウェアは通常、ユーザ(臨床医、医師、看護師等)または患者がより高い薬物レベルを明確に要求しない限り、薬物レベルを自動的に上昇させることはない。本発明のコンピュータ支援によるドラッグデリバリシステムはさらに、事前にプログラムされたソフトウェアや自動アクション(上述の「安全な自動アクション」を含む)をユーザが無効にし、それによって臨床医がドラッグデリバリを制御し続けることを可能にする。
Claims (2)
- 患者に対してドラッグデリバリを行うシステムであって、
ユーザからの入力を受け入れるユーザインタフェースと、
ある量の薬物を患者にデリバリするドラッグデリバリコントローラと、
患者に結合されて、該患者の少なくとも1つの健康状態を反映する信号を生成するようになっている患者健康モニタと、
前記ユーザインタフェース、ドラッグデリバリコントローラ、および患者健康モニタを薬物状態モデルに従って統合し、前記デリバリコントローラにより前記患者にデリバリされる薬物の量を前記ユーザからの入力および/または前記患者健康モニタが生成した信号に基づいて変化させるようにするプロセッサとを備える、ドラッグデリバリを行うシステム。 - 患者に対してドラッグデリバリを行う方法であって、
ユーザインタフェースによりユーザからの入力を受け入れるステップと、
ドラッグデリバリコントローラによりある量の薬物を患者にデリバリするステップと、
患者に結合されるようになっている患者健康モニタにより前記患者の少なくとも1つの健康状態を反映する信号を生成するステップと、
前記ユーザインタフェース、ドラッグデリバリコントローラ、および患者健康モニタを薬物状態モデルに従って統合するステップであって、それによって、前記デリバリコントローラにより前記患者にデリバリされる薬物の量を前記ユーザからの入力および/または前記患者健康モニタが生成した信号に基づいて変化させるようにする、統合するステップとを含む、ドラッグデリバリを行う方法。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US30859101P | 2001-07-31 | 2001-07-31 | |
PCT/US2002/024052 WO2003011358A2 (en) | 2001-07-31 | 2002-07-31 | Apparatuses and methods for titrating drug delivery |
Publications (3)
Publication Number | Publication Date |
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JP2005509465A true JP2005509465A (ja) | 2005-04-14 |
JP2005509465A5 JP2005509465A5 (ja) | 2006-01-05 |
JP4495962B2 JP4495962B2 (ja) | 2010-07-07 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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JP2003516588A Expired - Fee Related JP4495962B2 (ja) | 2001-07-31 | 2002-07-31 | ドラッグデリバリを滴定する装置および方法 |
Country Status (9)
Country | Link |
---|---|
US (1) | US7229430B2 (ja) |
EP (1) | EP1418976B1 (ja) |
JP (1) | JP4495962B2 (ja) |
CN (1) | CN1561241B (ja) |
AU (1) | AU2002322761B2 (ja) |
CA (1) | CA2455978C (ja) |
ES (1) | ES2429688T3 (ja) |
MX (1) | MXPA04001064A (ja) |
WO (1) | WO2003011358A2 (ja) |
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MXPA04001064A (es) | 2004-05-20 |
CN1561241B (zh) | 2013-07-10 |
US20030051737A1 (en) | 2003-03-20 |
EP1418976B1 (en) | 2013-06-26 |
WO2003011358A3 (en) | 2003-08-14 |
ES2429688T3 (es) | 2013-11-15 |
CA2455978C (en) | 2008-09-09 |
CN1561241A (zh) | 2005-01-05 |
JP4495962B2 (ja) | 2010-07-07 |
AU2002322761B2 (en) | 2008-08-21 |
WO2003011358A2 (en) | 2003-02-13 |
EP1418976A2 (en) | 2004-05-19 |
US7229430B2 (en) | 2007-06-12 |
CA2455978A1 (en) | 2003-02-13 |
EP1418976A4 (en) | 2010-04-14 |
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