JP5033794B2 - 麻酔用プロポフォールの時間制御された静脈投与用デバイス - Google Patents
麻酔用プロポフォールの時間制御された静脈投与用デバイス Download PDFInfo
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- JP5033794B2 JP5033794B2 JP2008516175A JP2008516175A JP5033794B2 JP 5033794 B2 JP5033794 B2 JP 5033794B2 JP 2008516175 A JP2008516175 A JP 2008516175A JP 2008516175 A JP2008516175 A JP 2008516175A JP 5033794 B2 JP5033794 B2 JP 5033794B2
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Classifications
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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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P23/00—Anaesthetics
-
- 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
-
- 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
- G16H50/50—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for simulation or modelling of medical disorders
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- Engineering & Computer Science (AREA)
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- General Health & Medical Sciences (AREA)
- Medical Informatics (AREA)
- Epidemiology (AREA)
- Biomedical Technology (AREA)
- Primary Health Care (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Anesthesiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Data Mining & Analysis (AREA)
- Vascular Medicine (AREA)
- Diabetes (AREA)
- Pathology (AREA)
- Databases & Information Systems (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Hematology (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Measuring And Recording Apparatus For Diagnosis (AREA)
Description
。肥満に於けるそれと同様な挙動が新生児(neonate)で観察され、そこでは周辺コンパートメントの容積が成人に於けるより比較的大きく、それは新生児に於ける身体脂肪の比較的高い比率により説明される。新生児は又プロポフォール注入の終了後一般的麻酔からもっと速く目覚めるが、後遺症からは比較的ゆっくりにしか回復せず、それは低下したシステム的クリアランスに帰せられる(非特許文献7)。
function)として使われる。生理学的パラメーターの実時間測定と組み合わせて、生理学的知識を使わない従来技術で引用されるブラックボックス(black−box)デバイスより実質的に良い閉じた制御サイクルが創られる。
)用のタンパク質の表現と機能を特徴付けるバラメーター、を含む。これらのパラメーターは直接測定されるか、又はそれらは、或る母集団について、年齢、性別、体重及びやせたボデイマス(body mass)の様な容易に測定される患者パラメーターと相関付けられる(非特許文献9)。これらのパラメーターの或るもの又は幾つかは本発明の手順で使われる。又血流レートの様にこれらのパラメーターの或るもの又は幾つかは時間が経って変化するので、シミュレーション時のこれらの変化を考慮することが賢明である。
ー(transporter)に関する表現データ(expression data)が、患者に個別に誂えられた用量を決定するよう使われ得るかを説明している。
応用例は、バイエルテクノロジーサービスゲーエムベーハー(Bayer Technology Service GmbH)により開発された、商業的に入手可能な生理学ベースの薬物動態学的モデルピーケー−シムアールと、インターネット上で刊行され、入手可能なチバ−トレイナーディプリフューザーテーエム(TIVA−Trainer DiprifusorTM)ソフトウエアと、を用いたシミュレーションに基づく。ピーケ
ー−シムアール用の物質依存の入力パラメーターとしてプロポフォールの下記値が使われた(表1)。
BMI)又は身長(H)から選択された2つのパラメーター(これらのパラメーターは式BMI=BW/H2により関係付けられる)と、を引用することにより特徴付けられる、仮想的個人(virtual individual)のシミュレーションを可能にする。もう1つの重要な入力パラメーターはクリアランスであり、それは物質の除去レート(rate of elimination)である。プロポフォールは肝臓で代謝される。代謝酵素の活動は年齢に依存(age−dependent)することが知られている。図2は年齢の関数としてのプロポフォールクリアランスを説明する実験データ(シンボル)を通るあてはめ(fit)(線)を示す。該“個別創生”機能は表2で引用された研究をシミュレートするため使われる。これらの場合は又チバ−トレイナーディプリフューザーテーエムソフトウエアを、そして小児科の研究の場合はパエドフューザーモデル(Paedfusor model)を、使ってシミュレートされた。
。この場合、ピーケー−シムアールで計算された脳内の活性成分濃度の相対標準偏差は18%であり、チバ−トレイナーでの効果コンパートメント濃度のそれは21%であった。
が排除され得ない。
Claims (7)
- 麻酔薬の時間制御された投与用のコンピュータ制御されたデバイスであって、
a)時間に応じて投与される脳内の望ましい濃度/時間クール又は望ましい効果/時間クールを示す物質依存的な目標プロファイルと同様に患者の個人的パラメーターと投与される麻酔薬の物質固有の入力パラメーターを入力するためのモジュールであって、b)に接続されるモジュールと
b)生理学ベースの及び/又は薬力学コンピューターモデルモジュールであって、
患者の個人的パラメーターと、投与されるべき麻酔薬の物質固有の入力パラメーターと、を考慮した、時間に応じて投与される投与量を特徴付ける投与時間プロファイルを用いた生理学ベースの薬物動態学的及び/又は薬物力学的シミュレーションのための該モジュールであって、ここでシュミレートされた投与時間プロファイルは、目標プロファイルに合致するか又は目標プロファイルに対して最大達成可能適合を示す、適合投与量が得られるまで反復して数値的に最適化され、そして、
適合投与時間プロファイルを出力する、
生理学ベースの及び/又は薬力学コンピューターモデルモジュールと、
c)出力された適合投与時間プロファイルに基づき制御された定量デバイスと、そして麻酔薬がプロポフォールであること、
を具備する該デバイス。 - 該麻酔薬が人間又は動物に投与されることを特徴とする請求項1の該デバイス。
- 該考慮されるべき患者の個人的パラメーターが下記、すなわち、体重、年齢、ボデイマス指数(ビーエムアイ)、血流レート、個別器官の容積及び組成、代謝的に活性の酵素又は活性トランスポーターの遺伝子表現データ、から選択したもの含むことを特徴とする請求項1の該デバイス。
- 1つ以上の解剖学的、生理学的及び/又は遺伝子的パラメーターが時間に亘り変化し得ることを特徴とする請求項3の該デバイス。
- 投与プロファイルをあてはめる方法が下記の数値的最適化法、すなわち、勾配法、詳細には準ニュートン法又はニュートン法;入れ子型インターバル法などの勾配フリー法、モンテカルロ法などの確率的方法、の1つを使うことを特徴とする請求項1のデバイス。
- 1つ以上の解剖学的、生理学的及び/又は遺伝子的なパラメーターが投与中実時間で測定されることを特徴とする請求項3の該デバイス。
- 治療結果が1つ以上の適当なセンサーを使ってオンラインでモニターされることが可能であり、該測定される信号又は複数信号が用量計測デバイスの制御に寄与出来ることを特徴とする請求項1の該デバイス。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102005028080.3 | 2005-06-17 | ||
DE102005028080A DE102005028080A1 (de) | 2005-06-17 | 2005-06-17 | Verfahren zur zeitlich gesteuerten intravenösen Verabreichung des Narkosemittels Propofol |
PCT/EP2006/005340 WO2006133825A1 (de) | 2005-06-17 | 2006-06-03 | Vorrichtung zur zeitlich gesteuerten intravenösen verabreichung des narkosemittels propofol |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2008546435A JP2008546435A (ja) | 2008-12-25 |
JP5033794B2 true JP5033794B2 (ja) | 2012-09-26 |
Family
ID=36940350
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2008516175A Expired - Fee Related JP5033794B2 (ja) | 2005-06-17 | 2006-06-03 | 麻酔用プロポフォールの時間制御された静脈投与用デバイス |
Country Status (7)
Country | Link |
---|---|
US (1) | US8038645B2 (ja) |
EP (1) | EP1904940A1 (ja) |
JP (1) | JP5033794B2 (ja) |
AU (1) | AU2006257418B2 (ja) |
CA (1) | CA2612215A1 (ja) |
DE (1) | DE102005028080A1 (ja) |
WO (1) | WO2006133825A1 (ja) |
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DE102004010516A1 (de) * | 2004-03-04 | 2005-09-22 | Bayer Technology Services Gmbh | Verbessertes Verfahren zur zeitlichen Dosierung von Arzneistoffen |
CN101472631A (zh) * | 2006-06-21 | 2009-07-01 | 伯尔尼大学 | 用于控制麻醉给药的系统 |
US9282927B2 (en) * | 2008-04-24 | 2016-03-15 | Invention Science Fund I, Llc | Methods and systems for modifying bioactive agent use |
US20090312595A1 (en) * | 2008-04-24 | 2009-12-17 | Searete Llc, A Limited Liability Corporation Of The State Of Delaware | System and method for memory modification |
US20100041958A1 (en) * | 2008-04-24 | 2010-02-18 | Searete Llc | Computational system and method for memory modification |
US20100004762A1 (en) * | 2008-04-24 | 2010-01-07 | Searete Llc, A Limited Liability Corporation Of The State Of Delaware | Computational system and method for memory modification |
US20100022820A1 (en) * | 2008-04-24 | 2010-01-28 | Searete Llc, A Limited Liability Corporation Of The State Of Delaware | Computational system and method for memory modification |
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US8876688B2 (en) * | 2008-04-24 | 2014-11-04 | The Invention Science Fund I, Llc | Combination treatment modification methods and systems |
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US8930208B2 (en) * | 2008-04-24 | 2015-01-06 | The Invention Science Fund I, Llc | Methods and systems for detecting a bioactive agent effect |
US9064036B2 (en) * | 2008-04-24 | 2015-06-23 | The Invention Science Fund I, Llc | Methods and systems for monitoring bioactive agent use |
US20100015583A1 (en) * | 2008-04-24 | 2010-01-21 | Searete Llc, A Limited Liability Corporation Of The State Of Delaware | Computational System and method for memory modification |
US20100017001A1 (en) * | 2008-04-24 | 2010-01-21 | Searete Llc, A Limited Liability Corporation Of The State Of Delaware | Computational system and method for memory modification |
US9239906B2 (en) * | 2008-04-24 | 2016-01-19 | The Invention Science Fund I, Llc | Combination treatment selection methods and systems |
US20090312668A1 (en) * | 2008-04-24 | 2009-12-17 | Searete Llc, A Limited Liability Corporation Of The State Of Delaware | Computational system and method for memory modification |
US9026369B2 (en) * | 2008-04-24 | 2015-05-05 | The Invention Science Fund I, Llc | Methods and systems for presenting a combination treatment |
US20090270694A1 (en) * | 2008-04-24 | 2009-10-29 | Searete Llc, A Limited Liability Corporation Of The State Of Delaware | Methods and systems for monitoring and modifying a combination treatment |
US20100081861A1 (en) * | 2008-04-24 | 2010-04-01 | Searete Llc | Computational System and Method for Memory Modification |
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-
2005
- 2005-06-17 DE DE102005028080A patent/DE102005028080A1/de not_active Withdrawn
-
2006
- 2006-06-03 EP EP06743110A patent/EP1904940A1/de not_active Withdrawn
- 2006-06-03 CA CA002612215A patent/CA2612215A1/en not_active Abandoned
- 2006-06-03 WO PCT/EP2006/005340 patent/WO2006133825A1/de active Application Filing
- 2006-06-03 US US11/917,452 patent/US8038645B2/en not_active Expired - Fee Related
- 2006-06-03 AU AU2006257418A patent/AU2006257418B2/en not_active Ceased
- 2006-06-03 JP JP2008516175A patent/JP5033794B2/ja not_active Expired - Fee Related
Also Published As
Publication number | Publication date |
---|---|
WO2006133825A1 (de) | 2006-12-21 |
JP2008546435A (ja) | 2008-12-25 |
US8038645B2 (en) | 2011-10-18 |
AU2006257418B2 (en) | 2011-07-14 |
CA2612215A1 (en) | 2006-12-21 |
US20100094202A1 (en) | 2010-04-15 |
AU2006257418A1 (en) | 2006-12-21 |
DE102005028080A1 (de) | 2006-12-21 |
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