JP6446030B2 - 薬剤注入装置を制御する制御装置を操作する方法 - Google Patents
薬剤注入装置を制御する制御装置を操作する方法 Download PDFInfo
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Classifications
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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
-
- 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
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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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- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/35—Communication
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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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
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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
- A61M2230/00—Measuring parameters of the user
- A61M2230/08—Other bio-electrical signals
- A61M2230/10—Electroencephalographic signals
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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
- A61M2230/00—Measuring parameters of the user
- A61M2230/40—Respiratory characteristics
- A61M2230/43—Composition of exhalation
Description
(a)患者の複数の区画における時間依存の薬剤濃度を予測するモデルを提供するステップと、
(b)前記患者の前記区画のうちの少なくとも1つで達成されるべき目標濃度値を設定するステップと、
(c)前記目標濃度値と前記区画のうちの前記少なくとも1つにおける定常状態の予想薬剤濃度との間の差が所定の閾値よりも小さくなるように、前記モデルを用いて、前記患者の前記複数の区画のうちの第1の区画に投与される薬剤投与量を求めるステップと、
(d)前記薬剤投与量を示す制御信号を、該薬剤投与量を前記患者に投与する薬剤注入装置に提供するステップと、
(e)1つ又は複数の測定時点での前記複数の区画のうちの少なくとも第2の区画における測定薬剤濃度を示す少なくとも1つの測定値を取得するステップと、
(f)前記モデルが、前記少なくとも第2の区画における前記測定薬剤濃度に少なくとも近似的に一致する、1つ又は複数の測定時点での前記少なくとも第2の区画における薬剤濃度を予測するように、該モデルを調整するステップと、
(g)前記目標濃度値と前記区画のうちの前記少なくとも1つにおける定常状態の予想薬剤濃度との間の差が前記所定の閾値よりも小さくなるように、前記モデルを用いて、前記患者の第1の区画に投与される新たな薬剤投与量を求めるステップと、
を含む。
−予測調査において、定常状態の条件がほぼ達成されるように、すなわち複数区画のPK/PDモデルが、異なる区画における薬剤濃度がもはや経時的に変化しない均衡を示すように、薬剤を投与する(これは、異なる区画間の時間遅延の影響を最小限にするために行われる)。
−患者の呼吸において測定を行い(例えば、患者の呼吸内のプロポフォールを測定する)、定常状態の条件に達した時点の測定情報を生成する。
−同時に血液サンプルを取得し、実験室設備を通じて血液サンプル内の薬剤濃度を測定し、それにより血漿区画における薬剤濃度についての正確な値を得る。
−血漿区画における計算された薬剤濃度が血液サンプル内の測定薬剤濃度と一致するように、PK/PDモデルが較正される。
−較正されたPK/PDモデルを用いて、測定時点での肺区画における薬剤濃度を計算し、それにより測定時点での肺区画における実際の薬剤濃度に対応する測定時点での測定信号を得る。実際の薬剤濃度と測定信号とを関連付けることによって、例えば患者の呼吸内の薬剤濃度を示す測定信号を肺区画における実際の薬剤濃度を示す測定値に変換するのに役立つことができる時間遅延のない変換関数を取得する。
−ステップは、異なる定常状態の条件(異なる連続的な投与率)について繰り返して、様々な異なる定常状態の条件について変換関数を完成させることができる。
(a)患者の複数の区画における時間依存の薬剤濃度を予測するモデルを提供し、
(b)前記患者の前記区画のうちの少なくとも1つで達成されるべき目標濃度値を設定し、
(c)前記目標濃度値と、前記区画のうちの前記少なくとも1つにおける定常状態の予想薬剤濃度との間の差が所定の閾値よりも小さくなるように、前記モデルを用いて、前記患者の前記複数の区画のうちの第1の区画に投与される薬剤投与量を求め、
(d)出力として、前記薬剤投与量を示す制御信号を、該薬剤投与量を前記患者に投与する薬剤注入装置に提供し、
(e)入力として、1つ又は複数の測定時点での前記複数の区画のうちの少なくとも第2の区画における測定薬剤濃度を示す少なくとも1つの測定値を取得し、
(f)前記モデルが、前記少なくとも第2の区画における前記測定薬剤濃度に少なくとも近似的に一致する、1つ又は複数の測定時点での前記少なくとも第2の区画における薬剤濃度を予測するように、該モデルを調整し、
(g)前記目標濃度値と前記区画のうちの前記少なくとも1つにおける定常状態の予想薬剤濃度との間の差が前記所定の閾値よりも小さくなるように、前記モデルを用いて、前記患者の第1の区画に投与される新たな薬剤投与量を求める、
ように構成される。
2 制御装置
20 測定装置
200 ライン
31、32、33 薬剤注入装置
310、320、320 ライン
4 呼吸装置
40 マウスピース
400 ライン
41 接点
5 EEG監視装置
50 電極
500 ライン
6 表示装置
A1〜A5 区画
D、D1〜D3 薬剤投与量
I0〜I6 入力
M1、M2 測定値
P モデル
P 患者
S1〜S3 制御信号
Claims (12)
- 薬剤を患者(P)に投与する薬剤注入装置(33)を制御する制御装置(2)の作動方法であって、
(a)患者(P)の時間依存の薬剤濃度(Cplasma、Clung、Cbrain)を予測するモデル(p)を前記制御装置(2)が提供するステップと、
(b)前記患者(P)の脳区画(A3)で達成されるべき目標濃度値(CTbrain)を前記制御装置(2)が設定するステップと、
(c)前記目標濃度値(CTbrain)と、肺区画(A2)における定常状態の予想薬剤濃度(Clung)との間の差が所定の閾値(L1brain)よりも小さくなるように、前記モデル(p)を用いて、前記患者(P)の血漿区画(A1)に投与される薬剤投与量(D1)を前記制御装置(2)が求めるステップと、
(d)前記薬剤投与量(D1)を示す制御信号(S1)を、該薬剤投与量(D1)を前記患者(P)に投与する薬剤注入装置(33)に前記制御装置(2)が提供するステップと、
(e)1つ又は複数の測定時点(t1、t2)での少なくとも1つの測定値(M1、M2)を患者(P)の呼吸内の薬剤濃度を測定するように構成される測定装置(20)が取得するステップと、
(f)前記モデル(p)が、前記患者(P)の呼吸内の測定薬剤濃度に少なくとも近似的に一致する、1つ又は複数の測定時点(t1、t2)での前記肺区画(A2)における薬剤濃度(Clung)を予測するように、該モデル(p)を前記制御装置(2)が調整するステップと、
(g)前記目標濃度値(CTbrain)と肺区画(A2)における定常状態の予想薬剤濃度(Clung)との間の差が前記所定の閾値(L1brain)よりも小さくなるように、前記モデル(p)を用いて、前記患者(P)の血漿区画(A1)に投与される新たな薬剤投与量(D2、D3)を前記制御装置(2)が求めるステップと、
を含む、方法。 - 前記薬剤は、麻酔薬であるプロポフォール、鎮痛剤であるフェンタニル若しくはレミフェンタニル、又は筋弛緩薬である、請求項1に記載の方法。
- 前記モデルは、薬剤濃度(Clung)を患者(P)の肺区画(A2)における時間(t)の関数として予想する薬物動態−薬物力学モデルである、請求項1又は2に記載の方法。
- ステップ(d)からステップ(g)は反復的に繰り返される、請求項1〜3に記載の方法。
- ステップ(f)は、前記モデル(p)の、異なる区画間の移動率を示す移動率定数と区画の体積を示す体積とのうちの少なくとも1つを前記制御装置(2)が調整することを含む、請求項1〜4に記載の方法。
- 前記少なくとも1つの測定値(M1、M2)は、所定の呼吸サイクル数にわたって前記患者(P)の呼吸内の前記薬剤濃度を連続的に測定することによって取得される、請求項1〜5に記載の方法。
- ステップ(e)の前記測定時点は、ステップ(d)の前記制御信号(S1〜S3)によって示される前記薬剤投与量(D1〜D3)の前記薬剤注入装置(33)による投与が、少なくとも前記血漿区画(A1)において定常状態の状況に達するか又は完了した後の或る範囲に存在する、請求項1〜6に記載の方法。
- ステップ(e)による1つ又は複数の測定時点での前記少なくとも1つの測定値(M1、M2)は、前記肺区画(A2)における前記薬剤濃度が定常的な状況に達するか又は完了する前に取得される、請求項1〜7に記載の方法。
- 変換関数TF(M1−7肺濃度C M1 Lung (t1))を用いて、前記測定値(M1)を、前記測定時点(t1)での前記肺区画(A2)における測定薬剤濃度に変換することを含む、請求項1〜8に記載の方法。
- 更なるステップ(h)において、1つ又は複数の測定時点(t1、t2)での前記脳区画(A3)における測定薬剤濃度を示す少なくとも1つの測定値が取得され、1つ又は複数の測定時点(t1、t2)における患者(P)の呼吸内の測定薬剤濃度を示す少なくとも1つの測定値が取得され、前記肺区画(A2)における薬剤濃度を示す第1の値が、前記モデル(p)を用いることによって前記脳区画(A3)における測定薬剤濃度を示す前記測定値に基づいて求められ、前記肺区画(A2)における薬剤濃度を示す第2の値が、前記変換関数(TF)を用いることによって患者(P)の呼吸内の測定薬剤濃度を示す前記測定値に基づいて求められ、更なるステップにおいて、前記第1の値と前記第2の値との間に差がある場合には、前記変換関数が修正され、前記第1の値及び前記第2の値が一致するか又は目標濃度値(C T brain)と肺区画(A2)における定常状態の予想薬剤濃度(Clung)との間の差が前記所定の閾値(L1brain)よりも小さくなるようにする、請求項9に記載の方法。
- 薬剤を患者(P)に投与する薬剤注入装置(33)を制御する制御装置(2)であって、
(a)患者(P)の時間依存の薬剤濃度(Clung、Cplasma、Cbrain)を予測するモデル(p)を提供し、
(b)前記患者(P)の脳区画(A3)で達成されるべき目標濃度値(CTbrain)を設定し、
(c)前記目標濃度値(CTbrain)と、前記肺区画(A2)における定常状態の予想薬剤濃度(Clung)との間の差が所定の閾値(L1brain)よりも小さくなるように、前記モデル(p)を用いて、前記患者(P)の血漿区画(A1)に投与される薬剤投与量(D1)を求め、
(d)出力として、前記薬剤投与量(D1)を示す制御信号(S1)を、該薬剤投与量(D1)を前記患者(P)に投与する薬剤注入装置(33)に提供し、
(e)入力として、1つ又は複数の測定時点(t1、t2)での患者(P)の呼吸内の測定薬剤濃度を示す少なくとも1つの測定値(M1、M2)を取得し、
(f)前記モデル(p)が、前記患者(P)の呼吸内の測定薬剤濃度に少なくとも近似的に一致する、1つ又は複数の測定時点(t1、t2)での前記肺区画(A2)における薬剤濃度(Clung)を予測するように、該モデル(p)を調整し、
(g)前記目標濃度値(CTbrain)と前記肺区画(A2)における定常状態の予想薬剤濃度(Clung)との間の差が前記所定の閾値(L1brain)よりも小さくなるように、前記モデル(p)を用いて、前記患者(P)の血漿区画(A1)に投与される新たな薬剤投与量(D2、D3)を求める、
ように構成される、制御装置。 - 前記制御装置(2)は、ステップ(d)に先立って入力として、前記制御信号(S1〜S3)を前記薬剤注入装置(33)に提供する前にユーザー情報を要求するように構成される、請求項11に記載の制御装置。
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EP2989569A1 (en) | 2016-03-02 |
US9849241B2 (en) | 2017-12-26 |
ES2877551T3 (es) | 2021-11-17 |
CN105144177A (zh) | 2015-12-09 |
EP2989569B1 (en) | 2021-06-23 |
WO2014173558A1 (en) | 2014-10-30 |
CN105144177B (zh) | 2019-05-28 |
US20160074582A1 (en) | 2016-03-17 |
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