Device for the time-controlled intravenous administering of the anesthetic propofol

• US 8,038,645 B2
• Filed: 06/03/2006
• Issued: 10/18/2011
• Est. Priority Date: 06/17/2005
• Status: Expired due to Fees

• Current Assignee: Bayer Intellectual Property GmbH (Bayer AG)
• Original Assignee: Bayer Technology Services GmbH (Bayer AG)
• Inventors: Edginton, Andrea Nicole, Schmitt, Walter, Willmann, Stefan
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): BERDICHEVSKY, AARTI
• Application Number:
  US11/917,452
• Publication Number:
  US 20100094202A1
• Time in Patent Office: 1,963 Days
• Field of Search: 604/66, 604/503
• US Class Current: 604/66
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61P 23/00 Anaesthetics
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

The invention relates to a device for the time-controlled intravenous administering of the anesthetic propofol by means of a method used for determining an adequate dosage profile and adequately controlling an infusion pump as a metering apparatus.

Claims

1. A computer-controlled device for time-controlled administration of an anesthetic, said device comprising:

a) a module for inputting individual parameters of the patient and substance-specific input parameters of the anesthetic to be administered as well as a substance-dependent target profile, which shows a desired concentration/time course in the brain or a desired effect/time course administered as a function of time, connected to

b) a physiology-based and/or pharmodynamic computer model module for a physiology-based pharmacokinetic and/or pharmacodynamic simulation of a dosage time profile which is variable over time taking into account the individual parameters of the patient and the substance-specific input parameters of the anesthetic to be administered, iterative numerical fit of the simulated dose profile until it agrees with the target profile or shows the maximum achievable agreement with it and output of an adapted dosage time profile, wherein the physiology-based and/or pharmodynamic computer model module is connected to

c) a metered dose device controlled on the basis of the outputted adapted dosage time profile, and

wherein the anesthetic is propofol.

2. The device as claimed in claim 1, wherein the anesthetic is administered to humans or animals.

3. The device as claimed in claim 1, wherein the fitting the dose profile uses one of the following numerical optimization procedures:

gradient procedures, particularly quasi-Newton or Newton procedures;

gradient-free procedures such as the nested-intervals procedure;

stochastic methods such as the Monte-Carlo procedure.

4. The device as claimed in claim 1, wherein the therapeutic outcome can be monitored on-line using one or more suitable sensors and the measured signal or signals can contribute to the control of the dose metering device.

5. The device as claimed in claim 1, wherein the individual patient parameters to be taken into account comprise a selection of the following:

body weight, age, body-mass index (BMI), blood flow rates, volumes and composition (proportion of water, fat and protein) of individual organs, gene expression data for metabolically active enzymes or active transporters.

6. The device as claimed in claim 5, wherein one or more anatomical, physiological and/or genetic parameters can vary over time.

7. The device as claimed in claim 5, wherein one or more anatomical, physiological and/or genetic parameters are measured in real time during administration.