Method of operating a control device for controlling an infusion device

Patent metadata

Field	Value
Publication number	US-9849241-B2
Application number	US-201414786118-A
Country	US
Kind code	B2
Filing date	Feb 24, 2014
Priority date	Apr 24, 2013
Publication date	Dec 26, 2017
Grant date	Dec 26, 2017

Abstract

Method of operating a control device for controlling an infusion device A method of operating a control device ( 2 ) for controlling an infusion device ( 33 ) for administering a drug to a patient (P) comprises the steps of: providing a model (p) to predict a time-dependent drug concentration (Cplasma, Clung, Cbrain) in multiple compartments (A 1 -A 5 ) of a patient (P); setting a target concentration value (CTbrain) to be achieved in at least one of the compartments (A 1 -A 5 ) of the patient (P); determining a drug dosage (D 1 ) to be administered to a first compartment (A 1 ) of the multiple compartments (A 1 -A 5 ) of the patient (P) using the model (p) such that the difference between the target concentration value (CTbrain) and a predicted steady-state drug concentration (Cplasma, Clung, Cbrain) in the at least one of the compartments (A 1 -A 5 ) is smaller than a pre-defined threshold value (Ub-rain); providing a control signal (S 1 ) indicative of the drug dosage (D 1 ) to an infusion device ( 33 ) for administering the drug dosage (D 1 ) to the patient (P); obtaining a measurement value (M 1 , M 2 ) indicating a measured drug concentration in a second compartment (A 2 , A 3 ) of the multiple compartments (A 1 -A 5 ) at a measurement time (t 1 , t 2 ); adjusting the model (p) such that the model (p) predicts a drug concentration (Clung, Cbrain) in the second compartment (A 2 , A 3 ) at the measurement time (t 1 , t 2 ) which at least approximately matches the measured drug concentration in the second compartment (A 2 , A 3 ); and determining a new drug dosage (D 2 , D 3 ) to be administered into the first compartment (A 1 ) of the patient (P) using the model (p) such that the difference between the target concentration value (CT-brain) and a predicted steady-state drug concentration (Cplasma, Clung, Cbrain) in the at least one of the compartments (A 1 , A 2 , A 3 ) is smaller than the predefined threshold value (Ubrain). In this way a method is provided which allows for an improved (personalized and predictive) control of a drug administration procedure, in particular when administering an anaesthetic drug such as Propofol and/or an analgesic drug such as Remifentanil within a procedure.

First claim

The invention claimed is:

1. A method of operating a control device for controlling an infusion device for administering a drug to a patient, the method comprising the steps of:
(a) providing a model to predict a time-dependent drug concentration in multiple compartments of a patient;
(b) setting a target concentration value to be achieved in at least one of the compartments of the patient;
(c) determining a drug dosage to be administered to a first compartment of the multiple compartments of the patient using the model such that the difference between the target concentration value and a predicted steady-state drug concentration in the at least one of the compartments is smaller than a pre-defined threshold value;
(d) providing a control signal indicative of the drug dosage to an infusion device for administering the drug dosage to the patient;
(e) obtaining at least one measurement value indicating a measured drug concentration in at least a second compartment of the multiple compartments at one or more measurement times;
(f) adjusting the model such that the model predicts a drug concentration in at least the second compartment at one or more measurement times, which at least approximately matches the measured drug concentration in at least said second compartment; and
(g) determining a new drug dosage to be administered into the first compartment of the patient using the model such that the difference between the target concentration value and a predicted steady-state drug concentration in the at least one of the compartments is smaller than the pre-defined threshold value.

2. The method according to claim 1 , wherein the drug is an anaesthetic drug such as Propofol, an analgesic drug such as Fentanil or Remifentanil, or a muscle relaxant.

3. The method according to claim 1 wherein the model is a pharmacokinetic-pharmacodynamic model to predict a drug concentration as a function of time in multiple compartments of a patient.

4. The method according to claim 1 , wherein the first compartment is a plasma compartment and the second compartment is a brain or lung compartment.

5. The method according to claim 1 , wherein the first compartment is a plasma compartment, the second compartment is a lung compartment and a third compartment is the brain compartment.

6. The method according to claim 1 , wherein steps (d) to (g) are iteratively repeated.

7. The method according to claim 1 , wherein step (f) includes:
adjusting at least one transfer rate constant or volume of the model indicating a transfer rate between different compartments or a volume of a compartment.

8. The method according to claim 1 , wherein the at least one measurement value is taken by a measurement device which is constituted to measure a drug concentration in the patient's breath.

9. The method according to claim 1 , wherein at least one measurement value is obtained by continuously measuring the drug concentration in the patient's breath over a predetermined number of breathing cycles.

10. The method according to claim 1 , wherein at least one measurement value is taken by a measurement device which is constituted to measure an EEG signal resulting in an EEG index value.

11. The method according to claim 1 , wherein the measurement time of step (e) lies in a range after the administration of the drug dosage by the infusion device indicated by the control signal of step (d) reaches a steady state status in at least the first compartment or is completed.

12. The method according to claim 1 , wherein the at least one measurement value at one or more measurement times according to step (e) is obtained before the drug concentration in at least the second compartment reaches a steady state status or is completed.

13. The method according to claim 1 , comprising:
transforming the measurement value into a measured drug concentration in the second compartment at the measurement time using a transformation function.

14. The method according to claim 1 , wherein in a further step (h) at least one measurement value is obtained indicating a measured drug concentration in the third compartment of the multiple compartments at one or more measurement times and at least one measurement value is obtained indicating a measured drug concentration in the second compartment of the multiple compartments at one or more measurement times, and a first value indicating a drug concentration in the second compartment is determined based on the measurement values indicating a measured drug concentration in the third compartment by using the model and a second value indicating a drug concentration in the second compartment is determined based on the measurement values indicating a measured drug concentration in the second compartment using a transformation function wherein, in a further step, in case there is a difference between the first value and the second value, the transformation function is adapted, so that the first value and the second value match or are within a defined range.

15. A control device for controlling an infusion device for administering a drug to a patient, the control device being constituted to:
(a) provide a model to predict a time-dependent drug concentration in multiple compartments of a patient;
(b) set a target concentration value to be achieved in at least one of the compartments of the patient;
(c) determine a drug dosage to be administered to a first compartment of the multiple compartments of the patient using the model such that the difference between the target concentration value and a predicted steady-state drug concentration in the at least one of the compartments is smaller than a pre-defined threshold value;
(d) provide, as an output, a control signal indicative of the drug dosage to an infusion device for administering the drug dosage to the patient;
(e) obtain, as an input, at least one measurement value indicating a measured drug concentration in a least a second compartment of the multiple compartments at a measurement time;
(f) adjust the model such that the model predicts a drug concentration in at least the second compartment at the one or more measurement time which at least approximately matches the measured drug concentration in at least the second compartment; and
(g) determine a new drug dosage to be administered into the first compartment of the patient using the model such that the difference between the target concentration value and a predicted steady-state drug concentration in the at least one of the compartments is smaller than the pre-defined threshold value.

16. The control device according to claim 15 , wherein the control device is constituted to request, as an input prior to step (d), a user information before providing the control signal to the infusion device.

Assignees

• Fresenius Kabi Deutschland Gmbh

Inventors

• Becker Michael

Classifications

• A61M2205/35

  Communication · CPC title

• A61M5/1723 Primary

  using feedback of body parameters, e.g. blood-sugar, pressure (measurement of body parameters A61B5/00) · CPC title

• A61M2230/10

  Electroencephalographic signals · CPC title

• A61M2230/43

  Composition of exhalation · CPC title

• A61M5/172

  electrical or electronic {(A61M5/16804, A61M5/16831 take precedence)} · CPC title