Automatic control of anesthesia using quantitative EEG

• US 6,016,444 A
• Filed: 12/10/1997
• Issued: 01/18/2000
• Est. Priority Date: 12/10/1997
• Status: Expired due to Term

• Current Assignee: New York University
• Original Assignee: New York University
• Inventors: John, Erwin Roy
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): ASTORINO, MICHAEL C
• Application Number:
  US08/988,076
• Time in Patent Office: 769 Days
• Field of Search: 600/544, 600/545, 128/897-898, 128/910, 604/64-67
• US Class Current: 600/544
• CPC Class Codes: A61B 5/1106 to assess neuromuscular blockade, e.g. to estimate depth of anaesthesia
• CPC Class Codes: A61B 5/4821 Determining level or depth of anaesthesia A61B5/1106 takes precedence
• CPC Class Codes: A61M 16/104 specially adapted for anaesthetics A61M16/18 takes precedence
• CPC Class Codes: A61M 2230/10 Electroencephalographic signals
• CPC Class Codes: A61M 2230/60 Muscle strain, i.e. measured on the user
• CPC Class Codes: Y10S 128/91 Anesthesia gas scavenging system

Abstract

A quantitative electroencephalograph (QEEG) based method and system for automatically controlling anesthesia is called a Closed Loop Anesthesia Controller (CLAC). An anesthetic is administered until the patient has attained the desired plane of anesthesia and a QEEG self-norm is then obtained. If the patient'"'"'s brain waves exceed a confidence interval, centered at the set-point of the self-norm, the administration of the anesthesia is automatically adjusted.

Claims

1. An electroencephalograph (EEG) method using a computer system for controlling anesthesia to a patient undergoing a medical procedure, comprising:

(a) removably connecting a set of at least two EEG electrodes to the scalp of the patient, at least one EEG electrode at the front of the scalp and at least one other electrode at the back of the scalp, and administering sufficient anesthesia to the patient for the patient to attain the plane of anesthesia selected by an operator;

(b) amplifying and digitizing the ongoing brain waves of the patient after the patient is anesthetized and before being operated upon and computing power spectrum to provide an initial set of covariance matrices which are self-norm digital data representing a comparison of EEG power in at least one selected frequency band at a frontal EEG electrode with EEG power in the same band at a posterior EEG electrode and recording this initial set of covariance matrices or the average across the set in computer system memory;

(c) computing the covariance matrix of features extracted from selected EEG electrodes;

(d) during the operation, digitizing the ongoing brain waves at the same EEG electrodes and extracting the same measures to provide a current set of covariance matrices for the selected measures at the selected EEG electrodes;

(e) in the computer system, statistically comparing the initial and subsequent sets of univariate digital data and coherence matrices to specify univariate and multivariate distances between the initial set and the current set;

(f) providing a control signal if the comparison of (e) indicates that the patient is emerging from his fully anesthetized state;

(g) automatically, in response to the control signal, adjusting the anesthesia administered to the patient during the operation in response to the control signal to restore the patient to the selected plane of anesthesia.

2. The method of claim 1 and automatically, after (a), calculating a system transfer function and defining a correction unit for the individual patient by withholding anesthesia delivery and/or delivering additional anesthetic until the patient'"'"'s EEG deviates from the self-norm mean value by a selected deviation which is a statistically significant interval.

3. The method of claim 1 and Z-transforming the initial set and current set of covariance matrices using population age-appropriate norms or the self-norm defined by the initial set.

4. The method of claim 1 and including statistically comparing the initial and subsequent sets of data with a normative reference database based on the successful outcomes of specific surgical procedures using specific anesthetic materials.

5. The method of claim 4 in which the normative reference database is in the form of age-corrected Z-scores which thereby transform all measures into the same dimensional units of probability.

6. The method of claim 1 and presenting a set of stimuli to the patient after the patient is anesthetized and both before and during the operation, and amplifying and digitizing the brain wave evoked responses and extracting quantitative descriptors as part of the initial and subsequent sets of digital data.

7. The method of claim 6 wherein the stimuli are auditory and the evoked responses are brain stem or cortical auditory responses (BSER) or auditory 40 Hz Steady State Evoked Potentials (SSEP).

8. The method of claim 6 wherein the stimuli are electrical or tactile and the evoked responses are brainstem or cortical somatosensory evoked responses (BSER).

9. The method of claim 1 wherein measures of the ongoing EEG are derived and recorded, ongoing EEG measures including absolute and relative power in the Delta, Theta, Alpha 1, Alpha 2, Beta 1 and Beta 2 bands, coherence and asymmetry between homologous EEG electrodes, ratios of measures within EEG electrodes or ratios of measures between electrodes, and the spectral edge frequencies below which are found 50% (SEF 50) or 95% (SEF 95) of the total power spectrum.

10. An electroencephalograph (EEG) method using a computer system for controlling anesthesia to a patient undergoing a medical procedure, comprising:

(a) removably connecting a set of at least two EEG electrodes to the scalp of the patient, at least one EEG electrode at the front of the scalp and at least one other electrode at the back of the scalp, and administering sufficient anesthesia to the patient for the patient to attain the plane of anesthesia selected by an operator;

(b) amplifying and digitizing the ongoing brain waves of the patient after the patient is anesthetized and before being operated upon to provide a first set of digital data representing a comparison of EEG power selected from one or more of the Alpha, and/or Theta bands at a frontal EEG electrode with EEG power in the same band at a posterior EEG electrode and recording the first set of digital data in computer system memory;

(c) during the operation, digitizing the ongoing brain waves at the same EEG electrodes and frequency band to provide a second set of digital data representing a co-variance comparison of EEG power in the selected band as between the selected frontal and posterior electrodes;

(d) using the computer system to statistically compare the first and second sets of digital data;

(e) providing a control signal if the comparison of (d) indicates that the patient is emerging from his fully anesthetized state;

(f) automatically, in response to the control signal, adjusting the anesthesia administered to the patient during the operation in response to the control signal to restore the patient to the selected plane of anesthesia.

11. The method of claim 10 and calculating a system transfer function and defining a correction unit for the individual patient by withholding anesthesia delivery and/or delivering extra anesthetic until the patient'"'"'s EEG deviates from a self-norm mean value by a selected deviation which is a statistically significant interval.

12. The method of claim 10 and including statistically comparing the initial and subsequent sets of data with a normative reference database based on the successful outcomes of specific surgical procedures using specific anesthetic materials.

13. The method of claim 12 in which the normative reference database is in the form of age-corrected Z-scores which thereby transform all measures into the same dimensional units of probability.

14. The method of claim 10 and presenting a set of stimuli to the patient after the patient is anesthetized and both before and during the operation, amplifying and digitizing the brainwave evoked responses and extracting quantitative descriptors of the first and second sets of digital data.

15. The method of claim 14 wherein the stimuli are auditory and the evoked responses are brain stem or cortical auditory responses (BSER) or auditory 40 Hz Steady State Evoked Potentials (SSEP).

16. The method of claim 14 wherein the stimuli are electrical or tactile and the evoked responses are brainstem or cortical somatosensory evoked responses (BSER).

17. The method of claim 10 wherein the measures of the ongoing EEG are derived and recorded and include absolute and relative power in the Delta, Theta, Alpha 1, Alpha 2 and Beta bands, coherence and asymmetry between homologous EEG electrodes, ratios of measures within EEG electrodes or ratios of measures between electrodes, and the spectral edge frequencies below which are found 50% (SEF) or 95% (SEF 95) of the total power spectrum.

18. An electroencephalograph (EEG) method for controlling anesthesia to a patient undergoing a medical procedure, comprising:

(a) removably connecting a set of at least two electrodes to the scalp of the patient, at least one EEG electrode at the front of the scalp and at least one other electrode at the back of the scalp, and administering sufficient anesthesia to the patient for the patient to attain the plane of anesthesia selected by an operator;

(b) providing concurrent sense stimuli in two or more different modes to the patient, the stimuli in one mode being at frequency F1 and the stimuli in the other mode being at a different frequency F2, F3, etc. and amplifying and digitizing the evoked brain waves of the patient after the patient is anesthetized and before being operated upon to provide a first set of F ratio data; and

recording the first set of F ratio data in computer system memory;

(c) during the operation repeating the stimulus of (b) and digitizing the evoked brain waves at the same EEG electrodes to provide a second set of F ratio data;

(d) using the computer system to statistically compare the first and second sets of F ratio data;

(e) providing a control signal if the comparison of the F ratio data of (d) indicates that the patient is emerging from his fully anesthetized state; and

(f) automatically, in response to the control signal, adjusting the anesthesia administered to the patient during the operation in response to the control signal to restore the patient to the selected plane of anesthesia.

19. A method as in claim 18 wherein the stimulus includes an audio click and a somatosensory skin response voltage or tactile vibration.

20. An electroencephalograph (EEG) system for controlling anesthesia to a patient undergoing a medical procedure, comprising:

(a) a set of at least two EEG electrodes adapted to be removably connected to the scalp of the patient, at least one EEG electrode at the front of the scalp and at least one other electrode at the back of the scalp, and means for administering sufficient anesthesia to the patient for the patient to attain the plane of anesthesia reflected by an operator;

(b) means for amplifying and digitizing the ongoing brain waves of the patient after the patient is anesthetized and before being operated upon to provide an initial set of covariance matrices which are self-norm digital data representing a comparison of EEG power in at least one selected frequency band at a frontal EEG electrode with EEG power in the same band at a posterior EEG electrode and computer system memory means for recording this initial set of covariance matrices;

(c) computer means for computing the covariance matrix of features extracted from selected EEG electrodes;

(d) means for, during the operation, digitizing the ongoing brain waves at the same EEG electrodes and extracting the same measures to provide a current set of covariance matrices for the selected measures at the selected EEG electrodes;

(e) computer means for statistically comparing the initial and subsequent sets of univariate digital data and coherence matrices to specify univariate and multivariate distances between the initial set and the current set;

(f) means for providing a control signal if the comparison of (e) indicates that the patient is emerging from his fully anesthetized state; and

(g) means for automatically, in response to the control signal, adjusting the anesthesia administered to the patient during the operation in response to the control signal to restore the patient to the selected plane of anesthesia.

21. The system of claim 20 and means for automatically, after (a), calculating a system transfer function and defining a correction unit for the individual patient by withholding anesthesia delivery or delivering extra anesthetic until the patient'"'"'s EEG deviates from the self-norm mean value by a selected deviation which is a statistically significant interval.

22. The system of claim 20 and computer means for Z-transforming the initial set and current set of covariance matrices using population age-appropriate norms or the self-norm defined by the initial set.

23. The system of claim 20 and including computer means for statistically comparing the initial and subsequent sets of data with a normative reference database based on the successful outcomes of specific surgical procedures using specific anesthetic materials.

24. The system of claim 23 in which the normative reference database is in the form of age-corrected Z-scores which thereby transform all measures into the same dimensional units of probability.

25. The system of claim 20 and stimuli means for presenting a set of stimuli to the patient before and/or after the patient is anesthetized and both before and during the operation, and means for amplifying and digitizing the brain wave evoked responses and extracting quantitative descriptors as part of the initial and subsequent sets of digital data.

26. The system of claim 25 wherein the stimuli are auditory and the evoked responses are brain stem or cortical auditory responses (BSER) or auditory 40 Hz Steady State Evoked Potentials (SSEP).

27. The system of claim 25 wherein the stimuli are electrical or tactile and the evoked responses are brainstem or cortical somatosensory evoked responses (BSER).

28. The system of claim 20 including means to derive and record ongoing EEG measures including absolute and relative power in the Delta, Theta, Alpha 1, Alpha 2, Beta 1 and Beta 2 bands, coherence and asymmetry between homologous EEG electrodes, ratios of measures within EEG electrodes or ratios of measures between electrodes, and the spectral edge frequencies below which are found 50% (SEF 50) or 95% (SEF 95) of the total power spectrum.

29. An electroencephalograph (EEG) system for controlling anesthesia to a patient undergoing a medical procedure, comprising:

(a) a set of at least two electrodes adapted to be removably connected to the scalp of the patient, at least one EEG electrode at the front of the scalp and at least one other electrode at the back of the scalp, and means for administering sufficient anesthesia to the patient for the patient to attain the plane of anesthesia selected by an operator;

(b) stimuli means for providing concurrent sense stimuli in two or more different modes to the patient, the stimuli in one mode being at frequency F1 and the stimuli in the other mode being at a different frequency F2, F3, etc. and means for amplifying and digitizing the evoked brain waves of the patient after the patient is anesthetized and before being operated upon to provide a first set of F ratio data; and

computer means for recording the first set of F ratio data;

(c) means for, during the operation, repeating the stimulus of (b) and digitizing the evoked brain waves at the same EEG electrodes to provide a second set of F ratio data;

(d) computer system means to statistically compare the first and second sets of F ratio data;

(e) means for providing a control signal if the comparison of the F ratio data of (d) indicates that the patient is emerging from his fully anesthetized state; and

(f) means for automatically, in response to the control signal, adjusting the anesthesia administered to the patient during the operation in response to the control signal to restore the patient to the selected plane of anesthesia.

30. A system as in claim 29 wherein the stimulus includes an audio click and a somatosensory skin response voltage or tactile vibration.

31. An electroencephalograph (EEG) method using a computer system for controlling anesthesia to a patient undergoing a medical procedure, comprising:

(a) removably connecting a set of at least two EEG electrodes to the scalp of the patient and administering sufficient anesthesia to the patient for the patient to attain the plane of anesthesia selected by an operator;

(b) amplifying and digitizing the brain waves of the patient before and/or after the patient is anesthetized and before being operated upon to provide an initial set of self-norm digital data of selected measures;

(c) during the operation, digitizing the brain waves at the same EEG electrodes and extracting the same measures to provide a current set of data for the selected measures at the selected EEG electrodes;

(d) calculating a system transfer function and defining a correction unit for the individual patient by withholding anesthesia delivery and/or delivering additional anesthetic until variables in the patient'"'"'s EEG depart from the self-norm mean value by a selected deviation which is a statistically significant interval, and measuring the total amounts of anesthetic required to produce these deviations;

(e) repeating the calculation of (d) at regular intervals during the operation to ascertain possible changes in pharmokinetics;

(f) in the computer system, statistically comparing the initial and subsequent sets of digital data to specify distances between the initial set and the current set;

(g) providing a control signal if the comparison of (f) indicates that the patient is emerging from his plane of anesthesia;

(h) automatically, in response to the control signal, adjusting the anesthetic administered to the patient during the operation in response to the control signal, in an amount determined by the transfer function of (d), to restore the patient to the selected plane of anesthesia.