Method and apparatus based on combination of physiological parameters for assessment of analgesia during anesthesia or sedation

• US 8,463,370 B2
• Filed: 03/20/2008
• Issued: 06/11/2013
• Est. Priority Date: 07/07/2003
• Status: Active Grant

• Current Assignee: Instrumentarium Dental Incorporated (Envista Holdings Corporation)
• Original Assignee: Instrumentarium Dental Incorporated (Envista Holdings Corporation)
• Inventors: Van Gils, Marcus Johannis, Paloheimo, Markku, Yli-Hankala, Arvi, Huiku, Matti Veli Tapani, Korhonen, Ilkka
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US12/052,542
• Publication Number:
  US 20080167540A1
• Time in Patent Office: 1,909 Days
• Field of Search: 600/544, 600/545
• US Class Current: 600/544
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 5/1106 to assess neuromuscular blockade, e.g. to estimate depth of anaesthesia
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/4821 Determining level or depth of anaesthesia A61B5/1106 takes precedence

Abstract

The invention relates to a method for monitoring a condition of a patient under anesthesia or sedation, whereupon one, two, three or more signals are acquired, and the signal(s) represent(s) cardiovascular and/or combined electrical biopotential on skull activity of the patient. From said signal or signals are derived or calculated at least two parameter values related to a quantity like waveform amplitude, waveform periodicity, waveform morphology, waveform variability, energy, power, signal complexity and frequency content. A predetermined mathematical index for probability of patient comfort is used, in which function said parameters are variables, and successively changing probability index values of said mathematical index is calculated.

Claims

1. A method for monitoring a condition of a patient under anesthesia or sedation, the method comprising the steps of:

acquiring at least a first signal representing a cardiovascular activity of the patent and a second signal representing a combined electrical biopotential obtained from a plurality of biopotential measurements on skull activity of the patient;

deriving, with a microprocessor, from said first signal, at least a first parameter value;

calculating, with the microprocessor, from said second signal, at least a second parameter value;

applying, with the microprocessor, a predetermined mathematical index for probability of patient comfort, in which index said at least first and second parameters are variables;

calculating, with the microprocessor, successively changing values of said mathematical index; and

indicating the condition of the patient under anesthesia or sedation with said successive index values.

2. A method according to claim 1, wherein at least first parameter value is related to a quantity selected from a group of quantities including waveform amplitude, waveform periodicity, waveform morphology, and waveform variability.

3. A method according to claim 1, wherein said at least second parameter value is related to a quantity selected from a group of quantities including energy, power, signal complexity and frequency content, each over a predetermined time period.

4. A method according to claim 1, wherein said first signal concerning cardiovascular activity is a blood volume signal measured non-invasively using photoplethysmography.

5. A method according to claim 4, wherein:

the quantity for said first parameter value is a pulse wave amplitude, or a dicrotic notch height in the pulse wave;

and calculating from said first signal a third parameter value, the quantity for said third parameter value being a pulse rate, or a heart beat interval, or a temporal position of the dicrotic notch.

6. A method according to claim 1, wherein said second signal is a non-invasive measurement concerning neuromuscular and brain activity.

7. A method according to claim 6, wherein said neuromuscular and brain activity measurement comprises electromyography and electroencephalogram.

8. A method according to claim 7, further comprising the step of extracting electric myographic component from said second signal as an EMG partial signal, and electroencephalographic component as an EEG partial signal.

9. A method according to claim 8, wherein the quantity for said second parameter value is a spectral power calculated from said EMG partial signal.

10. A method according to claim 7, wherein the quantity for said second parameter value is a subtraction of a response entropy, calculated from said second signal as a whole, and a state entropy, calculated from said EEG partial signal.

11. A method according to claim 1, wherein said first signal concerning cardiovascular activity is a cardiac excitation measured non-invasively using electrocardiogram.

12. A method according to claim 11, wherein the quantity for said first parameter value is a heart rate or inter beat interval of the electrical excitation.

13. A method according to claim 1, further comprising the steps of:

acquiring online a third signal representing a cardiovascular activity of the patient;

deriving, from said third signal, a fourth parameter value related to a quantity selected from a group of quantities including waveform amplitudes, waveform periodicity, waveform morphology, and waveform variability; and

introducing said at least fourth parameter in said predetermined mathematical index as an additional variable.

14. A method according to claim 13, wherein the quantity for said first parameter value is a heart rate or inter beat interval of the electrical excitation.

15. A method according to claim 1, wherein said mathematical index for probability is a nonlinear equation.

16. A method according to claim 1, wherein said mathematical index for probability is a neural network algorithm.

17. A method according to claim 1, wherein said mathematical index for probability is based on a defined or fuzzy rule-based reasoning procedure.

18. A method according to claim 1, further comprising the step of normalizing said first and second parameter values on the basis of their respective parameter values acquired over a predetermined fixed time window including or excluding the latest real-time parameter value.

19. A method according to claim 1, wherein said biopotential measurements are selected from electroencephalography, electromyography, and skin conductivity measurements.

20. A method for monitoring a condition of a patient under anesthesia or sedation, the method comprising the steps of:

acquiring at least a first signal representing a cardiovascular activity of the patient and a second signal representing a combined electrical biopotential obtained by a plurality of biopotential measurements on skull activity of the patient;

deriving, with a microprocessor, from said first signal, at least a first parameter value;

calculating, with a microprocessor, from said second signal, at least a second parameter value;

applying, with a microprocessor, a predetermined mathematical index for probability of patient comfort, in which index said at least first and second parameters are variables;

calculating, with a microprocessor, successively changing values of said mathematical index;

indicating the condition of the patient under anesthesia or sedation with said successive index values; and

normalizing said first and second parameter values on the basis of their respective parameter values acquired over a predetermined fixed time window including or excluding a latest real-time parameter value, wherein said normalized parameter values are acquired from;

said patient prior to incision, or prior to intubation, or prior to starting anesthesia or sedation, or

a group of patients prior to or during incision and/or intubation and/or anesthesia or sedation.