Objective pain measurement system and method

• US 6,757,558 B2
• Filed: 07/05/2001
• Issued: 06/29/2004
• Est. Priority Date: 07/06/2000
• Status: Expired due to Fees

• Current Assignee: Algodyne Limited
• Original Assignee: Algodyne Limited
• Inventors: Lewinsky, Reuven, Lange, Daniel H.
• Primary Examiner(s): Jones, Mary Beth
• Assistant Examiner(s): Mallari, Patricia C.
• Application Number:
  US09/899,824
• Publication Number:
  US 20020107434A1
• Time in Patent Office: 1,090 Days
• Field of Search: 600/300-301, 600/345, 600/544-547, 600/557
• 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 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/4824 Touch or pain perception evaluation A61B5/4821 takes precedence
• CPC Class Codes: A61B 5/483 by thermal stimulation
• CPC Class Codes: A61B 5/6833 Adhesive patches

Abstract

Methods, apparatuses and systems relating to the objective measurement of the subjective perception of pain in a subject are disclosed. In one aspect, a system for objectively measuring a subjective perception of pain by a subject comprises a plurality of electrodes, including a left channel electrode and a right channel electrode. The plurality of electrodes measures electrical activity at a respective plurality of sites on the subject to generate at least two sets of electrical activity measurements. The system further comprises a processor for processing the at least two sets of electrical activity measurements into at least two normalized signals, and comparing the at least two normalized signals to each other to identify the presence of pain in the subject.

Claims

1. A system for objectively measuring a subjective sensation of pain by a subject comprising:

(a) a plurality of sensors for measuring electrical activity at a respective plurality of sites on the subject to generate a set of electrical activity measurements; and

(b) a processor connected to the plurality of sensors for processing the set of electrical activity measurements into a normalized signal, determining a level value for the normalized signal within a predetermined range of frequencies, and scaling the level value for the signal into an objective measurement of a subjective perception of pain.

2. The system of claim 1, wherein the level value for the normalized signal comprises a measurement of the power spectrum of the normalized signal.

3. The system of claim 1, wherein the predetermined range of frequencies is from about 0.1 Hertz to about 5 Hertz.

4. The system of claim 3, wherein the level value for the normalized signal comprises a measurement of the power spectrum of the normalized signal.

5. The system of claim 1, wherein the processor processes the electrical activity measurements by normalizing the set of electrical activity measurements into a set of normalized values, applying digital filtering to the set of normalized values, and specifying the normalized signal from the set of normalized values.

6. The system of claim 5, wherein the processor normalizes the set of electrical activity measurements into a set of normalized values by subtracting a mean of the electrical activity measurements and dividing by a standard deviation of the electrical activity measurements from the electrical activity measurements.

7. The system of claim 6, wherein the level value for the normalized signal comprises a measurement of the power spectrum of the normalized signal.

8. The system of claim 7, wherein the predetermined range of frequencies is from about 0.1 Hertz to about 5 Hertz.

9. The system of claim 1, wherein the processor comprises an analog processor.

10. A system for objectively measuring a subjective sensation of pain in a subject comprising:

(a) means for measuring electrical activity at a respective plurality of sites on the subject to generate a set of electrical activity measurements;

(b) processing means for processing the set of electrical activity measurements into a normalized signal, and determining a level value for the normalized signal within a predetermined range of frequencies; and

(c) means for scaling the value for the signal into an objective measurement of a subjective perception of pain.

11. A method of objectively measuring a level of pain subjectively perceived by a subject comprising the steps of:

(a) selecting a plurality of sites on the subject for sensing electrical activity;

(b) making electrical activity measurements for the plurality of sites;

(c) processing the electrical activity measurements into a normalized signal;

(d) determining a level value for the normalized signal within a predetermined range of frequencies; and

(e) scaling the level value for the normalized signal into an objective measurement of a subjective perception of pain.

12. The method of claim 11, wherein steps (b) through (d) comprise analog processing.

13. The method of claim 11, wherein the level value for the normalized signal comprises a measurement of the power spectrum of the normalized signal.

14. The method of claim 11, wherein the predetermined range of frequencies is from about 0.1 Hertz to about 5 Hertz.

15. The method of claim 14, wherein the level value for the normalized signal comprises a measurement of the power spectrum of the normalized signal.

16. The method of claim 11, wherein the processing step further comprises normalizing the set of electrical activity measurements into a set of normalized values, applying digital filtering to the set of normalized values, and specifying the normalized signal from the set of normalized values.

17. The method of claim 16, wherein the level value for the normalized signal comprises a measurement of the power spectrum of the normalized signal.

18. The method of claim 17, wherein the predetermined range of frequencies is from about 0.1 Hertz to about 5 Hertz.

19. A network for objectively measuring pain subjectively perceived by subjects comprising:

(a) at least one signal acquisition subsystem for making electrical activity measurements at a respective plurality of sites on each of the subjects;

(b) a signal processing subsystem for analyzing the electrical activity measurements and for determining analysis values representing pain measurements for different periods of time; and

(c) a communication link linking the signal processing subsystem and the at least one signal acquisition subsystem for transmitting the electrical activity measurements of subjects to the signal processing subsystem, wherein the signal acquisition subsystem comprises;

(i) a memory for storing the electrical activity measurements; and

(ii) a processor connected to the memory for processing the electrical activity measurements into a normalized signal, determining a level value for the normalized signal within a predetermined range of frequencies, and scaling the level value for the signal into an objective measurement of a subjective perception of pain comprising one of the analysis values.

20. A computer-readable medium having stored therein one or more sequences of instructions for objectively measuring a subjective perception of pain in a subject, said one or more sequences of instructions causing one or more processors to perform a plurality of acts, said acts comprising:

(a) reading electrical activity measurements from a plurality of sites on the subject;

(b) processing the electrical activity measurements into a normalized signal;

(c) determining a level value for the normalized signal within a predetermined range of frequencies; and

(d) scaling the level value for the normalized signal into an objective measurement of a subjective perception of pain.

21. The computer-readable medium of claim 20, wherein the level value for the normalized signal comprises a measurement of the power spectrum of the normalized signal.

22. The computer-readable medium of claim 20, wherein the predetermined range of frequencies is from about 0.1 Hertz to about 5 Hertz.

23. The computer-readable medium of claim 22, wherein the level value for the normalized signal comprises a measurement of the power spectrum of the normalized signal.

24. The computer-readable medium of claim 20, wherein the processing step is performed by normalizing the set of electrical activity measurements into a set of normalized values, applying digital filtering to the set of normalized values, and extracting the normalized signal from the set of normalized values.

25. The computer-readable medium of claim 24, wherein the level value for the normalized signal comprises a measurement of the power spectrum of the normalized signal.

26. The computer-readable medium of claim 25, wherein the predetermined range of frequencies is from about 0.1 Hertz to about 5 Hertz.

27. A system for objectively measuring a subjective sensation of pain by a subject comprising:

(a) a plurality of sensors comprising a left channel electrode and a right channel electrode, for measuring electrical activity at a respective plurality of sites on the subject to generate at least two sets of electrical activity measurements; and

(b) a processor connected to the plurality of sensors for processing the at least two sets of electrical activity measurements into at least two normalized signals, and comparing the at least two normalized signals to each other to detect the sensation of pain experienced by the subject, wherein the processor compares the at least two normalized signals by measuring linearity and correlation between the at least two normalized signals.

28. The system of claim 27, the processor determining a level value within a predetermined range of frequencies for one of the at least two normalized signals.

29. The system of claim 28, wherein the level value comprises a measurement of the power spectrum.

30. The system of claim 28, wherein the predetermined range of frequencies is from about 0.1 Hertz to about 5 Hertz.

31. The system of claim 27, the processor measuring linearity between the at least two normalized signals by determining a coherence value between the at least two normalized signals, and measuring correlation between the at least two normalized signals by determining a correlation coefficient for the at least two normalized signals.

32. The system of claim 27, the processor registering the subjective perception of pain by the subject when the coherence value exceeds a predetermined linearity threshold and the correlation coefficient exceeds a predetermined correlation threshold.

37. The system of claim 27, wherein the left channel electrode is for positioning on a left side of the subject'"'"'s forehead and the right channel electrode is for positioning on a right side of the subject'"'"'s forehead.

38. The system of claim 32, the processor determining a level value within a predetermined range of frequencies for one of the at least two normalized signals.

33. A network for objectively measuring pain subjectively perceived by subjects comprising:

(a) at least one signal acquisition subsystem for making electrical activity measurements at a respective plurality of sites on each of the subjects;

(b) a signal processing subsystem for analyzing the electrical activity measurements and for determining analysis values representing pain measurements for different periods of time; and

(c) a communication link linking the signal processing subsystem and the at least one signal acquisition subsystem for transmitting the electrical activity measurements of subjects to the signal processing subsystem, wherein the signal acquisition subsystem comprises;

(i) a sensor array for obtaining an electrical signal at a site on the subject;

(ii) an amplifier connected to the sensor array for amplifying the signal;

(iii) a band-pass filter connected to the amplifier for at least partially removing components of the signal below about 0.1 Hertz and above about 5 Hertz;

(iv) an analog-to-digital converter connected to the band-pass filter for converting the signal into a set of discrete values comprising the electrical activity measurements;

(v) a memory for storing the electrical activity measurements; and

(vi) a processor connected to the memory for processing the electrical activity measurements into a normalized signal, determining a level value for the normalized signal within a predetermined range of frequencies, and scaling the level value for the signal into an objective measurement of a subjective perception of pain comprising one of the analysis values.

34. The system of claim 33, wherein the level value comprises a measurement of the power spectrum.

35. The system of claim 34, wherein the left channel electrode is for positioning on a left side of the subject'"'"'s forehead and the right channel electrode is for positioning on a right side of the subject'"'"'s forehead.

36. The system of claim 35, wherein the predetermined range of frequencies is from about 0.1 Hertz to about 5 Hertz.

39. A method of objectively measuring pain subjectively experienced by a subject, the method comprising the steps of:

(a) selecting a plurality of sites on the subject for sensing electrical activity;

(b) making electrical activity measurements for the plurality of sites;

(c) processing the electrical activity measurements into at least two normalized signals;

(d) comparing the at least two normalized signals to each other to identify a presence of pain in the subject, wherein the comparing step comprises measuring linearity and correlation between the at least two normalized signals.

40. The method of claim 39, further comprising a step of determining a level value within a predetermined range of frequencies for one of the at least two normalized signals.

41. The method of claim 40, wherein the level value comprises a measurement of the power spectrum.

42. The method of claim 40, wherein the predetermined range of frequencies is from about 0.1 Hertz to about 5 Hertz.

43. The method of claim 39, wherein the linearity between the at least two normalized signals is measured by determining a coherence value between the at least two normalized signals, and wherein the correlation between the at least two normalized signals is measured by determining a correlation coefficient for the at least two normalized signals.

44. The method of claim 43, wherein a subjective perception of pain by the subject is registered when the coherence value exceeds a predetermined linearity threshold and the correlation coefficient exceeds a predetermined correlation threshold.

45. The method of claim 44, further comprising a step of determining a level value within a predetermined range of frequencies for one of the at least two normalized signals.

46. The method of claim 45, wherein the level value comprises a measurement of the power spectrum.

47. The method of claim 46, wherein one of the at least two normalized signals relates to electrical activity measurements on a left side of the subject'"'"'s forehead and a second of the at least two normalized signals related to electrical activity measurements on a right side of the subject'"'"'s forehead.

48. The method of claim 47, wherein the predetermined range of frequencies is from about 0.1 Hertz to about 5 Hertz.

49. The method of claim 39, wherein one of the at least two normalized signals relates to electrical activity measurements on a left side of the subject'"'"'s forehead and a second of the at least two normalized signals related to electrical activity measurements on a right side of the subject'"'"'s forehead.

50. A computer-readable medium having stored therein one or more sequences of instructions for objectively evaluating a subjective sensation of pain in a subject, said one or more sequences of instructions causing one or more processors to perform a plurality effects, said acts comprising:

(a) reading electrical activity measurements from a plurality of sites on the subject;

(b) processing the electrical activity measurements into at least two normalized signals; and

(c) comparing the at least two normalized signals to each other to identify a presence of pain in the subject, wherein the comparing step comprises measuring linearity and correlation between the at least two normalized signals.

51. The computer-readable medium of claim 50, said acts further comprising determining a level value within a predetermined range of frequencies for one of the at least two normalized signals.

52. The computer-readable medium of claim 51, wherein the level value comprises a measurement of the power spectrum of the one of the at least two normalized signals.

53. The computer-readable medium of claim 52, wherein the predetermined range of frequencies is from about 0.1 Hertz to about 5 Hertz.

54. The computer-readable medium of claim 50, wherein one of the at least two normalized signals relates to electrical activity measurements on a left side of the subject'"'"'s forehead and a second of the at least two normalized signals related to electrical activity measurements on a right side of the subject'"'"'s forehead.

55. The computer-readable medium of claim 50, wherein the linearity between the at least two normalized signals is measured by determining a coherence value between the at least two normalized signals, and wherein the correlation between the at least two normalized signals is measured by determining a correlation coefficient for the at least two normalized signals.

56. The computer-readable medium of claim 55, wherein a subjective perception of pain by the subject is registered when the coherence value exceeds a predetermined linearity threshold and the correlation coefficient exceeds a predetermined correlation threshold.

57. The computer-readable medium of claim 56, said acts further comprising determining a level value within a predetermined range of frequencies for one of the at least two normalized signals.

58. The computer-readable medium of claim 57, wherein the level value comprises a measurement of the power spectrum of the one of the at least two normalized signals.

59. The computer-readable medium of claim 58, wherein one of the at least two normalized signals relates to electrical activity measurements on a left side of the subject'"'"'s forehead and a second of the at least two normalized signals related to electrical activity measurements on a right side of the subject'"'"'s forehead.

60. The computer-readable medium of claim 59, wherein the predetermined range of frequencies is from about 0.1 Hertz to about 5 Hertz.