Ambulatory electroencephalography system

• US 5,222,503 A
• Filed: 04/24/1991
• Issued: 06/29/1993
• Est. Priority Date: 04/24/1991
• Status: Expired due to Term

• Current Assignee: BETH Israel Hospital Association A Non-Profit Corporation of MA
• Original Assignee: BETH Israel Medical Center (Mount Sinai Beth Israel)
• Inventors: Mainwaring, Norman R., Ives, John R.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US07/690,733
• Time in Patent Office: 797 Days
• Field of Search: 128/731-732
• US Class Current: 600/544
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy

Abstract

An ambulatory electroencephalography (EEG) system includes a self-powered recording apparatus adapted to be worn by a patient. The recording apparatus includes an A/D converter and a digital memory capable of storing digital data representing analog waveform signals derived from a large number of electrodes secured to the patient. Recording of digital waveform data is governed by a controller, which upon the occurrence of a neurologically significant event (such as actuation of a switch by the patient or detection of EEG waveforms indicating a seizure state) causes the storage of waveform data over an interval immediately preceding the event and immediately following the event.

Claims

1. A system for unattended ambulatory neurological monitoring of a patient comprising a neurological signal recording apparatus adapted to be worn by a patient during a monitoring procedure and operable when worn without electrical connection to any apparatus not worn by the patient, said recording apparatus including:

an input means for receiving a plurality of analog EEG signals, each derived from one pair of a plurality of pairs of electrodes coupled to a patient'"'"'s head;

an A/D converter means having a converter input coupled to the apparatus input means and a converter output, said A/D converter means producing digital signals at said converter output which represent the waveforms of analog signals received at said converter input;

a digital memory means coupled to said converter output for storing digital data representing the waveforms of said analog EEG signals, said memory means storing all stored signals in digital form;

a controller means for controlling the storage of data in said memory means, said controller means causing temporary storage of data in said memory means representing the waveforms of EEG signals occurring over a predetermined interval of time representing a pre-event data storage interval and causing the periodic updating of the temporarily stored data to correspond with the data occurring in the predetermined interval immediately preceding each updating, said controller means further causing, upon the occurrence of a predetermined event, the permanent storage of data in said memory means including the temporarily stored data which represents the waveforms of EEG signals occurring over the pre-event data storage interval of time immediately preceding the event and data representing the waveforms of EEG signals occurring over an interval of time immediately following the event;

a self-contained power source means for providing operating power for said recording apparatus; and

an output means coupled to said memory means for outputting digital waveform data derived from said stored data.

2. A system according to claim 1, wherein said recording apparatus includes a switch coupled to said controller means, and said predetermined event is actuation of said switch by said patient.

3. A system according to claim 1, wherein said recording apparatus includes a clock coupled to said controller means, and said controller means causes the storage of digital data representing the waveforms of EEG signals upon receipt by said controller means of a signal from said clock.

4. A system according to claim 1, wherein said recording apparatus includes signal processing apparatus coupled to said input and to said controller means, and said predetermined event is detection by said signal processing apparatus of predetermined electrical signals occurring at said input.

5. A system according to claim 4, wherein said signal processing apparatus includes means for detecting EEG signals corresponding to a waveform spike or a patient seizure.

6. A system according to claim 1, wherein said digital memory means is a semiconductor memory.

7. A system according to claim 6, wherein said digital memory means comprises static RAM.

8. A system according to claim 1, wherein said digital memory means comprises a magnetic disc.

9. A system according to claim 1, wherein said system includes artifact reduction means for reducing storage of data representing patient movement artifacts.

10. A system according to claim 9, wherein said artifact reduction means includes a digital memory which is unaffected by the patient'"'"'s physical movement.

11. A system according to claim 9, wherein said artifact reduction means includes an electrical signal filter to remove EMG signal components.

12. A system according to claim 11, wherein said filter comprises an analog filter coupled to said input for filtering analog electrical signals.

13. A system according to claim 11, wherein said filter comprises a digital filter for receiving digital signals derived from said converter and producing filtered digital output signals.

14. A system according to claim 9, wherein said system includes a plurality of electrodes adapted to be coupled to a patient'"'"'s body, and includes means for coupling neurological electrical signals generated by said patient to said recording apparatus input.

15. A system according to claim 14, wherein said artifact reduction means includes said coupling means.

16. A system according to claim 15, wherein said coupling means includes at least one amplifier having an input receiving said neurological signals and an output coupled to said recording apparatus input.

17. A system according to claim 16, wherein said amplifier is adapted to be mounted to the patient'"'"'s head, whereby said amplifier input is close to electrodes to which it is coupled.

18. A system according to claim 17, wherein said coupling means includes a communication channel coupled to said recording apparatus input, and includes multiplexing means mounted to the patient'"'"'s head and coupled to said amplifier for coupling neurological electrical signals from a plurality of said electrodes to said communication channel.

19. A system according to claim 15, wherein said amplifier is mounted in an enclosure having a curved surface having a radius of curvature in the range of about 2 inches to about 5 inches, whereby said enclosure may be placed adjacent the patient'"'"'s head and generally conform to the surface thereof.

20. A system according to claim 14, wherein said artifact reduction means includes means for securing at least a portion of said coupling means to said patient'"'"'s head.

21. A system according to claim 14, wherein said artifact reduction means includes adhesive means for securing said electrodes to said patient.

22. A system, according to claim 1, wherein said digital memory means includes means for separately storing data representing neurological electrical signals derived from at least 16 electrodes.

23. A system according to claim 1, wherein said digital memory means includes a storage capacity of at least about 1 Megabyte.

24. A system according to claim 23, wherein said digital memory means includes a storage capacity of at least about 4 Megabytes.

25. A system according to claim 1, wherein said recording apparatus includes means for simultaneously receiving and recording both EEG waveform signals and EKG signals.

26. A system according to claim 1, wherein said system includes a portable auxiliary computer system including auxiliary digital memory and not adapted to be worn by the patient, and also includes means for coupling said recording apparatus output to said auxiliary computer system for interchanging digital data between them.

27. A system according to claim 1, wherein said system includes a digital display generator means for receiving digital data stored in said recording apparatus and to generate a graphic digital display corresponding to received data.

28. A system according to claim 27, wherein said graphic digital display includes a graphic representation of EEG or EKG waveforms.

29. A system according to claim 27, wherein said digital display includes text representing information relating to said patient or to the neurological monitoring procedure performed on said patient.

30. A system according to claim 27, wherein said digital display generator means includes a laser printer.

31. A system according to claim 27, wherein said graphic display includes a representation of locations of said electrodes on said patient during the monitoring procedure.

32. A system according to claim 1, wherein said system includes means for storing data relating to said patient or to the neurological monitoring procedure performed on said patients.

33. A method of determining the neurological condition of a patient comprising the steps of:

a. when a patient is in a first location, securing a plurality of electrodes to the patient, said electrodes producing analog neurological electrical signals relating to said patient;

b. securing a recording apparatus including a digital memory to said patient;

c. coupling said electrodes to said recording apparatus;

d. when the patient is in a second location different from the first location, recording digital data in said memory including data responsive to said analog neurological electrical signals produced by said patient;

e. when the recording apparatus is in a third location, transferring digital data stored in recording step d to a computer system including a graphic display generator; and

f. generating a graphic digital display representing data transferred to said computer system in step e.

34. A method according to claim 33, wherein said first location and said third location are the same.

35. A method according to claim 33, wherein said securing step a includes securing at least about 16 electrodes to the patient'"'"'s head.

36. A method according to claim 35, wherein said securing step a further includes securing at least one electrode to the patient'"'"'s chest adjacent the patient'"'"'s heart.

37. A method according to claim 33, wherein said securing step a includes gluing electrodes to said patient'"'"'s skin.

38. A method according to claim 37, wherein said predetermined conditions include derived signals corresponding spike or seizure conditions of said patient.

39. A method according to claim 33, wherein said coupling step includes providing one or more conductors coupled to said electrodes and to said recording apparatus, and securing at least a portion of said conductors to said patient.

40. A method according to claim 33, wherein said securing step b includes securing to said patient a recording apparatus having a memory size of at least about 1 Megabyte.

41. A method according to claim 33, wherein said coupling step includes amplification of analog neurological electrical signals.

42. A method according to claim 41, wherein said coupling step includes disposing an amplifier contained in a curved housing, having a radius of curvature of between about 2 inches and about 5 inches, adjacent said patient'"'"'s head.

43. A method according to claim 33, wherein said coupling step includes multiplexing of electrical signals derived from a plurality of said electrodes into a single communication channel.

44. A method according to claim 33, wherein said recording step includes an EMG signal filtration step.

45. A method according to claim 33, wherein said filtration step includes digital filtering.

46. A method according to claim 33, wherein said recording step includes recording digital data responsive to said analog electrical signals occurring over a period of at least about 12 hours.

47. A method according to claim 33, wherein said recording step includes recording data in response to a recording signal provided by said patient.

48. A method according to claim 33, wherein said recording step includes analyzing signals derived from said analog neurological electrical signals, and recording data in response to predetermined conditions of said derived signals.

49. A method according to claim 33, wherein said recording step includes intermittently recording data at predetermined times.

50. A method according to claim 33, wherein said display generating step includes generating a laser printed output.

51. A method according to claim 33, wherein said display generating step includes generating a graphic representation of EEG or EKG waveforms.

52. A method according to claim 33, wherein said display generating step includes generating text representing information relating to said patient or the neurological monitoring procedure performed on said patient.

53. A method according to claim 52, wherein said display generating step includes generating a graphic representation of the locations of said electrodes on said patient during said monitoring procedure.