Method and apparatus for facilitating recovery of patients in deep coma

• US 5,611,350 A
• Filed: 02/08/1996
• Issued: 03/18/1997
• Est. Priority Date: 02/08/1996
• Status: Expired due to Fees

• Current Assignee: Michael S. John
• Original Assignee: Michael S. John
• Inventors: John, Michael S.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): HUANG, STEPHEN D
• Application Number:
  US08/598,376
• Time in Patent Office: 404 Days
• Field of Search: 128/731, 128/732, 128/733, 128/642, 607/2, 607/3, 607/45, 607/53, 607/54, 607/55, 607/56
• US Class Current: 600/378
• CPC Class Codes: A61B 5/377 using evoked responses
• CPC Class Codes: A61B 5/383 Somatosensory stimuli, e.g. electric stimulation
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36103 Neuro-rehabilitation; Repair or reorganisation of neural tissue, e.g. after stroke

Abstract

In a medical procedure to treat a patient in a deep coma, an electrode is implanted on the vagus nerve (tenth cranial nerve) in the patient'"'"'s neck. A selected pulse train is generated and applied to the electrode as a treatment for the deep coma. The patient'"'"'s brain waves are collected, amplified and digitized before, during and after the treatment, and compared, using a computer system, against a reference (the patient or/and a normal group) to determine if the treatment is helping the patient.

Claims

1. A method for treatment of deep coma of a patient, including the steps of:

(a) surgically attaching an electrode to a cranial nerve of the patient, the electrode having electrical leads connected thereto;

(b) generating a selected pulse train of electrical pulses and applying the pulse train through the electrical leads to the electrode;

(c) deriving the patient'"'"'s brain waves, after the application of the pulse train, using EEG electrodes removably secured to the patient'"'"'s scalp;

(d) amplifying and analyzing in a computer system, the derived brain waves by comparison against a reference;

(e) based on the brain wave analysis, either continuing, discontinuing or changing the selected pulse train; and

(f) stopping the application of the pulse train if the patient'"'"'s vital signs decline into a dangerous range.

2. A method as in claim 1 herein the cranial nerve is the vagus nerve.

3. A method as in claim 1 and, after the application of the pulse train, stimulating senses of the patient to evoke the brain waves.

4. A method as in claim 1 and deriving the patient'"'"'s brain waves, using EEG electrodes, prior to application of the pulse train, and using the pre-application derived brain waves as a reference in (d).

5. A method as in claim 4 wherein the reference in (d) includes brain waves derived from a normal group of patients.

6. A method as in claim 5 wherein the derived brain waves are on-going EEG brain waves, or evoked EP brain waves, or both EEG and EP.

7. A method as in claim 1 wherein the reference in (d) includes brain waves derived from normal group of patients.

8. A method as in claim 1 wherein the derived brain waves are on-going EEG brain waves, or evoked EP brain waves, or both EEG and EP.

9. A method as in claim 1 and deriving the patient'"'"'s brain waves, using EEG electrodes, during the application of the pulse train and analyzing the so derived brain waves by comparison against a reference.

10. A method for treatment and monitoring of deep coma comprising:

(a) surgically removably attaching an electrode to a cranial nerve of a patient;

(b) removably connecting at least one EEG electrode to the patient'"'"'s scalp;

(c) presenting a set of stimuli to the patient and amplifying and digitizing brain wave evoked responses to the stimuli and the patient'"'"'s ongoing brain wave activity collected from the EEG electrode to provide a first set of digital data representing the patient'"'"'s brain waves in the patient'"'"'s pre-treatment state and recording a first set of digital data in computer system memory;

(d) generating a selected pulse train of electrical pulses and applying the pulse train to the electrode as a treatment of the patient'"'"'s deep coma;

(e) stopping the application of the pulse train of (d) if the patient'"'"'s vital signs decline into a dangerous range;

(f) after the treatment of (d), presenting another set of stimuli to the patient, which is the same as the set of stimuli presented in (c), and amplifying and digitizing the brain wave responses to the stimuli and the patient'"'"'s on-going brain wave activity to provide a second set of digital data;

(g) using a computer system and statistically comparing the first and second sets of digital data on a measure-by-measure basis; and

(h) adjusting the pulse train applied to the electrode in a subsequent treatment in response to the comparison of (f) to help bring the patient out of the deep coma.

11. A method as in claim 10 and also statistically comparing the second set of data with a normative reference database based on a pre-selected group of normal persons.

12. The method of claim 11 and wherein statistically comparing the second set of data with the normative reference database also includes taking into account factors of weight, age and sex of the patient.

13. The method of claim 10 wherein stimuli for one or more modalities are presented, said modalities including (i) auditory modality and evoked responses are auditory responses (Audio Evoked Response), (ii) sensory modality and the evoked responses are brainstem somatosensory evoked responses (BSER), or (iii) visual modality.

14. The method of claim 10 wherein measures of ongoing EEG and the measures of the brainwave evoked response include at least one of the following measures for at least one user specified band:

absolute power, relative power and coherence between a user specified set of electrodes.

15. The method of claim 10 wherein the measures of the brainwave evoked response include at least one of the following measures for user specified set of electrodes:

signal strength, variability and interhemispheric symmetry.