Devices and methods for the non-invasive detection of spontaneous myoelectrical activity

• US 7,493,157 B2
• Filed: 10/24/2002
• Issued: 02/17/2009
• Est. Priority Date: 10/24/2001
• Status: Expired due to Fees

• Current Assignee: Neurometrix, Inc.
• Original Assignee: Neurometrix, Inc.
• Inventors: Keller, Steven P., Gozani, Shai N.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US10/279,662
• Publication Number:
  US 20040225211A1
• Time in Patent Office: 2,308 Days
• Field of Search: 600/546
• US Class Current: 600/546
• CPC Class Codes: A61B 5/30 Input circuits therefor
• CPC Class Codes: A61B 5/313 for electromyography [EMG]

Abstract

A method of detecting neuromuscular pathology in an individual is disclosed comprising the steps of placing a detector on the skin surface of the individual substantially adjacent to a skeletal muscle; obtaining signals from the detector; processing the signals; and determining neuromuscular status in response to the signals. A system for detecting neuromuscular disease in an individual is disclosed, the system comprising at least one means for recording a first signal from a skeletal muscle; a filter in communication with the recording means to generate a second signal consisting substantially of spontaneous myoelectrical activity; and a processor in communication with the filter, wherein the first signal from the skeletal muscle is filtered so as to generate spontaneous myoelectrical signals, and further wherein the processor calculates the power spectral density of the filtered signals and determines the neuromuscular status in response to the power spectral density of the filtered signals.

Claims

1. A method of non-invasively detecting neuromuscular pathology in an at-rest individual comprising the steps of:

(a) placing on the skin surface of said individual substantially adjacent to a target skeletal muscle a detector capable of detecting both neurogenic and spontaneous myoelectrical activity;

(b) obtaining a first signal output from said detector that comprises bioelectrical signals representing the presence of both neurogenic and spontaneous myoelectrical activity within proximity of said skeletal muscle;

(c) processing said first signal output to remove any signals representative of neurogenic myoelectrical activity, whereby to produce a second signal output;

(d) processing said second signal output to identify any signals representative of spontaneous myoelectrical activity in said target muscle; and

(e) determining from said processed second signal output neuromuscular status of said target muscle.

2. The method of claim 1 wherein said second signal output comprises spontaneous myoelectrical activity within a frequency range of 100 to 500 Hz.

3. The method of claim 1 wherein step (c) comprises removing external electrical interference signals from said recorded signals.

4. The method of claim 1 wherein step (c) also comprises removing at least one signal generated from at least one muscle other than said skeletal muscle from said first signal output.

5. The method of claim 1 wherein said processing step (d) comprises determining a power spectral density of said second signal output.

6. The method of claim 5 wherein said power spectral density is determined over a particular frequency range.

7. The method of claim 6 wherein said range is between 100-500 Hz.

8. The method of claim 6 wherein said range is between 300-500 Hz.

9. The method of claim 1 wherein said step (e) comprises comparing at least one characteristic of the processed second signal output against at least one reference value for each of said at least one characteristic.

10. The method of claim 9 wherein step (d) further comprises deriving said at least one characteristic from a power spectral density measurement of said processed second signal output.

11. The method of claim 9 wherein a difference in said at least one characteristic of the processed second signal output as compared to the at least one reference value is an indicator of neuromuscular pathology.

12. The method of claim 5 further comprising displaying the power spectral density of said second signal output.

13. The method of claim 1 further comprising displaying a relative value quantifying the degree of neuromuscular pathology in response to the step of determining neuromuscular status.

14. The method of claim 1 wherein the neuromuscular disease is selected from the group of diseases consisting of radiculopathies, demyelinating neuropathies, intravertebral disc disease, and carpal tunnel syndrome.

15. The method of claim 1 further comprising comparing said processed second signal output at a first point in time to the processed signal output of the individual at a second point in time to monitor the progression of the neuromuscular pathology.

16. A method of detecting neuromuscular disease in an individual comprising the steps of:

measuring a bioeletrically-generated first signal output from a detector positioned on the skin surface and substantially adjacent to a target skeletal muscle of an individual at rest;

removing noise from said first signal output to generate a second signal output consisting substantially of myoelectrical activity;

processing said second signal output to derive a third signal output free of neurogenic myoelectrical activity; and

determining the neuromuscular status of said individual in response to said processed signal output.

17. The method of claim 16 wherein said noise comprises electrical signals having a frequency less than 0.1 Hz and a electrical signals having a frequency greater than 10 kHz.

18. The method of claim 16 wherein said third signal output also is subjected to a power spectral analysis, and further wherein a given difference in a power spectral density measurement of said third signal output as compared to a reference value is indicative of neuromuscular disease.

19. The method of claim 18 further comprising displaying a power spectral density measurement of said third signal output.

20. The method of claim 16 further comprising determining and displaying a relative value quantifying the degree of neuromuscular disease.

21. A system for detecting neuromuscular disease in an individual, said system comprising:

a detector positionable on the skin surface of said individual substantially adjacent to a target skeletal muscle and capable of sensing myoelectric activity via said skin surface and generating a first electrical signal output representative of said myoelectric activity;

at least one means for recording said first signal output from said detector;

a filter in communication with said recording means for generating from said first signal output a second signal output consisting substantially of signals representative of spontaneous myoelectrical activity; and

a processor in communication with said filter, said processor being programmed to (a) cause said first signal output from said skeletal muscle to be filtered so as to consist substantially of spontaneous myoelectrical signals, (b) calculates the power spectral density of the filtered second signal output and (c) determine the neuromuscular status in response to the power spectral density of the filtered second signals output.

22. A system for detecting neuromuscular disease in an individual, said system comprising:

at least one surface recording electrode placed on the skin surface of the individual for detecting bioelectrical potentials in response to myoelectrical activity of a skeletal muscle and to generate a first electrical signal output representative of said potentials;

means for processing said first signal output to generate a second signal output consisting substantially of signals representative of spontaneous myoelectrical activity; and

a processor for processing said second signal output and calculating the power spectral density of said signals representative of said spontaneous myoelectrical activity and for determining the presence of disease in skeletal muscle or the presence of nerve innervating skeletal muscle in the individual in response to said power spectral density of said signals representative of said spontaneous myoelectrical activity.

23. The system of claim 22 further including means for removing from said first signal output noise in a first frequency range below about 0.1 Hz and in a second frequency range above about 10,000 Hz.

24. A method of non-invasively detecting neuromuscular pathology in an at-rest individual comprising the steps of:

(a) placing a bioelectric signal detector on the skin surface of an at-rest individual substantially adjacent or proximate to a target skeletal muscle of that individual;

(b) using said detector to detect and capture myoelectric signals from said individual while said individual is at rest;

(c) filtering said myoelectric signals to eliminate signals having a frequency less than 0.1 Hz and greater than 10 kHz;

(d) processing said filtered myoelectric signals via a plurality of transformations to improve the signal-to-noise ratio of said signals;

(e) further processing said myoelectric signals to identify and remove any neurogenic myoelectric signal activity;

(f) subjecting said myoelectric signals to spectral analysis to determine the power spectral density of said signals; and

(g) using said power spectral density to determine the presence and extent of neuromuscular pathology of said target muscle.

25. Method according to claim 24 wherein step (f) comprises determining the power spectral density of said myoelectric signals within a frequency band of 100 to 500 Hz.

26. Method according to claim 24 wherein said step (g) comprises comparing the power spectral density of said myoelectric signals to one or more characteristics of myoelectric signals detected at a second point in time.

27. Method according to claim 25 wherein said step (g) comprises comparing the power spectral density of said myoelectric signals to a reference value.

28. Method according to claim 25 wherein said step (c) also comprises amplifying said myoelectric signals by a factor in the order of thousands.