EMG electrode apparatus and positioning system

• US 7,363,069 B2
• Filed: 10/20/2006
• Issued: 04/22/2008
• Est. Priority Date: 10/05/1998
• Status: Expired due to Fees

• Current Assignee: Vdi Acquisition Corp.
• Original Assignee: SpineMatrix, Inc.
• Inventors: Hitchcock, Richard L., Alexander, B. Russell, Finneran, Mark T., Alexander, Kathryn E., Wickham, Charles E. Jr., Howard, Scott D.
• Primary Examiner(s): Cohen; Lee S.
• Application Number:
  US11/551,294
• Publication Number:
  US 20070118032A1
• Time in Patent Office: 550 Days
• Field of Search: 600/392, 600/393
• US Class Current: 600/393
• CPC Class Codes: A61B 2562/0215 Silver or silver chloride containing
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/30 Input circuits therefor
• CPC Class Codes: A61B 5/313 for electromyography [EMG]
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses

Abstract

A system for detecting and analyzing electrical activity in the anatomy of an organism underlying an electrode array provides signals corresponding to electrical activity adjacent each electrode. Such signals are correlated to the underlying anatomy of the organism and representative outputs presented through various types of output devices. Such outputs may include variations in coloration or other qualities in correspondence with representations of underlying anatomical structures. The system includes novel electrode structures (200, 224, and 284) and methods for producing and attaching electrode arrays (240 and 280) to the organism. The exemplary form of the invention is used in connection with the diagnosis of muscle activity in the lower lumbar regions of humans. Levels of muscle activity detected are analyzed by correlation with the muscular structures underlying the electrode array. Forms of the invention may be used in other applications.

Claims

1. A method comprising:

a) removing a cover sheet from a first side of an electrode array, wherein the array includes at least one flexible substrate with a plurality of electrically conductive electrodes thereon;

b) applying the electrode array to a patient;

c) removing a release sheet from a second side of the electrode array; and

d) monitoring electrical signals in the patient with the electrodes.

2. The method according to claim 1, wherein the array includes a generally sheet like connection end with a plurality of electrically conductive traces thereon, wherein prior to (d) further comprising:

e) inserting the connection end into a throat area of a connector body, wherein the traces engage a plurality of electrical contacts in the throat area;

f) clamping the connection end within a throat area of the connector body.

3. The method according to claim 2, wherein each trace includes an electrical signal propagating therethrough, and further comprising:

g) amplifying each electrical signal with an amplifier in electrical connection with the electrical contacts.

4. The method according to claim 2, farther comprising:

g) lifting a connection end tail flap of the electrode array to expose the electrically conductive traces.

5. The method according to claim 2, wherein the connector body comprises a base member and a head member, wherein the throat area extends between the base member and the head member, wherein at least one of the base member and the head member is in operative connection with the electrical contacts, wherein the connector body further comprises a shaft member in operative connection with a cam surface, wherein (f) includes:

g) rotating the shaft member axially;

h) responsive to (g) causing with the cam surface the head member to move relative the base member such that the connection end of the electrode array is clamped between the head member and the base member.

6. The method according to claim 1, wherein the at least one flexible substrate is generally electrically non-conductive, wherein the at least one flexible substrate includes opposed first and second surfaces, wherein the plurality of electrically conductive electrodes are in supporting connection with the first surface of the at least one flexible substrate, wherein the first surface of the at least one flexible substrate is on the first side of the array, wherein the second surface of the at least one flexible substrate is on the second side of the array.

7. The method according to claim 1, wherein in (a) the at least one flexible substrate includes a plurality of perforations therethrough, wherein the perforations extend in generally surrounding relation of each of the electrodes and enable movement of each of the electrodes relative to each other, wherein prior to (c) the release sheet is operative to limit movement of each of the electrodes relative to each other.

8. The method according to claim 1, wherein in (a) the at least one flexible substrate includes a plurality of perforations therethrough, wherein the perforations extend in generally surrounding relation of each of the electrodes and enable movement of each of the electrodes relative portions of the at least one flexible substrate adjacent the perforations, wherein prior to (c) the release sheet is operative to limit movement of each of the electrodes relative the portions of the at least one flexible substrate adjacent the perforations.

9. The method according to claim 1, wherein prior to (c) the release sheet is in adhesive connection with the portions of the at least one flexible substrate which support the electrodes.

10. The method according to claim 1, wherein the release sheet has a plurality of apertures therethrough, wherein prior to (c) portions of the release sheet between the apertures are in adhesive connection with the portions of the at least one flexible substrate which support the electrodes.

11. The method according to claim 1, wherein in (a) the array includes a plurality of electrically conductive traces in supporting connection with the at least one flexible substrate, wherein at least one trace extends from each electrode, wherein the array includes a plurality of adjacent pairs of portions of the traces, wherein between each pair, the at least one flexible substrate includes a row of a plurality of separated and substantially longitudinally aligned perforations therethrough.

12. The method according to claim 11, wherein in (a) portions of the at least one flexible substrate between separated perforations in a first row are longitudinally offset from portions of the at least one flexible substrate between separated perforations in a second row adjacent to the first row.

13. The method according to claim 11, wherein in (a) the at least one flexible substrate includes a plurality of rows of perforations, wherein each row includes a plurality of the perforations, wherein in each row the perforations are separated and substantially longitudinally aligned.

14. The method according to claim 13, wherein in (a) portions of the at least one flexible substrate between separated perforations in a first row are longitudinally offset from portions of the at least one flexible substrate between separated perforations in a second row adjacent to the first row.

15. The method according to claim 13, wherein during (d) the patient moves causing the array to stretch in at least one dimension and portions of the at least one flexible substrate on opposed sides of at least one perforation spread apart, further comprising:

e) through operation of at least one computer, evaluating at least one medical condition with respect to the patient responsive to the electrical signals monitored in (d).

16. The method according to claim 1, wherein in (a) the array includes a plurality of electrically conductive traces in supporting connection with the at least one flexible substrate, wherein at least one trace extends to each electrode.

17. The method according to claim 1, wherein (b) includes adhesively connecting the electrodes to a back of the patient, wherein in (d) the electrical signals include electromyographic (EMG) signals, wherein during (d) the patient moves causing the distance between at least two electrodes to increase while each of the at least two electrodes remains in adhesive connection to the back of the patient, further comprising:

e) through operation of at least one computer, evaluating at least one back condition with respect to the patient responsive to the electrical signals monitored in (d).