Electrode assembly and method for signaling a monitor

• US 6,625,481 B2
• Filed: 03/20/2001
• Issued: 09/23/2003
• Est. Priority Date: 06/06/1995
• Status: Expired due to Fees

• Current Assignee: Bruce Jay Simon, Henry L. Bennett, Jeffrey R. Cram
• Original Assignee: Bruce Jay Simon, Henry L. Bennett, Jeffrey R. Cram
• Inventors: Bennett, Henry L., Simon, Bruce Jay, Cram, Jeffrey R.
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): Ruddy, David M.
• Application Number:
  US09/814,117
• Publication Number:
  US 20010031916A1
• Time in Patent Office: 917 Days
• Field of Search: 606/383, 606/546, 606/554, 606/557, 606/26, 607/46, 607/47, 607/62, 607/63, 607/139, 607/740, 607/741, 128/898
• US Class Current: 600/383
• CPC Class Codes: A61B 2562/0217 Electrolyte containing
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/4821 Determining level or depth of anaesthesia A61B5/1106 takes precedence

Abstract

An electrode assembly adapted to be attached to the skin over selected facial muscle groups picks up signals to be analyzed by an anesthesia adequacy monitor that measures the level of awareness of a living animal, typically a human being. The electrode assembly also includes a stimulator that stimulates a facial nerve to determine the level of paralysis, or neuro muscular block, of the facial muscles. Also disclosed is a method of manufacturing the electrode assembly by printing a pattern of electrically conductive material through a silk-screen or an ink type process onto a flexible layer, and then coating the result with a non-conducting adhesive except at points corresponding to sensing points for the desired muscle groups. Finally, a method for using such sensing and stimulating devices is shown in determining and maintaining an appropriate level of patient awareness, muscle paralysis, and analgesia under anesthesia.

Claims

1. A method of determining the consciousness of a person, the method comprising the steps of:

(A) mounting at least four facial muscle activity sensors so that each activity sensor generates an activity signal based on the level of activity of a different facial muscle group on the person; and

(B) processing said activity signals to generate a first output signal based on the summation of the activity signals for the sensed facial muscle groups;

and also including in step (B);

processing said activity signals to generate a second output signal based on the differences between the activity signals for the sensed facial muscle groups;

and also including in step (B);

filtering the activity signals to remove from the at least one output signal an artifact representing muscle activity caused by stimulus to the person not indicative of the person'"'"'s consciousness;

and wherein, in step (A), five facial muscle activity sensors are mounted, respectively, on the following five muscle areas;

the frontalis area, the corrugator area, the zygomatic area, the masseter area, and the orbicularis oculi area.

2. An electrode assembly for an awareness level monitor, comprising in combination:

(A) a flexible layer;

(B) a plurality of electrodes oriented in fixed positions and integrally formed with said flexible layer;

(C) plural electrical connecting paths disposed on said flexible layer extending from said plural electrodes to an input of the awareness level monitor, with each said electrode having its own said path;

said electrodes being located in at least four sensor clusters of fixed arrays to respectively sense muscle activity of separate facial muscle areas pre-selected from among the frontalis area, the corrugator area, the zygomatic area, the masseter area, and the orbicularis oculi area.

3. The assembly of claim 2 wherein said electrodes also having a stimulator cluster to stimulate a nerve in at least one of said separate facial muscle areas.

5. The assembly of claim 3 wherein said electrodes also include a ground electrode providing a grounding path for the sensing clusters.

7. The assembly of claim 2 including an artifact filtration device for removing anomalous surgically induced artifacts, said filtration device being coupled between said electrical connecting paths and said input of the awareness level monitor.

4. An electrode assembly for an awareness level monitor, comprising in combination:

(A) a flexible layer;

(B) a plurality of electrodes oriented in fixed positions and integrally formed with said flexible layer;

(C) plural electrical connecting paths disposed on said flexible layer extending from said plural electrodes to an input of the awareness level monitor, with each said electrode having its own said path;

said electrodes being located in at least (i) two sensor clusters of fixed arrays to respectively sense muscle activity of separate facial muscle areas pre-selected from among the frontalis area, the corrugator area, the zygomatic area, the masseter area, and the orbicularis oculi area; and

(ii) a stimulator cluster to stimulate a nerve in at least one of said separate facial muscle areas.

6. The assembly of claim 4 wherein said electrodes also include a ground electrode providing a grounding path for the sensing clusters and stimulating cluster.

8. The assembly of claim 4 including an artifact filtration device for removing anomalous surgically induced artifacts, said filtration device being coupled between said electrical connecting paths and said input of the awareness level monitor.

9. The assembly of claim 6 including an artifact filtration device for removing anomalous surgically induced artifacts, said filtration device being coupled between said electrical connecting paths and said input of the awareness level monitor.

10. The assembly of claim 9 wherein said flexible layer is linearly non-extensible along said electrical paths to thwart breaks in conductivity along said paths.

11. The assembly of claim 10 including an adhesive coating on said flexible layer overlaying said electrical paths but free from said electrodes.

12. The assembly of claim 11 including conductive coating overlaying said electrodes.

13. A method for maintaining an appropriate level of patient awareness under anesthesia, the steps including:

(A) providing at least one electrode assembly comprising;

a flexible layer;

a pattern of electrically conductive material, disposed upon one side of said flexible layer wherein said pattern contains at least two electrodes and is adapted to be connected to a signal receiving means;

a non-conducting adhesive that electrically isolates at least one electrode from another electrode, but allows at least two electrodes to contact the tissue of said patient;

(B) attaching said assembly to the face of said patient;

(C) picking up a signal with the electrodes;

(D) receiving the signal in a processing device through a signal receiving means;

(E) processing the signal received from the electrodes to determine what facial expression the signal represents by comparing the signals from different electrodes, the signals being reflective of the patient'"'"'s facial muscle tonus;

(F) displaying the processed signal for viewing by an anesthesiologist on a display;

(G) anesthetizing the patient with an initial dosage of anesthetic to create muscle relaxation in a desired level of awareness; and

(H) controlling the patient'"'"'s level of awareness.

14. The awareness level method of claim 13 wherein said processing step includes detecting and filtering out artifacts unrepresentative of the patient'"'"'s expression through the steps of:

(i) detecting when an artifact generating device is in operation;

(ii) quantifying the artifact generating device'"'"'s effect on the signal as picked up by the facial muscle sensors; and

(iii) subtracting from the signal the portion caused by the artifact;

whereby the artifact has a reduced effect on the signal.

15. The awareness level method of claim 13 including, after said attaching step, stimulating a nerve in the patient'"'"'s face with an electrode.

16. The awareness level maintenance method of claim 13 wherein said providing step includes:

(i) providing a non-extensible material characterized by resisting linear distortion;

(ii) applying through the mask means an electrically conductive material in pattern adapted to contact at appropriate sensing points the skin over at least one facial muscle group and to connect said electrically conductive material over said sensing points to a signal receiving means;

(iii) coating with a non-conducting adhesive said non-extensible material except at areas that correlate with said electrodes contacting appropriate sensing points of said face;

(iv) sealing the electrode assembly with a detachable cover layer opposite said flexible layer;

(v) separating electrode assemblies from each other if said non-extensible material has more than one electrode assembly prepared upon said non-extensible material;

and said attaching step includes detaching said cover layer before attaching said assembly to said face of said patient.

17. The awareness level maintenance method of claim 16 wherein said non-conducting adhesive is applied through a second mask means adapted to prevent adhesive from covering said electrodes at points correlating to said sensing points.

18. The awareness level maintenance method of claim 16 wherein said non-conducting adhesive is coated on said non-extensible material after releasable dots are placed over said electrically conductive material at points corresponding to said sensing points.

19. The awareness level maintenance method of claim 16 wherein said non-conducting adhesive is applied as a preshaped pad adapted to cover the electrically conductive material except at points correlating to said sensing points.

20. The awareness level method of claim 16 including, after said attaching step, stimulating a facial muscle nerve in the patient'"'"'s face with an electrode.

21. The awareness level maintenance method of claim 13 wherein said electrodes define a preconfigured array adapted to contact at appropriate sensing points the skin over one or more muscle groups of said race.

22. The awareness level maintenance method of claim 15 wherein said electrodes define a preconfigured array adapted to contact at appropriate sensing points the skin over one or more muscle groups of said face.

23. The awareness level maintenance method of claim 20, wherein said muscle groups are at least two of those among the corrogator, frontalis, zygomatic, orbicularis oculi, or masseter muscle groups.

24. The awareness level maintenance method of claim 20 wherein said muscle groups are at least four of those among the corrogator, frontalis, zygomatic, orbicularis oculi, or masseter muscle groups.

25. The awareness level maintenance method of claim 20 Therein said muscle groups are the corrogator, frontalis, zygomatic, orbicularis oculi, or masseter muscle groups.

26. The awareness level method of claim 21 including, after said attaching step, stimulating a facial muscle nerve in at least one of said muscle groups.

27. The awareness level method of claim 22 including, after said attaching step, stimulating a facial muscle nerve in the patient'"'"'s face with an electrode.

28. An apparatus for indicating the consciousness of a person, comprising, in combination:

an array of facial muscle sensors adapted to generate sensor signals representing the simultaneous activity of at least four different facial muscle areas, each of which elicit distinctive patterns of facial expressions of the person;

a sensor signal processor operatively coupled to the sensors to receive the sensor signals from the facial muscle sensors and, based on the sensor signals, automatically generate an output signal indicating the consciousness of the person; and

wherein the sensor signal processor generates at least a portion of the output signal based on relative differences among the sensor signals and thereby the different activities of the different facial muscle areas represented by the sensor signals; and

wherein the facial muscle sensors are surface electromyograms adapted to be physically attached the person'"'"'s face in positions allowing the monitoring of the different facial muscles; and

wherein said facial muscle areas are selected from among the frontalis area, the corrugator area, zygomatic area, the masseter area, and the orbilaris oculi area.

29. A method of determining the consciousness of a person, the method comprising the steps of:

(A) mounting at least four facial muscle activity sensors so that each activity sensor generates an activity signal based on the level of activity of a different facial muscle group on the person; and

(B) processing said activity signals to generate a first output signal based on the summation of the activity signals for the sensed facial muscle groups;

also including in step (B);

processing said activity signals to generate a second output signal based on the differences between the activity signals for the sensed facial muscle groups;

also including in step (B);

filtering the activity signals to remove from the at least one output signal an artifact representing muscle activity caused by stimulus to the person not indicative of the person'"'"'s consciousness; and

wherein, in step (A) five facial muscle activity sensors are mounted, respectively, on the following five muscle areas;

the frontalis area, the corrugator area, the zygomatic area, the masseter area, and the orbicularis oculi area.