Neuromuscular electrode

• US 6,132,387 A
• Filed: 03/16/1999
• Issued: 10/17/2000
• Est. Priority Date: 07/01/1997
• Status: Expired due to Term

• Current Assignee: Neurometrix, Inc.
• Original Assignee: Neurometrix, Inc.
• Inventors: Gozani, Shai N., Kassem, Salim
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US09/270,555
• Time in Patent Office: 581 Days
• Field of Search: 600/483, 600/554, 600/546
• US Class Current: 600/554
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/1106 to assess neuromuscular blockade, e.g. to estimate depth of anaesthesia
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/6824 Arm or wrist
• CPC Class Codes: A61B 5/6825 Hand
• CPC Class Codes: A61B 5/7217 of noise originating from a therapeutic or surgical apparatus, e.g. from a pacemaker
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence

Abstract

A neuromuscular electrode is provided for use in assessing a physiological function of a peripheral nerve and/or muscle innervated by that nerve. The electrode includes a stimulation site, a detection site, and a data memory for storing a signal representative of a characteristic of the electrode. For example, the data memory may include an indication of the size of the electrode, a height associated with the electrode, a unique serial number associated with the electrode, or an indication that the electrode has or has not been previously used on an individual.

Claims

1. A neuromuscular electrode for the assessment of a physiological function of a peripheral nerve and/or a muscle in communication with said nerve, said neuromuscular electrode comprising:

(a) a stimulation site for producing a stimulus and for applying said stimulus to a nerve of an individual;

(b) a detection site for detecting a bioelectric potential, whereby said bioelectric potential is generated by a nerve or muscle in response to said stimulus, said nerve or muscle being in communication with said stimulated nerve; and

(c) a data memory for storing a signal representative of a characteristic of said neuromuscular electrode, wherein a physiological function of said nerve and/or said muscle is evaluated in response to said stimulus, said bioelectric potential, and said stored characteristic.

2. The neuromuscular electrode of claim 1, wherein said bioelectric potential is a myoelectric potential, whereby said myoelectric potential is generated by a muscle in communication with said nerve.

3. The neuromuscular electrode of claim 1, wherein said detection site is in a fixed relationship with respect to said stimulation site.

4. The neuromuscular electrode of claim 1, wherein said characteristic of said neuromuscular electrode is selected from the group consisting of a size of said neuromuscular electrode, a height associated with a size of said neuromuscular electrode, a serial number of said neuromuscular electrode, an indication that said neuromuscular electrode has been used on an individual, and an indication that said neuromuscular electrode has not been used on an individual.

5. The neuromuscular electrode of claim 4, wherein said indication that said neuromuscular electrode has been used on an individual comprises an electronic flag in said data memory.

6. A neuromuscular electrode system for the assessment of a physiological function of a peripheral nerve and/or a muscle in communication with said nerve, said neuromuscular electrode system comprising:

(a) a neuromuscular electrode comprising;

(i) a stimulation site for producing a stimulus and for applying said stimulus to a nerve of an individual;

(ii) a detection site for detecting a bioelectric potential, whereby said bioelectric potential is generated by a nerve or muscle in response to said stimulus, said nerve or muscle being in communication with said stimulated nerve; and

(iii) a data memory for storing a signal representative of an indication of use of said neuromuscular electrode; and

(b) a controller in electrical communication said stimulation site, said detection site, and said data memory, said controller for determining whether said neuromuscular electrode has been used in response to said signal representative of an indication of use of said neuromuscular electrode, wherein said controller directs said stimulation site to stimulate said nerve if a determination that said neuromuscular electrode has not been used is made, and wherein said controller processes said bioelectric potential and said stimulus and correlates said processing results to a physiological function of said nerve and/or said muscle in response thereto.

7. The neuromuscular electrode system of claim 6, wherein said bioelectric potential is a myoelectric potential, whereby said myoelectric potential is generated by a muscle in communication with said nerve.

8. The neuromuscular electrode system of claim 6, wherein said detection site is in a fixed relationship with respect to said stimulation site.

9. The neuromuscular electrode system of claim 6, wherein said controller comprises a data processor in electrical communication with said data memory for processing said signal representative of an indication of use of said neuromuscular electrode to determine whether said neuromuscular electrode has been used.

10. The neuromuscular electrode system of claim 6, wherein said physiological function is selected from a delay between application of said stimulus to said nerve and detection of said bioelectric potential, a conduction velocity of said nerve, an F-wave latency between application of said stimulus to said nerve and detection of said bioelectric potential, and a determination of an amplitude of said bioelectric potential.

11. The neuromuscular electrode system of claim 6, wherein said data memory is further for storing a signal representative of a height associated with said neuromuscular electrode and said data processor is further for processing said signal to determine said height, for generating a signal representative of said height, and for transmitting said signal representative of said height to said controller.

12. The neuromuscular electrode system of claim 11, wherein said controller is further for modifying said physiological function in response to said height.

13. The neuromuscular electrode system of claim 6, wherein said data memory is further for storing a signal representative of a size associated with said neuromuscular electrode and said data processor is further for processing said signal to determine a height associated with said size and for generating a signal representative of said height and for transmitting said signal representative of said height to said controller.

14. The neuromuscular electrode system of claim 13, wherein said controller is further for modifying said physiological function in response to said height.

15. The neuromuscular electrode system of claim 6, wherein said controller is further for monitoring an impedance of skin of said individual.

16. The neuromuscular electrode system of claim 15, wherein said controller generates a deactivation signal upon detection of an impedance of skin that exceeds a predetermined value and wherein said controller transmits said deactivation signal to said data memory.

17. The neuromuscular electrode system of claim 16, wherein said data memory is for receiving said deactivation signal and for modifying said signal representative of an indication of use of said neuromuscular electrode in response thereto.

18. The neuromuscular electrode system of claim 17, wherein said data memory modifies said signal representative of an indication of use by generating an electronic flag in said data memory.

19. The neuromuscular electrode system of claim 6, wherein said controller is further for monitoring said bioelectric potential.

20. The neuromuscular electrode system of claim 19, wherein said controller generates a deactivation signal upon detection of a predetermined change in said bioelectric potential and wherein said controller transmits said deactivation signal to said data memory.

21. The neuromuscular electrode system of claim 20, wherein said data memory is for receiving said deactivation signal and for modifying said signal representative of an indication of use of said neuromuscular electrode in response thereto.

22. The neuromuscular electrode system of claim 21, wherein said data memory modifies said signal representative of an indication of use by generating an electronic flag in said data memory.

23. The neuromuscular electrode system of claim 6, wherein said data memory is further for storing a signal representative of a unique serial number of said neuromuscular electrode.

24. The neuromuscular electrode system of claim 23, wherein said controller is further for monitoring said bioelectric potential and for comparing said bioelectric potential to at least one bioelectric potential previously determined by said neuromuscular electrode as identified by said unique serial number.

25. The neuromuscular electrode system of claim 24, wherein said controller generates a deactivation signal upon detection of a change in a predetermined characteristic of said bioelectric potential with respect to said at least one previously determined bioelectric potential and wherein said controller transmits said deactivation signal to said data memory.

26. The neuromuscular electrode system of claim 25, wherein said data memory is for receiving said deactivation signal and for modifying said signal representative of an indication of use of said neuromuscular electrode in response thereto.

27. The neuromuscular electrode system of claim 26, wherein said data memory modifies said signal representative of an indication of use by generating an electronic flag in said data memory.

28. The apparatus of claim 23, wherein said controller is further for matching said physiological function with said unique serial number thereby to identify said physiological function with said individual.

29. The neuromuscular electrode system of claim 6, wherein said neuromuscular electrode further comprises a temperature sensor for measuring a temperature of skin of said individual, said temperature sensor being in electrical communication with said controller.

30. The neuromuscular electrode system of claim 29, wherein said controller is further for modifying said physiological function in response to said temperature.