Apparatus for methods for the assessment of neuromuscular function of the lower extremity

• US 6,146,335 A
• Filed: 03/16/1999
• Issued: 11/14/2000
• Est. Priority Date: 07/01/1997
• Status: Expired due to Term

• Current Assignee: Neurometrix, Inc.
• Original Assignee: Neurometrix, Inc.
• Inventors: Gozani, Shai N.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US09/270,551
• Time in Patent Office: 609 Days
• Field of Search: 600/483, 600/546, 600/554
• 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 5/395 Details of stimulation, e.g. nerve stimulation to elicit EMG response
• 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

Apparatus and methods are provided for the assessment of neuromuscular function. Using an apparatus of the invention, stimuli are applied to a nerve that traverses the ankle joint of an individual. The stimuli are applied at a point that is proximal to the ankle joint. Stimulation of the nerve causes a muscle innervated by that nerve to respond. The muscle response generates a myoelectric potential, which is detected by an apparatus of the invention at a point that is proximal to the ankle joint. The delay between stimulation of a nerve and detection of a muscular response to that stimulation is processed to indicate an assessment of neuromuscular function. For example, a sufficient delay between application of stimulus and muscle response may indicate the presence of diabetic neuropathy.

Claims

1. An apparatus for assessing a physiological function in a leg and a foot of an individual, comprising:

(a) a stimulator for producing a stimulus and for applying said stimulus proximal to an ankle joint of an individual, whereby application of said stimulus stimulates a nerve that traverses said ankle joint;

(b) a detector for detecting proximal to said ankle joint a myoelectric potential, whereby said myoelectric potential is generated by a muscle in a foot of said individual in response to said stimulus, said muscle being in communication with said nerve; and

(c) a controller for evaluating a physiological function in response to said stimulus and said myoelectric potential.

2. The apparatus of claim 1, wherein said stimulator comprises at least two stimulation electrodes for placement on said leg proximal to said ankle joint, said at least two stimulation electrodes for applying said stimulus at at least two different locations proximal to said ankle joint.

3. The apparatus of claim 2, wherein said stimulator is further for applying said stimulus at a first location proximal to said ankle joint and at a second location more proximal to said ankle joint.

4. The apparatus of claim 3, wherein said physiological function comprises a conduction velocity of said nerve and wherein said controller is further for determining said conduction velocity and for producing an indicia of said conduction velocity.

5. The apparatus of claim 4, further comprising a temperature sensor for measuring a temperature of skin proximal to said ankle joint, said temperature sensor in electrical communication with said controller and said controller for modifying said conduction velocity in response to said temperature.

6. The apparatus of claim 4, further comprising an indicator in electrical communication with said controller and for receiving said indicia from said controller and for indicating said conduction velocity in response to said indicia.

7. The apparatus of claim 6, wherein said indicator is selected from the group consisting of a light-emitting diode and a liquid crystal display.

8. The apparatus of claim 4, wherein said controller is further for determining a delay between application of said stimulus at said first location and detection of said myoelectric potential, for determining a delay between application of said stimulus at said second location and detection of said myoelectric potential, for determining a distance between said first stimulation location and said second stimulation location, and for correlating said delays and said distance to said conduction velocity.

9. The apparatus of claim 8, wherein said controller is further for producing a signal indicative of the presence or absence of diabetic neuropathy in response to said conduction velocity.

10. The apparatus of claim 9, further comprising an indicator in electrical communication with said controller and for receiving said signal from said controller and for indicating the presence or absence of diabetic neuropathy in response to said signal.

11. The apparatus of claim 10, wherein said indicator is selected from the group consisting of a light-emitting diode and a liquid crystal display.

12. The apparatus of claim 4, wherein said controller is further for modifying said conduction velocity in response to a height of said individual.

13. The apparatus of claim 4, wherein said controller is further for modifying said conduction velocity in response to an age of said individual.

14. The apparatus of claim 1, wherein said physiological function comprises a delay between application of said stimulus and detection of said myoelectric potential and wherein said controller is further for determining said delay and for producing an indicia of said delay.

15. The apparatus of claim 14, further comprising a temperature sensor for measuring a temperature of skin proximal to said ankle joint, said temperature sensor in electrical communication with said controller and said controller for modifying said delay in response to said temperature.

16. The apparatus of claim 14, further comprising an indicator in electrical communication with said controller and for receiving said indicia from said controller and for indicating said delay in response to said indicia.

17. The apparatus of claim 16, wherein said indicator is selected from the group consisting of a light-emitting diode and a liquid crystal display.

18. The apparatus of claim 14, wherein said controller is further for producing a signal indicative of the presence or absence of diabetic neuropathy in response to said delay.

19. The apparatus of claim 18, further comprising an indicator in electrical communication with said controller and for receiving said signal from said controller and for indicating the presence or absence of diabetic neuropathy in response to said signal.

20. The apparatus of claim 19, wherein said indicator is selected from the group consisting of a light-emitting diode and a liquid crystal display.

21. The apparatus of claim 14, wherein said stimulator comprises a stimulation electrode for placement on said leg proximal to said ankle joint.

22. The apparatus of claim 14, wherein said controller is further for modifying said delay in response to a height of said individual.

23. The apparatus of claim 14, wherein said controller is further for modifying said delay in response to an age of said individual.

24. The apparatus of claim 1, wherein said detector comprises a detection electrode for placement on said leg proximal to said ankle joint.

25. The apparatus of claim 1, wherein said stimulus is an electrical stimulus.

26. The apparatus of claim 1, wherein said stimulus is a magnetic stimulus.

27. The apparatus of claim 1, further comprising a communications port for establishing communication between said controller and an external device, whereby said external device is adapted for evaluating and for indicating said physiological function in response to said stimulus and said myoelectric potential.

28. A method of assessing a physiological function in a leg and a foot of an individual, comprising the steps of:

(a) applying a stimulus proximal to an ankle joint of an individual, whereby application of said stimulus stimulates a nerve that traverses said ankle joint;

(b) detecting a myoelectric potential proximal to said ankle joint, whereby said myoelectric potential is generated by a muscle in a foot of said individual in response to said stimulus, said muscle being in communication with said nerve;

(c) processing said stimulus and said myoelectric potential; and

(d) correlating said processing results to a physiological function of said nerve and said muscle.

29. The method of claim 28, wherein said physiological function comprises a delay between application of said stimulus and detection of said myoelectric potential and wherein said processing step further comprises the step of determining said delay and said correlating step further comprises the step of producing an indicia of said delay.

30. The method of claim 29, further comprising the step of indicating said indicia in response to said delay.

31. The method of claim 30, further comprising the step of producing a signal indicative of the presence or absence of diabetic neuropathy in response to said delay.

32. The method of claim 31, further comprising the step of indicating the presence or absence of diabetic neuropathy in response to said signal.

33. The method of claim 29, wherein said step of determining a delay between application of said stimulus and detection of said myoelectric potential comprises the step of determining a first derivative of said myoelectric potential.

34. The method of claim 29, wherein said step of determining a delay between application of said stimulus and detection of said myoelectric potential comprises the step of determining a second derivative of said myoelectric potential.

35. The method of claim 28, further comprising the steps of determining a delay between application of said myoelectric potential for at least two stimulus applications, comparing the delays determined in response to application of each of said at least two stimulus applications, and correlating said comparison to the presence or absence of diabetic neuropathy.

36. The method of claim 29, further comprising the steps of measuring a temperature of skin proximal to said ankle joint and adjusting said delay in response to said skin temperature.

37. The method of claim 29, further comprising the steps of determining a height of said individual and adjusting said delay in response to said height.

38. The method of claim 29, further comprising the steps of determining an age of said individual and adjusting said delay in response to said age.

39. The method of claim 28, wherein said step of applying a stimulus comprises the steps of applying said stimulus to a first location proximal to said ankle joint and applying said stimulus to a second location more proximal to said ankle joint.

40. The method of claim 39, wherein said physiological function comprises a conduction velocity of said nerve and wherein said processing step further comprises the step of determining said conduction velocity and said correlating step further comprises the step of producing an indicia of said conduction velocity.

41. The method of claim 40, wherein said step of determining a conduction velocity comprises the steps of:

(a) determining a delay between application of said stimulus at said first location and detection of said myoelectric potential;

(b) determining a delay between application of said stimulus at said second location and detection of said myoelectric potential;

(c) determining a distance between said first location and said second location; and

(d) correlating said delays and said distance to said conduction velocity.

42. The method of claim 40, further comprising the step of indicating said conduction velocity in response to said indicia.

43. The method of claim 40, further comprising the step of producing a signal indicative of the presence or absence of diabetic neuropathy in response to said conduction velocity.

44. The method of claim 43, further comprising the step of indicating the presence or absence of diabetic neuropathy in response to said signal.