Non-invasive acquisition of large nerve action potentials (NAPs) with closely spaced surface electrodes and reduced stimulus artifacts

• US 20080051647A1
• Filed: 05/11/2007
• Published: 02/28/2008
• Est. Priority Date: 05/11/2006
• Status: Abandoned Application

• Current Assignee: Neurometrix, Inc.
• Original Assignee: Neurometrix, Inc.
• Inventors: Wu, Changwang, Gozani, Shai
• Application Number:
  US11/801,865
• Publication Number:
  US 20080051647A1
• Time in Patent Office: Days
• US Class Current: 600/382
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/7217 of noise originating from a therapeutic or surgical apparatus, e.g. from a pacemaker
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/3603 Control systems

Abstract

The present invention addresses the foregoing problems associated with the prior art by providing a novel method and apparatus for, non-invasively detecting large nerve action potentials (NAPs) while effectively minimizing or substantially eliminating stimulus artifacts, even where the stimulation site and the detection site are in close physical proximity to one another, e.g., within about 2 cm of one another.

Claims

1. Apparatus for acquiring a nerve action potential (NAP) from a patient, the apparatus comprising:

a stimulator and a pair of stimulator electrodes connected to the stimulator for applying an electrical stimulus to the patient so as to evoke a nerve action potential (NAP) in the patient;

a detector and a pair of detector electrodes connected to the detector for acquiring a trace signal from the patient, wherein the trace signal includes the nerve action potential (NAP); and

shorting apparatus for shorting the pair of stimulator electrodes after application of the electrical stimulus to the patient in order to minimize the presence of stimulus artifacts in the trace signal.

2. Apparatus according to claim 1 further including a reference electrode for providing an electrical reference with respect to the pair of detector electrodes, the reference electrode being connected to the detector.

3. Apparatus according to claim 1 wherein the shorting apparatus is formed internal to the stimulator.

4. Apparatus according to claim 1 wherein the electrical stimulus comprises a monophasic electrical stimulus.

5. Apparatus according to claim 1 wherein the electrical stimulus comprises a biphasic electrical stimulus comprising a positive pulse and a negative pulse.

6. Apparatus according to claim 5 wherein the shorting apparatus is configured to short the pair of stimulator electrodes after application of the positive pulse and before application of the negative pulse.

7. Apparatus according to claim 1 wherein the shorting apparatus is configured to short the pair of stimulator electrodes in order to minimize the presence of stimulus artifacts at least one of:

(i) the time of the up-peak of the nerve action potential (NAP), and (ii) the time of the down-peak of the nerve action potential (NAP).

8. Apparatus according to claim 1 wherein the shorting apparatus is configured to short the pair of stimulator electrodes in order to minimize the presence of stimulus artifacts in the trace signal after the end of the electrical stimulus.

62. Apparatus according to claim 1 wherein the apparatus further comprises a controller/monitor for recording, measuring and analyzing the trace signal acquired by the detector and the pair of detector electrodes, wherein the controller/monitor is connected to the detector via a wireless connection.

9. A method for acquiring a nerve action potential (NAP) from a patient, the method comprising the steps of:

applying an electrical stimulus to the patient using a stimulator and a pair of stimulator electrodes connected to the stimulator so as to evoke a nerve action potential (NAP) in the patient; and

acquiring a trace signal from the patient which includes the nerve action potential (NAP);

wherein the pair of stimulator electrodes are shorted after the electrical stimulus has been applied to the patient in order to minimize the presence of stimulus artifacts in the trace signal.

10. A method according to claim 9 wherein a reference electrode is used to acquire the trace signal from the patient.

11. A method according to claim 9 wherein the shorting of the pair of stimulator electrodes is effected by a component internal to the stimulator.

12. A method according to claim 9 wherein the electrical stimulus comprises a monophasic electrical stimulus.

13. A method according to claim 9 wherein the electrical stimulus comprises a biphasic electrical stimulus comprising a positive pulse followed by a negative pulse.

14. A method according to claim 13 wherein the shorting of the pair of stimulator electrodes is effected after application of the positive pulse and before application of the negative pulse.

15. A method according to claim 9 wherein the shorting of the pair of stimulator electrodes is effected so as to minimize the presence of stimulus artifacts at least one of:

(i) the time of the up-peak of the nerve action potential (NAP), and (ii) the time of the down-peak of the nerve action potential (NAP).

16. A method according to claim 9 wherein the shorting of the pair of stimulator electrodes is effected so as to minimize the presence of stimulus artifacts in the trace signal after the end of the electrical stimulus.

63. A method according to claim 9 wherein the trace signal acquired from the patient is sent via a wireless connection to a controller/monitor for recording, measuring and analyzing.

17. Apparatus for acquiring a nerve action potential (NAP) from a patient, the apparatus comprising:

a stimulator and a pair of stimulator electrodes connected to the stimulator for applying an electrical stimulus to the patient so as to evoke a nerve action potential (NAP) in the patient;

a detector and a pair of detector electrodes connected to the detector for acquiring a trace signal from the patient, wherein the trace signal includes the nerve action potential (NAP);

wherein the stimulator is configured to produce a biphasic electrical stimulus consisting of a positive pulse followed by a negative pulse;

and further wherein the stimulator is configured to minimize the presence of stimulus artifacts in the trace signal by regulating the time duration of the negative pulse.

18. Apparatus according to claim 17 further including a reference electrode for providing an electrical reference with respect to the pair of detector electrodes, the reference electrode being connected to the detector.

19. Apparatus according to claim 17 wherein the stimulator is configured to regulate the time duration of the negative pulse in order to minimize the presence of stimulus artifacts at least one of:

(i) the time of the up-peak of the nerve action potential (NAP), and (ii) the time of the down-peak of the nerve action potential (NAP).

20. Apparatus according to claim 17 wherein the stimulator is configured to regulate the time duration of the negative pulse in order to minimize the presence of in order to minimize the presence of stimulus artifacts in the trace signal after the end of the electrical stimulus.

21. Apparatus according to claim 17 further including shorting apparatus for shorting the pair of stimulator electrodes after application of the electrical stimulus to the patient in order to minimize the presence of stimulus artifacts in the trace signal.

22. Apparatus according to claim 21 wherein the shorting apparatus is configured to short the pair of stimulator electrodes after application of the positive pulse and before application of the negative pulse.

23. Apparatus according to claim 21 wherein the shorting apparatus is formed internal to the stimulator.

24. Apparatus according to claim 21 wherein the shorting apparatus is configured to short the pair of stimulator electrodes in order to minimize the presence of stimulus artifacts at least one of:

(i) the time of the up-peak of the nerve action potential (NAP), and (ii) the time of the down-peak of the nerve action potential (NAP).

25. Apparatus according to claim 21 wherein the shorting apparatus is configured to short the pair of stimulator electrodes in order to minimize the presence of stimulus artifacts in the trace signal after the end of the electrical stimulus.

64. Apparatus according to claim 17 wherein the apparatus further comprises a controller/monitor for recording, measuring and analyzing the trace signal acquired by the detector and the pair of detector electrodes, wherein the controller/monitor is connected to the detector via a wireless connection.

26. A method for acquiring a nerve action potential (NAP) from a patient, the method comprising the steps of:

applying an electrical stimulus to the patient so as to evoke a nerve action potential (NAP) in the patient, wherein the electrical stimulus comprises a biphasic electrical stimulus comprising a positive pulse followed by a negative pulse; and

acquiring a trace signal from the patient which includes the nerve action potential (NAP);

wherein the time duration of the negative pulse is regulated so as to minimize the presence of stimulus artifacts in the trace signal.

27. A method according to claim 26 wherein the time duration of the negative pulse is regulated in order to minimize the presence of stimulus artifacts at least one of:

(i) the time of the up-peak of the nerve action potential (NAP), and (ii) the time of the down-peak of the nerve action potential (NAP).

28. A method according to claim 26 wherein the time duration of the negative pulse is regulated in order to minimize the presence of stimulus artifacts in the trace signal after the end of the electrical stimulus.

29. A method according to claim 26 wherein the electrical stimulus is applied to the patient using a stimulator and a pair of stimulator electrodes connected to the stimulator, and further wherein the pair of stimulator electrodes are shorted after the electrical stimulus has been applied to the patient in order to minimize the presence of stimulus artifacts in the trace signal.

30. A method according to claim 29 wherein the pair of stimulator electrodes are shorted after application of the positive pulse and before application of the negative pulse.

31. A method according to claim 29 wherein the shorting of the pair of stimulator electrodes is effected by a component internal to the stimulator.

32. A method according to claim 29 wherein the shorting of the pair of stimulator electrodes is effected so as to minimize the presence of stimulus artifacts at least one of:

(i) the time of the up-peak of the nerve action potential (NAP), and (ii) the time of the down-peak of the nerve action potential (NAP).

33. A method according to claim 29 wherein the shorting of the pair of stimulator electrodes is effected so as to minimize the presence of stimulus artifacts in the trace signal after the end of the electrical stimulus.

65. A method according to claim 26 wherein the trace signal acquired from the patient is sent via a wireless connection to a controller/monitor for recording, measuring and analyzing.

34. Apparatus for acquiring a nerve action potential (NAP) from a patient, the apparatus comprising:

a stimulator and a pair of stimulator electrodes connected to the stimulator for applying an electrical stimulus to the patient so as to evoke a nerve action potential (NAP) in the patient, wherein the stimulator is configured to produce a biphasic electrical stimulus consisting of a positive pulse followed by a negative pulse;

a detector and a pair of detector electrodes connected to the detector for acquiring a trace signal from the patient, wherein the trace signal includes the nerve action potential; and

a determining component for determining the amplitude of a stimulus artifact present in the trace signal;

wherein the stimulator is configured to minimize the presence of stimulus artifacts in the trace signal by regulating the time duration of the negative pulse based on the amplitude of a stimulus artifact present in a prior trace signal as determined by the determining component.

35. Apparatus according to claim 34 wherein the stimulator is configured to regulate the time duration of the negative pulse in order to minimize the presence of stimulus artifacts at least one of:

(i) the time of the up-peak of the nerve action potential (NAP), and (ii) the time of the down-peak of the nerve action potential (NAP).

36. Apparatus according to claim 34 wherein the stimulator is configured to regulate the time duration of the negative pulse in order to minimize the presence of stimulus artifacts in the trace signal after the end of the electrical stimulus.

37. Apparatus according to claim 34 wherein the determining component utilizes the trace signal and a feedback mechanism applied across multiple applications of the electrical stimulus in order to determine the amplitude of the stimulus artifact.

38. Apparatus according to claim 34 wherein the determining component detects the voltage between the pair of stimulator electrodes during the biphasic electrical stimulus, during the application of the positive pulse and during the application of the negative pulse, in order to determine the amplitude of the stimulus artifact.

39. Apparatus according to claim 34 wherein the determining component uses a tissue impedance model and tissue impedance measurements in order to predict the amplitude of the stimulus artifact in real-time.

40. Apparatus according to claim 39 wherein the tissue measurements comprise serial capacitance and serial resistance;

and/or parallel capacitance and parallel resistance between the pair of stimulator electrodes.

41. Apparatus according to claim 34 further including a reference electrode for providing an electrical reference with respect to the pair of detector electrodes, the reference electrode being connected to the detector.

42. Apparatus according to claim 34 further including shorting apparatus for shorting the pair of stimulator electrodes after application of the electrical stimulus to the patient in order to minimize the presence of stimulus artifacts in the trace signal.

43. Apparatus according to claim 42 wherein the shorting apparatus is configured to short the pair of stimulator electrodes after application of the positive pulse and before application of the negative pulse.

44. Apparatus according to claim 42 wherein the shorting apparatus is formed internal to the stimulator.

45. Apparatus according to claim 42 wherein the shorting apparatus is configured to short the pair of stimulator electrodes in order to minimize the presence of stimulus artifacts at least one of:

(i) the time of the up-peak of the nerve action potential (NAP), and (ii) the time of the down-peak of the nerve action potential (NAP).

46. Apparatus according to claim 42 wherein the shorting apparatus is configured to short the pair of stimulator electrodes in order to minimize the presence of stimulus artifacts in the trace signal after the end of the electrical stimulus.

66. Apparatus according to claim 34 wherein the apparatus further comprises a controller/monitor for recording, measuring and analyzing the trace signal acquired by the detector and the pair of detector electrodes, wherein the controller/monitor is connected to the detector via a wireless connection.

47. A method for acquiring a nerve action potential (NAP) from a patient, the method comprising the steps of:

applying an electrical stimulus to the patient so as to evoke a nerve action potential (NAP) in the patient, wherein the electrical stimulus comprises a biphasic electrical stimulus comprising of a positive pulse followed by a negative pulse;

acquiring a trace signal from the patient which includes the nerve action potential (NAP);

determining the amplitude of a stimulus artifact present in the trace signal; and

regulating the time duration of the negative pulse in a subsequent biphasic electrical stimulus so as to minimize the presence of stimulus artifacts in a current trace signal based on the amplitude of a stimulus artifact present in a prior trace signal.

48. A method according to claim 47 wherein determining the amplitude of a stimulus artifact present in the trace signal is effected by utilizing the trace signal and a feedback mechanism applied across multiple applications of the electrical stimulus in order to determine the amplitude of the stimulus artifact.

49. A method according to claim 47 wherein the electrical stimulus is applied to the patient with a pair of stimulator electrodes, and further wherein determining the amplitude of a stimulus artifact present in the trace signal is effected by detecting the voltage between the pair of stimulator electrodes after the application of the positive pulse and before the application of the negative pulse in order to determine the amplitude of the stimulus artifact.

50. A method according to claim 47 wherein determining the amplitude of a stimulus artifact present in the trace signal is effected by using a tissue impedance model and tissue measurements in order to predict the amplitude of the stimulus artifact in real-time.

51. A method according to claim 47 wherein the tissue measurements comprise serial capacitance, serial resistance, parallel capacitance, and parallel resistance between the pair of stimulator electrodes.

52. A method according to claim 47 wherein the time duration of the negative pulse is regulated in order to minimize the presence of stimulus artifacts at least one of:

(i) the time of the up-peak of the nerve action potential (NAP), and (ii) the time of the down-peak of the nerve action potential (NAP).

53. A method according to claim 47 wherein the time duration of the negative pulse is regulated in order to minimize the presence of in order to minimize the presence of stimulus artifacts in the trace signal after the end of stimulus.

67. A method according to claim 47 wherein the trace signal acquired from the patient is sent via a wireless connection to a controller/monitor for recording, measuring and analyzing.

54. Apparatus for measuring the stimulus artifact present when acquiring a nerve action potential (NAP) from a patient, the apparatus comprising:

a stimulator and a pair of stimulator electrodes connected to the stimulator for applying an electrical stimulus to the patient so as to evoke a nerve action potential (NAP) in the patient;

a detector and a pair of detector electrodes connected to the detector for acquiring a trace signal from the patient, wherein the trace signal includes the nerve action potential (NAP); and

a measuring component for measuring the voltage present between the pair of stimulator electrodes after application of the electrical stimulus to the patient.

55. Apparatus according to claim 54 wherein the electrical stimulus comprises a biphasic electrical stimulus comprising a positive pulse followed by a negative pulse, and further wherein the measuring component measures the voltage present between the pair of stimulator electrodes after application of the positive pulse and before the complete application of the negative pulse.

56. Apparatus according to claim 55 wherein the measuring component measures the voltage present between the pair of stimulator electrodes at least one of:

(i) the time of the up-peak of the nerve action potential (NAP), and (ii) the time of the down-peak of the nerve action potential (NAP).

68. Apparatus according to claim 54 wherein the apparatus further comprises a controller/monitor for recording, measuring and analyzing the trace signal acquired by the detector and the pair of detector electrodes, wherein the controller/monitor is connected to the detector via a wireless connection.

57. A method for measuring the stimulus artifact present when acquiring a nerve action potential (NAP) from a patient, the method comprising the steps of:

applying an electrical stimulus to the patient using a pair of stimulator electrodes, so as to evoke a nerve action potential (NAP) in the patient; and

acquiring a trace signal from the patient which includes the nerve action potential (NAP);

wherein the voltage between the pair of stimulator electrodes is measured after the beginning of application of the electrical stimulus to the patient.

58. A method according to claim 57 wherein the electrical stimulus comprises a biphasic electrical stimulus comprising a positive pulse followed by a negative pulse, and further wherein the voltage between the pair of stimulator electrodes is measured during application of the positive pulse and during the application of the negative pulse.

59. Apparatus according to claim 58 wherein the voltage between the pair of stimulator electrodes is measured at least one of:

(i) the time of the up-peak of the nerve action potential (NAP), and (ii) the time of the down-peak of the nerve action potential (NAP).

69. A method according to claim 57 wherein the trace signal acquired from the patient is sent via a wireless connection to a controller/monitor for recording, measuring and analyzing.

60. Apparatus for acquiring a large nerve action potential (NAP) from a patient, the apparatus comprising:

a stimulator and a pair of stimulator electrodes connected to the stimulator for applying an electrical stimulus to the patient so as to evoke a nerve action potential (NAP) in the patient; and

a detector and a pair of detector electrodes connected to the detector for acquiring a trace signal from a patient, wherein the trace signal includes the nerve action potential (NAP);

wherein at least one of the pair of detector electrodes is a surface electrode and is positioned less than 3 cm from the stimulator electrodes.

70. Apparatus according to claim 60 wherein the apparatus further comprises a controller/monitor for recording, measuring and analyzing the trace signal acquired by the detector and the pair of detector electrodes, wherein the controller/monitor is connected to the detector via a wireless connection.

61. A method for acquiring large nerve action potential (NAP) from a patient, the method comprising the steps of:

applying an electrical stimulus to the patient using a pair of stimulator electrodes so as to evoke a nerve action potential (NAP) in the patient; and

acquiring a trace signal from the patient which includes the nerve action potential (NAP), wherein the trace signal is acquired from the patient using a pair of detector electrodes;

wherein at least one of the pair of the detector electrodes is a surface electrode and is placed less than 3 cm from the stimulator electrodes.

71. A method according to claim 61 wherein the trace signal acquired from the patient is sent via a wireless connection to a controller/monitor for recording, measuring and analyzing.