APPARATUS FOR ELECTRICAL STIMULATION, IN PARTICULAR FOR BRUXISM

• US 20120271190A1
• Filed: 03/04/2010
• Published: 10/25/2012
• Est. Priority Date: 03/04/2009
• Status: Active Grant

• Current Assignee: Sunstar Suisse S.A (Hosei Gijuku Luxembourg SA)
• Original Assignee: Medotech A/S
• Inventors: Steen, Claus, Rasmussen, Erling, Mortensen, Troels Bierman, Haugland, Morten
• Granted Patent: US 10,292,638 B2
• Time in Patent Office: Days
• US Class Current: 600/546
• 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 5/4528 Joints A61B5/4533, A61B5/4538 take precedence
• CPC Class Codes: A61B 5/4547 Evaluating teeth
• CPC Class Codes: A61B 5/4557 Evaluating bruxism
• CPC Class Codes: A61B 5/7257 using Fourier transforms
• CPC Class Codes: A61F 2005/563 Anti-bruxisme
• CPC Class Codes: A61N 1/0452 Specially adapted for transcutaneous muscle stimulation [TMS]
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters

Abstract

The present invention relates to a method and an apparatus for preventing, diagnosing, monitoring, and/or treating bruxism as well as related diseases of an individual. In a first aspect the invention relates to an apparatus for preventing bruxism of an individual, comprising: means for applying a plurality of stimulation signals for providing relaxation of at least one of the masticatory and/or facial muscles of said individual, means for applying said stimulations signals with a predefined setting, and means for applying said stimulations signals independent of activity of said muscle(s). The invention may be suitable for both nocturnal and awake bruxism.

Claims

1. Apparatus for preventing bruxism of an individual, comprising:

a) means for applying a plurality of stimulation signals for providing relaxation of at least one of the masticatory and/or facial muscles of said individual,

b) means for applying said stimulations signals with a predefined setting, and

c) means for applying said stimulations signals independent of activity of said muscle(s).

2. Apparatus according claim 1, further comprising at least one electrode assembly for attaching to the skin of the individual for applying the stimulation signals.

3. Apparatus according to claim 1, wherein a stimulation signal is a pulse train with a one or more of the following parameters being predefined:

start current, end current, start voltage, end voltage, pulse width, pulse train duration, inter-pulse spacing, duty cycle (pulse), pulse set spacing, duty cycle (pulse set).

4. Apparatus according to claim 1, wherein said predefined setting comprises at least one frequency and/or at least one intensity of the applied stimulation signals.

5. Apparatus according to claim 1, wherein said stimulation signals are provided randomly and/or can be provided randomly, such as randomly distributed over at least one period of time.

6. Apparatus according to claim 1, wherein the stimulation signals over a period of time are applied with a frequency of 0.00001-100 Hz, such as 0.00001-0.0001 Hz, 0.0001-0.001 Hz, 0.001-0.01 HZ, 0.1-1 Hz, 1-5 Hz, 5-10 Hz and/or 10-100 Hz.

7. Apparatus according to claim 1, further comprising a housing and an electrode assembly, said housing accommodating at least one battery and necessary electronics, and a main terminal interface, said housing having outer dimensions of:

length less than 100 mm, such as less than 80 mm, such as less than 60 mm, such as less than 50 mm, such as less than 40 mm, such as less than 30 mm, such as less than 20 mm,

width less than 80 mm, such as less than 60 mm, such as less than 50 mm, such as less than 40 mm, such as less than 30 mm, such as less than 20 mm, such as less than 10 mm, and

height less than 30 mm, such as less than 25 mm, such as less than 20 mm, such as less than 18 nm, such as less than 16 mm, such as less than 14 mm, such as less than 12 mm, such as less than 10 mm, such as less than 8 mm, such as less than 6 mm, such as less than 4 mm, such as less than 2 mm.

8. Apparatus according to claim 1, further comprising means for monitoring signals indicative of bruxism, means for processing of said signals in order to detect bruxism, and means for providing a feedback signal in response to detection of bruxism.

9. Apparatus according to claim 1, wherein the frequency and/or intensity of the applied stimulation signals are adjusted in response to intensity, impact, frequency and/or duration of detected bruxism episodes.

27. A method for treating bruxism according to claim 18 by means of the apparatus according to claim 1.

81. A method for treating bruxism according to claim 72 by means of the apparatus as defined in any of the preceding claims.

10. A method for preventing bruxism of an individual, comprising:

a) applying a plurality of stimulation signals for relaxation of at least one of the masticatory and/or facial muscles of said individual,

b) applying said stimulations signals with a predefined setting, and

c) applying said stimulations signals independent of activity of said muscle(s).

11. A method according to claim 10, wherein a stimulation signal is a pulse train with a one or more of the following parameters being predefined:

start current, end current, start voltage, end voltage, pulse width, pulse train duration, inter-pulse spacing, duty cycle (pulse), pulse set spacing, duty cycle (pulse set).

12. A method according to claim 10, wherein the stimulation signals are applied to the individual by means of at least one electrode assembly is attached to the skin of the individual.

13. A method according to claim 10, wherein said predefined setting comprises at least one frequency and/or at least one intensity of the applied stimulation signals.

15. A method according to claim 10, wherein the stimulation signals over a period of time are applied with a frequency of 0.00001-100 Hz, such as 0.00001-0.0001 Hz, 0.0001-0.001 Hz, 0.001-0.01 HZ, 0.1-1 Hz, 1-5 Hz, 5-1 0 Hz and/or 10-100 Hz.

16. A method according to claim 10, further comprising:

monitoring signals indicative of bruxism,

processing of said signals in order to detect bruxism, and

providing a feedback signal in response to detection of bruxism.

17. A method according to claim 10, wherein the frequency and/or intensity of the applied stimulation signals are adjusted in response to intensity, impact, frequency and/or duration of detected bruxism episodes.

28. A method according to claim 10 for treatment of one or more of the following disorders:

bruxism, awake bruxism, chronic bruxism, night time bruxism, dental wear, temporal mandibular joint disease (TMJ), tinnitus, migraine, headache, tension headache.

14. A method according to claim, wherein said stimulation signals are provided randomly and/or can be provided randomly, such as randomly distributed over at least one period of time.

18. A method for treating bruxism, said method comprising applying a stimulus to the facial region, wherein the stimulus is sufficient for inducing an exteroceptive suppression period for the muscle(s) involved in bruxism.

19. The method according to claim 18, wherein the stimulus is selected from a tactile stimulus, a temperature stimulus and an electric stimulus.

20. The method according to claim 18, wherein the stimulus is an electric stimulus having a current of at least 0.5 mA, such as at least 1.0 mA, such as at least 1.5 mA, such as at least 2.0 mA, such as at least 2.5 mA, such as at least 5.0 mA, such as at least 7.5 mA, such as at least 10.0 mA, such as at least 12.5 mA, such as at least 15.0 mA, such as at least 17.5 mA, such as at least 20.0 mA,

21. The method according to claim 18, wherein the stimulus is one electric pulse.

22. The method according to claim 18, wherein the stimulus is a train of pulses, such as at least 5 pulses, such as at least 10 pulses, such as at least 15 pulses, such as at least 20 pulses, such as at least 25 pulses, such as at least 50 pulses, such as at least 75 pulses.

23. The method according to claim 22, wherein the duration of the train of pulses is at least 10 msec, such as at least 20 msec, such as at least 50 msec, such as at least 100 msec, such as at least 200 msec, such as at least 300 msec, such as at least 400 msec.

24. The method according to any claim 22, wherein the intensity of the pulse is increased during the train of pulses.

25. The method according to claim 22, wherein the intensity of the pulse decreases towards to end of the train of pulses.

26. The method according to claim 18, wherein the duration of each pulse is at least 50 microsec, such as at least 100 microsec, such as at least 150 microsec, such as at least 200 microsec, such as at least 250 microsec.

29. Apparatus for providing a plurality of current controlled electrical stimulation signals to at least one of the masticatory and/or facial muscles of an individual, said apparatus comprising:

a) at least one electrode assembly for applying the stimulation signals to the skin of the individual,

b) means for defining the intensity of the stimulation signals by a current value, and

c) means for adapting to change in the skin-electrode contact by means of regulating the stimulation signals by the current.

30. Apparatus according to claim 29, wherein electrical stimulation signal has a current of at least 0.5 mA, such as at least 1.0 mA, such as at least 1.5 mA, such as at least 2.0 mA, such as at least 2.5 mA, such as at least 5.0 mA, such as at least 7.5 mA, such as at least 10.0 mA, such as at least 12.5 mA, such as at least 15.0 mA, such as at least 17.5 mA, such as at least 20.0 mA, such as between 0 and 7 mA, such as between 1 and 7 mA.

31. Apparatus according to claim 29, further comprising:

a) means for providing supervisory signals indicative of muscle activity relating to bruxism of said individual by means of at least one electrode assembly,

b) means for processing said supervisory signals in order to detect bruxism, and

c) means for providing a current controlled electrical stimulation signal in response to detecting bruxism.

32. Apparatus according to claim 29, further comprising:

a) means for monitoring the skin-electrode contact by continuously monitoring the impedance between the electrodes in the electrode assembly by means of an embedded monitoring signal.

33. Apparatus according to claim 29, wherein a stimulation signal is 50-100% current controlled and 0-50% voltage controlled, such as 50% current controlled and 50% voltage controlled, such as 55% current controlled and 45% voltage controlled, such as 60% current controlled and 40% voltage controlled, such as 65% current controlled and 35% voltage controlled, such as 70% current controlled and 30% voltage controlled, such as 75% current controlled and 25% voltage controlled, such as 80% current controlled and 20% voltage controlled, such as 85% current controlled and 15% voltage controlled, such as 90% current controlled and 10% voltage controlled, such as 95% current controlled and 5% voltage controlled, such as 99% current controlled and 1% voltage controlled, such as 100% current controlled and 0% voltage controlled.

34. Apparatus according to claim 29, comprising more than one electrode assembly.

35. Apparatus according to claim 29, wherein the at least one electrode assembly can be applied to the skin of the individual at various positions of the head, such as at or near to the following anatomical regions:

temple, forehead, cheek, mandible, maxillary jaw, nose, neck, mouth, ear, and/or the like.

36. Apparatus for monitoring the anatomical location of muscular activity related to bruxism of an individual, said apparatus comprising:

means for providing signals indicative of muscle activity related to bruxism by means of a plurality of electrode assemblies applied to various facial positions of the individual, or,

means for providing signals indicative of muscle activity related to bruxism by means of one electrode assembly applied to various facial locations of the individual over a period of time, and

means for processing said signals in order to detect bruxism and provide a facial map of bruxism activity.

37. Apparatus according to claim 36, further comprising

a) means for monitoring bruxism of the individual over one or more periods of time, such as more than one night such as every night of a week,

b) means for collecting and storing bruxism data for each period of time,

c) means for processing bruxism data for analysis of impact of bruxism for each period of time, and

d) means for presenting bruxism impact vs. period of time and/or bruxism impact vs. facial location.

38. Apparatus according to claim 36, further comprising means for providing customised and/or individually adapted and/or individually adjusted muscular stimulation signals to different facial locations dependent on local occurrence and/or impact of bruxism.

39. A method for providing a plurality of current controlled electrical stimulation signals to at least one of the masticatory and/or facial muscles of an individual, said method comprising:

a) defining the intensity of the stimulation signals by a current value,

b) applying the stimulation signals to the skin of the individual by means of at least one electrode assembly, and

c) adapting to change in the skin-electrode contact by means of regulating the stimulation signals by the current.

40. A method according to claim 39 furthermore comprising:

providing supervisory signals indicative of muscle activity relating to bruxism of said individual by means of said at least one electrode assembly,

processing said supervisory signals in order to detect bruxism, and

providing a current controlled electrical stimulation signal in response to detecting bruxism, (said stimulation signal being applied to said at least one of the masticatory and/or facial muscles).

41. A method according to claim 39, wherein the impedance between the electrodes in the electrode assembly is monitored continuously by means of an embedded monitoring signal.

42. A method according to claim 39, wherein the feedback signal is 50-100% current controlled and 0-50% voltage controlled, such as 50% current controlled and 50% voltage controlled, such as 55% current controlled and 45% voltage controlled, such as 60% current controlled and 40% voltage controlled, such as 65% current controlled and 35% voltage controlled, such as 70% current controlled and 30% voltage controlled, such as 75% current controlled and 25% voltage controlled, such as 80% current controlled and 20% voltage controlled, such as 85% current controlled and 15% voltage controlled, such as 90% current controlled and 10% voltage controlled, such as 95% current controlled and 5% voltage controlled, such as 99% current controlled and 1% voltage controlled, such as 100% current controlled and 0% voltage controlled.

43. A method according to claim 39, wherein the at least one electrode assembly can be applied to the skin of the individual at various locations of the face.

44. A method for monitoring the (facial/local) distribution/location of muscular activity related to bruxism of an individual, said method comprising:

providing signals indicative of muscle activity related to bruxism by means of a plurality of electrode assemblies applied to various facial locations of the individual, or,

providing signals indicative of muscle activity related to bruxism by means of an electrode assembly applied to various facial locations of the individual over a period of time,

processing said signals in order to detect teeth grinding and provide a facial map of bruxism activity.

45. A method according to claim 44, wherein bruxism of an individual is monitored over a period of time, such as more than one night such as a week, and wherein the electrode assembly is placed at a new facial location each night and wherein bruxism data is collected and stored for each night for analysis of impact of bruxism and wherein impact vs. day and impact vs. facial location can be provided.

46. Apparatus for determining the impact and/or extent of bruxism of an individual for a period of time, said apparatus comprising:

a) means for monitoring muscle activity signals of at least one of the masticatory and/or facial muscles,

b) means for processing/analysing said signals in order to determine the duration and intensity of each bruxism episode and to count the number of bruxism episodes,

c) means for determining the total impact of bruxism for said period of time, and

d) means for displaying the result(s) of the impact.

47. Apparatus according to claim 46, wherein the means for determining the impact of bruxism comprises means for integrating the intensity vs. time for each bruxism episode.

48. Apparatus according to claim 46, further comprising means for storing the signals and/or the result(s) of the impact.

49. Apparatus according to claim 46, wherein the intensity of muscle activity must be above a predefined threshold to be characterised as bruxism.

50. Apparatus according to claim 46, wherein the total muscular activity intensity vs. time is integrated.

51. Apparatus according to claim 46, wherein only muscular activity intensity above a threshold is part of the integration.

52. Apparatus according to claim 46, wherein the muscle activity signals are monitored by means of at least one electrode assembly.

53. Apparatus according to claim 46, wherein said muscle activity signals are EMG signals from the at least one electrode assembly.

54. Apparatus according to claim 46, further comprising means for providing a feedback signal to the at least one masticatory and/or facial muscle in response to detecting a bruxism episode.

55. Apparatus according to claim 46, further comprising means for determining the dental wear of local areas of the set of teeth or a denture, such as dental wear of right and/or left side.

56. Apparatus according to claim 46, further comprising means for measuring muscle activity signals of left and right facial side concurrently.

57. Apparatus according to claim 46, further comprising means for entering at least one value representing the individual'"'"'s personal perception of pain and/or tenderness of the jaw and/or masticatory muscles and/or facial muscles on a scale, such as a psychometric response scale, such as a visual analogue scale (VAS), and wherein said at least one value is stored.

58. Apparatus according to claim 46, wherein the means for displaying comprises graphical and/or numerical displaying of one or more of the following parameters:

the total impact of bruxism, the average and/or median impact, duration, strength and/or biting force of each bruxism episode, the number of bruxism episodes, the number of bruxism episodes above a predefined (biting force) threshold, the progression of the impact during one or more periods of time, a long term evaluation of bruxism impact, short term and long term comparison with personal perception of pain and tenderness.

59. A method for determining the impact and/or extent of bruxism for a period of time of an individual, said method comprising:

a) measuring muscle activity signals of at least one of the masticatory and/or facial muscles,

b) processing/analysing said signals in order to determine the duration and intensity of each bruxism episode and to count the number of bruxism episodes,

c) determining the total impact of bruxism for said period of time by combining the results obtained in step b), and

d) displaying the result(s) of the impact.

60. A method according to claim 59, wherein step c) of determining the impact of bruxism comprises the step of integrating the intensity vs. time for each bruxism episode.

61. A method according to claim 59, wherein the intensity of muscle activity must be above a predefined threshold to be characterised as bruxism.

62. A method according to claim 59, wherein the total muscular activity intensity vs. time is integrated.

63. A method according to claim 59, wherein only muscular activity intensity above a threshold is part of the integration.

64. A method according to claim 59, wherein the muscle activity signals are provided by means of at least one electrode assembly.

65. A method according to claim 59, wherein said muscle activity signals are EMG signals from the at least one electrode assembly.

66. A method according to claim 59, wherein a feedback signal can be provided to the at least one masticatory and/or facial muscle in response to detecting a bruxism episode.

67. A method according to claim 59, wherein step a) of measuring comprises measuring muscle activity signals of both left and right side of the at least one masticatory and/or facial muscle.

68. A method according to claim 59, wherein step b) of processing the signals comprises determining the dental wear of local areas of the set of teeth or a denture, such as dental wear of right and/or left side.

69. A method according to claim 59, whereby the individual can enter at least one value representing the individual'"'"'s personal perception of pain and/or tenderness of the jaw and/or masticatory muscles and/or facial muscles on a scale, such as a psychometric response scale, such as a visual analogue scale, and wherein said at least one value is stored.

70. A method according to claim 59, wherein step d) of displaying comprises graphical and/or numerical displaying of one or more of the following parameters:

the total impact of bruxism, the average and/or median impact, duration, strength and/or biting force of each bruxism episode, the number of bruxism episodes, the number of bruxism episodes above a predefined (biting force) threshold, the progression of the impact during one or more periods of time, a long term evaluation of bruxism impact, short term and long term comparison with personal perception of pain and tenderness.

71. A method for screening and/or risk assessment of an individual prior to dental restoration and/or dental implant operation by determining the impact of bruxism for a period of time, such as a week, for said individual according to any of the preceding methods, thereby evaluating the total and local (left, right, molar, premolar, canine, incisor) dental wear, and/or the necessary strength and/or type of the dental implant.

72. A method for treating bruxism, said method comprising applying a stimulus to the facial region, wherein the stimulus is sufficient for inducing an exteroceptive suppression period for the muscle(s) involved in bruxism.

73. The method according to claim 72, wherein the stimulus is selected from a tactile stimulus, a temperature stimulus and an electric stimulus.

74. The method according to claim 72, wherein the stimulus is an electric stimulus having a current of at least 0.5 mA, such as at least 1.0 mA, such as at least 1.5 mA, such as at least 2.0 mA, such as at least 2.5 mA, such as at least 5.0 mA, such as at least 7.5 mA, such as at least 10.0 mA, such as at least 12.5 mA, such as at least 15.0 mA, such as at least 17.5 mA, such as at least 20.0 mA,

75. The method according to claim 72, wherein the stimulus is one electric pulse.

76. The method according to claim 72, wherein the stimulus is a train of pulses, such as at least 5 pulses, such as at least 10 pulses, such as at least 15 pulses, such as at least 20 pulses, such as at least 25 pulses, such as at least 50 pulses, such as at least 75 pulses.

77. The method according to claim 76, wherein the duration of the train of pulses is at least 10 msec, such as at least 20 msec, such as at least 50 msec, such as at least 100 msec, such as at least 200 msec, such as at least 300 msec, such as at least 400 msec.

78. The method according to claim 76, wherein the intensity of the pulse is increased during the train of pulses.

79. The method according to claim 76, wherein the intensity of the pulse decreases towards to end of the train of pulses.

80. The method according to claim 76, wherein the duration of each pulse is at least 50 microsec, such as at least 100 microsec, such as at least 150 microsec, such as at least 200 microsec, such as at least 250 microsec.