Method and apparatus for improving human balance and gait and preventing foot injury

• US 8,308,665 B2
• Filed: 03/08/2004
• Issued: 11/13/2012
• Est. Priority Date: 03/06/2003
• Status: Active Grant

• Current Assignee: Howmedica Osteonics Corp. (Stryker Corporation), Trustees of Boston University
• Original Assignee: Trustees of Boston University
• Inventors: Harry, Jason D., Collins, James J., Niemi, James B., Kleshinski, Stephen J., Priplata, Atilla A.
• Primary Examiner(s): Ostrup, Clinton T
• Application Number:
  US10/793,729
• Publication Number:
  US 20040173220A1
• Time in Patent Office: 3,172 Days
• Field of Search: 601/46, 601/48, 601/49, 601/57, 601/70, 601/79, 601/22, 600/595
• US Class Current: 601/22
• CPC Class Codes: A43B 13/00 Soles; Sole-and-heel integral units
• CPC Class Codes: A43B 17/00 Insoles for insertion, e.g. footbeds or inlays, for attachment to the shoe after the upper has been joined
• CPC Class Codes: A43B 19/00 Shoe-shaped inserts; Inserts covering the instep
• CPC Class Codes: A43B 3/34 with electrical or electronic arrangements
• CPC Class Codes: A43B 7/00 Footwear with health or hygienic arrangements
• CPC Class Codes: A43B 7/1464 with adjustable pads to allow custom fit
• CPC Class Codes: A61F 5/0111 for the feet or ankles
• CPC Class Codes: A61F 5/14 Special medical insertions for shoes for flat-feet, club-feet or the like
• CPC Class Codes: A61H 1/00 Apparatus for passive exercising A61H5/00 takes precedence; Vibrating apparatus driving means for vibrating A61H23/00; Chiropractic devices, e.g. body impacting devices, external devices for briefly extending or aligning unbroken bones
• CPC Class Codes: A61H 2205/125 Foot reflex zones
• CPC Class Codes: A61H 39/002 Using electric currents electrotherapy A61N1/32
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0468 Specially adapted for promoting wound healing
• 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 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/20 continuous direct currents
• CPC Class Codes: A61N 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• CPC Class Codes: A61N 2/06 using magnetic fields produced by permanent magnets A61N2/12 takes precedence

Abstract

A method and wearable system and for enhancing human balance and gait and preventing foot injury through neurological stimulation of the foot and the ankle. Subthreshold stimulation for neurosensory enhancement is provided via electrodes or vibrational actuators, or combination thereof, disposed in or on a wearable a platform, such as an insole, sock shoe, removable shoe insert, or applied without the support of a platform, to the skin surface of an individual. Suprathreshold stimulation for therapeutic purposes, such as improving blood flow, is also provided by the vibrational actuators. The actuators and electrodes are driven by bias signals generated by a bias signal generator that is coupled to a controller. The signal generator under the control of the controller is adapted to generate a non-deterministic random signal, a repetitive pattern or series of patterns. The controller optionally includes a communication port for interfacing with an external computer for purposes of optimizing and programming the controller. The wearable system is powered by a power source.

Claims

1. A wearable system for neurological stimulation of a human foot, the system comprising:

a platform having at least one stimulator adapted to apply a stimulation to mechanoreceptors in the foot;

a controller including at least one bias signal generator providing a driving signal to the at least one stimulator, the at least one stimulator providing a subthreshold bias signal to target cells in response to receiving the driving signal, the subthreshold bias signal having a magnitude that is below a threshold where the target cells are activated by a stimulus; and

a power source providing electrical energy to the controller, including the at least one bias signal generator.

2. The wearable system of claim 1, wherein the platform is a removable insole insert of a shoe.

3. The wearable system of claim 2, wherein the power source and the controller, including the at least one bias signal generator, are disposed on the removable insole insert.

4. The wearable system of claim 1, wherein the at least one stimulator is positioned such that stimulation is applied to the sides of the foot.

5. The wearable system of claim 1, wherein the at least one stimulator is positioned such that stimulation is applied to the plantar surface of the foot.

6. The wearable system of claim 1, wherein the at least one stimulator is positioned such that stimulation is applied to a combination of locations including the sides of the foot, the top of the foot, and the plantar surface of the foot.

7. The wearable system of claim 6, wherein the platform is a flexible disposable pad having a form of a foot with an underside coated with adhesive for removably attaching to an insole of a shoe.

8. The wearable system of claim 1, wherein the at least one stimulator is positioned on the platform to contact non-pressure point areas of the foot, so as to minimize discomfort to an individual wearing the platform, and to contact non-bending areas of the foot, so as to allow the flexing of the platform during foot movement without additional or uncomfortable stress being placed on the foot.

9. The wearable system of claim 1, wherein the at least one stimulator comprises at least one electrode placed on or near the foot that provides electrical stimulation to the mechanoreceptors of the foot.

10. The wearable system of claim 9, wherein the at least one stimulator further comprises at least one reference electrode placed on the body wearing the system.

11. The wearable system of claim 9, wherein the at least one stimulator is positioned such that stimulation is applied to the sides of the foot.

12. The wearable system of claim 9, wherein the at least one stimulator is positioned such that stimulation is applied to the plantar surface of the foot.

13. The wearable system of claim 9, wherein the at least one stimulator is positioned such that stimulation is applied to a combination of locations including the sides of the foot, the top of the foot, and the plantar surface of the foot.

14. The wearable system of claim 9, wherein the at least one stimulator is positioned on the platform to contact non-pressure point areas, so as to minimize discomfort to an individual wearing the platform, and to contact non-bending areas of the foot, so as to allow the flexing of the platform during foot movement without additional or uncomfortable stress being placed on the foot.

15. The wearable system of claim 1, wherein the at least one stimulator comprises at least one of a stick-slip electrode, a disposable electrode, and a reusable electrode.

16. The wearable system of claim 1, wherein the at least one stimulator is a vibrational actuator providing stimulating vibration to the mechanoreceptors of the foot.

17. The wearable system of claim 16, wherein the vibrational actuator is an active vibrational actuator.

18. The wearable system of claim 17, wherein the active vibrational actuator comprises at least one of an electromagnetic actuator, an electro-mechanical actuator, a solid-state actuator, a hydraulic actuator, a pneumatic actuator, a ferro-fluidic actuator, and an electroactive polymeric actuator.

19. The wearable system of claim 18, wherein the at least one electromagnetic actuator comprises at least one of a rotary motor and a linear motor.

20. The wearable system of claim 18, wherein the at least one solid-state actuator comprises at least one of a shape memory alloy, piezoelectric materials, and microelectromechanical actuator.

21. The wearable system of claim 16, wherein the platform is a flexible disposable pad having a form of a foot with an underside coated with adhesive for removably attaching to a sole of a shoe.

22. The wearable system of claim 16, wherein the platform comprises a flexible matrix material enclosing a vibration transmitting structure and at least one of the actuators, and the platform is optimized for transmitting vibration to surfaces of the foot.

23. The wearable system of claim 22, wherein the vibration transmitting material comprises at least one of polymeric gel and a viscoelastic foam.

24. The wearable system of claim 22, wherein the vibration transmitting material comprises at least one of rigid beads, polymeric gel, viscoelastic foam, a metallic structural element, and a composite structural element.

25. The wearable system of claim 22, wherein the at least one actuator is encapsulated within the flexible matrix material such that the matrix is optimized for transmitting vibration to the surface of the foot.

26. The wearable system of claim 22, wherein the flexible matrix material has a form factor of a shoe insert.

27. The wearable system of claim 22, wherein the vibration transmitting material comprises at least one of rigid beads, polymeric gel, a viscoelastic foam, a metallic structural element, and a composite structural element and is arranged in such a way as to effect adjustable vibration propagation.

28. The wearable system of claim 22, wherein the vibration transmitting material comprises at least one of rigid beads, polymeric gel, a viscoelastic foam, a metallic structural element, and a composite structural element and is arranged in such a way as to effect adjustable vibration propagation, and the at least one actuator is a plurality of actuators positioned at a predetermined spatial separation between the plurality of actuators to optimize the vibration propagation characteristics of the platform.

29. The wearable system of claim 16, wherein the at least one stimulator comprises one or more actuators positioned such that stimulation is applied to the sides of the foot.

30. The wearable system of claim 16, wherein the at least one stimulator comprises at least one actuator positioned such that stimulation is applied to the plantar surface of the foot.

31. The wearable system of claim 16, wherein the at least one stimulator comprises one or more actuators such that stimulation is applied to a combination of locations including the sides of the foot, the top of the foot, and the plantar surface of the foot.

32. The wearable system of claim 16, wherein the at least one stimulator comprises one or more actuators positioned on the platform to contact non-pressure point areas, so as to minimize discomfort to an individual wearing the platform, and to contact non-bending areas of the foot, so as to allow the flexing of the platform during foot movement without additional or uncomfortable stress being placed on the foot.

33. The wearable system of claim 16, wherein the at least one stimulator comprises a plurality of vibrational actuators adapted to create a vibration when being electrically biased, and wherein the at least one bias signal generator is adapted to generate stepped driving signals, wherein the duration of each step of the driving signals is of a time duration sufficient to avoid placing the actuators in its natural frequency of vibration.

34. The wearable system of claim 1, wherein the at least one stimulator comprises a combination of at least one vibrational actuator and at least one electrode pair for a delivery of mechanical and electrical stimulation to the mechanoreceptors of the foot.

35. The wearable system of claim 34, wherein the at least one stimulator is applied to the sides of the foot.

36. The wearable system of claim 34, wherein the at least one stimulator is positioned such that stimulation is applied to the plantar surface of the foot.

37. The wearable system of claim 34, wherein the at least one stimulator is positioned such that stimulation is applied to a combination of locations including the sides of the foot, the top of the foot, and the plantar surface of the foot.

38. The wearable system of claim 34, wherein the at least one stimulator is positioned on the platform to contact non-pressure point areas, so as to minimize discomfort to an individual wearing the platform, and to contact non-bending areas of the foot, so as to allow the flexing of the platform during foot movement without additional or uncomfortable stress being placed on the foot.

39. The wearable system of claim 1, wherein the power source and the controller, including the at least one bias signal generator, are integrated into a housing that is positioned remotely from the platform and is coupled to the platform.

40. The wearable system of claim 39, wherein the housing is securable onto a shoe.

41. The wearable system of claim 39, where the housing can be secured to a garment.

42. The wearable system of claim 39, wherein the platform further comprises a platform coupling means, and the controller further comprises a controller coupling means for coupling with the platform coupling means for transmitting the driving signal to the platform coupling means.

43. The wearable system of claim 42, wherein the platform coupling means and the controller coupling means are wireless communication means, comprising optical means, RF means, and induction means, or wired serial or parallel communication means.

44. The wearable system of claim 43, wherein the time duration is in a range of 2 to 8 msec.

45. The wearable system of claim 1, wherein the at least one stimulator comprises a plurality of vibrational actuators disposed on the platform at a predetermined spatial separation between the plurality of actuators to induce a vibration having a desirable amplitude by manipulating phase and amplitude of the driving signal of each vibrational actuator.

46. The wearable system of claim 1, wherein the controller is adapted to detect a stance phase and a swing phase, and to provide sub-threshold stimulation for sensory enhancement during a stance phase and to provide supra-threshold stimulation for improving blood flow during a swing phase.

47. The wearable system of claim 1, wherein the controller comprises means for detecting pressure exerted on the platform so as to detect to what degree the foot is bearing weight.

48. The wearable system of claim 47, wherein the controller further comprises power management means for placing the system in a power conservation mode when the foot is not substantially bearing weight.

49. The wearable system of claim 1, wherein the platform comprises means for detecting pressure exerted on the platform so as to detect what degree the foot is bearing weight.

50. The wearable system of claim 1, wherein the controller comprises means for determining gait cycles so as to place the system under a power conservation mode during predetermined phases of a predetermined gait cycle.

51. The wearable system of claim 1, further comprising a power recovery means for harnessing energy from gait cycles and means for recharging the power source from the harnessed energy.

52. The wearable system of claim 51, wherein the power recovery means comprises converting means for converting mechanical energy into electrical energy.

53. The wearable system of claim 52, wherein the converting means comprises at least one of a piezo-electric means, a linear electro-mechanical generator means, hydraulic generator means, and a electro-active polymer means.

54. The wearable system of claim 1, wherein the controller means further controls the power source to switch the power source on and off and to an activate power conservation mode based the detection of motion of the wearable system.

55. The wearable system of claim 1, wherein the power source comprises a recharging means.

56. The wearable system of claim 55, wherein the recharging means is an inductive coupling.

57. The wearable system of claim 55, wherein the recharging means is a electrical socket for receiving an electrical connector providing electrical energy to recharge the power source.

58. The wearable system of claim 1, wherein the power source and the controller, including the at least one bias signal generator, are disposed in the sole of the shoe.

59. The wearable system of claim 1, further comprising a thermal radiation source controlled by the control means for providing heating to the foot.

60. The wearable system of claim 59, wherein the thermal radiation source is an infrared light source.

61. The wearable system of claim 59, wherein the thermal radiation source is a heating filament.

62. The wearable system of claim 1, further comprising adjusting means for a wearer to adjust the amplitude of the bias signal, including threshold and therapeutic levels of one or more of the at least one stimulator.

63. The wearable system of claim 1, further comprising external power coupling means for recharging the power source, interface means for interfacing the controller with an external device for diagnostic, optimization, calibrating and programming the wearable system and recharging the power source.

64. The wearable system of claim 1, wherein the power source is at least one of a rechargeable lithium-ion battery, polymer battery, gel battery, and nickel metal hydride.

65. The wearable system of claim 64, wherein the power source is removably disposed in the sole of a shoe.

66. The wearable system of claim 64, wherein the power source is located separately from the platform.

67. The wearable system of claim 1 or 24, wherein the signal generator provides a signal of controllable signal amplitude, frequency content, waveform shape, and repetition.

68. The wearable system of claim 1 or 24, wherein the controller is adapted to control each individual stimulator so as to effect individually controllable amplitude, frequency content, waveform shape, and repetition of the bias signal.

69. A wearable system for neurological stimulation of a human foot, the system comprising:

a platform having at least one passive vibrational mechanical actuator, the at least one passive vibrational mechanical actuator providing a subthreshold bias signal to target cells in response to a compression or a decompression, the subthreshold bias signal having a magnitude that is below a threshold where the target cells are activated by a stimulus.

70. The wearable system of claim 69, wherein the passive vibrational actuator comprises at least one of ratcheting system and hook-and-eye filaments.

71. A system for optimizing neurological stimulation, comprising:

a platform having at least one stimulator adapted to apply a stimulation to a skin surface area of a test subject;

a controller including at least one bias signal generator providing a driving signal to the at least one stimulator, the at least one stimulator providing a subthreshold bias signal to target cells in response to receiving the driving signal, the subthreshold bias signal having a magnitude that is below a threshold where the target cells are activated by a stimulus;

a remote external computer for effecting the control of the controller during an optimization procedure;

a communication means between the remote external computer and the controller; and

a measurement means for measuring the responses of the test subject as stimulation is adjusted,

wherein the remote external computer is adapted to communicate with the controller to effect varying driving signals inputted into the at least one stimulator, while responses from a subject in contact with the platform and executing a prescribed task are observed and measured,

wherein the remote computer is adapted to determine the optimal driving signal parameters suitable for the subject based on the observed responses of the subject.

72. The system of claim 71, wherein the remote external computer communicates optimal bias signal parameters to a wearable system for neurological stimulation.

73. The system of claim 71, wherein the remote external computer selects bias signal parameters to test based on responses of the subject.

74. The system of claim 71, wherein the platform comprises means to provide test stimuli as well as a bias signal to the subject.

75. The system of claim 74, wherein the remote external computer comprises means for receiving and recording responses from the subject for each bias signal used and each test stimulus applied.

76. The system of claim 71, wherein the remote external computer comprises means for receiving and recording responses from the subject for each bias signal applied.

77. The system of claim 76, wherein the means for receiving subject responses is a wired means.

78. The system of claim 76, wherein the means for receiving subject responses is a wireless means.

79. The system of claim 76, wherein the remote computer is adapted to communicate with the controller to generate a test stimulation directed at a specific actuator and hence a specific region so as to observe and measure localized responses, whereby the response of the subject is recorded and adjustments in stimulation can be made to optimize performance.

80. The system of claim 76, wherein the remote computer is adapted to measure responses from the subject performing a prescribed task demonstrating balance or gait.

81. The system of claim 71, wherein the remote external computer is adapted to communicate with the controller to effect the generation of a bias signal of a predetermined one or more frequencies, amplitude, repetition, waveform shape, and pattern.

82. The system of claim 71, wherein the communication means is comprised of at least one of a wired or optical serial communication link, a wired or optical parallel communication link, a wireless RF communication link, and a wireless optical communication link.

83. A method for providing neurological stimulation in a wearable system, comprising:

providing a wearable platform having one or more stimulators a controller including at least one signal generator coupled to the one or more stimulators, and a power supply source for powering the controller;

adjusting or programming the controller to produce a sensory enhancement bias signal at a subthreshold level via the bias signal generator, the subthreshold level having a magnitude that is below a threshold where target cells are activated by a stimulus; and

activating the signal generator and supplying the subthreshold bias signal to the one or more sources of stimulation to stimulate mechanoreceptors based on a determined therapeutic need of an individual.

84. The method according to claim 83, further comprising measuring an individual'"'"'s threshold level of sensation in an area to receive stimulation.

85. The method according to claim 84, wherein adjusting or programming the controller to control the bias signal generator comprises producing a therapeutic level relative to the measured threshold level.

86. The method according to claim 84, wherein the subthreshold level is between 10 and 30% below the measured threshold level.

87. The method according to claim 84, wherein the measuring of a threshold level comprises inputting a minimal bias signal to the one or more actuators and progressively increasing the amplitude of the bias signal until an individual wearing the platform detects stimulations from the one or more of the actuators.

88. The method according to claim 84, wherein the measuring of a threshold level comprises a tracking procedure which begins with a minimal or maximal signal and makes incremental changes towards the final threshold based on an individual'"'"'s response.

89. The method according to claim 84, wherein the measuring of a threshold level comprises monitoring activity of sensory neurons emanating from the test area.

90. The method according to claim 84, wherein the measuring of threshold comprises monitoring brain function using tools including EEG or fMRI.

91. The method according to claim 83, further comprising determining an optimal level of stimulation.

92. The method according to claim 91, wherein adjusting or programming the bias signal generator comprises producing a therapeutic level relative to the optimal level of stimulation.

93. The method according to claim 91 wherein determining an optimal level of stimulation comprises repeatedly measuring the performance of an individual in a directed sensory or sensorimotor task and selecting the stimulation so as to optimize the measured performance.

94. The method according to claim 91, wherein determining an optimal level of stimulation comprises monitoring activity of sensory neurons emanating from the test area.

95. The method according to claim 91, wherein determining an optimal level of stimulation comprises monitoring brain function using tools including EEG or fMRI.

96. The method of claim 83, wherein programming the controller further comprises adapting the controller to activate a power conservation mode during a predetermined gait cycle.

97. The method of claim 83, wherein programming the controller further comprises adapting the controller to alternately provide subthreshold stimulation for sensory enhancement and suprathreshold stimulation for improving blood flow.

98. The method of claim 83, wherein programming the controller further comprises adapting the controller to detect a stance phase and a swing phase, and providing a subthreshold stimulation for sensory enhancement during a stance phase and a suprathreshold stimulation for improving blood flow during a swing phase.