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

• US 10,076,460 B2
• Filed: 11/12/2012
• Issued: 09/18/2018
• Est. Priority Date: 03/06/2003
• Status: Active Grant

• Current Assignee: Trustees of Boston University
• Original Assignee: Trustees of Boston University
• Inventors: Harry, Jason D., Collins, James J., Niemi, James B., Priplata, Attila A., Kleshinski, Stephen J.
• Primary Examiner(s): Thanh, Quang D
• Application Number:
  US13/674,769
• Publication Number:
  US 20130072835A1
• Time in Patent Office: 2,136 Days
• Field of Search: 601 22, 601 27, 601 30, 601 46, 601 48, 601 49, 601 57, 601 71, 601 79, 36136, 36140, 36141
• 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 vibrational actuator adapted to apply a mechanical stimulation to mechanoreceptors in the foot;

at least one signal generator adapted to provide at least one driving signal to drive the at least one vibrational actuator;

a controller configured to control the at least one signal generator and the at least one vibrational actuator;

a sensor coupled to the controller, the sensor configured to sense activity of the foot; and

a power source providing electrical energy to the controller and the at least one signal generator,

wherein the platform is a removable insole insert of a shoe, and wherein the controller is configured to adjust the at least one driving signal provided by the at least one signal generator to transition the at least one vibrational actuator between providing, to the mechanoreceptors in the foot, a mechanical stimulation having a subthreshold magnitude based on a first activity of the foot sensed by the sensor and a mechanical stimulation having a suprathreshold magnitude based on a second activity of the foot sensed by the sensor, the first activity being different from the second activity.

2. The wearable system of claim 1, wherein the removable insole insert comprises a flexible matrix material filled with rigid beads, and wherein the at least one vibrational actuator comprises a plurality of vibrational actuators disposed underneath the removable insole insert such that the removable insole insert is optimized for transmitting mechanical vibration to a plantar surface of the foot.

3. The wearable system of claim 1, wherein the removable insole insert comprises a flexible matrix material filled with rigid beads, and wherein the at least one vibrational actuator comprises a plurality of vibrational actuators embedded within the flexible matrix material such that the removable insole insert is optimized for transmitting mechanical vibration to a plantar surface of the foot.

4. The wearable system of claim 1, wherein the removable insole insert comprises a flexible matrix material enclosing a vibration transmitting structure and the at least one vibrational actuator, and wherein the flexible matrix material is optimized for transmitting mechanical vibration to surfaces of the foot.

5. The wearable system of claim 1, wherein the at least one vibrational actuator comprises a plurality of vibrational actuators disposed on the removable insole insert at a predetermined spatial separation between each of the plurality of vibrational actuators to induce random mechanical vibration by manipulating a phase of the at least one driving signal of each of the plurality of vibrational actuators.

6. The wearable system of claim 1, wherein the at least vibrational actuator comprises a plurality of vibrational actuators adapted to create a mechanical vibration when being electrically biased, and wherein the controller is configured to operate at least a first one of the plurality of vibrational actuators in a first direction of spin and at least a second one of the plurality of vibrational actuators in a second direction of spin so as to induce random vibrational mechanical stimulation.

20. The wearable system of claim 1, wherein the controller is configured to differentiate among different activities of the foot based on an output of the sensor, the activities including (a) a movement or acceleration of the foot and (b) a position change of the foot.

21. The wearable system of claim 20, wherein the movement includes movement of the foot during a gait between a swing phase and a stance phase and the position change includes a change in a position of the foot between a seated position and a standing position.

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

a platform having at least one vibrational actuator adapted to apply a mechanical stimulation to mechanoreceptors in the foot;

at least one signal generator adapted to provide at least one driving signal to drive the at least one vibrational actuator;

a sensor configured to sense a pressure on the foot and to sense activity of the foot, the activity of the foot including at least one of;

(i) movement of the foot between a swing phase and a stance phase;

(ii) position change of the foot between a seated position and a standing position;

(iii) acceleration of the foot;

or (iv) any combination of (i), (ii), and (iii);

a controller configured to control the at least one signal generator and the at least one vibrational actuator; and

a power source providing electrical energy to the controller and the at least one signal generator,

wherein the platform is a removable insole insert of a shoe, and wherein the at least one driving signal to drive the at least one vibrational actuator is composed of one or more frequencies with a bandwidth of greater than 0 Hz to about 1 KHz and wherein the controller is configured to adjust the at least one driving signal provided by the at least one signal generator based on the sensed pressure on the foot to thereby cause the at least one vibrational actuator to provide;

(i) at a first time, a first mechanical stimulation having a subthreshold magnitude when the pressure on the foot is greater than at least a pressure threshold;

(ii) at a second time after the first time, a second mechanical stimulation having a suprathreshold magnitude when the pressure on the foot is less than at least the pressure threshold; and

(iii) at a third time after the second time, a third mechanical stimulation having a subthreshold magnitude when the pressure on the foot is greater than at least the pressure threshold.

8. The wearable system of claim 7, wherein the at least one driving signal to drive the at least one vibrational actuator is composed of one or more frequencies with a bandwidth of greater than 0 Hz to about 500 Hz.

9. The wearable system of claim 8, wherein the at least one driving signal to drive the at least one vibrational actuator is composed of one or more frequencies with a bandwidth of greater than 0 Hz to about 100 Hz.

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

a removable insole insert comprising;

a platform having at least one vibrational actuator adapted to apply a mechanical stimulation to mechanoreceptors in the foot;

at least one signal generator adapted to provide at least one driving signal to drive the at least one vibrational actuator;

a controller configured to control the at least one signal generator and the at least one vibrational actuator;

a sensor coupled to the controller to sense activity of the foot; and

a power source providing electrical energy to the controller and the at least one signal generator,

wherein the controller is programmable and wherein the controller is configured to adjust the at least one driving signal provided by the at least one signal generator to transition the at least one vibrational actuator between providing, to the mechanoreceptors in the foot, a mechanical stimulation having a subthreshold magnitude and a mechanical stimulation having a suprathreshold magnitude based on the activity of the foot sensed by the sensor.

11. The wearable system of claim 10, further comprising a thermal radiation source configured to provide heat therapy to the foot.

12. The wearable system of claim 10, wherein the at least one signal generator provides a non-deterministic random signal driving the at least one vibrational actuator.

13. The wearable system of claim 10, wherein the at least one signal generator provides a signal of a predetermined at least one repetitive pattern and series of patterns.

14. The wearable system of claim 10, wherein the at least one driving signal has a controllable signal amplitude, a controllable frequency content, a controllable waveform shape, and a controllable repetition.

15. The wearable system of claim 10, wherein the at least one vibrational actuator comprises a plurality of vibrational actuators, and wherein the controller is adapted to control individually each of the plurality of vibrational actuators so as to effect individually controllable amplitude, individually controllable frequency content, individually controllable waveform shape, and individually controllable repetition of the mechanical stimulation provided by each of the plurality of vibrational actuators.

16. The wearable system of claim 10, wherein the controller controls the at least one signal generator and the at least one vibrational actuator to provide the mechanical stimulation having the subthreshold magnitude so as to effect sensory enhancement.

17. The wearable system of claim 10, wherein the controller controls the at least one signal generator and the at least one vibrational actuator to provide the mechanical stimulation having the suprathreshold magnitude so as to effect therapeutic massage and improvement of blood flow.

18. The wearable system of claim 10, wherein the controller controls the at least one signal generator and the at least one vibrational actuator to alternatively provide the mechanical stimulation having the subthreshold magnitude and the mechanical stimulation having the suprathreshold magnitude so as to effect sensory enhancement, therapeutic massage and improvement of blood flow.

19. The wearable system of claim 10, wherein the at least one vibrational actuator comprises a first vibrational actuator and a second vibrational actuator, and wherein the controller controls the at least one signal generator, the first vibrational actuator, and the second vibrational actuator, the first vibrational actuator providing the mechanical stimulation having the subthreshold magnitude and the second vibrational actuator providing the mechanical stimulation having the suprathreshold magnitude, so as to effect sensory enhancement, therapeutic massage and improvement of blood flow.