Functional electrical stimulation (FES) method and system to improve walking and other locomotion functions

• US 9,314,622 B2
• Filed: 10/25/2012
• Issued: 04/19/2016
• Est. Priority Date: 10/28/2011
• Status: Active Grant

• Current Assignee: Good Samaritan Hospital (PIH Health, Inc.)
• Original Assignee: Good Samaritan Hospital (PIH Health, Inc.)
• Inventors: Embrey, David G., Stonestreet, Jeffrey, Alon, Gadi
• Primary Examiner(s): Porter, Jr., Allen
• Application Number:
  US13/879,557
• Publication Number:
  US 20140128939A1
• Time in Patent Office: 1,272 Days
• Field of Search: 607/48, 607/49
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/112 Gait analysis
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/6828 Leg
• CPC Class Codes: A61N 1/0452 Specially adapted for transcutaneous muscle stimulation [TMS]
• 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 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters

Abstract

A method and system which provides wireless, noninvasive electrical stimulation to different muscle groups to allow the user to conduct physical activities, such as walking, by stimulating various muscle groups in the body at the correct times of activation or by stimulating muscle groups in a simulation mode when standing, sitting or lying down, whereby walking is not required to stimulate the various muscle groups. The system provides a small portable wearable system which utilizes available software, including Bluetooth technology, to provide electrical nerve stimulating pulses with low current, minimal phase charge which is controlled remotely and induce desired muscle contraction with increased comfort for the user. The present method and system applies electrical stimulation with accurate timing, based on a three-dimensional motion sensor, as a trigger to initiate stimulation and which is adapted to turn itself on and off when not walking.

Claims

1. A non-invasive, wearable electrical stimulator which consists essentially of

a controller,

a motion sensor in electrical communication with the controller and adapted to detect a beginning and end of cycles of locomotion activity, wherein the motion sensor does not include foot switches,

a power source, and

a constant current waveform generator receiving power from the power source and controlled by the controller, wherein the controller, motion sensor, power source and waveform generator are contained in a singular housing adapted to be worn on a body part of a user, and

a plurality of electrodes adapted to apply electrical stimulation in a timed stimulation pattern to multiple, different muscle groups of the user which contract synergistically and cooperate together to stimulate complete cycles of locomotion activity, said plurality of electrodes electrically connected to the waveform generator for supplying electrical stimuli to nerves and muscles of the user sufficient to cause timed contraction of the different muscle groups required for achieving each complete cycle of locomotion activity,

wherein the motion sensor functions to recognize the initiation of different complete cycles of locomotion activity which acts as a trigger for the electrodes to deliver the electrical stimulation to appropriate muscles of the multiple, different muscle groups to be active in each of the different locomotion activity cycles, at a time when the appropriate muscles of the multiple different muscle groups need to be activated to achieve each different locomotion activity cycle, said electrical stimulation being synchronized with each of the different complete cycles of locomotion activity and applied throughout an entire cycle of each of the different complete cycles.

2. The electrical stimulator of claim 1, further comprising a zener diode in the waveform generator.

3. The electrical stimulator of claim 1, wherein the power source includes an inductor.

4. The electrical stimulator of claim 1, wherein the motion sensor is one of a tri-axial accelerometer, a gyroscope, a magnetometer, and a pressure or sound sensor.

5. The electrical stimulator of claim 4, wherein the motion sensor enables activation of a plurality of different muscle groups at a correct timing sequence, regardless of a cadence of the user for repeatably achieving a desired complete cycle of locomotion activity.

6. The electrical stimulator of claim 4, wherein the motion sensor defines a dual-purpose trigger mechanism which turns the stimulator on when the user is walking or practicing other cyclical locomotion activity including repeatably standing up and sitting down, lifting, moving and placing objects and off when the user stops walking or stops repeating the other locomotion activities.

7. The electrical stimulator of claim 1, wherein the waveform generator outputs one of a monophasic, a triple monophasic, geometrically symmetric biphasic with intra-pulse interval and triple geometrically symmetrical biphasic with intra-pulse intervals waveform.

8. The electrical stimulator of claim 1, wherein the waveform generator is configured to generate a waveform with an adjustable phase duration and a fixed maximum peak current to minimize a phase charge needed to induce muscle contraction.

9. The electrical stimulator of claim 1, further comprising a remote control unit operatively communicating with the electrical stimulator and configured to allow adjustment of an intensity of the stimulus power (charge) output and to activate the waveform generator.

10. The electrical stimulator of claim 1, further comprising a wireless executive control unit which is operatively communicating with the controller to enable a clinician to selectively initiate a stimulation cycle to be provided to the electrodes to increase or decrease an intensity of the stimulation and other parameters, including pulse rate and to alter the electrical stimulation created by the electrical stimulator.

11. The electrical stimulator of claim 1, wherein the cycle of locomotion activity is walking with a defined gait of a user and the electrical stimulation of the different muscle groups is correctly timed to be activated when needed throughout the gait cycle.

12. The electrical stimulator of claim 11, wherein the motion sensor detects a cycle time of the gait and is adapted to adjust timing of the stimulation from a default setting to the detected cycle time established by the gait, with continual adjustment as the user increases or decreases gait cycle speed.

13. The electrical stimulator of claim 1, wherein the cycle of locomotion activity includes a repeating standing up to sitting down cycle, walking cycle, stair climbing cycle and lifting and moving objects from one location to another.

14. The electrical stimulator of claim 1, wherein the motion sensor is adapted to turn itself on and off.

15. The electrical stimulator of claim 1, wherein said stimulator is adapted to create different timed stimulation patterns and cycles depending on a particular, different synergistically coupling of muscle groups to which the electrodes are applied for performing the desired cycles of locomotion activity.

16. The electrical stimulator of claim 1, which comprises two electrical output channels electrically coupling to the plurality of electrodes to the constant current waveform generator for providing dual-muscle stimulation for targeted muscle groups.

17. The electrical stimulator of claim 1, wherein the electrical stimulation generates an electrical impulse which increases an intensity of the stimulation by increasing a phase duration of the impulse while maintaining a fixed maximal peak current in order to minimize a phase charge needed to induce muscle contraction and increase a comfort level of electrical stimulation.

18. The electrical stimulator of claim 1, wherein the stimulation timing pattern is a defined pattern which can be automatically modified to conform to an actual pattern of the muscle contractions in performing the different cycle of locomotion activity.

19. The electrical stimulator of claim 1 wherein the different muscle groups include the dorsiflexors and plantar flexors, abdominals and back extensors, quadriceps and hamstrings, hip abductors, hip adductors and hip extensors.

20. The electrical stimulator of claim 1, wherein the initiation of the cycle locomotion activity activates the motion sensor as a result of contact of a body part of the user with a surface.

21. The electrical stimulator of claim 20, wherein the surface is the ground, a floor, or a chair.

22. The electrical stimulator of claim 1, wherein cycle of the locomotion activity corresponds to the user'"'"'s demands or to a predetermined cycle time for each particular cycle of locomotion activity.

23. The electrical stimulator of claim 1, further comprising a remote control unit operatively communicating with the controller and configured to induce timely muscle contraction which coincides with a complete cycle of locomotion activity, without volitional participation of the user in activation of target muscles.

24. The electrical stimulator of claim 1, further comprising an executive control unit operatively communicating with the controller and configured to enable a clinician to induce timely muscle contraction which coincides with a complete cycle of locomotion activity without volitional participation of the user in activation of target muscles.

25. The electrical stimulator of claim 1, which further comprises a remote control unit operatively communicating with the controller and configured to induce timely muscle contraction in a timed stimulation associated with a complete cycle of locomotion activity which functions to modulate the central nervous system of the user to replicate the complete cycle of locomotion activity.

26. The electrical stimulator of claim 1, which further comprises an executive control unit operatively communicating with the controller and configured to induce timely muscle contraction in a timed stimulation associated with a complete cycle of locomotion activity which functions to modulate the central nervous system of the user to replicate the complete cycle of locomotion activity.