Non invasive neuromodulation device for enabling recovery of motor, sensory, autonomic, sexual, vasomotor and cognitive function

• US 10,124,166 B2
• Filed: 04/11/2016
• Issued: 11/13/2018
• Est. Priority Date: 11/11/2011
• Status: Active Grant

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: NeuroEnabling Technologies, Inc.
• Inventors: Edgerton, Victor Reggie, Gerasimenko, Yury P., Terrafranca, Nicholas A., Lu, Daniel C.
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US15/096,014
• Publication Number:
  US 20160220813A1
• Time in Patent Office: 946 Days
• Field of Search: 607 45- 46
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters

Abstract

In one example embodiment, a neuromodulation system for inducing locomotor activity in a mammal, in cooperation with a signal generator and an electrode, delivers a signal with an overlapping high frequency pulse to a mammal.

Claims

1. A neuromodulation system for inducing locomotor activity in a mammal, the neuromodulation system comprising:

a processor;

a signal generator communicatively coupled to the processor;

at least one electromyography electrode communicatively coupled to the processor;

at least two electrodes electrically coupled to the signal generator; and

a memory device communicatively coupled to the processor and configured to store instructions, which when executed by the processor, cause the processor, in cooperation with the signal generator and the at least two electrodes, to deliver a continuous therapeutic signal having parameter values including a 0.5 Hz to 100 Hz waveform with an overlapping high frequency pulse at 5 kHz to 10 kHz delivered at 30-200 mA to the mammal,

wherein the at least one electromyography electrode measures a response related to delivery of the continuous therapeutic signal to the mammal, and

wherein the processor is configured to synchronize the parameter values of the continuous therapeutic signal with the response measured by the at least one electromyography electrode and store to the memory the synchronization for selection of new parameter values to deliver a subsequent continuous therapeutic signal.

2. The neuromodulation system of claim 1, wherein the continuous therapeutic signal is delivered by the at least two electrodes to a human.

3. The neuromodulation system of claim 1, wherein the signal generator is configured to deliver the continuous therapeutic signal at 85-100 mA.

4. The neuromodulation system of claim 1, wherein the signal generator is configured to deliver the overlapping high frequency pulse by providing a 10 kHz pulse.

5. The neuromodulation system of claim 1, wherein the signal generator is configured to deliver the overlapping high frequency pulse by providing a 5 kHz pulse.

6. The neuromodulation system of claim 1, wherein the continuous therapeutic signal is delivered by the at least two electrodes paraspinally over a neck of the mammal.

7. The neuromodulation system of claim 6, wherein the neck of the mammal includes a cervical portion of a spinal cord and a brainstem.

8. The neuromodulation system of claim 1, wherein the signal generator is configured to deliver the continuous therapeutic signal paraspinally over a lower back of the mammal.

9. The neuromodulation system of claim 8, wherein the lower back includes at least one of a lumbar portion, a lumbosacral portion, and a sacral portion of the spinal cord.

10. The neuromodulation system of claim 1, wherein the signal generator is configured to deliver the continuous therapeutic signal to a thoracic portion of a spinal cord or to an end organ.

11. The neuromodulation system of claim 10, wherein the thoracic portion of the spinal cord includes T11-T12 vertebrae.

12. The neuromodulation system of claim 1, wherein the neuromodulation system is configured to treat the mammal for a spinal cord injury which is classified as one of motor complete and motor incomplete.

13. The neuromodulation system of claim 1, wherein the neuromodulation system is configured to treat the mammal for an ischemic brain injury which is an injury from at least one of a stroke and acute trauma, has a neurodegenerative brain injury, or a combination thereof.

14. The neuromodulation system of claim 13, wherein the neurodegenerative brain injury is a brain injury associated with a condition selected from the group consisting of Parkinson'"'"'s disease, Huntington'"'"'s disease, Alzheimer'"'"'s disease, ischemia, stroke, amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS) or other neurological disorders such as cerebral palsy.

15. The neuromodulation system of claim 1, wherein the neuromodulatoin system is used to treat chronic pain, spasm, autonomic function, sexual function, vasomotor function, or cognitive function.

16. The neuromodulation system of claim 1, wherein the system induces motor activity which comprises at least one of standing, stepping, a walking motor pattern, sitting down, laying down, reaching, grasping, pulling, chewing, swallowing, sexual function, respiratory function, and pushing.

17. The neuromodulation system of claim 1, wherein the continuous therapeutic signal and the overlapping high frequency pulse are square waves, and wherein the continuous therapeutic signal and the overlapping high frequency pulse have unequal parameter values.

18. A neuromodulation system comprising:

a processor;

a first signal generator communicatively coupled to the processor;

a second signal generator communicatively coupled to the processor;

at least one electromyography electrode communicatively coupled to the processor;

at least two electrodes electrically coupled to at least one of the first signal generator and the second signal generator; and

a memory device communicatively coupled to the processor and configured to store instructions, which when executed by the processor, cause the processor, in cooperation with the first signal generator, the second signal generator, and the at least two electrodes, to deliver a secondary high frequency electric pulse having a first parameter value of 10 kHz, which overlaps with a continuous therapeutic primary biphasic low frequency pulse delivered having a second parameter value of 0.5 Hz to 100 Hz resulting in less skin impedance and pain free stimulation, wherein the continuous therapeutic primary biphasic low frequency pulse is delivered at a third parameter value of 30-200 mA,

wherein the at least one electromyography electrode measures a response related to delivery of the continuous therapeutic primary biphasic low frequency pulse and the secondary high frequency electric pulse to the mammal, and

wherein the processor is configured to synchronize the parameter values of the secondary high frequency electric pulse and the continuous therapeutic primary biphasic low frequency pulse with the response measured by the at least one electromyography electrode and store to the memory the synchronization for selection of new parameter values to deliver at least one of a subsequent primary biphasic low frequency pulse and a subsequent secondary high frequency electric pulse.

19. The neuromodulation system of claim 18, wherein the processor, in cooperation with the first signal generator and the second signal generator is configured to deliver the continuous therapeutic primary biphasic low frequency pulse at 5-40 Hz.

20. The neuromodulation system of claim 18, wherein the processor, in cooperation with the first signal generator and the second signal generator is configured to deliver the secondary high frequency electric pulse paraspinally.