# US 10,478,624 B2 · Method and apparatus for multimodal electrical modulation of pain

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- Number: US 10,478,624 B2
- Document ID: US10478624B2
- Status: Granted
- Kind: B2
- Application number: 15/966,379
- Filed: 2018-04-30
- Published: 2018-09-06
- Granted: 2019-11-19
- Earliest claimed: 2015-03-20
- Assignees: Stimgenics, LLC
- Applicants: StimGenics, LLC
- Inventors: Ricardo Vallejo; David Leonardo Cedeno; Ramsin M. Benyamin
- Web page: https://patentgrep.com/patent/US10478624B2

## CPC

- A61N 1/36071: {Pain}
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 1/36062: {Spinal stimulation}
- A61N 1/36189: {using modulation techniques}
- A61N 1/36192: {Amplitude modulation}
- A61N 1/36196: {Frequency modulation}
- A61N 2/008: {for pain treatment or analgesia}
- A61N 2/002: {in combination with another treatment}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

Apparatus and methods for managing pain uses separate varying electromagnetic fields, with a variety of temporal and amplitude characteristics, which are applied to a particular neural structure to modulate glial and neuronal interactions as a mechanism for relieving chronic pain. In another embodiment, a single composite modulation/stimulation signal which has rhythmically varying characteristics is used to achieve the same results as separate varying electromagnetic fields. Also, disclosed is an apparatus and method for modulating the expression of genes involved in diverse pathways including inflammatory/immune system mediators, ion channels and neurotransmitters, in both the Spinal Cord (SC) and Dorsal Root Ganglion (DRG) where such expression modulation is caused by spinal cord stimulation or peripheral nerve stimulation using the disclosed apparatus and techniques. In one embodiment of multimodal modulation therapy, the prime signal may be monophasic, or biphasic, in which the polarity of the first phase of the biphasic prime signal may be either cathodic or anodic while the tonic signal may be either monophasic, or biphasic, with the polarity of the first phase of the biphasic tonic signal being either cathodic or anodic.

## Claims

### Claim 1

An electromagnetic stimulation system comprising:
a signal generation module, and
one or more leads operatively coupled to the signal generation module and configured for exposing glial cells and neurons of a subject simultaneously to a first oscillating electromagnetic stimulus and a second oscillating electromagnetic stimulus, and
wherein the first oscillating electromagnetic stimulus is provided by a first electrical signal having a current amplitude set to a value corresponding to a percentage of a Priming Perception Threshold (PPT) of the subject, and
wherein the second oscillating electromagnetic stimulus is provided by a second electrical signal having a current amplitude set to a value corresponding to a percentage of the paresthesia threshold (PT).

### Claim 2 (depends on 1)

The system of claim 1 wherein the first electric signal and the second electrical signal have any of different respective amplitudes, frequencies, relative phases, phase polarities, waveform shapes, and widths.

### Claim 3 (depends on 1)

The electromagnetic stimulation device of claim 1 wherein one of the first and second electric signals is a tonic stimulation signal and the other of the first and second electrical signals has a frequency higher than a frequency of the tonic stimulation signal.

### Claim 4 (depends on 1)

The system of claim 1 wherein the signal generator module is arranged for generating a composite electrical signal from the first and second electrical signals.

### Claim 5 (depends on 4)

The system of claim 4 wherein the composite electrical signal comprises any of a frequency modulated signal, an amplitude modulated signal or a pulse modulated signal.

### Claim 6

An electromagnetic stimulation system comprising:
memory for storing a plurality of multimodal signal parameter programs;
a selection device for selecting one of the plurality of multimodal signal parameter programs in memory,
a multimodal signal generator controllable by a selected of the plurality of multimodal signal parameter programs; and
one or more electrodes operatively coupled to the signal generation module and configured for exposing glial cells and neurons of a subject simultaneously to a first oscillating electromagnetic stimulus and a second oscillating electromagnetic stimulus,
wherein the stimulation system is configured to provide a multimodal stimulation signal generated by the multimodal signal generator in accordance with a selected of the multimodal signal parameter programs to the at least one electrode,
wherein the first oscillating electromagnetic stimulus is provided by a first electrical signal having a current amplitude set to a value corresponding to a percentage of a Priming Perception Threshold (PPT) of the subject, and
wherein the second oscillating electromagnetic stimulus is provided by a second electrical signal having a current amplitude set to a value corresponding to a percentage of a paresthesia threshold (PT) of the subject.

### Claim 7 (depends on 6)

The electromagnetic stimulation system of claim 6 further comprising:
an enclosure of biocompatible material surrounding the multimodal signal generator.

### Claim 8 (depends on 6)

The electromagnetic stimulation system of claim 6 wherein the first and second electrical signals have different respective frequencies.

### Claim 9 (depends on 6)

The electromagnetic stimulation system of claim 6 wherein the first and second electrical signals have any of different respective amplitudes, frequencies, waveform shapes, widths, and phases relative to each other.

### Claim 10 (depends on 6)

The electromagnetic stimulation system of claim 6 wherein the first and second electrical signals comprise one of monophasic electrical signals and biphasic electrical signals.

### Claim 11 (depends on 6)

The electromagnetic stimulation device of claim 6 wherein the signal generator is arranged for generating a composite electrical signal derived from the first and second electrical signals.

### Claim 12 (depends on 11)

The electromagnetic stimulation device of claim 11 wherein the composite electrical signal comprises any of a frequency modulated signal, an amplitude modulated signal or a pulse-width modulated signal.

### Claim 13

An electromagnetic stimulation system comprising:
a signal generation module, and
at least one lead operatively coupled to the signal generation module and configured for exposing glial cells and neurons of a subject simultaneously to a varying first electromagnetic stimulus and a second varying electromagnetic stimulus, and
wherein the first varying electromagnetic stimulus is provided by a first electrical signal having a current amplitude set to a value corresponding to a percentage of a Priming Perception Threshold (PPT) of the subject, and
wherein the second varying electromagnetic stimulus is provided by a second electrical signal having a current amplitude set to a value corresponding to a percentage of the paresthesia threshold (PT), and
wherein the signal generator module is arranged for generating a composite electrical signal from the first and second electrical signals.

### Claim 14 (depends on 13)

The electromagnetic stimulation system of claim 13 wherein the composite electrical signal comprises any of a frequency modulated signal, an amplitude modulated signal or a pulse modulated signal.

### Claim 15 (depends on 13)

The electromagnetic stimulation system of claim 13 wherein the first electric signal and the second electrical signal have any of different respective amplitudes, frequencies, relative phases, phase polarities, waveform shapes, and widths.

### Claim 16 (depends on 13)

The electromagnetic stimulation system of claim 13 wherein the first and second electrical signals have different respective frequencies.

### Claim 17 (depends on 16)

The electromagnetic stimulation device of claim 16 wherein one of the first and second electric signals is a tonic stimulation signal and the other of the first and second electrical signals has a frequency higher than a frequency of the tonic stimulation signal.

### Claim 18 (depends on 13)

The electromagnetic stimulation system of claim 13 further comprising:
an enclosure of biocompatible material surrounding the multimodal signal generator.
