IP Library Granted Patent US 11,045,651
Granted Patent B2
US 11,045,651 · App. 17/121,425 · Granted Jun 29, 2021

Method and apparatus for multimodal electrical modulation of pain

Inventors: Ricardo Vallejo (Bloomington, IL); David Leonardo Cedeno (Normal, IL); Ramsin M. Benyamin (Bloomington, IL)
Assignee: Medtronic SG, LLC
A61N1/36071A61N1/0551A61N1/36062A61N1/36192A61N1/36196A61N2/002A61N2/008
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Quick Facts
Patent No.
US 11,045,651
App. No.
17/121,425
Granted
Jun 29, 2021
Kind
B2
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 (27)

1. A system comprising:

a signal generator module, and

one or more electrodes configured to stimulate a first group of glial cells or neurons of a subject with a first electromagnetic stimulus and to simultaneously and differentially stimulate a second group of neurons or glial cells of the subject with a second electromagnetic stimulus having a different electrical parameter than the first electromagnetic stimulus,

wherein the signal generator module is configured to provide a priming signal having a frequency between 200 Hz and 1500 Hz to a first subgroup of the electrodes and simultaneously providing a tonic signal having a frequency between 10 Hz and 199 Hz to a second subgroup of the electrodes, such that the priming signal and the tonic signal have uncommon frequency parameters therebetween.

2. The system of claim 1 , wherein the signal generator module is configured to provide the tonic signal within a range of frequencies between 20 Hz and 150 Hz.

3. The system of claim 2 , wherein the signal generator module is configured to provide the tonic signal within a range of amplitudes between 0.2 mA and 3.0 mA.

4. The system of claim 3 , wherein the tonic signal comprises a biphasic, charge-balanced signal.

5. The system of claim 4 , wherein the signal generator module is configured to provide the tonic signal within a range of pulse widths between 1 microsecond to 250 microseconds.

6. The system of claim 1 , wherein the signal generator module is configured to provide the tonic signal within a range of frequencies below 100 Hz.

7. The system of claim 1 , wherein the signal generator module is configured to provide the priming signal within a range of frequencies between 500 Hz and 1500 Hz.

8. The system of claim 7 , wherein the signal generator module is configured to provide the priming signal within a range of amplitudes between 0.1 mA and 3.5 mA.

9. The system of claim 8 , wherein the priming signal comprises a biphasic, charge-balanced signal.

10. The system of claim 9 , wherein the signal generator module is configured to provide the priming signal within a range of pulse widths between 1 microsecond to 250 microseconds.

11. The system of claim 1 , wherein the signal generator module is configured to provide the priming signal within a range of frequencies between 1,200 Hz to 1,500 Hz.

12. The system of claim 1 , wherein the signal generator module is configured to provide: the tonic signal within a range of frequencies between 20 Hz and 150 Hz, the tonic signal within a range of amplitudes between 0.2 mA and 3.0 mA, the priming signal within a range of frequencies between 200 Hz and 1500 Hz, and the priming signal within a range of amplitudes between 0.1 mA and 3.5 mA.

13. The system of claim 12 , wherein the priming and tonic signals comprise biphasic, charge-balanced signals.

14. The system of claim 13 , wherein the signal generator module is configured to provide the priming signal frequency in a ratio to the tonic signal frequency that is in a range of ratios between 20:1 and 40:1.

15. The system of claim 13 , wherein the signal generator module is configured to provide the tonic signal and the priming signal within a range of pulse widths between 1 microsecond to 250 microseconds.

16. The system of claim 1 , wherein the signal generator module is configured with a combination of modulation parameters to provide: the tonic signal within a range of frequencies between 20 Hz and 150 Hz, the tonic signal within a range of amplitudes between 0.2 mA and 3.0 mA, the priming signal within a range of frequencies between 200 Hz and 1500 Hz, and the priming signal within a range of amplitudes between 0.1 mA and 3.5 mA, wherein the combination of modulation parameters provides superior pain relief based on a pain score for the subject compared to a therapy with only a tonic signal.

17. A signal generator module comprising electronic circuitry configured to:

stimulate a first group of glial cells or neurons of a subject with a first electromagnetic stimulus and to simultaneously and differentially stimulate a second group of neurons or glial cells of the subject with a second electromagnetic stimulus having a different electrical parameter than the first electromagnetic stimulus, and

provide a priming signal having a frequency between 200 Hz and 1500 Hz to a first subgroup of electrodes and simultaneously provide a tonic signal having a frequency between 10 Hz and 199 Hz to a second subgroup of electrodes, such that the priming signal and the tonic signal have uncommon frequency parameters therebetween.

18. The signal generator module of claim 17 , wherein the signal generator module is configured to provide: the tonic signal within a range of frequencies between 20 Hz and 150 Hz, the tonic signal within a range of amplitudes between 0.2 mA and 3.0 mA, the priming signal within a range of frequencies between 200 Hz and 1500 Hz, and the priming signal within a range of amplitudes between 0.1 mA and 3.5 mA.

19. A method comprising:

configuring a signal generator module to stimulate through a first subgroup of electrodes a first group of glial cells or neurons of a subject with a first electromagnetic stimulus comprising a priming signal having a frequency between 200 Hz and 1500 Hz, and

configuring the signal generator module to simultaneously and differentially stimulate through a second subgroup of electrodes a second group of neurons or glial cells of the subject with a second electromagnetic stimulus having a different electrical parameter than the first electromagnetic stimulus and the second electromagnetic stimulus comprising a tonic signal having a frequency between 10 Hz and 199 Hz, such that the priming signal and the tonic signal have uncommon frequency parameters therebetween.

20. The method of claim 19 , comprising configuring the signal generator module to provide: the tonic signal within a range of frequencies between 20 Hz and 150 Hz, the tonic signal within a range of amplitudes between 0.2 mA and 3.0 mA, the priming signal within a range of frequencies between 200 Hz and 1500 Hz, and the priming signal within a range of amplitudes between 0.1 mA and 3.5 mA.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 18, 2021
From: VALLEJO, RICARDO; CEDENO, DAVID LEONARDO; BENYAMIN, RAMSIN M.
To: STIMGENICS, LLC
Reel/Frame 055640/0793 →
MERGER Recorded Mar 18, 2021
From: STIMGENICS, LLC
To: MEDTRONIC SG, LLC
Reel/Frame 055640/0906 →
Continuity (6)
Continuation 17106589 · Nov 30, 2020
Continuation 16055787 · Aug 6, 2018
Continuation In Part 15075550 · Mar 21, 2016
Provisional Application 62135999 · Mar 20, 2015
Provisional Application 62196030 · Jul 23, 2015
Related Publication 20210146137A1 · May 20, 2021
Cited By (2)
US 12,311,177 US 12,502,540