IP Library Granted Patent US 12,201,828
Granted Patent B2
US 12,201,828 · App. 18/458,813 · Granted Jan 21, 2025

System and methods for therapeutic stimulation

Inventors: Martin Cholette (Van Alstyne, TX); Gary Dulak (Moorpark, CA)
Assignee: NeoGenesis Technologies LLC
A61N1/0551A61N1/36075A61N1/36139A61N1/36146A61N1/0526A61N1/36062A61N1/36071A61N1/36132A61N1/3615A61N1/36171A61N1/36175A61N1/37235
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Quick Facts
Patent No.
US 12,201,828
App. No.
18/458,813
Granted
Jan 21, 2025
Kind
B2
Abstract

A system and method for providing electrical stimulation to biological tissue to treat medical conditions. The system can include a lead configured to be positioned in contact with biological tissue proximate one or more occipital nerves, an implantable pulse generator configured to deliver electrical stimulation to the biological tissue via the one or more leads, and/or a power source configured to operatively connect and supply power to the implantable pulse generator. The system can further include a processor configured to communicate with the implantable pulse generator. The processor can operate the implantable pulse generator to deliver the electrical stimulation to the biological tissue via the lead. The implantable pulse generator can deliver the electrical stimulation by applying a stimulation waveform or a stimulation pattern. The stimulation waveform can include a series of stimulation pulses that can vary over time, which can reduce an effect of neural accommodation or adaptation.

Claims (35)

1. A system for providing electrical stimulation to biological tissue to treat one or more medical conditions comprising:

one or more leads configured to be positioned proximate to biological tissue that is proximate one or more nerves;

a pulse generator configured to deliver electrical stimulation to the biological tissue via the one or more leads;

a power source configured to operatively connect and supply power to the pulse generator;

a motion sensor positioned proximate to a body of a patient and configured to generate a raw patient signal; and

one or more processors configured to:

receive the raw patient signal from the motion sensor;

identify major variations and minor variations in the raw patient signal, wherein the major variations and minor variations correspond to one or more forces to which the body is exposed, wherein the major variations correspond to a signal of interest portion including physiologically significant information from the raw patient signal, and wherein the minor variations correspond to minute physiologically least significant information of an unwanted or left over signal portion of the raw patient signal;

periodically capture and extract insignificant data from minor variations that correspond to minute physiologically least significant information of the unwanted or left over signal portion of the raw patient signal unrelated to physiologically significant major variations of the signal of interest portion, wherein the insignificant data is limited to being extracted from portions corresponding to the minor variations, wherein the insignificant data is used to generate a stimulation signal by tuning a stimulation waveform according to the minor variations in the raw patient signal, and wherein the use of the insignificant data is unrelated to tailoring the stimulation based on the sensed physiologically significant major variations in the raw patient signal toward a predefined profile; and

cause the pulse generator to deliver the electrical stimulation via the stimulation signal.

2. The system of claim 1 , wherein the stimulation waveform comprises a series of pulses that vary in pulse width over time, wherein at least one of an inter-pulse frequency, a pulse amplitude, or the pulse width of the series of pulses increases over the time.

3. The system of claim 2 , wherein the at least one of the inter-pulse frequency, the pulse amplitude, or the pulse width of the series of pulses increases linearly over the time.

4. The system of claim 2 , wherein the at least one of the inter-pulse frequency, the pulse amplitude, or the pulse width of the series of pulses increases exponentially over the time.

5. The system of claim 2 , wherein at least one of an inter-pulse frequency, a pulse amplitude, or the pulse width of the series of pulses decreases over the time.

6. The system of claim 5 , wherein the at least one of the inter-pulse frequency, the pulse amplitude, or the pulse width of the series of pulses decreases linearly over the time.

7. The system of claim 5 , wherein the at least one of the inter-pulse frequency, the pulse amplitude, or the pulse width of the series of pulses decreases exponentially over the time.

8. The system of claim 2 , wherein at least one of an inter-pulse frequency, a pulse amplitude, or the pulse width of the series of pulses increases over the time, and wherein a different one of the at least one of the inter-pulse frequency, the pulse amplitude, or the pulse width of the series of pulses decreases over the time.

9. The system of claim 2 , wherein the series of pulses is a first series of pulses over a first time period, and wherein the stimulation waveform comprises a second series of pulses over a second time period.

10. The system of claim 9 , wherein a pattern of the second series of pulses matches a pattern of the first series of pulses.

11. The system of claim 9 , wherein a pattern of the second series of pulses comprises an inverted pattern of a pattern of the first series of pulses.

12. The system of claim 2 , wherein an inter-pulse frequency of the series of pulses varies over the time.

13. The system of claim 2 , wherein an amplitude of the series of pulses varies over the time.

14. The system of claim 9 , wherein the motion sensor is an accelerometer, wherein the stimulation waveform is characterized by a base frequency, amplitude, and pulse width, wherein tuning the stimulation waveform comprises modulating at least one of the base frequency, amplitude, or pulse width based on the minor variations in the raw patient signal.

15. The system of claim 1 , wherein the one or more processors is further configured to further tune the stimulation signal based at least in part on at least one of user input, a time of day, a user activity level, a physiological parameter, or a predetermined pattern.

16. The system of claim 1 , wherein the stimulation waveform is adapted to reduce an effect of neural accommodation or adaptation.

17. A method for providing electrical stimulation to biological tissue to treat medical conditions, the method comprising:

receiving a raw patient signal from a motion sensor, wherein the motion sensor is positioned proximate to a body of a patient;

identifying major variations and minor variations in the raw patient signal, wherein the major variations and minor variations correspond to one or more forces to which the body is exposed, wherein the major variations correspond to a signal of interest portion including physiologically significant information from the raw patient signal, and wherein the minor variations correspond to minute physiologically least significant information of an unwanted or left over signal portion of the raw patient signal;

periodically capturing and extracting insignificant data from minor variations that correspond to minute physiologically least significant information of the unwanted or left over signal portion of the raw patient signal unrelated to physiologically significant major variations of the signal of interest portion, wherein the insignificant data is limited to being extracted from portions corresponding to the minor variations, wherein the insignificant data is used to generate a stimulation signal by tuning a stimulation waveform according to the minor variations in the raw patient signal, and wherein the use of the insignificant data is unrelated to tailoring the stimulation based on the sensed physiologically significant major variations in the raw patient signal toward a predefined profile; and

causing a pulse generator to deliver electrical stimulation to biological tissue that is proximate one or more nerves, wherein to deliver the electrical stimulation, one or more processors causes the pulse generator to apply the stimulation signal via one or more leads positioned proximate to the biological tissue.

18. The method of claim 17 , wherein the stimulation waveform comprises a series of pulses, and wherein pulse width of the series of pulses varies over time, wherein at least one of an inter-pulse frequency, a pulse amplitude, or the pulse width of the series of pulses increases over the time, and wherein a different one of the inter-pulse frequency, the pulse amplitude, or the pulse width of the series of pulses decreases over the time.

19. The method of claim 18 , wherein the stimulation waveform comprises one or more relaxation pauses between at least some of the series of pulses.

20. The method of claim 18 , wherein an inter-pulse frequency of the series of pulses varies over the time.

21. The method of claim 18 , wherein an amplitude of the series of pulses varies over the time.

22. The method of claim 18 , wherein the stimulation waveform is adapted to reduce an effect of neural accommodation or adaptation.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 8, 2024
From: CHOLETTE, MARTIN; DULAK, GARY
To: NEURAMODIX INC.
Reel/Frame 069212/0370 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 8, 2024
From: NEURAMODIX INC.
To: NEOGENESIS TECHNOLOGIES LLC
Reel/Frame 069212/0393 →
Continuity (3)
Continuation 15961751 · Apr 24, 2018
Provisional Application 62489925 · Apr 25, 2017
Related Publication 20240165402A1 · May 23, 2024
References Cited (41)
US 11779755B2 · Cholette · 2023 [cited by examiner]
US 20050102006A1 · Whitehurst et al. · 2005 [cited by applicant]
US 20050216070A1 · Boveja et al. · 2005 [cited by applicant]
US 20060004423A1 · Boveja et al. · 2006 [cited by applicant]
US 20060206165A1 · Jaax et al. · 2006 [cited by applicant]
US 20080027505A1 · Levin et al. · 2008 [cited by applicant]
US 20080262566A1 · Jaax · 2008 [cited by applicant]
US 20080281381A1 · Gerber et al. · 2008 [cited by applicant]
US 20090076561A1 · Libbus et al. · 2009 [cited by applicant]
US 20100023090A1 · Jaax et al. · 2010 [cited by applicant]
US 20100121407A1 · Pfaff et al. · 2010 [cited by applicant]
US 20100280417A1 · Skelton et al. · 2010 [cited by applicant]
US 20110184488A1 · Ridder · 2011 [cited by applicant]
US 20120016437A1 · Altaris et al. · 2012 [cited by applicant]
US 20120197336A1 · Su · 2012 [cited by applicant]
US 20120277621A1 · Gerber et al. · 2012 [cited by applicant]
US 20130289667A1 · Wacnik et al. · 2013 [cited by applicant]
US 20150217117A1 · Hershey · 2015 [cited by applicant]
US 20180369573A1 · Cholette et al. · 2018 [cited by applicant]
US 20190001139A1 · Mishra et al. · 2019 [cited by applicant]
US 20200046980A1 · Moffitt et al. · 2020 [cited by applicant]
Abbott, L.F. et al., Synaptic Computation, Insight Review Articles, Volumed 431, Nature Publishing Group, Oct. 14, 2004 in 8 pages. [cited by applicant]
Bartsch et al., Stimulation of the Greater Occipital Nerve Induces Increased Central Excitability of Dural Afferent Input, Guarantors of Brain, 2002, in 14 pages. [cited by applicant]
Carod-Artal et al., Tackling Chronic Migraine: Current Perspectives, Dove Press Journal: Journal of Pain Research, Apr. 8, 2014 in 10 pages. [cited by applicant]
Dodick et al., Safety and Efficacy of Peripheral Nerve Stimulation of the Occipital Nerves for the Management of Chronic Migraine: Long-term Results from a Randomized, Multicenter, Double-blinded, Controlled Study, Ceph… [cited by applicant]
Haub et al., 2013 World Population Data Sheet. [cited by applicant]
Headache Classification Committee of the International Headache Society, The InternationalClassification of Headache Disorders, 3rd edition, Cephalalgia vol. 33 (9), International Headache Society, 2013 in 180 pages. [cited by applicant]
Latinovic et al., Headache and Migraine in Primary Care: Consultation, Prescription and Referral Rates in a Large Population, J Neural Neurosurg Psychiatry, 2006 in 3 pages. [cited by applicant]
Magis et al., Central Modulation in Cluster Headache Patients Treated with Occipital Nerve Stimulation: An FDG-PET Study, BMC Neurology, 2011 in 9 pages. [cited by applicant]
Matharu, Botox Botulinum Toxin Type A, BoNTA, Allergan in the Management of Chronic Migraine, Allergan Ltd., 2010 in 2 pages. [cited by applicant]
Matharu et al., Central Neuromodulation in Chronic Migraine Patients with Suboccipital Stimulators: a PET Study, Advanced Access, Nov. 7, 2003 in 11 pages. [cited by applicant]
Matthews et al., The Response of a Single End Organ, Physiological Laboratory, Cambridge in 49 pages. [cited by applicant]
Menken et al., The Global Burden of Disease Study, Arch Neurol vol. 57, Mar. 2000 in 3 pages. [cited by applicant]
Migraine Facts, Migraine Research Foundation in 4 pages. [cited by applicant]
Miller et al., Neurostimulation in the Treatment of Primary Headaches, Pract Neurol, 2016, in 14 pages. [cited by applicant]
Novartis, Novartis Announces AMG 334 Significantly Reduces Patients' Monthly Migraine Days in Phase II Study of Chronic Migraine Prevention, Novartis Media Release. [cited by applicant]
Saper et al., Occipital Nerve Stimulation for the Treatment of Intractable Chronic Migraine Headache: ONSTIM feasibility Study, Cephalalgia 31(3), International Headache Society, 2010 in 15 pages. [cited by applicant]
Schramm et al., Epidemiological Profiles of Patients with Chronic Migraine and Chronic Tension-type Headache, The Journal of Headache and Pain 2013 in 8 pages. [cited by applicant]
Silberstein et al., Efficacy and Safety of Topiramate for the Treatment of Chronic Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial, American Headache Society, 2007 in 11 pages. [cited by applicant]
Silberstein et al., Safety and Efficacy of Peripheral Nerve Stimulation of the Occipital Nerves for the Management of Chronic Migraine: Results from a Randomized, Multicenter, Double-blinded, Controlled Study, Cephalalg… [cited by applicant]
Vincent et al., Reduction of Calcitonin Gene-Related Peptide in Jugular Blood Following Electrical Stimulation of Rat Greater Occipital Nerve, Cephalalgia 1992 in 5 pages. [cited by applicant]