Granted Patent B2

US 12,279,871 · App. 17/984,062 · Granted Apr 22, 2025

Inventors: Eric A. Schepis (Alpharetta, GA); Amol Soin (Dayton, OH)

Assignee: Soin Neuroscience, LLC

A61B5/24A61N1/0472A61N1/36128G16H40/63

Abstract

Claims (57)

1. An electrical stimulation system for delivering spatially random electrical stimulation to a patient through an electrode array during electrical stimulation therapy of the patient, the electrical stimulation system comprising:

an electrode array comprising a plurality of electrodes spaced apart from one another;

a signal generator electrically coupled to the electrode array and configured to deliver an electrical stimulation signal; and

a controller comprising a processor and a memory having a plurality of instructions stored thereon that, in response to execution by the processor, causes the controller to:

randomly select, at periodic intervals based on a predefined period of time, an electrical configuration from the plurality of electrodes of the electrode array during the electrical stimulation therapy, wherein to randomly select the electrical configuration comprises to randomly select a first set of electrodes of the plurality of electrodes to function as electrical sources and a second set of electrodes of the plurality of electrodes, different from the first set of electrodes, to function as electrical sinks; and

instruct the signal generator to deliver the electrical stimulation signal to the patient for the predefined period of time via the randomly selected electrical configuration to improve a condition of the patient;

wherein the plurality of electrodes comprises a third set of electrodes of a first size and a fourth set of electrodes of a second size greater than the first size;

wherein the plurality of instructions further causes the controller to select each of the third set of electrodes and the fourth set of electrodes based on an electrode size;

wherein the signal generator is configured to deliver high-frequency signal components of the electrical stimulation signal through only the third set of electrodes; and

wherein the signal generator is configured to deliver low-frequency signal components of the electrical stimulation signal through only the fourth set of electrodes.

2. The electrical stimulation system of claim 1 , wherein the plurality of instructions further causes the controller to randomly assign a polarity to one or more of the electrodes of the first set of electrodes and the second set of electrodes.

3. The electrical stimulation system of claim 1 , wherein the electrical stimulation signal comprises a noise signal.

4. The electrical stimulation system of claim 1 , wherein the plurality of instructions further causes the controller to:

partition a frequency range of the electrical stimulation signal into a plurality of discrete frequency bands, each of the discrete frequency bands having a corresponding bandwidth;

adjust an amplitude of one or more of a voltage or a current of the electrical stimulation signal within a selected frequency band of the plurality of discrete frequency bands to generate an adjusted electrical signal based on feedback received from the patient; and

instruct the signal generator to deliver the adjusted electrical signal to the patient via the randomly selected electrical configuration.

5. The electrical stimulation system of claim 4 , wherein the feedback comprises at least one of feedback received from the patient as patient self-report regarding the therapy delivered to the patient, feedback based on data generated by one or more sensors of the electrical stimulation system, wherein the one or more sensors measure one or more physiological outcomes of the patient, or feedback data received from a machine learning system.

6. An electrical stimulation system for delivering spatially random electrical stimulation to a patient through an electrode array, the electrical stimulation system comprising:

an electrode array comprising a plurality of electrodes spaced apart from one another;

a signal generator electrically coupled to the electrode array and configured to deliver an electrical stimulation signal; and

a controller comprising a processor and a memory having a plurality of instructions stored thereon that, in response to execution by the processor, causes the controller to:

randomly select an electrical configuration from the plurality of electrodes of the electrode array, wherein to randomly select the electrical configuration comprises to randomly select a first set of electrodes of the plurality of electrodes to function as electrical sources and a second set of electrodes of the plurality of electrodes, different from the first set of electrodes, to function as electrical sinks; and

instruct the signal generator to deliver the electrical stimulation signal to the patient via the randomly selected electrical configuration;

wherein the plurality of electrodes comprises a third set of electrodes and a fourth set of electrodes different from the third set of electrodes; and

wherein to instruct the signal generator to deliver the electrical stimulation signal to the patient via the randomly selected electrical configuration comprises to instruct the signal generator to deliver a first set of features of the electrical stimulation signal to the patient via the third set of electrodes and a second set of features of the electrical stimulation signal, different from the first set of features, to the patient via the fourth set of electrodes;

wherein the plurality of instructions further causes the controller to select each of the third set of electrodes and the fourth set of electrodes based on an electrode size;

wherein the third set of electrodes includes electrodes of a first size and the fourth set of electrodes includes electrodes of a second size greater than the first size;

wherein the signal generator is configured to deliver high-frequency signal components of the electrical stimulation signal through only the third set of electrodes; and

wherein the signal generator is configured to deliver low-frequency signal components of the electrical stimulation signal through only the fourth set of electrodes.

7. The electrical stimulation system of claim 6 , wherein the plurality of instructions further causes the controller to select each of the third set of electrodes and the fourth set of electrodes based on an electrode location on an electrode assembly; and

wherein the electrode array comprises at least a distal section and a proximal section.

8. The electrical stimulation system of claim 7 , wherein the signal generator is configured to amplify signals transmitted through each electrode located on the distal section at a different weight from signals transmitted through each electrode located on the proximal section.

9. The electrical stimulation system of claim 6 , wherein the plurality of instructions further causes the controller to select each of the third set of electrodes and the fourth set of electrodes based on an electrode shape; and

wherein the third set of electrodes includes electrodes of a first cross-sectional shape and the fourth set of electrodes includes electrodes of a second cross-sectional shape different from the first cross-sectional shape.

10. The electrical stimulation system of claim 6 , wherein the plurality of instructions further causes the controller to select each of the third set of electrodes and the fourth set of electrodes based on an electrode material.

11. The electrical stimulation system of claim 10 , wherein the third set of electrodes includes electrodes composed of a first material and the fourth set of electrodes includes electrodes composed of a second material different from the first material.

12. The electrical stimulation system of claim 6 , wherein each of the third set of electrodes and the fourth set of electrodes is selected based on an electrode size, an electrode shape, an electrode material, and an electrode location on an electrode assembly.

13. The electrical stimulation system of claim 6 , wherein to deliver the first set of features of the electrical stimulation signal to the patient via the third set of electrodes comprises to deliver components of the electrical stimulation signal having a first set of amplitudes to the patient via the third set of electrodes; and

wherein to deliver the second set of features of the electrical stimulation signal to the patient via the fourth set of electrodes comprises to deliver components of the electrical stimulation signal having a second set of amplitudes, different from the first set of amplitudes, to the patient via the fourth set of electrodes.

14. The electrical stimulation system of claim 6 , wherein to deliver the first set of features of the electrical stimulation signal to the patient via the third set of electrodes comprises to deliver components of the electrical stimulation signal having a first set of charge densities to the patient via the third set of electrodes; and

wherein to deliver the second set of features of the electrical stimulation signal to the patient via the fourth set of electrodes comprises to deliver components of the electrical stimulation signal having a second set of charge densities, different from the first set of charge densities, to the patient via the fourth set of electrodes.

15. An electrical stimulation system for delivering spatially random electrical stimulation to a patient through an electrode array during electrical stimulation therapy of the patient, the electrical stimulation system comprising:

an electrode array comprising a plurality of electrodes spaced apart from one another;

a signal generator electrically coupled to the electrode array and configured to deliver an electrical stimulation signal; and

a controller comprising a processor and a memory having a plurality of instructions stored thereon that, in response to execution by the processor, causes the controller to:

randomly select an electrical configuration from the plurality of electrodes of the electrode array during the electrical stimulation therapy, wherein to randomly select the electrical configuration comprises to randomly select a first set of electrodes of the plurality of electrodes to function as electrical sources and a second set of electrodes of the plurality of electrodes, different from the first set of electrodes, to function as electrical sinks;

instruct the signal generator to deliver the electrical stimulation signal to the patient via the randomly selected electrical configuration to improve a condition of the patient; and

randomly select a new electrical configuration from the plurality of electrodes of the electrode array in response to a determination that a threshold period of time has been met;

wherein the plurality of electrodes comprises a third set of electrodes and a fourth set of electrodes different from the third set of electrodes; and

wherein the plurality of instructions further causes the controller to select each of the third set of electrodes and the fourth set of electrodes based on an electrode size;

wherein the third set of electrodes includes electrodes of a first size and the fourth set of electrodes includes electrodes of a second size greater than the first size;

wherein the signal generator is configured to deliver high-frequency signal components of the electrical stimulation signal through only the third set of electrodes; and

wherein the signal generator is configured to deliver low-frequency signal components of the electrical stimulation signal through only the fourth set of electrodes.

16. The electrical stimulation system of claim 15 , wherein the threshold period of time is associated with an amount of charge of the spatially random electrical stimulation delivered to the patient injected by electrodes of the randomly selected electrical configuration.

17. The electrical stimulation system of claim 15 , wherein the threshold period of time is based on a charge per pulse of the spatially random electrical stimulation being delivered to the patient.

18. The electrical stimulation system of claim 15 , wherein the threshold period of time is based on a charge density of the spatially random electrical stimulation being delivered to the patient.

19. The electrical stimulation system of claim 15 , wherein the threshold period of time is based on a previous stimulation history of the patient.

Assignments (3)

Continuity (1)

References Cited (77)