Granted Patent B2

US 12,402,826 · App. 18/603,165 · Granted Sep 2, 2025

Inventors: Jacob A. Levine (West Hempstead, NY); Michael A. Faltys (Valencia, CA)

Assignee: SetPoint Medical Corporation

A61B5/349A61B5/4047A61B5/4836A61B5/6877A61N1/0551A61N1/36053A61N1/36139A61N1/3702A61N1/37205A61N1/3756A61N1/3787

Abstract

Claims (45)

1. A method of closed-loop modulation of an inflammatory reflex, the method comprising:

sensing electrical activity on a vagus nerve from a microstimulator implanted around the vagus nerve;

determining a pattern of activity characteristic of tachyphylaxis based on neural feedback on patient accommodation to stimulus, wherein determining the pattern of activity characteristic of tachyphylaxis comprises accessing a neural signature database comprising neural signatures at various levels of inflammation before and after vagus nerve stimulation and comparing a sensed neural signature to the neural signature database to determine patient accommodation to stimulus;

adjusting one or more stimulation parameters to prevent tachyphylaxis based on the pattern of activity characteristic of tachyphylaxis;

determining a treatment dosage effective for treating inflammation using the adjusted one or more stimulation parameters; and

delivering the treatment dosage to a patient using the adjusted one or more stimulation parameters.

2. The method of claim 1 , wherein the one or more stimulation parameters includes one or more of: timing, duration, intensity, and frequency.

3. The method of claim 1 , wherein sensing the electrical activity includes recording the electrical activity a predetermined time after application each of a plurality of stimulations.

4. The method of claim 1 , wherein determining the pattern of activity characteristic of tachyphylaxis comprises determining neural signatures at various levels of inflammation before and after vagus nerve stimulation by:

performing a spectral analysis of the sensed electrical activity; and

identifying changes in power of the sensed electrical activity at one or more frequencies.

5. The method of claim 1 , wherein determining the pattern of activity characteristic of tachyphylaxis comprises determining neural signatures at various levels of inflammation before and after vagus nerve stimulation including counting electrical spikes.

6. The method of claim 1 , wherein determining the pattern of activity characteristic of tachyphylaxis comprises determining neural signatures at various levels of inflammation before and after vagus nerve stimulation and analyzing compound action potentials (CAPs) in neural recordings.

7. The method of claim 1 , wherein determining the pattern of activity characteristic of tachyphylaxis comprises comparing sensed electrical activity to one or more model neural signatures.

8. The method of claim 1 , further comprising determining a maximum physiologic response at minimal power based on the sensed electrical activity from the vagus nerve.

9. The method of claim 1 , wherein the microstimulator is implanted around a cervical portion of the vagus nerve.

10. The method of claim 1 , wherein a machine learning algorithm continuously adds sensed neural signatures to the neural signature database.

11. An implantable microstimulator device for treating chronic inflammation, the device comprising:

a hermetically sealed capsule body;

at least two electrically conductive capsule regions, wherein each region electrically connects to an electrode, wherein the electrodes are configured for applying stimulation to a vagus nerve to modulate an inflammatory reflex and for sensing electrical activity from the vagus nerve;

a power source within the sealed capsule body; and

a controller within the sealed capsule body configured to:

sense electrical activity on the vagus nerve from the microstimulator device implanted around the vagus nerve;

determine a pattern of activity characteristic of tachyphylaxis based on neural feedback on patient accommodation to stimulus, wherein determining the pattern of activity characteristic of tachyphylaxis comprises accessing a neural signature database comprising neural signatures at various levels of inflammation before and after vagus nerve stimulation and comparing a sensed neural signature to the neural signature database to determine patient accommodation to stimulus;

adjust one or more stimulation parameters to prevent tachyphylaxis based on the pattern of activity characteristic of tachyphylaxis;

determine a treatment dosage effective for treating inflammation using the adjusted one or more stimulation parameters; and

deliver the treatment dosage to a patient using the adjusted one or more stimulation parameters.

12. The implantable microstimulator device of claim 11 , further comprising an ASIC within the sealed capsule body having a spike counter for counting electrical spikes of the sensed electrical activity from the vagus nerve.

13. The implantable microstimulator device of claim 12 , further comprising a memory in communication with the spike counter for storing counts of the electrical spikes.

14. The implantable microstimulator device of claim 11 , wherein the electrode is a tri-polar, or a pseudotripolar, or a tetrode electrode.

15. The implantable microstimulator device of claim 11 , further comprising an ASIC within the sealed capsule body having a variable amplifier.

16. The implantable microstimulator device of claim 11 , wherein determining the treatment dosage is further based on deviation of a respiratory signal.

17. The implantable microstimulator device of claim 11 , wherein the treatment dosage is determined based on patient specific neural signatures at various levels of inflammation before and after treatment.

18. The implantable microstimulator device of claim 11 , wherein a machine learning algorithm continuously adds sensed neural signatures to the neural signature database.

19. A system for closed-loop modulation of an inflammatory reflex, the system comprising:

an implantable microstimulator adapted to be applied around a vagus nerve to stimulate the vagus nerve and modulate the inflammatory reflex;

at least one sensing electrode on the implantable microstimulator configured to detect bioelectric activity on the vagus nerve; and

a controller configured to:

sense electrical activity on the vagus nerve from the microstimulator implanted around the vagus nerve;

determine a pattern of activity characteristic of tachyphylaxis based on neural feedback on patient accommodation to stimulus, wherein determining the pattern of activity characteristic of tachyphylaxis comprises accessing a neural signature database comprising neural signatures at various levels of inflammation before and after vagus nerve stimulation and comparing a sensed neural signature to the neural signature database to determine patient accommodation to stimulus;

adjust one or more stimulation parameters to prevent tachyphylaxis based on the pattern of activity characteristic of tachyphylaxis;

determine a treatment dosage effective for treating inflammation using the adjusted one or more stimulation parameters; and

deliver the treatment dosage to a patient using the adjusted one or more stimulation parameters.

20. The system of claim 19 , wherein the one or more stimulation parameters includes one or more of: timing, duration, intensity, and frequency.

21. The system of claim 19 , wherein a machine learning algorithm continuously adds sensed neural signatures to the neural signature database.

Assignments (1)

Continuity (4)

References Cited (400)