IP Library › Granted Patent US 12,440,139
Granted Patent B2
US 12,440,139 · App. 17/747,081 · Granted Oct 14, 2025

System and method for non-invasively monitoring autonomic nerve activity

Inventor: Peng-Sheng Chen (Indianapolis, IN)
Assignee: Indiana University Research and Technology Corporation
A61B5/24A61B5/05A61B5/4029A61B5/6877A61B5/725A61N1/0456A61N1/0476A61N1/0504A61N1/0551A61N1/36017A61N1/36053A61N1/36031A61N1/36034A61N1/3627A61N1/36592
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Quick Facts
Patent No.
US 12,440,139
App. No.
17/747,081
Granted
Oct 14, 2025
Kind
B2
Abstract

System and methods for monitoring and/or controlling nerve activity in a subject are provided. In one embodiment, a system includes electrodes configured to be placed proximate to a subject's skin, and a signal detector configured to detect electrical signals using the electrodes. The system also includes a signal processor configured to receive the electrical signals to generate filtered signals, the filter configured to attenuate at least signals having frequencies corresponding to heart muscle activity during a heartbeat. The signal processor is also configured to identify a skin nerve activity using the filtered signals, estimate a sympathetic nerve activity using the identified skin nerve activity, and further to generate a report indicative of the estimated sympathetic nerve activity. In some aspects, the system further includes a signal generator to deliver the electrical stimulation to the subject's skin.

Claims (54)

1. A method for monitoring nerve activity in a subject, the method comprising:

amplifying electrical signals received from one or more electrodes of a plurality of electrodes, the one or more electrodes being placed in locations proximate to a subject's skin to generate a plurality of amplified signals;

applying a filter to the plurality of electrical signals to generate a plurality of filtered signals;

identifying, with a signal processor, a skin nerve activity using the plurality of filtered signals;

estimating, with the signal processor, a sympathetic nerve activity using the identified skin nerve activity;

generating a report indicative of the estimated sympathetic nerve activity;

generating, with a signal generator, electrical stimulation: based upon the estimated sympathetic nerve activity, based on manually-input instructions from an operator, and/or intermittently; and

applying the electrical stimulation to the subject with one or more cutaneously-placed electrodes of the plurality of electrodes or with one or more subcutaneously-placed electrodes of the plurality of electrodes,

wherein the electrical stimulation:

is applied with the one or more cutaneously-placed electrodes or the one or more subcutaneously-placed electrodes, at a location other than a vagus nerve, and

remodels a neural structure spaced away from the one or more cutaneously-placed electrodes or the one or more subcutaneously-placed electrodes.

2. The method of claim 1 , wherein the electrodes for applying the electrical stimulation are placed in a cutaneous arrangement.

3. The method of claim 1 , wherein the filter includes a high-pass filter with a cutoff frequency of at least 100 Hz.

4. The method of claim 1 , wherein the filter comprises a low-pass filter with a cutoff frequency of at least approximately 0.5 Hz.

5. The method of claim 1 , wherein the sympathetic nerve activity comprises a stellate ganglion nerve activity.

6. The method of claim 1 , wherein the method further comprises determining a medical condition of the subject using the estimated sympathetic nerve activity.

7. The method of claim 1 , wherein the report includes information derived from average signals, signal variations, signal frequencies, frequency variations, identified events, or event timings, the report being retrieved from a memory.

8. The method of claim 1 , wherein the report is in the form of real time data.

9. The method of claim 1 , wherein the electrical stimulation delivered with the one or more cutaneously-placed electrodes or with the one or more subcutaneously-placed electrodes includes electrical stimulation that causes the neural structure to include cells having pyknotic nuclei.

10. The method of claim 1 , wherein the electrical stimulation delivered with the one or more cutaneously-placed electrodes or with the one or more subcutaneously-placed electrodes includes electrical stimulation for reducing stellate ganglion activity.

11. The method of claim 1 , wherein the electrical stimulation is generated based on the estimated sympathetic nerve activity.

12. The method of claim 1 , wherein the electrical stimulation is generated based on the estimated sympathetic nerve activity and the electrodes for applying the electrical stimulation are placed in a subcutaneous arrangement under a layer of tissue that is under the skin.

13. The method of claim 1 , wherein the electrical stimulation is applied with the one or more subcutaneously-placed electrodes, the one or more electrodes from which the electrical signals are received being different from the one or more subcutaneously-placed electrodes that apply the electrical stimulation.

14. A method for monitoring nerve activity in a subject, the method comprising:

amplifying electrical signals received from a plurality of electrodes placed in locations proximate to a subject's skin to generate a plurality of amplified signals;

applying a filter to the plurality of electrical signals to generate a plurality of filtered signals;

identifying, with a signal processor, a skin nerve activity using the plurality of filtered signals;

estimating, with the signal processor, a sympathetic nerve activity using the identified skin nerve activity;

generating a report indicative of the estimated sympathetic nerve activity;

generating, with a signal generator, electrical stimulation; and

applying the electrical stimulation to the subject with an electrode that is placed at a location other than a vagus nerve, the electrical stimulation causing remodeling of a neural structure.

15. The method of claim 14 , wherein the electrodes for applying electrical stimulation are placed in a cutaneous arrangement.

16. The method of claim 14 , wherein the electrodes for applying electrical stimulation are placed in a subcutaneous arrangement.

17. The method of claim 14 , wherein the filter includes a high-pass filter with a cutoff frequency of at least 100 Hz.

18. The method of claim 14 , wherein the filter comprises a low-pass filter with a cutoff frequency of at least approximately 0.5 Hz.

19. The method of claim 14 , wherein the sympathetic nerve activity comprises a stellate ganglion nerve activity.

20. The method of claim 14 , wherein the method further comprises determining a medical condition of the subject using the estimated sympathetic nerve activity.

21. The method of claim 14 , wherein the report includes information derived from average signals, signal variations, signal frequencies, frequency variations, identified events, or event timings, the report being retrieved from a memory.

22. The method of claim 14 , wherein the report is in the form of real time data.

23. The method of claim 14 , wherein the electrical stimulation includes electrical stimulation generated intermittently for reducing stellate ganglion activity.

24. The method of claim 14 , wherein the electrical stimulation is generated based on the estimated sympathetic nerve activity.

25. The method of claim 14 , wherein the electrical stimulation is generated automatically based on programming for the signal generator.

26. The method of claim 14 , wherein the electrical stimulation is delivered according to a treatment protocol that is identified automatically.

27. A method for monitoring nerve activity in a subject, the method comprising:

amplifying electrical signals received from one or more electrodes of a plurality of electrodes, the one or more electrodes being placed in locations proximate to a subject's skin to generate a plurality of amplified signals;

applying a filter to the plurality of electrical signals to generate a plurality of filtered signals, the filter being capable of attenuating at least electrical signals having frequencies that correspond to heart muscle activity during a heartbeat;

identifying, with a signal processor, a skin nerve activity using the plurality of filtered signals;

estimating, with the signal processor, a sympathetic nerve activity using the identified skin nerve activity;

deriving information from the sympathetic nerve activity that was estimated using the identified skin nerve activity and according to the filtered signals; and

generating a report indicative of the estimated sympathetic nerve activity and the derived information,

wherein the report includes information associated with changes, when present, to detected sympathetic nerve activities, and

wherein the changes, when present, to detected sympathetic nerve activities includes a change resulting from electrical stimulation applied to remodel a neural structure with electrical stimulation that was generated with an electrode located at a location other than a vagus nerve and spaced away from the neural structure, the change being reflected in the filtered signals.

28. The method of claim 27 , wherein the derived information includes at least one of: average signals, signal variations, signal frequencies, frequency variations, identified events, event timings, or deviations from a baseline.

29. The method of claim 1 , wherein the electrical stimulation is applied, intermittently, for a period of at least two weeks.

Continuity (5)
Division 15490230 · Apr 18, 2017
Continuation PCTUS2015056419 · Oct 20, 2015
Provisional Application 62158323 · May 7, 2015
Provisional Application 62065854 · Oct 20, 2014
Related Publication 20220273216A1 · Sep 1, 2022
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