Control of vagal stimulation
Inventors
Levine, Jacob A. • Faltys, Michael A. • Simon, Jesse M.
Assignees
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Publication Number
US-11547852-B2
Publication Date
2023-01-10
Expiration Date
Abstract
Methods and apparatuses for stimulation of the vagus nerve to treat inflammation including adjusting the stimulation based on one or more metric sensitive to patient response. The one or more metrics may include heart rate variability, level of T regulatory cells, particularly memory T regulatory cells, temperature, etc. Stimulation may be provided through an implantable microstimulator.
Core Innovation
The invention relates to treating inflammation in a subject using vagus nerve stimulation with measurements from the subject to screen responders and guide stimulation. A first heart rate variability is measured using an electrode of an implantable microstimulator in electrical contact with the subject’s vagus nerve, a first electrical stimulation is applied, and a second heart rate variability is measured after the first electrical stimulation.
The invention includes applying a second electrical stimulation to the subject’s vagus nerve based on the first heart rate variability and the second heart rate variability. In described implementations, the heart rate variability is represented using high-frequency and low-frequency components and a high-frequency to low-frequency ratio, and the stimulation is adjusted based on these metrics.
The control logic is characterized as closed-loop, semi-closed-loop, or open-loop vagus nerve stimulation for inflammation, using patient-sensitive metrics to guide selection and dosing. The method includes adjusting the second electrical stimulation by increasing or decreasing it based on the first and second heart rate variability, and can constrain timing by applying the second stimulation after an off-period.
Claims Coverage
The document provides one independent claim supported by dependent claim refinements. Across the dependents, the inventive features focus on HRV-derived control logic, specific HRV metrics such as high-frequency and low-frequency components and their ratio, and operational refinements including increase or decrease behavior, stimulation parameter adjustment, timing constraints, and cervical placement of the vagus nerve electrode.
Heart rate variability-based vagus nerve stimulation for inflammation
measuring a first heart rate variability from the subject using an electrode of an implantable microstimulator, wherein the electrode is in electrical contact with the subject's vagus nerve; applying a first electrical stimulation to the subject's vagus nerve from the electrode; measuring a second heart rate variability from the subject after the first electrical stimulation; and applying a second electrical stimulation to the subject's vagus nerve based on the first heart rate variability and the second heart rate variability.
Increasing or decreasing second electrical stimulation based on HRV
adjusting a second electrical stimulation to a subject by increasing or decreasing it based on first heart rate variability and second heart rate variability.
Adjusting stimulation parameters for the second electrical stimulation
adjusting the second electrical stimulation by increasing or decreasing one or more specified stimulation parameters, including frequency of stimulation, duration of stimulation, burst duration, amplitude of electrical stimulation, and peak-to-peak voltage of the second electrical stimulation.
High-frequency to low-frequency HRV ratio used for control
applying a second electrical stimulation to a subject’s vagus nerve, where the stimulation is based on heart rate variability by determining the ratio of high-frequency to low-frequency components of the first and second heart rate variability.
Applying the second electrical stimulation after an off-period
specifying that the second electrical stimulation is applied after an off-period ranging from 30 minutes to 24 hours.
Electrode contact in the subject’s cervical region
having an electrode contact the subject’s vagus nerve in the subject’s cervical region.
Overall claim coverage centers on treating inflammation using VNS where first and second heart rate variability measurements drive a second electrical stimulation, with dependents specifying HRV feature selection, stimulation adjustment behavior and parameters, timing via an off-period window, and electrode contact location in the cervical region.
Stated Advantages
Documented Applications
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