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Publication Number
US-12402826-B2
Publication Date
2025-09-02
Expiration Date
Abstract
Devices, systems and methods for the treatment of chronic inflammatory disorders that include an implantable microstimulator and an external charger/controller wherein the microstimulator is configured to operate using closed-loop feedback. The feedback for the microstimulator can be electrical activity of the vagus nerve and/or heart sensed by the microstimulator. The feedback can be used to modulate the stimulation duration, intensity, frequency, on-time and off-time.
Core Innovation
The disclosed subject matter provides closed-loop modulation of an inflammatory reflex using vagus nerve stimulation and neural feedback to treat chronic inflammation. Electrical activity sensed from the vagus nerve is compared with a neural signature database containing signatures at various inflammation levels before and after stimulation. This comparison determines patient accommodation to stimulus and identifies a pattern of activity characteristic of tachyphylaxis, allowing stimulation parameters to be adjusted to prevent tachyphylaxis and deliver an effective inflammation-treatment dosage.
The implantable microstimulator device comprises a hermetically sealed capsule body, electrically conductive capsule regions connected to electrodes configured for stimulation and sensing, a power source, and a controller. The system specifies the implantable microstimulator, at least one sensing electrode configured to detect vagus nerve bioelectric activity, and a controller executing closed-loop parameter adjustments. Neural recordings, electrocardiogram recordings, and spectral analyses are associated with inflammation response and vagus nerve stimulation.
Claims Coverage
The claims identify three inventive features across three independent claims, comprising a closed-loop modulation method, an implantable microstimulator device, and a closed-loop modulation system.
Closed-loop modulation method
Claim 1 covers sensing electrical activity on a vagus nerve from an implanted microstimulator, comparing a sensed neural signature with a neural signature database containing signatures at various inflammation levels before and after stimulation to determine patient accommodation and identify activity characteristic of tachyphylaxis, adjusting stimulation parameters to prevent tachyphylaxis, and determining and delivering an effective inflammation-treatment dosage using the adjusted parameters.
Implantable microstimulator device
Claim 11 covers a device comprising a hermetically sealed capsule body, electrically conductive capsule regions connected to electrodes configured to stimulate and sense electrical activity from the vagus nerve, a power source, and a controller. The controller senses neural activity, compares a sensed neural signature with the database to identify activity characteristic of tachyphylaxis, adjusts stimulation parameters to prevent tachyphylaxis, and determines and delivers an effective inflammation-treatment dosage. Dependent claims add an ASIC with a spike counter, electrode configurations, dosage inputs, and continuous database updating using machine learning.
Closed-loop modulation system
Claim 19 covers an implantable microstimulator adapted for application around a vagus nerve, at least one sensing electrode configured to detect vagus nerve bioelectric activity, and a controller. The controller compares a sensed neural signature with the database to determine patient accommodation to stimulus, identifies a pattern characteristic of tachyphylaxis, adjusts stimulation parameters to prevent tachyphylaxis, and determines and delivers an effective inflammation-treatment dosage. Dependent claims specify timing, duration, intensity, or frequency as stimulation parameters, and continuous database updating using machine learning.
The three independent claims cover method, device, and system forms of closed-loop vagus nerve stimulation that use neural feedback and a neural signature database to identify activity characteristic of tachyphylaxis, adjust stimulation parameters to prevent tachyphylaxis, and determine and deliver an effective inflammation-treatment dosage.
Stated Advantages
Stimulation parameters are adjusted based on a pattern characteristic of tachyphylaxis to prevent tachyphylaxis.
The claims provide for determining a maximum physiologic response at minimal power based on sensed vagus nerve activity to maintain therapeutic response while reducing overstimulation.
The adjusted stimulation parameters determine and deliver a treatment dosage effective for treating inflammation.
Experimental plots in the drawing summary report reduced TNF production and intestinal lesion area with stimulation.
Documented Applications
Closed-loop vagus nerve stimulation to modulate an inflammatory reflex and treat chronic inflammation.
Animal-study recordings and spectral analyses of vagus nerve neural activity and ECG signals before and after [procedural detail omitted for safety] or vagus nerve stimulation.
Determining and delivering an inflammation-treatment dosage using adjusted stimulation parameters.
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