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Publication Number
US-11969253-B2
Publication Date
2024-04-30
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 invention relates to closed-loop modulation of an inflammatory reflex using vagus-nerve electrical activity sensing and subsequent adaptation of vagus-nerve stimulation. A microstimulator is implanted around a cervical portion of the vagus nerve and senses electrical activity during a baseline period and during a course of treatment at various levels of inflammation, including when accommodation is suspected of reducing an efficacy of the treatment.
The invention determines neural signatures for a plurality of inflammatory states based on the sensed electrical activity from the baseline period and from the sensed electrical activity at the various levels of inflammation. The neural signature determination includes characterizing a neural recording of the vagus nerve, and the neural signature for each inflammatory state is stored. An inflammatory state of the patient is determined by comparing a particular sensed electrical activity to at least one of the stored neural signatures.
After determining the inflammatory state, the invention delivers a therapeutic dose by stimulating the vagus nerve while controlling one or more characteristic of stimulation of the microstimulator. The controlled stimulation characteristic is selected from duration, intensity, frequency, on-time, and off-time, and the controlling is performed including the state of accommodation. In system form, the microstimulator includes sensing electrodes and a controller configured to perform the baseline sensing, treatment sensing across inflammation levels, neural-signature determination and storage, inflammatory-state determination by comparison, and stimulation with state-dependent control.
Claims Coverage
The independent claims identified are directed to a method of closed-loop modulation of an inflammatory reflex, an implantable microstimulator device for treating chronic inflammation, and a system for closed-loop modulation of an inflammatory reflex. Across these independent claims, the core coverage includes sensing vagus-nerve electrical activity during baseline and treatment, determining and storing neural signatures for multiple inflammatory states including suspected accommodation, determining an inflammatory state by comparison to stored signatures, and delivering a therapeutic dose by stimulating the vagus nerve with stimulation characteristics controlled by the determined inflammatory state.
Neural-signature based inflammatory-state determination with accommodation relationship
Determine a neural signature for each of a plurality of inflammatory states based on sensed electrical activity from a baseline period and sensed electrical activity at various levels of inflammation to determine a sensed electrical activity relationship to a state of accommodation, wherein determining the neural signature for each of the plurality of inflammatory states includes characterizing a neural recording of the vagus nerve.
Baseline and treatment vagus-nerve electrical activity sensing
Sense electrical activity on a vagus nerve of a patient during a baseline period from a microstimulator implanted around a cervical portion of the vagus nerve and sense electrical activity on the vagus nerve during a course of treatment at various levels of inflammation, including when accommodation is suspected of reducing an efficacy of the treatment.
Inflammatory state determination by comparison to stored neural signatures
Store the neural signature for each of the plurality of inflammatory states and determine an inflammatory state of the patient based on a comparison of a particular sensed electrical activity to at least one of the stored neural signatures.
State-dependent therapeutic-dose delivery by microstimulator stimulation control
Deliver a therapeutic dose to the patient by stimulating the vagus nerve while controlling one or more characteristic of stimulation of the microstimulator based on the determined inflammatory state, including the state of accommodation, wherein the one or more characteristic of stimulation is selected from duration, intensity, frequency, on-time and off-time.
Hermetically sealed capsule microstimulator with sensing electrodes
Provide an implantable microstimulator having a hermetically sealed capsule body with at least two electrically conductive capsule regions electrically connecting to electrodes configured for applying stimulation to a vagus nerve to modulate an inflammatory reflex and for sensing electrical activity from the vagus nerve.
The independent claims collectively cover a closed-loop inflammatory reflex approach in which baseline and treatment vagus-nerve electrical activity are sensed, neural signatures for multiple inflammatory states including a relationship to a state of accommodation are determined and stored, a current inflammatory state is determined by comparison to stored signatures, and stimulation is delivered with controller-controlled stimulation characteristics selected from duration, intensity, frequency, on-time, and off-time.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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