Neuromodulation therapy for auto-immune and inflammatory disorders
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Publication Number
US-11433237-B2
Publication Date
2022-09-06
Expiration Date
Abstract
The present disclosure relates to a method for modulating the nervous system in order to reduce inflammation. The method includes delivering a vagus nerve stimulation (VNS) therapy to a vagus nerve of a patient for the treatment of inflammation according to a first set of parameters. The method further includes delivering a secondary nerve stimulation (SNS) therapy to a secondary nerve of the patient for the treatment of a sleep disorder according to a second set of parameters different from the first set of parameters.
Core Innovation
The invention modulates the nervous system to reduce inflammation by delivering a vagus nerve stimulation (VNS) therapy to a vagus nerve of a patient for the treatment of inflammation according to a first set of parameters. In parallel, it delivers a secondary nerve stimulation (SNS) therapy to a secondary nerve of the patient for the treatment of a sleep disorder according to a second set of parameters that is different from the first set of parameters. The secondary nerve is different than the vagus nerve.
The approach is motivated by circadian or cyclic inflammatory biomarkers associated with inflammation, including TNF, IL-6, C-Reactive Protein, and fibrinogen, and by the relationship between sleep quality and inflammation. It supports multi-site, multi-nerve neuromodulation using implantable stimulation, including adaptive parameter modifications based on physiological, environmental, and patient-outcome inputs.
The invention includes sensor-driven optimization using physiological, environmental, and patient-outcome sensors, and it describes modifying stimulation parameters such as amplitude, frequency, pulse width, duty cycle, polarity, and number of active sites. It further describes wake/sleep detection, including estimating when a patient is awake, and uses that estimate to temporarily suspend SNS therapy during the patient’s awake state. The stimulation can also be scheduled such that VNS operates at a higher frequency than SNS.
The invention also describes multi-nerve benefits, including increased signaling and diversification across pathways to avoid acclimatization, as well as redundancy, balancing afferent and efferent pathways, and localizing targets to minimize side effects. It further describes possible cardiovascular co-treatment via nerves such as carotid sinus, aortic depressor, or splenic nerve.
Claims Coverage
The patent provides three independent claims—method, system, and non-transitory computer-readable medium. Each claim includes the core inventive combination of delivering VNS with a first parameter set to reduce inflammation and delivering SNS to a different nerve with a second parameter set to treat a sleep disorder.
Dual-nerve neuromodulation for inflammation and sleep disorder
Delivering vagus nerve stimulation (VNS) therapy to a vagus nerve of a patient for the treatment of inflammation according to a first set of parameters, and delivering secondary nerve stimulation (SNS) therapy to a secondary nerve of the patient for the treatment of a sleep disorder according to a second set of parameters different from the first set of parameters, wherein the secondary nerve is different than the vagus nerve.
Implantable pulse generation for dual-parameter dual-nerve stimulation
A system including a pulse generator generating pulsed electrical signals and one or more electrodes applying the pulsed electrical signal to one or more nerves, wherein the processor delivers VNS therapy to a vagus nerve for the treatment of inflammation according to a first set of parameters and delivers SNS therapy to a secondary nerve for the treatment of a sleep disorder according to a second set of parameters different from the first set of parameters, wherein the secondary nerve is different than the vagus nerve.
Non-transitory medium executable to deliver dual-nerve stimulation
A non-transitory computer-readable medium having instructions executable by a processor of an implantable neurostimulation system to deliver VNS therapy to a vagus nerve of a patient for the treatment of inflammation according to a first set of parameters and to deliver SNS therapy to a secondary nerve of the patient for the treatment of a sleep disorder according to a second set of parameters different from the first set of parameters, wherein the secondary nerve is different than the vagus nerve.
Across the independent claims, the inventive core is the concurrent use of VNS for inflammation reduction and SNS to a different secondary nerve for sleep disorder treatment, with separate first and second parameter sets.
Stated Advantages
Increased signaling and diversification across pathways to avoid acclimatization.
Redundancy, balancing afferent and efferent pathways, and localizing targets to minimize side effects.
Documented Applications
Treatment of inflammation.
Treatment of a sleep disorder.
Possible cardiovascular co-treatment via nerves such as carotid sinus, aortic depressor, or splenic nerve.
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