Extremely low duty-cycle activation of the cholinergic anti-inflammatory pathway to treat chronic inflammation
Inventors
Levine, Jacob A. • Faltys, Michael A.
Assignees
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Publication Number
US-12357826-B2
Publication Date
2025-07-15
Expiration Date
Abstract
Described herein are systems and methods for applying extremely low duty-cycle stimulation sufficient to treat chronic inflammation using feedback to adjust the off times between stimulations. In particular, the feedback include an assessment of the level of inflammation by the patient or the healthcare provider, or by measure the level of an inflammatory analyte or biomarker, or by detecting nerve activity correlated with inflammation.
Core Innovation
The invention describes a system and methods for treating chronic inflammation through vagus-nerve stimulation using an implantable microstimulator secured by a nerve cuff. Stimulation uses a single or a burst of supra-threshold biphasic pulses, and a controller or sensor monitors inflammation and adjusts the dose regimen. The regimen progressively delays stimulation and lengthens off periods while maintaining ongoing inhibition of the monitored inflammation.
The partial content identifies chronic inflammation as the treatment context and describes sparse stimulation as an approach associated with lower implant power demand and longer battery life. It also reports inflammation suppression and effects in intestinal inflammation. The background section is not included in the provided partial content, so the problem identified there is not explicitly described in patent.
Claims Coverage
The provided claims include three independent claims: claim 1 covers a system, while claims 12 and 20 cover methods. The main inventive features are summarized below, with one feature for each independent claim.
Cuff-mounted microstimulator system with an adaptive dose regimen
Claim 1 recites an implantable microstimulator secured around the vagus nerve by a nerve cuff, a bipolar current source for biphasic stimulation, and a controller that adjusts pulse amplitude based on monitored inflammation. The controller sets progressively delayed stimulation and longer off periods to maintain ongoing inhibition.
Feedback-adjusted vagus-nerve stimulation method
Claim 12 recites applying stimulation doses from a nerve-cuff-secured microstimulator to the vagus nerve, monitoring an indicator of inflammation, and adjusting pulse amplitude based on the monitored level. The dose regimen uses progressively delayed stimulation and longer off periods to maintain ongoing inhibition.
Sensor-monitored inflammation inhibition method
Claim 20 recites applying vagus-nerve stimulation from a nerve-cuff-secured microstimulator, monitoring inflammation with a sensor, and adjusting pulse amplitude between doses based on the monitored level. It also recites a bipolar current source with capacitive isolation and a regimen of progressively delayed stimulation and longer off periods to maintain ongoing inhibition.
The independent claims cover a cuff-mounted vagus-nerve microstimulator system and two methods that use monitored inflammation to adapt stimulation. Across the claims, the central features are biphasic supra-threshold stimulation, adjustment based on inflammation monitoring, and progressively delayed stimulation with longer off periods intended to maintain inhibition.
Stated Advantages
The disclosure associates sparse stimulation with lower implant power demand and longer battery life.
The reported results describe long-lasting suppression of inflammation, including TNF suppression comparable to that achieved with hundreds or thousands of pulses.
The reported results include reduced intestinal lesion area after a single pulse and anti-inflammatory effects in canine data lasting several days.
Documented Applications
Treatment of chronic inflammation using vagus-nerve stimulation.
Treatment of an intestinal disorder; the provided content also identifies intestinal inflammation, inflammatory bowel disease, and Crohn's disease.
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