US 12,357,826 B2
Extremely low duty-cycle activation of the cholinergic anti-inflammatory pathway to treat chronic inflammation
Jacob A. Levine, West Hempstead, NY (US); and Michael A. Faltys, Valencia, CA (US)
Assigned to SetPoint Medical Corporation, Valencia, CA (US)
Filed by SetPoint Medical Corporation, Valencia, CA (US)
Filed on Dec. 22, 2017, as Appl. No. 15/853,350.
Application 15/853,350 is a continuation of application No. 14/968,702, filed on Dec. 14, 2015, granted, now 9,849,286.
Application 14/968,702 is a continuation of application No. 14/336,942, filed on Jul. 21, 2014, granted, now 9,211,410, issued on Dec. 15, 2015.
Application 14/336,942 is a continuation in part of application No. 13/467,928, filed on May 9, 2012, granted, now 8,788,034, issued on Jul. 22, 2014.
Claims priority of provisional application 61/484,112, filed on May 9, 2011.
Prior Publication US 2018/0117320 A1, May 3, 2018
Int. Cl. A61N 1/00 (2006.01); A61N 1/36 (2006.01); A61N 1/372 (2006.01)
CPC A61N 1/36053 (2013.01) [A61N 1/36139 (2013.01); A61N 1/36167 (2013.01); A61N 1/36175 (2013.01); A61N 1/37205 (2013.01)] 21 Claims
OG exemplary drawing
 
1. A system for treating chronic inflammation in a subject, the system comprising:
an implantable microstimulator configured to apply a stimulation dose to a vagus nerve, wherein the stimulation dose provides a single supra-threshold pulse or a burst of supra-threshold pulses, wherein a pulse width of the single supra-threshold pulse or each of the pulses of the burst of supra-threshold pulses is from 20 microsec to 2000 microsec, wherein each supra-threshold pulse is a biphasic pulse comprising a first pulse and a second pulse separated by a non-zero inter-pulse interval (IPI), and wherein the first pulse has an opposite pulse amplitude as the second pulse;
a nerve cuff comprising at least two electrodes configured to enclose the implantable microstimulator and to secure it around the vagus nerve; and
a controller adapted to adjust a dose regimen, wherein the dose regimen comprises a pulse amplitude, wherein the controller adjusts the pulse amplitude based on a monitored degree or level of inflammation, wherein each single supra-threshold pulse or burst of supra-threshold pulses results in long-lasting suppression of the monitored degree or level of inflammation and an off period, such that the controller adapts the dose regimen to set progressively delayed single supra-threshold pulses and progressively longer off periods, wherein the controller includes a bipolar current source to generate the biphasic pulse for the at least two electrodes,
wherein the dose regimen applied at the progressively delayed single supra-threshold pulses and the progressively longer off periods maintains an ongoing inhibition of the monitored degree or level of inflammation.