US 11,872,371 B2
Systems and methods for real-time monitoring of physiological biomarkers through nerve signals and uses thereof
Theodoros Zanos, Astoria, NY (US); Todd Levy, Kew Gardens, NY (US); Emily Battinelli, Franklin Square, NY (US); Kevin J. Tracey, Old Greenwich, CT (US); Chad E. Bouton, Darien, CT (US); Sangeeta Chavan, Syosset, NY (US); and Harold Silverman, Plainview, NY (US)
Assigned to THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH, Manhasset, NY (US)
Appl. No. 16/605,818
Filed by THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH, Manhasset, NY (US)
PCT Filed Apr. 19, 2018, PCT No. PCT/US2018/028243
§ 371(c)(1), (2) Date Oct. 17, 2019,
PCT Pub. No. WO2018/195238, PCT Pub. Date Oct. 25, 2018.
Claims priority of provisional application 62/487,865, filed on Apr. 20, 2017.
Prior Publication US 2020/0179600 A1, Jun. 11, 2020
Int. Cl. A61M 5/172 (2006.01); A61B 5/145 (2006.01); A61B 5/00 (2006.01); A61N 1/36 (2006.01); A61N 7/00 (2006.01); A61B 5/388 (2021.01)
CPC A61M 5/1723 (2013.01) [A61B 5/14532 (2013.01); A61B 5/14546 (2013.01); A61B 5/388 (2021.01); A61B 5/7225 (2013.01); A61B 5/7264 (2013.01); A61B 5/7282 (2013.01); A61N 1/36053 (2013.01); A61N 1/36139 (2013.01); A61N 7/00 (2013.01); A61B 2560/0214 (2013.01); A61B 2560/0238 (2013.01); A61N 2007/0026 (2013.01)] 13 Claims
OG exemplary drawing
 
1. A method for diagnosing or treating or monitoring symptoms in a subject with diabetes based on the subject's nerve activity, wherein the nerve activity consists of vagus nerve activity, comprising a calibration phase and a real-time diagnostic, treatment or monitoring phase, wherein the calibration phase precedes the real-time diagnostic, treatment or monitoring phase, and wherein
the calibration phase comprises correlating a plurality of nerve activity measurements from a chronically implanted recording electrode in the subject, wherein the nerve activity measurements consists of vagus nerve activity measurements, with a plurality of concurrent measurements of glucose levels in the blood of the subject to obtain a functional relationship between blood glucose levels and vagus nerve activity recorded from the chronically implanted recording electrode in the subject, wherein the blood glucose measurements during the calibration phase consist of one or more of blood glucose levels that fluctuate naturally in the subject and blood glucose levels that occur in response to administration of one or more of insulin, glucose and glucagon to the subject; and
the real-time diagnostic, treatment or monitoring phase comprises analyzing the subject's real-time vagus nerve activity in accordance with the previously obtained functional relationship between blood glucose levels and vagus nerve activity to initiate a treatment method, wherein the treatment method consists of one or more of administering insulin, glucose or glucagon to the subject, and applying acoustic energy stimulus to the subject.