IP Library Granted Patent US 12,213,795
Granted Patent B2
US 12,213,795 · App. 18/389,119 · Granted Feb 4, 2025

Devices and methods for remote therapy and patient monitoring

Inventors: Bruce J. Simon (Santa Fe, NM); Joseph P. Errico (Palm Beach Gardens, FL)
A61B5/394A61B5/4035A61B5/4041A61B5/4803A61B5/4836A61B5/7264A61B5/7267A61N1/36021A61N1/36031A61N1/36034A61B5/02405A61B5/687A61B2090/3941A61N1/40
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Quick Facts
Patent No.
US 12,213,795
App. No.
18/389,119
Granted
Feb 4, 2025
Kind
B2
Abstract

Systems and methods for remote therapy and patient monitoring are provided. A method comprises contacting an outer skin surface of a patient with a contact surface of a stimulator and transmitting an electrical impulse from the stimulator transcutaneously through the outer skin surface to a nerve within the patient. Data related to parameters of the electrical impulse applied to the nerve is stored and transmitted to a remote source. The data may include duration of treatment, amplitude of the electrical impulse, compliance with a prescribed therapy regimen or other relevant data related to the therapy. The method may further include collecting patient status data, such as symptoms of a medical condition (e.g., severity of a headache) before, during and/or after stimulation. The patient status data is correlated with the treatment data to monitor compliance and/or the effectiveness of the therapy.

Claims (30)

1. A method for treating a patient with a medical condition, the method comprising:

contacting an outer skin surface of a patient with a contact surface of a stimulator;

generating an electrical impulse;

transmitting the electrical impulse from the stimulator transcutaneously through the outer skin surface to a nerve within the patient;

storing data related to parameters of the electrical impulse applied to the nerve, wherein the parameters include a therapy regimen that includes, transmitting the electrical impulses for a time period of about 30 seconds to about 5 minutes as a single dose;

transmitting the data to a remote source; and

collecting user status data from the patient and comparing the user status data with the data related to parameters of the electrical impulse, wherein the user status data comprises severity of a headache.

2. The method of claim 1 , wherein the data is stored within the stimulator.

3. The method of claim 1 , further comprising wirelessly transmitting the data to a mobile device and storing the data within the mobile device.

4. The method of claim 1 , wherein the parameters include a duration of time the electrical impulse is transmitted to the nerve.

5. The method of claim 1 , wherein the parameters include an amplitude of the electrical impulse transmitted to the nerve.

6. The method of claim 1 , wherein the therapy regimen includes one or more single doses applied on a daily basis.

7. The method of claim 6 , wherein the parameters include a number of single doses applied per day.

8. The method of claim 1 , further comprising determining motion data of the stimulator while the electrical impulse is transmitted to the nerve and transmitting the motion data to a remote source.

9. The method of claim 1 , further comprising detecting a physiological parameter of the patient and comparing the physiological parameter with the data related to parameters of the electrical impulse.

10. The method of claim 9 , wherein the physiological parameter is selected from the group consisting of: heart rate, heart rate variability, blood pressure, pupil diameter, electrodermal activity, vagal artery blood flow and cerebral blood flow.

11. The method of claim 1 , wherein the electrical impulse is sufficient to modulate a nerve within the patient to treat the medical condition.

12. The method of claim 11 , wherein the nerve is a vagus nerve.

13. The method of claim 1 , wherein the medical condition comprises headache.

14. A system for treating a patient with a medical condition, the system comprising:

a stimulator comprising an electrode for contacting an outer skin surface of a patient;

an energy source coupled to the electrode and configured to generate an electrical impulse and to transmit the electrical impulse transcutaneously through the outer skin surface to a nerve within the patient;

a storage device for storing data related to parameters of the electrical impulse, wherein the parameters include a therapy regimen that includes, transmitting the electrical impulses for a time period of about 30 seconds to about 5 minutes as a single dose;

a transmitter coupled to the storage device for transmitting the data related to parameters of the electrical impulse to a mobile device; and

an application configured to compare the user status data to parameters of the electrical impulse, wherein the user status data comprises severity of a headache.

15. The system of claim 14 , wherein the storage device is disposed within the stimulator.

16. The system of claim 14 , wherein the parameters include a duration of time the electrical impulse is transmitted to the nerve.

17. The system of claim 14 , further comprising a user interface configured to receive user status data of the patient.

18. The system of claim 14 , further comprising a sensor for detecting a physiological parameter of the patient, wherein the processor is configured to compare the physiological parameter with parameters of the electrical impulse.

19. The system of claim 18 , wherein the physiological parameter is selected from the group consisting of: heart rate, heart rate variability, blood pressure, pupil diameter, electrodermal activity, vagal artery blood flow and cerebral blood flow.

Assignments (2)
SECURITY INTEREST Recorded Aug 12, 2025
From: ELECTROCORE, INC.
To: AVENUE VENTURE OPPORTUNITIES FUND II, L.P.
Reel/Frame 072452/0559 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 13, 2023
From: ELECTROCORE, LLC
To: ELECTROCORE, INC.
Reel/Frame 065545/0487 →
Continuity (14)
Continuation 17874364 · Jul 27, 2022
Continuation 17514551 · Oct 29, 2021
Continuation 16459391 · Jul 1, 2019
Continuation 15018805 · Feb 8, 2016
Division 13872116 · Apr 28, 2013
Continuation In Part 13858114 · Apr 8, 2013
Continuation In Part 13603799 · Sep 5, 2012
Continuation In Part 13222087 · Aug 31, 2011
Continuation In Part 13183765 · Jul 15, 2011
Continuation In Part 13183721 · Jul 15, 2011
Continuation In Part 13109250 · May 17, 2011
Continuation In Part 13075746 · Mar 30, 2011
Continuation In Part 13005005 · Jan 12, 2011
Related Publication 20240090821A1 · Mar 21, 2024
References Cited (129)
US 3590810A · Kopecky · 1971 [cited by applicant]
US 4196737A · Bevilacqua · 1980 [cited by applicant]
US 4989605A · Rossen · 1991 [cited by applicant]
US 5109847A · Liss et al. · 1992 [cited by applicant]
US 5458141A · Neil · 1995 [cited by applicant]
US 5487759A · Bastyr et al. · 1996 [cited by applicant]
US 5782874A · Loos · 1998 [cited by applicant]
US 5899922A · Loos · 1999 [cited by applicant]
US 5983131A · Weaver et al. · 1999 [cited by applicant]
US 6104956A · Naritoku et al. · 2000 [cited by applicant]
US 6341236B1 · Osorio et al. · 2002 [cited by applicant]
US 6366814B1 · Boveja et al. · 2002 [cited by applicant]
US 6463327B1 · Lurie et al. · 2002 [cited by applicant]
US 6587719B1 · Barrett et al. · 2003 [cited by applicant]
US 6610713B2 · Tracey · 2003 [cited by applicant]
US 6631297B1 · Mo · 2003 [cited by applicant]
US 7254444B2 · Moore · 2007 [cited by applicant]
US 7734340B2 · De Ridder · 2010 [cited by applicant]
US 7797041B2 · Libbus et al. · 2010 [cited by applicant]
US 20020099417A1 · Naritoku et al. · 2002 [cited by applicant]
US 20020183237A1 · Puskas · 2002 [cited by applicant]
US 20020183804A1 · Malaney et al. · 2002 [cited by applicant]
US 20030212311A1 · Nova et al. · 2003 [cited by applicant]
US 20040073271A1 · Harry et al. · 2004 [cited by applicant]
US 20040243182A1 · Cohen et al. · 2004 [cited by applicant]
US 20040249416A1 · Yun et al. · 2004 [cited by applicant]
US 20050021092A1 · Yun et al. · 2005 [cited by applicant]
US 20050065574A1 · Rezai · 2005 [cited by applicant]
US 20050113630A1 · Fox et al. · 2005 [cited by applicant]
US 20050137644A1 · Boveja et al. · 2005 [cited by applicant]
US 20050165458A1 · Boveja · 2005 [cited by applicant]
US 20050187590A1 · Boveja et al. · 2005 [cited by applicant]
US 20050216062A1 · Herbst · 2005 [cited by applicant]
US 20050267544A1 · Lee et al. · 2005 [cited by applicant]
US 20050278001A1 · Qin et al. · 2005 [cited by applicant]
US 20060015153A1 · Gliner et al. · 2006 [cited by applicant]
US 20060074284A1 · Juola et al. · 2006 [cited by applicant]
US 20060074450A1 · Boveja et al. · 2006 [cited by applicant]
US 20060100668A1 · Ben-David et al. · 2006 [cited by applicant]
US 20060100671A1 · Ridder · 2006 [cited by applicant]
US 20060173510A1 · Besio et al. · 2006 [cited by applicant]
US 20060178703A1 · Huston et al. · 2006 [cited by applicant]
US 20070027496A1 · Parnis et al. · 2007 [cited by applicant]
US 20070038264A1 · Jaax et al. · 2007 [cited by applicant]
US 20070106337A1 · Errico et al. · 2007 [cited by applicant]
US 20070123952A1 · Strother et al. · 2007 [cited by applicant]
US 20070142886A1 · Fischell et al. · 2007 [cited by applicant]
US 20070150006A1 · Libbus · 2007 [cited by examiner]
US 20070150024A1 · Leyde · 2007 [cited by examiner]
US 20070156182A1 · Castel et al. · 2007 [cited by applicant]
US 20070233193A1 · Craig · 2007 [cited by examiner]
US 20070250145A1 · Kraus et al. · 2007 [cited by applicant]
US 20070276449A1 · Gunter et al. · 2007 [cited by applicant]
US 20080021512A1 · Knudson et al. · 2008 [cited by applicant]
US 20080027513A1 · Carbunaru · 2008 [cited by applicant]
US 20080045776A1 · Fischell et al. · 2008 [cited by applicant]
US 20080077192A1 · Harry et al. · 2008 [cited by applicant]
US 20080091256A1 · Libbus · 2008 [cited by examiner]
US 20080114199A1 · Riehl et al. · 2008 [cited by applicant]
US 20080132964A1 · Cohen et al. · 2008 [cited by applicant]
US 20080177190A1 · Libbus et al. · 2008 [cited by applicant]
US 20080208266A1 · Lesser et al. · 2008 [cited by applicant]
US 20080306325A1 · Burnett et al. · 2008 [cited by applicant]
US 20090036945A1 · Chancellor · 2009 [cited by applicant]
US 20090099622A1 · Fowler · 2009 [cited by applicant]
US 20090112283A1 · Kriksunov et al. · 2009 [cited by applicant]
US 20090132018A1 · DiUbaldi et al. · 2009 [cited by applicant]
US 20090157149A1 · Wahlgren et al. · 2009 [cited by applicant]
US 20090182393A1 · Bachinski · 2009 [cited by applicant]
US 20090234417A1 · Pastena et al. · 2009 [cited by applicant]
US 20090234419A1 · Maschino et al. · 2009 [cited by applicant]
US 20090240297A1 · Shavit et al. · 2009 [cited by applicant]
US 20090287035A1 · Dietrich et al. · 2009 [cited by applicant]
US 20090312817A1 · Hogle · 2009 [cited by examiner]
US 20100030299A1 · Covalin · 2010 [cited by applicant]
US 20100152794A1 · Radivojevic et al. · 2010 [cited by applicant]
US 20100152811A1 · Flaherty · 2010 [cited by applicant]
US 20100286553A1 · Feler et al. · 2010 [cited by applicant]
US 20110046432A1 · Simon et al. · 2011 [cited by applicant]
US 20110152967A1 · Simon et al. · 2011 [cited by applicant]
US 20110213295A1 · Henley et al. · 2011 [cited by applicant]
US 20110224749A1 · Ben-David et al. · 2011 [cited by applicant]
US 20110230701A1 · Simon et al. · 2011 [cited by applicant]
US 20120029601A1 · Simon et al. · 2012 [cited by applicant]
US 20120283697A1 · Kim et al. · 2012 [cited by applicant]
US 20120303080A1 · Ben-David et al. · 2012 [cited by applicant]
US 20130006322A1 · Tai · 2013 [cited by applicant]
US 20130060304A1 · LaTendresse et al. · 2013 [cited by applicant]
US 20130245486A1 · Simon et al. · 2013 [cited by applicant]
US 20140005743A1 · Giuffrida et al. · 2014 [cited by applicant]
US 20140172041A1 · Draghici · 2014 [cited by applicant]
US 20140222102A1 · Lemus · 2014 [cited by applicant]
US 20140236040A1 · Moon · 2014 [cited by applicant]
US 20140031895A1 · Rahimi · 2014 [cited by applicant]
US 20150165226A1 · Simon et al. · 2015 [cited by applicant]
US 20150190637A1 · Simon et al. · 2015 [cited by applicant]
EP 1967226 · 2008 [cited by applicant]
EP 2777764 · 2015 [cited by applicant]
JP 2006515192 · 2006 [cited by applicant]
JP 2009125263 · 2009 [cited by applicant]
JP 201252385 · 2013 [cited by applicant]
JP 2014510586 · 2014 [cited by applicant]
KR 101242190 · 2013 [cited by applicant]
WO WO199301862 · 1993 [cited by applicant]
WO WO2005007120 · 2005 [cited by applicant]
WO WO2007092062 · 2007 [cited by applicant]
WO WO2007149811 · 2007 [cited by applicant]
WO WO2008042902 · 2008 [cited by applicant]
WO WO2007058780 · 2008 [cited by applicant]
WO WO2009021080 · 2009 [cited by applicant]
WO WO2009064641 · 2009 [cited by applicant]
WO WO2009135693 · 2009 [cited by applicant]
WO WO2012121750 · 2012 [cited by applicant]
WO WO2012174330 · 2012 [cited by applicant]
WO WO2013066135 · 2013 [cited by applicant]
Greicius et al., Functional connectivity in the resting brain: A network analysis of the default mode hypothesis, PNAS, Jan. 2003, vol. 100, No. 1, pp. 253-258. [cited by applicant]
Heneka et al., Locus ceruleus controls Alzheimer's disease pathology by modulating microglial functions through norepinephrine, PNAS, Mar. 2010, vol. 107, No. 13, pp. 6058-6063. [cited by applicant]
Lee et al., Clustering of Resting State Networks, PLoS One, Jul. 2012, vol. 7, Issue 7, pp. 1-12. [cited by applicant]
Miyoshi, K. and Morimura, Y. “Clinical Manifestations of Neuropsychiatric Disorders,” 2010, Neuropsychiatric Disorders, Springer, XIV, pp. 1-15. [cited by applicant]
International Search Report and Written Opinion dated Aug. 25, 2015 in related Application No. PCT/US15/31847 filed May 20, 2015 (10 pages). [cited by applicant]
International Search Report and Written Opinion dated May 8, 2007 in related PCT Application No. PCT/US2006/042823 filed Nov. 2, 2006 (5 pages). [cited by applicant]
International Search Report and Written Opinion dated Sep. 17, 2007 in related PCT Application No. PCT/US2006/042828 filed Nov. 2, 2006 (5 pages). [cited by applicant]
International Search Report and Written Opinion dated Mar. 26, 2008 in related PCT Application No. PCT/US2006/042752 filed Nov. 1, 2006 (7 pages). [cited by applicant]
International Search Report and Written Opinion dated Dec. 22, 2011 in related PCT Application No. PCT/US2011/049844 filed Aug. 31, 2011 (9 pages). [cited by applicant]
International Search Report and Written Opinion dated Apr. 30, 2013 in related PCT Application No. PCT/US2013/023014 filed Jan. 24, 2013 (7 pages). [cited by applicant]
International Search Report and Written Opinion dated Dec. 11, 2013 in related PCT Application No. PCT/US2013/058079 filed Sep. 4, 2013 (8 pages). [cited by applicant]
International Search Report and Written Opinion dated Jan. 29, 2014 in related PCT Application No. PCT/US2013/068804 filed Nov. 6, 2013 (10 pages). [cited by applicant]
Europe Office Action dated Apr. 24, 2018 in related Application No. 15796247.3 filed May 20, 2015 (6 pages). [cited by applicant]
Europe Office Action dated Jul. 26, 2018 in related Application No. 11818591.7 filed Aug. 12, 2011 (8 pages). [cited by applicant]