US2022347471A1PendingUtilityA1

Devices and methods for non-invasive vagal nerve stimulation

Assignee: ELECTROCORE INCPriority: Aug 19, 2010Filed: Jul 6, 2022Published: Nov 3, 2022
Est. expiryAug 19, 2030(~4.1 yrs left)· nominal 20-yr term from priority
A61N 2/006A61N 1/0456A61N 2/02A61N 2/008A61N 1/36014A61N 1/40A61N 1/36021G09B 5/125G09B 5/14H04L 67/60G06F 30/20G06Q 10/10G09B 9/08A61N 1/36025A61N 1/36053A61N 1/36034G06F 9/542
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Claims

Abstract

Systems and methods are provided for modulating one or more nerves within patients. A method comprises generating a signal comprising an electrical impulse and contacting an interface with an outer skin surface of a patient. The electrical impulse is delivered from one or more electrode(s) through the interface and the outer skin surface of the patient to a vagus nerve, thereby modulating the vagus nerve sufficiently to treat a medical condition. The one or more electrode(s) are spaced from the interface by a distance of about 0.25 to about 4 times an outer dimension of the interface.

Claims

exact text as granted — not AI-modified
1 . A method for modulating a nerve within a body of a patient, the method comprising:
 generating a signal comprising an electrical impulse;   contacting an interface with an outer skin surface of a patient;   delivering the electrical impulse from an electrode through the interface and the outer skin surface of the patient to a vagus nerve, thereby modulating the vagus nerve sufficiently to treat a medical condition; and   wherein the electrode is spaced from the interface by a distance of about 0.25 to about 4 times an outer dimension of the interface.   
     
     
         2 . The method of  claim 1 , wherein the electrode comprises a first electrode and a second electrode and the interface comprises a first membrane corresponding to the first electrode and a second membrane corresponding to the second electrode, the method comprising spacing each electrode from its corresponding membrane by a distance of about 0.25 to about 4 times a diameter of its corresponding membrane. 
     
     
         3 . The method of  claim 1 , wherein the electrical impulse comprises bursts of pulses with a silent intra-burst interval between each of the bursts based on the single signal, wherein each of the bursts has a frequency of about 5 Hz to about 100 Hz and each of the pulses has a duration from about 50 microseconds to about 1000 microseconds. 
     
     
         4 . The method of  claim 1 , wherein the medical condition is one of epilepsy, depression, anxiety disorder, Alzheimer's disease, primary headache, bronchoconstriction, mild cognitive impairment (MCI), Parkinson's disease, multiple sclerosis, post-operative ileus (POI), postoperative cognitive dysfunction or postoperative delirium. 
     
     
         5 . The method of  claim 1 , wherein the medical condition comprises migraine or cluster headache. 
     
     
         6 . The method of  claim 1 , wherein the medical condition comprises rheumatoid arthritis. 
     
     
         7 . The method of  claim 1 , wherein the bursts have a frequency of about 15 Hz to 50 Hz. 
     
     
         8 . The method of  claim 1 , wherein the interface comprises a material that is permeable to charged particles. 
     
     
         9 . The method of  claim 1 , wherein the interface comprises a dielectric material. 
     
     
         10 . The method of  claim 1 , wherein the interface comprises a metal. 
     
     
         11 . The method of  claim 1 , further comprising generating the single signal within a housing having an outer enclosure housing the electrode and a source of energy, wherein at least a portion of the housing comprises the interface. 
     
     
         12 . A device for modulating a nerve within a body of a patient, the device comprising:
 an energy source for generating a signal comprising an electrical impulse;   a housing coupled to the energy source and comprising an interface for contacting an outer skin surface of a patient;   an electrode spaced from the interface by a distance of about 0.25 to about 4 times an outer dimension of the interface; and   wherein the energy source is configured to transmit the electrical impulse from the electrode through the interface and the outer skin surface of the patient to a vagus nerve, thereby modulating the vagus nerve sufficiently to treat a medical condition.   
     
     
         13 . The device of  claim 12 , wherein the electrode is housed within the housing. 
     
     
         14 . The device of  claim 12 , wherein the energy source is housed within the housing. 
     
     
         15 . The device of  claim 12 , wherein the housing comprises an outer enclosure and where at least a portion of the outer enclosure comprises the interface. 
     
     
         16 . The device of  claim 12 , wherein the electrode comprises a first electrode and a second electrode and the interface comprises a first membrane corresponding to the first electrode and a second membrane corresponding to the second electrode, wherein each electrode is spaced from its corresponding membrane by a distance of about 0.25 to about 4 times a diameter of its corresponding membrane. 
     
     
         17 . The device of  claim 12 , wherein the electrical impulse comprises bursts of pulses with a silent intra-burst interval between each of the bursts based on the single signal, wherein each of the bursts has a frequency of about 5 Hz to about 100 Hz and each of the pulses has a duration from about 50 microseconds to about 1000 microseconds. 
     
     
         18 . The device of  claim 12 , wherein the medical condition is one of epilepsy, depression, anxiety disorder, Alzheimer's disease, primary headache, bronchoconstriction, mild cognitive impairment (MCI), Parkinson's disease, multiple sclerosis, post-operative ileus (POI), postoperative cognitive dysfunction or postoperative delirium. 
     
     
         19 . The device of  claim 12 , wherein the medical condition comprises migraine or cluster headache. 
     
     
         20 . The device of  claim 12 , wherein the medical condition comprises rheumatoid arthritis. 
     
     
         21 . The device of  claim 12 , wherein the interface comprises a material that is permeable to charged particles. 
     
     
         22 . The device of  claim 12 , wherein the interface comprises a dielectric material. 
     
     
         23 . The device of  claim 12 , wherein the interface comprises a metal.

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