US2020101289A1PendingUtilityA1

Intranasal stimulation for enhanced release of ocular mucins and other tear proteins

56
Assignee: OCULEVE INCPriority: Dec 4, 2015Filed: Sep 5, 2019Published: Apr 2, 2020
Est. expiryDec 4, 2035(~9.4 yrs left)· nominal 20-yr term from priority
A61N 1/36031A61N 1/36034A61B 2562/04A61B 5/0538A61B 5/4848A61B 5/053A61N 1/0546A61N 1/36046A61B 5/6819A61B 5/0488A61N 1/36014A61B 5/389A61B 5/395
56
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Claims

Abstract

Described here are devices and methods for increasing ocular mucin and other tear protein release using intranasally delivered electrical stimulation. Generally, the devices may deliver electrical stimulation to the nasal mucosa. Intranasal stimulation may trigger degranulation of conjunctival goblet cells, which in turn releases secretory mucins into the tear fluid. The intranasal stimulation may also trigger release of lysozyme, lactoferrin, and other tear proteins into the aqueous layer of the tear film. The methods may further comprise obtaining feedback relating to the efficacy of the delivered electrical stimulation by measuring impedance or an electromyogram (EMG) signal.

Claims

exact text as granted — not AI-modified
1 - 56 . (canceled) 
     
     
         57 . A method for treating dry eye, comprising:
 intranasally delivering electrical stimulation to a subject afflicted with dry eye;   measuring an impedance signal from a facial muscle of the subject, the impedance signal indicating an efficacy of the intranasally delivered electrical stimulation; and   continuing, based on the efficacy of the intranasally delivered electrical stimulation, intranasal delivery of the electrical stimulation after measuring the impedance signal from the facial muscle of the subject,   wherein the intranasally delivered electrical stimulation increases the release of a tear protein to thereby treat the dry eye of the subject.   
     
     
         58 . The method of  claim 57 , wherein the efficacy is indicated by muscular contractions associated with one or more facial muscles. 
     
     
         59 . The method of  claim 57 , wherein the efficacy is indicated by an amount current flowing from a stimulator to tissue of the subject, the stimulator configured to deliver the electrical stimulation. 
     
     
         60 . The method of  claim 57 , wherein the facial muscle is located near a nose, cheek, or around an eye of the subject. 
     
     
         61 . The method of  claim 57 , wherein the impedance signal is measured intranasally by a device that delivers the electrical stimulation. 
     
     
         62 . The method of  claim 57 , wherein the impedance signal is measured using an extranasal device. 
     
     
         63 . The method of  claim 62 , wherein the extranasal device comprises a nose strip. 
     
     
         64 . The method of  claim 57 , further comprising optimizing, based on the efficacy of the intranasally delivered electrical stimulation, one or more parameters of the delivered electrical stimulation. 
     
     
         65 . The method of  claim 64 , wherein the one or more parameters of the delivered electrical stimulation comprises one or more of a duration of electrical stimulation, a type of stimulation waveform, a frequency of the stimulation waveform, an amplitude of the stimulation waveform, and a pulse width of the stimulation waveform. 
     
     
         66 . The method of  claim 64 , wherein the one or more parameters of the delivered electrical stimulation includes a duration of stimulation. 
     
     
         67 . The method of  claim 64 , wherein the one or more parameters of the delivered electrical stimulation includes an amplitude of the stimulation waveform. 
     
     
         68 . A method for treating dry eye, comprising:
 intranasally delivering electrical stimulation to a subject afflicted with dry eye;   measuring an electromyogram (EMG) signal from a facial muscle of the subject, the EMG signal indicating an efficacy of the intranasally delivered electrical stimulation; and   continuing, based on the efficacy of the intranasally delivered electrical stimulation, intranasal delivery of the electrical stimulation after measuring the EMG signal from the facial muscle of the subject,   wherein the intranasally delivered electrical stimulation increases the release of a tear protein to thereby treat the dry eye of the subject.   
     
     
         69 . The method of  claim 68 , wherein the efficacy is indicated by muscular contractions associated with one or more facial muscles. 
     
     
         70 . The method of  claim 68 , wherein the efficacy is indicated by an amount of current flowing from a stimulator to tissue of the subject, the stimulator being configured to deliver the electrical stimulation. 
     
     
         71 . The method of  claim 68 , wherein the facial muscle is located near a nose, cheek, or around an eye of the subject. 
     
     
         72 . The method of  claim 68 , wherein the EMG signal is measured intranasally by a device that delivers the electrical stimulation. 
     
     
         73 . The method of  claim 68 , wherein the EMG signal is measured using an extranasal device. 
     
     
         74 . The method of  claim 73 , wherein the extranasal device comprises a nose strip. 
     
     
         75 . The method of  claim 68 , further comprising optimizing, based on the efficacy of the intranasally delivered electrical stimulation, one or more parameters of the delivered electrical stimulation. 
     
     
         76 . The method of  claim 75 , wherein the one or more parameters of the delivered electrical stimulation comprises one or more of a duration of stimulation, a type of stimulation waveform, a frequency of the stimulation waveform, an amplitude of the stimulation waveform, and a pulse width of the stimulation waveform.

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