Stimulation devices and methods for treating dry eye

Abstract

Described herein are devices and methods of use thereof for treating dry eye, tired eye, or other forms of ocular discomfort such as from contact lenses. The methods generally include applying spatially and/or temporally patterned stimulation to one or more anatomical structures located in an ocular or nasal region. The electrical stimulation may elicit a reflex that activates the lacrimal gland or may directly activate the lacrimal gland or nerves innervating the lacrimal gland to produce tears. The devices may be implantable or handheld, and may be configured to deliver the spatially and/or temporally patterned stimulation patterns described.

1 .- 20 . (canceled) 
     
     
         21 . A device for delivering an electrical stimulus to nasal mucosa of a patient, comprising:
 a stimulator probe comprising a first nasal insertion prong including a first electrode configured to deliver current, the stimulator probe further comprising a second electrode;   a stimulator body comprising a power source and configured to releasably couple the stimulator probe to the stimulator body, the stimulator body being configured to be held by the patient while delivering current from the first electrode, the stimulator body comprising a return contact positioned to contact tissue of the patient while the patient is holding the stimulator body, the return contact configured to receive at least a portion of the delivered current.   
     
     
         22 . The device of  claim 21 , further comprising a user interface configured to allow the patient to adjust an amount of current delivered between the first electrode and the second electrode and between the first electrode and the return contact. 
     
     
         23 . The device of  claim 22 , wherein the user interface comprises one or more operating mechanisms configured to adjust one or more parameters of the delivered current. 
     
     
         24 . The device of  claim 21 , wherein the current is configured to be delivered between the first electrode and the return contact through tissue of the patient. 
     
     
         25 . The device of  claim 21 , wherein the current is configured to be delivered between the first electrode and the second electrode through tissue of the patient. 
     
     
         26 . The device of  claim 22 , wherein the user interface is positioned on the stimulator body. 
     
     
         27 . The device of  claim 21 , wherein the first electrode and the second electrode comprise a hydrogel. 
     
     
         28 . The device of  claim 21 , wherein the stimulator probe is disposable, and wherein the stimulator body is reusable. 
     
     
         29 . The device of  claim 21 , wherein the first electrode and the second electrode are spaced radially around a circumference of the first nasal insertion prong. 
     
     
         30 . The device of  claim 21 , wherein the first electrode and the second electrode are spaced longitudinally along a length of the first nasal insertion prong. 
     
     
         31 . The device of  claim 21 , wherein the first nasal insertion prong comprises an elongated extension configured to extend into a nasal cavity. 
     
     
         32 . The device of  claim 21 , wherein the first electrode is positioned along a distal portion of the first nasal insertion prong and the second electrode is positioned along a distal portion of a second nasal insertion prong of the stimulator probe. 
     
     
         33 . The device of  claim 21 , wherein the first electrode is configured to contact the nasal mucosa and stimulate a nerve in the nasal mucosa. 
     
     
         34 . A method of increasing tear production in a patient, comprising:
 delivering, from a first electrode of a handheld stimulation device, current to nasal mucosa of a patient, the handheld stimulation device comprising a stimulator probe comprising the first electrode, the stimulator probe being releasably coupled to a stimulator body of the handheld stimulation device, the stimulator body being configured to be held by the patient while delivering the current from the first electrode, the stimulator body comprising a return contact positioned to contact tissue of the patient while the patient is holding the stimulator body; and   receiving, at the return contact, at least a portion of the delivered current.   
     
     
         35 . The method of  claim 34 , wherein the first electrode, during the delivery of the current, is in contact with nasal mucosa on a side of a septum of the patient. 
     
     
         36 . The method of  claim 35 , wherein the first electrode contacts nasal mucosa such that delivering current from the first electrode stimulates a nerve in the nasal mucosa. 
     
     
         37 . The method of  claim 36 , wherein the nerve is an anterior ethmoidal nerve. 
     
     
         38 . The method of  claim 34 , wherein current is delivered simultaneously from the first electrode to the return contact and from the first electrode to a second electrode. 
     
     
         39 . The method of  claim 34 , wherein current is delivered sequentially from the first electrode to the return contact and from the first electrode to a second electrode. 
     
     
         40 . The method of  claim 39 , wherein the first electrode is positioned along a distal portion of a first nasal insertion prong and a second electrode is positioned along a distal portion of a second nasal insertion prong of the stimulator probe.