STIMULATION DEVICES AND METHODS FOR TREATING DRY EYE

• US 20170340884A1
• Filed: 08/14/2017
• Published: 11/30/2017
• Est. Priority Date: 10/22/2014
• Status: Active Grant

• Current Assignee: Oculeve Incorporated (Abbvie Incorporated)
• Original Assignee: Oculeve Incorporated (Abbvie Incorporated)
• Inventors: FRANKE, Manfred, LOUDIN, James Donald, WARDLE, John, HOLDBROOK, Mark Jeffrey
• Granted Patent: US 10,112,048 B2
• Time in Patent Office: Days
• CPC Class Codes: A61N 1/0526 Head electrodes A61N1/0551 takes precedence
• CPC Class Codes: A61N 1/0546 Nasal electrodes
• CPC Class Codes: A61N 1/36046 of the eye
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3758 Packaging of the components within the casing

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.

Claims

1. A method for treating dry eye in a patient in need thereof, comprising:

contacting nasal mucosa of the patient with a first electrode; and

delivering current from the electrode through tissue of the patient to a return contact,

wherein the electrode is located on a nasal insertion prong of a stimulator probe of a stimulator, and the return contact is located on a stimulator body of the stimulator, and wherein the stimulator probe is reversibly attachable to the stimulator body.

2. The method of claim 1, further comprising delivering current from the first electrode through tissue of the patient to a second electrode, wherein the second electrode is located on the nasal insertion prong.

3. The method of claim 2, wherein current is delivered simultaneously from the first electrode to the return contact and from the first electrode to the second electrode.

4. The method of claim 2, wherein current is delivered sequentially from the first electrode to the return contact and from the first electrode to the second electrode.

5. The method of claim 1, wherein the first electrode contacts nasal mucosa in the anterior nasal cavity.

6. The method of claim 5, wherein the first electrode contacts nasal mucosa at a location anterior to a middle or inferior turbinate of the nasal cavity.

7. The method of claim 2, wherein the first electrode and the second electrode are spaced longitudinally along a length of the nasal insertion prong.

8. The method of claim 2, wherein the first electrode and second electrode are spaced radially around a circumference of the nasal insertion prong.

9. The method of claim 2, wherein the first electrode and second electrode are in contact with nasal mucosa on a first side of a septum of the patient, and wherein no electrodes are placed in contact with nasal mucosa on a second side of the septum of the patient, and wherein delivering the electrical stimulation waveform results in bilateral lacrimation.

10. The method of claim 1, wherein the electrode comprises a hydrogel.

11. The method of claim 1, wherein the stimulator probe is disposable, and the stimulator body is reusable.

12. The method of claim 1, further comprising delivering current to nasal mucosa via a second nasal insertion prong.

13. The method of claim 1, wherein the stimulator body comprises a user interface.