STIMULATION DEVICES AND METHODS FOR TREATING DRY EYE

• US 20160121118A1
• Filed: 10/22/2015
• Published: 05/05/2016
• 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 9,737,712 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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. A device for delivering an electrical stimulus to nasal mucosa of a patient, comprising:

a stimulator probe comprising a nasal insertion prong, wherein a distal portion of the nasal insertion prong comprises first and second electrodes, wherein the first electrode is configured to deliver current;

a return contact located on the stimulator probe at the base of the nasal insertion prong; and

a user interface configured to allow the patient to adjust an amount of current delivered between the first and second electrodes and between the first electrode and the return contact.

11. The device of claim 10, wherein the first and second electrodes comprise a hydrogel.

12. The device of claim 11, wherein the return contact comprises a hydrogel.

13. The device of claim 10, wherein the return contact has an annular shape and is configured to contact tissue at a nostril.

14. A device for delivering an electrical stimulus to nasal mucosa of a patient having dry eye, comprising:

a first nasal insertion prong configured to be inserted into a first nostril, wherein the first nasal insertion prong comprises a first electrode; and

a second nasal insertion prong configured to be inserted into a second nostril, wherein the second nasal insertion prong comprises a second electrode; and

a user interface,

wherein the device is configured to deliver a biphasic charge-balanced pulsed waveform, and wherein the user interface is configured to allow the patient to adjust an amplitude;

duration aspect ratio of the waveform.

15. A method of increasing tear production in a patient, comprising:

delivering an electrical stimulus to tissue of a patient using a device comprising at least three electrical contacts, wherein the electrical stimulus takes one or more pathways between the at least three electrical contacts during delivery, and wherein the one or more pathways of the electrical stimulus change over time during delivery.

16. The method of claim 15, wherein the electrical stimulus takes two pathways between the at least three electrical contacts, such that a first amount of current takes the first pathway and a second amount of current takes the second pathway, and wherein a ratio of the first amount to the second amount changes over time during delivery.

17. The method of claim 15, wherein the device is implantable.

18. The method of claim 16, wherein the ratio of the first amount to the second amount is changed by the patient using a user interface of the device.

19. The method of claim 15, wherein the device has a single nasal insertion prong, and wherein the nasal insertion prong comprises two electrodes.

20. The method of claim 19, wherein the device comprises stimulator body, wherein the stimulator body comprises an electrical contact configured to deliver current or act as a return contact.