Stimulation devices and methods for treating dry eye

• US 9,737,712 B2
• Filed: 10/22/2015
• Issued: 08/22/2017
• 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
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US14/920,860
• Publication Number:
  US 20160121118A1
• Time in Patent Office: 670 Days
• Field of Search: None
• 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 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.

2. The method of claim 1, wherein the electrical stimulus takes two pathways between the at least three electrical contacts, wherein the percentage of the total electrical current traveling along the two pathways changes over time during delivery.

3. The method of claim 1, wherein the device is implantable.

4. The method of claim 2, wherein the device further comprises a user interface configured to adjust a parameter of the stimulus.

5. The method of claim 1, wherein the device has a single nasal insertion prong, and wherein the nasal insertion prong comprises two of the at least three electrical contacts.

6. The method of claim 5, wherein the device comprises a stimulator body, wherein the stimulator body comprises one of the at least three electrical contacts.

7. The method of claim 6, wherein the electrical contact of the stimulator body is a return contact.

8. The method of claim 6, wherein the stimulator body is configured to be held with a hand of the patient during delivery.

9. The method of claim 6, further comprising inserting the nasal insertion prong into a first nostril of the patient, such that the electrical contact of the stimulator body is in contact with an area of a nasal septum.

10. The method of claim 1, wherein the device comprises two nasal insertion prongs, and wherein each of the two nasal insertion prongs comprises one of the at least three electrical contacts.

11. The method of claim 1, wherein the electrical stimulus comprises a pulse-based electrical waveform.

12. The method of claim 11, wherein the pulse-based electrical waveform comprises a pulse width that changes over time during delivery.

13. The method of claim 12, wherein the pulse width changes over time according to an exponential function.

14. The method of claim 1, wherein the electrical stimulus takes two pathways between the at least three electrical contacts.

15. The method of claim 1, wherein the electrical stimulus takes two pathways between the at least three electrical contacts, and wherein the electrical stimulus cycles between the two pathways during delivery.