INTRANASAL STIMULATION FOR TREATMENT OF MEIBOMIAN GLAND DISEASE AND BLEPHARITIS

• US 20170312521A1
• Filed: 05/02/2017
• Published: 11/02/2017
• Est. Priority Date: 05/02/2016
• Status: Active Grant

• Current Assignee: Oculeve Incorporated (Abbvie Incorporated)
• Original Assignee: Oculeve Incorporated (Abbvie Incorporated)
• Inventors: FRANKE, Manfred, SENCHYNA, Diane Michelle, HAMILTON, Daniel N.
• Granted Patent: US 10,918,864 B2
• Time in Patent Office: Days
• CPC Class Codes: A61N 1/0546 Nasal electrodes
• CPC Class Codes: A61N 1/36014 External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625
• CPC Class Codes: A61N 1/3603 Control systems
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36046 of the eye

Abstract

Described here are devices, systems, and methods for treating meibomian gland disease and/or blepharitis by providing intranasal stimulation. Generally, the devices may deliver electrical stimulation to the nasal mucosa. Intranasal stimulation may unblock obstructed meibomian glands and increase the lipid content of tears, both acutely during stimulation and subsequent to intranasal stimulation. The methods may include an initial round of stimulation to unblock obstructed meibomian glands, and subsequent shorter rounds of stimulation to cause meibum secretion and maintain the open glands.

Claims

1-26. -26. (canceled)

27. A method for treating a subject, comprising:

visualizing an eyelid margin of the subject during intranasal electrical stimulation of the subject; and

stopping or instructing a subject to stop the intranasal electrical stimulation after observing secretion of meibum onto the eyelid margin,

wherein the subject has meibomian gland disease.

28. The method of claim 27, wherein the eyelid margin is visualized using a slit lamp.

29. The method of claim 27, further comprising adjusting at least one parameter of the intranasal electrical stimulation during visualization.

30. The method of claim 27, wherein the intranasal electrical stimulation is delivered by a stimulator comprising a nasal insertion prong, wherein a portion of the nasal insertion prong is in contact with nasal mucosa of the subject.

31. The method of claim 30, wherein the stimulator comprises a user interface configured to adjust at least one parameter of the electrical stimulation.

32. The method of claim 30, wherein the stimulator comprises a remote interface configured to adjust at least one parameter of the electrical stimulation.

33. The method of claim 32, further comprising adjusting at least one parameter of the electrical stimulation using the remote interface while visualizing the eyelid margin.

34. A method for treating a subject, comprising:

visualizing an eyelid margin of the subject during intranasal electrical stimulation of the subject; and

adjusting at least one parameter of the intranasal electrical stimulation based on the visualization,

wherein the subject has meibomian gland disease.

35. The method of claim 34, wherein a number of meibomian glands of the subject secreting meibum during the intranasal electrical stimulation is greater than a number of meibomian glands of the subject secreting meibum before the intranasal electrical stimulation.

36. The method of claim 35, wherein adjusting at least one parameter of the intranasal electrical stimulation comprises changing a first stimulation waveform to a second stimulation waveform, and wherein a difference between a number of meibomian glands of a first eye of the subject secreting meibum and a number of meibomian glands of a second eye of the subject secreting meibum during intranasal electrical stimulation with the first stimulation waveform is larger than a difference between a number of meibomian glands of a first eye of the subject secreting meibum and a number of meibomian glands of a second eye of the subject secreting meibum during intranasal electrical stimulation with the second stimulation waveform.

38. The method of claim 34, wherein the intranasal electrical stimulation is delivered by a stimulator comprising a nasal insertion prong, wherein a portion of the nasal insertion prong is in contact with nasal mucosa of the subject.

40. The method of claim 38, wherein the stimulator comprises a remote interface configured to adjust at least one parameter of the electrical stimulation.

41. The method of claim 40, further comprising adjusting at least one parameter of the electrical stimulation using the remote interface while visualizing the eyelid margin.

37. (canceled)

39. (canceled)

42-52. -52. (canceled)

53. A method of treating dry eye, comprising:

determining that a subject afflicted with dry eye is deficient in meibum secretion, and intranasally delivering an electrical stimulation to the subject,

wherein the intranasally delivered electrical stimulation is effective to increase meibum secretion.

54. The method of claim 53, wherein the duration of stimulation is between about three minutes and about five minutes.

55. The method of claim 54, wherein the duration of stimulation is verified by measuring impedance or an electromyogram signal from a facial muscle near the nose, cheeks, or around the eyes of the subject.

56. A method of treating dry eye, comprising:

repeatedly delivering intranasal electrical stimulation to a subject over a period of time, wherein the subject has meibomian gland disease, and wherein the intranasal electrical stimulation is effective to improve secreted meibum quality.

57. The method of claim 56, wherein the period of time is at least 30 days.

58. The method of claim 57, wherein the intranasal electrical stimulation is delivered at least once daily over the at least 30 days.

59. The method of claim 57, wherein the improvement in secreted meibum quality comprises an increased number of lower lid meibomian glands secreting clear meibum at 30 days as compared to at 0 days.