DRY EYE TREATMENT APPARATUS AND METHODS

• US 20130172790A1
• Filed: 01/04/2012
• Published: 07/04/2013
• Est. Priority Date: 01/04/2012
• Status: Active Grant

• Current Assignee: Sight Sciences, Inc.
• Original Assignee: Sight Sciences, Inc.
• Inventors: Badawi, Paul
• Granted Patent: US 9,724,230 B2
• Time in Patent Office: Days
• US Class Current: 601/15
• CPC Class Codes: A61F 13/00063 comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic drug delivery dressings A61K9/70; chemical aspect of the additives A61L15/00
• CPC Class Codes: A61F 2007/0004 Eyes or part of the face surrounding the eyes
• CPC Class Codes: A61F 2007/0071 using a resistor, e.g. near the spot to be heated
• CPC Class Codes: A61F 2007/0096 with a thermometer
• CPC Class Codes: A61F 2007/0226 adhesive, self-sticking
• CPC Class Codes: A61F 2007/0292 using latent heat produced or absorbed during phase change of materials, e.g. of super-cooled solutions
• CPC Class Codes: A61F 2013/00187 insulating; warmth or cold applying
• CPC Class Codes: A61F 2013/0028 applying of mechanical pressure; passive massage
• CPC Class Codes: A61F 2013/00497 eye patch
• CPC Class Codes: A61F 2013/00502 for eyelids
• CPC Class Codes: A61F 2013/00646 Medication patches, e.g. transcutaneous
• CPC Class Codes: A61F 7/02 Compresses or poultices for effecting heating or cooling
• CPC Class Codes: A61F 7/034 Flameless
• CPC Class Codes: A61F 7/106 self-cooling, e.g. using a chemical reaction
• CPC Class Codes: A61F 9/00 Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand caps with means for protecting the eyes A42B1/018; visors for helmets A42B3/22; retractors A61B17/02; manipulators specially adapted for use in surgery A61B34/70; appliances to aid invalids to move about A61H3/00; exercisers for the eyes A61H5/00; eye baths A61H35/02; sunglasses or goggles having the same features as spectacles G02C
• CPC Class Codes: A61F 9/04 Eye-masks ; Devices to be worn on the face, not intended for looking through; Eye-pads for sunbathing eye-bandages A61F13/12; protective face-masks A41D13/11; protectors for shampooing A45D
• CPC Class Codes: A61H 2201/0188 Illumination related features
• CPC Class Codes: A61H 2201/0207 heated
• CPC Class Codes: A61H 2201/0214 cooled
• CPC Class Codes: A61H 2201/0228 heated by an electric resistance element
• CPC Class Codes: A61H 2201/0257 : by a heat accumulator, e.g. a sand or liquid reservoir
• CPC Class Codes: A61H 2201/0278 : by chemical reaction
• CPC Class Codes: A61H 2201/10 : with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy
• CPC Class Codes: A61H 2201/105 : with means for delivering media, e.g. drugs or cosmetics
• CPC Class Codes: A61H 2201/5002 : Means for controlling a set of similar massage devices acting in sequence at different locations on a patient
• CPC Class Codes: A61H 2201/5035 : Several programs selectable
• CPC Class Codes: A61H 2201/5038 : freely programmable by the user
• CPC Class Codes: A61H 2201/5041 : control is restricted to certain individuals
• CPC Class Codes: A61H 2201/5082 : Temperature sensors
• CPC Class Codes: A61H 2205/024 : Eyes
• CPC Class Codes: A61H 23/0245 : with ultrasonic transducers, e.g. piezoelectric
• CPC Class Codes: A61H 23/0263 : using rotating unbalanced masses
• CPC Class Codes: A61M 35/10 : Wearable devices, e.g. garments, glasses or masks

Abstract

Dry eye treatment apparatus and methods are described herein which generally comprise a patch or strip affixed to the skin of the upper and/or lower eyelids to deliver heat or other forms of energy, pressure, drugs, moisture, etc. (alone or in combination) to the one or more meibomian glands contained within the underlying skin. The treatment strip or strips include one or more strips configured to adhere to an underlying region of skin in proximity to one or both eyes of a subject such that the one or more strips allow for the subject to blink naturally without restriction from the one or more patches. Moreover, the one or more strips may be configured to emit energy to the underlying region of skin and where the one or more strips are shaped to follow a location of one or more meibomiam glands contained within the underlying region of skin.

Claims

1. A treatment assembly for dry eye syndrome, comprising:

one or more strips configured to adhere to an underlying region of skin in proximity to one or both eyes of a subject such that the one or more strips allow for the subject to blink naturally without restriction from the one or more strips,

wherein the one or more strips are configured to emit energy to the underlying region of skin, and

wherein the strip is shaped to follow a location of one or more meibomian glands contained within the underlying region of skin.

2. The assembly of claim 1 wherein the energy comprises thermal energy.

3. The assembly of claim 1 wherein the one or more strips comprise a contact surface for placement against the region of skin.

4. The assembly of claim 1 wherein the one or more strips comprise a heating layer in thermal communication with the region of skin.

5. The assembly of claim 4 further comprising a thermochromic layer in thermal communication with the heating layer.

6. The assembly of claim 4 wherein the heating layer is configured to generate heat in a temperature range of about 20°

to 55°

C.

7. The assembly of claim 4 wherein the heating layer is configured to generate heat for a period of time of about 5 minutes to 24 hours.

8. The assembly of claim 1 wherein the one or more strips comprise a cooling layer in thermal communication with the region of skin.

9. The assembly of claim 8 wherein the cooling layer is configured to reduce in temperature over a range of about 0°

C. to 37°

C.

10. The assembly of claim 8 wherein the cooling layer comprises a hydrogel layer.

11. The assembly of claim 1 wherein the one or more strips comprise an insulative layer.

12. The assembly of claim 1 wherein the one or more strips each have a first curved or arcuate periphery and a second straightened periphery, wherein the first curved or arcuate periphery is shaped to extend and follow a border of the one or more meibomian glands and the second straightened periphery is shaped to extend and follow a free margin of an upper or lower eyelid.

13. The assembly of claim 1 wherein the one or more strips each has a length ranging from about 1 mm to 50 mm.

14. The assembly of claim 1 wherein the one or more strips each has a width ranging from about 1 mm to 25 mm.

15. The assembly of claim 1 further comprising a controller attached to the one or more strips.

16. The assembly of claim 15 wherein the controller is programmed to control one or more parameters of the one or more strips.

17. The assembly of claim 16 wherein the one or more parameters comprise a temperature, treatment time, frequency of treatment, or thermal profile of the one or more strips.

18. The assembly of claim 1 further comprising one or more additional strips configured to adhere to a second region of skin in proximity to a lacrimal gland of the subject.

19. The assembly of claim 1 further comprising one or more biasing mechanisms positioned along the one or more strips, where the one or more biasing mechanisms are configured to apply a pressure to the underlying region of skin.

20. The assembly of claim 1 further comprising one or more actuators positioned along the one or more strips, wherein the one or more actuators are configured to impart a mechanical vibration to the underlying region of skin.

21. The assembly of claim 1 further comprising an electrically conductive or resistive element positioned along the one or more strips.

22. The assembly of claim 21 wherein the electrically conductive element comprises an electrode.

23. The assembly of claim 21 wherein the electrically conductive element comprises a microwave antenna.

24. The assembly of claim 1 further comprising an indicator positioned along the one or more strips.

25. The assembly of claim 24 wherein the indicator comprises an auditory or visual alarm for alerting the subject.

26. The assembly of claim 1 further comprising one or more pharmaceutical, biological, or chemical agents infused within or along the one or more strips.

27. The assembly of claim 1 further comprising a power supply positioned along the one or more strips.

28. The assembly of claim 27 wherein the power supply is rechargeable.

29. A method of treating dry eye syndrome, comprising:

adhering one or more strips to a region of skin in proximity to one or both eyes of a subject such that the one or more strips allow for the subject to blink naturally without restriction from the one or more strips; and

,

emitting energy from the one or more strips to the region of skin,

wherein the one or more strips are shaped to follow a location of one or more meibomian glands contained within the region of skin.

30. The method of claim 29 wherein adhering comprises positioning the one or more strips in proximity to one or both eyes such that a first curved or arcuate periphery of the one or more strips extends and follows a border of the one or more meibomian glands and a second straightened periphery of the one or more strips extends and follows a free margin of an upper or lower eyelid.

31. The method of claim 29 wherein adhering comprises placing a contact surface of the one or more strips against the region of skin.

32. The method of claim 29 wherein emitting energy comprises applying thermal energy from a heating layer in the one or more strips to the underlying region of skin.

33. The method of claim 32 further comprising indicating a temperature change in the one or more strips via a thermochromic layer in thermal communication with the heating layer.

34. The method of claim 32 wherein applying thermal energy from a heating layer comprises increasing a temperature of the one or more strips to a temperature range of about 20°

to 55°

C.

35. The method of claim 32 wherein applying thermal energy from a heating layer comprises applying the thermal energy for a period of time of about 5 minutes to 24 hours.

36. The method of claim 29 wherein emitting energy comprises drawing thermal energy from the underlying region of skin via a cooling layer in the one or more strips.

37. The method of claim 36 wherein drawing thermal energy comprises cooling the cooling layer to a temperature range of about 0°

C. to 37°

C.

38. The method of claim 29 wherein the one or more strips each has a length ranging from about 1 mm to 50 mm.

39. The method of claim 29 wherein the one or more strips each has a width ranging from about 1 mm to 25 mm.

40. The method of claim 29 further comprising programming the one or more strips via a controller attached to the one or more strips.

41. The method of claim 40 wherein programming comprises controlling one or more parameters of the one or more strips.

42. The method of claim 41 wherein controlling comprises controlling a temperature, treatment time, frequency of treatment, or thermal profile of the one or more strips.

43. The method of claim 29 further comprising adhering one or more additional strips to a second region of skin in proximity to a lacrimal gland of the subject.

44. The method of claim 29 further comprising applying a pressure or force to the underlying region of skin via one or more biasing mechanisms positioned along the one or more strips.

45. The method of claim 29 further comprising imparting a mechanical vibration to the underlying region of skin.

46. The method of claim 29 further comprising applying an electrical force or electrical stimulation to the underlying region of skin.

47. The method of claim 29 further comprising alerting the subject via an indicator positioned along the one or more strips.

48. The method of claim 29 further comprising applying one or more pharmaceutical, biological, or chemical agents to the underlying skin via the one or more strips.

49. The method of claim 29 wherein the method of treating dry eye syndrome further comprises treating meibomitis, blepharitis, anterior blepharitis, posterior blepharitis, or ocular rosacea.

50. The method of claim 29 further comprising stimulating the subject to facilitate blinking, triggering a blink, or maintaining longer closure during a blink.