Dry eye treatment apparatus and methods

• US 9,724,230 B2
• Filed: 01/04/2012
• Issued: 08/08/2017
• Est. Priority Date: 01/04/2012
• Status: Active Grant

• Current Assignee: Sight Sciences, Inc.
• Original Assignee: Sight Sciences, Inc.
• Inventors: Badawi, Paul
• Primary Examiner(s): Yu, Justine
• Assistant Examiner(s): MILLER, CHRISTOPHER E
• Application Number:
  US13/343,407
• Publication Number:
  US 20130172790A1
• Time in Patent Office: 2,043 Days
• Field of Search: 301 15, 301 37, 301DIG 1, 602 1, 602 14, 607 96, 607 99, 607108, 607109, 607111, 607141, 219528, 219529
• 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 includes 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 strips. 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:

an upper strip configured to adhere to an underlying region of skin of an upper eyelid of a subject such that the treatment assembly is configured to allow for the subject to blink naturally without restriction from the upper strip, wherein the upper strip has an upper curved or arcuate periphery which is configured to extend and follow a superior border of the meibomian glands of the upper eyelid and a lower periphery which is configured to extend and follow a free margin of the upper eyelid such that an outer boundary of the upper strip is configured to be contained by an underlying tarsal plate of the upper eyelid;

a lower strip configured to adhere to an underlying region of skin of a lower eyelid of the subject, wherein the lower strip has an upper periphery which is configured to extend and follow a free margin of the lower eyelid and a lower curved or arcuate periphery which is shaped to extend and follow an inferior border of one or more meibomian glands of the lower eyelid such that an outer boundary of the lower strip is configured to be contained by an underlying tarsal plate of the lower eyelid; and

a controller in communication with the upper and lower strips, wherein the controller is programmed to control one or more parameters of the treatment assembly, wherein the one or more parameters include at least one heating parameter,

wherein the upper and lower strips each has a thickness of up to 3.175 mm,

wherein the upper and lower strips each further comprise a heating mechanism configured to be in thermal communication with the respective regions of skin of the upper eyelid and of the lower eyelid and is configured to emit thermal energy to the underlying regions of skin while the subject is unhindered from blinking during a heat treatment, and

wherein the heating mechanism of the upper strip substantially extends the entire length of the upper strip and the heating mechanism of the lower strip substantially extends the entire length of the lower strip such that at least a portion of the heating mechanism of the upper strip is configured to follow the superior border of the meibomian glands of the upper eyelid and at least a portion of the heating mechanism of the lower strip is configured to follow the inferior border of the one or more meibomian glands of the lower eyelid.

2. The assembly of claim 1 wherein the upper and lower strips each comprise a contact surface for placement against the regions of skin.

3. The assembly of claim 1 further comprising a thermochromic layer in thermal communication with the heating mechanism.

4. The assembly of claim 1 wherein the heating mechanism is configured to generate heat in a temperature range of about 20°

to 55°

C.

5. The assembly of claim 1 wherein the heating mechanism is configured to generate heat for a period of time of about 5 minutes to 24 hours.

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

7. The assembly of claim 6 wherein the cooling layer is configured to reduce in temperature over a range of about 0°

C. to 37°

C.

8. The assembly of claim 6 wherein the cooling layer comprises a hydrogel layer.

9. The assembly of claim 1 wherein the upper and lower strips each comprise an insulative layer.

10. The assembly of claim 1 wherein the upper and lower strips each has a length ranging from about 1 mm to 50 mm.

11. The assembly of claim 1 wherein the upper and log er strips each has a width ranging from about 1 mm to 25 mm.

12. The assembly of claim 1 wherein the controller is attached to the upper and lower strips.

13. The assembly of claim 1 wherein the one or more parameters comprise a temperature, treatment time, frequency of treatment, or thermal profile of the upper or lower strips.

14. 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.

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

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

17. The assembly of claim 1 further comprising an electrically conductive or resistive element positioned along the upper or lower strips.

18. The assembly of claim 17 wherein the electrically conductive or resistive element comprises an electrode.

19. The assembly of claim 17 wherein the electrical conductive or resistive element comprises a microwave antenna.

20. The assembly of claim 1 further comprising air indicator positioned along the upper or lower strips.

21. The assembly of claim 20 wherein the indicator comprises an auditory or visual alarm for alerting the subject.

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

23. The assembly of claim 1 further comprising a power supply positioned along the upper or lower strips.

24. The assembly of claim 23 wherein the power supply is rechargeable.

25. The assembly of claim 1 wherein the upper and lower strips each comprise an adhesive contact layer and an outer insulative layer.

26. The assembly of claim 1 wherein a width of the upper and lower strips is 25 mm or less.

27. The assembly of claim 1 wherein a length of the upper and lower strips is 50 mm or less.

28. The assembly of claim 1 further comprising one or more thermocouples or thermistors incorporated into the treatment assembly.

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

adhering an upper strip to an upper eyelid of a subject such that an upper curved or arcuate periphery of the upper strip extends and follows a superior border of the meibomian glands of the upper eyelid and a lower periphery extends and follows a free margin of the upper eyelid such that an outer boundary of the upper strip is contained by an underlying tarsal plate, and wherein the treatment assembly is configured to allow for the subject to blink naturally without restriction from the upper strip;

adhering a lower strip to a lower eyelid of the subject such that an upper periphery extends and follows a free margin of the lower eyelid and a lower curved or arcuate periphery extends and follows an inferior border of one or more meibomian glands of the lower eyelid such that an outer boundary of the lower strip is contained by an underlying tarsal plate;

applying thermal energy from a heating mechanism in the upper and lower strips to the underlying regions of skin such that the upper and lower strips emit thermal energy to the regions of skin while under control of a controller which is in communication with the upper and lower strips, wherein the controller is programmed to control one or more parameters of the treatment assembly, wherein the one or more parameters include at least one heating parameter, and wherein the heating mechanism of the upper strip substantially extends the entire length of the upper strip and the heating mechanism of the lower strip substantially extends the entire length of the lower strip such that at least a portion of the heating mechanism of the upper strip is configured to follow the superior border of the meibomian glands of the upper eyelid and at least a portion of the heating mechanism of the lower strip is configured to follow the inferior border of one or more meibomian glands of the lower eyelid;

maintaining the upper and lower strips upon the regions of skin until obstructions within the one or more meibomian glands are melted or liquefied at least partially; and

clearing the obstructions at least partially by maintaining natural blinking by the subject while maintaining the upper and lower strips upon the regions of skin, wherein the upper and lower strips each has a thickness of up to 3.175 nm.

30. The method of claim 29 wherein adhering the upper snip comprises placing a contact surface of the one or more strips against the upper eyelid.

31. The method of claim 29 further comprising indicating a temperature change in the upper and lower strips via a thermochromic layer in thermal communication with the heating mechanism.

32. The method of claim 29 wherein applying thermal energy from the heating mechanism comprises increasing a temperature of the one or more strips to a temperature range of about 20°

to 55°

C.

33. The method of claim 29 wherein applying thermal energy from the heating mechanism comprises applying the thermal energy for a period of time of about 5 minutes to 24 hours.

34. The method of claim 29 wherein emitting energy comprises drawing thermal energy from the underlying region of skin via a cooling layer in the upper and lower strips.

35. The method of claim 34 wherein drawing thermal energy comprises cooling the cooling layer to a temperature range of about 0°

C. to 37°

C.

36. The method of claim 29 wherein the upper and lower strips each has a length ranging from about 1 mm to 50 mm.

37. The method of claim 29 wherein the upper and lower strips each has a width ranging from about 1 mm to 25 mm.

38. The method of claim 29 wherein the controller is attached to the upper or lower strips.

39. The method of claim 29 wherein the one or more parameters of the treatment assembly comprise temperature, treatment time, frequency of treatment, or thermal profile of the upper and lower strips.

40. 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.

41. 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 upper or lower strips.

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

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

44. The method of claim 29 further comprising alerting the subject via an indicator positioned along the upper or lower strips.

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

46. 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.

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

48. The method of claim 29 further comprising monitoring a temperature of the treatment assembly via one or more thermocouples or thermistors.

49. A treatment assembly, comprising:

an upper strip configured to adhere to an underlying region of skin of an upper eyelid of a subject such that the treatment assembly is configured to allow ibr the subject to blink naturally without restriction from the upper strip, wherein the upper strip has an upper curved or arcuate periphery which is configured to extend and follow a superior border of the meibomian glands of the upper eyelid and a lower periphery which is configured to extend and follow a free margin of the upper eyelid such that an outer boundary of the upper strip is contained by an underlying tarsal plate;

a controller in communication with the upper strip, wherein the controller is programmed to control one or more parameters of the treatment assembly, wherein the one or more parameters include at least one heating parameter,

wherein the upper strip has a thickness of up to 3.175 mm,

wherein the upper strip further comprises a heating mechanism configured to be in thermal communication with the region of skin and is configured to emit thermal energy to the underlying region of skin while the subject is unhindered from blinking during a heat treatment, and

wherein the heating mechanism substantially extends the entire length of the upper strip such that at least a portion of the heating mechanism is configured to follow the superior border of the meibomian glands of the upper eyelid.

50. The assembly of claim 49 wherein the upper strip comprises a contact surface for placement against the region of skin.

51. The assembly of claim 49 further comprising a thermochromic layer in thermal communication with the heating mechanism.

52. The assembly of claim 49 wherein the heating mechanism is configured to generate heat in a temperature range of about 20′

to 55°

C.

53. The assembly of claim 49 wherein the heating mechanism is configured to generate heat for a period of time of about 5 minutes to 24 hours.

54. The assembly of claim 49 wherein the upper strip comprises a cooling layer in thermal communication with the region of skin.

55. The assembly of claim 54 wherein the cooling layer is configured to reduce in temperature over a range of about 0°

C. to 37°

C.

56. The assembly of claim 49 wherein the upper strip comprises an insulative layer.

57. The assembly of claim 49 wherein the upper strip as a length ranging from about 1 mm to 50 mm.

58. The assembly of claim 49 wherein the upper strip has a width ranging from about 1 mm to 25 mm.

59. The assembly of claim 49 wherein the controller is attached to the upper strip.

60. The assembly of claim 49 wherein the one or more parameters comprise a temperature, treatment time, frequency of treatment, or thermal profile of the one or more strips.

61. The assembly of claim 49 further comprising an electrically conductive or resistive element positioned along the upper strip.

62. The assembly of claim 61 wherein the electrically conductive or resistive element comprises an electrode.

63. The assembly of claim 49 further comprising an indicator positioned along the upper strip.

64. The assembly of claim 63 wherein the indicator comprises an auditory or visual alarm for alerting the subject.

65. The assembly of claim 49 further comprising one or pharmaceutical, biological, or chemical agents infused within or along the upper strip.

66. The assembly of claim 49 further comprising a power supply positioned along the upper strip.