Dry eye treatment systems

• US 10,052,226 B2
• Filed: 02/24/2017
• Issued: 08/21/2018
• 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): Zimbouski, Ariana
• Application Number:
  US15/442,003
• Publication Number:
  US 20170165106A1
• Time in Patent Office: 543 Days
• CPC Class Codes: A61F 13/124 specially adapted for the eyes
• CPC Class Codes: A61F 2007/0004 Eyes or part of the face surrounding the eyes
• CPC Class Codes: A61F 2007/0075 using a Peltier element, e.g. near the spot to be heated or cooled
• CPC Class Codes: A61F 2007/0078 with a battery
• CPC Class Codes: A61F 2007/0086 with a thermostat
• CPC Class Codes: A61F 2007/0093 programmed
• CPC Class Codes: A61F 2007/0094 using a remote control
• CPC Class Codes: A61F 2007/0095 with a temperature indicator
• CPC Class Codes: A61F 2007/0096 with a thermometer
• CPC Class Codes: A61F 2007/0226 adhesive, self-sticking
• CPC Class Codes: A61F 2007/0242 heated by microwaves
• CPC Class Codes: A61F 2007/0244 with layers
• CPC Class Codes: A61F 7/007 characterised by electric heating
• CPC Class Codes: A61F 7/02 Compresses or poultices for effecting heating or cooling
• CPC Class Codes: A61F 9/0008 Introducing ophthalmic products into the ocular cavity or retaining products therein putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 35/10 Wearable devices, e.g. garments, glasses or masks
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04

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 system, comprising:

a lower strip configured to adhere to an underlying region of skin of a lower eyelid of a subject such that the lower strip has a flexibility sufficient to assume a curvature of the lower eyelid of the subject when adhered and to accommodate movement of the lower eyelid to allow for the subject to blink naturally without restriction such that the lower strip is non-obtrusive to the subject when adhered;

a controller in communication with the lower strip via a connecting cable which transmits electrical energy to the lower strip, the controller being programmable for a treatment therapy,

wherein the lower strip is configured to receive the electrical energy and emit thermal energy to the underlying region of skin, and

wherein the lower strip has a first curved or arcuate periphery which is shaped to extend and follow a border of one or more meibomian glands contained within the underlying region of skin, and the lower strip further has a second curved or arcuate periphery which is shaped to extend and follow a free margin of the lower eyelid.

2. The system of claim 1 further comprising an upper strip configured to adhere to an underlying region of skin of an upper eyelid of the subject.

3. The system of claim 2 wherein the upper strip and lower strip are electrically coupled to one another.

4. The system of claim 2 wherein the upper strip and lower strip are electrically coupled to one another forming a wishbone design.

5. The system of claim 1 wherein the lower strip comprises a contact surface for placement against the region of skin.

6. The system of claim 1 wherein the lower strip comprises a heating layer configured to be in thermal communication with the region of skin.

7. The system of claim 6 further comprising a thermochromic layer in thermal communication with the heating layer.

8. The system of claim 1 wherein the controller is coupled to the connecting cable.

9. The system of claim 1 wherein the controller is programmed to control one or more parameters of the lower strip.

10. The system of claim 9 wherein the one or more parameters comprise a temperature, treatment time, frequency of treatment, or thermal profile of the lower strip.

11. The system of claim 9 wherein the controller is programmed to heat the lower strip to a temperature of between 40°

to 50°

C.

12. The system of claim 9 wherein the controller is programmed to heat the lower strip to a temperature up to 45°

C.

13. The system of claim 9 wherein the controller is programmed to heat the lower strip to a temperature of between 40.5°

to 44.5°

C.

14. The system of claim 9 wherein the controller is programmed to heat the lower strip to a temperature of between 41.5°

to 43.5°

C.

15. The system of claim 1 further comprising one or more temperature sensors incorporated into the lower strip for regulating a temperature of the lower strip.

16. The system of claim 9 wherein the controller is programmed to heat the lower strip for at least 10 minutes or more.

17. The system of claim 9 wherein the controller is programmed to heat the lower strip for up to 15 minutes.

37. The system of claim 9 wherein the controller is programmed to heat the lower strip to a temperature of 50°

C. or less.

18. A method of treating a subject, comprising:

adhering a lower strip to a lower eyelid of a subject such that the lower strip has a flexibility sufficient to assume a curvature of the lower eyelid of the subject and to accommodate movement of the lower eyelid to allow for the subject to blink naturally without restriction such that the lower strip is non-obtrusive to the subject while covering one or more meibomian glands contained within the lower eyelid with the lower strip, wherein the lower strip has a first curved or arcuate periphery which is shaped to extend and follow a border of the one or more meibomian glands contained within the lower eyelid and a second curved or arcuate periphery which is shaped to extend and follow a free margin of the lower eyelid;

initiating a treatment with the lower strip via a controller transmitting electrical energy to the lower strip via a connecting cable; and

emitting thermal energy from the lower strip to the lower eyelid.

19. The method of claim 18 further comprising adhering an upper strip to an upper eyelid of the subject such that one or more meibomian glands contained within the upper eyelid are covered by the upper strip.

20. The method of claim 19 wherein the upper strip and lower strip are electrically coupled to one another.

21. The method of claim 18 wherein emitting thermal energy comprises applying thermal energy from a heating layer in the lower strip.

22. The method of claim 18 wherein initiating comprises programming the lower strip via the controller attached to the lower strip.

23. The method of claim 22 wherein programming comprises controlling one or more parameters of the lower strip.

24. The method of claim 23 wherein controlling comprises controlling a temperature, treatment time, frequency of treatment, or thermal profile of the upper strip.

25. The method of claim 18 wherein initiating further comprises displaying at least one parameter.

26. The method of claim 18 further comprising wirelessly communicating with a remote server.

27. The method of claim 18 wherein the method of treating comprises treating one or more conditions selected from the group consisting of dry eye, evaporative dry eye, and Meibomian gland dysfunction.

28. The method of claim 18 wherein the method of treating comprises treating to improve one or more conditions selected from the group consisting of an ocular surface, tear quality, lipid layer of tears, and tear break up time.

29. The method of claim 18 wherein the method of treating comprises treating to reduce Meibomian gland inflammation or ocular surface inflammation.

30. The method of claim 23 wherein controlling one or more parameters comprises heating the lower strip to a temperature of between 40°

to 50°

C.

31. The method of claim 23 wherein controlling one or more parameters comprises heating the lower strip to a temperature up to 45°

C.

32. The method of claim 23 wherein controlling one or more parameters comprises heating the lower strip to a temperature of between 40.5°

to 44.5°

C.

33. The method of claim 23 wherein controlling one or more parameters comprises heating the lower strip to a temperature of between 41.5°

to 43.5°

C.

34. The method of claim 18 further comprising monitoring a temperature of the lower strip via one or more temperature sensors incorporated into the lower strip.

35. The method of claim 18 wherein emitting thermal energy comprises heating the lower strip for at least 10 minutes or more.

36. The method of claim 18 wherein emitting thermal energy comprises heating the lower strip for up to 15 minutes.

38. The method of claim 23 wherein controlling one or more parameters comprises heating the lower strip to a temperature of 50°

C. or less.