Dry eye treatment systems

• US 9,844,459 B2
• Filed: 11/29/2016
• Issued: 12/19/2017
• 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): Zalukaeva, Tatyana
• Assistant Examiner(s): Zimbouski, Ariana
• Application Number:
  US15/364,070
• Publication Number:
  US 20170079834A1
• Time in Patent Office: 385 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:

an upper strip configured to adhere to an underlying region of skin of an upper eyelid of a subject such that the upper strip has a flexibility sufficient to accommodate movement of the upper eyelid to allow for the subject to blink naturally without restriction from the upper strip;

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

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

wherein the upper 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 upper strip further has a second curved or arcuate periphery which is shaped to extend and follow a free margin of the upper eyelid.

2. The system of claim 1 further comprising a lower strip configured to adhere to an underlying region of skin of a lower 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 upper strip comprises a contact surface for placement against the region of skin.

6. The system of claim 1 wherein the upper strip comprises a heating layer 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 upper 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 upper strip.

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

to 50°

C.

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

C.

13. The system of claim 9 wherein the controller is programmed to heat the upper 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 upper 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 upper strip for regulating a temperature of the upper strip.

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

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

18. A method of treating a subject, comprising:

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

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

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

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

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

23. The method of claim 22 wherein programming comprises controlling one or more parameters of the upper 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 upper 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 upper strip to a temperature up to 45°

C.

32. The method of claim 23 wherein controlling one or more parameters comprises heating the upper 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 upper 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 upper strip via one or more temperature sensors incorporated into the upper strip.

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

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