System for inner eyelid treatment of meibomian gland dysfunction

• US 9,314,369 B2
• Filed: 01/17/2008
• Issued: 04/19/2016
• Est. Priority Date: 05/15/2006
• Status: Active Grant

• Current Assignee: TearScience Inc. (Johnson & Johnson)
• Original Assignee: TearScience Inc. (Johnson & Johnson)
• Inventors: Grenon, Stephen M., Jans, John Martin, Hutchinson, Jordan W., Gausmann, Keith
• Primary Examiner(s): Rodriguez, Cris L
• Assistant Examiner(s): Mai, Hao D
• Application Number:
  US12/015,600
• Publication Number:
  US 20080114424A1
• Time in Patent Office: 3,015 Days
• Field of Search: 604289-291, 604294-296, 607/109, 607/141, 607/96, 607/1
• US Class Current: 1/1
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2018/048 in gaseous form
• CPC Class Codes: A61F 2007/0004 Eyes or part of the face surrounding the eyes
• CPC Class Codes: A61F 2007/0059 with an open fluid circuit
• CPC Class Codes: A61F 7/007 characterised by electric heating
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61F 9/00772 Apparatus for restoration of tear ducts
• CPC Class Codes: A61H 2015/0014 cylinder-like, i.e. rollers
• CPC Class Codes: A61H 7/00 Devices for suction-kneading massage; Devices for massaging the skin by rubbing or brushing not otherwise provided for electro-medical massage devices applying electric current by contact A61N1/18
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

A system for treating meibomian gland dysfunction. A controller controls a lid warmer attached onto a patient'"'"'s eye to generate heat on the inside of the eyelid to provide conductive heat transfer to the meibomian glands. The application of heat assists in the expression of obstructions or occlusions in the meibomian glands to restore sufficient sebum flow to the lipid layer to treat dry eye. Temperatures at the meibomian glands reach desired levels more quickly and efficiently when heating the inside of the eyelid. Reaching such higher temperature levels may be instrumental in removing obstructions in the meibomian glands. Less time may also be required to reach desired temperature levels when applying heat to the inside of the eyelid. An eyecup may be employed to generate a force on the outside of the patient'"'"'s eyelid to improve conductive heat transfer and reduce blood flow in the eyelid that causes convective heat loss. Thus, the application of force can further increase the temperature level and/or reduce the time to reach desired temperature levels for removing obstructions.

Claims

1. A system for treating meibomian gland dysfunction, comprising:

a controller;

a lid warmer, wherein the lid warmer is adapted to be positioned behind a patient'"'"'s eyelid on an external surface of a sclera of a patient'"'"'s eye, wherein the lid warmer applies heat to an inner surface of a patient'"'"'s eyelid to a temperature level to melt, loosen, or soften an obstruction in a meibomian gland;

a heating element abutting against an eyelid side of the lid warmer so that heat generated is located adjacent an inner eyelid of the patient'"'"'s eye to apply heat to the meibomian gland;

a controller interface adapted to couple the controller to the lid warmer,

wherein the controller is further adapted to;

send a first signal to the lid warmer to apply heat to the inner surface of a patient'"'"'s eyelid to a temperature level to melt, loosen, or soften an obstruction in a meibomian gland; and

maintain the first signal to the lid warmer to maintain the heat on the inner surface of the patient'"'"'s eyelid for a period of time; and

an eye cup that is of a size and shape to conform to an external surface of a patient'"'"'s eyelid, wherein the eye cup, based on receiving a second signal from the controller, applies a force to the external surface of a patient'"'"'s eyelid sufficient to express the obstruction from the meibomian gland.

2. The system of claim 1, wherein the controller further comprises a lid warmer controller that is adapted to control the heating element to control the amount of heat generated by the heating element.

3. The system of claim 2, wherein the lid warmer controller is a pulse width modulated controller.

4. The system of claim 1, wherein the controller is further adapted to check a fuse on the lid warmer controller to determine if the lid warmer has been previously used before sending the first signal to the lid warmer to apply heat to the inner surface of a patient'"'"'s eyelid to a temperature level to melt, loosen, or soften an obstruction in a meibomian gland.

5. The system of claim 1, wherein the controller further comprises a therapy timer, wherein the therapy timer controls the amount of time the controller sends the first signal to the lid warmer to apply heat to the inner surface of a patient'"'"'s eyelid.

6. The system of claim 5, wherein the controller further comprises a display having a therapy timer display, wherein the controller is adapted to display the amount of time in the therapy timer on the therapy timer display.

7. The system of claim 1, wherein the lid warmer further comprises a temperature feedback device adapted to measure the temperature level at the lid warmer, wherein the controller is further adapted to monitor the temperature level at the lid warmer using the temperature feedback device.

8. The system of claim 7, wherein the temperature feedback device is comprised of at least one thermistor.

9. The system of claim 7, wherein the controller regulates the first signal to the lid warmer to regulate the heat generated by the heating element based on the temperature level at the lid warmer from the temperature feedback device.

10. The system of claim 9, wherein the controller is further adapted to generate an error and/or disable the first signal to the lid warmer to discontinue the generation of heat by the heating element if the temperature level at the lid warmer exceeds a threshold temperature level.

11. The system of claim 9, wherein the controller is further adapted to generate an error and/or not send the first signal to the lid warmer to have the heating element generate heat if the temperature level at the lid warmer does not initially meet or exceed body temperature.

12. The system of claim 1, wherein the controller further comprises a display comprising a temperature level display that displays the temperature level at the lid warmer.

13. The system of claim 1, wherein the controller further comprises a force controller that is adapted to control the eye cup to control an amount of force generated by the eye cup.

14. The system of claim 13, wherein the eye cup comprises a bladder, wherein the eye cup is adapted to be positioned on the external surface of the patient'"'"'s eyelid,

wherein the force controller is adapted to inflate the bladder to apply the force to the external surface of the patient'"'"'s eyelid.

15. The system of claim 1, wherein the controller further comprises a force lever, wherein the force controller is further adapted to control the force generated by the eye cup in response to engagement of the force lever.

16. The system of claim 1, wherein the controller further comprises a feedback device adapted to measure the force generated by the eye cup, wherein the controller is further adapted to monitor the force level at the external surface of the patient'"'"'s eyelid using the feedback device.

17. The system of claim 16, wherein the controller is further adapted to generate an error and/or disable the force generated by the eye cup to discontinue the force generated at the external surface of the patient'"'"'s eyelid if the force generated by the eye cup exceeds a threshold level.

18. The system of claim 1, wherein the controller further comprises a display comprising a force level display that displays an amount of the force applied to the external surface of the patient'"'"'s eyelid.

19. The system of claim 7, wherein the controller further comprises a data log, and wherein the controller is further adapted to store information relating to the temperature levels measured by the temperature feedback device.

20. The system of claim 16, wherein the controller further comprises a data log, and wherein the controller is further adapted to store information relating to the force levels measured by the feedback device.

21. The system of claim 1, wherein the controller further comprises an energy source to power the controller, and wherein the controller is further adapted to generate an error if the energy source cannot generate a threshold energy amount.

22. The system of claim 1, wherein the controller is further adapted to assist in the expression of the obstruction from the meibomian gland by controlling the force generated by the eye cup.

23. The system of claim 1, wherein the controller is further adapted to maintain the force generated by the eye cup while the controller is sending the first signal to the lid warmer to generate heat.

24. The system of claim 13, wherein the controller is further adapted to maintain the amount of the force generated by the eye cup while the controller is sending the first signal to the lid warmer to generate heat to reduce blood flow in the patient'"'"'s eyelid to reduce thermal dissipation from the eyelid.

25. The system of claim 1, wherein the controller is further adapted to generate the first signal to the lid warmer to generate the heat at a temperature level between approximately 35 and 47 degrees Celsius.

26. The system of claim 1, wherein the controller is further adapted to generate a variable signal to the lid warmer to generate the heat at a temperature level between approximately 35 and 55 degrees Celsius.

27. A system for treating meibomian gland dysfunction, comprising:

a controller;

a lid warmer, wherein the lid warmer is adapted to be positioned behind a patient'"'"'s eyelid on an external surface of a sclera of a patient'"'"'s eye, wherein the lid warmer applies heat to an inner surface of a patient'"'"'s eyelid to a temperature level to melt, loosen, or soften an obstruction in a meibomian gland;

a controller interface adapted to couple the controller to the lid warmer,

wherein the controller is further adapted to;

send a first signal to the lid warmer to apply heat to the inner surface of a patient'"'"'s eyelid to a temperature level to melt, loosen, or soften an obstruction in a meibomian gland; and

maintain the first signal to the lid warmer to maintain the heat on the inner surface of the patient'"'"'s eyelid for a period of time; and

an eye cup that is of a size and shape to conform to an external surface of a patient'"'"'s eyelid, wherein the eye cup, based on receiving a second signal from the controller, applies a force to the external surface of a patient'"'"'s eyelid sufficient to express the obstruction from the meibomian gland.

28. The system of claim 27, wherein the controller further comprises a lid warmer controller that is adapted to control a heating element to control the amount of heat generated by the heating element.

29. The system of claim 28, wherein the lid warmer controller is a pulse width modulated controller.

30. The system of claim 28, wherein the controller is further adapted to check a fuse on the lid warmer controller to determine if the lid warmer has been previously used before sending the first signal to the lid warmer to apply heat to the inner surface of a patient'"'"'s eyelid to a temperature level to melt, loosen, or soften an obstruction in a meibomian gland.

31. The system of claim 27, wherein the controller further comprises a therapy timer, wherein the therapy timer controls the amount of time the controller sends the first signal to the lid warmer to apply heat to the inner surface of a patient'"'"'s eyelid.

32. The system of claim 31, wherein the controller further comprises a display having a therapy timer display, wherein the controller is adapted to display the amount of time in the therapy timer on the therapy timer display.

33. The system of claim 28, wherein the lid warmer further comprises a temperature feedback device adapted to measure the temperature level at the lid warmer, wherein the controller is further adapted to monitor the temperature level at the lid warmer using the temperature feedback device.

34. The system of claim 33, wherein the temperature feedback device is comprised of at least one thermistor.

35. The system of claim 33, wherein the controller regulates the first signal to the lid warmer to regulate the heat generated by the heating element based on the temperature level at the lid warmer from the temperature feedback device.

36. The system of claim 35, wherein the controller is further adapted to generate an error and/or disable the first signal to the lid warmer to discontinue the generation of heat by the heating element if the temperature level at the lid warmer exceeds a threshold temperature level.

37. The system of claim 35, wherein the controller is further adapted to generate an error and/or not send the first signal to the lid warmer to have the heating element generate heat if the temperature level at the lid warmer does not initially meet or exceed body temperature.

38. The system of claim 27, wherein the controller further comprises a display comprising a temperature level display that displays the temperature level at the lid warmer.

39. The system of claim 27, wherein the controller further comprises a force controller that is adapted to control the eye cup to control an amount of the force generated by the eye cup.

40. The system of claim 39, wherein the eye cup comprises a bladder, wherein the eye cup is adapted to be positioned on the external surface of the patient'"'"'s eyelid,

wherein the force controller is adapted to inflate the bladder to apply the force to the external surface of the patient'"'"'s eyelid.

41. The system of claim 39, wherein the controller further comprises a force lever, wherein the force controller is further adapted to control the force generated by the eye cup in response to engagement of the force lever.

42. The system of claim 27, wherein the controller further comprises a feedback device adapted to measure the force generated by the eye cup, wherein the controller is further adapted to monitor the force level at the external surface of the patient'"'"'s eyelid using the feedback device.

43. The system of claim 42, wherein the controller is further adapted to generate an error and/or disable the force generated by the eye cup to discontinue the force generated at the external surface of the patient'"'"'s eyelid if the force generated by the eye cup exceeds a threshold level.

44. The system of claim 27, wherein the controller further comprises a display comprising a force level display that displays an amount of the force applied to the external surface of the patient'"'"'s eyelid.

45. The system of claim 33, wherein the controller further comprises a data log, and wherein the controller is further adapted to store information relating to the temperature levels measured by the temperature feedback device.

46. The system of claim 42, wherein the controller further comprises a data log, and wherein the controller is further adapted to store information relating to the force levels measured by the feedback device.

47. The system of claim 27, wherein the controller further comprises an energy source to power the controller, and wherein the controller is further adapted to generate an error if the energy source cannot generate a threshold energy amount.

48. The system of claim 27, wherein the controller is further adapted to assist in the expression of the obstruction from the meibomian gland by controlling the force generated by the eye cup.

49. The system of claim 27, wherein the controller is further adapted to maintain the force generated by the eye cup while the controller is sending the first signal to the lid warmer to generate heat.

50. The system of claim 39, wherein the controller is further adapted to maintain the amount of the force generated by the eye cup while the controller is sending the first signal to the lid warmer to generate heat to reduce blood flow in the patient'"'"'s eyelid to reduce thermal dissipation from the eyelid.

51. The system of claim 27, wherein the controller is further adapted to generate the first signal to the lid warmer to generate the heat at a temperature level between approximately 35 and 47 degrees Celsius.

52. The system of claim 27, wherein the controller is further adapted to generate a variable signal to the lid warmer to generate the heat at a temperature level between approximately 35 and 55 degrees Celsius.