System for outer eyelid heat and pressure treatment for treating meibomian gland dysfunction

• US 8,617,229 B2
• Filed: 02/07/2012
• Issued: 12/31/2013
• Est. Priority Date: 05/15/2006
• Status: Active Grant

• Current Assignee: TearScience Inc. (Johnson & Johnson)
• Original Assignee: TearScience Inc. (Johnson & Johnson)
• Inventors: Korb, Donald R., Grenon, Stephen M., Willis, Timothy R., Gravely, Benjamin Tyson
• Primary Examiner(s): Dvorak, Linda
• Assistant Examiner(s): SMITH, KAITLYN ELIZABETH
• Application Number:
  US13/367,908
• Publication Number:
  US 20120136285A1
• Time in Patent Office: 693 Days
• Field of Search: 607/96, 601/15
• US Class Current: 607/96
• 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 comprising a heating element that applies heat to the outside of the eyelid to provide conductive heat transfer to the meibomian glands, which 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. A force application device may also apply force to the patient'"'"'s eyelid during the application of heat to improve conductive heat transfer and reduce blood flow in the eyelid that causes convective heat loss, and to help express obstructions from the meibomian gland, including from a channel of the meibomian gland. Reaching increased temperature levels may improve the melting, loosening, or softening of obstructions or occlusions in the meibomian glands while reducing the amount of time to reach desired temperature levels and/or aid in reducing discomfort to the patient during treatment.

Claims

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

a lid warmer, wherein the lid wanner is configured to apply heat to an outer surface of a patient'"'"'s eyelid to a temperature level to melt, loosen, or soften an obstruction located within a meibomian gland channel of a meibomian gland;

a force application device configured to be positioned on the outer surface of the patient'"'"'s eyelid, wherein the force application device applies a regulated directional force to the meibomian gland channel in a direction from a bottom of the meibomian gland channel to a top of the meibomian gland channel; and

a controller communicatively coupled to the lid warmer and the force application device,

wherein the controller is further configured to;

send a signal to the lid warmer to apply heat to the outer surface of the patient'"'"'s eyelid to a temperature level to melt, loosen, or soften an obstruction located within a meibomian gland channel of a meibomian gland;

control the force application device to generate the regulated directional force to express the obstruction located within the meibomian gland channel and from within the meibomian gland channel through a meibomian gland orifice of the meibomian gland; and

maintain the signal to the lid warmer to maintain the heat to the outer surface of the patient'"'"'s eyelid for a period of time.

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

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

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

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

6. The system of claim 5, wherein the controller regulates the signal sent 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.

7. The system of claim 6, wherein the controller is further configured to generate an error and/or disable the signal to the lid warmer to discontinue generation of heat by the heating element if the temperature level at the lid warmer exceeds a threshold temperature level.

8. The system of claim 6, wherein the controller is further configured to generate an error and/or not send the 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.

9. The system of claim 1, wherein the controller further comprises a force controller that is configured to control the force application device to control the amount of regulated directional force generated by the force application device.

10. The system of claim 9, wherein the force application device is comprised of an eyecup comprising a bladder, wherein the eyecup is configured to be positioned on the outer surface of the patient'"'"'s eyelid, and wherein the force controller is configured to inflate the bladder to apply the regulated directional force to the outer surface of the patient'"'"'s eyelid.

11. The system of claim 1, wherein the controller further comprises a force lever, wherein the controller is further configured to control the regulated directional force applied by the force application device in response to engagement of the force lever.

12. The system of claim 1, wherein the controller further comprises a feedback device configured to measure the regulated directional force applied by the force application device, wherein the controller is further configured to monitor a level of the regulated directional force using the feedback device.

13. The system of claim 12, wherein the controller is further configured to generate an error and/or disable a regulated directional force applied by the force application device to discontinue the regulated directional force applied if the regulated directional force applied by the force application device exceeds a threshold level.

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

15. The system of claim 1, wherein the controller is further configured to assist in expressing the obstruction from the meibomian gland channel of the meibomian gland through the meibomian gland orifice of the meibomian gland by controlling the regulated directional force applied by the force application device.

16. The system of claim 1, wherein the controller is further configured to maintain the regulated directional force generated by the force application device while the controller is sending a signal to the lid warmer to generate heat.

17. The system of claim 1, wherein the controller is further configured to maintain the regulated directional force generated by the force application device while the controller is sending a signal to the lid warmer to generate heat to reduce blood flow in the patient'"'"'s eyelid to reduce convective heat loss from the heat applied to the outer surface of the patient'"'"'s eyelid.

18. The system according to claim 1, wherein the patient'"'"'s eyelid is a mammalian eyelid.

19. The system of claim 1, wherein the regulated directional force applied by the force application device is a milking type force.

20. The system of claim 1, wherein the regulated directional force applied by the force application device comprises RF energy.

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

a heating element configured to apply heat to an outer surface of a patient'"'"'s eyelid to a temperature level to melt, loosen, or soften an obstruction located within a meibomian gland channel of a meibomian gland; and

a force application device configured to be positioned on the outer surface of the patient'"'"'s eyelid, wherein the force application device applies a regulated directional force to the meibomian gland channel in a direction from a bottom of the meibomian gland channel to a top of the meibomian gland channel to express the obstruction located within the meibomian gland channel and from within the meibomian gland channel through a meibomian gland orifice of the meibomian gland.

22. The system of claim 21, wherein the heating element is part of a lid warmer.

23. The system of claim 22, further comprising a lid warmer controller that is configured to control the heating element to control an amount of heat generated by the heating element.

24. The system of claim 23, wherein the lid warmer further comprises a temperature feedback device configured to measure the temperature level at the lid warmer, and wherein the lid warmer controller is further configured to monitor the temperature level at the lid warmer using the temperature feedback device.

25. The system of claim 22, wherein the lid warmer further comprises a temperature feedback device configured to measure the temperature level at the lid warmer, and wherein a controller regulates the signal sent to the heating element to regulate the heat generated by the heating element based on the temperature level at the lid warmer from the temperature feedback device.

26. The system of claim 25, wherein the controller is further configured to generate an error and/or disable the signal to the heating element to discontinue generation of heat by the heating element if the temperature level at the lid warmer exceeds a threshold temperature level.

27. The system of claim 25, wherein the controller is further configured to generate an error and/or not send the signal to the heating element to have the heating element generate heat if the temperature level at the lid wanner does not initially meet or exceed body temperature.

28. The system of claim 21 , further comprising a controller communicatively coupled to the heating element and the force application device,

wherein the controller is further configured to:

send a signal to the heating element to apply heat to the outer surface of a patient'"'"'s eyelid to a temperature level to melt, loosen, or soften an obstruction located within the meibomian gland channel of a meibomian gland;

control the force application device to generate a regulated directional force on the outer surface of the patient'"'"'s eyelid to express the obstruction located within the meibomian gland channel and from within the meibomian gland channel through a meibomian gland orifice of the meibomian gland; and

maintain the signal to the heating element to maintain the heat on the outer surface of the patient'"'"'s eyelid for a period of time.

29. The system of claim 28, wherein the controller further comprises a force controller that is configured to control the force application device to control an amount of force generated by the force application device.

30. The system of claim 29, wherein the controller further comprises a force lever, wherein the force controller is further configured to control force generated by the force application device in response to engagement of the force lever.

31. The system of claim 28, wherein the controller further comprises a feedback device configured to measure a force generated by the force application device, wherein the controller is further configured to monitor a level at the outer surface of the patient'"'"'s eyelid using the feedback device.

32. The system of claim 31, wherein the controller is further configured to generate an error and/or disable force generated by the force application device to discontinue force generated at the outer surface of the patient'"'"'s eyelid if the force generated by the force application device exceeds a threshold level.

33. The system of claim 28, wherein the controller further comprises an energy source to power the controller, and wherein the controller is further configured to generate an error if the energy source cannot generate a threshold energy amount.

34. The system of claim 28, wherein the controller is further configured to assist in the expression of the obstruction from the meibomian gland channel by controlling a force generated by the force application device.

35. The system of claim 28, wherein the controller is further configured to maintain a force generated by the force application device while the controller is sending a signal to the lid warmer to generate heat.

36. The system of claim 28, wherein the controller is further configured to maintain a force generated by the force application device while the controller is sending a signal to the heating element to generate heat to reduce blood flow in the patient'"'"'s eyelid to reduce convective heat loss from the heat applied to the outer surface of the patient'"'"'s eyelid.

37. The system of claim 21, wherein the force application device is comprised of an eyecup comprising a bladder, wherein the eyecup is configured to be positioned on the outer surface of the patient'"'"'s eyelid, and wherein the bladder is configured to be inflated to apply the regulated directional force to the outer surface of the patient'"'"'s eyelid to express the obstruction from within the meibomian gland channel through the meibomian gland orifice of the meibomian gland.

38. The system according to claim 21, wherein the patient'"'"'s eyelid is a mammalian eyelid.

39. The system of claim 21, wherein the regulated directional force applied by the force application device is a milking type force.

40. The system of claim 21, wherein the regulated directional force applied by the force application device comprises RF energy.