System for providing heat treatment and heat loss reduction for treating meibomian gland dysfunction

• US 8,632,578 B2
• Filed: 02/08/2012
• Issued: 01/21/2014
• 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., Jans, John Martin
• Primary Examiner(s): Dvorak, Linda
• Assistant Examiner(s): SMITH, KAITLYN ELIZABETH
• Application Number:
  US13/368,976
• Publication Number:
  US 20120143102A1
• Time in Patent Office: 713 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 tissue proximate the patient'"'"'s meibomian glands 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 tissue proximate the patient'"'"'s meibomian glands during the application of heat to improve conductive heat transfer and reduce blood flow in tissue that causes convective heat loss, and to help express obstructions from the meibomian gland, including from a channel of the meibomian gland, with reduced discomfort to the patient. Reaching increased temperature levels may improve the melting, loosening, or softening of obstructions or occlusions in the meibomian glands.

Claims

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

a lid warmer containing a heating element, wherein the lid warmer is configured to be applied to tissue proximate a patient'"'"'s meibomian gland 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 tissue, 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 tissue 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 the regulated directional force on the tissue to reduce blood flow in an area of the tissue to reduce thermal dissipation in the tissue and 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 on the tissue 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 the heating element 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 tissue to a temperature level to melt, loosen, or soften an obstruction in a 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 tissue.

5. The system of claim 1, wherein the lid warmer further comprises a temperature feedback device configured to measure the 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 pressure controller that is configured to control the force application device to control an amount of regulated directional force generated by the force application device.

10. 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 generated by the force application device in response to engagement of the force lever.

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

12. The system of claim 11, wherein the controller is further configured to generate an error and/or disable the regulated directional force generated by the force application device to discontinue the regulated directional force generated if the level of the regulated directional force generated by the force application device exceeds a threshold level.

13. 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.

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

15. 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.

16. The system of claim 1, wherein the patient'"'"'s meibomian gland is a mammalian meibomian gland.

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

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

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

a heating element configured to apply heat to tissue proximate a patient'"'"'s meibomian gland 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 tissue, 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 reduce blood flow in an area of the tissue to reduce thermal dissipation in the tissue and 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.

20. The system of claim 19, wherein the heating element is part of a lid warmer, the lid warmer configured to be positioned on tissue proximate the patient'"'"'s meibomian gland.

21. The system of claim 20, 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.

22. The system of claim 21, 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.

23. The system of claim 20, 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.

24. The system of claim 23, 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.

25. The system of claim 23, 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 warmer does not initially meet or exceed body temperature.

26. The system of claim 19, 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 tissue 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 the 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 reduce the blood flow in the area of the tissue to reduce thermal dissipation in the tissue and 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 on the tissue for a period of time.

27. The system of claim 26, 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.

28. The system of claim 27, wherein the controller further comprises a force lever, wherein the force controller is further configured to control the amount of force generated by the force application device in response to engagement of the force lever.

29. The system of claim 26, 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 patient'"'"'s eyelid using the feedback device.

30. The system of claim 29, wherein the controller is further configured to generate an error and/or disable force generated by the force application device to discontinue force applied at the tissue if the force generated by the force application device exceeds a threshold level.

31. The system of claim 26, 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.

32. The system of claim 26, wherein the controller is further configured to assist in expressing the obstruction from the meibomian gland channel by controlling a force generated by the force application device.

33. The system of claim 26, 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.

34. The system of claim 26, 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 a patient'"'"'s eyelid to reduce convective heat loss from the heat applied to the tissue proximate the patient'"'"'s meibomian gland.

35. The system of claim 19, wherein the force application device is comprised of an eyecup comprising a bladder, wherein the eyecup is configured to be positioned proximate the patient'"'"'s meibomian gland, and wherein the bladder is configured to be inflated to apply the regulated directional force to the tissue proximate the patient'"'"'s meibomian gland to express the obstruction from within the meibomian gland channel through the meibomian gland orifice of the meibomian gland.

36. The system of claim 19, wherein the patient'"'"'s meibomian gland is a mammalian meibomian gland.

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

38. The system of claim 19, wherein the regulated directional force applied by the force application device comprises RF energy.