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

• US 8,128,674 B2
• Filed: 01/17/2008
• Issued: 03/06/2012
• Est. Priority Date: 05/15/2006
• Status: Expired due to Fees

• 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:
  US12/015,683
• Publication Number:
  US 20080114426A1
• Time in Patent Office: 1,510 Days
• Field of Search: 607/96, 607/1
• 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. A controller controls heat applied to the outside 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. A force is also applied to the outside of 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. Thus, the application of force can further increase the temperature level and/or reduce the time to reach desired temperature levels for removing obstructions or occlusions. 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 warmer is adapted 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 positioned on the outer surface of the patient'"'"'s eyelid, wherein the force application device applies a compressive force to the outer surface of the patient'"'"'s eyelid; and

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

wherein the controller is further adapted 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 a compressive 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 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 adapted to control a heating element in the lid warmer 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 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.

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 signal to the lid warmer to apply heat to the outer 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 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.

10. The system of claim 9, wherein the controller is further adapted to generate an error and/or disable the 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 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 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.

13. 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.

14. The system of claim 1, wherein the controller further comprises a pressure controller that is adapted to control the force application device to control the amount of compressive force generated by the force application device.

15. The system of claim 14, wherein the force application device is comprised of an eyecup comprising a bladder, wherein the eyecup is adapted to be positioned on the outer surface of the patient'"'"'s eyelid,

wherein the pressure controller is adapted to inflate the bladder to apply a compressive force to the outer surface of the patient'"'"'s eyelid.

16. The system of claim 1, wherein the controller further comprises a force lever, wherein the controller is further adapted to control the compressive force applied by the force application device in response to engagement of the force lever.

17. The system of claim 1, wherein the controller further comprises a pressure feedback device adapted to measure the compressive force applied by the force application device, wherein the controller is further adapted to monitor the pressure level of the compressive force at the outer surface of the patient'"'"'s eyelid using the pressure feedback device.

18. The system of claim 17, wherein the controller is further adapted to generate an error and/or disable compressive force applied by the force application device to discontinue the compressive force applied at the outer surface of the patient'"'"'s eyelid if the compressive force applied by the force application device exceeds a threshold pressure level.

19. The system of claim 17, wherein the controller further comprises a data log, and wherein the controller is further adapted to store information relating to the pressure levels of the compressive force measured by the pressure feedback device.

20. The system of claim 1, wherein the controller further comprises a display comprising a pressure level display that displays the pressure of the compressive force applied to the outer surface of the patient'"'"'s eyelid.

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 channel of the meibomian gland through the meibomian gland orifice of the meibomian gland by controlling the force applied by the force application device.

23. The system of claim 1, wherein the controller is further adapted to maintain the compressive force generated by the force application device while the controller is sending a signal to the lid warmer to generate heat.

24. The system of claim 1, wherein the controller is further adapted to maintain the compressive 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.

25. 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.