Method and apparatus for treating gland dysfunction

• US 8,187,311 B2
• Filed: 02/11/2011
• Issued: 05/29/2012
• Est. Priority Date: 07/18/2005
• Status: Active Grant

• Current Assignee: TearScience Inc. (Johnson & Johnson)
• Original Assignee: TearScience Inc. (Johnson & Johnson)
• Inventors: Korb, Donald R., Willis, Timothy R., Gravely, Benjamin T., Grenon, Stephen M.
• Primary Examiner(s): Shay, David
• Assistant Examiner(s): LIPITZ, JEFFREY BRIAN
• Application Number:
  US13/025,990
• Publication Number:
  US 20110130729A1
• Time in Patent Office: 473 Days
• Field of Search: 607/88, 607/89, 606/205
• US Class Current: 607/88
• 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 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 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 1/403 for thermotherapy, e.g. hyperthermia
• CPC Class Codes: A61N 2005/0643 Applicators, probes irradiating specific body areas in close proximity
• CPC Class Codes: A61N 2005/0659 infrared
• CPC Class Codes: A61N 5/025 Warming the body, e.g. hyperthermia treatment
• CPC Class Codes: A61N 5/0625 Warming the body, e.g. hyperthermia treatment
• CPC Class Codes: A61N 5/067 using laser light
• 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 method and apparatus for treating gland dysfunction caused by gland obstruction in order to restore the natural flow of secretion from the gland comprises the application of a combination of energy, suction, vibration, heat, aspiration, chemical agents and pharmacological agents to loosen and thereafter remove the obstructive material.

Claims

1. An apparatus for treating meibomian gland dysfunction wherein the flow of naturally occurring secretion from a meibomian gland in an eyelid may be occluded due to the presence of an obstruction within a meibomian gland channel of the meibomian gland, comprising:

a probe comprising a thermal energy applicator, at least one roller, a back plate, and an opening disposed between the at least one roller and the back plate, wherein the at least one roller is configured to be controllably actuated to regulate the distance between the at least one roller and the back plate;

wherein the opening in the probe is configured to receive at least a portion of an eyelid such that the at least one roller is disposed adjacent to a first surface of the eyelid and the back plate is disposed adjacent to a second surface of the eyelid opposite the first surface of the eyelid;

wherein the thermal energy applicator is disposed in the probe and configured to apply thermal energy to the meibomian gland channel; and

wherein the at least one roller is configured to be controllably actuated to regulate the distance between the at least one roller and the back plate such that the at least one roller comes into contact with the eyelid and applies a regulated force to the eyelid disposed in the opening to squeeze the meibomian gland channel in the eyelid between the at least one roller and the back plate to express the obstruction from within the meibomian gland channel through a meibomian gland orifice of the meibomian gland.

2. The apparatus of claim 1, further comprising a controller electrically coupled to the probe and configured to actuate the at least one roller to regulate the distance between the at least one roller and the back plate.

3. The apparatus of claim 1, wherein the probe further comprises a lever configured to be actuated to actuate the at least one roller.

4. The apparatus of claim 3, wherein the at least one roller is disposed on an end of the lever.

5. The apparatus of claim 3, wherein the back plate is disposed on an end of a rod provided in the probe.

6. The apparatus of claim 5, wherein the lever is pivotally mounted to the rod.

7. The apparatus of claim 1, wherein the at least one roller is configured to be actuated such that the at least one roller comes into contact with the eyelid and squeezes the meibomian gland channel in a direction from a bottom of the meibomian gland channel to a top of the meibomian gland channel.

8. The apparatus of claim 1, wherein the at least one roller is configured to be actuated such that the at least one roller comes into contact with the eyelid and applies a regulated constant force to the meibomian gland channel.

9. The apparatus of claim 1, wherein the at least one roller is configured to be actuated such that the at least one roller comes into contact with the eyelid and applies a regulated milking force to the meibomian gland channel.

10. The apparatus of claim 1, wherein the at least one roller further comprises a vibration means configured to apply a regulated pulsatile force to the meibomian gland channel.

11. The apparatus of claim 10, wherein the regulated pulsatile force is applied at a preselected frequency.

12. The apparatus of claim 11, wherein the preselected frequency is less than 1000 Hz.

13. The apparatus of claim 11, wherein the preselected frequency is between about 50 Hz and about 500 Hz.

14. The apparatus of claim 11, wherein the preselected frequency is between about 60 Hz and about 300 Hz.

15. The apparatus of claim 10, wherein the regulated pulsatile force has an amplitude of between 0.1 mm and 5.0 mm.

16. The apparatus of claim 10, wherein the regulated pulsatile force has an amplitude of between about 0.5 mm and 1.5 mm.

17. The apparatus of claim 10, wherein the regulated pulsatile force has an amplitude of approximately 1.00 mm.

18. The apparatus of claim 1, wherein the probe applies a second force to the meibomian gland channel to extract the obstruction from within the meibomian gland channel and through the meibomian gland orifice.

19. The apparatus of claim 18, wherein the second force is comprised of a pulsatile force.

20. The apparatus of claim 18, wherein the regulated force is comprised of a regulated constant force, and the second force is comprised of a pulsatile force.

21. The apparatus of claim 1, wherein the thermal energy applicator is comprised of a heater, wherein the heater is configured to apply thermal energy to the meibomian gland channel during squeezing of the eyelid to soften the obstruction within the meibomian gland channel.

22. The apparatus of claim 21, wherein the heater is comprised of a heating element.

23. The apparatus of claim 21, wherein the heater is comprised of a solid-state heating element.

24. The apparatus of claim 21, wherein the heater is configured to apply a regulated thermal energy to the meibomian gland channel.

25. The apparatus of claim 21, wherein the heater is configured to apply conduction thermal energy to the meibomian gland channel.

26. The apparatus of claim 21, wherein the heater is configured to apply convention thermal energy to the meibomian gland channel.

27. The apparatus of claim 21, wherein the heater is configured to apply radiation thermal energy to the meibomian gland channel.

28. The apparatus of claim 21, wherein the heater is configured to apply infrared thermal energy to the meibomian gland channel.

29. The apparatus of claim 21, wherein the heater is configured to apply ultrasonic thermal energy to the meibomian gland channel.

30. The apparatus of claim 21, wherein the heater is configured to apply laser thermal energy to the meibomian gland channel.

31. The apparatus of claim 21, wherein the heater is configured to apply radio frequency (RF) thermal energy to the meibomian gland channel.

32. The apparatus of claim 21, wherein the heater softens the obstruction from a meibomian gland wall within the meibomian gland channel through the application of the thermal energy to the meibomian gland channel.

33. The apparatus of claim 21, wherein the heater applies sufficient thermal energy to the meibomian gland channel to loosen the obstruction within the meibomian gland channel.

34. The apparatus of claim 21, wherein the heater applies sufficient thermal energy to the meibomian gland channel to liquefy the obstruction within the meibomian gland channel.

35. The apparatus of claim 21, wherein the heater applies applies sufficient thermal to the meibomian gland channel to partially liquefy the obstruction within the meibomian gland channel.

36. The apparatus of claim 1, further comprising an aspirator disposed in the probe and configured to be disposed proximate the meibomian gland orifice during application of the regulated force to the front surface of the eyelid to soften the obstruction within the meibomian gland channel, to assist in extracting the obstruction from the meibomian gland channel.

37. The apparatus of claim 1, further comprising a tube disposed in the probe and configured to deliver a chemical agent or chemical compound into the meibomian gland channel.

38. The apparatus of claim 1, wherein one of the at least one roller is configured to be positioned in front of the meibomian gland.

39. The apparatus of claim 1, wherein one of the at least one roller is configured to be positioned behind the meibomian gland.

40. The apparatus of claim 1, wherein a first one of the at least one roller is configured to be positioned in front of the meibomian gland and a second one of the at least one roller is configured to be positioned behind the meibomian gland.