Method and apparatus for treating gland dysfunction employing heated medium

• US 8,915,253 B2
• Filed: 05/15/2006
• Issued: 12/23/2014
• Est. Priority Date: 07/18/2005
• Status: Active Grant

• Current Assignee: TearScience Inc. (Johnson & Johnson)
• Original Assignee: TearScience Inc. (Johnson & Johnson)
• Inventors: Grenon, Stephen M., Korb, Donald R., Willis, Timothy R., Gravely, Benjamin T.
• Primary Examiner(s): ROANE, AARON F
• Application Number:
  US11/434,033
• Publication Number:
  US 20070016254A1
• Time in Patent Office: 3,144 Days
• Field of Search: 607/96, 128/898
• US Class Current: 128/898
• 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. A method of treating dry eye wherein a flow of naturally occurring secretion to an eye is occluded due to a presence of an obstruction of a meibomian gland in an eyelid, wherein the meibomian gland has a meibomian gland channel and a meibomian gland orifice, the method comprising:

softening an obstruction located in the meibomian gland channel;

positioning a bladder such that the bladder contacts the eyelid when the bladder is expanded; and

expressing the softened obstruction from the meibomian gland channel by expanding the bladder to apply a regulated compressive force to the eyelid to express the softened obstruction from the meibomian gland channel,

wherein the expanding the bladder expresses the softened obstruction from within the meibomian gland channel through the meibomian gland orifice using the regulated compressive force, and

wherein the expanding the bladder comprises expanding the bladder such that a force on the meibomian gland increases from a bottom of the meibomian gland channel up to a top end of the meibomian gland where the meibomian gland orifice is located and the obstruction in the meibomian gland channel is expressed from within the meibomian gland channel through the meibomian gland orifice in a milking type of action.

2. The method according to claim 1 wherein the softening comprises the application of regulated thermal energy to the eyelid to heat the obstruction to a temperature of between about 37°

C. to about 47°

C.

3. The method according to claim 2 wherein the regulated thermal energy applied is selected from the group of modalities comprising conduction, convection and radiation.

4. The method according to claim 1 wherein the softening further includes applying a contained medium to the surface of the eyelid and heating the contained medium until the obstruction is heated to a temperature of between about 37°

C. to about 47°

C.

5. The method according to claim 4 wherein the medium is a fluid.

6. The method according to claim 4 wherein the medium is a gas.

7. The method according to claim 4 wherein the obstruction is heated to a temperature of between about 42°

C. to about 46°

C.

8. The method according to claim 1 wherein a medium is contained within the bladder, and the method further comprises pulsating the medium within the bladder to express the obstruction from the meibomian gland.

9. The method according to claim 8 wherein the pulsating comprises moving a preselected quantity of the medium into and out of the bladder.

10. The method according to claim 8 wherein the pulsating comprises applying a repetitive external force to the bladder and transmitting the force through the medium to the surface of the eyelid and into the meibomian gland.

11. The method according to claim 8 wherein the pulsating is delivered at a frequency of less than 1000 Hz.

12. The method according to claim 8 wherein the pulsating is delivered at a frequency of between about 0 Hz to about 50 Hz.

13. The method according to claim 1 wherein the softening of the obstruction and the expanding of the bladder to apply the regulated force are both carried out with a hand held apparatus.

14. The method according to claim 1, wherein the bladder directly contacts the eyelid when the bladder is expanded.

15. The method according to claim 1, wherein the bladder contacts the eyelid before the bladder is expanded.

16. The method according to claim 1, wherein the eyelid is a human eyelid.

17. The method according to claim 1, wherein the eyelid is an animal eyelid.

18. A method of treating dry eye wherein a flow of naturally occurring secretion to an eye is occluded due to a presence of an obstruction in a meibomian gland in an eyelid, wherein the meibomian gland has a meibomian gland channel and a meibomian gland orifice, the method comprising:

softening an obstruction located in the meibomian gland channel by application of thermal energy to the eyelid to heat the obstruction to a temperature of between about 37°

C. to about 47°

C.;

applying a first force to the eyelid by positioning a bladder such that the bladder contacts the eyelid when the bladder is expanded and selectably expanding the bladder; and

applying a second pulsatile force to the eyelid while continuing to apply the first force,

wherein at least one of the first force and the second pulsatile force expresses the softened obstruction from within the meibomian gland channel through the meibomian gland orifice, and

wherein the selectably expanding the bladder comprises expanding the bladder such that a force on the meibomian gland increases from a bottom of the meibomian gland channel up to a top end of the meibomian gland where the meibomian gland orifice is located and the obstruction in the meibomian gland channel is expressed from within the meibomian gland channel through the meibomian gland orifice in a milking type of action.

19. The method according to claim 18 wherein the softening the obstruction comprises conduction of thermal energy to the gland from a heated medium applied to the surface of the eyelid.

20. The method according to claim 19 wherein the heated medium is contained within the bladder and wherein the bladder is expandable to a preselected size to deliver the first force to the surface of the eyelid.

21. The method according to claim 20 wherein the second pulsatile force is delivered by the movement of the heated medium into and out of the bladder at a preselected rate.

22. The method according to claim 19 wherein the second pulsatile force is delivered at a frequency of less than 1000 Hz.

23. The method according to claim 18 wherein the first force comprises the application of the heated medium to the surface of the eyelid.

24. The method according to claim 18 wherein the first force increases to a preselected maximum.

25. The method according to claim 18 wherein the second pulsatile force is delivered at a frequency of between about 0 Hz to about 50 Hz.

26. The method according to claim 18 further including applying a chemical or pharmacological agent to the gland.

27. The method according to claim 18, wherein the bladder directly contacts the eyelid when the bladder is expanded.

28. The method according to claim 18, wherein the bladder contacts the eyelid before the bladder is expanded.

29. The method according to claim 18, wherein the eyelid is a human eyelid.

30. The method according to claim 18, wherein the eyelid is an animal eyelid.

31. A method of treating dry eye wherein a flow of naturally occurring secretion to an eye is occluded due to a presence of an obstruction in a meibomian gland in an eyelid, wherein the meibomian gland has a meibomian gland channel and a meibomian gland orifice, the method comprising:

softening an obstruction located in the meibomian gland channel by application of thermal energy to the eyelid to heat the obstruction to a temperature of between about 37°

C. to about 47°

C., the thermal energy being delivered by conduction from a heated medium contained in an expandable bladder applied to the surface of the eyelid;

applying a first force to the eyelid by positioning the bladder such that the bladder contacts the eyelid when the bladder is expanded and selectably expanding the bladder; and

applying a second pulsatile force to the eyelid by applying a pulsatile force to the bladder,

wherein at least one of the first force and the second pulsatile force expresses the softened obstruction from within the meibomian gland channel through the meibomian gland orifice, and

wherein the selectably expanding the bladder comprises expanding the bladder such that a force on the meibomian gland increases from a bottom of the meibomian gland channel up to a top end of the meibomian gland where the meibomian gland orifice is located and the obstruction in the meibomian gland channel is expressed from within the meibomian gland channel through the meibomian gland orifice in a milking type of action.

32. The method according to claim 31 wherein the pulsatile force comprises the movement of a portion of the fluid into and out of the bladder at a preselected frequency.

33. The method according to claim 31, wherein the bladder directly contacts the eyelid when the bladder is expanded.

34. The method according to claim 31, wherein the bladder contacts the eyelid before the bladder is expanded.

35. The method according to claim 31, wherein the eyelid is a human eyelid.

36. The method according to claim 31, wherein the eyelid is an animal eyelid.

37. A method of treating dry eye wherein a flow of naturally occurring secretion to an eye is occluded due to a presence of an obstruction in a meibomian gland in an eyelid, wherein the meibomian gland has a meibomian gland channel and a meibomian gland orifice, the method comprising:

softening an obstruction located in the meibomian gland channel by application of thermal energy to the eyelid to heat the obstruction to a temperature of between about 37°

C. to about 47°

C.; and

positioning a bladder such that the bladder contacts the eyelid when the bladder is expanded; and

expressing the softened obstruction from the meibomian gland channel by expanding the bladder to apply a regulated compressive force to the eyelid,

wherein the expanding the bladder expresses the softened obstruction from within the meibomian gland channel through the meibomian gland orifice using the regulated compressive force, and

wherein the expanding the bladder comprises expanding the bladder such that a force on the meibomian gland increases from a bottom of the meibomian gland channel up to a top end of the meibomian gland where the meibomian gland orifice is located and the obstruction in the meibomian gland channel is expressed from within the meibomian gland channel through the meibomian gland orifice in a milking type of action.

38. The method according to claim 37 wherein the duration of treatment is 0 to 30 minutes.

39. The method according to claim 37 wherein the duration is selectable to range between 0 to 30 minutes.

40. The method according to claim 37, wherein the bladder directly contacts the eyelid when the bladder is expanded.

41. The method according to claim 37, wherein the bladder contacts the eyelid before the bladder is expanded.

42. The method according to claim 37, wherein the eyelid is a human eyelid.

43. The method according to claim 37, wherein the eyelid is an animal eyelid.