Treatment of meibomian glands

• US 7,981,145 B2
• Filed: 09/29/2006
• Issued: 07/19/2011
• 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., Willis, Timothy R., Korb, Donald R.
• Primary Examiner(s): Gibson; Roy
• Assistant Examiner(s): SMITH, KAITLYN ELIZABETH
• Application Number:
  US11/541,418
• Publication Number:
  US 20070027431A1
• Time in Patent Office: 1,754 Days
• Field of Search: 604/289
• US Class Current: 607/96
• CPC Class Codes: A61B 17/22004 using mechanical vibrations, e.g. ultrasonic shock waves A61B17/225 takes precedence
• 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 7/02 Compresses or poultices for effecting heating or cooling
• 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

In one embodiment consistent with the present invention a method of treating mammalian meibomian glands involves clearing the glands by applying a regulated heat to an eyelid containing the meibomian glands to a temperature adequate to melt obstructions in the meibomian glands to put the obstructions in a fluid or suspension (melted) state and maintaining the heat for a time period adequate to melt the obstructions. The glands can then be mechanically treated to express fluid from the glands, wherein the treating is carried out either during the time period or after the time period but while the obstruction remains in a fluid state. Subsequent pharmacological treatment of the glands by use a pharmacological agent (topical or systemic) can then be used to assist in maintaining proper flow of lipids from the glands. This abstract is not to be considered limiting, since other embodiments may deviate from the features described in this abstract.

Claims

1. A method of treating mammalian meibomian glands having a meibomian gland channel and a meibomian gland orifice at a top of the meibomian gland channel, comprising:

applying regulated heat to an eyelid containing the meibomian glands that reaches a temperature adequate to melt obstructions within the meibomian gland channel of the meibomian glands and place the obstructions in a melted state;

maintaining the heat for a time period adequate to melt the obstructions and place the obstructions in the melted state;

mechanically treating one or more of the meibomian glands by expressing the melted obstructions located within the meibomian gland channel from within the meibomian gland channel through the meibomian gland orifice using a compressive force, wherein the mechanical treating is carried out either during the time period or after the time period but while the obstruction remains in the melted state; and

subsequently treating the meibomian glands by use of a pharmacological agent.

2. The method according to claim 1, wherein the time period comprises approximately 10 to 60 minutes.

3. The method according to claim 1, wherein the mechanical treatment is carried out using a heated instrument.

4. The method according to claim 1, wherein the temperature reaches approximately 45 degrees Celsius.

5. The method according to claim 1, wherein the temperature reaches between approximately 44 and 47 degrees Celsius.

6. The method according to claim 1, wherein the temperature is at least 37 degrees Celsius.

7. The method according to claim 1, wherein the mechanical treating is carried out within 3 minutes after the end of the time period.

8. The method according to claim 1, wherein the mechanical treatment is carried out by milkingly expressing the melted obstructions located within the meibomian gland channel from within the meibomian gland channel through the meibomian gland orifice of one or more of the meibomian glands.

9. The method according to claim 1, wherein the pharmacological agent comprises a topical pharmacological agent.

10. The method according to claim 1, wherein the pharmacological agent comprises a systemic pharmacological agent.

11. The method according to claim 1, wherein the pharmacological agent is selected from the group consisting of antibiotics, topical tetracycline, oral tetracycline, topical corticosteroids, oral corticosteroids, topical androgens, topical androgen analogues, TGF-.beta., omega 3 compounds, enzymes that promote lipid production, agents that stimulate production of enzymes that promote lipid production, agents that act as a secretagogue to enhance Meibomian gland secretion, and agents that replace or promote production of any tear component.

12. The method according to claim 11, wherein a plurality of said pharmacological agents are selected.

13. The method according to claim 1, further comprising repeating the applying and maintaining of regulated heat after a time interval to maintain flow of fluids from the meibomian glands.

14. The method according to claim 13, further comprising repeating the mechanical treating at the time interval to maintain flow of fluids from the meibomian glands.

15. The method according to claim 1, wherein the mechanical treatment is carried out by applying mechanical energy stimulation to the eyelid.

16. The method according to claim 1, wherein the mechanical treatment is carried out by squeezing the eyelid and applying constant compressive force to the eyelid.

17. A method of treating mammalian meibomian glands having a meibomian gland channel and a meibomian gland orifice at a top of the meibomian gland channel, comprising:

applying a regulated heat of at least approximately 37 degrees Celsius to an eyelid containing the meibomian glands to melt obstructions within the meibomian gland channel of the meibomian glands and place such obstructions in a melted state;

maintaining the heat for a time period adequate to melt the obstructions and place the obstructions in the melted state, and wherein the time period is between approximately 10 and 60 minutes;

mechanically treating one or more of the meibomian glands by expressing the melted obstructions located within the meibomian gland channel from within the meibomian gland channel through the meibomian gland orifice using a compressive force, wherein the mechanical treating is carried out prior to 90 seconds after expiration of the time period and while the obstruction remains in the melted state; and

subsequently pharmacologically treating the meibomian glands by use a pharmacological agent.

18. The method according to claim 17, wherein the temperature reaches approximately 44 to 47 degrees Celsius.

19. The method according to claim 17, wherein the temperature reaches approximately 45 degrees Celsius.

20. The method according to claim 17, wherein the mechanical treatment is carried out by milkingly expressing the melted obstructions located within and from within the meibomian gland channel through the meibomian gland orifice of one or more of the meibomian glands.

21. The method according to claim 17, wherein the pharmacological agent comprises a topical pharmacological agent.

22. The method according to claim 17, wherein the pharmacological agent comprises a systemic pharmacological agent.

23. The method according to claim 17, wherein the mechanical treatment is carried out using a heated instrument.

24. The method according to claim 17, wherein the pharmacological agent is selected from the group consisting of antibiotics, topical tetracycline, oral tetracycline, topical corticosteroids, oral corticosteroids, topical androgens, topical androgen analogues, TGF-.beta., omega 3 compounds, enzymes that promote lipid production, agents that stimulate production of enzymes that promote lipid production, agents that act as a secretagogue to enhance Meibomian gland secretion, and agents that replace or promote production of any tear component.

25. The method according to claim 24, wherein a plurality of said pharmacological agents are selected.

26. The method according to claim 17, wherein the mechanical treatment is carried out by applying vibratory stimulation to the eyelid.

27. The method according to claim 17, wherein the mechanical treatment is carried out by squeezing the eyelid and applying constant compressive force to the eyelid.

28. The method according to claim 17, wherein the mechanical treatment is carried out by pulsating compressive force to the eyelid.

29. A method of treating mammalian meibomian glands having a meibomian gland channel and a meibomian gland orifice at a top of the meibomian gland channel, comprising:

applying a regulated heat in the range of approximately 44 to 47 degrees Celsius to an eyelid containing the meibomian glands to melt obstructions within the meibomian gland channel of the meibomian glands and place the obstructions in a melted state;

maintaining the heat for a time period adequate to melt the obstructions and place the obstructions in the melted state, wherein the time period is between approximately 10 and 60 minutes;

mechanically treating one or more of the meibomian glands by expressing fluid or suspension of the obstructions located within the meibomian gland channel from within the meibomian gland channel through the meibomian gland orifice using a compressive force, wherein the mechanical treating is carried out either during the time period or within 90 seconds following the end of the time period while the obstruction remains in the melted state, wherein the mechanical treating is carried out using a heated instrument; and

subsequently, pharmacologically treating the meibomian glands by use a pharmacological agent.

30. The method according to claim 29, wherein the mechanical treatment is carried out by milkingly expressing the fluid or suspension located within the meibomian gland channel from the meibomian gland channel through the meibomian gland orifice of one or more of the meibomian glands.

31. The method according to claim 29, wherein the pharmacological agent comprises a topical pharmacological agent.

32. The method according to claim 29, wherein the pharmacological agent comprises a systemic pharmacological agent.

33. The method according to claim 32, wherein a plurality of said pharmacological agents are selected.

34. The method according to claim 29, wherein the pharmacological agent is selected from the group consisting of antibiotics, topical tetracycline, oral tetracycline, topical corticosteroids, oral corticosteroids, topical androgens, topical androgen analogues, TGF-.beta., omega 3 compounds, enzymes that promote lipid production, agents that stimulate production of enzymes that promote lipid production, agents that act as a secretagogue to enhance Meibomian gland secretion, and agents that replace or promote production of any tear component.

35. The method according to claim 29, further comprising repeating the applying and maintaining regulated heat after a time interval.

36. The method according to claim 35, further comprising repeating the mechanically treating at the time interval to maintain flow of fluids from the meibomian glands.

37. The method according to claim 29, wherein the mechanical treatment is carried out by applying mechanical energy stimulation to the eyelid.

38. The method according to claim 29, wherein the mechanical treatment is carried out by applying vibratory energy to the eyelid.

39. The method according to claim 29, wherein the mechanical treatment is carried out by applying constant compressive force or pulsating compressive force to the eyelid.

40. A method of treating meibomian gland dysfunction in a mammal wherein an occlusion blocks at least a portion of the flow of naturally occurring secretions out of a meibomian gland channel having a meibomian gland orifice comprising:

a) applying a regulated heat source proximate to the meibomian gland orifice for a selected time and at a selected temperature adequate to soften or liquefy at least a portion of the occlusion;

b) mechanically treating the meibomian gland channel while the at least a portion of the occlusion remains softened or liquefied such that at least a portion of the occlusion located within the meibomian gland channel is removed from within the meibomian gland channel through the meibomian gland orifice using a compressive force; and

c) subsequently treating the mammal with a pharmacological agent which promotes the free flow of lipids from the meibomian gland.

41. The method according to claim 40, wherein the selected time comprises approximately 10 to 60 minutes.

42. The method according to claim 40, wherein the selected temperature reaches between approximately 44 and 47 degrees Celsius.

43. The method according to claim 40, wherein the selected temperature is at least 37 degrees Celsius.

44. The method according to claim 40, wherein the pharmacological agent comprises a topical pharmacological agent.

45. The method according to claim 40, wherein the pharmacological agent comprises a systemic pharmacological agent.

46. A method of treating meibomian gland dysfunction in a mammal wherein an occlusion blocks at least a portion of the flow of naturally occurring secretions out of a meibomian gland channel having a meibomian gland orifice comprising:

a) applying a regulated heat source proximate to the meibomian gland orifice for a selected time and at a selected temperature adequate to loosen, breakup, fracture, soften or liquefy at least a portion of the occlusion;

b) mechanically treating the meibomian gland channel prior to reversal of the effects of the application of the regulated heat source such that at least a portion of the occlusion located within the meibomian gland channel is removed from within the meibomian gland channel through the meibomian gland orifice using a compressive force; and

c) subsequently treating the mammal with a pharmacological agent which promotes the free flow of lipids from the meibomian gland.

47. The method according to claim 46, wherein the time period comprises approximately 10 to 60 minutes.

48. The method according to claim 46, wherein the temperature reaches between approximately 44 and 47 degrees Celsius.

49. The method according to claim 46, wherein the pharmacological agent comprises a topical pharmacological agent.

50. The method according to claim 46, wherein the pharmacological agent comprises a systemic pharmacological agent.