Apparatuses for treatment of meibomian glands

• US 9,216,028 B2
• Filed: 07/15/2011
• Issued: 12/22/2015
• 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., Grenon, Stephen M.
• Primary Examiner(s): Smith, Kaitlyn
• Application Number:
  US13/183,901
• Publication Number:
  US 20120016450A1
• Time in Patent Office: 1,621 Days
• Field of Search: 607/96
• US Class Current: 1/1
• 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, an apparatus for treating mammalian meibomian glands involves clearing the meibomian glands. The apparatus comprises a heater configured to apply 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 a controller maintaining the heat for a time period adequate to melt the obstructions. The glands can then be mechanically treated by a mechanical treatment applicator to express fluid from the glands by using a compressive force, 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. An apparatus treating mammalian meibomian glands wherein the flow of naturally occurring secretion from a meibomian gland is occluded due to the presence of an obstruction within a meibomian gland channel of the meibomian gland, comprising:

a heater configured to apply regulated heat to an eyelid containing the meibomian glands to reach a temperature adequate to melt obstructions within the meibomian gland channel of the meibomian glands and place the obstructions in a melted state;

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

a mechanical treatment applicator configured to mechanically treat one or more of the meibomian glands, wherein the mechanical treatment applicator is configured to contact the eyelid and to apply a directional compressive 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 while the obstruction remains in the melted state, wherein the directional compressive force expresses the melted obstructions located within the meibomian gland channel from within the meibomian gland channel through a meibomian gland orifice.

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

3. The apparatus according to claim 1, wherein the mechanical treatment applicator is at least partially heated.

4. The apparatus according to claim 1, wherein the heater is configured to apply the regulated heat until the temperature reaches approximately 45 degrees Celsius.

5. The apparatus according to claim 1, wherein the heater is configured to apply the regulated heat until the temperature reaches between approximately 44 and 47 degrees Celsius.

6. The apparatus according to claim 1, wherein the heater is configured to apply the regulated heat until the temperature is at least 37 degrees Celsius.

7. The apparatus according to claim 1, wherein the mechanical treatment applicator is further configured to carry out the mechanical treatment within 3 minutes after the end of the time period.

8. The apparatus according to claim 1, wherein the mechanical treatment applicator is configured to milkingly express 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 apparatus according to claim 1, wherein at least one of the heater and the controller is further configured to repeat the applying and maintaining of regulated heat after a time interval to maintain flow of fluids from the meibomian glands.

10. The apparatus according to claim 9, wherein the mechanical treatment applicator is further configured to repeat the mechanical treating at the time interval to maintain flow of fluids from the meibomian glands.

11. The apparatus according to claim 1, wherein the mechanical treatment applicator is further configured to carry out the mechanical treatment by applying mechanical energy stimulation to the eyelid.

12. The apparatus according to claim 11, wherein the mechanical treatment applicator is further configured to carry out the mechanical treatment by applying vibratory stimulation to the eyelid.

13. The apparatus according to claim 1, wherein the directional compressive force applied by the mechanical treatment applicator is constant.

14. The apparatus according to claim 1, wherein the mechanical treatment applicator is further configured to carry out the mechanical treatment by applying a pulsatile force to the eyelid.

15. The apparatus according to claim 1, wherein at least one of the heater and controller is configured to remove the applying of the regulated heat from the eyelid to allow the mechanical treatment applicator to mechanically treat the meibomian glands.

16. The apparatus according to claim 1, wherein the heater is configured to apply the regulated heat to the meibomian gland channel of one or more of the meibomian glands during the mechanical treating of the one or more of the meibomian glands.

17. The apparatus according to claim 1, wherein the heater further comprises a heating element.

18. The apparatus according to claim 17, wherein the heater further comprises a thermal heat sink coupled to the heating element in order to transfer heat from the heating element to the eyelid.

19. The apparatus according to claim 17, wherein the heater further comprises an insulator coupled to the heating element in order to reduce heat loss.

20. The apparatus according to claim 19, wherein the heater further comprises a back plate that couples to the insulator.

21. The apparatus of claim 1, wherein the mechanical treatment applicator is configured to apply the compressive force after the time period but while the obstruction remains in the melted state.

22. An apparatus treating mammalian meibomian glands wherein the flow of naturally occurring secretion from a meibomian gland is occluded due to the presence of an obstruction within a meibomian gland channel of the meibomian gland, comprising:

a heater configured to apply 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;

a controller configured to maintain 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; and

a mechanical treatment applicator configured to mechanically treat one or more of the meibomian glands, wherein the mechanical treatment applicator is configured to contact the eyelid and to apply a directional compressive 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 while the obstruction remains in the melted state, wherein the directional compressive force expresses the melted obstructions located within the meibomian gland channel from within the meibomian gland channel through a meibomian gland orifice.

23. The apparatus according to claim 22, wherein the heater is configured to apply the regulated heat until the temperature reaches approximately 44 to 47 degrees Celsius.

24. The apparatus according to claim 22, wherein the heater is configured to apply the regulated heat until the temperature reaches approximately 45 degrees Celsius.

25. The apparatus according to claim 22, wherein the mechanical treatment applicator is configured to milkingly express 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.

26. The apparatus according to claim 22, wherein the mechanical treatment applicator is at least partially heated.

27. The apparatus according to claim 22, wherein the mechanical treatment applicator is further configured to carry out the mechanical treatment by applying mechanical energy stimulation to the eyelid.

28. The apparatus according to claim 22, wherein the directional compressive force applied by the mechanical treatment applicator is constant.

29. The apparatus according to claim 22, wherein the mechanical treatment applicator is further configured to carry out the mechanical treatment by applying vibratory stimulation to the eyelid.

30. The apparatus according to claim 22, wherein the mechanical treatment applicator is further configured to carry out the mechanical treatment by applying a pulsatile force to the eyelid.

31. The apparatus according to claim 22, wherein at least one of the heater and controller is configured to remove the applying of the regulated heat from the eyelid to allow the mechanical treatment applicator to mechanically treat the meibomian glands.

32. The apparatus according to claim 31, wherein the selected time comprises approximately 10 to 60 minutes.

33. The apparatus according to claim 31, further comprising a controller for controlling the regulated heat source such that the selected temperature reaches between approximately 44 and 47 degrees Celsius.

34. The apparatus according to claim 22, wherein the heater is configured to apply the regulated heat to the meibomian gland channel of one or more of the meibomian glands during the mechanical treating of the one or more of the meibomian glands.

35. The apparatus according to claim 22, wherein the heater further comprises a heating element.

36. The apparatus according to claim 35, wherein the heater further comprises a thermal heat sink coupled to the heating element in order to transfer heat from the heating element to the eyelid.

37. The apparatus according to claim 35, wherein the heater further comprises an insulator coupled to the heating element in order to reduce heat loss.

38. The apparatus according to claim 37, wherein the heater further comprises a back plate that couples to the insulator.

39. The apparatus of claim 22, wherein the mechanical treating is carried out prior to ninety (90) seconds after expiration of the time period and while the obstruction remains in the melted state.

40. An apparatus treating mammalian meibomian glands wherein the flow of naturally occurring secretion from a meibomian gland is occluded due to the presence of an obstruction within a meibomian gland channel of the meibomian gland, comprising:

a heater configured to apply 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;

a controller configured to maintain 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; and

a mechanical treatment applicator configured to mechanically treat one or more of the meibomian glands, wherein the mechanical treatment applicator is configured to contact the eyelid and to apply a directional compressive 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 while the obstruction remains in the melted state, wherein the directional compressive force expresses fluid or suspension of the obstructions located within the meibomian gland channel from within the meibomian gland channel through a meibomian gland, and wherein the mechanical treatment applicator is at least partially heated during the mechanical treatment.

41. The apparatus according to claim 40, wherein the mechanical treatment applicator is configured to milkingly express 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.

42. The apparatus according to claim 40, wherein at least one of the heater and the controller is further configured to repeat the applying and maintaining regulated heat after a time interval.

43. The apparatus according to claim 42, wherein the mechanical treatment applicator is further configured to repeat the mechanically treating at the time interval to maintain flow of fluids from the meibomian glands.

44. The apparatus according to claim 40, wherein the mechanical treatment applicator is further configured to carry out the mechanical treatment by applying mechanical energy stimulation to the eyelid.

45. The apparatus according to claim 40, wherein the directional compressive force applied by the mechanical treatment applicator is constant.

46. The apparatus according to claim 40, wherein the mechanical treatment applicator is further configured to carry out the mechanical treatment by applying vibratory stimulation to the eyelid.

47. The apparatus according to claim 40, wherein the mechanical treatment applicator is further configured to carry out the mechanical treatment by applying a pulsatile force to the eyelid.

48. The apparatus according to claim 40, wherein at least one of the heater and controller is configured to remove the applying of the regulated heat from the eyelid to allow the mechanical treatment applicator to mechanically treat the meibomian glands.

49. The apparatus according to claim 40, wherein the heater is configured to apply the regulated heat to the meibomian gland channel of one or more of the meibomian glands during the mechanical treating of the one or more of the meibomian glands.

50. The apparatus according to claim 40, wherein the heater further comprises a heating element.

51. The apparatus according to claim 50, wherein the heater further comprises a thermal heat sink coupled to the heating element in order to transfer heat from the heating element to the eyelid.

52. The apparatus according to claim 50, wherein the heater further comprises an insulator coupled to the heating element in order to reduce heat loss.

53. The apparatus according to claim 52, wherein the heater further comprises a back plate that couples to the insulator.

54. The apparatus of claim 40, wherein the mechanical treating is carried out within ninety (90) seconds following the end of the time period and while the obstruction remains in the melted state.

55. An apparatus 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 regulated heat source configured to apply a regulated heat from the 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; and

a mechanical treatment applicator configured to mechanically treat the meibomian gland channel using a directional compressive force while the at least a portion of the occlusion remains softened or liquefied, wherein the mechanical treatment applicator is configured to contact the eyelid and to apply the directional compressive 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, wherein the directional compressive force removes at least a portion of the occlusion located within the meibomian gland channel from within the meibomian gland channel through the meibomian gland orifice.

56. The apparatus according to claim 55, wherein the selected time comprises approximately 10 to 60 minutes.

57. The apparatus according to claim 55, further comprising a controller for controlling the regulated heat source such that the selected temperature reaches between approximately 44 and 47 degrees Celsius.

58. The apparatus according to claim 55, further comprising a controller for controlling the regulated heat source such that the selected temperature is at least 37 degrees Celsius.

59. The apparatus according to claim 55, wherein the mechanical treatment applicator is further configured to carry out the mechanical treatment by applying mechanical energy stimulation to the eyelid.

60. The apparatus according to claim 55, wherein the directional compressive force applied by the mechanical treatment applicator is constant.

61. The apparatus according to claim 55, wherein the mechanical treatment applicator is further configured to carry out the mechanical treatment by applying vibratory stimulation to the eyelid.

62. The apparatus according to claim 55, wherein the mechanical treatment applicator is further configured to carry out the mechanical treatment by applying a pulsatile force to the eyelid.

63. The apparatus according to claim 55, wherein at least one of the heater and controller is configured to remove the applying of the regulated heat from the eyelid to allow the mechanical treatment applicator to mechanically treat the meibomian glands.

64. The apparatus according to claim 55, wherein the heater is configured to apply the regulated heat to the meibomian gland channel of one or more of the meibomian glands during the mechanical treating of the one or more of the meibomian glands.

65. The apparatus according to claim 55, wherein the heater further comprises a heating element.

66. The apparatus according to claim 65, wherein the heater further comprises a thermal heat sink coupled to the heating element in order to transfer heat from the heating element to the eyelid.

67. The apparatus according to claim 65, wherein the heater further comprises an insulator coupled to the heating element in order to reduce heat loss.

68. The apparatus according to claim 67, wherein the heater further comprises a back plate that couples to the insulator.

69. An apparatus 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 regulated heat source configured to be placed 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; and

a mechanical treatment applicator configured to mechanically treat the meibomian gland channel prior to reversal of the effects of the application of the regulated heat source, wherein the mechanical treatment applicator is configured to contact an eyelid and to apply a directional compressive 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, wherein the directional compressive force removes at least a portion of the occlusion located within the meibomian gland channel from within the meibomian gland channel through the meibomian gland orifice.