METHOD AND APPARATUS FOR TREATING GLAND DYSFUNCTION

• US 20110137214A1
• Filed: 02/11/2011
• Published: 06/09/2011
• Est. Priority Date: 07/18/2005
• Status: Active Grant

• Current Assignee: TearScience Inc. (Johnson & Johnson)
• Original Assignee: TearScience Inc. (Johnson & Johnson)
• Inventors: Gravely, Benjamin T., Grenon, Stephen M., Willis, Timothy R., Korb, Donald R.
• Granted Patent: US 8,187,310 B2
• Time in Patent Office: Days
• US Class Current: 601/3
• 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 meibomian gland dysfunction in humans 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:

softening the obstruction within the meibomian gland channel of a meibomian gland through an application of thermal energy to the obstruction; and

extracting the obstruction from within the meibomian gland channel and through a meibomian gland orifice of the meibomian gland through the application of a regulated force to the meibomian gland channel.

2. The method of claim 1, further comprising applying the regulated 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.

3. The method of claim 1, further comprising applying the regulated force to a surface of an eyelid to transmit the regulated force through tissue of the eyelid to the meibomian gland channel.

4. The method of claim 3, wherein the regulated force compresses the eyelid to express the obstruction from within the meibomian gland channel.

5. The method of claim 1, further comprising applying the regulated force to an outer surface of the eyelid to transmit the regulated force through tissue of the eyelid to the meibomian gland channel.

6. The method of claim 1, wherein the regulated force is comprised of a fluid jet.

7. The method of claim 1, wherein the regulated force is comprised of microwave energy.

8. The method of claim 1, wherein the regulated force is comprised of laser energy.

9. The method of claim 1, wherein the regulated force is comprised of radio-frequency (RF) energy.

10. The method of claim 1, wherein the regulated force is comprised of aspiration.

11. The method of claim 1, wherein the regulated force is comprised of a vacuum.

12. The method of claim 1, wherein the regulated force is comprised of piezoelectric.

13. The method of claim 1, wherein the regulated force is comprised of a compression force.

14. The method of claim 1, wherein the regulated force is comprised of applying needles.

15. The method of claim 1 wherein the regulated force comprises an electro-mechanical force applied to the meibomian gland channel.

16. The method of claim 15 wherein the electro-mechanical force is comprised of a pulsatile force.

17. The method of claim 1, wherein the regulated force is comprised of a constant force.

18. The method of claim 1, wherein the regulated force is comprised of a milking type regulated force.

19. The method of claim 1, wherein the regulated force is comprised of an increasing regulated force to a preselected maximum force level.

20. The method of claim 1, wherein the regulated force is comprised of a pulsatile force.

21. The method of claim 20, wherein the pulsatile force is applied at a preselected frequency.

22. The method of claim 21, wherein the preselected frequency is less than 1000 Hz.

23. The method of claim 22, wherein the preselected frequency is between about 50 Hz and about 500 Hz.

24. The method of claim 22, wherein the pulsatile force is delivered at a frequency of between about 60 Hz and about 300 Hz.

25. The method of claim 20, wherein the pulsatile force has an amplitude of between 0.1 mm and 5.0 mm.

26. The method of claim 20, wherein the pulsatile force has an amplitude of between about 0.5 mm and 1.5 mm.

27. The method of claim 20, wherein the pulsatile force has an amplitude of approximately 1.00 mm.

28. The method of claim 1, further comprising applying a second force to the meibomian gland channel to extract the obstruction from within the meibomian gland channel and through the meibomian gland orifice.

29. The method of claim 28, wherein the second force is comprised of a constant force.

30. The method of claim 28, wherein the second force is comprised of a milking type regulated force.

31. The method of claim 28, wherein the second force is comprised of an increasing regulated force to a preselected maximum force level.

32. The method of claim 28, wherein the second force is comprised of a pulsatile force.

33. The method of claim 28, wherein the regulated force is comprised of a constant force, and the second force is comprised of a milking type regulated force.

34. The method of claim 28, wherein the regulated force is comprised of an increasing regulated force to a preselected maximum force level, and the second force is comprised of a milking type regulated force.

35. The method of claim 28, wherein the regulated force is comprised of a pulsatile force, and the second force is comprised of a milking type regulated force.

36. The method of claim 28, wherein the regulated force is comprised of a constant force, and the second force is comprised of an increasing regulated force to a preselected maximum force level.

37. The method of claim 28, wherein the regulated force is comprised of a constant force, and the second force is comprised a pulsatile force.

38. The method of claim 1, further comprising applying the regulated force with a vibrating tip.

39. The method of claim 38, wherein the vibrating tip is heated to transmit thermal energy to the obstruction.

40. The method of claim 39, further comprising determining a temperature proximate an eyelid containing the meibomian gland during the application of the thermal energy and wherein the vibrating tip is maintained at a temperature sufficient to heat the obstruction to between about 37°

C. to about 55°

C.

41. The method of claim 40, wherein the regulated force comprises a pressure of the vibrating tip on an eyelid and a second force comprised of amplitudinal energy transferred by vibrations of the vibrating tip.

42. The method of claim 1, wherein the application of thermal energy is comprised of a regulated heat.

43. The method of claim 42, wherein the regulated heat is maintained by a temperature measurement and control feedback loop.

44. The method of claim 42, further comprising determining a temperature proximate an eyelid containing the meibomian gland during the softening of the obstruction with regulated heat, wherein the regulated heat heats the obstruction to between about 37°

C. to about 47°

C.

45. The method of claim 1, wherein the thermal energy applied is comprised of conduction heating.

46. The method of claim 1, wherein the thermal energy applied is comprised of convection heating.

47. The method of claim 1, wherein the thermal energy applied is comprised of radiation heating.

48. The method of claim 1, wherein the thermal energy applied is comprised of electrical heating.

49. The method of claim 48, wherein the electrical heating is applied by a solid state heating element.

50. The method of claim 1, wherein the thermal energy applied is comprised of laser heating.

51. The method of claim 1, wherein the thermal energy applied is comprised of hot water conductive heating.

52. The method of claim 1, wherein the thermal energy applied is comprised of infrared heating.

53. The method of claim 1, wherein the thermal energy applied is comprised of ultrasonic heating.

54. The method of claim 1, wherein the thermal energy is comprised of radio-frequency (RF) heating.

55. The method of claim 1, wherein softening the obstruction comprises softening the obstruction from a meibomian gland wall within the meibomian gland channel through the application of thermal energy to the obstruction.

56. The method of claim 1, wherein softening the obstruction comprises loosening the obstruction.

57. The method of claim 1, wherein softening the obstruction comprises liquefying the obstruction.

58. The method of claim 1, wherein softening the obstruction comprises partially liquefying the obstruction.

59. The method of claim 1, further comprising determining a temperature proximate an eyelid containing the meibomian gland during the application of thermal energy and wherein applying the thermal energy heats the obstruction to between about 37°

C. to about 50°

C.

60. The method of claim 1, further comprising determining a temperature proximate an eyelid containing the meibomian gland during the application of thermal energy and wherein applying the thermal energy heats the obstruction to between about 42°

C. to about 46°

C.

61. The method of claim 1, wherein softening the obstruction further comprises applying thermal energy to the obstruction for no more than approximately five (5) minutes.

62. The method of claim 1, wherein softening the obstruction further comprises applying thermal energy to the obstruction for between approximately one (1) and approximately two (2) minutes.

63. The method of claim 1, further comprising applying an aspiration force proximate the meibomian gland orifice to further assist in extracting the obstruction from the meibomian gland channel.

64. The method of claim 1, further comprising applying an aspiration force proximate the meibomian gland orifice to collect the obstruction expressed from the meibomian gland channel.