METHODS AND SYSTEMS FOR TREATING MEIBOMIAN GLAND DYSFUNCTION USING RADIO-FREQUENCY ENERGY

• US 20130053733A1
• Filed: 08/21/2012
• Published: 02/28/2013
• 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., Grenon, Stephen M., Willis, Timothy R., Gravely, Benjamin Tyson, Bacich, Steven
• Granted Patent: US 9,719,977 B2
• Time in Patent Office: Days
• US Class Current: 601/2
• 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: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/0271 Thermal or temperature sensors
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• 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 9/007 Methods or devices for eye surgery
• CPC Class Codes: A61F 9/00718 Restoration of lid function
• CPC Class Codes: A61H 2015/0014 cylinder-like, i.e. rollers
• CPC Class Codes: A61H 2201/0176 By stopping operation
• CPC Class Codes: A61H 2201/0207 heated
• CPC Class Codes: A61H 2201/0214 cooled
• CPC Class Codes: A61H 2201/5038 freely programmable by the user
• CPC Class Codes: A61H 2201/5043 Displays
• CPC Class Codes: A61H 2205/024 Eyes
• CPC Class Codes: A61H 23/0236 using sonic waves, e.g. using loudspeakers
• CPC Class Codes: A61H 23/0245 with ultrasonic transducers, e.g. piezoelectric
• CPC Class Codes: A61H 23/0263 using rotating unbalanced masses
• CPC Class Codes: A61H 39/086 : Acupuncture needles
• CPC Class Codes: A61H 7/003 : Hand-held or hand-driven devices
• CPC Class Codes: A61H 7/005 : hand-held
• CPC Class Codes: A61H 9/0057 : Suction suction kneading A61H7/008
• CPC Class Codes: A61H 9/0071 : by localized pressure, e.g. air streams or jets
• CPC Class Codes: A61H 9/0078 : with intermittent or alternately inflated bladders or cuffs mattresses for preventing bed-sores with alternated pressurized chambers A61G7/05776
• CPC Class Codes: A61N 1/403 : for thermotherapy, e.g. hyperthermia
• 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
• CPC Class Codes: G01N 33/227 : Explosives, e.g. combustive properties thereof detecting explosives in air G01N33/0057
• CPC Class Codes: Y10T 436/170769 : N-Nitroso containing [e.g., nitrosamine, etc.]
• CPC Class Codes: Y10T 436/173076 : Nitrite or nitrate
• CPC Class Codes: Y10T 436/173845 : Amine and quaternary ammonium
• CPC Class Codes: Y10T 436/178459 : Only nitrogen dioxide
• CPC Class Codes: Y10T 436/19 : Halogen containing
• CPC Class Codes: Y10T 436/206664 : Ozone or peroxide

Abstract

A method of treating meibomian gland dysfunction is disclosed. The method includes directing RF energy to an internal portion of a meibomian gland, selectively targeting an obstruction within a duct of the meibomian gland with the applied RF energy to melt, loosen, or soften the obstruction, and expressing the obstruction from the duct of the meibomian gland. An apparatus for treating meibomian gland dysfunction is also disclosed. The apparatus comprises at least one RF electrode configured to direct RF energy to an internal portion of a meibomian gland located in an eyelid of an eye, the at least one RF electrode further configured to selectively target an obstruction within a duct of the meibomian gland with the applied RF energy to melt, loosen, or soften the obstruction. The apparatus also comprises at least one expressor configured to express the obstruction from the duct of the meibomian gland.

Claims

1. A method of treating meibomian gland dysfunction, comprising the steps of:

directing RF energy to an internal portion of a meibomian gland;

selectively targeting an obstruction within a duct of the meibomian gland with the applied RF energy to melt, loosen, or soften the obstruction; and

expressing the obstruction from the duct of the meibomian gland.

2. The method of claim 1 further comprising directing the RF energy until an increase in thermal energy occurs at the obstruction in the duct.

3. The method of claim 1, wherein the selectively targeting further comprises directing RF energy waveforms such the RF energy waveforms are absorbed preferentially by energy absorbing cellular fluids, saline or lipid containing materials found in the duct of the meibomian gland.

4. The method of claim 1, wherein the selectively targeting further comprises directing RF energy at a predetermined depth in the meibomian gland.

5. The method of claim 1, wherein the applied RF energy causes contents within the duct of the meibomian gland to be heated to between 37 and 45 degrees Celsius.

6. The method of claim 1 further comprising controlling the amount of RF energy applied to an internal portion of a meibomian gland.

7. The method of claim 6, wherein the controlling further comprises directing an amount of RF energy sufficient to selectively heat contents within the duct of the meibomian gland to a known temperature.

8. The method of claim 6, wherein the controlling further comprises directing an amount of RF energy sufficient to selectively heat lipid containing materials in the meibomian gland.

9. The method of claim 1 further comprising adjusting a power and/or a duration of the RF energy.

10. The method of claim 1 further comprising adjusting a shape of a waveform of the RF energy.

11. The method of claim 1 further comprising providing pulsed waveforms of RF energy.

12. The method of claim 1 further adjusting a shape of an RF electrode that applies the RF energy.

13. The method of claim 1 further comprising monitoring a temperature at a surface of the eyelid.

14. The method of claim 1 further comprising controlling delivery of the RF energy to the meibomian gland through impedance monitoring.

15. The method of claim 1 further comprising sensing a presence of fluid being expressed from the gland.

16. The method of claim 15 further comprising reducing the application of RF energy based on the sensing the presence of fluid being expressed from the gland.

17. The method of claim 15 further comprising reducing the power of the applied RF energy based on the sensing the presence of fluid being expressed from the gland.

18. The method of claim 15 further comprising stopping the application of RF energy when the sensing the presence of fluid being expressed from the gland is indicative of no additional fluid being collected.

225. The method of claim 1, wherein the RF energy comprises energy having different frequencies.

19. An apparatus for treating meibomian gland dysfunction, comprising:

at least one RF electrode configured to direct RF energy to an internal portion of a meibomian gland located in an eyelid of an eye, the at least one RF electrode further configured to selectively target an obstruction within a duct of the meibomian gland with the applied RF energy to melt, loosen, or soften the obstruction; and

at least one expressor configured to express the obstruction from the duct of the meibomian gland.

20. The apparatus of claim 19 further comprising an eyecup configured to prevent RF energy from being delivered to sensitive structures of an eye.

21. The apparatus of claim 20, wherein the eyecup further comprises an inner sandwich.

22. The apparatus of claim 20, wherein the eyecup further comprises a conductive plate on the eyecup.

23. The apparatus of claim 20, wherein at least a portion of the eyecup is used as a backplate for expression of the obstruction.

24. The apparatus of claim 19 further comprising an aspiration means.

25. The apparatus of claim 19 further comprising at least one gutter structure disposed on the eyecup.

26. The apparatus of claim 19 further comprising an insulator.

27. The apparatus of claim 19 further comprising a cooling mechnism.

28. The apparatus of claim 19 further comprising a spacer configured to keep the at least one RF electrode from touching an eyelid.

29. The apparatus of claim 19, wherein the RF electrode is used as a backplate for expression of the obstruction.

30. The apparatus of claim 25, wherein the RF electrode is adjustable to express the obstruction.

31. The apparatus of claim 19, wherein the at least one expressor comprises a roller.

32. The apparatus of claim 19 further comprising an aspiration means on the inner eyelid surface help express the obstruction from the duct of the meibomian gland.

33. The apparatus of claim 19 further comprising a means for directing vibrational or ultrasonic energy to loosen the obstruction from the duct of the meibomian gland.

34. The apparatus of claim 19 further comprising fluid sensors configured to react to the presence of fluid being expressed from the gland.

35. The apparatus of claim 24 further comprising a conduit operably connected to the aspiration means that is configured withdraw expressed material from the glands.

36. The apparatus of claim 24 further comprising a mesh screen positioned at the meibomian gland orifices through which the aspiration means extracts the obstructions from within the duct of the meibomian gland.

37. The apparatus of claim 25, wherein the gutter structures focus a vacuum or aspiration force provided by an aspiration means.

38. The apparatus of claim 25, wherein the gutter structures are further configured to facilitate drug delivery.

39. The apparatus of claim 25, wherein the gutter structures are further configured to protrude meibomian gland orifices gland openings toward comprising a mesh screen positioned at the meibomian gland orifices through which the aspiration means extracts the obstructions from within the duct of the meibomian gland.

40. The apparatus of claim 35, wherein the conduit is further configured to deliver fluid intermittently to the eyelid to help improve the transport of the expressed obstructions.

41. The apparatus of claim 35, wherein the conduit is further configured to administer a topical agents and/or drugs to the meibomian glands.

226. The apparatus of claim 19, wherein the RF energy comprises energy having different frequencies.

42-224. -224. (canceled)