Method and apparatus for treating gland dysfunction employing heated medium

• US 9,060,843 B2
• Filed: 10/31/2007
• Issued: 06/23/2015
• 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:
  US11/931,398
• Publication Number:
  US 20080109052A1
• Time in Patent Office: 2,792 Days
• Field of Search: 607/96, 128/898
• US Class Current: 1/1
• 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 the presence of an obstruction in a meibomian gland channel of a meibomian gland in an eyelid, and comprising the steps of:

softening the obstruction in the meibomian gland channel of the meibomian gland; and

applying a regulated directional 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 to express the obstruction from the meibomian gland channel of the meibomian gland through an orifice of the meibomian gland located at the top of the meibomian gland channel.

2. The method according to claim 1 wherein the step of 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 thermal energy applied is selected from the group of modalities consisting of conduction, convection and radiation.

4. The method according to claim 2 wherein the step of softening further includes the step of applying a heated contained medium to the surface of the eyelid and heating the medium so that 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 comprised of either a fluid or a gas.

6. The method according to claim 5 wherein the obstruction is heated to a temperature of between about 42°

C. to about 46°

C.

7. The method according to claim 5 wherein the step of pulsating comprises the application of a repetitive external force to the container and transmitting the force through the medium to the surface of the eyelid and into the meibomian gland.

8. The method according to claim 4 wherein the heated contained medium is contained within a bladder positioned proximate the eyelid and further including the step of pulsating the contained medium to express the obstruction from the meibomian gland.

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

10. The method according to claim 8 wherein the step of pulsating is delivered at a frequency of either less than 1000 Hz or between about 0 Hz to about 50 Hz.

11. The method according to claim 1 wherein the softening of the obstruction and the regulated directional force applied to the meibomian gland are both applied with a hand held apparatus.

12. The method of claim 1, wherein the regulated directional force is a milking type force.

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

softening the obstruction in the meibomian gland channel of the meibomian gland 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, wherein the first force comprises a regulated directional force applied to the meibomian gland channel in a direction from a bottom of the meibomian gland channel to a top of the meibomian gland channel;

applying a second pulsatile force to the eyelid while continuing to apply the first force to express the obstruction from the meibomian gland channel of the meibomian gland through an orifice of the meibomian gland located at the top of the meibomian gland channel.

14. The method according to claim 13 wherein the step of softening the obstruction comprises conduction of thermal energy to the gland from a heated medium applied to the surface of the eyelid.

15. The method according to claim 13 wherein the first force comprises the application of the heated medium to the surface of the eyelid.

16. The method according to claim 15 wherein the heated medium is contained within a bladder positioned proximate the surface of the eyelid and wherein the bladder is expandable to a preselected size to deliver the first force to the surface of the eyelid.

17. The method according to claim 16 wherein the first force is constantly applied and increases to a preselected maximum.

18. The method according to claim 16 wherein the second pulsatile force is delivered by the movement of the medium into and out of the bladder at a preselected rate.

19. The method according to claim 13 wherein the second pulsatile force is delivered at a frequency of either less than 1000 Hz or between about 0 Hz to about 50 Hz.

20. The method according to claim 13 further including the step of applying a chemical or pharmacological agent to the gland.

21. The method of claim 13, wherein the regulated directional force is a milking type force.

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

softening the obstruction in the meibomian gland channel of the meibomian gland 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 proximate the eyelid and selectably expanding the bladder, wherein the first force comprises a regulated directional force applied to the meibomian gland channel in a direction from a bottom of the meibomian gland channel to a top of the meibomian gland channel;

applying a second pulsatile force to the eyelid by applying a pulsatile force to the bladder to express the obstruction from the meibomian gland channel of the meibomian gland through an orifice of the meibomian gland located at the top of the meibomian gland channel.

23. The method according to claim 22 wherein the pulsatile force comprises the movement of a portion of the fluid into and out of the bladder at a preselected frequency.

24. The method of claim 22, wherein the regulated directional force is a milking type force.

25. An apparatus for treating dry eye wherein the flow of naturally occurring secretion to an eye is occluded due to the presence of an obstruction in a meibomian gland channel of a meibomian gland in an eyelid, and comprising:

heating means for softening the obstruction in the meibomian gland channel of the meibomian gland 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;

means for delivering a first force to the eyelid by positioning the bladder proximate the eyelid and selectably expanding the bladder, wherein the first force comprises a regulated directional force applied to the meibomian gland channel in a direction from a bottom of the meibomian gland channel to a top of the meibomian gland channel;

means for applying a second pulsatile force to the eyelid by applying a pulsatile force to the bladder to express the obstruction from the meibomian gland channel of the meibomian gland through an orifice of the meibomian gland located at the top of the meibomian gland channel in connection with the second pulsatile force.

26. The system of claim 25, wherein the regulated directional force is a milking type force.

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

softening the obstruction in the meibomian gland channel of the meibomian gland 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 regulated directional 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 to express the obstruction from the meibomian gland channel of the meibomian gland through an orifice of the meibomian gland located at the top of the meibomian gland channel.

28. The method according to claim 27 wherein the duration of treatment is 0 to 30 minutes.

29. The method according to claim 27 wherein the duration is selectable to range between 0 to 30 minutes.

30. The method of claim 27, wherein the regulated directional force is a milking type force.