Methods and apparatuses for treating gland dysfunction
10905898 ยท 2021-02-02
Assignee
Inventors
- Stephen M. Grenon (Durham, NC, US)
- Donald R. Korb (Boston, MA, US)
- Timothy R. Willis (Raleigh, NC, US)
- Benjamin T. Gravely (Raleigh, NC, US)
Cpc classification
A61B18/12
HUMAN NECESSITIES
A61N2005/0643
HUMAN NECESSITIES
A61H7/00
HUMAN NECESSITIES
A61F2007/0004
HUMAN NECESSITIES
International classification
A61H7/00
HUMAN NECESSITIES
Abstract
A method of treating dry eye includes delivering light energy from outside an eyelid toward the eyelid, and maintaining the delivery of the light energy toward the eyelid for a period of time to soften an obstruction of at least one meibomian gland. The light energy may be delivered specifically to the obstruction in the at least one meibomian gland without physically contacting the at least one meibomian gland, or the light energy delivered toward the eyelid may conductively apply heat to the meibomian gland to melt the obstruction. A corresponding apparatus includes a light energy source positionable outside an eyelid and configured to deliver the light energy from outside an eyelid toward the eyelid, and a controller configured to control the light energy source to maintain the delivery of the light energy toward the eyelid for a period of time to soften the obstruction.
Claims
1. A method of treating dry eye, comprising the steps of: delivering light energy from outside an eyelid of a patient toward the eyelid, wherein the step of delivering the light energy comprises delivering the light energy such that an obstruction located in at least one meibomian gland located in the eyelid is heated; maintaining the delivery of the light energy toward the eyelid for a period of time to soften the obstruction located in the at least one meibomian gland located in the eyelid; and positioning a back plate behind the eyelid; mechanically actuating a force applicator of a device to move toward the back plate such that the eyelid is squeezed between the force applicator and the back plate and a force is applied to the eyelid to express the softened obstruction from the at least one meibomian gland.
2. The method of claim 1, wherein the step of mechanically actuating the force applicator comprises actuating a lever coupled to the force applicator to cause the force applicator to move toward the back plate such that the eyelid is squeezed between the force applicator and the back plate.
3. The method of claim 1, wherein the step of delivering the light energy comprises delivering the light energy specifically to the obstruction in the at least one meibomian gland without physically contacting the at least one meibomian gland during the delivering of the light energy.
4. The method of claim 1, wherein the obstruction is located within a meibomian gland channel of the at least one meibomian gland.
5. The method of claim 1, wherein the mechanically actuating the force applicator comprises applying a regulated directional force to express the obstruction from the at least one meibomian gland.
6. The method of claim 1, wherein the step of mechanically actuating the force applicator comprises applying a force to express the obstruction from within a meibomian gland channel of the at least one meibomian gland through an orifice of the at least one meibomian gland located at a top of the meibomian gland channel.
7. The method of claim 1, wherein the step of mechanically actuating the force applicator comprises applying a directional force to a meibomian gland in a direction from a bottom of the meibomian gland to a top of the meibomian gland.
8. The method of claim 1, wherein the step of mechanically actuating the force applicator comprises applying a milking type force.
9. The method of claim 1, wherein the delivering of the light energy is maintained for a period of time sufficient to heat the obstruction to a temperature of between about 37 C. to about 47 C.
10. The method of claim 1, wherein the delivering of the light energy is maintained for a period of time sufficient to heat the obstruction to a temperature of between about 42 C. to about 46 C.
11. The method of claim 1, wherein the delivering of the light energy toward the eyelid applies heat to the obstruction according to one or more of conduction, convection, and radiation.
12. The method of claim 1, wherein the delivering of the light energy toward the eyelid applies heat to the at least one meibomian gland sufficient to melt the obstruction.
13. The method of claim 1, wherein the delivering of the light energy toward the eyelid of the patient is done with a hand held apparatus.
14. The method of claim 1, wherein the step of mechanically actuating the force applicator of the device to move toward the back plate such that the eyelid is squeezed between the force applicator and the back plate and the force is applied to the eyelid is done with a hand held apparatus.
15. The method of claim 1, wherein the step of mechanically actuating the force applicator of the device to move toward the back plate such that the eyelid is squeezed between the force applicator and the back plate and the force is applied to the eyelid occurs at least in part during the maintaining of the delivery of the light energy toward the eyelid for the period of time.
16. The method of claim 1, wherein the step of mechanically actuating the force applicator of the device to move toward the back plate such that the eyelid is squeezed between the force applicator and the back plate and the force is applied to the eyelid comprises maintaining the force applicator and the back plate under tension such that the eyelid remains being squeezed for a preselected period of time.
17. The method of claim 1, wherein the step of mechanically actuating the force applicator of the device to move toward the back plate such that the eyelid is squeezed between the force applicator and the back plate and the force is applied to the eyelid is stopped and then repeated.
18. The method of claim 1, wherein the step of mechanically actuating the force applicator of the device to move toward the back plate such that the eyelid is squeezed between the force applicator and the back plate and the force is applied to the eyelid is regulated such that a regulated force is applied to the eyelid.
19. The method of claim 1, wherein the period of time is less than thirty (30) minutes.
20. The method of claim 1, wherein the period of time is selectable to range between zero (0) and thirty (30) minutes.
21. The method of claim 1, wherein the light energy is one or more of: laser light energy, infrared light, radio frequency (RF) energy, and microwave energy.
22. The method of claim 1, further comprising expressing the softened obstruction from the at least one meibomian gland through the force applied by the mechanically actuating of the force applicator of the device to move toward the back plate such that the eyelid is squeezed between the force applicator and the back plate.
23. The method of claim 1, wherein the step of mechanically actuating the force applicator occurs after the obstruction has been softened due to the maintaining of the delivery of the light energy toward the eyelid for the period of time.
24. The method of claim 1, further comprising monitoring a temperature at or near a surface of the eyelid.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
(22) While the present invention will be described more fully hereinafter, it is to be understood at the outset that persons of skill in the art may modify the invention herein described while still achieving the favorable results of this invention. Accordingly, the description that follows is to be understood as a broad teaching disclosure directed to persons of skill in the appropriate arts, and not as limiting upon the present invention.
(23) Referring now to
(24) As briefly mentioned herein above, obstruction composition will vary with the etiology which produced it. However, the obstruction will, in most cases, consist of a combination of, dead cells, keratin, bacteria, desquamated cells, sebaceous ground substance, milky fluid, inspissated or creamy secretions, or any combination of the foregoing in solid, semi-solid and thickened forms. The obstruction may be in the gland channel, at the gland orifice, atop the gland orifice or a combination of the foregoing. As employed herein, obstruction refers to any of the foregoing.
(25) Thus, it is self-evident that any obstruction of the channel will restrict or prevent secretions from exiting the gland and further, that in order to clear such obstructions or occlusions, the obstruction may be loosened from the gland wall, and/or broken up, fractured, softened, or liquefied so that it will fit through the gland orifice without causing excessive pain. Lastly, the obstruction remnants must be expressed from the gland. The present invention provides a method and apparatus to accomplish these tasks.
(26) According to the method of the present invention, the obstruction P should be softened or liquefied prior to attempting extraction or expression. With respect to the foregoing, the terms softened or liquefied are intended to mean a non-solid flowable state. In addition, in order to be clinically satisfactory, softening or liquefying of the obstruction P should be effected as quickly as possible and regulated heat treatment time should be less than five (5) minutes with one to two (1-2) minutes being preferred without causing damage to the surrounding tissues of the ocular globe or the eye, such heat treatments can be electrical, laser heating, hot water conductive heating, infrared heating, ultrasonic heating, RF heating, etc. This necessarily requires the addition of a greater amount of energy (heating) than is deliverable by the conventional application of hot compresses which according to current practice are applied for 3-15 minutes prior to the clinician attempting to remove the obstruction. Once the obstruction is softened or liquefied, removal is obtained by the application of a regulated force to the gland. More specifically, it is contemplated by the present invention that the force applied be a repeatable controlled force, as more fully explained herein below.
(27) Treatment to remove the obstruction will involve the application of an external regulated force to the eyelid and/or directly over the obstructed orifice to loosen the obstruction within the gland G and the orifice. The means for applying the force may be selected from one or more of a number of modalities wherein the frequency of vibration may be including low frequency vibration (generally less than 1000 Hz), sonic (generally 1000 Hz to 20,000 Hz) or ultrasonic energy (generally greater than 20,000 Hz), fluid jet such as air or water, microwave energy, needles, micro-needles, laser energy, RF energy, aspiration/suction, vacuum, pressure, compression and functional equivalents thereof. In addition, once a modality is chosen, the physician will have to determine the optimum treatment parameters so that each of the foregoing modalities will be applied to the eyelid such that the force (or energy, as appropriate) provided thereby is transmitted through the eyelid tissue to the obstruction. Further, the treatment intensity and length of application of these external forces will vary with the size and composition of the obstruction. Once a treatment protocol is established, the force can either be set or variable within a preselected range. Experiments were performed using an eccentric vibrating motor applied directly to the human eyelids. Bench tests of the vibration revealed the following data points, specifically setting number 3 was shown to be clinically effective to loosen the obstruction within the meibomian gland and orifice:
(28) TABLE-US-00001 Setting Vibration Freq. (Hz.) Vibration Amplitude (in/m) 1 51 .001 in. (25.4 m) 2 118 .004 in. (100 m) 3 165.5 .0062 in. (157.5 m)
(29) Once the obstruction has been loosened from the walls of the gland, it may be operated upon such that it will pass through the orifice O in a manner which causes little or no pain or discomfort to the patent. This can be accomplished by heating to soften or liquefy the obstruction up to a range of thirty seven degrees centigrade (37 C.) to fifty degrees centigrade (50 C.) with the preferred operating range being forty degrees centigrade (40 C.) to forty seven degrees centigrade (47 C.) and desired modality of forty two degrees centigrade (42 C.) to forty six degrees centigrade (46 C.) so that it easily passes through the orifice (or with minimal non-painful expansion thereof). Modalities for heating may include conduction, convection and radiation supplied by one or more of the following: thermal conduction, thermal convection, ultrasonic energy, laser energy, RF energy, direct and/or indirect transfer from heat source ad microwave energy which may be applied for a preselected period of time. By varying the amplitude, intensity and length of application, some of the foregoing modalities may also be employed to fracture or break up the obstruction. It will be noted that a closed loop feedback control system, well known to those skilled in the art (not shown) may be employed during heating to measure temperature proximate the eyelid to ensure that the obstruction does, in fact, reach a temperature sufficient to turn the obstructive material into a flowable, liquid or semi-liquid state.
(30) Extraction of the softened, broken apart or fractured obstruction may be accomplished by one or more of the following: needles, micro-needles, aspiration/suction, vacuum, pressure and compression. One embodiment of the invention is a suction system that is placed over the gland orifice may be employed to suck out the components of the softened, loosened or liquefied obstruction or the pieces thereof, as appropriate or alternatively, to employ suction to collect the obstruction as it exits the gland orifice. In order to be clinically effective, the foregoing modalities for extracting or expressing the obstruction should be administered in a fashion that is regulated, i.e., done in a repeatable manner.
(31) An apparatus for unplugging the obstructed gland channel C is schematically illustrated in
(32) Turning now to
(33) In addition to vibration alternative force, energy, aspiration and/or chemical/pharmacological agents can be used to open up the channel C. The probe may be further equipped with aspiration means 260 (best illustrated in
(34) In another aspect of the invention, the probe 230 may be equipped with a means for heating 270 such as a solid state heating element which may be regulated to provide relatively precise amounts of energy in the previously mentioned ranges that assists in softening, liquefying or melting the obstruction P via heat transfer through the tissue when the probe is placed against the tissue.
(35) A second embodiment of the invention (
(36) In operation, the clinician would place the abrasive tip 310 in contact over the gland orifice creating a seal between the tip and the skin. Movement of the probe 330 would cause the abrasive 310 on the bottom of the tip to separate the cells from the skin and the aspiration, suction or vacuum would extract the cellular material from the vicinity of the gland opening. In addition, depending upon the obstruction, aspiration, suction and/or vacuum alone may be sufficient to extract the obstruction.
(37) Additional features may also be providing to the microdermabraision tip such as a heating element 340 which could be placed in the outer covering 335 near the tip. In addition, the inner tube 320 could be equipped such that ultrasonic energy could be delivered to the obstruction as discussed herein above.
(38) Another embodiment of the invention may employ a chemical agent to clean the gland margin and to remove or exfoliate cells from the meibomian gland orifice. For example Ophthaine or a similar pharmacological agent may be employed to assist in removing epithelial cells from over the gland orifice. A probe similar to that shown in
(39) A further embodiment of the invention may deliver vibrational and/or thermal energy to the obstruction P without contacting the gland. One potential energy source is laser light supplied by titanium, argon, krypton or microwave energy. Extraction of the obstruction would be accomplished by the means described herein above.
(40) A third embodiment of the invention employs pressure applied to the tissue as shown in
(41) In operation, the physician would place the rollers 375 in contact with the eyelid, either inside, outside or both. Lateral movement of the rollers 375 would cause pressure to be applied to the gland to remove the obstruction. Alternatively, aspiration, suction and/or vacuum could be applied to extract the obstruction and material from the vicinity of the gland opening. In addition, depending upon the obstruction, aspiration, suction and/or vacuum alone may be sufficient to extract the obstruction.
(42) Additional features may also be provided to the rollers such as a regulated heating element (not shown) which could be placed in the outer covering near the tip as shown in
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(45) The embodiment illustrated in
(46) Another embodiment of the invention is shown in
(47) Another embodiment of the invention may employ a chemical agent or compound to clean the glandular margin to remove or exfoliate cells from the gland orifice. A probe similar to that shown in
(48) A further embodiment of the invention may deliver vibrational and/or thermal energy to the obstruction P without contacting the gland. One potential energy source is laser light supplied by a titanium-sapphire, argon, krypton, RF energy or microwave energy. Extraction of the obstruction would be accomplished by the means described herein above.
(49) Another embodiment of the invention employs the use of chemical or pharmacological agents to open or dilate the gland and gland orifice wherein the obstruction naturally is expressed and returns the normal secretions of the gland. Alternatively, the chemical or pharmaceutical agent would be used to soften or breakup the obstruction with such obstruction being expressed with the use of devices as defined above or combinations thereof. Chemical or pharmacological agents may also be used in connection with the device for post treatment. Once the glands have been opened then chemical or pharmacological agents may be used to enhance the normal production or secretion to maintain the glands in its unblocked state.
(50) Dilation of the meibomian gland channel and orifice may also be employed to loosen or free the obstruction from the gland walls. Dilation may be accomplished by chemical, pharmacological, or mechanical means.
(51) Stimulation of the meibomian gland may also be employed in conjunction with the other modalities discussed above to loosen or fracture the obstruction.
(52) As mentioned herein above, the present invention has been described in detail on conjunction with the figures in connection with the meibomian glands of the eye. The reader will note that the principals of this invention may be applied with equal efficacy to the other glands of the human body and potentially to valuable domesticated farm animals to treat various ailments.