Forceps and method for expressing eyelid meibomian glands

The forceps device with vibrating and heating mechanisms addresses the inefficiency of manual expression by effectively clearing meibum sludge and biofilm from meibomian glands, enhancing dry eye treatment efficacy.

WO2025250812A1PCT designated stage Publication Date: 2025-12-04RYNERSON JAMES M
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Patent Information

Application Number
PCT/US2025/031454
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-05-30
Filing Date
2025-05-29
Publication Date
2025-12-04

AI Technical Summary

Technical Problem

Existing manual expression forceps are ineffective in fully clearing meibum sludge and biofilm from meibomian glands, leading to persistent dry eye symptoms and inflammation.

Method used

A forceps device with vibrating and heating mechanisms to express meibomian gland contents, featuring a first paddle for vibration and a second paddle for heating, along with a compression control lever to compress the gland and facilitate expression.

Benefits of technology

Effectively clears meibum sludge and biofilm, reducing the likelihood of bacterial colonization and inflammation, thereby improving treatment outcomes for dry eye disease.

✦ Generated by Eureka AI based on patent content.

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Abstract

Forceps (10) for expressing a meibomian gland (174) is disclosed. The forceps (10) include a housing (12) and a head piece (44). The head piece (44) has first and second paddles (78, 82), the first paddle (78) being moveable between a first position and a second position. The forceps (10) includes a vibration generator (140) coupled to the first paddle (78), a heating mechanism (84) coupled to the second paddle (82), and a compression control lever (24) coupled to the first paddle (78). The compression control lever (24) may move the first paddle (78) from the first position to the second position. The first paddle (78) may engage an exterior surface (180) of an eyelid (170) and the second paddle (82) may engage an interior surface (182) of the eyelid (170) when the compression control lever (24) is engaged to compress a meibomian gland (174) between the first and second paddles (78, 82) to express contents from the meibomian gland (174). A method for expressing a meibomian gland (174) is also disclosed.
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Description

FORCEPS AND METHOD FOR EXPRESSING EYELID MEIBOMIAN GLANDSCROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 653,288 (pending), filed May 30, 2024, the disclosure of which is incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] The invention relates generally to an apparatus and method for expressing eyelid meibomian glands and, more particularly, forceps for expressing contents from the meibomian glands.BACKGROUND

[0003] Dry eye disease occurs when a person’s tears are unable to adequately lubricate their eyes. Dry eyes may occur when the person does not produce enough tears or they produce poor-quality tears. Dry eye disease may lead to inflammation and damage to the eye’s surface.

[0004] Dry eye disease is typically caused by the disruption of the healthy tear film, which has three layers: fatty oils, aqueous fluid, and mucus. A healthy tear film keeps the surface of the eye lubricated, smooth, and clear. A problem with any of these layers may cause dry eye disease.

[0005] During a treatment protocol for treating dry eye disease, most doctors recognize the benefits of heating and expressing the diseased meibum out of the meibomian glands. Healthy meibomian glands produce meibum, i.e., a clear oil thatlubricates the eyeball and provides for clear vision. Bacteria colonizing the eye lid margin and the interior of the meibomian glands use the meibum as a food source.

[0006] Once the bacteria are living in a self-produced biofilm, they can begin to produce toxins. The bacteria may produce a variety of toxins depending on the strain of the bacteria. These toxins are produced for a variety of reasons, but are usually food related, because nutrition is essential for the bacterial colony to survive.

[0007] Most strains of Staphylococcus aureus produce one of two enzymes— lipase and / or esterase-that convert the meibum into to a sludge or a solid so as to slow or stop their food source from egressing the meibomian gland. In essence, the bacteria are stocking themselves a pantry full of food. Converting the meibum to a sludge or a solid is detrimental to both the patient and the glands. First, over time, the sludge becomes thicker and cannot easily exit the gland to lubricate the eye. Second, a surface layer of biofilm seals off the meibomian gland openings. These two conditions cause the patient to suffer from dry eye symptoms, including poor vision.

[0008] Instead of utilizing the oil or solidified oil as food, Staphylococcus aureus may also produce cytolytic toxins that break down a patient’s cells lining the meibomian glands or on the eye lid margin itself. While the cytolytic toxins will not occlude the meibomian gland with sludge, they typically cause greater inflammation.

[0009] It is well accepted that heating the meibomian glands to melt the sludge into a more liquid oil, and then squeezing (expressing) it out, is an effective means to treat dry eye disease. There are several modalities heating the meibomian glands such as iLux™, LipiFlow™ and using manual expression forceps after heating the meibomian glands. The manual expression forceps are not fully effective at clearing the meibomian glands. Specifically, manual expression forceps and methods leavea significant amount of sludge and biofilm behind. What is needed, therefore, is an improved device and method for expressing the meibumASUMMARY

[0010] To these and other ends, a forceps for expressing a meibomian gland in an eyelid is disclosed and includes a housing having a first end and a second end and a head piece operatively coupled to the first end of the housing. The head piece has a first paddle and a second paddle, where the first paddle is configured to move between a first position and a second position toward the second paddle. The forceps further includes a vibration generator operatively coupled to the first paddle, where the vibration generator is configured to vibrate the first paddle at a predetermined frequency. The forceps includes a heating mechanism operatively coupled to the second paddle to heat the second paddle and a compression control lever operatively coupled to the first paddle. The compression control lever is configured to move the first paddle from the first position to the second position when the compression control lever is engaged. The first paddle is configured to engage an exterior surface of an eyelid and the second paddle is configured to engage an interior surface of the eyelid when the compression control lever is engaged to thereby compress a meibomian gland within the eyelid between the first and second paddles to express contents from the meibomian gland.

[0011] In one embodiment, the forceps may include an external controller operatively coupled to the vibration generator and the heating element. The external controller may be configured to operate the vibration generator during the expression of the contents from the meibomian gland and further configured to operate theheating element to heat the second paddle prior to expression of the contents from the meibomian gland.

[0012] In an embodiment, the forceps may include a foot controller operatively coupled to the external controller, wherein the foot controller is configured to activate the vibration generator when the foot controller is engaged.

[0013] In an embodiment, the heating mechanism may include a heating element, a heat dissipation sheet, and a thermistor configured to detect a temperature of the second paddle.

[0014] In an embodiment, the forceps may include a retaining member extending from the first end of the housing where the head piece is configured to be selectively removably connected to the retaining member. The retaining member may include an opposing pair of protrusions configured to removably engage a corresponding pair of tabs on the head piece so the head piece may be selectively removed from the retaining member.

[0015] In an embodiment, the forceps may include a lens operatively coupled to the first end of the housing, where the lens is configured to assist the operator of the forceps to view the expression of the contents from the meibomian gland.

[0016] In an embodiment, the forceps may include a light assembly positioned adjacent the lens and configured to illuminate the eyelid during the expression of the contents from the meibomian gland.

[0017] In an embodiment, the first paddle may include a biasing member configured to return the first paddle to the first position when the compression control lever is disengaged.

[0018] In an embodiment, the second paddle may be stationary relative to the first end of the housing when the compression controller lever is engaged and the first paddle moves from the first position toward the second paddle.

[0019] In an embodiment, the forceps may include a translating member operably coupled to the first paddle. The compression controller lever is coupled to the translating member so as to move the translating member when the compression controller lever is engaged to thereby move the first paddle from the first position toward the second position. The translating member may include a slotted member coupled to an end of the compression control lever such that when the compression control lever pivots in an arc, the translating member moves linearly to move the first paddle from the first position toward the second position.

[0020] In another aspect of the present disclosure, a method for expressing a meibomian gland in an eyelid is disclosed and comprises providing forceps having a first paddle and a second paddle, where the first paddle is configured to move between a first position and second position. The first paddle is configured to vibrate and the second paddle is configured to be heated. The method includes heating the second paddle, engaging an interior surface of an eyelid with the heated second paddle, moving the first paddle from the first position to an intermediate position such that the first paddle engages an exterior surface of the eyelid, vibrating the first paddle for a predetermined amount of time, moving the first paddle from the intermediate position to the second position so as to compress a meibomian glad in the eyelid between the first paddle and second paddle, and expressing contents from the meibomian gland.

[0021] In an embodiment, the second paddle may include a heating mechanism, and the step of heating the second paddle may include applying power to the heatingmechanism to raise the temperature of the second paddle to approximately 39 degrees C, slowing down the application of power to the heating mechanism until the temperature of the second paddle is approximately 43 degrees C, and then discontinuing the application of power to the heating mechanism.

[0022] In an embodiment, the predetermined amount of time for vibrating the first paddle may be in the range of 10-30 seconds.

[0023] In an embodiment, the first paddle may vibrate at a frequency range of 125 Hz to 250 Hz.

[0024] In an embodiment, the method may further include providing an external controller operative coupled to the forceps, where the external controller is configured to control the vibration of the first paddle and is further configured to control the heating of the second paddle.

[0025] In an embodiment, the method may further include providing a foot controller operative coupled to the external controller, where the foot controller is configured to start and stop the vibration of the first paddle.

[0026] In an embodiment, the forceps may include a lens and the method may further include viewing the expression of the contents from the meibomian glands through the lens. The forceps may also include a light assembly positioned adjacent the lens, the method may further include illuminating with the light assembly the eyelid during the expression of the contents from the meibomian glands.BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate one or more embodiments of the invention and,together with a general description of the invention given above, and the detailed description given below, serve to explain the invention.

[0028] Fig. 1 is a rear perspective view of forceps according to one embodiment to the present disclosure.

[0029] Fig. 2 is a front perspective view of the forceps of Fig. 1 .

[0030] Fig. 3 is a front exploded view of the forceps of Fig. 1 .

[0031] Fig. 4 is a rear exploded view of the forceps of Fig. 1 .

[0032] Fig. 5 is an exploded view of the head piece of the forceps of Fig. 1 .

[0033] Fig. 6 shows the assembled head piece ready to be attached to the head piece receiver of the forceps.

[0034] Fig. 7 is a cross-section view of the assembled head piece ready to be attached to the head piece receiver of the forceps.

[0035] Fig. 8 is an exploded view showing the carriage configured to move the expression paddle from a first position to a second position.

[0036] Fig. 9A is a cross-section view of the forceps of Fig. 1 with the expression paddle in the first position.

[0037] Fig. 9B is a cross-sectional view of the forceps of Fig. 1 with the expression paddle in the second position.

[0038] Fig. 10A is an enlarged cross-sectional view of the forceps expressing a meibomian gland in the lower eyelid of a patient.

[0039] Fig. 10B is an enlarged cross-sectional view of the forceps expressing a meibomian gland in the upper eyelid of a patient.

[0040] Fig. 11 is perspective view of an external controller connected to the forceps and a foot controller.DETAILED DESCRIPTION OF THE INVENTION

[0041] An expression forceps 10 (hereinafter “forceps 10”) according to one embodiment of the present disclosure is shown in Figs. 1 and 2. The forceps 10 include a housing 12 with a first end 14 and a second end 16. A head piece assembly 18 is coupled to and extends from the first end 14. A lens assembly 20 is also coupled to and extends from the first end 14. The housing 12 includes a grip portion 22 configured to be held by the hand of the operator of the forceps 10. The forceps also includes a compression control lever 24 that partially protrudes through the housing 12. The compression control lever 24 is position proximate the grip portion 22 so a thumb or finger gripping the housing 12 may operate the compression control lever 24, i.e., push on the compression control lever 24 to operate the forceps 10 as will be described below. The housing 12 may further include an on / off switch 26 (Fig. 2) for controlling whether power is being received by the forceps 10.

[0042] With reference to Figs. 3 and 4, the forceps 10 is shown in an exploded view. The housing 12 includes a first housing section 32 and a second housing section 34, which may be held together via a plurality of tabs 36 (Fig. 3) on the first housing section 32 which engage a plurality of protrusions 38 (Fig. 4) on the second housing section 34. In an embodiment, the first and second housing sections 32, 34 may be held together by one or more fasteners (not shown), such as screws. The compression control lever 24 is pivotably mounted to a circuit board which is secured to the second housing section 34 via fasteners 42. The head piece assembly 18 includes a head piece 44 and an retaining member 46. The head piece 44 includes tabs 48 configured to engage protrusions 50 on the retaining member 46 so that the head piece 44 may be selectively removed from the retaining member 46. In anembodiment, the selectively removable head piece 44 may be a one-time use per patient. In that regard, a single head piece 44 may be used for one patient to treat the eyelids of both eyes. Alternatively, one head piece 44 may be used for the eyelids of each eye. In other words, two head pieces 44 may be used for a single patient.

[0043] The forceps 10 further include a carriage assembly 56 which is secured to the second housing portion 34 via fasteners 58 such that a portion of the carriage assembly 56 is positioned within the retaining member 46 of the head piece assembly 18. The lens assembly 20 includes a frame 64 which holds a lens 66, such as a magnifying lens, and a light assembly 68, which may include plurality of individual lighting elements 70, such as LEDs for example. In an embodiment, the lighting elements 70 may illuminate in one or more colors such as white and yellow. The operator of the forceps may look through the lens 66 during the procedure to get close up look at the meibomian glands being expressed. The light assembly 68 is configured to illuminate the eyelids during the procedure so the operator may more clearly see the meibomian glands being expressed.

[0044] The head piece 44 is shown in an exploded view in Fig. 5. The head piece 44 includes connection member 74 having the tabs 48, a paddle backing member 76, a first or expression paddle 78, and a front cap 80 with a second or stationary paddle 82. The head piece 44 also includes a heating mechanism 84 including a heating element 86 and a heat dissipation sheet 88. The heating element 86 is coupled to a surface 90 of the stationary paddle 82 and the heat dissipation sheet 88 is coupled to the heating element 86. The heat dissipation sheet 88 is configured to evenly dissipate the heating coming from the heating element 86. In anembodiment, the heating element 86 may be powered by around 1 .8 volts to generate around 0.75 watts of power.

[0045] Figs. 6 and 7 show the fully assembled head piece 44 positioned to be attached to the retaining member 46 so as to form the complete head piece assembly 18. The connection member 74 includes a electrical connector 92 that is inserted into an opening 94 in the retaining member 46. The electrical connector 92 is electrically coupled to the heating element 86. When the head piece 44 is attached to the connection member 74, the electrical connector 92 is electrically removably coupled to an electrical connector 96 (Fig. 7) which is operably connected to the circuit board 40. Thus, when the head piece 44 is attached to the retaining member 46, the heating element 86 is operably connected to the circuit board 40. In an embodiment, the heating element 86 may include a thermistor 98 which is configured to monitor the temperature of the heating element 86 during the heating process. The thermistor 98 is operatively coupled to the circuit board 40.

[0046] The carriage assembly 56 is shown in an exploded view in Fig. 8. The carriage assembly 56 includes a translating member 102 having spaced apart throughways 104, 106, a receiver 107 at a first end 108 of the translating member 102, and a slotted member 1 10 at a second end 1 12 of the translating member 102. The receiver 107 is configured to removably receive the paddle backing member 76, which is attached to the expression paddle 78 inside of the head piece 44. The throughways 104 are configured to receive first and second rods 114, 116 therein. The first and second rods 114, 116 are longer that the length of the throughways 104, 106 such that the translating member 102 may move back and forth along the first and second rods 114, 116 during the use of the forceps 10. The first and second rods 1 14, 116 are attached to a support frame 118 which is removablycoupled to second housing portion f34 with fasteners 58. The compression control lever 24 may be coupled to the translating member 102 with a fastener 122 inserted through a pair of lugs 124 at the end of the compression control lever 24 and through a bearing or bushing 128 captured within the slotted member 110. See, e.g., Fig. 7. Nuts 130, 132 are secured to threaded ends 134 of the first and second rods 114, 116 to keep the translating member 102 on the first and second rods 1 14, 116. A vibration generator 140 may be coupled to the translating member 102 in a recess 142 (Fig. 7) in the underside of the translating member 102. The vibration generator 140 is operably connected to the circuit board 40. When the vibration generator 140 is active it vibrates the expression paddle 78 which is indirectly couple to the translating member 102 via the paddle backing member 76. In an embodiment, the vibration generator 140 may generate a frequency in a range of 125 Hz to 250 Hz or in the range of 150 Hz to 200 Hz.

[0047] Figs. 9A and 9B are cross-section views of the forceps 10. In Fig. 9A, the forceps 10 is shown in the non-operative state such that the expression paddle 78 is in first position away from the stationary paddle 82. In Fig. 9B, the forceps is shown in an operative state such that the expression paddle 78 is moved to a second position proximate the stationary paddle 82. The circuit board 40 includes a communication port 150, such as a USB-C port, so that the forceps 10 may receive power from and communicate with an external controller 152 (Fig .11 ) via a cable 154. The communication port 150 is operatively coupled to the vibration generator 140, the electrical connector 96, and a switch 158 mounted to the second housing portion 34. The switch 158 is normally open and when the compression control lever 24 is pushed downward into the housing 12 about a pivot point 159, the compression control lever 24 closes the switch 158 (Fig. 9B) so as to send power to the lightassembly 68 so that the light assembly 68 illuminates. In an embodiment, when the on / off switch 26 is in the on position and the compression control lever 24 not pushed downward, the light assembly 68 illuminates yellow light, but when compression control lever 24 is pressed down and the switch 158 is closed, the light assembly 68 switches from yellow light to white light. Also when the compression control lever 24 is pushed downward, the bearing 128 coupled to the end to end of the compression control lever 24 pushes against the slotted member 110 causing the translating member 102 to move linearly along the first and second rods 1 14, 116 so as to move the expression paddle 78 from the first position (Fig. 9A) to the second position proximate the stationary paddle 82 (shown in Fig. 9B). A biasing member 160 extending between the expression paddle 78 and the front cap 80 returns the expression paddle 78 to the first position when the compression control lever 24 is released and no longer pushed downwardly.

[0048] Fig. 10A shows the forceps 10 engaging the lower eyelid 170 of a patient’s eye 172. The lower eyelid 170 has at least one meibomian gland 174 which is typically filled with contents 176, such as meibum, sludge, or a mixture of both, that needs to be expressed out of the meibomian gland 174. As shown in Fig. 10A, the expression paddle 78 is in the second position such that expression paddle 78 is contacting the exterior surface 180 of the lower eyelid 170. The stationary paddle 82 is contacting the interior surface 182 of the lower eyelid 170. If the operator of the forceps 10 presses further down on the compression control lever 24, the expression paddle 78 and the stationary paddle 82 will compression the lower eyelid 170 and, therefore, the meibomian gland 174 causing the sludge 176 to be expressed through a duct 184 at an eyelid margin 186 of the lower eyelid 170. As will be discussed in more detail below, during the expression process the vibration generator 140 may beactivated to vibrate the expression paddle 78 and the heating element 86 may be activated to heat the stationary paddle 82.

[0049] Fig. 10B shows the forceps 10 flipped about a horizontal axis and engaging the upper eyelid 190. In a similar fashion to what was just described for Fig. 10A, the expression paddle 78 and the stationary paddle 82 compress the sludge 176 out of the meibomian gland 174 through the duct 184. Vibration and heat may be applied respectively to the expression paddle 78 and the stationary paddle 82 during the expression process.

[0050] As described above, the external controller 152 may be connected to the forceps 10 via a cable 154 as shown in Fig. 11 . A foot controller 200 may also be connected to the external controller via a cable 202. The foot controller 200 may be used to activate or deactivate the vibration generator 140. The external controller 152 may have an on / off button 204 various other control buttons 206-216. Buttons 206, 208 may be used to increase or decrease the temperature of the heating element 86. Buttons 210, 212 may be used to increase or decrease the amount of time the vibration generator 140 vibrates once activate by the foot controller 200. Buttons 214, 216 may be used to increase or decrease the frequency of the vibration created by the vibration generator 140. In an embodiment, the frequency created by the vibration generator 140 may be divided into four distinct steps from low to high. Thus, buttons 214, 216 may be used to change the frequency up or down according to those four distinct steps. The external controller 152 may include further buttons to adjust, stop, or start a functionality of the external controller 152. The external controller 152 may also include an emergency shut off button 220, which when pushed will stop all heating and vibration activities of the forceps 10. As used herein, the term button may include a push button, a switch, a toggle, a slide, a rotary knob,or any other device suitable for adjusting a parameter of the external controller 152. The external controller 152 may further include a screen 222 which may be configured to display information such as temperature of the heating element 86, frequency generated by the vibration generator 140, and time of applied vibration and / or heat, for example. Other information or parameters may also be shown on the screen 222. The controller may also include a start button 224 that may be activated to start the treatment process sequence. The controller may also include a stop button 226 that may be activated to stop the treatment process sequence.

[0051] In use, a previously unused head piece 44 is connected to the retaining member 46. The cable 154 is plugged into the communication port 150 on the forceps 10 and plugged into the external controller 152. The button 204 is pushed to turn on the external controller 152. The start button 224 is pressed to start a sequence of steps for the expression process. The start button 224 may be pressed one more time to supply power to the heating element 86 so that the heating element 86 begins to generate heat and heat the stationary paddle 82. The stationary paddle 82 may then be positioned against the inner surface ( / '.e., the palpebral conjunctiva) of either the temporal half or the nasal half of the lower eyelid 170. When the stationary paddle 82 reaches 39 degrees C as measured by the thermistor 98, the external controller 152 will aurorally announce “39 degrees Celsius” and a 20-second time will begin. At the beginning of the 20-second time period, the operator may press on the foot controller 200 so that the expression paddle 78 begins to vibrate. The operator may then begin depressing the compression control lever 24 so as to bring the vibrating expression paddle 78 to an intermediate position in contact with the exterior surface of the lower eyelid 170, but not so far that the meibomian gland 174 is compressed. When the compression control lever 24 is depressed, the yellowlight coming from the lighting elements 70 will turn to white light to illuminate the treatment area. The vibrating expression paddle 78 will be held in place during the 20-second time period. Typically, the heating mechanism 84 will shut down after the 20-second time period, but it may be reactivated by the operator at the operator’s discretion. At the end of the 20-second time period, the external controller 152 will aurorally announce “Expression.” The operator may then depress the compression control lever 24 further so that the expression paddle 78 and the stationary paddle 82 cooperate to compress the meibomian gland 174 in the lower eyelid 170 to express the sludge 176 from the meibomian gland 174. See, e.g., Fig. 10A. One expression cycle may last around 3 seconds. Typically, the vibration generator 140 will continue to vibrate the expression paddle 78 during the expression process. The operator, however may choose to shut off the vibration generator 140 during the expression process, depending on the needs of the patient. The buttons 214, 216 may be pressed to change (increase or decrease) the frequency level based on patient comfort. The operator may also deactivate the vibration generator 140 by stepping on the foot controller 200 again. Other time periods my be used besides 20 seconds. The time period may range between 5-35 seconds, between 10-30 seconds, and between 15-25 seconds.

[0052] During the expression process, the operator may view the expression of the sludge 176 through the lens 66 so the operator may visualize the sludge 176 exiting the meibomian gland 174 along the eyelid margin 186. The operator may also take one or more photographs during the expression process to create a visual record of the sludge 176 being expressed. The photographs create a record over several treatments as to whether the sludge 176 has turned into meibum, which is much clearer compared to the sludge 176. One the treatment of the initial half of thelower eyelid 170 is completed, the operator may press the stop button 226 to stop the expression process sequence being carried out by the external controller 152.

[0053] The operator may then reposition the forceps 10 to the other half (e.g., the temporal or nasal half) of the lower eyelid 170 so it may be treated with the forceps 10. The operator would then press the start button 224 to start the same expression process sequence as described above. Once the treatment of the other half of the lower eyelid is complete, the operator may press the stop button 226. At that time, the operator may begin the same expression process on the upper eyelid 190. To expression the upper eyelid 190, forceps 10 are flip about the horizontal to engage the upper eyelid 190 as shown in Fig. 10B. The expression process may also be competed on the patient’s other eye if necessary.

[0054] By vibrating and heating the lower and upper eyelids 170, 190, and hence the meibomian gland 174, while compressing the meibomian gland 174 between the expression paddle 78 and the stationary paddle 82, the melted sludge 176 and biofilm may be expressed more effectively. Because known expression methods leave a significant amount of sludge and biofilm behind, the remaining bacteria may almost immediately begin their destructive process of biofilm building and toxin production after the treatment is complete. The vibration from the expression paddle 78 adds energy to the molecules of melted sludge, biofilm, and bacteria making sludge / biofilm / bacteria more mobilized. Consequently, the sludge / biofilm / bacteria is less likely to stick to the inner surfaces of the meibomian gland 174 as it is being squeezed out. With the sludge / biofilm / bacteria being largely cleared from the meibomian gland 174, the dry eye condition will be more effectively treated and less likely to reoccur quickly.

[0055] While the invention has been illustrated by a description of various embodiments, and while these embodiments have been described in considerable detail, it is not the intention of the Applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The invention in its broader aspects is therefore not limited to the specific details, representative apparatus and method, and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the spirit or scope of the Applicant’s general inventive concept.

Claims

WHAT IS CLAIMED IS:1 . Forceps for expressing a meibomian gland in an eyelid, comprising: a housing having a first end and a second end; a head piece operatively coupled to the first end of the housing, the head piece having a first paddle and a second paddle, the first paddle configured to move between a first position and a second position toward the second paddle; a vibration generator operatively coupled to the first paddle, the vibration generator configured to vibrate the first paddle at a predetermined frequency; a heating mechanism operatively coupled to the second paddle and configured to heat the second paddle; and a compression control lever operatively coupled to the first paddle, the compression control lever configured to move the first paddle from the first position toward the second position when the compression control lever is engaged, wherein the first paddle is configured to engage an exterior surface of an eyelid and the second paddle is configured to engage an interior surface of the eyelid when the compression control lever is engaged to thereby compress a meibomian gland within the eyelid between the first and second paddles to express contents from the meibomian gland.

2. The forceps of claim 1 , further comprising an external controller operatively coupled to the vibration generator and the heating mechanism, the external controller configured to operate the vibration generator during the expression of the contents from the meibomian gland and further configured to operate the heating mechanism to heat the second paddle prior to expression of the contents from the meibomian gland.

3. The forceps of claim 2, further comprising foot controller operatively coupled to the external controller, wherein the foot controller is configured to activate the vibration generator when the foot controller is engaged.

4. The forceps of claim 1 , wherein the heating mechanism includes a heating element, a heat dissipation sheet, and a thermistor configured to detect a temperature of the second paddle.

5. The forceps of claim 1 , further comprising a retaining member extending from the first end of the housing, the head piece configured to be selectively removably connected to the retaining member.

6. The forceps of claim 5, wherein the retaining member includes an opposing pair of protrusions configured to removably engage a corresponding pair of tabs on the head piece so the head piece may be selectively removed from the retaining member.

7. The forceps of claim 1 , further comprising a lens operatively coupled to the first end of the housing, the lens configured to assist an operator of the forceps to view the expression of the contents from the meibomian gland.

8. The forceps of claim 7, further comprising a light assembly positioned adjacent the lens and configured to illuminate the eyelid during the expression of the contents from the meibomian gland.

9. The forceps of claim 1 , wherein the first paddle includes a biasing member configured to return the first paddle to the first position when the compression control lever is disengaged.

10. The forceps of claim 1 , wherein the second paddle is stationary relative to the first end of the housing when the compression controller lever is engaged and the first paddle moves from the first position toward the second paddle.11 . The forceps of claim 1 , further comprising a translating member operably coupled to the first paddle, the compression controller lever being coupled to the translating member so as to move the translating member when the compression controller lever is engaged to thereby move the first paddle from the first position toward the second position.

12. The forceps of claim 1 1 , wherein the translating member includes a slotted member coupled to an end of the compression control lever, wherein the slotted member is configured such that when the compression control lever pivots in an arc, the translating member moves linearly to move the first paddle from the first position toward the second position.

13. A method for expressing a meibomian gland in an eyelid, comprising: providing forceps having a first paddle and a second paddle, the first paddle configured to move between a first position and second position, the first paddle is configured to vibrate, the second paddle is configured to be heated,heating the second paddle; engaging an interior surface of an eyelid with the heated second paddle, moving the first paddle from the first position to an intermediate position such that the first paddle engages an exterior surface of the eyelid; vibrating the first paddle for a predetermined amount of time; moving the first paddle from the intermediate position to the second position so as to compress a meibomian glad in the eyelid between the first paddle and the second paddle, and expressing contents from the meibomian gland.

14. The method of claim 13, wherein the second paddle includes a heating mechanism, and the step of heating the second paddle includes applying power to the heating mechanism to raise a temperature of the second paddle to approximately 39 degrees C, slowing down the application of power to the heating mechanism until the temperature of the second paddle is approximately 43 degrees C, and then discontinuing the application of power to the heating mechanism.

15. The method of claim 13, wherein the predetermined amount of time for vibrating the first paddle is between 10-30 seconds.

16. The method of claim 13, wherein the first paddle is vibrated at a frequency range of 125 Hz to 250 Hz.

17. The method of claim 13, further comprising providing an external controller operative coupled to the forceps, the external controller configured to control thevibration of the first paddle and further configured to control the heating of the second paddle.

18. The method of claim 17, further comprising providing a foot controller operative coupled to the external controller, the foot controller configured to start and stop the vibration of the first paddle.

19. The method of claim 13, wherein the forceps include a lens and the method further comprises viewing the expression of the contents from the meibomian glands through the lens.

20. The method of claim 19, wherein the forceps include a light assembly positioned adjacent the lens, the method further comprising illuminating with the light assembly the eyelid during the expression of the contents from the meibomian glands.

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