OPHTHALMIC SPECIALTY INSTRUMENT FOR TREATING MEIBOMIAN GLAND DYSFUNCTION (MGD)

Abstract

Certain aspects are directed to an ophthalmic specialty instrument configured to allow patients to treat MGD and other dry eye conditions themselves which is easy to operate and more effective. The ophthalmic specialty instrument comprises a main body of two arms with a distal end and a proximal end; wherein the two arms are pivotably coupled to a common connection point at the proximal end and a pair of angled and slightly wedged pressure plates are attached to the distal end of the two arms; wherein an exfoliating member is also attached to the proximal end; and wherein the pressure plates are angled downwardly and outwardly from the longitudinal planes of the arms and have gentle radius of curvature that match the curvature of eyelids to facilitate a substantially 90° approaching angle to the eyelid margin as opposed to making contact with the eyelids tangentially.

Claims

1. An ophthalmic specialty instrument configured for treating meibomian gland dysfunction, the instrument comprising: a main body having a distal end and a proximal end, wherein the main body further comprises: a first elongated arm having a first longitudinal plane; and a second elongated arm having a second longitudinal plane; wherein the first elongated arm and the second elongated arm are stacked in a vertical direction such that the first longitudinal plane and the second longitudinal plane are connected at the proximal end of the main body; and wherein the first elongated arm and the second elongated arm are bent downwardly and outwardly from the first longitudinal plane and the second longitudinal plane respectively to form a first angle and a second angle at the distal end of the main body; a first pressure plate attached to the first elongated arm at the distal end of the main body; and a second pressure plate attached to the second elongated arm at the distal end of the main body.

2. The ophthalmic specialty instrument of claim 1, wherein the first pressure plate and the second pressure plate possess concave curvatures.

3. The ophthalmic specialty instrument of claim 1, wherein a thickness of the first pressure plate and the second pressure plate decreases from a distal end of each pressure plate to a proximal end of each pressure plate.

4. The ophthalmic specialty instrument of claim 1, wherein the main body further comprises an exfoliator located at the proximal end of the main body.

5. The ophthalmic specialty instrument of claim 1, wherein a thickness and a width of the exfoliator do not exceed a thickness and a width of the main body.

6. The ophthalmic specialty instrument of claim 1, wherein a width of the distal end is smaller than a width of the proximal end of the main body to allow for better gripping position.

7. The ophthalmic specialty instrument of claim 1, wherein the first and the second angles are 45 degrees to accommodate a utilization of the ophthalmic specialty apparatus by a patient without any supervision of a health care professional.

8. The ophthalmic specialty instrument of claim 1, wherein the first and the second angles are between 30 degrees and 80 degrees.

9. The ophthalmic specialty instrument of claim 1, wherein the distal ends of the first and the second pressure plates are 1 mm in width; and wherein the proximal ends of the first and the second pressure plates are 0.8 mm in width.

10. The ophthalmic specialty instrument of claim 1, wherein a radius of the concave curvatures of the first and the second pressure plates is 0.12 mm.

11. The ophthalmic specialty instrument of claim 1, wherein the pressure plates are removably attached to the distal end of the main body.

12. The ophthalmic specialty instrument of claim 1, wherein the first and the second pressure plates are flat and non-curved.

13. The ophthalmic specialty instrument of claim 1, wherein the distal ends of the first and the second pressure plates comprise non-marring round edges.

14. The ophthalmic specialty instrument of claim 1, wherein the first and the second elongated arms are made of an alloy that are non-magnetic, non-corrosive, and heat-resistant with materials selected from the group consisting of high tensile strength steel, chromium, nickel, cobalt, carbon steel alloy, non-magnetic stainless steel, titanium, carbon steel, stainless steel alloy, and plastic composites.

15. The ophthalmic specialty instrument of claim 1, wherein the first and the second pressure plates are made of material selected from the group consisting of medical-grade plastic composites, ceramics, polymers, and metal composites.

16. The ophthalmic specialty instrument of claim 1, wherein a coated surface of the first and the second pressure plates is non-scratching and non-marring.

17. The ophthalmic specialty instrument of claim 1, wherein a gap between the first pressure plate and the second pressure plate is 6 mm.

18. The ophthalmic specialty instrument of claim 4, wherein a back end of the exfoliator is recessed into the proximal end of the main body.

19. A method for treating meibomian gland dysfunction utilizing the ophthalmic specialty instrument of claim 1, the method comprising the steps of: holding a first elongated arm and a second elongated arm of an ophthalmic specialty instrument by a proximal end of the ophthalmic specialty apparatus; approaching an eyelid margin of a patient with the ophthalmic specialty instrument at a substantially 90-degree angle to the eyelid margin; positioning a first pressure plate attached to a distal end of the first elongated arm on an inside of the eyelid margin and a second pressure plate attached to a distal end of the second elongated arm on an outside of the eyelid margin; and applying pressure to one or more meibomian glands and mechanically expressing the one or more meibomian glands via the first pressure plate and the second pressure plate by squeezing the first elongated arm and the second elongated arm.

20. A method for treating meibomian gland dysfunction, utilizing the ophthalmic specialty instrument of claim 1, the method comprising the steps of: unblocking meibomian gland orifices of an eyelid margin by exfoliating and clearing away keratinized cells of the eyelid margin using an exfoliator located on a distal end of an ophthalmic specialty instrument; holding a first elongated arm and a second elongated arm of an ophthalmic specialty instrument by a proximal end of the ophthalmic specialty apparatus; approaching an eyelid margin of a patient with the ophthalmic specialty instrument at a substantially 90-degree angle to the eyelid margin; positioning a first pressure plate attached to a distal end of the first elongated arm on an inside of the eyelid margin and a second pressure plate attached to a distal end of the second elongated arm on an outside of the eyelid margin; and applying pressure to one or more meibomian glands and mechanically expressing the one or more meibomian glands via the first pressure plate and the second pressure plate by squeezing the first elongated arm and the second elongated arm.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0030] FIG. 1 illustrates a schematic diagram showing a perspective view of the ophthalmic specialty instrument for treating MGD.

[0031] FIG. 2 illustrates a schematic diagram showing another perspective view of the ophthalmic specialty instrument for treating MGD.

[0032] FIG. 3A illustrates a schematic diagram showing the front of the pressure plates of the ophthalmic specialty instrument for treating MGD.

[0033] FIG. 3B illustrates a schematic diagram showing the front of the pressure plates of the ophthalmic specialty instrument for treating MGD with non-marring edges.

[0034] FIG. 4 illustrates a schematic diagram showing the back of the ophthalmic specialty instrument for treating MGD.

[0035] FIG. 5 illustrates a schematic diagram showing the left side of the ophthalmic specialty instrument for treating MGD.

[0036] FIG. 6 illustrates a schematic diagram showing the right side of the ophthalmic specialty instrument for treating MGD.

[0037] FIG. 7 illustrates a schematic diagram showing the top of the ophthalmic specialty instrument for treating MGD.

[0038] FIG. 8 illustrates a schematic diagram showing the bottom of the ophthalmic specialty instrument for treating MGD.

[0039] FIG. 9 illustrates a schematic diagram showing a user using the ophthalmic specialty instrument to treat the lower eyelid.

[0040] FIG. 10 illustrates a schematic diagram showing a user using the ophthalmic specialty instrument to treat the upper eyelid.

[0041] FIG. 11 illustrates a schematic diagram showing a user using the exfoliator member of the ophthalmic specialty instrument to debride the upper eyelid margin.

[0042] FIG. 12 illustrates a schematic diagram showing a user using the exfoliator member of the ophthalmic specialty instrument to debride the lower eyelid margin.

[0043] FIG. 13 illustrates a flow chart showing a method of treating MGD.

[0044] FIG. 14 illustrates another flow chart showing another method of treating MGD with an exfoliating member attached to the main body of the ophthalmic specialty instrument.

DETAILED DESCRIPTION OF THE SEVERAL EMBODIMENTS

[0045] Reference will now be made to non-limiting embodiments, examples of which are illustrated in the Figures. FIGS. 1-2 illustrate a pair of two perspective views of an ophthalmic specialty instrument for treating MGD. In a preferred embodiment, the ophthalmic specialty instrument 100 comprises a main body 102 with a proximal end 102a and a distal end 102b, wherein the main body 102 further comprises a first arm 104 with a substantially flat surface on a first longitudinal plane 105 coupled to a second arm 106 with a substantially flat surface on a second longitudinal plane 107. The first arm 104 is configured to be stacked over the second arm 106 such that the first longitudinal plane 105 and the second longitudinal plane 107 are extended from a common pivotal connecting point 109 located near the proximal end 102a of the main body 102. In some embodiments, the arms 104 and 106 are made from an alloy blend of steel, chromium, nickel, and cobalt, which is non-magnetic and non-corrosive and may resist temperatures up to 1000° F. Alternatively, the first and second arms 104, 106 may be made of materials selected from the group consisting of high tensile strength chromium/carbon steel alloy, non-magnetic stainless steel, titanium, carbon steel, stainless steel alloy, and plastic composites. In one embodiment, the proximal end 102a of the instrument 100 is defined by a gently curved edge.

[0046] To facilitate the positioning of the specialty instrument 100 at the distal end 102b, the first arm 104 and the second arm 106 are bent downwardly and outwardly at an angle 120, preferably at forty-five degrees, from the first longitudinal plane 105 and the second longitudinal plane 107 respectively, wherein the first arm 104 is fixedly attached to a first pressure plate 110 and the second arm 106 is fixedly attached to a second pressure plate 112.

[0047] Each arm 104, 106 is configured to form the obtuse angle 120 with its respective pressure plate. The angle 120, as shown in FIG. 5, may range from thirty degrees to eighty degrees, and preferably at forty-five degrees to accommodate the approaching angle more effectively when the instrument 100 is operated by a patient without the supervision of a health care provider. The pressure plates 110 and 112 may have various shapes, including a rectangle, a square, a circle, etc., and they are configured to be substantially parallel to each other such that directional expressions to the meibomian glands are optimized. In some embodiments, the pressure plates 110 and 112 are coated with long lasting PVC or rubber coated with other similar material which is non-scratching and non-marring. In yet another embodiment, a gap 150 between the first pressure plate 110 and the second pressure plate 112 is approximately six to eight millimeters. In one embodiment, the pressure plates 110, 112 are removably attached to the distal ends 102b of the elongated arms 104, 106.

[0048] In a preferred embodiment, the proximal end 102a of the main body 102 comprises an exfoliating member 108 that may be around twenty-five millimeters in length with a peripheral edge 108a designed to exfoliate keratinized cells (hardened cells filled with protein) and debride the lid margin to facilitate the opening of the clogged meibomian gland orifices before pressure can be mechanically applied on the glands directly using the pressure plates 110 and 112 based on the severity of the condition. Both the first pressure plate 110 and the second pressure plate 112 have mild concave curvatures of approximately twelve millimeters downwardly to accommodate a wide range of contour of a patient's eyelid margin such that the curvatures of the pressure plates match the curvature of the eyelid which allows for complete contact to the eyelids and reduce the risk of unnecessary pulling and other types of damages. In alternative embodiments, the radius of the curvature of each pressure plate 110, 112 may vary depending on a patient's particular need and use for the instrument.

[0049] Additionally, the first and second pressure plates 110 and 112 comprise distal ends 110a and 112a and proximal ends 110b and 112b respectively, wherein the distal ends 110a and 112a are wider than the corresponding proximal ends 110b and 112b, thereby creating a slight wedging effect to enable a user to express a proportional and directional pressure gradient from the distal ends 110a, 110b to the proximal ends 112a, 112b of the pressure plates 110, 112 so as to generate more effective secretions to unblock the meibum gland openings from the eyelids.

[0050] In some embodiments, the distal ends 110a, 112a of each pressure plate 110, 112 are one millimeter in width and the proximal ends 110b, 112b of each pressure plate 110, 112 are eight tenths of one millimeter. The tapering of the pressure plates 110, 112 is designed to allow for more directional pressure on a patient's eyelid.

[0051] Further, in one embodiment, the exfoliating member 108 and the pressure plates 110 and 112 are removably attached to the main body 102. Further, the exfoliating member 108 is recessed into the proximal end 102a of the main body 102.

[0052] FIG. 3a illustrates the front view of the preferred embodiment of the specialty instrument, namely, the slightly curved pressure plates 110 and 112, wherein both pressure plates 110, 112 are angled downwards from the first and the second longitudinal planes 105, 107 of the elongated arms 104, 106. In the preferred embodiment, the pressure plates 110 and 112 are configured with a radius of curvature of about 0.12 mm.

[0053] In another embodiment as illustrated in FIG. 3b, the pressure plates 130, 132 are flat and non-curved, wherein the distal ends 130a, 132a are defined by non-marring round edges 130c, 132c to minimize the risk of damaging the delicate skins in the proximity of eyelids and eyeballs.

[0054] FIG. 4 illustrates the back view of the preferred embodiment of the specialty instrument, including the exfoliating member 108 located near the proximal end 102a, the first arm 104 with the first pressure plate 110, the second arm 106 with the second pressure plate 112, wherein the first pressure plate 110 further comprises the distal end 110a and the proximal end 110b, and wherein the second pressure plate 112 further comprises the distal end 112a and the proximal end 112b. In some embodiments, the first and the second pressure plates are made of medical-grade plastic composites as they are disposable after a single use which are configured to be removably attached to the arms 104 and 106 at the distal end 102b. In other embodiments, the pressure plates are made of metal composites, ceramics, or polymers as they are fully reusable or partially reusable.

[0055] FIGS. 5 and 6 illustrate the left and right-side views of the angled distal end 102b with the curved pressure plates 110 and 112 in the preferred embodiment. The overall length and width of the specialty instrument 100 may vary. However, in some embodiments, the length is between eighty to one hundred and twenty millimeters; the width is between five and ten millimeters; the length of the angled portion including the pressure plates is between ten and fifteen millimeters; and the average thickness of the specialty instrument is about six millimeters. The first arm 104 and the second arm 106 of the main body 102 preferably comprise continuous flat surfaces between the distal end 102a and the proximal end 102b.

[0056] The top and the bottom views of the specialty instrument 100 are shown in FIGS. 7 and 8. In one preferred embodiment, the width of the distal end 102b of the main body 102 is slightly smaller than that of the proximal end 102a. The overall thickness and the width of the exfoliating member 108 does not exceed those of the main body 102. In other embodiments, the overall width of the arms 104 and 106 are substantially the same.

[0057] FIG. 9 illustrates a schematic diagram showing a user using the ophthalmic specialty instrument 100 to treat a lower eyelid 210 of the user by positioning the instrument 100 at a 90° angle as it approaches the lower eyelid 210. The first pressure plate 110 is placed against the palpebral conjunctiva inside the lower eyelid 210 and the second pressure plate 112 is placed outside the lower eyelid 210 such that the user may exert pressure on the lower eyelid 210 by squeezing the first arm 104 and the second arm 106 against each other.

[0058] FIG. 10 illustrates a schematic diagram showing a user using the ophthalmic specialty instrument 100 to treat the upper eyelid 211 of the user by positioning the instrument at a 90° angle as it approaches the upper eyelid 211. The first pressure plate 110 is placed against the palpebral conjunctiva inside the upper eyelid 211 and the second pressure plate 112 is placed outside the upper eyelid 211 such that the user may exert pressure on the upper eyelid 211 by squeezing the first arm 104 and the second arm 106 against each other.

[0059] FIGS. 11-12 illustrate schematic diagrams showing a user utilizing the exfoliator member 108 of the ophthalmic specialty instrument 100 to debride his or her upper eyelid margin 221 and the lower eyelid margin 220. In one embodiment, the exfoliating member 108 is 25 mm long and is gently curved to exfoliate keratinized cells and debride the eyelid margins to facilitate the opening of the clogged meibomian gland orifices before pressuring the glands directly using the pressure plates based on the severity of the condition. In another embodiment, the exfoliating member 108 is recessed into the proximal end of the instrument 100 and extended longitudinally such that the back end of the exfoliating member is flush with the common pivotal connecting point.

[0060] FIG. 13 illustrates a flow diagram for one method of treating patients with MGD 3, wherein initially at step 510, a patient is holding the first and the second arms of the specialty instrument near the middle of the main body. At step 520, the patient is approaching the eyelid with MGD syndrome at a substantially ninety-degree angle (preferably between eighty-five to ninety-five degrees to the eyelid margin (as opposed to sideways as taught in the relevant art)). At step 530, the patient is positioning the first pressure plate 110 on the inside of the eyelid and the second pressure plate 112 in apposition on the outside of the eyelid. At step 540, the patient is applying pressure to one or more meibomian glands and mechanically expressing the one or more meibomian glands via the first pressure plate 110 and the second pressure plate 112 by squeezing the first arm and the second arm towards each other such that the first pressure plate exerts a downward pressure against the eyelid from the inside and the second pressure plate exerts an upward pressure against the eyelid from the outside. Alternatively,

[0061] In another method of treating patients with more severe MGD as shown in FIG. 14, if the one or more meibomian glands are severely clogged, the patient may first use the exfoliating member to unclog the meibomian glands gently before positioning the pressure plates on the distal end of the specialty instrument over the eyelid. At step 610, the patient is exfoliating the clearing away keratinized cells (hardened cells filled with protein) of the lid margin to unblock the meibomian gland orifices of debris and dead cells, which allows for easier expression of meibomian gland content. At step 620, the patient is holding the first arm and the second arm of the specialty instrument near the middle portion of the main body. At step 630, the patient is approaching the eyelid with MGD at a substantially 90° angle (preferably between eighty-five to ninety-five degrees to the eyelid margin to the eyelid margin). At step 640, the patient is positioning the first pressure plate on the inside of the eyelid and the second pressure plate in apposition on the outside of the eyelid. At step 650, the patient is applying pressure to one or more meibomian glands and mechanically expressing the one or more meibomian glands via the first and the second pressure plates by squeezing the first and the second arms toward each other such that the first pressure plate exerts a downward pressure against the eyelid from the inside and the second pressure plate exerts an upward pressure against the eyelid from the outside.

[0062] As shown herein, an ophthalmic specialty instrument configured to allow patients to treat MGD and other dry eye conditions themselves which is easy to operate and more effective is disclosed by utilizing a pair of angled and slightly wedged pressure plates attached to the distal ends of two arms and an exfoliating member attached to the proximal end of the arms; wherein the two arms are pivotably coupled to a common connection point; and wherein the pressure plates are bent downwardly and outwardly from the longitudinal planes of the arms and have gentle radius of curvature that match the curvature of eyelids.