Apparatus for inverting an eyelid, a pair of gripping parts used for the apparatus for inverting an eyelid, and a kit for inverting an eyelid

Abstract

An eyelid flipping device and a pair of disposable grippers for use with the eyelid flipping device are described. The eyelid flipping device includes first and second arms extending from a common joint end and each having a distal end opposite the common joint end, a first gripper attached to the distal end of the first arm and having a contact surface on its inwardly facing surface, and a second gripper attached to the distal end of the second arm and having a contact surface on its inwardly facing surface, the contact surfaces facing opposite and spaced apart, such that the contact surfaces come into contact when the arms are pressed together, and at least one of the grippers has an extended tab protruding from its outwardly facing surface opposite the contact surface.

Description

Technical Field

[0001] This application generally relates to medical devices, and more specifically, to an instrument for eversion of the eyelid.

Background Art

[0002] It is estimated that 18% of Americans are diagnosed with dry eye disease, and another 30% of the population may have dry eye disease but have not yet been diagnosed. Usually, dry eye disease is known to be more common in the elderly, especially postmenopausal women, but currently it affects all age groups regardless of gender, mainly due to the increasing use of smartphones and computers.

[0003] Dry eye is a multifactorial disease of the ocular surface characterized by the loss of tear film homeostasis, and is accompanied by symptoms of the eye in which tear film instability and high osmotic pressure (inflammation and damage of the ocular surface) and sensory nerve abnormalities play etiological roles. It has been concluded that the main cause of dry eye disease is meibomian gland dysfunction (MGD). MGD is a broad term that defines functional abnormalities of the meibomian glands.

[0004] The meibomian glands are vertically present in the upper and lower eyelids. There are 30 - 40 meibomian glands in the upper eyelid and 20 - 30 meibomian glands in the lower eyelid. They differ in number, secretion volume, and length. The meibomian glands supply lipids, which constitute most of the surface layer of the tear film and play a role in preventing evaporation of the aqueous layer. The meibomian glands play an important role in the health of the ocular surface. When meibomian gland dysfunction occurs, the quality and quantity of meibum (the oily substance that prevents evaporation of the eye's tear film) change, which has an adverse effect on the ocular surface.

[0005] For the diagnosis of MGD, both meibography and the evaluation of the expression and quality of meibomian glands in both the upper and lower meibomian glands are required. Meibography enables objective and reproducible observation of meibomian glands. Meibography is used to evaluate the integrity of the glands, including gland shedding, atrophy, truncation, and other abnormalities related to MGD. Currently available meibographs not only provide clear images of the patient's meibomian glands but also support the storage of the patient's images for comparison and follow-up over time.

[0006] Comparison and follow-up over time are important for both disease management and patient engagement. Recent advances suggest that gland atrophy, which was believed to be permanent, may be reversible with appropriate treatment. MGD is a chronic disease that requires treatment by eye care professionals supported by patient home care. As with any chronic disease state, patient engagement and compliance are the keys to success. The patient's ability to understand the disease and how they can affect disease management over time is important. Showing the patient their own meibography images of their meibomian glands and demonstrating changes over time is beneficial in promoting the patient's continued participation in their own care.

Summary of the Invention

Problems to be Solved by the Invention

[0007] To best examine the structure and function of the meibomian glands, imaging and clinical evaluation of both the upper and lower eyelids are required. To visualize the meibomian glands, the eyelids need to be flipped. The lower eyelid can be easily flipped with one hand using a cotton swab. The upper eyelid is more difficult and requires both hands. This is usually done using the fingers of one hand and a cotton swab held by the other hand. The important challenge is to stretch both hands around the meibograph to flip the upper eyelid, move the patient forward to rest the forehead and chin, and then focus on the eyelid to take an image. In many cases, in practice, only the meibomian glands of the lower eyelid are evaluated and imaged.

Brief Description of the Drawings

[0008] Here, as an example, refer to the accompanying drawings showing embodiments of the present application.

Figure 1

Figure 2

Figure 3A

Figure 3B

Figure 3C

Figure 3D

Figure 4

Figure 5

Figure 6

Figure 7

[0009] For the purpose of showing similar components, the same reference numerals may be used in different figures.

Embodiments for Carrying Out the Invention

[0010] In a first aspect, the present application describes an instrument for eversion of the eyelid. The instrument includes a first arm and a second arm extending from a common joint end, each having a distal end opposite the common joint end, a first gripping portion attached to the distal end of the first arm and having a contact surface on its inner face, and a second gripping portion attached to the distal end of the second arm and having a contact surface on its inner face. These contact surfaces face each other and are spaced apart, and when the first arm and the second arm are pressed against each other, these contact surfaces come into contact. At least one of the first gripping portion and the second gripping portion has an extension tab protruding from the outer face opposite its contact surface.

[0011] In some embodiments, the common joint end is joined to provide elastic deformation when these arms are pressed against each other.

[0012] In some embodiments, the instrument further includes a first handgrip provided on the first arm and a second handgrip provided on the second arm, and the first handgrip and the second handgrip are each provided between the distal end and the common joint end. In some examples, the first arm, the second arm, the first handgrip, and the second handgrip are integrally formed as one unit. In some examples, the first handgrip and the second handgrip are partially circular to facilitate rotation by the user of the instrument. In such examples, the first handgrip and the second handgrip are in a semi-cylindrical shape, each handgrip extending axially along the length of its respective arm, and when these arms are pressed against each other, the first handgrip and the second handgrip together form a cylindrical shape and these contact surfaces come into contact.

[0013] In some embodiments, the common joint end is fixed by a hinge, elastically biased in the open position, and provides mechanical resistance when the arms are pressed against each other.

[0014] In some embodiments, the first gripping portion is frictionally attached to the distal end of the first arm, and the second gripping portion is frictionally attached to the distal end of the second arm.

[0015] In some embodiments, each of the first gripping portion and the second gripping portion has an axially key-shaped hole, and each of the first arm and the second arm has a corresponding key shape that matches the axially key-shaped hole.

[0016] In some embodiments, the first gripping portion and the second gripping portion are made of silicon.

[0017] In some embodiments, the first gripping portion and the second gripping portion are disposable.

[0018] In some embodiments, the contact surface of the first gripping portion defines a longitudinally extending groove parallel to the axis along which the first arm extends, and the contact surface of the second gripping portion defines a protruding tongue that extends longitudinally parallel to the axis along which the second arm extends. When these contact surfaces come into contact, the tongue fits into the groove.

[0019] In some embodiments, the protruding expansion tab extends longitudinally along at least a portion of the length of at least one of the first gripping portion and the second gripping portion, and the protruding expansion tab is shaped such that its width decreases at the arcuate tip from a wide base located on the outer surface of at least one of the first gripping portion and the second gripping portion.

[0020] In some embodiments, each of the first gripping portion and the second gripping portion has an expansion tab protruding from its respective outer surface opposite the contact surface.

[0021] In a second aspect, the present application describes a pair of disposable gripping parts for use in an instrument for eversion of the eyelid. The pair of disposable gripping parts includes a first disposable gripping part having a contact surface on its first surface and a second disposable gripping part having a contact surface on its first surface, and at least one of the first disposable gripping part and the second disposable gripping part has an extension tab protruding from a second surface opposite to the contact surface.

[0022] In some embodiments, each of the first disposable gripping part and the second disposable gripping part has an axially key-shaped hole formed to match the corresponding key shape of the arm of the instrument for eversion of the eyelid.

[0023] In some embodiments, the first disposable gripping part and the second disposable gripping part are made of silicon.

[0024] In some embodiments, the contact surface of the first disposable gripping part defines a groove extending in the longitudinal direction along the length of the first disposable gripping part, and the contact surface of the second disposable gripping part defines a protruding tongue extending in the longitudinal direction along the length of the second disposable gripping part, and when these contact surfaces come into contact, the tongue fits into the groove.

[0025] In some embodiments, the protruding extension tab extends in the longitudinal direction along at least a part of the length of at least one of the first disposable gripping part and the second disposable gripping part, and the extension tab is shaped such that the width decreases at the arcuate tip from a wide base located on the second surface of at least one of the first disposable gripping part and the second disposable gripping part.

[0026] In some embodiments, each of the first disposable gripping part and the second disposable gripping part has an extension tab protruding from its respective second surface opposite to the contact surface.

[0027] Other aspects and features of the present application will be understood by those skilled in the art by considering the following description of the examples in conjunction with the accompanying drawings.

[0028] In this application, the terms "about", "approximately", and "substantially" mean including variations of the upper and lower limits of a range of values, such as variations in characteristics, parameters, dimensions, etc. By way of non-limiting example, the terms "about", "approximately", "substantially" may mean plus or minus 10% or less.

[0029] In this application, the term "and / or" means including all possible combinations and sub-combinations of the recited elements, which includes any one only of the recited elements, any sub-combination, or all of the elements, and does not necessarily exclude additional elements.

[0030] In this application, the phrase "at least one of" means including any one or more of the recited elements, which includes any one only of the recited elements, any sub-combination, or all of the elements, and does not necessarily exclude additional elements and does not necessarily require all of the elements.

[0031] First, refer to FIG. 1, which is a perspective view of an example of an instrument 100 for flipping the eyelid. This instrument 100 includes a first arm 102, a second arm 104, a first handgrip 108, a second handgrip 110, a first gripping portion 112, and a second gripping portion 114. As shown in the figure, both the first arm 102 and the second arm 104 extend from a common joint end 106 and each have a distal end opposite to the common joint end 106. In one embodiment, the common joint end 106 is joined, thereby providing elastic deformation when these arms are pressed against each other (like the operation of pliers). The arms can be joined at the common joint end 106 using, for example, an adhesive or a fixing part. In some embodiments, except for the gripping portions 112, 114, the complete instrument 100 is integrally formed as one unit, that is, the connected first arm 102, second arm 104, first handgrip 108, and second handgrip 110 can be formed in a pre-machined mold by injection molding, multi-material injection molding, or other such manufacturing methods. The parts of the instrument 100 can be made of, for example, metal, plastic, rubber, other polymers, or any combination of materials. In another embodiment, the common joint end 106 is fixed by a hinge and is elastically biased in the open position, providing mechanical resistance when these arms are pressed against each other.

[0032] An instrument 100 for inverting an eyelid includes a first handgrip 108 provided on a first arm 102 and a second handgrip 110 provided on a second arm 104. Each handgrip 108, 110 is provided between a distal end of its respective arm and a common joint end 106. In one embodiment, the first handgrip 108 and the second handgrip 110 can be partially circular, or in other words, can be circular in any way to facilitate rotation of the instrument 100. As shown in FIG. 1, in an exemplary embodiment, the first handgrip 108 and the second handgrip 110 can be semi-cylindrical, and each handgrip 108, 110 can extend axially along the length of its respective arm 102, 104. In other words, each semi-cylindrical handgrip 108, 110 can be provided or formed at any location between both ends of its respective arm 102, 104 and can have any suitable length. The handgrips 108, 110 in this example have a semi-circular cross-section. With this semi-cylindrical shape, when the first arm 102 and the second arm 104 are pressed against each other to such an extent that the contact surfaces of the first gripping portion 112 and the second gripping portion 114 come into contact, the operator of the instrument 100 can easily rotate the instrument 100 axially by utilizing the handgrips 108, 110 and the rotational movement between the operator's thumb and fingers holding the handgrips 108, 110. Such a circular shape facilitates the rotation of the pinched thumb and fingers and can reduce the required amount of rotation of the operator's wrist. This mechanism will be further described in relation to FIG. 7.

[0033] The first gripping portion 112 is attached to the distal end of the first arm 102 and has a contact surface on its inward-facing surface. The second gripping portion 114 is attached to the distal end of the second arm 104 and has a contact surface on its inward-facing surface. As shown in the figure, in the open (unpressurized) state of the instrument 100, the contact surfaces of the respective gripping portions 112, 114 face each other and are separated. When the first arm 102 and the second arm 104 are pressed against each other, the contact surfaces of the first gripping portion 112 and the second gripping portion 114 come into contact. The first gripping portion 112 and the second gripping portion 114 can be made of, for example, silicon or other materials suitable for contact with the human eye. For hygienic purposes, the gripping portions 112, 114 can be used only once and / or be disposable.

[0034] Figure 2 is a perspective view of an example of a pair of disposable gripping portions used in an instrument for flipping the eyelid. The pair of disposable gripping portions includes a first disposable gripping portion 202 having a contact surface on its inner surface and a second disposable gripping portion 204 having a contact surface on its inner surface. In a state where the instrument is in an open position, the inner surfaces of the respective gripping portions 202, 204 face each other and are separated. In an exemplary embodiment, the contact surface of the first disposable gripping portion 202 defines a groove 206 extending in the longitudinal direction along the length of the first disposable gripping portion 202, and the contact surface of the second disposable gripping portion 204 defines a protruding tongue portion 208 extending in the longitudinal direction along the length of the second disposable gripping portion 204. In some examples, the tongue portion 208 is shaped and arranged to fit into the groove 206 when the contact surfaces come into contact, thereby enabling reliable gripping. At least one of the first disposable gripping portion 202 and the second disposable gripping portion 204 has an extension tab 210 protruding from the outer surface opposite to its inner surface. In the example of Figure 2, each of the first disposable gripping portion 202 and the second disposable gripping portion 204 has an extension tab 210 protruding from the respective outer surface opposite to its respective inner surface. In one embodiment, the protruding extension tab 210 extends in the longitudinal direction along at least a part of the length of each gripping portion 202, 204. In some exemplary embodiments, the extension tab 210 is shaped such that its width decreases at the arcuate tip from a wide base.

[0035] Figures 3A-3D are perspective views of an alternative pair of disposable gripping portions used in an instrument for flipping an eyelid. In the example of FIG. 3A, the shape of the pair of disposable gripping portions is wider than the shape of the gripping portion of FIG. 2. Further, the extension tabs form arcuate or curved tips 302 that protrude from the wide base 304 but have different shapes. However, it will be understood that the extension tabs need not have arcuate or curved tips 302, nor need they have a base 304 that is wider than the tip 302. As will be described later, the extension tabs protrude so as to provide a fulcrum for the tarsus in the patient's eyelid when rotating the flipping instrument to flip the patient's eyelid. As shown in the alternative disposable gripping portions of FIGS. 3B, 3C, and 3D, the extension tabs need not be distinct extensions protruding from the outer surface of the gripping portion, but can be, for example, part of the gripping portion on the side opposite the inner surface. In other words, the extension tabs can be formed (integrally) in the longitudinal direction along the entire length of each gripping portion between the base 304 and the tip 302 near the contact surface.

[0036] In some of the examples described above, each contact surface features a gripping surface (FIGS. 3A, 3B) with a tongue and groove, but it will be understood that different gripping surfaces can be used in other embodiments. For example, the contact surface can be flat (FIG. 3C). In some examples, the contact surface can have a pattern such as ridges, cross-ridges, pits, knobs, or other such gripping patterns (FIG. 3D).

[0037] Any shape of disposable gripping portion can be utilized as long as their contact surfaces cooperate to grip and contact.

[0038] FIG. 4 is a side view and a detailed cross-sectional view along line A-A of an example of a disposable gripping portion. The disposable gripping portion 402 is attached to the arm of an instrument for flipping an eyelid. As shown in the detailed cross-sectional view A-A, the disposable gripping portion 402 has an axially key-shaped hole 404. The shape of the axially key-shaped hole 404 can be selected as any suitable shape having at least one flat surface and / or right angle that prevents movement or rotation of the disposable gripping portion 402.

[0039] Figure 5 shows the attachment and detachment of the exemplary disposable gripping portion of FIG. 4 to the arm of the eyelid flipping instrument. The distal end of the arm of the instrument has a corresponding key shape 502 that mates with the axially key-shaped hole 404 of the disposable gripping portion 402. As a result, the disposable gripping portion 402 can be frictionally attached to the distal end of the arm. The disposable gripping portion 402 can be removed by simply sliding it off the instrument arm.

[0040] Figure 6 is a side view showing an example of the sequence showing the flipping of the upper eyelid of a subject by the eyelid flipping instrument.

[0041] Step 602 shows the subject's eye in an open state, with the upper eyelashes shown.

[0042] In step 604, the eyelid flipping instrument is placed near the subject's eye in an unpressurized state, and the subject's upper eyelashes are placed between the first gripping portion and the second gripping portion.

[0043] In step 606, the eyelid flipping instrument is pressurized by squeezing the arm handgrips (not shown) together to securely grip the subject's upper eyelashes.

[0044] In step 608, the eyelid flipping instrument is pulled directly away from the subject, thereby pulling the subject's eyelid away from the surface of the subject's eye.

[0045] In step 610, while pulling the instrument directly away from the subject, the eyelid flipping instrument is rotated using the handgrips, and the expansion tab is pressed against the subject's upper eyelid.

[0046] In step 612, the rotation of the instrument is continued until the subject's eyelid flips and the meibomian glands are exposed.

[0047] FIG. 7 shows the ergonomics of the device for flipping the eyelid of FIG. 1 in use. As described above, the first handgrip and the second handgrip of the device are semi-cylindrical in shape and can extend axially along the length of their respective arms. As shown in the figure, the user of the device is holding the device using the index finger and the thumb. The arms of the device are fully pressed against each other, and the gripping portions are in contact at the contact surfaces. In this initial position 700, both the first handgrip and the second handgrip together form a cylindrical shape in the user's hand. This integrated circular-shaped handgrip facilitates rotation by the user of the device when the user rotates the device to the rotational position 710 using the handgrip. As shown in FIG. 7, since this device can be easily used with one hand, the other hand of the user can operate the myograph or perform other such tasks.

[0048] As described above, certain adjustments and modifications of the described embodiments are possible. Accordingly, the above embodiments are illustrative and not limiting.

Claims

1. An instrument for eversion of the eyelid, comprising: a first arm and a second arm extending from a common joint end along respective individual longitudinal axes, each having a distal end opposite said common joint end; a first gripping portion configured to be attached by friction to the distal end of said first arm, said first gripping portion having a contact surface on its inner face; a second gripping portion configured to be attached by friction to the distal end of said second arm, said second gripping portion having a contact surface on its inner face; wherein said contact surfaces face each other and are spaced apart, and when said first arm and said second arm are pressed against each other, said contact surfaces come into contact; at least one of said first gripping portion and said second gripping portion is an extension tab provided parallel to one of said individual longitudinal axes, protruding radially outward from the outer face of at least one of said first gripping portion and said second gripping portion, located on the side opposite to said contact surface; An instrument for eversion of the eyelid.

2. The instrument for eversion of the eyelid according to claim 1, wherein said common joint end is joined and provides elastic deformation when said first arm and said second arm are pressed against each other.

3. The instrument for eversion of the eyelid according to claim 1, wherein said common joint end is fixed by a hinge and is elastically biased in an open position, and provides mechanical resistance when said first arm and said second arm are pressed against each other.

4. further comprising a first handgrip provided on said first arm and a second handgrip provided on said second arm, wherein said first handgrip and said second handgrip are each provided between the distal end and said common joint end, and said first handgrip and said second handgrip are partially circular to facilitate rotation by a user of the instrument, the instrument for eversion of the eyelid according to any one of claims 1 to 3.

5. said first handgrip and said second handgrip are in a semi-cylindrical shape, each handgrip extending axially along the length of its respective arm, and when said arms are pressed against each other and said contact surfaces come into contact, said first handgrip and said second handgrip together form a cylindrical shape, the instrument for eversion of the eyelid according to claim 4.

6. Each of the first gripping part and the second gripping part has an axially key-shaped hole. The eyelid flipping device according to any one of claims 1 to 5, wherein each of the first arm and the second arm has a corresponding key shape that matches the axially key-shaped hole.

7. The eyelid flipping device according to any one of claims 1 to 6, wherein the first gripping part and the second gripping part are made of silicon.

8. The eyelid flipping device according to any one of claims 1 to 7, wherein the first gripping part and the second gripping part are disposable.

9. The contact surface of the first gripping part defines a groove extending in the length direction parallel to the first individual lengthwise axis along which the first arm extends. The contact surface of the second gripping part defines a protruding tongue extending in the length direction parallel to the second individual lengthwise axis along which the second arm extends. The eyelid flipping device according to any one of claims 1 to 8, wherein when the contact surfaces come into contact, the tongue fits into the groove.

10. The protruding expansion tab is shaped such that the width decreases at the arcuate tip from a wide base located on the outer surface of at least one of the first gripping part and the second gripping part. The eyelid flipping device according to any one of claims 1 to 9.

11. A pair of gripping parts for use in an eyelid flipping device, the eyelid flipping device having a first arm and a second arm extending from a common joint end along individual lengthwise axes, the first arm and the second arm each having a distal end on the opposite side of the common joint end. The pair of gripping parts are A first gripping part having a first central axis, configured to be frictionally attached to the distal end of the first arm along the individual lengthwise axis, and having a contact surface on its first surface. A second gripping part having a second central axis, configured to be frictionally attached to the distal end of the second arm along the individual lengthwise axis, and having a contact surface on its first surface. At least one of the first gripping part and the second gripping part is an expansion tab provided parallel to its central axis, and has an expansion tab protruding radially from a second surface opposite to the contact surface. A pair of gripping parts.

12. Each of the first gripping portion and the second gripping portion is an axially key-shaped hole extending in the longitudinal direction, and when attached by friction, is shaped to accommodate a corresponding key shape of the distal end portion of the first arm or the second arm. The pair of gripping portions according to claim 11, having an axially key-shaped hole.

13. The contact surface of the first gripping portion defines a groove extending in the longitudinal direction along the length of the first gripping portion. The contact surface of the second gripping portion defines a protruding tongue-shaped portion extending in the longitudinal direction along the length of the second gripping portion. When the contact surfaces come into contact, the tongue-shaped portion fits into the groove. The pair of gripping portions according to claim 11 or 12.

14. A kit for flipping an eyelid, An instrument for flipping an eyelid, including a first arm and a second arm extending from a common joint end along individual longitudinal axes, wherein the first arm and the second arm each have a distal end on the opposite side of the common joint end. An instrument for flipping an eyelid, A first gripping portion configured to be attached by friction to the distal end of the first arm, having a contact surface on its inward-facing surface. A first gripping portion, A second gripping portion configured to be attached by friction to the distal end of the second arm, having a contact surface on its inward-facing surface. A second gripping portion, The contact surfaces face each other and are spaced apart, and when the first arm and the second arm are pressed against each other, the contact surfaces come into contact. At least one of the first gripping portion and the second gripping portion is an expansion tab provided parallel to one of the individual longitudinal axes, and projects radially outward from an outer surface of at least one of the first gripping portion and the second gripping portion, located on the side opposite to the contact surface. An expansion tab. A kit for flipping an eyelid.

15. Each of the first gripping portion and the second gripping portion has an axially key-shaped hole. Each of the first arm and the second arm has a corresponding key shape that matches the axially key-shaped hole. The kit for flipping an eyelid according to claim 14.

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