Eye implants

Abstract

This invention discloses an eyeball implant. According to this invention, an eyeball implant can be permanently implanted on the eyeball without the hassle of attachment and detachment, and can form a beautiful appearance that is integrated with the pupil without blocking the light-entering aperture.

Description

Technical Field

[0001] The present invention relates to an implant for the eye.

Background Art

[0002] A circular lens for shaping purposes to enlarge the appearance of the iris - pupil complex is formed with a structure in which a dye is inserted between two different lenses. Compared with contact lenses for vision correction, there are problems such as a decrease in oxygen permeability and a non - uniform surface. As a result, while the contact area and contact opportunity between bacteria and the circular lens increase, there is a risk of causing side effects such as neovascularization, keratitis, corneal ulcer, corneal edema, etc. For example, neovascularization can reduce the appearance of the pupil contrary to the shaping purpose of the circular lens that attempts to enlarge the appearance of the pupil, and there is a risk of side effects such as corneal hypoxia causing the periphery of the cornea to become white and turbid due to neovascularization.

Summary of the Invention

Problems to be Solved by the Invention

[0003] One embodiment of the present invention includes an implant for the eye that can be permanently implanted on the eye without the hassle of attachment and detachment, and can form a beautiful appearance integrated with the pupil without blocking the light incident aperture.

[0004] One embodiment of the present invention includes an implant for the eye that adheres to discontinuous edges on the eye, minimizes side effects, and improves handling convenience.

[0005] One embodiment of the present invention includes an implant for the eye that can be adaptively deformed into a shape optimized for different pupil shapes and sizes for each implant recipient of the eye implant, while reducing production costs through a single - design mold to provide versatility.

[0006] One embodiment of the present invention includes an ophthalmic implant that improves the ease of the procedure and prevents side effects caused by a structure that takes ease of procedure into consideration. [Means for solving the problem]

[0007] An eye implant according to one embodiment of the present invention is An eye implant that is permanently implanted on the recipient's eyeball to provide the recipient's pupil with an enlarged appearance, A central opening that accommodates the incoming light toward the pupil (or iris) that provides the opening of the eyeball, The inner annular edge that surrounds the aforementioned opening and defines the opening, An outer annular edge that surrounds the opening together with the inner annular edge on the opposite side of the inner annular edge that defines the opening, The system may include a pupil expansion portion having a variable thickness that changes from the inner annular edge toward the outer annular edge between the inner annular edge and the outer annular edge.

[0008] An eye implant according to one embodiment of the present invention is An eye implant that is permanently implanted on the recipient's eyeball to provide the recipient's pupil with an enlarged appearance, A central opening that accommodates the incoming light toward the pupil, providing the opening of the eyeball, The inner annular edge that surrounds the aforementioned opening and defines the opening, An outer annular edge that surrounds the opening together with the inner annular edge on the opposite side of the inner annular edge that defines the opening, It may include an adaptive expandable portion that adaptively expands or contracts in length along at least one of the inner annular edge and the outer annular edge.

[0009] An eye implant according to one embodiment of the present invention is An eye implant that is permanently implanted on the recipient's eyeball to provide the recipient's pupil with an enlarged appearance, A central opening that accommodates the incoming light toward the pupil, providing the opening of the eyeball, The inner annular edge that surrounds the aforementioned opening and defines the opening, An outer annular edge that surrounds the opening together with the inner annular edge on the opposite side of the inner annular edge that defines the opening, The pupil dilator includes a pupil dilator formed between the inner annular edge and the outer annular edge, having first and second ends that are separated from each other via an incision and bound together toward each other via a surgical hole formed therein.

[0010] An eye implant according to one embodiment of the present invention is An eye implant that is permanently implanted on the recipient's eyeball to provide the recipient's pupil with an enlarged appearance, A central opening that accommodates the incoming light toward the pupil, providing the opening of the eyeball, The inner annular edge that surrounds the aforementioned opening and defines the opening, An outer annular edge that surrounds the opening together with the inner annular edge on the opposite side of the inner annular edge that defines the opening, The pupil dilator may include a pupil dilator formed between the inner annular edge and the outer annular edge, having first and second ends that are separated from each other via an incision and form a locking step joint or hook joint with respect to each other. [Effects of the Invention]

[0011] According to the present invention, it is possible to provide an eye implant that can be permanently implanted on the eyeball without the hassle of attachment and detachment, and that can form a beautiful appearance integrated with the pupil without blocking the light-entering aperture.

[0012] According to the present invention, it is possible to provide an intraocular implant that adheres to discontinuous edges on the eyeball, minimizes side effects, and improves handling convenience.

[0013] According to the present invention, by means of a single-designed mold to provide versatility, the production cost is reduced, and an intraocular implant that can be adaptively deformed into a shape optimized for the differential pupil shape and size for each transplant recipient of the intraocular implant can be provided.

[0014] According to the present invention, it is possible to provide an intraocular implant that improves the convenience of the operation of the intraocular implant and can block side effects caused by a structure considering the convenience of the operation.

Brief Description of the Drawings

[0015] [Figure 1] It is a diagram for explaining a schematic structure of an eyeball to which an intraocular implant according to an embodiment of the present invention is permanently implanted. [Figure 2] It is a diagram for explaining the implantation of an intraocular implant according to an embodiment of the present invention, and is a diagram showing an incision formed at any one location along the outer ring of the pupil. [Figure 3] It is a perspective view of an intraocular implant according to an embodiment of the present invention. [Figure 4] It is a plan view showing the intraocular implant shown in FIG. 3 as viewed from the front direction. [Figure 5] It is a cross-sectional view taken along the line V-V' of FIG. [Figure 6] It is a perspective view for explaining an adaptive expansion / contraction part applied to an intraocular implant according to an embodiment of the present invention. [Figure 7] It is a perspective view for explaining an adaptive expansion / contraction part applied to an intraocular implant according to an embodiment of the present invention, and is a perspective view for explaining a modified example of FIG. [Figure 8a] and [Figure 8b]A cross-sectional view of an intraocular implant along the circumferential direction of the pupil expansion part, which is a cross-sectional view for explaining different roughened surfaces having isotropic rotational resistance and anisotropic rotational resistance respectively. [Figure 9] A view for explaining an operative hole applied to an intraocular implant according to an embodiment of the present invention, which is a plan view of the intraocular implant shown as viewed from the front direction. [Figure 10a] to [Figure 10c] A view for explaining the locking step connection or hook connection of the first slit and the second slit applied to an intraocular implant according to different embodiments of the present invention, which is a perspective view of different intraocular implants. [Figure 11a] and [Figure 11b] Different views for explaining the locking step connection or hook connection of the assembly slit and the assembly hole applied to an intraocular implant according to an embodiment of the present invention. [Figure 12] A view showing a modified embodiment of the intraocular implant shown in FIG. 4. [Figure 13] A view showing a modified embodiment of the intraocular implant shown in FIG. 6. [Figure 14] In one embodiment of the present invention, it is a view for explaining a configuration in which different mechanisms for binding the first and second ends separated from each other through an incision portion toward each other are combined. [Figure 15] A view showing a modified embodiment of the intraocular implant shown in FIG. 9.

Mode for Carrying Out the Invention

[0016] [Best Mode for Carrying Out the Invention]

[0017] An intraocular implant according to an embodiment of the present invention is An intraocular implant that is permanently implanted on the eye of a transplant recipient so as to provide an appearance in which the pupil of the transplant recipient is enlarged, A central opening that accommodates the incoming light toward the pupil (or iris) that provides the opening of the eyeball, The inner annular edge that surrounds the aforementioned opening and defines the opening, An outer annular edge that surrounds the opening together with the inner annular edge on the opposite side of the inner annular edge that defines the opening, The system may include a pupil expansion portion having a variable thickness that changes from the inner annular edge toward the outer annular edge between the inner annular edge and the outer annular edge.

[0018] For example, the inner annular edge and the outer annular edge can surround the opening along different shapes.

[0019] For example, the inner annular edge is formed in an elliptical shape along the shape of the pupil and surrounds the outer ring of the pupil at adjacent positions, so as not to obstruct the pupil (or pupil) that forms the light entry aperture and to provide an appearance integrated with the pupil. The outer annular edge can be formed in a circular shape to provide a beautiful circular appearance.

[0020] For example, the inner annular edge is formed in an ellipse shape having different major axis lengths and minor axis lengths. The length of the aforementioned long axis is formed along the direction in which the transplant recipient's pair of eyes face each other. The aforementioned short axis length can be formed along a direction perpendicular to the aforementioned long axis length.

[0021] For example, the pupil dilation portion between the inner annular edge and the outer annular edge is formed such that one of the two positions along the short axis of the inner annular edge is wider than the other position. Within the circular area of ​​the outer annular edge, the elliptical shape of the inner annular edge can be formed in a deflected position, biased toward the other position.

[0022] For example, the pupil dilation portion is A posteriorly inclined surface positioned toward the eyeball so as to be in close contact with the eyeball, This may include a forward-facing curved surface positioned facing the outside world opposite the eyeball.

[0023] For example, the inner annular edge and the outer annular edge each form the front of the eyeball and are observed as elliptical and circular, respectively, along the frontal direction from the front to the back of the eyeball, where the lens (crystalline lens) that performs the lens function and the pupil (or pupil) that forms the aperture for light entry are located. The rearward inclined surface can be formed as a surface inclined at a constant tilt angle from a vertical plane perpendicular to the front direction, such that the inner annular edge and the outer annular edge form the front and rear positions, respectively.

[0024] For example, the rearward inclined surface can provide a support surface that is supported on an inclined surface formed on the packaging container of the eye implant.

[0025] For example, the forward curved surface can be formed along a spline curve in which the curvature or radius of curvature changes along the direction of inclination of the rear inclined surface.

[0026] For example, the pupil dilation portion may have a variable thickness, where the thickness between the rearward inclined surface and the front curved surface is variable.

[0027] For example, the thickness of the pupil dilation portion can be measured along a direction perpendicular to the rearward inclined surface, from the rearward inclined surface to the frontward curved surface.

[0028] For example, the inner annular edge can be formed with the forward curved surface and the rear inclined surface that form the thickness of the pupil dilation portion in contact with each other at a position where they are in contact with the opening.

[0029] For example, the outer annular edge can be formed such that the forward curved surface and the backward inclined surface that form the thickness of the pupil dilation portion abut each other on the opposite side of the inner annular edge that defines the opening.

[0030] For example, the forward curved surface and the backward inclined surface that form the thickness of the pupil dilation portion can come into contact with each other while forming an inner annular edge and an outer annular edge with rounded corner shapes, respectively.

[0031] For example, the inner annular edge is formed with a relatively gently rounded corner shape. The outer annular edge can be formed into a relatively sharply rounded corner shape.

[0032] For example, the thickness of the corner of the inner annular edge can be made thinner than the thickness of the corner of the outer annular edge.

[0033] For example, among the membrane tissue that surrounds the eyeball to maintain its shape, the inner annular edge that is drawn in to the discontinuous edge between the cornea, which has a large curvature that protrudes forward in a convex shape, and the sclera, which has a small curvature that extends posteriorly from the cornea, has a relatively gently rounded corner shape, which can be used to finish one side of an eyeball implant.

[0034] The outer annular edge of the large curvature portion that adheres closely to the sclera has a relatively sharply rounded corner shape to prevent lifting from the sclera or the formation of gaps between it and the sclera, and allows for finishing of the other side of the ophthalmic implant.

[0035] The pupil dilation portion has a maximum thickness portion having the greatest thickness between the inner annular edge and the outer annular edge, An inner portion formed relatively adjacent to the opening, between the inner annular edge and the maximum thickness portion, It may include an outer portion formed relatively far from the opening, between the maximum thickness portion and the outer annular edge.

[0036] For example, the inner and outer portions, which are positioned on either side of the maximum thickness portion, may have asymmetrical shapes or asymmetrical thickness profiles.

[0037] For example, the inner portion is formed to be relatively flexible so as to adapt to the pupil of each transplant recipient. The outer portion can be formed relatively rigid to maintain a beautiful circular appearance against deformation of the inner portion and to reinforce the flexibility of the inner portion, thereby providing support rigidity for the eye implant.

[0038] For example, the inner portion can be formed to be thinner than the outer portion so as to be drawn in to the discontinuous edge between the cornea, which is a large curvature portion that protrudes forward in a convex shape, and the sclera, which is a small curvature portion that extends posteriorly from the cornea, and to adhere closely to the discontinuous edge so as not to form a gap between it and the discontinuous edge.

[0039] For example, the inner and outer parts are formed from the same material, The thickness of the inner portion can be formed to be relatively thinner than the thickness of the outer portion.

[0040] For example, the pupil dilation portion includes a forward curved surface and a backward inclined surface that form the thickness of the pupil dilation portion. The first average thickness of the inner portion and the second average thickness of the outer portion formed by the rearward inclined surface and the front curved surface can be formed such that the first average thickness < the second average thickness.

[0041] For example, using the rearward inclined surface that provides a reference for the thickness of the pupil dilation portion as a reference, The forward curved surface forming the inner portion extends along a trajectory that is relatively adjacent to the rearward inclined surface, and the forward curved surface forming the outer portion extends along a trajectory that is relatively far from the rearward inclined surface, thereby creating a difference in thickness between the inner and outer portions formed on both sides with respect to the maximum thickness portion.

[0042] For example, the forward curved surface forming the inner portion extends along a trajectory relatively adjacent to the rearward inclined surface, forming a relatively thin thickness, and further follows a relatively gentle downward curve toward the rearward inclined surface, forming a corner that is gently rounded by an inner annular edge. The forward curved surface forming the outer portion extends along a trajectory relatively far from the rearward inclined surface, forming a relatively thick surface, and further follows a relatively steep downward curve toward the rearward inclined surface, forming a corner that is sharply rounded at the outer annular edge.

[0043] For example, the forward curved surface forming the inner portion follows a downward curve from the maximum thickness portion toward the inner annular edge, and forms a gently rounded inner annular edge that follows a more abrupt downward curve via an inner inflection point, so as to finish one side of the eye implant. The forward curved surface forming the outer portion can form a sharply rounded outer annular edge by following a more abrupt downward curve via an outer inflection point, so as to finish the other side of the eye implant by following a downward curve from the maximum thickness portion toward the outer annular edge.

[0044] For example, along the inclination direction of the rearward inclined surface, the distance from the outer annular edge to the outer inflection point can be made relatively longer than the distance from the inner annular edge to the inner inflection point.

[0045] For example, the inner and outer inflection points can form the points with the largest change in curvature along the profiles of the forward curved surfaces that form the inner and outer portions, respectively.

[0046] An eye implant according to one embodiment of the present invention is An eye implant that is permanently implanted on the recipient's eyeball to provide the recipient's pupil with an enlarged appearance, A central opening that accommodates the incoming light toward the pupil (or iris) that provides the opening of the eyeball, The inner annular edge that surrounds the aforementioned opening and defines the opening, An outer annular edge that surrounds the opening together with the inner annular edge on the opposite side of the inner annular edge that defines the opening, The system may include an adaptive expandable section that provides adaptive length expansion and contraction around the inner annular edge and around at least one of the outer annular edges.

[0047] For example, the adaptive expandable portion can expand or contract in length along the inner annular edge so as to adaptively deform to the shape and size of each transplant recipient's pupil.

[0048] For example, the inner annular edge is formed in an ellipse shape having different major axis lengths and minor axis lengths. The adaptive expandable portion can provide length expansion and contraction along the major axis and / or minor axis so as to suitably and adaptively provide a slip-type ellipse with a relatively elongated major axis length and / or shortened minor axis length, and a nearly circular ellipse with a relatively shortened major axis length and / or elongated minor axis length inner annular edge to the pupil of the transplant recipient.

[0049] For example, the adaptive expandable portion may include at least one slit formed around the inner annular edge.

[0050] For example, the adaptive expandable portion may include a plurality of slits formed spaced apart from each other along the inner annular edge.

[0051] For example, the plurality of slits can be formed along the inner annular edge, spaced apart from each other at uniform intervals.

[0052] For example, the adaptive expandable portion may include a group of slits formed at positions on both sides along the long axis and / or on both sides along the short axis.

[0053] For example, the adaptive expandable part is, The fragments, separated from each other through the first and second groups of slits formed on both sides along the short axis, overlap each other, extending the short axis length while shortening the long axis length. The fragments, separated from each other through the third and fourth groups of slits formed on both sides along the longitudinal axis, overlap each other, allowing the longitudinal length to be extended while the minor length to be shortened.

[0054] For example, the slits can be formed at positions separated by a certain angle, with the center of the opening where the major axis length and minor axis length of the inner annular edge intersect as the rotation center.

[0055] For example, the slit is The first and second groups of slits are formed at 0-degree and 180-degree angular positions, respectively, along the short axis direction, The system may include third and fourth groups of slits formed at 90-degree and 270-degree angular positions, respectively, along the longitudinal axis.

[0056] For example, the slit can be drawn into the pupil dilator along the depth direction from the inner annular edge to the outer annular edge.

[0057] For example, the slit can be drawn into the pupil dilator with the radial direction from the center of the opening where the long axis length and the short axis length intersect as the depth direction.

[0058] For example, the adaptive expandable portion allows the segments, which are divided along the slits around the inner annular edge, to overlap with each other, thereby expanding or contracting the length of the inner annular edge.

[0059] For example, the pupil dilation portion is A posteriorly inclined surface positioned toward the eyeball so as to be in close contact with the eyeball, It is positioned facing the external world opposite to the eyeball and forms a thickness profile with respect to a rearward inclined surface, forming an inner annular edge while abutting with the rearward inclined surface at a position adjacent to the opening, forming an outer annular edge while abutting with the rearward inclined surface on the opposite side of the opening, and includes a front curved surface that forms a thickness profile with respect to the rearward inclined surface such that a relatively thin inner portion and a relatively thick outer portion are formed with respect to the maximum thickness portion which forms the maximum thickness between the inner annular edge and the outer annular edge, The fragments, separated from each other through the slits forming the adaptive expandable portion, can overlap each other and expand or contract the length of the inner annular edge, thereby forming an extra thickness that increases the thickness of the inner portion where the slits drawn in from the inner annular edge are formed.

[0060] For example, the adaptive expandable portion is formed on the inner annular edge surrounding the outer ring of the pupil at a position relatively adjacent to the outer annular edge, so as to adaptively deform to the shape and size of each transplant recipient's pupil. The outer annular edge does not need to be formed in order to maintain a beautiful circular appearance against deformation of the inner annular edge.

[0061] For example, the inner annular edge, in which the fragments divided through the slit forming the adaptive expandable portion are arranged to overlap each other, is formed with a relatively gently rounded corner shape. The outer annular edge can be formed into a relatively sharply rounded corner shape.

[0062] An eye implant according to one embodiment of the present invention is An eye implant that is permanently implanted on the recipient's eyeball to provide the recipient's pupil with an enlarged appearance, A central opening that accommodates the incoming light toward the pupil (or iris) that provides the opening of the eyeball, The inner annular edge that surrounds the aforementioned opening and defines the opening, An outer annular edge that surrounds the opening together with the inner annular edge on the opposite side of the inner annular edge that defines the opening, The pupil dilator includes a pupil dilator formed between the inner annular edge and the outer annular edge, having first and second ends that are separated from each other via an incision and bound together toward each other via a surgical hole formed therein.

[0063] For example, in the pupil dilation portion between the inner annular edge and the outer annular edge, Along the short axis direction of the inner annular edge, the positions on both sides are formed with a width that is relatively wider than the positions on both sides along the long axis direction of the inner annular edge, such that the ellipse of the inner annular edge is formed inside the circle of the outer annular edge. The incision, the first and second ends separated from each other through the incision, and the surgical holes formed on the first and second ends can be formed at either one of the two positions along the relatively wide short axis.

[0064] For example, in the pupil dilation portion between the inner annular edge and the outer annular edge, Along the short axis direction of the inner annular edge, the positions on both sides are formed with a relatively smaller curvature than the positions on both sides along the long axis direction of the inner annular edge. The aforementioned treatment hole can be formed at either one of two positions along the short axis direction, which is formed with a relatively small curvature.

[0065] For example, the incision is formed along the short axis direction of the inner annular edge, The first and second ends, separated from each other through the aforementioned incision, are bound together along the longitudinal axis of the inner annular edge. Each of the first and second ends may have a plurality of treatment holes arranged along the long axis of the inner annular edge.

[0066] For example, the aforementioned treatment hole is A first surgical hole through which a suture thread for binding the first end and the second end passes, The procedure may include a second surgical hole through which an implantation instrument can pass to pull the eyeball implant, so that the eyeball implant can be routed around the outer rim of the operator's pupil via an incision in the conjunctiva on the sclera.

[0067] For example, the first treatment hole is formed to be relatively small in diameter. The second treatment hole can be formed to be relatively large in diameter.

[0068] For example, the first surgical hole is formed in a position adjacent to the incision, The second surgical hole can be formed at a location relatively far from the incision site.

[0069] An eye implant according to one embodiment of the present invention is An eye implant that is permanently implanted on the recipient's eyeball to provide the recipient's pupil with an enlarged appearance, A central opening that accommodates the incoming light toward the pupil (or iris) that provides the opening of the eyeball, The inner annular edge that surrounds the aforementioned opening and defines the opening, An outer annular edge that surrounds the opening together with the inner annular edge on the opposite side of the inner annular edge that defines the opening, The pupil dilator includes a pupil dilator formed between the inner annular edge and the outer annular edge, which is separated from each other via an incision and includes first and second ends that form a locking step joint or hook joint with respect to each other.

[0070] For example, in the pupil dilation portion between the inner annular edge and the outer annular edge, Along the short axis direction of the inner annular edge, the positions on both sides are formed with a width that is relatively wider than the positions on both sides along the long axis direction of the inner annular edge, such that the ellipse of the inner annular edge is formed inside the circle of the outer annular edge. The incision, the first and second ends separated from each other through the incision, and the locking step joint or hook joint between the first and second ends can be formed at either one of the two positions along the short axis, which is formed with a relatively wide width.

[0071] For example, the locking step coupling or hook coupling is The first and second slits formed on the first and second ends, respectively, may be included.

[0072] For example, at least a portion of the first and second slits can be formed in complementary shapes to each other to form a locking step connection or hook connection and can be fitted together with each other.

[0073] For example, the first and second slits are, A first portion extending along the longitudinal axis of the inner annular edge, The implant may include a second portion that extends from the first portion toward the inner or outer annular edge along the short axis direction of the inner annular edge, or along a diagonal direction that simultaneously follows the short axis direction and the long axis direction, and is open to the outside of the ophthalmic implant.

[0074] For example, the first portion of the first slit and the first portion of the second slit extend side by side along the longitudinal axis of the inner annular edge, The second portions of the first and second slits are formed in complementary shapes, and the second portion of either one of the first and second slits and the other slit are open to the outside of the eye implant, extending in opposite directions toward the outer and inner annular edges, respectively.

[0075] For example, the incision is formed along the short axis direction of the inner annular edge, The first and second ends are adjacent to each other along the longitudinal axis of the inner annular edge, Either the first or second slit may include an array of slits formed along the longitudinal axis on the first or second end, while the other slit may be formed as a single slit.

[0076] For example, the locking step coupling or hook coupling is The assembly slit formed at the first end, The second end may include an assembly hole formed therein, into which the assembly slit is fitted.

[0077] For example, an assembly guide portion can be formed on the first end, positioned in front of the assembly slit along the assembly direction between the first end and the second end.

[0078] For example, the assembly guide unit is It includes a front end projection formed with a relatively narrow width at the tip of the first end along the assembly direction between the first and second ends, and a rear end located behind the front end projection and in front of the assembly slit, but formed with a width relatively wider than the narrowed portion of the assembly slit, The variable width portion may further include a variable width portion that converges toward the projection along a diagonal direction that simultaneously follows the long axis direction corresponding to the assembly direction and the short axis direction intersecting the long axis direction, so as to connect the front end projection, which is formed with a relatively narrow width, and the rear end, which is formed with a relatively wide width, with a width that is equal to the difference between them.

[0079] For example, the rear end of the assembly guide portion can be connected to the entire width of the first end portion interposed between the assembly guide portion and the assembly slit.

[0080] For example, a cutting line including an arrangement of multiple perforations can be formed between the assembly guide portion and the entire width of the first end portion.

[0081] For example, the assembly slit is drawn in from both sides of the inner and outer annular edges along the short axis direction of the inner annular edge, forming a narrowed portion of the minimum width. By fitting the narrowed portion of the assembly slit into the assembly hole on the second end side, separation between the first and second ends can be prevented through the entire width of the relatively wide first end formed before and after the assembly slit.

[0082] [Modes for carrying out the invention] Hereinafter, with reference to the attached drawings, a preferred embodiment of the eye implant 100 of the present invention will be described.

[0083] Figure 1 shows a schematic diagram illustrating the structure of an eyeball to which an eyeball implant according to one embodiment of the present invention will be permanently placed. Figure 2 is a diagram illustrating the procedure for an eyeball implant according to one embodiment of the present invention, showing an incision made at one location along the outer ring of the pupil. Figure 3 shows a perspective view of an eye implant according to one embodiment of the present invention. Figure 4 shows a plan view of the eye implant shown in Figure 3, viewed from the front. Figure 5 shows a cross-sectional view along line VV' in Figure 3. Figure 6 shows a perspective view illustrating an adaptive expandable section applied to an ophthalmic implant according to one embodiment of the present invention. Figure 7 is a perspective view illustrating an adaptive expandable section applied to an eye implant according to one embodiment of the present invention, and shows a perspective view illustrating a modified example of Figure 6. Figures 8a and 8b show cross-sectional views of an eyeball implant taken along the circumferential direction of the pupil dilator, illustrating cross-sectional views of surfaces with different roughness levels, one having isotropic rotational resistance and the other anisotropic rotational resistance. Figure 9 is a diagram illustrating a surgical hole applied to an ophthalmic implant according to one embodiment of the present invention, and shows a plan view of the ophthalmic implant as seen from the front. Figures 10a to 10c are diagrams illustrating the locking step connection or hook connection between a first slit and a second slit applied to eye implants according to different embodiments of the present invention, and show perspective views of different eye implants. Figures 11a and 11b show different diagrams illustrating locking step or hook connections of assembly slits and assembly holes applied to an ophthalmic implant according to one embodiment of the present invention.

[0084] The following describes an eyeball implant 100 according to one aspect of the present invention, comprising a pupil dilator 105 formed with a variable thickness between an inner annular edge 101 and an outer annular edge 102, the shape of a front curved surface 120 that forms a variable thickness profile on the rearward inclined surface 110 of the pupil dilator 105, and the circular and elliptical profiles formed by the inner annular edge 101 and the outer annular edge 102, respectively.

[0085] Figure 1 shows a schematic diagram illustrating the structure of an eyeball to which an eyeball implant according to one embodiment of the present invention will be permanently placed. Figure 2 is a diagram illustrating the procedure for an eyeball implant according to one embodiment of the present invention, showing an incision made at one location along the outer ring of the pupil. Figure 3 shows a perspective view of an eye implant according to one embodiment of the present invention. Figure 4 shows a plan view of the eye implant shown in Figure 3, viewed from the front. Figure 5 shows a cross-sectional view along line VV' in Figure 3.

[0086] An eye implant 100 according to one embodiment of the present invention is An eye implant 100 that is permanently implanted on the recipient's eyeball EB to provide the recipient's pupil with an enlarged appearance, A central opening OP that accommodates the incoming light toward the pupil (or pupil) providing the opening of the eyeball EB, The inner annular edge 101 that surrounds the aforementioned opening OP and defines the opening OP, An outer annular edge 102 surrounds the opening OP together with the inner annular edge 101 on the opposite side of the inner annular edge 101 that defines the opening OP, The pupil expansion portion 105, which has a variable thickness that changes from the inner annular edge 101 toward the outer annular edge 102 between the inner annular edge 101 and the outer annular edge 102, may be included.

[0087] For example, the inner annular edge 101 and the outer annular edge 102 can surround the opening OP along different shapes.

[0088] For example, the inner annular edge 101 is formed in an elliptical shape along the shape of the pupil and surrounds the outer ring of the pupil at adjacent positions, so as not to obstruct the pupil (or pupil) that forms the light entry aperture and to provide an appearance integrated with the pupil. The outer annular edge 102 can be formed in a circular shape to provide a beautiful circular appearance.

[0089] For example, the inner annular edge 101 is formed in an ellipse shape having different major axis lengths L1 and minor axis lengths L2. The aforementioned long axis length L1 is formed along the direction in which the transplant recipient's pair of eyes face each other. The aforementioned short axis length L2 can be formed along a direction perpendicular to the aforementioned long axis length L1.

[0090] For example, the pupil dilation portion 105 between the inner annular edge 101 and the outer annular edge 102 is formed such that one of the two positions along the short axis Z2 of the inner annular edge 101 is wider than the other position. Within the circular interior of the outer annular edge 102, the elliptical shape of the inner annular edge 101 can be formed in a deflected position that is biased toward the other position.

[0091] For example, the pupil dilation portion 105 is A posteriorly inclined surface 110 is positioned facing the eyeball EB so as to be in close contact with the eyeball EB, This may include a forward curved surface 120 positioned facing the external world OS opposite to the eyeball EB.

[0092] For example, the inner annular edge 101 and the outer annular edge 102 each form the front of the eyeball EB, and are observed as elliptical and circular shapes, respectively, along the frontal direction Z3 from the front to the back of the eyeball EB, where the lens-forming crystalline lens and the pupil (or pupil) forming the light-entering aperture are located. The rearward inclined surface 110 can be formed as a surface inclined at a constant tilt angle θ from a vertical plane G perpendicular to the front direction Z3, such that the inner annular edge 101 and the outer annular edge 102 form the front and rear positions, respectively.

[0093] For example, the rearward inclined surface 110 can provide a support surface that is supported on an inclined surface formed on the packaging container of the eye implant 100.

[0094] For example, the forward curved surface 120 can be formed along a spline curve whose curvature or radius of curvature changes along the inclination direction of the rear inclined surface 110.

[0095] For example, the pupil dilation portion 105 may have a variable thickness, where the thickness between the rearward inclined surface 110 and the front curved surface 120 is variable. In this case, the thickness of the pupil dilation portion 105 can be measured along a direction perpendicular to the rearward inclined surface 110, from the rearward inclined surface 110 to the front curved surface 120.

[0096] For example, the inner annular edge 101 can be formed with the forward curved surface 120 and the rear inclined surface 110, which form the thickness of the pupil dilation portion 105, in contact with each other at the position where they are in contact with the opening OP.

[0097] For example, the outer annular edge 102 can be formed with the forward curved surface 120 and the rear inclined surface 110, which form the thickness of the pupil dilation portion 105, in contact with each other on the opposite side of the inner annular edge 101 that defines the opening OP.

[0098] For example, the forward curved surface 120 and the rear inclined surface 110 that form the thickness of the pupil dilation portion 105 can abut each other while forming an inner annular edge 101 and an outer annular edge 102, respectively, with rounded corner shapes. In this case, the inner annular edge 101 can be formed with a relatively gently rounded corner shape, and the outer annular edge 102 can be formed with a relatively sharply rounded corner shape.

[0099] For example, the thickness of the corner of the inner annular edge 101 can be made thinner than the thickness of the corner of the outer annular edge 102.

[0100] For example, among the membrane tissue that surrounds the eyeball EB to maintain its shape, the inner annular edge 101 that is drawn in to the discontinuous edge DE between the cornea, which has a large curvature that protrudes forward in a convex shape, and the sclera, which has a small curvature that extends posteriorly from the cornea, allows one side of the eyeball implant 100 to be finished with a relatively gently rounded corner shape.

[0101] The outer annular edge 102 that adheres closely to the sclera of the large curvature portion can be finished on the other side of the ophthalmic implant 100 to have a relatively sharp, rounded corner shape so as not to lift away from the sclera or to prevent the formation of a gap between it and the sclera.

[0102] For example, the pupil dilation portion 105 is The maximum thickness portion t5 having the greatest thickness between the inner annular edge 101 and the outer annular edge 102, An inner portion IA formed relatively adjacent to the opening OP, between the inner annular edge 101 and the maximum thickness portion t5, The outer portion OA, formed relatively far from the opening OP, is located between the maximum thickness portion t5 and the outer annular edge 102.

[0103] For example, the inner portion IA and the outer portion OA, which are arranged on both sides with respect to the maximum thickness portion t5, may have asymmetrical shapes or asymmetrical thickness profiles.

[0104] For example, the inner portion IA is formed to be relatively flexible so as to adapt to the pupil of each transplant recipient. The outer portion OA can be formed relatively rigid to maintain a beautiful circular appearance against deformation of the inner portion IA, and to reinforce the flexibility of the inner portion IA, thereby providing support rigidity for the eyeball implant 100.

[0105] For example, the inner portion IA can be formed to be thinner than the outer portion OA so as to be drawn in to the discontinuous edge DE between the cornea, which is a large curvature portion that protrudes forward in a convex shape, and the sclera, which is a small curvature portion that extends posteriorly from the cornea, and to adhere closely to the discontinuous edge DE so as not to form a gap between it and the discontinuous edge DE.

[0106] For example, the inner part IA and the outer part OA are formed from the same material, The thickness of the inner portion IA can be formed to be relatively thinner than the thickness of the outer portion OA.

[0107] For example, the first average thickness of the inner portion IA and the second average thickness of the outer portion OA formed by the rearward inclined surface 110 and the front curved surface 120 can be formed such that the first average thickness < the second average thickness.

[0108] For example, using the rearward inclined surface 110 that provides a reference for the thickness of the pupil dilation portion 105 as a reference, The forward curved surface 120 forming the inner portion IA extends along a trajectory that is relatively adjacent to the rear inclined surface 110, and the forward curved surface 120 forming the outer portion OA extends along a trajectory that is relatively far from the rear inclined surface 110, thereby forming a difference in thickness between the inner portion IA and the outer portion OA formed on both sides with respect to the maximum thickness portion t5.

[0109] For example, the forward curved surface 120 forming the inner portion IA extends along a trajectory relatively adjacent to the rear inclined surface 110, forming a relatively thin thickness, and further follows a relatively gentle downward curve toward the rear inclined surface 110, forming a corner that is gently rounded by the inner annular edge 101.

[0110] The forward curved surface 120 forming the outer portion OA extends along a trajectory relatively far from the rear inclined surface 110, forming a relatively thicker surface, and further follows a relatively steep downward curve toward the rear inclined surface 110, forming a sharply rounded corner at the outer annular edge 102.

[0111] For example, the forward curved surface 120 forming the inner portion IA follows a downward curve from the maximum thickness portion t5 toward the inner annular edge 101, finishing one side of the eye implant 100, and forms a gently rounded inner annular edge 101 by following a more abrupt downward curve via an inner inflection point 101'. The forward curved surface 120 forming the outer portion OA can form a sharply rounded outer annular edge 102 by following a sharper downward curve via an outer inflection point 102', so as to finish the other side of the eyeball implant 100 while following a downward curve from the maximum thickness portion t5 toward the outer annular edge 102.

[0112] For example, along the inclination direction of the rearward inclined surface 110, the distance from the outer annular edge 102 to the outer inflection point 102' can be made relatively longer than the distance from the inner annular edge 101 to the inner inflection point 101'. In this case, the inner inflection point 101' and the outer inflection point 102' can form the points with the largest change in curvature along the profile of the front curved surface 120 that forms the inner part IA and the outer part OA, respectively.

[0113] The eyeball implant 100 of the present invention can be formed as a substantially annular member with an opening OP in the center so that light can enter toward the crystalline lens that performs the lens function of the eyeball EB or toward the pupil (or pupil) that forms the opening of the eyeball EB.

[0114] The aforementioned eyeball implant 100 can enlarge the size of the pupil while surrounding the outer ring of the implant recipient's pupil, and can be formed as an annular member with an opening OP in the center to allow light to enter the pupil while surrounding the outer ring of the implant recipient's pupil.

[0115] In one embodiment of the present invention, the eye implant 100 may include an inner annular edge 101 surrounding the rim of the pupil of the implant recipient, an outer annular edge 102 on the opposite side of the inner annular edge 101 that surrounds the rim of the pupil together with the inner annular edge 101, and a pupil dilator 105 having a variable thickness that changes from the inner annular edge 101 toward the outer annular edge 102 between the inner annular edge 101 and the outer annular edge 102. The pupil dilator 105 can be defined between the inner annular edge 101 and the outer annular edge 102 that surround the rim of the pupil together at an inner and outer position, respectively, and can provide a pupil dilation area in the eye implant 100 according to one embodiment of the present invention. In one embodiment of the present invention, the inner annular edge 101 and the outer annular edge 102 can define the shape of the eye implant 100 or the pupil dilator 105 that forms the body of the eye implant 100, and can define at least a part of the shape of the eye implant 100.

[0116] An eye implant 100 according to one embodiment of the present invention can be formed in a three-dimensional shape so as to adhere closely to a substantially spherical eyeball EB. Considering that one of the main functions of the eye implant 100 according to one embodiment of the present invention is to aesthetically improve the shape of the pupil or iris as observed from the frontal direction Z3 of the recipient's face, and that the shape of the pupil or iris as observed from the frontal direction Z3 of the recipient's face can be defined by an inner annular edge 101 and an outer annular edge 102 that define the shape of the pupil dilator 105 as observed from the frontal direction Z3, the shapes of the inner annular edge 101 and the outer annular edge 102 can mean the two-dimensional line shape as observed from the frontal direction Z3 of the recipient's face. However, since the eye implant 100 according to one embodiment of the present invention is permanently placed on the recipient's eyeball EB, it can be formed in a suitable three-dimensional shape so as to adhere closely to a substantially spherical eyeball EB. For example, the cross-sectional shape of the pupil dilator 105, incised along the frontal direction Z3, can have a variable thickness that changes from the inner dilation edge to the outer dilation edge so as to adhere closely to the substantially spherical eyeball EB.

[0117] More specifically, the pupil dilator 105 can be formed in a three-dimensional shape so as to be in close contact with the eyeball EB, which is made up of a substantially spherical shape, and may include a cross-sectional shape cut along the front direction Z3, a rearward inclined surface 110 inclined at a constant tilt angle θ from a vertical plane G perpendicular to the front direction Z3 so as to be in close contact with the eyeball EB, and a front curved surface 120 that is positioned facing the outside world OS opposite to the eyeball EB.

[0118] In one embodiment of the present invention, the eyeball EB is protected by a tough membrane tissue that surrounds the eyeball EB as a whole, and the overall shape of the eyeball EB can be maintained, and the membrane tissue may include the cornea on the anterior side into which light is incident, and the sclera extending posteriorly from the cornea. For example, the cornea may be formed in an anterior position of the anterior chamber formed in front of the pupil, and may form a large curvature portion of membrane tissue that is formed with a relatively large curvature, surrounding the anterior part of the eyeball EB formed by the lens, pupil, and anterior chamber. The sclera may extend posteriorly from the cornea and form a small curvature portion of membrane tissue that is formed with a relatively small curvature. The cornea and sclera, while surrounding the eyeball EB and maintaining its shape, form large and small curvature sections, respectively, and can also form discontinuous edges DE and other morphological singularities between them.

[0119] Thus, the cornea and sclera can form large and small curvature portions of membrane tissue that surround the eyeball EB overall and maintain the shape of the eyeball EB, and substantially the same membrane tissue can be formed to protrude convexly toward the external world OS opposite the eyeball EB while enclosing the lens and the like at an anterior position, and the sclera extending posteriorly from the cornea at the anterior position is formed with a reduced curvature than the cornea, and from the sclera away from the discontinuous edge DE between the cornea and the sclera to the curved portion AC of the sclera can be formed to be substantially closer to an inclined surface than a curved surface. An eyeball implant 100 according to one embodiment of the present invention can be implanted on the sclera, for example, on the sclera away from the cornea positioned anteriorly, such as the lens, for example, on the cornea into which light is incident, and in one embodiment of the present invention, the eyeball implant 100 can be pulled forward to the discontinuous edge DE between the sclera and the cornea. At this time, the cornea at the anterior position is formed with a relatively large curvature in the anterior position of the lens, while the sclera extending posteriorly from the cornea is formed with a relatively small curvature. A discontinuous edge DE is formed between the cornea and the sclera, and the eye implant 100, which can be pulled into such a discontinuous edge DE, can accommodate the discontinuous edge DE between the cornea and the sclera, and the medial part IA in contact with the opening OP can be formed with a relatively thinner thickness than the lateral part OA which is relatively far from the opening OP, so as not to form a gap between the tissue of the eyeball EB and the transplanted eye implant 100.

[0120] In one embodiment of the present invention, the pupil dilation portion 105 may include a rearward inclined surface 110 positioned facing the eyeball EB so as to be in close contact with the eyeball EB, and a forward curved surface 120 positioned facing the outside world OS opposite to the eyeball EB so as to be opposite to the rearward inclined surface 110, and may be formed with a variable thickness that changes between the rearward inclined surface 110 and the forward curved surface 120. In one embodiment of the present invention, the thickness of the pupil dilation portion 105 may correspond to the dimension along the direction perpendicular to the rearward inclined surface 110, of the rearward inclined surface 110 and the forward curved surface 120 that define a part of the pupil dilation portion 105.

[0121] In one embodiment of the present invention, the pupil dilation portion 105 can be formed with a variable thickness that changes from the inner annular edge 101 toward the outer annular edge 102. More specifically, the thickness can be gradually reduced toward both sides of the inner annular edge 101 and the outer annular edge 102, with a maximum thickness portion t5 having the greatest thickness between the inner annular edge 101 and the outer annular edge 102 as the reference point, while both sides of the pupil dilation portion 105 are finished toward the inner annular edge 101 and the outer annular edge 102.

[0122] In one embodiment of the present invention, the thickness of the pupil expansion portion 105 can be defined between the rearward inclined surface 110 and the front curved surface 120 along a direction perpendicular to the rearward inclined surface 110, and the rearward inclined surface 110 and the front curved surface 120 can abut each other at an inner annular edge 101 that is relatively in contact with the opening OP and an outer annular edge 102 that is far from the opening OP, thereby forming rounded corners at each inner annular edge 101 and the inner annular edge 102. In one embodiment of the present invention, with respect to the rearward inclined surface 110, the front curved surface 120 can form the thickness profile of the pupil dilation portion 105 on the rearward inclined surface 110, and can form a trajectory at the furthest distance from the rearward inclined surface 110 so as to form the maximum thickness portion t5 between the inner annular edge 101 and the outer annular edge 102, and can form the inner annular edge 101 and the outer annular edge 102 of the rounded corner by contacting the rearward inclined surface 110 while forming a downward trajectory that gradually moves toward the rearward inclined surface 110 as it moves toward both sides of the maximum thickness portion t5 so as to form the inner annular edge 101 and the outer annular edge 102 from both sides of the maximum thickness portion t5.

[0123] In one embodiment of the present invention, the maximum thickness portion t5 of the pupil dilation portion 105 may be formed at a central position between the inner annular edge 101 and the outer annular edge 102, and the pupil dilation portion 105 may include an inner portion IA between the maximum thickness portion t5 and the inner annular edge 101, i.e., an inner portion IA adjacent to the central opening OP, and an outer portion OA between the maximum thickness portion t5 and the outer annular edge 102, i.e., an outer portion OA relatively far from the central opening OP, which corresponds to the opposite side of the inner portion IA.

[0124] Thus, in one embodiment of the present invention, the pupil dilation portion 105 may include an inner portion IA that is relatively close to the opening OP and an outer portion OA that is relatively far from the opening OP, and may include an inner portion IA and an outer portion OA having different thickness deviations from each other. In one embodiment of the present invention, the statement that the inner portion IA and the outer portion OA of the pupil dilation portion 105 have different thickness deviations from each other may mean that, in one embodiment of the present invention, the pupil dilation portion 105 including the inner portion IA and the outer portion OA has an asymmetrical thickness profile or asymmetrical shape with respect to the maximum thickness portion t5 that forms the boundary between the inner portion IA and the outer portion OA. For example, the forward curved surface 120 forming the inner portion IA may form a trajectory that is relatively adjacent to the rear inclined surface 110, and the forward curved surface 120 forming the outer portion OA may form a trajectory that is relatively far from the rear inclined surface 110, while forming a difference in thickness between the inner portion IA and the outer portion OA formed on both sides with respect to the maximum thickness portion t5 of the pupil dilation portion 105. In one embodiment of the present invention, the fact that the inner portion IA and the outer portion OA of the pupil dilation portion 105 have different thickness deviations from each other means that, when comparing the integral thickness value of the inner portion IA, obtained by accumulating the thickness between the rear inclined surface 110 and the front curved surface 120 that provide a thickness reference along the direction of the inclined surface over the entire length of the inner portion IA, with the integral thickness value of the outer portion OA, obtained by accumulating the thickness from the rear inclined surface 110 to the front curved surface 120 that provide a thickness reference along the direction of the inclined surface over the entire length of the outer portion OA, the integral thickness value of the outer portion OA is relatively larger than the integral thickness value of the inner portion IA. For example, even when the lengths of the inner part IA and the outer part OA are different along the direction of the inclined surface, when comparing the integral thickness value of the inner part IA per unit length, obtained by dividing the integral thickness value of the inner part IA by the length of the inner part IA following the direction of the inclined surface, with the integral thickness value of the outer part OA per unit length, obtained by dividing the integral thickness value of the outer part OA by the length of the outer part OA following the direction of the inclined surface, it can be said that the integral thickness value of the outer part OA per unit length is relatively larger than the integral thickness value of the inner part IA per unit length.In this specification, the average thickness of the inner portion IA and the average thickness of the outer portion OA can mean the integral value of the thickness of the inner portion IA per unit length and the integral value of the thickness of the outer portion OA per unit length, respectively.

[0125] Thus, in one embodiment of the present invention, the pupil dilation portion 105 can form a maximum thickness portion t5 at the central position between the inner annular edge 101 and the outer annular edge 102, while forming an inner portion IA and an outer portion OA having unequal average thicknesses on both sides of the maximum thickness portion t5. In this case, the inner portion IA, which is formed with a relatively low average thickness, can be drawn in to the discontinuous edge DE between the cornea with a large curvature, which is formed in a shape that protrudes forward in a convex shape to enclose the lens and the like within the sclera, and the sclera with a small curvature that extends posteriorly from the cornea. By forming the average thickness of the inner portion IA that is drawn in to the discontinuous edge DE to a relatively low degree, the inner portion IA can be drawn in to a sufficient depth to prevent the formation of a gap between the discontinuous edge DE between the cornea and sclera of the eyeball EB and the inner portion IA. For example, in one embodiment of the present invention, the medial portion IA can be implanted in a form that is inserted into a part of the eyeball EB, and the medial portion IA can be inserted between the sclera and conjunctiva through an incision EBC formed in the conjunctiva covering the sclera, and drawn forward to the discontinuous edge DE between the sclera and cornea. The medial portion IA can be formed with a relatively lower average thickness compared to the lateral portion OA, and can be inserted into a narrow implantation space between the sclera and conjunctiva secured through the procedure, and can be drawn to a sufficient depth to the discontinuous edge DE between the sclera and cornea. For example, if the medial portion IA of the pupillary dilator 105 is not formed with a sufficiently thin thickness, a gap can be formed between the discontinuous edge DE between the sclera and cornea and the medial portion IA, and side effects such as bacteria and inflammation (e.g., corneal ulcer due to infection by bacteria, viruses, fungi, etc.) may occur in the gap between the medial portion IA and the discontinuous edge DE, which does not adhere sufficiently to the discontinuous edge DE of the eyeball EB.For example, if the discontinuous edge DE between the sclera and the cornea and the medial part IA of the pupil dilator 105 do not adhere tightly to each other, the shape of the pupil or iris as observed from the front of the transplantor's face Z3 may be distorted or collapsed, resulting in an aesthetically pleasing appearance (cosmetic problems). Furthermore, if the medial part IA of the pupil dilator 105 is not formed with a sufficiently thin thickness but is formed with a thicker thickness, tears may not be able to adequately wet the cornea, potentially leading to corneal ulcers due to infection.

[0126] In one embodiment of the present invention, the outer portion OA can be formed with a relatively higher average thickness compared to the inner portion IA, and the outer portion OA can provide overall support rigidity for the eye implant 100 through its relatively higher average thickness. For example, in one embodiment of the present invention, the eye implant 100 can be formed from a flexible material that is harmless to the human body, such as silicone, and can flexibly adhere to the eyeball EB. Even when formed from a flexible material, it may be necessary to ensure a certain degree of support rigidity, taking into account ease of handling in production, packaging, and distribution, and ease of procedure for the placement of the eye implant 100. For this reason, unlike the inner portion IA, which has a relatively low average thickness to be advantageous for adhesion to the eyeball EB or a portion of the tissue of the eyeball EB despite the structure of the eyeball EB being relatively unfavorable in terms of adhesion, such as a discontinuous edge DE, the outer portion OA can be formed with a relatively high average thickness to take into account the support rigidity for the overall eye implant 100. As will be described later, in one embodiment of the present invention, the eyeball implant 100 can be made of a flexible material that is highly flexible, given that it is permanently placed on the eyeball EB. However, even if it is made of a single material, it may include an inner part IA that is relatively more flexible and an outer part OA that is relatively more rigid, depending on the difference in shape.

[0127] In one embodiment of the present invention, the inner portion IA can be formed relatively flexible to adaptively deform to the pupil of each implanter, and the outer portion OA can be formed relatively rigid to maintain a circular appearance in opposition to the deformation of the inner portion IA and to reinforce the flexibility of the inner portion IA, thereby providing support rigidity for the eyeball implant 100.

[0128] In one embodiment of the present invention, the inner portion IA needs to be in close contact with a morphological singularity such as a discontinuous edge DE formed between the sclera and the cornea. For example, the inner portion IA can be formed with a relatively low average thickness so that it can be finely adjusted according to the size of the cornea to be in maximum close contact with the cornea. The outer portion OA can be placed on the sclera with relatively small curvature, at a position relatively far from a morphological singularity such as a discontinuous edge DE between the sclera and the cornea. For example, it can be placed on the sclera with relatively small curvature, closer to an inclined surface than the curved surface from the sclera away from the discontinuous edge DE between the cornea and the sclera to the curved portion AC of the sclera (requiring less flexibility for contact on the sclera). In particular, it can be formed with a relatively high average thickness so that it can supplement the rigidity of the inner portion IA, which has a relatively low average thickness, and provide the support rigidity of the overall eye implant 100. For example, in one embodiment of the present invention, the first average thickness of the inner portion IA and the second average thickness of the outer portion OA formed by the rearward inclined surface 110 and the front curved surface 120 can satisfy the relationship that the first average thickness < the second average thickness.

[0129] In one embodiment of the present invention, the opening OP can be formed in a shape that does not obstruct the incidence of light, for example, the incidence of light directed toward the pupil (or iris) that provides the opening of the eyeball EB, and the flexibility of the inner part IA of the pupil dilator 105 can be increased via the opening OP. For example, in one embodiment of the present invention, the inner part IA is preferably observed integrally with the pupil (or iris) that forms the opening of the eyeball EB for accommodating light, while surrounding the outer rim of the pupil at a position adjacent to the pupil without obstructing the pupil, and in particular, sufficient flexibility can be provided so that it can adaptively expand and contract in length so that it can surround the outer rim of each pupil, taking into account the differences in pupil shape and size depending on the physical condition of the transplantor. For this reason, in one embodiment of the present invention, unlike the comparative example in which the central position is covered with a light-transparent material so as not to obstruct the incidence of light, sufficient flexibility can be provided to the inner part IA via the central opening OP that abuts the inner part IA, so that it can be permanently implanted according to the physical condition of the transplantor, for example, the shape and size of the pupil, while not obstructing the incidence of light via the central opening OP. As will be described later, in one embodiment of the present invention, the inner portion IA may include an adaptive expandable portion 151 capable of adaptively expanding or contracting in length so that pupils of varying shapes and sizes, regardless of the individual physical conditions of each transplant recipient, can be surrounded by the outer ring of the pupil at the most adjacent position. Such an adaptive expandable portion 151 may be formed adjacent to the inner portion IA of the pupil dilator 105, for example, to the inner annular edge 101 that forms the end of the inner portion IA. However, in various embodiments of the present invention, even without the additional adaptive expandable portion 151, some degree of expansion or contraction in length may be possible due to the flexibility of the inner portion IA itself, for example, which is formed with a relatively low average thickness, and deformation can be permitted to suit the shape and size of each individual pupil.

[0130] In one embodiment of the present invention, the pupil dilation portion 105 may include an inner portion IA having a relatively low average thickness and an outer portion OA having a relatively high average thickness, and may have an asymmetrical shape with respect to a maximum thickness portion t5 formed at the central position between the inner annular edge 101 and the outer annular edge 102 of the pupil dilation portion 105, with respect to each other the inner portion IA and the outer portion OA having different average thicknesses. In one embodiment of the present invention, the inner portion IA and the outer portion OA may have an asymmetrical shape with respect to the maximum thickness portion t5, and the inner annular edge 101 and the outer annular edge 102 forming the ends of the respective inner portion IA and outer portion OA may also have an asymmetrical shape with respect to each other.

[0131] In one embodiment of the present invention, the pupil dilator 105 may include a rearward inclined surface 110 positioned facing the eyeball EB so as to be in close contact with the eyeball EB, and a front curved surface 120 positioned facing the outside world OS opposite to the eyeball EB, which forms a thickness profile with respect to the rearward inclined surface 110, forming an inner annular edge 101 while in contact with the rearward inclined surface 110 at a position in contact with the opening OP, and forming an outer annular edge 102 while in contact with the rearward inclined surface 110 on the opposite side of the opening OP, and forming a thickness profile with respect to the rearward inclined surface 110 such that a relatively thin inner portion IA and a relatively thick outer portion OA are formed with respect to a maximum thickness portion t5 which forms the maximum thickness between the inner annular edge 101 and the outer annular edge 102.

[0132] In one embodiment of the present invention, the forward curved surface 120 that forms a thickness profile on the rear inclined surface 110 with respect to the rear inclined surface 110 can form a profile that has heights and falls in the thickness direction along the inclination direction of the rear inclined surface 110 so as to form a variable thickness from the rear inclined surface 110. For example, the forward curved surface 120 that forms such a thickness profile can be formed along a spline curve in which the curvature or radius of curvature changes along the inclination direction of the rear inclined surface 110.

[0133] In one embodiment of the present invention, the inner annular edge 101 and the outer annular edge 102 can be formed in a rounded corner shape such that the forward curved surface 120 and the rear inclined surface 110 constituting the thickness of the pupil dilation portion 105 abut each other. That is, in one embodiment of the present invention, both the inner annular edge 101 and the outer annular edge 102 can be formed in a rounded corner shape, and do not have to be formed in an angular corner shape, for example. In this case, even if both the inner annular edge 101 and the outer annular edge 102 are formed in a rounded corner shape, the curvature formed by the corners of the inner annular edge 101 and the curvature formed by the corners of the outer annular edge 102 can be set to be unequal to each other. For example, in one embodiment of the present invention, the curvature formed by the corner of the inner annular edge 101 can be made smaller than the curvature formed by the corner of the outer annular edge 102, or in other words, the radius of curvature formed by the corner of the inner annular edge 101 can be made larger than the radius of curvature formed by the corner of the outer annular edge 102.

[0134] In one embodiment of the present invention, setting the curvature of the corner of the inner annular edge 101 to be smaller than the curvature of the corner of the outer annular edge 102 can be interpreted as meaning that the corner of the inner annular edge 101 is formed in a relatively rounded shape, or more gently rounded, or in other words, the corner of the outer annular edge 102 is formed in a relatively sharply rounded shape.

[0135] In one embodiment of the present invention, the inner annular edge 101, which is drawn into the discontinuous edge DE between the cornea with a large curvature that protrudes forward and the sclera with a small curvature that extends posteriorly from the cornea, can be finished to a relatively gently rounded corner shape on one side of the eye implant 100, while the outer annular edge 102, which is in close contact with the sclera of the large curvature, can be finished to a relatively sharply rounded corner shape on the other side of the eye implant 100, so as not to lift away from the sclera or form a gap between it and the sclera.

[0136] In one embodiment of the present invention, the inner portion IA needs to be in close contact with morphological singularities such as discontinuous edges DE formed by the sclera and cornea, and for example, the inner portion IA can be formed with a relatively low average thickness so that it is finely adjusted according to the size of the cornea to be in close contact with the cornea as much as possible.

[0137] Thus, the inner portion IA can be formed with a relatively low average thickness to allow for close contact with the discontinuous edge DE of the eyeball EB, while being finished with a relatively gently rounded inner annular edge 101 to allow for potential damage to the internal tissues of the eyeball EB. In one embodiment of the present invention, by forming the inner annular edge 101, which is inserted into the interior of the eyeball EB or into a relatively complex implantation space such as a narrow implantation space or a discontinuous edge DE of the eyeball EB and forms contact with the internal tissues of the eyeball EB, in a relatively gently rounded shape, irritation and damage to the internal tissues of the eyeball EB can be prevented during the permanent placement of the eyeball implant 100.

[0138] In one embodiment of the present invention, the inner annular edge 101, with its relatively gently rounded shape, can prevent irritation and damage to the internal tissues of the eyeball EB, whereas the outer annular edge 102, with its relatively sharply rounded shape, can block side effects such as the penetration of foreign bodies and bacteria. An eyeball implant 100 according to one embodiment of the present invention can be implanted on the sclera in a state where it is relatively elevated from the surface of the sclera by the rounded corner of the outer annular edge 102, for example, a gap can be provided between the eyeball implant 100 and the sclera via the rounded corner of the outer annular edge 102. In one embodiment of the present invention, by forming the corner of the outer annular edge 102 relatively sharply, in other words, the forward curved surface 120 that forms the thickness of the outer part OA can form a relatively high average thickness while forming a trajectory that is relatively far from the rearward inclined surface 110, and further, the outer annular edge 102 can form a sharply rounded corner while following a relatively steep downward curve. In this way, the forward curved surface 120 that forms the thickness of the outer part OA follows a sharp downward curve as it approaches the outer annular edge 102, forming a sharply rounded outer annular edge 102 with the rearward inclined surface 110, and finishing the pupil dilator 105 via the sharply rounded outer annular edge 102. This creates a gentle curve while blocking the penetration and side effects of foreign substances, bacteria, viruses, etc. that may be caused by lifting from the surface of the sclera.

[0139] In one embodiment of the present invention, the specific cross-section of the pupil dilation portion 105, which includes the forward curved surface 120 and the rear inclined surface 110, and the inner annular edge 101 and outer annular edge 102 that the forward curved surface 120 and the rear inclined surface 110 abut each other, can be designed to have a variety of numerical values ​​and shapes depending on the specific design. For example, in one embodiment of the present invention, the maximum thickness t5 of the pupil dilation portion 105 can be set to a thickness of 50 μm to 200 μm (for example, 120 μm), the corner of the inner annular edge 101 can be set to a thickness of 20 μm to 100 μm (for example, 40 μm), and the corner of the outer annular edge 102 can be set to a thickness of 60 μm to 200 μm (for example, 80 μm).

[0140] The thickness t1 formed at the corner of the inner annular edge 101 can be said to be the thickness between the inner inflection point 101' of the front curved surface 120 and the rear inclined surface 110 when the front curved surface 120, which forms a thickness profile on the rear inclined surface 110, contacts the rear inclined surface 110 while following a more downward curve via the inner inflection point 101' to form the corner of the inner annular edge 101. Similarly, the thickness t2 formed at the corner of the outer annular edge 102 can be said to be the thickness between the outer inflection point 102' of the front curved surface 120 and the rear inclined surface 110 when the front curved surface 120, which forms a thickness profile on the rear inclined surface 110, contacts the rear inclined surface 110 while following a more downward curve via the outer inflection point 102' to form the corner of the outer annular edge 102.

[0141] In one embodiment of the present invention, the pupil expansion portion 105 may include a profile of a forward curved surface 120 that approaches the rearward inclined surface 110 from both sides of the maximum thickness portion t5, and the profile of the forward curved surface 120 may form an inner annular edge 101 and an outer annular edge 102 by contacting the rearward inclined surface 110 while following a steeper downward profile via an inner inflection point 101' and an outer inflection point 102'. In one embodiment of the present invention, the distance from the outer annular edge 102 to the outer inflection point 102' may be formed to be longer than the distance from the inner annular edge 101 to the inner inflection point 101' along the direction of the inclined surface. For example, in one embodiment of the present invention, the outer inflection point 102' can be formed with a relatively deeper thickness as it moves downward from the front surface 120, which has a relatively high average thickness, to form a relatively sharply rounded outer annular edge 102; in other words, the inner inflection point 101' can be formed with a relatively thinner thickness as it moves from the front surface 120, which has a relatively low average thickness, to form a relatively gently rounded inner annular edge 101. With considerations as described above, the distance from the outer inflection point 102' to the outer annular edge 102 can be formed to be longer than the distance from the inner inflection point 101' to the inner annular edge 101.

[0142] For example, in one embodiment of the present invention, the outer inflection point 102' and the inner inflection point 101' can mean points that are inflected relatively steeply downward along the profile of the forward surface 120 to form the outer annular edge 102 and the inner annular edge 101, and can mean, for example, two points that are inflected downward at positions adjacent to the outer annular edge 102 and the inner annular edge 101, respectively, where the change in curvature is greatest along the profile of the forward surface 120. In one embodiment of the present invention, the thickness t2 of the corner of the outer annular edge 102 can be formed higher than the thickness t1 of the corner of the inner annular edge 101, and the thickness of the corner of the outer annular edge 102 can be formed relatively higher, corresponding to the distance moved downward from the outer inflection point 102', to form an outer annular edge 102 that is sharply rounded from the outer portion OA which has a relatively high average thickness.

[0143] For reference, in this specification, the thickness of the outer part OA and the inner part IA, their average thickness, or the thickness t2 of the corner of the outer annular edge 102, the thickness t1 of the corner of the inner annular edge 101, etc., can correspond to the thickness dimension that follows vertically from the rear inclined surface 110. The relative magnitudes of the thickness dimensions are expressed as high or low, similar to the height dimension, but this is for the sake of ease of understanding, and can mean thick or thin in terms of the thickness dimension, respectively.

[0144] In one embodiment of the present invention, the rearward inclined surface 110 can be formed as a surface inclined at a constant tilt angle θ from a vertical plane G perpendicular to the front direction Z3, along the front direction Z3 extending from the front to the rear, where a housing that functions as a lens or a pupil (or pupil) that forms an opening for accommodating light is formed, and the rearward inclined surface 110 can be formed to be inclined at a tilt angle θ of approximately 20 to 40 degrees on the vertical plane G. In one embodiment of the present invention, the rearward inclined surface 110 can be in close contact with the sclera, for example, from the discontinuous edge DE between the cornea and the sclera to the curved portion AC of the sclera, where the curvature is relatively small and closer to an inclined surface than a curved surface. In one embodiment of the present invention, the section from the sclera beyond the discontinuous edge DE between the cornea and the sclera to the curved portion AC of the sclera can be considered to be approximately an inclined surface rather than a curved surface, and the rearward inclined surface 110 can be formed as an inclined surface inclined at a constant tilt angle θ on the vertical plane G so as to be in close contact with the sclera where the curvature is small and closer to an inclined surface.

[0145] In one embodiment of the present invention, the rearward inclined surface 110 can adhere closely to a substantially inclined surface or a scleral surface formed adjacent to the inclined surface, and depending on the flexibility of the rearward inclined surface 110 or the eye implant 100 including the rearward inclined surface 110, the rearward inclined surface 110 can adhere closely to the sclera. In one embodiment of the present invention, the rearward inclined surface 110 can form a support surface for the entire eye implant 100 by being formed as an inclined surface inclined at a constant tilt angle θ from a vertical plane G. As will be described later, the packaging container for the eye implant 100 according to one embodiment of the present invention may include an inclined support surface formed to support the rearward inclined surface 110, and considering the ease of manufacturing the eye implant 100 and the packaging container for the eye implant 100, the rear support surface of the eye implant 100 and the support surface of the packaging container can be formed to follow the same constant inclined profile so as to provide a solid support force between them.

[0146] In one embodiment of the present invention, the inner annular edge 101 and the outer annular edge 102 each form the front of the eyeball EB and can be observed as elliptical and circular, respectively, along the front direction Z3 extending from the front to the rear of the eyeball EB, where the lens-forming crystalline lens and the pupil (or pupil) forming the light-entering aperture are located. The rear inclined surface 110 can be formed as a surface inclined at a constant tilt angle θ from a vertical plane G perpendicular to the front direction Z3, such that the inner annular edge 101 and the outer annular edge 102 each form the front and rear positions.

[0147] An eye implant 100 according to one embodiment of the present invention, when viewed from the front direction Z3, can take on a shape in which the inner annular edge 101 at the front position and the outer annular edge 102 at the rear position overlap with each other, depending on the inclination of the rearward inclined surface 110 provided with respect to its thickness, and the ellipse of the inner annular edge 101 is enclosed within the circular part of the outer annular edge 102. In this case, the pupil dilation portion 105 between the inner annular edge 101 and the outer annular edge 102 can be formed in a deflected position within the circular part of the outer annular edge 102, such that one of the two positions along the short axis direction Z2 of the inner annular edge 101 is formed with a wider width than the other position. As will be described later, one of the positions on either side of the elliptical short axis Z2 of the inner annular edge 101 where the pupil dilation portion 105 is formed with a relatively wider width can correspond to the central position S of the procedure, and at one of the positions of the pupil dilation portion 105, an incision portion C, first and second ends E1 and E2 separated from each other via the incision portion C, and a procedure hole 10, a locking step joint or a hook joint for binding the first and second ends E1 and E2 toward each other can be formed.

[0148] In one embodiment of the present invention, the inner annular edge 101 and the outer annular edge 102 can surround the opening OP along different shapes. For example, the inner annular edge 101 can be formed elliptical along the shape of the pupil so as to provide an appearance integrated with the pupil without obstructing the pupil (or pupil) that forms the light-entering opening, and can surround the outer ring of the pupil at adjacent positions. The outer annular edge 102 can be formed circularly to provide a beautiful circular appearance. For example, the inner annular edge 101 can be formed elliptical with different major axis lengths L1 and minor axis lengths L2, where the major axis length L1 can be formed along the direction in which the transplanter's pair of eyes face each other, and the minor axis length L2 can be formed along a direction perpendicular to the major axis length L1.

[0149] Thus, in one embodiment of the present invention, the inner annular edge 101 surrounding the outer ring of the transplanter's pupil can be formed in an elliptical shape according to the shape of the transplanter's pupil, and can be deformed into an elliptical shape optimized for the individual physical conditions of the transplanter, such as the shape and size of the pupil which are formed differently for each transplanter. For example, on an adult basis, the major axis length L1 of the pupil can be formed to be 9 mm to 15 mm (e.g., 12 mm), and the minor axis length L2 can be formed to be 8 mm to 14 mm (e.g., 11 mm), and the shape of the pupil can be formed to be a slip-type ellipse in which the major axis length L1 is relatively longer than the average shape, or a nearly circular ellipse in which the minor axis length L2 is relatively longer than the average shape, according to the shape ratio of the major axis length L1 to the minor axis length L2.

[0150] Hereinafter, in an eyeball implant 100 according to another aspect of the present invention, an adaptive expandable portion 151 that adaptively expands and contracts in length along the inner annular edge 101 and roughened surfaces 152 and 153 that generate rotational resistance in the rotational direction along the pupil dilation portion 105 formed between the inner annular edge 101 and the outer annular edge 102 will be described.

[0151] Figure 6 shows a perspective view illustrating an adaptive telescopic section 151 applied to an eye implant 100 according to one embodiment of the present invention. Figure 7 is a perspective view illustrating an adaptive telescopic section 151 applied to an eye implant 100 according to one embodiment of the present invention, and shows a perspective view illustrating a modified example of Figure 6. Figures 8a and 8b show cross-sectional views of the eyeball implant 100 taken along the circumferential direction of the pupil dilator 105, illustrating the different roughened surfaces 152 and 153 having isotropic and anisotropic rotational resistance, respectively.

[0152] The eye implant 100 according to the above-described embodiment is An eye implant 100 that is permanently implanted on the recipient's eyeball EB to provide the recipient's pupil with an enlarged appearance, A central opening OP that accommodates the incoming light toward the pupil (or pupil) providing the opening of the eyeball EB, The inner annular edge 101 that surrounds the aforementioned opening OP and defines the opening OP, An outer annular edge 102 surrounds the opening OP together with the inner annular edge 101 on the opposite side of the inner annular edge 101 that defines the opening OP, The system may include an adaptive expandable section 151 that adaptively expands and contracts in length along the inner annular edge 101.

[0153] For example, the adaptive expandable portion 151 can expand or contract in length along the inner annular edge 101 so as to adaptively deform to the shape and size of each transplant recipient's pupil.

[0154] For example, the inner annular edge 101 is formed in an ellipse shape having different major axis lengths L1 and minor axis lengths L2. The adaptive expandable portion 151 can provide length expansion and contraction along the longitudinal axis Z1 and / or the minor axis Z2 to suitably and adaptively provide the inner annular edge 101 of a slip-type ellipse with a relatively elongated major axis length L1 and / or shortened minor axis length L2, and a nearly circular ellipse with a relatively shortened major axis length L1 and / or extended minor axis length L2, to the pupil of the transplant recipient.

[0155] For example, the adaptive expandable portion 151 may include at least one slit 151s formed around the inner annular edge 101.

[0156] For example, the adaptive expandable portion 151 may include a plurality of slits 151s formed spaced apart from each other along the inner annular edge 101.

[0157] For example, the plurality of slits 151s are formed along the inner annular edge 101, spaced apart from each other at uniform intervals.

[0158] For example, the adaptive expandable portion 151 may include a group of slits 151s formed at positions on both sides along the long axis Z1 and / or on both sides along the short axis Z2.

[0159] For example, the adaptive expandable portion 151 is The fragments, separated from each other by the first and second groups of slits 151s formed on both sides along the short axis direction Z2, overlap each other, extending the short axis length L2 while shortening the long axis direction Z1. The fragments, separated from each other by the third and fourth groups of slits 151s formed on both sides along the longitudinal axis Z1, overlap each other, thereby extending the longitudinal length L1 while shortening the minor axis length L2.

[0160] For example, the slits 151s can be formed at positions separated by a constant angle, with the center O of the opening OP, where the major axis length L1 and minor axis length L2 of the inner annular edge 101 intersect, as the rotation center.

[0161] For example, the slit 151s is The first and second groups of slits 151s are formed at 0-degree angular position A1 and 180-degree angular position A2, respectively, along the short axis direction Z2, The system may include third and fourth groups of slits 151s formed at 90-degree angular positions A3 and 270-degree angular positions A4, respectively, along the longitudinal axis Z1.

[0162] For example, the slit 151s can be drawn into the pupil dilation portion 105 along the depth direction from the inner annular edge 101 to the outer annular edge 102.

[0163] For example, the slit 151s can be drawn into the pupil dilation section 105 with the radial direction from the center O of the opening OP where the long axis length L1 and the short axis length L2 intersect as the depth direction.

[0164] For example, the adaptive expandable portion 151 allows the segments, which are divided along the inner annular edge 101 via the slits 151s, to overlap with each other, thereby expanding or contracting the length of the inner annular edge 101.

[0165] For example, the pupil dilation portion 105 is A posteriorly inclined surface 110 is positioned facing the eyeball EB so as to be in close contact with the eyeball EB, The surface is positioned facing the external world OS opposite to the eyeball EB and forms a thickness profile with respect to the rearward inclined surface 110, forming an inner annular edge 101 while in contact with the rearward inclined surface 110 at a position adjacent to the opening OP, forming an outer annular edge 102 while in contact with the rearward inclined surface 110 on the opposite side of the opening OP, and includes a front curved surface 120 that forms a thickness profile with respect to the rearward inclined surface 110 such that a relatively thin inner portion IA and a relatively thick outer portion OA are formed with respect to the maximum thickness portion t5 which forms the maximum thickness between the inner annular edge 101 and the outer annular edge 102. The fragments, separated from each other through the slits 151s forming the adaptive expandable portion 151, overlap with each other, expanding or contracting the length of the inner annular edge 101, and can form an extra thickness to increase the thickness of the inner portion IA where the slits 151s are formed and are drawn in from the inner annular edge 101.

[0166] For example, the adaptive expandable portion 151 is formed on the inner annular edge 101 that surrounds the outer ring of the pupil at a position relatively adjacent to the outer annular edge 102, so as to adaptively deform to the shape and size of each transplant recipient's pupil. The outer annular edge 102 does not need to be formed in order to maintain a beautiful circular appearance against deformation of the inner annular edge 101.

[0167] For example, the inner annular edge 101, in which the fragments divided through the slits 151s forming the adaptive expandable portion 151 are arranged to overlap each other, is formed in a relatively gently rounded angular shape. The outer annular edge 102 may be formed into a relatively sharply rounded corner shape.

[0168] In an eye implant 100 according to one embodiment of the present invention, the shape and size of the pupil to be enlarged can be formed differently according to the physical conditions of the implanter, and the inner annular edge 101 can accommodate the shape and size of the pupil according to the individual physical conditions of the implanter, so as to form an enlarged pupil integrated with the pupil without obstructing the pupil (or pupillary opening) that forms the opening for light entry, and the eye implant 100 may include an adaptive expandable portion 151 that can adaptively expand or contract in length along the circumferential direction of the inner annular edge 101. For example, in one embodiment of the present invention, the adaptive expandable portion 151 can expand or contract in length along the inner annular edge 101 so as to adaptively deform to the shape and size of the pupil of each implanter.

[0169] In this specification, the adaptive expandable portion 151 adaptively provides length expansion or contraction along the circumferential direction of the inner annular edge 101, which may include providing length expansion along either the major axis Z1 or minor axis Z2 of the elliptical inner annular edge 101, or length contraction along the other, and may include expanding or contracting the entire area around the inner annular edge 101 regardless of a particular direction.

[0170] In one embodiment of the present invention, the adaptive expandable portion 151 may include a plurality of slits 151s formed in the inner annular edge 101 or in the pupil dilation portion 105 adjacent to the inner annular edge 101. For example, the adaptive expandable portion 151 may include at least one slit 151s formed around the inner annular edge 101, and in one embodiment of the present invention, the adaptive expandable portion 151 may include a plurality of slits 151s spaced apart from each other along the circumferential direction of the inner annular edge 101 and drawn in from the inner annular edge 101 toward the pupil dilation portion 105.

[0171] For example, for a surgeon performing an eyeball implant 100, it is more economical to manufacture multiple eyeball implants 100 using a single, versatile mold rather than manufacturing an eyeball implant 100 to match the individual pupil shape and size of each implant recipient. This is because manufacturing an eyeball implant 100 that is adaptively expandable and contractible to fit the individual pupil shape and size of each recipient during the procedure, and consequently, implanting an eyeball implant 100 optimized for the uniquely formed pupil shapes and sizes, reduces manufacturing costs compared to introducing individually formed molds to produce each uniquely individualized eyeball implant 100.

[0172] In one embodiment of the present invention, the adaptive expandable portion 151 may include a plurality of slits 151s formed to be spaced apart from each other along the inner annular edge 101, and the slits 151s may be retracted from the inner annular edge 101 toward the pupil dilator 105 at their respective positions along the inner annular edge 101. For example, in one embodiment of the present invention, the inner annular edge 101 may be the innermost component surrounding the rim of the pupil in the eye implant 100, and may be, for example, a configuration that directly surrounds the rim of the pupil or a configuration in which expansion and contraction deformation is induced for a design optimized for the shape and size of the pupil of each implanter. In one embodiment of the present invention, the inner annular edge 101 can be deformed via the adaptive expandable portion 151 to induce deformation with a high degree of freedom according to the optimized shape or size of the inner annular edge 101, such as deformation such as crushing and deformation such as expansion or contraction of the overall length, so as to be optimized for the shape and size of the pupil of each implanter, that is, so as to surround pupils of various shapes and sizes at the closest positions without obstructing the pupil (or pupillary opening) corresponding to the light entry aperture. In this specification, the length expansion or contraction of the inner annular edge 101 can be comprehensively understood as including both deformation such as crushing of the inner annular edge 101 and expansion or contraction of the overall length of the inner annular edge 101 as described above.

[0173] In one embodiment of the present invention, the adaptive expandable portion 151 may include a plurality of slits 151s spaced apart from each other along the inner annular edge 101. For example, the plurality of slits 151s may be formed at equal intervals along the inner annular edge 101, and may be formed evenly at angular positions spaced apart by a constant angle around the center O of the opening OP as the center of rotation.

[0174] In one embodiment of the present invention, the slits 151s forming the adaptive expandable portion 151 can be drawn into the pupil dilation portion 105 along a depth direction from the inner annular edge 101 toward the outer annular edge 102. More specifically, each slit 151s forming the adaptive expandable portion 151 can be formed in a manner drawn from the inner annular edge 101 toward the pupil dilation portion 105, for example, each slit 151s can be drawn from each point on the inner annular edge 101 toward the pupil dilation portion 105 along a direction perpendicular to the inner annular edge 101. In various embodiments of the present invention, the slits 151s can be drawn from the inner annular edge 101 toward a direction perpendicular to the inner annular edge 101, or drawn radially from the inner annular edge 101. For example, in various embodiments of the present invention, the slits 151s can be drawn radially toward the center O of the opening OP surrounded by the inner annular edge 101 toward the pupil dilation portion 105 adjacent to the inner annular edge 101, with the depth direction being radial toward the center O of the opening OP surrounded by the inner annular edge 101. For example, in this specification, the center O of the opening OP surrounded by the inner annular edge 101 can mean the center O of the opening OP where the major axis length L1 and minor axis length L2 of the elliptical inner annular edge 101 or the elliptical opening OP intersect each other. However, in various embodiments of the present invention, the slit 151s can be drawn into the pupil dilator 105 from the inner annular edge 101 along various directions, and the depth direction in which the slit 151s are drawn can be set in various ways depending on the shape formed by the inner annular edge 101, for example, the elliptical shape formed by the inner annular edge 101, and, as will be described later, depending on the deformation of the inner annular edge 101 induced by the individual physical conditions of the implant recipient.

[0175] In one embodiment of the present invention, the slits 151s forming the adaptive expandable portion 151 can be formed in a range of 30 to 360 along the inner annular edge 101. For example, when they are evenly spaced at a constant angle, approximately 30 slits can be formed at an angle of approximately 12 degrees, or approximately 360 slits can be formed at an angle of approximately 1 degree. Furthermore, the width d of the slits 151s forming the adaptive expandable portion 151 can be formed to be approximately 1 / 4 to 1 / 2 of the width of the pupil expansion portion 105 between the inner annular edge 101 and the outer annular edge 102, along the depth direction from the inner annular edge 101 to the outer annular edge 102.

[0176] In one embodiment of the present invention, the inner annular edge 101 can be formed in an ellipse shape having different major axis lengths L1 and minor axis lengths L2, and the adaptive expandable portion 151 can provide length expansion and contraction along the major axis Z1 and / or minor axis Z2 to suitably and adaptively provide the inner annular edge 101 in a slip-type ellipse shape with a relatively elongated major axis length L1 and / or shortened minor axis length L2, and in a nearly circular ellipse shape with a relatively shortened major axis length L1 and / or elongated minor axis length L2, to the pupil of the transplant recipient.

[0177] The inner annular edge 101, or the pupil dilation portion 105 adjacent to the inner annular edge 101, can be divided into a plurality of segments along the circumferential direction of the inner annular edge 101 via each slit 151s, and the plurality of segments divided on both sides of each slit 151s along the circumferential direction of the inner annular edge 101 can overlap with each other, thereby expanding or contracting the length of the inner annular edge 101. For example, in one embodiment of the present invention, an adaptive expandable portion 151 including an array of multiple slits 151s can be deformed so that the segments divided on both sides via each slit 151s overlap so that they are close to each other via the slits 151s, thereby enabling expansion or contraction of the overall shape and length of the inner annular edge 101.

[0178] In one embodiment of the present invention, the inner annular edge 101 to which the adaptive expandable portion 151 is applied, or the inner portion IA having the inner annular edge 101 as an end, is formed with a relatively low average thickness while being relatively free to deform. For example, the inner portion IA with a relatively low average thickness can provide a marginal space along the thickness direction so as to accommodate the overlap of the fragments divided in both sides through the slit 151s. In one embodiment of the present invention, the adaptive expandable portion 151 formed on the inner annular edge 101 and the inner portion IA formed with a relatively low average thickness with the inner annular edge 101 as its end, cooperate with each other to adaptively deform the inner annular edge 101 into a shape and size optimized according to the physical conditions of the implanter. For example, the inner annular edge 101 formed with a relatively low average thickness can provide flexibility that is advantageous for the fragments divided through the slit 151s to deform so that they overlap each other while being close to each other, and the inner portion IA formed with a relatively low average thickness can provide space that can accommodate the extra thickness formed when the fragments divided through the slit 151s overlap each other.

[0179] For example, in one embodiment of the present invention, the pupil dilation portion 105 may include a rearward inclined surface 110 positioned facing the eyeball EB so as to be in close contact with the eyeball EB, and a front curved surface 120 positioned facing the outside world OS opposite to the eyeball EB, which forms a thickness profile with respect to the rearward inclined surface 110, forming an inner annular edge 101 while in contact with the rearward inclined surface 110 at a position in contact with the opening OP, and forming an outer annular edge 102 while in contact with the rearward inclined surface 110 on the opposite side of the opening OP, and forming a thickness profile with respect to the rearward inclined surface 110 so as to form a relatively thin inner portion IA and a relatively thick outer portion OA with respect to a maximum thickness portion t5 which forms the maximum thickness between the inner annular edge 101 and the outer annular edge 102, and the fragments separated from each other via slits 151s forming the adaptive expandable portion 151 may overlap with each other and expand or contract the length of the inner annular edge 101, thereby forming an extra thickness to increase the thickness of the inner portion IA where the slits 151s drawn in from the inner annular edge 101 are formed.

[0180] In one embodiment of the present invention, the pupil surrounded by the inner annular edge 101 can be formed as an ellipse having different major axis lengths L1 and minor axis lengths L2 when viewed from the front direction Z3, the major axis length L1 of the ellipse formed by the pupil can be formed along the direction in which the pair of eyes face each other, and the minor axis length L2 of the ellipse formed by the pupil can be formed along a direction perpendicular to the major axis length L1. For example, the major axis length L1 formed by the pupil may be formed to be 9 mm to 15 mm, and the minor axis length L2 formed by the pupil may be formed to be 8 mm to 14 mm. That is, the shape and size of the pupil to be enlarged by the eyeball implant 100 according to one embodiment of the present invention can have the above-mentioned deviations, and for example, even if the shape of the pupil has different minor axis lengths L2 and major axis lengths L1, it can be formed as different elliptical shapes and different sizes due to the distribution of lengths as described above. For example, in one embodiment of the present invention, the shape and size of the inner annular edge 101 may need to be deformed to a slip-type ellipse having a relatively longer major axis length L1 and / or a relatively shorter minor axis length L2 compared to the average shape and size, depending on the physical conditions of each individual implant recipient, or to be deformed to a nearly circular ellipse with a relatively longer minor axis length L2 and / or a relatively shorter major axis length L1. In this specification, different elliptical shapes such as slip-type ellipse and nearly circular ellipse may be defined by the relative shape ratio of the major axis length L1 and the minor axis length L2, and may not refer to the individual or absolute lengths of the major axis length L1 and the minor axis length L2. For example, deforming the adaptive expandable portion 151 so that the major axis length L1 is relatively elongated or the minor axis length L2 is relatively elongated in order to optimize it for the varying pupil shapes and sizes of the transplant recipient can mean that the deformation of the adaptive expandable portion 151 is induced so that the relative shape ratio between the major axis length L1 and the minor axis length L2 that defines the elliptical shape of the inner annular edge 101 surrounding the outer ring of the transplant recipient's pupil is changed.

[0181] In one embodiment of the present invention, the inner annular edge 101 surrounding the pupil may be designed to match the average pupil shape and size without requiring a separate adaptive expandable portion 151 or deformation of the inner portion IA, and in a single-design eye implant 100 that can be used universally, it may be manufactured to match the average pupil shape and size without deformation. For example, in one embodiment of the present invention, the shape of the opening OP surrounding the inner annular edge 101 can be formed as an ellipse having a relatively long major axis length L1 and a relatively short minor axis length L2, for example, the major axis length L1 and minor axis length L2 of the ellipse formed by the central opening OP can be formed to match the average pupil, with L1 and L2 being 12 mm and L2, respectively.

[0182] In one embodiment of the present invention, a plurality of slits 151s can be formed around the inner annular edge 101, and the plurality of slits 151s can be formed evenly along the entire circumference of the inner annular edge 101. For example, a plurality of slits 151s formed evenly around the inner annular edge 101 can induce different deformations from each other depending on the individual physical conditions of each implant recipient. For example, in one embodiment of the present invention, instead of overlapping with each other and shortening the minor axis length L2, the fragments divided by slits 151s formed on both sides along the major axis length L1 of the inner annular edge 101 can extend the major axis length L1, so as to be optimized for a slip-type elliptical pupil that needs to have a longer major axis length L1, depending on the shape of the pupil of each implant recipient having different physical conditions, from an elliptical inner annular edge 101 that does not induce deformation. Conversely, to optimize for nearly circular elliptical pupils where the minor axis length L2 needs to be extended, the fragments divided via slits 151s formed on both sides along the minor axis length L2 of the inner annular edge 101 can overlap with each other, extending the minor axis length L2 instead of shortening the major axis length L1.

[0183] In one embodiment of the present invention, the inner annular edge 101 can flexibly absorb deformation in response to deformation induced in the inner annular edge 101, for example, by having the inner annular edge 101 deform to an optimized shape at the location where each slot is formed through slots evenly formed around the inner annular edge 101. Depending on the degree and direction of deformation induced in the inner annular edge 101, the excess portion of the inner annular edge 101 cannot maintain coplanarity, resulting in the formation of strain, or damage to the eye implant 100 including the inner annular edge 101 due to excessive stress and stress accumulation in response to insufficient portion of the inner annular edge 101 can be prevented. However, in various embodiments of the present invention, considering that maximum deformation can be required in the slits 151s formed on both sides of the major axis length L1 and the slits 151s formed on both sides of the minor axis length L2, depending on the shape of the pupil, such as a slip-type ellipse or a nearly circular ellipse, and considering that the overall rigidity of the eye implant 100 may decrease if multiple slits 151s are formed evenly, potentially reducing handling during distribution or procedure, the adaptive expandable portion 151 may include multiple slits 151s concentrated at positions on both sides along the major axis length L1 and multiple slits 151s concentrated at positions on both sides along the minor axis length L2. For example, when viewed from the front direction Z3, it may include multiple slits 151s concentrated at 0-degree angle position A1, 90-degree angle position A3, 180-degree angle position A2, and 270-degree angle position A4 along the inner annular edge 101. For example, multiple slits 151s can be formed concentrated at angle positions spaced approximately 90 degrees apart so as to follow the main deformation.For example, in one embodiment of the present invention, the adaptive expandable portion 151 may include a first group of slits 151s formed at a 0-degree angular position A1 corresponding to both sides along the short axis Z2 around the inner annular edge 101, and a second group of slits 151s formed at a 180-degree angular position A2. These first and second groups of slits 151s, formed at the 0-degree angular position A1 and the 180-degree angular position A2 respectively, are formed at both sides along the short axis Z2, and extend the short axis length L2 or shorten the long axis length L1. The adaptive expandable portion 151 can also include a third group of slits 151s at a 90-degree angular position A3 and a fourth group of slits 151s formed at a 270-degree angular position A4, which correspond to positions on both sides along the longitudinal axis Z1 around the inner annular edge 101. These third and fourth group slits 151s formed at the 90-degree angular position A3 and the 270-degree angular position A4 are formed on both sides along the longitudinal axis Z1 and can provide extension of the longitudinal length L1 and shortening of the minor axis length L2.

[0184] In one embodiment of the present invention, the plurality of slits 151s forming the adaptive expandable portion 151 can be formed at equal intervals along the inner annular edge 101 with a constant angle between them. However, the first to fourth groups of slits 151s, which are arranged with a 90-degree angle between them, which contributes relatively more to the expansion and contraction of the long axis length L1 and the short axis length L2, or which are arranged on both sides of the long axis direction Z1 and on both sides of the short axis direction Z2, can be formed more densely around their respective 0-degree angle position A1, 90-degree angle position A3, 180-degree angle position A2, and 270-degree angle position A4. For example, the first to fourth groups of slits 151s can be formed at a greater depth along the depth direction from the inner annular edge 101 to the outer annular edge 102 than the remaining other slits 151s, or they can be formed with a closer angle between them.

[0185] For example, in one embodiment of the present invention, the adaptive expandable portion 151 may include a first group of slits 151s concentrated around a 0-degree angular position A1, a second group of slits 151s concentrated around a 180-degree angular position A2, a third group of slits 151s concentrated around a 90-degree angular position A3, and a fourth group of slits 151s concentrated around a 270-degree angular position A4, and each of the first to fourth groups of slits 151s may be formed in different numbers, for example, including at least one slit 151s. In various embodiments of the present invention, each of the first to fourth groups of slits 151s may include one slit 151s, and each may include a single slit 151s formed at a 0-degree angular position A1, a 90-degree angular position A3, a 180-degree angular position A2, and a 270-degree angular position A4, respectively.

[0186] In various embodiments of the present invention, at angular positions corresponding to positions on both sides along the long axis Z1 and positions on both sides along the short axis Z2, that is, at angular positions arranged with a 90-degree angle requiring a relatively high degree of deformation, slits 151s drawn to a relatively deep depth or slits 151s arranged with a relatively close angle between them can be formed, and at the remaining other angular positions, slits 151s drawn to a relatively shallow depth or slits 151s arranged with a relatively coarse angle between them can be formed.

[0187] In one embodiment of the present invention, the adaptive expandable portion 151 does not need to be formed on the outer annular edge 102. For example, in one embodiment of the present invention, the adaptive expandable portion 151 formed on the inner annular edge 101 takes into account the shape and size of the pupil, which are formed differently from one another to another, and is formed on the inner annular edge 101 surrounding the pupil. It is a configuration for inducing deformation so that permanent implantation can be performed in a form optimized for the individual physical conditions of each implant recipient, while drastically reducing the unit cost of production through a single-design eye implant 100 or a single-design mold that can be used for general procedures. In contrast, the outer annular edge 102 does not necessarily have a structure that induces deformation or is advantageous for deformation. For example, if a structure advantageous for deformation, such as a slit 151s, is formed on the outer annular edge 102, it is possible to prevent the beautiful appearance given to the outer annular edge 102 from being damaged while the initially designed circular appearance is damaged in response to unintended deformation of the outer annular edge 102 following the deformation induced in the inner annular edge 101, and to maintain the beautiful circular appearance as originally designed. Thus, in one embodiment of the present invention, the outer annular edge 102 is formed in a circular shape, which can enhance the satisfaction of the appearance, and a deformation-adaptive structure (adaptive expansion / contraction portion 151) such as a slit 151s is not required to be formed so that the circular appearance can be maintained despite deformation induced in the inner annular edge 101, for example, excessive deformation induced in the inner annular edge 101 to conform to a slip-type elliptical pupil or a nearly circular elliptical pupil.

[0188] In one embodiment of the present invention, the outer annular edge 102 can be formed with relatively higher rigidity than the inner annular edge 101, and although it is formed from the same material, it can be formed with a relatively higher average thickness than the inner annular edge 101 so as to create a difference in rigidity through different shape designs. As a result, in one embodiment of the present invention, the outer annular edge 102 can have higher shape stability or shape retention than the inner annular edge 101, and can maintain a beautiful circular shape despite deformation induced in the inner annular edge 101.

[0189] In one embodiment of the present invention, the eyeball implant 100 or the pupil dilator 105 forming the body of the eyeball implant 100 may include a rearward inclined surface 110 facing the eyeball EB and a front curved surface 120 facing the external environment OS opposite to the eyeball EB. In one embodiment of the present invention, the external environment OS opposite to the eyeball EB may mean the external environment of the eyeball EB itself rather than the external environment of the body, and for example, body tissues such as eyelids that cover the front of the eyeball EB may also be considered part of the external environment OS of the eyeball EB.

[0190] The eye implant 100 can be implanted on the sclera such that the posterior inclined surface 110 is in close contact with the sclera, and the roughened surfaces 152 and 153 can be formed with an appropriate degree of roughness to generate appropriate friction with the sclera. In other words, the posterior inclined surface 110 and the forward curved surface 120 can be formed with different degrees of roughness or different degrees of roughness from each other, the posterior inclined surface 110 can be formed with roughened surfaces 152 and 153 to have an appropriate degree of roughness or roughness that can induce friction, and the forward curved surface 120 can be formed as a smooth surface to form a beautiful appearance.

[0191] In one embodiment of the present invention, the eye implant 100 can be formed in a rotationally asymmetric shape rather than a rotationally symmetric shape. For example, the inner annular edge 101 surrounding the pupil of the eye implant 100 can be formed in an ellipse shape having different major axis lengths L1 and minor axis lengths L2. The eye implant 100 formed in such a rotationally asymmetric shape can be rotated arbitrarily on the spherical eyeball EB. For example, in the case of permanent surgery, where adjusting the position of the eye implant 100 is difficult, the rearward inclined surface 110 facing the eyeball EB can be formed as roughened surfaces 152 and 153 with an appropriate roughness to induce friction, so as to maintain the direction of the major axis length L1 and minor axis length L2 and prevent arbitrary rotation on the eyeball EB. For example, in one embodiment of the present invention, the rearward inclined surface 110 may be formed in any shape that can induce friction, and may be formed in any uneven shape that can create roughness. In one embodiment of the present invention, the rearward inclined surface 110 may include roughened surfaces 152 and 153 in which a continuously uneven shape like a wave is repeatedly formed, and in various embodiments of the present invention, the roughened surface 152 may be formed to have isotropic rotational resistance so as to induce the same friction from each other along one rotation direction and the opposite rotation direction, or the roughened surface 153 may be formed to have anisotropic rotational resistance so as to induce different friction from each other along one rotation direction and the opposite rotation direction.

[0192] For example, when the eyeball implant 100 is implanted through the implantation space between the conjunctiva and the sclera, secured from an incision (EBC) formed on the conjunctiva covering the sclera during the procedure for implanting the eyeball implant 100, a relatively small rotational resistance acts on the roughened surface 153 that provides anisotropic rotational resistance depending on the implantation direction. However, when the implanted eyeball implant 100 attempts to rotate arbitrarily in the opposite direction to the implantation direction, a relatively high rotational resistance acts on it. For example, the roughened surface 153 that provides anisotropic rotational resistance can be formed with a waveform that has anisotropy along the direction of rotation. For example, it can be formed with a waveform that is relatively horizontal in one rotational direction corresponding to the implantation direction, a waveform with a gentle slope that forms a relatively low rotational resistance in one rotational direction corresponding to the implantation direction, and a waveform with a steep slope that forms a relatively high rotational resistance in the opposite rotational direction to the implantation direction. In one embodiment of the present invention, the roughened surfaces 152 and 153 formed on the rearward inclined surface 110 can be formed along the periphery of the pupillary dilator 105, for example, and can be implanted along a rotational direction so as to surround the outer ring of the pupil, thereby forming a relatively small rotational resistance in one rotational direction and a relatively large rotational resistance in the opposite rotational direction, thereby providing a positional fixing force to the implantation site of the eyeball implant 100.

[0193] Thus, the inner annular edge 101 is configured to surround the transplantee's pupil at the closest possible position. Considering that if it is positioned so as close to the pupil as possible and reflects the shape of the pupil, without overlapping with the pupil so as not to obstruct the incidence of light toward the pupil, i.e., if it surrounds the outer rim of the pupil but is excessively far from the pupil, forming an arm region of relatively low brightness, it may not be possible to provide an appearance integrated with the pupil, and satisfaction with the appearance of the enlarged pupil may decrease, it is preferable to form it as close to the pupil as possible and reflect the shape of the pupil. Therefore, in one embodiment of the present invention, the inner annular edge 101 can be formed in an elliptical shape that reflects the shape of the pupil, and can surround the outer rim of the pupil in an elliptical shape optimized for the transplantee's pupil, which is differentially formed via an adaptive expandable portion 151 formed on the inner annular edge 101. In this case, the outer annular edge 102 can be formed in a circular shape so that the outer shape of the enlarged pupil can be observed as circular, and unlike the inner annular edge 101, it can be formed in a circular shape so that the outer shape of the substantially enlarged pupil can be determined instead of the problem of obstructing the incidence of light toward the pupil, and a more aesthetically pleasing appearance can be provided.

[0194] In one embodiment of the present invention, the plurality of slits 151s forming the adaptive expandable portion 151 can be formed along the inner annular edge 101, and the segments divided through the plurality of slits 151s formed along the inner annular edge 101 can overlap with each other to provide length expansion and contraction along the inner annular edge 101. In this case, the inner annular edge 101 on which the slits 151s are formed can be formed with a relatively gently rounded corner shape so that the segments divided with each other through the slits 151s can easily overlap with each other, for example, with a corner shape that is relatively gently rounded compared to the outer annular edge 102 which is formed with a relatively sharply rounded corner shape.

[0195] For example, a fragment of the inner annular edge 101 divided via a relatively gently rounded corner shape or a slit 151s can provide a gap that rises above the floor surface via the gently rounded corner shape, allowing it to easily enter the lower part of an adjacent fragment through the gap that rises above the floor surface and overlap with other fragments, and the length of the inner annular edge 101 can be easily extended or retracted.

[0196] In the following, a surgical hole 10, a locking step joint, or a hook joint will be described for binding together the first end E1 and the second end E2, which are separated from each other via an incision C, in an eyeball implant 100 according to another aspect of the present invention.

[0197] Figure 9 is a diagram illustrating a surgical hole 10 applied to an eye implant according to one embodiment of the present invention, and shows a plan view of the eye implant 100 as seen from the front. Figures 10a to 10c are diagrams illustrating the locking step connections or hook connections of the first and second slits 154a, 154b, 155a, and 155b applied to eye implants 100 according to different embodiments of the present invention, and show perspective views of the different eye implants 100. Figures 11a and 11b show different diagrams illustrating the locking step connection or hook connection of the assembly slit 156a and assembly hole 156b applied to an eye implant 100 according to one embodiment of the present invention.

[0198] The eye implant 100 according to the above-described embodiment is An eye implant 100 that is permanently implanted on the recipient's eyeball EB to provide the recipient's pupil with an enlarged appearance, A central opening OP that accommodates the incoming light toward the pupil (or pupil) providing the opening of the eyeball EB, The inner annular edge 101 that surrounds the aforementioned opening OP and defines the opening OP, An outer annular edge 102 surrounds the opening OP together with the inner annular edge 101 on the opposite side of the inner annular edge 101 that defines the opening OP, The pupil dilator 105 includes a first end E1 and a second end E2 formed between the inner annular edge 101 and the outer annular edge 102, separated from each other via an incision C, and bound together toward each other via a surgical hole 10 formed therein.

[0199] For example, the pupil dilation portion 105 between the inner annular edge 101 and the outer annular edge 102 is formed such that, along the short axis Z2 of the inner annular edge 101, one of the two positions is wider than the other position, and the ellipse of the inner annular edge 101 is formed in a deflected position biased towards the other position within the circular shape of the outer annular edge 102. The incision portion C, the first end portion E1 and the second end portion E2 separated from each other via the incision portion C, and the treatment hole 10 formed on the first end portion E1 and the second end portion E2 can be formed at one of the positions which are formed with a relatively wide width along the short axis direction Z2.

[0200] For example, in the pupil dilation portion 105 between the inner annular edge 101 and the outer annular edge 102, Along the short axis direction Z2 of the inner annular edge 101, the positions on both sides are formed with a relatively smaller curvature than the positions on both sides along the long axis direction Z1 of the inner annular edge 101. The treatment hole 10 can be formed at either one of the two positions along the short axis direction Z2, which is formed with a relatively small curvature.

[0201] For example, the incision C is formed along the short axis direction Z2 of the inner annular edge 101, The first end E1 and the second end E2, separated from each other through the incision C, are bound to each other along the longitudinal axis Z1 of the inner annular edge 101. Multiple treatment holes 10 can be formed in each of the first end E1 and the second end E2, arranged along the longitudinal axis Z1 of the inner annular edge 101.

[0202] For example, the treatment hole 10 is A first surgical hole 11 through which a suture thread for binding the first end E1 and the second end E2 passes, The procedure may include a second surgical hole 12 through which an implantation instrument can pass to pull the eyeball implant 100, so that the eyeball implant 100 can be routed around the outer rim of the operator's pupil via a conjunctival incision C on the sclera.

[0203] For example, the first treatment hole 11 is formed to be relatively small in diameter. The second treatment hole 12 can be formed to be relatively large in diameter.

[0204] For example, the first surgical hole 11 is formed in a position relatively adjacent to the incision C, The second surgical hole 12 can be formed at a location relatively far from the incision C.

[0205] On the other hand, the eye implant 100 according to other aspects of the above-described embodiment is: An eye implant 100 that is permanently implanted on the recipient's eyeball EB to provide the recipient's pupil with an enlarged appearance, A central opening OP that accommodates the incoming light toward the pupil (or pupil) providing the opening of the eyeball EB, The inner annular edge 101 that surrounds the aforementioned opening OP and defines the opening OP, An outer annular edge 102 surrounds the opening OP together with the inner annular edge 101 on the opposite side of the inner annular edge 101 that defines the opening OP, The pupil dilator 105 includes a first end E1 and a second end E2 formed between the inner annular edge 101 and the outer annular edge 102, separated from each other via an incision C, and forming a locking stepped joint or hook joint with each other.

[0206] For example, the pupil dilation portion 105 between the inner annular edge 101 and the outer annular edge 102 is formed such that one of the two positions along the short axis Z2 of the inner annular edge 101 is wider than the other position, and the ellipse of the inner annular edge 101 is formed in a deflected position biased towards the other position within the circular shape of the outer annular edge 102. The incision portion C, the first end portion E1 and the second end portion E2 separated from each other via the incision portion C, and the locking step joint or hook joint between the first end portion E1 and the second end portion E2 can be formed at one of the positions that are formed with a relatively wide width along the short axis direction Z2.

[0207] For example, the locking step coupling or hook coupling is The first and second slits 154a, 154b, 155a, and 155b are formed on the first end E1 and the second end E2, respectively.

[0208] For example, the first and second slits 154a, 154b, 155a, and 155b are, The first portions 1541, 1551 extend along the longitudinal axis Z1 of the inner annular edge 101, The device may include second portions 1542, 1552 extending from the first portions 1541, 1551 toward the inner annular edge 101 or the outer annular edge 102 along a diagonal direction that follows the short axis direction Z2 or both the short axis direction Z2 and the long axis direction Z1 of the inner annular edge 101, and opening to the outside of the eye implant 100.

[0209] For example, at least a portion of the first and second slits 154a, 154b, 155a, and 155b can be formed in complementary shapes to each other to form locking stepped connections or hook connections and be fitted together.

[0210] For example, the first portions 1541 and 1551 of the first and second slits 154a, 154b, 155a, and 155b extend side by side along the longitudinal axis Z1 of the inner annular edge 101. The second portions 1542 and 1552 of the first and second slits 154a, 154b, 155a, and 155b are formed in complementary shapes, and each of the second portions 1542 and 1552 of the first and second slits 154a, 154b, 155a, and 155b and the other can be opened to the outside of the eye implant 100, extending in opposite directions toward the outer annular edge 102 and the inner annular edge 101, respectively.

[0211] For example, the incision C is formed along the short axis direction Z2 of the inner annular edge 101, The first and second ends E1 and E2 are adjacent to each other along the longitudinal axis Z1 of the inner annular edge 101, Any one of the first and second slits 154a, 154b, 155a, 155b includes an array of first slits 154a, 155a or an array of second slits 154b, 155b formed on the first end E1 or second end E2 along the longitudinal axis Z1, while the other can be formed by a single second slit 154b, 155b or a single first slit 154a, 155a.

[0212] The aforementioned locking step coupling or hook coupling is The assembly slit 156a formed in the first end E1, The second end E2 may include an assembly hole 156b into which the assembly slit 156a is fitted.

[0213] For example, an assembly guide portion 158 can be formed on the first end portion E1, positioned in front of the assembly slit 156a along the assembly direction between the first and second ends E1 and E2.

[0214] For example, the assembly guidance unit 158 ​​is The first and second ends E1 and E2 include a front end projection 158a formed with a relatively narrow width at the tip of the first end E1 along the assembly direction, and a rear end 158c located behind the front end projection 158a and in front of the assembly slit 156a, but with a width that is relatively wider than the constricted portion W1 of the assembly slit 156a. The variable width portion 158b may further include a variable width portion 158b that converges toward the front end projection 158a along a diagonal direction that simultaneously follows the long axis direction Z1 corresponding to the assembly direction and the short axis direction Z2 intersecting the long axis direction Z1, so as to connect the front end projection 158a, which is formed with a relatively narrow width, and the rear end 158c, which is formed with a relatively wide width, with an equal width between them.

[0215] For example, the rear end 158c of the assembly guide portion 158 can be connected to the entire width W0 of the first end portion E1 interposed between the assembly guide portion 158 and the assembly slit 156a.

[0216] For example, a cutting line CL including an arrangement of multiple perforations can be formed between the assembly guide portion 158 and the total width W0 of the first end portion E1.

[0217] For example, the assembly slit 156a is drawn in from both sides of the inner annular edge 101 and the outer annular edge 102 along the short axis direction Z2 of the inner annular edge 101 to form a narrowed portion W1 of minimum width. As the narrowed portion W1 of the assembly slit 156a is fitted into the assembly hole 156b on the second end E2 side, separation between the first and second ends E1 and E2 can be prevented via the total width W0 of the relatively wide first end E1 formed before and after the assembly slit 156a.

[0218] An eyeball implant 100 according to one embodiment of the present invention can be inserted between the sclera and conjunctiva by forming an incision EBC in the conjunctiva surrounding the sclera, and while being inserted through the incision EBC in the conjunctiva, it can be inserted between the sclera and conjunctiva so as to surround the outer ring of the pupil along the space between the sclera and conjunctiva corresponding to the outer ring of the pupil. An eyeball implant 100 according to one embodiment of the present invention can be inserted along a rotational direction so as to surround the outer ring of the pupil, and for this purpose, rather than being formed continuously along a rotational direction around the outer ring of the pupil, the eyeball implant 100 can be formed in a form that is disconnected from each other by incisions C formed along any one angular position (0-degree angular position A1) with the center O of the opening OP as the rotational center, and first and second ends E1 and E2 can be formed that are disconnected from each other by the incisions C. For example, an eyeball implant 100 according to one embodiment of the present invention may include an opening OP that is open to the outside through an incision C, rather than including a closed form of opening OP. The structure may also include first and second ends E1 and E2, separated from each other by the incision C.

[0219] In one embodiment of the present invention, the incision C can be formed along the inner annular edge 101, or along the short axis direction Z2 of the opening OP surrounded by the inner annular edge 101, and the first and second ends E1 and E2 separated from each other via the incision C can be bound toward each other along the long axis direction Z1. In one embodiment of the present invention, the first and second ends E1 and E2 separated from each other via the incision C can be bound toward each other along the long axis direction Z1 via a treatment hole 10 formed on the first and second ends E1 and E2, or via a locking step joint or hook joint described later, and in this case, the first and second slits 154a, 154b, 155a, 155b or assembly slit 156a forming the treatment hole 10, or the locking step joint or hook joint can be arranged in a plurality along the long axis direction Z1 to which the first and second ends E1 and E2 extend.

[0220] In this specification, the pupil dilation portion 105, on which the incision portion C and the first and second ends E1 and E2 are formed, is formed on a rearward inclined surface 110 with reference to a rearward inclined surface 110 inclined at a constant tilt angle θ from a vertical plane G perpendicular to the front direction Z3, and the front curved surface 120 forms a thickness profile (the pupil dilation portion 105 is not a flat structure aligned with the vertical plane G perpendicular to the front direction Z3). In this case, the long axis direction Z1 and the short axis direction Z2 can be defined in the front direction Z3, but in this specification, for the sake of understanding, for example, the rearward inclined surface 110 is formed as a surface inclined at a constant tilt angle θ such that the inner annular edge 101 is positioned in the front position and the outer annular edge 102 is positioned in the rear position, and the pupil dilation portion 105 formed between the relatively front-positioned inner annular edge 101 and the relatively rear-positioned outer annular edge 102 forms a thickness profile that is variable toward the front curved surface 120 formed on the rearward inclined surface 110. Although it has a file, it can have a shape that is generally inclined from front to back, so that the incision C is formed along the short axis Z2 on the pupil dilation part 105 so that it coincides with the long axis Z1 and short axis Z2 defined in the front direction Z3, or the first and second ends E1 and E2 separated from each other via the incision C may not be bound together along the long axis Z1 via the treatment hole 10 or the locking step joint or hook joint, but the rear inclined surface 110 is inclined at a small angle of about 20 to 40 degrees from the vertical plane G perpendicular to the front direction Z3, so when the pupil dilation part 105 on which the incision C, treatment hole 10, locking step joint or hook joint etc. are formed is projected onto the vertical plane G perpendicular to the approximately front direction Z3, the direction of the incision C, treatment hole 10, locking step joint or hook joint etc. formed on the pupil dilation part 105 can be sufficiently depicted along the long axis Z1 and short axis Z2 defined in the front direction Z3. For example, in one embodiment of the present invention, the longitudinal axis Z1 and the minor axis Z2 may refer to the longitudinal and width directions of the first and second ends E1 and E2, in relation to the incision C, treatment hole 10, locking step joint, or hook joint formed on the first and second ends E1 and E2, or on the first and second ends E1 and E2.

[0221] In one embodiment of the present invention, the pupil dilation portion 105 between the inner annular edge 101 and the outer annular edge 102 is formed such that one of the two positions along the short axis Z2 of the inner annular edge 101 is wider than the other position, with the ellipse of the inner annular edge 101 being formed in a deflected position biased towards the other position within the circular shape of the outer annular edge 102. The incision C, the first and second ends E1 and E2 separated from each other via the incision C, and the surgical holes 10, locking step joints, or hook joints for binding the first and second ends E1 and E2 together can be formed at one of the positions formed with a relatively wide width along the short axis Z2, for example, the one position formed with a relatively wide width along the short axis Z2 can correspond to the central position S of the procedure in the procedure of the eye implant 100.

[0222] In this specification, when the pupil dilator 105 between the inner annular edge 101 and the outer annular edge 102 has first and second ends E1 and E2 separated by an incision C, the incision C and the first and second ends E1 and E2 separated from each other by the incision C can be formed extending from the pupil dilator 105 to the inner annular edge 101 defining one end of the pupil dilator 105 and to the outer annular edge 102 defining the other end of the pupil dilator 105. In this sense, the incision C can be said to form the first and second ends E1 and E2 that separate the eye implant 100 from each other.

[0223] In one embodiment of the present invention, in the pupil dilation portion 105 between the inner annular edge 101 and the outer annular edge 102, the positions on both sides along the short axis direction Z2 of the inner annular edge 101 can be formed with a relatively smaller curvature than the positions on both sides along the long axis direction Z1 of the inner annular edge 101, and one of the two positions having a selectively wider width can be designated as the central position S of the procedure, and the incision portion C, the first and second ends E1 and E2, the procedure hole 10, the locking step joint or hook joint, and other components can be formed at the central position S of the procedure, which corresponds to the position formed with a relatively small curvature and a wide width.

[0224] In the surgery of the ocular implant 100 according to an embodiment of the present invention, the first end E1 of the ocular implant 100 is inserted through the incision EBC formed on the conjunctiva, and is wound around the outer ring of the pupil while making one round along the outer ring of the pupil, and then returns again and the first end E1 drawn out through the incision C and the second end E2 remaining without being inserted through the incision C are tied to each other, so that the ocular implant 100 wound around the outer ring of the pupil can be permanently implanted. At this time, in tying the first and second ends E1 and E2, a suture is passed through the surgical holes 10 formed in the first and second ends E1 and E2 so as to penetrate, and the surgical holes 10 of the first and second ends E1 and E2 are tied to each other through the knot of the suture, whereby the first and second ends E1 and E2 can be joined to each other. In an embodiment of the present invention, at least one surgical hole 10 can be formed in each of the first end E1 and the second end E2, and in various embodiments of the present invention, a plurality of surgical holes 10 can be formed in each of the first end E1 and the second end E2. In various embodiments of the present invention, a plurality of surgical holes 10 can be formed in each of the first end E1 and the second end E2 of the pupil dilator 105 forming the body of the ocular implant 100 or the ocular implant 100, and in each of the first end E1 and the second end E2, a plurality of surgical holes 10 can be formed at regular intervals along the long axis direction Z1. For example, depending on the shape and size of the pupil formed differentially according to the physical condition of the transplant recipient, the tying between the first and second ends E1 and E2 can be performed through the surgical hole 10 at the optimized position among the surgical holes 10 formed in the first and second ends E1 and E2. For example, as the surgeon of the ocular implant 100, the surgical hole 10 at the position suitable for the individualized pupil shape and size of each transplant recipient is selectively taken, and the first and second ends E1 and E2 are tied to each other through the surgical hole 10 at the position optimized to surround the outer ring of the pupil along the periphery of the pupil of each transplant recipient.

[0225] For example, the surgeon can select a surgical hole 10 in a position optimized to surround the outer rim of the transplanted eye, pass a suture through the selected surgical hole 10, and tie them together. If the distance between the two surgical holes 10, where the suture passes through and ties the first and second ends E1 and E2 together, is set too far, the pupil dilator 105 between the two surgical holes 10, where the first and second ends E1 and E2 are tied together, may be distorted and deformed, negatively affecting the coplanarity of the entire pupil dilator 105. This could lead to side effects such as the entire eye implant 100, including the pupil dilator 105, not adhering tightly to the sclera and creating a gap. Conversely, if the distance between the two surgical holes 10, where the suture passes through and ties the first and second ends E1 and E2 together, If the distance between the holes 10 is set too short, excessive tensile stress may accumulate along the eye implant 100 or the pupil dilator 105 that forms the body of the eye implant 100 due to the suturing force between the surgical holes 10 that bind the first and second ends E1 and E2 to each other. This accumulated tensile stress may affect the lifespan of the eye implant 100 or the pupil dilator 105 that forms the body of the eye implant 100, or the pupil dilator 105 may deform to reduce its circumference, causing fatal surgical errors such as the pupil dilator 105 obstructing the recipient's pupil, or the pupil dilator 105 may become distorted and deformed, preventing the pupil dilator 105 or the eye implant 100 including the pupil dilator 105 from adhering closely to the recipient's sclera, thus creating a gap.

[0226] Thus, in one embodiment of the present invention, eye implants 100 of the same specifications are formed through the same mold design, but to optimize for the shape and size of the pupil which is formed differently for each transplant recipient's physical condition, a binding position optimized to surround the outer rim of the transplant recipient's pupil is selected from among a plurality of surgical holes 10 formed in the first and second ends E1 and E2 of the eye implant 100 that encircles the outer rim of the pupil, and a suture is passed through the surgical hole 10 at the selected binding position, thereby binding the eye implant 100 that encircles the transplant recipient's pupil or the first and second ends E1 and E2 of the pupil dilator 105 that forms the body of the eye implant 100 to each other. For example, in one embodiment of the present invention, the practitioner can cut and remove any excess pupil dilation portion 105 that remains excessively between the two treatment holes 10 selected as binding positions from among the multiple treatment holes 10 formed in the first and second ends E1 and E2 of the eye implant 100. For example, the excess pupil dilation portion 105 remaining between the two treatment holes 10 selected as binding positions may be subject to deformation in response to stress that tends to reduce its length in response to the tensile stress of the suture thread passed through these treatment holes 10 selected as binding positions. Therefore, the excess pupil dilation portion 105 can be removed between the two treatment holes 10 selected as binding positions at the first and second ends E1 and E2. In this case, the practitioner can refer to the multiple treatment holes 10 formed at regular intervals in the first and second ends E1 and E2 and set the cutting position based on the positions of the multiple treatment holes 10.In one embodiment of the present invention, the circumference of the eye implant 100 or the pupil dilation portion 105 forming the body of the eye implant 100 is preferably set to a size optimized to surround the outer ring of the pupil without blocking the pupil (or the pupil) that provides the light incident aperture while forming an integrated appearance with the individualized pupil of each transplant recipient. For example, in a manner of cutting the pupil dilation portion 105 formed in a standardized size or a single size so as to form a circumference optimized to surround the outer ring of the individualized pupil for each transplant recipient, a circumference optimized to surround the outer ring of the individualized pupil for each transplant recipient can be adaptively formed, for example, a circumference optimized to go around the outer ring of the transplant recipient's pupil. At this time, as the operator, referring to the positions of the surgical holes 10 formed at regular intervals at the first and second ends E1 and E2 of the pupil dilation portion 105 forming the body of the eye implant 100 or the eye implant 100, at least a part of at least one of the first and second ends E1 and E2 can be cut to provide an optimized circumference for each transplant recipient.

[0227] For example, as the operator, the circumference of the eye implant 100 or the pupil dilation portion 105 optimized to surround the pupil of the transplant recipient can be set by examining or measuring the eyeball EB, and the cutting position can be set from at least one end of the first and second ends E1 and E2 so as to form the set circumference of the pupil dilation portion 105. At this time, the cutting position can be set based on the positions of the plurality of surgical holes 10 formed at regular intervals along the long axis direction Z1 at the first and second ends E1 and E2. For example, in one embodiment of the present invention, the plurality of surgical holes 10 formed at each of the first end E1 and the second end E2 can be formed at an interval of 0.5 mm along the long axis direction Z1.

[0228] Thus, in one embodiment of the present invention, the multiple surgical holes 10 formed along the length of the longitudinal axis Z1 or the first and second ends E1, E2 can provide binding positions optimized to surround the iris of the pupil, which is individualized in shape and size for each transplant recipient, and can provide a reference or basis for setting cutting positions to form a circumference optimized to surround the iris of the transplant recipient, for example, a circumference optimized to go around the iris of the transplant recipient.

[0229] In one embodiment of the present invention, the surgical hole 10 forms an incision (EBC) in the conjunctiva on the sclera, and a space-securing device (not shown) can be inserted along the incision (EBC) to secure a space for implanting the eyeball implant 100 between the sclera and the conjunctiva. The eyeball implant 100 can be pulled into the implantation space via the implantation insertion device so that it circles the outer rim of the recipient's pupil by pulling the eyeball implant 100 toward the implantation space secured by the space-securing device. At this time, the implantation insertion device (not shown) inserts the first end E1 of the eyeball implant 100 toward the implantation space secured along the outer rim of the recipient's pupil through the surgical hole 10 formed in the first end E1 of the eyeball implant 100, and the eyeball implant 100 can be inserted into the implantation space secured along the outer rim of the pupil from the first end E1 into which the implantation insertion device is fitted, in accordance with the rotational movement forced by the implantation insertion device (not shown), and can circle along the outer rim of the pupil. Thus, the surgical hole 10 formed at the first end E1 or the second end E2 can provide a position for physical interference with an implantation device (not shown) for pulling the entire eyeball implant 100, that is, a position for the implantation device (not shown) for pulling the eyeball implant 100 to pass through, for example, the surgical hole 10 into which the implantation device (not shown) is fitted can follow the implantation device (not shown) fitted into the surgical hole 10, or the implantation device (not shown) can follow the implantation device (not shown) and go all the way around the outer rim of the pupil from the first end E1 where the surgical hole 10 is formed, surrounding the outer rim of the pupil.

[0230] In one embodiment of the present invention, the procedure hole 10 provides a binding position between the first and second ends E1 and E2, and may include a first procedure hole 11 for the passage of a suture and a second procedure hole 12 for the physical interference of the implantation device or for the passage of the implantation device. In one embodiment of the present invention, the first procedure hole 11 and the second procedure hole 12 may be formed in substantially the same shape and size, and depending on the operator's choice, some procedure holes 10 may function as the first procedure hole 11 for the passage of a suture, and some procedure holes 10 may function as the second procedure hole 12 for the passage of an implantation device (not shown), and a plurality of procedure holes 10 formed in the same shape along the longitudinal axis Z1 or the length of the first and second ends E1 and E2 may provide relatively free positional selection and may function as the first and second procedure holes 11 and 12 depending on the operator's choice.

[0231] In various embodiments of the present invention, the surgical hole 10 may include a first surgical hole 11 formed to be relatively small in diameter to accommodate a relatively thin strand of suture, and a second surgical hole 12 formed to be relatively large in diameter to accommodate a relatively thick implantation device (not shown) for traction of a whole eye implant 100. In one embodiment of the present invention, the first surgical hole 11 and the second surgical hole 12 can be formed at different positions along the first end E1 and the second end E2, the first surgical hole 11 for suture penetration is formed relatively close to the ends of the first end E1 and the second end E2 along the longitudinal axis Z1 so as not to be interposed between the two first surgical holes 11 which provide a binding position for binding the first end E1 and the second end E2 together, and the second surgical hole 12 is formed relatively far from the ends of the first end E1 and the second end E2 along the longitudinal axis Z1 so as not to cause damage to the first end E1 and the second end E2 while the eye implant 100 is being pulled through an implantation device (not shown) fitted into the second surgical hole 12.

[0232] In one embodiment of the present invention, the eye implant 100 can be formed in a symmetric shape with respect to the center O of the opening OP. For example, in one embodiment of the present invention, the eye implant 100, or the pupil dilator 105 forming the body of the eye implant 100, can be formed in a symmetric shape along the long axis Z1 and short axis Z2 that cross the center O of the opening OP. In one embodiment of the present invention, an incision C can be formed in the eye implant 100 or the pupil dilator 105 forming the body of the eye implant 100, incised along the short axis Z2, and a plurality of treatment holes 10 can be formed in the first end E1 and second end E2 separated by the incision C. In this case, the plurality of treatment holes 10 can be arranged along the long axis Z1 and formed symmetrically along the short axis Z2. For example, the plurality of treatment holes 10 formed in the first and second end E1 and E2 separated from each other by the incision C along the short axis Z2 that the incision C follows can be formed symmetrically. For example, the procedure can be performed without the need to separate the first and second ends E1 and E2 by using a plurality of surgical holes 10 formed symmetrically on the first and second ends E1 and E2 with respect to the incision C, thus improving the convenience of the procedure. In one embodiment of the present invention, the first and second surgical holes 11 and 12 of different sizes can be formed symmetrically on the first and second ends E1 and E2, and the second surgical hole 12 that is fitted into the implantation insertion device is formed symmetrically on the first and second ends E1 and E2, so the procedure can be performed by implanting the eye implant 100 through the implantation insertion device fitted into the second surgical hole 12 of either the first or second end E1 or E2.

[0233] In one embodiment of the present invention, the incision C can be formed along the short axis direction Z2 of the opening OP, and can be formed at either one position along the short axis direction Z2 of the opening OP, and a plurality of surgical holes 10 can be formed in the first and second ends E1 and E2 that are divided through the incision C formed at either one position along the short axis direction Z2. The first and second ends E1 and E2 in which the surgical holes 10 are formed, or the one position in which the incision C dividing the first and second ends E1 and E2 is formed, can be either one along the short axis direction Z2 of the opening OP, and can be a part of an eyeball implant 100 extending in parallel with the long axis direction Z1, or a part of a pupil dilator 105 that forms the body of the eyeball implant 100.

[0234] In one embodiment of the present invention, the opening OP formed at the central position of the eye implant 100, or the inner annular edge 101 defining the opening OP, can be formed in an elliptical shape having different major axis lengths L1 and minor axis lengths L2, and the outer annular edge 102 formed on the opposite side of the inner annular edge 101 can be formed in a circular shape to provide an aesthetically pleasing appearance. Thus, in one embodiment of the present invention, the pupil dilator 105 formed between the inner annular edge 101 and the outer annular edge 102 can be formed in a shape in which the elliptical inner annular edge 101 is formed inside the circular outer annular edge 102, and the pupil dilator 105 defined by the outer annular edge 102 and the inner annular edge 101 of different shapes can be formed at different angular positions and with different widths around the central opening OP as the center of rotation. For example, in one embodiment of the present invention, the pupil dilator 105 can be formed with the widest width at the 0-degree angle position A1 where the incision C is formed, and can be formed with approximately equal widths at the remaining 90-degree angle position A3, 180-degree angle position A2, and 270-degree angle position A4. In one embodiment of the present invention, the incision C or the first end E1 and second end E2 separated through the incision C can correspond to the central position S for the procedure of the eye implant 100, and for example, the first end E1 and second end E2 can be bound together toward each other while sutures are passed through a plurality of procedure holes 10 (e.g., first procedure hole 11) formed in the first end E1 and second end E2, and the eye implant 100 can be implanted along the outer rim of the recipient's pupil while an implantation insertion instrument is inserted through the procedure holes 10 (e.g., second procedure hole 12) formed in the first end E1 and second end E2.

[0235] In one embodiment of the present invention, in the pupil dilation portion 105 defined by an elliptical inner annular edge 101 and a circular outer annular edge 102, the pupil dilation portion 105 that forms the body of the eyeball implant 100 or the position corresponding to the central position S of the procedure (e.g., the 0-degree angle position A1) is formed with a relatively wide width at either the inner annular edge 101 or along the minor axis Z2 of the ellipse surrounded by the inner annular edge 101, in other words, either the 0-degree angle position A1 and the 180-degree angle position A2 that form both sides along the minor axis Z2 with the center O of the opening OP as the rotation center, thereby providing ease of procedure. Thus, in one embodiment of the present invention, the elliptical inner annular edge 101 is positioned inside the circular outer annular edge 102 so as to form the widest pupil dilation portion 105 at the position corresponding to the central position S of the procedure (for example, the 0-degree angle position A1). Rather than positioning the elliptical inner annular edge 101 in the middle of the circular outer annular edge 102, the elliptical inner annular edge 101 can be positioned at a biased position toward the other position along the short axis Z2 such that a relatively wider width is secured at one of the two positions. In other words, in one embodiment of the present invention, the elliptical inner annular edge 101 that defines the opening OP can be positioned at a biased position toward the other position along the short axis Z2 from the middle position of the circular outer annular edge 102 such that the width of one of the two positions increases.

[0236] In one embodiment of the present invention, the position corresponding to the central position S of the procedure can be either one of the positions on both sides along the short axis direction Z2, or one of the positions on both sides along the short axis direction Z2 that has a relatively wider width, and the incision C and the procedure hole 10 can be formed at the one position corresponding to the central position S of the procedure, and the locking step joint and hook joint described later can also be formed at one position of the pupil dilation portion 105 along the shortening direction Z2.

[0237] Thus, in one embodiment of the present invention, one of the two positions along the short axis Z2 can be formed with a relatively wide width, forming a portion with relatively small curvature that extends substantially along the long axis Z1, while the other two positions along the long axis Z1 can be formed with a relatively narrow width, forming a portion with relatively large curvature that extends substantially along the short axis Z2. By setting one of the two positions along the short axis Z2 that forms the portion with relatively small curvature as the central position S of the procedure, the convenience of the procedure can be improved through the incision C formed in the portion formed with a relatively wide width and small curvature, and the procedure holes 10 formed in the first and second ends E1 and E2 that are divided through the incision C. Thus, at one of the two positions along the short axis Z2 that corresponds to the central position S of the procedure, a locking step joint or hook joint, which will be described later, can also be formed along with the incision C and the procedure hole 10.

[0238] In one embodiment of the present invention, the first end E1 and the second end E2 can be bound together via sutures passed through surgical holes 10 formed in the first end E1 and the second end E2. However, in various embodiments of the present invention, the first end E1 and the second end E2 can also form a locking step joint or hook joint between the first end E1 and the second end E2, in which one of the first end E1 and the second end E2 is fitted into the other, thereby forming a locking step between them, preventing them from separating from each other.

[0239] More specifically, the first and second ends E1 and E2 can have first and second slits 154a, 154b, 155a, and 155b formed therein, into which the second and first ends E1 and E2 corresponding to the other end can be fitted. The first and second ends E1 and E2 are fitted into each other via the first and second slits 154a, 154b, 155a, and 155b, which are formed in a complementary shape to each other. Once fitted, the first and second ends E1 and E2 can be prevented from separating via the complementary first and second slits 154a, 154b, 155a, and 155b, and the first and second ends E1 and E2 can be bound to each other via the first and second slits 154a, 154b, 155a, and 155b.

[0240] In various embodiments of the present invention, the first and second slits 154a, 154b, 155a, and 155b formed in the first and second ends E1 and E2, respectively, may include first portions 1541 and 1551 extending along the longitudinal axis Z1 where the first and second ends E1 and E2 face each other across the incision C, or along the longitudinal axis Z1 intersecting the short axis Z2 on which the incision C extends, and second portions 1542 and 1552 extending from the first portions 1541 and 1551 along the short axis Z2 to the outside of the eye implant 100 or the pupil dilator 105 of the eye implant 100. In this case, the second portions 1542 and 1552 can be formed in complementary shapes, for example, the second portions 1542 and 1552 of the first and second slits 154a, 154b, 155a, and 155b formed at the first and second ends E1 and E2, respectively, can be open to the outside of the pupil dilator 105, extending in opposite directions along the minor axis Z2 from the first portions 1541 and 1551 extending along the major axis Z1, i.e., toward the inner annular edge 101 and the outer annular edge 102 formed on opposite sides from the first portions 1541 and 1551, respectively. Furthermore, the first and second slits 154a, 154b, 155a, and 155b of the first and second ends E1 and E2, which are fitted together, can prevent each other from separating, with the second portions 1542 and 1552 of the first and second slits 154a, 154b, 155a, and 155b, which are formed in complementary shapes to each other, functioning as locking steps or hooks. In various embodiments of the present invention, the first and second slits 154a, 154b, 155a, and 155b can either extend from the first portions 1541 and 1551 extending along the longitudinal axis Z1 toward the outside of the pupil dilator 105 along the minor axis Z2 perpendicular to the first portions 1541 and 1551 and open toward the outside of the pupil dilator 105, or extend from the first portions 1541 and 1551 extending along the longitudinal axis Z1 toward the outside of the pupil dilator 105 along a diagonal direction that simultaneously follows the longitudinal axis Z1 and the minor axis Z2 and open toward the outside of the pupil dilator 105.

[0241] In one embodiment of the present invention, at least one of the first and second slits 154a, 154b, 155a, and 155b formed in the first and second ends E1 and E2 can be arranged in multiples along the longitudinal axis Z1 or the length of the first and second ends E1 and E2. In one embodiment of the present invention, the longitudinal direction of the first and second ends E1 and E2, in which the multiple first and second slits 154a, 154b, 155a, and 155b or the multiple treatment holes 10 are arranged, can correspond to the longitudinal axis Z1 perpendicular to the short axis Z2, in which the incision C separating the first and second ends E1 and E2 extends. For example, at least one of the multiple slits 154a, 154b, 155a, 155b arranged along the length of the first and second ends E1, E2 can be bound together via the first and second slits 154a, 154b, 155a, 155b at a position selected from among the multiple first and second slits 154a, 154b, 155a, 155b arranged along the length of the first and second ends E1, E2, by adjusting the binding position between the first and second slits 154a, 154b, 155a, 155b to form an ophthalmic implant 100 optimized to surround the pupil of the implanter, or the circumference of the pupil dilator 105 of the ophthalmic implant 100.

[0242] In various embodiments of the present invention, the incision C can be formed along the short axis direction Z2 of the inner annular edge 101, the first and second ends E1 and E2 can be adjacent to each other along the long axis direction Z1 of the inner annular edge 101, and either of the first and second slits 154a, 154b, 155a, 155b can include an array of first slits 154a, 155a or an array of second slits 154b, 155b formed on the first end E1 or second end E2 along the long axis direction Z1, while the other can be formed by a single second slit 154b, 155b or first slits 154a, 155a.

[0243] In one embodiment of the present invention, an assembly slit 156a can be formed in either the first end E1 or the second end E2 to form a locking step joint or hook joint for fastening the first end E1 and the second end E2, and an assembly hole 156b into which the assembly slit 156a is fitted can be formed in the other end. For example, in one embodiment of the present invention, an assembly slit 156a can be formed in the first end E1, and an assembly hole 156b into which the assembly slit 156a is fitted can be formed in the second end E2. In one embodiment of the present invention, the assembly hole 156b on the second end E2 side into which the assembly slit 156a on the first end E1 side is fitted is not open toward the outside of the second end E2, but is formed in a closed form isolated from the outside of the second end E2. Considering the ease of assembly of fitting the assembly slit 156a on the first end E1 side, an assembly guide portion 158 can be formed at the end of the first end E1. The assembly guide portion 158 includes a rear end 158c with a relatively wide width and a front end projection 158a formed with a relatively narrow width along the assembly direction or the longitudinal axis Z1, and may include a variable width portion 158b that converges toward the front end projection 158a along a diagonal direction that simultaneously follows the longitudinal axis Z1 and the minor axis Z2 so as to connect the mutually equal widths of the rear end 158c and the front end projection 158a. In one embodiment of the present invention, the rear end 158c that forms the boundary of the assembly guide portion 158 can mean the boundary of the assembly guide portion 158 having a wide width corresponding to the total width W0 of the pupil dilation portion 105, in which case the total width W0 of the pupil dilation portion 105 is the width of the complete pupil dilation portion 105 in which no assembly slit 156a is formed, such as the assembly slit 156a which is drawn in from the inner annular edge 101 and / or the outer annular edge 102, and can mean, for example, the pupil dilation portion 105 having a wider width than the constricted portion W1 which has a narrow width limited by the assembly slit 156a.

[0244] In one embodiment of the present invention, an assembly guide portion 158 can be formed on the front side of the first end portion E1 along the assembly direction or longitudinal axis Z1 of the first end portion E1 and the second end portion E2, and an assembly slit 156a can be formed on the rear side of the first end portion E1. In one embodiment of the present invention, a relatively wide first end portion E1 can be interposed between the front assembly guide portion 158 and the rear assembly slit 156a. For example, the relatively wide first end portion E1 interposed between the assembly guide portion 158 and the assembly slit 156a can mean the total width W0 of the pupil expansion portion 105 which has a relatively wide and complete width and does not have an assembly slit 156a drawn in from the inner annular edge 101 and / or outer annular edge 102.

[0245] For example, in one embodiment of the present invention, the assembly slit 156a can be formed in such a way that it is drawn in from the inner annular edge 101 and the outer annular edge 102 toward the interior of the pupil dilation portion 105 between them along the short axis direction Z2, and the width of the constricted portion W1 that forms the minimum width while being drawn in from the inner annular edge 101 and the outer annular edge 102 on both sides that define the pupil dilation portion 105 may be the same as or smaller than the width W2 of the assembly hole 156b on the second end E2 side. In one embodiment of the present invention, the assembly slit 156a on the first end E1 side can be arranged in a plurality along the long axis direction Z1 or the length of the first end E1, and for example, in one embodiment of the present invention, the binding position between the first end E1 and the second end E2 can be varied to form a circumference optimized to surround the pupil of the transplanter via an arrangement of assembly slits 156a formed along the long axis direction Z1 or the length of the first end E1.

[0246] In one embodiment of the present invention, the assembly guide portion 158 on the first end E1 side aligns the fastening positions between the first end E1 and the second end E2 with each other, while guiding the assembly slit 156a formed behind the assembly guide portion 158 on the first end E1 side toward the assembly hole 156b on the second end E2 side. In one embodiment of the present invention, the width of the front end projection 158a formed on the assembly guide portion 158 on the first end E1 side can be formed to be narrower than the width W2 of the assembly hole 156b on the second end E2 side, and the fastening positions of the first and second ends E1 and E2 can be aligned relative to each other as the front end projection 158a on the first end E1 side is fitted into the assembly hole 156b on the second end E2 side, and the operator of the eye implant 100 can pull the front end projection 158a on the first end E1 side, which is fitted into the assembly hole 156b on the second end E2 side, toward the second end E2, while the relatively wide first end E1 ( The entire width W0 of the first end E1 can be guided toward the assembly hole 156b on the second end E2 side, and the assembly hole 156b on the second end E2 side is fitted into the narrowed portion W1 of the assembly slit 156a connected to the wide first end E1 (the entire width W0 of the first end E1), thereby preventing the first and second ends E1 and E2 from separating from each other. For example, the relatively wide first end E1 (the entire width W0 of the first end E1) functions as a locking step or hook with the narrowed portion W1 of the assembly slit 156a on the first end E1 side, which is fitted into the assembly hole 156b on the second end E2 side, in front of and behind it, thereby preventing the first and second ends E1 and E2 from separating from each other.

[0247] In one embodiment of the present invention, the assembly guiding portion 158 is configured to guide a locking step connection or a hook connection between the narrow portion W1 of the rear assembly slit 156a and the assembly hole 156b through the front assembly guiding portion 158 along the assembly direction or the long axis direction Z1, such that the relatively thick rear first end portion E1 (the total width W0 of the first end portion E1) passes through the assembly hole 156b formed with a relatively narrow width. After the first and second end portions E1 and E2 are bound to each other through a locking step connection or a hook connection, that is, after the narrow portion W1 of the assembly slit 156a of the first end portion E1 is fitted into the assembly hole 156b of the second end portion E2, by removing the used assembly guiding portion 158, for example, by removing the assembly guiding portion 158 that overlaps on the second end portion E2 to form an additional thickness, it is possible to remove the adverse effect on the peripheral eyeball EB tissue and block forcing deformation of the intraocular implant 100.

[0248] In one embodiment of the present invention, a cut-off line CL can be formed by a rear boundary corresponding to the rear end 158c of the assembly guiding portion 158 along the assembly direction or the long axis direction Z1. After the first and second end portions E1 and E2 are bound to each other through a locking step connection or a hook connection, the assembly guiding portion 158 can be separated and removed along the cut-off line CL. In one embodiment of the present invention, the cut-off line CL may be formed between the front assembly guiding portion 158 and the rear assembly slit 156a. More specifically, it can be formed along the boundary between the front assembly guiding portion 158 and the first end portion E1 (the total width W0 of the first end portion E1) having a relatively wide width formed between the front assembly guiding portion 158 and the rear assembly slit 156a (the rear boundary of the assembly guiding portion 158 forming the rear end 158c of the assembly guiding portion 158). In one embodiment of the present invention, the cut-off line CL may include a plurality of perforations formed along the cut-off line CL or a display line indicating the cut-off position in a form that is not a perforation. In one embodiment of the present invention, the cut-off line CL may be formed along the short axis direction Z2 beside the cut-open portion C.

[0249] In various embodiments of the present invention, the first and second ends E1 and E2, separated from each other by the incision C, are bound together by passing sutures through the surgical holes 10 formed in the first and second ends E1 and E2, or by using the first and second slits 154a, 154b, 155a, and 155b formed in the first and second ends E1 and E2 to fasten the sutures together. The first and second ends E1 and E2 can be bound together by fitting them into each other via b, 155a, and 155b, or by using the assembly slits 156a and assembly holes 156b formed in the first and second ends E1 and E2, with the assembly slit 156a on the first end E1 side fitting into the assembly hole 156b on the second end E2 side. Thus, in various embodiments of the present invention, when binding the first and second ends E1 and E2, the first and second ends E1 and E2 that are to be bound do not overlap with each other and are bound to each other while facing each other along the assembly direction or the longitudinal axis Z1, or the first and second ends E1 and E2 can overlap with each other while forming a binding. As shown in Figures 10a to 11b, in a structure in which first and second slits 154a, 154b, 155a, and 155b are formed in the first and second ends E1 and E2 and fitted together, or in a structure in which assembly slits 156a and assembly holes 156b are formed in the first and second ends E1 and E2 respectively and fitted together, the first and second ends E1 and E2 can overlap with each other to form an extra thickness, and this extra thickness can locally form an extra thickness along the circumferential direction of the eyeball implant 100 or the pupil dilator 105 that forms the body of the eyeball implant 100, thereby forcing stress and deformation.Therefore, taking these considerations into account, the first and second ends E1 and E2 are positioned such that they overlap with each other between the first and second slits 154a, 154b, 155a, 155b, which are fitted together to fasten the first and second ends E1 and E2 toward each other, and the incision C, or the first and second ends E1 and E2 overlap with each other between the constricted portion W1 of the assembly slit 156a, which is fitted together to fasten the first and second ends E1 and E2 toward each other, the assembly slit 15 that is fitted into the assembly hole 156b. Except for a portion of the first end E1 that forms the total width W0 of the pupil dilator 105, which is formed in front of the constricted portion W1 of 6a and functions as a locking step or hook, and a portion of the second end E2 that is formed in front of the assembly hole 156b to maintain the closed form of the assembly hole 156b, the first and second ends E1 and E2 that overlap each other in the remaining positions are formed with a relatively thin thickness so that a uniform thickness can be formed around the entire circumference surrounding the outer rim of the implanter's pupil in the implanted eyeball implant 100 or in the eyeball implant 100 after the binding between the first and second ends E1 and E2 has been completed. For example, around the first and second slits 154a, 154b, 155a, and 155b on the first and second end E1 and E2 sides, thin sections can be formed with a relatively thin thickness so as not to create additional extra thickness from the overlap of the first and second end E1 and E2, and the thin sections of the first and second end E1 and E2 can overlap with each other to form the normal thickness of the eye implant 100.

[0250] In one embodiment of the present invention, the locking step joint or hook joint that connects the first and second ends E1 and E2, which are separated from each other via the incision C, can be formed at one of two positions along the short axis Z2, with a relatively wide width, or at one of two positions extending along the long axis Z1 with a relatively small curvature, thereby making it relatively easy to connect the first and second ends E1 and E2 during the procedure of the eye implant 100, and such one position can form the central position S of the procedure during the implant procedure.

[0251] In this specification, the central position S of the implant procedure is described as one of the two positions of the pupil dilator 105 that form positions on both sides along the short axis Z2, where the elliptical profile of the inner annular edge 101 is formed with a relatively wide width while being deflected to the other position within the circular profile of the outer annular edge 102. However, in the embodiments shown in the drawings attached to this specification, the central position S of the procedure can be selectively formed at one of two positions (0-degree angle position A1) and the other position (180-degree angle position A2) where the elliptical profile of the inner annular edge 101 is formed symmetrically with each other, without being deflected to either one of the two positions along the short axis Z2, and having substantially the same width. In one embodiment of the present invention, the one position forming the central position S of the procedure can be selected from the two positions along the short axis Z2, thereby forming a relatively small curvature while generally following the long axis Z1.

[0252] In this specification, with respect to an array of prosthetic holes 10 formed along the first and second ends E1 and E2 separated from each other via an incision C, or an array of first and second slits 154a, 154b, 155a, 155b formed along the first and second ends E1 and E2 to form a locking step joint or a hook joint, or an array of assembly slits 156a formed along the first and second ends E1 and E2, the array of these configurations can be arranged along the length of the first and second ends E1 and E2, for example, along the length of the first and second ends E1 and E2 that form a part of the circumferential direction of the pupil dilator 105, so in this specification, when these arrays are arranged along the longitudinal axis Z1, it can be said that they are arranged along the circumferential direction of the pupil dilator 105.

[0253] Figure 12 shows a modified embodiment of the eye implant shown in Figure 4. Referring to the drawing, the outer annular edge 102 can be formed as a circular profile, and the inner annular edge 101 can be formed as a circular profile inside the circular profile of the outer annular edge 102. For example, in one embodiment of the present invention, the inner annular edge 101 and the outer annular edge 102 can surround the opening OP with the same circular profile, for example, surrounding the opening OP in a concentric circle with the center O of the opening OP as the origin. In one embodiment of the present invention, the inner annular edge 101 can be formed with a long axis length L1 along the direction in which the transplanter's pair of eyes face each other, and a short axis length L2 perpendicular to the long axis length L1, both being the same circular shape. By forming the long axis length L1 and the short axis length L2 as circular profiles of the same length, alignment with the transplanter's pupil is not required, thus improving the convenience of the procedure. Furthermore, the outer annular edge 102 and the inner annular edge 101 are formed in a concentric circular shape with the center O of the opening OP as the origin, thereby improving the convenience of the processing steps for forming the eyeball implant 100.

[0254] Figure 13 shows a modified embodiment of the eye implant shown in Figure 6. Referring to the drawing, the adaptive expandable sections 1511 and 1512 can provide length expansion and contraction along the inner annular edge 101 and outer annular edge 102 to adaptively deform to the shape and size of each implanter's pupil. For example, the adaptive expandable section 1511 of the inner annular edge 101 may include a plurality of slits 1511s formed spaced apart from each other along the inner annular edge 101, and the adaptive expandable section 1512 of the outer annular edge 102 may include a plurality of slits 1512s formed spaced apart from each other along the outer annular edge 102. In one embodiment of the present invention, the width d1 of the slit 1511s forming the adaptive expandable portion 1511 of the inner annular edge 101 can be formed along the depth direction from the inner annular edge 101 toward the outer annular edge 102, and the width d2 of the slit 1512s forming the adaptive expandable portion 1512 of the outer annular edge 102 can be formed along the depth direction from the outer annular edge 102 toward the inner annular edge 101. In one embodiment of the present invention, the width d2 of the slit 1152s forming the adaptive expandable portion 1152 of the outer annular edge 102 can be formed to be smaller than the width d1 of the slit 1151s forming the adaptive expandable portion 1151 of the inner annular edge 101. For example, in one embodiment of the present invention, the widths d1 and d2 of the slits 1151s and 1152s forming the respective adaptive expandable portions 1151 and 1152 can be adjusted so that the range of length expansion provided by the adaptive expandable portion 1151 of the inner annular edge 101 is wider than the range of length expansion provided by the adaptive expandable portion 1152 of the outer annular edge 102. In one embodiment of the present invention, the widths d1 and d2 of the slits 1151s and 1152s forming the respective adaptive expandable portions 1511 and 1512 can be adjusted so that the range of length expansion of the inner annular edge 101 surrounding the pupil at a relatively adjacent position is wider than the range of length expansion of the outer annular edge 102 surrounding the pupil at a relatively distant position, so that the adaptive expandable portions 1511 and 1512 can adaptably deform to the shape and size of the pupil of each transplant recipient.In various embodiments of the present invention, the adaptive expandable portions 1511 and 1512 may be formed along either one of the inner annular edge 101 and the outer annular edge 102, or they may be formed on both sides along the inner annular edge 101 and the outer annular edge 102.

[0255] Figure 14 shows a diagram illustrating a configuration in one embodiment of the present invention in which different mechanisms are combined to bind together the first and second ends E1 and E2, which are separated from each other via an incision C. In one embodiment of the eye implant 100 shown in the drawing, a procedure hole 10 and a locking step connection or hook connection can be formed in combination. Referring to Figure 14, in one embodiment of the present invention, the eye implant 100 can have a procedure hole 10, along with a first slit 154a and a second slit 154b formed on the first end E1 and second end E2 sides as a locking step connection or hook connection. Referring to both Figure 14 and Figure 11a, in another embodiment of the present invention, the eye implant 100 can also have a procedure hole 10, along with an assembly slit 156a and an assembly hole 156b formed on the first end E1 and second end E2 sides as a locking step connection or hook connection.

[0256] Thus, in one embodiment of the present invention, along with a surgical hole 10 for passing a suture and binding the first and second ends E1 and E2 together via the knot of the suture, there is another mechanism for binding the first and second ends E1 and E2 together, which is formed by combining a locking step joint or a hook joint, for example, by combining different mechanisms for binding the first and second ends E1 and E2 together. The binding force between the two can be increased. For example, if the practitioner determines that sufficient binding force can be formed between the first and second ends E1 and E2 using only the locking step joint or hook joint, then suturing through the treatment hole 10 is not required. Alternatively, the binding force between the first and second ends E1 and E2, which are temporarily fixed by the locking step joint or hook joint, can be reinforced by suturing through the treatment hole 10, thereby firmly binding these first and second ends E1 and E2 together. For example, in one embodiment of the present invention, the treatment hole 10, which is formed in combination with the locking step joint or hook joint, provides a binding position between the first and second ends E1 and E2, and may include a first treatment hole 11 for the passage of a suture and a second treatment hole 12 for physical interference with or passage of a transplant insertion device.

[0257] In this specification, as a binding mechanism for binding the first and second ends E1 and E2, which are separated from each other through the incision C, in addition to sutures, locking step joints, or hook joints that penetrate the treatment hole 10, the first and second ends E1 and E2 may be arranged to overlap each other and a bio-adhesive may be applied between them, or the first and second ends E1 and E2 may be arranged to overlap each other and one end of the first and second ends E1 and E2 may be welded to the other end by heating and melting, and in the fusion joining of the first and second ends E1 and E2, the first and second ends E1 and E2, which become adhesive due to high heat input, may also be pressed toward each other to join them together. In other words, in various embodiments of the present invention, the various mechanisms for binding the first and second ends E1 and E2 together may be formed individually or in combination of different mechanisms. For example, as described above, if a bonding agent such as a bio-adhesive or heat fusion is applied, the first and second slits 154a, 154b, assembly slit 156a, or assembly hole 156b for treatment holes 10 or locking step joints or hook joints may not be formed on the first and second ends E1 and E2.

[0258] In an eye implant 100 according to one embodiment of the present invention, the pupil dilation portion 105 between the inner annular edge 101 and the outer annular edge 102 can be formed in a deflected position within the circular profile of the outer annular edge 102, such that one of the two positions along the short axis of the inner annular edge 101 is wider than the other position, thereby providing the central position O of the procedure with one of the two positions along the short axis of the elliptical or circular inner annular edge 101 having a relatively wider pupil dilation portion 105.

[0259] However, in one embodiment of the present invention, the elliptical or circular profile of the inner annular edge 101 can be formed with equal widths along the short axis direction, without bias towards one or the other position, within the circular profile of the outer annular edge 102. This can cause inconvenience for the practitioner, as they must confirm a position with a relatively wide width along the short axis direction to take the central position O for the procedure of the eye implant 100. Similarly, in the molding of the eye implant 100, a shape biased towards one or the other position may result in handling inconvenience due to insufficient rigidity at one or the other position with a relatively thin width. Therefore, in one embodiment of the present invention, the inner annular edge 101 can be formed symmetrically within the circular profile of the outer annular edge 102, such that both positions are formed symmetrically along the short axis direction. On the other hand, in various embodiments of the present invention, the inner annular edge 101 can be formed as an elliptical or circular profile, and the major axis or minor axis of the inner annular edge 101 can be defined in a structure where the major axis length L1 and the minor axis length L2 are different from each other, as in an ellipse, where the major axis length L1 and the minor axis length L2 are equal to each other in a circle, the major axis can mean the direction in which the transplanter's pair of eyes face each other, and the minor axis can mean the direction intersecting the major axis.

[0260] Figure 15 shows a modified embodiment of the eye implant 100 shown in Figure 9. Referring to the drawing, in one embodiment of the present invention, the surgical holes 10 formed on the first and second ends E1 and E2, separated from each other by the incision C, can be formed in an asymmetrical number, thereby allowing the surgeon performing the eye implant 100 to confirm the orientation of the eye implant 100. For example, in one embodiment of the present invention, during the procedure of the eye implant 100, the eye implant 100 can be pulled along the outer rim of the pupil through a second surgical hole 12 fitted into an implantation insertion instrument for inserting the eye implant 100 so as to circle around the outer rim of the recipient's pupil. The direction in which the eye implant 100 is pulled along the outer rim of the pupil via the implantation insertion instrument can be predetermined from the shape design of the implantation insertion instrument. Thus, after the eye implant 100 of the present invention is aligned to the correct orientation by the surgeon who has recognized its orientation, it is necessary to fit the implantation insertion instrument into the second surgical hole 12 and operate the implantation insertion instrument so as to circle around the outer rim of the recipient's pupil. In this embodiment, the eye implant 100 can be formed from a soft material such as silicone that is harmless to the eye EB tissue while being able to flexibly and adaptively deform on the eye EB tissue. Therefore, the anterior curved surface 120 and the posterior inclined surface 110 of the eye implant 100 can be inverted. Even if the anterior curved surface 120 and the posterior inclined surface 110 of the eye implant 100 are inverted in this way, for example, if the eye implant 100 is inverted so that the anterior curved surface 120 and the posterior inclined surface 110 are swapped with each other, the anterior curved surface 120 may be positioned facing the eye EB instead of the posterior inclined surface 110, and the posterior inclined surface 110 may be positioned facing the outside world opposite to the eye EB. In this case, it may be difficult for the practitioner to easily detect such an error in the orientation of the eye implant 100.In one embodiment of the present invention, the eyeball implant 100 has a number of surgical holes 10 formed on the first and second ends E1 and E2, which are separated from each other via an incision C, which are formed in an asymmetrical number. For example, the number of surgical holes 10 formed on the first and second ends E1 and E2 is different from the number of surgical holes 10 formed on the first and second ends E1 and E2, or the number of surgical holes 10 formed on one end is an even number and the remaining end is an odd number. Therefore, the surgeon performing the eyeball implant 100 can confirm from the shape design of the implantation device which end of the first and second ends E1 and E2 will be fitted with the implantation device. If a normal number of treatment holes 10, a normal odd number, or a normal even number of treatment holes 10 are not found, it can be recognized that the eye implant 100 in question is inverted, with the anterior curved surface 120, which is formed to face the external world OS opposite to the eyeball EB, and the posterior inclined surface 110, which is formed to face the eyeball EB, swapped. This allows for correction of the incorrect orientation of the eye implant 100, and the orientation of the eye implant 100 can be correctly corrected so that the anterior curved surface 120 faces the external world OS opposite to the eyeball EB and the posterior inclined surface 110 faces the eyeball EB, based on the intended design of the eye implant 100. For example, in various embodiments of the present invention, the orientation of the eye implant 100 can be confirmed by an asymmetrical design in which the number of surgical holes 10 formed on the first and second end E1 and E2 sides, which are separated from each other via the incision C, are different, or by forming an even or odd number of surgical holes 10 on the first and second end E1 and E2 sides.

[0261] Although the present invention has been described with reference to embodiments shown in the accompanying drawings, these are merely illustrative, and a person with ordinary skill in the art to which the present invention pertains will understand that a variety of modifications and equivalent other embodiments are possible therefrom. [Industrial applicability]

[0262] This invention is applicable to the medical industry related to the manufacture of eye implants for transplant recipients and the production of surgical instruments.

Claims

1. An eye implant that is permanently implanted on the recipient's eyeball to provide the recipient's pupil with an enlarged appearance, A central opening that accommodates the incoming light toward the pupil, providing the opening of the eyeball, The inner annular edge that surrounds the aforementioned opening and defines the opening, An outer annular edge that surrounds the opening together with the inner annular edge on the opposite side of the inner annular edge that defines the opening, An eye implant comprising a pupil dilator having a variable thickness that changes from the inner annular edge toward the outer annular edge between the inner annular edge and the outer annular edge.

2. The pupil dilation portion is, A posteriorly inclined surface positioned so as to be in close contact with the eyeball, An eye implant according to claim 1, characterized by including a forward curved surface positioned facing the external world opposite to the eyeball.

3. The inner and outer annular edges each form the front of the eyeball and are observed as circular or elliptical in shape along the frontal direction from the front to the back of the eyeball, where the lens (crystalline lens) and the pupil (which forms the aperture for light entry) are located. The eye implant according to claim 2, characterized in that the rearward inclined surface is formed as a surface inclined at a constant tilt angle from a vertical plane perpendicular to the front direction, such that the inner annular edge and the outer annular edge each form a front and rear position, respectively.

4. The ophthalmic implant according to claim 2, characterized in that the rearward inclined surface provides a support surface that is supported on an inclined surface formed in the packaging container of the ophthalmic implant.

5. The eye implant according to claim 2, characterized in that the forward curved surface is formed along a spline curve whose curvature or radius of curvature changes along the direction of inclination of the backward inclined surface.

6. The eye implant according to claim 2, characterized in that the pupil dilation portion has a variable thickness such that the thickness between the posterior inclined surface and the anterior curved surface is variable.

7. The eye implant according to claim 6, characterized in that the thickness of the pupil dilation portion is measured along a direction perpendicular to the posterior inclined surface from the posterior inclined surface to the anterior curved surface.

8. The eye implant according to claim 2, characterized in that the inner annular edge is formed with a forward curved surface and a backward inclined surface that form the thickness of the pupil dilation portion, in contact with each other at a position where they are in contact with the opening.

9. The eye implant according to claim 2, characterized in that the outer annular edge is formed such that the forward curved surface and the backward inclined surface that form the thickness of the pupil dilation portion abut each other on the opposite side of the inner annular edge that defines the opening.

10. The eye implant according to claim 2, characterized in that the forward curved surface and the backward inclined surface that form the thickness of the pupil dilation portion abut each other while forming an inner annular edge and an outer annular edge with rounded corner shapes, respectively.

11. The inner annular edge is formed with a relatively gently rounded corner shape. The eye implant according to claim 10, characterized in that the outer annular edge is formed in a relatively sharply rounded corner shape.

12. The eye implant according to claim 11, characterized in that the thickness of the corner of the inner annular edge is formed to be thinner than the thickness of the corner of the outer annular edge.

13. Of the membrane tissue that surrounds the eyeball to maintain its shape, the inner annular edge, which is drawn in to the discontinuous edge between the cornea (a large curvature portion that protrudes forward) and the sclera (a small curvature portion that extends posteriorly from the cornea), is finished on one side of the eye implant with a relatively gently rounded corner shape. The eye implant according to claim 11, characterized in that the outer annular edge of the large curvature portion that adheres to the sclera is finished on the other side of the eye implant to a relatively sharply rounded corner shape so as not to lift away from the sclera or to form a gap between it and the sclera.

14. The pupil dilation portion has a maximum thickness portion having the greatest thickness between the inner annular edge and the outer annular edge, An inner portion formed relatively adjacent to the opening, between the inner annular edge and the maximum thickness portion, An eye implant according to claim 1, characterized in that it includes an outer portion formed relatively far from the opening, between the maximum thickness portion and the outer annular edge.

15. The eye implant according to claim 14, characterized in that the inner and outer portions, which are arranged on both sides with respect to the maximum thickness portion, have asymmetrical shapes or asymmetrical thickness profiles.

16. The aforementioned inner portion is formed to be relatively flexible so as to adapt to the pupil of each transplant recipient. The eye implant according to claim 14, characterized in that the outer portion is formed to be relatively rigid so as to maintain a beautiful circular appearance against deformation of the inner portion and to reinforce the flexibility of the inner portion and provide support rigidity for the eye implant.

17. The eye implant according to claim 16, characterized in that the inner portion is formed to be thinner than the outer portion so as to be drawn in to the discontinuous edge between the cornea, which is a large curvature portion that protrudes forward in a convex shape, and the sclera, which is a small curvature portion that extends posteriorly from the cornea, and to adhere closely to the discontinuous edge so as not to form a gap between it and the discontinuous edge.

18. The inner and outer parts are formed from the same material. The eye implant according to claim 16, characterized in that the thickness of the inner portion is formed to be relatively thinner than the thickness of the outer portion.

19. The pupil dilation portion includes a forward curved surface and a backward inclined surface that form the thickness of the pupil dilation portion. The eye implant according to claim 18, characterized in that the first average thickness of the inner portion and the second average thickness of the outer portion formed by the rearward inclined surface and the front curved surface are formed such that the first average thickness is less than the second average thickness.

20. Using the rearward inclined surface that provides a reference for the thickness of the pupil dilation portion as a reference, The eye implant according to claim 18, characterized in that the forward curved surface forming the inner portion extends along a trajectory relatively adjacent to the rearward inclined surface, and the forward curved surface forming the outer portion extends along a trajectory relatively far from the rearward inclined surface, thereby forming a difference in thickness between the inner portion and the outer portion formed on both sides with respect to the maximum thickness portion.

21. The forward curved surface forming the inner portion extends along a trajectory relatively adjacent to the rearward inclined surface, forming a relatively thin thickness, and further follows a relatively gentle downward curve toward the rearward inclined surface, forming a corner that is gently rounded by an inner annular edge. The eye implant according to claim 20, characterized in that the forward curved surface forming the outer portion extends along a trajectory relatively far from the rearward inclined surface, forming a relatively thicker surface, and further follows a relatively steep downward curve toward the rearward inclined surface, forming a corner that is sharply rounded at the outer annular edge.

22. An eye implant that is permanently implanted on the recipient's eyeball to provide the recipient's pupil with an enlarged appearance, A central opening that accommodates the incoming light toward the pupil, providing the opening of the eyeball, The inner annular edge that surrounds the aforementioned opening and defines the opening, An outer annular edge that surrounds the opening together with the inner annular edge on the opposite side of the inner annular edge that defines the opening, An eye implant comprising an adaptive telescopic section that adaptively expands and contracts in length along at least one of the inner annular edge and the outer annular edge.

23. The eye implant according to claim 22, characterized in that the adaptive expandable portion provides length expansion and contraction along the inner annular edge so as to adaptively deform to the shape and size of each implanter's pupil.

24. The eye implant according to claim 22, characterized in that the adaptive expandable portion includes at least one slit formed around the inner annular edge.

25. The eye implant according to claim 24, characterized in that the adaptive expandable portion includes a plurality of slits formed spaced apart from each other along the inner annular edge.

26. The eye implant according to claim 25, characterized in that the adaptive expandable portion includes a group of slits formed at positions on both sides along the long axis and / or at positions on both sides along the short axis.

27. The aforementioned adaptive expandable section is, The fragments, separated from each other through the first and second groups of slits formed on both sides along the short axis, overlap each other, extending the short axis length while shortening the long axis length. The eye implant according to claim 26, characterized in that fragments separated from each other through third and fourth groups of slits formed on both sides along the longitudinal axis overlap each other, thereby extending the longitudinal length and shortening the minor axis length.

28. The pupil dilation portion is, A posteriorly inclined surface positioned toward the eyeball so as to be in close contact with the eyeball, It is positioned facing the outside world opposite to the eyeball and forms a thickness profile with respect to a rearward inclined surface, forming an inner annular edge while in contact with the rearward inclined surface at a position adjacent to the opening, forming an outer annular edge while in contact with the rearward inclined surface on the opposite side of the opening, and includes a front curved surface that forms a thickness profile with respect to the rearward inclined surface such that a relatively thin inner portion and a relatively thick outer portion are formed with respect to the maximum thickness portion which forms the maximum thickness between the inner annular edge and the outer annular edge, The eye implant according to claim 24, characterized in that the fragments, separated from each other through the slit forming the adaptive expandable portion, overlap each other, expanding and contracting the length of the inner annular edge, and forming an extra thickness such that the thickness of the inner portion where the slit is formed and drawn in from the inner annular edge is increased.

29. The inner annular edge, in which the fragments divided through the slit forming the adaptive expandable portion are arranged to overlap each other, is formed with a relatively gently rounded corner shape. The eye implant according to claim 1, characterized in that the outer annular edge is formed in a relatively sharply rounded corner shape.

30. An eye implant that is permanently implanted on the recipient's eyeball to provide the recipient's pupil with an enlarged appearance, A central opening that accommodates the incoming light toward the pupil, providing the opening of the eyeball, The inner annular edge that surrounds the aforementioned opening and defines the opening, An outer annular edge that surrounds the opening together with the inner annular edge on the opposite side of the inner annular edge that defines the opening, An eye implant comprising: a pupil dilator formed between the inner annular edge and the outer annular edge, having a first end and a second end that are separated from each other via an incision and bound together toward each other via a surgical hole formed therein.

31. The aforementioned treatment hole is, A first surgical hole through which a suture thread for binding the first end and the second end passes, The eye implant according to claim 30, further comprising: a second surgical hole through which an implantation insertion instrument penetrates for traction of the eye implant, such that the eye implant is routed around the outer rim of the eye of the practitioner via an incision in the conjunctiva on the sclera.

32. The first treatment hole is formed to be relatively small in diameter. The eye implant according to claim 31, characterized in that the second surgical hole is formed to be relatively large in diameter.

33. The first surgical hole is formed in a position adjacent to the incision site, The eye implant according to claim 31, characterized in that the second surgical hole is formed at a position relatively far from the incision site.

34. An eye implant that is permanently implanted on the recipient's eyeball to provide the recipient's pupil with an enlarged appearance, A central opening that accommodates the incoming light toward the pupil, providing the opening of the eyeball, The inner annular edge that surrounds the aforementioned opening and defines the opening, An outer annular edge that surrounds the opening together with the inner annular edge on the opposite side of the inner annular edge that defines the opening, An eye implant comprising: a pupil dilator formed between the inner annular edge and the outer annular edge, having first and second ends that are separated from each other via an incision and form a locking stepped joint or hook joint with respect to each other.

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