Eyeball implant

Abstract

The invention discloses an eyeball implant. According to the present invention, the eyeball implant permanently implanted in the eyeball can be provided, and the eyeball implant can be integrated with the eyeball without repeated disassembly and assembly without blocking the light inlet hole, thereby achieving a graceful appearance effect.

Description

Technical Field

[0001] This invention relates to an ocular implant. Background Technology

[0002] Colored contact lenses, used for cosmetic purposes to enlarge the appearance of the eyes, are formed by injecting dye between two different lenses. Compared to contact lenses used for vision correction, they have lower oxygen permeability and an uneven surface, leading to an increased contact area and frequency of bacterial contact with the lenses. This can cause side effects such as neovascularization, keratitis, corneal ulcers, and corneal edema. For example, neovascularization can shrink the appearance of the eye, which contradicts the cosmetic purpose of colored contact lenses, and due to corneal hypoxia, neovascularization may cause a white haze around the cornea. Summary of the Invention

[0003] Technical issues

[0004] One embodiment of the present invention includes an eye implant that can be permanently implanted in the eye without the cumbersome operation of removal and insertion, and can form a beautiful appearance that is integrated with the eyeball without obstructing the light aperture.

[0005] One embodiment of the present invention includes an ocular implant that fits closely to a discontinuous edge on the eyeball, thereby improving ease of operation while minimizing side effects.

[0006] One embodiment of the invention includes an eye implant that provides versatility through a single-design mold, thereby reducing manufacturing costs, while being able to adaptively deform into an optimized shape according to the different eye shape and size of each eye implant recipient.

[0007] One embodiment of the present invention includes an ocular implant that improves the ease of ocular implant surgery while preventing side effects caused by structures designed for ease of surgery.

[0008] Technical solution

[0009] An ocular implant according to an embodiment of the present invention,

[0010] It is permanently implanted in the recipient's eyeball to provide the appearance of an enlarged eye, and may include:

[0011] A central opening for receiving incident light toward the eyeball (or pupil), which provides the opening to the eye;

[0012] The inner annular edge surrounds and defines the opening;

[0013] An outer annular edge, which, on the opposite side of the inner annular edge defining the opening, surrounds the opening together with the inner annular edge; and

[0014] An eyeball expansion portion is formed between the inner annular edge and the outer annular edge, and has a variable thickness that gradually changes from the inner annular edge to the outer annular edge.

[0015] An ocular implant according to an embodiment of the present invention,

[0016] It is permanently implanted in the recipient's eyeball to provide the appearance of an enlarged eye, and may include:

[0017] A central opening for receiving incident light toward the eyeball, which provides the eyeball opening;

[0018] The inner annular edge surrounds and defines the opening;

[0019] An outer annular edge, which, on the opposite side of the inner annular edge defining the opening, surrounds the opening together with the inner annular edge; and

[0020] An adaptive telescopic portion that provides adaptive length extension along the periphery of at least one of the inner annular edge and the outer annular edge.

[0021] An ocular implant according to an embodiment of the present invention,

[0022] It is permanently implanted in the recipient's eyeball to provide the appearance of an enlarged eye, and may include:

[0023] A central opening for receiving incident light toward the eyeball, which provides the eyeball opening;

[0024] The inner annular edge surrounds and defines the opening;

[0025] An outer annular edge, which, on the opposite side of the inner annular edge defining the opening, surrounds the opening together with the inner annular edge; and

[0026] An eyeball dilatation portion is formed between the inner annular edge and the outer annular edge, and includes a first end and a second end, which are separated from each other by an incision and joined together toward each other by surgical holes formed thereon, respectively.

[0027] An ocular implant according to an embodiment of the present invention,

[0028] It is permanently implanted in the recipient's eyeball to provide the appearance of an enlarged eye, and may include:

[0029] A central opening for receiving incident light toward the eyeball, which provides the eyeball opening;

[0030] The inner annular edge surrounds and defines the opening;

[0031] An outer annular edge, which, on the opposite side of the inner annular edge defining the opening, surrounds the opening together with the inner annular edge; and

[0032] An eyeball expansion portion is formed between the inner annular edge and the outer annular edge, and includes a first end and a second end that are separated from each other by a cut and form a snap-fit ​​or hook-fit with each other.

[0033] Beneficial effects

[0034] According to the present invention, an eye implant that is permanently implanted on the eyeball can be provided, which eliminates the cumbersome operation of repeated removal and insertion, and forms an aesthetically pleasing appearance that is integrated with the eyeball without obstructing the light entry aperture.

[0035] According to the present invention, an ocular implant can be provided that fits closely to the discontinuous edge of the eyeball, thereby improving ease of operation while minimizing side effects.

[0036] According to the present invention, an eye implant can be provided that provides versatility through a single-design mold, thereby reducing manufacturing costs, while adaptively deforming into an optimized shape according to the different eye shapes and sizes of each implantee.

[0037] According to the present invention, an ocular implant can be provided that improves surgical convenience while preventing side effects caused by structures designed for surgical convenience. Attached Figure Description

[0038] Figure 1 This is a schematic diagram illustrating the general structure of an eyeball permanently implanted with an eyeball implant according to an embodiment of the present invention.

[0039] Figure 2 This is a schematic diagram illustrating the surgical procedure of an ocular implant according to an embodiment of the present invention, showing an incision formed at a certain location along the outer edge of the eyeball.

[0040] Figure 3 A perspective view of an ocular implant according to an embodiment of the present invention is shown.

[0041] Figure 4 Show Figure 3 The image shows a plan view of the ocular implant from the front.

[0042] Figure 5 Show along Figure 3 The cross-sectional view taken from the V–V' line.

[0043] Figure 6 A perspective view of an adaptive stretchable portion used in an ocular implant according to an embodiment of the present invention is shown.

[0044] Figure 7 This is a perspective view illustrating the adaptive stretchable portion used in an ocular implant according to an embodiment of the present invention, shown for illustrative purposes. Figure 6 A three-dimensional view of the modified example.

[0045] Figures 8A and 8B are cross-sectional views of an ocular implant taken along the circumferential direction of the ocular expansion portion, showing cross-sectional views of different roughness surfaces with isotropic rotational resistance and anisotropic rotational resistance, respectively.

[0046] Figure 9 This is a schematic diagram illustrating the surgical port used in an ocular implant according to an embodiment of the present invention, showing a plan view of the ocular implant from the front direction.

[0047] Figures 10A to 10C are schematic diagrams illustrating the snap-fit ​​or hook-shaped connection of the first slit and the second slit used in ocular implants according to different embodiments of the present invention, showing perspective views of different ocular implants.

[0048] Figures 11A and 11B are schematic diagrams illustrating different snap-fit ​​or hook-shaped connections of assembly slits and assembly holes used in an ocular implant according to an embodiment of the present invention.

[0049] Figure 12 Show Figure 4 A schematic diagram of a modified embodiment of the ocular implant shown.

[0050] Figure 13 Show Figure 6 A schematic diagram of a modified embodiment of the ocular implant shown.

[0051] Figure 14 The diagram illustrates a composite structure in one embodiment of the invention in which a first end and a second end, separated from each other by a cut portion, are oriented toward each other and joined together by different mechanisms.

[0052] Figure 15 Show Figure 9 A schematic diagram of a modified embodiment of the ocular implant shown.

[0053] Invention Embodiments

[0054] An ocular implant according to an embodiment of the present invention,

[0055] It is permanently implanted in the recipient's eyeball to provide the appearance of an enlarged eye, and may include:

[0056] A central opening for receiving incident light toward the eyeball (or pupil), which provides the opening to the eye;

[0057] The inner annular edge surrounds and defines the opening;

[0058] An outer annular edge, which, on the opposite side of the inner annular edge defining the opening, surrounds the opening together with the inner annular edge; and

[0059] An eyeball expansion portion is formed between the inner annular edge and the outer annular edge, and has a variable thickness that gradually changes from the inner annular edge to the outer annular edge.

[0060] For example, the inner annular edge and the outer annular edge may surround the opening in different shapes.

[0061] For example, the inner annular edge can be formed into an ellipse to follow the shape of the eyeball, so as to provide an integrated appearance with the eyeball without obstructing the light-entry aperture (or pupil) and to surround the outer edge of the eyeball at adjacent positions.

[0062] The outer annular edge can be formed into a circle to provide an aesthetically pleasing circular appearance.

[0063] For example, the inner annular edge can be formed into an ellipse with different major axis lengths and minor axis lengths.

[0064] The major axis length can be shaped along the direction in which the implantee's two eyes face each other.

[0065] The minor axis length can be formed along a direction perpendicular to the major axis length.

[0066] For example, the eyeball expansion portion between the inner and outer annular edges, along the short axis direction of the inner annular edge, has a wider width on one side than the other.

[0067] Therefore, the ellipse of the inner annular edge can be formed at an offset position inside the circle of the outer annular edge, biased to the other side.

[0068] For example, the iris dilatation portion may include:

[0069] The posterior sloping surface faces the eyeball and is configured to conform to the surface of the eyeball; and

[0070] The anterior curved surface is oriented outwards in the opposite direction to the eyeball.

[0071] For example, the inner and outer annular edges can respectively form the front of the eyeball, and when viewed from the front of the eyeball, which is equipped with a lens and forms the entrance aperture (or pupil), in a frontal direction towards the back of the eyeball, they appear to be circular or elliptical, respectively.

[0072] The rear slope can be formed as a slope inclined at a certain angle on a vertical plane perpendicular to the front direction, such that the inner annular edge and the outer annular edge form the front position and the rear position, respectively.

[0073] For example, the rear slope can provide a support surface that rests on the slope of the ocular implant packaging container.

[0074] For example, the front surface can be formed along a spline curve, the curvature or radius of curvature of which varies along the inclination direction of the back slope.

[0075] For example, the eyeball expansion portion may have a variable thickness that varies between the rear slope and the front curved surface.

[0076] For example, the thickness of the iris expansion portion can be measured from the rear slope to the front curved surface in a direction perpendicular to the rear slope.

[0077] For example, the inner annular edge can be formed by the front curved surface and the rear inclined surface that form the thickness of the eyeball expansion contacting each other at the position where they meet the opening.

[0078] For example, the outer annular edge can be formed by the front curved surface and the rear inclined surface that form the thickness of the eyeball expansion contacting each other on the opposite side of the inner annular edge that defines the opening.

[0079] For example, the anterior curved surface and the posterior inclined surface that form the thickness of the eyeball expansion portion can respectively form an inner annular edge and an outer annular edge with rounded corners, and they are in contact with each other.

[0080] For example, the inner annular edge can be formed into a relatively gentle rounded corner shape.

[0081] The outer annular edge can be formed into a relatively sharp rounded shape.

[0082] For example, the edge thickness of the inner annular edge can be less than the edge thickness of the outer annular edge.

[0083] For example, the inner annular edge can be introduced into the discontinuous edge between the anteriorly convex, high-curvature portion of the cornea and the posteriorly low-curvature portion of the sclera, within the membrane tissue surrounding the entire eyeball to maintain its shape, and close one side of the ocular implant with a relatively gentle, rounded shape.

[0084] The outer annular edge that fits onto the sclera of the high curvature portion can close the other side of the ocular implant with a relatively sharp rounded corner shape to prevent the sclera from lifting or forming a gap between it and the sclera.

[0085] The eyeball expansion portion may include: a maximum thickness portion, which has a maximum thickness between the inner annular edge and the outer annular edge;

[0086] The inner portion, which is relatively close to the opening and is formed between the inner annular edge and the maximum thickness portion; and

[0087] The outer portion is relatively far from the opening and is formed between the maximum thickness portion and the outer annular edge.

[0088] For example, the inner and outer portions may be provided on both sides based on the maximum thickness portion, and have mutually asymmetrical shapes or asymmetrical thickness profiles.

[0089] For example, the inner portion can be formed to be relatively flexible to adapt to the deformation of each implantee's eyeball.

[0090] The outer portion can be formed to be relatively rigid to resist deformation of the inner portion and maintain a circular appearance, thereby enhancing the flexibility of the inner portion and providing supporting rigidity for the ocular implant.

[0091] For example, the inner portion can be formed to be thinner than the outer portion, such that in the membrane tissue surrounding the entire eyeball to maintain the shape of the eyeball, a discontinuous edge is introduced between the high curvature portion of the cornea that bulges forward and the low curvature portion of the sclera that extends backward from the cornea, and fits against the discontinuous edge to prevent the formation of a gap between the discontinuous edge and the inner portion.

[0092] For example, the inner and outer portions can be formed of the same material.

[0093] Furthermore, the thickness of the inner portion is relatively smaller than the thickness of the outer portion.

[0094] For example, the iris dilatation may include an anterior curved surface and a posterior inclined surface that form the thickness of the iris dilatation.

[0095] Of the first average thickness of the inner portion and the second average thickness of the outer portion that can be formed by the rear slope and the front curved surface, the first average thickness is less than the second average thickness.

[0096] For example, using the posterior slope that provides a reference for the thickness of the iris expansion as a reference,

[0097] The front curved surface forming the inner portion can extend along a trajectory relatively close to the rear slope, and the front curved surface forming the outer portion can extend along a trajectory relatively far from the rear slope, thereby forming a thickness difference between the inner portion and the outer portion formed on both sides with the maximum thickness portion as a reference.

[0098] For example, the front curved surface forming the inner portion can extend along a trajectory relatively close to the rear slope, forming a relatively thin thickness while following a relatively gentle downward curve towards the rear slope, and forming a gentle rounded corner at the inner annular edge.

[0099] The front curved surface forming the outer portion can extend along a trajectory relatively far from the rear slope, forming a relatively thick thickness while following a relatively steep downward curve towards the rear slope, and forming a sharp rounded corner at the outer annular edge.

[0100] For example, the anterior curved surface forming the inner portion can follow a steeper downward curvature line through the inner inflection point, thereby forming a gently rounded inner annular edge, so that the downward curvature line follows from the maximum thickness portion to the inner annular edge, and closes one side of the ocular implant.

[0101] The anterior curved surface forming the outer portion can follow a steeper downward curvature line through the outer inflection point, thereby forming a sharp, rounded outer annular edge, which extends from the maximum thickness portion to the outer annular edge, following the trajectory of the downward curvature line, and closes the other side of the ocular implant.

[0102] For example, along the inclination direction of the rear slope, the distance from the outer annular edge to the outer inflection point can be relatively longer than the distance from the inner annular edge to the inner inflection point.

[0103] For example, the inner inflection point and the outer inflection point can be the points on the contours of the front surfaces that form the inner and outer portions, respectively, where the curvature changes the most.

[0104] An ocular implant according to an embodiment of the present invention,

[0105] It is permanently implanted in the recipient's eyeball to provide the appearance of an enlarged eye, and the eye implant may include:

[0106] A central opening for receiving incident light toward the eyeball (or pupil), which provides the opening to the eye;

[0107] The inner annular edge surrounds and defines the opening;

[0108] An outer annular edge, which, on the opposite side of the inner annular edge defining the opening, surrounds the opening together with the inner annular edge; and

[0109] An adaptive telescopic portion that provides adaptive length extension along the periphery of at least one of the inner annular edge and the outer annular edge.

[0110] For example, the adaptive telescopic portion can provide length extension along the periphery of the inner annular edge to adapt to the shape and size of each implantee's eyeball.

[0111] For example, the inner annular edge can be formed into an ellipse with different major axis lengths and minor axis lengths.

[0112] The adaptive telescopic portion, in order to adaptively fit the inner annular edge to the recipient's eyeball, can provide length extension along the long axis and / or short axis direction. The inner annular edge is either an elongated ellipse with an extension relative to the long axis and / or a shortening relative to the short axis, or a nearly circular ellipse with a shortening relative to the long axis and / or an extension relative to the short axis.

[0113] For example, the adaptive telescopic portion may include at least one slit formed on the periphery of the inner annular edge.

[0114] For example, the adaptive telescopic portion may include a plurality of slits spaced apart from each other along the periphery of the inner annular edge.

[0115] For example, the plurality of slits may be arranged at uniform intervals along the periphery of the inner annular edge.

[0116] For example, the adaptive telescopic portion may include a set of slits formed on both sides along the long axis and / or on both sides along the short axis.

[0117] For example, the adaptive telescopic part,

[0118] The segmented pieces can be made to overlap each other by forming a first set of slits and a second set of slits on both sides along the minor axis, thereby extending the minor axis length while shortening the major axis length.

[0119] By forming a third and fourth set of slits on both sides along the long axis, the segmented pieces overlap each other, thereby extending the length of the long axis while shortening the length of the short axis.

[0120] For example, the slit can be formed at each angular position at certain included angle intervals, with the center of rotation of the opening where the major axis length and minor axis length of the inner annular edge intersect.

[0121] For example, the slit may include:

[0122] The first set of slits and the second set of slits are respectively formed along the minor axis at 0° and 180° angle positions corresponding to the two sides; and

[0123] The third and fourth slits are formed along the long axis at 90° and 270° angle positions corresponding to the two sides, respectively.

[0124] For example, the slit can be introduced into the interior of the ocular dilatation along a depth direction from the inner annular edge toward the outer annular edge.

[0125] For example, the slit can be introduced into the interior of the ocular dilatation from the center of the opening where the long axis and the short axis intersect, with the depth direction being radial.

[0126] For example, the adaptive telescopic portion can extend or retract the length of the inner annular edge by overlapping the segmented pieces along the periphery of the inner annular edge through the slit.

[0127] For example, the iris dilatation portion may include:

[0128] The posterior sloping surface faces the eyeball and is configured to conform to the surface of the eyeball; and

[0129] An anterior curved surface, which is configured to face outwards opposite to the eyeball, and forms a thickness profile based on the posterior slope, contacts the posterior slope at a position where it meets the opening and forms an inner annular edge, and contacts the posterior slope at a position opposite to the opening and forms an outer annular edge, and forms a thickness profile relative to the posterior slope based on a maximum thickness portion where the maximum thickness is formed between the inner and outer annular edges, such that a relatively thin inner portion and a relatively thick outer portion are formed;

[0130] The segments divided by the slits forming the adaptive telescopic portion can overlap each other, increasing the thickness of the inner portion introduced from the inner annular edge and forming the slit while extending the length of the inner annular edge, thus forming an additional thickness.

[0131] For example, the adaptive stretchable portion can be formed on the inner annular edge surrounding the outer edge of the eyeball at a position more adjacent to the outer annular edge, so as to adaptively deform according to the shape and size of each implantee's eyeball.

[0132] It can also be left unformed on the outer annular edge to maintain a beautiful circular appearance that resists deformation of the inner annular edge.

[0133] For example, the inner annular edge, formed by segments overlapping each other through the slits that create the adaptive telescopic portion, can be formed into a relatively gently rounded shape.

[0134] The outer annular edge is formed into a relatively sharp rounded shape.

[0135] An ocular implant according to an embodiment of the present invention,

[0136] It is permanently implanted in the recipient's eyeball to provide the appearance of an enlarged eye, and the eye implant may include:

[0137] A central opening for receiving incident light toward the eyeball (or pupil), which provides the opening to the eye;

[0138] The inner annular edge surrounds and defines the opening;

[0139] An outer annular edge, which, on the opposite side of the inner annular edge defining the opening, surrounds the opening together with the inner annular edge; and

[0140] An eyeball dilatation portion is formed between the inner annular edge and the outer annular edge, and includes a first end and a second end, which are separated from each other by a cut and joined together toward each other by forming surgical holes thereon, respectively.

[0141] For example, in the iris dilatation between the inner annular edge and the outer annular edge.

[0142] The width at both sides along the minor axis of the inner annular edge is relatively larger than that at both sides along the major axis of the inner annular edge, forming an ellipse within the circle of the outer annular edge.

[0143] The cutting portion, the first end and the second end separated from each other by the cutting portion, and the surgical hole formed on the first end and the second end can be formed on one side with a relatively wide width in the two positions along the short axis direction.

[0144] For example, in the iris dilatation between the inner and outer annular edges.

[0145] The curvature of the two sides along the minor axis of the inner annular edge is relatively smaller than that of the two sides along the major axis of the inner annular edge.

[0146] The surgical hole can be formed on the side with the relatively smaller curvature of the two positions along the short axis.

[0147] For example, the cut portion may be formed along the minor axis direction of the inner annular edge.

[0148] The first and second ends, which are separated from each other by the cut, can be joined together along the long axis of the inner annular edge.

[0149] Furthermore, multiple surgical holes can be formed on the first end and the second end, respectively, arranged along the long axis of the inner annular edge.

[0150] For example, the surgical port may include:

[0151] A first surgical opening for inserting a suture to join the first end to the second end; and

[0152] The second surgical port is through which the insertion mechanism for implantation passes to pull the ocular implant so that the ocular implant passes around the outer edge of the recipient's eyeball via a conjunctival incision on the sclera.

[0153] For example, the first surgical opening can be formed with a relatively small diameter.

[0154] The second surgical hole is formed with a relatively large diameter.

[0155] For example, the first surgical hole can be formed relatively close to the incision.

[0156] The second surgical hole may be formed at a location relatively far from the incision.

[0157] An ocular implant according to an embodiment of the present invention,

[0158] It is permanently implanted in the recipient's eyeball to provide the appearance of an enlarged eye, and the eye implant may include:

[0159] A central opening for receiving incident light toward the eyeball (or pupil), which provides the opening to the eye;

[0160] The inner annular edge surrounds and defines the opening;

[0161] An outer annular edge, which, on the opposite side of the inner annular edge defining the opening, surrounds the opening together with the inner annular edge; and

[0162] An eyeball expansion portion is formed between the inner annular edge and the outer annular edge, and includes a first end and a second end that are separated from each other by a cut and form a snap-fit ​​or hook-fit with each other.

[0163] For example, in the iris dilatation between the inner annular edge and the outer annular edge.

[0164] The width at both sides along the minor axis of the inner annular edge is relatively larger than that at both sides along the major axis of the inner annular edge, forming an ellipse within the circle of the outer annular edge.

[0165] The cut portion, the first end and the second end separated by the cut portion, and the snap-fit ​​or hook-shaped engagement between the first end and the second end can be formed on one side with a relatively wide width in the two positions along the short axis direction.

[0166] For example, the snap-fit ​​connection or the hook-shaped connection may include:

[0167] A first slit and a second slit are respectively formed on the first end and the second end.

[0168] For example, at least a portion of the first slit and the second slit may be formed in complementary shapes to form a snap-fit ​​or hook-fit with each other.

[0169] For example, the first slit and the second slit may include:

[0170] The first part extends along the long axis of the inner annular edge; and

[0171] The second part extends from the first part along the short axis direction of the inner annular edge or along an oblique direction that simultaneously follows the short axis direction and the long axis direction to the inner annular edge or the outer annular edge, and opens to the outside of the ocular implant.

[0172] For example, the first portion of the first slit and the second slit may extend side by side along the long axis direction of the inner annular edge.

[0173] The second portion of either the first slit or the second slit extends in opposite directions toward the outer annular edge and the inner annular edge, respectively, and opens toward the outside of the ocular implant, such that the second portion is formed in a complementary shape.

[0174] For example, the cut portion may be formed along the minor axis direction of the inner annular edge.

[0175] The first end and the second end are adjacent along the long axis direction of the inner annular edge.

[0176] Either the first slit or the second slit may include an array of multiple slits formed at the first end or the second end along the long axis direction, while the other may be formed as a single slit.

[0177] For example, the snap-fit ​​connection or the hook-shaped connection may include:

[0178] An assembly slit, formed on the first end; and

[0179] An assembly hole is formed on the second end and is used for the assembly slit to be inserted.

[0180] For example, an assembly guide may be formed on the first end, which is positioned in front of the assembly slit along the assembly direction of the first end and the second end.

[0181] For example, the assembly guide may include:

[0182] The front end protrusion has a relatively small width at the front end of the first end along the assembly direction of the first end and the second end; and the rear end is located behind the front end protrusion and in front of the assembly slot, and is formed to be wider than the neck of the assembly slot.

[0183] The assembly guide may further include a variable width portion that converges obliquely toward the front end protrusion along a direction that simultaneously follows the major axis direction corresponding to the assembly direction and the minor axis direction intersecting the major axis direction, so as to connect the different widths between the relatively narrow front end protrusion and the relatively wide rear end protrusion.

[0184] For example, the rear end of the assembly guide can be connected at full width to a first end disposed between the assembly guide and the assembly slit.

[0185] For example, a dummy tangent line comprising a plurality of perforations may be formed between the assembly guide and the full width of the first end.

[0186] For example, the assembly slit can be introduced from both sides of the inner and outer annular edges along the short axis direction of the inner annular edge to form a neck with minimum width.

[0187] When the neck of the assembly slit is inserted into the assembly hole on the second end side, the relatively wide full width of the first end formed before and after the assembly slit can prevent the separation between the first end and the second end.

[0188] The ocular implant 100 according to a preferred embodiment of the present invention will now be described with reference to the accompanying drawings.

[0189] Figure 1 This is a schematic diagram illustrating the general structure of an eyeball permanently implanted with an eyeball implant according to an embodiment of the present invention.

[0190] Figure 2 This is a schematic diagram illustrating the surgical procedure of an ocular implant according to an embodiment of the present invention, showing an incision formed at a certain location along the outer edge of the eyeball.

[0191] Figure 3 A perspective view of an ocular implant according to an embodiment of the present invention is shown.

[0192] Figure 4 Show Figure 3 The image shows a plan view of the ocular implant from the front.

[0193] Figure 5 Show along Figure 3 The cross-sectional view taken from the V–V' line.

[0194] Figure 6 A perspective view of an adaptive stretchable portion used in an ocular implant according to an embodiment of the present invention is shown.

[0195] Figure 7 This is a perspective view illustrating the adaptive stretchable portion used in an ocular implant according to an embodiment of the present invention, shown for illustrative purposes. Figure 6 A three-dimensional view of the modified example.

[0196] Figures 8A and 8B are cross-sectional views of an ocular implant taken along the circumferential direction of the ocular expansion portion, showing cross-sectional views of different roughness surfaces with isotropic rotational resistance and anisotropic rotational resistance, respectively.

[0197] Figure 9 This is a schematic diagram illustrating the surgical port used in an ocular implant according to an embodiment of the present invention, showing a plan view of the ocular implant from the front direction.

[0198] Figures 10A to 10C are schematic diagrams illustrating the snap-fit ​​or hook-shaped connection of the first slit and the second slit used in ocular implants according to different embodiments of the present invention, showing perspective views of different ocular implants.

[0199] Figures 11A and 11B are schematic diagrams illustrating different snap-fit ​​or hook-shaped connections of assembly slits and assembly holes used in an ocular implant according to an embodiment of the present invention.

[0200] The following description pertains to an ocular implant 100 according to one aspect of the present invention, which includes an ocular expansion portion 105 formed with variable thickness between an inner annular edge 101 and an outer annular edge 102, an anterior curved surface 120 with a variable thickness profile formed on the posterior slope 110 of the ocular expansion portion 105, and circular and elliptical profiles formed by the inner annular edge 101 and the outer annular edge 102, respectively.

[0201] Figure 1 This is a schematic diagram illustrating the general structure of an eyeball permanently implanted with an eyeball implant according to an embodiment of the present invention.

[0202] Figure 2This is a schematic diagram illustrating the surgical procedure of an ocular implant according to an embodiment of the present invention, showing an incision formed at a certain location along the outer edge of the eyeball.

[0203] Figure 3 A perspective view of an ocular implant according to an embodiment of the present invention is shown.

[0204] Figure 4 Show Figure 3 The image shows a plan view of the ocular implant from the front.

[0205] Figure 5 Show along Figure 3 The cross-sectional view taken from the V–V' line.

[0206] An ocular implant 100 according to an embodiment of the present invention,

[0207] It is permanently implanted on the EB of the recipient's eye to provide the appearance of an enlarged eyeball, and may include:

[0208] A central opening OP is provided for receiving incident light toward the eyeball (or through-hole), which provides the eyeball EB opening;

[0209] The inner annular edge 101 surrounds and defines the opening OP;

[0210] An outer annular edge 102, which, on the side opposite to the inner annular edge 101 defining the opening OP, surrounds the opening OP together with the inner annular edge 101; and

[0211] An eyeball expansion portion 105 is formed between the inner annular edge 101 and the outer annular edge 102, and has a variable thickness that gradually changes from the inner annular edge 101 to the outer annular edge 102.

[0212] For example, the inner annular edge 101 and the outer annular edge 102 can surround the opening OP in different shapes.

[0213] For example, the inner annular edge 101 can be formed into an ellipse following the shape of the eyeball, so as to provide an integrated appearance with the eyeball without obstructing the light-entry aperture (or pupil) of the eyeball, and surround the outer edge of the eyeball at adjacent positions.

[0214] The outer annular edge 102 can be formed into a circle to provide an aesthetically pleasing circular appearance.

[0215] For example, the inner annular edge 101 can be formed as an ellipse with different major axis lengths L1 and minor axis lengths L2.

[0216] The major axis length L1 can be formed along the direction in which the implantee's two eyes face each other.

[0217] The minor axis length L2 can be formed along a direction perpendicular to the major axis length L1.

[0218] For example, the eyeball expansion portion 105 between the inner annular edge 101 and the outer annular edge 102 has a wider width on one side than the other along the minor axis direction Z2 of the inner annular edge 101.

[0219] Therefore, the ellipse of the inner annular edge 101 can be formed at an offset position on the other side inside the circle of the outer annular edge 102.

[0220] For example, the eyeball dilation portion 105 may include:

[0221] The posterior bevel 110 faces the EB of the eyeball and is configured to conform to the surface of the EB of the eyeball; and

[0222] The anterior curved surface 120 is oriented in the opposite direction to the external OS configuration of the eyeball EB.

[0223] For example, the inner annular edge 101 and the outer annular edge 102 can respectively form the front of the eyeball EB, and when viewed from the front of the eyeball EB, which is equipped with a lens and forms the light entrance aperture (or pupil), along the frontal direction Z3 towards the back of the eyeball EB, they appear to be circular or elliptical respectively.

[0224] The rear slope 110 can be formed as a slope inclined at a certain angle θ on 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 position and the rear position respectively.

[0225] For example, the rear slope 110 can provide a support surface that rests on the slope of the packaging container of the ocular implant 100.

[0226] For example, the front surface 120 can be formed along a spline curve, the curvature or radius of curvature of which varies along the inclination direction of the rear slope 110.

[0227] For example, the eyeball expansion portion 105 may have a variable thickness that varies between the rear slope 110 and the front curved surface 120. In this case, the thickness of the eyeball expansion portion 105 can be measured from the rear slope 110 to the front curved surface 120 in a direction perpendicular to the rear slope 110.

[0228] For example, the inner annular edge 101 can be formed by the front curved surface 120 and the rear inclined surface 110, which form the thickness of the eyeball expansion portion 105, contacting each other at the position where they meet the opening OP.

[0229] For example, the outer annular edge 102 can be formed by the front curved surface 120 and the rear inclined surface 110 that form the thickness of the eyeball expansion 105 contacting each other on the opposite side of the inner annular edge 101 that defines the opening OP.

[0230] For example, the front curved surface 120 and the rear inclined surface 110 that form the thickness of the eyeball expansion portion 105 can respectively form an inner annular edge 101 and an outer annular edge 102 with rounded corners, and they are in contact with each other. At this time, the inner annular edge 101 can be formed with a relatively gentle rounded corner shape, and the outer annular edge 102 can be formed with a relatively sharp rounded corner shape.

[0231] For example, the edge thickness of the inner annular edge 101 may be less than the edge thickness of the outer annular edge 102.

[0232] For example, the inner annular edge 101 can be introduced into the membrane tissue surrounding the entire ocular implant EB to maintain the shape of the ocular implant EB, into the discontinuous edge DE between the anteriorly convex high-curvature portion of the cornea and the posteriorly extending low-curvature portion of the sclera, and close one side of the ocular implant 100 with a relatively gentle rounded shape.

[0233] The outer annular edge 102, which is attached to the sclera of the high curvature portion, can close the other side of the ocular implant 100 with a relatively sharp rounded shape to prevent the sclera from lifting or forming a gap between it and the sclera.

[0234] For example, the eyeball dilation portion 105 may include:

[0235] The maximum thickness portion t5 has the maximum thickness between the inner annular edge 101 and the outer annular edge 102;

[0236] The inner portion IA, which is relatively close to the opening OP and is formed between the inner annular edge 101 and the maximum thickness portion t5; and

[0237] The outer portion OA is relatively far from the opening OP and is formed between the maximum thickness portion t5 and the outer annular edge 102.

[0238] For example, the inner portion IA and the outer portion OA can be provided on both sides based on the maximum thickness portion t5, and have mutually asymmetrical shapes or asymmetrical thickness profiles.

[0239] For example, the inner portion IA can be formed to be relatively flexible to adapt to the deformability of each implantee's eyeball, and

[0240] The outer portion OA can be formed to be relatively rigid to resist deformation of the inner portion IA and maintain a circular appearance, thereby enhancing the flexibility of the inner portion IA and providing supporting rigidity for the ocular implant 100.

[0241] For example, the inner portion IA can be formed with a thickness less than the outer portion OA, such that in the membrane tissue surrounding the entire eyeball EB to maintain the shape of the eyeball EB, a discontinuous edge DE is introduced between the high curvature portion of the cornea protruding forward and the low curvature portion of the sclera extending backward from the cornea, and is attached to the discontinuous edge DE to prevent the formation of a gap between the discontinuous edge DE and the inner portion IA.

[0242] For example, the inner portion IA and the outer portion OA can be formed of the same material.

[0243] Furthermore, the thickness of the inner portion IA is relatively smaller than the thickness of the outer portion OA.

[0244] For example, in the first average thickness of the inner portion IA and the second average thickness of the outer portion OA formed by the rear slope 110 and the front curved surface 120, the first average thickness may be less than the second average thickness.

[0245] For example, taking the rear slope 110, which provides a thickness reference for the eyeball expansion portion 105, as a reference,

[0246] The front curved surface 120 forming the inner portion IA can extend along a trajectory relatively close to the rear inclined surface 110, and the front curved surface 120 forming the outer portion OA can extend along a trajectory relatively far away from the rear inclined surface 110, thereby forming a thickness difference between the inner portion IA and the outer portion OA formed on both sides with the maximum thickness portion t5 as a reference.

[0247] For example, the front curved surface 120 forming the inner portion IA can extend along a trajectory relatively close to the rear slope 110, forming a relatively thin thickness while following a relatively gentle downward curvature towards the rear slope 110, and forming a gentle rounded corner at the inner annular edge 101.

[0248] The front curved surface 120 forming the outer portion OA can extend along a trajectory relatively far from the rear slope 110, forming a relatively thick thickness while following a relatively steep downward curvature line toward the rear slope 110, and forming a sharp rounded corner at the outer annular edge 102.

[0249] For example, the anterior curved surface 120 forming the inner portion IA can follow a steeper downward curvature line through the inner inflection point 101', thereby forming a gently rounded inner annular edge 101, so that the downward curvature line follows from the maximum thickness portion t5 towards the inner annular edge 101, and closes one side of the ocular implant 100.

[0250] The anterior curved surface 120 forming the outer portion OA can follow a steeper downward curvature line through the outer inflection point 102', thereby forming a sharp rounded outer annular edge 102, so that the downward curvature line follows from the outer annular edge 102 from the maximum thickness portion t5, and closes the other side of the ocular implant 100.

[0251] For example, along the inclination direction of the rear slope 110, the distance from the outer annular edge 102 to the outer inflection point 102' can be 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 be the points with the greatest curvature change on the front surface contours forming the inner portion IA and the outer portion OA, respectively.

[0252] The ocular implant 100 of the present invention can be configured as a generally annular member having a central opening OP for allowing light to enter the lens that functions as a lens or the eyeball (or pupil) that forms the EB opening of the eyeball.

[0253] The eye implant 100 can be formed as a ring-shaped component that surrounds the outer edge of the recipient's eyeball and provides an enlarged appearance of the eyeball, and has a central opening OP to allow light to enter the eyeball.

[0254] In one embodiment of the present invention, the ocular implant 100 may include: an inner annular edge 101 surrounding the outer edge of the recipient's eyeball; an outer annular edge 102, which, on the opposite side of the inner annular edge 101 at the opening, surrounds the outer edge of the eyeball together with the inner annular edge 101; and an ocular expansion portion 105 formed between the inner annular edge 101 and the outer annular edge 102, having a variable thickness that gradually changes from the inner annular edge 101 to the outer annular edge 102. The ocular expansion portion 105 may be defined as surrounding the outer edge of the eyeball together at an inner and outer position, respectively, between the inner annular edge 101 and the outer annular edge 102, and in the ocular implant 100 according to an embodiment of the present invention, provides an expansion region for the eyeball. In one embodiment of the present invention, the inner annular edge 101 and the outer annular edge 102 may define the shape of the ocular implant 100 or the ocular expansion portion 105 forming the body of the ocular implant 100, and may at least define a portion of the shape of the ocular implant 100.

[0255] In one embodiment of the invention, the ocular implant 100 may be formed in a three-dimensional shape to allow for close fit to the generally spherical eyeball EB. In one embodiment of the invention, considering that a primary function of the ocular implant 100 is to aesthetically improve the shape of the eyeball or pupil as viewed from the frontal direction Z3 of the implantee's face, and that the shape of the eyeball or pupil as viewed from the frontal direction of the implantee's face can be defined by the inner annular edge 101 and the outer annular edge 102 defining the shape when viewed from the frontal direction Z3 of the eyeball expansion 105, the shapes of the inner annular edge 101 and the outer annular edge 102, as described below, may refer to two-dimensional lines as viewed from the frontal direction Z3 of the implantee's face. However, in one embodiment of the invention, the ocular implant 100 is permanently implanted onto the implantee's eyeball EB and can therefore be formed in a suitable three-dimensional shape to allow for close fit to the generally spherical eyeball EB. For example, the cross-sectional shape of the eyeball expansion portion 105, which is cut along the frontal direction Z3, can be formed to have a variable thickness, which gradually changes from the inner expansion edge to the outer expansion edge, so as to be able to fit tightly onto the approximately spherical eyeball EB.

[0256] More specifically, the eyeball expansion portion 105 may be formed in a three-dimensional shape to fit closely to the generally spherical eyeball EB, and may include: a rear slope 110 having a cross-sectional shape cut along the frontal direction Z3 and a vertical plane G perpendicular to the frontal direction Z3 at a certain angle θ; and a front curved surface 120 facing the outer OS opposite to the eyeball EB.

[0257] In one embodiment of the invention, the EB (extraocular lens) may be protected by a tough membrane tissue surrounding the entire EB, thereby maintaining the overall shape of the EB. The membrane tissue may include a cornea located anteriorly and allowing light to enter, and a sclera extending posteriorly from the cornea. For example, the cornea may be formed anterior to the lens, pupil, and anterior chamber, and may form a high-curvature portion of the membrane tissue. The lens functions as a lens, focusing the light onto the retina posterior to the EB. The pupil forms an opening for light to enter anterior to the lens, and the anterior chamber is formed anterior to the pupil. The membrane tissue surrounds the anterior portion of the EB formed by the lens, pupil, and anterior chamber, and has a relatively high curvature. The sclera extends posteriorly from the cornea and may form a low-curvature portion of the membrane tissue with a relatively low curvature. The cornea and sclera may respectively form a high-curvature portion and a low-curvature portion for surrounding and maintaining the shape of the EB, forming a v between them.

[0258] As described above, the cornea and sclera can respectively form high-curvature and low-curvature portions of membranous tissue that surround the entire eyeball (EB) and maintain its shape. Essentially identical membranous tissue surrounds the lens, etc., at an anterior position and protrudes outwards (OS) opposite to the eyeball (EB), while the sclera, extending posteriorly from the cornea at the anterior position, forms with a smaller curvature relative to the cornea. The actual curvature of the sclera from the discontinuous edge (DE) between the cornea and sclera to the curved portion (AC) of the sclera can be formed as an approximate slope rather than a curved surface. In one embodiment of the invention, the ocular implant 100 can be implanted onto the sclera. For example, it can be implanted onto the cornea located anterior to the lens, etc., or onto the sclera beyond the cornea where light is incident. In one embodiment of the invention, the ocular implant 100 can be introduced anteriorly to the discontinuous edge (DE) between the cornea and sclera. At this time, the cornea, located in the anterior position, is positioned in front of the lens or the like and is formed with a relatively high curvature, while the sclera, extending posteriorly from the cornea, is formed with a relatively low curvature, thereby forming a discontinuous edge DE between the cornea and the sclera. The medial portion IA of the ocular implant 100, which can be introduced to this discontinuous edge DE, adjacent to the opening OP, can have a relatively small thickness relative to the lateral portion OA, which is farther from the opening OP, so as to accommodate the discontinuous edge DE between the cornea and the sclera and prevent the formation of a gap between the ocular EB tissue and the implanted ocular implant 100.

[0259] In one embodiment of the invention, the ocular expansion portion 105 may include: a posterior slope 110 disposed facing and conforming to the surface of the eyeball EB; and an anterior curved surface 120 disposed facing the outer OS opposite to the eyeball EB, opposite to the posterior slope 110, wherein the ocular expansion portion 105 is formed with a variable thickness between the posterior slope 110 and the anterior curved surface 120. In one embodiment of the invention, the thickness of the ocular expansion portion 105 may refer to the dimension in the direction perpendicular to the posterior slope 110, in the posterior slope 110 and the anterior curved surface 120 that define a portion of the ocular expansion portion 105.

[0260] In one embodiment of the invention, the eyeball expansion portion 105 may have a variable thickness that gradually changes from the inner annular edge 101 to the outer annular edge 102. More specifically, the eyeball expansion portion 105 may have a maximum thickness t5 between the inner annular edge 101 and the outer annular edge 102, with the thickness gradually decreasing towards the inner annular edge 101 and the outer annular edge 102, such that both sides of the eyeball expansion portion 105 are closed at the inner annular edge 101 and the outer annular edge 102.

[0261] In one embodiment of the invention, the thickness of the eyeball expansion portion 105 can be defined between the rear slope 110 and the front curved surface 120 in a direction perpendicular to the rear slope 110. The rear slope 110 and the front curved surface 120 respectively contact the inner annular edge 101 that is in contact with the opening OP and the outer annular edge 102 that is away from the opening OP, and form rounded edges at each inner annular edge 101 and outer annular edge 102. In one embodiment of the invention, the rear slope 110 is used as a reference, and the front curved surface 120 can form the thickness profile of the eyeball expansion portion 105 on the rear slope 110, and can form a trajectory furthest from the rear slope 110, thereby forming the maximum thickness portion t5 between the inner annular edge 101 and the outer annular edge 102. Furthermore, the front curved surface 120 can form a downward trajectory that gradually extends towards the rear inclined surface 110 on both sides of the maximum thickness portion t5 and contacts the rear inclined surface 110, thereby forming the rounded edges of the inner annular edge 101 and the outer annular edge 102.

[0262] In one embodiment of the present invention, the maximum thickness t5 of the eyeball expansion portion 105 may be formed at the central position between the inner annular edge 101 and the outer annular edge 102. The eyeball expansion portion 105 may include: an inner portion IA, which is located between the maximum thickness t5 and the inner annular edge 101, i.e., relatively close to the central opening OP; and an outer portion OA, which is located between the maximum thickness t5 and the outer annular edge 102 on the opposite side to the inner portion IA, i.e., relatively far from the central opening OP.

[0263] As described above, in one embodiment of the present invention, the eyeball expansion portion 105 may include an inner portion IA relatively close to the opening OP and an outer portion OA relatively far from the opening OP, and the two portions have different thickness deviations. In one embodiment of the present invention, the so-called different thickness deviations between the inner portion IA and the outer portion OA mean that, in one embodiment of the present invention, the eyeball expansion portion 105 including the inner portion IA and the outer portion OA has an asymmetrical thickness profile or asymmetrical shape based on the maximum thickness t5 forming its boundary. For example, the anterior curved surface 120 forming the inner portion IA may form a similar trajectory relative to the posterior inclined surface 110, while the anterior curved surface 120 forming the outer portion OA may form a more distant trajectory relative to the posterior inclined surface 110, thereby creating a thickness difference between the inner portion IA and the outer portion OA formed on both sides based on the maximum thickness t5. In one embodiment of the present invention, the so-called different thickness deviations between the inner portion IA and the outer portion OA of the eyeball expansion portion 105 may mean that the thickness integral value of the outer portion OA is relatively greater than the thickness integral value of the inner portion IA. The thickness integral value of the inner portion IA refers to the thickness from the rear inclined surface 110 to the front curved surface 120, which provides the thickness reference, integrated along the overall length of the inner portion IA in the inclined direction. The thickness integral value of the outer portion OA refers to the thickness from the rear inclined surface 110 to the front curved surface 120, which provides the thickness reference, integrated along the overall length of the outer portion OA in the inclined direction. For example, even if the lengths of the inner portion IA and the outer portion OA are different along the inclined direction, the thickness integral value per unit length of the outer portion OA can be greater than the thickness integral value per unit length of the inner portion IA. The thickness integral value per unit length of the inner portion IA is obtained by dividing the thickness integral value of the inner portion IA by the length of the inner portion IA following the inclined direction; the thickness integral value per unit length of the outer portion OA is obtained by dividing the thickness integral value of the outer portion OA by the length of the outer portion OA following the inclined direction. As can be seen from this specification, the average thickness of the inner portion IA and the average thickness of the outer portion OA represent the thickness integral value per unit length of the inner portion IA and the thickness integral value per unit length of the outer portion OA, respectively.

[0264] As described above, in one embodiment of the present invention, the ocular expansion portion 105 may form a maximum thickness portion t5 at the central position between the inner annular edge 101 and the outer annular edge 102, and an inner portion IA and an outer portion OA with different average thicknesses may be formed on both sides of the maximum thickness portion t5. In this case, the inner portion IA, with its relatively small average thickness, can be introduced into the discontinuous edge DE between the cornea and sclera. In the membrane tissue, the cornea of ​​the high curvature portion is formed to bulge forward relatively and surround the lens, etc., while the sclera of the low curvature portion extends backward from the cornea. Since the average thickness of the inner portion IA introduced into the discontinuous edge DE is relatively small, it can be introduced into the discontinuous edge DE at a sufficient depth to prevent the formation of a gap between the discontinuous edge DE between the cornea and sclera of the ocular EB and the inner portion IA. For example, in one embodiment of the present invention, the inner portion IA can be implanted as a part inserted into the ocular EB, and inserted between the sclera and conjunctiva through an incision EBC formed on the conjunctiva covering the sclera, and introduced forward into the discontinuous edge DE between the cornea and sclera. Compared to the lateral portion OA, the medial portion IA can be formed with a relatively smaller average thickness, thereby enabling insertion within the narrow implantation space between the sclera and conjunctiva obtained through surgery, and allowing it to be introduced to sufficient depth to the discontinuous edge DE between the cornea and sclera. For example, if the medial portion IA of the ocular vasaculum 105 is not formed thin enough, a gap may occur between the discontinuous edge DE between the sclera and cornea and the medial portion IA. This gap, resulting in insufficient adhesion between the medial portion IA and the discontinuous edge DE of the ocular EB, may trigger side effects such as bacteria or inflammation (e.g., corneal ulcers caused by bacterial, viral, or fungal infections). For example, if the discontinuous edge DE between the sclera and cornea fails to adhere tightly to the medial portion IA of the ocular vasaculum 105, the shape of the eyeball or pupil viewed from the frontal direction Z3 of the implantee's face may appear deformed or sunken, failing to provide an aesthetically pleasing appearance (causing cosmetic problems). Furthermore, when the medial portion IA of the ocular dilatation 105 is not formed to be sufficiently thin and thick, the tear film may not adequately moisten the cornea, leading to corneal ulcers caused by infection.

[0265] In one embodiment of the present invention, the outer portion OA may be formed with a relatively large average thickness relative to the inner portion IA, and this larger average thickness can provide supporting rigidity for the entire ocular implant 100. For example, in one embodiment of the present invention, the ocular implant 100 may be formed of a flexible material such as silicone that is harmless to the human body and can flexibly conform to the surface of the ocular EB. Even when using a flexible material, a certain level of supporting rigidity must be ensured for ease of operation such as production, packaging, and distribution, as well as for the ease of surgery in which the ocular implant 100 is implanted. To this end, the inner portion IA is formed with a relatively small average thickness, thereby facilitating conformation to the surface of the ocular EB or its partial tissues, even on ocular EB structures that are relatively unfavorable for conformation, such as discontinuous edges DE. In contrast, the outer portion OA may be formed with a relatively large average thickness based on the overall supporting rigidity of the ocular implant 100. As described below, in one embodiment of the present invention, the ocular implant 100, which needs to be permanently implanted on the eyeball EB, can be made of a material with excellent flexibility. However, while using a single material, it can include a relatively flexible inner portion IA and a relatively rigid outer portion OA through shape differences.

[0266] In one embodiment of the invention, the inner portion IA may be formed as a structure with relatively high flexibility to adapt to the deformation of each implantee's eyeball. The outer portion OA may be formed as a structure with relatively high rigidity to maintain a circular appearance relative to the deformation of the inner portion IA, and to provide supporting rigidity to the ocular implant 100 by enhancing the flexibility of the inner portion IA.

[0267] In one embodiment of the invention, the medial portion IA needs to closely conform to morphological features such as the discontinuous edge DE formed by the sclera and cornea. For example, the medial portion IA can provide relatively superior flexibility and form a relatively small average thickness to allow for fine-tuning according to the size of the cornea, making it conform to the cornea as closely as possible. The lateral portion OA, on the other hand, is located at a position on the sclera with relatively low curvature, relatively far from the discontinuous edge DE between the sclera and cornea. For example, it is located on a sclera with relatively low curvature near the slope rather than on the curved surface of the sclera extending beyond the discontinuous edge DE between the cornea and sclera to the scleral curvature AC (requiring less flexibility to conform to the sclera). In particular, to supplement the rigidity of the relatively small average thickness of the medial portion IA and to provide supporting rigidity for the overall ocular implant 100, the lateral portion OA can form a relatively large average thickness. For example, in one embodiment of the present invention, the first average thickness of the inner portion IA formed by the rear slope 110 and the front curved surface 120 and the second average thickness of the outer portion OA can satisfy the following relationship: first average thickness < second average thickness.

[0268] In one embodiment of the invention, the opening OP does not obstruct light incidence; for example, it may be formed in an open shape to not obstruct light incidence to the eyeball (or pupil) opening that provides the eyeball EB opening. The opening OP increases the flexibility of the inner portion IA of the eyeball expansion 105. For example, in one embodiment of the invention, the inner portion IA may be integral with the eyeball (or pupil) observation that forms the eyeball EB opening for receiving light, preferably surrounding the outer edge of the eyeball at an adjacent position to avoid obstructing the eyeball. In particular, considering different eyeball shapes and sizes according to the different body conditions of different implantees, it can adaptively expand and contract around their respective outer edges of the eyeball, thereby providing sufficient flexibility. Therefore, unlike the contrasting approach of using a light-transparent material to cover the central position, thus obstructing light incidence, in one embodiment of the invention, the opening OP at the central position provides sufficient flexibility to the inner portion IA without obstructing light incidence, allowing for permanent implantation according to the implantee's body conditions (e.g., eyeball shape and size). As described below, in one embodiment of the invention, the inner portion IA may include an adaptive telescoping portion 151 with an adaptive length, so that even under different physical conditions of the implantee, the shape and size of the outer edge of the eyeball can vary at the location closest to the outer rim of the eyeball. This adaptive telescoping portion 151 may be formed on the inner portion IA of the eyeball expansion portion 105, i.e., adjacent to the inner annular edge 101 forming the end of the inner portion IA. However, in various embodiments of the invention, even without the additional adaptive telescoping portion 151, for example, a certain degree of length extension can be achieved through the flexibility of the inner portion IA itself, formed with a relatively small average thickness, thereby allowing adaptive deformation according to the differences in the shape and size of each individual's eyeball.

[0269] In one embodiment of the invention, the eyeball expansion portion 105 may include an inner portion IA with a relatively small average thickness and an outer portion OA with a relatively large average thickness, and may have an asymmetrical shape based on a maximum thickness t5 located at the central position between the inner annular edge 101 and the outer annular edge 102, by having inner portions IA and outer portions OA with different average thicknesses located on both sides. In one embodiment of the invention, the inner portion IA and the outer portion OA may have an asymmetrical shape based on the maximum thickness t5, and may have an asymmetrical shape relative to the inner annular edge 101 and the outer annular edge 102 forming the ends of each inner portion IA and outer portion OA.

[0270] In one embodiment of the present invention, the ocular expansion portion 105 may include: a posterior slope 110, which faces the eyeball EB and is disposed in contact with the surface of the eyeball EB; and an anterior curved surface 120, which faces the outer OS opposite to the eyeball EB and forms a thickness profile based on the posterior slope 110, contacts the posterior slope 110 at a position adjacent to the opening OP and forms an inner annular edge 101, contacts the posterior slope 110 at a position relative to the opening OP and forms an outer annular edge 102, and is capable of forming a thickness profile based on the posterior slope 110, such that a relatively thin inner portion IA and a relatively thick outer portion OA are formed based on a maximum thickness portion t5 with the maximum thickness between the inner annular edge 101 and the outer annular edge 102.

[0271] In one embodiment of the invention, a front surface 120, on which a thickness profile is formed, is based on the rear slope 110 and can be formed with a profile that varies in height in the thickness direction along the inclination direction of the rear slope 110, so as to form a variable thickness from the rear slope 110. For example, the front surface 120 forming the thickness profile can be formed along a spline curve, the curvature or radius of curvature of which varies along the inclination direction of the rear slope 110.

[0272] In one embodiment of the present invention, the inner annular edge 101 and the outer annular edge 102 may be formed as rounded edges where the front curved surface 120 and the rear inclined surface 110 contact each other, thereby constituting the thickness of the eyeball expansion portion 105. That is, in one embodiment of the present invention, both the inner annular edge 101 and the outer annular edge 102 may be formed as rounded edges, and for example, not as angular edges. In this case, even if both the inner annular edge 101 and the outer annular edge 102 are formed as rounded edges, the curvature formed by the edge of the inner annular edge 101 and the curvature formed by the edge of the outer annular edge 102 may be set differently. For example, in one embodiment of the present invention, the curvature formed by the edge of the inner annular edge 101 may be smaller than the curvature formed by the edge of the outer annular edge 102; in other words, the radius of curvature formed by the edge of the inner annular edge 101 may be larger than the radius of curvature formed by the edge of the outer annular edge 102.

[0273] In one embodiment of the present invention, the fact that the edge curvature of the inner annular edge 101 is less than that of the outer annular edge 102 can mean that the edge of the inner annular edge 101 is formed with a relatively rounded corner and can be formed with a more gentle rounded corner. In other words, it can mean that the edge of the outer annular edge 102 is formed with a relatively sharp rounded corner.

[0274] In one embodiment of the invention, the inner annular edge 101 may be introduced into the membrane tissue surrounding the entire EB of the eyeball to maintain the shape of the EB, into the discontinuous edge DE between the high-curvature portion of the cornea protruding forward and the low-curvature portion of the sclera extending backward from the cornea, and close one side of the eyeball implant 100 with a relatively gentle rounded shape. The outer annular edge 102, which is attached to the high-curvature portion of the sclera, may close the other side of the eyeball implant 100 with a relatively sharp rounded shape to prevent the sclera from lifting or forming a gap with the sclera.

[0275] In one embodiment of the invention, the inner portion IA needs to be closely fitted to morphological features such as the discontinuous edge DE formed by the sclera and cornea. For example, the inner portion IA can be formed with a relatively small average thickness so that it can be finely adjusted according to the size of the cornea to fit the cornea as closely as possible.

[0276] As described above, the inner portion IA can be formed with a relatively small average thickness while taking into account its fit with the discontinuous edge DE of the ocular EB, and can be closed with a relatively gently rounded inner annular edge 101 while taking into account the possibility of damage to the internal tissues of the ocular EB. In one embodiment of the invention, by forming the inner annular edge 101, which is inserted into the ocular EB or into a narrow implantation space of the ocular EB, or a relatively complex implantation space such as the discontinuous edge DE, and which contacts the internal tissues of the ocular EB, a relatively gently rounded shape, irritation or damage to the internal tissues of the ocular EB can be prevented during permanent surgery of the ocular implant 100.

[0277] In one embodiment of the invention, the inner annular edge 101 can prevent irritation or damage to the internal tissues of the EB (endothelial fossa) through a relatively gentle rounded corner shape. Conversely, the outer annular edge 102 can block side effects such as foreign body or bacterial invasion through a relatively sharp rounded corner shape. According to one embodiment of the invention, the ocular implant 100 can be implanted onto the sclera in a state where it is relatively slightly raised above the scleral surface through the rounded corner edge of the outer annular edge 102. For example, a gap can be formed between the ocular implant 100 and the sclera through the rounded corner edge of the outer annular edge 102. In one embodiment of the invention, by forming the edge of the outer annular edge 102 into a relatively sharp shape, that is, by forming a relatively large average thickness after the anterior curved surface 120 forming the outer OA thickness forms a relatively distant trajectory from the posterior slope 110, and then following a relatively steep downward curvature line, a sharp rounded corner edge is formed on the outer annular edge 102. As described above, the anterior curved surface 120, which forms the thickness of the outer OA, follows a steep downward curve as it approaches the outer annular edge 102, forming a sharp rounded outer annular edge 102 with the posterior slope 110. This sharp rounded outer annular edge 102 closes the iris expansion portion 105, thereby forming a smooth transition while preventing the invasion and side effects of foreign bodies, bacteria, and viruses caused by the lifting of the scleral surface.

[0278] In one embodiment of the present invention, the eyeball expansion portion 105 includes the anterior curved surface 120 and the posterior inclined surface 110, as well as an inner annular edge 101 and an outer annular edge 102 that contact each other. The cross-section of the eyeball expansion portion 105 can adopt different values ​​and shapes according to specific designs. For example, in one embodiment of the present invention, the maximum thickness t5 of the eyeball expansion portion 105 can be set to 50 μm to 200 μm (e.g., 120 μm), the edge thickness of the inner annular edge 101 can be set to 20 μm to 100 μm (e.g., 40 μm), and the edge thickness of the outer annular edge 102 can be set to 60 μm to 200 μm (e.g., 80 μm).

[0279] In one embodiment of the present invention, the edge thickness t1 of the inner annular edge 101 refers to the thickness between the inner inflection point 101' and the rear slope 110 when the front curved surface 120, which forms a thickness profile on the rear slope 110, follows the downward curvature line through the inner inflection point 101' and contacts the rear slope 110 to form the edge of the inner annular edge 101. Similarly, the edge thickness t2 of the outer annular edge 102 refers to the thickness between the outer inflection point 102' and the rear slope 110 when the front curved surface 120, which forms a thickness profile on the rear slope 110, follows the downward curvature line through the outer inflection point 102' and contacts the rear slope 110 to form the edge of the outer annular edge 102.

[0280] In one embodiment of the invention, the eyeball expansion portion 105 may include the contour of an anterior curved surface 120 extending laterally toward the rear slope 110 from the maximum thickness portion t5. The contour of the anterior curved surface 120 may extend along a steeper downward-curving profile via an inner inflection point 101' and an outer inflection point 102', thereby forming an inner annular edge 101 and an outer annular edge 102. In one embodiment of the invention, the distance from the inner annular edge 101 to the inner inflection point 101' along the slope direction may be less than the distance from the outer annular edge 102 to the outer inflection point 102'. For example, in one embodiment of the invention, the downward thickness at the outer inflection point 102' may be relatively greater, so that an outer annular edge 102 with relatively sharp rounded corners is formed from the anterior curved surface 120 having a relatively large average thickness. In other words, the downward thickness at the inner inflection point 101' can be relatively smaller, so that an inner annular edge 101 with relatively gentle rounded corners is formed from the front curved surface 120 having a relatively small average thickness. As a result, the distance from the outer inflection point 102' to the outer annular edge 102 can be greater than the distance from the inner inflection point 101' to the inner annular edge 101.

[0281] For example, in one embodiment of the invention, the outer inflection point 102' and the inner inflection point 101' may represent points where the front surface 120 bends sharply downward to form the outer annular edge 102 and the inner annular edge 101. For example, they may be the two points where the curvature change is greatest due to the front surface 120 profile, i.e., two points that bend downward near the outer annular edge 102 and the inner annular edge 101, respectively. In one embodiment of the invention, the edge thickness t2 of the outer annular edge 102 may be greater than the edge thickness t1 of the inner annular edge 101, and the edge thickness of the outer annular edge 102 may be relatively large when moving downward along the front surface 120 from the outer portion OA, which has a relatively large average thickness, to the outer inflection point 102' to form the outer annular edge 102 with sharp rounded corners.

[0282] It should be noted that, according to this specification, the thickness of the outer portion OA and the inner portion IA, their average thickness, the edge thickness t2 of the outer annular edge 102, and the edge thickness t1 of the inner annular edge 101, etc., can all correspond to the thickness dimensions measured from the rear inclined surface 110 along the vertical direction. Although the size relationship of the thickness dimensions is described using "high" or "low" in a manner similar to the height dimension, this is only for ease of understanding, and in reality, they respectively indicate "thicker" or "thinner" in the thickness dimension.

[0283] In one embodiment of the invention, the posterior slope 110 may be formed as a slope inclined at a certain angle θ relative to a vertical plane G perpendicular to the frontal direction Z3 along a frontal direction Z3 from front to rear, wherein the front corresponds to the direction in which a receptor with lens function is formed or an opening for receiving light is formed in the eyeball (or pupil). The posterior slope 110 may be inclined at an angle θ of about 20° to 40° on the vertical plane G. In one embodiment of the invention, the posterior slope 110 may be adhered to the sclera, for example, in the section from the discontinuous edge DE between the cornea and sclera to the scleral curvature AC, it may be adhered to the sclera with a relatively low curvature more closely as a slope rather than a curved surface. In one embodiment of the invention, the section extending from the discontinuous edge DE between the cornea and sclera to the scleral curvature AC may be generally a slope, and in order to adhere to the scleral surface with a low curvature and close to the slope, the posterior slope 110 may be formed as a slope inclined at a certain angle θ on the vertical plane G.

[0284] In one embodiment of the invention, the posterior slope 110 may conform to a scleral surface that is generally or nearly sloped, and the posterior slope 110 may conform to the scleral surface depending on the flexibility of the posterior slope 110 or the ocular implant 100 including the posterior slope 110. In one embodiment of the invention, the posterior slope 110 is formed at a certain angle θ relative to the vertical plane G, thereby forming a support surface for the entire ocular implant 100. As described later, the packaging container of the ocular implant 100 according to an embodiment of the invention may include an inclined support surface formed for supporting the posterior slope 110, taking into account the convenience of manufacturing and assembling the ocular implant 100 and its packaging container, and providing a stable support force between the two, thereby forming a posterior support surface of the ocular implant 100 and a support surface of the packaging container that follow the same certain inclined contour.

[0285] In one embodiment of the present invention, the inner annular edge 101 and the outer annular edge 102 respectively form the front of the eyeball EB, and when viewed from the front of the eyeball EB towards the frontal direction Z3, they can respectively appear elliptical and circular. A lens that functions as a lens and an eyeball (or pupil) forming an entrance aperture are disposed on the front of the eyeball EB. The rear slope 110 can be formed as a plane inclined at a certain angle θ relative to the vertical plane G perpendicular to the frontal direction Z3, so that the inner annular edge 101 and the outer annular edge 102 respectively form the frontal and rearal positions.

[0286] According to one embodiment of the present invention, when viewed from the frontal direction Z3, the ocular implant 100 may exhibit a shape in which the inner annular edge 101 at the front position overlaps with the outer annular edge 102 at the rear position due to the inclination of the posterior slope 110 providing a thickness reference, while the inner annular edge 101 is included in the circle of the outer annular edge 102. In this case, the ocular expansion portion 105 between the inner annular edge 101 and the outer annular edge 102 may be formed such that, in one position along the minor axis direction Z2 of the inner annular edge 101, the width of one position is greater than the width of the other position, thereby causing the ellipse of the inner annular edge 101 to be formed biased towards the other side within the circle of the outer annular edge 102. As will be described later, on one side of the relatively wider ocular expansion portion 105, located along the short axis direction Z2 of the inner annular edge 101, the position can correspond to the surgical center position S. On one side of the ocular expansion portion 105, an incision portion C, a first end portion E1 and a second end portion E2 separated from each other by the incision portion C, and a surgical hole 10 for connecting the first end portion E1 and the second end portion E2, or a snap-fit ​​connection, or a hook connection, etc., can be formed.

[0287] In one embodiment of the invention, the inner annular edge 101 and the outer annular edge 102 may surround the opening OP in different shapes. For example, the inner annular edge 101 may be formed into an ellipse following the shape of the eyeball and surround the outer edge of the eyeball at adjacent positions so as not to obstruct the eyeball (or pupil) forming the light-entry hole, and to provide an integrated appearance. The outer annular edge 102 may be formed into a circle to provide an aesthetically pleasing circular appearance. For example, the inner annular edge 101 may be formed into an ellipse with different major axis lengths L1 and minor axis lengths L2, in which case the major axis length L1 may be formed in the direction in which the implantee's two eyes face each other, while the minor axis length L2 may be formed in a direction perpendicular to the major axis length L1.

[0288] As described above, in one embodiment of the invention, the inner annular edge 101 surrounding the outer edge of the implantee's eyeball can be elliptical according to the shape of the implantee's eyeball, and can be optimized to a corresponding ellipse according to the implantee's physical condition (e.g., differences in the shape and size of the eyeball among different implantees). For example, based on an adult, the major axis length L1 of the eyeball can be 9 mm to 15 mm (e.g., 12 mm), and the minor axis length L2 can be 8 mm to 14 mm (e.g., 11 mm). The shape of the eyeball can be formed into different types according to the shape ratio between the major axis length L1 and the minor axis length L2, for example, an elongated ellipse with the major axis length L1 extending longer than the average shape, or a near-circular ellipse with the minor axis length L2 extending relatively longer.

[0289] The following describes an ocular implant 100 according to another embodiment of the present invention, which includes an adaptive telescopic portion 151 that adaptively provides length extension along the periphery of an inner annular edge 101, and roughened surfaces 152, 153 on the periphery of an ocular expansion portion 105 formed between the inner annular edge 101 and the outer annular edge 102 for generating rotational resistance in the direction of rotation.

[0290] Figure 6 A perspective view is shown of an adaptive telescopic portion 151 used in an ocular implant 100 according to an embodiment of the present invention.

[0291] Figure 7 This is a perspective view illustrating the adaptive telescopic portion 151 used in an ocular implant 100 according to an embodiment of the present invention. Figure 6 A three-dimensional view of the modified example.

[0292] Figures 8A and 8B are cross-sectional views of the ocular implant 100 taken along the circumference of the ocular expansion portion 105, showing cross-sectional views of the machined surfaces 152 and 153 with different roughnesses, which have isotropic rotational resistance and anisotropic rotational resistance, respectively.

[0293] According to the ocular implant 100 described above

[0294] It is permanently implanted on the EB of the recipient's eye to provide the appearance of an enlarged eyeball, and may include:

[0295] A central opening OP is provided for receiving incident light toward the eyeball (or pupil), which provides the eyeball EB opening.

[0296] The inner annular edge 101 surrounds and defines the opening OP;

[0297] An outer annular edge 102, which, on the side opposite to the inner annular edge 101 defining the opening OP, surrounds the opening OP together with the inner annular edge 101; and

[0298] An adaptive telescopic section 151 provides adaptive length extension along the periphery of the inner annular edge 101.

[0299] For example, the adaptive telescopic portion 151 can provide length extension along the periphery of the inner annular edge 101 to adapt to the shape and size of each implantee's eyeball.

[0300] For example, the inner annular edge 101 can be formed as an ellipse with different major axis lengths L1 and minor axis lengths L2.

[0301] The adaptive telescopic portion 151, in order to adaptively fit the inner annular edge 101 to the eyeball of the implantee, can provide length extension along the major axis direction Z1 and / or the minor axis direction Z2. The inner annular edge 101 is either an elongated ellipse extending relative to the major axis length L1 and / or shortened relative to the minor axis length L2, or a near-circular ellipse shortened relative to the major axis length L1 and / or extended relative to the minor axis length L2.

[0302] For example, the adaptive telescopic portion 151 may include at least one slit 151s formed on the periphery of the inner annular edge 101.

[0303] For example, the adaptive telescopic portion 151 may include a plurality of slits 151s spaced apart from each other along the periphery of the inner annular edge 101.

[0304] For example, the plurality of slits 151s may be arranged at uniform intervals along the periphery of the inner annular edge 101.

[0305] For example, the adaptive telescopic portion 151 may include a set of slits 151s formed on both sides along the long axis direction Z1 and / or formed on both sides along the short axis direction Z2.

[0306] For example, the adaptive telescopic part 151,

[0307] By forming a first set of slits 151s and a second set of slits 151s at positions on both sides along the minor axis Z2, the segmented pieces can overlap each other, thereby extending the minor axis length L2 while shortening the major axis Z1.

[0308] By forming a third set of slits 151s and a fourth set of slits 151s on both sides along the long axis Z1, the segmented pieces overlap each other, thereby extending the long axis length L1 while shortening the short axis length L2.

[0309] For example, the slit 151s can be formed at each angular position with a certain included angle interval, 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.

[0310] For example, the slit 151s may include:

[0311] The first set of slits 151s and the second set of slits 151s are formed along the minor axis direction Z2 at 0° angle position A1 and 180° angle position A2, respectively, corresponding to the positions on both sides; and

[0312] The third set of slits 151s and the fourth set of slits 151s are formed along the long axis direction Z1 at 90° angle position A3 and 270° angle position A4, respectively, corresponding to the positions on both sides.

[0313] For example, the slit 151s can be introduced into the interior of the eyeball expansion portion 105 along the depth direction from the inner annular edge 101 toward the outer annular edge 102.

[0314] For example, the slit 151s can be introduced into the interior of the eyeball expansion portion 105 from the center O of the opening OP where the major axis length L1 and the minor axis length L2 intersect, with the radial direction as the depth direction.

[0315] For example, the adaptive telescopic portion 151 can extend or retract the length of the inner annular edge 101 by overlapping the segments that are separated from each other along the periphery of the inner annular edge 101 through the slit 151s.

[0316] For example, the eyeball dilation portion 105 may include:

[0317] The posterior bevel 110 faces the EB of the eyeball and is configured to conform to the surface of the EB of the eyeball; and

[0318] An anterior curved surface 120 is configured to face outwards opposite to the eyeball EB, and forms a thickness profile based on the posterior slope 110. It contacts the posterior slope 110 at a position where it meets the opening OP and forms an inner annular edge 101, and contacts the posterior slope 110 at a position opposite to the opening OP and forms an outer annular edge 102. Based on a maximum thickness portion t5 where the maximum thickness is formed between the inner annular edge 101 and the outer annular edge 102, a thickness profile is formed relative to the posterior slope 110, such that a relatively thin inner portion IA and a relatively thick outer portion OA are formed.

[0319] The segments divided by the slits 151s forming the adaptive telescopic portion 151 overlap each other, and while extending the length of the inner annular edge 101, the thickness of the inner portion IA introduced from the inner annular edge 101 and forming the slits 151s is increased to form an additional thickness.

[0320] For example, the adaptive telescoping portion 151 is formed on the inner annular edge 101 surrounding the outer edge of the eyeball at a position more adjacent to the outer annular edge 102, so as to adaptively deform according to the shape and size of each implantee's eyeball.

[0321] It can also be left unformed on the outer annular edge 102 to maintain a beautiful circular appearance that resists deformation of the inner annular edge 101.

[0322] For example, the inner annular edge 101, which is formed by segments overlapping each other through the slits 151s that create the adaptive telescopic portion 151, can be formed into a relatively gently rounded shape.

[0323] The outer annular edge 102 can be formed into a relatively sharp rounded shape.

[0324] In one embodiment of the invention, the shape and size of the enlarged eyeball in the ocular implant 100 may vary depending on the implantee's physical condition. To form an enlarged eyeball integrated with the eyeball without obstructing the light-entry aperture (or pupil), the inner annular edge 101 may be provided with an adaptive telescoping portion 151 along its circumference to accommodate differences in eyeball shape and size under the implantee's physical condition. For example, in one embodiment of the invention, the adaptive telescoping portion 151 may provide length extension along the periphery of the inner annular edge 101 so that it can adaptively deform according to the shape and size of each implantee's eyeball.

[0325] In this specification, the adaptive telescopic portion 151 providing adaptive length extension along the circumference of the inner annular edge 101 means that the length can be extended in one direction (Z1) or shortened in the other direction (Z2) of the major axis of the inner annular edge 101. It may also include extending or shortening the periphery of the inner annular edge 101 as a whole without being restricted to a specific direction.

[0326] In one embodiment of the invention, the adaptive telescopic portion 151 may include a plurality of slits 151s formed on the inner annular edge 101 or the adjacent ocular expansion portion 105. For example, the adaptive telescopic portion 151 may include at least one slit 151s formed on the periphery of the inner annular edge 101. In one embodiment of the invention, the adaptive telescopic portion 151 includes a plurality of slits 151s spaced apart from each other circumferentially along the inner annular edge 101 and introduced from the inner annular edge 101 into the ocular expansion portion 105.

[0327] For example, for patients undergoing eye implant surgery, instead of customizing each eye implant 100 to fit the individual shape and size of each patient's eye, it would be more efficient to manufacture a single, universal eye implant 100 that can be adapted to the shape and size of each patient's eye. This allows the eye implant 100 to be adapted to the shape and size of each patient's eye during surgery, ultimately enabling the implantation of an eye implant 100 optimized for different eye shapes and sizes. Therefore, compared to creating individual molds for each different eye implant 100, forming multiple eye implants 100 using a single, universally designed mold can save manufacturing costs and achieve an economical product design.

[0328] In one embodiment of the invention, the adaptive telescopic portion 151 may include a plurality of slits 151s spaced apart from each other along the periphery of the inner annular edge 101, the slits 151s being introduced from the inner annular edge 101 at their respective positions along the periphery of the inner annular edge 101 toward the ocular expansion portion 105. For example, in one embodiment of the invention, the inner annular edge 101 is the innermost structure surrounding the outer edge of the ocular implant 100, for example, a structure directly surrounding the outer edge of the ocular eye, or a structure that guides telescopic deformation to achieve an optimized design for the shape and size of each implantee's ocular eye. In one embodiment of the present invention, in order to optimize for the shape and size of each implantee's eyeball, that is, to ensure that the eyeball (or pupil) corresponding to the light entrance is not obstructed at the most adjacent position around eyeballs of different shapes and sizes, the adaptive telescopic portion 151 can guide the deformation of the inner annular edge 101, for example, including shape deformation such as concavity and deformation such as extension or shortening of the overall length, so as to guide the inner annular edge 101 to deform with a high degree of freedom according to the optimized shape or size. In this specification, the length extension and shortening of the inner annular edge 101 refers to a comprehensive change including morphological deformation such as flattening of the inner annular edge 101 as described above, as well as extension or shortening of the overall length of the inner annular edge 10.

[0329] In one embodiment of the present invention, the adaptive telescopic portion 151 may include a plurality of slits 151s formed at intervals along the periphery of the inner annular edge 101. For example, the plurality of slits 151s may be formed at equal intervals along the periphery of the inner annular edge 101. For example, they may be uniformly arranged at each angular position at a certain angle interval with the center O of the opening OP as the rotation center.

[0330] In one embodiment of the invention, the slits 151s forming the adaptive telescopic portion 151 may be introduced into the interior of the eyeball expansion portion 105 along a depth direction from the inner annular edge 101 to the outer annular edge 102. More specifically, each slit 151s forming the adaptive telescopic portion 151 may be formed to be introduced into the interior of the eyeball expansion portion 105 from the inner annular edge 101. For example, each slit 151s may be introduced into the interior of the eyeball expansion portion 105 from various points on the inner annular edge 101 in a direction perpendicular to the inner annular edge 101. In various embodiments of the invention, the slits 151s may be introduced from the inner annular edge 101 in a direction perpendicular to the inner annular edge 101, or they may be introduced from the inner annular edge 101 in a radial direction. For example, in various embodiments of the present invention, the slit 151s may be introduced into the interior of the ocular expansion portion 105 adjacent to the inner annular edge 101, with the depth direction being a radial direction toward the center O of the opening OP surrounded by the inner annular edge 101. For example, as can be seen from this specification, the center O of the opening OP surrounded by the inner annular edge 101 refers to 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 elliptical opening OP intersect. However, in various embodiments of the present invention, the slit 151s may also be introduced into the interior of the ocular expansion portion 105 from the inner annular edge 101 in various directions, and the depth direction of its introduction may be varied according to the shape formed by the inner annular edge 101 (e.g., elliptical), and as described below, according to the deformation of the inner annular edge 101 caused by the individual physical condition of the implantee.

[0331] In one embodiment of the invention, 30 to 360 slits 151s forming the adaptive telescopic portion 151 may be formed along the periphery of the inner annular edge 101. For example, when evenly spaced at a certain angle, approximately 30 slits may be formed at an angle of approximately 12°, or approximately 360 slits may be formed at an angle of approximately 1°. Furthermore, the width d of the slits 151s forming the adaptive telescopic portion 151 may be formed in a range of approximately 1 / 4 to 1 / 2 of the width of the eyeball expansion portion 105 located 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.

[0332] In one embodiment of the invention, the inner annular edge 101 may be formed as an ellipse with different major axis lengths L1 and minor axis lengths L2. The adaptive telescopic portion 151 may be extended and / or shortened along the major axis direction Z1 and / or the minor axis direction Z2 to adaptively provide an elongated ellipse with an extended major axis length L1 and / or a shortened minor axis length L2, and a near-circular ellipse inner annular edge 101 with a shortened major axis length L1 and / or an extended minor axis length L2, thereby adapting to the eyeball of the implantee.

[0333] In one embodiment of the present invention, the inner annular edge 101 or the adjacent ocular expansion portion 105 may be divided into multiple segments along the circumference of the inner annular edge 101 by respective slits 151s, and the multiple segments divided on both sides of each slit 151s overlap each other along the circumference of the inner annular edge 101, thereby allowing the length of the inner annular edge 101 to stretch or contract. For example, in one embodiment of the present invention, an adaptive stretching portion 151 including multiple slits 151s may be provided, and the segments divided by each slit 151s may approach and overlap each other through the slits 151s, thereby allowing the shape and length of the overall inner annular edge 101 to stretch or contract.

[0334] In one embodiment of the invention, the inner annular edge 101 of the adaptive telescopic portion 151, or the inner portion IA ending at the inner annular edge 101, can be formed with a smaller average thickness to allow for greater deformation freedom. For example, the inner portion IA with a smaller average thickness can provide extra space in the thickness direction to accommodate overlapping segments divided by the slits 151s. In one embodiment of the invention, the adaptive telescopic portion 151 disposed on the inner annular edge 101 and the inner portion IA ending at the inner annular edge 101 with a smaller average thickness work together to adaptively deform the inner annular edge 101 into an optimized shape and size according to the implantee's physical condition. For example, the inner annular edge 101 with a smaller average thickness provides good flexibility to allow segments divided by the slits 151s to approach and overlap each other, while the inner portion IA with a smaller average thickness also provides space to accommodate the extra thickness formed by the overlapping of these segments.

[0335] For example, in one embodiment of the invention, the ocular expansion portion 105 may include a posterior slope 110 arranged toward the eyeball EB for attachment thereto, and a front curved surface 120 facing the outer surface OS opposite to the eyeball EB and forming a thickness profile based on the posterior slope 110. The front curved surface 120 contacts the posterior slope 110 at a position where it meets the opening OP and forms an inner annular edge 101, and contacts the posterior slope 110 at a position opposite to the opening OP and forms an outer annular edge 102, and forms a thickness profile based on the posterior slope 110, such that a relatively thin inner portion IA and a relatively thick outer portion OA are formed based on a maximum thickness portion t5 where the maximum thickness is formed between the inner annular edge 101 and the outer annular edge 102. The segments that are divided by forming the slits 151s of the adaptive telescopic portion 151 can overlap each other, thereby forming an extra thickness, so that while the length of the inner annular edge 101 is stretched, the thickness of the inner portion IA formed by the slits 151s introduced from the inner annular edge 101 is increased.

[0336] In one embodiment of the present invention, when viewed from the frontal direction Z3, the eyeball surrounded by the inner annular edge 101 can form an ellipse with different major axis lengths L1 and minor axis lengths L2. The major axis length L1 of the ellipse formed by the eyeball can be formed along the direction in which a pair of eyes face each other, while the minor axis length L2 of the ellipse formed by the eyeball can be formed along a direction perpendicular to the major axis length L1. For example, the major axis length L1 of the eyeball can be 9 mm to 15 mm, and the minor axis length L2 of the eyeball can be 8 mm to 14 mm. That is, in one embodiment of the present invention, the shape and size of the eyeball, which is the object of the eyeball implant 100, can have the above-mentioned deviations. For example, even if the shape of the eyeball has different minor axis lengths L2 and major axis lengths L1, different elliptical shapes and different sizes can be formed due to the above-mentioned dispersion of lengths. For example, in one embodiment of the invention, the shape and size of the inner annular edge 101 can be adjusted according to the individual's physical condition. For instance, compared to the average shape and size, it can be formed into an elongated ellipse with a relatively longer major axis length L1 and / or a relatively shorter minor axis length L2, or a near-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 elongated ellipse or near-circular ellipse, can be defined according to the relative shape ratio between the major axis length L1 and the minor axis length L2, and do not necessarily refer to the absolute length or individual length of the major axis length L1 and the minor axis length L2. For example, in order to optimize for different eye shapes and sizes of implantees, the deformation to relatively extend the long axis length L1 or relatively extend the short axis length L2 may refer to guiding the deformation of the adaptive telescoping part 151 such that the relative shape ratio between the long axis length L1 and the short axis length L2 of the ellipse that defines the inner annular edge 101 for surrounding the outer edge of the implantee's eye changes.

[0337] In one embodiment of the invention, the inner annular edge 101 surrounding the eyeball can be designed according to the shape and size of an average eyeball without the need for additional adaptive extension portion 151 or deformation of the inner portion IA, and in a single-design ocular implant 100 suitable for universal surgery, it can be manufactured according to the shape and size of an average eyeball without deformation. For example, in one embodiment of the invention, the shape of the opening OP surrounding the inner annular edge 101 can be formed as an ellipse with a relatively long extended major axis length L1 and a relatively short extended 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 12 mm and 11 mm, respectively, to accommodate an average eyeball.

[0338] In one embodiment of the invention, a plurality of slits 151s may be formed on the periphery of the inner annular edge 101, and the plurality of slits 151s may be uniformly arranged along the entire periphery of the inner annular edge 101. For example, the plurality of slits 151s uniformly formed along the periphery of the inner annular edge 101 may be deformed in different ways according to the individual physical conditions of each implantee. For example, in one embodiment of the invention, when it is necessary to further extend the long axis length L1 of the un-induced deformed elliptical inner annular edge 101 to optimize the slender elliptical eyeball according to the eyeball shape of implantees with different physical conditions, the segments divided by the slits 151s formed at the positions on both sides of the long axis length L1 of the inner annular edge 101 may overlap each other, thereby extending the long axis length L1 rather than shortening the short axis length L2. Conversely, when optimizing a near-circular elliptical eyeball that requires an extended minor axis length L2, the minor axis length L2 can be extended by overlapping segments formed by slits 151s on both sides of the minor axis length L2 along the inner annular edge 101. Instead of shortening the major axis length L1, this can be achieved by having these segments overlap each other.

[0339] In one embodiment of the invention, the inner annular edge 101 is deformed in an optimized form at each slit formation location by a plurality of slits 151s uniformly formed along the periphery of the inner annular edge 101. For example, since the deformation induced by the inner annular edge 101 can be flexibly adapted to deformation, deformation imbalance or damage caused by the degree and direction of such deformation is prevented, including preventing deformation caused by excess portions of the inner annular edge 101 that cannot maintain coplanarity, and preventing damage to the ocular implant 100 including the inner annular edge 101 caused by excessive stress and stress accumulation due to insufficient portions of the inner annular edge 101. However, in various embodiments of the invention, it should be considered that for ocular shapes such as elongated elliptical or near-circular elliptical, the slits 151s formed on both sides of the long axis length L1 and the slits 151s formed on both sides of the short axis length L2 may require maximum deformation, and it should be considered that the uniformly formed plurality of slits 151s may lead to a decrease in the overall rigidity of the ocular implant 100 and reduce its operability during circulation or surgery. Therefore, the adaptive telescopic portion 151 may include multiple sets of slits 151s concentrated on both sides of the major axis length L1 and multiple sets of slits 151s concentrated on both sides of the minor axis length L2. For example, when viewed from the front direction Z3, multiple sets of slits 151s may be concentrated at 0° angle position A1, 90° angle position A3, 180° angle position A2, and 270° angle position A4 on the periphery of the inner annular edge 101. For example, in order to follow the main deformation, multiple slits 151s may be concentrated at various angles approximately 90° apart. For example, in one embodiment of the present invention, the adaptive telescopic portion 151 may include a first set of slits 151s formed at 0° angle position A1 on both sides of the minor axis direction Z2 along the periphery of the inner annular edge 101, and a second set of slits 151s formed at 180° angle position A2. The first and second sets of slits 151s, located at 0° angle position A1 and 180° angle position A2 respectively, are situated on both sides of the minor axis direction Z2, enabling the extension of the minor axis length L2 or the shortening of the major axis length L1. Furthermore, the adaptive telescopic part 151 may also include a third set of slits 151s formed at 90° angle position A3 on both sides of the major axis direction Z1, and a fourth set of slits 151s formed at 270° angle position A4, both located along the periphery of the inner annular edge 101. The third and fourth sets of slits 151s, located at 90° angle position A3 and 270° angle position A4 respectively, are situated on both sides of the major axis direction Z1, thereby enabling the extension of the major axis length L1 or the shortening of the minor axis length L2.

[0340] In one embodiment of the invention, the plurality of slits 151s forming the adaptive telescopic portion 151 may be uniformly spaced at a certain angle along the periphery of the inner annular edge 101. However, the first to fourth groups of slits 151s, which contribute significantly to the telescopic extension of the major axis length L1 and the minor axis length L2 and are arranged at approximately 90° angles or located on both sides of the major axis direction Z1 and the minor axis direction Z2 respectively, may be concentrated around their respective 0° angle position A1, 90° angle position A3, 180° angle position A2, and 270° angle position A4. For example, compared to other slits 151s, the first to fourth groups of slits 151s may be formed deeper or at more dense angles in the depth direction from the inner annular edge 101 toward the outer annular edge 102.

[0341] For example, in one embodiment of the present invention, the adaptive telescopic portion 151 may include a first group of slits 151s arranged around a 0° angle position A1, a second group of slits 151s arranged around a 180° angle position A2, a third group of slits 151s arranged around a 90° angle position A3, and a fourth group of slits 151s arranged around a 270° angle position A4. The number of each of the first to fourth groups of slits 151s may vary; for example, at least one slit 151s may be included. In various embodiments of the present invention, each of the first to fourth groups of slits 151s may include a single slit 151s, i.e., a single slit 151s is formed at the 0° angle position A1, 90° angle position A3, 180° angle position A2, and 270° angle position A4, respectively.

[0342] In various embodiments of the present invention, at angular positions corresponding to the positions on both sides of the major axis Z1 and the positions on both sides of the minor axis Z2—that is, at angular positions spaced at approximately 90° intervals with a relatively large degree of deformation—slits 151s that are introduced relatively deeper in the depth direction, or slits 151s that are arranged at relatively denser angular intervals, can be formed. At other angular positions, slits 151s that are introduced relatively shallowly in the depth direction, or slits 151s that are arranged at relatively sparser angular intervals, can be formed.

[0343] In one embodiment of the invention, the adaptive expansion portion 151 may not be formed on the outer annular edge 102. For example, in one embodiment of the invention, the adaptive expansion portion 151 formed on the inner annular edge 101 is provided to accommodate the different shapes and sizes of the eyeballs formed by each individual. It is formed on the inner annular edge 101 surrounding the eyeball and can achieve universally applicable surgery through a single-designed eye implant 100 or a single-designed mold, thereby significantly reducing manufacturing costs and enabling permanent implantation in an optimized form according to the individual's physical condition. Conversely, structures for guiding deformation or facilitating deformation may not be formed on the outer annular edge 102. For example, if a deformation-facilitating structure such as a slit 151s is formed on the outer annular edge 102, it can follow the guided deformation of the inner annular edge 101, thereby preventing the aesthetic appearance of the outer annular edge 102 from being destroyed by unintended deformation of the outer annular edge 102 and maintaining the aesthetic appearance without compromising the originally designed circular shape. As described above, in one embodiment of the present invention, the outer annular edge 102 is formed as a circle, thereby improving aesthetic satisfaction. Although the inner annular edge 101 is guided to deform, for example, to produce excessive deformation in order to match an elongated oval or near-circular oval eyeball, structures that facilitate deformation, such as slits 151s (adaptive expansion portions 151), may not be formed on the outer annular edge 102, so that the outer annular edge 102 maintains a circular appearance.

[0344] In one embodiment of the invention, the outer annular edge 102 may be formed with a structure having higher rigidity relative to the inner annular edge 101. It may be made of the same material but formed with a relatively larger average thickness than the inner annular edge 101 through different structural designs to create a difference in rigidity. Thus, the outer annular edge 102 may have higher shape stability or shape retention than the inner annular edge 101, and can maintain its aesthetically pleasing circular shape even if the inner annular edge 101 is guided to deform.

[0345] In one embodiment of the present invention, the ocular implant 100 or the ocular expansion portion 105 forming the main body of the ocular implant 100 may include a posterior slope 110 facing the EB of the eyeball and an anterior curved surface 120 facing the external OS opposite to the EB of the eyeball. In one embodiment of the present invention, the external OS opposite to the EB of the eyeball does not refer to the external environment of the human body, but may refer to the external environment of the EB of the eyeball itself. For example, human tissues such as the eyelids covering the front of the EB of the eyeball can also be regarded as the external OS of the EB of the eyeball.

[0346] The ocular implant 100 can be implanted onto the sclera such that the posterior slope 110 conforms to the sclera and is formed with roughened surfaces 152, 153 having appropriate roughness to generate moderate friction on the sclera. In other words, the posterior slope 110 and the anterior curved surface 120 can have different roughnesses or different degrees of surface roughness, with the posterior slope 110 formed with roughened surfaces 152, 153 to have appropriate roughness or a rough surface for guiding friction, while the anterior curved surface 120 can form a smooth surface to provide an aesthetically pleasing appearance.

[0347] In one embodiment of the invention, the ocular implant 100 is not formed in a rotationally symmetric shape, but rather in a rotationally asymmetric shape. For example, in the ocular implant 100, the inner annular edge 101 surrounding the eyeball can be formed as an ellipse with different major axis lengths L1 and minor axis lengths L2. The ocular implant 100, thus formed in a rotationally asymmetric shape, can rotate arbitrarily on the spherical structure of the eyeball EB. For example, considering that the position of the ocular implant 100 is difficult to adjust after permanent implantation, in order to maintain the orientation of the major axis length L1 and minor axis length L2 and prevent arbitrary rotation on the eyeball EB, the posterior slope 110 facing the eyeball EB can be formed as roughened surfaces 152, 153 with appropriate roughness to guide friction. For example, in one embodiment of the invention, the posterior slope 110 can be formed in any shape capable of guiding friction and can have an uneven structure forming roughness. In one embodiment of the invention, the posterior slope 110 may include roughened surfaces 152, 153 that continuously repeat an uneven shape, such as a wave pattern. In various embodiments of the invention, in order to guide the same friction in one rotational direction and the opposite rotational direction, the roughened surface 152 may be formed to have isotropic rotational resistance, or the roughened surface 153 may be formed to have anisotropic rotational resistance.

[0348] For example, when the ocular implant 100 is implanted in the implantation space between the conjunctiva and sclera formed by the incision EBC formed on the conjunctiva covering the sclera, a relatively small rotational resistance can be generated along the implantation direction by means of the roughened surface 153 that provides anisotropic rotational resistance. When the ocular implant 100, which has been implanted at one end, tends to rotate arbitrarily in the direction opposite to the implantation direction, in order to generate a relatively large rotational resistance, for example, to generate a low rotational resistance in the implantation direction and a high rotational resistance in any rotational direction opposite to the implantation direction, the roughened surface 153 that provides the anisotropic rotational resistance can be formed with a waveform structure that is anisotropic along the rotational direction. For example, in the rotational direction corresponding to one side of the implantation direction, a relatively gently sloping waveform can be formed, and a lower rotational resistance can be generated by this gentle slope; while in the opposite rotational direction, a relatively high rotational resistance can be generated by a waveform with a steeper slope. In one embodiment of the present invention, the roughened surfaces 152, 153 formed on the posterior slope 110 can be provided along the periphery of the ocular expansion portion 105. For example, it can be implanted along one rotation direction to surround the outer edge of the eyeball, wherein a relatively small rotational resistance is formed in the one rotation direction and a relatively large rotational resistance is formed in the opposite rotation direction, thereby giving the eyeball implant 100 a positional fixation force at the implantation site.

[0349] As described above, the inner annular edge 101 is formed around the eyeball at a position closest to the location of the implantee's eyeball, preferably positioned so as not to obstruct light incidence toward the eyeball and not to overlap with the eyeball. In other words, if it surrounds the outer edge of the eyeball while being excessively separated from the eyeball, which forms a relatively low-brightness dark area, it is difficult to provide an integrated appearance with the eyeball, resulting in a decrease in the satisfaction of the enlarged eyeball's appearance. Therefore, it is preferable to form it according to the shape of the eyeball at a position as close to the eyeball as possible. Thus, in one embodiment of the invention, the inner annular edge 101 can be formed into an ellipse according to the shape of the eyeball, and through an adaptive extension portion 151 formed on the inner annular edge 101, it can surround the outer edge of the eyeball in an optimized ellipse shape that matches the eyeball with differences in the implantee's appearance. At this time, the outer annular edge 102 can be formed into a circle so that the enlarged eyeball can present a circular appearance. Unlike the inner annular edge 101, the outer annular edge 102 does not need to consider the problem of obstructing light incidence, and can substantially determine the shape of the enlarged eyeball, and can provide a more aesthetically pleasing appearance by forming a circle.

[0350] In one embodiment of the invention, a plurality of slits 151s forming the adaptive telescopic portion 151 may be formed along the periphery of the inner annular edge 101. The segments divided by the plurality of slits 151s formed along the periphery of the inner annular edge 101 can overlap each other, thereby providing length extension along the periphery of the inner annular edge 101. In this case, to make it easier for the segments divided by the slits 151s to overlap each other, the inner annular edge 101 forming the slits 151s may be formed with a relatively gentle rounded edge shape. For example, the inner annular edge 101 may be formed with a relatively gentle rounded edge shape compared to the outer annular edge 102, which has a relatively sharp rounded edge shape.

[0351] For example, an inner annular edge 101 with a relatively gentle rounded edge shape, or a segment of the inner annular edge 101 divided by a slit 151s, can form a slightly raised gap at the bottom through the gentle rounded edge shape. Through the gap raised from the bottom, it is easy to enter the lower part of another adjacent segment, thereby overlapping with other segments and allowing the length extension and contraction of the inner annular edge 101 to be smoothly achieved.

[0352] The following will describe the surgical hole 10, snap-fit ​​connection or hook-shaped connection in the ocular implant 100 according to another aspect of the present invention, wherein the surgical hole 10 is connected to each other by a first end E1 and a second end E2 that are separated from each other by the incision portion C.

[0353] Figure 9 This is a schematic diagram illustrating the surgical port 10 used in an ocular implant 100 according to an embodiment of the present invention, showing a plan view of the ocular implant 100 viewed from the front direction Z3.

[0354] Figures 10A to 10C are schematic diagrams illustrating the snap-fit ​​or hook-shaped connection of the first slit 154a, 155a and the second slit 154b, 155b used in the ocular implant 100 according to different embodiments of the present invention, showing perspective views of different ocular EB implants 100.

[0355] Figures 11A and 11B are schematic diagrams illustrating different snap-fit ​​or hook-shaped connections of the assembly slit 156a and assembly hole 156b used in an ocular implant 100 according to an embodiment of the present invention.

[0356] According to the ocular implant 100 described above

[0357] It is permanently implanted on the EB of the recipient's eye to provide the appearance of an enlarged eyeball, and may include:

[0358] A central opening OP is provided for receiving incident light toward the eyeball (or pupil), which provides the pupil of the eyeball EB opening;

[0359] The inner annular edge 101 surrounds and defines the opening OP;

[0360] An outer annular edge 102, which, on the side opposite to the inner annular edge 101 defining the opening OP, surrounds the opening OP together with the inner annular edge 101; and

[0361] An eyeball expansion portion 105 is formed between the inner annular edge 101 and the outer annular edge 102, and includes a first end portion E1 and a second end portion E2, which are separated from each other by a cutting portion C and joined together toward each other by surgical holes 10 formed thereon, respectively.

[0362] For example, the eyeball expansion portion 105 between the inner annular edge 101 and the outer annular edge 102 can be formed such that, in either position along the minor axis direction Z2 of the inner annular edge 101, the width on one side is greater than the width on the other side, thereby causing the ellipse of the inner annular edge 101 to be formed offset to the other side within the circle of the outer annular edge 102.

[0363] The incision C, the first end E1 and the second end E2 separated from each other by the incision C, and the surgical hole 10 formed on the first end E1 and the second end E2 may be formed at the position of the side formed with a relatively wide width along the short axis direction Z2.

[0364] For example, in the eyeball expansion portion 105 between the inner annular edge 101 and the outer annular edge 102

[0365] The two sides of the inner annular edge 101 along the minor axis direction Z2 have a relatively smaller curvature than the two sides of the inner annular edge 101 along the major axis direction Z1.

[0366] The surgical hole 10 can be formed on the side with relatively smaller curvature of the two positions along the short axis Z2.

[0367] For example, the cut portion C can be formed along the minor axis direction Z2 of the inner annular edge 101.

[0368] The first end E1 and the second end E2, which are separated from each other by the cut portion C, can be joined together along the long axis Z1 of the inner annular edge 101.

[0369] Furthermore, multiple surgical holes 10 can be formed on the first end E1 and the second end E2, respectively, arranged along the long axis Z1 of the inner annular edge 101.

[0370] For example, the surgical port 10 may include:

[0371] A first surgical hole 11 is provided for the insertion of a suture to join the first end E1 and the second end E2; and

[0372] The second surgical hole 12 is for the insertion mechanism to pass through, so as to pull the eye implant 100 so that the eye implant 100 passes around the outer edge of the recipient's eyeball through the conjunctival incision C on the sclera.

[0373] For example, the first surgical hole 11 can be formed with a relatively small diameter.

[0374] The second surgical hole 12 is formed with a relatively large diameter.

[0375] For example, the first surgical hole 11 can be formed at a position relatively adjacent to the incision C.

[0376] The second surgical hole 12 may be formed at a position relatively far away from the incision C.

[0377] Furthermore, according to another aspect of the ocular implant 100 described above,

[0378] It is permanently implanted on the EB of the recipient's eye to provide the appearance of an enlarged eyeball, and may include:

[0379] A central opening OP is provided for receiving incident light toward the eyeball (or pupil), which provides the eyeball EB opening.

[0380] The inner annular edge 101 surrounds and defines the opening OP;

[0381] An outer annular edge 102, which, on the side opposite to the inner annular edge 101 defining the opening OP, surrounds the opening OP together with the inner annular edge 101; and

[0382] The eyeball expansion portion 105 is formed between the inner annular edge 101 and the outer annular edge 102, and includes a first end portion E1 and a second end portion E2 that are separated from each other by a cut portion C and are engaged with each other by a snap-fit ​​or hook-shaped engagement.

[0383] For example, the eyeball expansion portion 105 between the inner annular edge 101 and the outer annular edge 102 can be formed such that, in order to make the width of the inner annular edge 101 at either side of its minor axis direction Z2 greater than the width of the other side where the position is relatively wider, thereby forming an ellipse of the inner annular edge 101 inside the circle of the outer annular edge 102, which is offset to the other side within the circle of the outer annular edge 102.

[0384] The cut portion C, the first end E1 and the second end E2 separated by the cut portion C, and the snap-fit ​​or hook-shaped engagement between the first end E1 and the second end E2 can be formed at the position of the side formed with a relatively wide width.

[0385] For example, the snap-fit ​​connection or the hook-shaped connection,

[0386] It may include a first slit and a second slit 154a, 154b, 155a, 155b respectively formed on the first end E1 and the second end E2.

[0387] For example, the first slit and the second slits 154a, 154b, 155a, 155b may include:

[0388] The first part extends along the long axis direction Z1 of the inner annular edge 101; and

[0389] The second part extends from the first part 1541, 1551 along the short axis direction Z2 of the inner annular edge 101 or along an oblique direction that simultaneously follows the short axis direction Z2 and the long axis direction Z1 to the inner annular edge 101 or the outer annular edge 102, and opens to the outside of the ocular implant 100.

[0390] For example, at least a portion of the first slit and the second slits 154a, 154b, 155a, 155b may be formed in complementary shapes to form a snap-fit ​​or hook-fit with each other.

[0391] For example, the first portions of the first slit and the second slits 154a, 154b, 155a, 155b may extend side by side along the long axis direction Z1 of the inner annular edge 101.

[0392] The first slit, the second slit 154a, 154b, 155a, 155b, and the other second portion 1542, 1552 extend in opposite directions toward the outer annular edge 102 and the inner annular edge 101, respectively, and open toward the outside of the ocular implant 100, so that the second portions 1542, 1552 are formed in complementary shapes.

[0393] For example, the cut portion C is formed along the minor axis direction Z2 of the inner annular edge 101.

[0394] The first end E1 and the second end E2 are adjacent to each other along the long axis Z1 of the inner annular edge 101.

[0395] Any one of the first slit and the second slit 154a, 154b, 155a, 155b may include a plurality of first slit arrays 154a, 155a or second slit arrays 154b, 155b formed on the first end E1 or the second end E2 along the long axis direction Z1, and the other may be formed as a single first slit 154a, 155a or second slit 154b, 155b.

[0396] For example, the snap-fit ​​connection or the hook-shaped connection may include:

[0397] Assemble slit 156a, which is formed on the first end portion E1; and

[0398] An assembly hole 156b is formed on the second end E2 and is used for the assembly slit 156a to be inserted.

[0399] For example, an assembly guide 158 may be formed on the first end E1, which is located in front of the assembly slit 156a along the assembly direction of the first end E1 and the second end E2.

[0400] For example, the assembly guide 158 may include:

[0401] The front end protrusion 158a has a relatively small width formed at the front end of the first end E1 along the assembly direction of the first end E1 and the second end E2; and

[0402] The rear end 158c, located behind the front end protrusion 158a and in front of the assembly slit 156a, is formed to be wider than the neck W1 of the assembly slit 156a. It may further include a variable width portion 158b, which converges toward the front end protrusion 158a along an oblique direction that follows both the major axis direction Z1 corresponding to the assembly direction and the minor axis direction Z2 intersecting the major axis direction Z1, so as to connect the different widths between the relatively narrow front end protrusion 158a and the relatively wide rear end 158c.

[0403] For example, the rear end 158c of the assembly guide 158 can be connected to the full width W0 of the first end E1 disposed between the assembly guide 158 and the assembly slit 156a.

[0404] For example, a dummy tangent line CL comprising a plurality of perforations may be formed between the assembly guide portion 158 and the full width W0 of the first end portion E1.

[0405] For example, the assembly slit 156a can be introduced from both sides of the inner annular edge 101 and the outer annular edge 102 along the minor axis direction Z2 of the inner annular edge 101 to form a neck W1 with minimum width.

[0406] When the neck W1 of the assembly slit 156a is inserted into the assembly hole 156b on the side of the second end E2, the full width W0 of the relatively wide first end E1 formed before and after the assembly slit 156a can prevent the first end E1 and the second end E2 from separating.

[0407] According to one embodiment of the present invention, an ocular implant 100 may have an incision portion EBC formed on the conjunctiva surrounding the sclera, and be inserted between the sclera and conjunctiva through the incision portion EBC, such that it is inserted at a position corresponding to the outer edge of the eyeball between the sclera and conjunctiva, thereby surrounding the outer edge of the eyeball. According to one embodiment of the present invention, the ocular implant 100 may be inserted in a rotational direction to surround the outer edge of the eyeball. For this purpose, the ocular implant 100 is not continuously formed in a rotational direction surrounding the outer edge of the eyeball, but rather, with the center O of the opening OP as the center of rotation, a structure is formed by an incision portion C formed at a certain angular position (e.g., 0° angle position A1), and a first end E1 and a second end E2, which are separated from each other, are formed through the incision portion C. For example, according to one embodiment of the present invention, the ocular implant 100 does not include a closed opening OP, but rather an opening OP that is open to the outside can be formed through the incision portion C, and may include a first end E1 and a second end E2 that are separated from each other on both sides of the incision portion C.

[0408] According to one embodiment of the present invention, the incision C may be formed along the short axis direction Z2 of the inner annular edge 101 or the opening OP surrounded by the inner annular edge 101, and the first end E1 and the second end E2, which are separated from each other by the incision C, may be joined together along the long axis direction Z1. In one embodiment of the present invention, the first end E1 and the second end E2, which are separated by the incision C, may be connected together along the long axis direction Z1 by means of surgical holes 10 formed on the first end E1 and the second end E2, or by means of snap-fit ​​or hook-shaped connection as described below. At this time, the first slit and the second slit 154a, 154b, 155a, 155b or the assembly slit 156a for forming the surgical hole 10 or the snap-fit ​​or hook-shaped connection may be arranged in multiple ways along the long axis direction Z1 extending from the first end E1 and the second end E2.

[0409] In this specification, the eyeball expansion portion 105, which has the cut portion C, the first end portion E1, and the second end portion E2, is based on a rear inclined surface 110 that is inclined at a certain angle θ relative to a vertical plane G perpendicular to the frontal direction Z3. The thickness profile structure is formed by the front curved surface 120 formed on the rear inclined surface 110 (the eyeball expansion portion 105 is not a flat structure parallel to the vertical plane G perpendicular to the frontal direction Z3). In this case, the major axis direction Z1 and the minor axis direction Z2 can be defined in the frontal direction Z3. For ease of understanding, in this specification, for example, the inner annular edge 101 is positioned at the front, and the outer annular edge 102 is positioned at the rear, so that the rear inclined surface 110 is formed as an inclined surface inclined at a certain angle θ. The eyeball expansion portion 105, formed between the inner annular edge 101 located at the relatively forward position and the outer annular edge 102 located at the relatively rear position, has a thickness profile with variable thickness formed by the front curved surface 120 facing the rear slope 110, but can present an overall shape that tilts from front to back. Therefore, although the incision C is formed along the short axis direction Z2 on the eyeball expansion portion 105 in order to align with the long axis direction Z1 and the short axis direction Z2 defined from the frontal direction Z3, or the first end E1 and the second end E2 separated from each other by the incision C may not be connected to each other through the surgical hole 10, snap-fit ​​or hook-shaped connection along the long axis direction Z1, the directional nature of the incision C, surgical hole 10, snap-fit ​​or hook-shaped connection formed on the eyeball expansion portion 105 is fully described by the long axis direction Z1 and the short axis direction Z2 defined on the frontal direction Z3 when the eyeball expansion portion 105 with the incision C, surgical hole 10, snap-fit ​​or hook-shaped connection formed thereon is small (about 20° to 40°) relative to the vertical plane G perpendicular to the frontal direction Z3. For example, in one embodiment of the present invention, the long axis direction Z1 and the short axis direction Z2 can refer to the length direction and width direction of the first end E1 and the second end E2, respectively, when forming the first end E1 and the second end E2, or in relation to the cutting portion C, surgical hole 10, snap fastener or hook-shaped connection formed on the first end E1 and the second end E2.

[0410] In one embodiment of the present invention, the eyeball expansion portion 105 between the inner annular edge 101 and the outer annular edge 102 may be formed such that, in either position along the minor axis direction Z2 of the inner annular edge 101, the width of one side is greater than the width of the other side, thereby forming an ellipse of the inner annular edge 101 offset to the other side within the circle of the outer annular edge 102.

[0411] The incision C, the first end E1 and the second end E2 separated from each other by the incision C, and the surgical hole 10 for engaging the first end E1 and the second end E2, or a snap-fit ​​or hook-shaped engagement, may be located on one side where the width is greater along the short axis direction Z2. For example, the location where the width is greater along the short axis direction Z2 may correspond to the surgical center position S during the surgery of the ocular implant 100.

[0412] In this specification, when describing the ocular expansion portion 105 between the inner annular edge 101 and the outer annular edge 102 as having a first end E1 and a second end E2 separated by a cut portion C, the cut portion C and the first end E1 and the second end E2 separated from each other by the cut portion C may span across the ocular expansion portion 105, the inner annular edge 101 defining one end of the ocular expansion portion 105, and the outer annular edge 102 defining the other end of the ocular expansion portion 105. Thus, it can be understood that the cut portion C forms the first end E1 and the second end E2 that separate the ocular implant 100 from each other.

[0413] In one embodiment of the present invention, in the ocular expansion portion 105 between the inner annular edge 101 and the outer annular edge 102, the two sides along the short axis direction Z2 of the inner annular edge 101 have a relatively smaller curvature than the two sides along the long axis direction Z1 of the inner annular edge 101. The side with the wider curvature can be selectively chosen as the surgical center position S, and at the surgical center position S corresponding to the side with the relatively smaller curvature and wider width, structures such as an incision portion C, a first end portion E1 and a second end portion E2, a surgical hole 10, and snap-fit ​​or hook-shaped connections can be formed.

[0414] In a surgical procedure for an ocular implant 100 according to an embodiment of the present invention, the first end E1 of the ocular implant 100 is inserted through an incision EBC formed on the conjunctiva, so that it surrounds the outer edge of the eyeball and is then repositioned. The first end E1, which is led out through the incision C, and the second end E2, which is retained without being inserted through the incision C, are then joined together, thereby permanently implanting the ocular implant 100 surrounding the outer edge of the eyeball. At this time, when joining the first end E1 and the second end E2, a suture can be inserted to pass through surgical holes 10 formed on the first end E1 and the second end E2, and the surgical holes 10 of the first end E1 and the second end E2 are joined together by knotting the suture. In one embodiment of the present invention, at least one surgical hole 10 may be formed on the first end E1 and the second end E2, respectively. In various embodiments of the present invention, multiple surgical holes 10 may be formed on the first end E1 and the second end E2, respectively. In various embodiments of the present invention, a plurality of surgical holes 10 may be formed on the first end E1 and the second end E2 of the ocular expansion portion 105 forming the main body of the ocular implant 100, and the plurality of surgical holes 10 may be formed at a certain interval along the long axis direction Z1 on the first end E1 and the second end E2. For example, depending on the different ocular shapes and sizes formed by the implantee's physical conditions, the connection between the first end E1 and the second end E2 can be achieved by selecting the surgical hole 10 at the optimal position formed on the first end E1 and the second end E2. For example, the surgeon of the ocular implant 100 may, according to the individualized ocular shape and size of each implantee, connect the first end E1 and the second end E2 through the surgical hole 10 located most suitable for surrounding the outer edge of the ocular circumference of each implantee.

[0415] For example, in one embodiment of the present invention, the surgeon can select a surgical hole 10 located most suitable for surrounding the outer edge of the implantee's eyeball, insert a suture through the selected surgical hole 10, and thus combine the two together. When the distance between the two surgical holes 10 that combine the first end E1 and the second end E2 due to the passage of the suture is set too large, the eyeball expansion portion 105 between the two surgical holes 10 that combine the first end E1 and the second end E2 will be twisted and deformed, thereby adversely affecting the coplanarity of the entire eyeball expansion portion 105. This results in the entire eyeball implant 100, including the eyeball expansion portion 105, failing to fit tightly with the sclera, and may produce side effects such as gaps. Conversely, if the distance between the two surgical holes 10 that connect the first end E1 and the second end E2 due to the passage of sutures is set too short, excessive tensile stress will accumulate along the ocular implant 100 or the ocular expansion portion 105 forming its main body due to the suture tension between the two surgical holes 10 that connect the first end E1 and the second end E2. This may affect the durability of the ocular implant 100 or the ocular expansion portion 105 forming its main body. Or, due to the accumulated tensile stress, the ocular expansion portion 105 may deform and shrink its circumference, resulting in serious surgical errors such as the ocular expansion portion 105 obscuring the patient's eyeball. Or, due to the distortion and deformation of the ocular expansion portion 105, side effects such as the ocular expansion portion 105 or the ocular implant 100 containing it failing to fit tightly with the patient's sclera and creating gaps may occur.

[0416] In one embodiment of the invention, eye implants 100 of the same specifications can be formed using the same mold design. However, in order to optimize the shape and size of the eyeball for different body conditions of each implantee, the most suitable connection position around the outer edge of the implantee's eyeball can be selected from a plurality of surgical holes 10 formed on the first end E1 and the second end E2 of the eye implant 100 surrounding the outer edge of the implantee's eyeball. Sutures are then inserted through the surgical hole 10 at the selected connection position, thereby connecting the first end E1 and the second end E2 of the eye implant 100 surrounding the outer edge of the implantee's eyeball or the eyeball expansion portion 105 forming its main body to each other. For example, in one embodiment of the invention, the surgeon can remove excess eyeball expansion portion 105 between the two surgical holes 10 selected as the connection position from among the plurality of surgical holes 10 formed on the first end E1 and the second end E2 of the eye implant 100. For example, the remaining ocular expansion portion 105 between the two surgical holes 10 selected as the joining position may be twisted and deformed due to the tendency of the contraction length caused by the tensile stress generated by the sutures passing through the selected surgical holes 10. Therefore, the excess ocular expansion portion 105 between the two surgical holes 10 selected as the joining position in the first end E1 and the second end E2 can be removed. At this time, the surgeon can refer to the positions of the plurality of surgical holes 10 arranged at a certain interval on the first end E1 and the second end E2, and determine the excision position based on the positions of the plurality of surgical holes 10. In one embodiment of the present invention, the perimeter of the ocular implant 100 or the ocular expansion portion 105 forming the body of the ocular implant 100 is preferably set to an optimal size that can form an integrated appearance with the individualized ocular pupil of each implantee without obstructing the ocular pupil (or pupil) used to provide light inlet, thereby surrounding the outer edge of the implantee's ocular pupil. For example, the circumference of the ocular expansion 105, formed to a standardized or single size, can be adjusted as needed to create an optimal circumference suitable for the individualized outer edge of the ocular rim of each implantee. For instance, an optimal circumference can be adaptively formed around the outer edge of the implantee's ocular rim. Here, the surgeon can refer to the positions of the surgical holes 10 spaced at intervals on the first end E1 and the second end E2 of the ocular expansion 105 forming its body, to provide the optimal circumference according to the individual implantee's condition, and remove portions from at least one of the first end E1 and the second end E2.

[0417] For example, in one embodiment of the present invention, the surgeon can determine the optimal circumference of the ocular implant 100 or the ocular expansion portion 105 surrounding the outer edge of the patient's eyeball by detecting or measuring the EB of the eyeball, and can determine the cutting position based on the determined circumference of the ocular expansion portion 105, starting from at least one of the first end E1 and the second end E2. In this case, the cutting position can be determined based on the positions of a plurality of surgical holes 10 formed at a certain interval along the long axis direction Z1 on the first end E1 and the second end E2. For example, in one embodiment of the present invention, the plurality of surgical holes 10 formed on each of the first end E1 and the second end E2 can be arranged at a interval of 0.5 mm along the long axis direction Z1.

[0418] Thus, in one embodiment of the invention, the plurality of surgical holes 10 formed along the long axis direction Z1 or along the length direction of the first end E1 and the second end E2 can provide each implantee with an optimal fitting position around the individualized outer edge of their eyeball, and can provide a reference or benchmark for setting the cutting position to form a circumference optimally around the outer edge of the implantee's eyeball. For example, a reference or benchmark can be provided for the cutting position to form a circumference optimally around the outer edge of the implantee's eyeball.

[0419] In one embodiment of the invention, the surgical hole 10 can be used to form an incision portion EBC in the conjunctiva on the sclera, and a space retention mechanism (not shown) for ensuring an implantation space for the ocular implant 100 between the sclera and conjunctiva is inserted along the incision portion EBC. The implantation space ensured by the space retention mechanism allows the ocular implant 100 to be pulled into the implantation space by an implantation insertion mechanism, thereby causing the ocular implant 100 to surround the outer edge of the recipient's eyeball. At this time, the implantation insertion mechanism (not shown) can be inserted through the surgical hole 10 formed on the first end portion E1 of the ocular implant 100 along the implantation space ensured by the outer edge of the recipient's eyeball through the first end portion E1 of the ocular implant 100, and through a forced circumferential movement by the implantation insertion mechanism, the ocular implant 100 is inserted from the first end portion E1 into the implantation space ensured along the outer edge of the eyeball, thereby surrounding the outer edge of the eyeball. As described above, the surgical hole 10 formed on the first end E1 or the second end E2 provides a physical interference position with the implantation insertion mechanism (not shown) for pulling the entire ocular implant 100, i.e., provides a passage position for the implantation insertion mechanism (not shown) for pulling the ocular implant 100. For example, the implantation insertion mechanism inserted into the surgical hole 10 can be followed from the surgical hole 10 into which the implantation insertion mechanism is inserted or from the first end E1 where the surgical hole 10 is formed, and can be followed along the outer edge of the eyeball to surround the outer edge of the eyeball.

[0420] In one embodiment of the invention, the surgical hole 10 may include a first surgical hole 11 for providing a connection position between the first end E1 and the second end E2 and for a suture to pass through, and a second surgical hole 12 for physically interfering with or for the implantation insertion mechanism to pass through. In one embodiment of the invention, the first surgical hole 11 and the second surgical hole 12 may be formed with substantially the same shape and size, and depending on the surgeon's choice, a portion of the surgical holes 10 may be used as the first surgical hole 11 for the suture to pass through, while another portion of the surgical holes 10 may be used as the second surgical hole 12 for the implantation insertion mechanism (not shown) to pass through. Multiple surgical holes 10 formed with the same shape along the long axis direction Z1 or along the length direction of the first end E1 and the second end E2 provide relatively free positional selection, and the functions of the first surgical hole 11 and the second surgical hole 12 may be respectively performed according to the implanter's choice.

[0421] In various embodiments of the present invention, the surgical hole 10 may include a relatively small-diameter first surgical hole 11 formed to accommodate a relatively fine suture, and a relatively large-diameter second surgical hole 12 formed to accommodate a relatively large implantation insertion mechanism (not shown) for pulling the entire ocular implant 100. In one embodiment of the present invention, the first surgical hole 11 and the second surgical hole 12 may be formed at different locations depending on the first end E1 and the second end E2. The first surgical hole 11 for suture passage may be formed along the long axis direction Z1 at a position near the ends of the first end E1 and the second end E2 to prevent excessive ocular implant 100 or ocular expansion portion 105 from being clamped between the two first surgical holes 11 that provide the mutual engagement position of the first end E1 and the second end E2. The second surgical hole 12 may be formed along the long axis direction Z1 at a position relatively far from the ends of the first end E1 and the second end E2 to prevent damage to the first end E1 and the second end E2 when the ocular implant 100 is pulled by the implantation insertion mechanism (not shown) inserted into the second surgical hole 12.

[0422] In one embodiment of the present invention, the ocular implant 100 may be formed in a symmetrical shape with reference to the center O of the opening OP. For example, in one embodiment of the present invention, the ocular implant 100 or the ocular expansion portion 105 forming the main body of the ocular implant 100 may be formed in a symmetrical shape along the major axis direction Z1 and the minor axis direction Z2 passing through the center O of the opening OP. In one embodiment of the present invention, the ocular implant 100 or the ocular expansion portion 105 forming the main body of the ocular implant 100 may form an incision C along the minor axis direction Z2, and a plurality of surgical holes 10 may be formed on the first end E1 and the second end E2 separated by the incision C. Here, the plurality of surgical holes 10 may be arranged along the major axis direction Z1 and symmetrically formed along the minor axis direction Z2. For example, the plurality of surgical holes 10 formed on the first end E1 and the second end E2 separated by the incision C along the minor axis direction Z2 following the incision C may be symmetrically arranged. For example, the surgeon can perform surgery through multiple surgical holes 10 symmetrically arranged on the first end E1 and the second end E2 with the incision C as a reference, without having to distinguish between the first end E1 and the second end E2, thereby improving surgical convenience. In one embodiment of the present invention, first surgical holes 11 and second surgical holes 12 of different sizes can be symmetrically formed on the first end E1 and the second end E2, and since the second surgical holes 12 for inserting the implantation mechanism are symmetrically arranged on the first end E1 and the second end E2, the surgeon can perform the implantation operation of the ocular implant 100 by inserting the implantation mechanism into any of the second surgical holes 12 in the first end E1 and the second end E2.

[0423] In one embodiment of the present invention, the incision C can be formed along the minor axis direction Z2 of the opening OP, and can be located on either side of the minor axis direction Z2. Multiple surgical holes 10 can be formed on the first end E1 and the second end E2 divided by the incision C located on one side of the minor axis direction Z2. The location of the first end E1 and the second end E2 where the surgical holes 10 are formed, or the location of the incision C dividing the first end E1 and the second end E2, can correspond to one side of the minor axis direction Z2 of the opening OP, and can correspond to a portion of the ocular implant 100 extending parallel to the major axis direction Z1, or to a portion of the ocular expansion portion 105 constituting the main body of the ocular implant 100.

[0424] In one embodiment of the invention, the opening OP formed at the central position of the ocular implant 100, or the inner annular edge 101 defining the opening OP, can be formed as an ellipse with different major axis lengths L1 and minor axis lengths L2. The outer annular edge 102 formed on the opposite side of the inner annular edge 101 can be formed as a circle to provide an aesthetically pleasing appearance. Thus, in one embodiment of the invention, the ocular expansion portion 105 formed between the inner annular edge 101 and the outer annular edge 102 can be formed as a structure in which an elliptical inner annular edge 101 is provided inside the circular outer annular edge 102. The ocular expansion portion 105 defined by the outer annular edge 102 and the inner annular edge 101 of different shapes can form different widths at different angular positions with the central opening OP as the center of rotation. For example, in one embodiment of the invention, the ocular expansion portion 105 may be formed at the 0° angle position A1 where the incision portion C is formed, with the widest width, while at other 90° angle positions A3, 180° angle positions A2, and 270° angle positions A4, it may be formed with a structure of approximately equal width. In one embodiment of the invention, the incision portion C, or the first end portion E1 and the second end portion E2 divided by the incision portion C, may correspond to the surgical center position S of the ocular implant 100. For example, sutures may pass through a plurality of surgical holes 10 (e.g., a first surgical hole 11) formed on the first end portion E1 and the second end portion E2, thereby connecting the first end portion E1 and the second end portion E2 together, and an implantation insertion mechanism may pass through the surgical holes 10 (e.g., a second surgical hole 12) formed on the first end portion E1 and the second end portion E2, thereby implanting the ocular implant 100 along the outer edge of the recipient's eyeball.

[0425] In one embodiment of the invention, in the ocular expansion portion 105 defined by the elliptical inner annular edge 101 and the circular outer annular edge 102, the ocular implant 100 or the ocular expansion portion 105 forming the main body of the ellipse may be formed at a position along the inner annular edge 101 or on one side of the ellipse surrounding the inner annular edge 101 in the minor axis direction Z2. In other words, at one side of the 0° angle position A1 and the 180° angle position A2 formed on both sides with the center O of the opening OP as the rotation center, for example, the widest width is formed at the 0° angle position A1, so that by forming the ocular implant 100 or the ocular expansion portion 105 forming the main body of the ellipse at this position, the portion corresponding to the surgical center position S (e.g., 0° angle position A1) has a relatively wide width, thereby improving the convenience of the surgery. Therefore, in one embodiment of the present invention, in order to form the widest ocular expansion portion 105 at the position corresponding to the surgical center position S (e.g., 0° angle position A1), the elliptical inner annular edge 101 can be disposed inside the circular outer annular edge 102. However, instead of displacing the elliptical inner annular edge 101 at the exact center of the circular outer annular edge 102, it is disposed at a position offset to one side of the two positions along the minor axis direction Z2, so that a relatively wider width is obtained at that side position. In other words, in one embodiment of the present invention, the elliptical inner annular edge 101 for defining the opening OP can be disposed at a position offset from the exact center of the circular outer annular edge 102, so that the width at one side of the two positions along the minor axis direction Z2 is increased.

[0426] In one embodiment of the present invention, the position corresponding to the surgical center position S can be one of the two positions along the minor axis direction Z2, and can correspond to the one with a relatively wider width among the two positions along the minor axis direction Z2. At the position corresponding to the surgical center position S, an incision portion C and a surgical hole 10 can be formed. The snap-fit ​​and hook-shaped coupling structures described later can also be formed along the minor axis direction Z2 at one side of the eyeball expansion portion 105.

[0427] Therefore, in one embodiment of the present invention, one of the two positions along the minor axis Z2 can be formed with a relatively wide width and extend approximately along the major axis Z1, thereby forming a portion with relatively small curvature. Conversely, the two positions along the major axis Z1 can be formed with a relatively narrow width and extend approximately along the minor axis Z2, thereby forming a portion with relatively large curvature. As described above, by setting one of the two positions along the minor axis Z2 that forms the portion with relatively small curvature as the surgical center position S, the convenience of surgery can be improved by the incision C and the surgical holes 10 formed on the first end E1 and the second end E2 through the incision at this location with a relatively wide width and small curvature. Therefore, the incision C, the surgical hole 10, and the snap-fit ​​or hook-shaped connection structure described later can be formed on one side of the two positions along the minor axis Z2 corresponding to the surgical center position S.

[0428] In one embodiment of the invention, the first end E1 and the second end E2 can be joined together by inserting a suture through a surgical hole 10 formed on the first end E1 and the second end E2. However, in various embodiments of the invention, one end of the first end E1 and the second end E2 can be inserted into the other end, thereby forming a snap-fit ​​between them, preventing disengagement between the first end E1 and the second end E2, to form a snap-fit ​​or hook-fit structure.

[0429] More specifically, first slits and second slits 154a, 154b, 155a, and 155b may be formed on the first end E1 and the second end E2, respectively, for inserting the second end E2 or the first end E1 as a coupling object. By forming the first slits and second slits 154a, 154b, 155a, and 155b in a complementary manner on the first end E1 and the second end E2, the first end E1 and the second end E2 can be fitted together, and after fitting together, the complementary first slits and second slits 154a, 154b, 155a, and 155b prevent separation, thereby enabling the first end E1 and the second end E2 to be coupled together through the first slits and second slits 154a, 154b, 155a, and 155b.

[0430] In various embodiments of the present invention, the first slit and the second slit 154a, 154b, 155a, 155b formed on the first end E1 and the second end E2 respectively may each include a first portion 1541, 1551 extending along the long axis direction Z1, and a second portion 1542, 1552 extending from the first portion 1541, 1551 along the short axis direction Z2 to the outside of the ocular implant 100 or its ocular expansion portion 105. The long axis direction Z1 is either the direction in which the first end E1 and the second end E2 are opposite each other with the cut portion C spaced apart, or the direction intersecting the short axis direction Z2 extending from the cut portion C. The second portions 1542, 1552 may be formed in complementary shapes. For example, the second portions 1542 and 1552 of the first and second slits 154a, 154b, 155a, and 155b respectively formed on the first end E1 and the second end E2 can extend in opposite directions from the first portions 1541 and 1551 extending along the long axis direction Z1, that is, towards the inner annular edge 101 and the outer annular edge 102 formed on opposite sides of the first portions 1541 and 1551, and open to the outside of the eyeball expansion portion 105. In the first and second slits 154a, 154b, 155a, and 155b of the first end E1 and the second end E2 after fitting, the complementary second portions 1542 and 1552 can be used as snap-fit ​​or hook components to prevent them from disengaging from each other. In various embodiments of the present invention, the first slit and the second slit 154a, 154b, 155a, 155b may extend from the first portion 1541, 1551 extending along the long axis direction Z1 and perpendicularly to it along the short axis direction Z2 to the outside of the eyeball expansion portion 105 and open outward, or extend from the first portion 1541, 1551 extending along the long axis direction Z1 in an oblique direction that simultaneously follows the long axis direction Z1 and the short axis direction Z2 to the outside of the eyeball expansion portion 105 and open outward.

[0431] In one embodiment of the present invention, at least one of the first slits and second slits 154a, 154b, 155a, 155b formed on the first end E1 and the second end E2 may be arranged in multiple ways along the long axis direction Z1 or along the length direction of the first end E1 and the second end E2. In one embodiment of the present invention, the length direction of the first end E1 and the second end E2 arranged with multiple first slits and second slits 154a, 154b, 155a, 155b or multiple surgical holes 10 may be the long axis direction Z1, which is perpendicular to the short axis direction Z2 extending from the incision C separating the first end E1 and the second end E2. For example, in the aforementioned first slit and second slits 154a, 154b, 155a, 155b, at least one of the plurality of arrangements can achieve mutual combination of the first end E1 and the second end E2 by adjusting the combination position between the first slit and the second slit 154a, 154b, 155a, 155b. The first end E1 and the second end E2 are mutually combined by the first slit and the second slit 154a, 154b, 155a, 155b selected from the positions of the plurality of first slits and second slits 154a, 154b, 155a, 155b arranged along the length direction of the first end E1 and the second end E2, so as to form an ocular implant 100 or its ocular expansion portion 105 with an optimal circumference suitable for the periphery of the implantee's eyeball.

[0432] In various embodiments of the present invention, the cut portion C may be formed along the minor axis direction Z2 of the inner annular edge 101, and the first end portion E1 and the second end portion E2 may be arranged adjacent to each other along the major axis direction Z1 of the inner annular edge 101. Any one of the first slit and the second slits 154a, 154b, 155a, 155b may include an arrangement of a plurality of first slits 154a, 155a or an arrangement of second slits 154b, 155b formed on the first end portion E1 or the second end portion E2 along the major axis direction Z1, while the other may be formed as a single second slit 154b, 155b or a single first slit 154a, 155a.

[0433] In one embodiment of the present invention, to form a snap-fit ​​or hook-like engagement that connects the first end E1 and the second end E2, an assembly slit 156a may be formed on either the first end E1 or the second end E2, and an assembly hole 156b that engages with the assembly slit 156a may be formed on the other end. For example, in one embodiment of the present invention, an assembly slit 156a may be formed on the first end E1, and an assembly hole 156b that engages with the assembly slit 156a may be formed on 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 inserted, is not open to the outside of the second end E2, but is formed in a closed form that is isolated from the outside of the second end E2. Considering the assemblability when the assembly slit 156a on the first end E1 side is inserted, an assembly guide portion 158 may be formed at the end of the first end E1. The assembly guide 158 may include a rear end 158c having a relatively large width along the assembly direction or the major axis direction Z1, and a front end protrusion 158a having a relatively small width. Furthermore, the assembly guide 158 may include a variable width portion 158b that converges obliquely toward the front end protrusion 158a along both the major axis direction Z1 and the minor axis direction Z2, so as to connect the different widths between the relatively narrow front end protrusion 158a and the relatively wide rear end 158c. In one embodiment of the invention, the rear end 158c forming the boundary of the assembly guide 158 refers to the boundary of the assembly guide 158 having a wider width corresponding to the full width W0 of the eyeball expansion portion 105. At this time, the full width W0 of the eyeball expansion portion 105 refers to the width of the complete eyeball expansion portion 105 without forming slits introduced from the inner annular edge 101 and / or the outer annular edge 102, such as the assembly slit 156a. For example, it refers to the width of the eyeball expansion portion 105 having a larger width than the narrower bottleneck W1 defined by the assembly slit 156a.

[0434] In one embodiment of the invention, along the assembly direction or long axis direction Z1 of the first end E1 and the second end E2, an assembly guide 158 may be formed on the front side of the first end E1, and an assembly slit 156a may be formed on the rear side of the first end E1. In one embodiment of the invention, a first end E1 with a relatively large width may be provided between the front assembly guide 158 and the rear assembly slit 156a. For example, the relatively large width of the first end E1 provided between the assembly guide 158 and the assembly slit 156a refers to the full width W0 of the eyeball expansion portion 105, which has a relatively large and complete width and does not have an assembly slit 156a introduced from the inner annular edge 101 and / or the outer annular edge 102.

[0435] For example, in one embodiment of the invention, the assembly slit 156a may be formed by being introduced along the minor axis direction Z2 from the inner annular edge 101 and the outer annular edge 102 into the interior of the ocular expansion portion 105 therebetween. As described above, the width of the minimum width bottleneck W1 formed when introduced from the inner annular edge 101 and the outer annular edge 102 on both sides defining the ocular expansion portion 105 may be less than or equal to the width W2 of the assembly hole 156b on the second end E2 side. In one embodiment of the invention, the assembly slits 156a on the first end E1 side may be arranged in multiple ways along the major axis direction Z1 or along the length direction of the first end E1. For example, in one embodiment of the invention, by arranging the assembly slits 156a formed along the major axis direction Z1 or along the length direction of the first end E1, the connection position between the first end E1 and the second end E2 can be adjusted, thereby forming an optimal circumference suitable for surrounding the implantee's eyeball.

[0436] In one embodiment of the present invention, the assembly guide 158 on the first end E1 side can be used to align the connection 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 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 protrusion 158a formed on the first end E1 side of the assembly guide 158 can be smaller than the width W2 of the assembly hole 156b on the second end E2 side. When the front end protrusion 158a on the first end E1 side is inserted into the assembly hole 156b on the second end E2 side, the connection positions of the first end E1 and the second end E2 can be aligned with each other. When the surgeon operating the ocular implant 100 pulls the front end protrusion 158a of the first end E1 side, which is embedded in the assembly hole 156b on the second end E2 side, toward the second end E2, the assembly hole 156b on the second end E2 side, which is connected to the variable width portion 158b of the first end E1 side assembly guide portion 158 and has a relatively large width (the full width W0 of the first end E1), can be guided toward the second end E2 side. When the bottleneck W1 of the assembly slit 156a, which is connected to the larger width of the first end E1 (the full width W0 of the first end E1), is embedded in the assembly hole 156b on the second end E2 side, the first and second ends E1 and E2 can be prevented from moving away from each other (i.e., disengaging). For example, before and after the bottleneck W1 of the first end E1 side assembly slit 156a is embedded in the assembly hole 156b on the second end E2 side, the relatively large width of the first end E1 (the full width W0 of the first end E1) can be used as a snap or hook component to prevent disengagement between the first and second ends E1 and E2.

[0437] In one embodiment of the invention, the assembly guide 158 may be disposed along the assembly direction or the long axis direction Z1. It guides the relatively thicker first end E1 (the full width W0 of the first end E1) through the relatively narrow assembly hole 156b, thereby forming a snap-fit ​​or hook-fit between the bottleneck W1 of the rear assembly slit 156a and the assembly hole 156b. The assembly guide 158 is a structure for guiding the aforementioned fit. After the first end E1 and the second end E2 are connected to each other via the snap-fit ​​or hook-fit, i.e., after the bottleneck W1 of the assembly slit 156a of the first end E1 is inserted into the assembly hole 156b of the second end E2, the assembly guide 158, which has lost its function, can be removed. For example, by removing the assembly guide 158, which adds extra thickness by overlapping the second end E2, adverse effects on the surrounding ocular EB tissue can be eliminated, and deformation of the ocular implant 100 caused by its forced application can be prevented.

[0438] In one embodiment of the invention, a cutting line CL may be formed at the rear boundary corresponding to the rear end 158c of the assembly guide 158 along the assembly direction or the long axis direction Z1. After the first end E1 and the second end E2 are connected to each other by a snap-fit ​​or hook-fit, the assembly guide 158 can be separated and removed along the cutting line CL. In one embodiment of the invention, the cutting line CL may be formed between the front assembly guide 158 and the rear assembly slit 156a. More specifically, it may be formed at the boundary between the front assembly guide 158 and the first end E1 (the full width W0 of the first end E1) located between the front assembly guide 158 and the rear assembly slit 156a and having a relatively large width, i.e., at the rear boundary of the rear end 158c of the assembly guide 158. In one embodiment of the invention, the cutting line CL may include a plurality of perforations formed thereal, or a marking line indicating the cutting position in a non-perforated form. In one embodiment of the invention, the cutting line CL may be parallel to the cut portion C along the short axis direction Z2.

[0439] In various embodiments of the present invention, the first end portion E1 and the second end portion E2, which are separated from each other by the incision portion C, can be joined together by passing a suture through the surgical hole 10 formed on the first end portion E1 and the second end portion E2. Furthermore, the first end portion E1 and the second end portion E2 are joined together by fitting together along the slits formed on the first end portion E1 and the second end portion E2. Additionally, the first end portion E1 and the second end portion E2 are joined together by inserting the assembly slit 156a on the first end portion E1 and the assembly hole 156b on the second end portion E2. As described above, in various embodiments of the present invention, regarding the joining of the first end portion E1 and the second end portion E2, the first end portion E1 and the second end portion E2, as the objects of connection, can be joined together opposite each other along the assembly direction or the long axis direction Z1 in a non-overlapping state, or they can be joined together in an overlapping state. As shown in Figures 10A to 11B, when the first slit and the second slit 154a, 154b, 155a, 155b are formed on the first end E1 and the second end E2 and interlocked, or when the assembly slit 156a and the assembly hole 156b are formed and interlocked, an additional thickness is generated when the first end E1 and the second end E2 overlap. This additional thickness is locally formed in the circumferential direction of the ocular implant 100 or the ocular expansion portion 105 forming its body, which may force stress or deformation. Therefore, based on the above considerations, in order to allow the first end E1 and the second end E2 to fit together and achieve interconnection, the first end E1 and the second end E2 can be made relatively thin in the following locations: between the first and second slits 154a, 154b, 155a, 155b and the incision C; or between the bottleneck W1 of the assembly slit 156a and the assembly hole 156b and the incision C, and as positions where the first end E1 and the second end E2 overlap; in the portion of the full width W0 of the eyeball expansion portion 105 formed in front of the bottleneck W1 of the assembly slit 156a embedded into the assembly hole 156b, and having a snap-fit ​​or hook function; and in other locations other than the portion of the second end E2 formed in front of the assembly hole 156b to maintain the closed shape of the assembly hole 156b. This allows the implanted eyeball implant 100 or the eyeball implant 100 after the connection between the first end E1 and the second end E2 to form a uniform thickness on the periphery of the recipient's eyeball. For example, a relatively thin section may be formed around the first slit and the second slit 154a, 154b, 155a, 155b on the first end E1 and the second end E2 sides to prevent additional thickness from being generated due to the overlap of the first end E1 and the second end E2.When the thin portions of the first end E1 and the second end E2 overlap each other, the normal thickness of the ocular implant 100 can be formed.

[0440] In one embodiment of the invention, a snap-fit ​​or hook-shaped connection that binds the first end E1 and the second end E2, which are separated by the incision C, together can be formed on the side with a relatively larger width, located on both sides along the short axis direction Z2. This connection is positioned on the side extending substantially along the long axis direction Z1, which has a relatively smaller curvature, making it relatively easy to connect the first end E1 and the second end E2 during surgery for the ocular implant 100. Such a side position can constitute the surgical center position S during implant surgery.

[0441] In this specification, the surgical center position S of the implant is described as follows: in one of the two positions of the ocular expansion portion 105 formed along the minor axis direction Z2, the elliptical contour of the inner annular edge 101 is offset to the other side within the circular contour of the outer annular edge 102, thereby forming a relatively large width on one side. However, in the embodiment shown in the accompanying drawings, the surgical center position S may optionally be formed within the circular contour of the outer annular edge 102, in one of the two positions along the minor axis direction Z2 where the elliptical contour of the inner annular edge 101 is not offset, but is formed in a symmetrical position with substantially the same width: a 0° angle position A1 and a 180° angle position A2. In one embodiment of the invention, the one side position forming the surgical center position S may be selected from the two positions along the minor axis direction Z2, thereby extending approximately along the major axis direction Z1 and forming a relatively small curvature.

[0442] In this specification, the arrangement of multiple surgical holes 10 formed on the first end E1 and the second end E2, which are separated from each other by the incision C, or the arrangement of multiple first slits and second slits 154a, 154b, 155a, 155b formed along the first end E1 and the second end E2 to form a snap-fit ​​or hook-like connection, or the arrangement of assembly slit 156a formed along the first end E1 and the second end E2, etc., can all be arranged along the length direction of the first end E1 and the second end E2. For example, they can be arranged along the circumference of the eyeball expansion portion 105, that is, along the length direction of the first end E1 and the second end E2 that form part of its periphery. Therefore, in this specification, the arrangement along the long axis direction Z1 can be understood as an arrangement along the circumference of the eyeball expansion portion 105.

[0443] exist Figure 12 It shows Figure 4A modified embodiment of the ocular implant shown is illustrated. Referring to this figure, the outer annular edge 102 can be formed with a circular outline, and an inner annular edge 101 with a circular outline can be formed inside the circular outline of the outer annular edge 102. For example, in one embodiment of the invention, the inner annular edge 101 and the outer annular edge 102 can have the same circular outline to surround the opening OP, for example, they can surround the opening OP in a concentric circle shape with the center O of the opening OP as the center. In one embodiment of the invention, the inner annular edge 101 can be formed as a circle, wherein the length of the major axis L1 extending in the opposite direction of the implantee's pair of eyes and the length of the minor axis L2 perpendicularly intersecting the length of the major axis L1 are equal. Since the length of the major axis L1 and the length of the minor axis L2 are equal to form a circular outline, it is not necessary to align it with the implantee's eyeball, thereby improving surgical convenience. Furthermore, the outer annular edge 102 and the inner annular edge 101 form a concentric circle structure with the center O of the opening OP as the center, thereby improving the ease of manufacturing the ocular implant 100.

[0444] Figure 13 Show Figure 6 A modified embodiment of the ocular implant shown. (Refer to...) Figure 13The adaptive telescopic portions 1511 and 1512 can provide length extension along the periphery of the inner annular edge 101 and the outer annular edge 102 to accommodate changes in the shape and size of each implantee's eyeball. For example, the adaptive telescopic portion 1511 of the inner annular edge 101 may include a plurality of slits 1511s spaced apart from each other along the periphery of the inner annular edge 101, while the adaptive telescopic portion 1512 of the outer annular edge 102 may include a plurality of slits 1512s spaced apart from each other along the periphery of the outer annular edge 102. In one embodiment of the invention, the width d1 of the slits 1511s forming the adaptive telescopic portion 1511 of the inner annular edge 101 may be formed along a depth direction extending from the inner annular edge 101 to the outer annular edge 102. The width d2 of the slits 1512s forming the adaptive telescopic portion 1512 of the outer annular edge 102 may be formed along a depth direction extending from the outer annular edge 102 to the inner annular edge 101. In one embodiment of the present invention, the width d2 of the slit 1152s of the adaptive telescopic portion 1152 forming the outer annular edge 102 may be smaller than the width d1 of the slit 1151s of the adaptive telescopic portion 1151 forming the inner annular edge 101. For example, in one embodiment of the present invention, in order to make the length extension range provided by the adaptive telescopic portion 1152 of the outer annular edge 102 smaller than the length extension range provided by the adaptive telescopic portion 1151 of the inner annular edge 101, the dimensions of the widths d1 and d2 of the slits 1151s and 1152s forming the adaptive telescopic portions 1151 and 1152 may be adjusted. In one embodiment of the present invention, in order to enable the adaptive telescopic portions 1511 and 1512 to adaptably deform according to the shape and size of each implantee's eyeball, the length extension range of the inner annular edge 101 around the relatively close position of the eyeball can be set to be greater than the length extension range of the outer annular edge 102 around the relatively far position of the eyeball. This is achieved by adjusting the widths d1 and d2 of the slits 1151s and 1152s that form each adaptive telescopic portion 1151 and 1152. In various embodiments of the present invention, the adaptive telescopic portions 1511 and 1512 can be formed along either the inner annular edge 101 or the outer annular edge 102, or formed on both sides along the peripheries of both the inner annular edge 101 and the outer annular edge 102.

[0445] exist Figure 14 A schematic diagram of an embodiment of the present invention is shown to illustrate a composite structure of a first end E1 and a second end E2, separated from each other by a cut portion C, formed by different mechanisms. As shown, in an ocular implant 100 according to an embodiment of the present invention, a surgical hole 10 can be compositely formed with a snap-fit ​​or hook-shaped connection. (Refer to...) Figure 14In an ocular implant 100 according to one embodiment of the present invention, in addition to the surgical hole 10, a first slit and a second slit 154a and 154b are formed on the first end E1 and the second end E2 sides, respectively, to serve as a snap-fit ​​connection or a hook-shaped connection. (See reference...) Figure 14 As shown in Figure 11A, in another embodiment of the ocular implant 100 of the present invention, in addition to the surgical hole 10, a first slit and a second slit 154a and 154b are formed on the first end E1 and the second end E2 sides, respectively, to serve as a snap-fit ​​connection or a hook-shaped connection.

[0446] As described above, in one embodiment of the present invention, in addition to connecting the first end E1 and the second end E2 through the surgical hole 10 by inserting sutures and using suture knots, snap-fit ​​or hook-fitting mechanisms can also be combined as another mechanism for connecting the first end E1 and the second end E2. For example, by combining different mechanisms for connecting the first end E1 and the second end E2, the connection strength between the first end E1 and the second end E2 can be improved. Furthermore, if the surgeon believes that sufficient bonding strength can be formed between the first end E1 and the second end E2 using only snap-fit ​​or hook-fitting mechanisms, suturing can be performed without using the surgical hole 10. Conversely, the first end E1 and the second end E2 are initially fixed by snap-fit ​​or hook-fitting mechanisms, and the connection strength between the first end E1 and the second end E2 can be reinforced by suturing through the surgical hole 10 to make them firmly bonded. For example, in one embodiment of the present invention, the surgical hole 10 formed by snap-fit ​​or hook-shaped combination may include a first surgical hole 11 for inserting a suture and a second surgical hole 12 for physical interference with the implantation insertion mechanism or for the insertion mechanism to pass through.

[0447] In this specification, as a connecting mechanism for joining the first end E1 and the second end E2 separated by the incision C, in addition to suturing through the surgical hole 10, snap fastening, or hook fastening, the first end E1 and the second end E2 can be overlapped and a biological adhesive can be applied between them. Alternatively, the first end E1 and the second end E2 can be overlapped and fused to the other end by heating one end to melt it. In the fusion bonding of the first end E1 and the second end E2, high heat input can make the first end E1 and the second end E2 adhesive, and pressure can be applied to the first end E1 and the second end E2 in opposite directions to join them together.

[0448] According to an embodiment of the present invention, an ocular implant 100 may form an ocular expansion portion 105 between an inner annular edge 101 and an outer annular edge 102, such that, in the direction of the minor axis of the inner annular edge 101, the width of one side is greater than the width of the other side. Thus, within the circular contour of the outer annular edge 102, the elliptical or circular contour of the inner annular edge 101 may be formed at a position biased to the other side. Accordingly, the side of the ocular expansion portion 105 with a relatively larger width in the direction of the minor axis of the elliptical or circular contour of the inner annular edge 101 may serve as the surgical center position O.

[0449] However, in one embodiment of the present invention, the elliptical or circular outline of the inner annular edge 101 can be formed inside the circular outline of the outer annular edge 102, and is formed with equal width on both sides along the minor axis without bias to either side. As described above, when performing surgery on the eye implant 100, the surgeon may encounter operational difficulties in finding the surgical center position O with a larger width along the minor axis. Simultaneously, if the eye implant 100 is formed with a shape biased to one side during its shaping process, the relatively narrower portion on the other side may cause operational difficulties due to insufficient rigidity. Therefore, in one embodiment of the present invention, no bias is generated along the minor axis, resulting in equal width on both sides. In other words, in one embodiment of the present invention, the eye implant 100 can be formed as a symmetrical structure in which the inner annular edge 101 is evenly distributed on both sides along the minor axis inside the circular outline of the outer annular edge 102. Furthermore, in various embodiments of the present invention, the inner annular edge 101 may be formed as an elliptical or circular outline, wherein the major axis or minor axis of the inner annular edge 101 may be defined in a structure in which the length of the major axis L1 and the length of the minor axis L2 are not equal (e.g., an elliptical structure), while in a circular structure in which the length of the major axis L1 and the length of the minor axis L2 are equal, the major axis may be understood as the direction extending along the relative direction of the implanter's pair of eyes, and the minor axis is the direction intersecting the major axis.

[0450] exist Figure 15 Show Figure 9The figure shows a modified embodiment of the ocular implant 100. As shown, according to one embodiment of the present invention, the number of surgical holes 10 formed on the sides of the first end E1 and the second end E2, which are separated from each other by the incision C, can be asymmetrical. This allows the surgeon performing the ocular implant 100 surgery to confirm the orientation of the ocular implant 100. For example, in one embodiment of the present invention, during the ocular implant 100 surgery, the ocular implant 100 can be pulled along the outer edge of the eyeball through a second surgical hole 12 arranged on an implantation insertion mechanism for inserting the ocular implant 100, so that it surrounds the outer edge of the patient's eyeball. The direction of pulling along the outer edge of the eyeball by the implantation insertion mechanism can be preset according to the shape design of the implantation insertion mechanism. Therefore, after the patient identifies the orientation of the ocular implant 100 of the present invention and aligns it correctly, the implantation insertion mechanism needs to be inserted into the second surgical hole 12 and operated to make the ocular implant 100 surround the outer edge of the patient's eyeball. In one embodiment of the present invention, since the ocular implant 100 can be formed of a flexible material such as silicone that is harmless to the EB tissue of the eyeball and can flexibly adapt and deform on the EB tissue, the anterior curved surface 120 and the posterior inclined surface 110 of the ocular implant 100 may be flipped over each other. Even if the anterior curved surface 120 and the posterior inclined surface 110 of the ocular implant 100 are flipped over each other, for example, when the ocular implant 100 is flipped so that the anterior curved surface 120, instead of the posterior inclined surface 110, faces the EB tissue and the posterior inclined surface 110 faces the outside opposite to the EB tissue, the surgeon may have difficulty in timely detecting such an orientation error of the ocular implant 100. According to one embodiment of the present invention, the surgical holes 10 formed on the first end E1 and the second end E2 of the ocular implant 100, which are separated from each other on both sides of the incision portion C, can be formed in an asymmetrical structure. For example, the number of surgical holes 10 formed on the first end E1 and the second end E2 may be different, or the number of surgical holes 10 on one end may be even, while the number of surgical holes 10 on the other end may be odd. As described above, when the surgeon confirms the end of the implantation mechanism to be inserted according to its shape design, if the normal number of surgical holes 10 or the normal odd or even number of surgical holes 10 is not found, it can be identified that the ocular implant 100 has been flipped, with the posterior slope 110, which should face the eyeball EB, and the anterior curved surface 120, which should face the external surface OS opposite to the eyeball EB, being in an inverted state. Accordingly, the incorrect orientation of the ocular implant 100 can be corrected, so that, according to the original design intent, the anterior curved surface 120 of the ocular implant 100 faces the external surface OS and the posterior slope 110 faces the eyeball EB, thereby correcting the correct orientation of the ocular implant 100.For example, in various embodiments of the present invention, the orientation of the ocular implant 100 can be determined by varying the number of surgical holes 10 formed on the first end E1 and the second end E2 separated by the incision C, or by an asymmetrical design in which the number of surgical holes 10 formed on the first end E1 and the second end E2 is odd or even.

[0451] The present invention has been described in conjunction with the embodiments shown in the accompanying drawings, but these are merely illustrative and not restrictive descriptions. Those skilled in the art will understand that various modifications or equivalent embodiments can be made without departing from the spirit and scope of the invention and the claims.

[0452] Industrial applicability

[0453] This invention can be applied to the medical industry related to the manufacture of ocular implants for implantation surgery and the production of surgical facilities.

Claims

1. An ocular implant permanently implanted in the eye of a recipient to provide the recipient with an enlarged appearance of the eyeball, comprising: A central opening for receiving incident light toward the eyeball, which provides the eyeball opening; The inner annular edge surrounds and defines the opening; An outer annular edge, which, on the opposite side of the inner annular edge defining the opening, surrounds the opening together with the inner annular edge; as well as An eyeball expansion portion is formed between the inner annular edge and the outer annular edge, and has a variable thickness that gradually changes from the inner annular edge to the outer annular edge.

2. The ocular implant according to claim 1, wherein, The eyeball dilation portion includes: The posterior sloping surface faces the eyeball and is configured to conform to the surface of the eyeball; and The anterior curved surface is oriented outwards in the opposite direction to the eyeball.

3. The ocular implant according to claim 2, wherein, The inner and outer annular edges form the front of the eyeball, and when viewed from the front of the eyeball, which is equipped with a lens and forms the entrance aperture, in a frontal direction towards the back of the eyeball, it appears circular or elliptical. The rear slope is formed as a slope inclined at a certain angle on a vertical plane perpendicular to the front direction, such that the inner annular edge and the outer annular edge form the front position and the rear position, respectively.

4. The ocular implant according to claim 2, wherein, The rear slope provides a support surface, which is supported on the slope of the ocular implant packaging container.

5. The ocular implant according to claim 2, wherein, The front surface is formed along a spline curve, and the curvature or radius of curvature of the spline curve varies along the inclination direction of the rear slope.

6. The ocular implant according to claim 2, wherein, The eyeball expansion portion has a variable thickness that varies between the rear slope and the front curved surface.

7. The ocular implant according to claim 6, wherein, The thickness of the iris expansion portion is measured from the rear slope to the front curved surface in a direction perpendicular to the rear slope.

8. The ocular implant according to claim 2, wherein, The inner annular edge is formed by the contact between the front curved surface and the rear inclined surface that form the thickness of the eyeball expansion portion at the position where they meet the opening.

9. The ocular implant according to claim 2, wherein, The outer annular edge is formed by the contact between the anterior curved surface and the posterior inclined surface that form the thickness of the eyeball expansion on opposite sides of the inner annular edge that defines the opening.

10. The ocular implant according to claim 2, wherein, The anterior curved surface and the posterior inclined surface that form the thickness of the eyeball expansion portion respectively form an inner annular edge and an outer annular edge with rounded corners, and they are in contact with each other.

11. The ocular implant according to claim 10, wherein, The inner annular edge is formed with a relatively gentle rounded corner shape, while the outer annular edge is formed with a relatively sharp rounded corner shape.

12. The ocular implant according to claim 11, wherein, The edge thickness of the inner annular edge is less than the edge thickness of the outer annular edge.

13. The ocular implant according to claim 11, wherein, The inner annular edge, within the membrane tissue surrounding the entire eyeball to maintain its shape, extends into the discontinuous edge between the anteriorly convex, high-curvature portion of the cornea and the posteriorly extending, low-curvature portion of the sclera, and closes one side of the eye implant with a relatively gentle, rounded shape. The outer annular edge, which fits onto the sclera of the high curvature portion, closes the other side of the ocular implant with a relatively sharp rounded corner shape to prevent the sclera from lifting or forming a gap between it and the sclera.

14. The ocular implant according to claim 1, wherein, The eyeball dilation portion includes: The portion with the maximum thickness has the maximum thickness between the inner annular edge and the outer annular edge; The inner portion, which is relatively close to the opening and is formed between the inner annular edge and the maximum thickness portion; and The outer portion is relatively far from the opening and is formed between the maximum thickness portion and the outer annular edge.

15. The ocular implant according to claim 14, wherein, The inner and outer portions are provided on both sides based on the maximum thickness portion, and have mutually asymmetrical shapes or asymmetrical thickness profiles.

16. The ocular implant according to claim 14, wherein, The inner portion is formed to be relatively soft, so as to conform to the shape of each implantee's eyeball. The outer portion is formed to be relatively rigid to resist deformation of the inner portion and maintain a circular appearance, thereby enhancing the flexibility of the inner portion and providing supporting rigidity for the ocular implant.

17. The ocular implant according to claim 16, wherein, The inner portion is formed to be thinner than the outer portion, such that it is introduced into the discontinuous edge between the high-curvature portion of the cornea that bulges forward and the low-curvature portion of the sclera that extends backward from the cornea in order to maintain the shape of the eyeball, and fits against the discontinuous edge to prevent the formation of a gap between the discontinuous edge and the inner portion.

18. The ocular implant according to claim 16, wherein, The inner and outer portions are formed of the same material, and the thickness of the inner portion is relatively smaller than the thickness of the outer portion.

19. The ocular implant according to claim 18, wherein, The iris expansion portion includes an anterior curved surface and a posterior inclined surface that form the thickness of the iris expansion portion. In the first average thickness of the inner portion and the second average thickness of the outer portion formed by the rear slope and the front curved surface, the first average thickness is less than the second average thickness.

20. The ocular implant according to claim 18, wherein, Using the rear slope that provides the thickness reference for the ocular expansion portion as a reference, The front curved surface forming the inner portion extends along a trajectory relatively close to the rear slope, and the front curved surface forming the outer portion extends along a trajectory relatively far from the rear slope, thereby creating a thickness difference between the inner and outer portions formed on both sides with the maximum thickness portion as a reference.

21. The ocular implant according to claim 20, wherein, The front curved surface forming the inner portion extends along a trajectory relatively close to the rear slope, forming a relatively thin thickness while following a relatively gentle downward curve towards the rear slope, and forming a gentle rounded corner at the inner annular edge. The front curved surface forming the outer portion extends along a trajectory relatively far from the rear slope, forming a relatively thick thickness while following a relatively steep downward curvature towards the rear slope, and forming a sharp rounded corner at the outer annular edge.

22. An ocular implant permanently implanted in the eye of a recipient to provide the recipient with an enlarged appearance of the eyeball, comprising: A central opening for receiving incident light toward the eyeball, which provides the eyeball opening; The inner annular edge surrounds and defines the opening; An outer annular edge, which, on the opposite side of the inner annular edge defining the opening, surrounds the opening together with the inner annular edge; as well as An adaptive telescopic section provides adaptive length extension along the periphery of at least one of the inner annular edge and the outer annular edge.

23. The ocular implant according to claim 22, wherein, The adaptive telescopic portion provides length extension along the periphery of the inner annular edge to adapt to the shape and size of each implantee's eyeball.

24. The ocular implant according to claim 22, wherein, The adaptive telescopic portion includes at least one slit formed on the periphery of the inner annular edge.

25. The ocular implant according to claim 24, wherein, The adaptive telescopic portion includes a plurality of slits spaced apart from each other along the periphery of the inner annular edge.

26. The ocular implant according to claim 25, wherein, The adaptive telescopic portion includes a set of slits formed on both sides along the long axis and / or on both sides along the short axis.

27. The ocular implant according to claim 26, wherein, The adaptive telescopic section, through a first set of slits and a second set of slits formed on both sides along the minor axis, allows the segmented pieces to overlap, thereby extending the minor axis length while shortening the major axis length. By forming a third and a fourth set of slits on both sides along the long axis, the segmented pieces overlap each other, thereby extending the length of the long axis while shortening the length of the short axis.

28. The ocular implant according to claim 24, wherein, The eyeball dilation portion includes: The posterior sloping surface faces the eyeball and is configured to conform to the surface of the eyeball; and An anterior curved surface, which is configured to face outwards opposite to the eyeball, and forms a thickness profile based on the posterior slope, contacts the posterior slope at a position where it meets the opening and forms an inner annular edge, and contacts the posterior slope at a position opposite to the opening and forms an outer annular edge, and forms a thickness profile relative to the posterior slope based on a maximum thickness portion where the maximum thickness is formed between the inner and outer annular edges, such that a relatively thin inner portion and a relatively thick outer portion are formed; The segments divided by the slits forming the adaptive telescopic portion overlap each other, and while extending the length of the inner annular edge, the thickness of the inner portion introduced from the inner annular edge and forming the slit is increased to form an additional thickness.

29. The ocular implant according to claim 1, wherein, The inner annular edges, formed by segments overlapping each other through the slits that create the adaptive telescopic portion, are shaped into relatively gentle rounded corners. The outer annular edge is formed into a relatively sharp rounded shape.

30. An ocular implant permanently implanted in the eye of a recipient to provide the recipient with an enlarged appearance of the eyeball, comprising: A central opening for receiving incident light toward the eyeball, which provides the eyeball opening; The inner annular edge surrounds and defines the opening; An outer annular edge, which, on the opposite side of the inner annular edge defining the opening, surrounds the opening together with the inner annular edge; as well as An eyeball dilatation portion is formed between the inner annular edge and the outer annular edge, and includes a first end and a second end, which are separated from each other by an incision and joined together toward each other by surgical holes formed thereon, respectively.

31. The ocular implant according to claim 30, wherein, The surgical port includes: A first surgical opening for inserting a suture to join the first end to the second end; and The second surgical port is through which the insertion mechanism for implantation passes to pull the ocular implant so that the ocular implant surrounds the outer edge of the recipient's eyeball via a conjunctival incision in the sclera.

32. The ocular implant according to claim 31, wherein, The first surgical hole is formed with a relatively small diameter, and the second surgical hole is formed with a relatively large diameter.

33. The ocular implant according to claim 31, wherein, The first surgical hole is formed relatively close to the incision, and the second surgical hole is formed relatively far away from the incision.

34. An ocular implant permanently implanted in the eye of a recipient to provide the recipient with an enlarged appearance of the eyeball, comprising: A central opening for receiving incident light toward the eyeball, which provides the eyeball opening; The inner annular edge surrounds and defines the opening; An outer annular edge, which, on the opposite side of the inner annular edge defining the opening, surrounds the opening together with the inner annular edge; as well as An eyeball expansion portion is formed between the inner annular edge and the outer annular edge, and includes a first end and a second end that are separated from each other by a cut and form a snap-fit ​​or hook-fit with each other.

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