Ocular implant
A permanently implanted ocular implant with a central opening and annular edges addresses the issues of conventional circle lenses by enhancing pupil appearance without blocking light and minimizing side effects, offering adaptability and cost-effectiveness through a single-design mold.
Patent Information
- Application Number
- PCT/KR2024/006877
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-02-27
- Filing Date
- 2024-05-21
- Publication Date
- 2025-01-02
AI Technical Summary
Conventional circle lenses for cosmetic purposes face issues such as reduced oxygen permeability and uneven surface, leading to increased bacterial contact and side effects like new blood vessels, keratitis, and corneal ulcers, which can reduce the appearance of the eye and cause discomfort.
A permanently implanted ocular implant with a central opening for light entry, an inner annular edge, and an outer annular edge that includes a pupil expansion portion with variable thickness or adaptive stretchable features, designed to adhere closely to the eye's surface without blocking light and minimizing side effects, while being adaptable to different pupil shapes and sizes.
The ocular implant provides a cosmetic enhancement of enlarged pupils without obstructing light, reduces side effects by minimizing bacterial contact, and is adaptable to various eye shapes and sizes, improving convenience and reducing manufacturing costs through a single-design mold.
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Figure KR2024006877_02012025_PF_FP_ABST
Abstract
Description
ocular implants
[0001] The present invention relates to an ocular implant.
[0002] Circle lenses, which are designed for the purpose of plastic surgery to enlarge the appearance of the pupil, are formed by inserting a dye between two different lenses, and compared to contact lenses for vision correction, have problems such as reduced oxygen permeability and an uneven surface. As a result, the contact area and opportunity for bacteria to come into contact with the circle lens increase, which may cause side effects such as neovascularization, keratitis, corneal ulcers, and corneal edema. For example, neovascularization may reduce the appearance of the pupil, which is contrary to the plastic purpose of circle lenses to enlarge the appearance of the pupil, and corneal hypoxia may cause the side effect of neovascularization clouding the peripheral cornea white.
[0003] One embodiment of the present invention includes an ocular implant that is permanently implanted on the eyeball without the hassle of attachment or detachment, and that can form an attractive appearance integrated with the pupil without blocking the light entrance aperture.
[0004] One embodiment of the present invention includes an ocular implant that adheres closely to a discontinuous edge of the eye, thereby minimizing side effects and improving handling convenience.
[0005] One embodiment of the present invention comprises an ocular implant that can be adaptively deformed into a shape optimized for the shape and size of the pupil of each recipient of the ocular implant, while reducing manufacturing costs through a single design mold to provide versatility.
[0006] One embodiment of the present invention includes an ocular implant that can improve the convenience of surgery while blocking side effects resulting from a structure that takes convenience of surgery into consideration.
[0007] An ocular implant according to one embodiment of the present invention,
[0008] An ocular implant that is permanently implanted on the recipient's eye to provide the recipient's pupil with an enlarged appearance,
[0009] The central opening that admits light toward the pupil (or iris), which provides the opening for the eye;
[0010] An inner annular edge defining the opening by surrounding the opening;
[0011] an outer annular edge surrounding said opening together with said inner annular edge opposite the inner annular edge defining said opening; and
[0012] It may include a pupil expansion portion formed with a variable thickness that changes from the inner annular edge to the outer annular edge between the inner annular edge and the outer annular edge.
[0013] An ocular implant according to one embodiment of the present invention,
[0014] An ocular implant that is permanently implanted on the recipient's eye to provide the recipient's pupil with an enlarged appearance,
[0015] A central opening that admits light toward the pupil, which provides the opening for the eyeball;
[0016] An inner annular edge defining the opening by surrounding the opening;
[0017] an outer annular edge surrounding said opening together with said inner annular edge opposite the inner annular edge defining said opening; and
[0018] It may include an adaptive elastic member that adaptively provides length expansion along the perimeter of at least one of the inner annular edge and the outer annular edge.
[0019] An ocular implant according to one embodiment of the present invention,
[0020] An ocular implant that is permanently implanted on the recipient's eye to provide the recipient's pupil with an enlarged appearance,
[0021] A central opening that admits light toward the pupil, which provides the opening for the eyeball;
[0022] An inner annular edge defining the opening by surrounding the opening;
[0023] an outer annular edge surrounding said opening together with said inner annular edge opposite the inner annular edge defining said opening; and
[0024] It may include a pupil expansion portion formed between the inner annular edge and the outer annular edge, and including first and second ends separated from each other through an incision and joined toward each other through a surgical hole formed therein.
[0025] An ocular implant according to one embodiment of the present invention,
[0026] An ocular implant that is permanently implanted on the recipient's eye to provide the recipient's pupil with an enlarged appearance,
[0027] A central opening that admits light toward the pupil, which provides the opening for the eyeball;
[0028] An inner annular edge defining the opening by surrounding the opening;
[0029] an outer annular edge surrounding said opening together with said inner annular edge opposite the inner annular edge defining said opening; and
[0030] It may include a pupil expansion portion formed between the inner annular edge and the outer annular edge, and including first and second ends separated from each other through a cut and forming a catch joint or hook joint with respect to each other.
[0031] According to the present invention, an ocular implant can be provided that is permanently implanted on the eyeball without the hassle of attachment or detachment, and that can form a beautiful appearance integrated with the pupil without blocking the light entrance aperture.
[0032] According to the present invention, an ocular implant can be provided that adheres closely to a discontinuous edge of the eyeball, thereby minimizing side effects and improving handling convenience.
[0033] According to the present invention, an ocular implant can be provided that can be adaptively transformed into a shape optimized for the shape and size of the pupil of each recipient while reducing the manufacturing cost through a single design mold to provide versatility.
[0034] According to the present invention, it is possible to provide an ocular implant in which the convenience of the procedure of the ocular implant is improved, while side effects resulting from a structure that takes the convenience of the procedure into consideration are prevented.
[0035] FIG. 1 is a drawing illustrating a schematic structure of an eye into which an ocular implant according to one embodiment of the present invention is permanently implanted.
[0036] FIG. 2 is a drawing for explaining the procedure of an ocular implant according to one embodiment of the present invention, and is a drawing showing an incision formed at a certain location along the outer ring of the pupil.
[0037] FIG. 3 is a perspective view of an ocular implant according to one embodiment of the present invention.
[0038] FIG. 4 is a plan view of the ocular implant illustrated in FIG. 3 from the frontal direction.
[0039] Figure 5 shows a cross-sectional view taken along line VV` of Figure 3.
[0040] FIG. 6 is a perspective view illustrating an adaptive elastic member applied to an ocular implant according to one embodiment of the present invention.
[0041] FIG. 7 is a perspective view illustrating an adaptive elastic member applied to an ocular implant according to one embodiment of the present invention, and is a perspective view illustrating a modified example of FIG. 6.
[0042] FIGS. 8A and 8B are cross-sectional views of an ocular implant taken along the circumferential direction of the pupillary dilation, illustrating cross-sectional views illustrating different roughness processing surfaces having isotropic rotational resistance and anisotropic rotational resistance, respectively.
[0043] FIG. 9 is a drawing for explaining a surgical hole applied to an ocular implant according to one embodiment of the present invention, and is a plan view of the ocular implant as viewed from the front.
[0044] FIGS. 10A to 10C are perspective views of different ocular implants, illustrating the hook connection or the hook connection of the first and second slits applied to ocular implants according to different embodiments of the present invention.
[0045] FIGS. 11A and 11B illustrate different drawings for explaining the engagement of a catch or hook of an assembly slit and an assembly ball applied to an ocular implant according to one embodiment of the present invention.
[0046] FIG. 12 is a drawing showing a modified embodiment of the ocular implant illustrated in FIG. 4.
[0047] FIG. 13 is a drawing showing a modified embodiment of the ocular implant illustrated in FIG. 6.
[0048] FIG. 14 is a drawing illustrating a composite configuration of different mechanisms for connecting first and second ends separated from each other through a cut portion toward each other in one embodiment of the present invention.
[0049] FIG. 15 is a drawing showing a modified embodiment of the ocular implant illustrated in FIG. 9.
[0050] An ocular implant according to one embodiment of the present invention,
[0051] An ocular implant that is permanently implanted on the recipient's eye to provide the recipient's pupil with an enlarged appearance,
[0052] The central opening that admits light toward the pupil (or iris), which provides the opening for the eye;
[0053] An inner annular edge defining the opening by surrounding the opening;
[0054] an outer annular edge surrounding said opening together with said inner annular edge opposite the inner annular edge defining said opening; and
[0055] It may include a pupil expansion portion formed with a variable thickness that changes from the inner annular edge to the outer annular edge between the inner annular edge and the outer annular edge.
[0056] For example, the inner annular edge and the outer annular edge may surround the opening along different shapes.
[0057] For example, the inner annular edge is formed in an oval shape following the shape of the pupil so as not to obscure the pupil (or pupil) that forms the entrance opening of light, but to provide an appearance that is integrated with the pupil, and surrounds the outer ring of the pupil at an adjacent position;
[0058] The outer annular edge may be formed into a circle to provide a beautiful circular appearance.
[0059] For example, the inner annular edge is formed into an oval shape having different major and minor axis lengths,
[0060] The above longitudinal length is formed along the direction in which a pair of eyes of the transplanter face each other,
[0061] The above-mentioned short-axis length can be formed along a direction perpendicular to the above-mentioned long-axis length.
[0062] For example, the pupillary expansion portion between the inner annular edge and the outer annular edge is formed such that one of the two positions along the short axis of the inner annular edge has a wider width than the other position.
[0063] The oval of the inner annular edge may be formed at a biased position that is biased toward the other side within the circular shape of the outer annular edge.
[0064] For example, the above pupil dilation part,
[0065] A posterior slope positioned toward the eye to adhere closely to the eye; and
[0066] It may include a front surface that is positioned toward the outside world, opposite the eye.
[0067] For example, the inner annular edge and the outer annular edge, which form the front of the eyeball, are observed as oval and circular, respectively, along the frontal direction from the front of the eyeball toward the back of the eyeball, where the crystalline lens performing the lens function and the pupil (or pupil) forming the light entrance opening are placed.
[0068] The rear inclined surface may be formed as a surface inclined at a constant tilting angle from a vertical plane perpendicular to the front direction so that the inner annular edge and the outer annular edge form a front position and a rear position, respectively.
[0069] For example, the rear slope may provide a support surface that is supported on a slope formed on the packaging container of the ocular implant.
[0070] For example, the front curved surface may be formed along a spline curve in which the curvature or radius of curvature changes along the slope direction of the rear sloped surface.
[0071] For example, the pupillary dilation portion may have a variable thickness, with the thickness varying between the rear slope and the front curve.
[0072] For example, the thickness of the pupillary dilation can be measured along a direction perpendicular to the posterior slope from the posterior slope to the anterior curve.
[0073] For example, the inner annular edge may be formed by the front curved surface and the rear inclined surface, which form the thickness of the pupillary expansion portion, contacting each other at a location where they contact the opening.
[0074] For example, the outer annular edge may be formed such that the anterior curved surface and the posterior sloped surface, which form the thickness of the pupillary expansion portion, abut against each other on opposite sides of the inner annular edge, which defines the opening.
[0075] For example, the front curved surface and the rear inclined surface forming the thickness of the pupil expansion portion may abut against each other while forming an inner annular edge and an outer annular edge of a rounded corner shape, respectively.
[0076] For example, the inner annular edge is formed into a relatively gently rounded corner shape,
[0077] The above outer annular edge can be formed into a relatively sharply rounded corner shape.
[0078] For example, the thickness of the edge of the inner annular edge may be formed to be thinner than the thickness of the edge of the outer annular edge.
[0079] For example, among the membrane tissues that surround the eyeball to maintain its shape, the inner annular edge that extends to the discontinuous edge between the cornea in the greater curvature portion that protrudes convexly toward the front and the sclera in the less curvature portion that extends posteriorly from the cornea can be finished on one side of the ocular implant with a relatively gently rounded corner shape.
[0080] The outer annular edge that adheres closely to the cornea of the above-mentioned large curvature portion can be finished on the other side of the ocular implant with a relatively sharp rounded corner shape so as not to lift off from the cornea or form a gap between the cornea and the cornea.
[0081] The pupillary expansion portion has a maximum thickness portion having a maximum thickness between the inner annular edge and the outer annular edge;
[0082] An inner portion formed relatively adjacent to the above opening, between the inner annular edge and the maximum thickness portion; and
[0083] It may be formed relatively far from the above opening and may include an outer portion between the maximum thickness portion and the outer annular edge.
[0084] For example, the inner and outer parts arranged on both sides based on the maximum thickness part may have an asymmetrical shape or an asymmetrical thickness profile.
[0085] For example, the inner portion is formed relatively softly so as to adaptively deform to the pupil of each transplant recipient,
[0086] The outer portion may be formed to be relatively rigid so as to maintain a neat circular appearance against deformation of the inner portion and to reinforce the ductility of the inner portion to provide support rigidity of the ocular implant.
[0087] For example, the inner portion may be formed with a thinner thickness than the outer portion so that it is inserted up to the discontinuous edge between the cornea, which is a large curvature portion that protrudes convexly toward the front among the membrane tissues that entirely surround the eyeball to maintain the shape of the eyeball, and the sclera, which is a small curvature portion that extends posteriorly from the cornea, and is in close contact with the discontinuous edge so that no gap is formed between the discontinuous edge and the inner portion.
[0088] For example, the inner and outer parts are formed of the same material,
[0089] The thickness of the inner portion can be formed relatively thinner than the thickness of the outer portion.
[0090] For example, the pupil expansion portion includes a front curved surface and a rear sloped surface that form the thickness of the pupil expansion portion,
[0091] The first average thickness of the inner portion formed by the rear slope and the front curved surface and the second average thickness of the outer portion may be formed such that the first average thickness < the second average thickness.
[0092] For example, based on the posterior slope that provides the reference for the thickness of the pupillary dilation,
[0093] The front curved surface forming the inner portion extends along a relatively close trajectory with respect to the rear inclined surface, and the front curved surface forming the outer portion extends along a relatively far trajectory with respect to the rear inclined surface, thereby forming a difference in thickness between the inner portion and the outer portion formed on both sides based on the maximum thickness portion.
[0094] For example, the front curve forming the inner portion forms a relatively thin thickness while extending along a relatively adjacent trajectory to the rear slope, and then forms a gently rounded corner at the inner annular edge while following a relatively gentle downward curve toward the rear slope.
[0095] The front curve forming the outer portion may form a relatively thick thickness while extending along a relatively distant trajectory with respect to the rear slope, and then form a sharply rounded corner at the outer annular edge while following a relatively steep downward curve toward the rear slope.
[0096] For example, the front curve forming the inner portion follows a downward curve from the maximum thickness portion toward the inner annular edge, and then follows a more steep downward curve through the inner inflection point to form a gently rounded inner annular edge so as to finish one side of the ocular implant.
[0097] The front curve forming the outer portion may follow a downward curve from the maximum thickness portion toward the outer annular edge and then follow a more steep downward curve through the outer inflection point to form a sharply rounded outer annular edge so as to finish the other side of the ocular implant.
[0098] For example, along the slope direction of the rear slope, the distance from the outer annular edge to the outer inflection point may be formed to be relatively longer than the distance from the inner annular edge to the inner inflection point.
[0099] For example, the inner and outer inflection points may form points with the greatest change in curvature along the profile of the front surface forming the inner and outer portions, respectively.
[0100] An ocular implant according to one embodiment of the present invention,
[0101] An ocular implant that is permanently implanted on the recipient's eye to provide the recipient's pupil with an enlarged appearance,
[0102] The central opening that admits light toward the pupil (or iris), which provides the opening for the eye;
[0103] An inner annular edge defining the opening by surrounding the opening;
[0104] an outer annular edge surrounding said opening together with said inner annular edge opposite the inner annular edge defining said opening; and
[0105] It may include an adaptive elastic member that adaptively provides length expansion along at least one of the perimeter of the inner annular edge and the outer annular edge.
[0106] For example, the adaptive elastic member may provide longitudinal elasticity along the perimeter of the inner annular edge to adaptively deform to the shape and size of the pupil of each recipient.
[0107] For example, the inner annular edge is formed into an oval shape having different major and minor axis lengths,
[0108] The adaptive elastic member may provide a length extension along the major axis direction and / or the minor axis direction to adaptively provide an inner annular edge of a slip-shaped ellipse having a relatively long axis length extended and / or a relatively short axis length shortened and a root-shaped ellipse having a relatively long axis length shortened and / or a relatively short axis length extended to suit the pupil of the recipient.
[0109] For example, the adaptive elastic member may include at least one slit formed around the perimeter of the inner annular edge.
[0110] For example, the adaptive elastic member may include a plurality of slits formed spaced apart from each other along the perimeter of the inner annular edge.
[0111] For example, the plurality of slits may be formed spaced apart from each other at equal intervals along the perimeter of the inner annular edge.
[0112] For example, the adaptive elastic member may include a group of slits formed at opposite positions along the longitudinal direction and / or at opposite positions along the short-axis direction.
[0113] For example, the adaptive elastic member,
[0114] The pieces divided into the first and second groups are overlapped through the slits formed on both sides along the above-mentioned shortening direction, thereby shortening the long axis length while extending the short axis length.
[0115] The pieces divided into the third and fourth groups formed at both sides along the longitudinal direction can be overlapped to extend the longitudinal length and shorten the short-axis length.
[0116] For example, the slits can be formed at positions at angles spaced apart by a constant angle, with the center of rotation being the center of the opening where the major axis and minor axis of the inner annular edge intersect each other.
[0117] For example, the above slit,
[0118] First and second groups of slits formed at 0 degree angle positions and 180 degree angle positions corresponding to both sides along the above-mentioned short-axis direction; and
[0119] It may include third and fourth groups of slits formed at 90 degree angle positions and 270 degree angle positions corresponding to both sides along the longitudinal direction.
[0120] For example, the slit may be introduced into the interior of the pupillary dilatation along a depth direction from the inner annular edge toward the outer annular edge.
[0121] For example, the slit can be introduced into the interior of the pupil dilatation portion in a radial direction from the center of the opening where the major axis and the minor axis intersect, with the depth direction being the direction of the radial direction.
[0122] For example, the adaptive elastic member may be configured to stretch the length of the inner annular edge by overlapping pieces separated from each other through the slits along the perimeter of the inner annular edge.
[0123] For example, the above pupil dilation part,
[0124] A posterior slope positioned toward the eye to adhere closely to the eye; and
[0125] A front curved surface is disposed toward the outside opposite to the eyeball and forms a thickness profile based on the rear slope, such that an inner annular edge is formed while contacting the rear slope at a position in contact with the opening, an outer annular edge is formed while contacting the rear slope at a position opposite to the opening, and a maximum thickness portion forming a maximum thickness between the inner annular edge and the outer annular edge is formed, such that a relatively thin inner portion and a relatively thick outer portion are formed based on the rear slope,
[0126] The pieces divided through the slits forming the above adaptive elastic portion can be overlapped with each other to increase the thickness of the inner portion where the slits formed from the inner annular edge are formed while stretching the length of the inner annular edge, thereby forming an extra thickness.
[0127] For example, the adaptive elastic portion is formed on the inner annular edge surrounding the outer ring of the pupil at a position relatively closer to the outer annular edge so as to adaptively deform to the shape and size of the pupil of each transplant recipient,
[0128] In order to maintain a beautiful circular appearance against deformation of the inner annular edge, the outer annular edge may not be formed.
[0129] For example, the inner annular edge, where the pieces divided through the slit forming the adaptive elastic portion are arranged to overlap each other, is formed in a relatively gently rounded corner shape,
[0130] The above outer annular edge can be formed into a relatively sharply rounded corner shape.
[0131] An ocular implant according to one embodiment of the present invention,
[0132] An ocular implant that is permanently implanted on the recipient's eye to provide the recipient's pupil with an enlarged appearance,
[0133] The central opening that admits light toward the pupil (or iris), which provides the opening for the eye;
[0134] An inner annular edge defining the opening by surrounding the opening;
[0135] an outer annular edge surrounding said opening together with said inner annular edge opposite the inner annular edge defining said opening; and
[0136] It may include a pupil expansion portion formed between the inner annular edge and the outer annular edge, and including first and second ends separated from each other through an incision and joined toward each other through a surgical hole formed therein.
[0137] For example, in the pupillary dilation between the inner annular edge and the outer annular edge,
[0138] The oval shape of the inner annular edge is formed inside the circle of the outer annular edge so that the positions on both sides along the short axis direction of the inner annular edge are formed with a relatively wider width than the positions on both sides along the long axis direction of the inner annular edge,
[0139] The above-mentioned incision, the first and second ends separated from each other through the above-mentioned incision, and the surgical hole formed on the first and second ends can be formed at any one of the two positions along the short-axis direction formed with a relatively wide width.
[0140] For example, in the pupillary dilation between the inner annular edge and the outer annular edge,
[0141] The positions on both sides along the short axis direction of the inner annular edge are formed with a relatively smaller curvature than the positions on both sides along the long axis direction of the inner annular edge,
[0142] The above-mentioned surgical hole can be formed at any one of the two positions along the short-axis direction formed with a relatively small curvature.
[0143] For example, the incision is formed along the short axis direction of the inner annular edge,
[0144] The first and second ends separated from each other through the above-mentioned cut portion are joined to each other along the longitudinal direction of the inner annular edge,
[0145] Each of the first and second ends may have a plurality of surgical holes formed along the longitudinal direction of the inner annular edge.
[0146] For example, the above treatment hole,
[0147] A first surgical hole for passing a suture for binding between the first and second ends; and
[0148] The ocular implant may include a second surgical hole through which an implantation insertion device passes to tract the ocular implant so that the ocular implant can be guided along the outer ring of the surgeon's pupil through an incision in the conjunctiva on the cornea.
[0149] For example, the first treatment hole is formed with a relatively small diameter,
[0150] The above second treatment hole can be formed with a relatively large diameter.
[0151] For example, the first surgical hole is formed at a location relatively close to the incision,
[0152] The second surgical hole may be formed at a location relatively far from the incision site.
[0153] An ocular implant according to one embodiment of the present invention,
[0154] An ocular implant that is permanently implanted on the recipient's eye to provide the recipient's pupil with an enlarged appearance,
[0155] The central opening that admits light toward the pupil (or iris), which provides the opening for the eye;
[0156] An inner annular edge defining the opening by surrounding the opening;
[0157] an outer annular edge surrounding said opening together with said inner annular edge opposite the inner annular edge defining said opening; and
[0158] It may include a pupil expansion portion formed between the inner annular edge and the outer annular edge, and including first and second ends separated from each other through a cut and forming a catch joint or hook joint with respect to each other.
[0159] For example, in the pupillary dilation between the inner annular edge and the outer annular edge,
[0160] The oval shape of the inner annular edge is formed inside the circle of the outer annular edge so that the positions on both sides along the short axis direction of the inner annular edge are formed with a relatively wider width than the positions on both sides along the long axis direction of the inner annular edge,
[0161] The above-mentioned cut portion, the first and second ends separated from each other through the above-mentioned cut portion, and the hook joint or the catch joint between the first and second ends can be formed at any one of the two positions along the short-axis direction formed with a relatively wide width.
[0162] For example, the above-mentioned hitch joint or hook joint,
[0163] It may include first and second slits formed on the first and second ends, respectively.
[0164] For example, at least some of the first and second slits may be formed in complementary shapes to form a catch joint or a hook joint with respect to each other and may be fitted to each other.
[0165] For example, the first and second slits,
[0166] a first portion extending along the longitudinal direction of the inner annular edge; and
[0167] It may include a second portion extending from the first portion toward the inner annular edge or the outer annular edge along a diagonal direction that simultaneously follows the short axis direction of the inner annular edge or the short axis direction and the long axis direction, and opening to the outside of the ocular implant.
[0168] For example, the first part of the first and second slits extends parallel to the longitudinal direction of the inner annular edge,
[0169] The second portions of the first and second slits may be formed in complementary shapes, such that the second portions of one of the first and second slits and the other of the slits may be opened toward the outside of the ocular implant while extending in opposite directions toward the outer annular edge and the inner annular edge, respectively.
[0170] For example, the above-mentioned incision is formed along the short axis direction of the inner annular edge,
[0171] The first and second ends are adjacent to each other along the longitudinal direction of the inner annular edge,
[0172] Among the first and second slits, one of the slits may include an array of slits formed in multiple numbers on the first end or the second end along the longitudinal direction, and the remaining other slits may be formed as a single slit.
[0173] For example, the above-mentioned hitch joint or hook joint,
[0174] an assembly slit formed in the first end; and
[0175] It may include an assembly hole formed in the second end and into which the assembly slit is fitted.
[0176] For example, an assembly guide portion may be formed on the first end portion and positioned in a forward position of the assembly slit along the assembly direction between the first and second ends.
[0177] For example, the above assembly induction part,
[0178] It includes a protrusion of the front end formed with a relatively narrow width at the front end of the first end along the assembly direction of the first and second ends, and a rear end formed with a relatively wider width than the bottleneck of the assembly slit while being behind the protrusion of the front end and in front of the assembly slit.
[0179] The variable width portion may further include a shape that converges toward the protrusion along a diagonal direction that simultaneously follows the major axis direction corresponding to the assembly direction and the minor axis direction intersecting the major axis direction to connect the protrusion of the front end formed with a relatively narrow width and the protrusion of the rear end formed with a relatively wide width with differential widths.
[0180] For example, the rear end of the assembly guide section can be connected to the full width of the first end interposed between the assembly guide section and the assembly slit.
[0181] For example, a cut line including an array of perforations formed in a plurality may be formed between the assembly guide portion and the full width of the first end portion.
[0182] For example, the assembly slit is introduced on both sides from the inner annular edge and the outer annular edge along the shortened direction of the inner annular edge to form a bottleneck of minimum width,
[0183] When the bottleneck of the above assembly slit is fitted into the assembly hole on the second end side, the separation between the first and second ends can be prevented through the relatively wide width of the first end formed before and after the assembly slit.
[0184] Hereinafter, with reference to the attached drawings, an ocular implant (100) according to a preferred embodiment of the present invention will be described.
[0185] FIG. 1 is a drawing illustrating a schematic structure of an eye into which an ocular implant according to one embodiment of the present invention is permanently implanted.
[0186] FIG. 2 is a drawing for explaining the procedure of an ocular implant according to one embodiment of the present invention, and is a drawing showing an incision formed at a certain location along the outer ring of the pupil.
[0187] FIG. 3 is a perspective view of an ocular implant according to one embodiment of the present invention.
[0188] FIG. 4 is a plan view of the ocular implant illustrated in FIG. 3 from the frontal direction.
[0189] Figure 5 shows a cross-sectional view taken along line VV` of Figure 3.
[0190] FIG. 6 is a perspective view illustrating an adaptive elastic member applied to an ocular implant according to one embodiment of the present invention.
[0191] FIG. 7 is a perspective view illustrating an adaptive elastic member applied to an ocular implant according to one embodiment of the present invention, and is a perspective view illustrating a modified example of FIG. 6.
[0192] FIGS. 8A and 8B are cross-sectional views of an ocular implant taken along the circumferential direction of the pupillary dilation, illustrating cross-sectional views illustrating different roughness processing surfaces having isotropic rotational resistance and anisotropic rotational resistance, respectively.
[0193] FIG. 9 is a drawing for explaining a surgical hole applied to an ocular implant according to one embodiment of the present invention, and is a plan view of the ocular implant as viewed from the front.
[0194] FIGS. 10A to 10C are perspective views of different ocular implants, illustrating the hook connection or the hook connection of the first and second slits applied to ocular implants according to different embodiments of the present invention.
[0195] FIGS. 11A and 11B illustrate different drawings for explaining the engagement of a catch or hook of an assembly slit and an assembly ball applied to an ocular implant according to one embodiment of the present invention.
[0196] Hereinafter, an ocular implant (100) according to one aspect of the present invention will be described, which comprises a pupil expansion portion (105) formed with variable thickness between an inner annular edge (101) and an outer annular edge (102), a shape of a front curved surface (120) forming a profile with variable thickness on a rear slope (110) of the pupil expansion portion (105), and circular and elliptical profiles formed by the inner annular edge (101) and the outer annular edge (102), respectively.
[0197] FIG. 1 is a drawing illustrating a schematic structure of an eye into which an ocular implant according to one embodiment of the present invention is permanently implanted.
[0198] FIG. 2 is a drawing for explaining the procedure of an ocular implant according to one embodiment of the present invention, and is a drawing showing an incision formed at a certain location along the outer ring of the pupil.
[0199] FIG. 3 is a perspective view of an ocular implant according to one embodiment of the present invention.
[0200] FIG. 4 is a plan view of the ocular implant illustrated in FIG. 3 from the frontal direction.
[0201] Figure 5 shows a cross-sectional view taken along line VV` of Figure 3.
[0202] An ocular implant (100) according to one embodiment of the present invention,
[0203] An ocular implant (100) that is permanently implanted on the recipient's eye (EB) to provide an enlarged appearance to the recipient's pupil,
[0204] A central opening (OP) that admits light toward the pupil (or iris), which provides the opening of the eyeball (EB);
[0205] An inner annular edge (101) defining the opening (OP) by surrounding the opening (OP);
[0206] An outer annular edge (102) surrounding the opening (OP) together with the inner annular edge (101) on the opposite side of the inner annular edge (101) defining the opening (OP); and
[0207] It may include a pupil expansion portion (105) formed with a variable thickness that changes from the inner annular edge (101) to the outer annular edge (102) between the inner annular edge (101) and the outer annular edge (102).
[0208] For example, the inner annular edge (101) and the outer annular edge (102) may surround the opening (OP) along different shapes.
[0209] For example, the inner annular edge (101) is formed in an oval shape along the shape of the pupil so as not to obscure the pupil (or pupil) forming the light entrance opening, but to provide an appearance integrated with the pupil, and surrounds the outer ring of the pupil at an adjacent position.
[0210] The above outer annular edge (102) may be formed in a circular shape to provide a beautiful circular appearance.
[0211] For example, the inner annular edge (101) is formed in an elliptical shape having different major axis lengths (L1) and minor axis lengths (L2),
[0212] The above longitudinal length (L1) is formed along the direction in which a pair of eyes of the transplanter face each other,
[0213] The above-mentioned short-axis length (L2) can be formed along a direction perpendicular to the above-mentioned long-axis length (L1).
[0214] For example, the pupil expansion portion (105) between the inner annular edge (101) and the outer annular edge (102) is formed so that one of the two positions along the short axis direction (Z2) of the inner annular edge (101) has a wider width than the other position.
[0215] The oval shape of the inner annular edge (101) within the circular shape of the outer annular edge (102) may be formed at a biased position that is biased toward the other side.
[0216] For example, the pupil dilation part (105)
[0217] A rear slope (110) positioned toward the eyeball (EB) so as to adhere closely to the eyeball (EB);
[0218] It may include a front curve (120) positioned toward the outer world (OS) opposite to the eyeball (EB).
[0219] For example, the inner annular edge (101) and the outer annular edge (102) are observed as oval and circular, respectively, along the frontal direction (Z3) from the front of the eye (EB) toward the back of the eye (EB) where the crystalline lens performing the lens function and the pupil (or pupil) forming the light entrance opening are arranged, respectively, forming the front of the eye (EB).
[0220] The rear inclined surface (110) may be formed as a surface inclined at a constant tilting angle (θ) from a vertical plane (G) perpendicular to the front direction (Z3) so that the inner annular edge (101) and the outer annular edge (102) form a front position and a rear position, respectively.
[0221] For example, the rear slope (110) may provide a support surface supported on a slope formed on the packaging container of the ocular implant (100).
[0222] For example, the front curved surface (120) may be formed along a spline curve in which the curvature or radius of curvature changes along the slope direction of the rear inclined surface (110).
[0223] For example, the pupil expansion portion (105) may have a variable thickness that varies from the rear slope (110) to the front curved surface (120). In this case, the thickness of the pupil expansion portion (105) may be measured along a direction perpendicular to the rear slope (110) from the rear slope (110) to the front curved surface (120).
[0224] For example, the inner annular edge (101) may be formed by the front curved surface (120) and the rear inclined surface (110) forming the thickness of the pupil expansion portion (105) contacting each other at a position where they are in contact with the opening (OP).
[0225] For example, the outer annular edge (102) may be formed such that the front curved surface (120) and the rear inclined surface (110), which form the thickness of the pupil expansion portion (105), contact each other on opposite sides of the inner annular edge (101) that defines the opening (OP).
[0226] For example, the front curved surface (120) and the rear inclined surface (110) forming the thickness of the pupil expansion portion (105) may be in contact with each other while forming an inner annular edge (101) and an outer annular edge (102) of a rounded corner shape, respectively. At this time, the inner annular edge (101) may be formed in a relatively gently rounded corner shape, and the outer annular edge (102) may be formed in a relatively sharply rounded corner shape.
[0227] For example, the thickness of the edge of the inner annular edge (101) may be formed thinner than the thickness of the edge of the outer annular edge (102).
[0228] For example, among the membrane tissues that entirely surround the eyeball (EB) to maintain the shape of the eyeball (EB), the inner annular edge (101) that extends to the discontinuous edge (DE) between the cornea in the large curvature portion that protrudes convexly toward the front and the sclera in the small curvature portion that extends posteriorly from the cornea can be finished on one side of the ocular implant (100) with a relatively gently rounded corner shape.
[0229] The outer annular edge (102) that adheres closely to the cornea of the above-mentioned large curvature portion can be finished on the other side of the ocular implant (100) with a relatively sharply rounded corner shape so as not to lift off from the cornea or to prevent a gap from being formed between the cornea and the cornea.
[0230] For example, the pupil dilation part (105)
[0231] A maximum thickness portion (t5) having a maximum thickness between the inner annular edge (101) and the outer annular edge (102);
[0232] An inner portion (IA) formed relatively adjacent to the above opening (OP) between the inner annular edge (101) and the maximum thickness portion (t5); and
[0233] It may be formed relatively far from the above opening (OP) and may include an outer portion (OA) between the maximum thickness portion (t5) and the outer annular edge (102).
[0234] For example, the inner part (IA) and the outer part (OA) arranged on both sides based on the maximum thickness part (t5) may have an asymmetrical shape or an asymmetrical thickness profile.
[0235] For example, the inner portion (IA) is formed relatively softly so as to adaptively deform to the pupil of each recipient.
[0236] The outer portion (OA) may be formed to be relatively rigid so as to maintain a neat circular appearance against deformation of the inner portion (IA) and to reinforce the ductility of the inner portion (IA) to provide support rigidity of the ocular implant (100).
[0237] For example, the inner portion (IA) may be formed to have a thinner thickness than the outer portion (OA) so that it is inserted up to the discontinuous edge (DE) between the cornea, which is a convex portion protruding forward among the membrane tissues that entirely surround the eyeball (EB) to maintain the shape of the eyeball (EB), and the sclera, which is a less curvature portion extending posteriorly from the cornea, and adheres closely to the discontinuous edge (DE) so that no gap is formed between the discontinuous edge (DE).
[0238] For example, the inner part (IA) and outer part (OA) are formed of the same material,
[0239] The thickness of the inner portion (IA) can be formed relatively thinner than the thickness of the outer portion (OA).
[0240] For example, 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 be formed as the first average thickness < the second average thickness.
[0241] For example, based on the rear slope (110) that provides a reference for the thickness of the pupil expansion portion (105),
[0242] The front curved surface (120) forming the inner portion (IA) extends along a relatively close trajectory with respect to the rear inclined surface (110), and the front curved surface (120) forming the outer portion (OA) extends along a relatively far trajectory with respect to the rear inclined surface (110), thereby forming a difference in thickness between the inner portion (IA) and the outer portion (OA) formed on both sides based on the maximum thickness portion (t5).
[0243] For example, the front curved surface (120) forming the inner portion (IA) forms a relatively thin thickness while extending along a trajectory relatively close to the rear inclined surface (110), and then forms a gently rounded corner at the inner annular edge (101) while following a relatively gentle downward curve toward the rear inclined surface (110).
[0244] The front curved surface (120) forming the above outer portion (OA) may form a relatively thick thickness while extending along a relatively distant trajectory with respect to the rear inclined surface (110), and then form a sharply rounded corner at the outer annular edge (102) while following a relatively steep downward curve toward the rear inclined surface (110).
[0245] For example, the front curved surface (120) forming the inner portion (IA) follows a downward curve from the maximum thickness portion (t5) toward the inner annular edge (101) and then forms a gently rounded inner annular edge (101) while following a more steep downward curve through the inner inflection point (101`) to finish one side of the ocular implant (100).
[0246] The front curved surface (120) forming the outer portion (OA) may follow a downward curve from the maximum thickness portion (t5) toward the outer annular edge (102) and then form a sharply rounded outer annular edge (102) by following a more steep downward curve through the outer inflection point (102`) so as to finish the other side of the ocular implant (100).
[0247] For example, along the slope direction of the rear slope (110), the distance from the outer annular edge (102) to the outer inflection point (102`) may be formed to be relatively longer than the distance from the inner annular edge (101) to the inner inflection point (101`). At this time, the inner inflection point (101`) and the outer inflection point (102`) may form points at which the change in curvature is greatest along the profile of the front curved surface (120) forming the inner portion (IA) and the outer portion (OA), respectively.
[0248] The ocular implant (100) of the present invention may be provided as a roughly ring-shaped member having an opening (OP) formed in the center so that light can be incident toward the crystalline lens (or pupil) that performs the lens function of the eyeball (EB) or the pupil that forms the opening of the eyeball (EB).
[0249] The above ocular implant (100) can enlarge the size of the pupil by surrounding the outer ring of the pupil of the implant recipient, and can be formed as a ring-shaped member with an opening (OP) formed in the center to allow the incidence of light toward the pupil by surrounding the outer ring of the pupil of the implant recipient.
[0250] In one embodiment of the present invention, the ocular implant (100) may include an inner annular edge (101) surrounding the outer ring of the pupil of the implant recipient, an outer annular edge (102) surrounding the outer ring of the pupil together with the inner annular edge (101) on the opposite side of the inner annular edge (101), and a pupil expansion portion (105) formed between the inner annular edge (101) and the outer annular edge (102) with a variable thickness that changes from the inner annular edge (101) to the outer annular edge (102). The pupil expansion portion (105) may be defined between an inner annular edge (101) and an outer annular edge (102) that surround the pupil outer ring at the inner and outer positions, respectively, and may provide an expansion area of the pupil in an ocular implant (100) according to one embodiment of the present invention. In one embodiment of the present invention, the inner annular edge (101) and the outer annular edge (102) may define the shape of the pupil expansion portion (105) forming the ocular implant (100) or the body of the ocular implant (100), and may define at least a part of the shape of the ocular implant (100).
[0251] According to one embodiment of the present invention, an ocular implant (100) can be formed into a three-dimensional shape so as to be closely attached to an approximately spherical eyeball (EB), and considering that a major function of the ocular implant (100) according to one embodiment of the present invention is to beautifully improve the shape of the pupil or pupils observed in the frontal direction (Z3) of the recipient's face, and since the shape of the pupil or pupils observed in the frontal direction (Z3) of the recipient's face can be defined by an inner annular edge (101) and an outer annular edge (102) defining a shape observed in the frontal direction (Z3) of the pupil dilation portion (105), the shape of the inner annular edge (101) and the outer annular edge (102) hereinafter may mean a two-dimensional line shape observed in the frontal direction (Z3) of the recipient's face. However, since the ocular implant (100) according to one embodiment of the present invention is to be permanently implanted on the recipient's eye (EB), it can be formed into an appropriate three-dimensional shape so as to be closely fitted on the approximately spherical eye (EB), and for example, the cross-sectional shape of the pupil expansion portion (105) cut in the frontal direction (Z3) can be formed with a variable thickness that changes from the inner expansion edge to the outer expansion edge so as to be closely fitted on the approximately spherical eye (EB).
[0252] More specifically, the pupil expansion portion (105) may be formed in a three-dimensional shape so as to be closely fitted onto an eyeball (EB) formed in a roughly spherical shape, and may include a posterior slope (110) inclined at a constant tilting angle (θ) from a vertical plane (G) perpendicular to the frontal direction (Z3) so as to be closely fitted onto the eyeball (EB), and a front curved surface (120) arranged toward the outside world (OS) opposite to the eyeball (EB), in a cross-sectional shape cut along the frontal direction (Z3).
[0253] In one embodiment of the present invention, the eyeball (EB) is protected by a strong and tough membrane tissue that entirely surrounds the eyeball (EB) and maintains the overall shape of the eyeball (EB), and the membrane tissue may include a cornea on the anterior side where light enters and a sclera extending posteriorly from the cornea. For example, the cornea may be formed at an anterior position of an anterior chamber formed in front of the pupil, a lens that functions as a lens and focuses light on the retina at the posterior side of the eyeball (EB), and a pupil that forms an opening through which light enters in front of the lens, and the anterior chamber formed in front of the pupil, and may form a large curvature portion of the membrane tissue formed with a relatively large curvature while surrounding the anterior part of the eyeball (EB) formed by the lens, the pupil, and the anterior chamber. The sclera may extend posteriorly from the cornea and form a small curvature portion of the membrane tissue formed with a relatively small curvature. The cornea and sclera, respectively, surround the eyeball (EB) and form large and small curvatures that maintain the shape of the eyeball (EB), while forming geometrical singularities such as discontinuous edges (DE) between them.
[0254] In this way, the cornea and the sclera can form large and small curvatures of the membrane tissue that maintain the shape of the eyeball (EB) while surrounding the entire eyeball (EB), and substantially the same membrane tissue can be formed in a convex shape toward the outer world (OS) opposite to the eyeball (EB) while containing the lens, etc. in the anterior position, and the sclera extending posteriorly from the cornea in the anterior position can be formed with a reduced curvature compared to the cornea, and from the sclera beyond the discontinuous edge (DE) between the cornea and the sclera to the curved portion (AC) of the sclera can be formed in a shape closer to a slope than a curved surface. An ocular implant (100) according to one embodiment of the present invention can be implanted on the sclera, for example, on the cornea positioned in front of the lens or the like, for example, on the sclera away from the cornea onto which light is incident, and in one embodiment of the present invention, the ocular implant (100) can be introduced forward to the discontinuous edge (DE) between the sclera and the cornea. At this time, the cornea in the anterior position is formed with a relatively large curvature in the anterior position of the lens, etc., whereas the sclera extending posteriorly from the cornea is formed with a relatively small curvature, and a discontinuous edge (DE) is formed between the cornea and the sclera. The ocular implant (100) that can be introduced up to this discontinuous edge (DE) can accommodate the discontinuous edge (DE) between the cornea and the sclera and, so as not to form a gap between the tissue of the eye (EB) and the transplanted ocular implant (100), the inner part (IA) in contact with the opening (OP) can be formed with a relatively thinner thickness than the outer part (OA) that is relatively far from the opening (OP).
[0255] In one embodiment of the present invention, the pupil dilatation part (105) may include a posterior slope (110) arranged toward the eyeball (EB) so as to be in close contact with the eyeball (EB), and an anterior curved surface (120) arranged toward the outer world (OS) opposite the eyeball (EB) so as to be opposite to the posterior slope (110), and may be formed with a variable thickness that changes between the posterior slope (110) and the anterior curved surface (120). In one embodiment of the present invention, the thickness of the pupil dilatation part (105) may correspond to a dimension along a direction perpendicular to the posterior slope (110) among the posterior slope (110) and the anterior curved surface (120) defining a portion of the pupil dilatation part (105).
[0256] In one embodiment of the present invention, the pupil expansion portion (105) may be formed with a variable thickness that changes as it goes from the inner annular edge (101) to the outer annular edge (102), and more specifically, the thickness may be gradually reduced as it goes to both sides of the inner annular edge (101) and the outer annular edge (102) based on a maximum thickness portion (t5) having the maximum thickness between the inner annular edge (101) and the outer annular edge (102), so that both sides of the pupil expansion portion (105) may be finished at the inner annular edge (101) and the outer annular edge (102).
[0257] In one embodiment of the present invention, the thickness of the pupil expansion portion (105) can be defined along a direction perpendicular to the posterior slope (110) between the posterior slope (110) and the anterior curved surface (120), and the posterior slope (110) and the anterior curved surface (120) can contact each other at an inner annular edge (101) relatively in contact with the opening (OP) and an outer annular edge (102) far from the opening (OP), respectively, and form rounded corners at the inner annular edge (101) and the inner annular edge (102), respectively. In one embodiment of the present invention, based on the rear slope (110), the front curved surface (120) can form a thickness profile of the pupil expansion portion (105) on the rear slope (110), and can form a trajectory that is the farthest distance from the rear slope (110) to form a maximum thickness portion (t5) between the inner annular edge (101) and the outer annular edge (102), and can form a downward trajectory gradually toward the rear slope (110) while going from both sides of the maximum thickness portion (t5) to both sides of the maximum thickness portion (t5) to form the inner annular edge (101) and the outer annular edge (102), and can form the inner annular edge (101) and the outer annular edge (102) of the rounded corners while coming into contact with the rear slope (110).
[0258] In one embodiment of the present invention, the maximum thickness portion (t5) of the pupil expansion portion (105) may be formed at a central position between the inner annular edge (101) and the outer annular edge (102), and the pupil expansion portion (105) may include an inner portion (IA) between the maximum thickness portion (t5) and the inner annular edge (101), that is, an inner portion (IA) relatively adjacent to the central opening (OP), and an outer portion (OA) between the maximum thickness portion (t5) opposite to the inner portion (IA) and the outer annular edge (102), that is, an outer portion (OA) relatively far from the relatively central opening (OP).
[0259] As such, in one embodiment of the present invention, the pupil dilation part (105) may include an inner portion (IA) that is relatively close to the opening (OP) and an outer portion (OA) that is relatively far from the opening (OP), and may include the inner portion (IA) and the outer portion (OA) that have different thickness deviations. In one embodiment of the present invention, the fact that the inner portion (IA) and the outer portion (OA) of the pupil dilation part (105) have different thickness deviations may mean that, in one embodiment of the present invention, the pupil dilation part (105) including the inner portion (IA) and the outer portion (OA) has an asymmetrical thickness profile or an asymmetrical shape based on the maximum thickness portion (t5) that forms the boundary between the inner portion (IA) and the outer portion (OA). For example, the front curved surface (120) forming the inner portion (IA) can form a trajectory that is relatively close to the rear slope (110), and the front curved surface (120) forming the outer portion (OA) can form a trajectory that is relatively far from the rear slope (110), and a difference in thickness between the inner portion (IA) and the outer portion (OA) formed on both sides can be formed based on the maximum thickness portion (t5) of the pupil dilation portion (105). In one embodiment of the present invention, the fact that the inner part (IA) and the outer part (OA) of the pupil expansion part (105) have different thickness deviations may mean that, between the thickness integral of the inner part (IA) calculated along the slope direction over the entire length of the inner part (IA) from the rear slope (110) providing a thickness reference to the front curved surface (120), and the thickness integral of the outer part (OA) calculated along the slope direction over the entire length of the outer part (OA) from the rear slope (110) providing a thickness reference to the front curved surface (120), the thickness integral of the outer part (OA) has a relatively larger value than the thickness integral of the inner part (IA).For example, even when the lengths of the inner part (IA) and the outer part (OA) are different along the slope direction, when comparing the thickness integral of the inner part (IA) per unit length, which is obtained by dividing the thickness integral of the inner part (IA) by the length of the inner part (IA) following the slope direction, and the thickness integral of the outer part (OA) per unit length, which is obtained by dividing the thickness integral of the outer part (OA) by the length of the outer part (OA) following the slope direction, it may mean that the thickness integral of the outer part (OA) per unit length has a relatively larger value than the thickness integral of the inner part (IA) per unit length. Throughout the present specification, the average thickness of the inner part (IA) and the average thickness of the outer part (OA) may mean the thickness integral of the inner part (IA) per unit length and the thickness integral of the outer part (OA) per unit length, respectively.
[0260] In this way, in one embodiment of the present invention, the pupil expansion portion (105) may form a maximum thickness portion (t5) at a central position between the inner annular edge (101) and the outer annular edge (102), and may form an inner portion (IA) and an outer portion (OA) having differential average thicknesses on both sides of the maximum thickness portion (t5), and at this time, the inner portion (IA) formed with a relatively low average thickness may be introduced up to the discontinuous edge (DE) between the cornea of the large curvature portion formed in a convex shape protruding forward to include the lens, etc. in the sclera, and the sclera of the small curvature portion extending backward from the cornea, and by forming the average thickness of the inner portion (IA) introduced up to the discontinuous edge (DE) to be relatively low, a gap is not formed between the discontinuous edge (DE) and the inner portion (IA) between the cornea and the sclera of the eyeball (EB). In order to be inserted to a sufficient depth to the edge (DE), the medial portion (IA) can be formed with a relatively low average thickness. For example, in one embodiment of the present invention, the medial portion (IA) can be transplanted in a form that is inserted into a part of the eyeball (EB), and the medial portion (IA) can be inserted between the sclera and the conjunctiva through an incision (EBC) formed in the conjunctiva covering the sclera, and can be inserted to a sufficient depth to the discontinuous edge (DE) between the sclera and the cornea toward the front. The medial portion (IA) can be formed with a relatively low average thickness compared to the lateral portion (OA), and can be inserted into a narrow transplant space between the sclera and the conjunctiva secured through the procedure, and can be inserted to a sufficient depth to the discontinuous edge (DE) between the sclera and the cornea.For example, if the inner part (IA) of the pupil expansion part (105) is not formed with a sufficiently thin thickness, a gap may be formed between the inner part (IA) and the discontinuous edge (DE) between the sclera and the cornea, and the gap between the inner part (IA) and the discontinuous edge (DE) that is not sufficiently adhered to the discontinuous edge (DE) of the eyeball (EB) may cause adverse effects such as bacteria or inflammation (e.g., corneal ulcer due to infection by bacteria, viruses, fungi, etc.). For example, if the discontinuous edge (DE) between the sclera and the cornea and the inner side (IA) of the pupillary expansion portion (105) are not closely adhered to each other, the shape of the pupil or the pupil observed from the frontal direction (Z3) of the recipient's face may be distorted or dented, and thus an attractive appearance may not be provided (causing cosmetic problems). In addition, if the inner side (IA) of the pupillary expansion portion (105) is not formed to a sufficiently thin thickness but is formed to be thick, a corneal ulcer due to infection may occur as tears cannot sufficiently wet the cornea.
[0261] In one embodiment of the present invention, the outer portion (OA) can be formed with a relatively high average thickness compared to the inner portion (IA), and the outer portion (OA) can provide support rigidity of the entire ocular implant (100) through the relatively high average thickness. For example, in one embodiment of the present invention, the ocular implant (100) may be formed of a soft material, such as silicone, that is harmless to the human body and can flexibly adhere to the eyeball (EB). Even if formed of a soft material, a certain degree of support rigidity may need to be secured in consideration of ease of handling, such as production, packaging, and distribution, and ease of procedure for the procedure of the ocular implant (100). To this end, unlike the inner portion (IA) having a relatively low average thickness, the outer portion (OA) may be formed to have a relatively high average thickness in consideration of the support rigidity of the entire ocular implant (100) so as to be advantageous in adherence to the eyeball (EB) or a part of the tissue of the eyeball (EB) despite the structure of the eyeball (EB) being relatively disadvantageous in terms of adhesion, such as a discontinuous edge (DE). As described below, in one embodiment of the present invention, the ocular implant (100) may be formed of a soft material with excellent flexibility in that it is permanently implanted on the eye (EB), but may include an inner part (IA) with relatively excellent flexibility and an outer part (OA) with relatively excellent rigidity through differences in shape while being formed of a single material.
[0262] In one embodiment of the present invention, the inner portion (IA) may be formed relatively softly so as to be adaptively deformed to the pupil of each recipient, and the outer portion (OA) may be formed relatively rigidly so as to maintain a circular appearance prepared to counter deformation of the inner portion (IA) and to reinforce the softness of the inner portion (IA) to provide support rigidity of the ocular implant (100).
[0263] In one embodiment of the present invention, the inner portion (IA) needs to adhere to a geometrically specific point, such as a discontinuous edge (DE) formed by the sclera and the cornea, and, for example, can be finely adjusted according to the size of the cornea so as to adhere as closely to the cornea as possible, and the inner portion (IA) can provide relatively excellent ductility and can be formed with a relatively low average thickness. And, the outer portion (OA) may be placed on the sclera with a relatively small curvature at a location relatively far from a geometric singularity such as a discontinuous edge (DE) between the sclera and the cornea, for example, it may be placed on the sclera with a relatively small curvature closer to a slope than a curve from the sclera away from the discontinuous edge (DE) between the cornea and the sclera to the curvature (AC) of the sclera (less ductility for adhesion on the sclera is required), and in particular, it may be formed with a relatively high average thickness so as to supplement the rigidity of the inner portion (IA) with a relatively low average thickness and provide the supporting rigidity of the overall ocular implant (100). For example, in one embodiment of the present invention, the first average thickness of the inner portion (IA) formed by the posterior slope (110) and the anterior curved surface (120) and the second average thickness of the outer portion (OA) may satisfy a magnitude relationship of the first average thickness < the second average thickness.
[0264] In one embodiment of the present invention, the opening (OP) may be formed in an open shape so as not to obstruct the incidence of light, for example, so as not to obstruct the incidence of light toward the pupil (or iris) that provides the opening of the eyeball (EB), and the flexibility of the inner part (IA) of the pupil dilation part (105) may be increased through the opening (OP). For example, in one embodiment of the present invention, the inner part (IA) is preferably observed as an integral part of the pupil (or pupil) that forms the opening of the eyeball (EB) for receiving light, while surrounding the outer ring of the pupil adjacent to the pupil so as not to block the pupil. In particular, sufficient flexibility can be provided so as to enable adaptive length expansion and contraction so as to surround the outer ring of each differential pupil, taking into account the shape and size of the pupil that are differentially different depending on the physical condition of the recipient. To this end, in one embodiment of the present invention, unlike the comparative example that covers the central position with a transparent material so as not to obstruct the incidence of light, sufficient flexibility can be provided to the inner part (IA) through the opening (OP) at the central position that is in contact with the inner part (IA) so that it can be permanently transplanted in a manner customized to the physical condition of the recipient, for example, the shape and size of the pupil, without obstructing the incidence of light. As described below, in one embodiment of the present invention, the inner portion (IA) may include an adaptive elastic portion (151) that can adaptively provide elasticity in length so that the pupils of differentially formed shapes and sizes can be surrounded by the outer ring of the pupils at the closest positions despite the individual physical conditions of each recipient, and this adaptive elastic portion (151) may be formed at a position adjacent to the inner portion (IA) of the pupil expansion portion (105), for example, the inner annular edge (101) forming the end of the inner portion (IA).However, in various embodiments of the present invention, even without the additional adaptive elastic portion (151), a certain degree of length elasticity may be possible through the flexibility of the inner portion (IA) itself formed with a relatively low average thickness, for example, and deformation may be allowed to be customized to the shape and size of each individual pupil.
[0265] In one embodiment of the present invention, the pupil dilation portion (105) may include an inner portion (IA) having a relatively low average thickness and an outer portion (OA) having a relatively high average thickness, and may have an asymmetrical shape through the inner portions (IA) and the outer portions (OA) on both sides having different average thicknesses based on a maximum thickness portion (t5) formed at a central position between the inner annular edge (101) and the outer annular edge (102) of the pupil dilation portion (105). In one embodiment of the present invention, the inner portion (IA) and the outer portion (OA) may have an asymmetrical shape based on the maximum thickness portion (t5), and the inner annular edge (101) and the outer annular edge (102) forming the ends of each of the inner portions (IA) and the outer portion (OA) may also have asymmetrical shapes with respect to each other.
[0266] In one embodiment of the present invention, the pupil expansion part (105) includes a posterior slope (110) arranged toward the eye (EB) so as to be mounted on the eye (EB), and a front curved surface (120) formed with a thickness profile based on the posterior slope (110) arranged toward the outer world (OS) opposite to the eye (EB), such that the posterior slope (110) forms an inner annular edge (101) while contacting the posterior slope (110) at a position in contact with the opening (OP), and forms an outer annular edge (102) while contacting the posterior slope (110) at a position opposite to the opening (OP), and forms a maximum thickness portion (t5) between the inner annular edge (101) and the outer annular edge (102), so as to form a relatively thin inner portion (IA) and a relatively thick outer portion (OA). Can be.
[0267] In one embodiment of the present invention, with respect to the rear inclined surface (110), the front curved surface (120) forming a thickness profile on the rear inclined surface (110) can form a profile having a height and depth in the thickness direction along the slope direction of the rear inclined surface (110) so as to form a variable thickness from the rear inclined surface (110). For example, the front curved surface (120) forming such a thickness profile can be formed along a spline curve in which the curvature or radius of curvature changes along the slope direction of the rear inclined surface (110).
[0268] In one embodiment of the present invention, the inner annular edge (101) and the outer annular edge (102) may be formed in a rounded corner shape in which the front curved surface (120) and the rear inclined surface (110) forming the thickness of the pupil expansion portion (105) are in contact with each other. That is, in one embodiment of the present invention, both the inner annular edge (101) and the outer annular edge (102) may be formed in a rounded corner shape, and for example, may not be formed in an angular corner shape. At this time, even if both the inner annular edge (101) and the outer annular edge (102) are formed in a rounded corner shape, the curvature formed by the corner of the inner annular edge (101) and the curvature formed by the corner of the outer annular edge (102) may be set differentially from each other. For example, in one embodiment of the present invention, the curvature formed by the edge of the inner annular edge (101) may be formed to be smaller than the curvature formed by the edge of the outer annular edge (102), or in other words, the radius of curvature formed by the edge of the inner annular edge (101) may be formed to be larger than the radius of curvature formed by the edge of the outer annular edge (102).
[0269] In one embodiment of the present invention, the curvature of the corner of the inner annular edge (101) being set to be smaller than the curvature of the corner of the outer annular edge (102) may mean, in other words, that the corner of the inner annular edge (101) is formed in a relatively rounded shape, and may mean that it is formed in a more gentle round, or in other words, that the corner of the outer annular edge (102) is formed in a relatively sharply rounded shape.
[0270] In one embodiment of the present invention, an inner annular edge (101) that extends to a discontinuous edge (DE) between the cornea in the large curvature portion that protrudes convexly toward the front and the sclera in the small curvature portion extending posteriorly from the cornea among the membrane tissues that entirely surround the eyeball (EB) to maintain the shape of the eyeball (EB) can finish one side of the ocular implant (100) with a relatively gently rounded corner shape, and an outer annular edge (102) that adheres closely to the sclera in the large curvature portion can finish the other side of the ocular implant (100) with a relatively sharply rounded corner shape so as not to lift off from the sclera or form a gap between the sclera and the cornea.
[0271] In one embodiment of the present invention, the inner portion (IA) needs to be in close contact with a geometrically singular point, such as a discontinuous edge (DE) formed by the sclera and the cornea, and for example, the inner portion (IA) can be formed with a relatively low average thickness so as to be in close contact with the cornea as closely as possible by being finely adjusted according to the size of the cornea.
[0272] In this way, the inner portion (IA) may be formed with a relatively low average thickness in consideration of close contact with the discontinuous edge (DE) of the eyeball (EB), while being finished with a relatively gently rounded inner annular edge (101) in consideration of the possibility of damage to the internal tissue of the eyeball (EB). In one embodiment of the present invention, the inner annular edge (101), which is inserted into the interior of the eyeball (EB) or into a relatively complex transplant space such as a narrow transplant space or a discontinuous edge (DE) of the eyeball (EB) and forms contact with the internal tissue of the eyeball (EB), is formed in a relatively gently rounded shape, thereby preventing irritation or damage to the internal tissue of the eyeball (EB) through permanent surgery of the ocular implant (100).
[0273] In one embodiment of the present invention, the inner annular edge (101) can prevent irritation or damage to the internal tissue of the eye (EB) through a relatively gently rounded shape, and in contrast, the outer annular edge (102) can block adverse effects such as the penetration of foreign substances or bacteria through a relatively sharply rounded shape. The ocular implant (100) according to one embodiment of the present invention can be transplanted onto the sclera in a state relatively lifted from the surface of the sclera through the rounded corner of the outer annular edge (102), and for example, a gap can be provided between the ocular implant (100) and the sclera through the rounded corner of the outer annular edge (102). In one embodiment of the present invention, by forming the corner of the outer annular edge (102) relatively sharply, in other words, the front curved surface (120) forming the thickness of the outer portion (OA) forms a relatively high average thickness while forming a trajectory relatively far from the rear inclined surface (110), and then forms a sharply rounded corner at the outer annular edge (102) while following a relatively steep downward curve. In this way, the front curved surface (120) forming the thickness of the outer portion (OA) follows a steep downward curve as it approaches the outer annular edge (102) to form a sharply rounded outer annular edge (102) with the rear slope (110), and by closing the pupil expansion portion (105) through the sharply rounded outer annular edge (102), it is possible to form a gentle round while blocking the penetration and side effects of foreign substances, bacteria, viruses, etc. that may be caused by lifting from the surface of the cornea.
[0274] In one embodiment of the present invention, the specific cross-section of the pupil expansion part (105) including the front curved surface (120) and the rear inclined surface (110), and the inner annular edge (101) and the outer annular edge (102) where the front curved surface (120) and the rear inclined surface (110) are in contact with each other can be designed in various numbers and shapes according to the specific design, but for example, in one embodiment of the present invention, the maximum thickness part (t5) of the pupil expansion part (105) can be set to a thickness of 50 μm to 200 μm (for example, 120 μm), the edge of the inner annular edge (101) can be set to a thickness of 20 μm to 100 μm (for example, 40 μm), and the edge of the outer annular edge (102) can be set to a thickness of 60 μm to 200 μm (for example, It can be set to a thickness of 80 μm.
[0275] The thickness (t1) formed by the edge of the inner annular edge (101) may refer to the thickness between the inner inflection point (101`) of the front curved surface (120) and the rear inclined surface (110) when the front curved surface (120) forming the thickness profile on the rear inclined surface (110) forms the edge of the inner annular edge (101) by contacting the rear inclined surface (110) while following a more downward curve through the inner inflection point (101`). Similarly, the thickness (t2) formed by the edge of the outer annular edge (102) may mean the thickness between the outer inflection point (102`) of the front curved surface (120) and the rear inclined surface (110) when the front curved surface (120) forming the thickness profile on the rear inclined surface (110) forms the edge of the outer annular edge (102) by contacting the rear inclined surface (110) while following a more downward curve through the outer inflection point (102`).
[0276] In one embodiment of the present invention, the pupil expansion portion (105) may include a profile of a front curved surface (120) approaching a rearward slope (110) from a maximum thickness portion (t5) on both sides, and the profile of the front curved surface (120) may form an inner annular edge (101) and an outer annular edge (102) while contacting the rearward slope (110) while following a more steeply downward profile through an inner inflection point (101`) and an outer inflection point (102`). In one embodiment of the present invention, the distance from the outer annular edge (102) to the outer inflection point (102`) may be formed to be longer than the distance from the inner annular edge (101) to the inner inflection point (101`) along the slope direction. For example, in one embodiment of the present invention, the outer inflection point (102`) may be formed with a relatively deeper thickness moving downward to form a relatively sharply rounded outer annular edge (102) from a front curved surface (120) having a relatively high average thickness, and in other words, the inner inflection point (101`) may be formed with a relatively thinner thickness moving downward to form a relatively gently rounded inner annular edge (101) from a front curved surface (120) having a relatively low average thickness. From the above considerations, the distance from the outer inflection point (102`) to the outer annular edge (102) may be formed to be longer than the distance from the inner inflection point (101`) to the inner annular edge (101).
[0277] For example, in one embodiment of the present invention, the outer inflection point (102`) and the inner inflection point (101`) may mean points that are bent downward relatively sharply to form an outer annular edge (102) and an inner annular edge (101) along the profile of the front curved surface (120), and, for example, may mean two points that are bent downward at positions adjacent to the outer annular edge (102) and the inner annular edge (101), respectively, as two points with the greatest change in curvature through the profile of the front curved surface (120). In one embodiment of the present invention, the thickness (t2) of the edge of the outer annular edge (102) may be formed to be higher than the thickness (t1) of the edge of the inner annular edge (101), and the thickness of the edge of the outer annular edge (102) corresponding to the distance moving downward from the outer inflection point (102`) may be formed to be relatively higher so as to form a sharply rounded outer annular edge (102) from the outer portion (OA) having a relatively high average thickness.
[0278] For reference, throughout this specification, the thickness of the outer portion (OA) and the inner portion (IA), their average thickness, or the thickness (t2) of the edge of the outer annular edge (102), the thickness (t1) of the edge of the inner annular edge (101), etc. may correspond to the dimension of thickness that follows the vertical direction from the rear slope (110), and while expressing the relationship between the dimensions of thickness, they are expressed as being high or low similarly to the dimension of height, but this is for the convenience of understanding, and may mean being thick or thin, respectively, in the dimension of thickness.
[0279] In one embodiment of the present invention, the posterior inclined surface (110) may be formed as a surface inclined at a constant tilting angle (θ) from a vertical plane (G) perpendicular to the frontal direction (Z3) along the frontal direction (Z3) facing backward from the front where the pupil (or pupil) forming the opening for receiving light or the receptor that performs the function of the lens is formed, and the posterior inclined surface (110) may be formed to be inclined at a tilting angle (θ) of approximately 20 to 40 degrees on the vertical plane (G). In one embodiment of the present invention, the posterior inclined surface (110) may be in close contact with the sclera, and for example, may be in close contact with the sclera having a relatively small curvature closer to the slope than the curved surface from the discontinuous edge (DE) between the cornea and the sclera to the curved portion (AC) of the sclera. In one embodiment of the present invention, the section from the sclera beyond the discontinuous edge (DE) between the cornea and the sclera to the curvature (AC) of the sclera can be viewed as a roughly inclined plane rather than a curved surface, and the rear inclined plane (110) can be formed as an inclined plane inclined at a constant tilting angle (θ) on the vertical plane (G) so as to adhere closely to the sclera having a small curvature close to the inclined plane.
[0280] In one embodiment of the present invention, the posterior slope (110) can be closely adhered to a surface of the cornea that is formed approximately as an inclined surface or close to an inclined surface, and depending on the flexibility of the ocular implant (100) including the posterior slope (110) or the posterior slope (110), the posterior slope (110) can be closely adhered to the cornea. In one embodiment of the present invention, the posterior slope (110) can be formed as an inclined surface inclined at a constant tilting angle (θ) from a vertical plane (G), thereby forming a support surface of the entire ocular implant (100). As described below, the packaging container of the ocular implant (100) according to one embodiment of the present invention may include an inclined support surface formed to support the rear inclined surface (110), and considering the ease of manufacturing the ocular implant (100) and the packaging container of the ocular implant (100), the rear supporting surface of the ocular implant (100) and the supporting surface of the packaging container may be formed to follow the same constant inclined profile so as to provide a firm supporting force therebetween.
[0281] In one embodiment of the present invention, the inner annular edge (101) and the outer annular edge (102) may be observed as having an oval and a circle, respectively, along a frontal direction (Z3) from the front of the eye (EB) where a crystalline lens performing a lens function and a pupil (or pupil) forming an entrance opening for light are arranged toward the back of the eye (EB), and the rearward inclined surface (110) may be formed as a surface inclined at a constant tilting angle (θ) from a vertical plane (G) perpendicular to the frontal direction (Z3) such that the inner annular edge (101) and the outer annular edge (102) form a front position and a rear position, respectively.
[0282] According to one embodiment of the present invention, the ocular implant (100) may take a form in which the inner annular edge (101) at the front position and the outer annular edge (102) at the rear position overlap each other according to the slope of the rear slope (110) that provides the thickness as a reference when observed in the frontal direction (Z3), and the oval of the inner annular edge (101) is included within the circle of the outer annular edge (102). At this time, the pupil expansion portion (105) between the inner annular edge (101) and the outer annular edge (102) is formed so that one of the two positions along the short axis direction (Z2) of the inner annular edge (101) has a wider width than the other other position, and the oval of the inner annular edge (101) is biased toward the other position within the circle of the outer annular edge (102). Can be formed at a location. As described below, one side of the pupil expansion portion (105) formed with a relatively wide width among the two sides along the elliptical short axis direction (Z2) of the inner annular edge (101) may correspond to the central location (S) of the procedure, and at one side of the pupil expansion portion (105), a first end (E1, E2) separated from each other through an incision (C) and the incision (C), and a hole (10) for the procedure, a catch joint, a hook joint, etc. for binding the first and second ends (E1, E2) toward each other may be formed.
[0283] In one embodiment of the present invention, the inner annular edge (101) and the outer annular edge (102) can surround the opening (OP) along different shapes, for example, the inner annular edge (101) can be formed in an oval shape along the shape of the pupil so as to not cover the pupil (or pupil) forming the light entrance opening, but to surround the outer ring of the pupil at an adjacent position so as to provide an appearance integrated with the pupil, and the outer annular edge (102) can be formed in a circular shape so as to provide an appearance of an attractive circle. For example, the inner annular edge (101) may be formed into an ellipse having different major axis lengths (L1) and minor axis lengths (L2), wherein the major axis length (L1) may be formed along a direction in which a pair of eyes of the transplanter face each other, and the minor axis length (L2) may be formed along a direction perpendicular to the major axis length (L1).
[0284] As such, in one embodiment of the present invention, the inner annular edge (101) surrounding the outer ring of the pupil of the recipient may be formed into an elliptical shape according to the shape of the pupil of the recipient, and may be deformed into an elliptical shape optimized for the individual physical condition of the recipient, for example, the shape and size of the pupil formed differentially for each recipient. For example, based on the shape ratio between the major axis length (L1) and the minor axis length (L2) of the pupil may be formed into a 9 mm to 15 mm (ex. 12 mm) and a 8 mm to 14 mm (ex. 11 mm) for the adult, and the shape of the pupil may be formed into a slip-shaped ellipse in which the major axis length (L1) is relatively longer than the average shape, or a prolate ellipse in which the minor axis length (L2) is relatively longer than the average shape, depending on the shape ratio between the major axis length (L1) and the minor axis length (L2).
[0285] Hereinafter, an ocular implant (100) according to another aspect of the present invention will be described, which includes an adaptive elastic portion (151) that adaptively provides length expansion along the perimeter of an inner annular edge (101), and a roughened surface (152, 153) for generating rotational resistance in the rotational direction along the perimeter of a pupil expansion portion (105) formed between the inner annular edge (101) and the outer annular edge (102).
[0286] FIG. 6 is a perspective view illustrating an adaptive elastic member (151) applied to an ocular implant (100) according to one embodiment of the present invention.
[0287] FIG. 7 is a perspective view illustrating an adaptive elastic portion (151) applied to an ocular implant (100) according to one embodiment of the present invention, and is a perspective view illustrating a modified example of FIG. 6.
[0288] FIGS. 8a and 8b are cross-sectional views of an ocular implant (100) taken along the circumferential direction of a pupil dilatation portion (105), and illustrate cross-sectional views for explaining different roughness processing surfaces (152, 153) having isotropic rotational resistance and anisotropic rotational resistance, respectively.
[0289] The ocular implant (100) according to the above aspects is:
[0290] An ocular implant (100) that is permanently implanted on the recipient's eye (EB) to provide an enlarged appearance to the recipient's pupil,
[0291] A central opening (OP) that admits light toward the pupil (or iris), which provides the opening of the eyeball (EB);
[0292] An inner annular edge (101) defining the opening (OP) by surrounding the opening (OP);
[0293] An outer annular edge (102) surrounding the opening (OP) together with the inner annular edge (101) on the opposite side of the inner annular edge (101) defining the opening (OP); and
[0294] It may include an adaptive elastic member (151) that adaptively provides length expansion along the perimeter of the inner annular edge (101).
[0295] For example, the adaptive elastic member (151) may provide longitudinal elasticity along the perimeter of the inner annular edge (101) so as to adaptively change to the shape and size of the pupil of each transplant recipient.
[0296] For example, the inner annular edge (101) is formed in an elliptical shape having different major axis lengths (L1) and minor axis lengths (L2),
[0297] The adaptive elastic portion (151) can provide length expansion along the major axis direction (Z1) and / or the minor axis direction (Z2) to adaptively provide an inner annular edge (101) of a slip-shaped ellipse whose major axis length (L1) is relatively elongated and / or the minor axis length (L2) is shortened, and a root-shaped ellipse whose major axis length (L1) is relatively shortened and / or the minor axis length (L2) is elongated, to suit the pupil of the recipient.
[0298] For example, the adaptive elastic member (151) may include at least one slit (151s) formed around the perimeter of the inner annular edge (101).
[0299] For example, the adaptive elastic member (151) may include a plurality of slits (151s) formed spaced apart from each other along the perimeter of the inner annular edge (101).
[0300] For example, the plurality of slits (151s) may be formed spaced apart from each other at equal intervals along the perimeter of the inner annular edge (101).
[0301] For example, the adaptive elastic member (151) may include a group of slits (151s) formed at both sides along the longitudinal direction (Z1) and / or at both sides along the short-axis direction (Z2).
[0302] For example, the above adaptive elastic member (151)
[0303] The pieces divided into the first and second groups (151s) formed at both sides along the above-mentioned shortened direction (Z2) overlap each other to extend the shortened length (L2) and shorten the long axis direction (Z1).
[0304] The pieces divided through the slits (151s) of the third and fourth groups formed at both sides along the longitudinal direction (Z1) can overlap each other to extend the longitudinal length (L1) and shorten the short-axis length (L2).
[0305] For example, the slit (151s) can be formed at positions at angles spaced apart by a constant angle, with the center (O) of the opening (OP) where the major axis length (L1) and the minor axis length (L2) of the inner annular edge (101) intersect each other as the rotation center.
[0306] For example, the above slit (151s)
[0307] First and second groups of slits (151s) formed at 0 degree angle positions (A1) and 180 degree angle positions (A2) corresponding to both sides along the above-mentioned short-axis direction (Z2); and
[0308] It may include third and fourth groups of slits (151s) formed at 90 degree angle positions (A3) and 270 degree angle positions (A4) corresponding to both sides along the longitudinal direction (Z1).
[0309] For example, the slit (151s) may be introduced into the interior of the pupil expansion portion (105) along a depth direction from the inner annular edge (101) toward the outer annular edge (102).
[0310] For example, the slit (151s) can be introduced into the interior of the pupil expansion portion (105) in a radial direction in the depth direction from the center (O) of the opening (OP) where the major axis length (L1) and the minor axis length (L2) intersect.
[0311] For example, the adaptive elastic member (151) can stretch the length of the inner annular edge (101) by overlapping pieces divided from each other through the slits (151s) along the perimeter of the inner annular edge (101).
[0312] For example, the pupil dilation part (105)
[0313] A rear slope (110) positioned toward the eyeball (EB) so as to adhere closely to the eyeball (EB); and
[0314] A front curved surface (120) is disposed toward the outer world (OS) opposite to the above-mentioned eye (EB), and forms a thickness profile based on the rear slope (110), such that an inner annular edge (101) is formed while contacting the rear slope (110) at a position in contact with the opening (OP), an outer annular edge (102) is formed while contacting the rear slope (110) at the opposite side of the opening (OP), and a maximum thickness portion (t5) forming a maximum thickness between the inner annular edge (101) and the outer annular edge (102) is formed, and a front curved surface (120) forms a thickness profile based on the rear slope (110) so as to form a relatively thin inner portion (IA) and a relatively thick outer portion (OA),
[0315] The pieces divided through the slits (151s) forming the above-described adaptive elastic portion (151) can be overlapped with each other to increase the thickness of the inner portion (IA) where the slits (151s) introduced from the inner annular edge (101) are formed while stretching the length of the inner annular edge (101), thereby forming an extra thickness.
[0316] For example, the adaptive elastic portion (151) is formed on the inner annular edge (101) surrounding the outer ring of the pupil at a position relatively closer to the outer annular edge (102) so as to adaptively deform to the shape and size of the pupil of each transplant recipient.
[0317] In order to maintain a beautiful circular appearance against deformation of the inner annular edge (101), the outer annular edge (102) may not be formed.
[0318] For example, the inner annular edge (101) in which the pieces divided through the slit (151s) forming the adaptive elastic portion (151) are arranged to overlap each other is formed in a relatively gently rounded corner shape,
[0319] The above outer annular edge (102) can be formed in a relatively sharply rounded corner shape.
[0320] In an ocular implant (100) according to one embodiment of the present invention, the shape and size of the pupil corresponding to the enlargement target can be differentially formed according to the physical condition of the recipient, and the inner annular edge (101) can absorb the shape and size of the pupil according to the individual physical condition of the recipient so as to form an enlarged pupil that is integrated with the pupil without blocking the pupil (or pupil) that forms the light entrance opening. The ocular implant (100) can include an adaptive elastic portion (151) that can adaptively expand in length along the circumference of the inner annular edge (101) so as to be able to adaptively change in length to the shape and size of the pupil of each recipient. For example, in one embodiment of the present invention, the adaptive elastic portion (151) can provide expansion in length along the circumference of the inner annular edge (101) so as to be adaptively deformed to the shape and size of the pupil of each recipient.
[0321] In the present specification, the adaptive elastic portion (151) adaptively provides length expansion along the circumferential direction of the inner annular edge (101), which may include providing length expansion along one of the elliptical major axis direction (Z1) and minor axis direction (Z2) of the inner annular edge (101), or providing length expansion along the other direction, and may include expanding or shortening the circumference of the inner annular edge (101) as a whole without being restricted to a specific direction.
[0322] In one embodiment of the present invention, the adaptive elastic portion (151) may include a plurality of slits (151s) formed in the inner annular edge (101) or the pupil dilatation portion (105) adjacent to the inner annular edge (101). For example, the adaptive elastic portion (151) may include at least one slit (151s) formed around the periphery of the inner annular edge (101), and in one embodiment of the present invention, the adaptive elastic portion (151) may include a plurality of slits (151s) spaced apart from each other along the circumferential direction of the inner annular edge (101) and introduced from the inner annular edge (101) toward the pupil dilatation portion (105).
[0323] For example, as a surgeon performing an ocular implant (100), rather than manufacturing each ocular implant (100) customized to the shape and size of the individual pupil of the implant recipient, a surgeon may manufacture an ocular implant (100) that can be performed universally but is designed to be adaptively stretchable to the shape and size of each individual pupil, and then, during the surgery, adaptively stretch to fit the shape and size of the pupil of each recipient, thereby performing an ocular implant (100) optimized for the shape and size of the pupil that is differentially formed. In this way, rather than introducing individually formed molds to manufacture each differently individualized ocular implant (100), forming a plurality of ocular implants (100) through a mold of a universal single design can reduce the manufacturing cost, thereby promoting an economical product design.
[0324] In one embodiment of the present invention, the adaptive elastic portion (151) may include a plurality of slits (151s) formed to be spaced apart from each other along the periphery of the inner annular edge (101), and the slits (151s) may be introduced from the inner annular edge (101) toward the pupil expansion portion (105) from each position along the periphery of the inner annular edge (101). For example, in one embodiment of the present invention, the inner annular edge (101) may correspond to an innermost configuration surrounding the outer ring of the pupil in the ocular implant (100), for example, a configuration directly surrounding the outer ring of the pupil, or a configuration in which elastic deformation is induced for a design optimized for the shape and size of the pupil of each implant operator. In one embodiment of the present invention, the inner annular edge (101) can be deformed with a high degree of freedom according to the optimized shape or size, for example, shape deformation such as distortion and deformation such as overall length expansion, through the adaptive expansion portion (151), so as to be optimized for the shape and size of the pupil of each implant operator, that is, to surround pupils of various shapes and sizes at the closest position and not to block the pupil (or pupil) corresponding to the light entrance aperture. In this specification, the length expansion of the inner annular edge (101) can comprehensively mean both shape deformation such as distortion of the inner annular edge (101) as described above and expansion of the overall length of the inner annular edge (101).
[0325] In one embodiment of the present invention, the adaptive elastic portion (151) may include a plurality of slits (151s) spaced apart from each other along the perimeter of the inner annular edge (101), for example, the plurality of slits (151s) may be formed at equal intervals along the perimeter of the inner annular edge (101), for example, may be formed at equal angular positions spaced apart at a constant angle with the center (O) of the opening (OP) as the rotation center.
[0326] In one embodiment of the present invention, the slits (151s) forming the adaptive elastic portion (151) can be introduced into the interior of the pupil dilatation portion (105) along a depth direction from the inner annular edge (101) toward the outer annular edge (102). More specifically, each slit (151s) forming the adaptive elastic portion (151) can be formed in a shape that is introduced from the inner annular edge (101) toward the interior of the pupil dilatation portion (105), for example, each slit (151s) can be introduced from each location of the inner annular edge (101) toward the interior of the pupil dilatation portion (105) along a direction perpendicular to the inner annular edge (101). In various embodiments of the present invention, the slit (151s) may be introduced from the inner annular edge (101) in a direction perpendicular to the inner annular edge (101) or may be introduced radially from the inner annular edge (101). For example, in various embodiments of the present invention, the slit (151s) may be introduced into the inner pupil dilation portion (105) adjacent to the inner annular edge (101) in a radial depth direction toward the center (O) of the opening (OP) surrounded by the inner annular edge (101). For example, throughout the present specification, the center (O) of the opening (OP) surrounded by the inner annular edge (101) may mean the center (O) of the opening (OP) where the major axis length (L1) and the minor axis length (L2) of the elliptical inner annular edge (101) or the elliptical opening (OP) intersect each other.However, in various embodiments of the present invention, the slit (151s) can be introduced into the pupil expansion portion (105) in various directions from the inner annular edge (101), and the depth direction in which the slit (151s) is introduced can be variously set according to the shape formed by the inner annular edge (101), for example, an elliptical shape formed by the inner annular edge (101), and, as described below, according to the deformation of the inner annular edge (101) induced according to the individual physical condition of the implant recipient.
[0327] In one embodiment of the present invention, the slits (151s) forming the adaptive elastic portion (151) may be formed in the range of 30 to 360 along the periphery of the inner annular edge (101), and for example, when they are evenly spaced apart at a constant angle, they may be formed in the range of 30 at an angle of approximately 12 degrees, or in the range of 360 at an angle of approximately 1 degree. In addition, the width (d) of the slits (151s) forming the adaptive elastic portion (151) may be formed to be approximately 1 / 4 to 1 / 2 of the width of the pupil expansion portion (105) between the inner annular edge (101) and the outer annular edge (102) along the depth direction from the inner annular edge (101) toward the outer annular edge (102).
[0328] In one embodiment of the present invention, the inner annular edge (101) may be formed into an oval shape having different major axis lengths (L1) and minor axis lengths (L2), and the adaptive elastic portion (151) may provide a length extension along the major axis direction (Z1) and / or the minor axis direction (Z2) to adaptively provide an inner annular edge (101) of a slip-type oval shape in which the major axis length (L1) is relatively elongated and / or the minor axis length (L2) is shortened, and a root-type oval shape in which the major axis length (L1) is relatively shortened and / or the minor axis length (L2) is elongated, to suit the pupil of the recipient.
[0329] The inner annular edge (101) or the pupillary expansion portion (105) adjacent to the inner annular edge (101) may be divided into a plurality of pieces along the circumferential direction of the inner annular edge (101) through each slit (151s), and the length of the inner annular edge (101) may be expanded and contracted as the plurality of pieces divided into both sides of each slit (151s) along the circumferential direction of the inner annular edge (101) overlap each other. For example, in one embodiment of the present invention, an adaptive expansion portion (151) including an array of a plurality of slits (151s) may be deformed so that the shape and length of the entire inner annular edge (101) may be expanded and contracted as the pieces divided through each slit (151s) overlap each other so as to be close to each other through the slits (151s).
[0330] In one embodiment of the present invention, the inner annular edge (101) to which the adaptive elastic portion (151) is applied or the inner portion (IA) having the inner annular edge (101) as an end portion can be relatively freely deformed while being formed with a relatively low average thickness, and for example, the inner portion (IA) with a relatively low average thickness can provide a free space along the thickness direction so as to accommodate overlapping of pieces divided through the slit (151s). In one embodiment of the present invention, the adaptive elastic portion (151) formed on the inner annular edge (101) and the inner portion (IA) formed with a relatively low average thickness and having the inner annular edge (101) as an end can cooperate with each other to adaptively deform the inner annular edge (101) into a shape and size optimized according to the physical condition of the implant surgeon. For example, the inner annular edge (101) formed with a relatively low average thickness can provide a ductility that is advantageous for deforming the pieces divided through the slit (151s) to overlap each other while approaching each other, and further, the inner portion (IA) formed with a relatively low average thickness can provide a space that can accommodate the extra thickness formed when the pieces divided through the slit (151s) overlap each other.
[0331] For example, in one embodiment of the present invention, the pupil expansion portion (105) has a posterior slope (110) arranged toward the eyeball (EB) so as to be in close contact with the eyeball (EB), and is arranged toward the outer world (OS) opposite to the eyeball (EB), and forms a thickness profile based on the posterior slope (110), and forms an inner annular edge (101) by contacting the posterior slope (110) at a position in contact with the opening (OP), and forms an outer annular edge (102) by contacting the posterior slope (110) at the opposite side of the opening (OP), and forms a maximum thickness portion (t5) that forms the maximum thickness between the inner annular edge (101) and the outer annular edge (102), and forms a thickness profile based on the posterior slope (110) to form a relatively thin inner portion (IA) and a relatively thick outer portion (OA). The pieces that can include a curved surface (120) and are divided into pieces through the slits (151s) forming the adaptive elastic portion (151) can overlap each other to increase the thickness of the inner portion (IA) where the slits (151s) introduced from the inner annular edge (101) are formed while stretching the length of the inner annular edge (101), thereby forming an extra thickness.
[0332] In one embodiment of the present invention, the pupil surrounded by the inner annular edge (101) may be formed in an oval shape having different major axis lengths (L1) and minor axis lengths (L2) when observed in a frontal direction (Z3), and the major axis length (L1) of the oval formed by the pupil may be formed along a direction in which a pair of eyes face each other, and the minor axis length (L2) of the oval formed by the pupil may be formed along a direction perpendicular to the major axis length (L1). For example, the major axis length (L1) formed by the pupil may be formed to be 9 mm to 15 mm, and the minor axis length (L2) formed by the pupil may be formed to be 8 mm to 14 mm. That is, the shape and size of the pupil to be enlarged by the ocular implant (100) according to one embodiment of the present invention may have the above deviations, and for example, even if the pupil has different minor axis lengths (L2) and major axis lengths (L1), it may be formed into different elliptical shapes and different sizes due to the dispersion of lengths as described above. For example, in one embodiment of the present invention, the shape and size of the inner annular edge (101) may need to be transformed into a slip-like ellipse having a relatively longer major axis length (L1) and / or a relatively shorter minor axis length (L2) compared to the average shape and size, or may need to be transformed into a proto-ellipse approaching a circle while having a relatively longer minor axis length (L2) and / or a relatively shorter major axis length (L1), depending on the physical condition of each individual implant recipient. Throughout this specification, different shapes of ellipses, such as slip-shaped ellipses or root-shaped ellipses, may be defined according to the relative shape ratio between the major axis length (L1) and the minor axis length (L2), and may not mean the individual lengths or absolute lengths of the major axis length (L1) and the minor axis length (L2).For example, the fact that the major axis length (L1) is relatively elongated or the minor axis length (L2) is relatively elongated to optimize the shape and size of the recipient's differential pupil may mean that the adaptive elastic portion (151) is induced to change the relative shape ratio of the major axis length (L1) and the minor axis length (L2) defining the elliptical shape of the inner annular edge (101) surrounding the outer ring of the recipient's pupil.
[0333] In one embodiment of the present invention, the inner annular edge (101) surrounding the pupil can be designed to fit the shape and size of an average pupil without requiring deformation of a separate adaptive elastic portion (151) or the inner portion (IA), and a single-design ocular implant (100) that can be universally operated can be manufactured to fit the shape and size of an average pupil without deformation. For example, in one embodiment of the present invention, the shape of the opening (OP) surrounded by the inner annular edge (101) can be formed into an oval shape having a relatively long major axis length (L1) and a relatively short minor axis length (L2), and for example, the major axis length (L1) and the minor axis length (L2) of the oval shape formed by the central opening (OP) can be formed to be 12 mm and 11 mm to fit the average pupil.
[0334] In one embodiment of the present invention, a plurality of slits (151s) may be formed along the perimeter of the inner annular edge (101), and the plurality of slits (151s) may be formed evenly along the entire perimeter of the inner annular edge (101). For example, the plurality of slits (151s) formed evenly along the perimeter of the inner annular edge (101) may induce different deformations according to the individual physical conditions of each implant recipient. For example, in one embodiment of the present invention, in order to optimize the slip-type oval pupil, which needs to further extend the major axis length (L1), the pieces divided through slits (151s) formed at both sides along the major axis length (L1) of the inner annular edge (101) may be overlapped with each other to extend the major axis length (L1) instead of shortening the minor axis length (L2), depending on the shape of the pupil of the implant recipient with each different physical condition from the oval-shaped inner annular edge (101) where no deformation is induced. Conversely, in order to optimize the proto-oval pupil, which needs to further extend the minor axis length (L2), the pieces divided through slits (151s) formed at both sides along the minor axis length (L2) of the inner annular edge (101) may be overlapped with each other to extend the minor axis length (L2) instead of shortening the major axis length (L1).
[0335] In one embodiment of the present invention, through the inner annular edge (101) which is deformed into an optimized shape at each location where each slot is formed through slots which are evenly formed along the circumference of the inner annular edge (101), for example, deformation can be flexibly absorbed according to deformation induced in the inner annular edge (101), and depending on the degree and direction of deformation induced in the inner annular edge (101), damage to the ocular implant (100) including the inner annular edge (101) can be prevented from being formed by distortion without maintaining coplanarity due to the excess inner annular edge (101) or from being caused by excessive stress and stress accumulation due to the insufficient inner annular edge (101). However, in various embodiments of the present invention, considering that the maximum deformation may be required in the slits (151s) formed on both sides of the major axis length (L1) and the slits (151s) formed on both sides of the minor axis length (L2) depending on the shape of the pupil, such as a slip-shaped oval or a near-oval, and considering that the rigidity of the overall ocular implant (100) may be reduced and the handling during distribution or surgery may be reduced due to the slits (151s) being formed in a large number of evenly spaced positions, the adaptive elastic portion (151) may include a plurality of slits (151s) formed concentratedly at both sides along the major axis length (L1) and a plurality of slits (151s) formed concentratedly at both sides along the minor axis length (L2), and, for example, when observed in the frontal direction (Z3), along the perimeter of the inner annular edge (101), at a 0 degree angle position (A1), a 90 degree angle position (A3), It may include a plurality of slits (151s) formed intensively at 180 degree angular positions (A2) and 270 degree angular positions (A4), and for example, a plurality of slits (151s) may be formed intensively at angular positions spaced approximately 90 degrees apart so as to be able to track a major deformation.For example, in one embodiment of the present invention, the adaptive elastic portion (151) may include a first group of slits (151s) formed at 0 degree angle positions (A1) corresponding to opposite positions along the short axis direction (Z2) along the perimeter of the inner annular edge (101) and a second group of slits (151s) formed at 180 degree angle positions (A2), and the first and second groups of slits (151s) formed at 0 degree angle positions (A1) and 180 degree angle positions (A2), respectively, are formed at opposite positions along the short axis direction (Z2), thereby providing elongation of the short axis length (L2) or shortening of the long axis length (L1), and further, the adaptive elastic portion (151) may include a third group of slits (151s) formed at 90 degree angle positions (A3) corresponding to opposite positions along the long axis direction (Z1) along the perimeter of the inner annular edge (101). It may include a slit (151s) of the third group formed at a 90 degree angle position (A3) and a 270 degree angle position (A4) of the fourth group, and the slits (151s) of the third and fourth groups formed at the 90 degree angle position (A3) and the 270 degree angle position (A4) are formed at positions on both sides along the long axis direction (Z1), thereby providing an extension of the long axis length (L1) or a shortening of the short axis length (L2).
[0336] In one embodiment of the present invention, a plurality of slits (151s) forming the adaptive elastic portion (151) may be formed at equal intervals with a constant angle between them along the periphery of the inner annular edge (101), but the first to fourth groups of slits (151s) arranged with a 90-degree angle between them, which contributes relatively greatly to the elasticity of the major axis length (L1) and the elasticity of the minor axis length (L2), or arranged at opposite positions in the major axis direction (Z1) and the minor axis direction (Z2), may be formed intensively around the 0-degree angle position (A1), the 90-degree angle position (A3), the 180-degree angle position (A2), and the 270-degree angle position (A4), for example, the first to fourth groups of slits (151s) may be formed at an outer angle from the inner annular edge (101) than the other slits (151s). It can be formed at a deeper depth along the depth direction toward the annular edge (102) or can be formed with a tighter angle between them.
[0337] For example, in one embodiment of the present invention, the adaptive elastic member (151) may include a first group of slits (151s) concentratedly arranged around a 0 degree angle position (A1), a second group of slits (151s) concentratedly formed around a 180 degree angle position (A2), a third group of slits (151s) concentratedly arranged around a 90 degree angle position (A3), and a fourth group of slits (151s) concentratedly arranged around a 270 degree angle position (A4), and each of the first to fourth groups of slits (151s) may be formed in a different number, for example, may include at least one slit (151s). In various embodiments of the present invention, the first to fourth groups of slits (151s) may each include one slit (151s), and may each include a single slit (151s) formed at a 0 degree angle position (A1), a 90 degree angle position (A3), a 180 degree angle position (A2), and a 270 degree angle position (A4).
[0338] In various embodiments of the present invention, at angular positions corresponding to both sides along the major axis direction (Z1) and both sides along the minor axis direction (Z2), that is, at angular positions arranged at a 90-degree angle where a relatively high degree of deformation is required, slits (151s) inserted at a relatively deep depth or slits (151s) arranged with a relatively tight angle between them may be formed, and at the remaining angular positions, slits (151s) inserted at a relatively thin depth or slits (151s) arranged with a relatively tight angle between them may be formed.
[0339] In one embodiment of the present invention, the adaptive elastic portion (151) may not be formed on the outer annular edge (102). For example, in one embodiment of the present invention, the adaptive elastic portion (151) formed on the inner annular edge (101) is formed in consideration of the shape and size of the pupil that is formed differentially for each individual, and is a configuration for inducing deformation so that a single-design ocular implant (100) that can be universally operated or a single-design mold can be used to drastically reduce the manufacturing cost while enabling permanent implantation in a shape optimized for the individual physical condition of each implant recipient. In contrast, the outer annular edge (102) may not be formed with a structure that induces deformation or is advantageous to deformation. For example, when a structure advantageous to deformation, such as a slit (151s), is formed on the outer annular edge (102), the deformation induced in the inner annular edge (101) is followed while unintended deformation of the outer annular edge (102) is prevented. Accordingly, the originally designed circular appearance can be prevented from being damaged, thereby preventing the beautiful appearance imparted to the outer annular edge (102) from being damaged, and the beautiful circular appearance as originally designed can be maintained. As such, in one embodiment of the present invention, the outer annular edge (102) is formed in a circular shape, thereby increasing the satisfaction with the appearance, and a structure (adaptive elastic portion 151) that is advantageous to deformation, such as a slit (151s), may not be formed on the outer annular edge (102) so as to maintain the circular appearance of the outer annular edge (102) despite deformation induced in the inner annular edge (101), for example, excessive deformation induced in the inner annular edge (101) to match a slip-type oval pupil or a root-type oval pupil.
[0340] In one embodiment of the present invention, the outer annular edge (102) can be formed with a relatively higher rigidity than the inner annular edge (101), and can be formed with a relatively higher average thickness than the inner annular edge (101) so as to form a difference in rigidity through different shape designs while being formed with the same material, and accordingly, in one embodiment of the present invention, the outer annular edge (102) can have a higher shape stability or shape retention force than the inner annular edge (101), and can maintain a beautiful circular shape despite deformation induced in the inner annular edge (101).
[0341] In one embodiment of the present invention, the pupillary expansion portion (105) forming the ocular implant (100) or the body of the ocular implant (100) may include a posterior slope (110) facing the eyeball (EB) and a front curved surface (120) facing the outer world (OS) opposite the eyeball (EB). In one embodiment of the present invention, the outer world (OS) opposite the eyeball (EB) may mean the outer world of the eyeball (EB) itself rather than the outer world of the body, and for example, a body tissue such as an eyelid covering the front of the eyeball (EB) may also correspond to the outer world (OS) of the eyeball (EB).
[0342] The above ocular implant (100) can be transplanted onto the sclera so that the posterior slope (110) adheres closely to the sclera, and can be formed with a roughened surface (152, 153) having an appropriate roughness to generate appropriate friction with the sclera. In other words, the posterior slope (110) and the anterior curved surface (120) can be formed with different roughnesses or different roughnesses, and the posterior slope (110) can be formed with a roughened surface (152, 153) so as to have an appropriate roughness or roughness capable of inducing friction, and the anterior curved surface (120) can be formed with a smooth surface so as to form an attractive appearance.
[0343] In one embodiment of the present invention, the ocular implant (100) may be formed in a rotationally asymmetric shape rather than a rotationally symmetric shape. For example, the inner annular edge (101) surrounding the pupil of the ocular implant (100) may be formed in an elliptical shape having different major axis lengths (L1) and minor axis lengths (L2). The ocular implant (100) formed in such a rotationally asymmetric shape may be arbitrarily rotated on the eyeball (EB) formed in a spherical shape. For example, since it is difficult to adjust the position of the ocular implant (100) after permanent surgery, the posterior slope (110) facing the eyeball (EB) may be formed as a roughened surface (152, 153) formed with an appropriate roughness to induce friction so as to maintain the direction of the major axis length (L1) and the minor axis length (L2) and prevent arbitrary rotation on the eyeball (EB). For example, in one embodiment of the present invention, the rear inclined surface (110) may be formed in any shape capable of inducing friction, and may be formed in any concave-convex shape capable of forming a roughness. In one embodiment of the present invention, the rear inclined surface (110) may include a roughened surface (152, 153) in which a concave-convex shape is repeatedly formed continuously, such as a wave shape, and in various embodiments of the present invention, the roughened surface (152) may be formed to have an isotropic rotational resistance so as to induce the same friction along one rotational direction and an opposite rotational direction, or the roughened surface (153) may be formed to have an anisotropic rotational resistance so as to induce different friction along one rotational direction and an opposite rotational direction.
[0344] For example, when the ocular implant (100) is transplanted through the transplant space between the conjunctiva and the sclera secured from the incision (EBC) formed on the conjunctiva covering the sclera in the procedure of the ocular implant (100), a relatively small rotational resistance is applied along the transplantation direction through the roughened surface (153) providing anisotropic rotational resistance, but a relatively high rotational resistance is applied when the ocular implant (100) once transplanted tries to rotate arbitrarily in a direction opposite to the transplantation direction. For example, the roughened surface (153) providing the anisotropic rotational resistance may be formed in a waveform having an anisotropy along the rotational direction, for example, a relatively lying-down waveform may be formed along one rotational direction corresponding to the transplantation direction, a relatively low rotational resistance may be formed through a gently sloping waveform along one rotational direction corresponding to the transplantation direction, and a relatively low rotational resistance may be formed through a waveform having a gentle slope along one rotational direction corresponding to the transplantation direction, and a relatively high rotational resistance may be applied in the opposite direction to the transplantation direction. A relatively high rotational resistance can be formed through a steeply inclined waveform along the rotational direction. In one embodiment of the present invention, the roughened surface (152, 153) formed on the rear inclined surface (110) can be formed along the periphery of the pupil expansion portion (105), and for example, can be implanted along one rotational direction to surround the outer ring of the pupil, and a relatively small rotational resistance can be formed along one rotational direction, and a relatively large rotational resistance can be formed along an opposite rotational direction different from one rotational direction, thereby providing a position fixing force for the surgical position of the ocular implant (100).
[0345] In this way, the inner annular edge (101) is configured to surround the pupil of the recipient at the closest position, and is formed at a position that does not overlap with the pupil so as not to obstruct the incidence of light toward the pupil, that is, while surrounding the outer ring of the pupil, considering that if it is excessively spaced away from the pupil, which forms a dark area with a relatively low brightness, it may not provide an appearance that is integrated with the pupil and may lower the satisfaction with the appearance of the enlarged pupil, it may be preferable to form it to reflect the shape of the pupil at a position as close to the pupil as possible. Accordingly, in one embodiment of the present invention, the inner annular edge (101) may be formed in an elliptical shape reflecting the shape of the pupil, and may surround the outer ring of the pupil in an elliptical shape optimized for the pupil of the recipient that is differentially formed through the adaptive elastic portion (151) formed on the inner annular edge (101). At this time, the outer annular edge (102) can be formed in a circular shape so that the outer shape of the expanded pupil can be observed as a circle, and unlike the inner annular edge (101), instead of the problem of obstructing the incidence of light toward the pupil, the outer shape of the expanded pupil can be substantially determined and can be formed in a circular shape so as to provide a more beautiful appearance.
[0346] In one embodiment of the present invention, a plurality of slits (151s) forming the adaptive elastic portion (151) may be formed along the periphery of the inner annular edge (101), and the pieces divided through the plurality of slits (151s) formed along the periphery of the inner annular edge (101) may overlap with each other to provide elongation along the periphery of the inner annular edge (101). At this time, in order for the pieces divided through the slits (151s) to easily overlap with each other, the inner annular edge (101) where the slits (151s) are formed may be formed with a relatively gently rounded corner shape, for example, may be formed with a relatively gently rounded corner shape rather than the outer annular edge (102) which is formed with a relatively sharply rounded corner shape.
[0347] For example, a piece of the inner annular edge (101) or the inner annular edge (101) divided through a slit (151s) with a relatively gently rounded corner shape can provide a gap raised from the bottom through the gently rounded corner shape, and can easily enter the bottom of another adjacent piece through the gap raised from the bottom and overlap another piece, and the length of the inner annular edge (101) can be easily expanded.
[0348] Hereinafter, in an ocular implant (100) according to another aspect of the present invention, a surgical hole (10), a catch joint, or a hook joint that connects the first and second ends (E1, E2) separated from each other through an incision (C) toward each other will be described.
[0349] FIG. 9 is a drawing for explaining a surgical hole (10) applied to an ocular implant according to one embodiment of the present invention, and is a plan view of an ocular implant (100) shown in a frontal direction.
[0350] FIGS. 10a to 10c are drawings for explaining the hook or latching joint of the first and second slits (154a, 154b, 155a, 155b) applied to ocular implants (100) according to different embodiments of the present invention, and perspective views of different ocular implants (100) are shown.
[0351] FIGS. 11a and 11b illustrate different drawings for explaining the hook or latching joint of the assembly slit (156a) and the assembly hole (156b) applied to the ocular implant (100) according to one embodiment of the present invention.
[0352] The ocular implant (100) according to the above aspects is:
[0353] An ocular implant (100) that is permanently implanted on the recipient's eye (EB) to provide an enlarged appearance to the recipient's pupil,
[0354] A central opening (OP) that admits light toward the pupil (or iris), which provides the opening of the eyeball (EB);
[0355] An inner annular edge (101) defining the opening (OP) by surrounding the opening (OP);
[0356] An outer annular edge (102) surrounding the opening (OP) together with the inner annular edge (101) on the opposite side of the inner annular edge (101) defining the opening (OP); and
[0357] It may include a pupil expansion portion (105) formed between the inner annular edge (101) and the outer annular edge (102), which includes first and second ends (E1, E2) that are separated from each other through an incision (C) and connected toward each other through a surgical hole (10) formed therein.
[0358] For example, the pupil expansion portion (105) between the inner annular edge (101) and the outer annular edge (102) is formed in a biased position that is biased toward the other side position, such that one side position among the two sides along the short axis direction (Z2) of the inner annular edge (101) is formed with a wider width than the other side position, and the oval of the inner annular edge (101) is formed in a biased position within the circle of the outer annular edge (102).
[0359] The above-mentioned incision (C), the first and second ends (E1, E2) separated from each other through the above-mentioned incision (C), and the surgical hole (10) formed on the first and second ends (E1, E2) can be formed at the one-sided position formed with a relatively wide width along the short-axis direction (Z2).
[0360] For example, in the pupil expansion portion (105) between the inner annular edge (101) and the outer annular edge (102),
[0361] The positions on both sides along the short axis direction (Z2) of the inner annular edge (101) are formed with a relatively smaller curvature than the positions on both sides along the long axis direction (Z1) of the inner annular edge (101).
[0362] The above-mentioned treatment hole (10) can be formed at either one of the two positions along the short-axis direction (Z2) formed with a relatively small curvature.
[0363] For example, the above-mentioned incision (C) is formed along the short-axis direction (Z2) of the inner annular edge (101),
[0364] The first and second ends (E1, E2) separated from each other through the above-mentioned incision (C) are connected to each other along the longitudinal axis direction (Z1) of the inner annular edge (101),
[0365] A plurality of surgical holes (10) arranged along the longitudinal direction (Z1) of the inner annular edge (101) may be formed in each of the first and second ends (E1, E2).
[0366] For example, the above treatment hole (10) is
[0367] A first surgical hole (11) for passing a suture for binding between the first and second ends (E1, E2); and
[0368] It may include a second surgical hole (12) for a transplantation insertion device to penetrate through the ocular implant (100) to allow the ocular implant (100) to travel along the outer ring of the surgeon's pupil through an incision (C) in the conjunctiva on the cornea.
[0369] For example, the first treatment hole (11) is formed with a relatively small diameter,
[0370] The above second treatment hole (12) can be formed with a relatively large diameter.
[0371] For example, the first treatment hole (11) is formed at a location relatively adjacent to the incision (C),
[0372] The above second treatment hole (12) can be formed at a location relatively far from the incision (C).
[0373] Meanwhile, an ocular implant (100) according to another aspect of the above-mentioned aspect is
[0374] An ocular implant (100) that is permanently implanted on the recipient's eye (EB) to provide an enlarged appearance to the recipient's pupil,
[0375] A central opening (OP) that admits light toward the pupil (or iris), which provides the opening of the eyeball (EB);
[0376] An inner annular edge (101) defining the opening (OP) by surrounding the opening (OP);
[0377] An outer annular edge (102) surrounding the opening (OP) together with the inner annular edge (101) on the opposite side of the inner annular edge (101) defining the opening (OP); and
[0378] It may include a pupil expansion portion (105) formed between the inner annular edge (101) and the outer annular edge (102), which are separated from each other through a cut portion (C) and form a hook-joint or a hook-joint with each other.
[0379] For example, the pupil expansion portion (105) between the inner annular edge (101) and the outer annular edge (102) is formed in a biased position that is biased toward the other side position, such that one side position among the two sides along the short axis direction (Z2) of the inner annular edge (101) is formed with a wider width than the other side position, and the oval of the inner annular edge (101) is formed in a biased position within the circle of the outer annular edge (102).
[0380] The above-mentioned cut portion (C), the first and second ends (E1, E2) separated from each other through the above-mentioned cut portion (C), and the catch joint or hook joint between the first and second ends (E1, E2) can be formed at the one-piece position formed with a relatively wide width along the short-axis direction (Z2).
[0381] For example, the above-mentioned hitch joint or hook joint,
[0382] It may include first and second slits (154a, 154b, 155a, 155b) formed on the first and second ends (E1, E2), respectively.
[0383] For example, the first and second slits (154a, 154b, 155a, 155b)
[0384] A first portion (1541, 1551) extending along the longitudinal direction (Z1) of the inner annular edge (101); and
[0385] It may include a second portion (1542, 1552) extending from the first portion (1541, 1551) toward the inner annular edge (101) or the outer annular edge (102) along a diagonal direction that simultaneously follows the short axis direction (Z2) of the inner annular edge (101) or the short axis direction (Z2) and the long axis direction (Z1) and opens to the outside of the ocular implant (100).
[0386] For example, at least some of the first and second slits (154a, 154b, 155a, 155b) may be formed in complementary shapes to form a catch joint or a hook joint with respect to each other and may be fitted to each other.
[0387] For example, the first part (1541, 1551) of the first and second slits (154a, 154b, 155a, 155b) extends parallel to the longitudinal direction (Z1) of the inner annular edge (101),
[0388] The second portions (1542, 1552) of the first and second slits (154a, 154b, 155a, 155b) may be formed in complementary shapes, such that one of the first and second slits (154a, 154b, 155a, 155b) and the second portions (1542, 1552) of the other one may extend in opposite directions toward the outer annular edge (102) and the inner annular edge (101), respectively, and may be opened toward the outside of the ocular implant (100).
[0389] For example, the above-mentioned incision (C) is formed along the short-axis direction (Z2) of the inner annular edge (101),
[0390] The first and second ends (E1, E2) are adjacent to each other along the longitudinal axis direction (Z1) of the inner annular edge (101),
[0391] One of the first and second slits (154a, 154b, 155a, 155b) may include an array of first slits (154a, 155a) or an array of second slits (154b, 155b) formed in a plurality on the first end (E1) or the second end (E2) along the longitudinal direction (Z1), and the other may be formed as a single second slit (154b, 155b) or a single first slit (154a, 155a).
[0392] The above-mentioned hook and loop joint or hook joint is,
[0393] An assembly slit (156a) formed in the first end (E1);
[0394] It may include an assembly hole (156b) formed in the second end (E2) and into which an assembly slit (156a) is fitted.
[0395] For example, an assembly guide portion (158) may be formed on the first end portion (E1) and positioned in front of the assembly slit (156a) along the assembly direction between the first and second ends (E1, E2).
[0396] For example, the above assembly induction unit (158)
[0397] It includes a protrusion (158a) of a front end formed with a relatively narrow width at the front end of the first end (E1) along the assembly direction of the first and second ends (E1, E2), and a rear end (158c) formed with a relatively wider width than the bottleneck (W1) of the assembly slit (156a) while being at the rear of the protrusion (158a) of the front end and in front of the assembly slit (156a).
[0398] A variable width portion (158b) may further be included in a shape that converges toward the projection (158a) of the front end along a diagonal direction that simultaneously follows the major axis direction (Z1) corresponding to the assembly direction and the minor axis direction (Z2) intersecting the major axis direction (Z1) to connect the differential widths between the projection (158a) of the front end formed with a relatively narrow width and the rear end (158c) formed with a relatively wide width.
[0399] For example, the rear end (158c) of the assembly guide portion (158) can be connected to the full width (W0) of the first end (E1) interposed between the assembly guide portion (158) and the assembly slit (156a).
[0400] For example, a cut line (CL) including an array of perforations formed in multiple numbers may be formed between the assembly guide section (158) and the full width (W0) of the first end (E1).
[0401] For example, the assembly slit (156a) is introduced on both sides from the inner annular edge (101) and the outer annular edge (102) along the shortening direction (Z2) of the inner annular edge (101) to form a bottleneck (W1) of minimum width.
[0402] When the bottleneck (W1) of the above assembly slit (156a) is fitted into the assembly hole (156b) on the second end (E2) side, the separation between the first and second ends (E1, E2) can be prevented through the overall width (W0) of the first end (E1) formed in front and behind the assembly slit (156a) with a relatively wide width.
[0403] An ocular implant (100) according to one embodiment of the present invention can be inserted between the sclera and the conjunctiva by forming an incision (EBC) in the conjunctiva surrounding the sclera and inserting it between the sclera and the conjunctiva through the incision (EBC) of the conjunctiva so as to surround the outer ring of the pupil along the space between the sclera and the conjunctiva corresponding to the outer ring of the pupil. An ocular implant (100) according to one embodiment of the present invention can be inserted along a rotational direction so as to circle the outer ring of the pupil. To this end, the ocular implant (100) may be formed in a form that is disconnected from each other through a cut portion (C) formed along a certain angular position (0 degree angular position A1) with the center (O) of the opening (OP) as the rotational center, rather than being formed continuously along the rotational direction that circles the outer ring of the pupil, and first and second ends (E1, E2) that are disconnected from each other through the cut portion (C) may be formed. For example, the ocular implant (100) according to one embodiment of the present invention may include an opening (OP) that is open to the outside through the cut portion (C), rather than including a closed opening (OP). In addition, it may include first and second ends (E1, E2) that are separated from each other with the cut portion (C) therebetween.
[0404] In one embodiment of the present invention, the cut portion (C) can 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 and second ends (E1, E2) separated from each other through the cut portion (C) can be joined toward each other along the long axis direction (Z1). In one embodiment of the present invention, the first and second ends (E1, E2) separated through the cut portion (C) can be joined to each other along the longitudinal direction (Z1) through a surgical hole (10) formed on the first and second ends (E1, E2) or a catch joint or hook joint as described below. At this time, the first and second slits (154a, 154b, 155a, 155b) or the assembly slits (156a) forming the surgical hole (10) or the catch joint or hook joint can be arranged in multiple numbers along the longitudinal direction (Z1) along which the first and second ends (E1, E2) extend.
[0405] Through this specification, the pupil expansion part (105) in which the above-mentioned cut-out (C) and the first and second ends (E1, E2) are formed is a structure in which the front curved surface (120) is formed on the rear slope (110) based on the rear slope (110) inclined at a constant tilting angle (θ) from the vertical plane (G) perpendicular to the front direction (Z3) and forms a thickness profile (the pupil expansion part 105 is not a flat structure parallel to the vertical plane G perpendicular to the front direction Z3). At this time, the major axis direction (Z1) and the minor axis direction (Z2) can be defined in the front direction (Z3), but in this specification, for the convenience of understanding, for example, the rear slope (110) is formed as a surface inclined at a constant tilting angle (θ) so that the inner annular edge (101) is arranged in the front position and the outer annular edge (102) is arranged in the rear position, and the inner annular edge (101) is arranged in the relatively front position. The pupil expansion portion (105) formed between the annular edge (101) and the outer annular edge (102) positioned relatively posteriorly may have a shape that is generally inclined from the front to the back, although it has a thickness profile to form a thickness that varies toward the front curved surface (120) formed on the posterior slope (110), and accordingly, the incision portion (C) is formed along the short axis direction (Z2) so as to coincide with the long axis direction (Z1) and the short axis direction (Z2) defined in the frontal direction (Z3) on the pupil expansion portion (105), or the first and second ends (E1, E2) separated from each other through the incision portion (C) may not be joined along the long axis direction (Z1) through the surgical hole (10) or the catch joint or the hook joint, but the posterior slope (110) may be approximately perpendicular to the frontal direction (Z3) from the vertical plane (G) When the pupil expansion part (105) in which the above-mentioned incision part (C), surgical hole (10), and hook joint or chin joint are formed is projected onto a vertical plane (G) approximately perpendicular to the frontal direction (Z3), since it is inclined at a small angle of about 20 to 40 degrees,The directionality of the incision (C), the surgical hole (10), the catch joint or the hook joint formed on the pupil expansion portion (105) can be sufficiently described by the major axis direction (Z1) and the minor axis direction (Z2) defined in the front direction (Z3). For example, in one embodiment of the present invention, the major axis direction (Z1) and the minor axis direction (Z2) may mean the length direction and the width direction of the first and second ends (E1, E2) in relation to the incision (C), the surgical hole (10), the catch joint or the hook joint formed on the first and second ends (E1, E2).
[0406] In one embodiment of the present invention, the pupil expansion portion (105) between the inner annular edge (101) and the outer annular edge (102) is formed in a biased position that is biased toward the other side position, such that one side position among the two sides along the short axis direction (Z2) of the inner annular edge (101) is formed with a wider width than the other side position, and the oval of the inner annular edge (101) is formed in a biased position within the circle of the outer annular edge (102).
[0407] The above-mentioned incision (C), the first and second ends (E1, E2) separated from each other through the above-mentioned incision (C), and the surgical hole (10) or the catch joint or the hook joint for connecting the first and second ends (E1, E2) to each other can be formed at the one-sided position formed with a relatively wide width along the short-axis direction (Z2), and for example, the one-sided position formed with a relatively wide width along the short-axis direction (Z2) can correspond to the center position (S) of the surgical procedure in the surgical procedure of the ocular implant (100).
[0408] When the pupil expansion portion (105) between the inner annular edge (101) and the outer annular edge (102) is defined as having first and second ends (E1, E2) separated by a cut (C) through the present specification, the cut (C) and the first and second ends (E1, E2) separated from each other through the cut (C) can be formed across the pupil expansion portion (105) and the inner annular edge (101) defining one end of the pupil expansion portion (105) and the outer annular edge (102) defining the other end of the pupil expansion portion (105), and in this sense, the cut (C) can be said to form the first and second ends (E1, E2) separating the ocular implant (100) from each other.
[0409] In one embodiment of the present invention, in the pupil expansion portion (105) between the inner annular edge (101) and the outer annular edge (102), positions on both sides along the short axis direction (Z2) of the inner annular edge (101) can be formed with a relatively smaller curvature than positions on both sides along the long axis direction (Z1) of the inner annular edge (101), and among the positions on both sides, one position having a wider width can be selectively set as the center position (S) of the procedure, and at the center position (S) of the procedure corresponding to the one position formed with a relatively smaller curvature and wider width, a configuration such as the incision (C), the first and second ends (E1, E2), the procedure hole (10), the catch joint or the hook joint can be formed.
[0410] In the procedure of an ocular implant (100) according to one embodiment of the present invention, a first end (E1) of the ocular implant (100) is inserted through an incision (EBC) formed on the conjunctiva, and the first end (E1) is made to circle along the outer ring of the pupil, circle along the circumference of the outer ring of the pupil, and then returns to connect the first end (E1) pulled out through the incision (C) and the second end (E2) that remains without being inserted through the incision (C) to each other, thereby permanently transplanting the ocular implant (100) that has circled along the outer ring of the pupil. At this time, in the binding of the first and second ends (E1, E2), the first and second ends (E1, E2) can be joined to each other by inserting a suture so as to pass through the surgical holes (10) formed in the first and second ends (E1, E2) and binding the surgical holes (10) of the first and second ends (E1, E2) to each other through the knot of the suture. In one embodiment of the present invention, at least one surgical hole (10) may be formed in each of the first and second ends (E1, E2), and in various embodiments of the present invention, a plurality of surgical holes (10) may be formed in each of the first and second ends (E1, E2). In various embodiments of the present invention, a plurality of surgical holes (10) may be formed in the first and second ends (E1, E2) of the eye implant (100) or the pupil expansion part (105) forming the body of the eye implant (100), and a plurality of surgical holes (10) may be formed at regular intervals along the longitudinal direction (Z1) in each of the first and second ends (E1, E2).For example, depending on the shape and size of the pupil formed differentially according to the physical condition of the recipient, the first and second ends (E1, E2) can be connected through a surgical hole (10) at an optimized position among the surgical holes (10) formed in the first and second ends (E1, E2). For example, the surgeon of the ocular implant (100) can selectively select a surgical hole (10) at a position suitable for the shape and size of the individualized pupil of each recipient, and connect the first and second ends (E1, E2) to each other through a surgical hole (10) at an optimized position for surrounding the outer ring of the pupil along the circumference of the pupil of each recipient.
[0411] For example, the surgeon can select a surgical hole (10) at an optimized position to surround the outer ring of the pupil of the recipient, insert a suture through the selected surgical hole (10), and bind them to each other. If the distance between the surgical holes (10) on both sides that bind the first and second ends (E1, E2) to each other as the suture penetrates is set too far, the pupil dilatation (105) between the surgical holes (10) on both sides that bind the first and second ends (E1, E2) to each other may be distorted, which may adversely affect the coplanarity of the entire pupil dilatation (105), and side effects such as the entire ocular implant (100) including the pupil dilatation (105) not being in close contact with the sclera and forming an empty space may occur. On the other hand, if the suture penetrates the first and second ends (E1, E2) to each other, If the distance between the surgical holes (10) on both sides for binding is set excessively short, excessive tensile stress is accumulated along the pupillary expansion part (105) forming the ocular implant (100) or the body of the ocular implant (100) depending on the sealing force between the surgical holes (10) for binding the first and second ends (E1, E2) to each other, and the accumulated tensile stress affects the durability of the ocular implant (100) or the pupillary expansion part (105) forming the body of the ocular implant (100), or the pupillary expansion part (105) is deformed to reduce the circumference of the pupillary expansion part (105) depending on the accumulated tensile stress, and a fatal surgical error such as the pupillary expansion part (105) covering the pupil of the recipient is caused, or the pupillary expansion part (105) is distorted and deformed, and the pupillary expansion part (105) or the pupil is damaged. An ocular implant (100) including an extension portion (105) may cause side effects, such as failure to adhere to the recipient's cornea and formation of an empty space.
[0412] In this way, in one embodiment of the present invention, an ocular implant (100) of the same specification is formed through the same mold design, but so as to be optimized for the shape and size of the pupil formed differentially according to the physical condition of each recipient, a binding position optimized for surrounding the outer ring of the recipient's pupil is selected from among a plurality of surgical holes (10) formed in the first and second ends (E1, E2) of the ocular implant (100) that circle the outer ring of the pupil, and a suture is passed through the surgical hole (10) of the selected binding position, and the first and second ends (E1, E2) of the pupil expansion part (105) that forms the ocular implant (100) that circles the recipient's pupil or the body of the ocular implant (100) can be bound to each other. For example, in one embodiment of the present invention, the surgeon can cut and remove the excess pupil dilatation portion (105) that remains excessively between the surgical holes (10) on both sides selected as the binding positions among the plurality of surgical holes (10) formed at the first and second ends (E1, E2) of the ocular implant (100). For example, the excess pupil dilatation portion (105) that remains between the surgical holes (10) on both sides selected as the binding positions may be distorted in response to the stress that tends to reduce the length according to the tensile stress of the suture inserted to penetrate the surgical holes (10) selected as the binding positions. Therefore, the surgeon can remove the excess pupil dilatation portion (105) between the surgical holes (10) on both sides selected as the binding positions at the first and second ends (E1, E2). At this time, the surgeon can refer to the plurality of surgical holes (10) formed at regular intervals at the first and second ends (E1, E2) and remove the plurality of surgical holes. The cutting position can be set based on the position of the hole (10).In one embodiment of the present invention, the circumferential length of the pupillary expansion part (105) forming the ocular implant (100) or the body of the ocular implant (100) may be preferably set to a size optimized for surrounding the outer ring of the pupil so that the implanted pupillary expansion part (105) forms an appearance that is integrated with the individualized pupil of each recipient while not blocking the pupil (or pupil) that provides the light entrance opening. For example, the pupillary expansion part (105) formed in a standardized size or a single size so as to form a circumferential length optimized for surrounding the outer ring of the individualized pupil of each recipient can be adaptively formed, for example, a circumferential length optimized for surrounding the outer ring of the individualized pupil of each recipient, can be formed. At this time, the operator may refer to the positions of the surgical holes (10) formed at regular intervals in the first and second ends (E1, E2) of the ocular implant (100) or the pupil expansion part (105) forming the body of the ocular implant (100), and cut at least a part of one end among the first and second ends (E1, E2) to provide an optimized circumferential length for each implant.
[0413] For example, as a surgeon, the circumference of the ocular implant (100) or pupillary expansion portion (105) optimized to surround the pupil of the recipient can be set through examination or measurement of the eye (EB), and the cutting position can be set from the end of at least one of the first and second ends (E1, E2) to form the set circumference of the pupillary expansion portion (105). At this time, the cutting position can be set based on the positions of a plurality of surgical holes (10) formed at regular intervals along the longitudinal direction (Z1) in the first and second ends (E1, E2). For example, in one embodiment of the present invention, the plurality of surgical holes (10) formed in each of the first and second ends (E1, E2) can be formed at 0.5 mm intervals along the longitudinal direction (Z1).
[0414] In this way, in one embodiment of the present invention, the plurality of surgical holes (10) formed along the length of the longitudinal direction (Z1) or the first and second ends (E1, E2) can provide a binding position optimized for surrounding the outer ring of the pupil of an eye of an individualized shape and size for each transplant recipient, and can provide a reference or standard for setting a cutting position to form a circumference optimized for surrounding the outer ring of the pupil of the transplant recipient, for example, a circumference optimized for circling the outer ring of the pupil of the transplant recipient.
[0415] In one embodiment of the present invention, the surgical hole (10) forms an incision (EBC) in the conjunctiva on the sclera, and a space securing device (not shown) can be inserted to secure a space for transplantation of the ocular implant (100) between the sclera and the conjunctiva along the incision (EBC), and the ocular implant (100) can be pulled toward the transplantation space secured by the space securing device, so that the ocular implant (100) can be pulled into the transplantation space through the transplantation insertion device so that the ocular implant (100) goes around the outer ring of the pupil of the recipient. At this time, the implant insertion device (not shown) inserts the first end (E1) of the ocular implant (100) through the surgical hole (10) formed in the first end (E1) of the ocular implant (100) toward the implantation space secured along the outer ring of the pupil of the recipient, and the ocular implant (100) is inserted from the first end (E1) to which the implant insertion device is fitted along the circumferential movement forced by the implant insertion device (not shown) into the implantation space secured along the outer ring of the pupil, thereby being able to circumnavigate along the outer ring of the pupil. In this way, the surgical hole (10) formed in the first end (E1) or the second end (E2) can provide a physical interference with the implantation insertion device (not shown) for pulling the entire ocular implant (100), that is, a position through which the implantation insertion device (not shown) for pulling the ocular implant (100) passes, and for example, the implantation insertion device (not shown) fitted into the surgical hole (10) can follow the implantation insertion device (not shown) fitted into the surgical hole (10) or the implantation insertion device (not shown) from the first end (E1) where the surgical hole (10) is formed to circle along the outer ring of the pupil so as to surround the outer ring of the pupil.
[0416] In one embodiment of the present invention, the surgical hole (10) may include a first surgical hole (11) for penetration of a suture and a second surgical hole (12) for physical interference with a transplant insertion device or penetration of a transplant insertion device, which provides a binding position between the first and second ends (E1, E2). In one embodiment of the present invention, the first and second surgical holes (11, 12) can be formed with substantially the same shape and size, and some of the surgical holes (10) can function as first surgical holes (11) for the passage of a suture, and some of the surgical holes (10) can function as second surgical holes (12) for the passage of an implant insertion device (not shown), depending on the surgeon's selection. A plurality of surgical holes (10) formed with the same shape along the longitudinal direction (Z1) or the length of the first and second ends (E1, E2) can provide relatively free position selection, and can function as the first and second surgical holes (11, 12) depending on the surgeon's selection.
[0417] In various embodiments of the present invention, the surgical hole (10) may include a first surgical hole (11) formed with a relatively small diameter to accommodate a relatively thin strand of suture, and a second surgical hole (12) formed with a relatively large diameter to accommodate a relatively thick implant insertion tool (not shown) for pulling the entire ocular implant (100). In one embodiment of the present invention, the first and second surgical holes (11, 12) may be formed at different positions along the first and second ends (E1, E2), and the first surgical hole (11) for the penetration of the suture may be formed at a position relatively close to the ends of the first and second ends (E1, E2) along the longitudinal direction (Z1) to provide a binding position for binding the first and second ends (E1, E2) to each other, so that no excessive extra ocular implant (100) or pupil dilatation part (105) may be interposed between the first surgical holes (11) on both sides, and the second surgical hole (12) may be formed at a position relatively far from the ends of the first and second ends (E1, E2) along the longitudinal direction (Z1) to allow the ocular implant (100) to be pulled through an implantation insertion device (not shown) fitted into the second surgical hole (12), thereby preventing the first and second surgical holes (11) from being interposed. It is possible to prevent damage to the second end (E1, E2).
[0418] In one embodiment of the present invention, the ocular implant (100) may be formed in a symmetrical shape based on the center (O) of the opening (OP), and for example, in one embodiment of the present invention, the pupillary expansion portion (105) forming the ocular implant (100) or the 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) crossing the center (O) of the opening (OP). In one embodiment of the present invention, the pupillary expansion portion (105) forming the ocular implant (100) or the body of the ocular implant (100) may have a cut portion (C) formed along the minor axis direction (Z2), and a plurality of surgical holes (10) may be formed in the first and second ends (E1, E2) separated by the cut portion (C). At this time, the plurality of treatment holes (10) may be arranged along the major axis direction (Z1) and may be symmetrically formed along the minor axis direction (Z2). For example, the plurality of treatment holes (10) formed in the first and second ends (E1, E2) separated from each other through the incision (C) along the minor axis direction (Z2) followed by the incision (C) may be symmetrically formed. For example, since the operator can perform the treatment without having to distinguish between the first and second ends (E1, E2) through the plurality of treatment holes (10) symmetrically formed in the first and second ends (E1, E2) based on the incision (C), the convenience of the treatment can be improved. In one embodiment of the present invention, first and second surgical holes (11, 12) of different sizes can be formed symmetrically in the first and second ends (E1, E2), and the second surgical hole (12) fitted into the implantation insertion device is formed symmetrically in the first and second ends (E1, E2), so that the surgeon can perform the implantation of the ocular implant (100) through the implantation insertion device fitted into the second surgical hole (12) of any one of the first and second ends (E1, E2).
[0419] In one embodiment of the present invention, the incision (C) may be formed along the short axis direction (Z2) of the opening (OP), and may be formed at any one position along the short axis direction (Z2) of the opening (OP), and a plurality of surgical holes (10) may be formed in the first and second ends (E1, E2) divided by the incision (C) formed at any one position along the short axis direction (Z2). The position at which the first and second ends (E1, E2) where the surgical holes (10) are formed, or the one position at which the incision (C) dividing the first and second ends (E1, E2) is formed, may correspond to any one position along the short axis direction (Z2) of the opening (OP), and may correspond to a part of the ocular implant (100) extending parallel to the long axis direction (Z1) or a part of the pupil expansion part (105) forming the body of the ocular implant (100).
[0420] In one embodiment of the present invention, the opening (OP) formed at the center position of the ocular implant (100) or the inner annular edge (101) defining the opening (OP) may be formed in an elliptical shape having different major axis lengths (L1) and minor axis lengths (L2), and the outer annular edge (102) formed on the opposite side to the inner annular edge (101) may be formed in a circular shape to provide an attractive appearance, and thus, in one embodiment of the present invention, the pupil expansion portion (105) formed between the inner annular edge (101) and the outer annular edge (102) may be formed in a shape in which the elliptical inner annular edge (101) is formed inside the circular outer annular edge (102), and the pupil defined by the outer annular edge (102) and the inner annular edge (101) of different shapes The expansion portion (105) may be formed with different widths at different angular positions with the central opening (OP) as the rotation center. For example, in one embodiment of the present invention, the pupil expansion portion (105) may be formed with the widest width at the 0 degree angular position (A1) where the incision portion (C) is formed, and may be formed with widths of the same degree at the remaining 90 degree angular positions (A3), 180 degree angular positions (A2), and 270 degree angular positions (A4). In one embodiment of the present invention, the first and second ends (E1, E2) divided through the incision (C) or the incision (C) may correspond to the center position (S) of the procedure of the ocular implant (100), and for example, the first and second ends (E1, E2) may be connected toward each other by inserting a suture so as to pass through a plurality of procedure holes (10, for example, first procedure hole 11) formed in the first and second ends (E1, E2), and the ocular implant (100) may be implanted along the outer ring of the pupil of the recipient by inserting a transplantation insertion device so as to pass through the procedure holes (10, for example, second procedure hole 12) formed in the first and second ends (E1, E2).
[0421] In one embodiment of the present invention, the pupil dilation portion (105) forming the ocular implant (100) or the body of the ocular implant (100) is formed so as to have the widest width at any one side along the short axis direction (Z2) of the oval surrounded by the inner annular edge (101) or the inner annular edge (101), in other words, at any one side among the 0 degree angle position (A1) and the 180 degree angle position (A2) forming both sides along the short axis direction (Z2) with the center (O) of the opening (OP) as the rotation center, so that the position corresponding to the center position (S) of the procedure (for example, the 0 degree angle position A1) is formed with a relatively wide width, thereby providing ease of procedure. In this way, in one embodiment of the present invention, the oval inner annular edge (101) is arranged inside the circular outer annular edge (102) so as to form the widest pupil dilation portion (105) at a position corresponding to the center position (S) of the procedure (for example, 0 degree angle position A1). However, rather than arranging the oval inner annular edge (101) at the exact center of the circular outer annular edge (102), the oval inner annular edge (101) may be arranged at a position offset toward the other side position so as to secure a relatively wide width at one of the two sides along the short axis direction (Z2). In other words, in one embodiment of the present invention, the oval inner annular edge (101) defining the opening (OP) may be arranged at a biased position so that the width of one of the two positions increases along the short-axis direction (Z2) from the center position of the circular outer annular edge (102) toward the other position.
[0422] In one embodiment of the present invention, the position corresponding to the center position (S) of the procedure may correspond to any one position among the positions on both sides along the short axis direction (Z2), and may correspond to one position having a relatively wide width among the positions on both sides along the short axis direction (Z2), and an incision (C) and a hole (10) for the procedure may be formed at the one position corresponding to the center position (S) of the procedure, and a catch joint and a hook joint, etc. described below, may also be formed at one position of the pupil expansion portion (105) along the short axis direction (Z2).
[0423] In this way, in one embodiment of the present invention, among the positions on both sides along the short axis direction (Z2), one side position can be formed with a relatively wide width and can form a part with a relatively small curvature while extending approximately along the long axis direction (Z1), and in contrast, among the positions on both sides along the long axis direction (Z1), can be formed with a relatively narrow width and can form a part with a relatively large curvature while extending approximately along the short axis direction (Z2). In this way, by setting one side position among the positions on both sides along the short axis direction (Z2), which forms a part with a relatively small curvature, as the center position (S) of the procedure, the convenience of the procedure can be improved through the incision (C) formed in the part formed with a relatively wide width and small curvature, and the procedure hole (10) formed in the first and second ends (E1, E2) divided by the incision (C). In this way, at one side position corresponding to the center position (S) of the procedure among the two sides along the short-axis direction (Z2), a catch joint or hook joint, as described later, can be formed together with an incision (C) and a hole (10) for the procedure.
[0424] In one embodiment of the present invention, the first and second ends (E1, E2) can be joined to each other through a suture that is inserted so as to pass through a surgical hole (10) formed in the first and second ends (E1, E2), but in various embodiments of the present invention, the first and second ends (E1, E2) can form a hook joint or a hook joint in which one of the first and second ends (E1, E2) is inserted into the other to form a hook joint for each other, thereby preventing the first and second ends (E1, E2) from being separated from each other.
[0425] More specifically, the first and second ends (E1, E2) may be formed with first and second slits (154a, 154b, 155a, 155b) for fitting the second and first ends (E1, E2) corresponding to the opposite ends of the coupling, respectively, and the first and second ends (E1, E2) may be fitted to each other through the first and second slits (154a, 154b, 155a, 155b) formed in a complementary shape to each other, and once fitted, the first and second ends (E1, E2) may be prevented from being separated through the first and second slits (154a, 154b, 155a, 155b) formed complementarily, and the first and second ends (E1, E2) may be prevented from being separated through the first and second slits (154a, 154b, 155a, 155b) formed complementarily. Through this, we can bond with each other.
[0426] In various embodiments of the present invention, the first and second slits (154a, 154b, 155a, 155b) formed in the first and second ends (E1, E2), respectively, may include a first portion (1541, 1551) extending along a major axis direction (Z1) in which the first and second ends (E1, E2) face each other with a cut portion (C) therebetween or a major axis direction (Z1) that intersects a minor axis direction (Z2) in which the cut portion (C) extends, and a second portion (1542, 1552) extending from the first portion (1541, 1551) along the minor axis direction (Z2) to the outside of the ocular implant (100) or the pupil expansion portion (105) of the ocular implant (100). At this time, the second parts (1542, 1552) may be formed in complementary shapes, for example, the second parts (1542, 1552) of the first and second slits (154a, 154b, 155a, 155b) formed in the first and second ends (E1, E2) respectively may extend from the first part (1541, 1551) along the major axis direction (Z1) in opposite directions along the minor axis direction (Z2), that is, may be opened toward the outside of the pupil expansion part (105) while extending toward the inner annular edge (101) and the outer annular edge (102) formed on opposite sides from the first part (1541, 1551), respectively. And, the first and second slits (154a, 154b, 155a, 155b) of the first and second ends (E1, E2) fitted to each other can prevent separation from each other by having the second portion (1542, 1552) formed in a complementary shape among the first and second slits (154a, 154b, 155a, 155b) function as a catch or hook to prevent separation from each other.In various embodiments of the present invention, the first and second slits (154a, 154b, 155a, 155b) may extend from the first portion (1541, 1551) extending along the major axis direction (Z1) toward the outside of the pupil dilatation portion (105) while being perpendicular to the first portion (1541, 1551) along the minor axis direction (Z2) and open toward the outside of the pupil dilatation portion (105), or may extend from the first portion (1541, 1551) extending along the major axis direction (Z1) toward the outside of the pupil dilatation portion (105) along a diagonal direction that simultaneously follows the major axis direction (Z1) and the minor axis direction (Z2) and open toward the outside of the pupil dilatation portion (105).
[0427] In one embodiment of the present invention, at least one of the first and second slits (154a, 154b, 155a, 155b) formed in the first and second ends (E1, E2) may be arranged in a plurality along the longitudinal direction (Z1) or the length of the first and second ends (E1, E2). In one embodiment of the present invention, the longitudinal direction of the first and second ends (E1, E2) in which the plurality of first and second slits (154a, 154b, 155a, 155b) or the plurality of surgical holes (10) are arranged may correspond to the longitudinal direction (Z1) perpendicular to the short-axis direction (Z2) in which the incision (C) separating the first and second ends (E1, E2) extends. For example, at least one of the first and second slits (154a, 154b, 155a, 155b) arranged in a plurality of positions can be adjusted to form a circumferential length of the ocular implant (100) or the pupil expansion portion (105) of the ocular implant (100) optimized for surrounding the pupil of the patient by adjusting the binding position between the first and second slits (154a, 154b, 155a, 155b), thereby binding the first and second ends (E1, E2) to each other through the first and second slits (154a, 154b, 155a, 155b) at a position selected from among the plurality of first and second slits (154a, 154b, 155a, 155b) arranged along the length of the first and second ends (E1, E2).
[0428] In various embodiments of the present invention, the cutout (C) may be formed along the short axis direction (Z2) of the inner annular edge (101), the first and second ends (E1, E2) may be adjacent to each other along the long axis direction (Z1) of the inner annular edge (101), and one of the first and second slits (154a, 154b, 155a, 155b) may include an array of first slits (154a, 155a) or an array of second slits (154b, 155b) formed in multiple numbers 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 second slit (154b, 155b) or a single first slit (154a, 155a).
[0429] In one embodiment of the present invention, in order to form a catch joint or hook joint that binds the first and second ends (E1, E2), an assembly slit (156a) may be formed in one of the first and second ends (E1, E2), and an assembly hole (156b) into which the assembly slit (156a) is fitted may be formed in the other end. For example, in one embodiment of the present invention, an assembly slit (156a) may be formed in the first end (E1), and an assembly hole (156b) into which the assembly slit (156a) is fitted may be formed in the second end (E2). In one embodiment of the present invention, the second end (E2) side assembly hole (156b) into which the first end (E1) side assembly slit (156a) is fitted is formed in a closed form isolated from the outside of the second end (E2) without being opened toward the outside of the second end (E2), so that in consideration of the assembling property of the fitting of the first end (E1) side assembly slit (156a), an assembly guide portion (158) may be formed at the end of the first end (E1), and the assembly guide portion (158) includes a rear end (158c) having a relatively wide width and a front end protrusion (158a) having a relatively narrow width along the assembly direction or the major axis direction (Z1), and simultaneously follows the major axis direction (Z1) and the minor axis direction (Z2) so as to connect the differential widths of the rear end (158c) having a wide width and the front end protrusion (158a) having a narrow width. It may include a variable width portion (158b) that converges toward the projection (158a) of the shear in the diagonal direction.In one embodiment of the present invention, the rear end (158c) forming the boundary of the assembly guide portion (158) may mean the boundary of the assembly guide portion (158) having a wide width corresponding to the full width (W0) of the pupil expansion portion (105), and at this time, the full width (W0) of the pupil expansion portion (105) may mean the width of the complete pupil expansion portion (105) in which the assembly slit (156a) introduced from the inner annular edge (101) and / or the outer annular edge (102) such as the assembly slit (156a) is not formed, and may mean, for example, the pupil expansion portion (105) having a wider width than the bottleneck (W1) having a narrow width limited by the assembly slit (156a).
[0430] In one embodiment of the present invention, an assembly guide portion (158) may be formed on the front side of the first end portion (E1) along the assembly direction or longitudinal direction (Z1) of the first and second ends (E1, E2), and an assembly slit (156a) may be formed on the rear side of the first end portion (E1). In one embodiment of the present invention, a first end portion (E1) having a relatively wide width may be interposed between the front side assembly guide portion (158) and the rear side assembly slit (156a). For example, the relatively wide first end (E1) interposed between the assembly guide portion (158) and the assembly slit (156a) may mean the full width (W0) of the pupil expansion portion (105) having a relatively wide full width in which the assembly slit (156a) introduced from the inner annular edge (101) and / or the outer annular edge (102) is not formed.
[0431] For example, in one embodiment of the present invention, the assembly slit (156a) may be formed in a shape that is introduced from the inner annular edge (101) and the outer annular edge (102) along the short axis direction (Z2) toward the inside of the pupil expansion portion (105) therebetween, and in this way, the width of the bottle neck (W1) that forms the minimum width while being introduced from the inner annular edge (101) and the outer annular edge (102) on both sides that define the pupil expansion portion (105) may be equal to or smaller than the width (W2) of the assembly hole (156b) on the second end (E2) side. In one embodiment of the present invention, the assembly slits (156a) on the first end (E1) side can be arranged in a plurality along the longitudinal direction (Z1) or the length of the first end (E1), and for example, in one embodiment of the present invention, through the arrangement of the assembly slits (156a) formed along the longitudinal direction (Z1) or the length of the first end (E1), the binding position between the first and second ends (E1, E2) can be varied to form a circumferential length optimized for surrounding the pupil of the recipient.
[0432] In one embodiment of the present invention, the assembly guide portion (158) on the first end (E1) side can align the fastening positions between the first and second ends (E1, E2) with each other, while guiding the assembly slit (156a) formed at the rear of the assembly guide portion (158) on the first end (E1) side toward the assembly hole (156b) on the second end (E2) side. In one embodiment of the present invention, the width of the protrusion (158a) of the front end formed on the assembly guide portion (158) on the first end (E1) side can be formed to be narrower than the width (W2) of the assembly hole (156b) on the second end (E2) side, and when the protrusion (158a) of the front end on the first end (E1) side is fitted into the assembly hole (156b) on the second end (E2) side, the fastening positions of the first and second ends (E1, E2) can be aligned with respect to each other, and when the operator of the ocular implant (100) pulls the protrusion (158a) of the front end on the first end (E1) side fitted into the assembly hole (156b) on the second end (E2) side toward the second end (E2), the first end (E1) side assembly guide portion (158) of the relatively wide width connected to the variable width portion (158b) of the first end (E1) side assembly guide portion The end (E1, the full width W0 of the first end E1) can be guided toward the assembly hole (156b) on the second end (E2) side, and when the assembly hole (156b) on the second end (E2) side is fitted into the bottleneck (W1) of the assembly slit (156a) that continues to the first end (E1, the full width W0 of the first end E1) with a wide width, the first and second ends (E1, E2) can be prevented from moving away from each other, and for example, when the first end (E1, the full width W0 of the first end E1) side's bottleneck (W1) of the assembly slit (156a) fitted into the assembly hole (156b) on the second end (E2) side functions as a catch or hook, the first and second ends (E1, E2) can be prevented from moving away from each other. there is.
[0433] In one embodiment of the present invention, the assembly guide part (158) is configured to induce a hook connection or a catch joint between the bottle neck (W1) of the assembly slit (156a) and the assembly hole (156b) at the rear by passing through the assembly guide part (158) at the front along the assembly direction or the long axis direction (Z1) and the assembly hole (156b) formed with a relatively narrow width, and after the first and second ends (E1, E2) are connected to each other through the catch joint connection or the hook connection, that is, after the bottle neck (W1) of the assembly slit (156a) at the first end (E1) is fitted into the assembly hole (156b) at the second end (E2), the assembly guide part (158) that has served its purpose is removed, for example, the second By removing the assembly guide (158) that overlaps and forms additional thickness on the end (E2), the adverse effects on the surrounding eye (EB) tissue can be eliminated and deformation of the ocular implant (100) can be prevented.
[0434] In one embodiment of the present invention, a cut line (CL) may be formed along the rear boundary corresponding to the rear end (158c) of the assembly guide portion (158) along the assembly direction or the longitudinal direction (Z1), and after the first and second ends (E1, E2) are fastened to each other through a catch joint or a hook joint, the assembly guide portion (158) may be separated and removed along the cut line (CL). In one embodiment of the present invention, the cutting line (CL) may be formed between the front assembly guide portion (158) and the rear assembly slit (156a), and more specifically, may be formed along the boundary (rear boundary of the assembly guide portion 158 forming the rear end 158c of the assembly guide portion 158) between the front assembly guide portion (158) and the relatively wide first end portion (E1, full width W0 of the first end portion E1) formed between the front assembly guide portion (158) and the rear assembly slit (156a). In one embodiment of the present invention, the cutting line (CL) may include a plurality of perforations formed along the cutting line (CL) or may include an indication line indicating a cutting position in a form other than perforations. In one embodiment of the present invention, the cutting line (CL) may be formed along the short axis direction (Z2) parallel to the cut portion (C).
[0435] In various embodiments of the present invention, the first and second ends (E1, E2) separated from each other with the incision (C) therebetween are connected to each other by using a surgical hole (10) formed in the first and second ends (E1, E2) and a suture thread passing through the first and second ends (E1, E2), or by using the first and second slits (154a, 154b, 155a, 155b) formed in the first and second ends (E1, E2) so that the first and second ends (E1, E2) are fitted to each other through the first and second slits (154a, 154b, 155a, 155b), or by using the assembly slits (156a) and assembly holes (156b) formed in the first and second ends (E1, E2). The first and second ends (E1, E2) can be connected to each other by fitting the assembly slit (156a) on the end (E1) side into the assembly hole (156b) on the second end (E2) side. In this way, in various embodiments of the present invention, in the fastening of the first and second ends (E1, E2), the first and second ends (E1, E2) corresponding to the objects of fastening may be fastened to each other while facing each other along the assembly direction or the long axis direction (Z1) without overlapping each other, or the fastening may be formed while the first and second ends (E1, E2) overlap each other. As shown in FIGS. 10a and 11b, in a structure in which first and second slits (154a, 154b, 155a, 155b) are formed in the first and second ends (E1, E2) and are fitted to each other, or in a structure in which an assembly slit (156a) and an assembly hole (156b) are formed in the first and second ends (E1, E2) and are fitted to each other, the first and second ends (E1, E2) overlap each other to form an extra thickness. It is possible, and the extra thickness formed in this way can locally form extra thickness along the circumference of the eye implant (100) or the pupil expansion portion (105) forming the body of the eye implant (100), thereby forcing stress or deformation, etc. Therefore, from this consideration, the first and second ends (E1,Among E2), the first and second ends (E1, E2) are overlapped with each other between the first and second slits (154a, 154b, 155a, 155b) and the cutout (C) that are fitted against each other to bind the first and second ends (E1, E2) toward each other, or the first and second ends (E1, E2) are overlapped with each other between the bottle neck (W1) of the assembly slit (156a) that is fitted against each other to bind the first and second ends (E1, E2) toward each other, the assembly hole (156b) and the cutout (C), and a part of the first end (E1) that forms the full width (W0) of the pupil expansion part (105) that functions as a catch or hook and is formed in front of the bottle neck (W1) of the assembly slit (156a) that is fitted into the assembly hole (156b). Except for a part of the second end (E2) formed in front of the assembly hole (156b) to maintain the closed shape of the hole (156b), the first and second ends (E1, E2) that overlap each other at the remaining positions are formed with a relatively thin thickness, so that a uniform thickness can be formed over the entire circumference surrounding the outer ring of the pupil of the recipient in the ocular implant (100) in which the transplantation is completed or in the ocular implant (100) in which the bonding between the first and second ends (E1, E2) is completed. For example, a thin portion formed with a relatively thin thickness may be formed around the first and second slits (154a, 154b, 155a, 155b) on the first and second ends (E1, E2) so as not to form additional extra thickness from the overlapping of the first and second ends (E1, E2), and the thin portions of the first and second ends (E1, E2) may overlap each other to form a normal thickness of the ocular implant (100).
[0436] In one embodiment of the present invention, the hook joint or the hook joint that connects the first and second ends (E1, E2) separated from each other through the cut portion (C) toward each other can be formed at a position of one side formed with a relatively wide width among the positions of both sides along the short-axis direction (Z2), and can be formed at a position of one side extending along the long-axis direction (Z1) with a relatively small curvature, thereby making it possible to relatively easily connect the first and second ends (E1, E2) in the procedure of the ocular implant (100), and this position of one side can form a central position (S) of the procedure in the procedure of the implant.
[0437] Throughout this specification, the center position (S) of the implant procedure is described as a one-sided position formed with a relatively wide width while the elliptical profile of the inner annular edge (101) is deflected to the other side within the circular profile of the outer annular edge (102) among the one-sided position and the other side position of the pupil expansion portion (105) forming the two-sided positions along the short axis direction (Z2), but in the embodiment illustrated in the drawings attached to this specification, the center position (S) of the procedure may be selectively formed at any one position among the one-sided position (0 degree angle position A1) and the other side position (180 degree angle position A2) having substantially the same width while the elliptical profile of the inner annular edge (101) is formed at a symmetrical position without being deflected to either one side position or the other side position along the short axis direction (Z2), and in one embodiment of the present invention, the one-sided position forming the center position (S) of the procedure is By selecting from the positions on both sides along the direction (Z2), a relatively small curvature can be formed while generally following the long axis direction (Z1).
[0438] In this specification, with regard to the arrangement of the plurality of surgical holes (10) formed along the first and second ends (E1, E2) separated from each other through the incision (C), or the arrangement of the plurality of first and second slits (154a, 154b, 155a, 155b) formed along the first and second ends (E1, E2) to form a catch joint or a hook joint, or the arrangement of the assembly slits (156a) formed along the first and second ends (E1, E2), the arrangement of these configurations may be arranged along the length of the first and second ends (E1, E2), and for example, may be arranged along the length of the first and second ends (E1, E2) forming a part of the circumference along the circumference direction of the pupil dilatation part (105), so that through this specification, the arrangement of these configurations along the longitudinal direction (Z1) means that the pupil dilatation part (105) It could mean that they are arranged along the circumferential direction.
[0439] FIG. 12 is a drawing showing a modified embodiment of the ocular implant illustrated in FIG. 4. Referring to the drawing, the outer annular edge (102) may be formed with a circular profile, and an inner annular edge (101) of a circular profile may be formed inside the circular profile of the outer annular edge (102). For example, in one embodiment of the present invention, the inner annular edge (101) and the outer annular edge (102) may surround the opening (OP) with the same circular profile, for example, may surround the opening (OP) in a concentric shape with the center (O) of the opening (OP) as the centroid. In one embodiment of the present invention, the inner annular edge (101) may be formed in a circular shape in which a major axis length (L1) along the direction in which a pair of eyes of the recipient face each other and a minor axis length (L2) perpendicular to the major axis length (L1) and intersect each other are equal, and the convenience of the procedure may be improved by forming a circular profile in which the major axis length (L1) and the minor axis length (L2) are equal in length so that alignment with the pupil of the recipient is not required, and the convenience of the processing process for forming the ocular implant (100) may be improved by forming the outer annular edge (102) and the inner annular edge (101) in a concentric shape with the center (O) of the opening (OP) as the centrifugal force.
[0440] FIG. 13 is a drawing showing a modified embodiment of the ocular implant illustrated in FIG. 6. Referring to the drawing, the adaptive stretching portions (1511, 1512) can provide longitudinal stretching along the periphery of the inner annular edge (101) and the outer annular edge (102) so as to adaptively change to the shape and size of the pupil of each recipient. For example, the adaptive stretching portion (1511) of the inner annular edge (101) can include a plurality of slits (1511s) formed spaced apart from each other along the periphery of the inner annular edge (101), and the adaptive stretching portion (1512) of the outer annular edge (102) can include a plurality of slits (1512s) formed spaced apart from each other along the periphery of the outer annular edge (102). In one embodiment of the present invention, the width (d1) of the slit (1511s) forming the adaptive elastic portion (1511) of the inner annular edge (101) can be formed along the depth direction from the inner annular edge (101) toward the outer annular edge (102), and the width (d2) of the slit (1512s) forming the adaptive elastic portion (1512) of the outer annular edge (102) can be formed along the depth direction from the outer annular edge (102) toward the inner annular edge (101). In one embodiment of the present invention, the width (d2) of the slit (1152s) forming the adaptive elastic portion (1152) of the outer annular edge (102) may be formed smaller than the width (d1) of the slit (1151s) forming the adaptive elastic portion (1151) of the inner annular edge (101). For example, in one embodiment of the present invention, the size of the widths (d1, d2) of the slits (1151s, 1152s) forming each of the adaptive elastic portions (1151, 1152) may be adjusted so that the range of length elongation provided by the adaptive elastic portion (1151) of the inner annular edge (101) is wider than the range of length elongation provided by the adaptive elastic portion (1152) of the outer annular edge (102).In one embodiment of the present invention, the adaptive elastic portions (1511, 1512) can be adjusted in size of the widths (d1, d2) of the slits (1151s, 1152s) forming each adaptive elastic portion (1151, 1152) so that the range of longitudinal elasticity of the inner annular edge (101) surrounding the pupil at a relatively close position is wider than the range of longitudinal elasticity of the outer annular edge (102) surrounding the pupil at a relatively far position so that the adaptive elastic portions (1511, 1512) can adaptively change to the shape and size of the pupil of each recipient. In various embodiments of the present invention, the adaptive elastic portion (1511, 1512) may be formed along the perimeter of either the inner annular edge (101) or the outer annular edge (102), or may be formed on both sides along the perimeter of the inner annular edge (101) and the outer annular edge (102).
[0441] FIG. 14 illustrates a drawing for explaining a composite configuration of different mechanisms that connect first and second ends (E1, E2) separated from each other through a cut portion (C) toward each other in one embodiment of the present invention. In the ocular implant (100) according to one embodiment illustrated in the drawing, a surgical hole (10) and a catch joint or a hook joint may be formed in a composite manner. Referring to FIG. 14, an ocular implant (100) according to one embodiment of the present invention may be formed with a surgical hole (10) and first and second slits (154a, 154b) on the sides of the first and second ends (E1, E2) as a hook joint or a hook joint, respectively. Referring to FIG. 14 and FIG. 11A together, an ocular implant (100) according to another embodiment of the present invention may be formed with a surgical hole (10) and an assembly slit (156a) and an assembly hole (156b) on the sides of the first and second ends (E1, E2) as a hook joint or a hook joint.
[0442] In this way, in one embodiment of the present invention, by forming a treatment hole (10) for inserting a suture and connecting the first and second ends (E1, E2) to each other through a knot of the suture, as another mechanism for connecting the first and second ends (E1, E2) to each other, a hook connection or a catch joint is formed in combination, for example, by combining different mechanisms for connecting the first and second ends (E1, E2) to each other, the connection force between the first and second ends (E1, E2) can be increased, and for example, if it is determined that sufficient connection force between the first and second ends (E1, E2) can be formed only with the hook connection or the catch joint according to the judgment of the operator, the suture passing through the treatment hole (10) may not be made, and in contrast, the first and second ends (E1, E2) temporarily fixed by the hook connection or the catch joint The binding force between the first and second ends (E1, E2) can be reinforced and the first and second ends (E1, E2) can be firmly bound by suturing through the surgical hole (10). For example, in one embodiment of the present invention, the surgical hole (10) formed in combination with a catch joint or a hook joint provides a binding position between the first and second ends (E1, E2), and may include a first surgical hole (11) for the passage of a suture and a second surgical hole (12) for physical interference with a transplant insertion device or for the passage of a transplant insertion device.
[0443] Through this specification, as a binding mechanism for binding the first and second ends (E1, E2) separated from each other through the incision (C) toward each other, in addition to the suturing or the hook binding or the hook binding that penetrates the surgical hole (10), the first and second ends (E1, E2) may be placed overlapping each other and a bioadhesive may be applied between the first and second ends (E1, E2), or the first and second ends (E1, E2) may be placed overlapping each other and one of the first and second ends (E1, E2) may be heated and melted to be bonded to the other end, and in the fusion bonding of the first and second ends (E1, E2), the first and second ends (E1, E2) that have become adhesive through high heat input may be pressed toward each other to bond these first and second ends (E1, E2) to each other. There is. In other words, in various embodiments of the present invention, various mechanisms for bonding the first and second ends (E1, E2) to each other may be formed singly or in combinations of different mechanisms, and for example, if a bonding method such as a bioadhesive or heat fusion is applied as described above, the surgical hole (10) or the first and second slits (154a, 154b) for hook coupling or hook coupling, the assembly slit (156a) or the assembly hole (156b) may not be formed on the first and second ends (E1, E2).
[0444] According to one embodiment of the present invention, an ocular implant (100) is configured such that a pupil dilation portion (105) between an inner annular edge (101) and an outer annular edge (102) is formed with a wider width at one of the two positions along the short axis of the inner annular edge (101) than at the other position, and thus, an elliptical or circular profile of the inner annular edge (101) can be formed at a biased position that is biased toward the other position within the circular profile of the outer annular edge (102), and accordingly, one position of the pupil dilation portion (105) formed with a relatively wider width at one of the two positions along the short axis of the elliptical or circular shape of the inner annular edge (101) can provide a central position (O) of the procedure.
[0445] However, in one embodiment of the present invention, the elliptical or circular profile of the inner annular edge (101) within the circular profile of the outer annular edge (102) may be formed with equal widths without being biased toward either one or the other of the two positions along the short axis direction, and this may cause inconvenience in the procedure in that the practitioner must confirm a position with a relatively wide width along the short axis direction to take the center position (O) of the procedure of the ocular implant (100), and in the molding of the ocular implant (100), this may cause inconvenience in handling due to lack of rigidity at one or the other position with a relatively thin width in a shape biased toward either one or the other position. Accordingly, in one embodiment of the present invention, the ocular implant (100) may be formed so that one side position or the other side position has an equal width without being biased toward either side position or the other side position along the short axis direction. In other words, in one embodiment of the present invention, the inner annular edge (101) may be formed at a symmetrical position so that the positions on both sides are formed in a balanced manner within the circular profile of the outer annular edge (102) along the short axis direction. Meanwhile, in various embodiments of the present invention, the inner annular edge (101) may be formed as an oval or circular profile, and the major axis or minor axis of the inner annular edge (101) may be defined in a structure in which the major axis length (L1) and the minor axis length (L2) are different from each other, and in a circle in which the major axis length (L1) and the minor axis length (L2) are equal to each other, the major axis may mean a direction in which a pair of eyes of the implanter face each other, and the minor axis may mean a direction intersecting the major axis.
[0446] FIG. 15 is a drawing showing a modified embodiment of the ocular implant (100) illustrated in FIG. 9. Referring to the drawing, in one embodiment of the present invention, the surgical holes (10) formed on the first and second ends (E1, E2) separated from each other through the incision (C) can be formed in an asymmetrical number, and accordingly, a surgeon performing the ocular implant (100) can confirm the orientation of the ocular implant (100). For example, in one embodiment of the present invention, in the procedure of the ocular implant (100), the ocular implant (100) may be pulled along the outer ring of the pupil through a second procedure hole (12) fitted into a transplant insertion tool for inserting the ocular implant (100) so as to travel along the outer ring of the pupil of the recipient, and the direction of pulling along the outer ring of the pupil through the transplant insertion tool may be set in advance from the shape design of the transplant insertion tool, and accordingly, after the orientation of the ocular implant (100) of the present invention is aligned to the correct orientation by a surgeon who recognizes the orientation of the ocular implant (100), it is necessary to insert the transplant insertion tool into the second procedure hole (12) and operate the transplant insertion tool so as to travel along the outer ring of the pupil of the recipient.At this time, in one embodiment of the present invention, since the ocular implant (100) can be formed of a soft material such as silicone that can be flexibly and adaptively deformed on the ocular (EB) tissue and is harmless to the ocular (EB) tissue, the front curved surface (120) and the posterior slope (110) of the ocular implant (100) can be flipped over to each other, and even if the front curved surface (120) and the posterior slope (110) of the ocular implant (100) are flipped over in this way, for example, even if the ocular implant (100) is flipped so that the front curved surface (120) and the posterior slope (110) of the ocular implant (100) are flipped over to each other, the front curved surface (120) rather than the posterior slope (110) is arranged toward the eye (EB) and the posterior slope (110) is arranged toward the outside opposite to the eye (EB), the ocular implant (100) It may be difficult for the practitioner to easily detect errors in orientation.According to one embodiment of the present invention, the ocular implant (100) is formed with a number of operation holes (10) that are asymmetrical to each other on the first and second ends (E1, E2) that are separated from each other through the incision (C), for example, the number of operation holes (10) formed on the first and second ends (E1, E2) is formed differently from each other, or the number of operation holes (10) formed on the first and second ends (E1, E2) is formed with an even number on one end side and an odd number on the other end side, so that when a surgeon performing the ocular implant (100) confirms the end side into which the implant insertion device is inserted among the first and second ends (E1, E2) from the shape design of the implant insertion device, if a normal number of operation holes (10) or a normal odd number or a normal even number of operation holes (10) are not confirmed, The ocular implant (100) can be recognized as having an anterior curved surface (120) formed to face the outer world (OS) opposite to the eyeball (EB) and a posterior slope (110) formed to face the eyeball (EB) reversed, thereby correcting an erroneous orientation of the ocular implant (100) and correctly correcting the orientation of the ocular implant (100) so that the anterior curved surface (120) faces the outer world (OS) opposite to the eyeball (EB) and the posterior slope (110) faces the eyeball (EB) according to the intended design of the ocular implant (100). For example, in various embodiments of the present invention, the orientation of the ocular implant (100) can be confirmed through an asymmetrical design in which the number of treatment holes (10) formed on the first and second ends (E1, E2) separated from each other through the incision (C) is different, or the number of treatment holes (10) formed on the first and second ends (E1, E2) is formed as an even or odd number.
[0447] Although the present invention has been described with reference to the embodiments shown in the attached drawings, these are merely exemplary, and those skilled in the art to which the present invention pertains will understand that various modifications and equivalent other embodiments are possible therefrom.
[0448] The present invention can be applied to the medical industry related to the manufacture of ocular implants for transplant surgery and the production of surgical instruments.
Claims
1. An ocular implant that is permanently implanted on the recipient's eye to provide the recipient's pupil with an enlarged appearance. A central opening that admits light toward the pupil, which provides the opening for the eyeball; An inner annular edge defining the opening by surrounding the opening; an outer annular edge surrounding said opening together with said inner annular edge opposite the inner annular edge defining said opening; and An ocular implant comprising a pupillary expansion member formed between the inner annular edge and the outer annular edge with a variable thickness that changes from the inner annular edge to the outer annular edge.
2. In paragraph 1, The above pupil dilation part is, A posterior slope positioned toward the eye to adhere closely to the eye; and An ocular implant characterized by comprising an anterior surface arranged toward the outside world opposite to the eye.
3. In paragraph 2, The inner annular edge and the outer annular edge, which form the front of the eyeball, are observed as circular or oval in the frontal direction from the front of the eyeball toward the back of the eyeball, where the lens, which performs the lens function, and the pupil, which forms the entrance opening for light, are placed. An ocular implant characterized in that the rear inclined surface is formed as a surface inclined at a constant tilting angle from a vertical plane perpendicular to the frontal direction so that the inner annular edge and the outer annular edge form an anterior position and a posterior position, respectively.
4. In paragraph 2, An ocular implant characterized in that the above rear slope provides a support surface supported on an inclined surface formed on a packaging container of the ocular implant.
5. In paragraph 2, An ocular implant characterized in that the front curved surface is formed along a spline curve in which the curvature or radius of curvature changes along the slope direction of the rear sloped surface.
6. In paragraph 2, An ocular implant characterized in that the pupil expansion portion has a variable thickness in which the thickness between the posterior slope and the anterior curve is variable.
7. In paragraph 6, An ocular implant characterized in that the thickness of the pupillary expansion portion is measured along a direction perpendicular to the posterior slope from the posterior slope to the anterior curve.
8. In paragraph 2, An ocular implant characterized in that the inner annular edge is formed by the anterior curved surface and the posterior slope forming the thickness of the pupil expansion portion contacting each other at a position where they are in contact with the opening.
9. In paragraph 2, An ocular implant characterized in that the outer annular edge is formed by a front curved surface and a rear inclined surface forming the thickness of the pupillary expansion portion contacting each other on opposite sides of the inner annular edge defining the opening.
10. In paragraph 2, An ocular implant characterized in that the front curved surface and the rear inclined surface forming the thickness of the pupil expansion portion are in contact with each other while forming an inner annular edge and an outer annular edge having a rounded corner shape, respectively.
11. In paragraph 10, The above inner annular edge is formed into a relatively gently rounded corner shape, An ocular implant characterized in that the outer annular edge is formed into a relatively sharply rounded corner shape.
12. In paragraph 11, An ocular implant characterized in that the thickness of the edge of the inner annular edge is formed thinner than the thickness of the edge of the outer annular edge.
13. In paragraph 11, Among the membrane tissues that surround the entire eyeball to maintain the shape of the eyeball, the inner annular edge that extends to the discontinuous edge between the cornea in the greater curvature portion that protrudes convexly toward the front and the sclera in the less curvature portion that extends posteriorly from the cornea is relatively gently rounded and finishes one side of the ocular implant. An ocular implant characterized in that the outer annular edge of the above-mentioned large curvature portion is finished on the other side of the ocular implant with a relatively sharp rounded corner shape so as not to lift off from the sclera or form a gap between the sclera and the ocular implant.
14. In paragraph 1, The pupillary expansion portion has a maximum thickness portion having a maximum thickness between the inner annular edge and the outer annular edge; An inner portion formed relatively adjacent to the above opening, between the inner annular edge and the maximum thickness portion; and An ocular implant characterized in that it is formed relatively far from the opening and includes an outer portion between the maximum thickness portion and the outer annular edge.
15. In paragraph 14, An ocular implant characterized in that the inner and outer portions arranged on both sides based on the maximum thickness portion have an asymmetrical shape or an asymmetrical thickness profile.
16. In paragraph 14, The inner portion is formed relatively softly so as to be adaptively deformed to the pupil of each transplant recipient, An ocular implant characterized in that the outer portion is formed to be relatively rigid so as to maintain a delicate circular appearance against deformation of the inner portion and to reinforce the ductility of the inner portion to provide support rigidity of the ocular implant.
17. In paragraph 16, An ocular implant characterized in that the inner portion is formed with a thinner thickness than the outer portion so that it is inserted up to the discontinuous edge between the cornea of the large curvature portion that protrudes convexly toward the front among the membrane tissues that entirely surround the eyeball to maintain the shape of the eyeball, and the sclera of the small curvature portion that extends posteriorly from the cornea, and adheres closely to the discontinuous edge so that no gap is formed between the discontinuous edge and the inner portion.
18. In paragraph 16, The inner and outer parts are formed of the same material, An ocular implant characterized in that the thickness of the inner portion is formed relatively thinner than the thickness of the outer portion.
19. In paragraph 18, The pupil expansion portion includes a front curved surface and a rear inclined surface that form the thickness of the pupil expansion portion, An ocular implant characterized in that the first average thickness of the inner portion formed by the posterior slope and the anterior curve and the second average thickness of the outer portion are formed such that the first average thickness is less than the second average thickness.
20. In paragraph 18, Based on the posterior slope that provides the standard for the thickness of the pupillary expansion portion, An ocular implant characterized in that the anterior curved surface forming the inner portion extends along a trajectory relatively close to the posterior slope, and the anterior curved surface forming the outer portion extends along a trajectory relatively far from the posterior slope, thereby forming a difference in thickness between the inner portion and the outer portion formed on both sides based on the maximum thickness portion.
21. In paragraph 20, The front curve forming the inner portion forms a relatively thin thickness while extending along a relatively adjacent trajectory to the rear slope, and then forms a gently rounded corner at the inner annular edge while following a relatively gentle downward curve toward the rear slope. An ocular implant characterized in that the anterior curve forming the outer portion extends along a relatively distant trajectory with respect to the posterior slope, forms a relatively thick thickness, and then follows a relatively steep downward curve toward the posterior slope, forming a sharply rounded corner at the outer annular edge.
22. An ocular implant that is permanently implanted on the recipient's eye to provide the recipient's pupil with an enlarged appearance, A central opening that admits light toward the pupil, which provides the opening for the eyeball; An inner annular edge defining the opening by surrounding the opening; an outer annular edge surrounding said opening together with said inner annular edge opposite the inner annular edge defining said opening; and An ocular implant comprising an adaptive elastic member that adaptively provides length expansion along at least one of the inner annular edge and the outer annular edge.
23. In paragraph 22, An ocular implant characterized in that the adaptive elastic portion provides longitudinal elasticity along the circumference of the inner annular edge so as to adaptively change to the shape and size of the pupil of each recipient.
24. In paragraph 22, An ocular implant characterized in that the adaptive elastic member comprises at least one slit formed around the periphery of the inner annular edge.
25. In paragraph 24, An ocular implant characterized in that the adaptive elastic member comprises a plurality of slits formed spaced apart from each other along the periphery of the inner annular edge.
26. In paragraph 25, An ocular implant characterized in that the adaptive elastic member comprises a group of slits formed at both sides along the longitudinal direction and / or at both sides along the short-axis direction.
27. In paragraph 26, The above adaptive elastic member is, The pieces divided into the first and second groups are overlapped through the slits formed on both sides along the above-mentioned shortening direction, thereby shortening the long axis length while extending the short axis length. An ocular implant characterized in that the pieces divided into the third and fourth groups are overlapped with each other through slits formed at both sides along the longitudinal direction, thereby extending the longitudinal length and shortening the short-axis length.
28. In paragraph 24, The above pupil dilation part is, A posterior slope positioned toward the eye to adhere closely to the eye; and A front curved surface is disposed toward the outside opposite to the eyeball and forms a thickness profile based on the rear slope, such that an inner annular edge is formed while contacting the rear slope at a position in contact with the opening, an outer annular edge is formed while contacting the rear slope at a position opposite to the opening, and a maximum thickness portion forming a maximum thickness between the inner annular edge and the outer annular edge is formed, such that a relatively thin inner portion and a relatively thick outer portion are formed based on the rear slope, An ocular implant characterized in that the pieces divided from each other through the slit forming the above-mentioned adaptive elastic portion overlap each other to stretch the length of the inner annular edge and form an extra thickness to increase the thickness of the inner portion where the slit introduced from the inner annular edge is formed.
29. In paragraph 1, The inner annular edge, in which the pieces divided through the slit forming the above-mentioned adaptive elastic portion are arranged to overlap each other, is formed in the shape of a relatively gently rounded corner, An ocular implant characterized in that the outer annular edge is formed in a relatively sharply rounded corner shape.
30. An ocular implant that is permanently implanted on the recipient's eye to provide the recipient's pupil with an enlarged appearance, A central opening that admits light toward the pupil, which provides the opening for the eyeball; An inner annular edge defining the opening by surrounding the opening; an outer annular edge surrounding said opening together with said inner annular edge opposite the inner annular edge defining said opening; and An ocular implant comprising a pupil expansion portion formed between the inner annular edge and the outer annular edge, the first and second ends being separated from each other through an incision and connected to each other through a surgical hole formed therein.
31. In paragraph 30, The above treatment hole is, A first surgical hole for passing a suture for binding between the first and second ends; and An ocular implant characterized by including a second surgical hole for a transplantation insertion device to penetrate the ocular implant for traction so that the ocular implant can travel along the outer ring of the surgeon's pupil through an incision in the conjunctiva on the sclera.
32. In paragraph 31, The above first treatment hole is formed with a relatively small diameter, An ocular implant characterized in that the second surgical hole is formed with a relatively large diameter.
33. In paragraph 31, The above first surgical hole is formed at a location relatively close to the incision site, An ocular implant characterized in that the second surgical hole is formed at a location relatively far from the incision site.
34. An ocular implant that is permanently implanted on the recipient's eye to provide the recipient with an enlarged appearance of the pupil, A central opening that admits light toward the pupil, which provides the opening for the eyeball; An inner annular edge defining the opening by surrounding the opening; an outer annular edge surrounding said opening together with said inner annular edge opposite the inner annular edge defining said opening; and An ocular implant comprising a pupil expansion portion formed between the inner annular edge and the outer annular edge, the first and second ends being separated from each other through an incision and forming a latching joint or a hook joint with respect to each other.
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