Pupil enlargement member for ocular cosmetics

Abstract

The present invention relates to a pupil enlargement member to be surgically inserted into an eyeball without damaging the eyeball, the pupil enlargement member comprising: a ring-shaped lens body inserted between the conjunctiva and sclera of the eyeball to surround the outer ring of the pupil; a cut portion provided in the lens body to be inserted into the incised conjunctiva; and two thread members formed as flexible bodies at both ends of the cut portion and cut upon completion of insertion into the eyeball by an insertion procedure tool.

Description

Pupil enlargement device for cosmetic purposes

[0001] The present invention relates to a pupil enlargement member inserted into the eye to enlarge the pupil and make it visible.

[0002] The round, black part in the center of the eyeball is called the pupil, and is often called the iris and pupil of the eye.

[0003] The pupil is the opening at the center of the iris (aperture). Light passing through the cornea passes through the lens and refracts here before reaching the retina. Muscles within the iris contract and relax, causing the pupil to contract in bright light and dilate in dark environments, allowing the retina to receive an appropriate amount of light. This adjustment can be lost in brain damage, particularly to the midbrain, such as from a severe stroke or head trauma. For this reason, neurologists, neurosurgeons, and emergency medicine doctors and nurses always examine the patient's pupils with a penlight in unconscious patients.

[0004] Originally, the term "pupil" referred only to the pupil, but it is generally considered to include the iris as well. Since the pupil is literally an empty part, it is the same black color for all people on Earth, but the iris has various colors depending on the race, which also acts as a characteristic element.

[0005] The pupil is actually transparent, but appears black because the retina reflects very little light entering the eye. Conversely, if a strong, brief flash of light directly hits the pupil, the red color of the inner lining of the eye (red due to blood vessels) is visible through the pupil, causing the red-eye phenomenon (red-eye) that occurs when using a flash.

[0006] The color of the pupil varies slightly from person to person, especially depending on race, and is generally broadly categorized as blue, brown, and dark brown. The iris, which represents the color of the pupil, contains the pigment melanin. The color of the pupil is determined by the amount and distribution of this melanin pigment. If the amount of melanin pigment is low, the pupil appears blue, if it is high, the pupil appears brown, if the pigment is lacking, the pupil appears red, the color of blood vessels, and if the melanin pigment is high, the pupil appears dark brown.

[0007] However, since the pupil in the center of the eye (usually black for Asians) is usually surrounded by white (commonly called the 'white of the eye'), the color contrasts sharply, making the size of the pupil stand out, and clear, large eyes are a measure of beauty and an object of envy for women.

[0008] For this reason, circle lenses have been widely worn recently to make the pupils appear larger and clearer.

[0009] Circle lenses are a type of colored contact lens. They are often colored black around the edges for cosmetic reasons, making the eyes appear larger. However, the pigment in circle lenses makes them thicker, reducing oxygen permeability. This reduces oxygen supply and can easily lead to eye inflammation, potentially leading to vision loss. A side effect is a blurring of the border between the whites of the eye and the blacks of the pupil, which can make the eyes appear smaller.

[0010] Circle lenses, which have colored edges to make the pupils appear larger, are primarily used for cosmetic purposes rather than vision correction. However, circle lenses sold without a prescription can cause eye diseases if used indiscriminately. In addition, cosmetic contact lenses have lower oxygen permeability than regular soft lenses for vision correction because the colorant blocks the microscopic pores on the lens surface. In addition, the rough and irregular surface of the lens can easily irritate the eyes, and the increased contact area and opportunity between bacteria and the lens creates a favorable environment for bacterial growth. Therefore, wearing circle lenses for cosmetic purposes for a long period of time can cause side effects such as neovascularization, keratitis, corneal ulcers, and corneal edema.

[0011] Among these, in the case of new blood vessels, it can have the effect of making the pupil size look smaller. This is because when wearing cosmetic contact lenses for a long period of time, the oxygen permeability decreases and it is easy to be exposed to corneal hypoxia. As a result, new blood vessels can form at the edge of the cornea, which we commonly call black pupils, and the new blood vessels that form rise to the periphery of the cornea and cause the edge of the cornea to become white and cloudy, which can make the black pupil look smaller when wearing contact lenses for a long period of time. Therefore, there is an urgent need for a means to replace circle lenses that can achieve cosmetic purposes without harming the health of the eye.

[0012] Accordingly, the inventor of the present invention proposed a pupil enlargement member for cosmetic purposes of the eye and a surgical device for inserting the enlargement member into the eye in Korean Patent Registration No. 10-171355 (Patent Document 1).

[0013] As shown in FIGS. 1 and 2 (a, b, c), the pupil expansion member (or pupil implant) (30) disclosed in the above-mentioned patent document 1 is inserted between the conjunctiva (24) and the sclera (26) of the eyeball (10), and for this purpose, has an inner diameter (d1) of a size that surrounds at least the outer ring of the pupil (28), and has a ring-shaped body (42) whose outer diameter (D1) is extended to cover the white part of the eyeball, so that the ring-shaped body (42) has a cut end (46) that enables insertion into the eyeball (10) through the incision (40) of the conjunctiva (24), and the cut end (46) is inserted by pushing one end through the incision of the conjunctiva (24) and, after the insertion into the eyeball (10) is completed, the two cut ends are cut off to cut off the excess length and then butted together, or both ends are butted together. It is formed so that the ends can be overlapped and glued or sewn (sealed) with a suture.

[0014] However, in order to insert the pupil expansion member (30) of the above-described structure into the eye, a dedicated insertion and withdrawal mechanism is required. Before using the insertion and withdrawal mechanism, as shown in FIG. 3, a semicircular ring-shaped member (54) having a predetermined thin thickness and a predetermined width and a predetermined handle (56) that can be used to rotate the ring-shaped member in a circular motion is used to first form a ring-shaped empty space by pushing the end of the mechanism (52) between the conjunctiva (24) and the sclera (26) through the incision (40) of the eyeball (10), thereby securing a ring-shaped space in advance into which the pupil expansion member (30) can be inserted. Once the ring-shaped space is secured using the insertion space securing mechanism (52), the insertion mechanism (58) and withdrawal mechanism (66) of the pupil expansion member shown in FIG. 4 (a, b) are inserted into the ring-shaped space inside the eyeball.To this end, a U-shaped hook (64) formed at one end of the insertion device (58) (see FIG. 4a) is hooked into a hole (50) formed at one end of the pupil enlargement member (30), and the pupil enlargement member (30) is inserted into the ring-shaped insertion space formed in advance through the incision (40) to insert the pupil enlargement member (30) into the lower part of the conjunctiva (24) to a 180° position (thereby inserting half of the body of the pupil enlargement member (30) into the ring-shaped space), and in that state, only the insertion device (58) is retracted and removed through the incision (40), and then the extraction device (66) (see FIG. 4b) of the pupil enlargement member (30) is inserted in the opposite direction through the incision (40) of the eyeball so that the tip of the extraction device (66) reaches the 180° position of the eyeball, and then the extraction device (66) is left waiting at the 180° position opposite the incision (40). After the U-shaped hook (74) of the tip of the extraction mechanism (66) is hooked onto the hole (50) of the end (46) of the pupil expansion member (30), the extraction mechanism (66) is retracted so that the end (46) provided with the hole (50) is extracted to the outside of the eyeball (10) through the cut portion (40), and thereby the pupil expansion member (30) is inserted into the ring-shaped space within the eyeball (10) for a full 360°. After cutting and adjusting the length of the ends (46, 48) of the pupil expansion member (30) located outside the eyeball so that they match or overlap slightly, leaving only a portion, both ends are sewn (sutured) or welded, and the conjunctival incision (40) of the opened eyeball (10) is sewn, the ring-shaped pupil expansion member (30) is inserted in a ring shape between the conjunctiva (24) and the sclera (26) to wrap the outside of the pupil (28) of the eyeball, thereby completing the procedure.According to this patent document 1, when another person looks at the eyes, the diameter of the pupil appears to be enlarged (the size of the pupil before the procedure is d1, but after the procedure, the pupil appears enlarged to D1: FIG. 2b) by the pupil enlargement member (30) that makes the pupil appear to be of a color identical or similar to the pupil or of various colors such as blue, green, gold, purple, and red selected according to each person's fashion or taste, thereby making the eyes appear larger, so it is still an effective invention, but it was discovered that several inconvenient problems arose during the procedure.

[0015] According to the prior art patented invention (patent document 1), in order to insert the pupil expansion member (30) into the eye, an insertion space securing device (52) that forms a space for the pupil expansion member (30) to be inserted and an insertion and withdrawal device (58, 66) that positions the pupil expansion member (30) in the insertion space are used separately, which requires multiple surgical devices (52, 58, 66), which entails inconvenience in the surgical work and maintenance of the surgical devices, and in particular, the tips of the insertion and withdrawal devices (58, 66) are bent in a T-shape and a U-shape and protrude from the main body, so that when the device (58, 66) is inserted and withdrawn into the ring-shaped space, the T-shaped and U-shaped tip bent protrusions (64, 74) that protrude toward the conjunctiva scratch the surface of the conjunctiva (24), so that if considerable care is not taken, the thin conjunctiva (24) may be injured or damaged. Also, because of this, in order to prevent damage to the conjunctiva (24), the rotational movement speed of the insertion and withdrawal device (58, 66) must be performed very slowly and very carefully, which greatly reduces the speed of the procedure. In addition, there is a problem that it causes inconvenience in the procedure due to the operator's fine force control and hand tremors due to the operation, and greatly increases the fatigue of the ophthalmologist who is the operator.

[0016] This problem is that the pupil expansion member (30) proposed in Patent Document 1 has a hook hole (50) (see FIG. 1) formed at its end (46), and a dedicated insertion surgical instrument (58) (66) was designed to hook the pupil expansion member (30) into the gap space within the eye by hooking it to the hook hole (50). To this end, the tip of the insertion surgical instrument (58, 66) is formed in a 'ㄷ' shape and a 'U' shape so that it can be inserted into the hook hole (50) at the tip of the pupil expansion member (30) and transported, and these 'ㄷ' and 'U' hooks (64, 74) are inserted into the hook hole (50) at the tip of the pupil expansion member (30) so that the insertion surgical instrument (58) (66) can be inserted into the ring-shaped gap space provided under the conjunctiva. Since it is structured to lead the insertion movement, when the insertion surgical instrument (58)(66) draws a circle and rotates forward and backward, the protruding objects from the surface of the main body, the 'ㄷ-shaped' and 'U-shaped' hooks (64, 74), come into contact with the conjunctiva and apply strong pressure, causing movement. It was found that there is a possibility that the conjunctiva (24) may be damaged. In rare but severe cases, the hooks (64, 74) may scratch the conjunctiva, causing it to tear or stretch significantly, requiring surgery, or the conjunctiva may lose elasticity and stretch due to the application of great pressure to the eye tissue, requiring a lot of time for recovery of the stretched conjunctiva, etc., which may cause side effects.

[0017] On the other hand, in a situation where the pupil expansion member, which is a ring-shaped lens body, is installed in the gap between the conjunctiva and the sclera, the front and back ocular tissues are separated and blocked by the ring-shaped lens body, which blocks the smooth circulation of body fluids including tears and blood flow, which can be a factor that harms the health of the eye.

[0018] {Prior art literature}

[0019] [Patent Document]

[0020] (Patent Document 1) Korean Patent No. 10-171355 (announced on March 7, 2017)

[0021] Accordingly, the present invention has been proposed in consideration of the above-mentioned points, and its purpose is to provide a pupil enlargement member having a structure that can be inserted into the eye accurately and safely without damaging the eye for cosmetic purposes.

[0022] Another object of the present invention is to provide a pupil dilating member that minimizes the area protruding toward the conjunctiva due to increased thickness of the suture area when the pupil dilating member for cosmetic purposes is inserted into the eye, thereby significantly reducing pressure on the eye tissue and causing no injury.

[0023] Another object of the present invention is to provide a pupil dilating member having a structure capable of preventing damage to ocular tissue caused by an insertion surgical device by enabling a dedicated insertion surgical device to be designed flat without any sharp protrusions in the thickness direction through an optimized design of the pupil dilating member.

[0024] Another object of the present invention is to provide a pupil expansion member having a structure that allows circulation of body fluids including tears and blood flow back and forth of a ring-shaped lens body while the pupil expansion member is installed within the eye, thereby preventing damage to the eye due to foreign body reaction or inflammation and maintaining the eye in good health.

[0025] In order to achieve the above object, the pupil enlargement member for cosmetic purposes of the present invention includes a ring-shaped lens body having an inner diameter of a size that at least surrounds the outer ring of the pupil and a predetermined width that extends so that the outer diameter covers the white of the eye, and is formed of a flexible material so as to have a color according to the color of the pupil or an individual's fashion and taste, and the ring-shaped lens body has a cut portion so as to be inserted into the eye through the incised conjunctiva of the eye, and the cut portion is formed so that one end is pushed through the incised portion of the conjunctiva and, after the insertion into the eye is completed, both ends of the cut portion are sealed to each other by adhesive or sewing, in the pupil enlargement member for cosmetic purposes of the eye, both ends of the cut portion of the ring-shaped lens body are formed as a flexible body that extends in the same plane as the ring-shaped lens body and is free to bend in a U shape, and also has a predetermined diameter and a diameter with respect to the diameter. It is characterized by having a length of 40 to 95 times and including two real parts that are cut when inserted into the eyeball by an insertion device.

[0026] According to a preferred embodiment of the present invention, the ring-shaped lens body is characterized in that it is formed of any one material selected from a flexible and human body-safe hydrogel, silicone hydrogel, hydroxyethyl methacrylate (HEMA), a copolymer of vinyl pyrrolidone with HEMA or methyl methacrylate, a copolymer of glyceryl methacrylate and methacrylate, a copolymer of HEMA and diacetone acrylamide, a silicone derivative, polyamide, PHEMA (polyhydroxyethyl methacrylate), PVP (polyvinyl pyrrolidone), RPG (methyl methacrylate-acrylic acid polymer), CAB (cellulose acetate butylate), polymethyl methacrylate (PMMA), and a soft acrylic acid material.

[0027] According to a preferred embodiment of the present invention, the connection portion between the ring-shaped lens body and the real member is characterized in that the end of the inner diameter of the ring-shaped lens body is rounded.

[0028] According to a preferred embodiment of the present invention, the end of the inner diameter of the ring-shaped lens body forms a two-layered single layer, and each corner of the single layer is rounded.

[0029] According to a preferred embodiment of the present invention, the outer surface of the ring-shaped lens body on both sides of the cut portion is characterized in that one to four suture needle holes are formed at a predetermined interval from the end along the circumferential direction.

[0030] According to a preferred embodiment of the present invention, the outer surface of the ring-shaped lens body on both sides of the cut portion is characterized in that a semicircular groove of a predetermined depth and width is formed along the circumferential direction over a predetermined length.

[0031] According to a preferred embodiment of the present invention, the depth of the semicircular groove is characterized in that it is greater than the radius size of the suture used for suturing.

[0032] According to a preferred embodiment of the present invention, the depth of the semicircular groove is characterized by being the diameter size of the suture used for suturing.

[0033] According to a preferred embodiment of the present invention, the suture needle hole is characterized in that it is formed in the semicircular groove.

[0034] According to a preferred embodiment of the present invention, the end of the real member is formed as a tapered portion whose diameter gradually decreases.

[0035] According to a preferred embodiment of the present invention, the ring-shaped lens body is characterized in that the thickness decreases as it approaches both ends.

[0036] According to a preferred embodiment of the present invention, the diameter of the real member is 0.2 mm to 0.4 mm.

[0037] According to a preferred embodiment of the present invention, the ring-shaped lens body is characterized by having an inclination angle of 20° to 40° with respect to the horizontal plane.

[0038] According to a preferred embodiment of the present invention, the maximum thickness of the center of the ring-shaped lens body is 0.08 mm to 0.20 mm, and the width is 0.5 mm to 2.5 mm.

[0039] According to a preferred embodiment of the present invention, the ring-shaped lens body is characterized in that a plurality of micro-holes are formed in front and back to allow the forward and backward circulation of body fluids including tears and blood.

[0040] According to a preferred embodiment of the present invention, the diameter size of the plurality of micro-holes formed by penetrating the ring-shaped lens body is 10 µm to 100 µm.

[0041] According to the present invention, a pupil dilating member inserted between the conjunctiva and the sclera to wrap around the outer circumference of the pupil is formed by a long, flexible, and tough thread member from both ends facing each other by a cut portion, so that the thread member can be inserted into a thread-fitting hole formed in a flat end of an insertion surgical instrument including a semicircular body and drawn into and seated within an insertion space (preliminarily formed gap) within the eye (after the seat is established, the thread member is cut and removed), and thus, due to this unique configuration of the pupil dilating member, the function of securing an insertion space within the eye is secured with only one surgical instrument, and the insertion of the pupil dilating member is advantageous in that, compared to the conventional method, the preparation of the insertion surgical instrument is simplified, and the procedure is economical due to a shortened and convenient procedure time. In addition, since there is no structure protruding from the surfaces of both sides of the insertion surgical instrument, the instrument does not scratch the conjunctiva and sclera, etc., when forming an insertion space or during the procedure of inserting the pupil dilating member within the eye. It has the effect of preventing damage to the eyeball by preventing it from passing by.

[0042] In particular, since the pupil expansion member decreases in thickness toward the cut end, when overlapping both ends and suturing with adhesive or suturing using a suture, the end does not protrude in the thickness direction more than the remaining part of the lens body other than the end, thereby reducing the local pressure applied to the eye at the sutured part. Furthermore, since a semicircular groove is formed at both ends and needle holes for suturing are formed within the semicircular groove, when suturing with a suture, the suture is accommodated in the semicircular groove and does not protrude above the outer surface of the lens body, thereby further reducing the pressure load applied to the eye.

[0043] Additionally, the lens body of the pupil expansion device has many micron-sized holes formed, which ensures the circulation and movement of body fluids including tears and blood flow, thus helping to keep the eye healthy.

[0044] Figure 1 is a drawing showing a pupil expansion member conventionally inserted into the eye for cosmetic purposes.

[0045] FIG. 2(a,b,c) are drawings showing an incision in the conjunctiva for inserting a conventional pupil expansion member according to FIG. 1 into the eye, and a pupil expansion member inserted under the conjunctiva through the incision in the eye using a conventional surgical instrument.

[0046] Figure 3 is a drawing showing an insertion space securing device used to secure space before inserting a conventional pupil expansion member into the eyeball.

[0047] Figure 4(a,b) is a drawing showing an insertion and withdrawal mechanism used to draw the pupil expansion member into the insertion space within the eye and insert and secure it.

[0048] Figure 5 is a perspective view of a pupil expansion member according to the present invention.

[0049] Figure 6 is a front view of a pupil expansion member according to the present invention.

[0050] Fig. 7 is a partially enlarged perspective view showing the connection portion between the lens body and the real member of the pupil expansion member according to the present invention.

[0051] Figure 8 is a partially enlarged front view showing the connection portion between the lens body and the real member of the pupil expansion member according to the present invention.

[0052] Figure 9 is a side view of a pupil expansion member according to the present invention.

[0053] Fig. 10 is a cross-sectional view showing the lens body of the pupil expansion member according to the present invention.

[0054] Fig. 11 is a partially enlarged perspective view showing the change in thickness of both ends of the lens body of the pupil expansion member according to the present invention.

[0055] Fig. 12 is a partially enlarged perspective view showing the pupil expansion member according to the present invention as viewed from the bottom side.

[0056] Fig. 13 is a perspective view showing an insertion surgical instrument having a structure exclusively usable for the pupil expansion member according to the present invention.

[0057] Fig. 14 is a side view showing an insertion surgical instrument having a structure exclusively usable for the pupil expansion member according to the present invention.

[0058] Figure 15 is an enlarged view of the main part of an insertion surgical instrument having a structure exclusively usable for a pupil expansion member according to the present invention.

[0059] Figure 16 is a drawing showing the steps of forming incisions at 180° angles at two locations on the conjunctiva of the eye before implanting the pupil expansion member into the eye.

[0060] Figure 17 is a drawing showing a process of forming a gap (space) in the cornea for inserting a pupil expansion member into one side of the eyeball using an insertion surgical device according to the present invention.

[0061] Figure 18 is a drawing showing a process of inserting a part of the body corresponding to half of the pupil expansion member into a gap space formed in the eyeball using an insertion surgical instrument according to the present invention.

[0062] FIG. 19 is a drawing showing a process of inserting a part of a body corresponding to half of a pupil expansion member into a gap space formed in an eyeball using an insertion surgical instrument according to the present invention.

[0063] FIG. 20 is a drawing showing a process of connecting the real part of the pupil expansion member to the insertion surgical instrument in order to form a gap on the other side of the eyeball using the insertion surgical instrument according to the present invention and then insert the remaining body part of the pupil expansion member into the gap.

[0064] FIG. 21 is a drawing showing a process of pulling an eyelid expansion member connected to an insertion surgical instrument according to the present invention into a gap within the eye through the process of FIG. 19 and pulling it out toward the incision for instrument insertion.

[0065] Figure 22 is a drawing showing the process of suturing the angled end of the pupil expansion member using a suture after the insertion of the pupil expansion member into the eyeball is completed and the real member is removed.

[0066] Figure 23 is a drawing showing the process of suturing the two incisions formed above and below the eyeball using a bioadhesive after the pupil expansion member end suture is completed.

[0067] The advantages and features of the present invention, and the methods for achieving them, will become clear with reference to the embodiments described below in detail together with the accompanying drawings. However, the present invention is not limited to the embodiments disclosed below, but may be implemented in various different forms.

[0068] The embodiments described herein are provided to ensure a complete disclosure of the present invention and to fully convey the scope of the invention to those skilled in the art. Accordingly, the shapes of elements in the drawings may be exaggerated for clarity. Furthermore, the present invention is defined solely by the scope of the claims. Therefore, detailed descriptions of well-known functions and configurations that may unnecessarily obscure the gist of the present invention are omitted.

[0069] In addition, throughout the specification describing the configuration of the present invention, the same reference numerals refer to the same components. In addition, the terms used (referred to) in this specification are for the purpose of describing embodiments and are not intended to limit the present invention. In this specification, the singular also includes the plural unless specifically stated otherwise. In addition, the components and operations mentioned as "including (or, having)" do not exclude the presence or addition of one or more other components and operations.

[0070] Unless otherwise defined, all terms (including technical and scientific terms) used herein may be used with meanings that can be commonly understood by a person of ordinary skill in the art to which the present invention pertains. In addition, terms defined in commonly used dictionaries shall not be interpreted ideally or excessively unless defined. In the definition of terms, the pupil refers to the black part of the eye, including the pupil and iris, and the white part around the pupil is called the white of the eye. In addition, the term "sewing" or "sewing part" includes sewing (stitching) the two ends of a cut state using a suture, or suturing them through heat bonding or adhesive bonding, etc.

[0071] Hereinafter, the technical configuration of the present invention will be described in detail with reference to the attached drawings.

[0072] Figures 5 to 12 are drawings showing a pupil expansion member according to the present invention, and the pupil expansion member of the present invention is indicated as a whole by reference numeral 100.

[0073] The above pupil expansion member (100) includes a non-toxic ring-shaped lens body (102) that is biocompatible. The ring-shaped lens body (102) can be either a 'hard contact lens' or a 'soft contact lens', but is preferably a silicone-based material including a hydrogel (hydrophilic polymer: hydrogel) or a silicone hydrogel made of an organic polymer or copolymer material composed of a hydrophilic monomer, which is a high moisture content, soft material that expands and softens when hydrated and has flexibility. One particularly useful hydrogel is hydroxyethyl methacrylate (HEMA), which reduces the risk of endothelial damage when in contact with ocular tissue within the eye; other types of hydrogels used in the present invention include copolymers of vinyl pyrrolidone with HEMA or methyl methacrylate, copolymers of glyceryl methacrylate and methacrylate, and copolymers of HEMA and diacetone acrylamide.

[0074] In addition, it can be formed from any one material selected from silicone derivatives, polyamide, PHEMA (polyhydroxyethyl methacrylate), PVP (polyvinyl pyrrolidone), RPG (methyl methacrylate-acrylic acid polymer), CAB (cellulose acetate butylate), polymethyl methacrylate (PMMA), and soft acrylic acid materials.

[0075] The ring-shaped lens body (102) of the above pupil expansion member (100) has two ends (106, 108) separated by a cut portion (or connecting portion, 104) at a portion of the body, and the distance (t1) between the ends (106, 108) on both sides is 0.4 mm to 0.8 mm, preferably 0.5 mm to 0.7 mm, and optimally 0.6 mm.

[0076] The inner diameter (D1) of the above ring-shaped lens body (102) is formed to be 10.0 mm to 14.0 mm, preferably 12.0 mm to 13.0 mm, the outer diameter (D2) is formed to be 10.5 mm to 15.0 mm, preferably 13.5 mm to 14.5 mm, and the width (b1) is formed to be 0.5 mm to 2.5 mm, preferably 0.75 mm.

[0077] From both ends (106, 108) of the ring-shaped lens body (102), two solid members (110, 112) extend in parallel on the same plane. These solid members (110, 112) may be integrally formed using the same material as the ring-shaped lens body (102), or may be formed separately using the same material and then joined to the both ends (106, 108), or may be formed using a flexible material that has greater ductility than the ring-shaped lens body (102) and is softer and more flexible, allowing for excellent bending, and may be joined to the ring-shaped lens body (102). In addition, the ends of the solid members (110, 112) are provided with tapered portions (110a, 112a) whose diameters are gradually reduced to facilitate passage through narrow holes. The above-mentioned real member (110, 112) extending from both ends (106, 108) of the above-mentioned ring-shaped lens body (102) is formed as a flexible body that can freely bend into a U shape, and also has a predetermined diameter (d1) and a length that is approximately 40 to 95 times the diameter (d1), and is cut when insertion into the eye is completed by the insertion surgical instrument.

[0078] The above-mentioned thread member (110, 112) is formed with a diameter of 0.2 mm to 0.4 mm, and preferably, it is not too thin or thick, about 0.3 mm, so as to secure an appropriate tensile strength so as not to be cut by the traction force during the insertion procedure, while at the same time not to significantly increase the friction with the ocular tissue due to the protrusion height toward the surface of the lens body (102) in the ring shape. In addition, the length of the above-mentioned thread member (110, 112) is 8.0 mm to 38.0 mm, which is approximately 40 to 95 times its diameter (d1), preferably 15 mm to 25 mm, and more preferably 18 mm to 22 mm. In the present embodiment, it is formed with a length that is not easily detached from the surgical instrument during U-shaped bending movement and is not inconvenient for the task of inserting it into the hole and fastening it, but is formed with a length of 20.0 mm, which is necessary for stably maintaining the fastening state, because it is difficult to control if it is too long. In addition, the length of the tapered portion (110a, 112a), which is the tail portion, is designed to be approximately 1.8 mm to 2.2 mm, and in this embodiment, 2.0 mm.

[0079] The inner edge portion of the ends (106, 108) on both sides above is formed with at least one curved portion (R1, R2), and preferably, one step fault is formed from the inner edge portion, and the edge of the fault portion is also formed with a curved portion (R3, R4), so that damage to eye tissue caused by sharp edges when inserted into the eye can be prevented.

[0080] A semicircular groove (114, 116) having a predetermined depth and width and a predetermined length is formed along the circumferential direction on the outer surface of the ring-shaped lens body (102) from the above-mentioned both ends (106, 108) or in a horizontal direction perpendicular to the real member (110, 112), and at least one suture needle hole (118, 120) is formed at a predetermined interval from the end in the semicircular groove (114, 116), and preferably, 2 to 4 suture needle holes (118, 120) are formed.

[0081] The above-mentioned suture needle hole (118, 120) is formed to have a diameter of 0.13 mm to 0.17 mm, preferably 0.15 mm, so that a needle for suturing and a suture thread can pass through it, and the width of the semicircular groove (114, 116) is formed to be equal to or slightly larger than the suture needle hole (118, 120), and the distance from the end located at the cut portion of the ring-shaped lens body (102) to the suture needle hole (118, 120) and the interval between the holes (118, 120) are formed to have a distance of 0.3 mm to 0.7 mm, preferably 0.5 mm.

[0082] In addition, the depth of the semicircular groove (114, 116) is formed to be larger than the radius size of the suture used for suturing (i.e., formed to be the radius size or the diameter size), and by forming it in this way, when suturing both ends (106, 108) after finally cutting and removing the real material, the part of the suture accommodated in the semicircular groove (114, 116) becomes larger, so that the part of the body protruding above the surface of the ring-shaped lens body (102) is minimized, and it is possible to minimize the pressure applied to the eye tissue, i.e., the conjunctiva.

[0083] Fig. 10 is a cross-sectional view showing the shape of a ring-shaped lens body of a pupil expansion member according to the present invention, in which the central thickness (T1) of the ring-shaped lens body (102) is the maximum, and the central thickness (T1) is formed to be 0.10 mm to 0.14 mm, and 0.12 mm in the present embodiment, and has a curved surface whose thickness gradually decreases from the outer surface (102a) of the central portion to both sides, so that the ring-shaped lens body (102) has a cross-section like a convex lens. However, the inner surface (102b) of the ring-shaped lens body (102) may not be a straight line but may have a concave shape, a curved shape like a bow, or a crescent-shaped cross-section like the tip of a fingernail.

[0084] The inner surface (102b) of the above-mentioned ring-shaped lens body (102) has an inclination angle (α1) of 22° to 40° with respect to the ground (horizontal line, 122), preferably 24° to 25°, which is close to the average surface curvature of the eyeball, and in the embodiment of the present invention, it is formed at 24.33°, which is the average value of the individual eyeball curvature.

[0085] The lower edge surface (124) of the ring-shaped lens body (102) is aligned with the ground (horizontal line), and the size of the width (b2) of the lower edge surface (124) is 0.06 mm to 0.10 mm, or 0.08 mm in this embodiment, and the upper edge surface (l26) is formed as a surface that is almost perpendicular to the inner surface (102b), and the width (b3) of the upper edge surface (126) is formed to be 0.03 mm to 0.05 mm, or 0.04 mm in this embodiment. In addition, the maximum thickness (T1) of the center of the ring-shaped lens body (102) is 0.10 mm to 0.14 mm, or 0.12 mm in this embodiment, and the width (b1) thereof is 0.5 mm to 2.5 mm, or 1.0 mm in this embodiment.

[0086] Fig. 11 is a perspective view showing an enlarged portion of a pupil expansion member according to the present invention, and shows changes in the cross-sectional shape of both ends (106, 108) of a ring-shaped lens body (102).

[0087] The size of the cross-section (A1) at a predetermined distance from one end (106) of the ring-shaped lens body (102), in the illustrated example, at approximately the second hole (118) in the circumferential direction based on the end (106), is the same as that of the rest of the body, that is, the thickness at the center of the cross-section (A1) is T1, and the cross-section thickness gradually decreases from the cross-section (A1) toward the end (106), so that the thickness T2 at the center of the cross-section (A2) at the first hole is smaller than the thickness T1 of the cross-section A1, and the thickness T3 at the center of the cross-section A3 at the end is formed smaller than the thickness T2 at the center of the cross-section A2 of the hole, and this also applies to the other end (108) opposite to the one end (106). In this way, when the thickness decreases toward the end, when the ends on both sides are overlapped or sewn with a suture, it is effective in preventing the overall thickness at the sewing part from becoming greater than the thickness T1 of the ring-shaped lens body (102) and reducing the pressure applied to the eye tissue by the protruding part.

[0088] Meanwhile, although the size is too small to be specifically shown in the drawing and thus omitted, the ring-shaped lens body (102) has numerous micro-holes formed through the body from front to back, and the diameters of these micro-holes are 10㎛ to 100㎛, preferably 50㎛. The micro-holes allow body fluids such as tears or blood generated within the eye to circulate back and forth through the ring-shaped lens body (102), thereby helping to maintain the sound health of the eye. The reason for forming the holes so finely as described above is that if large holes are formed in a lens body having a color identical or similar to the color of the pupil or a predetermined color according to fashion and / or individual taste, the holes will be visible to others and will also appear different from the inherent color of the pupil, which will damage the appearance of the eye. Therefore, the present invention aims to help the smooth circulation and movement of body fluids without damaging the appearance of the eye.

[0089] FIGS. 13 to 15 are drawings showing an insertion surgical instrument (128) for an eyeball of a pupil expansion member for cosmetic purposes of the present invention, wherein the insertion surgical instrument (128) is formed of a metal alloy material, a plastic material, or a silicone material for surgical instruments, and is inserted by drawing an arc in one direction or the other direction of the eyeball through one side of the instrument insertion incision (144) among two incisions (see symbols 144 and 146 of FIG. 16) for instrument insertion and thread tying formed by cutting the conjunctiva (24) at a 180° position of the eyeball, and at this time, while being inserted into the lower part of the conjunctiva (140) through one side of the instrument insertion incision (144), a semicircular insertion port having a predetermined cross-sectional thickness and width forms a semicircular gap of a predetermined width between the conjunctiva (140) and the sclera so as to surround the outer periphery of the pupil (138). When the body (130a, 130b: representative symbol 130) and the tip (132a, 132b: representative symbol 132) of the semicircular insertion body (130) reach the position of the thread-tying cut-out (146) at the 180° position of the eyeball, a thread-fitting hole (134a, 134b: representative symbol 134) formed at the tip (130) of the semicircular insertion body (130) is inserted and hung on one of the thread members (110, 112) extended long from one end of the pupil expansion member (100), and a handle part (136) extended at the other end of the semicircular insertion body (130) opposite to the thread-fitting hole (134) to form an angle of 90° to 160° with respect to the semicircular insertion body (130), The semicircular insertion body (130a, 130b) is formed rotationally symmetrically on the handle portion (136), so that each of the semicircular insertion bodies (130a, 130b) is responsible for treating half of the eyeball.

[0090] The semicircular insertion body (130) is inserted by rotation under the conjunctiva (24) to form a semicircular gap in one half of the eyeball, and then the thread member (110, 112) extended from the pupil expansion member (100) is inserted into the thread insertion hole (134a, 134b) through the thread-binding cutout (146) and installed, and then the handle part (136) is rotated in the opposite direction so that the semicircular insertion body (130) draws an arc in the opposite direction to that during insertion and the tip (132) binding the thread member (110, 112) is pulled out through the instrument insertion cutout (144) to draw and insert the pupil expansion member (100) into the eyeball (138).

[0091] Hereinafter, the process of inserting a pupil expansion member (or pupil implant) (100) into an eyeball (138) using an insertion surgical device (128) according to the present invention will be described in detail step by step with reference to FIGS. 16 to 21.

[0092] In FIGS. 17 to 19, the semicircular insertion port body (130a) and the handle portion (136) of the insertion surgical instrument (128) are depicted as being on the same plane, but this is only to avoid complexity. In reality, the handle portion (136) forms an obtuse angle (α1) of approximately 135° with the semicircular insertion port body (130a) (130b) as shown in FIG. 14, so that it stands up radially with respect to the eyeball (138).

[0093] In the normal state, the eyeball (61) is in close contact with the conjunctiva (140) and the sclera inside thereof, so in order to perform a procedure to insert the pupil expansion member (128) into the eyeball (138), a space (gap) for insertion must be secured in advance. To this end, a procedure is performed to form a gap (space) in the eyeball (138) in advance that allows the insertion and placement of the external member (pupil expansion member 100) using the insertion procedure device (128) of the present invention.

[0094] FIG. 16 shows that before implanting the pupil expansion member (100) of the present invention into the eyeball (138), the operator (e.g., an ophthalmologist) makes a horizontal incision (or vertical in the case of forming on the left and right) of a predetermined length (width) using a surgical knife at two locations 180° above and below the conjunctiva (140) at a predetermined distance from the outer circumference of the pupil (142) of the eyeball (138) to form two incisions (144, 146) of a size that allows the semicircular insertion port body (130a) of the insertion surgical instrument (128) to freely pass in and out (step 1 of FIG. 16).

[0095] Next, the practitioner inserts the tip (132a) of the semicircular insertion port body (130a) of the insertion instrument (128) into the lower part of the conjunctiva (140) through the instrument insertion incision (144), and then, while lightly pinching the handle (136) of the insertion instrument (128) between the practitioner's thumb and the remaining fingers, the practitioner pushes the finger counterclockwise so that the handle (136) rotates counterclockwise (based on the illustrated state of FIG. 17) around the axis of the handle (136), so that the tip (132a) rotates counterclockwise around the axis as if drawing a circle (see the direction of the red arrow in FIG. 17), and the tip (132a), which moves in a circular motion by this counterclockwise rotation, digs between the contact boundary of the conjunctiva (140) and the sclera and moves in an arc through the process of the tip (132a) A gap with a width equal to the diameter (d1) is gradually formed into a semicircular ring shape. This operation rotates the handle (136) until the tip (132a) moves in an arc and reaches a 180° position (step 2 of Fig. 17).

[0096] In this way, when the tip (132a) of the semicircular insertion body (130a) reaches the 180° position, i.e., the position of the thread-tying cutout (146), the thin end of the thread member (112) of the pupil expansion member (100) that is extended long and thin through the thread-tying cutout (146) is inserted into the thread-fitting hole (134a) formed in the tip (132a) as if threading a needle hole, and is pulled out at least 1 / 2 of the length, thereby completing the binding operation of the pupil expansion member (100) to the insertion surgical instrument (128). Thereafter, when the handle part (74) is operated to rotate in the opposite direction, the tip (132a) moves backwards while drawing the same rotational trajectory in the opposite direction to the rotational trajectory at the time of entry (see the direction of the red arrow in FIG. 18), and accordingly, the flexible thread member (112) is drawn in a U-shaped folded state according to the backward movement of the tip (132a) and moves, and the thread member (112) first enters the gap matching the rotational trajectory through the thread fastening cutout (146), and the main body (102: ring-shaped lens body) of the pupil expansion member (100) integrally connected to the thread member (112) also moves together and enters the gap space of the same trajectory through the thread fastening cutout (146) (In order to avoid a complicated illustration in the drawings, the indication of the thread member (112) is omitted and the insertion process is conceptually explained). In this way, when the tip (132a) is retracted and returned to the original initial insertion position (incision 144 position), the tip (132a) is pulled out of the eyeball (138) through the incision (144) for instrument insertion, and at this time, the thread member (112) is also pulled out of the eyeball (138). From this point on, the operator grabs and pulls the thread member (112) pulled out, and this pulling operation is performed until the moment when the connection portion of the end (108) of the main body (102), which is the connection portion with the thread member (112), reaches the position of the incision (144) for instrument insertion (see step 3 of FIG. 18).

[0097] Next, the practitioner turns the two ends of the insertion instrument (128) in the opposite direction so that the semicircular insertion port body (130b) faces the eyeball (138), and then inserts the tip (132b) of the semicircular insertion port body (130b) through the instrument insertion incision (144). The rotation direction at this time is clockwise, which is opposite to steps 1 to 3. That is, if steps 1 to 3 are procedures for the right side of the eyeball (138), the procedure using the semicircular insertion port body (130b) is a procedure for the left side of the eyeball (138). Therefore, since the left side of the eyeball (138) does not yet have a gap formed, the gap is formed only by the insertion of the semicircular insertion port body (130b).

[0098] In this way, the tip (132b) of the semicircular insertion body (130b) moves clockwise along a circular trajectory to form a gap, and when the tip (132b) reaches the 180° position, i.e., the position of the thread-tying cutout (146) formed on the opposite side, the thin end (110a) of the thread member (110) that remains waiting outside the eyeball (138) in a long and thin state of the pupil expansion member (100) is grabbed and pulled into the thread-fitting hole (134b) formed in the tip (132b) as if threading it through the eye of a needle, and the thread is pulled out by at least 1 / 2 of the length, thereby completing the tying operation of the left half of the pupil expansion member (100) that remains outside the eyeball to the insertion surgical instrument (128) (see step 4 of FIG. 19).

[0099] Afterwards, when the handle part (136) is operated to rotate in the opposite direction, the tip (132b) moves backward while drawing the same rotational trajectory in the opposite direction to the rotational trajectory at the time of entry (see the red arrow direction in FIGS. 19 and 20), and accordingly, the real member (110) is connected to the tip (132b) in a U shape, so that the real member (110) first enters the gap matching the rotational trajectory through the thread fastening cutout (146) according to the backward movement of the tip (132b), and the remaining part (since the right half of the main body has already been inserted into the right side of the eyeball, the left half that is not inserted is 1 / 2 of the main body) that is integrally connected to the real member (110) that remained on the outside also moves together and enters the gap of the same trajectory through the thread fastening cutout (146). It enters the space (in order to avoid a complicated city in the city of the drawings, instead of omitting the indication of the real member (110), only the symbol 110 is indicated in FIG. 20 to conceptually explain the insertion process). In this way, when the tip (132b) returns to the original insertion position, the tip (132b) is pulled out of the eyeball (138) through the incision (144) for instrument insertion, and at this time, the real member (110) is also pulled out of the eyeball (138). From this time on, the operator grabs and pulls the real member (110) pulled out, and this pulling operation is performed until the moment when the connection (104) of the end (106) of the main body (102), which is the connection portion with the real member (110), reaches the position of the incision (144) for instrument insertion (see FIG. 20 Step 5).

[0100] In step 5, since both thread members (110, 112) are pulled out of the eyeball (138), the operator adjusts the optimal position of the main body (102: ring-shaped lens body) of the pupil expansion member (100) through relative pulling manipulation of the two thread members (110, 112), and once the position is determined, the two thread members (110, 112) are cut, so that only the main body (102) of the pupil expansion member (100) remains in a ring shape inside the eyeball (138). However, it goes without saying that either thread member (110, 112) can be cut at the moment it is pulled out first.

[0101] When the cutting of all the real parts (110, 112) extracted in the above step 5 is completed, the two ends (106, 108) of the main body (102) of the pupil expansion member (100) (if there is no need for special distinction, or when the procedure is completed, the ring-shaped lens body part, which is the main body, can be simply referred to as the pupil expansion member) are connected to each other or partially overlapped and sutured using a suture (148) that is harmless to the human body (see step 6 of FIG. 21).

[0102] When the suturing of both ends of the pupil expansion member (102) main body (102) is completed, the two incisions (144, 146) formed in the conjunctiva (140) are finally connected using a bioadhesive (150), thereby completing the insertion procedure of the pupil expansion member (100) into the eyeball (138). After that, all that is required is to wait for the wound at the sutured area to heal.

[0103] According to this procedure, the pupil enlargement member (100) is placed in a ring shape on the lower part of the conjunctiva (140) around the outer periphery of the pupil (142) of the eyeball (138), and when the pupil enlargement member (100), which is a ring-shaped lens body, is inserted in a ring shape between the conjunctiva (142) and the sclera so as to surround the outer periphery of the pupil (142) of the eyeball, when another person looks at the eye, the diameter of the pupil appears to be enlarged (the size of the pupil visible before the procedure is D1 in diameter, but after the procedure, the pupil appears enlarged to D2) by the pupil enlargement member (100) having the same or similar color as the pupil (142), thereby creating the effect of making the eyes appear larger, and allowing the user to have beautiful eyes.

[0104] According to the present invention, when the pupil enlargement member (100), which is a ring-shaped lens body, is no longer needed, an incision (144) is made in one location of the conjunctiva (140), the incision is removed, and then sutured again, thereby normalizing the eyeball and safely obtaining a cosmetic effect that makes the eye look bigger without side effects such as vision loss or inflammation. At this time, the insertion surgical tool (128) of the pupil enlargement member of the present invention is designed to be optimized for the structure of the pupil enlargement member (100), so that when inserting the pupil enlargement member (100) into the eyeball, it is possible to secure an insertion space at once without causing injury to the eyeball and without using another separate device, and to insert the pupil enlargement member (100) into the eyeball.

[0105] The embodiments of the present invention described above are merely exemplary, and those skilled in the art will readily appreciate that various modifications and equivalent other embodiments are possible. Therefore, it will be readily understood that the present invention is not limited to the forms mentioned in the detailed description above. Accordingly, the true technical protection scope of the present invention should be defined by the technical spirit of the appended claims. Furthermore, the present invention should be understood to include all modifications, equivalents, and alternatives within the spirit and scope of the present invention as defined by the appended claims.

[0106] {Explanation of symbols}

[0107] 100: pupil enlargement member 102: main body (ring-shaped lens body)

[0108] 102a: Outer surface 102b: Inner surface

[0109] 104: Cut (connection) 106,108: End

[0110] 110,112: Real member 110a,112a: Tapered part

[0111] 114,116: Semicircular groove 118,120: Suture needle hole

[0112] 122: Ground (horizontal line) 124: Bottom edge of lens body

[0113] 126: Top edge 128: Insertion device

[0114] 130(130a,130b): Circular insert body 132(a,b): Tip

[0115] 134(a,b): Threading hole 136: Handle

[0116] 138: Eyeball 140: Conjunctiva

[0117] 142: Pupil 144: Incision for instrument insertion

[0118] 146: Incision for thread tying 148: Suture

[0119] 150: Bioadhesive

[0120] b1: width of the body b2: bottom edge

[0121] b3: Top edge surface D1: Body (ring-shaped lens body) inner diameter

[0122] D2: Outer diameter of the main body (ring-shaped lens body) d1: Diameter of the actual material

[0123] R1, R2, R3, R4: Curved surface α1: Inclination angle

Claims

1. In a pupil enlargement member for cosmetic purposes of the eye, which is inserted between the conjunctiva and the sclera of the eye, and includes a ring-shaped lens body having an inner diameter at least large enough to surround the outer ring of the pupil and a predetermined width such that the outer diameter extends to cover the white of the eye, and is formed of a flexible material and has a predetermined color reflecting the color of the pupil or the fashion and taste of each individual, and the ring-shaped lens body has a cut portion to enable insertion into the eye through the incised conjunctiva of the eye, and the cut portion is formed so that one end is pushed through the incised portion of the conjunctiva and, after the insertion into the eye is completed, both ends of the cut portion are sealed to each other by adhesive or sewing, the ring-shaped lens body is formed with a flexible body that extends in the same plane as the ring-shaped lens body and is free to bend in a U shape, and also has a predetermined diameter and a length of 40 to 95 times the diameter, and is inserted into the eye by an insertion surgical instrument. An eye enlargement member characterized by including two real members that are cut when insertion into the eye is completed.

2. In paragraph 1, The above ring-shaped lens body is a pupil magnifying member characterized in that it is formed of any one material selected from a flexible and harmless hydrogel, silicone hydrogel, hydroxyethyl methacrylate (HEMA), a copolymer of vinyl pyrrolidone with HEMA or methyl methacrylate, a copolymer of glyceryl methacrylate and methacrylate, a copolymer of HEMA and diacetone acrylamide, a silicone derivative, polyamide, PHEMA (polyhydroxyethyl methacrylate), PVP (polyvinyl pyrrolidone), RPG (methyl methacrylate-acrylic acid polymer), CAB (cellulose acetate butylate), polymethyl methacrylate (PMMA), and a soft acrylic acid material.

3. In paragraph 1, An eye pupil enlargement member characterized in that the inner diameter end of the ring-shaped lens body is rounded as a connecting portion between the ring-shaped lens body and the real member.

4. In paragraph 2, An eye pupil enlargement member characterized in that the inner diameter end of the ring-shaped lens body forms a two-layered structure, and each corner of the single layer is rounded.

5. In any one of paragraphs 1 to 4, An eye enlargement member characterized in that one to four suture needle holes are formed at a predetermined interval from the end along the circumference on the outer surface of the ring-shaped lens body on both sides of the above-mentioned cut portion.

6. In any one of paragraphs 1 to 4, An eye pupil enlargement member characterized in that a semicircular groove of a predetermined depth and width is formed along a circumference for a predetermined length on the outer surface of the ring-shaped lens body on both sides of the above-mentioned cut portion to form a needle hole for suturing.

7. In paragraph 6, A pupil expansion member characterized in that the depth of the semicircular groove is greater than the radius size of the suture used for suturing.

8. In paragraph 7, A pupil expansion member characterized in that the depth of the semicircular groove is the diameter size of the suture used for suturing.

9. In paragraph 6, An eye enlargement member characterized in that one to four suturing needle holes are formed at a predetermined interval from the end of the semicircular groove.

10. In any one of paragraphs 1 to 4, An eye pupil enlargement member characterized in that the end of the above-mentioned real member is formed as a tapered portion with a gradually decreasing diameter.

11. In any one of paragraphs 1 to 4, An eye pupil expansion member characterized in that the ring-shaped lens body has a thickness that decreases as it approaches both ends.

12. In any one of paragraphs 1 to 4, An eye pupil enlargement member characterized in that the diameter of the above-mentioned real member is 0.2 mm to 0.4 mm.

13. In any one of paragraphs 1 to 4, An eye pupil magnifying member characterized in that the ring-shaped lens body has an inclination angle of 22° to 40° with respect to the horizontal plane.

14. In any one of paragraphs 1 to 4, A pupil magnifying member characterized in that the maximum thickness of the center of the ring-shaped lens body is 0.08 mm to 0.20 mm and the width is 0.5 mm to 2.5 mm.

15. In any one of paragraphs 1 to 4, An eye pupil magnifying member characterized in that a plurality of micro-holes are formed in the ring-shaped lens body to connect the front and back to allow the forward and backward circulation of body fluids including tears and blood flow.

16. In any one of paragraphs 1 to 4, A pupil magnifying member characterized in that the diameters of a plurality of micro-holes formed by penetrating the ring-shaped lens body are 10㎛ to 100㎛.

Images