Method for manufacturing aqueous shunt for controlling intraocular pressure having fine hollow

Abstract

Provided is a method for manufacturing an aqueous shunt for controlling intraocular pressure in which a silicone tube is precisely manufactured to have an inner diameter of 100 μm or less, and thus a minimum level of intraocular pressure can be maintained without a separate valve while achieving a proper flow rate. The method for manufacturing an aqueous shunt for controlling intraocular pressure comprises: a step for preparing a first mold having a first coupling surface in which a first cavity and a pair of first string grooves are formed, and a second mold having a second coupling surface in which a second cavity is formed; a step for disposing through strings on the pair of first string grooves; a step for injecting liquid silicone into the first cavity and the second cavity in a state in which the first mold and the second mold are coupled; and a step for separating the silicone that has been cured from the first mold and the second mold, and then removing the through strings from the cured silicone to form an aqueous shunt comprising a tube having a fine hollow formed therein.

Description

Method for manufacturing an aqueous humor drainage device for intraocular pressure control having a micro-hollow

[0001] The present invention relates to a method for manufacturing a drainage device for controlling intraocular pressure, and more specifically, to a method for manufacturing a drainage device for controlling intraocular pressure having a micro hollow that can stably maintain intraocular pressure without a separate valve structure by forming the inner diameter of a silicone tube to be 100 µm or less.

[0002] Aqueous humor refers to the clear fluid that fills the space between the cornea and the iris (called the 'anterior chamber') and between the iris and the lens (called the 'posterior chamber'); it has properties similar to lymph. Aqueous humor plays a role in maintaining pressure within the eye.

[0003] Meanwhile, glaucoma is a progressive optic neuropathy that causes dysfunction of the optic nerve and leads to visual field defects. The primary cause of glaucoma is elevated intraocular pressure, which occurs when the balance between the production and drainage of aqueous humor is disrupted. Aqueous humor is produced in the ciliary body behind the iris, passes through the anterior chamber, and is drained via the trabecular meshwork and Schlemm's canal; if this drainage pathway is not smooth, the aqueous humor accumulates, causing intraocular pressure to rise. Consequently, if the optic nerve is damaged by continuous compression due to this, glaucoma progresses, and in severe cases, it can lead to blindness.

[0004] Treatment methods for glaucoma are broadly classified into drug therapy and surgical treatment. Drug therapy controls intraocular pressure by suppressing aqueous humor production or promoting drainage; however, in some patients, it may be difficult to achieve sufficient effects with medication alone, or its use may be limited due to side effects. Consequently, when drug therapy is ineffective, surgical treatments such as trabeculectomy or the insertion of an aqueous shunt become necessary.

[0005] A glaucoma drainage device is a mechanism that lowers intraocular pressure by draining aqueous humor from the eye to the outside. The most widely used representative glaucoma drainage device both domestically and internationally is the Ahmed valve (see US 5,071,508). The Ahmed valve drains aqueous humor by inserting a silicone tube into the anterior chamber, and the inner diameter of the tube is approximately 300 µm. Because the inner diameter of the silicone tube is relatively large, there is a risk of hypotension occurring, where intraocular pressure drops below the normal range. To prevent this, the Ahmed valve is designed with a valve body connected to the tube that blocks aqueous humor outflow when intraocular pressure in the anterior chamber is low, and drains the aqueous humor only when the pressure reaches a certain level or higher.

[0006] However, clinically, existing aqueous humor drainage devices, including the Ahmed valve, have several drawbacks. First, the valve body is inserted beneath the conjunctiva, which can cause a foreign body sensation in the patient. Second, there have been reports of postoperative hypotension occurring because the membrane responsible for opening and closing the valve body does not function properly. Consequently, if aqueous humor is excessively drained, serious complications such as choroidal detachment or retinal folds may occur due to the hypotension. To prevent this, conventional clinical practice involves inserting a stent into the tube or tying the tube to reduce the inner diameter; however, this method has the disadvantage of being cumbersome to operate due to the additional procedural steps involved, and it is difficult to maintain long-term effectiveness if the stent is not properly secured.

[0007] To address these issues, research has recently been conducted on aqueous humor drainage devices that maintain a certain minimum intraocular pressure (6 mmHg) without a separate valve by reducing the inner diameter of the silicone tube. However, there is a technical limitation in that it is difficult to reduce the inner diameter of the tube to less than 100 µm when using extrusion molding, the conventional manufacturing method for silicone tubes. Furthermore, according to Poiseuille's law, in order to maintain a minimum intraocular pressure of 6 mmHg by draining aqueous humor through a tube with an inner diameter of 100 µm, the length of the tube must be at least approximately 708 mm. This poses a problem that makes it difficult to apply in reality due to the anatomical structure of the human body.

[0008] The problem that the present invention aims to solve is to provide a method for manufacturing a waterproof drainage device for controlling intraocular pressure that can maintain minimum intraocular pressure without a separate valve while securing an appropriate flow rate by precisely manufacturing the inner diameter of the silicone tube to 100 µm or less.

[0009] Another problem that the present invention aims to solve is to provide an aqueous drainage device for controlling intraocular pressure manufactured by this manufacturing method.

[0010] The problems that the present invention aims to solve are not limited to those mentioned above, and other unmentioned problems will be clearly understood by those skilled in the art to which the present invention belongs from the description below.

[0011] A method for manufacturing a waterproof drainage device for controlling intraocular pressure according to an embodiment of the present invention for achieving the above objective comprises: a method for manufacturing a waterproof drainage device for controlling intraocular pressure having a fine inner diameter, the method comprising the steps of: preparing a first mold having a first coupling surface and a second mold having a second coupling surface facing the first coupling surface, wherein a first cavity and a pair of first string groove portions connected to the upper and lower ends of the first cavity are formed on the first coupling surface, and a second cavity forming a space portion together with the first cavity is formed on the second coupling surface; a step of placing a through string on the pair of first string groove portions; and a step of injecting liquid silicone into the first cavity and the second cavity while the first mold and the second mold are coupled such that the first coupling surface and the second coupling surface are in contact with each other. The method includes the step of separating the cured silicone from the first mold and the second mold, and then removing the through string from the cured silicone to form a waterproof drainage device consisting of a tube having a fine hollow formed inside.

[0012] The above-mentioned waterproof discharge device may have an outer diameter of 100 to 300 µm, an inner diameter of 30 to 90 µm, and a length of 5 to 10 mm.

[0013] The above-mentioned through string may be made of stainless steel or spring steel.

[0014] At least one side wall groove may be formed on the inner wall of the first cavity and the inner wall of the second cavity, and at least one friction protrusion corresponding to the at least one side wall groove may be formed on the outer surface of the waterproof outflow device.

[0015] The method may further include the step of applying a coating layer to the outer surface of the end portion of the above-mentioned waterproof discharge device. Here, the coating layer may consist of a drug comprising a fibrosis inhibitor or an antibiotic; and a biodegradable polymer compound.

[0016] The above fibrosis inhibitor may consist of one or more selected from the group consisting of sirolimus, sirolimus derivatives, paclitaxel, 5-fluorouracil, and ibuprofen.

[0017] An aqueous drainage device for controlling intraocular pressure according to one embodiment of the present invention for achieving the above other objectives is manufactured according to the manufacturing method described above.

[0018] Each friction protrusion may be formed in an arc shape in the circumferential direction on the outer surface of the waterproof discharge device, and the friction protrusion may have a height of 50 to 300 μm and a width of 200 to 1000 μm.

[0019] Each friction protrusion may be formed in the shape of a square column protruding outwardly from the outer surface of the waterproof discharge device, and the friction protrusion may have a height of 50 to 300 µm, a width of 200 to 1000 µm, and a thickness of 20 to 200 µm.

[0020] Each friction protrusion may be formed in a cylindrical shape protruding outwardly from the outer surface of the waterproof discharge device, and the friction protrusion may have a height of 20 to 150 μm and a diameter of 20 to 300 μm.

[0021] The end of the above-mentioned waterproof drainage device may be formed in the shape of a curved corner or a sloped bevel.

[0022] A plurality of first coupling portions may be formed on the first coupling surface, and a plurality of second coupling portions that are inserted and coupled to the plurality of first coupling portions may be formed on the second coupling surface.

[0023] Specific details of other embodiments are included in the specific contents and drawings.

[0024] As described above, according to the method for manufacturing an aqueous humor outflow device for controlling intraocular pressure and the aqueous humor outflow device manufactured thereby, an aqueous humor outflow device having a micro-hollow can be manufactured using an injection molding process. Specifically, by injection molding liquid silicone using a mold with an internal cavity and a through string, and then removing the through string from the cured silicone, a micro-hollow with an inner diameter of 100 μm or less can be formed with uniform dimensions inside the tube. Since the aqueous humor outflow device according to the present invention can precisely control the amount of aqueous humor outflow solely by the inner diameter of the tube without a separate valve, it is possible to reduce the risk of low intraocular pressure and stably control intraocular pressure. In particular, since the inner diameter of the aqueous humor outflow device can be precisely manufactured to 100 μm or less, it is possible to maintain the desired flow rate while designing the tube length short according to Poiseuille's law, thereby facilitating actual clinical application.

[0025] Furthermore, the drainage device according to the present invention has at least one friction protrusion of various shapes formed on its outer surface, which effectively prevents positional displacement after insertion into the eyeball. Generally, silicone tubes have a slippery surface and are prone to movement within the eyeball; however, in the case of the present invention, soft tissue such as a Tenon capsule naturally fills the space between the at least one friction protrusion, thereby assisting in the stable fixation of the drainage device. Additionally, since the friction protrusion is manufactured using an injection molding method utilizing a sidewall groove formed in a mold, the shape and height of the friction protrusion can be precisely controlled. Through this, unnecessary friction or jamming can be prevented when inserting the drainage device into a needle-shaped injector for the procedure, thereby improving the smoothness and convenience of the procedure.

[0026] Furthermore, after the aqueous humor drainage device according to the present invention is inserted into the eyeball, its end is stably positioned in the subconjunctival space. At least one friction protrusion is formed in the central part of the aqueous humor drainage device, thereby fixing the position of the inserted device while minimizing the occurrence of fibrosis in the subconjunctival tissue around the end. Additionally, the end of the aqueous humor drainage device is designed with a curved edge structure or formed in a bevel shape so as not to penetrate the conjunctiva and protrude outward, thereby reducing the risk of endophthalmitis. Moreover, a coating layer composed of a fibrosis inhibitor or an antibiotic is applied to the outer surface of the end of the aqueous humor drainage device. The coating layer composed of a fibrosis inhibitor inhibits the occurrence of fibrosis around the end after the procedure, and the coating layer composed of an antibiotic effectively blocks external bacteria from penetrating into the eyeball through the end even if the end of the aqueous humor drainage device is exposed to the outside.

[0027] FIG. 1 is a perspective view showing a first mold and a second mold for manufacturing a waterproof drainage device according to a first embodiment of the present invention.

[0028] FIG. 2 is a perspective view showing a case where a through string is placed in the first mold of FIG. 1.

[0029] FIG. 3 is a perspective view showing a waterproof drainage device according to a first embodiment of the present invention.

[0030] FIG. 4 is a partially cutaway perspective view showing a first mold for manufacturing a waterproof drainage device according to a second embodiment of the present invention.

[0031] FIG. 5 is a perspective view showing a waterproof drainage device according to a second embodiment of the present invention.

[0032] FIG. 6 is a perspective view showing a waterproof drainage device according to a third embodiment of the present invention.

[0033] FIG. 7 is a perspective view showing a waterproof drainage device according to the fourth embodiment of the present invention.

[0034] FIG. 8 is a front view showing a waterproof drainage device according to the fifth embodiment of the present invention.

[0035] FIG. 9 is a front view showing a waterproof drainage device according to the 6th embodiment of the present invention.

[0036] FIG. 10 is a front view showing a waterproof drainage device according to the seventh embodiment of the present invention.

[0037] The advantages and features of the present invention and the methods for achieving them will become clear by referring 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. These embodiments are provided merely to ensure that the disclosure of the present invention is complete and to fully inform those skilled in the art of the scope of the invention, and the present invention is defined only by the scope of the claims. Throughout the specification, the same reference numerals refer to the same components.

[0038] The water discharge device of the present invention may have a constant outer diameter over its entire length, or it may have different outer diameters depending on the section. For example, when the front end of the water discharge device is positioned in front of the eyeball and the rear end is positioned around the conjunctiva, the foreign body sensation can be reduced by forming the outer diameter of the rear end smaller than the outer diameter of the front end. In addition, the water discharge device of the present invention may be composed of a first section having a first outer diameter and a second section having a second outer diameter larger than the first outer diameter, and the second section may be positioned on one side of the first section or between the first sections. The boundary between the first section and the second section may be tapered to form a smooth outer surface.

[0039]

[0040] Hereinafter, a waterproof drainage device according to the first embodiment of the present invention and a method for manufacturing the same will be described in detail with reference to FIGS. 1 to 3. FIG. 1 is a perspective view showing a first mold and a second mold for manufacturing a waterproof drainage device according to the first embodiment of the present invention. FIG. 2 is a perspective view showing a case where a through string is placed in the first mold of FIG. 1. FIG. 3 is a perspective view showing a waterproof drainage device according to the first embodiment of the present invention.

[0041] The present invention relates to a method for manufacturing a waterproof drainage device for controlling intraocular pressure having a fine inner diameter. First, as shown in FIG. 1, a first mold (10) and a second mold (12) are prepared to manufacture the waterproof drainage device by injection molding.

[0042] The first mold (10) has a first coupling surface (11), and a pair of first string grooves (30) are formed on the first coupling surface (11), each connected to the upper and lower ends of the first cavity (20). For example, the first cavity (20) may be formed in a semi-cylindrical shape having a diameter of 100 to 300 μm, preferably 150 to 200 μm, and a height of 5 to 10 mm. For example, the first string grooves (30) may be formed in a semi-cylindrical shape having a diameter of 30 to 90 μm, preferably 30 to 70 μm.

[0043] The second mold (12) has a second bonding surface (13) facing the first bonding surface (11), and the second bonding surface (13) has a second cavity (22) formed therein, which forms a space for liquid silicone to be injected together with the first cavity (20). For example, the second cavity (22) may be formed in a semi-cylindrical shape having a diameter of 100 to 300 μm, preferably 150 to 200 μm, and a height of 5 to 10 mm. On the second bonding surface (13), a pair of second string grooves (32) are formed at positions corresponding to the first string groove (30), each connected to the upper and lower ends of the second cavity (22). For example, the second string grooves (32) may be formed in a semi-cylindrical shape having a diameter of 30 to 90 μm, preferably 30 to 70 μm.

[0044] A plurality of first coupling portions (40) are formed on the first coupling surface (11), and a plurality of second coupling portions (42) are formed on the second coupling surface (13) to be inserted and coupled to the plurality of first coupling portions (40) during injection molding. For example, if the first coupling portion (40) is formed as a protrusion, the second coupling portion (42) may be formed as a groove. Conversely, if the first coupling portion (40) is formed as a groove, the second coupling portion (42) may be formed as a protrusion. The first coupling portion (40) and the second coupling portion (42) help the first mold (10) and the second mold (12) to be coupled at the correct position during injection molding.

[0045] Although not illustrated, the first mold (10) or the second mold (12) may additionally be provided with a gate into which a molding material, such as liquid silicone, is injected, and a vent for discharging air, etc., generated from the cavity due to the filling of the molding material.

[0046] Next, as illustrated in FIG. 2, a through string (60) is placed on a pair of first string grooves (30) formed in the first mold (10). It is preferable that the through string (60) be made of a material with low wettability or adhesion to the molding material or liquid silicone. In order to easily separate the through string (60) from the subsequently cured silicone, it is preferable that the intermolecular force (Van der Waals force) between the silicone and the through string (60) be very weak. To this end, it is advantageous to use a polar material that has little interaction with the non-polar silicone as the material for the through string (60), and for example, the through string (60) may be made of stainless steel or spring steel. The fine inner diameter of the waterproof discharge device is controlled according to the size or diameter of the through string (60). For example, the penetrating string (60) may be made of a string or rod, etc., having a diameter of 30 to 90 μm, preferably 30 to 70 μm.

[0047] A pair of fixing parts (50) to which a through string (60) is fixed may be formed on both sides of the first mold (10). For example, after placing the through string (60) in the first string groove (30), both ends thereof may be fixed or tied to the pair of fixing parts (50) so that the through string (60) can be pulled taut while maintaining a constant tension. For example, the fixing part (50) may be made of a screw-shaped column.

[0048] Next, with the first mold (10) and the second mold (12) joined so that the first joining surface (11) and the second joining surface (13) come into contact with each other, liquid silicone is injected into the first cavity (20) and the second cavity (22).

[0049] For example, liquid silicone hardens after several seconds to several minutes in the first mold (10) and the second mold (12) heated to 100 to 200 degrees. After separating the hardened silicone from the first mold (10) and the second mold (12) and removing the through string (60), a waterproof drainage device (200) consisting of a silicone tube (100) having a micro-hollow (102) formed inside is formed as shown in FIG. 3. At this time, the micro-hollow (102) can be uniformly formed by pulling the through string (60) in the longitudinal direction from the hardened silicone. For example, the drainage device (200) may have an outer diameter (D1) of 100 to 300 µm, preferably 150 to 200 µm, an inner diameter (D2) of 30 to 90 µm, preferably 30 to 70 µm, and a length (L) of 5 to 10 mm. Depending on the situation, after removing the through string (60), a biodegradable or removable wick (e.g., a suture made of nylon, polypropylene, etc.) having a diameter smaller or equal to that of the through string (60) may be temporarily inserted into the micro-hollow (102) to prevent hypotony in the early stages of surgery in patients (e.g., patients with high myopia) who are at high risk of complications such as retinal folds or choroidal detachment caused by low intraocular pressure.

[0050]

[0051] A waterproof drainage device and a method for manufacturing the same according to a second embodiment of the present invention will be described in detail below with reference to FIGS. 4 and 5. FIG. 4 is a partially cutaway perspective view showing a first mold for manufacturing a waterproof drainage device according to a second embodiment of the present invention. FIG. 5 is a perspective view showing a waterproof drainage device according to a second embodiment of the present invention. For convenience of explanation, components having the same function as each component shown in the drawings of the first embodiment ( FIGS. 1 to 3) are indicated by the same reference numerals, and their descriptions are omitted; the following description will focus on the differences.

[0052] In this embodiment, at least one side wall groove (70) is formed in the inner wall of the first cavity (20) of the first mold (10). Although not illustrated, at least one side wall groove of the same shape may also be formed in the inner wall of the second cavity (22). For example, two to five side wall grooves (70) may be formed, and they may have a depth (H) of 50 to 300 μm, preferably 50 to 150 μm, and a width (W) of 200 to 1000 μm, preferably 200 to 700 μm. However, the present invention is not limited to the number, depth, width, and shape of the side wall grooves (70) mentioned above as examples.

[0053] When a waterproof drainage device (202) is manufactured by injection molding using the first mold (10) and the second mold (12), at least one friction protrusion (110) corresponding to at least one side wall groove (70) is formed on the outer surface of the waterproof drainage device (202) or the tube (100), as shown in FIG. 5. Each friction protrusion (110) is formed in the shape of an arc formed in the circumferential direction on the outer surface of the waterproof drainage device (202) or the tube (100). For example, each friction protrusion (110) may have a height of 50 to 300 μm, preferably 50 to 150 μm, and a width of 200 to 1000 μm, preferably 200 to 700 μm. However, the present invention is not limited to the number, height, width, and shape of the friction protrusions (110) mentioned above as examples. For example, the friction protrusion may be formed in an annular shape that protrudes continuously 360 degrees along the entire circumferential direction.

[0054] The aqueous humor outflow device (202) is sequentially composed of an anterior section (A), a central section (B), and a posterior section (C) in the longitudinal direction, with the anterior section (A) positioned in front of the eyeball and the posterior section (C) positioned in the subconjunctival space. Accordingly, aqueous humor in the anterior region flows into the aqueous humor outflow device (202) through the anterior section (A), moves along the micro-hollow (102), and is discharged into the subconjunctival space through the posterior section (C). If the friction protrusion (110) is formed in the posterior section (C), it may induce fibrosis of the subconjunctival tissue, so it is preferable that it be formed in the central section (B). For example, the anterior section (A) may be formed with a length of 2 to 4 mm, the central section (B) with a length of 2 to 3 mm, and the posterior section (C) with a length of 1 to 3 mm.

[0055]

[0056] A waterproof drainage device according to a third embodiment of the present invention will be described in detail below with reference to FIG. 6. FIG. 6 is a perspective view showing a waterproof drainage device according to a third embodiment of the present invention. For convenience of explanation, components having the same function as those shown in the drawings of the second embodiment ( FIG. 4 to 5) are indicated by the same reference numerals, and their descriptions are omitted; the following description will focus on the differences.

[0057] In this embodiment, there is a difference in the shape of the side wall groove compared to the previous embodiment. When the waterproof discharge device (204) is manufactured by injection molding using the first mold (10) and the second mold (12), at least one friction protrusion (112) corresponding to at least one side wall groove is formed on the outer surface of the waterproof discharge device (204) or the tube (100), as shown in FIG. 6. Each friction protrusion (112) is formed in the shape of a square column protruding outward from the outer surface of the waterproof discharge device (204) or the tube (100). For example, each friction protrusion (112) may have a height of 50 to 300 µm, preferably 50 to 150 µm, a width of 200 to 1000 µm, preferably 200 to 700 µm, and a thickness of 20 to 200 µm, preferably 20 to 150 µm, more preferably 20 to 70 µm. However, the present invention is not limited to the number, height, width, thickness, and shape of the friction protrusions (112) mentioned above as examples.

[0058]

[0059] A waterproof drainage device according to the fourth embodiment of the present invention will be described in detail below with reference to FIG. 7. FIG. 7 is a perspective view showing a waterproof drainage device according to the fourth embodiment of the present invention. For convenience of explanation, components having the same function as those shown in the drawings of the second embodiment ( FIG. 4 to 5) are indicated by the same reference numerals, and their descriptions are omitted; the following description will focus on the differences.

[0060] In this embodiment, there is a difference in the shape of the side wall groove compared to the previous embodiment. When a waterproof discharge device (206) is manufactured by injection molding using the first mold (10) and the second mold (12), at least one friction protrusion (114) corresponding to at least one side wall groove is formed on the outer surface of the waterproof discharge device (206) or the tube (100), as shown in FIG. 7. Each friction protrusion (114) is formed in the shape of a cylinder protruding outward from the outer surface of the waterproof discharge device (206) or the tube (100). For example, each friction protrusion (114) may have a height of 20 to 150 μm and a diameter of 20 to 300 μm. However, the present invention is not limited to the number, height, diameter, and shape of the friction protrusions (114) mentioned as examples above.

[0061] In the second to fourth embodiments of the present invention, the friction protrusions were described as having an arc shape, a square column shape, or a cylinder shape; however, the present invention is not limited to the shape of such protrusions and can be formed in any shape, such as a triangular column or a rhombus column.

[0062]

[0063] A waterproof drainage device according to the fifth embodiment of the present invention will be described in detail below with reference to FIG. 8. FIG. 8 is a front view showing a waterproof drainage device according to the fifth embodiment of the present invention. For convenience of explanation, components having the same function as those shown in the drawings of the second embodiment ( FIG. 4 to 5) are indicated by the same reference numerals, and their descriptions are omitted; the following description will focus on the differences.

[0064] In this embodiment, there is a difference in the shape of the rear end (C) of the waterproof drainage device (208) compared to the previous embodiment. To prevent the rear end (C) of the waterproof drainage device (208) from penetrating the conjunctiva and protruding to the outside, the rear end (C) may be formed with a curved edge (120).

[0065]

[0066] A waterproof drainage device according to the sixth embodiment of the present invention will be described in detail below with reference to FIG. 9. FIG. 9 is a front view showing a waterproof drainage device according to the sixth embodiment of the present invention. For convenience of explanation, components having the same function as those shown in the drawings of the second embodiment ( FIG. 4 to 5) are indicated by the same reference numerals, and their descriptions are omitted; the following description will focus on the differences.

[0067] In this embodiment, there is a difference in the shape of the rear end (C) of the waterproof drainage device (210) compared to the previous embodiment. To prevent the rear end (C) of the waterproof drainage device (210) from penetrating the conjunctiva and protruding to the outside, the rear end (C) may be formed as a sloped bevel (122).

[0068]

[0069] A waterproof drainage device according to the seventh embodiment of the present invention will be described in detail below with reference to FIG. 10. FIG. 10 is a front view showing a waterproof drainage device according to the seventh embodiment of the present invention. For convenience of explanation, components having the same function as those shown in the drawings of the second embodiment ( FIG. 4 to 5) are indicated by the same reference numerals, and their descriptions are omitted; the following description will focus on the differences.

[0070] In this embodiment, compared to the previous embodiment, a coating layer (130) is applied to the outer surface of the rear end (C) of the waterproof drainage device (212). Specifically, liquid silicone is injected into the first cavity (20) and the second cavity (22) while the first mold (10) and the second mold (12) are combined, then the cured silicone is separated from the first mold (10) and the second mold (12), and the through string (60) is removed. Subsequently, a coating layer (130) is applied to the outer surface of the end of the waterproof drainage device (212).

[0071] The coating layer (130) is composed of a drug and a biodegradable polymer, and the drug may be a fibrosis inhibitor or an antibiotic. After the waterproof drainage device (212) is inserted into the eyeball and time elapses, the biodegradable polymer begins to be absorbed into the surrounding tissue and the drug gradually exerts its effect.

[0072] The fibrosis inhibitor is a substance that inhibits fibrosis from occurring in the surrounding tissue of the waterproofing device (212), and may consist of one or more selected from the group consisting of, for example, sirolimus, sirolimus derivatives, paclitaxel, 5-fluorouracil, and ibuprofen. The antibiotic may consist of one or more selected from the group consisting of penicillin-class antibiotics, aminoglycoside-class antibiotics, tetracycline-class antibiotics, and quinolone-class antibiotics. The biodegradable polymer may consist of one or more selected from the group consisting of PEG (polyethylene glycol), PLGA (poly(lactide-co-glycolide)), SIBS (poly(styrene-b-isobutylene-b-styrene)), PGA (polyglycolide), PLA (polylactide), and PCL (polycaprolactone).

[0073] If the drainage device (212) is inserted into the eye such that the anterior end (A) of the tube (100) is positioned in front of the eye and the posterior end (C) is positioned between the conjunctiva and the sclera, i.e., in the subconjunctival space, it is preferable that the coating layer (130) be composed of a drug consisting of a fibrosis inhibitor and a biodegradable polymer to inhibit fibrosis around the posterior end (C). Since the drug or fibrosis inhibitor may cause damage to corneal endothelial cells if introduced into the anterior region, it is preferable that the coating layer (130) be applied to only 10 to 40% of the tube (100) from the posterior end (C).

[0074] If the drainage device (212) is inserted into the eye so that the front end (A) of the tube (100) is positioned in front of the eye and the rear end (C) is exposed to the outside through the conjunctiva, it is preferable that the coating layer (130) be made of a drug consisting of an antibiotic and a biodegradable polymer to block external bacteria from penetrating through the rear end (C).

[0075] Although embodiments of the present invention have been described above with reference to the attached drawings, those skilled in the art will understand that the present invention may be implemented in other specific forms without changing its technical concept or essential features. Therefore, the embodiments described above should be understood as illustrative in all respects and not restrictive.

Claims

1. A method for manufacturing a water drainage device for controlling intraocular pressure having a fine inner diameter, wherein A step of preparing a first mold having a first coupling surface and a second mold having a second coupling surface facing the first coupling surface - wherein a first cavity and a pair of first string groove portions connected to the upper and lower ends of the first cavity are formed on the first coupling surface, and a second cavity forming a space portion together with the first cavity is formed on the second coupling surface. A step of placing a through string on the above-mentioned pair of first string grooves; A step of injecting liquid silicone into the first cavity and the second cavity while the first mold and the second mold are joined such that the first joining surface and the second joining surface are in contact with each other; and A method for manufacturing a waterproof drainage device for controlling intraocular pressure, comprising the step of separating the cured silicone from the first mold and the second mold, and then removing the through string from the cured silicone to form a waterproof drainage device consisting of a tube having a fine hollow formed inside.

2. In Paragraph 1, A method for manufacturing a water drainage device for controlling intraocular pressure, characterized in that the above-mentioned water drainage device has an outer diameter of 100 to 300 μm, an inner diameter of 30 to 90 μm, and a length of 5 to 10 mm.

3. In Paragraph 1, A method for manufacturing a waterproof drainage device for controlling intraocular pressure, characterized in that the above-mentioned penetrating string is made of stainless steel or spring steel.

4. In Paragraph 1, A method for manufacturing a waterproof drainage device for controlling intraocular pressure, characterized in that at least one side wall groove is formed on the inner wall of the first cavity and the inner wall of the second cavity, and at least one friction protrusion corresponding to the at least one side wall groove is formed on the outer surface of the waterproof drainage device.

5. In Paragraph 1, A method for manufacturing a drainage device for controlling intraocular pressure, further comprising the step of applying a coating layer to the outer surface of the end portion of the drainage device, wherein the coating layer is characterized by being composed of a drug comprising a fibrosis inhibitor or an antibiotic; and a biodegradable polymer compound.

6. In Paragraph 5, A method for manufacturing an aqueous humor outflow device for controlling intraocular pressure, characterized in that the above-mentioned fibrosis inhibitor comprises one or more selected from the group consisting of sirolimus, sirolimus derivatives, paclitaxel, 5-fluorouracil, and ibuprofen.

7. In Paragraph 1, A method for manufacturing a water drainage device for controlling intraocular pressure, characterized in that the end of the water drainage device is formed in a curved edge shape or a bevel shape.

8. An aqueous drainage device for controlling intraocular pressure manufactured according to any one of the manufacturing methods of paragraphs 1 to 7.

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