Implant device for eye diseases having a plurality of channels and method for manufacturing the same

Abstract

An implant device for eye diseases for insertion into the eye is configured such that one end is inserted into the anterior chamber of the eye, and includes a plurality of tubes each having a hollow formed for the drainage of aqueous humor; and a connecting member configured to connect the plurality of tubes. The connecting member is configured to be connected to the plurality of tubes such that the plurality of tubes extend through the connecting member. At this time, the plurality of tubes are configured such that their lengths, materials, diameters of the hollows, whether a tube core can be inserted, and the diameters and / or materials of the cores inserted into the tubes are different from each other, so that the aqueous humor drainage characteristics such as the amount of aqueous humor drained through the tubes and the drainage speed are different from each other, and / or the drainage positions of the aqueous humor through each tube can be different from each other. Since the implant device for eye diseases includes a plurality of tubes having different aqueous humor drainage characteristics and / or different aqueous humor drainage positions, it is possible to prevent the entire tubes of the implant device from being blocked due to fibrosis or foreign body contamination, etc.

Description

Technical Field

[0001] The present invention relates to an implant device for ophthalmic diseases and a method for manufacturing the same. More specifically, by connecting a plurality of tubes having different aqueous humor drainage characteristics (drainage volume, drainage speed, etc.) and / or drainage positions through a connecting member to form an implant device, it is configured to prevent the loss of aqueous humor drainage function due to fibrosis or foreign body contamination after implant surgery. The present invention relates to an implant device for ophthalmic diseases.

Background Art

[0002] For glaucoma patients whose intraocular pressure cannot be adjusted even with the use of an intraocular pressure lowering agent, a bypass is created so that aqueous humor is drained from the anterior chamber of the eye to the subconjunctiva outside the eye to lower the intraocular pressure. Among glaucoma filtration surgeries that create a bypass or fistula for aqueous humor drainage, trabeculectomy may result in a decrease in aqueous humor drainage volume due to the closure of the bypass again after surgery, leading to failure in intraocular pressure regulation. When glaucoma filtration surgery is performed again after the failure of the primary surgery, the frequency of bypass closure increases after surgery, and the success rate of the surgery decreases.

[0003] In addition, in the case of so-called refractory glaucoma, such as neovascular glaucoma or secondary glaucoma due to uveitis depending on the type of glaucoma, bypass occlusion frequently occurs after trabeculectomy, and the results are not good. In order to prevent the closure of the bypass and increase the success rate of the surgery in eyes with a past history of failure in glaucoma filtration surgery or in the case of refractory glaucoma, glaucoma implant surgery is performed. To date, glaucoma implants have been used as an alternative to trabeculectomy in some glaucomas that are particularly difficult to treat, not only in effectively lowering intraocular pressure but also in showing a predictable postoperative clinical course depending on the defined inner diameter of the tube.

[0004] However, existing glaucoma implants used in glaucoma implant surgery may cause various problems and complications, such as surgical difficulties due to relatively large sizes, postoperative exposure, infection, eye movement disorders caused by large bodies, and diplopia caused thereby. Therefore, recently, small-sized glaucoma implant tools for Minimally-Invasive Glaucoma Surgery (MIGS) have been developed to relatively easily reduce intraocular pressure using glaucoma implants and reduce postoperative side effects caused by the large sizes of conventional implants.

[0005] MIGS involves inserting a tube with a micrometer-level size into the anterior chamber of the eye to allow aqueous humor to be drained from the anterior chamber. At this time, the tube may be clogged by fibrosis of the tissue around the eye or foreign substances at the aqueous humor outlet of the tube. In particular, the degree of intraocular pressure regulation through the implant device appears to vary greatly depending on the postoperative period and the pattern of fibrosis of the tube and incorporation of foreign substances. For example, immediately after the implant surgery, a relatively large amount of aqueous humor is drained through the tube, and the intraocular pressure drops more than necessary. On the other hand, when several weeks have passed after the surgery, the area around the aqueous humor outlet of the tube becomes fibrotic, and the amount of aqueous humor drained through the tube can gradually decrease. When several months or more have passed after the surgery in this state, most of the area around the aqueous humor outlet becomes fibrotic, making it difficult for aqueous humor to be drained through the tube, and there is a risk that the effect of the implant surgery will rapidly decline. In some cases, foreign substances may also enter the tube, weakening the drainage function of the aqueous humor.

Summary of the Invention

Problems to be Solved by the Invention

[0006] According to one aspect of the present invention, it is an object to provide an implant device for eye diseases and a method for manufacturing the same, which solve the above-described problems of the prior art and are configured to appropriately maintain the aqueous humor drainage amount even when fibrosis of the surrounding tissue progresses after the implantation surgery or when foreign substances enter the tube.

[0007] Further, according to one aspect of the present invention, it is an object to provide an implant device for eye diseases configured such that a cross section of a connecting member that connects tubes of the implant device is at least partially larger than the diameter of the tubes, and when the tubes are pushed into the eyeball after the implantation surgery, the connecting member is applied to the sclera of the eyeball, thereby preventing the tubes from being completely inserted into the sclera.

Means for Solving the Problems

[0008] An implant device for eye diseases according to an embodiment of the present invention is for insertion into the eyeball, and includes a plurality of tubes configured such that one end is inserted into the anterior chamber of the eyeball and each has a hollow for discharging aqueous humor; and a connecting member configured to connect the plurality of tubes. At this time, the connecting member is configured to be connected to the plurality of tubes by the plurality of tubes extending through the connecting member.

[0009] In one embodiment, one or more of the length, material, and hollow diameter of the plurality of tubes are different from each other, and one or more of the aqueous humor drainage characteristics or the aqueous humor drainage positions of the plurality of tubes are different from each other.

[0010] In one embodiment, each of the plurality of tubes includes a first end for insertion into the anterior chamber of the eyeball and a second end opposite to the first end, and the second ends of the plurality of tubes are located at different distances from the connecting member.

[0011] The implant device for ophthalmic diseases according to one embodiment further includes a core inserted into the hollow of a part of the plurality of tubes. The implant device for ophthalmic diseases according to another embodiment further includes a plurality of cores respectively inserted into the hollows of the plurality of tubes, and the plurality of cores are configured such that at least one of the diameter and the material is different from each other.

[0012] In one embodiment, the connecting member includes a plurality of holes for the plurality of tubes to pass through respectively, and the plurality of holes are arranged spaced apart from each other on the cross-section of the connecting member. In another embodiment, the connecting member includes holes extending in a direction perpendicular to the longitudinal direction of the plurality of tubes so that the plurality of tubes pass through. In one embodiment, the connecting member has a cross-section larger than the width of the plurality of tubes.

[0013] In one embodiment, the connecting member includes a first portion configured such that the plurality of tubes pass through; and a second portion extending from the first portion in a direction different from the extending direction of the plurality of tubes and protruding in the side direction of the plurality of tubes. At this time, the thickness of the second portion may be smaller than the thickness of the first portion.

[0014] In one embodiment, the plurality of tubes are integrally formed with each other. Also, in one embodiment, the plurality of tubes and the connecting member are integrally formed with each other.

[0015] A method for manufacturing an implant device for ophthalmic diseases according to an embodiment of the present invention includes the steps of forming a plurality of tubes each having a hollow for the drainage of aqueous humor; forming a main body of a connecting member extending in one direction; forming one or more holes in the main body for the plurality of tubes to pass through; and inserting the plurality of tubes into the holes of the main body. At this time, the plurality of tubes are configured such that at least one of the aqueous humor drainage characteristics and the aqueous humor drainage position is different from each other.

[0016] Another manufacturing method of an implant device for eye diseases according to an embodiment of the present invention includes a step of forming a tube body including a plurality of tubes each having a hollow formed for the drainage of aqueous humor, and a connecting member integrally connected to the plurality of tubes. At this time, the connecting member extends in one direction, and the plurality of tubes are coupled to the plurality of tubes such that the plurality of tubes extend in a direction different from the longitudinal direction of the connecting member, and one or more of the aqueous humor drainage characteristics or the aqueous humor drainage positions of the plurality of tubes are configured to be different from each other.

Advantages of the Invention

[0017] According to an embodiment of the present invention, a plurality of tubes having different lengths, materials, hollow diameters, whether a tube core can be inserted, and the diameter and / or material of the core inserted into the tube are configured to be different from each other, and the aqueous humor drainage characteristics (drainage volume, drainage speed, etc.) and / or the drainage positions are different from each other. By connecting the plurality of tubes to the connecting member to form an implant device for eye diseases, there is an advantage that it is possible to prevent the entire aqueous humor drainage path of the tube from being blocked due to fibrosis of surrounding tissues or foreign body contamination after the implant surgery.

[0018] In addition, in the implant device for eye diseases according to an embodiment of the present invention, since the cross-section of the connecting member is formed to be at least partially larger than the diameter of the tube, even when the tube is pushed into the eyeball due to some cause after the implantation of the implant device, the connecting member with a relatively large cross-section can be hung on the sclera of the eyeball to prevent the tube from being completely inserted into the sclera of the eyeball.

Brief Description of the Drawings

[0019]

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Best Mode for Carrying Out the Invention

[0020] The terms used in this specification will be briefly explained, and the present invention will be specifically described. The terms used in the embodiments of the present invention are selected as general terms that are widely used at present as much as possible while considering the functions in the present invention, but they may change depending on the intentions or precedents of those skilled in the art, the realization of new technologies, etc. In addition, in certain cases, there are terms arbitrarily selected by the applicant, and in this case, the meaning thereof will be described in detail in the description of the invention. Therefore, the terms used in the present invention are not merely names of terms, but are defined based on the meaning of the terms and the overall content of the present invention. Throughout the specification, when a part refers to a certain component as "including", this means that, unless otherwise stated to the contrary, it does not exclude other components, but may further include other components. Also, throughout the specification, when a part is said to be "connected" to another part, this includes not only the case where it is "directly connected", but also the case where it is "connected with other components interposed therebetween". Hereinafter, with reference to the accompanying drawings, embodiments of the present invention will be described in detail so that those having ordinary knowledge in the technical field to which the present invention pertains can easily implement them. However, the present invention may be embodied in various different forms and is not limited to the embodiments described herein. And in order to clearly explain the present invention in the drawings, parts not related to the explanation are omitted, and similar parts are denoted by similar reference numerals throughout the specification. Hereinafter, the present invention will be described in detail with reference to the attached drawings.

[0021] FIG. 1 and FIG. 2 are conceptual diagrams showing a state in which an implant device for eye diseases according to an embodiment is inserted into the eyeball.

[0022] Referring to FIGS. 1 and 2, the implant device for eye diseases according to the embodiment is for controlling the drainage volume of aqueous humor generated from the anterior chamber 1 located in front of the lens and under the cornea 2 within the eyeball to adjust the intraocular pressure, and plays a role in preventing the intraocular pressure from rising due to eye diseases and damaging the optic nerve. The implant device for eye diseases according to the embodiment of the present invention can be used for treating or alleviating various eye diseases caused by or resulting from an increase in intraocular pressure.

[0023] Eye diseases herein can include glaucoma caused by an increase in intraocular pressure, and such glaucoma can include congenital glaucoma, traumatic glaucoma, glaucoma suspect, ocular hypertension, primary open-angle glaucoma, normal-tension glaucoma, lens capsular glaucoma with pseudoexfoliation of the lens, chronic simple glaucoma, low-tension glaucoma, pigmentary glaucoma, primary closed-angle glaucoma, acute closed-angle glaucoma, chronic closed-angle glaucoma, intermittent closed-angle glaucoma, secondary glaucoma following eye trauma, secondary glaucoma following eye inflammation, drug-induced glaucoma, neovascular glaucoma, or secondary glaucoma due to uveitis, etc., but is not limited thereto.

[0024] The implant device for eye diseases according to the embodiment includes a tube 10 applicable to minimally invasive glaucoma surgery (MIGS). One end of the tube 10 is inserted into the anterior chamber 1 of the eyeball, and the other end of the tube 10 may be configured to be located in the conjunctival tissue or the Tenon's tissue 4. The tube 10 includes a hollow inside which the aqueous humor of the eyeball can flow, and functions to discharge the aqueous humor from the anterior chamber 1 of the eyeball to the outside of the sclera 3 of the eyeball through the tube 10. In one embodiment, a core 30 that functions to adjust the drainage volume of the aqueous humor through the hollow of the tube 10 may be inserted into the tube 10.

[0025] Referring to FIG. 2, the implant device for eye diseases can be inserted by the operator after peeling the conjunctival tissue or Tenon's tissue 4 of the eyeball, and can be placed in the eyeball in a manner that covers the conjunctival tissue or Tenon's tissue 4 again after insertion. That is, after incising a part of the conjunctival tissue or Tenon's tissue 4 of the eyeball to generate a section 40, the distal ends of the tubes 11-13 can be inserted through the raised section 40 to penetrate the exposed sclera 3 of the eyeball. At this time, the implant device for eye diseases according to the embodiment has a form in which a plurality of tubes 11-13 are interconnected by a single connecting member 20. Further, each of the plurality of tubes 11-13 is not completely inserted into the sclera 3, and the proximal ends of the respective tubes 11-13 may be placed on or inserted into the conjunctival tissue or Tenon's tissue 4. After one end of each of the tubes 11-13 is inserted into the anterior chamber 1 through the sclera 3, the raised section 40 is lowered, and the insertion process of the implant device for eye diseases is completed.

[0026] In the implant device for eye diseases according to the embodiment, the plurality of tubes 11-13 are configured such that the aqueous humor drainage characteristics, for example, the drainage volume and drainage speed of the aqueous humor, are different from each other. By connecting the tubes 11-13 with different aqueous humor drainage characteristics to each other by the connecting member 20 to form an implant device, when fibrosis of the peripheral tissue or foreign body contamination occurs after the implant surgery, it is possible to prevent the drainage path of the aqueous humor through all the tubes 11-13 from being blocked. The plurality of tubes 11-13 may be configured such that their lengths, materials, and / or hollow diameters are different from each other so that the aqueous humor drainage characteristics are different from each other.

[0027] In one embodiment, the implant device for ophthalmic diseases further includes cores 31 to 33 inserted into the hollows of tubes 11 to 13. The cores 31 to 33 are for adjusting the intra-chamber forming pressure through the hollows of the tubes 11 to 13. When the cores 31 to 33 are inserted into the hollows of the tubes 11 to 13, the aqueous humor does not flow smoothly, so the aqueous humor accumulates in the anterior chamber of the eye, and the intraocular pressure relatively increases compared to the case without the cores 31 to 33. In this specification, the intra-chamber forming pressure means the intraocular pressure in the anterior chamber of the eyeball formed at this time. The implant device for ophthalmic diseases may be inserted into the eye with the cores 31 to 33 inserted into the tubes 11 to 13, or after inserting the implant device for ophthalmic diseases excluding the cores 31 to 33 into the eye, the cores 31 to 33 may be inserted into the tubes 11 to 13.

[0028] In FIG. 2, the cores 31 to 33 are inserted into all of the plurality of tubes 11 to 13 constituting the implant device, but this is exemplary. In other embodiments, by inserting cores only into some of the plurality of tubes 11 to 13, the aqueous humor drainage characteristics of the plurality of tubes 11 to 13 can be made different. Also, between the tubes into which the cores are inserted, the aqueous humor drainage characteristics of each tube may be made different from each other by making the diameters and / or materials of the cores inserted into each tube different.

[0029] Furthermore, in one embodiment, the implant device for ophthalmic diseases may further include an implant body (not shown) coupled to the proximal ends of the tubes 11-13 located in the conjunctival tissue or Tenon's tissue 4 of the eyeball. The implant body may be composed of one or more membranes arranged to surround the ends of the tubes 11-13, and each membrane may be made of, for example, urethane-based substances such as polytetrafluoroethylene (PTFE), polycarbonate polyurethane, silicone-based substances such as polydimethylsiloxane (PDMS), siloxane-based polyurethane, polyethylene, polypropylene, poly(methyl methacrylate) (PMMA), and the like.

[0030] The implant body is coupled behind the tubes 11-13 and serves to temporarily accommodate aqueous humor for effective regulation of intraocular pressure. For example, after the tubes 11-13 of the implant device for ophthalmic diseases are inserted into the anterior chamber 1 of the eyeball, the implant body can be coupled and arranged behind the tubes 11-13 through the dissected conjunctival tissue or Tenon's tissue 4 in consideration of clinical conditions such as changes in the patient's condition and fibrosis rate.

[0031] Alternatively, depending on the embodiment, the tubes 11-13 and the implant body may be coupled or arranged together inside the eyeball through the dissected conjunctival tissue or Tenon's tissue 4 of the eyeball in an integrated configuration. That is, the implant body may be pre-coupled to the tubes 11-13 before the implant device is placed inside the eyeball according to clinical needs or conditions, or may be coupled to the implant body after the tubes 11-13 are first placed inside the eyeball.

[0032] When an implant device for eye diseases is inserted into the eyeball, aqueous humor generated from the anterior chamber flows through the tubes 11 to 13 of the implant device for eye diseases, so that the aqueous humor can be discharged from the anterior chamber to lower the intraocular pressure. When the implant body is coupled to the tubes 11 to 13, the aqueous humor discharged from the anterior chamber may be temporarily accommodated in the implant body. When the amount of the aqueous humor accommodated in the implant body exceeds a certain amount, the accommodated aqueous humor can be discharged through the rear of the implant body to the conjunctival tissue or the Tenon's tissue 4, thereby effectively adjusting the intraocular pressure.

[0033] FIG. 3A is a perspective view of an implant device for eye diseases according to an embodiment, and FIG. 3B is a cross-sectional view of the implant device for eye diseases taken along the line segment connecting A-A' shown in FIG. 3A.

[0034] Referring to FIGS. 3A and 3B, the implant device for eye diseases according to the present embodiment includes a plurality of tubes 11 to 13 applicable to MIGS, and a connecting member 20 for interconnecting the plurality of tubes 11 to 13. For example, the connecting member 20 includes one or more holes for the plurality of tubes 11 to 13 to pass through the connecting member 20, and each of the tubes 11 to 13 can be coupled to the connecting member 20 in such a manner that the tubes 11 to 13 are inserted into one or more holes formed in the connecting member 20.

[0035] Each of the tubes 11 to 13 is inserted into the eyeball such that its first end (or distal end) 11, 121, 131 is located in the anterior chamber of the eyeball, and the opposite second end (or proximal end) 112, 122, 132 is located in the conjunctival tissue or the Tenon's tissue of the eyeball, and serves to discharge the aqueous humor generated from the anterior chamber of the eyeball to the conjunctival tissue or the Tenon's tissue through the hollow 100 in the tubes 11 to 13. In this specification, the distal ends 111, 121, 131 and the proximal ends 112, 122, 132 are defined by the direction from the operator inserting the implant device. Among the two ends of the tubes 11 to 13, the proximal ends 112, 122, 132 mean the ends in the direction toward the operator, and the distal ends 111, 121, 131 mean the ends in the direction toward the eye of the patient into whom the implant device is inserted.

[0036] In one embodiment, the tubes 11 to 13 may be made of a biocompatible material or a changeable material. For example, the tubes 11 to 13 may be made of silicone or other silicone-based materials, PTFE, urethane-based materials such as polycarbonate polyurethane, a composite of a silicone-based material and a polyurethane (PU)-based material such as silicone-PU, or a biocompatible metal or alloy.

[0037] In one embodiment, the tubes 11 to 13 may be made of any one of silicone, PTFE, polycarbonate, polyurethane, polyethylene, polypropylene, polyimide, PMMA, poly(styrene-b-isobutylene-b-sytrene) copolymer, polyethersulfone, gelatin, stainless steel, titanium, and nitinol, or a combination of one or more of these materials, but is not limited thereto.

[0038] In one embodiment, the tubes 11 to 13 can be formed into a curve having a predetermined curvature to prevent damage to the intraocular corneal endothelium. Due to the different sizes of the eyeballs for each patient, the proficiency of tube injection, etc., in the process of the tube being drawn into the anterior chamber of the eyeball, there may be a problem that the front end of the tube pierces and damages the cornea in the anterior chamber of the eyeball, and the damage to the cornea may cause complications such as corneal insufficiency required until future corneal transplantation. According to this embodiment, the tubes 11 to 13 can also be manufactured in a bent form having a predetermined curvature corresponding to the curvature of the eyeball surface so that the movement of the tubes can naturally form a curve in the process of the tubes being drawn into the anterior chamber of the eyeball.

[0039] The connecting member 20 serves to connect a plurality of tubes 11 to 13 to each other, and can have a form of a block or a tube configured such that the plurality of tubes 11 to 13 extend through the connecting member 20. The length L of the connecting member 20 along the longitudinal direction (x-axis direction in the figure) of the tubes 11 to 13 can be appropriately determined to be a size such that the connecting member 20 can fix and support the tubes 11 to 13 passing through it. Also, the width W of the connecting member 20 along the direction orthogonal to the longitudinal direction of the tubes 11 to 13 (y-axis direction in the figure) can be determined to have a size larger than the width D of the space occupied by the plurality of tubes 11 to 13.

[0040] That is, the connecting member 20 surrounds the plurality of tubes 11 to 13 and has a larger cross-section than the plurality of tubes 11 to 13. As a result, a part of the connecting member 20 protrudes in the side direction (y-axis direction in the figure) of the tubes 11 to 13. When the tubes 11 to 13 are pushed into the sclera direction of the eyeball due to the protrusion of the connecting member 20 in the side direction of the tubes 11 to 13, the connecting member 20 can be applied to the sclera to prevent the tubes 11 to 13 from being completely drawn into the eyeball. Also, the thickness T of the connecting member 20 in the direction orthogonal to the plane in which the tubes 11 to 13 are arranged (z-axis direction in the figure) can be determined to have a thin thickness such that the patient does not feel a foreign body sensation even when the connecting member 20 is arranged in an inserted state in the conjunctival tissue or the Tenon's tissue.

[0041] In the embodiments shown in FIGS. 3A and 3B, the connecting member 20 is positioned at a predetermined distance from the proximal ends 112, 122, 132 of the tubes 11 to 13. However, this is exemplary, and in other embodiments, the connecting member 20 may be arranged in contact with the proximal ends 112, 122, 132 of the tubes 11 to 13.

[0042] In an embodiment of the present invention, a plurality of tubes 11 to 13 coupled to each other through a connecting member 20 are configured to have different aqueous humor drainage characteristics. In the embodiment shown in FIGS. 3A and 3B, the plurality of tubes 11 to 13 are configured such that their outer diameters R1 to R3 are different from each other, thereby having different aqueous humor drainage characteristics. In the present embodiment, the outer diameter R1 of the tube 11 is larger than the outer diameter R2 of the tube 12, and the outer diameter R2 of the tube 12 is larger than the outer diameter R3 of the tube 13. When the plurality of tubes 11 to 13 are configured to have different outer diameters in this way, even when any of the aqueous humor drainage paths is blocked due to fibrosis of the surrounding tissue or foreign matter contamination after the implant surgery, it is possible to prevent a situation where all of the plurality of tubes 11 to 13 are blocked due to the same cause.

[0043] In FIGS. 3A and 3B, since the outer diameters of the respective tubes 11 to 13 are different from each other, the respective tubes 11 to 13 have different aqueous humor drainage characteristics, which is an assumption when the wall thicknesses forming the respective tubes 11 to 13 are the same. However, when the wall thicknesses of the tubes 11 to 13 are different from each other, even if the outer diameters of the respective tubes 11 to 13 are the same, the inner diameters are different from each other, so that the respective tubes 11 to 13 can also have different aqueous humor drainage characteristics. Therefore, by changing the outer diameter and / or inner diameter of the tubes 11 to 13 so that the diameters of the hollows 100 of the respective tubes 11 to 13, which are the substantial sizes of the channels through which the aqueous humor flows, are different from each other, the respective tubes 11 to 13 can be made to have different aqueous humor drainage characteristics.

[0044] Furthermore, in another embodiment, by changing, in addition to the diameter of the hollow of each of the tubes 11 to 13, the length, material, availability of using a core, and / or characteristics of the core to be used of the tubes 11 to 13, it is also possible to make each of the tubes 11 to 13 have different aqueous humor drainage characteristics, which will be described in detail later.

[0045] In one embodiment, the holes for passing the respective tubes 11 to 13 through the connecting member 20 can be positioned spaced apart from each other on the cross-section of the connecting member 20. As a result, the tubes 11 to 13 connected to each other through one connecting member 20 can be positioned spaced apart from each other in a direction orthogonal to their longitudinal directions (the y-axis direction in the figure). For example, in the embodiment of FIG. 3B, the tube 11 and the tube 12 are separated by a distance d12, and the tube 12 and the tube 13 are separated by a distance d23. However, this is exemplary, and in other embodiments, some or all of the plurality of tubes 11 to 13 may be coupled to the connecting member 20 in a state of being in close contact with other adjacent tubes. FIG. 4 is a perspective view of an implant device for eye diseases according to another embodiment.

[0046] Referring to FIG. 4, the implant device for eye diseases according to the present embodiment further includes a core 30 that is at least partially inserted into the hollow of a part of the tubes 11 and 12. In the present embodiment, the implant device includes a core 30 inserted only into a part of the plurality of tubes 11 and 12, i.e., the tube 11, and no core is inserted into the other tube 12. The core 30 can be a surgical non-absorbable suture, and can be made of, for example, nylon or prolene material, but is not limited thereto.

[0047] The core 30 inserted into the hollow 110 of the tube 11 serves to adjust the pressure formed in the anterior chamber. When the core 30 is thick, the space between the inner wall of the tube 11 and the core 30 becomes narrow, so the aqueous humor is discharged relatively slowly, thereby increasing the pressure formed in the anterior chamber. On the contrary, when the core 30 is thin, the space between the inner wall of the tube 11 and the core 30 becomes wide, so the aqueous humor is discharged relatively rapidly while the pressure formed in the anterior chamber is lowered. Therefore, the pressure formed in the anterior chamber can be optimized to a predetermined range, for example, the pressure after surgery is about 6 to 21 mmHg, through an appropriate configuration of the core 30. However, the preferred numerical range of the pressure formed in the anterior chamber is not limited thereto.

[0048] Since the core 30 is inserted only into some of the plurality of tubes 11, 12, the plurality of tubes 11, 12 have different aqueous humor drainage characteristics. Two tubes 11, 12 are shown in the drawings, and the core 30 is inserted only into one of the tubes 11, but it should be easily understood by an ordinary technician that the same principle can be realized in the form of an implant device having more tubes and / or cores.

[0049] In one embodiment, the core 30 may be operated by a clinician to adjust the pressure formed in the anterior chamber. For example, when the core 30 is drawn into the hollow 110 of the tube 11 and exposed at the rear end of the tube 11, the clinician can control the core 30 exposed at the rear end of the tube 11 to adjust the discharge amount of aqueous humor. That is, the clinician can appropriately adjust the intraocular pressure according to the patient's condition using the core 30.

[0050] In one embodiment, in order to prevent the user from feeling a foreign body sensation due to the core 30 exposed outside the tube 11, the core 30 may be configured such that the diameter gradually decreases from the point where it is exposed from the implant body (not shown) coupled to the tube 11 or the rear end of the tube 11.

[0051] In the embodiment shown in FIG. 4, the plurality of tubes 11, 12 constituting the implant device are made to have different aqueous humor drainage characteristics by inserting the core 30 only into some of the plurality of tubes 11, 12. However, this is exemplary, and in other embodiments, cores may be inserted into all of the plurality of tubes 11, 12, while the cores inserted into each of the tubes 11, 12 have different diameters and / or materials. For example, cores having different diameters can be inserted into each of the tubes 11, 12 so that the areas of the aqueous humor flow channels through each of the tubes 11, 12 are different. Alternatively, the materials of the cores inserted into each of the tubes 11, 12 can be made different from each other, and by making the degree of influence of the cores on the flow of aqueous humor different, the aqueous humor drainage characteristics through each of the tubes 11, 12 can be made substantially different.

[0052] In the operation of inserting the implant device for ophthalmic diseases according to the embodiment into the patient's eye, the clinician can prevent hypotony due to excessive outflow of aqueous humor immediately after the operation by inserting a core with an appropriate diameter into each tube or a specific tube of the implant device. As fibrosis progresses around the tube as time passes after the implant operation, the clinician can remove the core at an appropriate timing to make the intraocular pressure reducing effect through the implant device last longer. At this time, the diameter of the core can be appropriately determined according to the length of the tube constituting the implant device, the inner diameter of the tube, the degree of high intraocular pressure of the patient undergoing the implant operation, and the like.

[0053] In the embodiment described above with reference to FIGS. 1 to 4, the plurality of tubes included in the implant device have different aqueous humor drainage characteristics from each other through the physical characteristics of the plurality of tubes themselves or the presence or absence and characteristics of the cores inserted into each tube. On the other hand, in another embodiment, by making the drainage positions of the aqueous humor through the plurality of tubes (that is, the positions of the proximal ends of the tubes) different from each other on the eyeball tissue, it is possible to prevent a situation where all of the plurality of tubes are clogged due to the same cause. This will be described in detail with reference to FIGS. 5A to 6B.

[0054] FIG. 5A is also a perspective view of an implant device for ophthalmic diseases according to another embodiment, and FIG. 5B is a cross-sectional view of the implant device for ophthalmic diseases along the line segment connecting B - B' shown in FIG. 5A.

[0055] Referring to FIGS. 5A and 5B, the implant device for ophthalmic diseases in the present embodiment includes a plurality of tubes 11, 12 having different lengths from each other and a connecting member 20 that connects the plurality of tubes 11, 12. The plurality of tubes 11, 12 have different lengths from each other, and may be connected to the connecting member 20 such that the positions of the proximal ends of the respective tubes 11, 12 through which aqueous humor is discharged (i.e., the positions of aqueous humor discharge) are different from each other. At this time, the positions of the distal ends of the respective tubes 11, 12 may be the same or different from each other. For example, if the distance from the connecting member 20 to the proximal end of the tube 11 is l1 with reference to the insertion direction (the x-axis direction in the figure) of the tubes 11, 12, the distance from the connecting member 20 to the proximal end of the other tube 12 may be l2, which is smaller than l1.

[0056] Since the points where the proximal ends of the respective tubes 11, 12 are located are the positions of aqueous humor discharge, by making the distances from the connecting member 20 to the proximal ends of the respective tubes 11, 12 different, the positions of aqueous humor discharge through the respective tubes 11, 12 will be different. Therefore, even when fibrosis occurs at a specific point in the peripheral tissue after the implantation procedure and any of the tubes becomes clogged, the other tubes with different aqueous humor discharge positions will not become clogged, so that side effects due to tube blockage can be minimized.

[0057] Although the drawings exemplarily show an implant device including two tubes 11, 12, it should be easily understood by those skilled in the art that the same principle can be applied to an implant device including three or more tubes.

[0058] In one embodiment, the connecting member 20 includes a hole 21 through which a plurality of tubes 11, 12 pass. In this embodiment, one hole 21 is formed in the connecting member 20 through which all of the plurality of tubes 11, 12 can pass, and the plurality of tubes 11, 12 extend through the hole 21 side by side with each other. So that the plurality of tubes 11, 12 can pass through, the hole 21 can have a shape extending in a direction orthogonal to the longitudinal direction of the tubes 11, 12 (the y-axis direction in the figure). For example, the width w of the hole 21 may be larger than at least the sum R1 + R2 of the diameters of the plurality of tubes 11, 12 inserted into the hole 21.

[0059] In FIGS. 5A and 5B, by making the lengths of the respective tubes 11, 12 constituting the implant device different from each other, the aqueous humor discharge positions through the respective tubes 11, 12 are made different from each other. However, in other embodiments, a plurality of tubes having the same form can be used, and by adjusting the arrangement and bending of the tubes, the aqueous humor discharge positions through the respective tubes can be made different from each other.

[0060] For example, referring to FIG. 6A, in one embodiment, the implant device for eye diseases includes a plurality of tubes 11, 12 having the same physical form, and the positions where the respective tubes 11, 12 are coupled to the connecting member 20 are different from each other, so that an offset occurs between the ends of the respective tubes 11, 12. That is, in FIG. 6A, the length L1 of the first tube 11 and the length L2 of the second tube 12 are the same, but the second tube 12 is arranged further forward in the eyeball direction than the first tube 11, so that the distances l1, l2 from the connecting member 20 to the proximal ends of the respective tubes 11, 12 are different from each other, and therefore the aqueous humor discharge positions through the respective tubes 11, 12 may be different from each other.

[0061] Furthermore, referring to FIG. 6B, in one embodiment, the implant device for eye diseases includes a plurality of tubes 11, 12 having the same physical form, and by bending each of the tubes 11, 12 in different directions, the proximal ends 112, 122 of each of the tubes 11, 12 can be located at different points on the eye tissue. For example, although the plurality of tubes 11, 12 are commonly joined to a connecting member 20 in one area, they are bent in a Y shape such that the distance between each of the tubes 11, 12 widens as the distance from the connecting member 20 increases, so that the aqueous humor drainage positions through each of the tubes 11, 12 may be configured to be different from each other.

[0062] In FIGS. 6A and 6B, the positions and bends of the plurality of tubes 11, 12 having the same form as each other are adjusted so that the aqueous humor drainage positions through each of the tubes 11, 12 are different from each other. However, it should be easily understood by those skilled in the art that the same principle can also be applied when including a plurality of tubes having different physical forms (e.g., length, material, hollow diameter, whether a core can be inserted, and the diameter and / or material of the inserted core, etc.) from each other.

[0063] FIG. 7A is a conceptual diagram for explaining the manufacturing process of an implant device for eye diseases according to one embodiment. Referring to FIG. 7A, a main body 200 for forming into a connecting member and a plurality of tubes 11, 12 can be formed respectively to manufacture the implant device according to this embodiment. The main body 200 can be made of silicon or other suitable materials, and can also be made of the same material as the tubes 11, 12. When the tubes 11, 12 are formed of silicon, the tubes 11, 12 can be manufactured by an extrusion method. In order to join the extruded tubes 11, 12 to each other and fix the positions of the tubes 11, 12, a connecting member can be further manufactured separately from the tubes 11, 12, and the tubes 11, 12 can be assembled to the connecting member.

[0064] To manufacture the connecting member, the main body 200 of the connecting member having a block form extending in one direction can be formed by extrusion of silicon or the like. Next, one or more holes 201, 202 for the tubes 11, 12 to pass through can be formed in the main body 200. In one embodiment, a plurality of connecting members can also be produced at once by cutting the main body 200 in which the holes 201, 202 are formed along the longitudinal direction. The cutting line 210 shown in FIG. 7 indicates an exemplary cutting line for separating the main body 200 into a plurality of parts along the longitudinal direction of the main body 200. Finally, by inserting a plurality of tubes 11, 12 into one or more holes 201, 202 of the main body 200, the implant device for eye diseases according to the embodiment can be manufactured.

[0065] In the drawings, two holes 201, 202 having different diameters are formed in the main body 200 to allow two tubes 11, 12 having different diameters to pass through respectively, but this is exemplary. When the aqueous humor drainage characteristics of the tubes 11, 12 are different from each other through other characteristics rather than the diameter, or when tubes 11, 12 of the same standard are used and they are coupled to the main body 200 such that the drainage positions are different, the diameters of the holes formed in the main body 200 may be the same. In other embodiments, one hole penetrating the main body 200 can be formed, and the hole can be formed to a size such that a plurality of tubes 11, 12 can be inserted into one hole.

[0066] In the example shown in FIG. 7A, the manufacturing process of the implant device for eye diseases is described assuming the use of two tubes 11, 12, but it should be easily understood by those skilled in the art that the same principle can be applied to the manufacture of implant devices using three or more tubes.

[0067] On the other hand, in other embodiments, the implant device for eye diseases may be formed in an integrated form using injection molding or other different methods. That is, in the manufacture of the implant device for eye diseases according to the embodiments described above with reference to FIGS. 1 to 6B, a plurality of tubes 11 to 13 having different aqueous humor drainage characteristics may be integrally formed in one tube body, or / and a plurality of tubes 11 to 13 and a connecting member 20 coupled thereto may be integrally formed.

[0068] FIG. 7B is a view showing an embodiment of an implant device for eye diseases formed in an integrated form by injection molding or the like. Referring to FIG. 7B, in this embodiment, the tube body 15 has a shape in which a plurality of tubes defined by respective hollows 151 to 153 are integrated with each other. In other words, the tube body 15 is one tube member molded to include a plurality of hollows 151 to 153 having different aqueous humor drainage characteristics. The plurality of hollows 151 to 153 can have different diameters so that the aqueous humor drainage characteristics are different from each other. Further, a core 30 that functions to adjust the discharge amount of aqueous humor through the hollows 151 to 153 may be inserted into the tube body 15.

[0069] The connecting member 20 may be coupled to the tube body 15 such that the tube body 15 extends in a direction different from the longitudinal direction of the connecting member 20 (for example, a direction orthogonal to the longitudinal direction of the connecting member 20). The tube body 15 and the connecting member 20 may be separately molded and then coupled, or the implant device for eye diseases may be manufactured in an integrated form of the tube body 15 and the connecting member 20 from the beginning by a method such as injection molding. That is, when the implant device for eye diseases is formed in an integrated form, the tube body 15 and the connecting member 20 may refer to different parts in one molded product formed of silicon or other materials.

[0070] The shape of the implant device for eye diseases shown in Fig. 7B is merely exemplary, and the manufacturing method of integrally forming a plurality of tubes with each other or / and integrally forming a plurality of tubes and connecting members with each other can be similarly applied to the embodiments shown in other drawings of this specification.

[0071] Fig. 8A is also a perspective view of an implant device for eye diseases according to another embodiment, and Fig. 8B is a cross-sectional view of the implant device for eye diseases along the line segment connecting C-C' shown in Fig. 8A.

[0072] Referring to Figs. 8A and 8B, in this embodiment, the cross-section of the connecting member 25 can have an uneven shape in which all or a part of it is in a curved form corresponding to the shapes of the tubes 11 and 12. In the embodiment shown in the drawings, the bottom surface is flat, and the upper surface of the connecting member 25 shows a connecting member 25 in a cylindrical shape corresponding to the shapes of the tubes 12 and 13.

[0073] In one embodiment, the connecting member 25 can include a first portion 251 through which the plurality of tubes 11 and 12 pass, and a second portion 252 extending from the first portion 251 in the side direction of the tubes 11 and 12. That is, the second portion 252 can protrude in the side direction of the tubes 11 and 12 in a form like a wing. In one embodiment, the thickness t2 of the second portion 252 may be smaller than the thickness t1 of the first portion. In another embodiment, the second portion 252 can have a tapered shape in which the thickness t2 of the second portion 252 increases or decreases as it moves away from the side surfaces of the tubes 11 and 12.

[0074] In the present embodiment, the wing-shaped second portion 252 can be used to fix the position so that the implant device is properly placed on the eyeball. For example, by combining the second portion 252 with the surrounding tissue through fibrosis after the implantation surgery, the implant device can be fixed on the tissue. Further, since the connecting member 25 includes the wing-shaped second portion 252, the cross-sectional size of the implant device becomes larger, thereby preventing the tubes 11 and 12 from coming out of the eyeball after the implantation surgery. Furthermore, if necessary, the second portion 252 of the connecting member 25 can also be fixed to the eyeball using a suture thread.

[0075] FIGS. 8A and 8B illustratively show the application of the wing-shaped second portion 252 to the connecting member 25 having a concave-convex cross-section, but the wing-shaped second portion can also be applied to connecting members having other different cross-sectional shapes.

[0076] FIG. 9 is a cross-sectional view showing various cross-sectional shapes of the connecting member in the implant device for eye diseases according to the embodiment. In the embodiment of the present invention, the connecting member can have a square cross-section as shown in FIG. 9(a), or an elliptical cross-section as shown in FIG. 9(b), or a rhombus cross-section as shown in FIG. 9(c). Further, the connecting member can have a concave-convex shape having a curved cross-section corresponding to the shapes of the tubes 11 and 12 as shown in FIGS. 9(d) and (e), or can be formed to have other different forms of cross-sections not covered in the drawings of this specification. Furthermore, the connecting member can also have wings protruding in the side direction as shown in FIG. 9(e), and such wings can also be applied to connecting members having other different cross-sectional shapes shown in FIGS. 9(a) to (d).

[0077] FIG. 10 is a conceptual diagram showing the process of inserting the implant device for eye diseases according to an embodiment into the eyeball using an injector.

[0078] Referring to FIG. 10, the implant device for ophthalmic diseases according to the embodiment can be arranged in the same manner as shown in FIGS. 1 and 2 such that one end of the tubes 11 and 12 is inserted into the anterior chamber through the sclera 3 of the eyeball by being injected into the interior of the eyeball through an injector 5 equipped with a needle 50. Here, the injector 5 refers to any tool used to insert the implant device into the eyeball by housing the implant device in the needle 50 or fixing it to the needle 50 in another way and advancing the entire needle 50 or injector 5 by mechanical external force.

[0079] For example, with the implant device mounted on the needle 50, the operator advances the entire injector 5 so that one end of the tubes 11 and 12 of the implant device is inserted through the sclera 3 to the anterior chamber. Thereafter, the implant device can be inserted into the eyeball by either retracting only the needle 50 through any mechanism provided in the injector 5 while leaving the implant device in the inserted position or by the operator retracting the entire injector 5. Since the injector 5 for inserting the implant device can have various known or future-developed forms, a detailed description of the injector 5 is omitted in this specification to clarify the gist of the present invention.

[0080] On the other hand, since the implant device for ophthalmic diseases according to the embodiment includes a connecting member 20 having a cross-section larger than the diameters of the tubes 11 and 12, the connecting member 20 may be inserted into the needle 50 of the injector 5 together with the tubes 11 and 12, or the implant device may be inserted into the patient's eye with the connecting member 20 located outside the needle 50.

[0081] For example, in one embodiment, the connecting member 20 has a cross-section larger than the diameters of the tubes 11 and 12 and is made of a flexible material, which may be prone to being rolled up or folded. Therefore, the connecting member 20 is inserted into the needle 50 together with the tubes 11 and 12 in a state where it is rolled up or folded so as to be in close contact with the surfaces of the tubes 11 and 12. When the tubes 11 and 12 reach the insertion position, the connecting member 20 can expand while coming out of the needle 50 together with the tubes 11 and 12. Alternatively, the connecting member 20 is not inserted into the needle 50, and only the front end portion of the tubes 11 and 12 that is not coupled to the connecting member 20 is inserted into the needle 50, or in a state fixed to the needle 50, the implant device can also be disposed in the eyeball in such a manner that the needle 50 pulls the connecting member 20 together through the front end portion of the tubes 11 and 12.

[0082] However, the arrangement methods of the tubes 11 and 12 and the connecting member 20 are not limited to the examples described herein. For example, other arbitrary clinical methods can be used, such as coupling the connecting member 20 onto the tubes 11 and 12 through an additional procedure with only the tubes 11 and 12 inserted into the eyeball using the injector 5. The operator can also couple the tubes 11 and 12 with the connecting member 20 by pinching the connecting member 20 at the ends of the tubes 11 to 13 exposed outside the sclera after first inserting the tubes 11 and 12 of the implant device into the sclera of the patient.

[0083] As described above, in the implant device according to the embodiment, the tubes 11 and 12 are for MIGS and usually have a very fine diameter at the micrometer level. As a result, even after the tubes 11 and 12 are inserted into the sclera, the tubes 11 and 12 may be pushed into the sclera 3 due to impact or other reasons. However, according to the embodiment of the present invention, since the connecting member 20 having a cross-section larger than the diameters of the tubes 11 and 12 is coupled to the tubes 11 and 12, when the tubes 11 and 12 move in the direction of the sclera 3, the connecting member 20 catches on the sclera 3, thereby preventing the tubes 11 and 12 from being completely inserted into the sclera 3.

[0084] The implant device injected through the injector 5 shown in FIG. 10 is shown in a form in which a plurality of tubes 11 and 12 having different lengths are inserted into the connecting member 20 side by side in a state of being in close contact with each other as shown in FIG. 5A. However, this is exemplary, and it should be easily understood by those skilled in the art that an implant device for eye diseases configured according to the drawings attached to this specification or other embodiments described throughout this specification can be placed into the eyeball using the injector 5 in the above-described manner.

[0085] The above description of the present invention is for illustrative purposes, and those having ordinary knowledge in the technical field to which the present invention pertains can implement it in other specific forms without changing the technical idea and essential features of the present invention. Therefore, the above-described embodiments are illustrative in all aspects and not restrictive. For example, each component described as a single type may be implemented in a distributed manner, and similarly, components described as being distributed may also be implemented in a combined form. The scope of the present invention is defined by the claims described below rather than the above detailed description, and all changes or modified forms derived from the meaning and scope of the claims and their equivalent concepts are included in the scope of the present invention.

Industrial Applicability

[0086] The present invention relates to an implant device for eye diseases and a method for manufacturing the same. More specifically, by connecting a plurality of tubes having different aqueous humor drainage characteristics (drainage volume, drainage speed, etc.) and / or drainage positions through a connecting member to form an implant device, it is configured to prevent the loss of the aqueous humor drainage function due to fibrosis or foreign body contamination after the implant surgery.

Claims

1. An implant device for ophthalmic diseases for insertion into the eye, comprising: a plurality of tubes configured such that one end thereof is inserted into the anterior chamber of the eye and each having a hollow formed for draining aqueous humor; and a connecting member configured to connect the plurality of tubes, wherein the connecting member is configured to be coupled to the plurality of tubes by the plurality of tubes extending through the connecting member An implant device for ophthalmic diseases, characterized by the above.

2. In the implant device for ophthalmic diseases according to claim 1, one or more of the length, material, and hollow diameter of the plurality of tubes are different from each other, and one or more of the aqueous humor drainage characteristics or aqueous humor drainage positions of the plurality of tubes are different from each other. The implant device for ophthalmic diseases according to claim 1.

3. Each of the plurality of tubes includes a first end for insertion into the anterior chamber of the eye and a second end opposite to the first end, wherein the second ends of the plurality of tubes are located at different distances from the connecting member. The implant device for ophthalmic diseases according to claim 2.

4. Further comprising a core inserted into the hollow of some of the plurality of tubes. The implant device for ophthalmic diseases according to claim 1.

5. Further comprising a plurality of cores respectively inserted into the hollows of the plurality of tubes, wherein one or more of the diameters and materials of the plurality of cores are different from each other. The implant device for ophthalmic diseases according to claim 1.

6. The connecting member includes a plurality of holes through which the plurality of tubes respectively pass, and the plurality of holes are arranged spaced apart from each other on the cross-section of the connecting member. The implant device for ophthalmic diseases according to claim 1.

7. The connecting member includes a hole extending in a direction perpendicular to the longitudinal direction of the plurality of tubes so that the plurality of tubes pass through. The implant device for ophthalmic diseases according to claim 1.

8. The connecting member has a cross-section larger than the width of the plurality of tubes. The implant device for ophthalmic diseases according to claim 1.

9. The connecting member includes: a first portion configured such that the plurality of tubes pass through; and a second portion extending from the first portion in a direction different from the extension direction of the plurality of tubes and protruding in the side direction of the plurality of tubes. The implant device for ophthalmic diseases according to claim 8.

10. The thickness of the second portion is smaller than the thickness of the first portion. The implant device for ophthalmic diseases according to claim 9.

11. The plurality of tubes are integrally formed with each other. The implant device for ophthalmic diseases according to claim 1.

12. The plurality of tubes and the connecting member are integrally formed with each other. The implant device for ophthalmic diseases according to claim 1.

13. Forming a plurality of tubes each having a hollow for discharging aqueous humor; Forming a main body of a connecting member extending in one direction; Forming one or more holes in the main body for the plurality of tubes to pass through; and Inserting the plurality of tubes into the holes of the main body, wherein one or more of the aqueous humor discharge characteristics or the aqueous humor discharge positions of the plurality of tubes are different from each other. A method for manufacturing an implant device for ophthalmic diseases, characterized by the above.

14. Forming a tube body including a plurality of tubes each having a hollow for discharging aqueous humor and a connecting member integrally connected to the plurality of tubes, wherein the connecting member extends in one direction and is coupled to the plurality of tubes such that the plurality of tubes extend in a direction different from the longitudinal direction of the connecting member, wherein one or more of the aqueous humor discharge characteristics or the aqueous humor discharge positions of the plurality of tubes are different from each other. A method for manufacturing an implant device for ophthalmic diseases, characterized by the above.

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