Implant device for ophthalmic diseases with a matrix for drug delivery
The implant device with a matrix member that releases anti-fibrotic agents and has a larger cross-section than the tube prevents clogging and complete insertion into the sclera, ensuring effective glaucoma treatment without reoperation.
Patent Information
- Application Number
- JP2025501735
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-07-15
- Filing Date
- 2023-06-19
- Publication Date
- 2025-07-10
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
Existing glaucoma implants used in minimally-invasive glaucoma surgery (MIGS) can become clogged due to fibrosis at the aqueous humor outlet, leading to increased intraocular pressure and the need for reoperation, and they may be completely inserted into the sclera, causing complications.
An implant device with a matrix member that temporarily absorbs and releases anti-fibrotic agents, having a cross-section larger than the tube diameter, is coupled to the implant to prevent clogging and ensure the tube does not fully insert into the sclera.
Prevents aqueous humor outlet clogging by releasing anti-fibrotic agents to surrounding tissues, maintaining effective drainage and preventing the tube from being fully inserted into the sclera, thus reducing the need for reoperation.
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Figure 2025522110000001_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to an implant device for ophthalmic diseases. More specifically, the present invention relates to an implant device for ophthalmic diseases, which is configured such that a matrix member configured to temporarily absorb a drug is coupled to a tube of the implant device, and the implant device releases a drug such as an anti-fibrotic agent from the matrix member into the surrounding tissue when the implant device is inserted into the eye.
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 discharged 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 fail to adjust the intraocular pressure due to a decrease in the amount of aqueous humor drainage caused by the closure of the bypass again after the surgery. When glaucoma filtration surgery is performed again after the failure of the primary surgery, the frequency of bypass closure increases after the 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 an eye with a past history of failure of glaucoma filtration surgery or in the case of refractory glaucoma, glaucoma implant surgery is performed to prevent the closure of the bypass and increase the success rate of the surgery. To date, glaucoma implants have been used as an alternative to trabeculectomy in some glaucomas that are particularly difficult to treat, not only effectively lowering the intraocular pressure but also 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 due to 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] However, MIGS inserts a tube having a size at the micrometer level into the anterior chamber of the eye to allow aqueous humor to be discharged from the anterior chamber. At this time, the tube may be clogged by fibrosis of the surrounding tissue at the aqueous humor outlet of the tube. When the aqueous humor outlet of the tube is clogged in this way, aqueous humor cannot be discharged through the MIGS tube, so the intraocular pressure of glaucoma patients rises again. Therefore, in order to solve this problem, there is a problem that reoperation is required to open the fibrosed part or reinsert the implant. SUMMARY OF THE INVENTION PROBLEMS TO BE SOLVED BY THE INVENTION
[0006] According to one aspect of the present invention, an object is to provide an implant device for eye diseases in which a matrix member capable of impregnating and releasing a drug is coupled to a tube of the implant device for eye diseases, and a drug such as an anti-fibrotic agent is released from the matrix member into the surrounding tissue in a state where the implant device is inserted into the eye to prevent the aqueous humor outlet of the implant device from being clogged.
[0007] Further, according to one aspect of the present invention, a matrix member coupled to a tube of an implant device is configured such that a cross-section of the matrix member is at least partially larger than a diameter of the tube inserted into the eye, so that when the tube is pushed into the eye after an implant operation, the matrix member is applied to the sclera of the eye to prevent the tube from being completely inserted into the sclera. An object of the present invention is to provide an implant device for eye diseases.
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 eye, and includes a tube configured such that one end is inserted into the anterior chamber of the eye and having a hollow formed for discharging aqueous humor; and a matrix member coupled to an outer surface of the tube and made of a material capable of impregnating and releasing a drug. At this time, at least a part of the matrix member has a cross-section larger than a diameter of the tube.
[0009] In one embodiment, the tube includes a main body extending in one direction; and a wing integrated with the main body or detachably coupled to the main body and extending in a side direction of the main body. At this time, the matrix member is at least partially coupled to the wing.
[0010] In one embodiment, the matrix member includes a pair of sheet members. At this time, the tube is disposed between the pair of sheet members. In one embodiment, edges or vertices of the pair of sheet members can be at least partially joined to each other.
[0011] In one embodiment, the matrix member extends in a direction different from a longitudinal direction of the tube and is arranged to prevent the tube from being completely inserted into the sclera of the eye.
[0012] In one embodiment, the matrix member is coupled to the tube so as to protrude in the lateral direction of the tube at a position spaced apart from the distal end of the tube by a preset distance.
[0013] In one embodiment, the matrix member comprises any one selected from the group consisting of poly(acrylic acid), polyacrylamide, poly(sulfopropyl acrylate), poly(2-hydroxyethyl methacrylate), poly(vinyl alcohol), silicone, polyurethane, collagen, gelatin, hyaluronic acid, poly(aspartic acid), alginate, hydroxypropyl cellulose, hydroxypropyl methylcellulose acetate succinate, and chitosan, or a combination of one or more of these substances.
[0014] In one embodiment, the matrix member is made of a material containing a first substance that is not biodegradable in the eye and a second substance that can temporarily absorb a drug.
[0015] In one embodiment, the first material includes any one selected from the group consisting of silicone, polyethylene vinyl acetate, polyvinyl acetate, polycarbonate, polyvinyl chloride, polyurethane, PMMA, poly(butyl methacrylate), polyamide, polyethylene, polypropylene, PolyEthylene Terephthalate (PET), glycol-modified PTE, PTFE, polyhydroxyalkanoates, parylene, polyether ether ketone, polyimide, epoxy resins such as SU-8, poly(vinylidene fluoride), polyether block amides, 3-[tris(trimethylsiloxy)silyl]propyl methacrylate, poly(styrene-isobutylene-styrene) copolymer, cellulose acetate, poly((N-vinylpyrrolidone)-block-poly(vinyl acetate)), and ethyl cellulose, or a combination of one or more of these substances.
[0016] Furthermore, in one embodiment, the second substance is any one selected from the group consisting of polyethylene glycol (PEG), PEG derivatives, poly(ethylene oxide), poly(propylene oxide), polyvinyl alcohol, polyvinyl pyrrolidone, polyethersulfone, polyamide, polyacrylamide, polyglycolic acid, polyacrylic acid, glucuronic acid, hexuronic acid, hyaluronic acid, polyaspartic acid, alginate, polyorthoester, 2-hydroxyethyl methacrylate, Polycaprolactone (PCL), Polylactic acid (PLA), Poly(lactide-co-glycolide) (PLGA), Polydioxanone (PDO), Polyhydroxybutyrate (PHB), Polyhydroxyalkanoates (PHA), collagen, gelatin, hydroxypropyl cellulose, and chitosan, or a combination of one or more of these substances.
[0017] In one embodiment, the matrix member is configured to be impregnated with a drug containing any one selected from the group consisting of dexamethasone, mitomycin-C (MMC), 5-fluorouracil (5-FU), triamcinolone (TA), an anti-vascular endothelial growth factor (anti-VEGF) drug, and a transforming growth factor-beta (TGF-beta) inhibitor, or a combination of one or more of these substances.
Advantages of the Invention
[0018] According to the implant device for eye diseases according to one embodiment of the present invention, by coupling a matrix member capable of impregnating and releasing a drug, which is made of a material capable of temporarily absorbing the drug, to the tube of the implant device, the drug can be released to the surrounding tissue through the matrix member in a state where the implant device is inserted into the eyeball.
[0019] For example, when an anti-fibrotic agent such as dexamethasone, mitomycin-C (MMC), 5-fluorouracil (5-FU), triamcinolone (TA), an anti-vascular endothelial growth factor (anti-VEGF) drug, or a transforming growth factor-beta (TGF-beta) inhibitor is loaded on the matrix member, the anti-fibrotic agent is released from the matrix member coupled to the tube to the tissue around the aqueous humor outlet of the tube. Therefore, there is an advantage that it is possible to prevent the aqueous humor outlet from being blocked due to fibrosis of the tissue around the tube.
[0020] In addition, in the implant device for eye diseases according to an embodiment of the present invention, since the cross section of the matrix member is formed to be at least partially larger than the diameter of the tube, even if the tube is pushed into the eyeball for some reason after the implantation of the implant device, there is an advantage that the matrix 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
[0021]
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DETAILED DESCRIPTION OF THE INVENTION
[0022] The terms used in this specification will be briefly described, and the present invention will be specifically described.
[0023] The terms used in the embodiments of the present invention are selected as general terms that are currently widely used as much as possible while considering the functions in the present invention, but they may change depending on the intention or precedent 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 the names of the terms, but are defined based on the meaning of the terms and the overall content of the present invention.
[0024] Throughout the specification, when a certain 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 certain 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".
[0025] 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.
[0026] Hereinafter, the present invention will be described in detail with reference to the attached drawings.
[0027] FIGS. 1 and 2 are a conceptual diagram and an enlarged view showing a state in which an implant device for ophthalmic diseases according to an embodiment is inserted into the eyeball.
[0028] Referring to FIGS. 1 and 2, an implant device 10 for ophthalmic diseases according to an embodiment is for controlling the discharge amount 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 intraocular pressure, and plays a role in preventing the intraocular pressure from rising due to ophthalmic diseases and damaging the optic nerve. The implant device 10 for ophthalmic diseases according to an embodiment of the present invention can be used for treating or alleviating various ophthalmic diseases caused by or resulting from an increase in intraocular pressure.
[0029] Ophthalmic diseases in this specification 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 associated 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.
[0030] The implant device 10 for ophthalmic diseases according to the embodiment includes a tube 11 applicable to minimally invasive glaucoma surgery (MIGS). One end of the tube 11 is inserted into the anterior chamber 1 of the eyeball, and the other end of the tube 11 may be configured to be located in the conjunctival tissue or Tenon's tissue 4. The tube 11 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 11.
[0031] Referring to FIG. 2, the implant device 10 for ophthalmic diseases can be inserted by peeling the conjunctival tissue or Tenon's tissue 4 of the eyeball by the operator, and can be placed in the eyeball in a manner that covers the conjunctival tissue or Tenon's tissue 4 again after being inserted. 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 end of the tube 11 can be inserted so as to penetrate the exposed sclera 3 of the eyeball while lifting the generated section 40. At this time, the tube 11 is not completely inserted into the sclera 3, and the proximal end of the tube 11 may be placed on or inserted into the conjunctival tissue or Tenon's tissue 4. After one end of the tube 11 is inserted into the anterior chamber 1 through the sclera 3, the insertion process of the implant device 10 for ophthalmic diseases is completed by lowering the lifted section 40.
[0032] Furthermore, the implant device 10 for ophthalmic diseases according to the embodiment further includes a matrix member 12 made of a material capable of impregnating and releasing a drug, which is coupled to a region of the tube 11. In this specification, the matrix member 12 means a release control substance that functions to transmit the drug to be administered to the eye using the implant device 10 for ophthalmic diseases to the surrounding tissue of the eyeball into which the implant device 10 for ophthalmic diseases is inserted. That is, the matrix member 12 temporarily absorbs the drug, but releases the drug to the surrounding tissue of the eyeball when the implant device 10 for ophthalmic diseases is inserted into the eyeball.
[0033] The matrix member 12 of this specification can be hydrophobic or hydrophilic depending on the type of drug to be transmitted therethrough, and can be composed of a mixture of two or more substances having different hydrophilicity-related characteristics. Further, the matrix member 12 is made of a substance that has biocompatibility and is not immediately decomposed in the eye, and is preferably made of a material that can continuously release a drug (for example, for several days or more) in a state where the implant device 10 for eye diseases is inserted into the eye.
[0034] The description in this specification of not being immediately decomposed or not being biodegradable means that a specific substance is not affected or is very little affected by the biological environment surrounding it, and there is no or very little structural change over the treatment period using the implant device according to the embodiment. That is, even a material that is decomposed in the human body over a very long period exceeding the treatment period of eye diseases can correspond to the material that is not immediately decomposed or not biodegradable in this specification.
[0035] The matrix member 12 has a cross-section that is at least partially larger than the diameter of the tube 11. As a result, the matrix member 12 can extend and / or protrude in a side direction different from the longitudinal direction of the tube 11. The matrix member 12 may be configured in the form of a sheet that covers a part of the outer surface of the tube 11, or may be configured in the form of a plurality of sheets positioned with the tube 11 sandwiched therebetween. Further, in the matrix member 12 composed of a plurality of sheets, each sheet may be at least partially joined to each other.
[0036] In one embodiment, the implant device 10 for ophthalmic diseases further includes a core 13 inserted into the hollow of the tube 11. The core 13 is for adjusting the intra - anterior - chamber forming pressure through the hollow of the tube 11. When the core 13 is inserted into the hollow of the tube 11, since the aqueous humor does not flow smoothly, the aqueous humor accumulates in the anterior chamber of the eye, and the intraocular pressure relatively increases compared to the case without the core 13. In this specification, the intra - anterior - chamber forming pressure means the intra - anterior - chamber pressure of the eyeball formed at this time. The implant device 10 for ophthalmic diseases may be inserted into the eyeball with the core 13 inserted into the tube 11, or after inserting the implant device 10 for ophthalmic diseases excluding the core 13 into the eye, the core 13 may be inserted into the tube 11.
[0037] In one embodiment, an implant body (not shown) may be further coupled to the proximal end of the tube 11 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 end of the tube 11, 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), etc.
[0038] The implant body is coupled behind the tube 11 and serves to temporarily accommodate aqueous humor for effective regulation of intraocular pressure. For example, after the tube 11 of the implant device 10 for eye diseases is inserted into the anterior chamber 1 of the eyeball, the implant body can be coupled and disposed behind the tube 11 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.
[0039] Alternatively, depending on the embodiment, the tube 11 and the implant body may be coupled or integrally configured and disposed together inside the eyeball through the dissected conjunctival tissue or Tenon's tissue 4 of the eyeball. That is, the implant body may be pre-coupled to the tube 11 before the implant device is disposed inside the eyeball according to clinical needs or conditions, or may be coupled to the implant body after the tube 11 is first disposed inside the eyeball.
[0040] When the implant device 10 for eye diseases is inserted into the eyeball, the aqueous humor generated from the anterior chamber flows through the tube 11 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 tube 11, 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 to the conjunctival tissue or Tenon's tissue 4 through the rear of the implant body, thereby effectively regulating the intraocular pressure.
[0041] FIG. 3A is a perspective view of an implant device for eye diseases according to an embodiment.
[0042] Referring to FIG. 3A, the implant device for ophthalmic diseases according to the present embodiment includes a tube 11 applicable to MIGS and a matrix member 12 coupled to the tube 11. The matrix member 12 can be coupled to the outer surface of a region of the tube 11 and can be permanently coupled to the tube 11 or removably fixed to the tube 11. In one embodiment, the matrix member 12 can also be coupled onto the surface of the tube 11 using an adhesive substance.
[0043] The tube 11 is inserted into the eye such that its distal end 111 is located within the anterior chamber of the eye and its proximal end 112 is located within the conjunctival tissue or Tenon's tissue of the eye, and serves to discharge the aqueous humor generated from the anterior chamber of the eye through the hollow 110 within the tube 11 to the conjunctival tissue or Tenon's tissue. In this specification, the distal end 111 and the proximal end 112 are defined by the direction from the operator inserting the implant device. Among the two ends of the tube 11, the proximal end 112 means the end in the direction towards the operator, and the distal end 111 means the end in the direction towards the eye of the patient into whom the implant device is inserted.
[0044] In one embodiment, the tube 11 may be made of a biocompatible substance or a changeable material. For example, the tube 11 may be made of silicone or other silicone-based substances, PTFE, urethane-based substances such as polycarbonate polyurethane, a composite of a silicone-based substance and a polyurethane (PU)-based substance such as silicone-PU, or a biocompatible metal or alloy, etc.
[0045] In one embodiment, the tube 11 may be made of any one or a combination of one or more of silicone, PTFE, polycarbonate, polyurethane, polyethylene, polypropylene, polyimide, PMMA, poly(styrene-b-isobutylene-b-sytrene) copolymer, polyethersulfone, gelatin, stainless steel, titanium, and nitinol, but is not limited thereto.
[0046] In one embodiment, the tube 11 can be formed with a curve having a predetermined curvature to prevent damage to the intraocular corneal endothelium. Due to different eyeball sizes for each patient, proficiency in tube injection, etc., there is a possibility that during the process of the tube being drawn into the anterior chamber of the eyeball, the front end of the tube may pierce and damage the cornea in the anterior chamber of the eyeball. Corneal damage may cause complications such as corneal insufficiency required until future corneal transplantation. According to this embodiment, the tube 11 can also be manufactured in a bent form so as to have a predetermined curvature corresponding to the curvature of the eyeball surface so that the movement of the tube can naturally form a curve during the process of the tube being drawn into the anterior chamber of the eyeball.
[0047] The matrix member 12 is coupled to the outer surface of the tube 11, and at least a part of the matrix member 12 has a cross-section larger than the diameter of the tube 11. As a result, a part of the matrix member 12 protrudes in the side direction of the tube 11, that is, in a direction different from the longitudinal direction of the tube 11. The length L1 of the matrix member 12 extending in the side direction of the tube 11 and the length L2 of the matrix member 12 along the longitudinal direction of the tube 11 can be appropriately determined to such a size that the matrix member 12 can catch on the sclera and prevent the movement of the tube 11 when the tube 11 is pushed into the sclera direction of the eyeball.
[0048] In the embodiment shown in FIG. 3A, the matrix member 12 is disposed on the tube 11 in a form that partially covers the upper surface of the tube 11. For example, when the tube 11 is inserted into the sclera of the eyeball, the matrix member 12 coupled to the tube 11 can be placed on the sclera while covering a part of the tube 11. However, this is exemplary, and in other embodiments, it is also possible to dispose the matrix member 12 on the lower surface of the tube 11.
[0049] In yet another embodiment, the matrix member 12 is composed of a pair of sheet members 121 and 122 as in the embodiment shown in FIG. 3B, and the pair of sheet members 121 and 122 can also be respectively positioned above and below the tube 11 with the tube 11 sandwiched therebetween. By joining the corner portions and apex portions of the sheet members 121 and 122 to each other with the tube 11 inserted between the pair of sheet members 121 and 122, the matrix member 12 can be coupled to the tube 11. For example, the pair of sheet members 121 and 122 can be adhered to each other using an adhesive substance such as a silicone adhesive. In yet another embodiment, either one or both of the sheet members 121 and 122 can also be adhered to the surface of the tube 11 using an adhesive substance.
[0050] The matrix member 12 is made of a material that can be impregnated with a drug such as an anti-fibrotic agent, and is a release control substance that can release the absorbed drug to the surrounding tissue of the eyeball when the implant device is inserted into the eyeball. For example, an implant device including the tube 11 to which the matrix member 12 is coupled can be inserted into the patient's eyeball with the matrix member 12 that does not contain a drug immersed in a liquid drug so that the drug penetrates into the matrix member 12. However, this is exemplary, and in other embodiments, the matrix member 12 can be manufactured with the drug loaded in a state where the drug is mixed in a dispersion for producing a polymer.
[0051] In one embodiment, the tube 11 and the matrix member 12 constituting the implant device 10 for eye diseases may be coupled during the insertion process of the implant device. For example, the operator may first insert the tube 11 of the implant device into the sclera of the patient, and then couple the tube 11 and the matrix member 12 by placing the matrix member 12 on the surface of the tube 11 exposed outside the sclera. At this time, the matrix member 12 may be manufactured with a drug pre-mounted, or the matrix member 12 that does not contain a drug may be immersed in the drug by the operator at the operation site so that the drug penetrates into the matrix member 12, and this can also be placed on the tube 11. In addition, the operator can couple the tube 11 and the matrix member 12 by passing a suture through the matrix member 12 and fixing it to the eye tissue.
[0052] Examples of drugs for mounting on the matrix member 12 include, but are not limited to, anti-fibrotic agents such as dexamethasone, mitomycin-C (MMC), 5-fluorouracil (5-FU), triamcinolone (TA), anti-vascular endothelial growth factor (anti-VEGF) drugs, and transforming growth factor-beta inhibitor (TGF-beta inhibitor). For example, depending on the purpose of applying the drug to the matrix member 12, in addition to anti-fibrotic agents, anti-glaucoma agents such as prostaglandin, cefazidime or other cefa-based antibiotics, fluoroquinolone-based antibiotics such as levofloxacin and moxifloxacin, other types of antibiotics, or other different types of drugs can be mounted on the matrix member 12.
[0053] The matrix member 12 can be made of a material that is not immediately decomposed in the living body so that drug release occurs over a sufficient period of time and does not expand excessively enough to cause a foreign body sensation in the eye by the drug. In one embodiment, as the matrix member 12, a polymer having a membrane structure capable of forming a storage space for capturing a drug can be used.
[0054] For example, the matrix member 12 can be made of any one of poly(acrylic acid), polyacrylamide, poly(sulfopropyl acrylate), poly(2-hydroxyethyl methacrylate), poly(vinyl alcohol), silicone, polyurethane, collagen, gelatin, hyaluronic acid, poly(aspartic acid), alginate, hydroxypropyl cellulose, hydroxypropyl methylcellulose acetate succinate, and chitosan, or a combination of one or more of these substances, but is not limited thereto.
[0055] In one embodiment, the matrix member 12 can be a material having a bilayer structure formed of two or more different substances. At this time, since the first substance constituting the matrix member 12 has biocompatibility but is not immediately biodegradable in the eye, it can be a substance having mechanical properties for forming the skeleton of the matrix member 12. Further, the second substance, which is another material constituting the matrix member 12 together with the first substance, can be a substance that can temporarily absorb a drug while being bonded to the first substance. When the matrix member 12 is constituted by a composite of the first substance and the second substance as in the present embodiment, it is possible to easily impregnate the matrix member 12 with a drug suitable for the purpose while maintaining the mechanical strength of the matrix member 12. For example, the matrix member 12 can be constituted in the form of a sheet made of a composite of PU and PEG.
[0056] In one embodiment, the first material can be composed of any one or a combination of one or more of the following substances: silicone, polyethylene vinyl acetate, polyvinyl acetate, polycarbonate, polyvinyl chloride, polyurethane, PMMA, poly(butyl methacrylate), polyamide, polyethylene, polypropylene, PolyEthylene Terephthalate (PET), glycol-modified PTE, PTFE, polyhydroxyalkanoates, parylene, polyether ether ketone, polyimide, epoxy resins such as SU-8, poly(vinylidene fluoride), polyether block amides, 3-[tris(trimethylsiloxy)silyl]propyl methacrylate, poly(styrene-isobutylene-styrene) copolymer, cellulose acetate, poly((N-vinylpyrrolidone)-block-poly(vinyl acetate)), and ethyl cellulose, but is not limited thereto.
[0057] Furthermore, in one embodiment, the second substance may be composed of any one of polyethylene glycol (PEG), PEG derivatives, poly(ethylene oxide), poly(propylene oxide), polyvinyl alcohol, polyvinyl pyrrolidone, polyethersulfone, polyamide, polyacrylamide, polyglycolic acid, polyacrylic acid, glucuronic acid, hexuronic acid, hyaluronic acid, polyaspartic acid, alginate, polyorthoester, 2-hydroxyethyl methacrylate, Polycaprolactone (PCL), Polylactic acid (PLA), Poly(lactide-co-glycolide) (PLGA), Polydioxanone (PDO), Polyhydroxybutyrate (PHB), Polyhydroxyalkanoates (PHA), collagen, gelatin, hydroxypropyl cellulose, and chitosan, or a combination of one or more of these substances, but is not limited thereto.
[0058] In one embodiment, the matrix member 12 can be coupled to the tube 11 so as to be spaced apart from the distal end 111 and the proximal end 112 of the tube 11 by predetermined distances D1 and D2, respectively. When the agent released from the matrix member 12 is an anti-fibrotic agent, the matrix member 12 may be disposed adjacent to the proximal end 112 of the tube through which aqueous humor is discharged in order to prevent the aqueous humor drainage pathway from being blocked by tissue fibrosis. That is, in the present embodiment, the distance D1 between the distal end 111 of the tube 11 and the matrix member 12 may be larger than the distance D2 between the proximal end 112 of the tube 11 and the matrix member 12.
[0059] Also, the thickness t of the matrix member 12 can be thin enough that the patient does not feel a foreign body sensation even when the matrix member 12 is disposed in a state of being inserted into the conjunctival tissue or the Tenon's tissue. As in the embodiment shown in FIG. 3B, when the matrix member 12 is composed of a plurality of sheet members 121 and 122, the thickness t of the entire plurality of sheet members 121 and 122 can be determined to the extent that it does not cause a foreign body sensation in the patient. Further, in one embodiment, the thickness t of the matrix member 12 may be smaller than the diameter of the tube 11.
[0060] In one embodiment, the implant device for ophthalmic diseases further includes a core 13 that is at least partially inserted into the lumen 110 of the tube 11. The core 13 can be a surgical non-absorbable suture, and can be made of, for example, a nylon or prolene material, but is not limited thereto.
[0061] The core 12 inserted into the cavity 110 of the tube 11 serves to regulate the pressure formed within the anterior chamber. When the core 13 is thick, the space between the inner wall of the tube 11 and the core 13 becomes narrow, so the aqueous humor is discharged relatively slowly, thereby increasing the pressure formed within the anterior chamber. On the contrary, when the core 13 is thin, the space between the inner wall of the tube 11 and the core 13 becomes wide, so the aqueous humor is discharged relatively rapidly while the pressure formed within the anterior chamber becomes low. Therefore, through an appropriate configuration of the core 13, the pressure formed within the anterior chamber can be optimized to a predetermined range, for example, such that the pressure after surgery is about 6 to 21 mmHg. However, the preferred numerical range of the pressure formed within the anterior chamber is not limited to this.
[0062] In one embodiment, the core 13 may be operated by a clinician to regulate the pressure formed within the anterior chamber. For example, when the core 13 is retracted into the cavity 110 of the tube 11 and exposed at the rear end of the tube 11, the clinician can control the core 13 exposed at the rear end of the tube 11 to adjust the discharge amount of the aqueous humor. That is, the clinician can appropriately adjust the intraocular pressure according to the patient's condition using the core 13. In this embodiment, in order to prevent the user from feeling a foreign body sensation due to the core 13 exposed outside the tube 11, the core 13 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.
[0063] Referring to FIGS. 3A and 3B, in the above-described embodiment, the matrix member 12 was positioned at a predetermined distance D2 from the proximal end 112 of the tube 11. However, this is exemplary, and in other embodiments, the matrix member 12 may be disposed in contact with the proximal end 112 of the tube 11 (i.e., when the distance D2 is 0), or may further extend in the opposite direction of the eyeball beyond the proximal end 112 of the tube 11 (i.e., when the distance D2 is a negative number).
[0064] Figures 4A and 4B are perspective views showing the arrangement of the tube and the matrix member in the implant device for eye diseases according to the embodiment. In Figures 4A and 4B, the arrangement of the matrix member 12 using the matrix member 12 composed of a pair of sheet members 121 and 122 is shown, but the same arrangement form can also be applied to the matrix member 12 in a single sheet form as shown in Figure 3A.
[0065] Figure 4A shows an embodiment in which the matrix member 12 is coupled to the tube 11 such that one end of the matrix member 12 completely coincides with the proximal end 112 of the tube. In this case, since the drug such as the antifibrotic agent is discharged by the matrix member 12 at a position directly facing the proximal end 112 of the tube 11 through which the aqueous humor is discharged, it is possible to prevent the drainage path of the aqueous humor from being blocked due to fibrosis of the eye tissue or the like.
[0066] Furthermore, Figure 4B shows an embodiment in which one end of the matrix member 12 extends further in the proximal direction (i.e., in the opposite direction of the eyeball or the direction toward the operator) beyond the proximal end 112 of the tube 11. In this embodiment, the matrix member 12 completely wraps the proximal end 112 of the tube 11, and the aqueous humor discharged from the tube 11 is discharged after passing through the region covered by the matrix member 12. Therefore, when the matrix member 12 is impregnated with an antifibrotic agent or the like, it is possible to fundamentally block the source of the fibrosis and blockage of the aqueous humor drainage path.
[0067] In the embodiment shown in Figure 4B, the matrix member 12 is made of a flexible material, and in the portion where the matrix member 12 extends beyond the proximal end 112 of the tube 11, the form of the drainage path may not be supported in a fixed form. That is, when the matrix member 12 is composed of a single sheet, the matrix member 12 may cover the proximal end 112 of the tube 11 without a fixed drainage path, or when the matrix member 12 is composed of a plurality of sheets, the sheets facing each other may be positioned in a connected form without a fixed drainage path.
[0068] However, when aqueous humor is discharged from the proximal end 112 through the tube 11 and the pressure of the discharged aqueous humor reaches a certain level, the aqueous humor can be discharged while a discharge path that naturally passes through the matrix member 12 is formed by the pressure of the aqueous humor. That is, when the amount of aqueous humor discharged through the tube 11 exceeds a certain amount, the aqueous humor can be discharged to the outside of the matrix member 12 while pushing out the matrix member 12 made of a flexible material. For example, when the matrix member 12 is configured in the form of a sheet covering the proximal end 112 of the tube 11, when a certain amount or more of aqueous humor accumulates, the aqueous humor can form a fluid flow path while lifting the matrix member 12.
[0069] FIG. 5 is a conceptual diagram showing the process of inserting an implant device for ophthalmic diseases according to an embodiment into the eyeball using an injector.
[0070] Referring to FIG. 5, the implant device for ophthalmic diseases according to an embodiment may be arranged in the same manner as shown in FIGS. 1 and 2 such that one end of the tube 11 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 20 having a needle 21. Here, the injector 20 refers to any tool used to insert the implant device into the eyeball by housing the implant device in the needle 21 or fixing it to the needle 21 in another way and advancing the entire needle 21 or the injector 20 by mechanical external force.
[0071] For example, with the implant device mounted on the needle 21, the operator advances the entire injector 20 so that one end of the tube 11 of the implant device is inserted through the sclera 3 into the anterior chamber. Thereafter, with the implant device left in the inserted position, only the needle 21 can be retracted through an arbitrary mechanism provided in the injector 20, or the operator can retract the entire injector 20 so that the implant device can be inserted into the eyeball. Since the injector 20 for inserting the implant device can have various known or future-developed forms, in order to clarify the gist of the present invention, a detailed description of the injector 20 is omitted herein.
[0072] On the other hand, since the implant device for eye diseases according to the embodiment includes the matrix member 12 having a cross-section larger than the diameter of the tube 11, the matrix member 12 may be inserted into the needle 21 of the injector 20 together with the tube 11, or the implant device may be inserted into the patient's eye with the matrix member 12 located outside the needle 21.
[0073] For example, in one embodiment, the matrix member 12 has a cross-section larger than the diameter of the tube 11 but is made of a flexible material and may be rolled up or folded. Therefore, it is inserted into the needle 21 together with the tube 11 in a state where the matrix member 12 is rolled up or folded so as to be in close contact with the surface of the tube 11. When the tube 11 reaches the insertion position, the matrix member 12 can spread while coming out of the needle 21 together with the tube 11. Alternatively, the matrix member 12 is not inserted into the needle 21, and only the front end portion not connected to the matrix member 12 by the tube 11 is inserted into the needle 21, or in a state fixed to the needle 21, the implant device can also be arranged in the eyeball by a method in which the needle 21 pulls the matrix member 12 together through the front end portion of the tube 11.
[0074] However, the arrangement method of the tube 11 and the matrix member 12 is not limited to the examples described in this specification. For example, other arbitrary clinical methods such as coupling the matrix member 12 onto the tube 11 through additional procedures in a state where only the tube 11 is inserted into the eyeball using the injector 20 can be used.
[0075] As described above, in the implant device according to the embodiment, the matrix member 12 is impregnated with a drug such as an anti-fibrotic agent and functions to gradually release this into the eye tissue. On the other hand, the tube 11 is for MIGS and usually has a very fine diameter at the micrometer level, whereby there is a possibility that the tube 11 may be pushed into the sclera 3 due to impact or other causes even after the tube 11 is inserted into the sclera. However, according to the embodiment of the present invention, since the matrix member 12 having a cross-section larger than the diameter of the tube 11 is coupled to the tube 11, even when the tube 11 moves in the direction of the sclera 3, the matrix member 12 catches on the sclera 3, and it is possible to prevent the tube 11 from being completely inserted into the sclera 3.
[0076] FIG. 6A is also a perspective view of an implant device for eye diseases according to another embodiment.
[0077] Referring to FIG. 6A, the implant device for eye diseases according to the present embodiment includes a wing 14 that extends in the side surface direction of the main body of the tube 11. In the embodiment shown in FIG. 6A, by inserting the tube 11 of the implant device into another tube having a larger cross-sectional diameter, a part of the outer tube surrounding the tube 11 forms the wing 14.
[0078] However, this is exemplary, and the method of forming the wings extending on the side surface of the tube 11 is not limited thereto. It is also possible to couple another member serving as the wings to the surface of the tube 11, or configure the implant device such that the tube 11 itself has a portion where the outer diameter is expanded in a specific region to serve as the wings. Further, in one embodiment, the wings formed on the side surface of the tube 11 may be integrally formed with the tube 11 or may be configured to be detachable from the tube 11.
[0079] In the present embodiment, the matrix member 12 coupled to the tube 11 may be at least partially coupled to the wings 14 on the side surface of the tube 11. In one embodiment, the matrix member 12 includes a pair of sheet members 121 and 122, and the matrix member 12 can be coupled to the wings 14 in such a manner that the wings 14 of the tube 11 are positioned between the two sheet members 121 and 122 and the sheet members 121 and 122 are joined to each other. In the present specification, the joining between the sheet members can be performed by an adhesion method using a silicone adhesive or the like.
[0080] For example, in the embodiment of FIG. 6A, the upper and lower sheet members 121 and 122 each have a rectangular shape and are joined to each other at least at the apexes A, B, C, and D of the rectangular shape. The tube 11 or the wings 14 are positioned at the edge portions between the joining portions of the sheet members 121 and 122. That is, the tube 11 extends through the edges AD and BC of the rectangular sheet members 121 and 122, and the wings 14 orthogonal to the longitudinal direction of the tube 11 extend in the direction passing through the edges AB and CD of the sheet members 121 and 122. The length L31 of the wings 14 extending in the side surface direction of the tube 11 and the length L32 of the wings 14 along the longitudinal direction of the tube 11 may be appropriately determined so that the joining between the upper and lower sheet members 121 and 122 is not hindered by the presence of the wings 14.
[0081] In this embodiment, the wing 14 of the tube 11 serves to provide the bonding stability with the matrix member 12. In the bonding form shown in FIG. 6A, the upper and lower sheet members 121 and 122 are joined to each other at the respective vertex portions A, B, C, and D, and the wing 14 of the tube 11 is located therebetween. Therefore, even when an external force is applied to the tube 11 in the front-rear direction along its longitudinal direction, the wing 14 is fixed between the upper and lower sheet members 121 and 122, so that the matrix member 12 is not separated from the tube 11. In one embodiment, the matrix member 12 and the wing 14 may be joined to each other using an adhesive such as a silicone adhesive for bonding stability.
[0082] Further, according to this embodiment, not only does the matrix member 12 having a larger diameter than the tube 11 protrude on the side surface of the tube, but also the wing 14 protruding in the side surface direction of the tube 11 itself forms a step. Thereby, it is physically prevented that the tube 11 is excessively inserted into the eyeball after the insertion of the implant device, and it is possible to prevent or minimize the back-and-forth movement of the tube 11 after it is inserted by the step.
[0083] In the embodiment shown in FIG. 6A, the length L31 of the wing 14 extending in the side surface direction of the tube 11 was substantially the same as the length of the matrix member 12. However, this is exemplary, and depending on the embodiment, the length L31 of the wing 14 may have a size such that the wing 14 protrudes more than the matrix member 12 in the side surface direction of the tube 11 as shown in FIG. 6B, or may be determined such that the wing 14 protrudes less than the matrix member 12 in the side surface direction of the tube 11 as shown in FIG. 6C. When the matrix member 12 is arranged so as to completely cover the side surface of the wing 14 as shown in FIG. 6B, the upper and lower sheet members 121 and 122 can be joined to each other not only at their vertex portions A, B, C, and D but also at the side edges between the respective vertices, that is, at the edges AB and CD, to achieve the bonding stability.
[0084] Furthermore, in FIGS. 6A to 6C, embodiments are shown in which the length L31 of the wing 14 extending in the side direction of the tube 11 is variously changed. However, in other embodiments, by changing the length L32 of the wing 14 along the longitudinal direction of the tube 11, the wing 14 can protrude more or less than the matrix member 12 in the longitudinal direction of the tube 11, and the wing 14 and the matrix member 12 can be arranged accordingly.
[0085] Also, the matrix member 12 coupled to the wing 14 in FIGS. 6A to 6C was positioned spaced apart from the proximal end 112 of the tube 11. However, this is exemplary, and depending on the embodiment, the position of the wing 14 may be changed and / or the size of the matrix member 12 may be changed, so that the arrangement of the matrix member 12 with respect to the proximal end 112 of the tube 11 may change even when the wing 14 is in a certain state.
[0086] For example, as shown in FIG. 6D, by arranging the wing 14 adjacent to the proximal end 112 compared to the embodiment of FIG. 6A, the end of the matrix member 12 abuts against the proximal end 112 of the tube 11, or as shown in FIG. 6E, by arranging the wing 14 in contact with the proximal end 112 of the tube 11, the end of the matrix member 12 can extend beyond the proximal end 112. Furthermore, the matrix member 12 can be coupled to the wing 14 in any arrangement not shown in the drawings of this specification.
[0087] FIG. 7A is a perspective view of a tube according to another embodiment of the present invention, and FIG. 7B is a cross-sectional view of the tube shown in FIG. 7A. FIGS. 7A and 7B show another configuration for forming a wing protruding in the side direction of the tube in an implant device for eye diseases.
[0088] Referring to FIGS. 7A and 7B, in the present embodiment, the tube 11 is coupled to a support base 15 that extends in a direction different from the longitudinal direction of the tube 11. For example, the tube 11 can be coupled to the support base 15 in such a manner that it passes through a fixing hole formed in a central portion 150 of the support base 15 having a circular cross-section. The support base 15 extends in a direction different from the longitudinal direction of the tube 11 and intersects the tube 11, and a part of the support base 15 extending to the outer surface of the tube 11 corresponds to the wing 151.
[0089] Similar to the wing 14 described above with reference to FIGS. 6A to 6E, the wing 151 according to the present embodiment also serves to prevent the situation where the tube 11 is completely drawn into the anterior chamber of the eyeball and to provide binding stability with a matrix member (not shown). That is, although not shown in FIGS. 7A and 7B, a matrix member for impregnating and releasing a drug can also be coupled to the tube 11 of the eye disease treatment device according to the present embodiment. Further, the matrix member can be coupled to the tube 11 in a manner of being coupled to the wing 151 portion of the implant device according to the present embodiment. This can be easily understood from the above-described embodiment with reference to FIGS. 6A to 6E, and thus detailed description is omitted to avoid duplication of description.
[0090] In one embodiment, a protrusion 152 is formed in a region of the wing 151. The protrusion 152 is a portion that protrudes compared to other portions of the wing 151, that is, a portion where the width of the support base 15 is larger than other portions. For example, the protrusion 152 may be formed at each end of the wing 151 at both ends of the tube 11. The protrusion serves as unevenness to prevent the fixed thread from slipping when the implant wing 151 is additionally fixed with a thread as necessary in one embodiment.
[0091] In one embodiment, the outer diameter R1 of the tube 11 (i.e., the diameter of the fixing hole of the support base 15) is about 0.2 mm, and the outer diameter R2 of the central portion 150 of the support base 15 in which the fixing hole is formed is about 0.4 mm. Also, in one embodiment, the length L5 of the support base 15 is about 1.4 mm, the height H of the support base 15 including the height of the protruding portion 150 is about 0.25 mm, and the width W of the protruding portion 150 is about 0.1 mm. The length L4 of the wings 151 respectively formed at both ends of the central portion 150 of the support base 15 is 0.5 mm.
[0092] However, the above-described numerical values are merely exemplary, and the dimensions of each part of the tube 11 and the support base 15 may vary depending on the embodiment and are not limited to the numerical values described in this specification.
[0093] According to this embodiment, the wings 151 can be easily formed in such a manner that the tube 11 is fixed to the support base 15 intersecting the tube 11 without the need to attach or fix a member for forming wings to the outer surface of the tube 11. The tube 11 with the wings 151 formed thereon can be arranged such that a part thereof is inserted into the anterior chamber of the eyeball in a manner of being inserted therethrough after the surgeon has peeled the conjunctival tissue or Tenon's tissue of the eyeball.
[0094] Also, the tube 11 according to this embodiment can be inserted into the eyeball through an injector in the same manner as described with reference to FIG. 5. In this case, the support base 15 can be made of a flexible material that can be inserted into the needle 21 of the injector 20 by applying pressure and deforming it. For example, it can be pressed into the needle 21 in a state where the support base 15 is pushed down or rolled up and adhered to the tube 11. When the tube 11 is injected into the eyeball by the operation of the injector 20 by a clinician, the tube 11 and the support base 15 can come out of the injector through the front end of the needle 21, and the support base 15 can spread and play the role of the wings 151.
[0095] Furthermore, the wing shapes described above with reference to FIGS. 6A to 7B are merely exemplary, and in the implant device for eye diseases according to the embodiment, the wings of the tube can have other cross-sectional or planar shapes different from those described above. FIGS. 8 and 9 below show some exemplary and non-limiting embodiments of wings applicable to the implant device for eye diseases.
[0096] FIG. 8 is a cross-sectional view showing the shape of the wing in the implant device for eye diseases according to the embodiment. In the embodiment described above with reference to FIGS. 6A to 6E, the wing 14 is formed by surrounding the tube 11 or using other tubular members and has an overall elliptical cross-section. However, this is exemplary, and the wing 14 can be formed to have a square cross-section as shown in FIG. 8(a), a rhombus cross-section as shown in FIG. 8(b), or other different forms of cross-sections not covered in the drawings of this specification.
[0097] Also, FIG. 9 is a plan view showing the shape of the wing in the implant device for eye diseases according to the embodiment. In the implant device for eye diseases according to the embodiment, the wing can be coupled to the tube in various ways, such as being integrally manufactured with the tube or being manufactured separately from the tube and attached to the tube.
[0098] Referring to FIG. 9(a), the wing 16 can be coupled to the side surface of the tube 11 in a direction perpendicular to or inclined to the longitudinal direction of the tube 11. At this time, the inclination formed by the side surface of the tube 11 and the wing 16 can be formed in a direction in which the angle of the wing 16 increases from the distal end to the proximal end of the tube 11, or conversely, in a direction in which the angle of the wing 16 increases from the proximal end to the distal end of the tube 11. When the angle of the wing 16 increases toward the distal end of the tube 11, the wing 16 is arranged so as to be inclined in the opposite direction to the direction in which the tube 11 is inserted into the sclera. Therefore, even if the tube 11 moves in the eyeball direction after the implant device is inserted, the wing 16 can easily catch on the sclera and prevent the tube 11 from completely entering the sclera.
[0099] Also, referring to FIG. 9(b), the wing 17 may have a tapered shape with a length that varies according to the position and protrudes from the side surface of the tube 11. For example, the wing 17 may have a tapered shape in which the length increases from the proximal end to the distal end of the tube 11, or conversely, a tapered shape in which the length increases from the distal end to the proximal end of the tube 11. When the length of the wing 17 increases toward the distal end of the tube 11, the length of the wing 17 is maximum at the end in the eyeball direction. Thus, even if the tube 11 moves in the eyeball direction after the implantation of the implant device, the wing 17 can be easily caught on the sclera to prevent the tube 11 from completely entering the sclera.
[0100] Furthermore, referring to FIG. 9(c), the tapered shape of the wing 18 can also be configured such that the length of the wing 18 is maximum at the middle portion rather than at both ends of the wing 18, and the length of the wing 18 decreases toward both ends of the wing 18.
[0101] FIG. 10 is a plan view showing the shape of the matrix member in the implant device for eye diseases according to the embodiment.
[0102] In the above-described embodiment with reference to FIGS. 3A to 9, the matrix member 12 has been described as a rectangular sheet-like member. However, this is exemplary, and the matrix member 12 according to the embodiment can have various shapes such as circular as shown in FIG. 10(a), elliptical as shown in FIG. 10(b), and rhombic as shown in FIG. 10(c). For example, in other embodiments, the matrix member 12 can also be formed in a shape having an inclination with respect to the tube 11 or a tapered shape like the wings 16 to 18 shown in FIGS. 9(a) to (c).
[0103] FIG. 10 shows an exemplary shape of the matrix member 12 coupled to the tube 11 without wings, but it can be easily understood by those skilled in the art that various shapes of the matrix member 12 can also be applied to the case of the tube 11 having wings.
[0104] The foregoing description of the present invention is for illustrative purposes, and those with 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 foregoing embodiments are illustrative in all respects 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.
[0105] The scope of the present invention is defined by the claims set forth below rather than the foregoing detailed description, and all changes or modifications derived from the meaning and scope of the claims and their equivalent concepts are included within the scope of the present invention.
Industrial Applicability
[0106] The present invention relates to an implant device for eye diseases, and more particularly to an implant device for eye diseases configured such that a matrix member configured to temporarily absorb a drug is coupled to a tube of the implant device, and the drug such as an anti-fibrotic agent is released from the matrix member to the surrounding tissue with the implant device inserted into the eye.
Claims
1. An implant device for eye diseases to be inserted into the eye, a tube configured such that one end is inserted into the anterior chamber of the eye and having a hollow formed for the drainage of aqueous humor; and, including a matrix member coupled to the outer surface of the tube and made of a material capable of impregnating and releasing a drug, at least a part of the matrix member having a cross-section larger than the diameter of the tube The implant device for eye diseases, characterized in that.
2. The tube is a main body extending in one direction; and, including wings that are integrated with the main body or detachably coupled to the main body and extend in the lateral direction of the main body, the matrix member being at least partially coupled to the wings The implant device for eye diseases according to claim 1.
3. The matrix member includes a pair of sheet members, the tube being disposed between the pair of sheet members The implant device for eye diseases according to claim 1.
4. Edges or vertices of the pair of sheet members are at least partially joined to each other The implant device for eye diseases according to claim 3.
5. The matrix member is disposed so as to extend in a direction different from the longitudinal direction of the tube and prevent the tube from being completely inserted into the sclera of the eye. The implant device for eye diseases according to claim 1.
6. The matrix member is coupled to the tube so as to project in the lateral direction of the tube at a position separated from the distal end of the tube by a preset distance. The implant device for eye diseases according to claim 5.
7. The matrix member includes any one selected from the group consisting of polyacrylic acid, polyacrylamide, polysulfopropyl acrylate, polyhydroxyethyl methacrylate, polyvinyl alcohol, silicone, polyurethane, collagen, gelatin, hyaluronic acid, polyaspartic acid, alginate, hydroxypropyl cellulose, hydroxypropyl methylcellulose acetate succinate, and chitosan, or a combination of one or more of these substances. The implant device for eye diseases according to claim 1.
8. The matrix member is made of a material including a first substance that is not biodegradable in the eye and a second substance that can temporarily absorb a drug. The implant device for eye diseases according to claim 1.
9. The first substance includes any one selected from the group consisting of silicone, polyethylene vinyl acetate, polyvinyl acetate, polycarbonate, polyvinyl chloride, polyurethane, polymethyl methacrylate, polybutyl methacrylate, polyethylene, polypropylene, polyethylene terephthalate, glycol-modified polyethylene terephthalate, polytetrafluoroethylene, polyhydroxyalkanoate, paraffin, polyether ether ketone, polyimide, epoxy resin, polyvinylidene fluoride, polyether block amide, 3-tris(trimethylsiloxy)silyl]propyl methacrylate, poly(styrene-isobutylene-styrene) copolymer, cellulose acetate, poly(N-vinylpyrrolidone-block-poly(vinyl acetate)), and ethyl cellulose, or a combination of one or more of these substances. The implant device for eye diseases according to claim 8.
10. The second substance includes any one or a combination of a plurality of substances selected from the group consisting of polyethylene glycol, polyethylene glycol derivative, polyethylene oxide, polypropylene oxide, polyvinyl alcohol, polyvinylpyrrolidone, polyethersulfone, polyamide, polyacrylamide, polyglycolic acid, polyacrylic acid, glucuronic acid, hexuronic acid, hyaluronic acid, polyaspartic acid, alginate, polyorthoester, hydroxyethyl methacrylate, polycaprolactone, polylactic acid, polylactide-co-glycolide, polydioxanone, polyhydroxybutyrate, polyhydroxyalkanoate, collagen, gelatin, hydroxypropyl cellulose, and chitosan. The implant device for eye diseases according to claim 8.
11. In one embodiment, the matrix member is configured to impregnate a drug including any one or a combination of one or more substances selected from the group consisting of dexamethasone, mitomycin-C, 5-fluorouracil, triamcinolone, anti-vascular endothelial growth factor drugs, and transforming growth factor-beta inhibitors. The implant device for eye diseases according to claim 1.
Citation Information
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