An ophthalmic implant device with optimized inner diameter of the tube and core diameter, and a method for maintaining a patient's intraocular pressure using the same.

Abstract

To provide an implantable device for ophthalmic diseases that is configured to adjust the anterior chamber formation pressure to an optimal range through an appropriate combination of a tube and a core inserted into the tube, in a method of lowering intraocular pressure by draining aqueous humor through a tube inserted into the eyeball. [Solution] The eye disease implant device 10 for insertion into the eyeball may include a tube 11 configured such that one end is inserted into the anterior chamber of the eyeball and has a hollow for draining aqueous humor; and a core inserted into the hollow of the tube 11 to regulate the amount of aqueous humor drained through the tube 11. In the eye disease implant device 10, the inner diameter of the tube 11 and the diameter of the core are determined such that the pressure formed in the anterior chamber of the eyeball when the tube 11 is inserted into the anterior chamber of the eyeball is within a preset pressure range.

Description

Technical Field

[0001] The present invention relates to an implant device for eye diseases and a method for maintaining the intraocular pressure of a patient. More specifically, an embodiment relates to a technique for adjusting the pressure formed in the anterior chamber to an optimal range through an appropriate combination of a tube and a core inserted into the tube in a method of discharging aqueous humor through a tube inserted into the eyeball to lower the intraocular pressure, and maintaining the intraocular pressure of a patient at a preset intraocular pressure using the same.

Background Art

[0002] For glaucoma patients whose intraocular pressure cannot be adjusted even with the use of intraocular pressure-lowering agents, 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. Thus, in the case of an eye with a past history of failure in glaucoma filtration surgery or refractory glaucoma, glaucoma implant surgery is performed to prevent bypass closure and increase the surgical success rate. 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 the 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 are relatively large, which can lead to various problems and complications such as surgical difficulties, postoperative exposure, infection, impaired eye movement due to the large size of the implant, and resulting double vision. Therefore, recently, smaller glaucoma implant tools have been developed for minimally invasive glaucoma surgery (MIGS), making it relatively easier to lower intraocular pressure using glaucoma implants while reducing the postoperative side effects associated with the large size of conventional implants.

[0005] MIGS involves inserting a tube with an inner diameter measured in micrometers into the anterior chamber of the eye to allow aqueous humor to drain from the anterior chamber. However, if the proximal end of the tube, which is exposed outside the eyeball, comes into direct contact with the sclera and Tenon's capsule, there is a risk of the wound spreading and rupturing. In addition, the tube may become clogged due to fibrosis of the surrounding tissues at the end of the tube inserted into the eyeball, the surface where the tube is sutured, and the exposed aqueous outlet of the tube. If the aqueous outlet of the tube becomes clogged in this way, aqueous humor cannot be drained through the MIGS tube, causing the intraocular pressure of glaucoma patients to rise again. Therefore, resolving this problem requires either opening the fibrotic portion or performing a second surgery to reinsert the implant. In particular, when the tube is sutured to the eyeball, even if aqueous humor drains through the tube initially, there is a high risk that the outlet will gradually become clogged.

[0006] In addition, MIGS allows for the insertion of a core (Ripcord) inside the tube to regulate aqueous humor drainage. These cores are used to prevent initial hypotension after implantation and must be removed after a certain period (for example, about 4 to 16 weeks).

[0007] However, for aqueous humor to drain from the eyeball at the appropriate pressure, the diameter, length, and other dimensions of each part of the glaucoma implant, which is extremely small, must be precisely adjusted. If the size is not designed accurately, there is a risk of excessive drainage of aqueous humor, leading to hypotension, or insufficient drainage of aqueous humor. Despite this, sufficient research has yet to be conducted on the design of glaucoma implant tools optimized for the resulting anterior chamber pressure. [Prior art documents] [Patent Documents]

[0008] [Patent Document 1] Korean Patent Publication No. 10-2012-0064679 [Overview of the Initiative] [Problems that the invention aims to solve]

[0009] According to one aspect of the present invention, the objective is to provide an implantable device for eye diseases that is configured to adjust the anterior chamber formation pressure to an optimal range through an appropriate combination of a tube and a core inserted into the tube, in a method of lowering intraocular pressure by draining aqueous humor through a tube inserted into the eyeball.

[0010] Furthermore, according to one aspect of the present invention, an objective is to provide an implant device for eye diseases in which the inner diameter of the tube and the diameter of the core inserted into the tube are combined to have an optimal numerical range. [Means for solving the problem]

[0011] An implantable device for ocular diseases according to one aspect of the present invention is for insertion into the eyeball and comprises a tube configured such that one end is inserted into the anterior chamber of the eyeball and has a hollow formed therein for draining aqueous humor; and a core that is inserted into the hollow of the tube to regulate the amount of aqueous humor drained through the tube.

[0012] Furthermore, the inner diameter of the tube and the diameter of the core of the eye disease implant device are determined such that the pressure formed in the anterior chamber of the eye when the tube is inserted into the anterior chamber of the eyeball is within a predetermined pressure range. In one embodiment, the preset pressure range is 6 to 20 mmHg.

[0013] In one embodiment, the length of the tube is 4 to 10 mm, the inner diameter of the tube is 60 to 220 μm, and the diameter of the core is 1 to 180 μm.

[0014] In one embodiment, the length of the tube is 5 to 8 mm, the inner diameter of the tube is 60 to 140 μm, and the diameter of the core is 1 to 130 μm.

[0015] In one embodiment, one or more of the inner diameter of the tube and the diameter of the core are determined such that the ratio of the core diameter to the inner diameter of the tube falls between a predetermined lower limit and a predetermined upper limit. In one embodiment, the ratio of the diameter of the core to the inner diameter of the tube is 1:0.01 to 1:0.9. In one embodiment, one or more of the preset upper limit and the preset lower limit are determined to increase as the inner diameter of the tube increases.

[0016] In one embodiment, as the inner diameter of the tube increases, the increase in one or more of the preset upper limit and the preset lower limit decreases as the inner diameter of the tube increases.

[0017] Furthermore, in one embodiment, one or more of the preset upper limit and the preset lower limit are determined to decrease as the length of the tube increases.

[0018] In another embodiment, one or more of the inner diameter of the tube and the diameter of the core are determined such that the ratio of the square of the diameter of the core to the square of the inner diameter of the tube belongs between a preset lower limit and a preset upper limit.

[0019] In one embodiment, the implant device for ophthalmic diseases further includes a wing coupled to the tube so as to be located at a predetermined distance from the distal end of the tube and extending in a direction different from the longitudinal direction of the tube.

[0020] A method for maintaining the intraocular pressure of a patient who needs intraocular pressure maintenance according to one aspect of the present invention at a preset intraocular pressure includes the step of inserting an implant device for ophthalmic diseases according to any of the above-described embodiments into the anterior chamber of the patient's eyeball.

Advantages of the Invention

[0021] The implant device for ophthalmic diseases according to one aspect of the present invention achieves an optimal intraocular formation pressure in discharging aqueous humor to the conjunctival tissue or the Tenon's tissue through a tube inserted into the anterior chamber of the eyeball to lower the intraocular pressure, and by combining the inner diameter of the tube and the numerical value of the diameter of the core inserted into the tube, problems such as low intraocular pressure due to excessive aqueous humor drainage and insufficient aqueous humor drainage can be solved.

Brief Description of the Drawings

[0022] [Figure 1] It is a conceptual diagram showing a state where an implant device for ophthalmic diseases according to one embodiment is inserted into the eyeball. [Figure 2] It is an enlarged view showing a state where an implant device for ophthalmic diseases according to one embodiment is inserted into the eyeball. [Figure 3A] It is a perspective view of an implant device for ophthalmic diseases according to one embodiment. [Figure 3B] It is a cross-sectional view of the wing portion of the implant device for ophthalmic diseases shown in FIG. 3A. [Figure 4]This is a plan view illustrating the morphology of an eye disease implant device according to an embodiment. [Best Mode for Carrying Out the Invention]

[0023] The terms used herein will be briefly explained, and then the present invention will be described in detail. The terminology used in the embodiments of this invention has been selected as widely used and general terms as possible, taking into consideration the functions of the invention, but this may change depending on the intentions of the articulators, precedents, or the realization of new technologies. In some cases, the applicant may have arbitrarily selected terms, in which case their meaning will be described in detail in the description of the invention. Therefore, the terms used in this invention are not merely names of terms, but are defined based on the meaning of the terms and the overall content of the invention. Throughout the specification, when a part is said to "include" a component, this means, unless otherwise stated, that it may include other components rather than excluding them. Furthermore, when a part is said to be "linked" to another part, this includes not only cases where they are "directly linked," but also cases where they are linked "with other components in between." Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings, so that those with ordinary skill in the art 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. In order to clearly illustrate the present invention with the drawings, parts unrelated to the description have been omitted, and similar parts throughout the specification are denoted by similar reference numerals.

[0024] The present invention will be described in detail below with reference to the attached drawings. Ocular implants for minimally invasive glaucoma surgery (MIGS)

[0025] Figures 1 and 2 are conceptual diagrams illustrating an implant device used in a surgical method for inserting an implant for ocular diseases according to one embodiment, and the form in which the device is inserted into the eye.

[0026] Referring to Figures 1 and 2, the ophthalmic implant device 10 is intended to be inserted at least partially into the sclera 3 of the eyeball. In this specification, the implant device 10 used in the surgical method according to the embodiment will be described using an implant for the treatment of glaucoma as an example. However, the ophthalmic implant device 10 used in the surgical method according to the embodiment of the present invention may be used to treat or alleviate the symptoms of various eye diseases that cause or result from increased intraocular pressure.

[0027] When used to treat glaucoma, the implant device 10 regulates intraocular pressure by controlling the drainage of aqueous humor from the anterior chamber 1, which is located in front of the lens and beneath the cornea 2 within the eyeball. It plays a role in preventing damage to the optic nerve caused by elevated intraocular pressure due to eye disease.

[0028] In this specification, eye diseases may include, but are not limited to, congenital glaucoma, traumatic glaucoma, suspected glaucoma, ocular hypertension, primary open-angle glaucoma, normal-tension glaucoma, cystic 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, glaucoma resulting from trauma to the eye, glaucoma resulting from inflammation of the eye, drug-induced glaucoma, neovascular glaucoma, or secondary glaucoma due to uveitis.

[0029] In one embodiment, the implant device 10 may include a tube 11 applicable to minimally invasive glaucoma surgery (MIGS), where one end of the tube 11 is inserted into the anterior chamber 1 of the eyeball and the other end of the tube 11 is positioned in the conjunctival tissue or Tenon's tissue. The tube 11 contains a hollow space through which eye fluid can flow, and serves to allow the fluid to be drained from the anterior chamber 1 of the eyeball to the outside of the eyeball through the tube 11.

[0030] More specifically, the tube 11 is inserted into the eyeball such that its distal ends are located within the anterior chamber 1 and within the conjunctival or Tenon's tissue of the eyeball, and its role is to drain aqueous humor produced in the anterior chamber of the eyeball into the conjunctival or Tenon's tissue through the hollow of the tube 11. In this specification, the distal and proximal ends are defined by the direction from the operator inserting the implant device 10, with the proximal end of the tube 11 being the end facing the operator and the distal end being the end facing the patient's eye into which the implant device 10 is inserted.

[0031] In one embodiment, the tube 11 can be made of a biocompatible material and can be made of a deformable material. Furthermore, if the tube 11 is made of a viscous material, it may affect the flow of aqueous humor through the hollow of the tube 11, so the tube 11 can be made of a material with a surface smooth enough not to affect the flow of aqueous humor.

[0032] For example, tube 11 can be made of silicone or other silicone-based materials, urethane-based materials such as PTFE, polycarbonate, and polyurethane (PU), a compound of silicone-based and polyurethane-based materials such as silicone-PU, or a biocompatible metal or alloy.

[0033] Furthermore, in one embodiment, the tube 11 may be made of any of the following materials, or a combination of one or more of these materials: silicone, PTFE, polycarbonate, polyurethane, polyethylene, polypropylene, polyimide, PMMA, poly(styrene-b-isobutylene-b-sytrene) copolymer, polyethersulfone, gelatin, stainless steel, titanium, and nitinol.

[0034] In one embodiment, the tube 11 can be formed into a curve with a predetermined curvature to prevent damage to the corneal endothelium inside the eyeball. Due to differences in eyeball size from patient to patient and the skill level of tube injection, there is a possibility that the tube may puncture and damage the cornea in the anterior chamber of the eyeball during the process of the tube being drawn into the anterior chamber of the eyeball. Corneal damage can lead to complications such as corneal insufficiency that may require a future corneal transplant. According to this embodiment, the tube 11 can also be manufactured in a curved form that has 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.

[0035] A core 13 (ripcord) is inserted into the tube 11. The core 13 is an intraocular pressure control member inserted into the hollow of the tube 11 to control the flow of aqueous humor through the tube 11, and plays a role in maintaining the intraocular pressure of a patient who has had the eye disease implant device 10 inserted at a preset intraocular pressure. In one embodiment, the core 13 may have a cylindrical shape with a circular cross-section, but the cross-sectional shape of the core 13 is not limited to this.

[0036] In one embodiment, the implant device 10 includes a wing 12 coupled to the outer surface of the tube 11, having a cross-section at least partially larger than the diameter of the tube 11. As a result, a portion of the wing 12 protrudes laterally from the tube 11, i.e., in a direction different from the longitudinal direction of the tube 11. The presence of the wing 12 extending laterally from the tube 11 prevents the tube 11 from being fully inserted into the eyeball by engaging with the sclera 3 when the tube 11 is pushed toward the sclera 3 of the eyeball. Such a wing 12 can be formed by coupling or joining one or more members to the surface of the tube 11, or by inserting the tube 11 into a member extending in a direction different from the longitudinal direction of the tube 11.

[0037] Referring to Figure 2, when using the surgical method according to the embodiment, the eye disease implant device 10 can be inserted into the sclera 3 through the region beneath the scleral flap 40, which is formed by the surgeon peeling off a portion of the limbus 4 that surrounds the cornea 2 of the sclera of the eyeball. After the implant device 10 has been inserted, it can be positioned inside the eyeball again in a manner that covers the scleral flap 40.

[0038] Specifically, after incising the limbus 4 of the sclera 3 surrounding the cornea 2 to create a scleral flap 40, the distal end of the tube 11 can be inserted so as to lift the created scleral flap 40 and penetrate the exposed sclera 3. At this time, the tube 11 is not completely inserted into the sclera 3, and the proximal end of the tube 11, which includes a waterproof outlet, is located outside the sclera 3. After one end of the tube 11 is inserted into the anterior chamber 1 through the sclera 3, the lifted scleral flap 40 can be lowered. When the eye disease implant device 10 is inserted into the eyeball, aqueous humor generated from the anterior chamber flows through the tube 11 of the eye disease implant device, thereby draining the aqueous humor from the anterior chamber and lowering intraocular pressure.

[0039] In the following specification, when the implant device 10 or the tube 11 of the implant device 10 is said to be inserted into the eyeball, it means that at least a portion of the implant device 10 or the tube 11 of the implant device 10 is located within the sclera 3 of the eyeball. Conversely, when a portion of the implant device 10 or the tube 11 of the implant device 10 is said to be located outside the eyeball, it means that the portion is located outside the sclera 3 of the eyeball. However, the description "outside the eyeball" is intended to include a form in which the implant is outside the sclera 3 and covered by a scleral flap 40.

[0040] Furthermore, the ophthalmic implant device 10 further includes a core 13 inserted into the hollow of the tube 11. The core 13 is for regulating the anterior chamber formation pressure through the hollow of the tube 11. In one embodiment, the core 13 may be a non-absorbable surgical suture and may be made from, for example, nylon or prolene material, but is not limited thereto.

[0041] When the core 13 is inserted into the hollow of the tube 11, aqueous humor cannot flow smoothly, causing it to accumulate in the anterior chamber of the eye, and the intraocular pressure increases relatively compared to when the core 13 is not present. In this specification, anterior chamber pressure refers to the pressure in the anterior chamber of the eyeball that is formed at this time. The eye disease implant device 10 may be inserted into the eyeball with the core 13 inserted into the tube 11, or the eye disease implant device 10 without the core 13 may be inserted into the eye, and then the core 13 may be inserted into the tube 11.

[0042] In one embodiment, the insertion position of the implant device 10 may be determined such that the proximal end of the tube 11 of the implant device 10, which is exposed to the outside of the sclera 3, is not completely covered by the scleral flap 40. Furthermore, in one embodiment, through the process of suturing a portion of the scleral flap 40 to the other portion of the scleral flap 40, the eyeball, or the implant device 10, a portion of the scleral flap 40 covering the tube 11 exposed to the outside of the sclera 3 may be lifted upward (i.e., toward the outside of the eyeball).

[0043] Configuration of an implant device for eye diseases Figure 3A is a perspective view of an eye disease implant device according to one embodiment, and Figure 3B is a cross-sectional view of the wing portion of the eye disease implant device shown in Figure 3A.

[0044] Referring to Figures 3A and 3B, the ophthalmic implant device 10 according to this embodiment includes a tube 11 applicable to MIGS and a core 13 inserted into the tube 11. In one embodiment, the ophthalmic implant device 10 further includes a wing 12 coupled to the tube 11.

[0045] Tube 11 is inserted into the eyeball such that its distal end (right end in the drawing) is located in the anterior chamber of the eyeball and its proximal end (left end in the drawing) is located in the conjunctival tissue or Tenon's tissue of the eyeball, and its role is to drain aqueous humor produced in the anterior chamber of the eyeball through the hollow of the tube 11 into the conjunctival tissue or Tenon's tissue. In this specification, the distal end and proximal end are defined by the direction from the operator inserting the implant device, with the proximal end of tube 11 being the end facing the operator and the distal end being the end facing the patient's eye into which the implant device is inserted.

[0046] The wing 12 is attached to the outer surface of the tube 11, and at least a portion of the wing 12 has a cross-section larger than the diameter of the tube 11. As a result, a portion of the wing 12 protrudes in the lateral direction of the tube 11, i.e., in a direction different from the longitudinal direction of the tube 11. The size of the wing 12 may be appropriately determined so that, when the wing 12 extends in the lateral direction of the tube 11 and the tube 11 is pushed toward the sclera of the eyeball, the wing 12 can catch on the sclera and prevent the movement of the tube 11.

[0047] The wing 12 can be permanently bonded to the tube 11 or detachably attached from the tube 11. In one embodiment, the wing 12 can also be bonded to the surface of the tube 11 using an adhesive.

[0048] In another embodiment, the wing 12 is a block-shaped member containing a hole for the tube 11 to pass through, and the tube 11 can be connected to the wing 12 by inserting the tube 11 into the hole formed in the block-shaped member. In this case, both ends of the wing 12 protrude laterally from the tube 11, so that the wing 12 rests on the sclera during the MIGS procedure and prevents the tube 11 from being completely drawn into the eyeball. The thickness of the wing 12 may also be determined to be small enough (for example, about 350 μm) so that the patient does not feel a foreign body sensation even when the wing 12 is positioned in the conjunctival tissue or Tenon's tissue.

[0049] In another embodiment, the tube 11 and the blade 12 can be manufactured in a form that is integrated with each other from the beginning by methods such as extrusion or injection using synthetic resin.

[0050] The core 13 is inserted at least partially into the hollow of the tube 11 and plays a role in regulating the outflow of aqueous humor through the tube 11. If the core 13 is thick, the space between the inner wall of the tube 11 and the core 13 becomes narrower, causing the aqueous humor to drain relatively slowly, thereby increasing the anterior chamber formation pressure. Conversely, if the core 13 is thin, the space between the inner wall of the tube 11 and the core 13 becomes wider, causing the aqueous humor to drain relatively rapidly while the anterior chamber formation pressure decreases. Therefore, through the appropriate configuration of the core 13, the anterior chamber formation pressure can be optimized to a predetermined range, for example, a postoperative pressure of approximately 6 to approximately 20 mmHg or any value or partial range in that range, and in this specification, such anterior chamber formation pressure is also referred to as normal intraocular pressure. However, the preferred numerical range of the anterior chamber pressure formed by the eye disease implant device according to this embodiment is not limited thereto.

[0051] The embodiment of the present invention aims to provide a design for an implant device 10 that can maintain the drainage pressure of aqueous humor through the tube 11 (i.e., anterior chamber formation pressure) within a predetermined range by optimizing the numerical ranges of the inner diameter D1 of the tube 11 and the diameter D2 of the core 13, and this will be described in detail later.

[0052] Furthermore, the core 13 may be manipulated by a clinician to adjust the anterior chamber pressure. For example, when the core 13 is retracted into the hollow of the tube 11 and exposed at the posterior end of the tube 11, the clinician can control the core 13 exposed at the posterior end of the tube 11 to regulate the outflow of aqueous humor. In other words, the clinician can use the core 13 to appropriately adjust the intraocular pressure according to the patient's condition.

[0053] In one embodiment, the core 13 can be made of a material that can maintain its shape (e.g., diameter D2) without deforming even when in contact with aqueous humor. Furthermore, the core 13 can be made of a relatively rigid material so that it does not adhere to the inner surface of the tube 11 when a clinician pulls it out of the tube 11. For example, if the tube 11 is made of an elastomer, the core 13 can be made of a material that is relatively harder in comparison.

[0054] In one 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 so that its diameter gradually decreases from the point where it is exposed from the tube 11 or the implant body (not shown) connected to the rear end of the tube 11. Figure 4 is a plan view illustrating various forms of an ophthalmic implant device according to an embodiment.

[0055] Referring to Figures 3 and 4, in one embodiment, the length A of the tube 11 suitable for use in the eye disease implant device 10 is approximately 4 to approximately 10 mm or any value or partial range in between. If the length A of the tube 11 is too long, the aqueous humor may not drain smoothly, and conversely, if the length A of the tube 11 is too short, there is a problem of excessive drainage of aqueous humor, causing hypotension. Furthermore, as will be described later, the length A of the tube 11 affects the values ​​of the inner diameter D1 of the tube 11 and the diameter D2 of the core 13 that can be used in the eye disease implant device 10.

[0056] On the other hand, the ophthalmic implant device 10 can have various forms depending on the position of the part of the tube 11 to which the wing 12 is connected. Figure 4(a) shows an embodiment in which the distance B from the distal end of the tube 11 (i.e., the part inserted into the patient's eyeball) to the wing 12 is approximately 4.4 mm, and Figure 4(b) shows an embodiment in which the distance B from the distal end of the tube 11 to the wing 12 is approximately 2.3 mm. In one embodiment, the distance B from the distal end of the tube 11 to the wing 12 may be approximately 2.3 to approximately 4.4 mm or any numerical value or partial range in between.

[0057] The wing 12, by resting on the sclera during the insertion surgery of the eye disease implant device 10, serves to limit the extent to which the tube 11 is inserted into the eyeball. Therefore, the longer the distance B from the distal end of the tube 11 to the wing 12, the more of the tube 11 will be inserted into the eyeball. However, if the tube 11 is inserted too far into the eyeball, there is a risk of it poking the opposite side of the eyeball. Therefore, the distance B from the distal end of the tube 11 to the wing 12 can be determined based on the surgeon's skill level and the patient's condition, so that the wing 12 is in the appropriate position for the tube 11.

[0058] On the other hand, the width W of the wing 12 in the direction perpendicular to the longitudinal direction A of the tube 11 may be approximately 0.5 to approximately 1.5 mm or any value in between (e.g., approximately 1 mm) or a partial range. Furthermore, the overall length L of the eye disease implant device 10, including the length of the core 13, may be approximately 20 to approximately 40 mm or any value in between (e.g., approximately 30 mm) or a partial range. However, these values ​​are merely examples, and the length, width, thickness, etc., of each component constituting the eye disease implant device 10 can be appropriately set according to the embodiment.

[0059] Optimization of tube length, tube inner diameter, and core diameter

[0060] The eye disease implant device according to this embodiment is inserted into the anterior chamber of the eyeball of a glaucoma patient or the like to drain aqueous humor out of the eye in order to relieve the increased intraocular pressure caused by glaucoma. At this time, the device is differentiated from conventional technology in that the numerical ranges of the inner diameter D1 of the tube 11 and the diameter D2 of the core 13 are designed so that the aqueous humor can be drained at an appropriate pressure.

[0061] For example, if the anterior chamber pressure of the eyeball, measured through the implant device, is low (less than 6.0 mmHg), there is a problem of hypotension caused by excessive aqueous humor drainage. On the other hand, if the anterior chamber pressure exceeds approximately 20 mmHg, there is a problem of failure in intraocular pressure regulation because aqueous humor drainage is insufficient.

[0062] To solve these problems, the present applicant has completed the present invention by deriving numerical ranges for (i) the length A of the tube 11, (ii) the inner diameter D1 of the tube 11, and (iii) the diameter D2 of the core 13, in an implant device in which a tube is inserted into the anterior chamber of the eyeball and a core is drawn into the hollow of the tube, so that the anterior chamber formation pressure can be maintained within the desired range.

[0063] In particular, eye disease implants are highly specialized and specific devices called implants that are inserted into a particular position in the eyeball to treat eye diseases such as glaucoma, and the specifications, such as detailed numerical values ​​of the device, immediately affect the disease and health condition of the patient using the implant device. The applicant has derived combinations of dimensions for each component that result in the anterior chamber pressure of the eyeball being within the desired range (for example, about 6 to about 20 mmHg) by making predictions through experiments and calculations while adjusting (i) the length A of the tube 11, (ii) the inner diameter D1 of the tube 11, and (iii) the diameter D2 of the core 13 using minute numerical values ​​in micrometers (μm).

[0064] Specifically, the inventors set the length A of the tube 11, which is inserted into the anterior chamber of the eyeball, to approximately 4 to approximately 10 mm as part of the configuration of the implant device for eye diseases. By changing the inner diameter D1 of the tube 11 and the diameter D2 of the core 13 for each length of the tube, they derived the upper and lower limits of the numerical range in which the pressure formed in the anterior chamber can be maintained within the desired range.

[0065] To this end, the applicant assumed that the pressure difference across the tube, the amount of fluid flowing per unit time, the inner diameter D1 of the tube 11, the diameter D2 of the core 13, the viscosity (mu) of the fluid, and the length A of the tube 11 all affect intraocular pressure in the form of the Navier-Stokes equation. Based on this, the applicant selected values ​​from various combinations of the inner diameter D1 of the tube 11 and the diameter D2 of the core 13 that would allow the anterior chamber pressure to be maintained within the desired range, and verified some of these experimentally. At this time, the aqueous humor flow rate was assumed to be 2 μl / min, and the viscosity of the aqueous humor was assumed to be 0.0007191 μPa·s.

[0066] As derived from the process described above, the length A of the tube 11 in the eye disease implant device 10 according to one embodiment of the present invention is approximately 4 to approximately 10 mm. Furthermore, the inner diameter D1 of the tube 11 in the eye disease implant device 10 according to one embodiment is approximately 60 to approximately 220 μm. In addition, the diameter D2 of the core 13 in the eye disease implant device 10 according to one embodiment is approximately 1 to approximately 180 μm.

[0067] In other embodiments, (i) the length A of the tube 11, (ii) the inner diameter D1 of the tube 11, and (iii) the diameter D2 of the core 13 may be limited to a subset of these ranges, taking into consideration combinations with other numerical ranges within the available range described above. For example, if the diameter D2 of the core 13 is too small, it may be difficult for the clinician to insert the core 13 into the tube 11 or to withdraw the inserted core 13, so the ophthalmic implant device 10 may be designed so that the diameter D2 of the core 13 is in the range of approximately 20 to approximately 180 μm.

[0068] In other embodiments, (i) the length A of the tube 11, (ii) the inner diameter D1 of the tube 11, and (iii) the diameter D2 of the core 13 can also be determined as a partial range within the aforementioned usable range. In one embodiment of the eye disease implant device 10, the length A of the tube 11 is approximately 5 to approximately 8 mm. In one embodiment of the eye disease implant device 10, the inner diameter D1 of the tube 11 is approximately 60 to approximately 140 μm. Furthermore, in one embodiment of the eye disease implant device 10, the diameter D2 of the core 13 is approximately 1 to approximately 130 μm. In another embodiment, the diameter D2 of the core 13 is 2 to 118 μm.

[0069] Tables 1 to 4 below show the results obtained by the inventors of obtaining the perfusion pressure range through the implant device 10 while varying the inner diameter D1 of the tube 11 and the diameter D2 of the core 13, with the length A of the tube 11 fixed at approximately 5 mm, 6 mm, 7 mm, and 8 mm, respectively. The tube length, inner diameter, and core diameter listed in the tables herein are all approximate values.

[0070] [Table 1]

[0071] [Table 2]

[0072] [Table 3]

[0073] [Table 4]

[0074] Table 5 below summarizes the combinations of values ​​that can be used to achieve normal intraocular pressure based on the results described in Tables 1 to 4 above.

[0075] [Table 5]

[0076] As shown in Table 5, under the condition that the length A of the tube 11 in the eye disease implant device 10 according to one embodiment is about 5 to about 8 mm, the inner diameter D1 of the tube 11 can be about 60 to about 140 μm. Furthermore, the diameter D2 of the core 13 in the eye disease implant device 10 according to one embodiment can be about 1 to about 130 μm. In another embodiment, the diameter D2 of the core 13 can be about 11 to about 130 μm. In another embodiment, the diameter D2 of the core 13 can be about 20 to about 130 μm. In another embodiment, the diameter D2 of the core 13 can be about 20 to about 118 μm.

[0077] Furthermore, the inventors investigated the combination of values ​​that can obtain normal intraocular pressure by increasing the inner diameter D1 of the tube 11 by 10 μm increments within a range of approximately 60 to approximately 200 μm, while changing the length A of the tube 11 and the diameter D2 of the core 13 under the given conditions of the inner diameter D1 of the tube 11, and the results are shown in Table 6 below.

[0078] [Table 6]

[0079] As shown in Table 6, under the condition that the inner diameter D1 of the tube 11 in the eye disease implant device 10 according to one embodiment is about 60 to about 200 μm, the length A of the tube 11 may be about 4 to about 10 mm. Alternatively, it may be determined in a smaller range of about 4 to about 9 mm. Furthermore, the diameter D2 of the core 13 in the eye disease implant device 10 according to one embodiment may be about 20 to about 180 μm.

[0080] On the other hand, as shown in the table above, the inner diameter D1 of the tube 11 and the diameter D2 of the core 13 in the combination of values ​​that can obtain normal intraocular pressure can also be determined to have a predetermined ratio between them.

[0081] For example, in one embodiment of the eye disease implant device 10, the inner diameter D1 of the tube 11 and the diameter D2 of the core 13 form a constant ratio, or the square of the inner diameter D1 of the tube 11. 2 and the square of the diameter of core 13 D2 2 It is possible to design them to form a certain ratio. For example, suppose the ratio of the inner diameter D1 of tube 11 to the diameter D2 of core 13, or their squares, is expressed as 1:a to 1:b. When the length A of tube 11 is approximately 5 mm and the inner diameter D1 of tube 11 is approximately 60 μm, the diameter D2 of core 13 at which normal intraocular pressure was obtained was approximately 11 to approximately 28 μm. In this case, the range of the ratio between the inner diameter D1 of tube 11 and the diameter D2 of core 13 can be approximately 1:0.18 to approximately 1:0.47, or any value or sub-range in between.

[0082] In one embodiment, the ophthalmic implant device can be designed such that a and b, which define the lower and upper limits of the ratio of the diameter D2 of the core 13 to the inner diameter D1 of the tube 11, increase as the inner diameter D1 of the tube 11 increases. That is, when the inner diameter D1 of the tube 11 is small, normal intraocular pressure can be obtained by using a core with a diameter D2 having a ratio of approximately 3:1 or approximately 2:1 to the inner diameter D1 of the tube 11, but as the inner diameter D1 of the tube 11 increases, normal intraocular pressure can be obtained even when using a core with a larger diameter D2, where the ratio to the inner diameter D1 of the tube 11 is approximately 2:1 to approximately 1.75:1.

[0083] Table 7 below summarizes the ratio between the inner diameter D1 of the tube 11 and the diameter D2 of the core 13, based on the ratio between the inner diameter D1 of the tube 11 and the diameter D2 of the core 13 when the length A of the tube 11 is approximately 5 mm, approximately 6 mm, approximately 7 mm, and approximately 8 mm, respectively, in which normal intraocular pressure can be obtained.

[0084] [Table 7]

[0085] In one embodiment, the ratio between the inner diameter D1 of the tube 11 and the diameter D2 of the core 13 may be 1:0.01 to 1:0.9 or any numerical value or partial range therein. Furthermore, in one embodiment, the ratio between the inner diameter D1 of the tube 11 and the diameter D2 of the core 13 may be determined such that the lower and / or upper limits of the ratio increase as the inner diameter D1 of the tube 11 increases, as shown in Table 7.

[0086] In one embodiment, when the inner diameter D1 of the tube 11 is approximately 60 μm, the ratio between the inner diameter D1 of the tube 11 and the diameter D2 of the core 13 may be 1:0.03 to 1:0.47, or any numerical value or partial range within that range.

[0087] In one embodiment, when the inner diameter D1 of the tube 11 is approximately 70 μm, the ratio between the inner diameter D1 of the tube 11 and the diameter D2 of the core 13 may be 1:0.23 to 1:0.57, or any numerical value or partial range within that range.

[0088] In one embodiment, when the inner diameter D1 of the tube 11 is approximately 80 μm, the ratio between the inner diameter D1 of the tube 11 and the diameter D2 of the core 13 may be 1:0.38 to 1:0.65, or any numerical value or partial range within that range.

[0089] In one embodiment, when the inner diameter D1 of the tube 11 is approximately 90 μm, the ratio between the inner diameter D1 of the tube 11 and the diameter D2 of the core 13 may be 1:0.48 to 1:0.70, or any numerical value or partial range within that range.

[0090] In one embodiment, when the inner diameter D1 of the tube 11 is approximately 100 μm, the ratio between the inner diameter D1 of the tube 11 and the diameter D2 of the core 13 may be 1:0.55 to 1:0.74, or any numerical value or partial range within that range.

[0091] In one embodiment, when the inner diameter D1 of the tube 11 is approximately 110 μm, the ratio between the inner diameter D1 of the tube 11 and the diameter D2 of the core 13 may be 1:0.61 to 1:0.77, or any numerical value or partial range within that range.

[0092] In one embodiment, when the inner diameter D1 of the tube 11 is approximately 120 μm, the ratio between the inner diameter D1 of the tube 11 and the diameter D2 of the core 13 may be 1:0.66 to 1:0.80, or any numerical value or partial range within that range.

[0093] In one embodiment, when the inner diameter D1 of the tube 11 is approximately 130 μm, the ratio between the inner diameter D1 of the tube 11 and the diameter D2 of the core 13 may be 1:0.69 to 1:0.82, or any numerical value or partial range within that range.

[0094] In one embodiment, when the inner diameter D1 of the tube 11 is approximately 140 μm, the ratio between the inner diameter D1 of the tube 11 and the diameter D2 of the core 13 may be 1:0.72 to 1:0.84 or any numerical value or partial range between them.

[0095] Furthermore, in an eye disease implant device according to one embodiment, as the inner diameter D1 of the tube 11 increases, the usable core diameter D2 of the core 13 can increase at a predetermined ratio to the increase in the inner diameter D1 of the tube 11. Table 8 below shows the results of the inventors designing the lower and upper limits of the core diameter D2 so that normal intraocular pressure can be obtained when the length A of the tube 11 is approximately 5 mm, approximately 6 mm, approximately 7 mm, and approximately 8 mm, while sequentially increasing the inner diameter D1 of the tube 11 from 60 μm in increments of 10 μm.

[0096] [Table 8]

[0097] As described in Table 8 above, the length A of the tube 11 in the implant device for eye diseases according to one embodiment is approximately 5 to approximately 8 mm, and the inner diameter D1 of the tube 11 is approximately 60 μm to approximately 140 μm. In this case, the ratio between the inner diameter D1 of the tube 11 and the diameter D2 of the core 13 can be designed such that the lower limit and / or upper limit of the diameter D2 of the core 13 increase by approximately 1 to 1.5 times the increase in the inner diameter D1 of the tube 11 for each increase in the inner diameter D1 of the tube 11.

[0098] In other embodiments, the ratio between the inner diameter D1 of tube 11 and the diameter D2 of core 13 can be designed such that for every approximately 10 μm increase in the inner diameter D1 of tube 11, the lower and / or upper limits of the diameter D2 of core 13 increase by an arbitrary number or partial range between approximately 10 and approximately 15 μm. For example, the ratio between the inner diameter D1 of tube 11 and the diameter D2 of core 13 can be designed such that for every approximately 10 μm increase in the inner diameter D1 of tube 11, the lower and / or upper limits of the diameter D2 of core 13 increase by approximately 10 to approximately 14 μm.

[0099] Furthermore, in one embodiment, the ratio between the inner diameter D1 of the ophthalmic implant device and the tube 11 and the diameter D2 of the core 13 can be designed such that the range of increase in the lower and upper limits of the core diameter D2 decreases as the inner diameter D1 of the tube 11 increases, and eventually converges to a specific value (for example, about 10 to 12 μm).

[0100] For the sake of explanation, the above explanation assumes that the inner diameter D1 of tube 11 and the diameter D2 of core 13 are in a constant ratio, but the same principle applies to the square of the inner diameter D1 of tube 11. 2 and the square of the diameter of core 13 D2 2 It is also possible to design the implant device 10 for eye diseases by applying it as a ratio between [the two values].

[0101] Furthermore, in one embodiment, the ophthalmic disease implant device 10 according to the present invention can be designed such that, under the condition that the ratio of the inner diameter D1 of the tube 11 to the diameter D2 of the core 13 satisfies the aforementioned ratio, the longer the length A of the tube 11, the smaller the diameter D2 of the core 13 used (i.e., the lower and / or upper limits of the ratio to which the diameter D2 of the core 13 belongs relative to the inner diameter D1 of the tube 11 decreases). This is because, as the length A of the tube 11 increases, the resistance that aqueous humor experiences in passing through the implant device 10 increases, making it necessary to secure a wider space between the inner wall of the tube 11 and the core 13.

[0102] The above-described description of the present invention is illustrative, and a person with ordinary skill in the art to which the present invention pertains can implement the invention in other specific forms without altering the technical idea or essential features. Therefore, the above-described embodiments should be understood to be illustrative in all respects and not limiting. For example, each component described as a single type may be implemented in a distributed manner, and similarly, components described as distributed may be implemented in a combined manner. The scope of the present invention is defined more by the claims described below than by the detailed description above, and all modified or altered forms derived from the meaning and scope of the claims and the concept of equivalents thereof are included in the scope of the present invention.

Claims

1. An implantable device for treating eye diseases, to be inserted into the eyeball, A tube configured so that one end is inserted into the anterior chamber of the eyeball, with a hollow section formed for drainage of aqueous humor; and, The tube includes a core that is inserted into the hollow of the tube to regulate the outflow of aqueous humor through the tube, The inner diameter of the tube and the diameter of the core are determined such that the pressure formed in the anterior chamber of the eyeball when the tube is inserted into the anterior chamber of the eyeball falls within a predetermined pressure range. An implantable device for eye diseases characterized by the following features.

2. The aforementioned preset pressure range is 6 to 20 mmHg. An implantable device for eye diseases according to claim 1.

3. The length of the tube is 4 to 10 mm. The inner diameter of the tube is 60 to 220 μm. The diameter of the core is 1 to 180 μm. An implantable device for eye diseases according to claim 2.

4. The length of the tube is 5 to 8 mm. The inner diameter of the tube is 60 to 140 μm. The diameter of the core is 1 to 130 μm. An implantable device for eye diseases according to claim 2.

5. One or more of the inner diameter of the tube and the diameter of the core are determined such that the ratio of the core diameter to the inner diameter of the tube falls between a predetermined lower limit and a predetermined upper limit. An implantable device for eye diseases according to claim 1.

6. The ratio of the diameter of the core to the inner diameter of the tube is 1:0.01 to 1:0.

9. An implant device for eye diseases according to claim 5.

7. One or more of the aforementioned preset upper and lower limits are determined to increase as the inner diameter of the tube increases. An implant device for eye diseases according to claim 5.

8. As the inner diameter of the tube increases, the increase in one or more of the preset upper limit and the preset lower limit decreases as the inner diameter of the tube increases. An implantable device for eye diseases according to claim 7.

9. One or more of the aforementioned preset upper and lower limits are determined to decrease as the length of the tube increases. An implant device for eye diseases according to claim 5.

10. One or more of the inner diameter of the tube and the diameter of the core are determined such that the ratio of the square of the core diameter to the square of the inner diameter of the tube falls between a predetermined lower limit and a predetermined upper limit. An implantable device for eye diseases according to claim 1.

11. The tube further includes wings that are connected to the tube so as to be located at a predetermined distance from the distal end of the tube and that extend in a direction different from the longitudinal direction of the tube. An implantable device for eye diseases according to claim 1.

12. A method for maintaining the intraocular pressure of a patient requiring intraocular pressure maintenance, comprising the step of inserting an ophthalmic disease implant device according to any one of claims 1 to 11 into the anterior chamber of the patient's eyeball. A method characterized by the following:

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