Eye disease implant insertion device capable of fixing stent

Abstract

This eye disease implant insertion device for controlling eye pressure comprises: a cannula including an inner space for accommodating at least a portion of an eye disease implant having a stent, and an implant opening through which the eye disease implant is to be inserted thereinto; a handle part which is connected to the cannula and which is to be held by an operator; and a holder which is coupled to the handle part, and which includes an accommodation part for accommodating the stent of the eye disease implant. According to the eye disease implant insertion device, the stent inserted into a tube of the eye disease implant is suitably fixed by being held in the insertion device, and thus problems, during implant surgery, such as the stent falling out of the tube, the implant becoming separated from the insertion device due to the stent, or the visual field of the operator becoming blocked by the stent can be prevented.

Description

Insertion device for an implant for ocular diseases with a fixation of the wick

[0001] The embodiments relate to an insertion device for an implant for ocular disease, and more particularly, to an insertion device for an implant for draining intraocular fluid through a tube-shaped implant inserted into the eye to lower intraocular pressure, wherein a stent inserted into the tube of the implant is fixed to enable easy insertion of the implant into the eye and minimize damage to the eye.

[0002] For patients with glaucoma whose intraocular pressure (IOP) remains uncontrolled despite intraocular pressure-lowering medications, intraocular pressure is lowered by creating a bypass duct to drain the aqueous humor from the anterior chamber of the eye under the conjunctiva. Trabeculectomy, a glaucoma filtration procedure that creates a bypass duct or fistula for aqueous drainage, can sometimes fail to control IOP after surgery due to closure of the bypass duct, which reduces aqueous outflow. When glaucoma filtration surgery is performed again after a failed initial surgery, the incidence of bypass occlusion is higher and the success rate is poor.

[0003] Furthermore, depending on the type of glaucoma, even in the case of so-called refractory glaucoma, such as neovascular glaucoma or secondary glaucoma due to uveitis, bypass occlusion frequently occurs after trabeculectomy, resulting in poor outcomes. In eyes with a history of failed glaucoma filtration surgery or in refractory glaucoma, glaucoma implant surgery is performed to prevent bypass occlusion and increase the success rate of the surgery. To date, glaucoma implants have been used as an alternative to trabeculectomy in various difficult-to-treat glaucoma cases, as they not only effectively lower intraocular pressure but also show a predictable postoperative clinical course depending on the inner diameter of the tube.

[0004] However, conventional glaucoma implants used in glaucoma implant surgery can cause various problems and complications, such as difficulty in surgery due to their relatively large size, postoperative exposure, infection, ocular movement disorders due to their large body, and double vision due to them. Therefore, minimally invasive glaucoma surgery (Micro-Invasive Glaucoma Surgery (MIGS)) using small-sized glaucoma implant tools has been recently developed, making it possible to lower intraocular pressure using glaucoma implants relatively easily, while reducing postoperative side effects due to their large size.

[0005] Surgery using small glaucoma implants offers the advantage of being able to be completed by simply inserting the implant subconjunctivally into the anterior chamber of the eye. However, to ensure adequate drainage of aqueous humor from the eye at the appropriate pressure, the extremely small implant must be properly inserted and secured within the eye.

[0006] However, conventional implant insertion devices for ocular disease insert the implant itself into the insertion tube of the insertion device, insert the insertion device into the eye, and then push the implant out to insert the implant into the eye. This conventional method has the problem of damaging the ocular surface tissue by the outer diameter of the insertion device being larger than the outer diameter of the implant, and if the implant has a structure that protrudes laterally rather than longitudinally (e.g., wings or arms), the inner diameter of the insertion device needs to be enlarged to encompass the entire implant, which results in an increase in the cross-sectional area of ​​the insertion portion of the insertion device.

[0007] Furthermore, the aforementioned ocular implants often fail to perform their drainage function due to fibrosis or other factors after the procedure, necessitating additional procedures. However, conventional implant devices, such as those surrounding the implant, significantly increase the risk of external infection by causing significant damage to the ocular surface tissue. To address this issue, a new implant insertion method and device are needed that minimizes damage to the ocular surface tissue during implant insertion.

[0008] Additionally, implant devices for ocular diseases sometimes include a stent inserted into the tube of the implant to regulate the discharge of aqueous humor. These stents are intended to be removed after a certain period of time (e.g., one to two months) following implantation. However, if the stent is not properly secured during the implantation surgery, the stent may fall out of the implant or detach from the implant insertion device, and the stent may also obstruct the surgeon's field of vision.

[0009] The present invention is intended to improve the problems described above, and provides an implant insertion device for an ocular disease, which forms an implant opening in a cannula of an implant insertion device for an ocular disease, inserts an implant into the eye with a part of the implant inserted and fixed through the implant opening, thereby minimizing the extent of damage to ocular tissue, and prevents discomfort caused by a stent during the transplantation surgery by appropriately fixing a stent inserted into the implant tube.

[0010] An insertion device for an implant for an ophthalmic disease according to one embodiment of the present invention comprises: a cannula having an internal space for accommodating at least a portion of an implant for an ophthalmic disease having a wick, and an implant opening for inserting the implant for an ophthalmic disease; a handle portion configured to be connected to the cannula and for a practitioner to hold; and a holder configured to be coupled to the handle portion and including a receiving portion configured to receive the wick of the implant for an ophthalmic disease.

[0011] In one embodiment, the cannula comprises a first portion comprising one end of the cannula; a second portion connected to the first portion; and a third portion connected to the second portion and comprising an opening for the implant formed on a side thereof.

[0012] An insertion device for an implant for an ophthalmic disease according to one embodiment further includes the implant for an ophthalmic disease. At this time, the body of the implant for an ophthalmic disease is in the form of a tube, one end of the wick is inserted through the body in the form of a tube, the other end of the wick is inserted into the receiving portion of the holder, and at least a portion of the implant for an ophthalmic disease is located inside the second portion.

[0013] The above implant for ocular disease includes a wing portion that protrudes in a direction different from the longitudinal direction.

[0014] An implant insertion device for ocular disease according to one embodiment further includes a cannula assembly configured to be coupled with the cannula and inserted into the holder. The holder includes a body having an inner space into which the cannula assembly is inserted and through which the cannula coupled to the cannula assembly is exposed to the outside of the holder.

[0015] In one embodiment, the handle portion includes a protrusion formed at one end of the handle portion and inserted at least partially into the holder to couple the handle portion and the holder.

[0016] In one embodiment, the protrusion comprises a first protrusion configured to engage the handle portion with the cannula assembly by being inserted into the cannula assembly; and a second protrusion connected to the first protrusion and having a larger diameter than the first protrusion and configured to be inserted into the holder.

[0017] In one embodiment, the holder includes a catch jaw formed on an inner surface of the holder, wherein the catch jaw includes a third catch jaw connected to the second catch jaw and having a larger diameter than the second catch jaw, and including an engaging projection for engaging the catch jaw of the holder.

[0018] In one embodiment, the holder further includes an opening formed at one end of the holder and connected to the inner space of the holder. Furthermore, the receiving portion penetrates the body of the holder and is connected to the opening. Furthermore, the third protrusion includes a fixing protrusion configured to be positioned at one end of the receiving portion when the handle portion is coupled to the holder, thereby forming a receiving space for the wick.

[0019] In one embodiment, the opening includes an insertion groove that protrudes outward in a cross-sectional direction from a portion connected to the receiving portion. In addition, the handle portion is configured to be engaged with the holder such that the fixing protrusion is inserted into the insertion groove to fix the engagement angle of the holder.

[0020] According to an implant insertion device for ocular diseases according to one embodiment of the present invention, by appropriately fixing a stent inserted into an implant tube for ocular diseases by placing it on the insertion device, there is an advantage in that problems such as the stent falling out of the tube during the implant transplantation surgery, the implant being separated from the insertion device due to the stent, or the stent obstructing the surgeon's field of vision can be prevented in advance.

[0021] In addition, according to an implant insertion device for ocular disease according to one embodiment of the present invention, there is an advantage in that the extent of damage to the tissue of the eye can be minimized when the implant for ocular disease is inserted into the anterior chamber of the eye, and the portion of the implant that is not inserted into the anterior chamber is not inserted into the insertion device but hangs outside the insertion device, so there is an advantage in that the internal structure of the insertion device can be kept small.

[0022] Furthermore, since the implant is inserted with only a portion of the implant inserted into the insertion device, the insertion method or structure of the insertion device can be used even when there are laterally protruding structures, such as wings, arms, or sheets, at the rear end of the implant.

[0023] Figures 1 and 2 illustrate an insertion device for an implant for ocular disease according to one embodiment of the present invention.

[0024] Figure 3 shows a cannula (100) according to one embodiment of the present invention.

[0025] FIG. 4 shows cross-sectional views of a first portion (110) of a cannula (100) viewed from the side according to various embodiments of the present invention.

[0026] Figure 5 shows a cross-sectional side view of a cannula according to one embodiment of the present invention.

[0027] FIG. 6 is a diagram for explaining the range of the circumference value of a cannula according to one embodiment of the present invention.

[0028] FIG. 7a is a perspective view of an insertion device for an implant for ocular disease according to one embodiment of the present invention.

[0029] Fig. 7b is a side view of the holder (300) portion of the implant insertion device for ocular disease illustrated in Fig. 7a.

[0030] Figure 8 shows the combination of an implant insertion device and an implant for ocular disease according to one embodiment of the present invention.

[0031] FIGS. 9a to 9c illustrate an implant insertion process of an implant insertion device for ocular disease according to one embodiment of the present invention.

[0032] FIGS. 9d and 9e illustrate examples of implants for ocular diseases according to one embodiment of the present invention.

[0033] FIG. 10a is a horizontal cross-sectional view showing a joint configuration using a cannula joint (150) in an insertion device for an implant for ocular disease according to one embodiment of the present invention.

[0034] FIG. 10b is a vertical cross-sectional view showing a joint configuration using a cannula joint (150) in an insertion device for an implant for ocular disease according to one embodiment of the present invention.

[0035] Fig. 11 shows a handle portion (200) that is coupled to a holder in an implant for ocular disease according to one embodiment of the present invention.

[0036] Figures 12a and 12b illustrate a holder (300) of a portion coupled to a handle portion in an implant for ocular disease according to one embodiment of the present invention.

[0037] Fig. 13 shows the combined form of the handle part (200) and the holder (300) in an implant for ocular disease according to one embodiment of the present invention.

[0038] Fig. 14 shows a cross-sectional view of an implant insertion device for ocular disease according to one embodiment of the present invention in a coupled state.

[0039] The terms used in this specification will be briefly explained, and the present invention will be described in detail.

[0040] The terms used in this invention have been selected from widely used, current terms, taking into account the functions of the invention. However, these terms may vary depending on the intentions of those skilled in the art, precedents, the emergence of new technologies, etc. Furthermore, in certain cases, terms may be arbitrarily selected by the applicant, in which case their meanings will be described in detail in the relevant description of the invention. Therefore, the terms used in this invention should not be defined simply as names, but rather based on their inherent meanings and the overall content of the invention.

[0041] When a part of the specification is said to "include" a component, this does not mean that it excludes other components, but rather that it may include other components, unless otherwise specifically stated. Furthermore, when a part of the specification is said to be "connected" to another part, this includes not only cases where the connection is "directly connected," but also cases where the connection is "with other components interposed between them."

[0042] Below, with reference to the attached drawings, embodiments of the present invention are described in detail so that those skilled in the art can easily implement them. However, the present invention may be implemented in various different forms and is not limited to the embodiments described herein. In the drawings, irrelevant parts have been omitted for clarity of description, and similar reference numerals have been used throughout the specification to indicate similar elements.

[0043] An implant insertion device for ocular diseases according to embodiments of the present invention is a device for inserting a tube-shaped implant into the eye to control the discharge of aqueous humor produced in the anterior chamber located in front of the lens of the eyeball and thereby control intraocular pressure. Such an implant serves to prevent damage to the optic nerve due to increased intraocular pressure caused by ocular diseases. An implant for ocular diseases according to embodiments of the present invention can be used to treat or alleviate symptoms of various ocular diseases that cause or are caused by increased intraocular pressure.

[0044] The ocular disease of this specification may include glaucoma caused by increased intraocular pressure, and such glaucoma may include, but is not limited to, congenital glaucoma, traumatic glaucoma, suspected glaucoma, intraocular hypertension, primary open-angle glaucoma, normal-tension glaucoma, phacocystic glaucoma with pseudoexfoliation of the lens, chronic simple glaucoma, low-tension glaucoma, pigmentary glaucoma, primary angle-closure glaucoma, acute angle-closure glaucoma, chronic angle-closure glaucoma, intermittent angle-closure glaucoma, glaucoma secondary to eye trauma, glaucoma secondary to eye inflammation, glaucoma secondary to medication, neovascular glaucoma, or secondary glaucoma caused by uveitis.

[0045] The implant for ocular disease may be configured in a tube shape applicable to minimally invasive glaucoma surgery (MIGS), such that one end of the tube is inserted into the anterior chamber of the eye, and the other end of the tube is inserted into the conjunctival tissue or Tenon's tissue. In various embodiments of the present invention, the implant may have various shapes, such as a straight shape, a wedge shape, a cross shape, or a cover shape.

[0046] An implant for ocular disease may be inserted after the surgeon has peeled off the conjunctival tissue or Tenon's tissue of the eye, and after insertion, it may be placed within the eye in a manner that covers the conjunctival tissue or Tenon's tissue again. Alternatively, an implant for ocular disease may be partially inserted into the anterior chamber of the eye by being injected into the eye using an insertion device (injector) according to one embodiment of the present invention. Here, the insertion device may be a device that pushes the implant contained therein manually or with a mechanical external force to inject the implant into the eye.

[0047] The present invention will be described in detail with reference to the attached drawings below.

[0048] Figures 1 and 2 illustrate an insertion device for an implant for ophthalmic diseases according to one embodiment of the present invention. Referring to Figure 1, the insertion device for an implant for ophthalmic diseases may include a cannula (100) having an internal space, a handle (200) connected to the cannula (100) and for a practitioner to hold, and a holder (300) having a receiving portion (320) configured to be coupled to the handle (200) and configured to receive a stent of the implant for ophthalmic diseases.

[0049] The handle portion (200) may include a body (210) and a handle groove (220) for easy gripping by the practitioner. In one embodiment, the handle groove (220) may have a shape in which a portion of the surface of the body (210) is sunken inward and one or more protrusions (221) are formed within the sunken area to increase friction with the practitioner's fingers. However, the shape of the handle groove (220) is not limited thereto.

[0050] Although not shown, in one example, the handle portion (200) may further include a gear structure (not shown) for longitudinally moving the cannula (100) or rotating the cannula (100). Such a gear structure may enable delicate control of the cannula by moving or rotating the cannula (100) by a smaller amount than the movement of the operator's hand motion (e.g., forward / backward movement or rotation of the lever). Meanwhile, the linear or rotational movement described above may be simultaneously implemented through a helical gear.

[0051] The holder (300) has a body (310) coupled to a handle (220), and a receiving portion (320) is formed inside the body (310) for inserting a wick of an implant for ocular disease. The receiving portion (320) has a hole or channel formed through the body (310), and is configured so that the wick is inserted and held in the direction from the front end (i.e., the distal end facing the patient) of the holder (300) to the rear end (i.e., the proximal end facing the surgeon), thereby preventing problems such as the wick being pulled out of the implant during implant surgery, the implant being separated from the insertion device due to the wick, or the wick obstructing the surgeon's field of vision.

[0052] FIG. 3 illustrates a cannula (100) according to one embodiment of the present invention. Referring to FIG. 3, the cannula (100) includes a first part (110) including one end (110b) of the cannula, a second part (120) connected to the first part (110), and a third part (130) connected to the second part (120) and including an implant opening (131) formed on a side thereof. For example, the first part refers to a length region including the inclined part when the end of the cannula has an inclined shape. Accordingly, if the end of the cannula has a nearly right-angled surface, the first part can be defined as a minute length equal to the length of the corresponding surface. That is, the end of the cannula has an inclined surface, and the first part can be defined as a distance (l1) on the longitudinal axis of the first end (110a) and the second end (110b) of the inclined surface. Therefore, if the first end (110a) and the second end (110b) exist on the same vertical line, the first part may exist as a line having no volume.

[0053] Additionally, the third portion may be defined as a length formed by the implant opening (131). Additionally, the second portion may be defined as an area between the first portion and the third portion.

[0054] In one example, the length of the second portion may be 1 mm or more. In the insertion device according to one embodiment of the present invention, the implant is inserted intraoperatively with only a part thereof inserted into the cannula. At this time, in order for the implant to be properly fixed to the cannula, a predetermined length needs to be inserted into the cannula and fitted into the cannula. At this time, a part of the implant may be located in the second portion of the cannula. Therefore, the length of the second portion is preferably at least 1 mm. The implant must be inserted into the cannula by about 1 mm so that an appropriate fixing force is generated and the implant may not be pulled out of the cannula by the intraoperative tissue even when the cannula is inserted intraoperatively. The length of the second portion is preferably 1 mm or more, but may be 3 mm or more.

[0055] Meanwhile, when inserting a cannula for implant insertion, if the insertion depth is too deep, there is a risk of damaging the tissues inside the eye by touching the tissues on the opposite side of the inserted part. To prevent such damage, it is preferable that the sum of the lengths of the first and second parts of the cannula have a predetermined length. In one example, the sum of the lengths of the first and second parts may be 10 mm or less. If it is greater than 10 mm, there is a risk of damage to the intraocular tissues during the implant insertion and implant guide detachment processes.

[0056] That is, if the length of the second part is too short, there is a high possibility that the implant inserted into the cannula will fall out of the cannula due to resistance of the ocular tissue when the cannula is inserted into the eye, so it is desirable to have a length of 1 mm or more. If the sum of the lengths of the first part and the second part is longer than 10 mm, the implant inserted into the cannula will not be easily separated from the implant after the cannula is inserted into the eye, and damage to the ocular tissue may occur.

[0057] Additionally, a fourth part (140) connected to the third part (130) and connected to the handle part (200) may be further included. The fourth part (140) may be formed integrally with the handle part (200) described above, or may be fastened as a different member from the handle part (200).

[0058] FIG. 4 illustrates cross-sectional views of a first portion (110) of a cannula (100) as viewed from the side according to various embodiments of the present invention. Referring to FIG. 4, the end of the first portion (110) of the cannula may have, but is not limited to, a curved shape (a), a pointed shape (b), a right-angled cross-section shape (c), a curved shape inclined to one side (d), or a pointed shape inclined to one side (e). FIG. 4 (b) may mean that the first portion (110) has a cone shape or a cylinder whose end is cut diagonally around a point. That is, in one embodiment of the present invention, one end of the first portion (110) of the cannula may have one or more inclined surfaces. In addition, in one example, one end of the cannula may be open. Referring to FIGS. 1 to 3, the end of the first portion (110) of the cannula is illustrated as being open. When one end of the cannula is open, the surgeon can either protrude the implant through this opening to check and remove it, or the surgeon can push the implant back into the cannula. In this case, the protruding implant is pushed to a position at or adjacent to the opening, so the surgeon can advantageously use the opening at one end of the cannula as a means of checking and securing the implant's position within the cannula.

[0059] Referring again to FIG. 3, in the present invention, the first part (110) of the cannula may refer to a section where an inclined surface is formed, the third part (130) may refer to a section where an opening (131) for implantation is formed, and the second part (120) may refer to a section between the first part (120) and the third part (130).

[0060] In FIG. 3, the second portion (120) is illustrated as having a closed side, but in other embodiments, one or more openings may be formed. However, the longitudinal width of one or more openings formed in the second portion (120) may be smaller than the longitudinal width (l3) of the implant opening (131) of the third section (130). That is, the implant opening (131) is formed at a predetermined distance from one end of the cannula.

[0061] That is, if the length of the second part is too short, there is a high possibility that the implant inserted into the cannula will fall out of the cannula due to resistance of the ocular tissue when the cannula is inserted into the eye, so it is desirable to have a length of 1 mm or more. If the sum of the lengths of the first part and the second part is longer than 10 mm, there may be a problem that the implant inserted into the cannula will not be easily separated from the implant after the cannula is inserted into the eye.

[0062] In order to solve this problem, an insertion device according to one embodiment of the present invention defines the sum of the lengths of the first part and the second part to be 10 mm or less, so that when a cannula with a partially inserted implant is inserted into the eye, the implant is maintained in an inserted state, and when the implant is removed from the eye, the implant is easily removed.

[0063] In one example, the implant opening may be defined by a first opening end adjacent to the second portion and a second opening end adjacent to the fourth portion in the longitudinal direction. At this time, the heights of the first opening end and the second opening end may be different from each other. For example, the height of the first opening end may be greater than the height of the second opening end. Hereinafter, the change in height of the longitudinal ends of the implant opening and its function will be described with reference to FIG. 5.

[0064] Fig. 5 illustrates a cross-sectional side view of a cannula according to one embodiment of the present invention. Referring to Fig. 5 (a) and (b), the heights (h1) of the second and fourth portions are the same, and the height (h0) of the third portion may be smaller than the heights (h1) of the second and fourth portions. In other words, the opening for implantation may be formed in a concave shape.

[0065] In addition, as illustrated in (c) of Fig. 5, the height (h1) of the second portion may be greater than the height (h2) of the fourth portion. In this case, the angle formed between the implant inserted into the cannula and the cannula may be smaller than in the case of (a) or (b) of Fig. 5. In addition, since the height of the second portion is greater than that of the fourth portion, there may be an advantage in that the resistance applied to the implant is reduced when the cannula is inserted into the eye while the implant is partially inserted into the cannula. That is, there is an advantage in that the implant is inserted while being more inclined toward the cannula, thereby reducing the insertion area.

[0066] In another embodiment, the height of the fourth portion may be greater than the height of the second portion, as in (d) of FIG. 5, as opposed to (c) of FIG. 5. In this case, the angle between the implant and the cannula may increase. That is, the portion of the implant not inserted into the cannula may rise above the cannula. In this case, the surgeon has the advantage of being able to easily insert the cannula while holding the exposed portion of the implant with forceps. Alternatively, even without holding the implant with forceps, the exposed portion of the implant that is bent may be pushed against the fourth portion to prevent the implant from falling out when the cannula is inserted.

[0067] In another embodiment, as illustrated in (e) of FIG. 5, the second portion may include a protrusion (121) positioned adjacent to the implant opening. This protrusion may have a predetermined height (h5) and may function to reduce the force exerted by the ocular tissues on the exposed portion of the implant when the cannula is inserted into the eye. To this end, the protrusion may have a structure in which the height gradually increases in the direction from the first portion toward the third portion.

[0068] In addition, in another embodiment, referring to (f) to (i) of FIG. 5, the shape of the longitudinal ends of the implant opening (131) can be applied in various ways, such as an inclined plane, an inclined curved surface, and a case where the difference in the degree of inclination is different. In this way, by varying the shape of the longitudinal ends of the implant opening (131), an appropriate shape can be adopted for insertion into a cannula, strengthening of fixation force during intraocular insertion, and ease of separation from within the eye, depending on the shape of the implant.

[0069] FIG. 6 is a diagram illustrating a range of circumference values ​​of a cannula according to one embodiment of the present invention. Referring to FIG. 6, the circumference (R2) of the second direction (i.e., rotational direction with the longitudinal direction as the axis) of the implant opening may be 40% or less of the total circumference (R1) of the third portion. That is, it may be advantageous for 100*R2 / R1 to be less than 40. If the R2 value becomes too large, there is a risk that the portion forming the third portion (130) excluding the implant opening (131) may be destroyed or easily damaged by resistance of intraocular manipulation during cannula insertion. Therefore, in order to prevent such a problem, it is preferable that the circumference value of the implant opening does not exceed 40% of the total circumference.

[0070] In another example, the depth of the implant opening may be 40% of the outer diameter of the cannula. As in the example below, the vertical depth (i.e., the height of the empty portion) of the implant opening may be 40% of the outer diameter of the cannula.

[0071] <Example>

[0072]

[0073] However, this description is merely exemplary, and the above ratio may be applied differently depending on the material of the cannula. The purpose of explaining the aperture ratio in this specification with reference to Fig. 6 is to explain that the area of ​​the implant aperture applied to the cannula should be appropriately adjusted depending on the material and structure of the implant and the material and structure of the cannula.

[0074] FIG. 7a is a perspective view of an insertion device for an ocular disease implant according to an embodiment of the present invention, in which an ocular disease implant (400) is mounted, and FIG. 7b is a side view of the front end of the holder (300) in the insertion device for an ocular disease implant illustrated in FIG. 7a. After preparing an insertion device as illustrated in FIGS. 7a and 7b, the practitioner can insert the ocular disease implant into the insertion device and then proceed with intraocular insertion. Alternatively, the implant may be manufactured and packaged with a portion of the implant inserted into the insertion device and delivered to the practitioner.

[0075] As illustrated, in the present embodiment, the implant (400) for ophthalmic diseases has a tube-shaped body and includes a wick (420) that is partially inserted into the implant (400) to control the amount of aqueous humor discharged from the eye through the implant (400). Meanwhile, another part of the wick (420) is inserted and placed in the receiving portion (320) of the holder (300), so that the proximal end of the wick (420) facing the surgeon can be fixed while the implant (400) is inserted into the patient's eye using an insertion device for the implant for ophthalmic diseases. For example, both ends of the wick (420) can be inserted into the implant (400) and the holder (300), respectively. Meanwhile, one end of the wick (420) inserted into the implant (400) can be exposed through the distal end of the implant (400) that completely passes through the implant (400) and faces the patient's eye.

[0076] Fig. 8 illustrates an insertion device for an implant for ophthalmic diseases according to one embodiment of the present invention. Referring to Fig. 8, the insertion device for an implant for ophthalmic diseases may further include an implant for ophthalmic diseases (300). The implant for ophthalmic diseases may be in the form of a tube, and at least a portion of the implant for ophthalmic diseases may be positioned inside the second portion of the cannula. In order for a portion of the implant to be positioned inside the second portion of the cannula, the implant may be inserted toward one end through the implant opening (131), or may be inserted toward one end and a portion thereof may protrude outward through the implant opening (131).

[0077] In one example, the implant (300) for ocular disease may be in the form of a tube extending in the longitudinal direction and having an inner diameter.

[0078] In one embodiment, the implant may be made of, but is not limited to, one or a combination of one or more of the following materials: silicone, PTFE, polycarbonate, polyurethane, polyethylene, polypropylene, polyimide, poly(methyl methacrylate) (PMMA), poly(styrene-b-isobutylene-b-sytrene), polyethersulfone, gelatin, stainless steel, titanium, and nitinol.

[0079] In one embodiment, the implant may form a curve with a predetermined curvature to prevent damage to the corneal endothelium within the eye. Due to variations in eye size and the level of skill of the implant implanter, the implant may be inserted into the anterior chamber of the eye, potentially causing damage to the cornea. This corneal damage can lead to complications such as corneal insufficiency, potentially requiring a corneal transplant.

[0080] In one embodiment, the implant may be manufactured in a curved shape with a predetermined curvature corresponding to the curvature of the surface of the eye so that the implant can naturally form a curve during the process of being introduced into the front of the eye. Alternatively, even for a straight implant, an implant without a curvature may be used by using a material with sufficient elasticity or flexibility. In addition, although FIG. 8 shows a portion of the implant that is not inserted into the cannula and extends in a direction other than the longitudinal direction, this is merely exemplary, and the implant may extend in only one direction or may have any other arbitrary structure.

[0081] Referring to FIG. 8, only a portion of the ocular disease implant (300) passes through the implant opening and is inserted into the cannula toward the first portion (one end). That is, in the present invention, the ocular disease implant (300) is only partially inserted into the cannula of the insertion device, and is not completely inserted into the inside of the insertion device, or is not inserted into the eye with the insertion device inserted into the inside of the implant. When the ocular disease implant is inserted into the inside of the insertion device and then the intraocular insertion device is inserted and the implant is removed from the insertion device, there is a problem that the range of movement of the insertion device within the eye increases in order to separate the insertion device and the implant, thereby expanding the range of damage to the ocular tissue. In addition, there is a problem that the structure of the insertion device becomes complicated in order to implement a separate mechanism for separating the implant inserted within the insertion device, thereby increasing the manufacturing cost. In addition, the method in which the insertion device is inserted into the inside of the implant is difficult to apply to micro-unit implant components such as MIGS.

[0082] According to one embodiment of the present invention, an implant insertion device for ocular disease has the advantage of 1) limiting the range of damage to the ocular surface tissue to only the cross-sectional thickness of the cannula + a portion of the cross-sectional thickness of the implant during the process of inserting the cannula into the eye by inserting only at least a portion of the implant (300) into the inside of the cannula and then inserting the cannula into the eye, and 2) making it easy to separate the implant and the cannula within the eye.

[0083] FIGS. 9A to 9C illustrate an intraocular implant insertion process of an implant insertion device for ocular disease according to an embodiment of the present invention. Referring to FIG. 9A, the operator can insert a cannula into the eye (1) with a part of the implant (400) inserted through the implant opening as in FIG. 8. The operator can open the conjunctiva around the limbus with surgical scissors or create a scleral flap depending on the state of the sclera. Here, the size of the scleral flap can be a square or trapezoid shape of approximately 3*3mm, and the depth can be approximately ±50% of the sclera thickness, but the present invention is not limited thereto.

[0084] The surgeon can insert the cannula into the eye with the implant inserted (loaded) into the cannula. For example, the surgeon can advance the cannula at least 1 to 2 mm from the limbus. This allows the implant inserted into the anterior chamber to be positioned as far away from the cornea as possible.

[0085] As the cannula (100) is inserted into the eyeball (1), the implant (300) inserted into the cannula is also inserted into the eyeball. At this time, the surface of the eyeball is opened by the cross-sectional area of ​​the non-inserted portion of the implant and the cross-sectional area of ​​the cannula. The implant (400) is made of a very flexible material, and as the cannula is inserted, it receives resistance from the intraocular tissue and adheres to the side of the cannula. Accordingly, there is an advantage in that the area of ​​the opened surface of the eyeball can be minimized.

[0086] In one example, the surgeon needs to position the implant (400) at the required location within the eye (1) and then secure the implant in that location and remove the cannula (100) from the eye.

[0087] To this end, the operator can separate the implant from the cannula by rotating one end of the cannula (100) in a predetermined direction (opposite to the direction in which the implant opening faces). That is, the operator can separate the implant through the implant opening by rotating the cannula (100) in the pitch direction. Alternatively, the operator can facilitate separation of the implant by simultaneously rotating the cannula in the pitch direction and advancing the cannula a predetermined distance forward. For example, it is preferable that the cannula be advanced by about 1 mm, but the present invention is not limited thereto.

[0088] The reason why this separation is possible is that the first and second parts of the cannula are located in the intraocular cavity, and the fourth part is located on the ocular surface or outside, and the fourth part is supported by the ocular surface tissue (the surface tissue tightens the cannula and the implant), and based on this support, when the operator rotates the cannula in the pitch direction, the implant located in the intraocular cavity can be easily separated from the implant opening.

[0089] In another example, when the intraocular implant reaches a predetermined position, the operator can detach the implant from the cannula by rotating the cannula in a roll direction rather than a pitch direction. Referring to FIG. 9C, the implant is detached from the implant opening as the operator rotates the cannula (100) in a roll direction (r). When rotating the cannula in the roll direction, similar to the pitch direction rotation described above, the operator can also perform the roll direction rotation while advancing the cannula by a predetermined distance (approximately 1 mm). This forward movement can make detachment of the implant easier. In addition, since the roll rotation, rather than the pitch rotation, rotates the cannula as it is, it has the advantage of not further expanding the range of the ocular surface tissue that has already been separated compared to the pitch rotation.

[0090] Figures 9d and 9e illustrate examples of an implant (400) for ocular diseases according to one embodiment of the present invention. In one example, the implant for ocular diseases may include a body (410) and wing portions (440) that protrude in a direction different from the longitudinal direction of the body (410). Such wing portions (440) are illustrated in Figures 9a to 9d. The wing portions (440) may be perpendicular to the longitudinal direction of the body or may have a shape inclined at a certain angle. In addition, the wing portions (440) may extend in one direction, but may also have a portion that additionally protrudes in the other direction from the side (see Figure 9e). Such wing portions may function to prevent the implant inserted into the eye from entering the eye.

[0091] For example, an implant (400) for ocular disease may include a wick (420) inside the body. The wick (420) may function to prevent rapid leakage of aqueous humor immediately after the implant is inserted.

[0092] Also, referring to FIG. 9d, the ocular disease implant (400) may further include a matrix that at least partially covers the implant. The matrix (430) may perform the same or similar function as the wing portion described above. That is, it may prevent the implant from entering the eye. Furthermore, the matrix (430) may be loaded with an ocular disease medication. For example, the ocular disease medication may be immersed in the matrix or injected into the space within the matrix and then gradually discharged from the eye.

[0093] In one embodiment, the drugs to be loaded into the matrix 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 inhibitors. For example, depending on the purpose of applying the drug to the matrix, in addition to the antifibrotic agent, an intraocular pressure lowering agent such as prostaglandin, a cephalosporin series such as levofloxacin, moxifloxacin, ceftazidime, or another type of antibiotic, or another different type of drug may be loaded into the matrix. In addition, the matrix may be made of a material that does not immediately decompose in vivo so that the drug can be released over a sufficient period of time, and does not swell excessively to the point of causing a foreign body sensation in the eye due to the drug. In one embodiment, a polymer having a membrane structure capable of forming a storage space for capturing the drug may be used as the matrix.

[0094] In one example, the matrix (430) may be composed of, but is not limited to, any one material 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.

[0095] In one embodiment, the matrix (430) may be a material having a double-layer structure formed by two or more different materials. In this case, the first material constituting the matrix (430) may be a material having mechanical properties for forming the skeleton of the matrix (430) while being biocompatible and not immediately biodegradable within the eye. In addition, the second material, which is another material constituting the matrix (430) together with the first material, may be a material that has hydrophilic properties when bound to the first material and can temporarily absorb a water-soluble drug. When the matrix (430) is formed as a composite of the first and second materials as in the present embodiment, the matrix (430) can be easily impregnated with a drug suitable for the purpose while maintaining the mechanical strength of the matrix (430). For example, the matrix (430) may be formed in the form of a sheet made of a composite of PU and PEG.

[0096] In one embodiment, the first material is 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-based resins such as SU-8, poly(vinylidene fluoride), polyether block amides, 3-[tris(trimethylsiloxy)silyl]propyl methacrylate. It may be any one of, or a combination of one or more of, (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.

[0097] Additionally, in one embodiment, the second material may be, but is not limited to, one or a combination of one or more of poly(ethylene 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, collagen, gelatin, hydroxypropyl cellulose, and chitosan.

[0098] FIG. 10a is a horizontal cross-sectional view showing a coupling form using a cannula coupling body (150) in an insertion device for an implant for ocular disease according to one embodiment of the present invention, and FIG. 10b is a vertical cross-sectional view showing a coupling form using a cannula coupling body (150) in an insertion device for an implant for ocular disease according to one embodiment of the present invention.

[0099] Referring to FIGS. 10a and 10b, the insertion device for an implant for ocular disease according to the present embodiment further includes a cannula assembly (150) configured to be coupled with a cannula (100) and inserted into a holder (300). The cannula assembly (150) includes a hole or channel formed to have a diameter substantially similar to that of the cannula (100), and can be coupled with the cannula (100) by inserting one end of the cannula (100) into the hole or channel.

[0100] In addition, an opening is formed at the rear end of the cannula assembly (150), i.e., the proximal end facing the operator when the operator holds the insertion device for an ocular disease implant, into which a handle part (200) can be fitted. By attaching the rear end part (B) of the cannula assembly (150) coupled with the cannula (100) to the front end (i.e., the distal end facing the patient's eye) part (A) of the handle part (200), and attaching a holder (300) to the handle part (200) so as to cover the front end part (A) of the handle part (200) and the cannula assembly (150), an insertion device for an ocular disease implant according to the present embodiment can be prepared.

[0101] Meanwhile, the inner space of the holder (300) is formed to completely penetrate the body (310) of the holder (300), so that when the holder (300) is coupled to the cannula assembly (150), the end of the cannula (100) coupled to the cannula assembly (150) can be exposed toward the patient's eye through the front end (i.e., the distal end) of the holder (300).

[0102] FIG. 11 is a perspective view showing a joint portion of a handle portion (200) that is coupled to a holder in an insertion device for an implant for ocular disease according to one embodiment, and FIGS. 12a and 12b are perspective views showing a joint portion of a holder (300) that is coupled to a handle portion in an insertion device for an implant for ocular disease according to one embodiment.

[0103] Referring to FIG. 11, the handle portion (200) may include a protrusion (230) to be inserted into the holder (300) for coupling the handle portion (200) and the holder (300). The protrusion (230) is formed at one end of the body (210) of the handle portion (200), and the handle portion (200) may be coupled to the holder (300) in a fitting manner by inserting at least a portion of the protrusion (230) into the inner space of the holder (300). Accordingly, the protrusion (230) may be located at the front end of the handle portion (200) (i.e., the distal end facing the patient's eye).

[0104] In one embodiment, the protrusion (230) of the handle portion (200) may be configured with one or more steps having different diameters. That is, the protrusion (230) may include a first protrusion (231) positioned at the front end of the protrusion (230) and inserted into the cannula assembly (150) to couple the handle portion (200) and the cannula assembly (150), and a second protrusion (232) positioned at the rear end of the first protrusion (231) and connected to the first protrusion (231) and having a larger diameter than the first protrusion (231). The cannula assembly (150) may be coupled to the handle portion (200) by being fitted into the first protrusion (231), and an edge end of the cannula assembly (150) may be positioned on the second protrusion (232).

[0105] The second protrusion (232) has a diameter that can be inserted into the inner space of the holder (300), so that the holder (300) can be coupled to the handle portion (200) by inserting the second protrusion (232) into the holder (300).

[0106] In one embodiment, the protrusion (230) of the handle portion (200) may further include a third protrusion (233) located at the rear end of the second protrusion (232) and having a larger diameter than the second protrusion (232). That is, the third protrusion (233) is formed at one end of the body (210) of the handle portion (200), a second protrusion (232) having a smaller diameter than the third protrusion (233) is formed on the third protrusion (233), and a first protrusion (231) having a smaller diameter than the second protrusion (232) is formed on the second protrusion (232), so that the diameters of the protrusions decrease as they get farther from the body (210), thereby forming a multi-stage protrusion structure.

[0107] Referring to FIGS. 12a and 12b, the holder (300) includes a receiving portion (320) formed in the form of a hole or channel penetrating from the front end to the rear end of the body (310) of the holder (300). However, this is exemplary, and in another embodiment, the receiving portion (320) may be formed only in a portion of the body (310). In addition, the holder (300) has an inner space into which the cannula assembly (150) and the protrusion (230) of the handle portion (200) are inserted and coupled, and an opening (330) connected to the inner space is formed at one end of the body (310) of the holder (300). The holder (300) and the handle portion (200) may be coupled by inserting a portion of the cannula assembly (150) and the handle portion (200) coupled thereto through the opening (330).

[0108] In one embodiment, the cross-section of the opening (330) may have a shape forming a circle, an ellipse, a polygon, or any other arbitrary closed surface, and a portion of the opening (330) may protrude outwardly of the cross-section to form an insertion groove (3310). Meanwhile, the third protrusion (233) of the handle portion (200) described above with reference to FIG. 11 may be formed at a position corresponding to the insertion groove (3310) of the holder (300) and may include a fixing protrusion (2310) protruding outwardly of the cross-section of the third protrusion (233).

[0109] When the holder (300) and the handle part (200) are fixed by inserting the fixing protrusion (2310) of the third protrusion (233) into the insertion groove (3310) of the holder (300), unlike other areas of the two members, the fixing protrusion (230) and the insertion groove (3310) are interlocked, thereby preventing the combination angle of the handle part (200) and the holder (300) from changing (e.g., the holder (300) from rotating). This has the function of preventing the wick of the ocular disease implant placed in the receiving part (320) of the holder (300) from moving by stably fixing the combination angle of the holder (300) with respect to the handle part (200) during the insertion surgery of the ocular disease implant.

[0110] Fig. 13 is a vertical cross-sectional view showing the combined configuration of the handle portion (200) and the holder (300) in an ocular disease implant according to one embodiment of the present invention, and Fig. 14 is a vertical cross-sectional view showing the combined configuration of the ocular disease implant insertion device according to one embodiment of the present invention. Since the horizontal cross-section can be easily understood from the combined configuration through the vertical cross-section, a detailed description thereof will be omitted.

[0111] Referring to FIGS. 13 and 14, the receiving portion (320) of the holder (300) is formed in a form that penetrates the body (310) of the holder (300), and when the holder (300) is coupled to the handle portion (200), the third protrusion (233) of the handle portion (200) is positioned at the end of the receiving portion (320) to block one end of the receiving portion (320) and form a receiving space for the wick. For example, the fixing protrusion (2310) of the third protrusion (233) for preventing rotation of the holder (300) with respect to the handle portion (200) may be coupled to the insertion groove (3310) of the holder (300) and positioned at one end of the receiving portion (320).

[0112] A catch protrusion (3315) protruding toward the inner space of the holder (300) is formed in one area of ​​the inner surface of the holder (300), and a coupling protrusion (2315) is formed in a position corresponding to the catch protrusion (3315) in the protrusion (230) of the handle portion (200). As illustrated in FIG. 14, when the holder (300) is coupled to the handle portion (200), the catch protrusion (3315) and the coupling protrusion (2315) are engaged, thereby preventing the holder (300) from being detached from the handle portion (200) unless a force greater than a certain level is applied.

[0113] Although only cross-sectional views are shown in FIGS. 13 and 14, each of the catch jaw (3315) and the engaging protrusion (2315) may be formed to extend along the edge of each member. For example, the remaining portion of the edge of the third protrusion (233) of the handle portion (200), excluding the fixing protrusion (2310), may correspond to the engaging protrusion (2315) that engages with the catch jaw (2315).

[0114] The foregoing description of the present invention is for illustrative purposes only, and those skilled in the art will readily appreciate that the present invention can be readily modified into other specific forms without altering the technical spirit or essential characteristics of the present invention. Therefore, the embodiments described above should be understood as illustrative in all respects and not restrictive. For example, each component described as a single entity may be implemented in a distributed manner, and similarly, components described as distributed may be implemented in a combined manner.

[0115] The scope of the present invention is indicated by the claims described below rather than the detailed description, and all changes or modifications derived from the meaning and scope of the claims and their equivalent concepts should be interpreted as being included in the scope of the present invention.

[0116] The embodiments relate to an insertion device for an implant for ocular disease, and more particularly, to an insertion device for an implant for draining intraocular fluid through a tube-shaped implant inserted into the eye to lower intraocular pressure, wherein a stent inserted into the tube of the implant is fixed to enable easy insertion of the implant into the eye and minimize damage to the eye.

Claims

1. As an insertion device for an implant for ocular disease, A cannula comprising an internal space for accommodating at least a portion of an ocular disease implant having a core, and an implant opening for inserting the ocular disease implant; A handle configured to be connected to the above cannula and for the operator to grasp; and An insertion device for an ophthalmic implant, comprising a holder configured to be coupled to the handle portion and including a receiving portion configured to receive the wick of the ophthalmic implant.

2. In paragraph 1, The above cannula, A first part comprising one end of the cannula; a second part connected to the first part; and An insertion device for an implant for ocular disease, comprising a third part connected to the second part and including an opening for the implant formed on a side.

3. In paragraph 2, Further including implants for the above eye diseases, The body of the above implant for ocular disease is tube-shaped, One end of the wick is inserted through the tube-shaped body and the other end of the wick is inserted into the receiving portion of the holder, An insertion device for an ophthalmic implant, characterized in that at least a portion of the ophthalmic implant is located inside the second portion.

4. In paragraph 3, The implant for the above eye disease is, An insertion device for an implant for ocular disease, characterized by including a wing portion protruding in a direction different from the longitudinal direction.

5. In paragraph 1, Further comprising a cannula assembly configured to be coupled with the cannula and inserted into the holder, An insertion device for an implant for ocular disease, wherein the holder comprises a body having an inner space into which the cannula assembly is inserted and the cannula coupled to the cannula assembly is exposed to the outside of the holder.

6. In paragraph 5, An insertion device for an implant for ocular disease, wherein the handle portion includes a protrusion formed at one end of the handle portion and inserted at least partially into the holder to connect the handle portion and the holder.

7. In paragraph 6, The above protrusion is, a first protrusion configured to engage the handle portion with the cannula assembly by being inserted into the cannula assembly; and An insertion device for an implant for ocular disease, comprising a second protrusion connected to the first protrusion and having a larger diameter than the first protrusion and configured to be inserted into the holder.

8. In paragraph 7, The holder includes a catch formed on the inner surface of the holder, An insertion device for an implant for ocular disease, wherein the protrusion is connected to the second protrusion and includes a third protrusion having a larger diameter than the second protrusion and including an engaging projection for engaging the engaging jaw of the holder.

9. In paragraph 8, The holder further includes an opening formed at one end of the holder and connected to the inner space of the holder, The above storage portion penetrates the body of the holder and is connected to the opening, An insertion device for an implant for ocular disease, wherein the third protrusion includes a fixing protrusion configured to form a storage space for the wick by being located at one end of the storage portion when the handle portion is combined with the holder.

10. In paragraph 9, The above opening includes an insertion groove that protrudes in the outer direction of the cross-section of the opening at a portion connected to the storage portion, An insertion device for an implant for ocular disease, wherein the handle portion is configured to be coupled with the holder so that the fixing projection is inserted into the insertion groove to fix the coupling angle of the holder.

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