An insertion device for core-fixed implants for eye diseases

Abstract

An insertion device for an ocular implant for regulating intraocular pressure includes a cannula having an internal space for receiving at least a portion of an ocular implant having a stent and an implant opening for inserting the ocular implant; a handle configured to be connected to the cannula and held by a surgeon; and a holder configured to be coupled to the handle and including a receiving portion configured to receive the stent of the ocular implant. The ocular implant insertion device appropriately fixes the stent inserted into the tube of the ocular implant in a manner attached to the insertion device, thereby preventing problems such as the stent coming out of the tube, the implant being separated from the insertion device by the stent, or the stent obscuring the surgeon's field of vision during implant implantation surgery.

Description

[Technical Field]

[0001] The embodiment relates to an implant insertion device for eye diseases, and more particularly to an implant insertion device for lowering intraocular pressure by draining aqueous humor through a tube-shaped implant inserted into the eyeball. The embodiment relates to an implant insertion device that can easily insert the implant into the eyeball and minimize damage to the eyeball by fixing a stent inserted into the implant tube. [Background technology]

[0002] Glaucoma patients whose intraocular pressure does not decrease even with the use of intraocular pressure-lowering medications have their intraocular pressure reduced by creating a bypass to allow aqueous humor to drain from the anterior chamber to the subconjunctival space outside the eye. Trabeculectomy, a type of glaucoma filtration surgery that creates a bypass or fistula for aqueous humor drainage, can fail to control intraocular pressure due to a subsequent closure of the bypass after surgery, which reduces aqueous humor drainage. If a second glaucoma filtration surgery is performed after a failed primary surgery, the frequency of postoperative bypass closure increases, resulting in a lower success rate.

[0003] In addition, depending on the type of glaucoma, bypass closure frequently occurs after trabeculectomy in cases of so-called refractory glaucoma, such as neovascular glaucoma and secondary glaucoma caused by uveitis, resulting in poor outcomes. In cases of eyes with a history of failed glaucoma filtration surgery or refractory glaucoma, glaucoma implant surgery is performed to prevent bypass closure and increase the success rate. Glaucoma implants are currently used as an alternative to trabeculectomy, particularly for some types of glaucoma that are difficult to treat, as they not only effectively reduce intraocular pressure but also show a predictable postoperative clinical course depending on the tube's internal diameter.

[0004] However, existing glaucoma implants used in glaucoma implant surgery can cause various problems and complications, such as surgical difficulty due to their relatively large size, postoperative exposure, infection, impaired eye movement due to their large size, and resulting diplopia. Therefore, Minimally Invasive Glaucoma Surgery (MIGS), which uses small-sized glaucoma implant tools, has recently been developed, making it possible to lower intraocular pressure using relatively easy glaucoma implants while reducing postoperative side effects due to their large size.

[0005] Surgery using a small glaucoma implant has the advantage that the surgery can be completed simply by inserting the small implant under the conjunctiva into the anterior chamber of the eye. However, to ensure that aqueous humor is drained from the eyeball with the appropriate pressure, the very small glaucoma implant must be inserted and fixed in the appropriate position within the eyeball.

[0006] However, conventional implant insertion devices for ocular diseases require the implant itself to be fully inserted into the insertion tube of the insertion device, which is then inserted into the eyeball and the implant is then pushed out to insert the implant into the eyeball. This conventional method has the problem of damaging the ocular surface tissue by the amount of damage due to the outer diameter of the insertion device being larger than the outer diameter of the implant. Furthermore, if the implant has a structure (e.g., wings or arms) that protrudes laterally rather than longitudinally, it is necessary to enlarge the inner diameter of the insertion device to fit the entire implant, which results in a problem of increasing the cross-sectional area of ​​the insertion portion of the insertion device.

[0007] Furthermore, the aforementioned implants for ocular diseases may become unable to perform their drainage function due to fibrosis after surgery, often requiring additional surgery. As described above, conventional insertion devices that surround the implant have a problem of increasing the extent of damage to the ocular surface tissue and increasing the risk of external infection. To solve this problem, an insertion method and device that minimizes the extent of damage to the ocular surface tissue when inserting the implant is needed.

[0008] In addition, some implant devices for ocular diseases have a stent inserted into the tube of the implant device to regulate the outflow of aqueous humor. Such a stent is intended to be removed after a certain period of time (e.g., 1 to 2 months) has passed since implantation. However, if the stent is not properly fixed during implantation surgery, the stent may become dislodged from the implant or the implant may become separated from the insertion device. Furthermore, the stent may obstruct the surgeon's field of vision. Summary of the Invention [Problem to be solved by the invention]

[0009] The present invention aims to solve the above-mentioned problems by providing an implant insertion device for ophthalmic implants, which can minimize the extent of damage to ocular tissue by forming an implant opening in the cannula of the device for inserting an implant for ophthalmic implants, inserting and fixing a part of the implant through the implant opening, and inserting the implant into the eyeball, and can also properly fix a stent inserted into an implant tube, thereby eliminating the inconvenience caused by the stent during the transplant surgery. [Means for solving the problem]

[0010] An insertion device for an implant for ocular disease according to one embodiment of the present invention includes a cannula having an internal space for receiving at least a portion of an implant for ocular disease having a core and an implant opening for inserting the implant for ocular disease; a handle portion configured to be connected to the cannula and for gripping by a practitioner; and a holder configured to be coupled to the handle portion and including a storage portion configured to receive the core of the implant for ocular disease.

[0011] In one embodiment, the cannula includes a first portion including one end of the cannula; a second portion connected to the first portion; and a third portion connected to the second portion and including the implant opening formed in a side thereof.

[0012] In one embodiment, the ocular implant insertion device further includes the ocular implant, wherein the body of the ocular implant is tubular, one end of the core is inserted through the tubular body, the other end of the core is inserted into the receiving portion of the holder, and at least a portion of the ocular implant is located inside the second portion.

[0013] The ophthalmic implant includes wing portions that project in a direction other than the longitudinal direction.

[0014] In one embodiment, the insertion device for an ocular implant further includes a cannula assembly configured to be engaged with the cannula and inserted into the holder, wherein the holder includes a body having an internal space into which the cannula assembly is inserted and into which the cannula coupled to the cannula assembly is exposed to the outside of the holder.

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

[0016] In one embodiment, the protrusions include a first protrusion configured to be inserted into the cannula assembly to couple the handle portion with the cannula assembly; and a second protrusion coupled to the first protrusion, having a larger diameter compared to the first protrusion, and configured to be inserted into the holder.

[0017] In one embodiment, the holder includes a locking jaw formed on an inner surface of the holder, and the protrusion includes a third protrusion connected to the second protrusion, having a larger diameter than the second protrusion, and including an engaging protrusion for engaging the locking 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, the receiving portion penetrates the body of the holder and is connected to the opening, and the third protrusion includes a fixing protrusion configured to be located at one end of the receiving portion and form a receiving space for the lead when the handle portion is coupled to the holder.

[0019] In one embodiment, the opening includes an insertion groove protruding outward from a cross section of the opening at a portion connected to the receiving portion, and the handle is configured to be coupled to the holder with the fixing protrusion inserted into the insertion groove to fix a coupling angle of the holder. [Effects of the Invention]

[0020] According to an embodiment of the present invention, the stent inserted into the ophthalmic implant tube is properly fixed in place by attaching it to the insertion device, which has the advantage of preventing problems such as the stent coming out of the tube during the implant implantation surgery, the implant being separated from the insertion device by the stent, or the stent obscuring the surgeon's field of vision.

[0021] In addition, the implant insertion device for ocular diseases according to one embodiment of the present invention has the advantage of minimizing the extent of damage to ocular tissue when inserting the implant for ocular diseases into the anterior chamber of the eye, and the implant portion that is not inserted into the anterior chamber is not inserted into the insertion device but extends outside the insertion device, thereby maintaining the internal structure of the insertion device small.

[0022] In addition, since the implant is inserted with only a portion of the implant inserted into the insertion device, the insertion method and the structure of the insertion device can be used even when the implant has a protruding structure on the side, such as wings, arms, or a seat, at the rear end of the implant. [Brief explanation of the drawings]

[0023] [Figure 1] 1 illustrates an insertion device for an ocular implant according to one embodiment of the present invention. [Figure 2A] 10 is another view of an ocular implant insertion device according to an embodiment of the present invention. FIG. [Figure 2B] 10 is another view of an ocular implant insertion device according to an embodiment of the present invention. FIG. [Figure 3] 1 shows a cannula 100 according to one embodiment of the present invention. [Figure 4] 1 shows a cross-sectional side view of a first portion 110 of a cannula 100 according to various embodiments of the present invention. [Figure 5] 1 shows a side cross-sectional view of a cannula according to one embodiment of the present invention. [Figure 6] FIG. 10 is a diagram illustrating the range of circumference values ​​of a cannula according to an embodiment of the present invention. [Figure 7A] 1 is a perspective view of an insertion device for an ocular implant according to an embodiment of the present invention; FIG. [Figure 7B] FIG. 7B is a side view of the holder 300 portion of the implant insertion device for ocular diseases shown in FIG. 7A. [Figure 8] 1 illustrates the coupling of an insertion device and an implant for an ocular implant according to one embodiment of the present invention. [Figure 9A] 10A and 10B show a process of inserting an implant into the eye using an insertion device for an implant for eye diseases according to one embodiment of the present invention. [Figure 9B] 10A and 10B show a process of inserting an implant into the eye using an insertion device for an implant for eye diseases according to one embodiment of the present invention. [Figure 9C] 10A and 10B show a process of inserting an implant into the eye using an insertion device for an implant for eye diseases according to one embodiment of the present invention. [Figure 9D] 1 shows an example of an implant for an ocular disease according to one embodiment of the present invention. [Figure 9E] 1 shows an example of an implant for an eye disease according to one embodiment of the present invention. [Figure 10A] 1 is a horizontal cross-sectional view showing a coupling configuration using a cannula assembly 150 in an insertion device for an ocular implant according to one embodiment of the present invention. [Figure 10B] 1 is a vertical cross-sectional view illustrating a coupling configuration using a cannula assembly 150 in an ocular implant insertion device according to one embodiment of the present invention. [Figure 11] 2 shows a handle portion 200 of an implant for eye diseases according to one embodiment of the present invention, which is connected to a holder. [Figure 12A] 1 shows a holder 300 that is connected to a handle portion in an implant for eye diseases according to one embodiment of the present invention. [Figure 12B] 1 shows a holder 300 that is connected to a handle portion in an implant for eye diseases according to one embodiment of the present invention. [Figure 13] FIG. 13 shows a coupling form between the handle portion 200 and the holder 300 in an implant for eye diseases according to one embodiment of the present invention. [Figure 14] 1 shows a cross-sectional view of an ocular implant insertion device in a coupled state according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0024] The terms used in this specification will be briefly explained to more specifically describe the present invention.

[0025] The terms used in the embodiments of the present invention are generally used and widely as much as possible, taking into consideration the functions of the present invention, but may change depending on the intentions of engineers in the field, precedents, the realization of new technology, etc. In addition, in certain cases, the applicant may arbitrarily select terms, and in such cases, the meanings thereof will be described in detail in the description of the invention. Therefore, the terms used in the present invention are not simply the names of terms, but are defined based on the meanings of the terms and the overall content of the present invention.

[0026] Throughout this specification, when a part is said to "comprise" a certain component, this does not mean that it excludes other components, but that it may further include other components, unless otherwise specified. Also, throughout this specification, when a part is said to be "connected" to another part, this includes not only "directly connected" but also "connected with other components in between."

[0027] Hereinafter, with reference to the accompanying drawings, embodiments of the present invention will be described in detail so that those skilled in the art can easily carry out the present invention. However, the present invention may be embodied in various different forms and is not limited to the embodiments described herein. In order to clearly explain the present invention in the drawings, parts that are not relevant to the description are omitted, and similar parts are designated by similar reference numerals throughout the specification.

[0028] An implant insertion device for treating ocular diseases according to an embodiment of the present invention is a device for inserting a tube-shaped implant into the eye to regulate intraocular pressure by controlling the discharge of aqueous humor generated from the anterior chamber located in front of the lens in the eye. Such an implant serves to prevent damage to the optic nerve caused by elevated intraocular pressure due to ocular diseases. An implant for treating ocular diseases according to an embodiment of the present invention can be used to treat or alleviate symptoms of various ocular diseases that cause or result from elevated intraocular pressure.

[0029] The ocular disease referred to in this specification may include glaucoma caused by elevated intraocular pressure, and such glaucoma may include, but is not limited to, congenital glaucoma, traumatic glaucoma, suspected glaucoma, ocular hypertension, primary open-angle glaucoma, normal-tension glaucoma, lenticular cyst 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 ocular trauma, glaucoma secondary to ocular inflammation, drug-induced glaucoma, neovascular glaucoma, or glaucoma secondary to uveitis.

[0030] The implant for ocular diseases may be configured in a tubular form applicable to minimally invasive glaucoma surgery (MIGS), with one end of the tube inserted into the anterior chamber of the eyeball and the other end inserted into the conjunctival tissue or Tenon's tissue. In various embodiments of the present invention, the planar shape of the tubular implant may be various shapes such as a one-piece shape, a wedge shape, a cross shape, a cap shape, etc.

[0031] The implant for ocular diseases can be inserted after the surgeon separates the conjunctival tissue or Tenon's tissue of the eyeball, and then placed inside the eyeball in a manner that covers the conjunctival tissue or Tenon's tissue again. Alternatively, the implant for ocular diseases can be injected into the eyeball using an injector according to one embodiment of the present invention, thereby partially inserting the implant into the anterior chamber of the eyeball. Here, the injection device may be a device that injects the implant into the eyeball by manually or mechanically pushing out the implant housed therein.

[0032] The present invention will now be described in detail with reference to the accompanying drawings.

[0033] 1 and 2 show an insertion device for an implant for ocular disease according to one embodiment of the present invention. Referring to Fig. 1, the insertion device for an implant for ocular disease may include a cannula 100 having an internal space, a handle portion 200 connected to the cannula 100 and for a practitioner to hold, and a holder 300 configured to be coupled to the handle portion 200 and having a receiving portion 320 configured to receive a stent of the implant for ocular disease.

[0034] The handle 200 may include a main body 210 and a handle groove 220 to allow a practitioner to easily grip the handle. In one embodiment, the handle groove 220 may have a shape in which a portion of the surface of the main body 210 is recessed inward, and one or more protrusions 221 are formed inside the recessed area to increase friction with the practitioner's fingers. However, the shape of the handle groove 220 is not limited thereto.

[0035] Although not shown in the drawings, in one example, the handle portion 200 may further include a gear structure (not shown) for moving the cannula 100 in the longitudinal direction or for rotating the cannula 100. Such a gear structure may enable delicate control of the cannula by moving or rotating the cannula 100 with an amount smaller than the amount of movement of the practitioner's hand (e.g., forward / backward movement or rotation of a lever). Meanwhile, the linear or rotational movement described above may also be achieved simultaneously through a gear with a spiral structure.

[0036] The holder 300 has a main body 310 coupled to the handle 220, and a receiving portion 320 for inserting the core of an implant for ocular diseases is formed inside the main body 310. The receiving portion 320 has the form of a hole or channel formed through the main body 310, and is configured so that the core can be inserted and attached from the front end (i.e., the distal end facing the patient) to the rear end (i.e., the proximal end facing the surgeon) of the holder 300. This prevents problems such as the core coming out of the implant during implant surgery, the implant being separated from the insertion device by the core, or the core obstructing the surgeon's field of vision.

[0037] FIG. 3 shows a cannula 100 according to one embodiment of the present invention. Referring to FIG. 3, the cannula 100 includes a first portion 110 including one end 110b of the cannula, a second portion 120 connected to the first portion 110, and a third portion 130 connected to the second portion 120 and including an implant opening 131 formed in a side surface. For example, if the end of the cannula has a sloped shape, the first portion refers to the length of the sloped portion. Therefore, if the end of the cannula has a nearly perpendicular surface, the first portion can be defined as a length as small as the length of the surface. That is, if the end of the cannula has a sloped surface, the first portion can be defined by the distance l1 between the first end 110a and the second end 110b on the sloped surface along the longitudinal axis. Therefore, if the first end 110a and the second end 110b are on the same vertical line, the first portion can also exist as a line with no volume.

[0038] The third portion can also be defined as the length defined by the implant opening 131. The second portion can further be defined as the region between the first portion and the third portion.

[0039] In one example, the length of the second portion may be 1 mm or more. In an insertion device according to one embodiment of the present invention, the implant is inserted into the eye while only a portion of the implant is inserted into the cannula. At this time, in order for the implant to be properly fixed to the cannula, a certain length must be retracted into the cannula and fitted into the cannula. At this time, a portion of the implant can be located in the second portion of the cannula. Therefore, the length of the second portion is preferably at least 1 mm. Since an appropriate fixing force is generated only when the implant is retracted into the cannula by about 1 mm, the implant cannot be pulled out of the cannula by intraocular tissue when the cannula is inserted into the eye. The length of the second portion is preferably 1 mm or more, but may be 3 mm or more.

[0040] On the other hand, when inserting a cannula into the eye for implant insertion, if the insertion depth is too deep, there is a risk of contacting tissue on the opposite side of the insertion portion and damaging intraocular tissue. To prevent this damage, it is preferable that the total length of the first and second portions of the cannula be a predetermined length. In one example, the total length of the first and second portions may be 10 mm or less. If the total length exceeds 10 mm, there is a risk of damaging internal tissue during the process of inserting the implant and separating the implant guide.

[0041] That is, if the length of the second portion is too short, there is a high possibility that the implant inserted inside the cannula will come out of the cannula due to resistance from ocular tissue when the cannula is inserted into the eyeball, so a length of 1 mm or more is preferable. If the total length of the first and second portions is longer than 10 mm, the implant inserted inside the cannula will not be easily separated from the implant after insertion into the eyeball, and there is a possibility that the separation will be difficult and damage to intraocular tissue will occur.

[0042] The device may further include a fourth portion 140 connected to the third portion 130 and to the handle portion 200. The fourth portion 140 may be formed integrally with the handle portion 200, or may be fastened to the handle portion 200 as a separate member.

[0043] FIG. 4 shows a cross-sectional side view of the first portion 110 of the cannula 100 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 (c), a curved shape tilted to one side (d), or a pointed shape tilted to one side (e). FIG. 4(b) may refer to the first portion 110 having a conical or cylindrical shape with the end of the cannula cut at a diagonal line. That is, in one embodiment of the present invention, one end of the first portion 110 of the cannula may have one or more sloped surfaces. Furthermore, 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 shown as open. When the end of the cannula is open, the practitioner can push the implant through the opening to check the implant and then remove it, or the practitioner can push the implant back into the cannula. In this case, the protruding implant is pushed into the opening or adjacent to the opening, which has the advantage that the practitioner can use the opening at one end of the cannula as a means to confirm the position of the implant within the cannula and then secure it in place.

[0044] Referring again to FIG. 3, in the present invention, the first portion 110 of the cannula may refer to the section where the inclined surface is formed, the third portion 130 may refer to the section where the implant opening 131 is formed, and the second portion 120 may refer to the section between the first portion 120 and the third portion 130.

[0045] 3, second portion 120 is shown with 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 second portion 120 may be smaller than the longitudinal width 13 of implant opening 131 in third portion 130. That is, implant opening 131 is formed a predetermined distance away from one end of the cannula.

[0046] That is, if the length of the second part is too short, there is a high possibility that the implant inserted inside the cannula will come out of the cannula due to the resistance of the ocular tissue when the cannula is inserted into the eyeball, so a length of 1 mm or more is preferable. Note that if the total length of the first part and the second part is longer than 10 mm, there is a possibility that the implant inserted inside the cannula will not be easily separated from the implant after the cannula is inserted into the eyeball.

[0047] To solve these problems, the insertion device of one embodiment of the present invention defines the total length of the first and second parts as 10 mm or less, which has the advantage that the implant remains inserted when inserting a cannula with a partially inserted implant into the eyeball, and the implant can be easily separated when separating inside the eyeball.

[0048] In one example, the implant opening may be defined as a first opening end adjacent to the second portion and a second opening end adjacent to the fourth portion in the longitudinal direction. The heights of the first opening end and the second opening end may be different. For example, the height of the first opening end may be greater than the height of the second opening end. The height changes at both longitudinal ends of the implant opening and their functions will be described below with reference to FIG. 5.

[0049] 5A and 5B show side cross-sectional views of a cannula according to one embodiment of the present invention. Referring to FIGS. 5A and 5B, the height h1 of the second and fourth portions may be the same, and the height h0 of the third portion may be smaller than the height h1 of the second and fourth portions. In other words, the opening for the implant may be formed in a concave shape.

[0050] Furthermore, as shown in Figure 5(c), the height h1 of the second portion may be greater than the height h2 of the fourth portion. In this case, the angle that the implant inserted into the cannula makes with the cannula may be smaller than in Figures 5(a) or 5(b). Furthermore, having the height of the second portion greater than the fourth portion has the advantage of reducing the resistance applied to the implant when the cannula is inserted into the eyeball with the implant partially inserted into the cannula. In other words, the implant is inserted at a slight angle toward the cannula, which reduces the insertion area.

[0051] In another embodiment, as shown in FIG. 5(d), the height of the fourth portion may be greater than the height of the second portion, as opposed to FIG. 5(c). In this case, the angle between the implant and the cannula may be greater. That is, the portion of the implant not inserted into the cannula may be positioned so that it protrudes above the cannula. This has the advantage that the surgeon can easily insert the cannula while grasping the exposed portion of the implant with forceps. Alternatively, even without grasping the implant with forceps, the broken portion of the exposed portion of the implant can be pushed into the fourth portion, thereby supporting the fourth portion to prevent the implant from slipping out when inserting the cannula.

[0052] In another embodiment, as shown in Fig. 5(e), the second portion may include a protrusion 121 located adjacent to the implant opening. Such a protrusion may have a predetermined height h5 and may function to reduce the force with which ocular tissue pushes out the exposed portion of the implant when the cannula is inserted into the eye. For this purpose, the protrusion may have a structure in which its height gradually increases from the first portion toward the third portion.

[0053] 5(f) to 5(i), the shapes of both ends of the longitudinal direction of the implant opening 131 can be variously applied, such as an inclined plane, an inclined curved surface, and different degrees of inclination. By varying the shapes of both ends of the longitudinal direction of the implant opening 131 in this way, an appropriate shape can be adopted depending on the shape of the implant to enhance the fixation force when inserting it into a cannula or into the eyeball, and to facilitate separation from the eyeball.

[0054] FIG. 6 is a diagram illustrating the range of circumference values ​​of a cannula according to one embodiment of the present invention. Referring to FIG. 6, the circumference R2 of the implant opening in the second direction (i.e., the direction of rotation about the longitudinal axis) can 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 is 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 the resistance of intraocular manipulation during cannula insertion. Therefore, to prevent such problems, it is preferable that the circumference value of the implant opening does not exceed 40% of the total circumference.

[0055] In another example, the depth of the implant opening may be 40% of the outer diameter of the cannula. As shown below, the vertical depth of the implant opening (i.e., the height of the open portion) may be 40% of the outer diameter of the cannula.

[0056] TIFF2026505875000002.tif55166

[0057] However, these explanations are merely exemplary, and the aforementioned ratios may be applied differently depending on the material of the cannula. The purpose of explaining the ratio of the openings in this specification with reference to Figure 6 is to explain that the area of ​​the implant openings applied to the cannula must be appropriately adjusted depending on the material and structure of the implant and the material and structure of the cannula.

[0058] 7A is a perspective view of an insertion device for an ocular implant according to one embodiment of the present invention, equipped with an ocular implant 400, and FIG. 7B is a side view of the anterior section of a holder 300 in the insertion device for an ocular implant shown in FIG. 7A. After preparing the insertion device as shown in FIGS. 7A and 7B, a practitioner inserts the ocular implant into the insertion device. After that, intraocular insertion can proceed. Alternatively, the insertion device may be manufactured, packaged, and delivered to a practitioner with the implant partially inserted.

[0059] As shown in the drawings, in this embodiment, the implant for ocular disease 400 has a tubular body and includes a core 420, a portion of which is inserted into the implant 400 to regulate the amount of fluid discharged from the eye through the implant 400. Meanwhile, another portion of the core 420 is inserted and attached into the receiving portion 320 of the holder 300, so that the proximal end of the core 420 facing the practitioner is fixed during insertion of the implant 400 into the patient's eye using an ocular implant insertion device. For example, both ends of the core 420 can be inserted into the implant 400 and the holder 300, respectively. Meanwhile, one end of the core 420 inserted into the implant 400 may pass completely through the implant 400 and be exposed through the distal end of the implant 400 facing the patient's eye.

[0060] 8 illustrates an insertion device for an ocular implant according to one embodiment of the present invention. Referring to FIG. 8, the insertion device for an ocular implant may further include an ocular implant 300. The ocular implant is tubular, and at least a portion of the ocular implant may be located inside the second portion of the cannula. To position a portion of the implant inside the second portion of the cannula, the implant may be inserted toward one end through the implant opening 131, or may be inserted at one end and have a portion protrude to the outside through the implant opening 131.

[0061] In one example, the ocular implant 300 can be in the form of a longitudinally extending tube having a predetermined inner diameter.

[0062] In one embodiment, the implant may be made of any one or a combination of one or more of the following materials, including, but not limited to, silicone, PTFE, polycarbonate, polyurethane, polyethylene, polypropylene, polyimide, poly(methyl methacrylate; PMMA), poly(styrene-b-isobutylene-b-sytrene) copolymer, polyethersulfone, gelatin, stainless steel, titanium, and nitinol.

[0063] In one embodiment, the implant may be curved to prevent damage to the corneal endothelium within the eye. Due to differences in the size of the eyeball and the implant injection skill of each patient, the front end of the implant may puncture and damage the cornea in the anterior chamber of the eye as the implant is drawn into the anterior chamber. Corneal damage may lead to complications such as corneal failure, which may require a subsequent corneal transplant.

[0064] In one embodiment, the implant can be manufactured in a curved shape with a predetermined curvature corresponding to the curvature of the ocular surface so that the implant can naturally curve as it is drawn into the anterior chamber of the eye. Alternatively, a one-piece implant can be used without a curvature by using a material with sufficient elasticity or flexibility. Also, while Figure 8 shows a portion of the implant that is not inserted into the cannula extending in a direction other than the longitudinal direction, this is merely an example, and the implant may be formed in a shape that extends in only one direction, or may have any other structure.

[0065] Referring to FIG. 8, only a portion of the ocular 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 implant 300 is only partially inserted into the cannula of the insertion device, and is not completely inserted into the insertion device or inserted into the eyeball with the insertion device inserted into the implant. When the ocular implant is inserted into the insertion device and then inserted into the eyeball and the implant is then removed from the insertion device, the insertion device's range of movement within the eyeball increases to separate the insertion device from the implant, potentially increasing the extent of damage to the eyeball tissue. In addition, the insertion device's structure becomes complex due to the need to implement a separate mechanism for separating the implant from the insertion device, resulting in increased manufacturing costs. Furthermore, the method of inserting the insertion device into the implant is difficult to apply to micro-sized implant components such as MIGS.

[0066] The device for inserting an implant for eye disease according to one embodiment of the present invention inserts at least a portion of the implant 300 into a cannula, and then inserts the cannula into the eyeball. This has the advantages of limiting the extent of damage to the ocular surface tissue to only the cross-sectional thickness of the cannula plus a portion of the cross-sectional thickness of the implant during the process of inserting the cannula into the eyeball, and of 2) easily separating the implant and the cannula inside the eyeball.

[0067] 9A to 9C show an implant insertion process into the eye using an implant insertion device for an ocular disease according to one embodiment of the present invention. Referring to FIG. 9A, the surgeon can insert a cannula into the eyeball 1 with a portion of the implant 400 inserted through the implant opening, as shown in FIG. 8. The surgeon can open the conjunctiva around the limbus with surgical scissors and then create a scleral flap depending on the condition of the sclera. Here, the scleral flap has a rectangular or trapezoidal shape measuring approximately 3 x 3 mm, and its depth can be approximately ±50% of the scleral thickness, although the present invention is not limited thereto.

[0068] With the implant loaded into the cannula, the practitioner can insert the cannula into the eye. For example, the practitioner can push the cannula a minimum of 1 to 2 mm away from the limbus. At this time, the implant inserted into the anterior chamber can be positioned as far away from the cornea as possible.

[0069] When the cannula 100 is inserted into the eyeball 1, the implant 300 inserted in the cannula is also inserted into the eyeball. At this time, the surface of the eyeball expands by the cross-sectional area of ​​the non-inserted part 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 encounters resistance from the intraocular tissue and adheres to the side of the cannula. This has the advantage of minimizing the area of ​​expansion of the eyeball surface.

[0070] In one example, once the implant 400 is in the required position within the eye 1, the practitioner needs to fix the implant in place and remove the cannula 100 from the eye.

[0071] To achieve this, the surgeon can rotate one end of the cannula 100 in a predetermined direction (opposite the direction in which the implant opening faces) to separate the implant from the cannula. That is, the surgeon can rotate the cannula 100 in a pitch direction to separate the implant through the implant opening. Alternatively, the surgeon can easily separate the implant by rotating the cannula in the pitch direction and simultaneously advancing the cannula forward by a predetermined distance. As an example, it is preferable that the cannula be advanced by about 1 mm, but the present invention is not limited to this.

[0072] Such separation is possible because the first and second portions of the cannula are positioned in the chamber of the eye, and the fourth portion is positioned on the surface or outside of the eye, and the fourth portion is supported by the ocular surface tissue (the surface tissue clamps the cannula and implant), and based on this support, when the practitioner rotates the cannula in the pitch direction, the implant positioned in the chamber of the eye can be easily separated from the implant opening.

[0073] In another example, once the intraocular implant has reached a predetermined position, the practitioner can separate 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 shown being separated from the implant opening as the practitioner rotates the cannula 100 in the roll direction r. When rotating the cannula in the roll direction, similar to the pitch direction rotation described above, the practitioner can also perform the roll rotation while advancing the cannula a predetermined distance (approximately 1 mm). This advancement movement can make the implant easier to separate. Furthermore, roll rotation, rather than pitch rotation, involves simply rotating the cannula, which has the advantage of not further expanding the area of ​​the ocular surface tissue that has already been expanded, compared to pitch rotation.

[0074] 9D and 9E illustrate an example of an implant 400 for ocular disease according to one embodiment of the present invention. In one example, the implant for ocular disease may include a main body 410 and wing portions 440 that protrude in a direction different from the longitudinal direction of the main body 410. FIGS. 9A to 9D show such wing portions 440. The wing portions 440 may be perpendicular to the longitudinal direction of the main body or may have a shape that is inclined at a certain angle. Furthermore, the wing portions 440 may extend in one direction and have portions that protrude further in the other direction from the sides (see FIG. 9E). Such wing portions can function to prevent the implant from entering the interior of the eyeball after insertion.

[0075] For example, the implant for ocular diseases 400 may include a core 420 inside the body, which may serve to prevent aqueous humor from leaking out immediately after the implant is inserted.

[0076] 9D, the ocular implant 400 can further include a matrix that at least partially covers the implant. The matrix 430 can perform the same or a similar function as the wing portions described above, i.e., to prevent the implant from entering the eye. The matrix 430 can also be loaded with an ocular medication. For example, the ocular medication can be soaked in the matrix, or can be injected into the matrix's internal space and then gradually expelled from the eye.

[0077] In one embodiment, the drug to be loaded into the matrix may include, but is not limited to, anti-fibrotic agents such as dexamethasone, mitomycin-C (MMC), 5-fluorouracil (5-FU), triamcinolone (TA), anti-VEGF (Vascular Endothelial Growth Factor) agents, and transforming growth factor-beta (TGF) inhibitors. For example, depending on the purpose of applying the drug to the matrix, in addition to the anti-fibrotic agent, an intraocular pressure-lowering agent such as a prostaglandin, a cephalosporin such as levofloxacin, moxifloxacin, or ceftazidime, or other antibiotics, or other different drugs may be loaded into the matrix. Furthermore, the matrix can be made of a material that does not degrade rapidly in vivo to allow for sufficient time for drug release, and does not swell excessively with the drug to cause a foreign body sensation in the eye. In one embodiment, the matrix can be a polymer with a membrane structure that can form a reservoir space for capturing the drug.

[0078] In one embodiment, the matrix 430 may be made of any one of poly(acrylic acid), polyacrylamide, poly(sulfopropyl acrylate), poly(2-hydroxyethyl methacrylate), poly(vinyl alcohol), silicone, polyurethane, collagen, gelatin, hyaluronic acid, poly(aspartic acid), alginate, hydroxypropyl cellulose, hydroxypropyl methylcellulose acetate succinate, and chitosan, or a combination of one or more thereof, but is not limited to these.

[0079] In one embodiment, matrix 430 may be a material having a bilayer structure formed by two or more different materials. In this case, the first material constituting matrix 430 may be a material that is biocompatible and not readily biodegradable within the eye, and thus has the mechanical properties necessary to form the backbone of matrix 430. Furthermore, the second material constituting matrix 430 together with the first material may be a material that is hydrophilic and capable of temporarily absorbing a water-soluble drug while being bonded to the first material. When matrix 430 is formed from a composite of the first and second materials, as in this embodiment, the mechanical strength of matrix 430 can be maintained while the desired drug is easily impregnated into the matrix material. For example, matrix 430 may be formed in the form of a sheet made of a composite of PU and PEG.

[0080] In one embodiment, the first material is 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 resin such as SU-8, poly(vinylidene fluoride), polyether block amides, 3-[tris(trimethylsiloxy)silyl]propyl methacrylate, The material may be, but is not limited to, one of poly(N-vinylpyrrolidone-block-poly(vinyl acetate)), poly(styrene-isobutylene-styrene) copolymer, cellulose acetate, poly((N-vinylpyrrolidone)-block-poly(vinyl acetate)), and ethyl cellulose, or a combination of one or more of these materials.

[0081] Furthermore, in one embodiment, the second material may be any one of polyethylene glycol (PEG), PEG derivatives, polyethylene oxide, polypropylene 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, or a combination of one or more of these materials, but is not limited to this.

[0082] Figure 10A is a horizontal cross-sectional view showing a coupling configuration using cannula assembly 150 in an insertion device for an ocular implant according to one embodiment of the present invention, and Figure 10B is a vertical cross-sectional view showing a coupling configuration using cannula assembly 150 in an insertion device for an ocular implant according to one embodiment of the present invention.

[0083] 10A and 10B, the insertion device for an implant for ocular disease according to this embodiment further includes a cannula assembly 150 configured to be coupled to the cannula 100 and inserted into the holder 300. The cannula assembly 150 includes a hole or channel formed to have a diameter substantially the same as that of the cannula 100, and can be coupled to the cannula 100 in a form in which one end of the cannula 100 is inserted into the hole or channel.

[0084] An opening is formed at the rear end of the cannula assembly 150, i.e., the proximal end facing the practitioner when the practitioner holds the ocular implant insertion device, to which the handle unit 200 can be mated. The ocular implant insertion device according to this embodiment can be prepared by connecting the rear end portion B of the cannula assembly 150, which is connected to the cannula 100, to the front end portion A of the handle unit 200 (i.e., the distal end facing the patient's eyeball), and connecting the holder 300 to the handle unit 200 so as to cover the front end portion A of the handle unit 200 and the cannula assembly 150.

[0085] Meanwhile, the inner space of the holder 300 is configured to completely penetrate the main body 310 of the holder 300, so that when the holder 300 is attached to the cannula assembly 150, the tip of the cannula 100 attached to the cannula assembly 150 can be exposed toward the patient's eyeball through the front end (i.e., distal end) of the holder 300.

[0086] Figure 11 is a perspective view showing the connecting portion of the handle portion 200 that is connected to the holder in an insertion device for an implant for eye disease according to one embodiment, and Figures 12A and 12B are perspective views showing the engaging portion of the holder 300 that is connected to the handle portion in an insertion device for an implant for eye disease according to one embodiment.

[0087] 11, the handle 200 may include a protrusion 230 to be inserted into the holder 300 for coupling the handle 200 and the holder 300. The protrusion 230 is formed on one end of the body 210 of the handle 200, and the handle 200 may be coupled to the holder 300 in a fitting manner in which at least a portion of the protrusion 230 is inserted into the inner space of the holder 300. Therefore, the protrusion 230 may be located at the front end of the handle 200 (i.e., the distal end facing the patient's eyeball).

[0088] In one embodiment, the protrusion 230 of the handle portion 200 may be composed of one or more steps with different diameters. That is, the protrusion 230 may include a first protrusion 231 located at the front end of the protrusion 230 and inserted into the cannula assembly 150 to connect the handle portion 200 and the cannula assembly 150, and a second protrusion 232 connected to the first protrusion 231 and located at the rear end of the first protrusion 231, the second protrusion 232 having a larger diameter than the first protrusion 231. The cannula assembly 150 is connected to the handle portion 200 in a manner that fits onto the first protrusion 231, and an edge of the cannula assembly 150 may be positioned on the second protrusion 232.

[0089] The second protrusion 232 has a diameter large enough to be inserted into the inner space of the holder 300 , so that the holder 300 can be coupled to the handle 200 by inserting the second protrusion 232 into the holder 300 .

[0090] In one embodiment, the protrusion 230 of the handle 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 may be formed at one end of the body 210 of the handle 200, the second protrusion 232 having a smaller diameter than the third protrusion 233 may be formed on the third protrusion 233, and the first protrusion 231 having a smaller diameter than the second protrusion 232 may be formed on the second protrusion 232, and a multi-stage protrusion structure may be formed in which the diameter of the protrusion decreases as it gets farther from the body 210.

[0091] 12A and 12B, holder 300 includes a receiving portion 320 formed in the form of a hole or channel that penetrates from the front end to the rear end of body 310 of holder 300. However, this is merely an example, and in other embodiments, receiving portion 320 may be formed only in a portion of body 310. Holder 300 also has an internal space into which cannula assembly 150 and protrusion 230 of handle 200 are inserted and engaged, and one end of body 310 of holder 300 is formed with opening 330 connected to this internal space. Holder 300 and handle 200 can be coupled together by inserting cannula assembly 150 and a portion of handle 200 coupled thereto through opening 330.

[0092] In one embodiment, the cross section of the opening 330 may have a circular, elliptical, polygonal, or any other closed curved shape, and a region of the opening 330 may protrude outward from the cross section to form an insertion groove 3310. Meanwhile, the third protrusion 233 of the handle 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 outward from the cross section of the third protrusion 233.

[0093] When the holder 300 and the handle part 200 are fixed together by inserting the fixing protrusion 2310 of the third protrusion 233 into the insertion groove 3310 of the holder 300, the fixing protrusion 2310, which protrudes in one direction unlike other areas of both components, engages with the insertion groove 3310, thereby preventing the coupling angle between the handle part 200 and the holder 300 from changing (for example, the holder 300 from rotating). This stably fixes the coupling angle of the holder 300 relative to the handle part 200 during the surgery to insert the implant for ocular disease, thereby preventing the core of the implant for ocular disease attached in the receiving part 320 of the holder 300 from moving.

[0094] Fig. 13 is a vertical cross-sectional view showing the engagement between the handle 200 and the holder 300 of an implant for ocular disease according to one embodiment of the present invention, and Fig. 14 is a vertical cross-sectional view showing the assembled state of an implant insertion device for ocular disease according to one embodiment of the present invention. Since the horizontal cross-section can be easily understood from the assembly form through the vertical cross-section, detailed description thereof will be omitted.

[0095] 13 and 14, receiving portion 320 of holder 300 is formed to penetrate main body 310 of holder 300, and when holder 300 is coupled to handle 200, third protrusion 233 of handle 200 is located at an end of receiving portion 320 to close one end of receiving portion 320 and form a space for receiving the lead. For example, fixing protrusion 2310 of third protrusion 233, which prevents rotation of holder 300 relative to handle 200, may be coupled to insertion groove 3310 of holder 300 and be located at one end of receiving portion 320.

[0096] A locking jaw 3315 protruding toward the interior space of holder 300 is formed in one region of the inner surface of holder 300, and an engaging protrusion 2315 is formed on protrusion 230 of handle 200 at a position corresponding to locking jaw 3315. As shown in Fig. 14, when holder 300 is coupled to handle 200, locking jaw 3315 engages with engaging protrusion 2315, preventing holder 300 from detaching from handle 200 unless a force greater than a certain level is applied.

[0097] 13 and 14, the locking 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 end of the third protrusion 233 of the handle 200, excluding the fixing protrusion 2310, may correspond to the engaging protrusion 2315 that engages with the locking jaw 2315.

[0098] The above description of the present invention is for illustrative purposes only, and those skilled in the art will understand that the present invention may be embodied in other specific forms without changing the technical spirit or essential features of the present invention. Therefore, it should be understood that the above-described embodiments are illustrative in all respects and not limiting. For example, each component described as a single component may be implemented in a distributed form, and components described as distributed may also be implemented in a combined form.

[0099] The scope of the present invention is indicated by the claims below rather than the above detailed description, and all modifications and variations that fall within the meaning and scope of the claims and their equivalents are included within the scope of the present invention. [Industrial Applicability]

[0100] The embodiment relates to an implant insertion device for eye diseases, and more particularly to an implant insertion device for lowering intraocular pressure by draining aqueous humor through a tube-shaped implant inserted into the eyeball. The embodiment relates to an implant insertion device that can easily insert the implant into the eyeball and minimize damage to the eyeball by fixing a stent inserted into the implant tube.

Claims

1. 1. A device for inserting an implant for an eye disease, comprising: a cannula including an interior space for receiving at least a portion of an ocular implant having a core, and an implant opening for inserting the ocular implant; a handle configured to be coupled to the cannula and to be grasped by a practitioner; and a holder configured to be coupled to the handle portion and including a receptacle configured to receive the core of the ocular implant; An implant insertion device for eye diseases.

2. The cannula comprises: a first portion comprising one end of the cannula; a second portion coupled to the first portion; and a third portion connected to the second portion and including the implant opening formed on a side thereof; The device for inserting an implant for an eye disease according to claim 1.

3. The implant for an ocular disease further comprises: the body of the ophthalmic implant is in the form of a tube; One end of the wick is inserted through the tubular body, and the other end of the wick is inserted into the receiving portion of the holder; At least a portion of the ocular implant is located within the second portion. The device for inserting an implant for eye disease according to claim 2.

4. The implant for eye diseases comprises: Includes wings that protrude in directions other than the longitudinal direction The device for inserting an implant for eye disease according to claim 3.

5. a cannula assembly configured to engage the cannula and be inserted into the holder; The holder includes a body having an internal space into which the cannula assembly is inserted and into which the cannula coupled to the cannula assembly is exposed to the outside of the holder. The device for inserting an implant for an eye disease according to claim 1.

6. The handle includes a protrusion formed at one end thereof and adapted to be at least partially inserted into the holder to couple the handle to the holder. The ophthalmic implant insertion device according to claim 5.

7. The protrusion is a first protrusion configured to be inserted into the cannula assembly to couple the handle portion with the cannula assembly; and a second protrusion coupled to the first protrusion, having a larger diameter than the first protrusion, and configured to be inserted into the holder; The device for inserting an implant for eye disease according to claim 6.

8. the holder includes a locking jaw formed on an inner surface of the holder; The protrusions include a third protrusion connected to the second protrusion, having a larger diameter than the second protrusion, and including an engaging protrusion for engaging the locking jaw of the holder. The device for inserting an implant for eye disease according to claim 7.

9. The holder further includes an opening formed at one end of the holder and connected to the inner space of the holder, the receiving portion penetrates the body of the holder and is connected to the opening; The third protrusion includes a fixing protrusion configured to be located at one end of the receiving portion and form a receiving space for the lead when the handle portion is coupled to the holder. The device for inserting an implant for an eye disease according to claim 8.

10. the opening includes an insertion groove protruding outward in a cross-sectional direction of the opening at a portion connected to the accommodating portion, The handle is configured to be coupled with the holder so that the fixing protrusion is inserted into the insertion groove to fix the coupling angle of the holder. The device for inserting an implant for an eye disease according to claim 9.

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