Device for inserting intraocular tubular implants

Abstract

To provide a tubular implant insertion device which inserts a tubular implant housed in the needle of the insertion device into the eyeball while supporting it with a hollow guide pin, and after insertion, retracts the needle and / or guide pin using a handle, thereby enabling the implant with a core body inserted therein to be easily inserted into the eyeball without being separated from the core body. [Solution] A tubular implant insertion device can include a needle having an internal space for accommodating a tubular implant to be inserted into an eyeball, a handle connected to the needle for manipulating the position of the needle, and a guide pin having a hollow space smaller than the outer diameter of the implant, which is positioned to support the implant accommodated in the needle. Use of the tubular implant insertion device has the advantage that the tubular implant is supported by the hollow guide pin and inserted into the eyeball, and after insertion, the needle is retracted using the handle, allowing the implant with a core inserted therein to be easily inserted into the eyeball without being separated from the suture.

Description

[Technical Field]

[0001] The embodiment relates to an insertion device for a tubular implant, and more particularly to an insertion device that can easily insert a tubular implant into the eyeball, such as a tube for draining aqueous humor from the eyeball to reduce intraocular pressure, and minimize damage to the eyeball. [Background technology]

[0002] Glaucoma patients whose intraocular pressure is not controlled even with 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 reduced aqueous humor drainage caused by re-closure of the bypass after surgery. If a second glaucoma filtration surgery is performed after a failed primary surgery, the frequency of post-operative 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 difficulty in surgery due to their relatively large size, post-operative 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 glaucoma implants relatively easily while reducing post-operative 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] Conventional implant insertion devices operate by inserting the implant itself into an insertion tube of the insertion device into the eyeball, and then pushing the implant into the eyeball.

[0007] However, because this conventional method involves pushing the implant itself from the rear to the front, it is difficult to insert the implant into the eyeball if other components, such as a core body, are attached to the implant. Furthermore, because the conventional method requires the entire implant to be inserted into the insertion tube, it is difficult to apply it to implants of various lengths. Furthermore, because conventional insertion devices do not have a means for easily fixing the position of the needle of the insertion device and the implant inserted therein, there is a problem in that the needle of the insertion device is easily retracted unintentionally during insertion into the eyeball, exposing the implant. Summary of the Invention [Problem to be solved by the invention]

[0008] The present invention aims to solve the above-mentioned problems by providing a tubular implant insertion device that inserts a tubular implant housed in a needle of the insertion device into the eyeball while supporting it with a hollow guide pin, and after insertion, retracts the needle and / or guide pin using a handle, so that the implant with a core body inserted therein can be easily inserted into the eyeball without being separated from the core body. [Means for solving the problem]

[0009] A tubular implant insertion device according to one embodiment of the present invention includes a needle having an internal space for accommodating a tubular implant to be inserted into an eyeball; a handle connected to the needle for manipulating the position of the needle; and a guide pin having a hollow space smaller than the outer diameter of the implant, which is arranged to support the implant accommodated within the needle.

[0010] In one embodiment, the implant further includes a core body inserted into the implant, the hollow of the guide pin configured to allow the core body to be inserted into the hollow, and the tubular implant insertion device further includes a support rod disposed at least partially within the guide pin to support the core body.

[0011] The tubular implant insertion device according to one embodiment further includes a handle body connecting the needle and the handle, and a housing configured to accommodate the needle, the handle body, and the guide pin and having an opening extending in one direction, wherein the handle is exposed to the outside of the housing through the opening and configured to be slidable along the opening.

[0012] In one embodiment, the tubular implant insertion device further includes a transport adjuster coupled to the guide pin and one end of the housing to adjust the relative position of the guide pin with respect to the needle.

[0013] In one embodiment, the opening includes a first portion extending in a first direction and a second portion connected to the first portion from a second direction different from the first direction to limit movement of the handle along the first direction, wherein the handle body is disposed within the housing to be movable in the first direction and rotatable in the second direction.

[0014] In one embodiment, the tubular implant insertion device further includes a stopper formed at an end of the housing to limit movement of the housing into the eye.

[0015] In one embodiment, the stopper has a larger diameter than the needle.

[0016] In one embodiment, the needle is coupled to the handle such that the needle is slidably moved along the outer surface of the guide pin by operating the handle, thereby selectively exposing the implant to the outside of the needle.

[0017] In one embodiment, the tubular implant insertion device further includes a piston coupled to the guide pin and disposed within the housing for selective contact with the handle body upon manipulation of the handle.

[0018] In one embodiment, the tubular implant insertion device further includes a pipe coupled to the housing and connected to the piston; and a packing member disposed between the piston and the pipe.

[0019] In one embodiment, the packing member is configured to allow the piston to move relative to the pipe by operating the handle with the handle body in contact with the piston.

[0020] In one embodiment, the tubular implant insertion device further comprises one or more markers formed on the surface of the needle. [Effects of the Invention]

[0021] According to the tubular implant insertion device of one embodiment of the present invention, when inserting a tubular implant into an eyeball, such as an implant for ocular diseases that drains aqueous humor from the anterior chamber of the eyeball, the implant is supported by a hollow guide pin and inserted into the eyeball, and after insertion, the needle and / or guide pin is retracted using a handle, thereby having the advantage that the implant with a core body inserted therein can be easily inserted into the eyeball without being separated from the core body.

[0022] In addition, the tubular implant insertion device according to one embodiment of the present invention can be used with implants of various lengths because the positions of each component, such as the needle, guide pin, pipe, and transport adjustment unit, can be adjusted. Furthermore, the needle position can be fixed by rotating the handle for operating the needle along the opening formed on the surface of the insertion device, which has the advantage of preventing the needle from unintentionally retracting and exposing the implant during the process of inserting the needle into the eyeball. [Brief explanation of the drawings]

[0023] [Figure 1] 1 shows an insertion device for a tubular implant according to one embodiment of the present invention. [Figure 2A] 2 is a cross-sectional view taken along the line AA' of the insertion device for the tubular implant shown in FIG. 1. FIG. [Figure 2B] 2B is a partial cross-sectional view of the insertion device for the tubular implant shown in FIG. 2A. [Figure 3A] 1 shows a state in which an implant is loaded into a tubular implant insertion device according to an embodiment of the present invention. [Figure 3B] 1 is a perspective view showing the placement of an implant and a guide pin in a tubular implant insertion device according to one embodiment of the present invention; FIG. [Figure 3C]1 is a side view showing the arrangement of an implant and a guide pin in a tubular implant insertion device according to one embodiment of the present invention. FIG. [Figure 4A] 10 shows a state in which the guide pin has been advanced in the tubular implant insertion device according to one embodiment of the present invention. [Figure 4B] 4B is a cross-sectional view of the insertion device for the tubular implant shown in FIG. 4A. [Figure 4C] 4C is a partial cross-sectional view of the insertion device for the tubular implant shown in FIG. 4B. [Figure 5A] 1 is a perspective view showing a state in which the handle of the tubular implant insertion device according to one embodiment of the present invention has been rotated to a moving position. FIG. [Figure 5B] 1 is a side view showing a state in which the handle of the tubular implant insertion device according to one embodiment of the present invention has been rotated to a moving position. FIG. [Figure 5C] 5C is a side view of the tubular implant insertion device shown in FIG. 5B with the handle retracted. FIG. [Figure 6A] 1 is a perspective view showing a state in which the needle is retracted in a tubular implant insertion device according to an embodiment of the present invention. FIG. [Figure 6B] 6B is a cross-sectional view of the insertion device for the tubular implant shown in FIG. 6A. [Figure 6C] FIG. 6C is a partial cross-sectional view of the insertion device for the tubular implant shown in FIG. 6B. [Figure 7A] FIG. 10 is a cross-sectional view showing a state in which an implant is loaded onto a tubular implant insertion device according to another embodiment of the present invention. [Figure 7B] 7B is a partial cross-sectional view of the insertion device for the tubular implant shown in FIG. 7A. [Figure 8A] 7B is a cross-sectional view showing the state in which the guide pin is advanced in the tubular implant insertion device shown in FIG. 7A. FIG. [Figure 8B] 8B is a partial cross-sectional view of the insertion device for the tubular implant shown in FIG. 8A. [Figure 9A] 8B is a cross-sectional view of the tubular implant insertion device shown in FIG. 8A with the handle partially retracted. [Figure 9B] 9B is a partial cross-sectional view of the insertion device for the tubular implant shown in FIG. 9A. [Figure 10A] 9B is a cross-sectional view showing the tubular implant insertion device shown in FIG. 9A with the handle further retracted. FIG. [Figure 10B] 10B is a partial cross-sectional view of the insertion device for the tubular implant shown in FIG. 10A. [Figure 11A] 10 shows an example of a stopper for preventing excessive needle insertion in an insertion device for a tubular implant according to an embodiment of the present invention. [Figure 11B] 10 shows another example of a stopper for preventing excessive insertion of a needle in an insertion device for a tubular implant according to an embodiment of the present invention. [Figure 11C] 10 shows yet another example of a stopper for preventing excessive insertion of a needle in an insertion device for a tubular implant according to an 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. The terms used in the embodiments of the present invention are currently commonly used and generally selected as much as possible while taking into consideration the functions of the present invention, but they 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 the terms, but are defined based on the meanings of the terms and the overall content of the present invention. 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." 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.

[0025] A tubular implant insertion device according to an embodiment of the present invention is used to insert a tubular implant into the eye, where a tubular implant refers to an implant that has a generally longitudinally extending tubular shape with a hollow interior, or that includes such a tubular shape as at least one of its components.

[0026] This specification describes the application of an implant insertion device according to embodiments to insert an implant for ocular diseases that regulates intraocular pressure by controlling the discharge of aqueous humor generated from the anterior chamber in front of the lens in the eye. Such an implant serves to prevent damage to the optic nerve due to elevated intraocular pressure caused by an eye disease, and can be used to treat or alleviate symptoms of various eye diseases that cause or result from elevated intraocular pressure. However, the types of implants that can be used with the implant insertion device according to embodiments are not limited thereto.

[0027] The ocular disease referred to herein 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 secondary glaucoma due to uveitis.

[0028] 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.

[0029] 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. Before inserting the implant into the eyeball using the insertion device according to the embodiment, 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 size of the scleral flap is a square or trapezoidal shape with dimensions of approximately 3 mm in width and length, and its depth can be approximately ±50% of the scleral thickness, although the present invention is not limited thereto.

[0030] Next, the implant for an ocular disease can be injected into the eyeball through the insertion device according to the embodiment, thereby inserting a portion of the implant into the anterior chamber of the eyeball. The practitioner can insert the needle into the eyeball with the implant inserted (loaded) into the needle. For example, the practitioner can push the needle a minimum of 1 to 2 mm away from the limbus. At this time, the implant inserted into the anterior chamber of the needle can be positioned as far away from the cornea as possible. Next, the practitioner can use the handle of the insertion device to ensure that only the implant remains in the eyeball, and then withdraw the insertion device.

[0031] The configuration of the tubular implant insertion device according to the embodiment for the above-described operation will be described in detail below with reference to the accompanying drawings.

[0032] FIG. 1 shows an insertion device for a tubular implant according to one embodiment of the present invention.

[0033] 1, an insertion device for a tubular implant can include a needle 10 having an internal space. The insertion device can also include a handle 30 connected to the needle 10 to allow manipulation of the needle's position. The insertion device can also include one or more housings 100, 200 that accommodate the needle 10 and the handle 30 and form an outer surface of the insertion device so that a practitioner can grasp the insertion device. For example, the housings can include, but are not limited to, a first housing 100 that forms the front end of the insertion device and a second housing 200 that is coupled to the first housing 100 and forms the rear end of the insertion device.

[0034] In one embodiment, the handle 30 is exposed to the outside through an opening 110 formed in the surface of the housing 100. The handle 30 can move back and forth in the longitudinal direction of the insertion device along the opening 110. The practitioner can manipulate the position of the needle 10 connected to the handle 30 through the inside of the housing 100 by sliding the handle 30 along the opening 110. The practitioner can insert the needle 10 into the eyeball using the insertion device when the handle 30 is advanced to the front end of the opening 110 (i.e., toward the patient's eye), and then retract the needle 10 connected to the handle 30 by pulling the handle 30 backward along the opening 110 (i.e., toward the practitioner).

[0035] In one embodiment, the tubular implant insertion device includes a transport adjuster 70 coupled to one end of the housing 200. The transport adjuster 70 is a part that the surgeon operates to control the position of a guide pin housed in the housing 100, 200, and has a mechanism for switching the forward and backward movement and / or rotation of the transport adjuster 70 to advance and retreat the guide pin. The relative position of the guide pin with respect to the needle 10 can be adjusted through the transport adjuster 70. Position adjustment using the transport adjuster 70 will be described in detail below.

[0036] The needle 10, which is the part that is inserted into the eye with the implant loaded, can be made of stainless steel or other biocompatible materials. Furthermore, other components of the insertion device, such as the handle 30, the housings 100, 200, and the transfer control part 70, can also be made of stainless steel, or can be made of medical-grade plastics based on polycarbonate, polypropylene, polyethylene, polyvinyl chloride, etc., silicone, silicone rubber, etc.

[0037] Although not shown in the drawings, in one example, the insertion device may further include a gear structure (not shown) for moving the needle 10 in the longitudinal direction of the insertion device. Such a gear structure may allow for delicate needle control by moving or rotating the needle 10 by an amount smaller than the movement of the practitioner's hand (e.g., forward / backward movement or rotation of the handle 30). Furthermore, although not shown in the drawings, one or more markers may be formed on the surface of the needle to allow the practitioner to easily confirm the needle's position.

[0038] 2A is a cross-sectional view taken along the line AA' of the insertion device for the tubular implant shown in FIG. 1, and FIG. 2B is a partial cross-sectional view of the insertion device for the tubular implant shown in FIG. 2A.

[0039] 2A and 2B, the tubular implant insertion device according to this embodiment includes a guide pin 20 that is positioned at least partially within a needle 10 and serves to support the implant to be inserted into the eye. The implant to be inserted into the eye is positioned so that it is located in the space between the front end of the needle 10 and the guide pin 20. For insertion into the eye, the front end of the needle 10 can protrude forward by a predetermined length d1 from the front end of the housing 100 of the insertion device. Here, if the end of the needle 10 has a beveled shape, the length d1 refers to the length including the beveled portion.

[0040] The guide pin 20 includes a hollow interior, but the hollow interior of the guide pin 20 is smaller than the size (i.e., the outer diameter of the tube) of a tubular implant to be inserted into the needle 10, so that the implant cannot be inserted into the guide pin 20. Furthermore, the hollow interior of the guide pin 20 must be larger than the diameter of the core body coupled to the implant so that the core body can be inserted into the guide pin 20. Like the needle 10, the guide pin 20 can be made of stainless steel or other biocompatible materials.

[0041] In this embodiment, the handle 30 is connected to the needle 10 via a handle body 31 housed within the housing 100. Therefore, forward and backward movement or rotation of the handle 30 can be transmitted to the needle 10 via the handle body 31. For example, the handle body 31 has the form of a piston or pipe whose front end is connected to the needle 10, and a knob protruding from the outer surface of the handle body 31 corresponds to the handle 30. Like the handle 30, the handle body 31 can also be made of stainless steel, medical-grade plastic, silicone, etc.

[0042] In one embodiment, the handle body 31 is configured as an at least partially hollow cylinder, and a piston 60 located at the rear of the handle body 31 is configured to be inserted into the handle body 31. When the practitioner operates the handle 30 to retract the handle body 31, the inner surface of the handle body 31 slides along the outer surface of the piston 60, causing the handle body 31 to move rearward, and as a result, the needle 10 connected to the handle body 31 is retracted rearward.

[0043] In one embodiment, the rear end of the piston 60 may be connected to the pipe 40. The pipe 40 supports other components of the insertion device, such as the needle 10, the handle body 31, and the piston 60, and serves to fix their positions so that they do not shake during implant insertion. In one embodiment, the rear end of the pipe 40 is connected to the transport control unit 70, and the pipe 40 and the piston 60 connected thereto may be configured to move forward or backward as the surgeon moves the transport control unit 70 back and forth or rotates it. Furthermore, a support rod 50 capable of supporting the core body of the implant may be located within the pipe 40.

[0044] In one embodiment, the piston 60 and pipe 40 may be made from stainless steel, medical grade plastic, silicone, or the like.

[0045] In one embodiment, a packing member 61 such as an O-ring may be positioned between the pipe 40 and the piston 60. For example, the rear end of the piston 60, which surrounds the outer periphery of the pipe 40, may be closed by a cap 62, and the packing member 61 may be positioned in the space between the cap 62 and the piston 60. The packing member 61 functions to seal the gap between the pipe 40 and the piston 60, but is made of a flexible material that allows the piston 60 to move relative to the pipe 40 when the practitioner applies force to the handle 30 to move the piston 60 backward. The cap 62 serves to prevent the packing member 61 from coming off the piston 60 when the piston 60 moves in this manner.

[0046] The implant insertion process using the tubular implant insertion device configured as above will be described in detail below.

[0047] Fig. 3A shows a state in which an implant is loaded into a tubular implant insertion device according to one embodiment of the present invention, and Figs. 3B and 3C are a perspective view and a side view showing the arrangement of the implant and guide pin in the state shown in Fig. 3A.

[0048] 3A to 3C, the implant 300 to be inserted into the eye may be inserted into the needle 10 through the front end of the needle 10. After preparing an insertion device according to an embodiment, the practitioner can insert the implant 300 into the insertion device and then proceed with the insertion into the eye. Alternatively, the insertion device according to an embodiment may be manufactured, packaged, and delivered to the practitioner with the implant 300 at least partially inserted. The implant 300 includes a hollow interior to drain aqueous humor from the eye.

[0049] Furthermore, a core 400 for adjusting the drainage rate of aqueous humor may be inserted into the hollow of the implant 300. The core 400 may be a non-absorbable surgical suture, for example, but not limited to, nylon or prolene. The core 400 is inserted at least partially into the hollow of the implant 300 to adjust the formation pressure in the anterior chamber. If the core 400 is thick, the space between the inner wall of the implant 300 and the core 400 becomes narrower, so aqueous humor is drained relatively slowly, thereby increasing the formation pressure in the anterior chamber. Conversely, if the core 400 is thin, the space between the inner wall of the implant 300 and the core 400 becomes wider, so aqueous humor is drained relatively quickly and the formation pressure in the anterior chamber decreases.

[0050] Therefore, the core body 400 can be configured with a diameter and material that optimizes the intraanterior chamber formation pressure to a predetermined range, for example, a pressure of approximately 6 to 21 mmHg after surgery. However, the preferred numerical range of the intraanterior chamber formation pressure is not limited thereto. Furthermore, the core body 400 may be configured to be operated by a clinician to adjust the intraanterior chamber formation pressure. For example, when the core body 400 is retracted into the hollow of the implant 300 and exposed at the rear end of the implant 300, the clinician can adjust the amount of aqueous humor drained by adjusting the core body 400 exposed at the rear end of the implant 300.

[0051] In one embodiment, the implant 300 may be made of any one or a combination of one or more of the following materials, including, but not limited to, silicone, polytetrafluoroethylene, polycarbonate, polyurethane, polyethylene, polypropylene, polyimide, poly(methyl methacrylate; PMMA), poly(styrene-b-isobutylene-b-sytrene) copolymer, polyethersulfone, gelatin, stainless steel, titanium, and nitinol.

[0052] In one embodiment, the implant 300 may be curved to prevent damage to the corneal endothelium within the eye. Depending on the size of the eyeball and the implant injection skill level of each patient, the front end of the implant may puncture and damage the cornea within 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. For example, the implant may be curved to have a predetermined curvature corresponding to the curvature of the ocular surface, so that it naturally curves as it is drawn into the anterior chamber of the eye. Alternatively, a one-piece implant without a curvature may be used by using a material with sufficient elasticity or flexibility.

[0053] The implant 300 housed in the needle 10 is located between the front end of the needle 10 and the guide pin 20. The guide pin 20 supports the implant 300 and houses the core body 400 connected to the implant 300 in the hollow of the guide pin 20. For this purpose, the inner diameter R of the guide pin 20 is 21The core body 400 is large enough to be inserted into the guide pin 20, but the inner diameter R of the guide pin 20 is large enough to prevent the implant 300 from being pushed into the guide pin 20. 21 is the outer diameter R of the implant 300 12 For example, the inner diameter R of the guide pin 20 21 is the inner diameter R of implant 300 11 and outer diameter R 12 The outer diameter R of the guide pin 20 may be, but is not limited to, 22 is the outer diameter of the tube R 12 It may be equal to or greater than, but is not limited to.

[0054] That is, the insertion device according to the embodiment is configured to support the tubular implant 300 with the guide pin 20, which is another tubular member. By supporting the implant 300 with the guide pin 20 having a hollow, even if the core body 400 is connected inside the implant 300, there is no need to drive the core body 400 into the needle 10 in a bent or bundled state, and there is an advantage that the implant 300 can be placed in the insertion device with the core body 400 inserted inside the guide pin 20.

[0055] Meanwhile, the insertion device according to the embodiment is configured so that the positions of the guide pin 20 and the support rod 50 connected thereto can be adjusted by operating the transport adjustment unit 70. The implant 300 to be inserted into the eyeball is disposed between the front end of the needle 10 and the guide pin 20, and therefore, in order to use implants 300 of various lengths, the position of the guide pin 20 can be adjusted according to the length of the implant 300. At the same time, the position of the support rod 50 that supports the core body 400 connected to the implant 300 is also adjusted by operating the transport adjustment unit 70, and therefore, the position of the support rod 50 can be appropriately adjusted according to the length of the core body 400 connected to the implant 300.

[0056] Once the implant 300 is placed in the insertion device, the practitioner can move the insertion device so that the end of the implant 300 is positioned at the desired insertion point within the eye. Furthermore, after the practitioner inserts the needle 10 into the part of the eye where the implant 300 should be positioned, the practitioner can operate the transport adjuster 70 to confirm the position of the implant 300. Operation of the transport adjuster 70 causes the guide pin 20 to advance, pushing the implant 300 into the anterior chamber.

[0057] FIG. 4A shows a state in which a guide pin has been advanced in a tubular implant insertion device according to one embodiment of the present invention, and FIGS. 4B and 4C are cross-sectional views of the tubular implant insertion device shown in FIG. 4A.

[0058] 4A to 4C, the surgeon can advance the guide pin 20 using the transport adjuster 70 while placing the implant 300 in the needle 10, as described above with reference to FIG. 3A. More specifically, the transport adjuster 70 is connected to the pipe 40, which is connected to the piston 60, which is connected to the guide pin 20. When the transport adjuster 70 is advanced until it contacts the housing 200, the pipe 40, the piston 60, and the guide pin 20 connected to the transport adjuster 70 advance accordingly. If the transport adjuster 70 has a rotation mechanism, the insertion device may include a rotation gear (not shown) for converting the rotation of the transport adjuster 70 into forward and backward movement of the pipe 40.

[0059] The rear of the implant 300 is supported by the guide pin 20, and the implant 300 is configured not to be pushed into the guide pin 20. Therefore, when the guide pin 20 is advanced by the operator, only the implant 300 advances while the position of the needle 10 remains fixed. Using this, the operator can operate the transport adjuster 70 to the extent that the implant 300 is slightly exposed outside the front end of the needle 10, allowing the operator to confirm the position of the implant 300 inserted into the needle 10.

[0060] In one embodiment, the support rod 50, located behind the guide pin 20, can be moved forward or backward by the operator operating the transport adjuster 70, similar to the pipe 40. Furthermore, the support rod 50 is at least partially inserted within the guide pin 20 and serves to support the core body 400 coupled to the implant 300. When the operator operates the transport adjuster 70 to push the guide pin 20 and advance the implant 300, the support rod 50 simultaneously pushes and advances the core body 400, preventing the implant 300 from advancing alone while the core body 400 remains inside the insertion device. The support rod 50 can be made of stainless steel or other biocompatible materials.

[0061] Once the implant 300 is inserted into the eye at the insertion position, the practitioner can use the handle 30 of the insertion device to retract the needle 10 so that only the implant 300 remains in the eye.

[0062] 5A to 5C show the process in which the practitioner retracts the needle 10 using the handle 30 once the implant 300 has been placed in the insertion position.

[0063] 5A and 5B, the opening 110 of the housing 100 through which the handle 30 slides can include a portion bent in a different direction from the other portions to restrict movement of the handle 30. That is, the opening 110 generally extends in the longitudinal direction of the insertion device and includes a groove 111 that extends in a different direction from the longitudinal direction of the insertion device. Alternatively, if the portion of the opening 110 extending in the longitudinal direction is referred to as a first portion, the portion of the opening 110 extending in the different direction can also be referred to as a second portion. For example, the opening 110 having a first portion and a second portion can have a shape such as "┐", "└", "┤", or "├".

[0064] The first portion of the opening 110 corresponds to a movable position where the handle 30 can be moved, and the second portion corresponds to a fixed position where the handle 30 cannot be moved. The practitioner rotates the handle 30 to the fixed position to prevent the handle 30 from moving back and forth, and inserts the needle 10 into the eye. Once the needle 10 is inserted to the desired position, the practitioner can rotate the handle 30 to the movable position as shown in Figures 5A and 5B. Next, the practitioner can retract the needle 10 along the longitudinal direction of the insertion device by sliding the handle 30 backward as shown in Figure 5C.

[0065] Conversely, if the practitioner wishes to fix the position of the needle 10, the practitioner can advance the handle 30 to the end of the opening 110 and then rotate the handle 30 so that it is positioned within the groove 111. When the handle 30 is positioned within the groove 111, the forward and backward movement of the handle 30 is restricted, preventing the needle 10 from shaking.

[0066] Conventional implant insertion devices have a problem in that a lot of force is required to retract the needle after inserting it into the eyeball, which can cause strain on the patient's eyeball. However, the implant insertion device according to the embodiment can easily adjust the position of the needle 10 by sliding the handle 30, and the position of the handle 30 can be fixed, so that the needle 10 can be prevented from unintentionally retracting and exposing the implant 300 during the process of inserting the needle 10 into the eyeball.

[0067] FIG. 6A shows a state in which the needle is retracted in a tubular implant insertion device according to one embodiment of the present invention, and FIGS. 6B and 6C show cross-sectional views of the tubular implant insertion device shown in FIG. 6A.

[0068] 6A to 6C, with the implant 300 inserted at the intraocular insertion position, the needle 10 can be retracted into the housing 100 by sliding the handle 30 along the opening 110. As a result, as shown in Fig. 6C, only the implant 300 remains outside the insertion device. In this state, the practitioner can place the implant 300 at the desired position in the eye by withdrawing the insertion device. The core body 400 inserted into the guide pin 20 of the insertion device comes out of the guide pin 20 while the practitioner withdraws the insertion device, and is positioned inside the eye together with the implant 300.

[0069] The tubular implant insertion device according to the embodiment of the present invention described above is configured to retract the needle during implant insertion, leaving the implant in the eye. However, other embodiments of the tubular implant insertion device may be configured to retract both the needle and the guide pin during implant insertion, as described in more detail below.

[0070] FIG. 7A shows a state in which an implant is loaded into a tubular implant insertion device according to another embodiment of the present invention, and FIG. 7B shows a partial cross-sectional view of the tubular implant insertion device shown in FIG. 7A.

[0071] 7A and 7B, an implant 300 to be inserted into the eyeball can be inserted into the needle 10 through the front end of the needle 10. The implant 300 inserted into the needle 10 is disposed between the front end of the needle 10 and the guide pin 20. This is the same as the arrangement described above with reference to FIGS. 3A to 3C, so a detailed description will be omitted to avoid duplication. However, in the case of an insertion device configured so that the needle 10 and the guide pin 20 retract together, the length d2 of the needle protruding from the front end of the housing 100 of the insertion device may be greater than the length d1 of the needle 10 protruding from the front end of the insertion device housing 100 in the case of an insertion device configured so that only the needle 10 retracts.

[0072] After the implant 300 is placed in the insertion device, the guide pin 20 and support rod 50 can be advanced by rotating the transport adjuster 70, thereby moving the implant 300 forward. FIG. 8A shows the tubular implant insertion device shown in FIG. 7A with the guide pin advanced, and FIG. 8B shows a partial cross-sectional view of the tubular implant insertion device shown in FIG. 8A. As described above with reference to FIGS. 4A to 4C, the positions of the guide pin 20 and support rod 50 can be adjusted by operating the transport adjuster 70 to use implants 300 and core bodies 400 of various lengths. Furthermore, after the needle 10 is inserted into the eye, the guide pin 20 and support rod 50 can be advanced to the extent that the implant 300 is slightly exposed outside the needle 10 in order to confirm the position of the implant 300.

[0073] Once the implant 300 has been inserted into the intraocular insertion position, the surgeon can use the handle 30 to retract the needle 10 and the guide pin 20, leaving only the implant 300 in the eye. At this time, the process of retracting the needle 10 and the guide pin 20 may include a step of partially retracting the handle 30 to retract the needle 10, and a step of further retracting the handle 30 to retract both the needle 10 and the guide pin 20.

[0074] 9A shows the tubular implant insertion device shown in FIG. 8A with the handle partially retracted, and FIG. 9B shows a partial cross-sectional view of the tubular implant insertion device shown in FIG. 9A.

[0075] 9A and 9B, when the handle 30 is slid, the handle body 31 moves rearward, and the needle 10 connected to the handle body 31 moves backward. At this time, the piston 60 is located behind the handle body 31, and since the piston 60 is arranged so that it can be inserted at least partially into the handle body 31, the handle 30 can be moved rearward until the inner surface of the handle body 31 comes into contact with the piston 60. In this state, when the practitioner applies further force to the handle 30, both the handle body 31 and the piston 60 move rearward, as shown in FIGS. 10A and 10B.

[0076] FIG. 10A shows the tubular implant insertion device shown in FIG. 9A with the handle further retracted, and FIG. 10B shows a partial cross-sectional view of the tubular implant insertion device shown in FIG. 10A.

[0077] 10A and 10B, when the practitioner applies further force backward on the handle 30 while the inner surface of the handle body 31 is in contact with the piston 60, a packing member 61, such as an O-ring, disposed between the piston 60 and the pipe 40 slides, causing the piston 60 to slide along the outer surface of the pipe 40. Therefore, the more force the practitioner applies to the handle 30, the further the handle body 31 and the piston 60 can move backward simultaneously. Because the guide pin 20 is connected to the piston 60, when the needle 10 moves backward due to the movement of the handle body 31, the guide pin 20 connected to the piston 60 also moves backward by the same distance.

[0078] As a result, all or most of the needle 10 and guide pin 20 are housed inside the housing 100, leaving only the implant 300 outside the insertion device. In this state, the surgeon can place the implant 300 at the desired position in the eyeball by withdrawing the insertion device in the opposite direction from when it was inserted. The core body 400 inserted into the guide pin 20 of the insertion device comes out of the guide pin 20 while the surgeon is withdrawing the insertion device, and is positioned inside the eyeball together with the implant 300.

[0079] The insertion device for a tubular implant according to an embodiment may include a stopper for preventing the needle from being inserted too far into the eye. Figures 11A to 11C show a stopper for preventing excessive needle insertion in an insertion device for a tubular implant according to an embodiment of the present invention.

[0080] 11A to 11C, the insertion device according to the embodiment is located at the front end of the housing 100 and may include stoppers 120-122, which are portions having a larger diameter than the needle 10. The stoppers 120-122 are configured to catch on the sclera of the eyeball when the surgeon inserts the implant, making it easier for the surgeon to adjust the insertion position of the implant and preventing the needle 10 of the insertion device from being inserted too deeply into the eyeball and causing damage to the eyeball.

[0081] 11A, the stopper 120 can also refer to the end of the housing 100 itself that is engaged with the needle 10. In this case, the diameter of the end of the housing 100 that serves as the stopper 120 must be at least larger than the diameter of the needle 10, and the front end of the needle 10 must protrude a predetermined length from the stopper 120 to enable insertion of the implant.

[0082] 11B, stopper 121 may be a separate member coupled to or formed on the end of housing 100 and having a larger diameter than the end of housing 100 so as to hook onto the sclera. Furthermore, referring to FIG. 11C, stopper 121 may have a curved shape with a predetermined curvature corresponding to the curvature of the surface of the eyeball to prevent damage to the eyeball. However, the shapes of stoppers 120-122 shown in the drawings herein are merely exemplary, and in embodiments, stoppers may have any shape or structure that can contact the sclera to prevent the needle from being inserted too far into the eyeball.

[0083] 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 are 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. 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]

[0084] The present invention provides an insertion device for a tubular implant, and more specifically, an insertion device that can easily insert a tubular implant, such as a tube for draining aqueous humor from the eyeball to reduce intraocular pressure, into the eyeball and minimize damage to the eyeball. Therefore, the present invention has extremely high industrial applicability.

Claims

1. a needle having an internal space for receiving a tubular implant to be inserted into the eye; a handle coupled to the needle for manipulating the position of the needle; and a guide pin arranged to support the implant housed in the needle and having a hollow having a size smaller than the outer diameter of the implant; 1. A device for inserting a tubular implant, comprising:

2. the implant further comprises a core inserted within the implant; The hollow of the guide pin is configured so that the core body is inserted into the hollow, and a support rod disposed at least partially within the guide pin for supporting the core. The device for inserting a tubular implant according to claim 1 .

3. a handle body connecting the needle and the handle; and a housing configured to accommodate the needle, the handle body, and the guide pin, the housing having an opening extending in one direction; The handle is exposed to the outside of the housing through the opening and configured to be slidable along the opening.

3. A device for inserting a tubular implant according to claim 1 or 2.

4. a movement adjusting portion coupled to the guide pin and one end of the housing to adjust the relative position of the guide pin with respect to the needle; 4. The device for inserting a tubular implant according to claim 3.

5. the opening includes a first portion extending in a first direction and a second portion connected to the first portion from a second direction different from the first direction to limit movement of the handle along the first direction; The handle body is disposed within the housing so as to be movable in the first direction and rotatable in the second direction.

4. The device for inserting a tubular implant according to claim 3.

6. and a stopper formed at an end of the housing to limit movement of the housing into the eye.

4. The device for inserting a tubular implant according to claim 3.

7. The stopper has a larger diameter than the needle.

7. The device for inserting a tubular implant according to claim 6.

8. The needle is coupled to the handle so as to selectively expose the implant to the outside of the needle by sliding along the outer surface of the guide pin through operation of the handle.

4. The device for inserting a tubular implant according to claim 3.

9. a piston coupled to the guide pin and disposed within the housing for selective contact with the handle body upon operation of the handle; 9. The device for inserting a tubular implant according to claim 8.

10. a pipe coupled to the housing and connected to the piston; and a packing member disposed between the piston and the pipe.

10. The device for inserting a tubular implant according to claim 9.

11. The packing member is configured to allow the piston to move relative to the pipe by operating the handle while the handle body is in contact with the piston.

11. The device for inserting a tubular implant according to claim 10.

12. and one or more markers formed on the surface of the needle. The device for inserting a tubular implant according to claim 1 .

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