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 embodiments relate to an insertion device for a tubular implant, and more particularly to an insertion device that can easily insert a tubular implant to be inserted into the eye, such as a tube for draining aqueous humor in the eye to reduce intraocular pressure, into the eye and minimize damage to the eye.

Background Art

[0002] For glaucoma patients whose intraocular pressure cannot be adjusted even with the use of intraocular pressure-lowering agents, a bypass is created so that aqueous humor is drained from the anterior chamber of the eye to the subconjunctiva outside the eye to lower the intraocular pressure. Among glaucoma filtration surgeries that create a bypass or fistula for aqueous humor drainage, trabeculectomy may fail to adjust the intraocular pressure due to a decrease in the amount of aqueous humor drainage caused by closure of the bypass again after the surgery. When glaucoma filtration surgery is performed again after the failure of the primary surgery, the frequency of bypass closure increases after the surgery and the success rate of the surgery decreases.

[0003] In addition, in the case of so-called refractory glaucoma, such as neovascular glaucoma or secondary glaucoma due to uveitis, depending on the type of glaucoma, bypass occlusion frequently occurs after trabeculectomy, and the results are not good. Thus, in the case of an eye with a past history of failure in glaucoma filtration surgery or refractory glaucoma, glaucoma implant surgery is performed to prevent bypass closure and increase the success rate of the surgery. To date, glaucoma implants have been used as an alternative to trabeculectomy in some glaucomas that are particularly difficult to treat in that they not only effectively lower intraocular pressure but also show a predictable postoperative clinical course depending on the defined inner diameter of the tube.

[0004] However, existing glaucoma implants used in glaucoma implant surgery are relatively large, which can lead to various problems and complications such as surgical difficulties, postoperative exposure, infection, impaired eye movement due to the large size of the implant, and resulting double vision. Therefore, minimally invasive glaucoma surgery (MIGS), which uses smaller glaucoma implant tools, has recently been developed, making it relatively easier to lower intraocular pressure using glaucoma implants while reducing postoperative side effects caused by larger implants.

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

[0006] Conventional implant insertion devices operate by first inserting the entire implant into the insertion tube of the device, then inserting the device into the eyeball, and finally pushing the implant out into the eyeball.

[0007] However, this conventional method involves pushing the implant itself from rear to front, which presents a problem in that it is difficult to insert the implant into the eyeball if other components, such as a core, are attached to it. Furthermore, since the conventional method requires inserting the entire implant into the insertion tube, it is difficult to apply to implants of various lengths. Moreover, conventional insertion devices do not have a means to easily fix the position of the needle of the insertion device and the implant inserted within it, so there is a problem in that the needle of the insertion device is likely to retract unintentionally during the process of inserting the needle into the eyeball, exposing the implant. [Overview of the project] [Problems that the invention aims to solve]

[0008] The present invention aims to improve upon the aforementioned problems and provides an insertion device for a tubular implant, which allows for easy insertion into the eyeball without separating the implant, by supporting the tubular implant housed within the needle of the insertion device with a hollow guide pin, and then retracting the needle and / or guide pin using a handle after insertion. [Means for solving the problem]

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

[0010] In one embodiment, the implant further includes a core body that is inserted into the implant. In this case, the hollow of the guide pin is configured so that the core body is inserted into the hollow. Furthermore, the insertion device for the tubular implant further includes a support rod (rod) that is at least partially positioned within the guide pin to support the core body.

[0011] An insertion device for a tubular implant 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. In this case, the handle is exposed to the outside of the housing through the opening and is configured to slide along the opening.

[0012] An insertion device for a tubular implant according to one embodiment further includes a transfer adjustment unit coupled to one end of the guide pin and 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 in order to restrict the movement of the handle along the first direction. In this case, the handle body is arranged to be movable in the first direction and rotatable in the second direction within the housing.

[0014] An insertion device for a tubular implant according to one embodiment further includes a stopper formed at the end of the housing to restrict the movement of the housing into the eyeball.

[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 it slides along the outer surface of the guide pin by operating the handle, thereby selectively exposing the implant to the outside of the needle.

[0017] An insertion device for a tubular implant according to one embodiment further includes a piston coupled to the guide pin and positioned within the housing so as to selectively contact the handle body by operation of the handle.

[0018] An insertion device for a tubular implant according to one embodiment 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 relative movement of the piston with respect to the pipe by operating the handle while the handle body is in contact with the piston.

[0020] An insertion device for a tubular implant according to one embodiment further includes one or more markers formed on the surface of the needle.

Advantages of the Invention

[0021] According to the insertion device for a tubular implant according to an embodiment of the present invention, when inserting a tubular implant, such as an implant for an eye disease for discharging aqueous humor from the anterior chamber of the eye, into the eye, the implant is supported by a hollow guide pin and inserted into the eye. After insertion, by using a handle to retract the needle and / or the guide pin, there is an advantage that the implant with a core inserted therein can be easily inserted into the eye without being separated from the core.

[0022] Moreover, the insertion device for a tubular implant according to an embodiment of the present invention can adjust the positions of each part through the needle, guide pin, pipe, and transfer adjustment part that constitute it, so it can be used together with implants of various lengths. Furthermore, by rotating the handle for operating the needle along the opening formed on the surface of the insertion device, the position of the needle can be fixed. Therefore, there is an advantage that it can prevent the needle from retreating unintentionally during the process of inserting the needle into the eye and exposing the implant.

Brief Description of the Drawings

[0023] [Figure 1] Shows an insertion device for a tubular implant according to an embodiment of the present invention. [Figure 2A] It is a cross-sectional view along the line segment connecting A-A' in the insertion device for the tubular implant shown in FIG. 1. [Figure 2B] \It is a partial cross-sectional view of the insertion device for the tubular implant shown in FIG. 2A. [Figure 3A] Shows a state in which an implant is mounted on the insertion device for a tubular implant according to an embodiment of the present invention. [Figure 3B] It is a perspective view showing the arrangement of the implant and the guide pin in the insertion device for a tubular implant according to an embodiment of the present invention. [Figure 3C]This is a side view showing the arrangement of the implant and guide pin in a tubular implant insertion device according to one embodiment of the present invention. [Figure 4A] This shows a state in which the guide pin has been advanced in an insertion device for a tubular implant according to one embodiment of the present invention. [Figure 4B] Figure 4A is a cross-sectional view of the insertion device for the tubular implant shown. [Figure 4C] Figure 4B is a partial cross-sectional view of the tubular implant insertion device. [Figure 5A] This is a perspective view showing the handle of a tubular implant insertion device according to one embodiment of the present invention rotated to the movable position. [Figure 5B] This is a side view showing the handle of a tubular implant insertion device according to one embodiment of the present invention rotated to the movable position. [Figure 5C] Figure 5B is a side view showing the tubular implant insertion device with the handle retracted. [Figure 6A] This is a perspective view showing the needle in a retracted position in a tubular implant insertion device according to one embodiment of the present invention. [Figure 6B] Figure 6A is a cross-sectional view of the insertion device for the tubular implant shown. [Figure 6C] Figure 6B is a partial cross-sectional view of the tubular implant insertion device. [Figure 7A] This is a cross-sectional view showing an implant mounted on a tubular implant insertion device according to another embodiment of the present invention. [Figure 7B] Figure 7A is a partial cross-sectional view of the insertion device for the tubular implant shown. [Figure 8A] Figure 7A is a cross-sectional view showing the tubular implant insertion device with the guide pin advanced. [Figure 8B] Figure 8A is a partial cross-sectional view of the tubular implant insertion device. [Figure 9A] Figure 8A is a cross-sectional view showing the tubular implant insertion device with the handle partially retracted. [Figure 9B] Figure 9A is a partial cross-sectional view of the tubular implant insertion device. [Figure 10A] Figure 9A is a cross-sectional view showing the tubular implant insertion device with the handle further retracted. [Figure 10B] Figure 10A is a partial cross-sectional view of the tubular implant insertion device. [Figure 11A] An example of a stopper for preventing excessive needle insertion in a tubular implant insertion device according to an embodiment of the present invention is shown. [Figure 11B] Another example of a stopper for preventing excessive needle insertion in a tubular implant insertion device according to an embodiment of the present invention is shown. [Figure 11C] Another example of a stopper for preventing excessive needle insertion in a tubular implant insertion device according to an embodiment of the present invention is shown. [Modes for carrying out the invention]

[0024] The terms used herein will be briefly explained, and then the present invention will be described in detail. The terminology used in the embodiments of this invention has been selected as widely used and general terms as possible, taking into consideration the functions of the invention, but this may change depending on the intentions of the articulators, precedents, or the realization of new technologies. In certain cases, the applicant may have arbitrarily selected terms, in which case their meaning will be described in detail in the description of the invention. Therefore, the terminology used in this invention is not merely a name of a term, but is defined based on the meaning of that term and the overall content of the invention. Throughout the specification, when a part is said to "include" a component, this means, unless otherwise stated, that it may include other components rather than excluding them. Furthermore, when a part is said to be "linked" to another part, this includes not only cases where they are "directly linked," but also cases where they are linked "with other components in between." Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings, so that those with ordinary skill in the art to which the present invention pertains can easily implement them. However, the present invention may be embodied in various different forms and is not limited to the embodiments described herein. In order to clearly illustrate the present invention with the drawings, parts unrelated to the description have been omitted, and similar parts throughout the specification are denoted by similar reference numerals.

[0025] The tubular implant insertion device according to an embodiment of the present invention is used to insert a tubular implant into the eyeball. Here, a tubular implant refers to an implant that has a tube shape that extends longitudinally overall and has a hollow interior, or an implant that includes such a tube as at least one of its components.

[0026] This specification describes the application of an implant insertion device according to the embodiment for the insertion of an implant for ophthalmic diseases to regulate intraocular pressure by controlling the drainage of aqueous humor generated from the anterior chamber located in front of the lens of the eyeball. Such an implant serves to prevent the optic nerve from being damaged by elevated intraocular pressure caused by ophthalmic diseases and can be used to treat or alleviate symptoms of various ophthalmic 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 the embodiment are not limited thereto.

[0027] In this specification, ocular diseases may include, but are not limited to, glaucoma caused by elevated intraocular pressure, and such glaucoma may include, but are not limited to, congenital glaucoma, traumatic glaucoma, suspected glaucoma, ocular hypertension, primary open-angle glaucoma, normal-tension glaucoma, cystic glaucoma with pseudoexfoliation of the lens, chronic simple glaucoma, low-tension glaucoma, pigmentary glaucoma, primary closed-angle glaucoma, acute closed-angle glaucoma, chronic closed-angle glaucoma, intermittent closed-angle glaucoma, glaucoma resulting from trauma of the eye, glaucoma resulting from inflammation of the eye, drug-induced glaucoma, neovascular glaucoma, or secondary glaucoma due to uveitis.

[0028] The implant for ophthalmic diseases is 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 can be a variety of forms, such as integral, wedge-shaped, cruciate, or cap-shaped.

[0029] The eye disease implant can be inserted after the surgeon has detached the conjunctival tissue or Tenon's tissue of the eyeball, and after insertion, it can be positioned 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 may open the conjunctiva around the limbus with surgical scissors, or afterwards create a scleral flap depending on the condition of the sclera. Here, the size of the scleral flap is a rectangular or trapezoidal shape with dimensions of approximately 3 mm in both width and length, and its depth can be approximately ±50% of the scleral thickness, but the present invention is not limited thereto.

[0030] Next, the implant for eye diseases 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 already inserted (loaded) into the needle. For example, the practitioner can push the needle to a distance of at least 1 to 2 mm from the limbus of the cornea. 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 inside the eyeball, and then retrieve the insertion device.

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

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

[0033] Referring to Figure 1, the insertion device for a tubular implant may include a needle 10 having an internal space. The insertion device may also include a handle 30 connected to the needle 10 to allow for positional manipulation of the needle 10. Furthermore, the insertion device may include one or more housings 100, 200 that house the needle 10 and the handle 30, and form the outer surface of the insertion device so that the operator can grasp the insertion device. For example, the housings may 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 on the surface of the housing 100. The handle 30 can move back and forth along the opening 110 in the longitudinal direction of the insertion device. 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 inserts the needle 10 into the eyeball using the insertion device with the handle 30 advanced to the front end of the opening 110 (i.e., toward the patient's eye), and then pulls the handle 30 backward along the opening 110 (i.e., toward the practitioner), thereby retracting the needle 10 connected to the handle 30.

[0035] In one embodiment, the insertion device for a tubular implant includes a transport adjustment unit 70 coupled to one end of the housing 200. The transport adjustment unit 70 is operated by the operator to control the position of a guide pin housed within the housings 100, 200, and has a mechanism for switching the forward and backward movement and / or rotation of the transport adjustment unit 70 to the forward and backward movement of the guide pin. The relative position of the guide pin to the needle 10 can be adjusted through the transport adjustment unit 70. Position adjustment using the transport adjustment unit 70 will be described in detail below.

[0036] Since the needle 10 is the part that is inserted into the eyeball with the implant attached, it can be made from stainless steel or other biocompatible material. Furthermore, other components of the insertion device, such as the handle 30, housings 100 and 200, and transport adjustment unit 70, can also be made from stainless steel, or from medical plastics based on polycarbonate, polypropylene, polyethylene, polyvinyl chloride, 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 can enable delicate needle control by moving or rotating the needle 10 by an amount less than the amount of movement of the practitioner's hand (e.g., forward / backward 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 so that the practitioner can easily confirm the position of the needle.

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

[0039] Referring to Figures 2A and 2B, the tubular implant insertion device according to this embodiment includes a guide pin 20 that supports the implant to be inserted into the eyeball, while being at least partially located within the needle 10. The implant to be inserted into the eyeball is positioned in the space between the front end of the needle 10 and the guide pin 20. For insertion into the eyeball, 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, length d1 means the length including the inclined portion if the end of the needle 10 has an inclined shape.

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

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

[0042] In one embodiment, the handle body 31 is configured as a hollow cylindrical shape at least partially, and a piston 60 located at the rear of the handle body 31 is inserted into the interior of 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 backward, and as a result, the needle 10 connected to the handle body 31 moves backward.

[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 plays a role in fixing their position so that they do not wobble during implant insertion. In one embodiment, the rear end of the pipe 40 may be connected to a transport adjustment unit 70, and the pipe 40 and the piston 60 connected to it may be configured to move forward or backward as the operator moves or rotates the transport adjustment unit 70. Furthermore, a support rod 50 capable of supporting the core body of the implant may be located inside the pipe 40.

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

[0045] In one embodiment, a packing member 61, such as an O-ring, can be positioned between the pipe 40 and the piston 60. For example, the rear end of the piston 60 surrounding the outer circumference of the pipe 40 is closed by a cap 62, and the packing member 61 can be positioned in the space between the cap 62 and the piston 60. The packing member 61 has the function of sealing the space 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 operator applies force to the handle 30 to retract the piston 60. The cap 62 plays a role in preventing the packing member 61 from detaching from the piston 60 when the piston 60 moves in this manner.

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

[0047] Figure 3A shows a tubular implant insertion device according to one embodiment of the present invention with an implant mounted on it. Figures 3B and 3C are perspective and side views showing the arrangement of the implant and guide pin in the state shown in Figure 3A.

[0048] Referring to Figures 3A to 3C, the implant 300 to be inserted into the eyeball may be inserted into the needle 10 through the front end of the needle 10. After the practitioner prepares the insertion device according to the embodiment, the implant 300 can be inserted into the insertion device and then the intraocular insertion can be performed. Alternatively, the insertion device according to the embodiment may be manufactured and packaged with the implant 300 at least partially inserted and delivered to the practitioner. The implant 300 contains a hollow interior to drain aqueous humor from within the eyeball.

[0049] Furthermore, a core 400 may be inserted into the hollow of the implant 300 to regulate the drainage rate of aqueous humor. The core 400 may be a non-absorbable surgical suture and may be made of, for example, nylon or prolene material. The core 400 is at least partially inserted into the hollow of the implant 300 and plays a role in regulating the anterior chamber formation pressure. If the core 400 is thick, the space between the inner wall of the implant 300 and the core 400 becomes narrower, so the aqueous humor drains relatively slowly, thereby increasing the anterior chamber formation pressure. On the other hand, if the core 400 is thin, the space between the inner wall of the implant 300 and the core 400 becomes wider, so the aqueous humor drains relatively rapidly while the anterior chamber formation pressure is lower.

[0050] Therefore, the core 400 can be configured with a diameter and material to optimize the anterior chamber formation pressure within a predetermined range, for example, so that the postoperative pressure is approximately 6 to 21 mmHg. However, the preferred numerical range of the anterior chamber formation pressure is not limited thereto. Furthermore, the core 400 may be configured to be manipulated by a clinician to adjust the anterior chamber formation pressure. For example, once the core 400 is retracted into the hollow of the implant 300 and exposed at the posterior end of the implant 300, the clinician can adjust the core 400 exposed at the posterior end of the implant 300 to regulate the outflow of aqueous humor.

[0051] In one embodiment, the implant 300 may be made of any of the following materials, or a combination of one or more of these materials: 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 can form a curve with a predetermined curvature to prevent damage to the corneal endothelium inside the eyeball. Due to differences in eyeball size and the skill level of implant injection among patients, there is a risk that the anterior end of the implant may puncture and damage the cornea in the anterior chamber of the eyeball during the process of the implant being drawn into the anterior chamber. Corneal damage can lead to complications such as corneal insufficiency requiring a future corneal transplant. For example, the implant can be manufactured in a curved shape with a predetermined curvature corresponding to the curvature of the eyeball surface, so that it can naturally form a curve during the process of being drawn into the anterior chamber of the eyeball. Alternatively, even with a one-piece implant, it is possible to use an implant without curvature by using a material with sufficient elasticity or flexibility.

[0053] The implant 300, housed within the needle 10, is positioned between the front end of the needle 10 and the guide pin 20. The guide pin 20 supports the implant 300 and simultaneously houses the core body 400, which is coupled to the implant 300, within the hollow space of the guide pin 20. For this purpose, the inner diameter R of the guide pin 20 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 such that the implant 300 is not pushed into the guide pin 20. 21 The outer diameter R of implant 300 12 It must be smaller than the inner diameter R of the guide pin 20. 21 The inner diameter R of implant 300 11 and outer diameter R 12 The size may be between, but is not limited to, the outer diameter R of the guide pin 20. 22 The outer diameter of the tube is R 12 It may be equal to or greater than, but is not limited to.

[0054] In other words, the insertion device according to the embodiment is configured to support the tubular implant 300 with a guide pin 20, which is another tubular member. By supporting the implant 300 with the hollow guide pin 20, even if the core body 400 is connected inside the implant 300, it is not necessary to bend or bundle the core body 400 and drive it into the needle 10, and there is an advantage that the implant 300 can be placed inside the insertion device with the core body 400 inserted inside the guide pin 20.

[0055] On the other hand, the insertion device according to the embodiment is configured so that the positions of the guide pin 20 and support rod 50 connected to the transfer adjustment unit 70 can be adjusted by operating the transfer adjustment unit 70. Since the implant 300 inserted into the eyeball is positioned between the front end of the needle 10 and the guide pin 20, the position of the guide pin 20 can be adjusted according to the length of the implant 300 in order to use implants of various lengths. At the same time, the position of the support rod 50 that supports the core body 400 connected to the implant 300 can also be adjusted by operating the transfer adjustment unit 70, so 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 positioned within the insertion device, the operator can move the device so that the end of the implant 300 is positioned at the desired insertion point within the eyeball. Furthermore, after inserting the needle 10 into the area within the eyeball where the implant 300 must be located, the operator can operate the transport adjustment unit 70 to confirm the position of the implant 300. Operating the transport adjustment unit 70 causes the guide pin 20 to advance, pushing the implant 300 into the anterior chamber.

[0057] Figure 4A shows a tubular implant insertion device according to one embodiment of the present invention with the guide pin advanced, and Figures 4B and 4C are cross-sectional views of the tubular implant insertion device shown in Figure 4A.

[0058] Referring to Figures 4A to 4C, the operator can advance the guide pin 20 using the transfer adjustment unit 70 with the implant 300 positioned inside the needle 10, as described above with reference to Figure 3A. More specifically, the transfer adjustment unit 70 is connected to the pipe 40, the pipe 40 is connected to the piston 60, and the piston 60 is connected to the guide pin 20. When the transfer adjustment unit 70 is advanced until it contacts the housing 200, the pipe 40, piston 60, and guide pin 20 connected to the transfer adjustment unit 70 advance accordingly. If the transfer adjustment unit 70 has a rotation mechanism, the insertion device may include a rotating gear (not shown) for converting the rotation of the transfer adjustment unit 70 into the forward and backward movement of the pipe 40.

[0059] The rear of the implant 300 is supported by a 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's manipulation, only the implant 300 advances while the position of the needle 10 remains fixed. Using this, the operator can operate the transfer adjustment unit 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, positioned behind the guide pin 20, is moved forward or backward by the operator's operation of the transport adjustment unit 70, similar to the pipe 40. Furthermore, the support rod 50 plays a role in supporting the core body 400, which is at least partially inserted into the guide pin 20 and coupled to the implant 300. When the operator pushes the guide pin 20 to advance the implant 300 by operating the transport adjustment unit 70, the support rod 50 simultaneously pushes the core body 400 to advance, thus preventing the implant 300 from advancing while the core body 400 remains inside the insertion device. The support rod 50 can be made from stainless steel or other biocompatible material.

[0061] With the implant 300 inserted into the insertion position within the eyeball, the practitioner can use the handle 30 of the insertion device to retract the needle 10, so that only the implant 300 remains inside the eye.

[0062] Figures 5A to 5C show the process by which the operator uses the handle 30 to retract the needle 10 when the implant 300 is positioned in the insertion location.

[0063] Referring to Figures 5A and 5B, the opening 110 of the housing 100 for the handle 30 to slide may include a portion that is bent in a different direction from the rest of the housing to restrict the movement of the handle 30. That is, the opening 110 extends overall 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 that extends in the longitudinal direction is referred to as the first portion, the portion of the opening 110 that is oriented in a different direction may also be referred to as the second portion. For example, the opening 110 having the first and second portions may have shapes such as "┐", "└", "┤", and "├".

[0064] The first part of the opening 110 corresponds to a movable position where the handle 30 can move, and the second part corresponds to a fixed position where the handle 30 cannot move. The practitioner rotates the handle 30 to the fixed position so that the handle 30 is fixed and does not move back and forth, and inserts the needle 10 into the eyeball. Once the needle 10 is inserted to the desired position, the handle 30 can be rotated to the movable position as shown in Figures 5A and 5B. Next, the practitioner slides the handle 30 backward as shown in Figure 5C, thereby retracting the needle 10 along the longitudinal direction of the insertion device.

[0065] Conversely, if the practitioner wants to fix the position of the needle 10, they can advance the handle 30 to the end of the opening 110 and then rotate the handle 30 so that it is inside the groove 111. When the handle 30 is inside the groove 111, its movement in the forward and backward direction is restricted, so that the needle 10 does not wobble.

[0066] Conventional implant insertion devices had the problem that when retracting the needle after inserting it into the eyeball, too much force was required, potentially putting undue stress on the patient's eyeball. However, in the implant insertion device according to this embodiment, the position of the needle 10 can be easily adjusted by sliding the handle 30, and the position of the handle 30 can be fixed, thus preventing the needle 10 from unintentionally retracting and exposing the implant 300 during the process of inserting the needle 10 into the eyeball.

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

[0068] Referring to Figures 6A to 6C, with the implant 300 inserted into 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 Figure 6C, only the implant 300 remains outside the insertion device, and the practitioner can then retrieve the insertion device to position the implant 300 in the desired location within the eyeball. The core 400, which is inserted into the guide pin 20 of the insertion device, disengages from the guide pin 20 while the practitioner retrieves the insertion device and becomes positioned within the eyeball 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 while leaving the implant inside the eyeball during implant insertion. However, the tubular implant insertion device according to other embodiments can also be configured to retract both the needle and the guide pin during implant insertion, and this will be described in detail below.

[0070] Figure 7A shows a tubular implant insertion device with an implant mounted according to another embodiment of the present invention, and Figure 7B shows a partial cross-sectional view of the tubular implant insertion device shown in Figure 7A.

[0071] Referring to Figures 7A and 7B, the 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 positioned between the front end of the needle 10 and the guide pin 20. This is the same arrangement as described above with reference to Figures 3A to 3C, so a detailed explanation will be omitted to avoid repetition. However, in the case of an insertion device configured so that both the needle 10 and the guide pin 20 retract, 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 protruding in 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 transfer adjustment unit 70, thereby moving the implant 300 forward. Figure 8A shows the state in which the guide pin has been advanced in the tubular implant insertion device shown in Figure 7A, and Figure 8B shows a partial cross-sectional view of the tubular implant insertion device shown in Figure 8A. As described above with reference to Figures 4A to 4C, the position of the guide pin 20 and support rod 50 can be adjusted by operating the transfer adjustment unit 70 to use implants 300 and cores 400 of various lengths. Furthermore, after inserting the needle 10 into the eyeball, 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 is inserted into the intraocular insertion position, the operator can use the handle 30 to retract the needle 10 and guide pin 20, leaving only the implant 300 inside the eyeball. At this time, the process of retracting the needle 10 and guide pin 20 may consist of 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 guide pin 20.

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

[0075] Referring to Figures 9A and 9B, when the handle 30 is slid, the handle body 31 moves backward, causing the needle 10 connected to the handle body 31 to retract. At this time, the piston 60 is located behind the handle body 31, and since the piston 60 is positioned to be at least partially insertable into the handle body 31, it is possible to move the handle 30 backward until the inner surface of the handle body 31 contacts the piston 60. If the practitioner applies further force to the handle 30 in this state, both the handle body 31 and the piston 60 move backward, as shown in Figures 10A and 10B.

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

[0077] Referring to Figures 10A and 10B, when the inner surface of the handle body 31 is in contact with the piston 60, if the practitioner applies further force to the handle 30 backward, the packing member 61, such as an O-ring, positioned 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. Since the guide pin 20 is connected to the piston 60, as the needle 10 retracts due to the movement of the handle body 31, the guide pin 20 connected to the piston 60 also retracts by the same distance.

[0078] As a result, the needle 10 and guide pin 20 are all or most housed inside the housing 100, leaving only the implant 300 outside the insertion device. In this state, the practitioner can position the implant 300 at the desired location within the eyeball by retrieving the insertion device in the opposite direction from which it was inserted. The core body 400 inserted into the guide pin 20 of the insertion device disengages from the guide pin 20 while the practitioner retrieves the insertion device and becomes positioned within the eyeball together with the implant 300.

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

[0080] Referring to Figures 11A to 11C, the insertion device according to the embodiment may include stoppers 120 to 122 located at the front end of the housing 100, which have a larger diameter than the needle 10. In this case, the stoppers 120 to 122 are configured to catch on the sclera of the eyeball when the practitioner inserts the implant, making it easier for the practitioner 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] Referring to Figure 11A, the stopper 120 can also refer to the end of the housing 100 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 greater 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 allow for implant insertion.

[0082] Alternatively, referring to Figure 11B, the stopper 121 may be a separate member that is coupled to or formed at the end of the housing 100 and has a larger diameter than the end of the housing 100 so as to catch on the sclera. Furthermore, referring to Figure 11C, the stopper 121 may have a shape that is bent to a predetermined curvature corresponding to the curvature of the surface of the eyeball in order to prevent damage to the eyeball. However, the shapes of the stoppers 120-122 shown in the drawings herein are merely illustrative, and in embodiments, the stopper 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-mentioned description of the present invention is illustrative, and a person with ordinary skill in the art to which the present invention pertains will understand that the invention can be implemented in other specific forms without altering the technical idea or essential features. Therefore, the embodiments described above should be understood to be illustrative in all respects and not limiting. For example, each component described as a single type may be implemented in a distributed manner, and similarly, components described as distributed may be implemented in a combined manner. The scope of the present invention is defined more by the claims described below than by the detailed description above, and all modified or altered forms derived from the meaning and scope of the claims and the concept of equivalents thereof are included in the scope of the present invention. [Industrial applicability]

[0084] The embodiment provides an insertion device for tubular implants, and more specifically, an insertion device that allows for easy insertion of a tubular implant into the eyeball, such as a tube for draining aqueous humor from the eyeball to lower intraocular pressure, thereby minimizing damage to the eyeball. Therefore, the industrial applicability of the present invention is extremely high.

Claims

1. A needle having an internal space for accommodating a tube-shaped implant inserted into the eyeball; A handle connected to the needle for manipulating the position of the needle; and, It includes a guide pin that is positioned to support the implant housed within the needle and has a hollow shape smaller than the outer diameter of the implant, The implant further includes a core that is inserted into the implant, The hollow of the guide pin is configured such that the core body is inserted into the hollow. The further includes a support rod at least partially positioned within the guide pin to support the core body. An insertion device for tubular implants, characterized by the following features.

2. A handle body connecting the needle and the handle; and, The present invention further includes a housing configured to accommodate the needle, the handle body, and the guide pin, and having an opening extending in one direction, The handle is exposed to the outside of the housing through the opening and is configured to slide along the opening. An insertion device for a tubular implant according to claim 1.

3. The housing further includes a transfer adjustment unit 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. The insertion device for a tubular implant according to claim 2.

4. 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 in order to restrict the movement of the handle along the first direction. The handle body is arranged to be movable in the first direction and rotatable in the second direction within the housing. The insertion device for a tubular implant according to claim 2.

5. The housing further includes a stopper formed at the end of the housing to restrict the housing's movement into the eyeball. The insertion device for a tubular implant according to claim 2.

6. The stopper has a larger diameter than the needle. The insertion device for a tubular implant according to claim 5.

7. The needle is coupled to the handle so that it slides along the outer surface of the guide pin by the operation of the handle, thereby selectively exposing the implant to the outside of the needle. The insertion device for a tubular implant according to claim 2.

8. The housing further includes a piston coupled to the guide pin and positioned within the housing to selectively contact the handle body by the operation of the handle. The insertion device for a tubular implant according to claim 7.

9. A pipe coupled to the housing and connected to the piston; and The packing member further includes a packing member disposed between the piston and the pipe. The insertion device for a tubular implant according to claim 8.

10. The packing member is configured to allow relative movement of the piston relative to the pipe by operating the handle while the handle body is in contact with the piston. An insertion device for a tubular implant according to claim 9.

11. The needle further includes one or more markers formed on its surface. An insertion device for a tubular implant according to claim 1.

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