Ophthalmic sealing device for sealing sclera perforation formed by trocar

WO2025048023A1PCT designated stage expired Publication Date: 2025-03-06MSC LAB CO LTD
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Patent Information

Application Number
PCT/KR2023/014263
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-08-29
Filing Date
2023-09-20
Publication Date
2025-03-06

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Abstract

The present invention relates to an ophthalmic sealing device, and to an ophthalmic sealing device capable of very easily sealing, without sutures, a perforation formed in the sclera when a trocar inserted into an eyeball is removed after surgery. The present invention relates to the ophthalmic sealing device for sealing a perforation formed in the sclera when a trocar penetrating the sclera of an eyeball is removed, the device comprising: a body part coupled to a cannula part of the trocar; and a holding part formed at the body part in order to keep the body part in the perforation when the trocar is removed from the sclera.
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Description

An ophthalmic sealing device for filling a perforation of the cornea created by a trocar

[0001] The present invention relates to an ophthalmic sealing device, and more particularly, to an ophthalmic sealing device that can very easily fill a perforation of the cornea formed by a trocar inserted into the eye during ophthalmic surgery in a sutureless manner.

[0002] The retina is a thin, transparent membrane located at the innermost part of the eyeball and bordering the vitreous body. It serves as the primary visual information organ, converting optical information from objects into electrical signals and transmitting images to the central visual area of ​​the brain via the optic nerve. Approximately 30% of our brain cells are dedicated to processing visual information sent by the retina. However, as the retina ages or develops abnormalities due to external factors, visual impairments can gradually occur, leading to vision and field of vision impairment, and even blindness.

[0003] Retinal diseases can be broadly classified into retinal detachment, which occurs when abnormalities in the tissues surrounding the retina cause the neural retina to separate from the pigment epithelium layer and the retina to separate toward the back of the eye, causing vision impairment; peripheral retinal degeneration, which causes abnormalities in the tissues surrounding the retina; and macular degeneration, which causes abnormalities in the macula.

[0004] Ophthalmic surgery to treat these retinal diseases may require a vitrectomy, which involves incising and removing the vitreous body, a clear, jelly-like substance that fills the posterior segment of the eye. Vitrectomy is an eye surgery used to treat conditions that cause vitreous hemorrhage or opacity from various causes, as well as retinal detachment and retinal wrinkles.

[0005] During ophthalmic surgeries such as vitrectomy, a passage is needed to insert surgical instruments and lights into the eye. In this case, a device called a trocar is inserted into the eye to secure the passage.

[0006] As an example, as illustrated in Fig. 1, the eyelids are forcibly opened using an eyelid retractor (5), and then three trocars (7) are inserted into the cornea (3). A lighting device for illuminating the inside of the eye is inserted into one trocar (7), a resecting device required for surgery is inserted into another trocar (7), and an irrigation tube for injecting surgical fluid to ensure that the environment, such as intraocular pressure, does not change is inserted into yet another trocar (7).

[0007] And Fig. 2 shows a trocar (7) inserted into the eyeball (1) through the sclera (3). When the trocar (7) is inserted into the sclera (3) using a needle and the needle is removed, the trocar (7) is maintained in a state in which the tube portion (8) penetrates the sclera (3) as shown in Fig. 2. In this state, a surgical tool or lighting device is inserted into the passage of the trocar (7) to perform the necessary surgery. After the surgery, the trocar (7) is removed by pulling it out of the sclera (3), and at this time, a perforation is formed at the location where the trocar (7) penetrated. If the perforation of the sclera (3) is not blocked after the trocar (7) is removed, the problem of vitreous fluid leakage and resulting low intraocular pressure may occur.

[0008] The size of a corneal perforation varies depending on the diameter of the trocar's cannula. A perforation formed by a relatively small trocar, such as a 27G (gauge) trocar, can be self-sealing. However, as the diameter gradually increases to 25G, 23G, or 20G, the perforation size increases, making self-sealing difficult and requiring suturing after trocar removal. Furthermore, a method of plugging the perforation by inserting a plug is also used, as disclosed in Korean Patent No. 10-0313268.

[0009] These conventional techniques require a separate suturing process to close the perforation after removing the trocar, or require a process of inserting a tool into the perforation to close the perforation, which requires more time and effort.

[0010] The present invention was created to improve the above-mentioned problems, and its purpose is to provide an ophthalmic sealing device that does not require a separate suturing process by allowing a perforation formed in the cornea to be filled during the process of removing a trocar.

[0011] In order to achieve the above object, the present invention provides an ophthalmic sealing device for filling a perforation formed in the sclera by a trocar penetrating the sclera of the eye, comprising: a body part coupled to the trocar and inserted into the perforation when the trocar penetrates the sclera; and a holding part formed on the body part so that when the trocar is removed from the sclera, the body part can be separated from the trocar and remain in the perforation.

[0012] The holding portion is formed on the outer surface of the body portion and has a plurality of hooks that catch on the cornea when the trocar is removed.

[0013] The above hooks protrude upwardly from the outer surface of the body portion, and the ends of the hooks are formed to be pointed.

[0014] A passage is formed in the body portion so that the trocar can pass through the body portion.

[0015] When the trocar is separated from the body, a passage sealing means is provided in the body so that the passage can be blocked.

[0016] The above passage sealing means is formed in the body part to block the passage and has a plurality of elastic flaps that are elastically bent when the trocar passes through.

[0017] The above passage sealing means is formed to protrude convexly from the inner surface of the body portion to block the passage, and has an expansion portion that elastically opens when the trocar passes through.

[0018] As described above, the sealing device of the present invention can be used while attached to a trocar. Accordingly, during the process of inserting the trocar into the eye, the sealing device of the present invention is inserted into the perforation of the cornea, and during the process of removing the trocar after surgery, the sealing device of the present invention is naturally separated from the trocar and remains in the perforation.

[0019] Thus, the present invention does not require a separate procedure or time to fill a perforation in the cornea. Therefore, the present invention can effectively fill a perforation simply, conveniently, and without sutures.

[0020] Figure 1 is a drawing showing a trocar inserted into the eye through the cornea for ophthalmic surgery.

[0021] Figure 2 is a cross-sectional view of Figure 1,

[0022] Figure 3 is a perspective view of an ophthalmic sealing device according to an example of the present invention.

[0023] Figure 4 is a bottom view of the ophthalmic sealing device of Figure 3,

[0024] Figure 5 is a cross-sectional view of the ophthalmic sealing device of Figure 3.

[0025] Figure 6 is a side view showing the insertion of the trocar's tube into the ophthalmic sealing device of Figure 3.

[0026] Figure 7 is a cross-sectional view showing the ophthalmic sealing device of Figure 3 coupled to the trocar's tube portion.

[0027] Figure 8 is a cross-sectional view showing a trocar combined with the ophthalmic sealing device of Figure 3 inserted into the eye through the cornea.

[0028] Figure 9 is a cross-sectional view showing the ophthalmic sealing device of Figure 3 remaining in the perforation of the cornea and filling the perforation after removal of the trocar.

[0029] Figure 10 is a side view showing an ophthalmic sealing device according to another example of the present invention coupled to the tube portion of a trocar.

[0030] Figure 11 is a cutaway perspective view of an ophthalmic sealing device according to another example of the present invention.

[0031] Figure 12 is a cutaway perspective view of an ophthalmic sealing device according to another example of the present invention.

[0032] Hereinafter, an ophthalmic sealing device for filling a perforation of the cornea formed by a trocar according to a preferred embodiment of the present invention will be described in detail.

[0033] Referring to FIGS. 2 to 9, the ophthalmic sealing device (10) of the present invention is used to fill a perforation (4) formed in the sclera (3) when removing a trocar (7) penetrating the sclera (3) of the eyeball (1).

[0034] A trocar (7) typically used for ophthalmic surgery is composed of a tube portion (8) that penetrates the sclera (3) and is inserted into the vitreous body inside the eyeball (1), and a head portion (9) that is provided on the upper portion of the tube portion (8) and has a larger diameter than the tube portion (8). This trocar (7) is inserted into the eyeball (1) using a separate needle tool. At this time, as illustrated in FIG. 2, the tube portion (8) is inserted into the vitreous body by penetrating the sclera (3), and the head portion (9) is exposed to the outside of the eyeball (1).

[0035] The tube portion (8) of the trocar (7) is classified by its internal diameter. Generally, in ophthalmic surgery, the tube portions (8) of 27G (gauge), 25G, 23G, and 20G are used. The tube portion (8) of these specifications has an internal diameter of approximately 0.6 to 0.9 mm.

[0036] The ophthalmic sealing device (10) of the present invention is formed of a biocompatible material that is harmless to the human body. Various known materials can be used as such biocompatible materials. Examples of biocompatible materials include bio-derived materials isolated from human or animal tissues (collagen, gelatin, laminin, elastin, fibrin, fibronectin, hyaluronic acid, etc.), bio-derived materials isolated from plants, fish, and seaweed (alginate, chitin, chitosan, etc.), and polymer-based synthetic materials such as silicone.

[0037] Preferably, the ophthalmic sealing device (10) of the present invention may be formed of a biodegradable material that is harmless to the body and can be decomposed in the body. Examples of such biodegradable materials include hyaluronic acid, polydioxanone, polylactide copolymers, polyglycolic acid copolymers, and polyvinyl alcohol.

[0038] The ophthalmic sealing device (10) of the present invention can be formed into an elastic hydrogel structure using the above-described material. Hydrogel is a material having a three-dimensional hydrophilic polymer network structure using water as a dispersion medium, capable of absorbing large amounts of moisture, and having flexibility similar to natural biological tissue.

[0039] The ophthalmic sealing device (10) of the present invention comprises a body part (11) coupled to the tube part (8) of the trocar (7), and a holding part formed in the body part (11) to leave the body part (11) in the perforation (4) when the trocar (7) is removed from the cornea (3).

[0040] The body part (11) is connected to the tube part (8) of the trocar (7). A passage (13) may be formed in the body part (11) so that the tube part (8) may pass through. The passage (13) is formed by penetrating the body part (11) in the vertical direction. The diameter of the passage (13) may be formed to a size corresponding to the outer diameter of the tube part (8). Therefore, the diameter of the passage (13) can be appropriately changed according to the specifications of the trocar (7). The entrance of the passage (13) is formed wide so that the tube part (8) can easily enter the passage (13). To this end, the thickness of the upper part of the body part (11) may be formed thinner than the thickness of the lower part.

[0041] The tube portion (8) of the trocar (7) is inserted into the passage (13) of the body portion (11), and then the body portion (11) is positioned at an appropriate location in the tube portion (8). The location of the body portion (11) coupled to the tube portion (8) is illustrated in Fig. 7. With the trocar (7) inserted into the cornea (3), the body portion (11) is positioned appropriately in the tube portion (8) so that the body portion (11) can be positioned within the perforation (4) of the cornea (3). When the tube portion (8) penetrates the cornea (3) while the body portion (11) is coupled to the tube portion (8) of the trocar (7), the body portion (11) is inserted into the perforation (4).

[0042] A holding portion is formed in the body portion (11). The holding portion serves to leave the body portion (11) within the perforation (4) when the trocar (7) is removed from the cornea (3). By means of this holding portion, in the process of removing the tube portion (8) of the trocar (7) from the cornea (3), the body portion (11) can be separated from the tube portion (8) and naturally remain within the perforation (4) of the cornea (3).

[0043] The illustrated holding portion has a plurality of hooks (15) formed on the outer surface of the body portion (11). The hooks (15) gradually narrow toward the ends, forming a pointed needle shape.

[0044] The hook (15) protrudes upwardly from the outer surface of the body portion at an angle. For example, the angle formed by the hook (15) with respect to the outer surface of the body portion (11) may be formed to be 15 to 40°. The end of the hook (15) is formed to be sharp. The sharp end of the hook (15) faces in a direction for removing the trocar (7) from the cornea, i.e., in the outer direction of the eyeball (1).

[0045] A plurality of hooks (15) are arranged in rows in a vertical direction. In the illustrated example, a total of eight rows are formed along the outer circumference of the body portion (11). Alternatively, the hooks may be arranged in two to seven rows, or in nine or more rows. Furthermore, although the hooks forming each row (15) are arranged in a vertical direction, they may be arranged staggered.

[0046] When the tube (8) of the trocar (7) is inserted into the eyeball (1) by penetrating the cornea (3), the body (11) is inserted into the perforation (4). Then, when the tube (8) is pulled out from the cornea (3) to remove the trocar (7) after surgery, the hook (15) is caught by being stuck in the cornea (3), so the body (11) cannot move within the perforation (4). Therefore, the body (11) is separated from the tube (8) and remains within the perforation (4).

[0047] The sealing means serves to block the passage (13) of the body part (11) remaining within the perforation (4).

[0048] A sealing means comprises a plurality of elastic flaps (17). The elastic flaps (17) are provided at the lower portion of the body portion (11). The elastic flaps (17) are elastically deformed by an external force and can be restored to their original state when the external force is removed. The elastic flaps (17) are formed of an elastic material.

[0049] The elastic flap (17) is curved from the edge of the body part (11) toward the center of the body part (11). The elastic flap (17) is formed in a triangular shape whose width gradually narrows as it progresses toward the center of the body part (11). The ends of the elastic flaps (17) are formed to meet each other at one point. And the edges of the elastic flaps (17) are maintained in a state of contact with each other. Accordingly, the passage of the body part (11) is blocked by the elastic flaps (17).

[0050] When the tube part (8) is inserted into the body part (11), the tube part (8) passes through the passage (13) and forcibly pushes the elastic flap (17). Accordingly, the elastic flap (17) is forcibly bent and opens downward. When the tube part (8) is separated from the body part (11), the elastic flap (17) is restored to its original state and blocks the passage (13) of the body part (11).

[0051] The hook (15) and the elastic flap (17) may be formed integrally with the body portion (11). In addition, the hook (15) and the elastic flap (17) may be manufactured separately and then joined to the body portion (11). The hook (15) and the elastic flap (17) may be formed of the same material as the body portion (11).

[0052] The ophthalmic sealing device (10) of the present invention described above allows the perforation (4) formed in the cornea (3) to be filled during the process of removing the trocar (7), eliminating the need for a separate suturing process. Therefore, not only can the surgical time be shortened, but the perforation (4) can also be effectively blocked.

[0053] Meanwhile, if the body portion (11) is formed of a known super absorbent polymer, the elastic flap can be omitted. Super absorbent polymers absorb water tens to hundreds of times their own weight and swell. Cross-linked sodium polyacrylate can be used as such a super absorbent polymer. The body portion (11) formed of a super absorbent polymer can absorb moisture or vitreous fluid and swell, thereby self-sealing the passage (13) of the body portion (11).

[0054] Meanwhile, unlike the drawing, a passage may not be formed in the body portion (11). If the body portion (11) is formed of a soft, elastic material, the tube portion (8) can be forcibly inserted into the body portion (11). In this case, if the tube portion (8) penetrating the body portion (11) is separated from the body portion (11), the position through which the tube portion (8) penetrated is blocked by the elastic force of the body portion (11). If a passage is not formed in the body portion (11) in this way, the configuration of the elastic flap described above can also be omitted.

[0055] Meanwhile, as shown in Fig. 10, the present invention may further include a stopper ring (20).

[0056] The stopper ring (20) is formed of an elastic rubber material. The stopper ring (20) is formed in a ring shape and is connected to the tube portion (8) of the trocar (7). The stopper ring (20) is connected to the tube portion (8) so as to tightly tighten the tube portion (8), so that it is not easily moved even with a small external force. The stopper ring (20) limits the position of the body portion (11) connected to the tube portion (8) of the trocar (7).

[0057] For example, when the trocar (7) is removed from the cornea, the passage of the body (11) can be made sufficiently larger than the outer diameter of the tube (8) so that the body (11) can easily remain within the perforation of the cornea. In this case, when the trocar (7) is inserted into the eye, the body (11) coupled to the tube (8) cannot be inserted into the perforation of the cornea, but can be pushed upward along the tube (8) and pushed up to the head (9). However, when the stopper ring (20) is coupled to a specific position of the tube (8), the body (11) can be pushed up only to the stopper ring (20). Therefore, even if the passage of the body (11) is sufficiently larger than the outer diameter of the tube (8), it is easy to insert the body (11) into the perforation of the cornea if the position of the stopper ring (20) is appropriately adjusted.

[0058] Another example of a sealing means is illustrated in Fig. 11. The sealing means comprises a plurality of elastic flaps (19). The elastic flaps (19) are formed on the passage (13) of the body part (11) to block the passage (13).

[0059] When the tube is inserted into the body (11), the tube is forced to push the elastic flap (19). Accordingly, the elastic flap (19) is forcibly bent and spreads downward. Then, when the tube is separated from the body (11), the elastic flap (19) is restored to its original state and blocks the passage (13) of the body (11).

[0060] Another example of a sealing means is shown in Fig. 12.

[0061] The illustrated sealing means has an expansion portion (31) formed on the inner surface of the body portion (11). The expansion portion (31) is formed to protrude convexly from the inner surface of the body portion (11) toward the passage (13) to block the passage (13). This expansion portion (31) elastically opens when the tube portion passes through. When the tube portion is separated from the body portion (11), the expansion portion (31) is restored to its original state by elastic force to block the passage (13) of the body portion (11).

[0062] And, in order to promote deformation and restoration of the expansion portion (31), an empty internal space (33) may be formed on the inside of the expansion portion (31), and a cut line (35) connected to the internal space (33) may be formed on the upper part of the body portion (11). When the tube portion is inserted into the passage (13) of the body (11), the expansion portion (31) is compressed, and the air in the internal space (33) is discharged through the cut line (35), thereby facilitating deformation of the expansion portion (31). And, when the tube portion is separated from the body portion (11), the restoration of the expansion portion (31) may be promoted as air flows into the internal space (33) through the cut line (35).

[0063] While the present invention has been described with reference to one embodiment, this is merely exemplary, and those skilled in the art will understand that various modifications and equivalent embodiments are possible. Therefore, the true scope of protection of the present invention should be determined solely by the appended claims.

Claims

1. In an ophthalmic sealing device for filling a perforation formed in the cornea of ​​the eye by a trocar penetrating the cornea, A body part that is connected to the trocar and inserted into the perforation when the trocar penetrates the cornea; An ophthalmic sealing device for filling a perforation of the cornea formed by a trocar, characterized in that it comprises a holding portion formed on the body portion so that the body portion can be separated from the trocar and remain in the perforation when the trocar is removed from the cornea.

2. An ophthalmic sealing device for filling a perforation of the cornea formed by a trocar, characterized in that in the first paragraph, the holding portion is formed on the outer surface of the body portion and has a plurality of hooks that catch on the cornea when the trocar is removed.

3. An ophthalmic sealing device for filling a perforation of the cornea formed by a trocar, characterized in that in the second paragraph, the hooks protrude upwardly from the outer surface of the body portion in an inclined manner, and the ends of the hooks are formed to be pointed.

4. An ophthalmic sealing device for filling a perforation of the cornea formed by a trocar, characterized in that a passage is formed in the body portion so that the trocar can pass through the body portion in the first paragraph.

5. An ophthalmic sealing device for filling a perforation of the cornea formed by a trocar, characterized in that, in the fourth paragraph, the body part is provided with a passage sealing means so that the passage can be blocked when the trocar is separated from the body part.

6. An ophthalmic sealing device for filling a perforation of the cornea formed by a trocar, characterized in that in the fifth paragraph, the passage sealing means is formed in the body part to block the passage and has a plurality of elastic flaps that are elastically bent when the trocar passes through.

7. An ophthalmic sealing device for filling a perforation of the cornea formed by a trocar, characterized in that in paragraph 5, the passage sealing means is formed to protrude convexly from the inner surface of the body portion to block the passage and has an expansion portion that elastically opens when the trocar passes.

Citation Information

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