Non-surgical method for inserting aqueous humor outflow valve

Abstract

The present invention relates to a non-surgical method for inserting an aqueous humor outflow valve, wherein the aqueous humor outflow valve is manufactured using a shape memory polymer that is restored to the original state while reacting at the temperature of the human body, and thus the aqueous humor outflow valve can be inserted into a Tenon's capsule using a syringe without incising ocular tissue.

Description

Non-surgical drainage valve insertion procedure

[0001] The present invention relates to a non-surgical aqueous outflow valve insertion method that allows insertion of an aqueous outflow valve into the eye without incision of ocular tissue.

[0002] In general, glaucoma is a type of eye disease that occurs when the intraocular pressure (IOP) is high. The increase in intraocular pressure damages the appearance and function of the optic nerve, and if it persists, it can lead to loss of vision.

[0003] The cause of increased intraocular pressure is that the aqueous humor, a liquid that fills the inside of the eye, supplies nutrients and transports waste products (metabolites), is unable to drain out of the eye normally or is produced in abnormal amounts.

[0004] At this time, the representative structure through which the aqueous humor drains is the trabecular meshwork. As shown in Figure 1, when the trabecular meshwork, which acts as a drainage duct for the aqueous humor to drain, fails to function properly and the aqueous humor cannot drain, or when an abnormal amount of aqueous humor is produced, a trabeculectomy is performed to surgically cut out part of the trabecular meshwork and create a new path for the aqueous humor to drain.

[0005] Meanwhile, recently, in addition to the above trabeculectomy, a surgical method for inserting an aqueous outflow valve has been disclosed to artificially drain the aqueous humor within the eye by inserting an aqueous outflow valve into the eye.

[0006] Compared to trabeculectomy, the surgical method of inserting an aqueous outflow valve has the advantage of making it easier to control intraocular pressure and minimizing the possibility of secondary surgery and medication administration.

[0007] However, the above-mentioned surgical method of inserting a drainage valve also has the following problems.

[0008] The surgical method for inserting an aqueous outflow valve requires making a large conjunctival incision to insert the aqueous outflow valve into the eye, which can cause damage to Tenon's membrane.

[0009] Damage to Tenon's membrane, as described above, can cause endophthalmitis by exposing the aqueous outflow valve outside the eye, leading to infection due to the exposure of the aqueous outflow valve, and can also cause the aqueous outflow valve to detach from the eye, leading to failure of glaucoma control and the need for secondary surgery.

[0010] Furthermore, the aqueous outflow valve insertion surgical procedure requires suturing to secure the valve to the sclera. Improper needle depth control during the suturing process can lead to scleral perforation. Such scleral perforation can lead to complications such as retinal detachment, retinal hemorrhage, and choroidal hemorrhage, and can even lead to blindness.

[0011] In addition, the conventional method of inserting an aqueous outflow valve can cause the aqueous outflow valve to protrude convexly in a spherical shape (see Fig. 6), which not only makes the eyes look unsightly but also causes friction and erosion every time the eyelid is blinked, which can cause inflammation.

[0012]

[0013] (Prior art literature)

[0014] (Patent Document)

[0015] Republic of Korea Patent No. 10-1812246

[0016]

[0017] The purpose of the present invention is to provide a non-surgical method for inserting an aqueous outflow valve into the eye without incising the ocular tissue.

[0018] Another object of the present invention is to provide a non-surgical method for inserting an aqueous outflow valve, which can firmly support the aqueous outflow valve to the ocular tissue without damaging the ocular tissue when inserting the aqueous outflow valve.

[0019] Another object of the present invention is to provide a non-surgical method for inserting a drainage valve that does not require suturing following an incision surgery.

[0020] In order to achieve the object of the present invention, the present invention discloses a non-surgical method for inserting an aqueous humor outflow valve, comprising the steps of: (a) manufacturing an aqueous humor outflow valve using a shape memory polymer so that the shape of the aqueous humor outflow valve is restored at the body temperature of the human body; (b) compressing the shape memory polymer that remembers the aqueous humor outflow valve into a cylinder shape; (c) injecting the compressed aqueous humor outflow valve in the step (b) into the Tenon's capsule of the eye using a surgical means; and (d) injecting the aqueous humor outflow valve injected into the Tenon's capsule into the shape of the aqueous humor outflow valve in response to the body temperature of the human body.

[0021] At this time, the step (b) may include a process of heat treating and hardening the shape memory polymer.

[0022] In addition, the aqueous outflow valve is formed of a tube that is located in the anterior chamber of the eye and the trabecular meshwork of the eye where the aqueous humor is contained and forms a channel through which the aqueous humor flows out, and a check valve that is located inside the Tenon's capsule and discharges the aqueous humor flowing out through the tube in only one direction, and is formed of a plate having a width larger than the diameter of the tube, and the aqueous outflow valve may be formed of an injection type in which both sides of the plate are rolled toward the tube with the tube as an axis, and the diameters of the tube and the plate are the same and the injection can be performed through a needle of a syringe.

[0023] At this time, the direction in which the plate dries may be in front of the eye.

[0024] Additionally, at least the above-mentioned waterproof discharge valve may indicate the upper and lower positions of the plate, and may indicate the start and end points of the plate.

[0025] In addition, the tube is composed of a first region located in the anterior chamber of the eye, and a second region located inside the trabecular meshwork and the Tenon's capsule through the anterior chamber of the eye and connected to the plate, and the diameter of the first region can be formed larger than the diameter of the second region.

[0026] Additionally, the operator (doctor) can inject the shape memory polymer by inserting the needle of the syringe into the Tenon's capsule by piercing the cornea opposite the Tenon's capsule where the aqueous outflow valve is located.

[0027] The effects of the present invention obtained through the above-described solution are as follows.

[0028] First, the present invention manufactures an aqueous outflow valve using a shape-memory polymer material capable of remembering its shape at human body temperature, and the aqueous outflow valve made of the shape-memory polymer material can be injected into the eye via a syringe. Accordingly, the present invention can insert the aqueous outflow valve into the eye without a surgical incision, thereby preventing damage to ocular tissue due to incision and preventing complications due to ocular tissue damage.

[0029] Furthermore, the present invention can prevent damage to ocular tissue, and thus has the effect of firmly supporting the aqueous outflow valve to ocular tissue.

[0030] Second, the present invention eliminates the need for suturing to secure the drainage valve, thereby eliminating the risk of perforation and other complications that may arise during suturing. Accordingly, the present invention is effective in preventing complications resulting from ocular tissue perforation.

[0031] Third, since the present invention does not require the formation of an incision for inserting an aqueous outflow valve, it is possible to prevent the aqueous outflow valve from being exposed or protruding from the ocular tissue due to damage to ocular tissue such as Tenon's membrane tissue that may occur during the formation of the incision.

[0032] Accordingly, the present invention has the effect of preventing the appearance from being deteriorated due to exposure or protrusion of the waterproofing valve.

[0033] Figure 1 is a diagram showing a condition in which the trabecular meshwork is blocked and the aqueous humor in the eye cannot drain, to explain the cause of glaucoma.

[0034] Figure 2 is a drawing showing a waterproof discharge valve in plan view.

[0035] Figure 3 is a flowchart showing a non-surgical drainage valve insertion method according to a preferred embodiment of the present invention.

[0036] FIG. 4a is a plan view of a heat-treated drainage valve for a non-surgical drainage valve insertion procedure according to a preferred embodiment of the present invention.

[0037] FIG. 4b is a plan view showing a state in which a plate of a heat-treated drainage valve is rolled around a tube axis for a non-surgical drainage valve insertion procedure according to a preferred embodiment of the present invention.

[0038] FIG. 4c is a plan view showing a state in which a plate of a heat-treated drainage valve is rolled around a tube axis to make the diameter of the tube and the diameter of the plate the same, for a non-surgical drainage valve insertion procedure according to a preferred embodiment of the present invention.

[0039] FIG. 4d is a drawing showing one side of the aqueous outflow valve in a dried state, positioned on the tissue of the eye, for a non-surgical aqueous outflow valve insertion procedure according to a preferred embodiment of the present invention.

[0040] FIG. 4e is a drawing showing one side of the aqueous outflow valve, in which the dried aqueous outflow valve is restored to its shape memory on the tissue of the eye and adheres closely to the curvature of the tissue of the eye, through a non-surgical aqueous outflow valve insertion procedure according to a preferred embodiment of the present invention.

[0041] FIG. 5a is a drawing showing a state in which a syringe needle penetrates the cornea, passes through the trabecular meshwork, and is positioned in the Tenon's capsule on the opposite side of the Tenon's capsule where the aqueous outflow valve is positioned, for a non-surgical aqueous outflow valve insertion procedure according to a preferred embodiment of the present invention.

[0042] FIG. 5b is a drawing showing a state in which a syringe piston is operated to inject a drainage valve into a Tenon's capsule from a needle of a syringe for a non-surgical drainage valve insertion procedure according to a preferred embodiment of the present invention.

[0043] FIG. 5c is a drawing showing a state in which an aqueous outflow valve is injected into a Tenon's capsule through a trabecular meshwork from a needle of a syringe for a non-surgical aqueous outflow valve insertion procedure according to a preferred embodiment of the present invention.

[0044] FIG. 5d is a drawing showing a state in which an aqueous outflow valve inserted into a Tenon's cyst is restored to its original state through a non-surgical aqueous outflow valve insertion method according to a preferred embodiment of the present invention.

[0045] FIG. 6 is a drawing comparing an eye in which an aqueous outflow valve is inserted into a Tenon's capsule through a conventional aqueous outflow valve insertion surgical method and an eye in which an aqueous outflow valve is inserted into a Tenon's capsule through a non-surgical aqueous outflow valve insertion surgical method according to a preferred embodiment of the present invention.

[0046] Below, the non-surgical drainage valve insertion method is described in more detail with reference to drawings.

[0047] In describing the embodiments disclosed in this specification, if it is determined that a detailed description of a related known technology may obscure the gist of the embodiments disclosed in this specification, the detailed description is omitted.

[0048] The attached drawings are only intended to facilitate understanding of the embodiments disclosed in this specification, and the technical ideas disclosed in this specification are not limited by the attached drawings, and should be understood to include all modifications, equivalents, or substitutes included in the spirit and technical scope of the present invention.

[0049] In the following description, singular expressions include plural expressions unless the context clearly indicates otherwise.

[0050] In this application, terms such as “include” or “have” are intended to specify the presence of a feature, number, step, operation, component, part or combination thereof described in the specification, but should be understood not to exclude in advance the possibility of the presence or addition of one or more other features, numbers, steps, operations, components, parts or combinations thereof.

[0051] Hereinafter, a non-surgical drainage valve insertion method according to a preferred embodiment of the present invention will be described with reference to the attached drawings 2 to 6.

[0052] The aqueous outflow valve is inserted into the Tenon's capsule through the trabecular meshwork in the anterior chamber of the eye, and serves to artificially drain the aqueous humor accumulated in the anterior chamber into the Tenon's capsule.

[0053] The waterproof leak valve may be composed of a tube (100) and a plate (200), as shown in FIG. 2.

[0054] The tube (100) forms a conduit through which the aqueous humor flows out of the anterior chamber, and may be formed in a straight shape. At this time, the tube (100) may be divided into a first region (110) located in the anterior chamber when the aqueous humor outflow valve is inserted into the eyeball, and a second region (120) inserted into the trabecular meshwork.

[0055] At this time, the diameter of the first region (110) may be formed to be larger than the diameter of the second region (120). With this configuration, the aqueous outflow valve inserted into the eye can be prevented from easily being detached from the eye. A detailed description of this will be provided later.

[0056] Meanwhile, the plate (200) allows the aqueous humor flowing out through the tube (100) to flow out into the Tenon's sac, and can control the amount of aqueous humor flowing out. That is, the plate (200) reduces the inner diameter of the nozzle where excessive aqueous humor flows out, and when the amount of aqueous humor flows out decreases, the inner diameter of the nozzle is restored, thereby controlling the amount of aqueous humor flowing out (negative feedback).

[0057] In addition, the plate (200) includes a check valve (not shown) that allows the outflow of waterproof water to occur only in one direction, and has a width that is larger than the diameter of the tube (100). The configuration and operating principle of this plate (200) can be applied to a plate configured by a known waterproof outflow valve.

[0058] Meanwhile, the above-mentioned waterproof leak valve can be manufactured from a shape memory polymer (SMP) material.

[0059] The shape memory polymer material for manufacturing the above waterproof leak valve can be %PCL-co%PGMA (PCL: polycaprolactone, PGMA: polyglycidil metacrylate). As can be seen in Table 1 below, the higher the PGMA component, the lower the melting point. Therefore, the optimal ratio for the shape memory polymer material to be restored to the shape of the waterproof leak valve at a melting point near 36.5 degrees, which is the temperature of the human body, is 89% PCL and 11% PGMA.

[0060] X%PCL-y%PGMACL(mmol)GMA(mmol)HQ(mmol)GMA(%)T m (℃XT m (℃) Comparative Example 100%PCL 100---52.453.7 Example 194%PCL-6%PGMA 90 1016.145.241.4 Example 292%PCL-8%PGMA 86 141.48.140.439.3 Example 390%PCL-10%PGMA 82 181.810.639.636.0 Example 488%PCL-12%PGMA 78 222.212.035.628.4

[0061] Meanwhile, the manufacturing process of a waterproof leak valve using a shape memory polymer material is as follows. The manufacturer first manufactures a waterproof leak valve that can be shaped and restored at 36.5℃, which is the temperature of the human body, using a shape memory polymer material. At this time, the waterproof leak valve can be manufactured through a casting method. (S100) At this time, FIG. 4a shows a plane of a completed waterproof leak valve, and it can be seen that the second region (120) of the tube (100) is manufactured to have a smaller diameter than the first region (110) of the tube (100). In addition, the plate (200) can be formed to be round so as to correspond to the curvature of the eyeball, as illustrated in FIG. 4e.

[0062] Meanwhile, the manufacturer heat-treats the waterproof drain valve illustrated in Fig. 4a to compress the waterproof drain valve into a syringe-type cylinder shape, as illustrated in Figs. 4b to 4d. (S200)

[0063] At this time, it is preferable that the heat treatment temperature be 60℃.

[0064] That is, when a waterproof leakage valve manufactured at the temperature of the human body is heat-treated at a high temperature, deformation of the waterproof leakage valve becomes possible. The manufacturer compresses and deforms the heat-treated waterproof leakage valve into a cylinder shape by rolling both sides of the plate (200) around the tube (100) as an axis, as shown in FIGS. 4b to 4d. At this time, the cylinder-shaped waterproof leakage valve is made of a syringe type in which the diameter of the plate (200) and the diameter of the tube (100) are the same so that the valve can be drawn out through the needle of the syringe (S).

[0065] At this time, the direction in which the plate (200) dries is preferably above the waterproof drain valve, as can be seen from FIGS. 4a to 4d. At this time, the upper side of the waterproof drain valve refers to the front of the eye, as shown in FIGS. 4d and 4e.

[0066] That is, in order to prevent the aqueous outflow valve from being turned over during the process of being restored after being inserted into the eye, it is preferable to roll in the same direction on both sides of the plate (200) toward the upper side of the plate (200) as shown in FIG. 4d.

[0067] At this time, in order to prevent the top and bottom of the plate (200) from being changed during the process of inserting the waterproof drain valve, it is preferable for the operator to mark the upper surface of the plate (200) rolled in a syringe shape with an easily identifiable red dot or the like.

[0068] Next, the waterproof discharge valve compressed into a cylinder shape as described above is hardened. At this time, the hardening time of the waterproof discharge valve may be approximately 3 minutes, and the hardened, rigid waterproof discharge valve can maintain its cylinder shape.

[0069] Next, the surgeon uses a surgical tool to insert a hardened cylindrical aqueous outflow valve into the patient's eye. (S300) At this time, the surgical tool may be a medical syringe.

[0070] In detail, as shown in Fig. 5a, the surgeon inserts the needle of the syringe (S) into the Tenon's capsule through the anterior chamber of the eye, through the trabecular meshwork, and into the Tenon's capsule by piercing the cornea 2 mm away from the limbus, which is the boundary between the cornea and the conjunctiva, on the opposite side of the Tenon's capsule where the aqueous outflow valve is to be positioned.

[0071] Next, the surgeon pushes the piston of the syringe (S) to inject the aqueous discharge valve inside the syringe (S) into the Tenon's sac, as shown in Figure 5b. (S400)

[0072] At this time, the surgeon marks the start and end points of the plate (200) that is rolled up in a syringe shape and performs the procedure until the plate (200) is sufficiently inserted into the Tenon's sac.

[0073] For example, if the drainage valve is inserted excessively into the Tenon's capsule, the entire tube (100) including the first region may be inserted into the trabecular meshwork, and if the drainage valve is inserted insufficiently, the plate (200) may be restored before being inserted into the Tenon's capsule. Therefore, the insertion position of the drainage valve is very important, and therefore, it is desirable to mark the start and end points of the plate (200) so that the surgeon can easily recognize the position of the plate (200).

[0074] Thereafter, the plate (200) of the aqueous outflow valve is injected into the inside of the Tenon capsule, as shown in FIG. 5c, and the tube (100) is positioned in front of the eye through the trabecular meshwork.

[0075] Next, the surgeon removes the needle of the syringe inserted into the eye from the eye.

[0076] Afterwards, the aqueous outflow valve inserted into the eye tissue restores its shape memory at 36.5℃, the body temperature. (S500)

[0077] That is, the waterproof drain valve, which was rolled up in a cylinder shape, is restored to its original state inside the Tenon cyst as shown in FIGS. 4d and 4e.

[0078] At this time, since the first area (110) of the tube (100) and the plate (200) are formed to have a larger diameter than the second area (120) of the tube (100), the waterproofing valve is firmly fixed to the tissue of the eye, as shown in FIG. 5d.

[0079] That is, the aqueous outflow valve can be firmly supported within the tissue of the eyeball by having the first region (110) of the tube (100) be supported by being caught in the trabecular meshwork and the plate (200) be supported by being caught in the Tenon capsule.

[0080] Accordingly, the present invention may not cause complications due to displacement of the aqueous outflow valve, and, as shown in FIG. 6, unlike the prior art, the aqueous outflow valve can be smoothly operated without protruding from the eyeball.

Claims

1. (a) A step of manufacturing a waterproof leak valve using a shape memory polymer so that the shape of the waterproof leak valve is restored at body temperature of the human body; (b) a step of compressing a shape memory polymer that remembers the above-mentioned waterproof leak valve into a cylinder shape; (c) a step of injecting the compressed aqueous outflow valve in step (b) into the Tenon capsule of the eye using a surgical means; and (d) The aqueous outflow valve injected into the above-mentioned Tenon cyst includes a step of restoring the shape of the aqueous outflow valve in response to the body temperature of the human body. Non-surgical drainage valve insertion method 2. In paragraph 1, The above step (b) is characterized by including a process of heat treating and hardening the shape memory polymer. Non-surgical drainage valve insertion method.

3. In paragraph 1, The waterproof discharge valve of step (b) above, A tube located in the anterior chamber of the eye and the trabecular meshwork of the eye, which stores the aqueous humor, and forms a channel through which the aqueous humor flows out; It is located inside the above-mentioned Tenon cyst and includes a check valve that discharges the aqueous humor flowing out through the tube in only one direction, and is made of a plate having a width larger than the diameter of the tube. The above waterproofing valve is characterized in that both sides of the plate are rolled toward the tube with the tube as the axis, and the tube and the plate are provided in the form of a cylinder with the same diameter, so that the injection can be performed through a syringe needle. Non-surgical drainage valve insertion method.

4. In paragraph 3, The direction in which the above plate dries is characterized by being in front of the eyeball. Non-surgical drainage valve insertion method.

5. In paragraph 3, At least the waterproof discharge valve is characterized in that the upper and lower positions of the plate are indicated and the start and end points of the plate are indicated. Non-surgical drainage valve insertion method.

6. In paragraph 3, The above tube, It is composed of a first region located in the anterior chamber of the eyeball, and a second region located inside the trabecular meshwork and the Tenon's capsule through the anterior chamber of the eyeball and connected to the plate. The diameter of the first region is characterized in that it is formed larger than the diameter of the second region. Non-surgical drainage valve insertion method.

7. In paragraph 1, The operator (doctor) inserts the needle of the syringe into the Tenon's capsule by piercing the cornea opposite to the Tenon's capsule where the aqueous outflow valve is located, thereby injecting the shape memory polymer. Non-surgical drainage valve insertion method.

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