KR100323807B1 - A novel valve implant which is used for treatment of glaucoma and injection apparatus thereof - Google Patents

Abstract

The present invention relates to a waterproof outflow device for glaucoma treatment and its insertion mechanism for adjusting the intraocular pressure by outflowing the waterproof in the eye, specifically, the conduit flow path when the proper intraocular pressure abnormality in the inside of the conduit that communicates the inside and outside of the eye. Preventing hypotension after surgery by installing an open valve-type check valve, forming a conduit with a length similar to the thickness of the cornea of the eye and forming a fixed wing on the outer periphery of the tube Minimization and prevention of catheter insertion into the eye, and insertion of the waterproof drainage device immediately after the conjunctival detachment through the corneal limbus, so the procedure is simple and the operation is performed near the corneal limbus so that the catheter enters through the cornea. In order to facilitate the procedure for removing the catheter and reforming the filter cloth when fibrosis of the filter cloth occurs or a problem occurs after the surgery Will.

Description

A novel valve implant which is used for treatment of glaucoma and injection apparatus

The present invention relates to a waterproof outflow apparatus and its insertion mechanism for adjusting the intraocular pressure by outflowing the waterproof in the glaucoma treatment and the like.

More specifically, by installing a valve-type check valve to open the conduit passage in case of abnormal intraocular pressure in the inside of the conduit that communicates the inside and outside of the eye, it prevents hypotension occurring after surgery and shortens the length of the conduit. Minimize the incidence of catheter closure and form a fixed wing on the outer periphery of the catheter to prevent the catheter movement after insertion of the eye, and to facilitate the removal of the catheter after fibrosis or postoperative problem The present invention relates to a waterproof outflow device for adjusting intraocular pressure, and an insertion mechanism for accurately and easily inserting the waterproof outflow device into an eyeball.

Glaucoma refers to a condition in which intraocular pressure increases due to a disorder of local or central IOP, and causes eye failure and anatomical lesions. It is called primary glaucoma that occurs without other eyelids that may be a direct cause, and secondary glaucoma is called secondary glaucoma.

Neovascular glaucoma is a disease in which the blood vessels of the posterior eye, such as diabetic retinopathy, retinal vein occlusion, carotid artery disease, hypertension, etc., develop neovascularization in the anterior, especially the iris, and the intraocular pressure is elevated by blocking the fibroblasts. Before the etiology of neovascular glaucoma was established, many patients with severe pain and loss of vision had been treated with posterior alcohol injection or ocular extraction just to improve symptoms. On the other hand, many studies have now been accepted as the etiology of the ischemia of the rear eye, based on which various treatment methods have been developed. First, it is known that sufficient panretinal laser coagulation can induce the production of neovascularization factors in the posterior eye, and induce neovascular degeneration by preventing migration to the anterior eye (Branch Retinal Occlusion Study Group, Argon laser scatter photocoagulation for prevention of neovascularization, Arch.Ophthalmol., 1986, 104: 34-41). In practice, however, laser treatment is often impossible due to clouding of the medium. If the anterior chamber is closed and there is a constant intraocular pressure increase, filtration, ciliary cryotherapy, laser destruction of the ciliary body, ciliary diarrhea can be performed. However, these procedures have a high failure rate due to poor intraocular pressure control or a high incidence of complications, and it is reported that ciliary cryotherapy is not desirable because of wide-angle loss and ocular atrophy (Krupin T. et al., Cyclocryotherapy in neovascular). glaucoma.Am J. Ophthalmol., 1978, 86: 24-26). On the other hand, the method of destroying the ciliary body with a laser has the advantage of being relatively simple and non-invasive, but requires expensive equipment, difficult to calculate a quantified formula for predicting the result, and high re-treatment rate. In addition, maximal drug therapy or conventional filtration surgery is used, and even with maximal drug therapy, intraocular pressure is not well controlled, and even if controlled, it cannot be used continuously due to side effects of the drug, and the effect is temporary. Conventional filtration surgery has been reported to have a high risk of bleeding during or after surgery, obstruction of the periphery due to continuous fibrovascular proliferation, and very low success rate due to excessive wound healing (Allen RC, et al., Filtration surgery). in the treatment of neovascular glaucoma, Ophthalmology, 1982, 89: 1181-1187). Accordingly, the success rate has been increased by performing trabeculectomy or modified trabeculectomy in combination with mitomycin C.

Primary open-angle glaucoma, false scale glaucoma, and pigmented glaucoma have been shown to have a relatively high success rate of 70-90% with trabeculectomy, but primary congenital glaucoma, iris corneal endothelial syndrome, neovascular glaucoma, secondary glaucoma due to uveitis, and trabeculectomy Failed glaucoma and glaucoma after penetrating keratoplasty are known to have a low success rate with conventional trabeculectomy.

In another way, tube-based glaucoma treatment devices have been developed, such as waterproof bypass devices. The artificial drainage device was first developed by Zolab in 1912 and has been improved since 1969 with a Malteno implant.It is widely used around the world, with low intraocular pressure, low vision loss, and intraocular pressure control. It is known to be better than the method. However, the waterproof drainage devices without a valve system to prevent hypotension caused a lot of complications such as hypotony and its complications, such as anterior loss and choroidal detachment. Therefore, to prevent hypotony, temporarily tie the tube, cut the tube with a laser, two-stage surgery to induce water leakage after several days after forming the filter cloth, and put the thread in the silicone tube and remove it later. In addition, methods have been developed to inject viscoelastic materials or gases to the front. However, these methods have the disadvantage of being exposed to high pressure before opening the tube and the troublesome operation.

To overcome this problem, waterproof drainage devices with various valve systems have been developed, modified, and supplemented to prevent low intraocular pressure and subsequent complications after surgery. One of their common features is that they have a waterproof tube made of flexible silicone rubber, and that the equatorial explant consists of a material that prevents fibroblasts from firmly attaching. Waterproof drainage device, a glaucoma treatment device that is mainly used in recent years, is a device that allows waterproofing to flow from the front without limiting the flow of waterproofing, such as Molteno, Socket, Baerveldt and valves or membranes, or It is classified as Krupin, Joseph, White, Optitimed, Ahmed, etc., which are resistant to water flow due to the resistance material.Molteno Implant glucoma valve implants with valves or valves are increasingly used.

However, such a conventional artificial waterproof organ is known to cause hypotension, fibrosis of the filter cloth for subconjunctival filtration, vascular obstruction, tube migration, cataracts, retinal detachment, malignant glaucoma, endophthalmitis, eyeball as a complication. have. There are several causes of this failure, the first of which is due to the loss of vision due to the worsening of the underlying disease, the second because of ocular atrophy, and finally, the formation of fibrous sac and the waterproofing through the fibrous wall. This is because passive passive flow is blocked, causing a sustained intraocular pressure elevation. Low intraocular pressure is also thought to be due to the presence of a leak of water around the silicone tube or to the reduction of the generation of water. In order to prevent this, the method of lengthening the path through which the silicon tube passes forward and the method of reducing the diameter of the needle used to make the front puncture have been used.However, the silicone tube produced by the fibrin, blood clot, iris, and vitreous body has been used. Closure has been pointed out as a big problem.

Recently, valve implantation, which is widely performed, is divided into non-restrictive implants and restrictive implants. Non-limiting inserts are the most representative of the moleno valve (Moleno valve), the most restrictive inserts are Ahmed valve (Ahmed valve).

First, the Morteno valve consists of a 13 mm diameter silicone tube (exhaust tube) and an acrylic plate (or silicone plate) that acts as a reservoir, and drains the waterproofing from the front to the reservoir under the Tenon's capule through the limbus. Device. This prevents the closure due to fibrosis by inserting the rear outlet of the tube into the reservoir, and because the subconjunctival space is large, more water can be discharged and the effect of intraocular pressure drop is greater. In addition, because the reservoir is under the tenon bag, the conjunctiva is less damaged by the drainage device. However, complications such as low intraocular pressure, anterior shallowening, and contact between the tube and the corneal endothelium have problems in most patients immediately after surgery. Backflow from the reservoir into the front has also been pointed out as a problem.

The Ahmed valves, on the other hand, consist of a polypropylene Western pear reservoir (13 mm x 16 mm x 1.9 mm) and a 25 mm silicone outlet. The main feature of this valve is the presence of a membrane-type check valve in the reservoir that only opens at 8-12 mmHg. This reduces the risk of hypotony immediately after surgery. It also reduces the risk of backflow present in the Morteno valves. However, the long silicone tube caused the risk of closure of the tube due to the postoperative fibrin, blood clots, irises and vitreous bodies, and the adhesion between the tube and the surrounding tissues makes it difficult to remove the closed tube.

Therefore, the present inventors have studied to solve the problems of the above-described waterproofing device for glaucoma treatment, prevent hypotension after surgery, minimize the incidence of vascular obstruction, easy surgery and reoperation, less movement of the catheter The present invention has been completed by developing a new waterproofing device and an insertion mechanism capable of accurately and easily inserting the same into an eyeball.

Therefore, the present invention is conceived to solve the problems that the conventional waterproof outflow device for adjusting the intraocular pressure as described above, the first object is a waterproof outflow for intraocular pressure adjustment to prevent hypotension occurring after surgery To provide a device.

In addition, the second object of the present invention is to provide a waterproof outflow device for adjusting the intraocular pressure to prevent the movement of the conduit after the eye insertion and at the same time to minimize the incidence of tube closure.

In addition, the third object of the present invention is to provide a waterproof outflow device for the adjustment of the intraocular pressure to facilitate the insertion surgery, the removal of the conduit in the case of fibrosis of the filter cloth or post-operative problems that occur after the operation, the procedure for reforming the filter cloth. have.

Finally, a fourth object of the present invention is to provide an insertion mechanism of a waterproof outlet device for intraocular pressure adjustment that allows the waterproof outlet device to be accurately and easily inserted into the eye.

1 is a partial cutaway cross-sectional view of the eyeball is inserted a waterproof outflow device for adjusting the intraocular pressure according to an embodiment of the present invention.

2 and 3 show the operation of the check valve according to the internal structure and intraocular pressure of the waterproof outflow device for intraocular pressure adjustment according to an embodiment of the present invention,

Figure 2a is a state in which the check valve is closed.

2B is a cross-sectional view taken along the line A-A of FIG. 2A.

Figure 3a is a state in which the check valve is closed.

3B is a cross-sectional view taken along the line B-B in FIG. 3A.

Figure 4 is a partial cutaway cross-sectional view showing the insertion mechanism of the waterproof outflow device for adjusting the intraocular pressure according to an embodiment of the present invention.

5 is an exploded perspective view of the insertion mechanism shown in FIG.

Explanation of symbols on the main parts of the drawings

100: waterproof discharge device 110: conduit

111: conduit flow path 120: check valve

121: distribution hole 130: fixture

131: backing fixed blade 135: surface support fixed blade

200: insertion mechanism 210: metal needle

211: awl blade 213: male thread

220: connecting rod 221: female thread

In order to achieve the first object described above, the present invention provides a waterproof discharge device for intraocular pressure adjustment in which a check valve for opening and closing a conduit flow path in accordance with a predetermined intraocular pressure is installed in a conduit for communicating the inside and outside of the eye in a straight line.

In addition, the check valve has a distribution hole in the center of the elastic valve, preferably configured to open the distribution hole when the intraocular pressure is 20 mmHg or more.

In order to achieve the second object of the present invention, the conduit is formed with a length close to the thickness of the cornea of the eyeball, and provides a waterproof outflow device for intraocular pressure control is formed a plurality of fixtures on the outer periphery of the conduit.

At this time, the length of the conduit is made of 1.5 ~ 2.0mm and the diameter is made of 0.4 ~ 0.7mm, the fixture is a retrograde anti-tip fixed wing and the conduit protruding in a pin shape to the rear on the outer circumference of the conduit It is preferable that it is composed of a surface-supported fixed blade protruding in a flange shape at the rear end of the support to support the outer surface of the eyeball.

In addition, the conduit should be made of a material that is flexible and harmless to the human body, and in order to prevent the blockage of the tube due to fibrosis by attaching fibroblasts, polymethylmethacrylate, polypropylene, silicone rubber It is preferable to use (silicon rubber) or the like. In addition, when applied to the eyes that tend to bleed, heparin-treated silicone tube can be used to prevent the tube from clogging, and after the sterilization of the conduit with ethylene oxide (ethylene oxide) gas for antibacterial treatment It is preferable to use.

In order to achieve the third object, the present invention provides a waterproof discharge device for adjusting intraocular pressure in which a conduit having the check valve and the fixture is inserted into the limbal portion. The check valve is preferably manufactured to a length of about 0.25 mm and a thickness of 0.1 ~ 0.15 mm so that the passage can be opened when the intraocular pressure is 20 mmHg or more, the position is ± 1 of the total length from the center or the center of the waterproof outlet conduit It is preferable that it is / 4. Like the conduit, the material of the check valve may be polymethylmethacrylate, polypropylene, silicone rubber, or the like.

In order to achieve the fourth object, the present invention provides a mechanism for inserting a waterproof discharge device having a configuration in which a check valve for opening and closing a conduit flow path in accordance with an operating pressure in the conduit and protruding to a fixture on an outer circumference thereof, It is inserted in close contact with the conduit and provides an insertion mechanism of the waterproof discharge device including a metal needle to form an auger blade in the front, and a connecting rod screwed to the rear end of the metal needle.

Hereinafter, an embodiment of the present invention will be described in more detail based on the accompanying drawings.

1 is a partial cutaway cross-sectional view of the eyeball 1 is inserted into the waterproof outlet device 100 for adjusting the intraocular pressure in accordance with an embodiment of the present invention, Figures 2 and 3 are for adjusting the intraocular pressure in accordance with an embodiment of the present invention It is a cross-sectional view showing the waterproof outflow apparatus 100 in detail.

As shown, the waterproof outflow apparatus 100 for adjusting the intraocular pressure according to an embodiment of the present invention is a conduit 110 to communicate the inside and outside of the eyeball 1 and the flow path of the conduit 110 according to the intraocular pressure And a check valve 120 for opening and closing the 111 and a fixture 130 for fixing the conduit 110 to the eyeball 1.

In other words, the conduit 110 is formed of a circular tube and formed to have a length close to the corneal thickness of the eyeball 1 so as to communicate linearly inside and outside the eyeball 1. The length of the conduit 110 is slightly different depending on the eyeball 1, and consists of approximately 1.5 to 2.0 mm, and has a diameter of 0.4 to 0.7 mm. In addition, the conduit 110 is inserted into the circumference of the cornea 3 of the eyeball 1 in consideration of the insertion surgery in the eyeball 1, the removal of the conduit 110, and a procedure for reforming the filter cloth.

Then, the check valve 120 is made of a flexible valve structure has a distribution hole 121 for communicating the conduit 110 in the center. When the intraocular pressure in the eyeball 1 reaches an appropriate value, that is, 20 mmHg or more, the distribution hole 121 is opened and expanded as shown in FIGS. 3A and 3B in a closed state as shown in FIGS. 2A and 2B to be waterproofed in the eyeball 1. It will be leaked to the outside, and in a state lower than 20mmHg will remain closed to block the leakage of waterproof. At this time, the check valve 120 has a length of about 0.25 mm and is preferably manufactured to a thickness of 0.1 ~ 0.15 mm, it can be located at a quarter of the total length ± ± from the center or the center of the conduit 110.

In addition, the fastener 130 is a means for preventing the short conduit 110 from moving in and out of the eyeball 1 by the intraocular pressure and the movement of the eyeball 1, and the like. 1) back check fixing blade 131 to suppress the movement from the side to the outside, and the back check fixing blade 131, as well as to prevent the conduit 110 to move to the inside of the eye (1), as well as the conduit 110 It is composed of a surface support fixed blade 135 to determine the complete insertion position of the).

Here, the non-returning fixed blade 131 is formed of a pin-shaped pickaxe structure having an inclination angle rearward on the outer circumference of the conduit 110, the surface supporting fixed blade 135 is flanged to the rear end of the conduit 110. It protrudes and consists of the structure which supports the corneal surface of the eyeball 1. In the figure, reference numeral 4 is the iris, 5 is the sclera, 6 is the lens, and 7 is the conjunctiva.

4 and 5 show a waterproof outflow device insertion mechanism 200 according to an embodiment of the present invention for inserting the waterproof outflow device 100 as described above to the eyeball (1). As shown in the waterproof outlet device insertion mechanism 200, a metal needle 210 for puncturing the cornea of the eyeball 1, like the conduit 110, and a connecting rod 220 for long connecting the metal needle 210. It is composed of

The metal needle 210 has a diameter that is inserted in close contact with the inner side of the conduit 110, and a cone-shaped awl blade 211 is formed at the front end, and a male screw portion 213 is formed at the rear end. In addition, the connecting rod 220 is formed with a female threaded portion 221 coupled to the male threaded portion 213 of the metal needle 210, the length of which may be formed in various sizes for ease of use.

Looking at the operation of the waterproof outflow device 100 after the insertion procedure and the operation of the waterproof outflow device 100 in the embodiment of the present invention configured as described above are as follows.

First, in order to insert the waterproof drainage device 100 into the eyeball 1, the metal needle 210 of the insertion mechanism is inserted into the conduit 110 of the waterproof drainage device 100 as shown in FIG. 4. do. At this time, the metal needle 210 is in close contact with the inner circumferential surface of the conduit 110 while expanding the distribution hole 121 of the check valve 120 located in the conduit 110.

Then, the conjunctiva 7 of the portion covering the limbus portion of the cornea 3 of the eyeball 1 is peeled off, and then the metal needle 210 to which the waterproof drainage device 100 is coupled is connected to the cornea using the connection portion of the insertion mechanism. It is inserted in the rim of (3). The metal needle 210 stops insertion when the surface support fixing blade 135 positioned at the rear end of the conduit 110 comes into contact with the surface of the cornea 3, and then pulls in the opposite direction to the insertion. At this time, since the waterproof outflow apparatus 100 is fixed to the cornea by the anti-backing fixed blade 131 of the pickaxe structure formed on the outer circumference of the conduit 110, it is separated from the metal needle 210 and separated into the cornea 3. Will be located.

Then, when the peeled portion of the conjunctiva 7 is sewn and closed, the insertion procedure of the waterproof drainage device 100 is completed.

In this way, looking at the waterproof outflow device 100 inserted into the eyeball 1, as shown in Figures 2a and 2b, the pressure in the eyeball 1, that is acting on the check valve 120 of the waterproof outflow device 100 For example, when the pressure P1 is lower than 20 mmHg, the distribution hole 121 of the check valve 120 maintains the closed state, thereby preventing the waterproofing in the eyeball 1 from flowing out through the conduit 110. Done. The closing action of the check valve 120 prevents hypotension of the eyeball 1 due to excessive leakage of water through the conduit 110 after the insertion of the waterproof outlet 100.

3A and 3B, when the pressure P2 acting on the check valve 120 of the waterproof outlet device 100 becomes 20 mmHg or more, the flow hole 121 of the check valve 120 is in a closed state. It opens as it expands. At this time, since the waterproof in the eyeball 1 flows out through the conduit 110, it maintains the proper intraocular pressure in the eyeball (1).

As described above, the present invention can prevent hypotension occurring after surgery by configuring a check valve that is opened and closed in accordance with intraocular pressure inside the conduit.

In addition, the present invention can minimize the incidence of tube closure by forming a conduit with a short length close to the thickness of the cornea, and also to prevent the movement of the conduit after inserting the eye by forming a movement preventing fixture on the outer circumference of the conduit. do.

In addition, the present invention is a waterproof drainage device is inserted immediately through the limbal conjunctiva after the detachment of the conjunctiva, the procedure is easy, and the operation is performed near the limbal limbus so that the catheter enters through the cornea, so that the fibrosis of the filter cloth that occurs after the operation or a problem after the operation Removal, and the procedure for reforming the filter cloth is easy.

Finally, the present invention can be accurately and easily inserted into the eyeball by using the insertion mechanism consisting of a metal needle and a connecting rod.

While the invention has been shown and described with respect to particular embodiments, those skilled in the art will recognize that various modifications and changes can be made without departing from the spirit and scope of the invention as indicated by the appended claims. Anyone can easily know.

Claims (10)

And a check valve for opening and closing a conduit flow path in accordance with a predetermined intraocular pressure in a conduit for communicating the inside and outside of the eye in a straight line. The method of claim 1, The check valve has a flow hole in the central portion of the valve having a stretch, waterproof discharge device for intraocular pressure control, characterized in that configured to open the flow hole when the intraocular pressure is 20mmHg or more. The method of claim 1, The conduit is formed with a length close to the thickness of the cornea of the eyeball, a waterproof outflow device for intraocular pressure control, characterized in that a plurality of fasteners are formed protruding on the outer circumference. The method of claim 1, The conduit is waterproof discharge device for intraocular pressure control, characterized in that made of a material of polymethyl methacrylate, polypropylene or silicone rubber. The method of claim 1, Waterproofing device for intraocular pressure control, characterized in that the treatment of heparin inside the conduit. The method of claim 1, Waterproofing device for intraocular pressure control, characterized in that the disinfection with ethylene oxide (ethylene oxide) gas to prevent infection of bacteria or the like inside or outside the conduit. The method of claim 3, wherein The length of the conduit 110 is made of 1.5 ~ 2.0mm, the diameter of the waterproof discharge device for intraocular pressure control, characterized in that consisting of 0.4 ~ 0.7mm. The method of claim 3, wherein The fastener 130 has a backward preventing fixed wing 131 protruding in the pin phenomenon with an inclination angle rearward on the outer circumference of the conduit 110, and protrudes in a flange shape at the rear end of the conduit 110 to the eyeball ( Waterproofing device for intraocular pressure adjustment, characterized in that it comprises a surface support fixed blade (135) for supporting the outer surface of 1). The method according to any one of claims 1 to 8, The conduit 110 is waterproof leakage device for intraocular pressure control, characterized in that inserted into the limbal portion. In the conduit 110, a check valve 120 for opening and closing the conduit flow path 111 is installed in accordance with the working pressure, and the waterproof outflow device having a configuration protruding from the fixture 130 on the outer circumference is inserted into the eyeball 1. In the apparatus, The metal needle 210 is inserted in close contact with the conduit 110 and forms an awl blade 211 in front, and a connecting rod 220 screwed to a rear end of the metal needle 210. Insertion mechanism of waterproof drainage device.