KR20160030766A - Intraocular pressure device and method of using the same - Google Patents

Abstract

Provided is an intraocular pressure device which is inserted into an eyeball to extract body fluid and adjust the intraocular pressure, so as to be used for glaucoma treatment, etc. The intraocular pressure device is attached to the surface of the eyeball and applied to drain body fluid. The intraocular pressure device comprises: (i) a flap valve; (ii) a drainage tube connected to the flap valve; and (iii) a plurality of hydrogels spaced apart from each other in the drainage tube.

Description

TECHNICAL FIELD [0001] The present invention relates to an intraocular pressure (IOP) regulating device,

The present invention relates to an intraocular pressure regulating device. More particularly, the present invention relates to an intraocular pressure (IOP) regulating device for injecting body fluids into the eyeball for use in the treatment of glaucoma and the like, and to regulate the intraocular pressure.

Glaucoma (glaucoma) is caused by damage to the optic nerve or blood supply due to elevated intraocular pressure, resulting in abnormal function of the optic nerve. If the optic nerve breaks down, visual field defects appear, and at the end of the day, vision is lost.

There is laser-assisted ciliary decompression and conventional filtration surgery to prevent intraocular pressure rise which is the cause of glaucoma. However, the method of destroying the ciliary body using the laser requires expensive equipments, and it is difficult to calculate the quantified formula for predicting the result, and the retreatment rate is high. In addition, conventional filtration surgery is highly risky of postoperative or postoperative hemorrhage, and the right wing can be closed due to continuous fibrovascular proliferation.

The present invention provides an intraocular pressure (IOP) regulating device capable of inserting an intraocular lens and discharging body fluid to control the intraocular pressure. The present invention also provides a method of using the above-described intraocular pressure regulating device.

The intraocular pressure regulating device according to an embodiment of the present invention includes i) a flap valve, ii) a drain tube connected to the flap valve, and iii) a plurality of hydrogels spaced apart from each other in the drain tube.

The hydrogels of the plurality of hydrogels may each have through holes extending along the arrangement direction of the plurality of hydrogels, and the diameters of the through holes may be substantially equal to each other. The plurality of hydrogels include a first hydrogel formed with i) a first through hole extending long along the arrangement direction of the hydrogels, and ii) a first hydrogel separated from the first hydrogel and extending in a direction parallel to the long direction of the first through hole And a second hydrogel having a through-hole formed therein. The first hydrogel may be located closer to the flap valve than the second hydrogel, and the diameter of the first through-hole may be less than the diameter of the second through-hole.

The flap valve may include a flap portion, i) a base, ii) a protrusion located on the base, and iii) a flap portion located on the protrusion and adapted to vary the distance from the protrusion. The separation distance may be proportional to the pressure of the bodily fluid applied to the protrusions. When the flow rate of the body fluid is 2 μl / min to 3 μl / min and the pressure of the body fluid is equal to or greater than the predetermined value, the separation distance becomes larger than 0, so that the body fluid can pass through the flap valve. The default value may be from 5 mmHg to 20 mmHg.

The drainage tube may comprise a tube body portion comprising i) at least one material selected from the group consisting of polypropylene and silicone, and ii) a coating comprising heparin coated on the tube body portion. Pores may be formed in the plurality of hydrogels.

In the method of using the intraocular pressure regulating device according to an embodiment of the present invention, the intraocular pressure regulating device can be applied to be inserted into the eye. The intraocular pressure regulating device comprises i) a flap valve, ii) a drain tube connected to the flap valve, and iii) a plurality of hydrogels spaced from each other in the drain tube. The method of using the intraocular pressure regulating device according to an embodiment of the present invention includes the steps of: i) inserting the intraocular pressure regulating device into the eye; ii) when the pressure of the body fluid generated in the eye is higher than the predetermined value, Irradiating the farthest hydrogel with a laser to remove it, and iii) confirming whether the pressure of the body fluid is decreased. The method of using the intraocular pressure regulating device according to an embodiment of the present invention may further include irradiating a gel to another side by irradiating laser to another hydrogel adjacent to the hydrogel.

The intraocular pressure can be efficiently controlled by inserting an intraocular pressure regulator into the eye. Therefore, it is possible to control the intraocular pressure of eye related patients such as glaucoma. And it can prevent hypotony that may occur after surgery.

1 is a schematic perspective view of an intraocular pressure regulating device according to an embodiment of the present invention.
Fig. 2 is a schematic cross-sectional view of the drain tube of the gauge adjusting device of Fig. 1 taken along line II-II.
3 is a schematic view of a state in which a laser is irradiated to the drain tube of FIG. 2. FIG.
Figs. 4 and 5 are views schematically showing a modification of the drain tube of Fig. 2. Fig.
6 is a view schematically showing the use state of the intraocular pressure regulating device of FIG.
Figs. 7 and 8 are views sequentially showing the schematic operating states of the flap valve of Fig.
Fig. 9 is a schematic flow chart of the method of using the glaucoma control device of Fig. 1;
10 is a graph comparing the theoretical value and the measured value of the flow resistance using the Poissy's equation of the hydrogel in Experimental Example 1. FIG.
11 is a graph of changes in the internal pressure of the glaucometer according to time in Experimental Example 2. FIG.
12 is a graph showing the flow resistance at the time of in vitro experiment of the glaucoma control apparatus of Experimental Example 3. Fig.
13 is a graph showing a change in pressure of the intraocular pressure regulating device according to the flow rate in Experimental Example 4. FIG.
14 is a graph of the flow resistance at the time of in vitro experiment of the glaucoma control device of Comparative Example 1. Fig.
15 is a graph showing a change in pressure of the glaucoma control device according to the flow rate in Comparative Example 2. FIG.
16 is a graph of a rabbit eye insertion test of the glaucoma control device according to Experimental Example 5 and Comparative Example 3. Fig.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the invention. The singular forms as used herein include plural forms as long as the phrases do not expressly express the opposite meaning thereto. Means that a particular feature, region, integer, step, operation, element and / or component is specified, and that other specific features, regions, integers, steps, operations, elements, components, and / And the like.

Unless otherwise defined, all terms including technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Commonly used predefined terms are further interpreted as having a meaning consistent with the relevant technical literature and the present disclosure, and are not to be construed as ideal or very formal meanings unless defined otherwise.

Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings so that those skilled in the art can easily carry out the present invention. The present invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.

1 schematically shows an intraocular pressure regulating apparatus 100 according to an embodiment of the present invention. The structure of the intraocular pressure regulating device 100 of FIG. 1 is only for illustrating the present invention, and the present invention is not limited thereto. Therefore, the structure of the intraocular pressure regulating device 100 can be modified in other forms.

1, the intraocular pressure regulating device 100 includes a flap valve 10, a drainage tube 20, a housing 30, and a hydrogel 40 (shown in FIG. 2 and the same below) . In addition, the IOP regulator 100 may further include other components as needed.

First, the flap valve 10 has a rectangular shape and can be stably bent according to the shape of the eyeball while being in contact with the curved portion of the eyeball. The flap valve 10 can be made of biocompatible silicone or polypropylene with good flexibility. More preferably, the flap valve 10 can be made of a silicone material.

The drain tube 20 is connected to the flat valve 10. The drain tube 20 is positioned closer to the front of the eye than the flat valve 10. Therefore, the body fluid can be sucked from the back of the eyeball and discharged to the front of the eyeball. The drain tube 20 has an elongated cylindrical shape. In comparison with tubes having other shapes, such as semicircular, elliptical, and rectangular cross-sections, the cylindrical shaped drain tube 20 has the least amount of body fluid lost and can effectively inhale, drain or pass body fluids .

The diameter of the drain tube inlet 203 and the diameter of the drain tube outlet 205 may be greater than the average diameter of the drain tube 20. If the diameter of the drain tube inlet 203 and the drain tube outlet 205 are less than the predetermined diameter of the drain tube 20, it may be difficult to suck body fluids at the drain tube inlet 203. It is therefore desirable to adjust the diameter of the drain tube inlet 203 and the diameter of the drain tube outlet 205 to be greater than the average diameter of the drain tube 20.

As shown in Fig. 1, the housing 30 incorporates a flap valve 10 therein. The pressure of the eye can not always be constant because it reacts to the external environment. Therefore, compared with the case where the flap valve 10 is embedded in the housing 30 and the flap valve 10 is directly inserted into the eyeball, the sensitivity to the external environment can be further reduced. In addition, the housing 30 partially embeds the drain tube 20. The housing 30 is fixed so as not to move the drain tube 20, thereby minimizing the incidence of post-operative complication of the tube closure and re-performing the operation easily if necessary.

On the other hand, the housing 30 can be made of a flexible material that can bend well to the curved eye shape. That is, the flap valve 10 can be made of biocompatible silicon or polypropylene having excellent flexibility as described above. Hereinafter, the structure of the drainage tube 20 will be described in more detail with reference to FIG.

Fig. 2 schematically shows a cross-sectional structure of the drain tube 20 cut along the line II-II in Fig. That is, the drain tube 20 is cut out along the yz plane direction and shown in an enlarged scale.

As shown in FIG. 2, the drain tube 20 includes a plurality of spaced apart hydrogels 40. If only one hydrogel is formed in the drain tube 20, the hydrogel is removed by laser irradiation, so that even if the intraocular pressure regulator is normally operated, it can not be prepared for the subsequent complications such as hypotony. Therefore, in one embodiment of the present invention, not only the pressure due to body fluids can be appropriately adjusted by using the plurality of hydrogels 40, but also it is possible to easily remove it by laser to prevent hypotony after the surgery.

Each hydrogel 40 is formed with a through hole 401 extending along the direction of arrangement thereof. The through hole 401 discharges the body fluid entering from the drain tube inlet 203 (shown in FIG. 1 and the same below) into the outlet 205 of the drain tube 20 (shown in FIG. 1 and the same below) It is located in the middle of the passage. The diameters d401 of the through holes 401 may be substantially equal to each other. Accordingly, when the body fluid is discharged to the outlet 205 through the drain tube 20 by adjusting the flow rate of the body fluid constantly, the pressure of the body fluid can be kept constant without large fluctuations. On the other hand, each of the hydrogels 40 may be formed without a through hole 401 if necessary. However, in the case of applying the hydrogels 40 in which the through holes 401 are formed, the flow rate and pressure of the body fluid can be controlled more efficiently.

The diameter d401 of each of the through holes 401 may be 20 占 퐉 to 30 占 퐉. If the diameter d401 of the through hole 401 is too large, the pressure of the body fluid applied to each hydrogel 40 becomes too low. In addition, when the diameter d401 of the through hole 401 is too small, the pressure of the body fluid applied to each hydrogel 40 becomes too large. That is, it is difficult to control the pressure of the eyeball due to the diameter d401 of the through-hole 401. Therefore, preferably, the diameter d401 of the through hole 401 may be 20 占 퐉 to 30 占 퐉. More preferably, the diameter d401 of the through hole 401 may be 25 占 퐉.

On the other hand, the diameter d20 of the drainage tube 20 may be 290 m to 310 m. If the diameter d20 is too large, the seat surface of the drain tube 20 that is seated in the eye becomes large. Therefore, the patient who has inserted the intraocular pressure regulating apparatus 100 into the eyeball may feel a sense of discomfort due to an increase in the foreign body sensation. Further, the amount of the hydrogels 40 included in the drain tube 20 is increased, so that the manufacturing cost of the intraocular pressure adjusting device 100 can be increased.

Conversely, when the diameter d20 is too small, the diameter of the through hole 401 also decreases accordingly. In this case, the setting range of the initial intraocular pressure becomes narrower as the diameter of the through-hole 401 becomes smaller. Therefore, the diameter d20 is adjusted to the above-mentioned range. More preferably, the diameter d20 may be between 295 and 305 mu m. More preferably, the diameter d20 may be 300 mu m.

The drain tube 20 can be made of biocompatible polypropylene or silicone material having excellent flexibility. More preferably, the tube body can be coated with heparin over the body after the tube body has been prepared.

Fig. 3 schematically shows a state in which the hydrogels 40 formed in the drain tube 20 of Fig. 2 are irradiated with the laser L and removed. The process of removing the hydrogels 40 of FIG. 3 is only for illustrating the present invention, and the present invention is not limited thereto. Therefore, the hydrogels 40 can be removed by other methods.

The length d1 of the hydrogel 40 in the extending direction of the drainage tube 20, that is, in the y-axis direction may be 0.4 mm to 2 mm. When the length d1 is too large, the laser irradiation site becomes large when the laser L is irradiated. Further, when the length d1 is too small, precision manipulation is required to prevent the patient from being hurt when the laser L is irradiated. In addition, the removal time of the hydrogels 40 may be long, which may be inefficient. Therefore, it is preferable to adjust the length d1 of the hydrogels 40 to the above-mentioned range.

As shown in Fig. 3, the hydrogel 40 is removed by irradiating the laser L. As shown in Fig. That is, when the laser L is irradiated to the hydrogel 40 formed on the drain tube 20, the hydrogel 40 is removed, so that the pressure change of the body fluid passing through the drain tube 20 is controlled, The device 100 operates smoothly.

The color of the hydrogels 40 is transparent, but can have a color as required. That is, the color of the hydrogels 40 can be made blue or red so as to be distinguished from the color of the human eye. In this case, when irradiating the hydrogels 40 with the laser L, it is easy to distinguish the irradiation site, so that the hydrogels 40 can be removed efficiently and quickly.

Fig. 4 shows a modification of the hydrogels 40 formed in the drainage tube 20 of Fig. Since the drain tube 20 of FIG. 4 is similar to the drain tube 20 of FIG. 2, the same reference numerals are used for the same parts, and a detailed description thereof is omitted.

As shown in FIG. 4, each of the hydrogels 40 includes a first through hole 401, a second through hole 403, and a third through hole 405 of different sizes. Although the three through holes 401, 403, and 405 are shown in FIG. 4, the number of the through holes 401, 403, and 405 can be adjusted differently. The hydrogel on the right hand side of each of the hydrogels 40 is positioned closer to the flap valve 10 (shown in FIG. 1 and the same below) than the other hydrogel.

Each of the hydrogels 40 is separated from each other and each of the hydrogels 40 is formed with a first through hole 401, a second through hole 403, and a third through hole 405, respectively. Here, the diameter d401 of the first through hole 401 is smaller than the diameter d403 of the second through hole 403. The diameter of the through-hole gradually increases from right to left in Fig. 4, that is, from the drain tube inlet 203 (shown in Fig. 1 and the following) to the drain tube outlet 205 . In this case, the first through-hole 401 having a relatively small diameter can efficiently control the pressure applied by the body fluid. Further, the second through-hole 403 and the third through-hole 405 having a relatively large diameter can discharge the body fluids to the outside more quickly.

Fig. 5 shows another modification of the hydrogels 40 formed in the drainage tube 20 of Fig. Since the drain tube 20 of FIG. 5 is similar to the drain tube 20 of FIG. 2, the same reference numerals are used for the same parts, and a detailed description thereof is omitted.

As shown in FIG. 5, pores 407 are formed in each of the hydrogels 40. In this case, the hydrogels 40 can be removed within a short period of time by irradiating the laser L to the hydrogels 40. The pores 407 increase the absorption rate of the laser irradiated on the hydrogels 40 to smoothly remove the hydrogels 40. Pores 407 may be formed in the hydrogels 40 using salt leaching or PMMA (polymethylmethacrylate) beads. The pores 407 may be formed by mixing the hydrogels 40 with PMMA or the like.

Fig. 6 schematically shows the use state of the glaucoma control apparatus 100 of Fig. 6, the flap valve 10 is partially enlarged and schematically shown.

The flap valve 10 has a structure complementary to a conventional body fluid discharge valve. That is, the conventional body fluid discharge valve is a unidirectional chamber system, and the valve is operated by the venturi effect, and the pressure holding ability is not constant. More particularly, as the body fluid slowly flows into the trapezoidal chamber, the valve is actuated when the pressure of the body fluid is increased and the pressure of the predetermined body fluid is reached. In this case, the velocity and pressure of the body fluid were not constant due to the body fluid slowly flowing into the trapezoidal chamber. Therefore, the pressure holding ability of the valve was deteriorated when compared with a valve in which a constant body fluid velocity and pressure flow. If the valve's ability to maintain pressure is reduced, it is difficult to control the pressure of the bodily fluid, and the consequences of the pressure change can not be predicted. However, in one embodiment of the present invention, the above-described problems can be solved by simply adjusting the pressure of the body fluid using the flap valve 10. [

6, the flap valve 10 includes a protruding portion 101 and a flap portion 103. As shown in Fig. First, the protruding portion 101 has a rectangular parallelepiped shape having a long side extending long in the x-axis direction and a short side extending in the y-axis direction. The protrusions 101 can be manufactured by injecting polydimethylsiloxane (PDMS) resin into the embossed PMMA mold. The flap portion 103 is positioned to cover the protruding portion 101. [ The separation distance between the flap portion 103 and the projection 101 can be varied in proportion to the pressure of the body fluid applied to the projection 101. [ Hereinafter, the operating state of the flap valve 10 will be described in more detail.

Figs. 7 and 8 schematically show the operating states of the flap valve 10 of Fig. 6, respectively. 7 and 8 schematically show a cross-sectional structure of the flat valve 10 taken along line VII-VII of FIG. Fig. 7 schematically shows a state in which the flat valve 10 is initially operated, and Fig. 8 schematically shows a state in which the flat valve 10 is restarted after the first operation.

7 (a) shows a state prior to the operation of the flap valve 10, and FIG. 7 (b) shows a state where the flap valve 10 starts to be opened. In FIG. 7 (c) (10) is fully opened. 7 (a), in the initial state, since the pressure of body fluids is not high enough to spread between the protruding portion 101 located on the base 105 and the flap portion 103, the flap valve 10 ) Is not opened. However, as the amount of the body fluid increases, the pressure of the body fluid increases in Fig. 7 (b), and the gap between the protrusion 101 and the flap portion 103 starts to expand. In this case, the pressure of the body fluid capable of opening the flap valve 10 may be 5 mmHg or more. However, the pressure of the body fluid capable of opening the flap valve 10 can be set according to the eye condition of the patient in which the intraocular pressure regulating device is inserted.

7 (b), when the pressure of the body fluid becomes equal to or greater than the predetermined value, the distance between the flap portion 103 and the protruding portion 101 becomes larger than zero as the flap portion 103 rises. And the body fluid passes through it. That is, since the flap valve 10 opens and discharges the body fluid, the pressure of the body fluid is lowered again. As a result, as shown in Fig. 6 (c), the flap valve 10 is closed again, and the flap portion 103 tries to return to its original shape again. As a result, the flap valve 10 can maintain the above-mentioned preset value of the body fluid pressure at 5 mmHg to 20 mmHg through the operation of the flap portion 103 described above. More specifically, the above-mentioned initial value can be maintained at 5 mmHg to 20 mmHg at a body fluid flow rate of 2 μl / min to 3 μl / min on a normal basis. If the current setting is too high, body fluids may not be evacuated even if the body fluid pressure is too high. Further, when the preset value is too small, the flap valve 10 can discharge the body fluid as it is regardless of the pressure of the body fluid. Therefore, it is necessary to adjust the pressure of the body fluid to the above-mentioned range.

Fig. 8 shows an operating state in which the flap valve 10 opened in Fig. 7 is opened again in a closed state. 8 (a) shows a state in which the flap valve 10 is closed again, and FIG. 8 (b) shows a state in which the flap valve 10 is opened again.

8 (a) shows a state in which the inflow pressure of the body fluids is smaller than the cracking pressure, that is, the pressure for opening the flap valve 10. Fig. For example, the cracking pressure is less than 5 mmHg and is a reference pressure of low intraocular pressure. When the intraocular pressure becomes equal to or less than 5 mmHg, the flap portion 103 climbed upward and comes into contact with the projecting portion 101 again. 8 (b), the flap portion 103 rises and is spaced apart from the protruding portion 101. Therefore, when the amount of body fluids increases and the pressure becomes equal to or greater than the predetermined value, Body fluids pass through. Therefore, since the flap valve 10 can be adjusted to adjust the intraocular pressure, it can be very helpful for the management of ocular disease due to hypotony after surgery in patients with glaucoma as well as eye surgery.

Fig. 9 schematically shows a flowchart of the method of using the glaucoma control device of Fig. 1; The method of using the glaucoma control device of FIG. 9 is only for illustrating the present invention, and the present invention is not limited thereto. Therefore, the use of the intraocular pressure regulating device can be modified to other forms.

As shown in Fig. 9, first, in step S10, the intraocular pressure regulating device is inserted into the eye. Insert the intraocular pressure regulator into the eyeball and fix it so that it does not disturb the user.

Next, in step S20, the pressure of the body fluid is measured. That is, when the patient uses an intraocular pressure regulating device, pressure can be gradually applied to the intraocular pressure regulating device while increasing body fluids. Therefore, it is necessary to continuously check the current state of the IOP regulator.

In step S30, it is determined whether or not the pressure of the measured body fluid is equal to or more than the predetermined value. If the pressure of the body fluid is large or small based on the established value, it is necessary for the user to take other measures depending on the state. If the pressure of the body fluid measured in step S30 is less than the preset value, the pressure of the eye can be regarded as normal. Therefore, returning to step S20, the pressure of the body fluid is continuously measured again. On the contrary, when the pressure of the body fluid confirmed in step S30 is equal to or greater than the predetermined value, it can be seen that the pressure of the body fluid continues to increase beyond the preset value. That is, since the body fluid is largely secreted, it is necessary to discharge the body fluid.

Therefore, in this case, in step S40, the hydrogel, which is located closest to the flap valve among the hydrogels formed in the drain tube, is irradiated with the laser. As a result, the hydrogel can be removed by the laser and the pressure by the body fluid can be reduced.

In step S50, it is confirmed whether or not a plurality of hydrogels formed on the drain tube have been completely removed. If the hydrogel is completely removed, no further action can be taken in the glaucoma control device. Conversely, when the plurality of hydrogels are not completely removed, another hydrogels may be removed to appropriately adjust the pressure due to body fluids.

Thus, in step S60, the body fluid pressure is measured again. In step S70, it is determined whether the pressure of the measured body fluid is equal to or greater than the reference value. If the pressure of the body fluid is less than the preset value, the pressure of the eye can be regarded as normal. Therefore, the flow returns to step S60 to measure the pressure.

On the contrary, if the pressure of the body fluid identified in step S70 is equal to or higher than the predetermined value, the flow returns to step S40 to irradiate another hydrogel with a laser to remove the hydrogel. As a result, a person who checks the health status of the patient such as a doctor can remove the plurality of hydrogels according to the condition of the patient, and appropriately adjust the pressure due to body fluids. It is also possible to know whether the intraocular pressure regulator works well. Through the above-described process, the pressure of body fluids can be controlled by using a plurality of hydrogels.

Hereinafter, the present invention will be described in more detail with reference to experimental examples. These experimental examples are only for illustrating the present invention, and the present invention is not limited thereto.

Flow flow resistance measurement experiment

Experimental Example 1

An intraocular pressure regulating device having the same structure as in Fig. 1 was manufactured. Various experiments were performed using an intraocular pressure regulator. IOP regulator was manufactured using silicone. Air was injected into the intraocular pressure regulator using a syringe pump and the flow resistance was measured. The details of the experiment using the intraocular pressure regulator can be easily understood by those skilled in the art to which the present invention pertains, so that detailed description thereof will be omitted.

Experimental results of Experimental Example 1

)을 이용하여 유동 흐름 저항의 이론값과 측정값을 비교한 그래프를 나타낸다.Figure 10 shows the hagen-poiseuille equation of the hydrogel < RTI ID = 0.0 > (

) Is used to compare the measured value with the theoretical value of the flow resistance.

Referring to FIG. 10, theoretical and measured values of the flow resistance were compared using the Poissy equation of the hydrogel. In Fig. 10, S means simulation. A first set value in which the diameter of the through hole of the hydrogel was set to 90 탆 and a length was set to 1.5 mm, a second set value in which the diameter of the through hole of the hydrogel was set to 50 탆, and the length was set to 2 mm, And the length was set to 4 mm, was calculated as a theoretical value. A fourth set value in which the diameter of the through hole of the hydrogel was set to 30 탆 and the length was set to 4 mm by simulation, a fifth set value in which the diameter of the through hole of the hydrogel was set to 50 탆, and the length was set to 2 mm, A sixth set value was set, in which the diameter of the through hole was set to 30 mu m and the length was set to 1 mm. As a result, it was found that the theoretical value and the measured value were substantially similar as shown in Fig. Therefore, it was found that the gonioscopy apparatus according to Experimental Example 1 of the present invention satisfied the Poissy's equation.

Injection of Fluid Injection

Experimental Example 2

The diameter of the through hole of the hydrogel included in the intraocular pressure regulating device was set to 25 mu m and the length was set to 4 mm, and the fluid was injected using a syringe pump. And we confirmed the change of pressure flow over time. The remaining experimental procedure was the same as Experimental Example 1 described above.

Experimental result of Experimental Example 2

11 is a graph showing changes in the internal pressure of the glaucometer according to time in Experimental Example 2 of the present invention.

As shown in Fig. 11, it was observed that the pressure increased with time, and the pressure suddenly dropped around 3800 seconds. That is, since the internal pressure of the intraocular pressure regulator is continuously increased by the air injection of the syringe pump, the flap valve is operated and the air is discharged to the outside, so that the internal pressure of the intraocular pressure regulator is decreased.

Experimental Example 3

The size of the hydrogel included in the glaucoma control apparatus of Experimental Example 1 was set to 0.3 mm, and the fluid was injected. Here, the hydrogels were prepared in the form of mutually spaced multi-patterns. Fluid was injected at 3 μl / min and pressure change with time was observed. The remaining experimental procedure was the same as Experimental Example 1 described above.

Experimental results of Experimental Example 3

12 shows a graph of changes in the internal pressure of the intraocular pressure adjusting device according to the flow rate.

As shown in FIG. 12, the internal pressure of the intraocular pressure regulator gradually increased as the flow rate into the intraocular pressure regulator increased. Therefore, it was found that the internal pressure of the intraocular pressure regulator was increased because the hydrogel could not escape from the intraocular pressure regulator.

Experimental Example 4

The length of the hydrogel was set at about 0.4 mm to about 0.6 mm. In addition, the laser intensity was set to 1.8 mJ (4 times), and the flow resistance of the hydrogel was measured by the Nd-YAG laser.

Experimental results of Experimental Example 4

13 shows a graph of the pressure change of the intraocular pressure regulating device according to the flow rate.

As shown by a dotted circle in FIG. 13, it is confirmed that there are two sections where the pressure inside the intraocular pressure regulating device is decreased. That is, when the hydrogel was gradually removed by using the laser, it was confirmed that the pressure inside the intraocular pressure regulator due to the fluid gradually decreased. Therefore, it was confirmed that the pressure inside the intraocular pressure regulating device can be differentiated and lowered in stages.

Comparative Example 1

A single pattern of hydrogel was formed in the intraocular pressure regulating device and fluid was injected. Here, the rest of the intraocular pressure regulator except the pattern of the hydrogel was similar to the intraocular pressure regulator of FIG. Here, the fluid was injected at 3 / / min, and the length of the hydrogel was set to about 0.4 mm to about 0.6 mm. The remaining experimental procedure was the same as Experimental Example 1 described above.

Experimental results of Comparative Example 1

Fig. 12 shows a flow resistance graph when an in vitro experiment was conducted using an intraocular pressure regulating device. As shown in FIG. 12, before the hydrogel was removed, it was confirmed that the pressure applied to the interior of the intraocular pressure adjusting device was increased with an increase in flow rate. In other words, it was confirmed that the hydrogels blocked the flow of the fluid and the pressure was increased.

Comparative Example 2

Experiments were conducted to remove the hydrogel by irradiating the hydrogel with a laser in the glaucoma control apparatus of Comparative Example 1. [ That is, by setting the laser intensity to 1.8 mJ, the hydrogels were removed by the laser, and the measured flow resistance values were measured. The remaining experimental procedure was the same as Experimental Example 1 described above.

Experimental results of Comparative Example 2

Figure 13 shows a graph of fluid pressure change over time using an intraocular pressure regulator.

As shown by a dotted circle in FIG. 13, it was confirmed that there is a section where the pressure inside the intraocular pressure regulating device is decreased. That is, when the hydrogel was removed using a laser, it was confirmed that the pressure inside the intraocular pressure regulator due to the fluid was reduced.

Rabbit application experiment

Experimental Example 5

The IOP regulator according to Experimental Example 1 was installed in the eye of a rabbit. Then, the intraocular pressure of the rabbit was raised to 40 mmHg (abnormal standard) using a syringe pump, and then the decreasing pressure was measured over time. The difference in resistance was calculated using half-life.

Comparative Example 3

A commercially available Ahmed valve was installed in the eye of the rabbit. The remaining experimental procedure was the same as Experimental Example 5 described above.

Experimental results of Experimental Example 5 and Comparative Example 3

16 is a graph showing the results of experiments in which an intraocular pressure regulating device was inserted into rabbit eyes according to Experimental Example 5 and Comparative Example 3. FIG. In FIG. 16, the triangle represents the change in pressure applied to the normal rabbit eyeball over time, and the circle represents the change in pressure applied to the rabbit eyeball over time in Experimental Example 5, It shows the pressure change in the rabbit's eyeball.

As shown in Fig. 16, in Experimental Example 5, compared with Comparative Example 3, the pressure was found to change similarly to the pressure applied to the normal rabbit eye. Therefore, it can be seen from the experiment example 5 that the glaucoma control device operates more normally than the conventional device.

It will be understood by those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the following claims.

10. Flap valve
20. Drain tube
30. Housing
40. Hydrogel
101. Projection
103. The flap portion
105. Base
203. Drain tube inlet
205. Drain tube outlet
401, 403, 405. Through-hole
407. Public

Claims (10)

An intraocular pressure (IOP) regulator adapted to be attached to an ocular surface to drain body fluids,
Flap valve,
A drain tube connected to the flap valve, and
A plurality of hydrogels spaced apart from each other in the drainage tube
And an intraocular pressure regulating device. The method of claim 1,
Wherein each hydrogel of the plurality of hydrogels is formed with through holes extending along the direction of arrangement of the plurality of hydrogels, and the diameters of the through holes are substantially equal to each other. The method of claim 1,
The plurality of hydrogels may include,
A first hydrogel formed with a first through hole extending along the arrangement direction of the plurality of hydrogels, and
The second hydrogel is spaced apart from the first hydrogel and has a second through-hole extending in a direction parallel to a direction in which the first through-
/ RTI >
Wherein the first hydrogel is located closer to the flap valve than the second hydrogel, and the diameter of the first through hole is smaller than the diameter of the second through hole. The method of claim 1,
Wherein the flap valve comprises:
Base,
A protrusion located on the base, and
And a flap portion positioned above the protrusion and adapted to vary a distance from the protrusion,
Lt; / RTI >
Wherein the spacing distance is proportional to the pressure of the body fluid applied to the projection. 5. The method of claim 4,
Wherein the body fluid has a flow rate of 2 μl / min to 3 μl / min, and when the pressure of the body fluid is equal to or greater than a predetermined value, the separation distance is greater than 0 so that the body fluid passes through the flap valve. The method of claim 5,
Wherein the predetermined value is from 5 mmHg to 20 mmHg. The method according to claim 1,
The drainage tube may comprise:
A tube body portion comprising at least one material selected from the group consisting of polypropylene and silicone, and
A coating part comprising heparin coated on the tube body part
And an intraocular pressure regulating device. The method of claim 1,
Wherein the plurality of hydrogels have pores formed therein. A method of using an intraocular pressure control device adapted to be inserted into an eye,
The intraocular pressure regulating device comprises:
Flap valve,
A drain tube connected to the flap valve, and
A plurality of hydrogels spaced apart from each other in the drainage tube
/ RTI >
Inserting the intraocular pressure regulating device into the eyeball,
Irradiating the hydrogels located closest to the flap valve among the plurality of hydrogels when the pressure of the bodily fluid generated in the eyeball is equal to or more than a predetermined value;
Determining whether the pressure of the body fluid is decreased or not
/ RTI > The method of using an intraocular pressure regulating device according to claim 1, The method of claim 9,
In the step of checking whether the pressure of the body fluid is reduced, when the pressure of the body fluid does not decrease below the predetermined value, another hydrogel adjacent to the hydrogel is irradiated with a laser to remove the another hydrogel ≪ / RTI >

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