JPS602055B2 - Contact lens disinfection methods and devices - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to contact lenses and artificial lens lenses (hereinafter referred to as "contact lenses, etc.") that are implanted after cataract surgery.
This article relates to a method and device for disinfection using objects to be disinfected.

Conventionally, water-containing contact lenses, which are mainly composed of hydrophilic monomers such as 2-hydroxyethyl methacrylate, usually contain approximately 3% or more of water by weight, so the water-containing contact lenses themselves can breed various harmful bacteria. In addition, wearing contact lenses that are contaminated with bacteria in the eyes can cause serious damage to the eye tissue, which is extremely dangerous. In the case of lenses, it is essential to disinfect them at regular intervals.

Therefore, the most common method for disinfecting hydrous contact lenses is to boil the lenses for a certain period of time, but in this case, it is a very effective method for disinfecting the lenses. However, at the same time, it has the following major drawbacks that can be called fateful.

In other words, (1) By boiling, the proteins in the tear fluid components that adhere to the lens undergo thermal denaturation and stick to the lens surface, impairing the optical properties of the lens and significantly reducing the feeling of wearing it on the eye. make it worse

[2- The slightly cross-linked hydrophilic polymer that is the material for water-containing contact lenses is prone to deterioration due to repeated harsh boiling treatments, which can cause the lenses to discolor or change their standard shape. This will significantly shorten the life of the product.

{3} Because the boiling heater uses AC power, it is inconvenient to carry the boiling sterilizer to travel destinations, and it cannot be used outdoors, especially at camping sites, because there is no AC power.

In the case of non-water-containing contact lenses made of '4' polymethyl methacrylate or silicone rubber, boiling sterilization cannot be applied.

As a means to overcome the difficulties associated with such boiling disinfection treatment, there is a method of disinfecting contact lenses with various bactericidal chemical solutions, for example, chemical solutions containing disinfectants such as thimerosal and chlorhexidine. Because the gaps between the molecules that make up the hydrous contact lens are large, bactericidal components are easily absorbed into the lens body, and there is a risk that the adsorbed bactericidal components may cause hypersensitivity inflammation in the eye tissue. .

Another method is to sterilize lenses with a 3% aqueous hydrogen peroxide solution and then contact the solution with a catalyst such as platinum to decompose the hydrogen peroxide into water and oxygen and detoxify it. However, ``Even in this case, sterilization requires a long time, and the operation is complicated and impractical. What's more, we have developed a contact lens sterilization method that does not have any negative effect on the lens and is safe for the eye tissue, and that is compact, lightweight, easy to operate, and can be sterilized even outdoors without an external power source. The object of the present invention is to overcome the drawbacks of the prior art by providing a device.

Next, the concept of the present invention will be explained.

First, water-containing contact lenses must be isotonic with lachrymal fluid to ensure compatibility with the eye tissue when worn on the eye.
It is preserved by immersion in 9% physiological saline.

However, the present inventors actively utilized this fact and electrolyzed the physiological saline in the container while the contact lens was still stored in the storage container filled with physiological saline to produce an effective amount. By producing sodium hypochlorite, the contact lenses were sterilized and sterilized, and the scales were examined and the present invention was completed.

That is, when a contact lens is immersed in a contact lens storage container filled with physiological saline and a current is passed through the physiological saline through an electrode installed in the container, the chlorine in the physiological saline is The ions become chlorine molecules through anodic oxidation, and these chlorine molecules react with sodium hydroxide, which is produced in physiological saline. It is thought that sodium hypochlorite is generated.

The reaction formula for this series of reactions is as follows.

Na+C, -etc.

Obata - Elementary 2 ↑ 10 12...2 22 Na. H→NaCI. 10 NaCI 10 Sodium hypochlorite thus produced is effective against most microorganisms such as viruses, general nonspore-forming bacteria, acid-fast bacteria, bacterial spores, filamentous fungi, algae, and protozoa, and is usually Approximately 0.5-5. Sterilization of about 30 to 18 sand particles can be completed in a very short time at low concentrations of Snake PM. Furthermore, despite its strong bactericidal properties, sodium hypochlorite has only weak toxicity to ocular tissue, and in this respect it is also extremely suitable as a disinfectant for contact lenses. In addition, the concentration of sodium hypochlorite used in contact lenses is approximately 0.4 to 4.0 pp.
A range of m is desirable, because if the concentration of sodium hypochlorite is within the above range, a sufficient sterilizing effect can be expected, and by leaving it at room temperature for about 6 hours, the sodium hypochlorite will turn into sodium chloride. This is because contact lenses are usually disinfected before going to bed, and contact lenses are usually disinfected before going to bed.
Considering that the product will be left at room temperature in a storage container until it is applied to the eye again the next morning, it is recommended to set the concentration of sodium hypochlorite within the above range.
This is extremely rational from the perspective of ensuring safety for eye tissues.

Furthermore, if the contact lens is worn on the eye within a short time after disinfection, the sodium hypochlorite concentration will be less than 1 ppm, and it will be possible to re-wear the contact lens within about 3 powders after disinfection is completed.

In addition, by contacting the physiological saline after disinfection with a catalyst such as platinum black, or adding a reducing agent such as sodium thiosulfate, sodium hypochlorite can be decomposed in a very short period of time. Of course, it is also possible to detoxify it by reducing it, and in this case, sodium hypochlorite can be used at a high concentration above the above range.

The decrease in the salt concentration in physiological saline due to the production of an effective amount of sodium hypochlorite is approximately 0.00001.
The amount is extremely small, on the order of %, and does not affect the function as a contact lens storage solution in any way.

The term physiological saline as used in the specification of this patent application should be understood in a broad sense as an aqueous sodium chloride solution that is isotonic with lachrymal fluid and physiologically harmless, and may contain other components such as buffers. be.

Next, the configuration of an embodiment of the present invention will be explained with reference to the drawings.

The synthetic resin cap 3 is attached to a contact lens storage container 2 made of synthetic resin such as polyethylene, polypropylene, polycarbonate, polysulfon, or glass and having a capacity of about 1 to 8 lenses, which is integrally molded with two contact lenses arranged side by side with a connecting plate 1 interposed therebetween. A contact lens of 0.9% physiological saline that is removably attached in a sealed state through a groove 4 formed on the outer periphery of the container 2 and a protrusion 5 formed on the inner periphery of the cap 3, and filled in the storage container 2. In the storage solution 6, the contact lens 7 is placed on the mounting surface of the synthetic resin contact lens mounting table 11, which allows the solution 6 to flow through the plurality of holes 8, 9 and the gap 10, that is, the contact lens. Platinum, which has a high ionization tendency and is molded onto a conductive plate 12 made of Shinsenita, is placed on the bottom of each storage container 2. An electrode 13 made of gold or the like is integrally embedded with the storage container 2 with the upper part of the electrode 13 exposed inside the storage container 2.

In addition, as the material for the electrode 13, we used platinum, gold, etc., which have a high ionization value, considering that the anode is subject to strong oxidation effects by electrolyzing physiological saline. The electrode 13 can be replaced with a metal such as nickel or a synthetic resin plated or vapor-deposited with gold or platinum, or the electrode 13 can be formed integrally with the conductive plate 12. As,
The storage container 2 and the connecting plate 1 may be coated with gold, platinum, or the like by vapor deposition.

Next, the case 16 of the DC power supply device 15, in which a current for electrolysis is applied to the storage solution 6 in the container 2 through the electrode 13 of the contact lens 7 portable container 14 configured in this way, is made of synthetic resin. On the surface of the case 16, a synthetic resin diamond body 19 is attached to the case body 17 via screws 18.
A sliding power switch 22 that turns on and off the power of a battery 21 that is replaceably housed in the case 16 via a socket 20, a push-pull start switch 23 that is pressed to start disinfecting the contact lenses 7, and a power supply. An LED 24 for confirming dew source input that lights up when the switch 22 is turned on, and an LED 25 for displaying disinfection that lights up during electrolysis of the storage solution 6 in the container 2 by pressing the start switch 23 are installed. , an insertion opening 26 for the portable container 14 is formed on the side surface of the case 16 of the DC power supply device 15;
The container 14 is placed in a state in which the protruding greens 28 formed on the left and right sides of the connecting plate 1 of the container 14 are aligned with the guide grooves 27 formed on the left and right sides.
When inserted into the case 16 through the insertion port 26, the container 14
The conductive plate 12 exposed on the bottom is attached to the screw 29 on the bottom of the case 16.
The electrode 13 of the container 14 is connected to a control device 31 mounted inside the case 16 via the conductive plate 12 and the elastic plate 30. Next, FIG. 7 is an electric circuit diagram of this embodiment, in which a variable resistor VRI is connected to the battery 21 via the power switch 22 by a trigger signal caused by turning on the starting switch 23.
A monostable multipipe layer timer 32 is connected to turn on each transistor Trl and Tr2 by inverting the output from "0" to "1" for a certain period of time determined by the resistance value of the transistor Tr2 and the power switch 22. via battery 2
1 includes an obeamp A1, a Zener diode ZD1,
The electrodes 13 of each container 2 are connected via the transistor Tr3 and variable resistor VR2 of a suction type constant current circuit 33 consisting of a transistor Tr3, a resistor RI, and a variable resistor VR2. A lower limit current setting circuit 34 inverts the output of the oven amplifier A2 from "0" to "1" and turns off the disinfection indication LED 25 when the voltage drop due to the flowing current becomes less than the specified voltage set by the variable resistor VR3. In addition to being connected, each circuit 32, 3
3 and 34 are circuit configuration resistors R2 to R9 and capacitor C.
1 and C2 are connected as appropriate.

Next, the operation of this embodiment will be explained.

First, the basic structure and operation of this embodiment are as shown in FIG. Physiological saline 6 is electrolyzed by passing a specified current determined by the resistance value of variable resistor VR from battery 21 through 22, and an amount of hypochlorite approximately proportional to the current value is added to physiological saline 6. The contact lens 7 is sterilized by generating sodium hypochlorite, and by natural disappearance after the current is cut off via the power switch 22, the sodium hypochlorite is converted into sodium chloride and oxygen, which are completely harmless to the eye tissues. It is decomposed into

In other words, the amount of sodium hypochlorite generated during sterilization of the contact lens 7 is kept almost constant to perform sterilization reliably and efficiently, and to shorten the natural disappearance time after the sterilization and disinfection action is completed. For example, the output of the timer 32 is set to 3 through the resistor VRI, and the variable resistor V
Each container 2 separate electrode 13 by constant current circuit 33 via R2
For example, the current value between them is set to 1.3 A and 2.6 A for both, and the lower limit current value of the lower limit current setting circuit 34 is set via the variable resistor VR3, that is, the power supply is For example, the current value when the voltage decreases and the output current of the constant current circuit 33 reaches the limit current value for obtaining the amount of sodium hypochlorite produced necessary for effective sterilization is determined by, for example, 2.
0 A, and when the output current from the constant current circuit 33 falls below the lower limit current value of 2.0 A, the oven amplifier A2
Set the output to be inverted from "OJ" to "1".

In the normal state of battery 21 consumption in this setting state, first, the contact lens mounting table 11 is stored in the left and right storage containers 2, and a certain amount of 0.9% physiological saline 6 is poured into the containers 2. At the same time as the injection, the pair of left and right hydrous contact lenses 7 worn on the eyes are rinsed in advance with 0.9% physiological saline 6, placed on the pupil surface of the Sendo table 11, and placed in the container 2. The contact lenses 7 are immersed in 0.9% physiological saline 6, and in this state, the cap 3 is ironed to the container 2 to seal it. When inserted into the case 16 of the DC power supply device 15 from the insertion port 26 through the iron fitting with the guide groove 27 of the case 16, the guide crab plate 12 of the container 14 is inserted into the elastic plate 3 of the case 16.
0, the electrode 13 of each container 2 is connected to the output terminal of the constant current circuit 33, and in this state, the setting for sterilizing the contact lens 7 is completed.

Next, when the power switch 22 is turned on in this set completion state, the "0" output before the timer 32 operates causes the LED 24 to light up to confirm that the power source has been turned on, allowing you to confirm that the power source has been turned on. When the start switch 23 is pressed, the output of the timer 32 is inverted from "0" to "1", and each transistor Trl, Tr2 becomes conductive. A constant current determined by the resistance value, in this case a current of 1.3 A flows between the electrodes 13 of each container 2, and since the voltage drop between the electrodes 13 due to this load current is large, the voltage at the inverting input of the amplifier A2 is higher, obeamp A
The output of timer 32 is "0" and the LED 25 lights up, confirming that effective sterilization and disinfection are in progress. When the preset 30 seconds elapse in this state, the output of timer 32 becomes "1". to "0" and each transistor Trl,
At the same time as Tr2 is turned off, the output of the constant current circuit 33 via the transistor Tr3 is also turned off, the current between the electrodes 13 is cut off, and the sterilization of the contact lens 7 is completed. Furthermore, the completion of sterilization is confirmed by turning off the LED 25. By turning off the power switch 22, all sterilization and disinfection actions are completed, and by remaining in this completed state for at least 30 minutes, the sodium hypochlorite in the storage solution 6 in the container 2 is completely harmless to the eye tissue. It decomposes into sodium chloride and oxygen, and the contact lens 7 that has been sterilized inside the container 2 can be worn immediately in a non-toxic state.

Next, in an abnormal state where the battery 21 is exhausted, the contact lens 7 portable container 14 is inserted into the case 16 of the DC power supply device 15.
Insert and set the power switch 22 and start switch 2
If the output current of the constant current circuit 33 with the constant current circuit 33 turned on becomes 2.0 A or less, which cannot guarantee effective sterilization, the input voltage of the obeamp A2 will change because the voltage drop between the electrodes 13 is small. is higher on the non-inverted side, so the output of the oven amplifier A2 is "1" and the LED 25 does not light up, thereby making it possible to confirm that the contact lens 7 is not being effectively sterilized. Next, a test example using this DC power supply device 16 will be shown.

Test Example 1 A contact lens storage container 2 shown in the schematic cross section of FIG. 8, in which a pair of platinum electrodes 13 with a surface area of 0.04 carp was installed, was filled with 0.9% physiological saline 6 of 2.2'.
Next, the water-containing contact lens 7 that had been actually worn on the eye and contaminated was immersed in the solution 6 (at this time, if the soaked water-containing contact lens 7 directly covered the electrode 13, especially the cathode, the cathode side (Please note that the production of chloride ions from the water will be inhibited and an effective amount of sodium hypochlorite cannot be obtained).

After sealing the lens storage container 2 with the cap 3 and shaking it lightly, transfer 60.2' of physiological saline from the container 2 to another sterilized test tube and use it as a sample for measuring the number of bacteria. did. Next, a current of 1.3 A is applied to the remaining physiological saline solution 62.0 through the platinum electrode 13 for 3 minutes to create an lppm concentration of hypochlorite in the solution 6. produced sodium chloride. After 10 minutes, add 62.0% of the above physiological saline and 1.0% of thioglycollate medium (15%) of sterility test based on the 9th revised Japanese Pharmacopoeia "General Test Methods Milk Sterility Test". ) and tested for the presence of bacteria.

This test was conducted on 75 contaminated water-containing contact lenses.

The results are shown in Table 111. Table (1) *The number of bacteria before disinfection is determined by adding 0.2 microns of physiological saline collected in advance before disinfection to 0.0 micron.
Divide into each autumn and inoculate each on a plain agar plate.37
It was determined by culturing at ℃ for 24 hours. Test Example 2 '11 Escherichia Coli ○: 55K as a donor strain
:59 [2- SPphylococcusaureu
s 209P [31 Pseudomonasae bonito nosa ATCC 9027] was cultured on an ordinary agar slant at 37°C for 2 feeding hours, and then 1 piccells of each culture was prepared using 0.9% sterile physiological saline. Next, each of the cocoon liquids was injected into the same lens storage container 2 as used in Test Example 1, sealed with a cap, and then a current of 1.3 A was applied through the platinum electrode 13 for three nights. Electricity was passed through the sand to generate lppm of sodium hypochlorite.

After 10 minutes, each of the three test solutions mentioned above was collected at a rate of 1.0 and inoculated into a thioglycollate medium (15%) for sterility testing based on the Japanese Pharmacopoeia sterility testing method to determine the presence or absence of bacteria. was tested.

The results are shown in Table ■. Table (2) As a result, the present invention can obtain the following effects.

{1) Does not adversely affect the material of contact lenses.

{2) Does not adversely affect the standard and shape of contact lenses.

'3} Disinfection can be completed in an extremely short time.

(4) Due to the natural or artificial disappearance of sodium hypochlorite, no harmful components will be adsorbed to contact lenses.
Extremely safe for ocular tissues.

{5} The structure is simple and the device can be made smaller and lighter, making it convenient to carry. ■ Contact lenses can be sterilized with extremely simple operations even while they are still stored in the storage container.'7} A disinfectant that is produced by electrolyzing physiological saline, which is the storage solution for contact lenses. Since disinfection is performed while producing sodium hypochlorite, there is no need to use a separate sterilizing chemical solution, and the economic burden on the Gontact lens user can be extremely reduced.

{81 Water-containing contact lenses as well as non-water-containing contact lenses made of polymethyl methacrylate, silicone rubber, etc. can be effectively applied to disinfect artificial lens lenses implanted after cataract surgery.

■ Due to the action of sodium hypochlorite, it is possible to sterilize contact lenses and at the same time remove proteins in tear fluid components that adhere to the lens surface, preventing proteins from adhering to the lens surface and also preventing proteins from adhering to the lens surface. It is also possible to remove stained proteins.

Brief explanation of Hakanran Fig. 1 is a front view of a DC power supply device 15 according to an embodiment of the present invention; Portable contact lens container amount 4
5 is a plan view of the container body, FIG. 6 is a plan view of the contact lens table 11, FIG. 7 is an electric circuit diagram thereof, and FIG. 8 is an explanatory diagram thereof.

2...〇Storage container~ 6...Preservation solution "T...Contact lens" 2...Conductive plate, 13...Electrode, 16...〇DC power supply ~ 21...Battery, 22...
...Timer, 33... Constant current circuit.

Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8

Claims (1)

[Scope of Claims] 1. A contact characterized in that hypochlorite is generated in the saline water by passing an electric current through the saline water through an electrode while the object to be disinfected is immersed in the saline water. How to disinfect lenses. 2. The method for disinfecting contact lenses according to claim 1, characterized in that the object to be disinfected is a hydrous contact lens, and the saline is physiological saline for storing contact lenses. 3. After passing an electric current through the saline solution in which the object to be disinfected is immersed for a certain period of time necessary for sterilization of the object to be disinfected, the object to be disinfected is heated until the hypochlorite disappears by cutting off the current. 2. The method for disinfecting contact lenses according to claim 1, which comprises immersing the body in the saline solution. 4. Attach an electrode to the container in which the object to be disinfected is immersed in the saline solution for flowing an electric current into the saline solution, and apply an electric current to the saline solution through the same electrode to generate hypochlorite. A contact lens sterilization device characterized by being provided with a DC power supply device that flows. 5. Claim No. 5, characterized in that an electrode for passing an electric current into the preservation solution is attached to a closed container with a lid that holds a hydrous contact lens immersed in a physiological saline solution for preserving the lens. The contact lens disinfection device according to item 4. 6. Claim 4, characterized in that the DC power supply device is provided with a timer device that cuts off the energization when the energization time to the saline solution reaches a preset fixed time.
5. The contact lens disinfection device according to item 5. 7. A contact lens according to claims 4 and 5, characterized in that the DC power supply device is provided with a constant current device that maintains the current applied to the saline solution at a preset constant current value. Disinfection equipment. 8. A patent claim characterized in that a DC power supply device is provided with a constant current device and a timer device that apply current to saline solution while maintaining it at a preset constant current value and for a preset fixed period of time. A contact lens disinfection device according to items 4 and 5.