JP5957912B2 - Treatment method for intraocular lens insertion device - Google Patents

Description

  The present invention relates to a method for processing an intraocular lens insertion device for inserting an intraocular lens into the eye.

  A foldable intraocular lens that is attached to the eye as an alternative to the lens removed by cataract surgery is folded into a small size with an intraocular lens insertion device (hereinafter referred to as an injector) and inserted into the eye. In such an injector, an injector formed by injection molding or the like using a resin material such as polypropylene so as to be disposable is known. In addition, in such resin materials, a small amount of additives such as a release agent (lubricant) and an antistatic agent are used in advance for the purpose of facilitating the removal of the molded injector from the mold and for preventing the adhesion of dirt. include.

  On the other hand, there is known a technique for improving lubricity when an intraocular lens is delivered by positively mixing such an additive such as a release agent into a resin material in advance and depositing it from the inner wall of the injector. (For example, refer to Patent Document 1). However, with this method, the additive is inserted into the eye with the additive attached to the intraocular lens at the time of delivery. Then, the technique which improves lubricity by giving a coating process to an inner wall without intentionally mixing an additive into an injector is proposed (for example, refer patent document 2).

JP 2004-339405 A JP 2006-197994 A

  However, even if additives are not intentionally mixed into the resin material, resin materials for resin molded products usually contain a very small amount of additives, which are precipitated by the influence of temperature change, humidity change, etc. I understood. Therefore, even in the technique disclosed in Patent Document 2, a trace amount of additive may be deposited and attached to the intraocular lens.

  In view of the above-described problems of the prior art, the present invention provides a method for treating an intraocular lens insertion device that can suppress and prevent an additive contained in a resin from adhering to an intraocular lens and can be suitably ejected. Let it be an issue.

  In order to solve the above problems, the present invention is characterized by having the following configuration.

(1) In the processing method for an intraocular lens insertion device having an insertion portion made of a resin molded product, a first step of precipitating a predetermined additive added to the insertion portion by a heating process, and an intraocular lens A second step of removing the additive deposited on the inner wall of the insertion portion in the first step in order to suppress adhesion of the predetermined additive .

  ADVANTAGE OF THE INVENTION According to this invention, it can suppress that the additive contained in resin adheres to an intraocular lens, and can provide the processing method of the intraocular lens insertion instrument which can be suitably inject | emitted.

  An embodiment of the present invention will be described. FIG. 1 is an external view of an intraocular lens insertion device (hereinafter referred to as an injector) 1, and FIG. FIG. 3 is a front view of the intraocular lens 2.

The injector 1 includes a cylindrical body 30 that includes an insertion portion 10 and a mounting portion 20 on the distal end side, and an extrusion member (hereinafter referred to as a plunger) 40 that is provided on the proximal end side of the cylindrical body 30 so as to be movable forward and backward. Consists of The insertion portion 10 has a hollow cylindrical shape having an area (inner wall shape) in which the inner diameter of the passage gradually decreases (thinner) toward the distal end, and the intraocular lens 2 is sent to the distal end 11 to the outside. A notch (bevel) is formed. An intraocular lens is placed on the placement portion 20 provided at the proximal end of the insertion portion 10. When the pressure from the plunger 40 is applied to the intraocular lens 2 placed on the mounting part 20, the intraocular lens 2 is folded slightly along the inner wall of the insertion part 10 and is externally (intraocularly) from the distal end 11. Sent out. The injector 1 having the above configuration is formed by molding with a resin material.
In addition, although the example of the disposable (disposable) type injector 1 by which the whole injector 1 was resin-molded is shown here, the cartridge (insertion part 10 and mounting part 20) resin-molded is attached with respect to the main body 30. The present invention can be applied to a disposable cartridge in the type of injector that can be used.

  The intraocular lens 2 is a one-piece type intraocular lens in which an optical part 2a and a pair of support parts 2b are integrally formed of a flexible material (see FIG. 3). The one-piece type intraocular lens is formed of a conventionally known foldable soft intraocular lens material such as a simple substance such as HEMA (hydroxyethyl methacrylate) or a composite material of acrylic ester and methacrylic ester. . In addition, a known lens that can be bent using the injector 1a is used for the intraocular lens 2. For example, a three-piece intraocular lens, a plate-type intraocular lens, and the like that are integrated after forming the optical part and the pair of support parts as separate members may be used.

  Next, the manufacturing process of the injector 10 will be described. FIG. 4 is a flowchart of the manufacturing process of the intraocular lens insertion device. First, in the first step 101, the main body of the injector 10 is formed. After each of the above components constituting the injector 10 is formed by injection molding using a resin, the injector 10 is formed by joining or combining the injection molded components. Note that the resin forming the injector 10 contains a small amount of additives in advance in consideration of releasability and antistatic properties.

  For example, examples of the resin include well-known thermoplastic resins such as polyethylene, polypropylene, polybutene, or polyalkene resins made of copolymers thereof, or polycarbonate resins. Additives contained in the resin include glycerol esters of carboxylic acids such as glycerol monooleate, glycerol monopalmitate, glycerol monostearate, glycerol monolaurate, glycerol monolignoserate, glycerol monomontanate, glycerol monomyristate . Examples thereof include additives suitable for a substrate formed by injection molding, such as fatty acid amides such as erucic acid amide, oleic acid amide, and stearic acid amide, to have releasability and antistatic properties.

  It was found that when a small amount of an additive is contained in the resin material constituting the injector 10, the additive gradually precipitates on the surface of the injector 10 due to the influence of temperature change or humidity change over time. When trying to push out the intraocular lens 2 using the injector 10 in a state where the additive is deposited, the additive may be attached to the intraocular lens 2 while being visually recognized.

  Therefore, in the second step (first heating process) 102, the injector 10 is warmed and held for a predetermined period in order to intentionally precipitate the additive mixed in the injector 10 (main body 30). It is assumed that the temperature of the first heating process 102 is set to a temperature higher than room temperature. For example, the ambient temperature of the first heating process 102 is set to 40 ° C. or higher. More preferably, the temperature is set to 50 ° C. or higher and 65 ° C. or lower. When the temperature of the first heating treatment is lower than room temperature (for example, 40 ° C.), the additive is less likely to be deposited from the resin material constituting the injector 10, and the additive is easily left in the resin material. On the other hand, if the temperature of the first heating treatment is higher than 65 ° C. (melting point), the additive may be melted in the resin material and hardly deposited outside.

  Moreover, the period of a 1st heating process shall be 10 days or more and 1 month (4 weeks) or less, for example. More preferably, it is 14 days or more and 1 month or less. When the period of the first heating treatment is shorter than 10 days, the additive is not sufficiently precipitated and tends to remain in the resin material. On the other hand, if the period of the first heating treatment is longer than one month, the heating is continued even after the precipitation amount of the additive mixed in the resin material is saturated, and the manufacturing period of the injector 10 is long. There will be a disadvantage.

In addition, the temperature and period of such a 1st heating process should just be determined by the kind and combination of a resin material and an additive. That is, the temperature of the first heating process may be set to a temperature at which the additive is precipitated without deformation of the resin material. Further, the period of the first heating process may be set to a period in which the precipitation amount of the additive contained in the resin material is saturated.
In addition, a known constant temperature oven etc. are used for such a heating process.

  In the first heating process of the second step 102, most of the additives mixed in the resin material are deposited on the surface of the injector 10, so that the additives previously contained in the resin material are as much as possible outside. Discharged. Thus, when the injector 10 is stored for a long period of time, it is less susceptible to changes in temperature and humidity, and the additive is less likely to be deposited outside. Moreover, an additive becomes difficult to appear on the injector 10 surface also by the coating process mentioned later.

  In the next third step (cleaning treatment) 103, the additive deposited on the surface of the injector 10 in the second step 102 is removed. Specifically, the deposited additive is washed away from the surface (inner wall) of the injector 10 using a known ultrasonic cleaner or the like. The cleaning is performed under conditions and time for sufficiently removing the additive deposited from the surface of the injector 10 in the second step. In addition to the cleaning, the third step 103 may be performed by a method in which the additive accumulated on the inner wall of the injector 10 is removed. For example, the third step 103 is added by blowing compressed air or the like on the surface (inner wall) of the injector 10. Objects may be removed.

  Next, in the 4th process (coating process) 104, a coating layer is formed in the inner wall of the injector 10 (insertion part 20). Materials used for coating are, for example, polyethylene glycol, polypropylene glycol, sodium polyacrylate, polyacrylamide, sodium polystyrene sulfonate, polyvinyl pyrrolidone, polyvinyl alcohol, polyethylene imine, carboxymethyl cellulose, dextran sulfate sodium, polyphosphoric acid, polyethylene oxide And water-soluble polymer materials such as polysaccharides such as polypropylene oxide and sodium hyaluronate, hydroxymethylcellulose, hydroxypropylmethylcellulose, and polypeptides.

The coating process is performed by placing the insertion unit 20 in a coating solution and placing it in a known constant temperature oven and holding it at a predetermined temperature (for example, 60 ° C.) for a certain time (for example, 10 minutes).
Note that the surface state of the inner wall of the insertion portion 20 may be roughened by a known plasma treatment before the coating treatment. If it does in this way, a coating layer will be combined more suitably in injector 10 (insertion part 20).

  In this embodiment, since many of the additives mixed in the injector 10 (insertion portion 20) in the second step are discharged, the surface of the injector 10 (even if the coating process is performed in the fourth step) It is difficult for the additive to be deposited from the inner wall. That is, in the prior art, precipitation of the additive contained in the resin material may be promoted by the coating treatment, but in the present invention, the absolute amount of the additive contained in the resin material is reduced by the first heating treatment. Therefore, even if the additive is stored in a state where it is likely to precipitate, the additive can be stably stored without being deposited on the inner wall of the injector 10.

  Thereafter, sterilization is performed in the fifth step. The sterilization process is performed by holding the injector 10 for a predetermined time in an atmosphere of a sterilization gas maintained at a predetermined temperature. In addition, well-known things, such as ethylene oxide gas, are used for the sterilization gas used for a sterilization process.

  Next, in the sixth step (second heating process), the surface of the injector 10 is heated again. In the second warming treatment, the ambient temperature is set so that the surface temperature of the injector 10 becomes a temperature at which the additive is melted, and is maintained for a time necessary for the additive to melt completely. For example, the ambient temperature is set so that the surface temperature of the injector 10 (insertion portion 20) is 70 ° C. or more and 100 ° C. or less, and the period is held for 15 minutes or more and 60 minutes or less. If the surface temperature of the injector 10 is lower than 70 ° C., the additive is hardly melted. On the other hand, if the temperature is higher than 100 ° C., the resin material itself is more likely to be deformed by heating for about 60 minutes. Similarly, when the treatment time is shorter than 15 minutes, the additive is hardly melted, and when it is longer than 60 minutes, the injector 10 is more likely to be unintentionally deformed.

By heating the injector 10 again to melt the trace amount of the additive, the trace amount of the additive remaining in the resin material in the second step (first heating treatment) is the surface of the injector 10 (inner wall). Is further suppressed from being precipitated. Further, even if a small amount of additive remains on the injector surface by the cleaning in the third step, the adhesion to the intraocular lens 2 is further suppressed by melting.
As a result, the state in which no additive is deposited on the surface of the injector 10 can be more suitably maintained over a long period of time.

Next, examples of the present invention will be specifically described. In addition, this invention is not limited only to a following example.
(Example)
Polypropylene mixed with a small amount of additive as a resin for forming the insertion portion of the injector (note that it is assumed that glycerol monostearate is contained in an amount of about 100 to 3000 ppm) is used. The insert was formed by injection molding using a mold. Thereafter, the injector was placed in a constant temperature blowing oven (DN600, manufactured by Yamato Kagaku Co., Ltd.) in the first heating treatment, and held at a temperature of 60 ° C. for 1 month to precipitate the additive inside the injector (insertion portion). . In the subsequent washing step, the additive deposited outside was washed away. Thereby, it was confirmed that there was no additive in the surface of an injector (insertion part).
Then, sodium hyaluronate as a water-soluble polymer material was dissolved in ultrapure water to prepare a 0.5 wt% coating solution. In the coating treatment, the interior of the insertion portion was immersed in a coating solution and then placed in a constant temperature oven (Yamato Scientific Co., Ltd., DN600) to physically fix the coating layer on the inner wall surface of the insertion portion.
After the injector with the coating layer formed in the insertion part is sterilized (gas sterilization), the injector is inserted into the product package, and the injector (insertion part) is used as the second heating treatment using the same constant temperature oven as above. The surface temperature was set to about 100 ° C., and the remaining additive was melted by heating for 15 minutes.
Then, the intraocular lens was ejected using the injector that had been subjected to a series of surface treatments as described above, and the presence or absence of adhesion of the additive (precipitate) to the intraocular lens was observed (precipitate adhesion evaluation). . As the intraocular lens, a bendable acrylic (frequency 25D) was used.

  For deposit adhesion evaluation, the petri dish was filled with ultrapure water to the extent that the intraocular lens was hidden, and the rear surface of the intraocular lens after injection (the surface that rubbed the inner wall surface of the injector) was placed in the petri dish. . And surface observation was performed at 15 times magnification using an optical microscope (manufactured by Nikon Corporation, SMZ-1500). Further, the ratio (area) of the additive was determined from the luminance distribution by image processing. The intraocular lens was ejected in units of about 1 month from immediately after production until 9 months later, and the change with time of the deposit on the intraocular lens was observed.

FIG. 5 shows a graph of the change over time in the amount of additive adhering to the intraocular lens when the intraocular lens was ejected using the injector of the example. Here, the horizontal axis is the elapsed time (actual months), and the vertical axis is the area value (mm ² ) of the adhering additive.
As shown in FIG. 5, the injector of the example did not confirm an increase in the amount of the additive attached to the intraocular lens with time, and confirmed that the precipitation of the additive can be suitably suppressed over a long period of time. It was done.

It is an external view of an injector. It is sectional drawing of an injector. It is a front view of an intraocular lens. It is a flowchart of the manufacturing process of an intraocular lens insertion instrument. It is an experimental result using the injector of an Example.

2 Intraocular lens 10 Insertion section 20 Placement section 30 Tube body 40 Plunger

Claims (2)

In the processing method of the intraocular lens insertion instrument having an insertion portion made of a resin molded product
A first step of precipitating a predetermined additive added to the insertion portion by a heating treatment;
A second step of removing the additive deposited on the inner wall of the insertion portion in the first step in order to suppress adhesion of the predetermined additive to the intraocular lens ;
A method for processing an intraocular lens insertion device, comprising: In the processing method of the intraocular lens insertion instrument of Claim 1,
A third step in which after the additive is removed in the second step, a water-soluble polymer is applied to the inner wall of the insertion portion and dried to form a coating layer of the water-soluble polymer;
A method for processing an intraocular lens insertion device, comprising:

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