JP2939305B2 - Method for manufacturing intraocular lens - Google Patents

Description

Description: TECHNICAL FIELD The present invention relates to a method for manufacturing an intraocular lens, and more particularly to a one-piece intraocular lens in which an optical unit and a support unit are integrally formed, and the support unit is colored. And a method for manufacturing an intraocular lens.

(Background Art) An intraocular lens includes an optical unit as a lens body and a support unit for attaching and fixing the optical unit to a predetermined position in the eye. Conventionally, the optical unit and the support unit are used. Are formed separately, and a three-piece or two-piece intraocular lens in which a support part is fixed to an optical part, and a one-piece intraocular lens in which the optical part and the support part are integrally formed are known. ing.

In any type of intraocular lens, when the intraocular lens is inserted into the eye, the support portion is usually colored to make the position of the support portion easily visible. However, in the case of a one-piece intraocular lens in which the optical section and the support section are integrally formed, it is very difficult to color only the support section.

Therefore, conventionally, a method as disclosed in Japanese Patent Application Laid-Open No. 2-7954 has been considered in order to produce a one-piece type intraocular lens having a colored supporting portion. That is,
First, after forming the central portion of the lens blank with a transparent plastic, a liquid colored plastic material is disposed around the central portion and polymerized and cured, and the central portion and the colored peripheral portion are bonded by polymerization. To obtain a lens blank. Alternatively, conversely, after the peripheral portion of the lens blank is formed of a coloring material, a transparent liquid plastic material is poured into a hole provided in the center thereof, thereby similarly forming a transparent central portion and a coloring peripheral portion. To obtain a lens blank bound by polymerization. Then, an optical part of the intraocular lens is formed from the transparent central part of the obtained lens blank, and a supporting part of the intraocular lens is formed from the colored peripheral part, thereby producing a target intraocular lens. You do it.

However, in such a method, when the central portion is polymerized later in the hole of the peripheral colored portion of the lens blank, there is a problem that the central portion is distorted, which adversely affects the optical performance of the lens. There was a fear of coming out. On the other hand, if the transparent central portion of the lens blank is formed first and the colored peripheral portion is subsequently polymerized, it is difficult to match the center of the central portion to the center of the central portion of the lens blank. Was inherent. If the center of the entire lens blank and the center of the central part are shifted, the colored part appears in the optical part in the intraocular lens obtained as the final product by performing shape processing with the center of the entire lens blank as the processing center. This causes a problem in that a transparent portion appears on the support portion, causing a color shift.

JP-A-62-161360 also discloses a method of manufacturing a one-piece type intraocular lens in which a support portion is colored. Surround with colored plastic material, integrate them by heat fusion to get lens blank,
The objective intraocular lens is manufactured from the lens blank. Therefore, also in this manufacturing method, it is difficult to make the center of the optical member coincide with the center of the entire lens blank, and it is inevitable that color shift occurs.

(Solution problem) Under such circumstances, the present invention has been made, and a problem to be solved is that, when manufacturing a one-piece type intraocular lens in which a support portion is colored, distortion or coloring of an optical portion is caused. It is to eliminate the problem such as displacement.

According to the present invention, there is provided a method for manufacturing a one-piece type intraocular lens in which an optical unit and a support unit are integrally formed. Providing a convex portion that provides an optical portion and the support portion, a lens blank having a flange portion that is lower than the convex portion,
A step of preparing a jetty having a predetermined height integrally or separately provided over the entire periphery of the outer periphery;
(B) using a coloring liquid containing a predetermined coloring agent added and contained in a solvent capable of at least swelling the lens blank, and placing it on the brim portion of the lens blank surrounded by the jetty; Pouring and coloring the upper surface of the collar portion to a depth of 0.05 mm or more; and (c) using the colored lens blank, the convex portion as the optical portion, and the colored collar portion as the support portion. And forming a target intraocular lens.

(Operation / Effect) In short, according to the present invention, since the lens blank is formed and then colored, the central portion is an optical portion and the peripheral portion is processed into a support portion. What is necessary is to prepare a transparent thing. Therefore, the lens blank can be entirely polymerized at the same time regardless of the central portion and the peripheral portion, and unlike the case where the central portion is polymerized later, distortion does not occur in the optical portion and the lens blank is stable. Optical characteristics can be obtained.

In addition, in the lens blank, the portion corresponding to the optical portion is formed as a convex portion, and the portion corresponding to the support portion is formed as a brim portion. The collar can be dyed separately. Therefore, if the target intraocular lens is processed from such a lens blank, the convex portion can be easily matched with the transparent optical portion, and the collar portion can be easily matched with the colored support portion. As described above, no color shift occurs.

(Specific Configuration) In the present invention, the material for forming the lens blank is not particularly limited, and various hard materials and soft materials conventionally used as intraocular lens materials may be used.

For example, a predetermined hard material or soft material can be obtained by polymerizing a polymerizable monomer as described below. In the notation, "... (meth) acrylate" means "... acrylate" or ".
.. methacrylate ", and the same applies to other (meth) acrylic derivatives.

That is, methyl (meth) acrylate, ethyl (meth) acrylate, propyl (meth) acrylate, n
-Butyl (meth) acrylate, tert-butyl (meth)
Acrylate, isobutyl (meth) acrylate, n-
Pentyl (meth) acrylate, tert-pentyl (meth) acrylate, hexyl (meth) acrylate, 2
-Methylbutyl (meth) acrylate, heptyl (meth) acrylate, octyl (meth) acrylate, 2
Linear, branched chains such as ethylhexyl (meth) acrylate, nonyl (meth) acrylate, decyl (meth) acrylate, dodecyl (meth) acrylate, stearyl (meth) acrylate, cyclopentyl (meth) acrylate, and cyclohexyl (meth) acrylate; Shape,
Cyclic alkyl (meth) acrylates; fluorine-containing (meth) acrylates; silicon-containing (meth) acrylates; styrene derivatives; fluorine-containing styrene derivatives; N-vinyllactams; hydroxyethyl (meth)
Acrylate, hydroxypropyl (meth) acrylate, hydroxybutyl (meth) acrylate, dihydroxypropyl (meth) acrylate, dihydroxybutyl (meth) acrylate, diethylene glycol mono (meth) acrylate, triethylene glycol mono (meth) acrylate, dipropylene glycol mono Hydroxyl group-containing (meth) acrylates such as (meth) acrylate; (meth) acrylamide, N-methyl (meth)
Acrylamide, N-ethyl (meth) acrylamide,
N-hydroxyethyl (meth) acrylamide, N, N-
Dimethyl (meth) acrylamide, N, N-diethyl (meth) acrylamide, N-ethylaminoethyl (meth)
And (meth) acrylamides such as acrylamide.

One or more of these may be selected and used, or one or more selected from them may be polymerized to form a macromonomer, which may be used as one of the polymerization components. I can do it. The combination and blending ratio of these polymerization components are appropriately determined according to the polymer to be obtained.

If necessary, a commonly used polymerizable ultraviolet absorber or a polymerizable dye can be added as a polymerization component.

Further, a polymer material which is not crosslinked can be used, but in consideration of the stability of the coloring liquid in a solvent, etc., it is preferable that the polymer is crosslinked, and it is desirable to add a crosslinking agent as described below.

For example, 4-vinylbenzyl (meth) acrylate,
3-vinylbenzyl (meth) acrylate, ethylene glycol di (meth) acrylate, diethylene glycol di (meth) acrylate, triethylene glycol di (meth) acrylate, propylene glycol di (meth) acrylate, dipropylene glycol di (meth)
There are acrylate, allyl (meth) acrylate, vinyl (meth) acrylate and the like, and one or more of them are selected and blended. Further, a macromonomer having at least two or more polymerizable groups in a molecule may be used as a crosslinking agent. If the amount of the crosslinking agent is too large, the obtained material becomes brittle and weak against stress such as impact.On the other hand, if the amount is too small, the effect is not sufficiently obtained. Of the polymerization component
The amount is preferably about 0.5 to 15 parts by weight, more preferably 1 to 10 parts by weight, per 100 parts by weight.

Then, these polymerization components are uniformly blended, a predetermined polymerization initiator is added, and the polymerization operation is performed. The polymerization operation is performed according to various methods conventionally performed.For example, in the case of heat polymerization, after blending a radical polymerization initiator such as azobisisobutyronitrile and azobisdimethylvaleronitrile, the mixture is cooled to room temperature. To 130 ° C. over about ten and several hours in order to polymerize. In the case of performing photopolymerization, a photopolymerization initiator such as benzoin or methylorthobenzoylbenzoate is blended, and then a light beam having a wavelength corresponding to the absorption band of the photopolymerization initiator is irradiated to perform polymerization. Furthermore,
It is also possible to carry out heat polymerization and photopolymerization in combination.

Incidentally, the polymerization initiator may be used alone or in combination of two or more thereof from various commonly used ones.The compounding amount is 0.0 parts by weight based on 100 parts by weight of all the polymerization components.
It is about 0.01 to 5 parts by weight, preferably 0.01 to 2 parts by weight.

From the polymer thus obtained, a lens blank having a convex portion for providing an optical portion of the intraocular lens and a brim portion for providing a support portion of the intraocular lens is formed. here,
In the present invention, since the projections and the brim portions only need to be formed as transparent, unlike the conventional method,
The entire blank can be polymerized at the same time, so that distortion in the center of the lens blank can be very well prevented.

Incidentally, the more specific shape of the lens blank is not particularly limited, and is appropriately determined according to the shape of the target intraocular lens. For example, FIG.
The lens blank 10 shown in (b) has a disk shape as a whole, has a spherical convex portion 12 concentrically at the center thereof, and extends annularly around the convex portion 12. Collar part
Has 14 Reference numeral 16 denotes a jetty for preventing the coloring liquid from spilling when the coloring liquid is applied to the brim portion 14, and facilitates the coloring operation.

In addition, the shape of the convex portion 12 can be a columnar shape as shown in FIGS. 2 (a) and 2 (b), or a shape combining a cylinder and a spherical surface as shown in FIG. It is also possible. Further, the collar portion 14 may be provided only at a portion where the support portion of the intraocular lens is to be formed. For example, in the specific example shown in FIGS. At two radially opposed
14,14 are provided. Further, the jetty 16 is not essential, and as shown in FIGS. 2 and 3, it may be omitted at all. In this case, as shown in FIG. 4, coloring can be performed by arranging the frame 20 surrounding the brim portion 14 as a jetty.

Furthermore, as shown in FIGS. 5 and 6, a blank 22 in which a plurality of lens blanks 10 are connected may be formed so that a plurality of lens blanks 10 can be colored simultaneously. In this case, as shown in FIG. 5, even if the jetty 16 is provided so as to correspond to each protruding portion 12, as shown in FIG. 6, one jetty 16 surrounding the entire blank 22 is provided. You may. Also, the jetty 16 can be omitted. And such a blank 22 is usually
After being colored, they are cut into individual lens blanks 10,
It will be processed to the final shape.

The specific size of the lens blank 10 is set slightly larger than the size of the intraocular lens as the final product, but if it is too large, it will take time and effort to remove unnecessary parts. The diameter (or length) of the protrusion 12 is about 5 to 15 mm, the diameter (or length, but not including the pier 16) including the collar 14 is about 10 to 20 mm, and the protrusion height of the protrusion is 1 It is set to about 5 mm.

On the other hand, the coloring liquid applied to the lens blank 10 is a solution in which a predetermined coloring agent is added to a solvent capable of at least swelling a polymer as a material for forming the lens blank 10, and the coloring agent is It may be in a state of being dissolved in a solvent or in a dispersed state. Also,
A solvent that dissolves the lens blank can be used as the solvent, but in this case, the coloring liquid is prevented from coming into contact with the lens blank for too long.

Specific examples of the solvent include polymerizable solvents such as the above-mentioned (meth) acrylate monomers, and water; alcohols such as methyl alcohol and ethyl alcohol; ketones such as acetone and methyl ethyl ketone as non-polymerizable solvents. Halogenated hydrocarbons such as dichloromethane and chloroform; ethers such as ethyl ether; esters such as ethyl acetate; and aromatic hydrocarbons such as benzene and toluene.

Among them, if a polymerizable solvent is used, the colorant contained in the solvent is polymerized in a state in which the solvent has penetrated into the swollen or dissolved lens blank 10 so that the colorant contained in the solvent is firmly attached to the polymer. Will be combined. On the other hand, when a non-polymerizable solvent is used, the coloring agent is physically sealed in the swollen or dissolved lens blank 10. In the case where a non-polymerizable solvent is used, if necessary, it is possible to mix water or an aqueous alkaline reduction solution. When a polymerizable solvent is used, the polymerization initiator is usually contained at a ratio of about 0.001 to 0.1% by weight.

The colorant added to such a solvent is not particularly limited, except for the requirement of safety for living organisms, and any of conventionally used dyes and pigments can be used. Specifically, pigments such as Red No. 101 and Blue No. 1 used in the fields of food and pharmaceuticals, direct dyes such as CI Direct Blue 237, CI Direct Yellow 8 and the like, CI Acid Blue 29, CI Acid dyes such as Acid Black 2, basic dyes such as CI Basic Blue 5, CI Basic Violet 1, vat dyes such as CI Vat Blue 18, SOLUBILISED CI Vat Blue 1, CI Solvent Violet 13, CI Oil-soluble dyes such as Solvent Green 3, CI Pigment Blue
15 and the like. In particular, a polymerizable dye as disclosed in Japanese Patent Application Laid-Open No. 1-299560 is preferable because it is strongly bonded to the lens blank 10.

One or two or more of these coloring agents are selected and added to the solvent to prepare a coloring liquid. The concentration of the coloring agent is usually about 0.01 to 30% by weight. It is said. If the amount is lower than 0.01% by weight, the coloring becomes too light, and if the amount is higher than 30% by weight, the color does not become deeper. When the colorant is difficult to dissolve or disperse in the solvent, a surfactant and / or a dispersant can be added.

The coloring liquid thus obtained is applied to at least one side of the collar portion of the lens blank 10 to form a lens blank.
Ten colorings are performed. Specifically, the first
In the case of the lens blank 10 as shown in FIGS. 5, 5 and 6, it is possible to apply coloring only to the upper surface of the brim portion 14 by pouring a coloring liquid into the brim portion 14 surrounded by the jetty 16, Further, even in the lens blank 10 in which such a jetty 16 is not provided, by providing the frame 20 as a separate jetty as shown in FIG. 4, coloring can be performed in a similar manner. In addition, even with the convex portion 12 of the lens blank 10, the surface layer portion that is removed by the final shape processing after coloring can be colored at all.Therefore, there is no mask by controlling the coloring depth. Then, the lens blank 10 is colored.

Thus, in the present invention, the lens blank 10 is
Since the projections 12 and the flanges 14 can be effectively dyed and separated from each other because they are three-dimensionally divided into the flanges 14 and the collars 14, the lens blank 10 does not have a color shift.

Then, with the colored liquid applied, remove the lens blank
10 is maintained for a certain period of time while the coloring liquid is penetrated or impregnated to a desired degree. In the meantime, if the holding temperature is low, the dyeing speed will be slow and the workability will be inferior, so that it is usually held at room temperature or higher, preferably at 50 ° C or higher.
Since 10 deformations are caused, the temperature is usually maintained at 150 ° C. or lower, preferably 120 ° C. or lower. The retention time is
Although it greatly varies depending on the holding temperature, the type of the coloring liquid, and the like, it is usually about 1 minute to 72 hours, preferably about 5 minutes to 48 hours. If the time is shorter than 1 minute, coloring cannot be sufficiently performed, and if the time is longer than 72 hours, workability is poor.

More specific holding conditions (coloring conditions) are determined based on the coloring depth set according to the content of the final shape processing performed after coloring. That is, in the present invention, since the shape processing is performed after coloring, in order to impart a desired coloring state (coloring depth and density) to the support portion of the finally obtained intraocular lens, Blank 10
This is because it is necessary to comprehensively control the depth and density of the coloring with respect to the final cutting contents (cutting amount and cutting portion). In addition, the coloring depth can also be controlled by the dye concentration of the coloring liquid.

For example, when trying to obtain an intraocular lens in which the entire support portion is colored, as shown in FIG. 7, it is assumed that a portion shown by a broken line in the figure is processed as a product (intraocular lens). The coloring depth of the lens blank is set to be equal to or greater than the depth obtained by adding the thickness of the support portion to the cutting amount. In addition, although it cannot be said unconditionally, after performing the cutting process to the final shape, the coloring depth is set to 0.05 mm or more so that at least the surface of the support portion is colored. .

Then, to control the coloring depth, the lens blank 10
Although it depends on the material and the type of the solvent of the coloring liquid, if the coloring depth is to be shallow, the holding condition (coloring condition) should be a low temperature and a short time, and if the coloring depth should be deep, the holding condition should be High temperature, set for a long time.

The lens blank 10 that has been colored as described above is subjected to the final shape processing such as cutting and polishing in the same manner as in the related art, and the transparent portion of the convex portion 12 is used. Thus, the optical portion 24 is formed, and the supporting portion 26 is formed by using the colored portion of the collar portion 14, thereby obtaining the intraocular lens 28 as shown in FIG. In addition, a precision processing machine such as a milling machine that is generally used is used for such shape processing.

(Examples) Hereinafter, some examples of the present invention will be shown to clarify the present invention more specifically. However, the present invention imposes some restrictions by the description of such examples. It goes without saying that you don't receive anything.

In addition, in addition to the following examples, the present invention, in addition to the above-described specific description, various changes, corrections, and modifications based on the knowledge of those skilled in the art without departing from the spirit of the present invention. It should be understood that improvements can be made.

Example 1 First, 97 parts by weight of methyl methacrylate and 3 parts by weight of diethylene glycol dimethacrylate were blended, and a crosslinked polymethyl methacrylate obtained by polymerization was used. From the polymer, the dimensions shown in FIG. mm) to produce a disc-shaped lens blank. Next, the annular collar portion of the lens blank was filled with a coloring liquid composed of a methyl methacrylate (polymerizable solvent) solution containing 0.1% CI acid violet 43 as a coloring agent. Then, cover the collar with a polyethylene film,
After holding for 4 hours at 50 ° C., the coloring liquid is removed and
The temperature was raised to 0 ° C over 8 hours.

Thereafter, when processed by a milling machine, an intraocular lens 28 having a colored support portion 26 was obtained as shown in FIG.

Example 2 The same lens blank as in Example 1 was used, and acetone (non-polymerizable solvent): 6 g, 4-phenylazo-1-methacryloylnaphthalene (polymerizable dye): 0.1 at the brim portion.
g, azobisisobutyronitrile (polymerization initiator): 0.02 g
Was coated with a polyethylene film and kept at 25 ° C. for 3 hours, and then the temperature was further raised from 25 ° C. to 110 ° C. over 6 hours.

Thereafter, when processed by a milling machine, an intraocular lens 28 having a colored support portion 26 was obtained as shown in FIG.

[Brief description of the drawings]

FIGS. 1 (a) and 1 (b) are a plan view and an AA sectional view showing an example of a lens blank, respectively, and FIGS. 2 (a) and (b) respectively show another example of a lens blank. FIG. 2 is a plan view showing the example of FIG. FIGS. 3 and 4 are longitudinal sectional views showing still another example of a lens blank. FIGS. 5 and 6 are plan views showing examples of different blanks in a form in which a plurality of lens blanks are integrally formed. Further, FIG. 7 is an explanatory sectional view showing a state where the collar portion of the lens blank is colored, and FIG. 8 is a plan view showing an example of an intraocular lens produced according to the present invention. FIG. 9 is an explanatory view showing the dimensions and shapes of the lens blanks manufactured in Examples 1 and 2. FIG. 10 is an illustration showing the dimensions and shapes of the lens blanks manufactured in Examples 3 and 4. FIG. 10: Lens blank, 12: Convex part 14: Collar part, 16: Jetty 24: Optical part, 26: Support part 28: Intraocular lens

Continued on front page (58) Field surveyed (Int.Cl. ⁶ , DB name) A61F 2/16 A61L 27/00

Claims (2)

(57) [Claims] 1. A method for manufacturing a one-piece type intraocular lens in which an optical part and a support part are integrally formed, wherein a convex part providing the optical part and a support part are provided. A step of preparing a lens blank having a low brim portion and having a ridge of a predetermined height provided integrally or separately over the entire periphery of the lens blank; and A predetermined colorant is added to a solvent that can be swelled, and a coloring liquid containing the coloring agent is used. The colorant is poured onto the collar surrounded by the jetty of the lens blank, and the upper surface of the collar is cleaned. A step of coloring at a depth of 0.05 mm or more, and processing the convex part into an optical part and the colored brim part into a supporting part from the colored lens blank to form an objective intraocular lens And a step of forming A method for producing an intraocular lens, which is a feature of the present invention. 2. The method for manufacturing an intraocular lens according to claim 1, wherein the upper surface of the collar portion is formed as a surface extending linearly.