JP2942410B2 - Method for manufacturing intraocular lens - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

TECHNICAL FIELD The present invention relates to a method for manufacturing an intraocular lens,
In particular, the present invention relates to a method for manufacturing an intraocular lens in which an optical unit and a support unit are integrally formed as a one-piece type intraocular lens, and at least a part of the support unit is colored.

[0002]

2. Description of the Related Art An intraocular lens includes an optical section as a lens body and a support section for mounting and fixing the optical section at a predetermined position in the eye. 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.

[0003] In any of these types of intraocular lenses, when the intraocular lens is inserted into the eye, the support portion is usually colored to make it easy to visually recognize the position of the support portion. Have been. However, in the case of a one-piece type intraocular lens in which the optical unit and the support unit are integrally formed, it is very difficult to color only the support unit.

[0004] Therefore, conventionally, in order to produce a one-piece type intraocular lens in which a support portion is colored, Japanese Patent Application Laid-Open No. HEI 2 (1990) -197686 discloses a method.
A method such as that disclosed in JP-A-7954 is considered. That is, first, the central portion of the lens blank is formed of a transparent plastic material, and then a liquid colored plastic forming material (polymerized material) is disposed around the central portion, and is polymerized and cured. A lens blank is obtained in which the parts are joined by polymerization. Alternatively, conversely, after forming the peripheral portion of the lens blank with a colored plastic material, by pouring a transparent liquid plastic forming material into a hole provided in the center thereof, the transparent central portion is similarly colored. A lens blank having a peripheral portion bonded by polymerization is obtained. And
Since the optical portion of the intraocular lens is formed from the transparent central portion of the obtained lens blank and the support portion of the intraocular lens is formed from the colored peripheral portion, the objective intraocular lens is manufactured. is there.

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, and the optical characteristics of the lens are reduced. There was a risk that performance would be adversely affected. 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 transparent central portion with the center of the central portion of the lens blank. The problem was inherent. When the center of the entire lens blank and the center of the transparent central portion are displaced from each other, by performing shape processing with the center of the entire lens blank as a processing center, a colored portion is added to the optical portion in the intraocular lens obtained as a final product. Or a transparent portion appears on the supporting portion, which causes a problem of color shift.

[0006] Japanese Patent Application Laid-Open No. 62-161360 also discloses one method of manufacturing a one-piece type intraocular lens having a colored supporting portion. In this method, an optical member made of a transparent plastic material is surrounded by a colored plastic material, and they are integrated by heat fusion.
A lens blank is obtained, and a target intraocular lens is manufactured from the lens blank. However, 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.

[0007]

The present invention has been made in view of such circumstances, and an object of the present invention is to provide a simple one-piece type intraocular lens having a colored supporting portion. Another object of the present invention is to eliminate problems such as distortion, center shift, and color shift of the optical unit.

[0008]

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, wherein (a) the optical unit and the support unit are provided. (B) providing a lens blank having a size large enough to provide a desired intraocular lens shape including the optical section and the supporting section; and c) At least a part of the supporting portion constituting the intraocular lens-shaped frame of the lens blank, using a coloring liquid in which a predetermined coloring agent is added and contained in a solvent capable of at least swelling the lens blank. And (d) taking out the bordered intraocular lens-shaped portion from the colored lens blank, wherein at least a part of the supporting portion is colored. And a step of processing the intraocular lens, a method of manufacturing the intraocular lens, characterized in that it comprises, is to its gist.

[0009]

As described above, according to the present invention, since a predetermined portion is colored after forming a lens blank, the center portion is formed into an optical portion, and the peripheral portion is formed into a support portion. What is necessary is just to prepare what is entirely transparent as a blank. 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.

[0010] In addition, the colored lens blank is provided with an edge processing for providing a desired intraocular lens shape including an optical portion and a support portion, and the support portion defined thereby. Since it suffices to apply only coloring to the constituent parts, there is no occurrence of color shift or center shift unlike the conventional method, and coloring of the support portion can be made extremely easy.

[0011]

In the present invention, the material for forming the lens blank is not particularly limited.
Various hard materials and soft materials conventionally used as an intraocular lens material can be used.For example, a predetermined hard material or a soft material is obtained by polymerizing a polymerizable monomer as described below. Can be done. 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-ethylhexyl (meth) acrylate, nonyl (meth) acrylate, decyl (meth) acrylate,
Linear, branched, and cyclic alkyl (meth) acrylates such as dodecyl (meth) acrylate, stearyl (meth) acrylate, cyclopentyl (meth) acrylate, and cyclohexyl (meth) acrylate; 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 (meth) acrylate Hydroxyl group-containing (meth) acrylate and the like; (meth) acrylamide, N- methyl (meth)
Acrylamide, N-ethyl (meth) acrylamide,
N-hydroxyethyl (meth) acrylamide, N, N
And (meth) acrylamides such as -dimethyl (meth) acrylamide, N, N-diethyl (meth) acrylamide and N-ethylaminoethyl (meth) acrylamide.

One or more of these are selected and used, or one or more selected from these are polymerized to form a macromonomer, which is used as one of the polymerization components. Can also be used. 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. However, considering 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) acrylate, allyl (meth) acrylate,
There are vinyl (meth) acrylates 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. The amount is preferably about 0.5 to 15 parts by weight, more preferably 1 to 10 parts by weight, based on 100 parts by weight of the polymerization component.

Then, these polymerization components are uniformly blended, and a predetermined polymerization initiator is added to carry out a polymerization operation. The polymerization operation will be carried out according to various methods conventionally carried out, for example,
In the heat polymerization, after a radical polymerization initiator such as azobisisobutyronitrile or azobisdimethylvaleronitrile is blended, the temperature is sequentially raised from room temperature to 130 ° C. over about ten and several hours to carry out polymerization. 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 combine heat polymerization and photopolymerization. The polymerization initiator may be used singly or in combination of two or more of various commonly used ones.
The amount is about 0.001 to 5 parts by weight, preferably 0.01 to 2 parts by weight with respect to parts by weight.

The lens blank made of the polymer material obtained in this manner has a predetermined thickness suitable for processing, and is large enough to provide an optical portion and a support portion of a target intraocular lens. But, specifically,
The size is set slightly larger than the size of the intraocular lens that is the final product. However, if the lens blank is too large, it will take time to remove unnecessary portions, and the diameter is usually set to about 10 to 30 mm.

When rimming is performed on such a lens blank, as shown in FIGS. 1 and 2, one surface (upper surface) of the lens blank 2 is applied to an NC engraving machine or the like. The edging process is performed so as to give a desired intraocular lens shape 8 including the optical part and the support part provided by the optical part formation part 4 and the support part formation part 6. That is, as is apparent from the drawing, a rim groove 10 having a predetermined depth is provided on the upper surface of the lens blank 2 with a predetermined width so as to draw the planar shape 8 of the target intraocular lens.

The width of the edging groove 10 is generally
It is set to about 0.05 to 2.0 mm. Edging groove 10
When the width is 0.05 mm or less, it is not preferable because sufficient dyeing liquid cannot be injected, and when the width is 2.0 mm or more, a large amount of dyeing liquid is required. This is because it is not preferable.

The depth of the edging groove 10 is generally set to about 0.05 to 2.0 mm (however, not to penetrate the lens blank 2). When the depth of the edging groove 10 is shallower than 0.05 mm,
This is because the supporting portion forming portion 6 is too thin, which is not preferable. If the supporting portion forming portion 6 is deeper than 2.0 mm, the supporting portion forming portion 6 may be damaged during processing, which is not preferable.

Next, at least a part of the support portion forming portion 6 of the intraocular lens shape 8 of the lens blank 2 subjected to the above-described edging is colored according to the present invention. One method for that coloring is shown in FIGS. FIG. 3 shows the mounting angle of the support portion forming portion 6 with respect to the optical portion forming portion 4 at 0 °.
FIG. 4 shows a case of the coloring example of the lens blank 2 in which FIG.
Is a case of a coloring example of the lens blank 2 larger than 0 °. There, in order to color at least a part of the framed support portion forming portion 6, at least one of the groove 10 for forming the support portion forming portion 6 and the upper surface of the support portion forming portion 6 has a coloring liquid 12 formed thereon. Is given. That is, in FIGS. 3 and 4, the predetermined coloring liquid 12 is applied to at least one of the grooves 10, 10 on both sides of the support portion forming portion 6 and the upper surface of the support portion forming portion 6.

When the coloring liquid 12 is applied, the upper surface of the supporting portion forming portion 6 bordered by the groove 10 in the lens blank 2 is screen-printed or octopus-printed. The other portions are filled with the predetermined coloring liquid 12 in the grooves 10 so that the intended supporting portion forming portion 6 is colored. When the groove 10 is filled with the coloring liquid 12, the coloring liquid 12 may come into contact with the optical part forming part 4 if it is a little, but the supporting part forming part 6 and the optical part A coloring liquid 12 is provided at the boundary with the formation site 4.
It is preferable not to provide a ridge or to provide a jetty with a wax or the like at a boundary portion.

The coloring liquid 12 applied to the supporting portion forming portion 6 is obtained by adding a predetermined coloring agent to a solvent capable of swelling at least a polymer as a material for forming the lens blank 2. In some cases, the colorant may be in a state of being dissolved in a solvent or in a state of being dispersed. A solvent that dissolves the lens blank 2 can be used as the solvent.
2 does not contact the lens blank 2 for too long.

Specific examples of the solvent constituting the coloring liquid 12 include, in addition to the above-mentioned polymerizable solvents such as the (meth) acrylate monomer, non-polymerizable solvents such as water; Alcohols such as ethyl alcohol; ketones such as acetone and methyl ethyl ketone; 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. Can be mentioned.

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 2 so that the colorant contained in the solvent is polymerized. Will be firmly bound to. On the other hand, when a non-polymerizable solvent is used, the colorant is physically sealed in the swollen or dissolved lens blank 2. In the case where a non-polymerizable solvent is used, if necessary, it is possible to mix water or an aqueous alkaline reduction solution.

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

One or two or more of these colorants are selected and added to the solvent to prepare the coloring liquid 12. The concentration of the colorant is usually
It is about 0.01 to 30% by weight. If the content is lower than 0.01% by weight, the coloring becomes too light.
Even if it is higher than the weight%, the color will not be further darkened. When the colorant is difficult to dissolve or disperse in the solvent, a surfactant and / or a dispersant can be added.

The coloring liquid 12 thus obtained is applied to at least a part of the support portion forming portion 6 in the shape of an intraocular lens which is framed by the lens blank 2, and the support portion forming portion 6 is colored. is there.

Then, in a state where the coloring liquid 12 is applied, the lens blank 2 is held for a certain time while the coloring liquid 12 is penetrated or impregnated to a desired degree. In the meantime, if the holding temperature is low, the dyeing speed becomes slow and the workability deteriorates. Therefore, it is usually held at room temperature or higher, preferably at 50 ° C. or higher. Since the deformation of No. 2 is caused, the temperature is usually kept at 150 ° C. or lower, preferably 120 ° C. or lower. The retention time varies greatly depending on the retention temperature, the type of the coloring liquid, and the like, but is usually about 1 minute to 72 hours, preferably about 5 minutes to 48 hours. 1
If the length is shorter than 10 minutes, coloring cannot be sufficiently performed.
If the time is longer than 2 hours, workability is poor. Unnecessary (excess) coloring liquid 12 is removed (volatilized, etc.) by holding at a holding temperature for a certain period of time.

In the coloring operation, more specific holding conditions (coloring conditions) are appropriately determined based on the coloring depth set according to the final shape processing performed after coloring. It is determined. 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, the coloring depth of the lens blank 2 and the like are determined. This is because it is necessary to comprehensively control the density in accordance with the content of the final cutting process (cutting amount and cutting site). Note that the coloring depth can also be controlled by the dye concentration in the coloring liquid 12. To control the coloring depth, it depends on the material of the lens blank 2 and the type of the solvent of the coloring liquid 12. However, when the coloring depth is reduced, the holding condition (coloring condition) is set to a low temperature and a short time. When the coloring depth is increased, the holding condition is set to a high temperature and a long time.

Then, from the lens blank 2 which has been colored as described above, a portion of the intraocular lens shape 8 which is bordered by the groove 10 is taken out by an operation such as cutting, cutting, and the like. By performing the final shape processing such as cutting and polishing, the intraocular lens 18 having the colored support portion 16 integrally with the optical portion 14 as shown in FIG. 6 is obtained. In addition, a precision processing machine such as a milling machine that is generally used is used for such shape processing.

It should be noted that, in the above-described manufacturing process of the intraocular lens 18, each operation is performed while holding the lower surface (A surface) of the lens blank 2 until the coloring process of the lens blank 2. In the process of processing the intraocular lens 18 from the blank 2, the upper surface (B surface) of the lens blank 2
Thus, desired processing is performed to leave the upper surface (B surface) side of the support portion forming portion 6 and the intraocular lens 18 is completed. 3 and 4, the portion of the intraocular lens 18 taken out of the lens blank 2 is shown by hatching.

[0033]

EXAMPLES Hereinafter, some examples of the present invention will be described 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, the present invention, in addition to the following examples, in addition to the above specific description, various modifications based on the knowledge of those skilled in the art, unless departing from the spirit of the present invention,
It should be understood that modifications, improvements and the like can be made.

Example 1 First, 97 parts by weight of methyl methacrylate, 3 parts by weight of diethylene glycol dimethacrylate and 0.1 part by weight of azobisisobutyronitrile were blended, and a crosslinked polymethyl methacrylate obtained by polymerization was used. From this polymer, a disc-shaped lens blank 2 having the dimensions (unit: mm) shown in FIG.
A predetermined intraocular lens shape 8 was trimmed with an engraving machine.
Next, 5% of C.I. as a coloring agent was introduced into the groove 10 defining the support portion forming portion 6 bordered by the intraocular lens.
I. A coloring liquid 12 consisting of a solution of methyl methacrylate (polymerizable solvent) containing solvent violet 13 was filled. Then, after holding at 40 ° C. for 60 minutes, 50
The temperature was raised from 100 ° C. to 100 ° C. over 4 hours, and the coloring liquid 1
2 was removed. Thereafter, when processed by a milling machine, an intraocular lens 18 having a colored support portion 16 integrally with the optical portion 14 as shown in FIG. 6 was obtained.

Example 2 First, 97 parts by weight of methyl methacrylate, 3 parts by weight of diethylene glycol dimethacrylate and 0.1 part by weight of azobisisobutyronitrile were blended, and a crosslinked polymethyl methacrylate obtained by polymerization was used. From this polymer, a disc-shaped lens blank 2 having the dimensions (unit: mm) shown in FIG.
A predetermined intraocular lens shape 8 was trimmed with an engraving machine.
Next, the supporting portion forming portion 6 which is edged into an intraocular lens shape
10% CI as a colorant in the groove 10
A coloring liquid 12 composed of an ethyl methacrylate (polymerizable solvent) solution containing Solvent Green 3 was filled.
Then, after holding at 50 ° C. for 30 minutes, the temperature is further lowered from 50 ° C. to 8 ° C.
The temperature was raised to 0 ° C. over 5 hours to remove the coloring liquid 12. After that, after processing with a milling machine,
As shown in the figure, an intraocular lens 18 having an optical portion 14 and a colored support portion 16 integrally was obtained.

Example 3 First, using a non-crosslinked polymethyl methacrylate obtained by polymerizing 100 parts by weight of methyl methacrylate, a disc-shaped polymer having the dimensions (unit: mm) shown in FIG. A lens blank 2 was prepared, and one surface of the lens blank 2 was edged with a predetermined intraocular lens shape 8 using an NC engraving machine. Next, the coloring liquid 12 composed of an ethanol solution containing 10% of 1-phenylazo-4-methacryloyloxynaphthalene as a coloring agent is filled in the groove 10 defining the supporting portion forming portion 6 bordered in the shape of the intraocular lens. Was. Then, after holding at 35 ° C. for 30 minutes, the temperature is further increased to 50 ° C.
To 70 ° C. over 3 hours to remove the coloring liquid 12. Thereafter, when processed by a milling machine, an intraocular lens 18 integrally having an optical portion 14 and a colored support portion 16 was obtained as shown in FIG.

[Brief description of the drawings]

FIG. 1 is a plan view showing a lens blank that has been subjected to edging to give a predetermined intraocular lens shape.

FIG. 2 is a sectional view taken along the line II-II in FIG.

FIG. 3 is a cross-sectional explanatory view showing a form in which a support portion in the shape of a truncated intraocular lens is colored in which an attachment angle of the support portion to the optical unit is 0 °.

FIG. 4 is an explanatory cross-sectional view showing a form in which a support portion in the shape of a truncated intraocular lens is colored in which an attachment angle of the support portion to the optical unit is larger than 0 °.

FIG. 5 is an explanatory sectional view corresponding to FIG. 2 and showing a dimensional shape of a lens blank employed in an example.

FIG. 6 is a plan view showing an example of an intraocular lens manufactured according to the present invention.

[Explanation of symbols]

 2 Lens blank 8 Intraocular lens shape 4 Optical part forming part 6 Support part forming part 10 Groove 12 Coloring liquid 14 Optical part 16 Supporting part 18 Intraocular lens

──────────────────────────────────────────────────続 き Continuation of front page (56) References JP-A-4-309347 (JP, A) JP-A-4-212349 (JP, A) JP-A-4-44755 (JP, A) JP-A-4- 183466 (JP, A) JP-A-2-7954 (JP, A) JP-A-4-295353 (JP, A) JP-A-62-161360 (JP, A) (58) Fields investigated (Int. Cl. ⁶ , DB name) A61F 2/16 A61L 27/00

Claims (1)

(57) [Claims] 1. A method of manufacturing a one-piece type intraocular lens in which an optical part and a support part are integrally formed, and preparing a lens blank large enough to provide the optical part and the support part. Performing a edging process on the lens blank to give a desired intraocular lens shape including the optical portion and the supporting portion; and adding a predetermined coloring agent to a solvent capable of at least swelling the lens blank; Using the coloring liquid to be contained,
A step of coloring at least a part of the support portion constituting a framed intraocular lens shape of the lens blank; and removing the framed intraocular lens shape portion from the colored lens blank, Processing a target intraocular lens in which at least a part of the intraocular lens is colored.