CN113545886A - Method for manufacturing artificial lens - Google Patents
Method for manufacturing artificial lens Download PDFInfo
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- CN113545886A CN113545886A CN202110369189.1A CN202110369189A CN113545886A CN 113545886 A CN113545886 A CN 113545886A CN 202110369189 A CN202110369189 A CN 202110369189A CN 113545886 A CN113545886 A CN 113545886A
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- lens
- polymer
- intraocular lens
- manufacturing
- monomer mixture
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- VENJJOGQEGHFPI-UHFFFAOYSA-N butyl prop-2-enoate;2-methylidenehexanoic acid Chemical compound CCCCOC(=O)C=C.CCCCC(=C)C(O)=O VENJJOGQEGHFPI-UHFFFAOYSA-N 0.000 description 1
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- HXDBMSZZSWTGKB-UHFFFAOYSA-N ethyl prop-2-enoate;2-methylidenebutanoic acid Chemical compound CCOC(=O)C=C.CCC(=C)C(O)=O HXDBMSZZSWTGKB-UHFFFAOYSA-N 0.000 description 1
- 229910052731 fluorine Inorganic materials 0.000 description 1
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
- A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
- A61F2/1616—Pseudo-accommodative, e.g. multifocal or enabling monovision
- A61F2/1618—Multifocal lenses
Landscapes
- Health & Medical Sciences (AREA)
- Ophthalmology & Optometry (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
Abstract
The invention relates to a manufacturing method of an artificial lens, which comprises the following steps: an inner lens molding step, injecting the first monomer mixture into an inner lens molding die, and polymerizing to obtain a first polymer with a first refractive index; an outer lens molding step of disposing the first polymer in an outer lens molding mold, injecting a second monomer mixture, and forming a second polymer having a second refractive index in a state where the second monomer mixture is immersed in the first polymer to obtain an intraocular lens molded body; a drying step of heating and drying the obtained intraocular lens molded body to remove unreacted monomers; and a demolding step, namely demolding and cutting the dried artificial lens molded body to obtain the artificial lens.
Description
Technical Field
The invention relates to a method for manufacturing an artificial lens, in particular to a method for manufacturing a multifocal artificial lens made of multiple materials with different refractive indexes.
Background
An intraocular lens (IOL) is an artificial lens that can be implanted in the eye to replace the natural lens in a human eye that has become clouded due to cataract disease, or for refractive surgery to correct the vision of the human eye. Since the lens in a human eye has some flexibility, it allows the eye to accommodate far or near vision through the action of the ciliary muscles. If a monofocal intraocular lens is used to replace the natural lens, the patient's focal distance is fixed and improved results cannot be achieved at both near and far distances, i.e., the range of clear vision will become narrower. To solve this problem, multifocal intraocular lenses have been proposed. Furthermore, a colored lens is manufactured by adding specific pigment to the inner side of the artificial lens, so as to reduce glare after operation, reduce retinal light injury and reduce color vision abnormality (such as blue vision) after operation.
Conventionally, methods for producing multifocal intraocular lenses include a method for producing an intraocular lens by a machine cutting and a method for producing an intraocular lens by a mold. However, in either method, the basic power and the add power of the multifocal intraocular lens need to be considered together for design planning, and thus complicated calculations and relatively advanced techniques are required.
Disclosure of Invention
Technical problem to be solved by the invention
As a conventional technique, a colored lens has been widely used in a monofocal or multifocal intraocular lens. However, since the conventional colored intraocular lens is made of a single material, the color of the lens varies depending on the power and the thickness of the lens.
Accordingly, an object of the present invention is to provide a method for manufacturing an intraocular lens, which can easily manufacture a colored intraocular lens by a simple design structure and manufacturing process, and which can maintain a uniform lens color regardless of the power of the intraocular lens.
Solution for solving the above technical problem
A first aspect of the present invention relates to a method for manufacturing an intraocular lens, the method comprising: an inner lens molding step of injecting the first monomer mixture into an inner lens molding die and polymerizing to obtain a first polymer having a first ultraviolet visible transmittance; an outer lens molding step of setting the first polymer in an outer lens molding mold, injecting a second monomer mixture, and polymerizing the second monomer mixture in a state where the first polymer is immersed in the second monomer mixture to form a second polymer having a second ultraviolet visible transmittance, thereby obtaining an intraocular lens molded body; a drying step of heating and drying the obtained intraocular lens molded body to remove unreacted monomers; and a demolding step, namely demolding and cutting the dried artificial lens molded body to obtain the artificial lens.
In the method for manufacturing an intraocular lens according to the second aspect of the present invention, in the first aspect, the first ultraviolet visible transmittance is smaller than the second ultraviolet visible transmittance.
A method for manufacturing an intraocular lens according to a third aspect of the present invention is the first or second aspect wherein, in the outer lens molding step, after the second monomer mixture is injected into the outer lens molding die, the temperature is first raised to the first temperature and held for 2 hours, and then further raised to the second temperature and held for 4 hours.
In the method for producing an intraocular lens according to the fourth aspect of the present invention, in the first or second aspect, the second polymer coats the first polymer and forms an interpenetrating polymer with the first polymer.
A method of manufacturing an intraocular lens according to a fifth aspect of the present invention is the first aspect wherein the outer lens forming mold has an optical portion-forming portion and a non-optical portion-forming portion.
In the method for producing an intraocular lens according to the sixth aspect of the present invention, in the first aspect, the first monomer mixture and/or the second monomer mixture includes a blend of at least a (meth) acrylate monomer having an aryl group and a (meth) acrylate having a fluorine-substituted alkyl group.
A method for producing an intraocular lens according to a seventh aspect of the present invention is the first aspect wherein the second monomer mixture contains a polymerizable monomer having colorability.
In the method for producing an intraocular lens according to the eighth aspect of the present invention, according to the seventh aspect, photochromism occurs in the intraocular lens molded body.
In the eighth aspect of the method for producing an intraocular lens according to the ninth aspect of the present invention, the intraocular lens molded body has a photochromic effect.
Technical effects
According to the technical scheme of the invention, the artificial lens is manufactured by forming the inner package structure by using two polymer materials with different ultraviolet visible transmittances, so that the multifocal artificial lenses with various correction degrees can be easily realized by using a simple mold design structure, and the color of the lens is uniform. In addition, the multifocal intraocular lens with the basic focal power and the additional focal power can be manufactured in a mode that the size of the inner lens is unchanged and only the curvature of the single surface of the outer lens is changed, the manufacturing process of the multifocal intraocular lens is simplified into the manufacturing process of a single-focus intraocular lens, the requirements on the operation difficulty and the manufacturing technology are greatly reduced, and the customized requirements are easily met.
Drawings
Fig. 1 is a perspective view of an intraocular lens according to the present invention.
Figure 2 is a top view of an intraocular lens according to the present invention.
Figure 3 is a cross-sectional view in the direction a-a of the intraocular lens of figure 2.
Fig. 4 is a sectional view of a molding die for producing an inner lens according to the present invention.
Fig. 5 is a sectional view of a molding die for producing an outer lens according to the present invention.
FIG. 6 is a flow chart of the manufacture of an intraocular lens according to the present invention.
Description of the reference numerals
100 intraocular lens
1 lens unit
2 part
11 inner lens part
12 outer lens portion.
Detailed Description
Embodiments of the present invention will be described in detail below with reference to the accompanying drawings.
< multifocal intraocular lens >
Figure 1 shows a perspective view of a multifocal intraocular lens 100 according to the present invention. Figure 2 shows a top view of a multifocal intraocular lens 100 according to the present invention. Fig. 3 is a cross-sectional view in the direction a-a of intraocular lens 100 of fig. 2.
As shown in fig. 1, the intraocular lens 100 is composed of a lens portion 1 and portions 2 connected to the outer edge of the lens portion 1. The lens portion 1 is substantially disk-shaped and has a thick central portion and slightly convex on both sides. The lens unit 1 is a member having a function of correcting the visual function of the eyeball, and is composed of an inner lens 11 inside and an outer lens 12 outside. the part 2 serves as a connecting and fixing member for supporting and fixing the lens part 1 by adhering the hook-shaped part 2 to the eyeball when the intraocular lens 100 is implanted into the eyeball.
The lens unit 1 is formed by combining an inner lens 11 and an outer lens, and the inner lens 11 and the outer lens 12 are respectively formed by polymer materials having different refractive indexes. The composition and method of formation of the polymeric material will be described later. As can be seen from fig. 3, the inner lens 11 is completely enclosed in the outer lens 12, and the centers of the outer lens 12 and the inner lens 11 are superposed on the same optical axis, and the optical characteristics of the two lenses are superimposed on each other, thereby providing the optical performance which the multifocal intraocular lens finally has.
The optical performance of the multifocal intraocular lens can have special optical performance such as a specific ultraviolet visible transmittance and photochromism, in addition to a specific vision correction power, which enables simultaneous correction of far vision and near vision by having a plurality of focuses, as in a common vision function correction tool.
In the entire lens unit 1, a plurality of focal points are formed at positions in the overlapping region and the vicinity of the overlapping region of the outer lens 12 and the inner lens 11 for correcting the eyesight of the human eye. This portion is also commonly referred to as the optic. The peripheral portion of the outer lens 12 has no such vision correction function, and hence this portion is referred to as an non-optical portion (not shown). However, in the intraocular lens of the present invention, optical properties such as photochromism can be imparted to the non-optical portion, and the details will be described later.
As described above, the lens portion 1 of the intraocular lens 100 according to the present invention is formed in a shape having a thick central portion and a thin peripheral portion. Correspondingly, the inner lens 11 and the outer lens 12 are both in a disk shape with a thick center and thin edges, and form an inner wrap structure in a concentric circle state. In an intraocular lens obtained by the manufacturing method described later, the thickness of the central portion of the inner lens 11 was about 0.1mm, and the thickness of the central portion of the outer lens 12 was 0.75 mm.
But the shapes and the arrangement positions of the inner lens 11 and the outer lens 12 are not limited thereto. For example, the center positions of the inner lens 11 and the outer lens 12 may not coincide with each other. Alternatively, the inner lens 11 may be formed in a fan shape. Further, the inner package structure of the multiple lens materials may have more than one layer, or the multi-focal intraocular lens may be formed by forming two inner packages of three lens materials or multiple inner packages of more lens materials.
Next, the polymer used for producing the intraocular lens material will be described.
< polymers for producing multifocal intraocular lenses >
In the polymer for the preparation of multifocal intraocular lenses employed in the present invention, a combination of a (meth) acrylate monomer having an aryl group and a (meth) acrylate having a fluorine substituted alkyl group, which have high refractive indexes, and a low refractive index, is contained for the purpose of adjusting the refractive index.
As the (meth) acrylate monomer having an aryl group used in the present invention, any one or a combination of more of 2-Phenylethyl methacrylate (Ph-MA, 2-Phenylethyl methacrylate), 2-Phenylethyl acrylate (Ph-a, 2-Phenylethyl acrylate), 2-Phenoxyethyl methacrylate (2-Phenoxy methacrylate), 2-Phenoxyethyl acrylate (2-Phenoxyethyl acrylate), n-Butyl acrylate (n-Butyl acrylate), n-Butyl methacrylate (n-Butyl methacrylate), Ethyl acrylate (Ethyl acrylate), and Ethyl methacrylate (Ethyl methacrylate) can be exemplified.
As the (meth) acrylate having a fluorine-substituted alkyl group used in the present invention, Trifluoroethyl methacrylate (TFE-MA) and/or Trifluoroethyl acrylate (TFE-a) can be exemplified.
On the basis, in order to satisfy the hardness of the polymer obtained by polymerization so that the manufactured intraocular lens can meet the requirement of being foldable, a polymer having a lower glass transition temperature (Tg) can be obtained by appropriately adjusting the mixing ratio of the (meth) acrylate monomer having an aryl group to the (meth) acrylate having a fluorine-substituted alkyl group, or further adding an appropriate amount of an alkyl (meth) acrylate-free compound. As the (meth) acrylate monomer having no aromatic group, n-Butyl acrylate (n-BuA, n-Butyl acrylate) may be exemplified. Examples of the polymer composition ratio and the addition amount and the expected glass transition temperature are shown in table 1 below.
[ TABLE 1 ]
In addition to the (meth) acrylate monomer having an aryl group and the (meth) acrylate having a fluorine-substituted alkyl group as main components, the following other additional components are contained in the polymer.
For example, in order to improve the safety of the polymer to be produced, it is desirable to add a proper amount of a di (meth) acrylate component as a crosslinkable monomer. Examples of the crosslinking monomer to be added for improving the crosslinking property of the polymer include Ethylene Glycol Dimethacrylate (EGDMA) and Butanediol diacrylate (BDDA). In addition, 2,2'-azobis (isobutyronitrile), (AIBN, 2,2' -azobis (isobutonitrile)) was added as a polymerization initiator.
As will be described later, the multifocal intraocular lens of the present invention can be produced as an intraocular lens having different refractive indexes, an intraocular lens having different ultraviolet visible transmittances, an intraocular lens having a photochromic function, or the like. In response to such a production demand, it is also considered to add a polymerizable monomer having ultraviolet absorbability, for example, 2- (2'-Hydroxy-5' -methacryloyloxyethylphenyl) -2H-Benzotriazole (Norbloc7966, 2- (2'-Hydroxy-5' -methacryloyloxyphenyl) -2H-Benzotriazole) as needed; polymerizable monomers having coloring properties, such as 4- (Phenyldiazenyl) phenyl-2-methacrylate (BL01, 4- (Phenyldiazenyl) phenyl-2-methacrylate); and 1-acryloyloxyethyl-3, 3-dimethylspiro [ indoline-2,3'- [3H ] -naphtho [2,1-b ] (1,4) oxazine ] (ADINO, 1-Acryloxyethyl-3, 3' - [3H ] -naptho [2,1-b ] (1,4) oxazine) having a photochromic polymerizable monomer.
Here, it is particularly noted that the specific structural formula of the photochromic polymerizable monomer ADINO is shown below (compound 1).
[ CHEM 1 ]
The photochromic material for intraocular lens is selected from triarylmethane, stilbene, azastilbene, nitrone, fulgide, spiropyran, naphthopyran, spirooxazine, etc. Typical examples thereof include 1',3' -Dihydro-1',3',3'-trimethyl-6-nitro spiro [2H-1-benzopyran-2,2' - (2H) -indole ] (1',3' -Dihydro-1',3',3 '-trimethy-6-nitro spiro [2H-1-benzopyran-2,2' - (2H) -indole ], compound 2), 1,3-Dihydro-1,3,3-trimethyl-spiro [2H-indole-2,3'- [3H ] phenanthro [9,10-b ] (1,4) oxazine (1,3-Dihydro-1,3, 3-trimethy-spiro [2H-indole-2,3' - [3H ] phenanthro [9,10-b ] (1,4) oxazine as a spirooxazine, 3' - [3H ] phenonthro [9,10-b ] (1,4) oxazine, compound 3). Also, a method of manufacturing a photochromic intraocular lens by including these compounds in an intraocular lens material at a concentration of 0.01 to 0.4% by weight is known (see US8,133,274).
[ CHEM 2 ]
[ CHEM 3 ]
In addition, the use of a polymerizable photochromic material is very important for suppressing elution of the material and improving safety, and specific examples of the compound shown in U.S. Pat. No. 5,166,345 are: 1-acryloyloxyethyl-3, 3-dimethylspiro [ indoline-2,3'- [3H ] naphtho [2,1-b ] (1,4) oxazine ] (1-acryloyloxyethyl-3, 3-dimethylspiro [ indoline-2,3' - [3H ] naphtho [2,1-b ] (1,4) oxazine ]), 1-methacryloyloxyethyl-3, 3-dimethylspiro [ indoline-2,3'- [3H ] naphtho [2,1-b ] (1,4) oxazine ] (1-methacryloyloxyethyl-3, 3-dimethylspiro [ indoline-2,3' - [3H ] naphtho [2,1-b ] (1,4) oxazine ]), 1-methacryloyloxypropyl-3, 3-dimethylspiro [ indoline-2,3' - [3H ] naphtho [2,1-b ] (1,4) oxazine ] (1-methacryloxypropyl-3,3-dimethylspiro [ indoline-2,3' - [3H ] naphtho [2,1-b ] (1,4) oxazine ]), 1-methacryloylethyl-3, 3-dimethyl-5-chlorospiro [ indoline-2,3' - [3H ] naphtho [2,1-b ] (1,4) oxazine ] (1-methacryloylamidoethyl-3, 3-dimethylspirol-5-chlorospiro [ indoline-2,3' - [3H ] naphtho [2,1-b ] (1,4) oxazine ]), 1-methacryloyloxyethyl-3, 3-dimethyl-8' -methoxyspiro (p-vinylphenethyl) -3,3-dimethyl-5, 6-dichlorospiro [ indoline-2,3'- [3H ] -naphtho [2,1-b ] (1,4) oxazine ] (1-methacryloxyeth-3, 3-dimethyl-8' -methoxylphiro (p-vinylphenylethy) -3, 3-dimethyll-5, 6-dhichlorospiro [ indoline-2,3'- [3H ] -naphtho [2,1-b ] (1,4) oxazine ]), 1,3,3-trimethyl-9' -methacryloxyspiro [ indoline-2,3'- [3H ] -naphtho [2,1-b ] (1,4) oxazine ] (1,3, 3-trimethylloxyspiro [ indoline-2,3' - [3H ] -naphtho [2,1-b ] (1,4) oxazine ] (1,3, 3-trimethyloxy-9 '-methacryloxyspirol [ indoline-2,3' - [3H ] -naphtho [2,1-b ] (1,4) oxazine ], 1,3,3-trimethyl-5 '-methacryloyloxymethyl spiro [ indoline-2,3' - [3H ] -naphtho [2,1-b ] (1,4) oxazine ] (1,3,3-trimethyl-5 '-methacryloyloxymethyl spiro [ indoline-2,3' - [3H ] -naphtho [2,1-b ] (1,4) oxazine ]), 1,3,3-trimethyl-9'-methacrylamide spiro [ indoline-2,3' - [3H ] -naphtho [2,1-b ] (1,4) oxazine ] (1,3,3-trimethyl-9 '-methacrylamido [ indoline-2,3' - [3H ] -naphtho [2,1-b ] (1,4) oxazine), 1,3,3-trimethyl-5-chloro-8'-acryloxyspiro [ indoline-2,3' - [3H ] -naphtho [2,1-b ] (1,4) oxazine ] (1,3,3-trimethyl-5-chloro-8'-acryloxyspiro [ indoline-2,3' - [3H ] -naphtho [2,1-b ] (1,4) oxazine ]), 1-benzyl-3,3-dimethyl-9'-vinylbenzoyloxyspiro [ indoline-2,3' - [3H ] -naphtho [2,1-b ] (1,4) oxazine ] (1-benzyl-3,3-dimethyl-9'-vinylbenzoyloxyspiro [ indoline-2,3' - [3H ] -naphtho [2,1-b ] (1,4) oxazine), 3-trimethyl-9 '-methacryloyloxyspiro [ indoline-2,3' - [3H ] -pyrido [2,1-b ] (1,4) benzoxazine (3-trimethyl-9 '-methacryloyloxyspiro [ indoline-2,3' - [3H ] -pyrido [2,1-b ] (1,4) benzoxazine), 1 '- (1, 5-pentadiyl) bis [3,3-dimethyl-9' -methacryloyloxyspiro [ indoline-2,3'- [3H ] -naphtho [2,1-b ] (1,4) oxazine ] (1, 1' - (1, 5-pentanyl) bis [3,3-dimethyl-9 '-methacryloyloxyspiro [ indoline-2,3' - [3H ] -naphtho [2,1-b ] (1,4) oxazine ] ] (1,1 '- (1, 5-pentanyl) bis [3,3-dimethyl-9' -methacryloyloxyspiro [ indoline-2,3' - [3H ] -naphtho [2,1-b ] (1,4) oxazine ] ]), 1' - [1,4-phenylenebis (methylene) bis [3,3-dimethyl-5' - (meth) acryloyloxymethyl spiro [ indoline-2,3' - [3H ] -naphtho [2,1-b ] (1,4) oxazine ] ] (1, 1' - [1,4-phenylenebis (methyl) bis [3,3-dimethyl-5' - (meta) acryloyloxymethyl piro [ indole-2,3' - [3H ] -naphtho [2,1-b ] (1,4) oxazine ] ]), 1' - (1,4-butanediyl) bis [5,6-dichloro-3,3-dimethyl-8' - (meth) acryloyloxy spiro [ indoline-2,3' - [3H ] -naphtho [2,1-b ] (1,4) oxazine ] (1,1"- (1, 4-butandediyl) bis [5, 6-dichoro-3, 3-dimethyl-8' - (meta) acryloxyspiro [ indoline-2,3' - [3H ] -naphtho [2,1-b ] (1,4) oxazine ] ]) or a compound represented by the following chemical formula 4, chemical formula 5 or chemical formula 6.
[ CHEM 4 ]
[ CHEM 5 ]
[ CHEM 6 ]
The method for producing the multifocal intraocular lens of the present invention will be specifically described below with reference to fig. 6.
< method for producing multifocal intraocular lens >
Example 1
The multifocal intraocular lenses of the invention are polymerized from two polymeric materials each having a different refractive index.
The inner lens polymer material is first prepared. Ph-A, n-BuA, TFE-MA, TFE-A, EGDMA, Norbloc7966 and AIBN were added to a 10mL glass bottle in the following amounts, and the mixture was stirred at room temperature for 20 hours to obtain a polymer mixture for an inner lens.
Ph-A: 15g (15 mass%, 13 mol%)
n-BuA: 28g (28 mass%, 33.4 mol%)
TFE-MA: 35g (35 mass%, 31.8 mol%)
TFE-A: 22g (22 mass%, 21.8 mol%)
EGDMA: 2g (2% by mass based on the total amount of Ph-A, n-BuA, TFE-MA and TFE-A)
Norbloc 7966: 0.4g (0.4 mass% based on the total amount of Ph-A, n-BuA, TFE-MA, and TFE-A)
AIBN: 0.3g (0.3% by mass based on the total amount of Ph-A, n-BuA, TFE-MA and TFE-A)
Fig. 4 shows a mold for an inner lens. The mold is made of a resin material and has a pair of upper and lower hollow shapes. The overall diameter length l of the die was 12 mm. A biconvex lens having a diameter r of 2mm was formed in the central portion as an optical portion-forming portion of the inner lens, and the peripheral portion was formed in a uniform flat plate shape having a thickness h of 0.2mm as a non-optical portion-forming portion. The curvature of the inner lens of the two convex shapes is designed to be 40.00mm on the front and 50.00mm on the back.
The polymer mixture for the inner lens is slowly injected into the mold for the inner lens so that no air bubbles are mixed in the polymer mixture injected into the mold. Thereafter, the resin mold filled with the polymer mixture is placed in a polymerization apparatus. The polymerization apparatus was kept under a nitrogen atmosphere, and the pressure in the apparatus was set to 0.2kgf/cm2(0.0196MPa)。
As a specific procedure of the polymerization, first, the polymerization apparatus was heated from 20 ℃ to 50 ℃ over a period of 30 minutes, and maintained at the 50 ℃ temperature for 8 hours. Then, the temperature was again slowly raised to 120 ℃ over a period of 6 hours, maintained at 120 ℃ for 2 hours, and finally lowered to 40 ℃ over a period of 4 hours.
After completion of the polymerization, the mold is taken out of the polymerization apparatus, opened and the polymer material of the polymerized inner lens is taken out. The polymer material of the inner lens is prepared to have a refractive index nD 201.450 polymer material.
The polymer material of the outer lens is next prepared. Ph-MA, Ph-A, n-BuA, EGDMA, Norbloc7966 and AIBN were added to a glass bottle having a capacity of 10mL in the following amounts, respectively, and the mixture was stirred at room temperature for 20 hours to prepare a polymer mixture for an outer lens.
Ph-MA: 56g (56 mass%, 52.1 mol%)
Ph-A: 34g (34% by mass, 34.1 mol%)
n-BuA: 10g (10 mass%, 13.8 mol%)
EGDMA: 2g (2% by mass based on the total amount of Ph-MA and Ph-A, n-BuA)
Norbloc 7966: 0.4g (0.4% by mass based on the total amount of Ph-MA and Ph-A, n-BuA)
AIBN: 0.3g (0.3% by mass based on the total amount of Ph-MA and Ph-A, n-BuA)
Fig. 5 shows a mold for the outer lens. The mold is a pair of upper and lower hollow molds made of a resin material in the same manner. The overall diameter length L of the die is 13-14 mm. A biconvex lens shape with a diameter R of 6mm was formed in the central portion as an optical portion of the outer lens, and the peripheral portion was formed in a uniform flat plate shape with a thickness H of 0.32mm as a non-optical portion. The curvature of the two convex outer lenses is designed to be 25.00mm on the front surface and-19.00 mm on the back surface, and the overall thickness of the two convex lenses can reach 0.70 mm.
Then, the polymer material of the inner lens prepared previously is put into the outer lensThe polymer mixture for the outer lens is slowly injected into the mold for the outer lens at the center of the optical portion of the mold of (1), so that no air bubbles are mixed in the polymer mixture injected into the mold. Then, the resin mold filled with the polymer mixture and having the polymer material of the inner lens immersed in the center thereof is placed in a polymerization apparatus. The inside of the polymerization apparatus was kept in a nitrogen atmosphere, and the pressure in the apparatus was set to 0.2kgf/cm 2(0.0196MPa)。
The polymerization process of the outer lens is substantially the same as the polymerization process of the inner lens. First, the polymerization apparatus was heated from 20 ℃ to 50 ℃ over 30 minutes, and maintained at the 50 ℃ temperature for 8 hours. Then, the temperature was again slowly raised to 120 ℃ over a period of 6 hours, maintained at 120 ℃ for 2 hours, and finally lowered to 40 ℃ over a period of 4 hours.
The refractive index of the polymer material of the outer lens taken out of the mold after completion of the polymerization is nD 201.550. And the outer lens polymer material is in a state of containing the inner lens polymer material therein.
The intraocular lens material having the inner coating structure was placed in a desiccator set at 120 ℃ in advance, and heat treatment was performed for 8 hours. Unreacted polymer monomer in the intraocular lens material is removed by the heating process.
This gives an intraocular lens material composed of polymers with two different refractive indices. Then, a machine tool is used to cut a predetermined shape into the material, and finally, a bifocal intraocular lens having two different refractive indices is manufactured.
The intraocular lens thus produced was analyzed by an optical measurement machine, and it was found that the focal power of the central 2mm diameter portion of the intraocular lens was 15.3D, the focal power of the peripheral portion was 19.8D, the entire intraocular lens was formed as a bifocal intraocular lens, and the add power was 4.5D.
In this embodiment 1, the refractive index of the polymer material for the outer lens is formed to be greater than the refractive index of the polymer material for the inner lens. Of course, the refractive index of the polymer material of the outer lens element can be made smaller than that of the polymer material of the inner lens element according to actual needs. The technical solution of the present application can be realized by stacking the inner lens polymer material and the outer lens polymer material having different refractive indexes.
By adopting the manufacturing method, the design process of the bifocal intraocular lens is decomposed into the design of two monofocal intraocular lenses, so that the design difficulty is greatly reduced, and the operation is easy.
It is particularly worth mentioning that during the polymerization of the outer lens polymer material, the outer lens polymer monomer mixture is contacted with the inner lens polymer material immersed therein, and an interpenetrating polymer is formed at the contact interface during the polymerization. The interpenetrating polymers are formed on the interface of the two polymer materials, and the molecular chains penetrate through each other, so that the two polymer materials are mutually embedded, no obvious boundary interface exists, and natural connection is realized. Therefore, the artificial lens material forms a unified whole, the optical performances of different diopters, focuses and the like in different areas are naturally and transitionally changed, and the use feeling of a patient can be improved.
Example 2
The following is a description of the process for making a multifocal intraocular lens formed of two polymers having different visible ultraviolet transmittances.
First, an inner lens polymer material was prepared in the same manner as in example 1. Ph-MA, Ph-A, n-BuA, TFE-MA, BL01, EGDMA, Norbloc7966 and AIBN were added to a 10mL glass bottle and stirred at room temperature for 20 hours to prepare a polymer mixture for an inner lens.
Ph-MA: 24g (24 mass%, 22.1 mol%)
Ph-A: 64g (64 mass%, 63.7 mol%)
n-BuA: 5g (5 mass%, 6.8 mol%)
TFE-MA: 7g (7 mass%, 7.3 mol%)
BL 01: 0.02g (0.02 mass% based on the total amount of Ph-MA, Ph-A, n-BuA, and TFE-MA)
EGDMA: 2g (2% by mass based on the total amount of Ph-MA, Ph-A, n-BuA, and TFE-MA)
Norbloc 7966: 1.5g (0.4% by mass based on the total amount of Ph-MA, Ph-A, n-BuA, and TFE-MA)
AIBN: 0.3g (0.3% by mass based on the total amount of Ph-MA, Ph-A, n-BuA, and TFE-MA)
Similarly to example 1, the polymer mixture liquid for an inner lens was gradually injected into a mold for an inner lens so that no air bubbles were mixed in the polymer mixture liquid injected into the mold. Thereafter, the resin mold filled with the polymer mixture is placed in a polymerization apparatus. The inside of the polymerization apparatus was kept in a nitrogen atmosphere, and the pressure in the apparatus was set to 0.2kgf/cm 2(0.0196MPa)。
As a specific procedure of the polymerization, first, the polymerization apparatus was heated from 20 ℃ to 50 ℃ over a period of 30 minutes, and maintained at the 50 ℃ temperature for 8 hours. Then, the temperature was again slowly raised to 120 ℃ over a period of 6 hours, maintained at 120 ℃ for 2 hours, and finally lowered to 40 ℃ over a period of 4 hours.
After completion of the polymerization, the mold is taken out of the polymerization apparatus, opened and the polymerized inner lens polymer material is taken out. The polymer material of the inner lens is prepared to have the refractive index of nD 201.450 polymer material.
After the inner lens is manufactured, the manufactured inner lens may be subjected to a surface treatment such as a plasma treatment in order to improve the affinity with the polymerization of the outer lens. The process is equally applicable to other embodiments.
The outer lens polymer material is next fabricated. Ph-MA, Ph-A, n-BuA, TFE-MA, EGDMA, Norbloc7966 and AIBN were added to a 10mL glass bottle and stirred at room temperature for 20 hours to prepare a polymer mixture for an outer lens. The composition ratio in the polymer mixture for the outer lens was completely the same as that in the polymer mixture for the inner lens except that no BL01 was included.
Then, the polymer material of the inner lens prepared previously is put inThe polymer mixture liquid for the outer lens is slowly injected into the mold for the outer lens after being injected into the center of the optical portion of the mold for the outer lens, so that no air bubbles are mixed in the polymer mixture liquid injected into the mold. Thereafter, the resin mold filled with the polymer mixture is placed in a polymerization apparatus. The inside of the polymerization apparatus was kept in a nitrogen atmosphere, and the pressure in the apparatus was set to 0.2kgf/cm2(0.0196MPa)。
The polymerization process of the outer lens is substantially the same as the polymerization process of the inner lens. First, the polymerization apparatus was heated from 20 ℃ to 50 ℃ over 30 minutes, and maintained at the 50 ℃ temperature for 8 hours. Then, the temperature was again slowly raised to 120 ℃ over a period of 6 hours, maintained at 120 ℃ for 2 hours, and finally lowered to 40 ℃ over a period of 4 hours.
Following completion of polymerization, the intraocular lens material with the outer lens polymer material encapsulating the inner lens polymer material is removed from the mold. The intraocular lens material was placed in a desiccator set at 120 ℃ in advance, and heat treatment was performed for 8 hours. Unreacted polymer in the intraocular lens material is removed by the heating process.
The intraocular lens material thus obtained was a central lens yellow intraocular lens material composed of polymers having two different visible transmittances of ultraviolet rays. And is formed such that the ultraviolet visible transmittance of the inner lens polymer material is less than the ultraviolet visible transmittance of the outer lens polymer material. Next, a predetermined shape was cut out of this material by a machine tool, and finally, a multifocal intraocular lens having a yellow central lens was produced.
Tinted lenses are also currently known, which are made by adding specific pigments to the inner side of the intraocular lens to reduce post-operative glare, reduce retinal light damage, and reduce post-operative color vision abnormalities. However, conventional colored intraocular lenses are made of a single material, and the lens color varies depending on the refractive power and the thickness of the lens. The multifocal intraocular lens produced in example 2 of the present invention has the advantage that the intraocular lens itself always has a constant visible transmittance of ultraviolet light regardless of whether the focal power is high or low.
Example 3
The following is a description of the process for making a multifocal intraocular lens formed of two polymers having photochromic properties.
The photochromic material is discolored by irradiation of light and becomes transparent in a dark place. Thus, if it is used in an intraocular lens material, it can function like an iris. Its optical performance is similar to that of a camera diaphragm, which controls the amount of light by changing the aperture. And the photochromic material can control the brightness by changing the transmittance of the lens. The two principles are different, but the technical effects can be realized by the two principles are the same.
Conventional photochromic intraocular lenses are made of a homogeneous material, and therefore, the color density is different in lenses of different powers and thicknesses. By using the method of the present invention, however, the color density of the intraocular lens can be maintained consistently across all sizes and all ranges of optical properties.
In the same manner as in example 2, first, an inner lens polymer material was produced. Ph-MA, Ph-A, n-BuA, TFE-MA, ADINO, EGDMA, Norbloc7966 and AIBN were added to a 10mL glass bottle and stirred at room temperature for 20 hours to prepare a polymer mixture for an inner lens.
Ph-MA: 24g (24 mass%, 22.1 mol%)
Ph-A: 64g (64 mass%, 63.7 mol%)
n-BuA: 5g (5 mass%, 6.8 mol%)
TFE-MA: 7g (7 mass%, 7.3 mol%)
ADINO: 0.1g (0.1% by mass based on the total amount of Ph-MA, Ph-A, n-BuA, and TFE-MA)
EGDMA: 2g (2% by mass based on the total amount of Ph-MA, Ph-A, n-BuA, and TFE-MA)
Norbloc 7966: 1.5g (1.5% by mass based on the total amount of Ph-MA, Ph-A, n-BuA, and TFE-MA)
AIBN: 0.3g (0.3% by mass based on the total amount of Ph-MA, Ph-A, n-BuA, and TFE-MA)
Next, the polymer mixture liquid for the inner lens is slowly poured into the mold for the inner lens so that no air bubbles are mixed in the polymer mixture liquid poured into the mold. Then, the resin mold filled with the polymer mixture liquid for the inner lens is set in a polymerization apparatus. The inside of the polymerization apparatus was kept in a nitrogen atmosphere, and the pressure in the apparatus was set to 0.2kgf/cm2(0.0196MPa)。
As a specific procedure of the polymerization, first, the polymerization apparatus was heated from 20 ℃ to 50 ℃ over a period of 30 minutes, and maintained at the 50 ℃ temperature for 8 hours. Then, the temperature was again slowly raised to 120 ℃ over a period of 6 hours, maintained at 120 ℃ for 2 hours, and finally lowered to 40 ℃ over a period of 4 hours.
Next, an outer lens polymer material is prepared. Ph-MA, Ph-A, n-BuA, TFE-MA, EGDMA, Norbloc7966 and AIBN were added to a 10mL glass bottle and stirred at room temperature for 20 hours to prepare a polymer mixture for an outer lens. The composition ratio in the polymer mixture for the outer lens is completely the same as that in the polymer mixture for the inner lens except that ADINO is not contained.
Then, the polymer material for the inner lens prepared previously is put into the center of the optical portion of the mold for the outer lens, and the polymer mixture for the outer lens is slowly injected into the mold for the outer lens so that the polymer mixture injected into the mold is free from air bubbles. Thereafter, the resin mold filled with the polymer mixture is placed in a polymerization apparatus. The inside of the polymerization apparatus was kept in a nitrogen atmosphere, and the pressure in the apparatus was set to 0.2kgf/cm2(0.0196MPa)。
The polymerization process of the outer lens is substantially the same as that of the inner lens. First, the polymerization apparatus was heated from 20 ℃ to 50 ℃ over 30 minutes, and maintained at the 50 ℃ temperature for 8 hours. Then, the temperature was again slowly raised to 120 ℃ over a period of 6 hours, maintained at 120 ℃ for 2 hours, and finally lowered to 40 ℃ over a period of 4 hours.
The outer lens polymer material with the inner lens polymer material encapsulated therein is removed from the mold after polymerization is complete. The intraocular lens material was placed in a desiccator set at 120 ℃ in advance, and heat treatment was performed for 8 hours. Unreacted polymer in the intraocular lens material is removed by the heating process.
Thus, an intraocular lens material having photochromic material encapsulated therein is obtained. Next, the material was cut into a predetermined shape by a machine tool, and finally, an intraocular lens made of a photochromic material was produced. The intraocular lens is provided with a photochromic region for adjusting the amount of light entering the lens at the edge of the outer lens.
The color of the conventional photochromic artificial lens varies with the focal power. In contrast, the intraocular lens produced according to example 3 of the present invention has a constant ultraviolet visible transmittance regardless of whether the focal power of the intraocular lens is high or low.
Further, by applying to examples 1 to 3 above, it is possible to more easily produce a plurality of types of bifocal lenses having a specific add power to the base power by changing only the shape of the outer lens to be produced to have various curvatures while keeping the shape and size of the polymer material of the inner lens placed in the center unchanged.
For example, the inner lens polymer material is formed into a biconvex lens having a front surface with a curvature of 40.00mm and a back surface with a curvature of-50.00 mm, and then the outer lens polymer material is formed to enclose the inner lens polymer material therein, and the outer lens polymer material is formed such that the curvature of the back surface is fixed to-19.00 mm. In this state, a bifocal lens having a specific basic power and a plurality of additional powers can be easily produced simply by freely changing the curvature of the front surface of the outer lens polymer material within the range of 25.00mm to 10.00 mm.
The changes in the base power and the add power of the intraocular lens obtained using the method of making a multifocal lens of the present invention when the curvature of the inner lens is constant and the curvature of the outer lens is changed only in the front are shown in table 2 below.
[ TABLE 2 ]
In general, in order to fabricate a multifocal intraocular lens, a separate design is required according to the entire combination of the base power and the add power even if the add power is constant. In contrast, according to the present method, it is possible to easily produce a variety of bifocal lenses by changing only the refractive power of the outer lens without changing the design of the inner lens, or by changing only the refractive power of the inner lens while keeping the design of the outer lens constant. In addition, the design of each bifocal lens is disassembled into a pure single-focal lens design, so that the complexity of designing the artificial lens is avoided, and the number of the molds which need to be opened again in the manufacturing process can be reduced.
In addition to the above examples, the composition of the polymer mixed liquid for the inner lens and the composition of the polymer mixed liquid for the outer lens can be freely combined. For example, as shown in table 3 below, polymers having various refractive indexes can be obtained by freely selecting the polymer mixture for the inner lens and the polymer mixture for the outer lens from composition examples 1 to 5 shown below. In example 1 above, a combination of composition example 1 as the outer lens and composition example 5 as the inner lens was used, but it is needless to say that other combinations may be used to obtain multifocal intraocular lenses having various optical designs.
[ TABLE 3 ]
It should be appreciated that in the description of exemplary embodiments of the invention, various features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects may lie in less than all features of a single foregoing disclosed embodiment. Thus, the claims following the detailed description are hereby expressly incorporated into this detailed description, with each claim standing on its own as a separate embodiment of this invention.
Furthermore, although some embodiments described herein include some but not other features included in other embodiments, combinations of features of different embodiments are intended to fall within the scope of the invention and form different embodiments as would be understood by those of skill in the art. For example, in the appended claims, any of the claimed embodiments may be used in any combination.
It should be noted that the use of particular terminology when describing certain features or aspects of the invention should not be taken to imply that the terminology is being redefined herein to be restricted to including any specific characteristics of the features or aspects of the invention with which that terminology is associated.
In the description provided herein, numerous specific details are set forth. However, it is understood that embodiments of the invention may be practiced without these specific details. In other instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description.
Claims (9)
1. A method of making an intraocular lens, the method comprising:
an inner lens molding step of injecting the first monomer mixture into an inner lens molding die and polymerizing to obtain a first polymer having a first ultraviolet visible transmittance;
an outer lens molding step of setting the first polymer in an outer lens molding mold, injecting a second monomer mixture, and polymerizing the second monomer mixture in a state where the first polymer is immersed in the second monomer mixture to form a second polymer having a second ultraviolet visible transmittance, thereby obtaining an intraocular lens molded body;
A drying step of heating and drying the obtained intraocular lens molded body to remove unreacted monomers;
and a demolding step, namely demolding and cutting the dried artificial lens molded body to obtain the artificial lens.
2. The method of manufacturing an intraocular lens of claim 1,
the first ultraviolet visible transmittance is less than the second ultraviolet visible transmittance.
3. The method of manufacturing an intraocular lens according to claim 1 or 2,
in the outer lens forming step, after the second monomer mixture is injected into the outer lens forming mold, the temperature is first raised to the first temperature and held for 2 hours, and then further raised to the second temperature and held for 4 hours.
4. The method of manufacturing an intraocular lens according to claim 1 or 2,
the second polymer encapsulates the first polymer and forms an interpenetrating polymer with the first polymer.
5. The method of manufacturing an intraocular lens of claim 1,
the outer lens forming mold has an optical portion forming portion and a non-optical portion forming portion.
6. The method of manufacturing an intraocular lens of claim 1,
The first monomer mixture and/or the second monomer mixture include at least a (meth) acrylate monomer having an aryl group and a (meth) acrylate having a fluorine-substituted alkyl group.
7. The method of manufacturing an intraocular lens of claim 1,
the second monomer mixture contains a polymerizable monomer having colorability.
8. The method of manufacturing an intraocular lens of claim 7,
photochromism occurs in the intraocular lens molded body.
9. The method of manufacturing an intraocular lens of claim 8,
the intraocular lens molded body has a photochromic effect.
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|---|---|---|---|---|
| EP0329981A1 (en) * | 1988-02-11 | 1989-08-30 | ADVANCE MEDICAL S.r.l. | Intraocular lens with chromatic and absorption-diagram correction |
| CN101564551A (en) * | 2009-06-05 | 2009-10-28 | 北京科技大学 | Acrylic acid ester shape-memory intraocular lens material and preparation method thereof |
| CN103930455A (en) * | 2011-09-16 | 2014-07-16 | 宾视研发公司 | Ultraviolet light absorbing materials for intraocular lens and uses thereof |
| CN106632826A (en) * | 2016-10-31 | 2017-05-10 | 四川大学 | Foldable artificial lens material and preparation method thereof |
| CN110003385A (en) * | 2019-04-19 | 2019-07-12 | 四川大学 | A kind of high refractive index hydrophobicity foldable intraocular lens material and preparation method thereof |
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2021
- 2021-04-06 CN CN202110369189.1A patent/CN113545886A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0329981A1 (en) * | 1988-02-11 | 1989-08-30 | ADVANCE MEDICAL S.r.l. | Intraocular lens with chromatic and absorption-diagram correction |
| CN101564551A (en) * | 2009-06-05 | 2009-10-28 | 北京科技大学 | Acrylic acid ester shape-memory intraocular lens material and preparation method thereof |
| CN103930455A (en) * | 2011-09-16 | 2014-07-16 | 宾视研发公司 | Ultraviolet light absorbing materials for intraocular lens and uses thereof |
| CN106632826A (en) * | 2016-10-31 | 2017-05-10 | 四川大学 | Foldable artificial lens material and preparation method thereof |
| CN110003385A (en) * | 2019-04-19 | 2019-07-12 | 四川大学 | A kind of high refractive index hydrophobicity foldable intraocular lens material and preparation method thereof |
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