Intraocular lenses

Abstract

The present invention relates to an intraocular lens, characterized in that it comprises: an inner lens having a first refractive index and being composed of a first polymer; and an outer lens having a second refractive index and being composed of a second polymer, formed in a manner of covering the inner lens. By using two polymer materials having different refractive indexes to form an inner package structure to manufacture a multifocal intraocular lens, a multifocal intraocular lens having a plurality of different refractive indexes can be easily realized with a simple mold design structure.

Description

Technical Field

[0001] The invention relates to an artificial lens, in particular to a multifocal artificial lens made of a plurality of materials with different refractive powers. Background Art

[0002] An intraocular lens (IOL) is an artificial lens that can be implanted in the eye to replace the natural lens in the human eye that has become cloudy due to cataract disease, or to be used in refractive surgery to correct the vision of the human eye. Since the lens in the human eye has a certain degree of flexibility, it allows the eye to adapt to distance vision or near vision through the action of the ciliary muscle. If a monofocal intraocular lens is used to replace the natural lens, the patient's focal distance will be fixed, and the effect of improving both near and far distances at the same time cannot be achieved, that is, the range of clear vision will become narrower. In order to solve this problem, a multifocal intraocular lens has been proposed.

[0003] In the past, there were two main methods for making multifocal intraocular lenses: one was to make intraocular lenses by cutting in a workshop, and the other was to make intraocular lenses by using a mold.

[0004] Regarding the method of making artificial lenses by workshop cutting, there is a known method generally known as a zone-type cutting method, which requires pre-setting multiple cutting curves with different curvatures in the cutting program, and cutting the block of lens material layer by layer according to all the cutting curves to finally obtain the desired multifocal artificial lens.

[0005] Another method of making intraocular lenses through molds is to use the principle of casting. By designing a mold that matches the desired focal length of the intraocular lens, a polymer monomer mixture, which is the raw material of the intraocular lens, is injected into the mold, and the liquid mixture is polymerized in the mold to form an intraocular lens material with a specific curvature. Finally, a mechanical cutting tool is used to cut the intraocular lens into a specific size. Summary of the invention

[0006] Technical problem to be solved by the invention

[0007] In the workshop cutting method described above, in order to cut out an intraocular lens with multiple focal points, it is necessary to design cutting curves with different curvatures for different refractive powers of different parts, and obtain a complete cutting program by combining these cutting curves and perform the cutting process to obtain the final basic optical power and additional optical power. Since it is necessary to comprehensively consider the basic optical power and additional optical power of the multifocal intraocular lens to comprehensively design the cutting program, very precise calculations and advanced cutting technology are required.

[0008] The other method of using a mold is mainly used in the production of diffractive multifocal intraocular lenses. Similar to the cutting method, in order to produce a mold with a complex sawtooth diffraction pattern, it is also necessary to comprehensively consider the basic optical power and additional optical power of the multifocal intraocular lens for overall design, so the mold design process also requires complex calculations and quite advanced technology.

[0009] Therefore, an object of the present invention is to provide an intraocular lens that can be easily manufactured as a multifocal intraocular lens with a variety of different refractive powers through a simple design structure and manufacturing process.

[0010] Solutions for solving the above technical problems

[0011] A first aspect of the present invention relates to an artificial lens, characterized by comprising: an inner lens having a first refractive index and composed of a first polymer; and an outer lens formed so as to cover the inner lens, having a second refractive index and composed of a second polymer.

[0012] The artificial lens according to a second aspect of the present invention is characterized in that, in the first aspect, the first refractive index is greater than the second refractive index or less than the second refractive index.

[0013] The third embodiment of the present invention relates to an intraocular lens, wherein in the first embodiment, the first polymer and / or the second polymer is polymerized from a monomer mixture comprising at least a (meth)acrylate monomer having an aromatic group and a (meth)acrylate monomer having a fluorine-substituted alkyl group.

[0014] The intraocular lens according to a fourth aspect of the present invention is the intraocular lens in the first aspect or the second aspect, wherein the inner lens and the outer lens are both circular and the centers of the circles are arranged on the same optical axis.

[0015] The artificial lens according to a fifth aspect of the present invention is, in the first aspect or the second aspect, wherein the inner lens and the outer lens are both circular and their centers are arranged on different optical axes.

[0016] An intraocular lens according to a sixth aspect of the present invention is the intraocular lens according to the first aspect, wherein the inner lens is formed in a fan shape.

[0017] A seventh aspect of the present invention is an intraocular lens according to the first aspect, wherein the inner lens is formed of at least two polymers in a concentric circle structure.

[0018] An artificial lens according to an eighth aspect of the present invention is the intraocular lens according to the first aspect, wherein the outer lens includes a non-optical portion and an optical portion, and the optical portion is in contact with an outer edge of the inner lens.

[0019] Technical Effects

[0020] According to the technical solution of the present invention, two polymer materials with different refractive indices are used to form an inner package structure to manufacture an intraocular lens, and a multifocal intraocular lens with a variety of different refractive indices can be easily realized with a simple mold design structure. In addition, a multifocal intraocular lens with two refractive indices, including basic optical power and additional optical power, can be manufactured by changing the single-sided curvature of the outer lens while keeping the size of the inner lens unchanged, or a multifocal intraocular lens with two refractive indices, including basic optical power and additional optical power, can be manufactured by changing the single-sided curvature of the inner lens while keeping the size of the outer lens unchanged. The manufacturing process of the multifocal intraocular lens is simplified to the manufacturing process of the monofocal intraocular lens, which greatly reduces the requirements for calculation difficulty and manufacturing technology, making it easier to meet customized needs. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is a stereoscopic diagram of the intraocular lens according to the present invention.

[0022] Figure 2 It is a top view of the intraocular lens involved in the present invention.

[0023] Figure 3 yes Figure 2 Cross-sectional view of the intraocular lens in the AA direction.

[0024] Figure 4 It is a cross-sectional view of a molding die for manufacturing the inner lens according to the present invention.

[0025] Figure 5 It is a cross-sectional view of a molding die for manufacturing the outer lens according to the present invention.

[0026] Figure 6 The present invention is a flowchart of the production of an intraocular lens.

[0027] Description of Reference Numerals

[0028] 100 Intraocular Lens

[0029] 1 Lens unit

[0030] 2 Kaibu

[0031] 11 Inner lens part

[0032] 12 Outer lens portion. DETAILED DESCRIPTION

[0033] The embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

[0034] <Multifocal intraocular lens>

[0035] Figure 1 A perspective view of a multifocal intraocular lens 100 according to the present invention is shown. Figure 2 A top view of a multifocal intraocular lens 100 according to the present invention is shown. Figure 3 yes Figure 2 A cross-sectional view of the intraocular lens 100 taken along the AA direction.

[0036] like Figure 1 As shown, the intraocular lens 100 is composed of a lens portion 1 and a ridge portion 2 connected to the outer edge of the lens portion 1. The lens portion 1 is roughly disc-shaped and has a thicker center portion and is slightly convex on both sides. The lens portion 1 is a component that has a corrective effect on the visual function of the eyeball, and is composed of an inner lens 11 inside and an outer lens 12 on the outer circle. The ridge portion 2 is a connecting and fixing component. When the intraocular lens 100 is implanted into a human eyeball, the hook-shaped ridge portion 2 is adhered to the eyeball, thereby supporting and fixing the lens portion 1.

[0037] The lens unit 1 is formed by combining an inner lens 11 and an outer lens. The inner lens 11 and the outer lens 12 are formed of polymer materials having different refractive indices. The composition and formation method of the polymer materials will be described later. Figure 3 It can be seen that 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 coincide on the same optical axis. By superimposing the optical properties of the two layers of lenses, the final optical performance of the multifocal intraocular lens is formed.

[0038] As for the optical properties of multifocal artificial lenses, in addition to having specific vision correction degrees and multiple focal points to correct hyperopia and myopia at the same time like common visual function correction tools, they can also have special optical properties such as specific ultraviolet visible transmittance and photochromism.

[0039] In the entire lens portion 1, the overlapping area of ​​the outer lens 12 and the inner lens 11 and the position near the overlapping area form multiple focal points for correcting the vision of the human eye. This part is usually also called the optical part. The edge of the outer lens 12 does not have such a vision correction function, so this part is called the non-optical part (not shown). However, in the artificial lens of the present invention, optical properties such as photochromicity can also be given to the non-optical part, and the specific content will be described in detail below.

[0040] As described above, the lens portion 1 of the intraocular lens 100 of the present invention is formed into a shape with a thicker center portion and a thinner edge portion. Correspondingly, the inner lens 11 and the outer lens 12 are also disc-shaped with a thicker center portion and a thinner edge portion, and form an inner package structure in a concentric circle state. In the intraocular lens obtained by the manufacturing method described below, the center portion thickness of the inner lens 11 is about 0.1 mm, and the center portion thickness of the outer lens 12 is 0.75 mm.

[0041] However, the shapes and 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 overlap. Alternatively, the inner lens 11 may be formed in a fan shape. Furthermore, the inner packaging structure of multiple lens materials may have more than one layer, and a multifocal intraocular lens may be formed by forming a double inner packaging of three lens materials or forming a multi-inner packaging of more than one lens material.

[0042] Next, the polymer used for preparing the intraocular lens material will be described.

[0043] <Polymers for preparing multifocal intraocular lenses>

[0044] The polymer used in the present invention for preparing a multifocal intraocular lens contains a combination of a (meth)acrylate monomer having an aromatic group with a high refractive index and a (meth)acrylate monomer having a fluorine-substituted alkyl group with a low refractive index in order to adjust the refractive index.

[0045] Examples of the (meth)acrylate monomer having an aromatic group used in the present invention include 2-phenylene methacrylate (Ph-MA, 2-Phenylethyl methacrylate), 2-phenylene acrylate (Ph-A, 2-Phenylethylacrylate), 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 any one or more combinations of ethyl methacrylate (Ethylmethacrylate).

[0046] Examples of the (meth)acrylate having a fluorine-substituted alkyl group used in the present invention include trifluoroethyl methacrylate (TFE-MA, Trifluoroethyl methacrylate) and / or trifluoroethyl acrylate (TFE-A, Trifluoroethyl acrylate).

[0047] On this basis, in order to meet the hardness of the polymer obtained by polymerization so that the artificial lens produced can meet the requirements of being foldable, the mixing ratio of the (meth)acrylate monomer with an aromatic group and the (meth)acrylate with a fluorine-substituted alkyl group can be appropriately adjusted, or an appropriate amount of an alkyl ester without (meth)acrylate can be added to obtain a polymer with a lower glass transition temperature (Tg). As a (meth)acrylate monomer without an aromatic group, n-butyl acrylate (n-BuA, n-Butyl acrylate) can be cited. The following Table 1 shows an example of the polymer composition ratio and the amount added and the expected glass transition temperature.

[0048]

Table 1

[0049]

[0050] In addition to the (meth)acrylate monomer having an aromatic group and the (meth)acrylate having a fluorine-substituted alkyl group as main components, the following other additive components are contained in the polymer.

[0051] For example, in order to improve the safety of the prepared polymer, it is desirable to add a proper amount of a di(methyl)acrylate component as a crosslinking monomer. Examples of crosslinking monomers that need to be added to improve the crosslinking property of the polymer include ethylene glycol dimethacrylate (EGDMA) or butanedioldiacrylate (BDDA). In addition, 2,2'-azobis(isobutyronitrile) (AIBN) is added as a polymerization initiator.

[0052] As will be described later, the multifocal intraocular lens of the present invention can be manufactured into intraocular lenses with different refractive powers, intraocular lenses with different ultraviolet visible transmittances, or intraocular lenses with photochromic functions, etc. In response to such production requirements, it is also considered to add polymerizable monomers with ultraviolet absorption as needed, such as 2-(2'-hydroxy-5'-methacryloxyethylphenyl)-2H-benzotriazole (Norbloc7966, 2-(2'-Hydroxy-5'-methacryloxyethylphenyl)-2H-Benzotriazole); polymerizable monomers with coloring properties, such as 4-(phenyldiazenyl)phenyl-2-methacrylate (BL01, 4-(Phenyldiazenyl)phenyl-2-methacrylate); and photochromic polymerizable monomers 1-acryloxyethyl-3,3-dimethylspiro[indoline-2,3'-[3H]-naphtho[2,1-b](1,4)oxazine] (ADINO, 1-Acryloxyethyl-3,3-dimethylspiro[indoline-2,3'-[3H]-naphtho[2,1-b](1,4)oxazine]).

[0053] It is worth mentioning here that the specific structural formula of the photochromic polymerizable monomer ADINO is shown below (Compound 1).

[0054]

Chemistry 1

[0055]

[0056] The types of compounds that can be used as photochromic materials for intraocular lenses include triarylmethanes, stilbenes, azastilbenes, nitrones, fulgides, spiropyrans, naphthopyrans, spirooxazines and the like. Representative examples include 1',3'-Dihydro-1',3',3'-trimethyl-6-nitrospiro[2H-1-benzopyran-2,2'-(2H)-indole] (Compound 2) as a spiropyran and 1,3-Dihydro-1,3,3-trimethyl-spiro[2H-indole-2,3'-[3H]phenanthro[9,10-b](1,4)oxazine (Compound 3) as a spirooxazine. Furthermore, there is known a method for producing a photochromic intraocular lens by incorporating these compounds into an intraocular lens material at a concentration of 0.01 to 0.4% by weight (see US Pat. No. 8,133,274).

[0057]

Chemistry 2

[0058]

[0059]

Chemistry 3

[0060]

[0061] In addition, the use of polymerizable photochromic materials is very important for inhibiting the elution of materials and improving safety. Specific examples of the compounds shown in U.S. Pat. No. 5,166,345 include: 1-acryloxyethyl-3,3-dimethylspiro[indoline-2,3'-[3H]naphtho[2,1-b](1,4)oxazine], 1-methacryloxyethyl-3,3-dimethylspiro[indoline-2,3'-[3H]naphtho[2,1-b](1,4)oxazine], ro[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-methacryloxypropyl-3,3-dimethylspiro[indoline-2,3'-[3H]naphtho[2,1-b](1,4)oxazine]), 1-methacryloxyethyl-3,3-dimethyl-5-chlorospiro[indoline-2,3'-[3H]naphtho[2,1-b](1,4)oxazine oxazine](1-methacrylamideethyl-3,3-dimethyl-5-chlorospiro[indoline-2,3'-[3H]naphtho[2,1-b](1,4)oxazine]), 1-methacryloxyethyl-3,3-dimethyl-8'-methoxyspiro(p-vinylphenylethyl)-3,3-dimethyl-5,6-dichlorospiro[indoline-2,3'-[3H]-naphtho[2,1-b](1,4)oxazine] nylphenethyl)-3,3-dimethyl-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-trimethyl-9'-methacryloxyspiro[indoline-2,3'-[3H]-naphtho[2,1-b](1,4)oxazine], 1,3,1,3,3-trimethyl-5'-methacryloxymethylspiro[indoline-2,3'-[3H]-naphtho[2,1-b](1,4)oxazine]), 1,3,3-trimethyl-9'-methacrylamidespiro[indoline-2,3'-[3H]-naphtho[2,1-b](1,4)oxazine] ,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] enzyl-3,3-dimethyl-9'-vinylbenzoyloxyspiro[indoline-2,3'-[3H]-naphtho[2,1-b](1,4)oxazine]), 3-trimethyl-9'-methacryloxyspiro[indoline-2,3'-[3H]-pyrido[2,1-b](1,4)benzooxazine), 1,1"-(1,5-pentanediyl)bis[3, 3-Dimethyl-9'-methacryloxyspiro[indoline-2,3'-[3H]-naphtho[2,1-b](1,4)oxazine]](1,1"-(1,5-pentanediyl)bis[3,3-dimethyl-9'-methacryloxyspiro[indoline-2,3'-[3H]-naphtho[2,1-b](1,4)oxazine]]), 1,1"-[1,4-phenylenebis(methylene)bis[3,3-dimethyl-5'-(meth)acryloxymethylspiro[indoline-2,3'-[3H]-naphtho[2,1-b](1,4)oxazine]](1,1"-[1,4-phenylenebis(methylene)bis[3,3-dimethyl-5'-(meth)acryloxymethylspiro[indoline-2,3'-[3H]-naphtho[2,1-b](1,4)oxazine]][indoline-2,3'-[3H]-naphtho[2,1-b](1,4)oxazine]]), 1,1"-(1,4-butanediyl)bis[5,6-dichloro-3,3-dimethyl-8'-(meth)acryloxyspiro[indoline-2,3'-[3H]-naphtho[2,1-b](1,4)oxazine]]), or the compounds represented by the following chemical formula 4, chemical formula 5, or chemical formula 6. ,

[0062]

Chemistry 4

[0063]

[0064]

Chemistry 5

[0065]

[0066]

Chemistry 6

[0067]

[0068] Below, refer to Figure 6 The method for preparing the multifocal intraocular lens of the present invention is described in detail.

[0069] <Method for preparing multifocal intraocular lens>

[0070] Example 1

[0071] The multifocal intraocular lens of the present invention is formed by polymerizing two polymer materials each having different refractive powers.

[0072] First, prepare the inner lens polymer material. In a 10 mL glass bottle, add Ph-A, n-BuA, TFE-MA, TFE-A, EGDMA, Norbloc7966 and AIBN in the following amounts, respectively, and stir at room temperature for 20 hours to obtain a polymer mixed solution for the inner lens.

[0073] Ph-A: 15 g (15 mass%, 13 mol%)

[0074] n-BuA: 28 g (28 mass%, 33.4 mol%)

[0075] TFE-MA: 35 g (35 mass%, 31.8 mol%)

[0076] TFE-A: 22 g (22 mass%, 21.8 mol%)

[0077] EGDMA: 2 g (2 mass % relative to the total amount of Ph-A, n-BuA, TFE-MA, and TFE-A)

[0078] Norbloc 7966: 0.4 g (0.4 mass % relative to the total amount of Ph-A, n-BuA, TFE-MA, and TFE-A)

[0079] AIBN: 0.3 g (0.3 mass % relative to the total amount of Ph-A, n-BuA, TFE-MA, and TFE-A)

[0080] Figure 4 The mold for the inner lens is shown. The mold is made of a resin material and has a pair of hollow shapes. The overall diameter length l of the mold is 12mm. A biconvex lens shape with a diameter r of 2mm is formed in the center part as the optical part molding part of the inner lens, and the peripheral part is formed into a uniform flat plate with a thickness h of 0.2mm as the non-optical part molding part. The curvature of the biconvex inner lens is designed to be 40.00mm on the front and 50.00mm on the back.

[0081] The polymer mixture for the inner lens is slowly injected into the mold for the inner lens, so that no bubbles are mixed into the polymer mixture injected into the mold. Then, the resin mold filled with the polymer mixture is placed in a polymerization device. The polymerization device is maintained in a nitrogen atmosphere, and the pressure in the device is set to 0.2 kgf / cm 2 (0.0196MPa).

[0082] As a specific step of polymerization, first, the polymerization device was heated from 20°C, heated to 50°C over 30 minutes, and maintained at 50°C for 8 hours. Then, the temperature was slowly raised to 120°C over 6 hours, maintained at 120°C for 2 hours, and finally cooled to 40°C over 4 hours.

[0083] After the polymerization is completed, the mold is taken out from the polymerization device, the mold is opened and the polymer material of the inner lens after the polymerization is completed is taken out. The prepared polymer material of the inner lens has a refractive index of n D 20 =1.450 polymer material.

[0084] Next, the polymer material for the outer lens was prepared by adding the following amounts of Ph-MA, Ph-A, n-BuA, EGDMA, Norbloc 7966 and AIBN to a 10 mL glass bottle and stirring at room temperature for 20 hours to prepare a polymer mixed solution for the outer lens.

[0085] Ph-MA: 56 g (56 mass%, 52.1 mol%)

[0086] Ph-A: 34 g (34 mass%, 34.1 mol%)

[0087] n-BuA: 10 g (10 mass%, 13.8 mol%)

[0088] EGDMA: 2 g (2 mass % relative to the total amount of Ph-MA, Ph-A, and n-BuA)

[0089] Norbloc 7966: 0.4 g (0.4 mass % relative to the total amount of Ph-MA, Ph-A, and n-BuA)

[0090] AIBN: 0.3 g (0.3 mass % relative to the total amount of Ph-MA, Ph-A, and n-BuA)

[0091] Figure 5 The mold for the outer lens is shown. The mold is also a pair of upper and lower hollow molds made of resin material. The overall diameter length L of the mold is 13-14mm. A biconvex lens shape with a diameter R of 6mm is formed in the center part as the optical part of the outer lens, and the peripheral part is formed into a uniform flat plate with a thickness H of 0.32mm as the non-optical part. The curvature of the biconvex outer lens is designed to be 25.00mm on the front and -19.00mm on the back, and the overall thickness of the biconvex lens can reach 0.70mm.

[0092] Next, the previously prepared inner lens polymer material is placed in the center of the optical part of the outer lens mold, and then the outer lens polymer mixture is slowly injected into the outer lens mold, so that no bubbles are mixed into the polymer mixture injected into the mold. After that, the resin mold filled with the polymer mixture and soaked with the inner lens polymer material in the center is placed in the polymerization device. The polymerization device is maintained in a nitrogen atmosphere, and the pressure in the device is set to 0.2kgf / cm 2 (0.0196MPa).

[0093] The polymerization process of the outer lens is basically the same as that of the inner lens. First, the polymerization device is heated from 20°C, and the temperature is raised to 50°C in 30 minutes, and the temperature is maintained at 50°C for 8 hours. Then, the temperature is slowly raised to 120°C in 6 hours, and the temperature is maintained at 120°C for 2 hours, and finally the temperature is lowered to 40°C in 4 hours.

[0094] The refractive index of the polymer material of the outer lens removed from the mold after polymerization is n D 20 =1.550. And the outer lens polymer material is in a state where the inner lens polymer material is enclosed in the outer lens polymer material.

[0095] The intraocular lens material having such an inner package structure is placed in a dryer set to 120° C. and subjected to a heat treatment for 8 hours. The heat treatment removes unreacted polymer monomers in the intraocular lens material.

[0096] Thus, an intraocular lens material composed of polymers with two different refractive indices is obtained. Then, a predetermined shape is cut out of the material using a machining machine, and finally a bifocal intraocular lens with two different refractive indices is manufactured.

[0097] Analysis of the artificial lens made in this way using an optical measuring machine showed that the optical focal length of the central 2 mm diameter portion of the artificial lens was 15.3D, and the optical focal length of the peripheral portion was 19.8D. The entire artificial lens was formed into a bifocal artificial lens with an additional optical focal length of 4.5D.

[0098] In the present embodiment 1, the refractive index of the outer lens polymer material is greater than that of the inner lens polymer material. Of course, the refractive index of the outer lens polymer material can also be made smaller than that of the inner lens polymer material according to actual needs. As long as the inner lens polymer material and the outer lens polymer material with different refractive indexes are superimposed, the technical solution of the present application can be realized.

[0099] By adopting such a manufacturing method, the design process of a bifocal intraocular lens is decomposed into the design of two monofocal intraocular lenses, which greatly reduces the design difficulty and facilitates operation.

[0100] It is particularly worth mentioning that during the polymerization of the outer lens polymer material, the outer lens polymer monomer mixture comes into contact with the inner lens polymer material immersed therein, and an interpenetrating polymer is formed at the contact interface during the polymerization process. By forming an interpenetrating polymer at the interface between the two polymer materials, the molecular chains penetrate each other, so that the two polymer materials are interlocked with each other, and there is no obvious boundary interface, thus achieving a natural connection. As a result, the artificial lens material forms a unified whole, and the optical properties such as different refractive powers and focal points in different regions change naturally, which can improve the patient's feeling of use.

[0101] Example 2

[0102] The following is an explanation of the manufacturing process of a multifocal intraocular lens composed of two polymers having different ultraviolet visible transmittances.

[0103] First, the 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 10 mL glass bottle in the following amounts, respectively, and stirred at room temperature for 20 hours to prepare a polymer mixed solution for the inner lens.

[0104] Ph-MA: 24 g (24 mass%, 22.1 mol%)

[0105] Ph-A: 64 g (64 mass%, 63.7 mol%)

[0106] n-BuA: 5 g (5 mass%, 6.8 mol%)

[0107] TFE-MA: 7 g (7 mass%, 7.3 mol%)

[0108] BL01: 0.02 g (0.02 mass % relative to the total amount of Ph-MA, Ph-A, n-BuA, and TFE-MA)

[0109] EGDMA: 2 g (2 mass % relative to the total amount of Ph-MA, Ph-A, n-BuA, and TFE-MA)

[0110] Norbloc 7966: 1.5 g (0.4 mass % relative to the total amount of Ph-MA, Ph-A, n-BuA, and TFE-MA)

[0111] AIBN: 0.3 g (0.3 mass % relative to the total amount of Ph-MA, Ph-A, n-BuA, and TFE-MA)

[0112] As in Example 1, the polymer mixture for the inner lens is slowly injected into the mold for the inner lens, so that no bubbles are mixed into the polymer mixture injected into the mold. Then, the resin mold filled with the polymer mixture is placed in a polymerization device. The polymerization device is maintained in a nitrogen atmosphere, and the pressure in the device is set to 0.2 kgf / cm 2 (0.0196MPa).

[0113] As a specific step of polymerization, first, the polymerization device was heated from 20°C, heated to 50°C over 30 minutes, and maintained at 50°C for 8 hours. Then, the temperature was slowly raised to 120°C over 6 hours, maintained at 120°C for 2 hours, and finally cooled to 40°C over 4 hours.

[0114] After the polymerization is completed, the mold is taken out from the polymerization device, the mold is opened and the polymer material of the inner lens after the polymerization is completed is taken out. The prepared polymer material of the inner lens has a refractive index of n D 20 =1.450 polymer material.

[0115] After the inner lens is manufactured, in order to improve its affinity with the outer lens, the manufactured inner lens may be subjected to surface treatment such as plasma treatment. This treatment is also applicable to other embodiments.

[0116] Next, prepare the outer lens polymer material. Ph-MA, Ph-A, n-BuA, TFE-MA, EGDMA, Norbloc7966 and AIBN were added to a 10 mL glass bottle in the following amounts, and stirred at room temperature for 20 hours to prepare a polymer mixture for the outer lens. The composition ratio in the polymer mixture for the outer lens was exactly the same as that in the polymer mixture for the inner lens, except that BL01 was not contained.

[0117] Next, the previously prepared inner lens polymer material is placed in the center of the optical part of the outer lens mold, and then the outer lens polymer mixture is slowly injected into the outer lens mold, so that no bubbles are mixed into the polymer mixture injected into the mold. After that, the resin mold filled with the polymer mixture is placed in the polymerization device. The polymerization device is maintained in a nitrogen atmosphere, and the pressure in the device is set to 0.2kgf / cm 2 (0.0196MPa).

[0118] The polymerization process of the outer lens is basically the same as that of the inner lens. First, the polymerization device is heated from 20°C, and the temperature is raised to 50°C in 30 minutes, and the temperature is maintained at 50°C for 8 hours. Then, the temperature is slowly raised to 120°C in 6 hours, and the temperature is maintained at 120°C for 2 hours, and finally the temperature is lowered to 40°C in 4 hours.

[0119] After the polymerization is completed, what is taken out of the mold is an intraocular lens material in which the outer lens polymer material contains the inner lens polymer material. Such intraocular lens material is placed in a dryer pre-set to 120°C and subjected to a heat treatment for 8 hours. The unreacted polymer in the intraocular lens material is removed by the heat treatment.

[0120] The artificial lens material thus obtained is an artificial lens material composed of polymers having two different ultraviolet visible transmittances, with a yellow center lens. The ultraviolet visible transmittance of the inner lens polymer material is formed to be lower than that of the outer lens polymer material. Next, a predetermined shape is cut out of the material using a machining machine, and finally a multifocal artificial lens with a yellow center lens is manufactured.

[0121] Tinted lenses are also an existing technology. Tinted lenses are made by adding specific pigments to the inside of artificial lenses to reduce postoperative glare, retinal light damage, and postoperative color vision abnormalities. However, the previous colored artificial lenses are made of a single material, and the color of the lens varies with the different focal powers and the thickness of the lens. The multifocal artificial lens made by the above-mentioned embodiment 2 of the present invention can have the advantage that the artificial lens itself always has a fixed ultraviolet visible transmittance regardless of whether the focal power is high or low.

[0122] Example 3

[0123] The following is an explanation of the manufacturing process of a multifocal intraocular lens composed of two photochromic polymers.

[0124] Photochromic materials change color when exposed to light and become transparent in the dark. Therefore, if used in artificial lens materials, they can function like an iris. Its optical performance is similar to the aperture of a camera, which controls the amount of light by changing the aperture. Photochromic materials can control light by changing the transmittance of the lens. The principles of the two are different, but the technical effects that can be achieved are the same.

[0125] In the past, photochromic intraocular lenses were made of homogeneous materials, so the color concentration was different in lenses of different focal powers and thicknesses. However, by using the manufacturing method of the present invention, the color concentration of intraocular lenses can be kept consistent across all sizes and all optical performance ranges.

[0126] The manufacturing method was the same as in Example 2. First, the inner lens polymer material was prepared. Ph-MA, Ph-A, n-BuA, TFE-MA, ADINO, EGDMA, Norbloc 7966 and AIBN were added to a 10 mL glass bottle in the following amounts, respectively, and stirred at room temperature for 20 hours to prepare a polymer mixed solution for the inner lens.

[0127] Ph-MA: 24 g (24 mass%, 22.1 mol%)

[0128] Ph-A: 64 g (64 mass%, 63.7 mol%)

[0129] n-BuA: 5 g (5 mass%, 6.8 mol%)

[0130] TFE-MA: 7 g (7 mass%, 7.3 mol%)

[0131] ADINO: 0.1 g (0.1 mass % relative to the total amount of Ph-MA, Ph-A, n-BuA, and TFE-MA)

[0132] EGDMA: 2 g (2 mass % relative to the total amount of Ph-MA, Ph-A, n-BuA, and TFE-MA)

[0133] Norbloc 7966: 1.5 g (1.5 mass % relative to the total amount of Ph-MA, Ph-A, n-BuA, and TFE-MA)

[0134] AIBN: 0.3 g (0.3 mass % relative to the total amount of Ph-MA, Ph-A, n-BuA, and TFE-MA)

[0135] Next, the polymer mixture for the inner lens is slowly injected into the mold for the inner lens, so that no bubbles are mixed into the polymer mixture injected into the mold. After that, the resin mold filled with the polymer mixture for the inner lens is placed in a polymerization device. The polymerization device is maintained in a nitrogen atmosphere, and the pressure in the device is set to 0.2kgf / cm 2 (0.0196MPa).

[0136] As a specific step of polymerization, first, the polymerization device was heated from 20°C, heated to 50°C over 30 minutes, and maintained at 50°C for 8 hours. Then, the temperature was slowly raised to 120°C over 6 hours, maintained at 120°C for 2 hours, and finally cooled to 40°C over 4 hours.

[0137] Next, prepare the outer lens polymer material. Ph-MA, Ph-A, n-BuA, TFE-MA, EGDMA, Norbloc7966 and AIBN were added to a 10 mL glass bottle, respectively, and stirred at room temperature for 20 hours to prepare a polymer mixture for the outer lens. The composition ratio in the polymer mixture for the outer lens is exactly the same as that in the polymer mixture for the inner lens, except that ADINO is not contained.

[0138] Next, the previously prepared inner lens polymer material is placed in the center of the optical part of the outer lens mold, and then the outer lens polymer mixture is slowly injected into the outer lens mold, so that no bubbles are mixed into the polymer mixture injected into the mold. After that, the resin mold filled with the polymer mixture is placed in the polymerization device. The polymerization device is maintained in a nitrogen atmosphere, and the pressure in the device is set to 0.2kgf / cm 2 (0.0196MPa).

[0139] The polymerization process of the outer lens is basically the same as that of the inner lens. First, the polymerization device is heated from 20°C, and the temperature is raised to 50°C in 30 minutes, and the temperature is maintained at 50°C for 8 hours. Then, the temperature is slowly raised to 120°C in 6 hours, and the temperature is maintained at 120°C for 2 hours, and finally the temperature is lowered to 40°C in 4 hours.

[0140] After the polymerization is completed, the artificial lens material taken out from the mold is a state in which the outer lens polymer material contains the inner lens polymer material. Such artificial lens material is placed in a dryer pre-set to 120°C and subjected to a heat treatment for 8 hours. The unreacted polymer in the artificial lens material is removed by the heat treatment.

[0141] In this way, an artificial lens material containing a photochromic material is obtained. Then, a machining machine is used to cut a specified shape on the material, and finally an artificial lens made of photochromic material is made. The artificial lens has a photochromic function area at the edge of the outer lens that can adjust the amount of light entering.

[0142] The color of the lens of the conventional photochromic intraocular lens varies with the different optical powers. However, the intraocular lens manufactured by the third embodiment of the present invention always has a fixed ultraviolet visible transmittance regardless of whether the optical power of the intraocular lens is high or low.

[0143] Furthermore, further applications of the above-mentioned embodiments 1-3 can be made by keeping the shape and size of the polymer material of the inner lens placed in the center unchanged and only changing the shape of the outer lens to be manufactured to have various curvatures, thereby making it easier to manufacture a variety of bifocal lenses with specific additional optical power to the basic optical power.

[0144] For example, the inner lens polymer material is formed into a biconvex lens with a front curvature of 40.00 mm and a back curvature of -50.00 mm, and then the outer lens polymer material is formed to enclose the inner lens polymer material, and the outer lens polymer material is formed so that the back curvature is fixed at -19.00 mm. In this state, a bifocal lens having a specific basic focal power and a plurality of additional focal powers can be easily manufactured by only freely changing the front curvature of the outer lens polymer material within the range of 25.00 mm to 10.00 mm.

[0145] The following Table 2 shows the changes in the basic optical power and additional optical power of the intraocular lens obtained using the method for manufacturing a multifocal lens of the present invention when the curvature of the inner lens is constant and only the front curvature of the outer lens changes.

[0146]

Table 2

[0147]

[0148] Generally speaking, in order to manufacture a multifocal intraocular lens, even if the additional optical power remains constant, a separate design is required based on the overall combination of the basic optical power and the additional optical power. According to the present method, the design of the inner lens can be kept constant, and only the optical power of the outer lens can be changed, or vice versa, the design of the outer lens can be kept constant, and only the optical power of the inner lens can be changed, thereby making it easy to manufacture a variety of bifocal lenses. In addition, since the design of each bifocal lens is disassembled into a simple single-focus lens design, the complexity of the intraocular lens design is avoided, and the number of molds that need to be re-molded during the manufacturing process can be reduced.

[0149] In addition to the above embodiments, the composition of the polymer mixture for the inner lens and the composition of the polymer mixture for the outer lens can be freely combined. For example, as shown in Table 3 below, by freely selecting the polymer mixture for the inner lens and the polymer mixture for the outer lens from the composition examples 1-5 shown below, polymers with various refractive indices can be obtained. The above embodiment 1 uses the combination of composition example 1 as the outer lens and composition example 5 as the inner lens. Of course, other combinations can also be used to obtain multifocal intraocular lenses with various optical designs.

[0150]

Table 3

[0151]

[0152] It should be appreciated that in the description of exemplary embodiments of the invention, for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects, the various features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof. However, this method of disclosure should not be interpreted as reflecting an intention that the claimed invention requires more features than those expressly recited in each claim. On the contrary, as reflected in the appended claims, the various inventive aspects may have fewer features than all of the features of a single preceding disclosed embodiment. Therefore, the claims appended after the specific description are hereby expressly incorporated into the specific description, with each claim acting alone as a separate embodiment of the invention.

[0153] In addition, although some embodiments described herein include some features included in other embodiments but do not include other features included in other embodiments, the combination of features of different embodiments is intended to fall within the scope of the present invention and form different embodiments as will be understood by those skilled in the art. For example, in the appended claims, any of the claimed embodiments may be used in any combination.

[0154] It should be noted that the use of a particular term in describing certain features or aspects of the present invention should not be used to imply that the term is redefined herein to be limited to include any specific characteristics of the feature or aspect of the present invention associated with the term.

[0155] In the description provided herein, numerous specific details are set forth. However, it should be understood that embodiments of the present invention may be practiced without these specific details. In other instances, well-known methods, structures, and techniques are not shown in detail to avoid obscuring the understanding of this description.

Claims

1. A multifocal intraocular lens, characterized in that: have: an inner lens having a first refractive index and composed of a first polymer; an outer lens, formed in a manner of covering the inner lens, having a second refractive index and composed of a second polymer; The first refractive index is greater than the second refractive index or less than the second refractive index; The second polymer is obtained by immersing the first polymer in a monomer mixture for preparing the second polymer after the polymerization of the first polymer is completed, so that the second polymer and the first polymer form an interpenetrating polymer; The multifocal intraocular lens includes a central portion and a peripheral portion, wherein the central portion is a portion corresponding to the optical portion of the inner lens, and the peripheral portion is a portion not corresponding to the optical portion of the inner lens. The optical power of the central portion is a basic optical power, the optical power of the peripheral portion is a second optical power, and the multifocal intraocular lens has an additional optical power so that the second optical power is different from the basic optical power; The basic optical focal length of the multifocal intraocular lens is adjusted by keeping the shape and size of the inner lens unchanged and changing the shape of the outer lens, or the basic optical focal length of the multifocal intraocular lens is adjusted by keeping the shape and size of the outer lens unchanged and changing the shape of the inner lens.

2. The multifocal intraocular lens according to claim 1, wherein: The first polymer and / or the second polymer is obtained by polymerizing a monomer mixture solution at least including a (meth)acrylate monomer having an aromatic group and a (meth)acrylate monomer having a fluorine-substituted alkyl group.

3. The multifocal intraocular lens according to claim 1, wherein: The inner lens and the outer lens are both circular, and the centers of the circles are arranged on the same optical axis.

4. The multifocal intraocular lens according to claim 1, wherein: The inner lens and the outer lens are both circular, and the centers of the circles are arranged on different optical axes.

5. The multifocal intraocular lens according to claim 1, wherein: The inner lens is formed in a fan shape.

6. The multifocal intraocular lens according to claim 1, wherein: The inner lens is formed of at least two polymers in a concentric circle structure.

7. The multifocal intraocular lens according to claim 1, wherein: The outer lens includes a non-optical portion and an optical portion, and the optical portion is in contact with an outer edge of the inner lens.

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