CN117462301A - intraocular lens - Google Patents

Abstract

The invention aims to provide an intraocular lens, which can improve the success rate of an intraocular lens with an inner lens wrapped in an outer lens obtained by polymerization molding in terms of optical performance. An intraocular lens comprising a lens part and a part connected to the outer edge of the lens part, the lens part comprising: an inner lens having a first refractive index and composed of an acrylic resin; the outer lens is formed so as to cover the inner lens, has a second refractive index, and is made of silicone.

Description

Intraocular lens

Technical Field

The present invention relates to intraocular lenses, and more particularly to multifocal intraocular lenses made of multiple materials having different refractive indices.

Background

Intraocular lenses (IOLs) are artificial lenses that can be implanted into the eye to replace natural lenses in the human eye that become clouded by cataract disease, or to refractive surgery to correct the vision of the human eye. Since the lens in the human eye has some flexibility, it allows the eye to accommodate far or near vision by the action of the ciliary muscle. If a single focus intraocular lens is used to replace the natural lens, the focal distance of the patient will be fixed and the effect of improving both near and far distances will not be achieved, i.e. the range of clear vision will be narrower.

In chinese patent document CN113545887a there is provided a multifocal intraocular lens having a first refractive index and consisting of a first polymer and an inner lens having a second refractive index and consisting of a second polymer. Thereby providing a multifocal intraocular lens to adapt the eye to both distance and near vision.

However, in the intraocular lens of the above prior art, both the inner lens and the outer lens are made of a polymer, and it is necessary to put a previously prepared inner lens polymer material into the center of a mold for preparing the outer lens, inject a monomer mixture constituting the outer lens raw material, and then perform polymerization molding of the outer lens. In polymerizing the outer lens, the inner lens polymer material may affect the polymerization process of the monomer mixture constituting the outer lens material or may be affected by the monomer mixture constituting the outer lens material, for example, because the inner and outer lens materials are similar or identical, the solvent in the monomer mixture constituting the outer lens material used in the polymerization process may cause swelling of the inner lens polymer material or the outer lens polymer material, thereby resulting in a polymerized intraocular lens including the inner lens and the outer lens, which is not easily controlled in optical performance.

Disclosure of Invention

The invention aims to provide a multifocal intraocular lens, which can solve the problem that in the prior art, the polymerization processes of different polymers of intraocular lenses with different inner and outer lens materials are mutually interfered in the polymerization molding process, and the convenience and the yield of product preparation are improved.

Solution to the above technical problems

A first aspect of the present invention relates to an intraocular lens comprising a lens portion and a portion connected to an outer edge of the lens portion, the lens portion comprising: an inner lens having a first refractive index and composed of an acrylic resin; the outer lens is formed so as to cover the inner lens, has a second refractive index, and is made of silicone.

An intraocular lens according to a second aspect of the present invention is the intraocular lens according to the first aspect, wherein the portion is formed of an acrylic resin inside and a silicone outside.

In the intraocular lens according to a third aspect of the present invention, in the first or second aspect, the inner lens is formed in an asymmetric-area structure.

In a fourth aspect of the present invention, in the third aspect, the inner lens is a fan shape.

An intraocular lens according to a fifth aspect of the present invention is the intraocular lens according to the first or second aspect, wherein the inner lens has a rotationally symmetrical structure.

In a fifth aspect of the present invention, there is provided an intraocular lens according to the first aspect, wherein the inner lens is circular.

An intraocular lens according to a seventh aspect of the present invention is the first or second aspect, wherein a plurality of focal points are formed in the lens portion.

An intraocular lens according to an eighth aspect of the present invention is the intraocular lens according to the first or second aspect, wherein the first refractive index is greater than the second refractive index, or the first refractive index is less than the second refractive index.

An intraocular lens according to a ninth aspect of the present invention includes a non-optical portion and an optical portion, the optical portion being in contact with an outer edge of an inner lens.

Technical effects

According to the technical scheme of the invention, the inner lens of the artificial lens is formed by acrylic resin with high refractive index, and the outer lens of the artificial lens is formed by organosilicon with low refractive index, so that a plurality of focuses can be generated after incident light passes through the artificial lens provided by the invention, and the far and near vision of a patient can be better improved.

When the monomer mixture constituting the outer lens raw material is polymerized in a state of being in contact with the inner lens polymer material, since the solvent for providing the silicone polymerization environment is not liable to swell the molded acrylic resin, the silicone constituting the outer lens and the acrylic resin constituting the inner lens can be kept to function independently of each other without causing physical or chemical changes to affect each other, thereby obtaining an intraocular lens conforming to the standard in optical performance. In addition, the organosilicon and the acrylic resin have certain softness and can be curled so as to be conveniently implanted into eyeballs.

In addition, the construction of the outer lens from silicone would be advantageous in obtaining a more contoured intraocular lens. Also, in view of the high temperature resistant nature of silicone, an intraocular lens with an outside lens made of silicone would have more alternative sterilization means, such as autoclaving.

According to a preferred embodiment of the present invention, the portion of the intraocular lens is formed internally of acrylic and externally of silicone. During release of the crimped intraocular lens using the injector, the soft nature of the inner acrylic of portion and the elastic restoring force of the outer silicone can work together so that portion of the intraocular lens can slowly resume its extended configuration as intended.

Drawings

Fig. 1 is a perspective view of an intraocular lens according to the present invention.

Fig. 2 is a top view of an intraocular lens according to the present invention.

Fig. 3 is a cross-sectional view of the intraocular lens of fig. 2 taken in the A-A direction.

Fig. 4 is a sectional view of a molding die for manufacturing an inner lens according to the present invention.

Fig. 5 is a cross-sectional view of a molding die for preparing an outer lens according to the present invention.

FIG. 6 is a result of an appearance test of an intraocular lens according to experimental example 1;

FIG. 7 is a result of an external test of an intraocular lens according to Experimental example 3

FIG. 8 is a result of an experiment of the appearance of an intraocular lens according to experiment example 4.

Reference numerals:

100. intraocular lens

1. Lens part

2. part

11. Inner lens

12. And an outer lens.

Detailed Description

The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

< multifocal intraocular lens >

Fig. 1 shows a perspective view of a multifocal intraocular lens 100 in accordance with the present invention. Fig. 2 shows a top view of a multifocal intraocular lens 100 in accordance with the present invention. Fig. 3 is a cross-sectional view of the intraocular lens 100 of fig. 2 in the A-A direction.

As shown in fig. 1, the intraocular lens 100 is composed of a lens portion 1 and two portions 2 connected to the outer edge of the lens portion 1. The lens portion 1 is substantially disc-shaped, has a thicker central portion, and slightly protrudes to both sides. The lens unit 1 is a member having a corrective action on the visual function of the eyeball, and is composed of an inner lens 11 and an outer lens 12. The part 2 serves as a connecting and fixing member, and when the intraocular lens 100 is implanted in a human eyeball, the part 2 having a hook shape is adhered to the eyeball, thereby supporting and fixing the lens part 1.

The lens portion 1 is formed by combining an inner lens 11 and an outer lens 12, and the inner lens 11 and the outer lens 12 are formed by an acrylic resin with high refractive index and a silicone with low refractive index, respectively.

Referring to 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 overlapped on the same optical axis, so that the optical properties of the two lenses are superimposed on each other, thereby forming the optical performance of the multifocal intraocular lens 100.

The multifocal intraocular lens 100 has specific optical properties such as specific ultraviolet-visible transmittance and photochromic properties in addition to specific vision correction power and the ability to simultaneously correct hyperopia and myopia by having a plurality of focuses as in the case of a conventional vision correction tool.

The lens portion 1 of the intraocular lens 100 of the present invention is formed in a shape in which the thickness of the central portion is thicker and the thickness of the peripheral portion is thinner. Correspondingly, the inner lens 11 and the outer lens 12 are also disc-shaped with thicker center and thinner edge, and form an inner package structure in a concentric circle state.

The shape and 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. Alternatively, the inner lens 11 may be formed in a fan shape. Still further, the multiple lens material inner package structure may be more than one layer, or the multifocal intraocular lens 100 may be formed by having three lens materials forming a dual inner package, or more lens materials forming multiple inner packages.

Next, a material for producing the intraocular lens 100 will be described.

< Polymer selection for producing intraocular lens part >

In selecting the polymer used to prepare the lens portion 1 of the intraocular lens 100, the following conditions are considered (for convenience of description, polymer a refers to the polymer constituting the inner lens 11 and polymer B refers to the polymer constituting the outer lens 12 in this section):

in condition one, polymer a and polymer B need to have different refractive indices;

second, polymer a and polymer B need to be able to function independently of each other without affecting each other to create physical or chemical changes;

thirdly, the polymer A and the polymer B are required to have certain softness and can be curled so as to be conveniently implanted into eyeballs;

condition four, polymer a and polymer B need to be able to be subsequently processed and sterilized;

and fifthly, the polymerization process of one of the polymer A and the polymer B is not influenced by the other, and the physical and chemical properties of the other are not influenced.

The polymer (polymer a) constituting the inner lens 11 and the polymer (polymer B) constituting the outer lens 12 selected in the embodiment of the present invention are acrylic resin and silicone, respectively.

The acrylic resin constituting the inner lens 11 used in the present invention may be composed of a combination of a (meth) acrylate monomer, a crosslinking agent, a polymerizable ultraviolet absorber, a polymerizable dye, and an initiator. Examples of the composition of the monomer that can be used in general include those described in known examples such as US5470932A, JP2724931B2 and JP 2019210345. Specifically, as the (meth)) acrylate monomer, there may be exemplified: 2-phenylethyl acrylate (PEA), 2-phenylethyl methacrylate (PEMA), perfluorooctylethyl dodecafluoroheptyl (PFMA) acrylate Butyl (BA); examples of the crosslinking agent include: butanediol diacrylate (BDDA), ethylene Glycol Dimethacrylate (EGDMA); examples of the polymerizable ultraviolet absorber include: 2- (2 '-hydroxy-5' -methacryloyloxyethylphenyl) -2H-benzotriazole (UV 01); examples of the polymerizable coloring matter include: 4- (phenyldiazenyl) phenyl-2-methacrylate (Yellow 01); examples of the initiator include: 2,2' -azobis (isobutyronitrile) (AIBN).

The silicone constituting the outer lens 12 used in the present invention may be preferably a two-part curable transparent silicone elastomer obtained by a crosslinking reaction of a silicone polymer having a vinyl group and a silicone polymer having a hydrosilyl group. Specific compounds were prepared by curing a mixed solution of dimethylsiloxane and dimethylsiloxane-methylhydrosiloxane copolymer having terminal vinyl groups with a platinum catalyst. Specifically, the products MED-6233 (refractive index 1.41) and MED-6820 (refractive index 1.43) of Avantor corporation may be used.

In addition to the acrylic resin and the silicone as the main components, the polymer constituting the lens portion 1 of the intraocular lens 100 contains the following other additive components.

For example, in order to improve the safety of the polymer produced, it is desirable to add a proper amount of a methyl dimethacrylate component as a crosslinkable monomer. Examples of the crosslinkable monomer to be added to improve the crosslinkability of the polymer include Ethylene Glycol Dimethacrylate (EGDMA) and butanediol diacrylate (BDDA, butanediol diacrylate). In addition, 2'-azobis (isobutyronitrile), (AIBN, 2' -Azobis (isobutyronitrile)) was added as a polymerization initiator.

< selection of Polymer for preparation of portion of intraocular lens >

For ease of preparation, the polymer constituting part 2 and the polymer constituting lens part 1 can be the same.

In addition, when selecting the polymer for preparing the part 2 of the intraocular lens 100, it is considered whether the part 2 in the folded state in the injector can be unfolded smoothly after being implanted into the eyeball for supporting and fixing the lens part 1. At the same time, the preferred form of deployment of portion 2 is relatively slow, which is advantageous for safety of intraocular lens 100 when implanted in the eye.

In one embodiment of the present invention, the interior and exterior portions of portion are each comprised of an acrylic and silicone, respectively, and the soft nature of the acrylic within portion and the elastic restoring force of the exterior silicone cooperate to allow portion of intraocular lens 100 to slowly resume its expanded configuration to its intended position within the eye during release of the curled intraocular lens 100 using a syringe.

The acrylic and silicone that can be exemplified are described in detail in the section "choice of polymer for making the lens portion of an intraocular lens" above and are not described in detail herein.

< method for producing intraocular lens >

Embodiments are described below:

embodiments of a method of manufacturing an intraocular lens 100 are provided as follows.

First, in order to prepare the inner lens 11, 2-phenylethyl acrylate (PEA), 2-phenylethyl methacrylate (PEMA), butanediol diacrylate (BDDA), 2- (2 ' -hydroxy-5 ' -methacryloyloxyethyl phenyl) -2H-benzotriazole (UV 01), 4- (phenyldiazenyl) phenyl-2-methacrylate (Yellow 01) and 2,2' -azobis (isobutyronitrile) (AIBN) were each added in the following amounts to a glass bottle having a capacity of 10mL, and stirred at room temperature until dissolved (about 1 hour), to obtain a monomer mixture constituting a raw material of the inner lens 11.

PEA 65 wt%

PEMA 30 wt%

BDDA 3.2 wt%

UV 01.8 wt%

Yellow 01.05 wt%

AIBN 0.3 wt%

Fig. 4 shows a mold for manufacturing the inner lens 11. The mold is made of a resin material into a hollow shape of a pair of upper and lower parts. The monomer mixture liquid constituting the raw material of the inner lens 11 is slowly injected into the mold for the inner lens 11, so that the monomer mixture liquid injected into the mold is free from air bubbles. Thereafter, the resin mold filled with the monomer mixture is placed in a polymerization apparatus. After the polymerization is completed, the mold is removed from the polymerization apparatus, the mold is opened, and the polymer material of the polymerized inner lens 11 is removed.

The outer lens 12 is then prepared using, for example, the product MED-6233 (refractive index 1.41) from Avantor. MED-6233 was composed of two liquids, part A and part B, and part A and part B were mixed in a weight ratio of 1:1, vacuum deaerated, and then dropped into the lower side of the resin mold shown in FIG. 5. Then, the polymer material of the inner lens 11 after the polymerization is placed in the mixture of MED-6233 collected by the dropping mold, and the mixture of MED-6233 is dropped therefrom, thereby completely burying the polymer material of the inner lens 11 in the MED-6233. At this time, in order to prevent the generation of bubbles, vacuum degassing is performed again. After degassing, the upper side of the resin mold was covered, and the temperature was 100℃for 20 minutes in this state.

And taking out from the mould after polymerization. And is in a state in which the polymer material of the outer lens 12 is internally wrapped with the polymer material of the inner lens 11.

The intraocular lens 100 material having the inner bag structure was placed in a dryer set at 120℃in advance, and heat treatment was performed for 8 hours. Unreacted polymer monomers in the intraocular lens 100 material are removed by this heat treatment.

Thus, an intraocular lens 100 material comprised of polymers having two different refractive indices was obtained. A prescribed shape is then cut into the material using a machining machine, and a bifocal intraocular lens 100 having two different refractive indices is finally produced.

< method for sterilizing intraocular lens >

In view of low heat resistance of the acrylic resin constituting the inner lens 11, EOG sterilization may be selected. EOG sterilization refers to sterilization with ethylene oxide, which has a strong oxidizing property and can cause bacterial death, but is prone to residue generation.

However, since the outer lens 12 is made of silicone in the present invention, the acrylic resin constituting the inner lens 11 can be protected, and silicone has a high temperature resistant property, a more reliable high-pressure steam sterilization method can be selected in the embodiment of the present invention in consideration of the above.

The experimental procedure for polymer selection of the lateral lens 12 and the medial lens 11 of intraocular lens 100 and the results are shown in table 1.

[ Table 1 ]

The chemical abbreviations in table 1 are illustrated below:

PEA 2-phenylethyl acrylate

PEMA 2-phenylethyl methacrylate

PFMA perfluorooctyl ethyl dodecafluoroheptyl acrylate

BA butyl acrylate

BDDA butanediol diacrylate

EGDMA ethylene glycol dimethacrylate

UV01 2- (2 '-hydroxy-5' -methacryloyloxyethylphenyl) -2H-benzotriazole

Yellow 01- (phenyldiazenyl) phenyl-2-methacrylate

AIBN 2,2' -azobis (isobutyronitrile)

Two-part curing silicone (vinyl-containing dimethylsiloxane and hydrosilyl-containing crosslinking agent as main components) manufactured by MED-6820Avantor company

Two-part curable silicone (dimethylsiloxane containing vinyl and phenyl groups as main components, and a hydrosilyl group-containing crosslinking agent) manufactured by MED-6233Avantor Inc

The compositions of MED-6233 and MED-6820 are shown in the following tables.

In experimental example 3 in table 1, the optical performance of the intraocular lens 100 produced by using acrylic resin for both the inner lens 11 and the outer lens 12 was not as expected, because the inner lens 11 swelled when the outer lens 12 was polymerized. The swelling ratio was measured and calculated as follows:

the obtained intraocular lens 100 was cut at the center as an optical portion material, and placed on a table of a microscope, and the dimensions of the optical portion material in the X-axis and Y-axis directions were measured, and the average value thereof was used as the diameter of the optical portion material to calculate the swelling ratio before and after polymerization. Wherein the X-axis and the Y-axis are two axes parallel to the plane of the optic material and passing through the center point of the optic material and intersecting each other.

The swelling ratio formula is calculated as follows.

Swelling ratio (%) = (D2-D1)/D1

Where D1 is an average value of X-axis and Y-axis dimensions of the optical portion material (inner lens 11 portion) before polymerization of the outer lens material, and D2 is an average value of X-axis and Y-axis dimensions of the optical portion material (inner lens 11 portion) after polymerization of the outer lens material.

Further, in order to confirm whether or not swelling may occur by accident, the applicant conducted experiment example 2a plurality of times and obtained the average value of the swelling ratios as shown in table 2, that is, the value of the swelling ratio obtained by each measurement was relatively stable, about 11%.

[ Table 2 ]

In addition to examples 1 to 3 shown in table 1, the applicant performed example 4, in example 4,

the inner lens 11 is selected from: polymethyl methacrylate (PMMA);

the outer lens 12 is selected from: acrylic resin.

Experimental results: as shown in fig. 8, the appearance was good, and swelling did not occur, and the optical performance was good. Just because the inner side is hard, the softness is insufficient and is not suitable for making the foldable intraocular lens 100 of the present invention.

Thus far, from experimental examples 1 and 2 successful in table 1 and experimental examples 3 and 4 which are not in agreement with expectations, it is understood that when the inner lens 11 is composed of acrylic resin and the outer lens 12 is composed of silicone, the prepared intraocular lens 100 has at least the following excellent effects:

(1) The silicone is less likely to swell the polymerized acrylic resin during polymerization, and an intraocular lens 100 having a stable appearance and good optical performance can be obtained.

(2) Both acrylic and silicone have a degree of softness that allows the finished intraocular lens 100 to be curled and implanted into the eye through a syringe.

(3) The intraocular lens 100 comprising silicone comprising the lateral lens 12 will have the property of being resistant to high temperatures, which can widen the range of alternative sterilization methods for the intraocular lens 100, such as autoclaving.

Those skilled in the art will appreciate 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 following claims are hereby expressly incorporated into this detailed description, with each claim standing on its own as a separate embodiment of this invention.

Furthermore, while some embodiments described herein include some features included in other embodiments but not others 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 will be appreciated 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 specific terms in describing certain features or aspects of the present invention should not be taken to imply that the terms are being redefined herein to be restricted to including any specific characteristics of the features or aspects of the present invention with which that term is associated.

In the description provided herein, numerous specific details are set forth. It is understood, however, 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. An intraocular lens comprising a lens portion and a portion connected to an outer edge of the lens portion, wherein the lens portion comprises:

an inner lens having a first refractive index and composed of an acrylic resin;

and an outer lens formed to cover the inner lens, having a second refractive index, and composed of silicone.

2. The intraocular lens of claim 1 wherein,

the part is formed of an acrylic resin inside and a silicone outside.

3. The intraocular lens of claim 1 or 2 wherein,

the inner lens is formed in an asymmetric area type structure.

4. The intraocular lens of claim 3 wherein,

the inner lens is fan-shaped.

5. The intraocular lens of claim 1 or 2 wherein,

the inner lens is formed in a rotationally symmetrical structure.

6. The intraocular lens of claim 5 wherein,

the inner lens is circular.

7. The intraocular lens of claim 1 or 2 wherein,

a plurality of focal points are formed in the lens portion.

8. The intraocular lens of claim 1 or 2 wherein,

the first refractive index is greater than the second refractive index, or the first refractive index is less than the second refractive index.

9. The intraocular lens of claim 1 or 2 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.