CN115373156A - Liquid-bag-shaped corneal contact lens and manufacturing method thereof - Google Patents

Abstract

The invention discloses a sac-shaped contact lens and a preparation method thereof. The sac-shaped contact lens is composed of a transparent film and a transparent oxygen-permeable liquid, and the oxygen-permeable liquid is wrapped in the film; the film It includes an inner elastomer layer and an outer hydrophilic polymer hydrogel layer. The sac-shaped corneal contact lens of the present invention has the characteristic of changeable shape, can be retained in a narrow channel in the form of liquid droplets, can be directly dripped into the eyes from the channel, spread on the corneal surface, and is easy to carry and easy to wear.

Description

A kind of sac-shaped corneal contact lens and its manufacturing method

technical field

The invention relates to the technical field of film contact lenses, in particular to a sac-shaped corneal contact lens and a manufacturing method thereof.

Background technique

Contact lenses, commonly known as contact lenses, are lenses worn on the cornea of the eye to correct vision or protect the eyes.

Contact lenses wear an optical lens system on the surface of the cornea to achieve functions such as vision correction for the wearer, and have the advantages of aesthetics and portability. Commonly used contact lens materials include hard oxygen-permeable materials, hydrogel materials, and silicon hydrogel materials. Starting from traditional hard contact lenses, hydrogel materials are constantly evolving to soft materials, among which hydrogel materials and silicon hydrogel materials are soft materials, which can provide higher safety and comfort. Furthermore, changing the contact lens into a softer droplet form can not only improve the overall wearing comfort, but also facilitate the formation of a drop-in wearing method for the contact lens.

The processing and manufacturing methods of contact lenses vary according to different contact lenses. For example, hard contact lenses can be directly obtained by cutting and grinding with precision machine tools. The soft contact lens can also be obtained by mold manufacturing.

For example, the Chinese patent document with the application number CN202110768129.7 discloses a method for preparing fully color-separated colored contact lenses, which includes the following steps: Step 1: Stir the color-changing raw materials and contact lens raw materials to form a mixed solution, and then print the mixed solution In the iris area of the contact lens mold; step 2: then react the mixture used to form the contact lens through a UV light program or a heating process to form a contact lens, and then hydrate; step 3: soak the contact lens in alcohol , water and finally soaked in a buffer solution for equilibrium.

The Chinese patent document with the application number 201821055491.X discloses a soft contact lens mold structure, including a front metal mold core and a rear metal mold core; the front metal mold core and the rear metal mold core cooperate with each other to form a plastic mold body , the upper surface of the front metal mold core is a convex arc body, the upper surface of the rear metal mold core is provided with a concave arc body, and the rear metal mold core is provided with an annular groove.

Existing contact lenses are usually put into the eyes by users directly for use, which is not portable to a certain extent; on the other hand, the existing preparation methods cannot produce softer contact lenses that can exist in the form of liquid sacs.

Contents of the invention

The invention provides a liquid capsule form corneal contact lens and a preparation method thereof. The liquid capsule form corneal contact lens is softer, has the characteristic of being changeable in shape, and is more portable.

Technical scheme of the present invention is as follows:

A sac-shaped corneal contact lens is composed of a transparent film and a transparent oxygen-permeable liquid, and the oxygen-permeable liquid is wrapped in the film;

The film includes an inner elastomer layer and an outer hydrophilic polymer hydrogel layer.

The inner layer refers to the layer of the film that is close to the inner oxygen-permeable liquid, and the outer layer refers to the layer that is close to the cornea when in use. The hydrogel layer has corneal affinity, and corneal affinity refers to that when the contact lens contacts the cornea: (1) the surface is softer, and its mechanical properties are compatible with the ocular surface; (2) the surface is more hydrophilic and can Effectively reduce the adhesion of oil and protein; (3) It has lower cytotoxicity and foreign body property, reducing the foreign body sensation on the ocular surface; (4) Lower friction coefficient, making it more slippery on the corneal surface.

The sac-shaped corneal contact lens of the present invention has the characteristic of changing the shape, and can be retained in the narrow channel in the form of liquid droplets; it can be directly dripped into the eyes from the channel, spread out on the surface of the cornea, according to the shape of the surface of the cornea, and The contact lens volume is designed to form a contact lens of a specific diopter to achieve vision correction.

Preferably, the elastomer layer is silicone rubber or silicone hydrogel; the hydrogel layer is at least one of polyacrylamide, polyhydroxyethyl methacrylate and polyvinyl alcohol; the The oxygen-permeable liquid is at least one of polydimethylsiloxane mother liquor, ethylene glycol, and glycerol.

Preferably, the thickness of the elastomer layer is 5-20 μm, and the thickness of the hydrophilic polymer hydrogel layer is 0.5-10 μm.

The present invention also provides a method for preparing a sac-shaped contact lens, comprising the following steps:

(1) preparing a film with an elastomer layer and a hydrophilic polymer hydrogel layer;

(2) Carry out surface activation treatment to the surface of the elastic body layer of two pieces of film respectively, the elastic body layer of two pieces of film is opposite, the oxygen permeable liquid of specific volume is injected between the elastic body layer of two pieces of film, afterwards two pieces of film The two films are assembled and bonded to seal the oxygen-permeable liquid between the two films;

(3) cutting the film along the bonding edge to obtain the sac-shaped contact lens;

According to the shape and size of the corneal surface and the required diopter, the size of the sac-shaped contact lens and the injection volume of the oxygen-permeable liquid are designed.

In the liquid sac-shaped contact lens of the present invention, the elastomer layer ensures that the internal oxygen-permeable liquid does not penetrate, and the hydrogel coating on the surface of the elastomer layer ensures good biocompatibility of the contact lens, and can be sufficiently compatible with the ocular surface. lubricating. Due to the high oxygen permeability liquid and high affinity hydrogel film coating, the entire contact lens can simultaneously have ultra-high oxygen permeability, super affinity and super lubricating surface.

Preferably, step (1) includes:

(1-1) Coating a sacrificial layer on the substrate, coating an elastomer layer pre-polymerization solution on the sacrificial layer, and forming an elastomer layer after curing;

(1-2) Activate the surface of the elastomer layer to form activated groups on the surface; then immerse in the surface treatment pre-preparation solution, rinse and air-dry; then immerse in the hydrogel pre-polymerization solution and solidify, A hydrophilic polymer hydrogel layer is formed on the surface of the elastomer layer;

(1-3) Obtaining the thin film after removing the sacrificial layer.

Preferably, the sacrificial layer is polyvinyl alcohol film.

Further, in step (1-2), the polyvinyl alcohol aqueous solution is coated on the substrate, and the water is evaporated by heating to form a polyvinyl alcohol sacrificial layer film.

The mass concentration of the polyvinyl alcohol aqueous solution is 3-10%.

Further, in step (1-3), the sacrificial layer is removed by soaking in hot water.

The sacrificial layer can also be photoresist.

Further preferably, in step (1-2), plasma is used to rinse the surface of the elastomer layer for 2-5 minutes to form activated groups on the surface.

The surface treatment preset solution is an ethanol solution of benzophenone, and the mass fraction of benzophenone is 5-20%.

The hydrogel prepolymerization solution is an aqueous solution of a hydrophilic hydrogel macromolecular monomer and a photoinitiator, comprising 10-30% by mass fraction of a hydrophilic hydrogel macromolecular monomer and 1-20% by volume Fraction of photoinitiator solution; the concentration of photoinitiator in the photoinitiator solution is 0.1mol/L.

Further preferably, the hydrophilic hydrogel polymer monomer is at least one of acrylamide, hydroxyethyl methacrylate and vinyl alcohol; the photoinitiator is α-ketoglutaric acid, At least one of I2959 and PI184.

Preferably, in step (1-2), ultraviolet light is used to light-cure the hydrogel prepolymer solution, and the curing time is 15-30 minutes.

Preferably, step (2) includes:

(2-1) Two hard bottom plates with round holes are used to support a piece of the film respectively, and the hydrogel layer is close to the hard bottom plate; size;

(2-2) Activate the surface of the elastomer layer of the film held up by the hard base plate, then drop a specific volume of oxygen-permeable liquid into the surface of one of the films at the round hole, and then pour another A thin film is covered on the oxygen-permeable liquid, aligning and assembling the two films facing the circular holes, and enclosing the oxygen-permeable liquid between the two films;

(2-3) Leave the assembled films at 60-70°C for 18-30 hours to bond the two films, take them out and cut the films along the bonding edge to obtain the sac-shaped contact lens .

Compared with prior art, the beneficial effect of the present invention is:

In the present invention, the high oxygen permeability liquid is sandwiched between two layers of films by a double-layer film sandwich method to prepare a contact lens in the form of a liquid sac; the films on both sides adopt a composite double-layer form, and the high oxygen permeability inside is ensured by an elastic body While the liquid is impermeable, it also forms a hydrogel coating on the surface of the elastomer to ensure the good biocompatibility of the contact lens, and it can be lubricated enough with the ocular surface to expand on the ocular surface; due to the use of high oxygen permeability liquid and High-affinity hydrogel film coating, the entire contact lens can have ultra-high oxygen permeability, super-affinity and super-lubricating surface at the same time; by controlling the internal volume of the liquid sac, the contact lens can reach the cornea After the surface, lenses of different shapes are formed to correct vision; it has the characteristic of changing the shape and can be retained in the narrow channel in the form of liquid droplets, which can be directly dripped into the eyes from the tube and spread out on the surface of the cornea , easy to carry and easy to wear.

Description of drawings

Fig. 1 is the structural schematic diagram of the sac-shaped contact lens of the present invention;

Fig. 2 is a schematic diagram of shaping the ocular surface of the sac-shaped contact lens of the present invention;

FIG. 3 is a schematic flowchart of a method for preparing a sac-shaped contact lens according to an embodiment of the present invention.

Detailed ways

As shown in Figure 1, the sac-shaped contact lens of the present invention is composed of two layers of films sandwiching an oxygen-permeable liquid, wherein the two layers of films all have an affinity hydrogel coating as the interface in contact with the cornea during use, The inner layer of the hydrogel coating is an elastomer layer; the friction between the hydrogel coating and the cornea is extremely small, which can ensure that the contact lens in the shape of a liquid sac is expanded and formed on the ocular surface. The sac-shaped contact lens of the present invention has no fixed shape. After the ocular surface is reshaped, due to its limited volume, it will present a concave lens shape as shown in FIG. 2 , thereby achieving the effect of refraction and vision correction.

Example 1

As shown in Figure 3, the present embodiment is a preferred preparation method of a sac-shaped contact lens, comprising the following steps:

1. Prepare surface treatment preset solution: dissolve benzophenone, a surface curing initiator, in absolute ethanol with a mass fraction of 5%-20% (preferably 10%).

Configure the hydrogel pre-polymerization solution: dissolve the hydrogel polymer acrylamide in water with a mass fraction of 10%-30% (preferably 15%), add 10-200 microliters of 0.1mol/ l ethanol solution of photoinitiator α-ketoglutaric acid.

2. Dissolve polyvinyl alcohol in 60-90°C hot water (preferably 75°C) with a mass fraction of 3%-10% (preferably 5%), and then spin-coat it on a hard substrate (spin-coating speed 300-1000 rpm per minute, preferably 500 revolutions per minute, spin coating time 2-5 minutes, preferably 3 minutes), heat to evaporate water, and form a polyvinyl alcohol sacrificial layer film with a thickness of 10-50 microns. Spin-coat the silicone rubber prepolymer solution on the sacrificial layer film to form an elastomer with a thickness of 5-20 microns.

3. After the elastomer is cured, perform surface treatment on the elastomer film to form activated groups on the surface (preferably plasma rinse for 2-5 minutes). Quickly soak the above materials in the surface treatment preparation solution prepared in step 1 for 0.5-5 minutes (preferably 1 minute). Then use excess absolute ethanol to rinse the surface for 1-5 minutes (preferably 2 minutes). The surface obtained after rinsing was air-dried with nitrogen, and then soaked in the hydrogel prepolymerization solution prepared in step 1. The hydrogel pre-polymerization solution is placed under 365nm ultraviolet light for curing, and the curing time is 15-30 minutes (preferably 20 minutes). The cured elastomer surface forms a hydrophilic hydrogel coating.

4. Soak the above materials in hot water at 90°C for more than 6 hours to dissolve the sacrificial layer, and the elastomer film will fall off and float on the water surface.

5. Use a hard bottom plate with a round hole as shown in Figure 3 to hold up the elastomer film (the diameter of the round hole is the diameter of the contact lens), and the side without the hydrogel coating faces outward. Perform the surface activation treatment described in step 3 on the surface of the elastomer, and then drop a specific volume of oxygen-permeable liquid (preferably polydimethylsiloxane mother solution, with a volume of 5-20 microliters) on the surface. Align the centers of two round-hole rigid bottom plates with elastomeric films to fit them together, and seal the oxygen-permeable liquid in the elastomeric films.

6. Put the above materials into an oven, treat at 65°C for 24 hours, put the whole mold in water, then take out the elastomer film with the liquid droplets sealed, and cut the film along the bonding edge to obtain the liquid sac Morphological contact lenses.

The hydrogel polymer monomer acrylamide in Example 1 can be replaced by hydrophilic polymers such as polyhydroxyethyl methacrylate, polyvinyl alcohol; the photoinitiator can be replaced by other photoinitiators, such as I2959, PI184, etc. ; Example 1 uses polyvinyl alcohol as a sacrificial layer to prepare a polymer film, and the sacrificial layer can also be realized with other materials, such as photoresist.

The embodiments described above have described the technical solutions and beneficial effects of the present invention in detail. It should be understood that the above descriptions are only specific embodiments of the present invention, and are not intended to limit the present invention. All within the scope of the principles of the present invention Any modifications, supplements and equivalent replacements should be included within the protection scope of the present invention.

Claims (10)

1. A liquid-bag-shaped corneal contact lens is characterized by comprising a transparent film and transparent oxygen-permeable liquid, wherein the oxygen-permeable liquid is wrapped in the film;

the film comprises an elastomer layer of an inner layer and a hydrophilic polymer hydrogel layer of an outer layer.

2. The sac-shaped contact lens according to claim 1, wherein the elastomer layer is silicone rubber or silicone hydrogel; the hydrogel layer is at least one of polyacrylamide, polyhydroxyethyl methacrylate and polyvinyl alcohol; the oxygen-permeable liquid is at least one of polydimethylsiloxane mother liquor, glycol and glycerol.

3. The sac-shaped corneal contact lens according to claim 1, wherein the thickness of the elastomer layer is 5-20 μm, and the thickness of the hydrophilic polymer hydrogel layer is 0.5-10 μm.

4. A method of making a liquid pocket-shaped contact lens as claimed in claims 1-3, comprising the steps of:

(1) Preparing a film having an elastomer layer and a hydrophilic polymeric hydrogel layer;

(2) Respectively carrying out surface activation treatment on the surfaces of the elastomer layers of the two films, enabling the elastomer layers of the two films to be opposite, injecting oxygen-permeable liquid with a specific volume between the elastomer layers of the two films, then assembling and bonding the two films, and sealing the oxygen-permeable liquid between the two films;

(3) Cutting the film along the bonding edge to obtain the liquid sac shape cornea contact lens;

the size of the liquid sac shape cornea contact lens and the injection volume of the oxygen permeable liquid are designed according to the shape and the size of the cornea surface and the required diopter.

5. The method according to claim 4, wherein the step (1) comprises:

(1-1) coating a sacrificial layer on a substrate, coating elastomer layer pre-polymerization liquid on the sacrificial layer, and curing to form an elastomer layer;

(1-2) performing an activation treatment on the surface of the elastomer layer to form an activated group on the surface; then immersing the substrate into surface treatment preset liquid, rinsing and air-drying; then soaking the elastomer into hydrogel pre-polymerization liquid and curing to form a hydrophilic polymer hydrogel layer on the surface of the elastomer layer;

and (1-3) removing the sacrificial layer to obtain the film.

6. The method according to claim 5, wherein the sacrificial layer is a polyvinyl alcohol film; in the step (1-3), the sacrificial layer is removed by hot water immersion.

7. The production method according to claim 5, wherein in the step (1-2), the surface of the elastomer layer is washed with plasma for 2 to 5 minutes to form activated groups on the surface.

8. The preparation method according to claim 5, wherein the hydrogel pre-polymerization solution is an aqueous solution of hydrophilic hydrogel polymer monomers and a photoinitiator, and comprises 10-30% by mass of hydrophilic hydrogel polymer monomers and 1-20% by volume of a photoinitiator solution; the concentration of photoinitiator in the photoinitiator solution was 0.1mol/L.

9. The method according to claim 8, wherein the hydrophilic hydrogel polymer monomer is at least one of acrylamide, hydroxyethyl methacrylate and vinyl alcohol; the photoinitiator is at least one of alpha-ketoglutaric acid, I2959 and PI 184.

10. The method according to claim 4, wherein the step (2) comprises:

(2-1) respectively supporting one film by adopting two hard bottom plates with round holes, and enabling the hydrogel layer to be close to the hard bottom plates; the size of the round hole is the size of the liquid sac shape cornea contact lens;

(2-2) carrying out activation treatment on the surface of the elastomer layer of the film supported by the hard bottom plate, then dripping oxygen-permeable liquid with a specific volume on the surface of one film at the round hole, covering the other film on the oxygen-permeable liquid, aligning and assembling the two films opposite to the round hole, and sealing the oxygen-permeable liquid between the two films;

and (2-3) standing the assembled films at 60-70 ℃ for 18-30h to bond the two films, taking out the films, and cutting the films along the bonding edge to obtain the liquid sac shape corneal contact lens.

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