Stabilizer, method for assisting processing of soft intraocular lens loop and intraocular lens

Abstract

The invention discloses a stabilizing agent, a method for assisting soft intraocular lens loop processing and an intraocular lens, and relates to the technical field of polymer optical device processing, the stabilizing agent is used for connecting an intraocular lens semi-forming product and a hydrophobic mold, and the stabilizing agent comprises an aqueous solution, the aqueous solution comprises an aqueous solution containing amphiphilic molecules and / or thickening molecules, the contact angle of the aqueous solution is 40-76 degrees, and the viscosity of the aqueous solution is 2-60 mPa.s. Meanwhile, the contact angle, the viscosity and the low-temperature hardening temperature of the stabilizing agent are controlled within the range, so that the stabilizing agent can form a uniform and complete liquid film at the junction of the artificial lens semi-forming product and the hydrophobic mold or on the surface of the soft artificial lens semi-forming product, and the liquid film is still kept complete and cannot be broken after being cooled; and the coating can be tightly adhered to the surface of a coated hydrophobic material for protection.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of high polymer optical device processing technology, in particular to a stabilizing agent, a method for assisting in processing of a soft intraocular lens haptic, and an intraocular lens. BACKGROUND

[0002] Cataract is a common eye aging problem, which needs to be cured by cataract surgery. Intraocular lens is the most direct medical product for cataract implantation, and its chemical nature is a kind of high polymer material, which has a thin external feature. As a kind of visual light medical product, it needs to meet more stringent manufacturing requirements, especially in mechanical processing.

[0003] For a molded high polymer optical device such as an intraocular lens, when the loaded mold sample is switched to a milling station for continuous processing, in order to ensure the optical parameters of the precision optical device, the sample is usually positioned without demolding, and then processed. In order to make the sample demold smoothly and without damage after processing, the mold is usually made of low-surface-energy polyolefin plastic components, but such a mold has the problem of not firmly bonding the sample. In addition, at room temperature, soft high polymer materials such as intraocular lenses have a certain surface tackiness, and when mechanical processing is performed, the material becomes soft, the processing site softens, resulting in inability to process, poor processing precision, and adhesion of debris. SUMMARY

[0004] The main purpose of the present application is to provide a stabilizing agent, a method for assisting in processing of a soft intraocular lens haptic, and an intraocular lens, which aims to solve the problems of easy separation of the intraocular lens from the mold during processing and difficult cleaning of processing debris in the prior art.

[0005] To achieve the above-mentioned purpose, the present application provides a stabilizing agent for stabilizing the connection between an intraocular lens semi-finished product and a hydrophobic mold, the stabilizing agent comprising an aqueous solution, the aqueous solution comprising an aqueous solution containing an amphiphilic molecule and / or a thickening molecule:

[0006] The contact angle of the aqueous solution is 40°-76°, and the viscosity of the aqueous solution is 2-60 mPa·s.

[0007] In an embodiment, the amphiphilic molecule comprises one or more of stearic acid, sodium dodecylbenzenesulfonate, poloxamer, quaternary ammonium compound, fatty acid glyceride, fatty acid sorbitan, and polysorbate; and / or,

[0008] The thickening molecule comprises one or more of polyethylene glycol, polyvinyl alcohol, hydroxypropyl methyl cellulose, and polyoxyethylene ether.

[0009] In an embodiment, the stabilizing agent comprises an aqueous solution of amphiphilic molecules, and the concentration of the aqueous solution of amphiphilic molecules is 2% to 25%; or,

[0010] The stabilizing agent comprises an aqueous solution of thickening molecules, and the concentration of the aqueous solution of thickening molecules is 10% to 20%.

[0011] The application also provides a method for assisting the processing of the haptics of a soft intraocular lens, which is used for a molded sample of an intraocular lens semi-finished product partially not separated from a hydrophobic mold, and comprises the following steps:

[0012] S1, coating the aforementioned stabilizing agent at least on the joint of the hydrophobic mold and the intraocular lens semi-finished product partially not separated from the hydrophobic mold;

[0013] S2, performing a cooling treatment on the molded sample coated with the stabilizing agent, so as to harden the intraocular lens semi-finished product and the coated stabilizing agent, to obtain a cooled molded sample;

[0014] S3, performing a haptic milling processing on the cooled molded sample, and performing a cleaning on the molded sample after the haptic milling processing, to remove the stabilizing agent and the haptic milling debris, and removing the hydrophobic mold, to obtain an intraocular lens finished product.

[0015] In an embodiment, step S1 comprises:

[0016] coating the aforementioned stabilizing agent on the joint of the hydrophobic mold and the intraocular lens semi-finished product, and on the surface of the intraocular lens semi-finished product partially separated from the hydrophobic mold.

[0017] In an embodiment, in step S2, the cooling treatment comprises spraying the molded sample coated with the stabilizing agent using a mixed gas with a temperature of T, and the mixed gas comprises a mixture of dry air and inert gas.

[0018] wherein T≤ the low-temperature hardening temperature of the stabilizing agent, and T< the glass transition temperature of the intraocular lens semi-finished product.

[0019] In an embodiment, the cooling treatment comprises spraying the molded sample coated with the stabilizing agent using a mixed gas with a temperature of T; and / or,

[0020] the T is -65 to -5℃, and the glass transition temperature of the intraocular lens semi-finished product is -5℃ to 15℃.

[0021] In an embodiment, the flow rate of the mixed gas is 0.5 to 2.5 Nm 3 / min; and / or,

[0022] The inert gas includes one or more of helium, neon, argon, krypton, xenon, radon, and nitrogen.

[0023] In one embodiment, the cleaning in step S3 includes ultrasonic cleaning or ultrasonic oscillation cleaning with water.

[0024] The application also provides an intraocular lens comprising an intraocular lens processed by the method for processing an auxiliary soft intraocular lens haptic.

[0025] In the technical scheme of the application, the stabilizing agent can be an aqueous solution containing an amphiphilic molecule, an aqueous solution containing a thickening molecule, or an aqueous solution containing both an amphiphilic molecule and a thickening molecule; limiting the contact angle of the stabilizing agent to 40°-76° can ensure that the stabilizing agent can form a relatively uniform liquid film at the junction of the soft intraocular lens semi-finished product and the hydrophobic mold or on the surface of the soft intraocular lens semi-finished product, which is made of a hydrophobic polymer; limiting the viscosity of the stabilizing agent to 2-60 mPa·s can ensure that it can form a gel or a solid substance that hardly flows after cooling, so as to tightly adhere or firmly adhere the intraocular lens semi-finished product and the mold or the exposed surface of the intraocular lens semi-finished product. Controlling the contact angle and the viscosity of the stabilizing agent within the above ranges can ensure that the stabilizing agent can form a relatively uniform and complete liquid film at the junction of the intraocular lens semi-finished product and the hydrophobic mold or on the surface of the soft intraocular lens semi-finished product, and the liquid film remains complete and does not break after cooling treatment, and can tightly adhere to the surface of the coated hydrophobic material for protection. BRIEF DESCRIPTION OF DRAWINGS

[0026] In order to more clearly illustrate the technical solutions of the embodiments of the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or prior art description. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can also be obtained according to the structures shown in the drawings without creative labor for those skilled in the art.

[0027] Figure 1 A simple diagram of the mixed cold gas cooling device provided in Embodiment 9 of the present application;

[0028] Figure 2 The static state of different stabilizing agents in Embodiments 1-8 and Comparative Examples 1-5 of the present application on the A2 sample;

[0029] Figure 3 A sample haptic and optical zone surface without debris adhesion state diagram of the A2 sample processed by the processing method in Embodiment 9 of the present application;

[0030] Figure 4Figure 9 is a profile of the sample haptic of the A1 sample processed according to the processing method of Example 10 of the present application.

[0031] Figure 5 Figure 10 is a surface debris adhesion profile of the sample haptic and optical zone of the A3 sample processed according to the processing method of Example 10 of the present application.

[0032] Figure 6 Figure 9 is a profile of the sample haptic of the A1 sample processed according to the processing method of Example 10 of the present application.

[0033] The object, functional characteristics and advantages of the present application will be further described with reference to the embodiments and the accompanying drawings. DETAILED DESCRIPTION

[0034] In order to make the object, technical solutions and advantages of the embodiments of the present application more clear, the technical solutions of the embodiments of the present application will be clearly and completely described below. If the specific conditions are not specified in the embodiments, the conventional conditions or the conditions suggested by the manufacturers are adopted. If the manufacturers of the reagents or instruments are not specified, the conventional products which can be purchased in the market are adopted. In addition, the meaning of "and / or" appearing in the whole text includes three parallel solutions. For example, "A and / or B" includes the solution of A, or the solution of B, or the solution of A and B. In addition, the technical solutions of each embodiment can be combined with each other, but it must be based on the premise that the person skilled in the art can realize it. When the combination of the technical solutions appears contradictory or unachievable, it should be considered that the combination of the technical solutions does not exist and is not within the protection scope of the present application. Based on the embodiments in the present application, all other embodiments obtained by the person skilled in the art without creative labor are within the protection scope of the present application.

[0035] Optical devices often need to ensure optical accuracy, intraocular lens is a typical medical optical device, which has fine optical design, high precision in manufacturing and high cleanliness of optical surface. First, in the processing process, the centering and rotation of the material need to be accurately controlled. Molding is a common way to construct the optical surface of the intraocular lens. After molding, the mechanical processing method is used to cut the required contour structure, and the finished product is obtained. Specifically: after molding, open the molding mold, the sample is attached to the inner surface of one side of the mold. In the process of milling the sample contour, two methods can be used. One is to peel the sample from the mold first, and then reattach it to a suitable base for machining. This method has the advantage of being able to choose a suitable base, but has problems in optical centering, which is not suitable for visual optical devices with precise optical requirements such as intraocular lenses. The second is to keep the sample on the mold and choose to place the mold with the attached sample in the processing position for machining, which can better ensure the optical parameters of the optical device and is more suitable for the processing of precise optical structures. However, the molding process usually uses a mold made of polyolefin composition, which has a relatively low surface energy and a small adhesion force to the sample. During machining, the sample is easily detached, displaced, and partially raised from the mold due to machine vibration and cooling fluid disturbance, leading to processing failure. In addition, soft intraocular lenses have a certain surface tackiness, and machining debris is easily attached to them, making subsequent cleaning difficult.

[0036] In view of this, the present application provides a stabilizing agent for stabilizing the connection between an intraocular lens semi-finished product and a hydrophobic mold, the stabilizing agent comprising an aqueous solution comprising an aqueous solution containing amphiphilic molecules and / or thickening molecules: the contact angle of the aqueous solution is 40°-76°, and the viscosity of the aqueous solution is 2-60 mPa·s.

[0037] In the technical solution of the present application, the stabilizing agent can be an aqueous solution containing amphiphilic molecules, an aqueous solution containing thickening molecules, or an aqueous solution containing both amphiphilic molecules and thickening molecules; limiting the contact angle of the stabilizing agent to 40°-76° can ensure that the stabilizing agent can form a relatively uniform liquid film at the interface between the soft intraocular lens semi-finished product made of hydrophobic polymer and the hydrophobic mold or on the surface of the soft intraocular lens semi-finished product; limiting the viscosity of the stabilizing agent to 2-60 mPa·s can ensure that it can form a gel or a solid substance that hardly flows after cooling, so as to tightly adhere the intraocular lens semi-finished product and the mold or firmly adhere the intraocular lens semi-finished product to the exposed surface of the intraocular lens semi-finished product. Simultaneously controlling the contact angle, viscosity, and low-temperature hardening temperature of the stabilizing agent within the above ranges can ensure that the stabilizing agent can form a relatively uniform and complete liquid film at the interface between the intraocular lens semi-finished product and the hydrophobic mold or on the surface of the soft intraocular lens semi-finished product, and the liquid film remains complete and does not break after the cooling treatment, and can tightly adhere to the surface of the coated hydrophobic material for protection.

[0038] It can be understood that the stabilizing agent can be an aqueous solution that is a liquid at room temperature and is a solid or viscous substance at a lower temperature, and the surface energy of the stabilizing agent is relatively low, and the stabilizing agent is easy to spread or adhere on the surface of the hydrophobic material at room temperature. Preferably, the stabilizing agent can form a uniform film layer on the surface of the hydrophobic intraocular lens semi-finished product.

[0039] Further, it can be understood that the mold is in a hard state at room temperature and is still in a hard state when frozen, and the output cold air temperature freezes the intraocular lens (below its glass transition temperature) and freezes the stabilizing agent during the processing.

[0040] It can be understood that limiting the cooling temperature to be lower than the low-temperature hardening temperature of the stabilizing agent and the glass transition temperature of the intraocular lens semi-finished product during processing can ensure that the stabilizing agent and the intraocular lens are completely hardened. The low-temperature hardening temperature in the present application refers to the temperature at which the liquid stabilizing agent begins to change into a gel or a solid as the temperature decreases.

[0041] In some embodiments, the amphiphilic molecule comprises one or more of stearic acid, sodium dodecyl benzene sulfonate, poloxamer, quaternary ammonium compound, fatty acid glyceride, fatty acid sorbitan, polysorbate. It can be understood that the amphiphilic molecule can be any one of stearic acid, sodium dodecyl benzene sulfonate, poloxamer, quaternary ammonium compound, fatty acid glyceride, fatty acid sorbitan, polysorbate, or two or more of stearic acid, sodium dodecyl benzene sulfonate, poloxamer, quaternary ammonium compound, fatty acid glyceride, fatty acid sorbitan, polysorbate, all of which are within the protection scope of the present application. Among them, the fatty acid sorbitan is also known as the commercial Span; the polysorbate is also known as the commercial Tween, including Tween 20 or Tween 60; the poloxamer is composed of the PEO-PPO-PEO triblock structure of polyethylene oxide (PEO) and polypropylene oxide (PPO); the quaternary ammonium compound is a kind of compound with four organic groups connected to a nitrogen atom. The above-mentioned amphiphilic molecules all have hydrophilic groups and hydrophobic groups, and can form a continuous liquid film at the interface between the hydrophobic intraocular lens semi-finished product and the mold at a certain concentration, which will not be broken after cooling, and has good adhesion.

[0042] In some embodiments, the thickening molecule comprises one or more of polyethylene glycol, polyvinyl alcohol, hydroxypropyl methyl cellulose, polyoxyethylene ether. It can be understood that the thickening molecule can be any one of polyethylene glycol, polyvinyl alcohol, hydroxypropyl methyl cellulose, polyoxyethylene ether, or two or more of polyethylene glycol, polyvinyl alcohol, hydroxypropyl methyl cellulose, polyoxyethylene ether, all of which are within the protection scope of the present application. Among them, the polyethylene glycol is a linear polymer polymerized from ethylene oxide, the polyvinyl alcohol is a synthetic resin made by alcoholysis reaction of polyvinyl acetate, and the polyoxyethylene ether refers to an ether compound containing ethylene oxide units. The above-mentioned thickening molecules can form a continuous liquid film at the interface between the hydrophobic intraocular lens semi-finished product and the mold at a certain degree of polymerization and concentration, which will not be broken after cooling, and has good adhesion.

[0043] In some embodiments, the stabilizing agent comprises an aqueous solution of amphiphilic molecules, and the concentration of the aqueous solution of amphiphilic molecules is 2% to 25%; or, the stabilizing agent comprises an aqueous solution of thickening molecules, and the concentration of the aqueous solution of thickening molecules is 10% to 20%.

[0044] The application also provides a method for assisting haptics processing of a soft intraocular lens, which is used for a mold-pressed sample of an intraocular lens semi-finished product partially not separated from a hydrophobic mold, and comprises the following steps: S1, coating the aforementioned stabilizing agent on at least the joint of the hydrophobic mold and the intraocular lens semi-finished product partially not separated from the hydrophobic mold; S2, performing a cooling treatment on the mold-pressed sample coated with the stabilizing agent, so that the intraocular lens semi-finished product is hardened and the coated stabilizing agent is hardened, to obtain a cooled mold-pressed sample; S3, performing haptics milling processing on the cooled mold-pressed sample, and performing cleaning on the mold-pressed sample after the haptics milling processing, to remove the stabilizing agent and haptics milling debris, remove the hydrophobic mold, and obtain an intraocular lens finished product.

[0045] In the technical scheme of the application, one side mold (male film) of a mold-pressed product is opened, an intraocular lens semi-finished product is attached to the other side mold (female film), and the aforementioned stabilizing agent is coated on the joint of the hydrophobic mold and the intraocular lens semi-finished product not separated from the hydrophobic mold, to obtain a mold-pressed sample coated with the stabilizing agent; then, the mold-pressed sample can be placed on a clamp (the clamp can effectively and directly clamp the female mold, and the female mold is attached to the intraocular lens semi-finished product), and then a cooling treatment is performed, so that the temperature of the intraocular lens semi-finished product is below the glass transition temperature and is hardened, the hardness is increased, subsequent haptics milling processing is facilitated, the viscosity of the coated stabilizing agent is reduced with cooling, and the joint of the mold and the intraocular lens semi-finished product is tightly adhered together, the stability of the mold-pressed sample is improved, and the probability of sample peeling off the mold or moving or locally warping in the mold in the subsequent machining process is reduced; the cooled mold-pressed sample can be machined through a conventional haptics milling processing program, the stabilizing agent can be removed together with haptics milling debris through cleaning, and then the mold is removed, to obtain a finished product. The method of the application comprises a stabilizing step and a cooling step, which is beneficial to machining, and the combination achieves the advantages of frozen non-injury, stable processing, and low cleaning residue, which are suitable for soft medical vision products such as intraocular lenses with thin and narrow structures.

[0046] In some embodiments, step S1 comprises: applying the aforementioned stabilizing agent to the interface between the hydrophobic mold and the intraocular lens semi-finished product, and the surface of the intraocular lens semi-finished product that is partially out of the hydrophobic mold. It can be understood that, in addition to the interface between the mold and the intraocular lens semi-finished product, the stabilizing agent can also be applied to the exposed surface of the intraocular lens semi-finished product (i.e., the portion out of the mold) to form a complete liquid film on the entire exposed surface and the interface, and then form a non-flowable film layer after cooling, which can tightly adhere to the mold and the intraocular lens semi-finished product, and isolate the gondola debris, so that the gondola debris is not directly adhered to the surface of the intraocular lens semi-finished product, thereby reducing the difficulty of subsequent cleaning, improving the processing efficiency and yield, and achieving the effect of cleaning without residue through physical isolation.

[0047] It should be noted that the liquid material with a lower temperature is directly sprayed to the processed part for cooling, which has the limitation that the liquid material may be infiltrated into the polymer material, which is not conducive to subsequent cleaning. Common cooling liquid materials generally use water as the main component. For polymer products with strong water absorption, material swelling may occur, which affects the processability. The gas is directly sprayed to the processed part by using compressed vortex refrigeration, and because of the particularity of the refrigeration mechanism, the impact force of the sprayed gas is often large, which may cause unstable material clamping or adhesion and large vibration of the fine processed part, which is not conducive to precision machining. The cooling effect of this method is related to the vortex structure and gas flow rate, and it is difficult to achieve instant controllable adjustment. In some embodiments, in step S2, the cooling treatment comprises spraying the mold pressing sample coated with the stabilizing agent with a mixed gas with a temperature of T, and the mixed gas comprises a mixture of dry air and inert gas; wherein T≤ the low-temperature hardening temperature of the stabilizing agent, and T< the glass transition temperature of the intraocular lens semi-finished product. It can be understood that the temperature of the mixed gas, i.e., the cooling temperature, should be lower than the glass transition temperature of the intraocular lens to ensure the hardening of the intraocular lens; at the same time, the temperature of the mixed gas should be lower than the temperature at which the stabilizing agent changes from a solution state to a gel state or a solid state, so that the stabilizing agent has a certain viscosity and does not flow or becomes a solid when the temperature decreases, and at the same time has a strong adhesion effect to resist the impact force of processing. Directly using liquid gas for spray cooling may damage the product or cause abnormal deformation due to a large temperature difference, and is only suitable for metal materials.

[0048] The mixed gas cooling method provided by the application has the following advantages:

[0049] (1) Buffering low temperatures and saving cooling media. Direct injection of liquefied inert gas results in too rapid cooling, resulting in uneven hot and cold temperatures in different parts of the cooled material, leading to greater internal stress and deformation, which is not conducive to maintaining the original properties of the material. Compared with liquid contact freezing, gas contact freezing of mixed cold air is more moderate, more conducive to uniform cooling and good processing of low thermal conductivity materials, and can also be more accurately controlled.

[0050] (2) The cooling airflow has low impact. The density of liquid is much greater than that of gas, so the impact of liquid cooling on the processed material is much greater. The gas for compressed vortex cooling needs to pass through a vortex tube to separate the low-temperature gas. Generally, compressed gas with a higher air pressure is used to separate it through a vortex tube to achieve the required cooling effect, which will also bring a large impact to the processed material. The refrigerant used in this method is a liquefied inert gas, which itself has a very low temperature. The "low-temperature atmosphere" exchanges heat with the dry air at room temperature and is driven and carried out together, which can easily make the processed material reach a low-temperature state. The required output airflow is kept gentle to meet the effect, which is very beneficial for the stable adhesion and stable processing of thin materials.

[0051] (3) Process Cleanliness. Intraocular lenses are a Class III ophthalmic medical device, and their production and manufacturing have strict cleanliness requirements. In addition, they are also a polymer. If water or other liquids are used for auxiliary processing, they are easily absorbed by them, causing the material to swell, thereby affecting precision processing and subsequent cleaning. In the present invention, what comes into contact with the processed material is dry air and inert gas. Both are non-toxic and harmless, do not infiltrate the material, and are easy to control manually. They will not cause swelling of the processed material and process contamination, and are very suitable for the processing of polymer medical products.

[0052] (4) The cooling temperature can be widely controlled. The freezing temperatures required for polymer materials with different degrees of softness are not the same. The method of the present invention has two main ways to control the cooling temperature: first, by selecting different liquid cooling media, differentiated freezing effects can be achieved. Under normal pressure, the liquefaction temperatures of common liquefiable inert gases vary greatly. For example, the liquid temperatures of helium, neon, argon, krypton, xenon, radon, and nitrogen are roughly between -100°C and -270°C. In particular, the lower limit of the freezing temperature can reach hundreds of degrees Celsius below zero, which is very beneficial to the freedom of adjusting the low temperature; second, as Figure 1 As shown, the refrigeration effect can be controlled by adjusting the input volume of external dry air through a pressure valve.

[0053] In some embodiments, the cooling process comprises jetting the molded sample coated with the stabilizing agent with mixed gas at a temperature T, wherein the T is -65 to -5℃, and the glass transition temperature of the intraocular lens semi-finished product is -5 to 15℃. It can be understood that when the glass transition temperature of the intraocular lens semi-finished product is between -5 to 15℃, controlling the temperature of the mixed gas in the above range can better ensure that the liquid film formed by the stabilizing agent is complete and does not flow, and at the same time the intraocular lens semi-finished product is better hardened.

[0054] In some embodiments, the flow rate of the mixed gas is 0.5 to 2.5 Nm 3 / min; and / or, the inert gas comprises one or more of helium, neon, argon, krypton, xenon, radon, and nitrogen. It can be understood that the flow rate of the mixed gas can be 0.5 Nm 3 / min, 1.5 Nm 3 / min, or 2.5 Nm 3 / min, and the mixed gas flow rate in the above range can ensure high cooling efficiency, the stabilizing agent and the sample are quickly frozen together, and the stabilizing agent film layer on the surface of the sample is relatively complete. The cooling speed can be instantaneously controlled and adjusted by controlling the flow rate of the mixed gas, which is beneficial for precision machining. The above-mentioned inert gas has good chemical stability, and its liquid state has a low temperature of below -80℃, so that the mixed gas at a temperature T can be obtained by directly mixing the liquefied inert gas with dry air at room temperature for heat exchange to cool the sample.

[0055] It should be noted that when the device shown in Figure 1 is used for gas mixing, the dry gas introduced from outside is a normal temperature gas, and the tank contains low-temperature liquefied inert gas. These low-temperature liquefied inert gases will continue to gasify when heated, but since the flow rate of the introduced gas is very small, the tank can slowly gasify for a long time (it takes several days to exhaust the liquid), so the output flow rate is slightly greater than or equal to the flow rate of the introduced gas.

[0056] In some embodiments, in step S3, the cleaning comprises ultrasonic cleaning or ultrasonic oscillation cleaning with water. Since the stabilizing agent is easily soluble in water, both ultrasonic cleaning and ultrasonic oscillation cleaning with water can quickly remove the stabilizing agent on the surface of the sample and the stabilizing agent adhered to the sample, which is not conducive to the visual function of the sample.

[0057] The present application also provides an intraocular lens comprising an intraocular lens processed by the method for processing the auxiliary soft intraocular lens haptic described above. Therefore, it has all the beneficial effects of the method for processing the auxiliary soft intraocular lens haptic described above, which will not be repeated here.

[0058] The technical solutions of the present application are further described in detail below in combination with specific embodiments and drawings. It should be understood that the following embodiments are only used to explain the present application and not used to limit the present application.

[0059] Example 1

[0060] A stabilizing agent, the component is a Tween 20 aqueous solution with a mass concentration of 5.0%.

[0061] Example 2

[0062] A stabilizing agent, the component is a Tween 20 aqueous solution with a mass concentration of 25.0%.

[0063] Example 3

[0064] A stabilizing agent, the component is a mixed aqueous solution of polyethylene glycol and polyvinyl alcohol (polyethylene glycol 2000 and polyvinyl alcohol 1788 type) with a mass ratio of 1:1, and the mass concentration of the mixed aqueous solution is 10.0%.

[0065] Example 4

[0066] A stabilizing agent, the component is a mixed aqueous solution of polyethylene glycol and polyvinyl alcohol (polyethylene glycol 2000 and polyvinyl alcohol 1788 type) with a mass ratio of 1:1, and the mass concentration of the mixed aqueous solution is 20.0%.

[0067] Example 5

[0068] A stabilizing agent, the component is a poloxamer aqueous solution with a mass concentration of 5.1% (poloxamer refers to poloxamer 188, purchased from Macklin Reagent Network).

[0069] Example 6

[0070] A stabilizing agent, the component is a poloxamer aqueous solution with a mass concentration of 3.1% (poloxamer refers to poloxamer 188, purchased from Macklin Reagent Network).

[0071] Example 7

[0072] A stabilizing agent, the component is a Brij 58 aqueous solution with a mass concentration of 7.4% (the average molecular weight of Brij 58 is 1124 Da, purchased from Reagent Network, produced by Saun Chemical Technology Co., Ltd. with batch number E5HRR2NU).

[0073] Example 8

[0074] A stabilizing agent, the component is a Brij 56 aqueous solution with a mass concentration of 2.2% (the average molecular weight of Brij 56 is 683 Da, purchased from Reagent Network, produced by Saun Chemical Technology Co., Ltd. with batch number EHR0RUR9).

[0075] Example 9

[0076] A method for assisting in processing of an intraocular lens haptics, for a partially un-molded intraocular lens semi-finished product without being removed from a polyolefin plastic mold, comprising the following steps:

[0077] S1, applying the stabilizing agent in Example 4 to the junction of the polyolefin plastic mold and the partially un-molded intraocular lens semi-finished product without being removed from the polyolefin plastic mold, and the surface of the partially un-molded intraocular lens semi-finished product without being removed from the hydrophobic mold;

[0078] S2, placing the molded sample coated with the stabilizing agent on a milling machine clamp, adjusting the mixed gas cooling device of dry air and liquid nitrogen, setting the mixed gas output flow rate to 0.99 Nm 3 / min, and cooling the molded sample coated with the stabilizing agent for 2 min to harden the intraocular lens semi-finished product and the coated stabilizing agent, to obtain a cooled molded sample;

[0079] S3, milling the haptics of the cooled molded sample, and ultrasonic cleaning the molded sample after milling the haptics with clean water to remove the stabilizing agent and milling debris, and removing the polyolefin plastic mold to obtain an intraocular lens finished product;

[0080] The schematic diagram of the cooling device is shown in Figure 1 The configuration method is as follows: a heat preservation tank with an inner cavity capacity of 20 liters is taken, liquid nitrogen is poured into it so that the liquid nitrogen occupies about 80% of the space in the inner cavity, and a input-output low-temperature resistant silicone tube and its accessory system are sleeved (the inner diameter of the silicone tube is 6 mm, the tube wall is 2 mm, the output silicone tube is sleeved with a heat preservation sleeve, the input silicone tube end is provided with a joint connected with a dry air pipe, the middle section of the input pipe is provided with a pressure valve, and the output pipe end is a specially designed oblique elliptical nozzle), the pipe joint is connected with the pipe of compressed dry air, and then the output end nozzle is spaced apart and placed at a distance of 1 cm from the molded sample.

[0081] Example 10

[0082] Compared with Example 9, the differences are as follows:

[0083] In step S2, the molded sample coated with the stabilizing agent is cooled by vortex air cooling.

[0084] Comparative Example 1

[0085] A stabilizing agent, the composition is a γ-cyclodextrin aqueous solution with a mass concentration of 15.3%.

[0086] Comparative Example 2

[0087] A stabilizing agent, which is composed of an aqueous solution of polyethylene glycol with a mass concentration of 18.0% (the molecular weight of the polyethylene glycol is 2000 Da).

[0088] Comparative Example 3

[0089] A stabilizing agent, which is composed of an aqueous solution of polyethylene glycol with a mass concentration of 9.1% (the molecular weight of the polyethylene glycol is 10000 Da).

[0090] Comparative Example 4

[0091] A stabilizing agent, which is composed of an aqueous solution of polyethylene glycol with a mass concentration of 9.9% (the molecular weight of the polyethylene glycol is 2000 Da).

[0092] Comparative Example 5

[0093] A stabilizing agent, which is composed of an aqueous solution of polyethylene glycol with a mass concentration of 9.1% (the molecular weight of the polyethylene glycol is 10000 Da).

[0094] Comparative Example 6

[0095] The difference between Comparative Example 6 and Example 9 is as follows:

[0096] Step S1 is not performed, and, in Step S2, the ice water direct spray cooling is used to cool the uncoated mold pressing sample without the stabilizing agent.

[0097] Performance test

[0098] 1. Soft intraocular lens material

[0099] A number of soft intraocular lens materials with different softness and hardness are prepared, which are composed of hydrophobic polymers (the component is a common acrylate polymer), and the parameters are shown in Table 1.

[0100] Table 1 Parameters of the soft intraocular lens materials to be processed

[0101] Material No. Glass transition temperature Elongation at break A1 -1.5℃ 51％ A2 5.1℃ 75％ A3 9.2℃ 43％ A4 13.6℃ 66％

[0102] 2. Comparison of the spreading of the stabilizing agent on the sample

[0103] (1) Contact angle detection: take a piece of soft intraocular lens material A2 sample obtained by mold pressing, place it horizontally on the experimental table, and drop the stabilizing agents of Examples 1-8 and Comparative Examples 1-5 on the surface of A2, respectively, and then use the contact angle measuring instrument (instrument model OCA15EC) of Dataphysics Company to measure the static contact angle of the liquid on the sample surface, and the results are shown in Table 2. Figure 2 and Table 2.

[0104] (2) Film formation detection: The stabilizing agent of Examples 1-8 and Comparative Examples 1-5 was taken respectively and dropped onto the surface of the A2 sample, and then the stabilizing agent on the surface of the A2 sample was coated with a soft brush, and the film formation of the stabilizing agent on the surface of the A2 sample was observed.

[0105] Table 2 Spreading of the stabilizing agent of Examples 1-8 and Comparative Examples 1-5 on the sample

[0106]

[0107]

[0108] As shown in Table 2, the results of the above-mentioned spreading test of different stabilizing agents on the surface of the A2 sample showed that in Comparative Example 2, the contact angle of water on the surface of the A2 sample was 85.4°, indicating that the A2 sample had strong hydrophobicity, and the coating test proved that water could not be coated into a film on the A2 sample. In contrast, the Examples all had relatively low contact angles, indicating that the solutes in the stabilizing agents in Examples 1-8 reduced the surface energy of water on the A2 sample, enabling it to spread better on the sample surface. Among them, Examples 1-8, the contact angle of the stabilizing agent on the surface of the A2 sample was reduced, and the solution had a certain consistency, and a relatively uniform and complete liquid film could be obtained by coating with a brush, i.e. the stabilizing agent was more suitable for being attached to the surface of the A2 material. In Comparative Examples 1, 3, 4 and 5, although the contact angle of water on the A2 sample was lower to some extent, the wettability was not enough to form an effective protective liquid film by coating.

[0109] Therefore, the above tests proved that by using a suitable stabilizing agent and adjusting the appropriate concentration and viscosity, a good liquid film could be formed on the surface of the soft intraocular lens material, and the liquid film could be frozen at a suitably low temperature, which created a prerequisite for the subsequent freezing, stabilization and debris isolation of the sample.

[0110] 3. Effect of cooling method on cooling effect

[0111] The cooling device described in Example 9 (as shown in Figure 1 ) was controlled for testing, the output gas flow rate of the output pipeline was adjusted by the pressure valve, and after the gas flow was stabilized, the constant temperature at 1 cm from the outlet of the jet was tested to simulate the distance of the sample from the outlet of the cold gas during reagent processing, and the gas flow rate and the corresponding constant temperature value were recorded. In addition, the same pipeline as the cooling device in Example 9 was used to test the cooling effect of the AIRTX vortex air cooling device, and the gas flow rate and the corresponding constant temperature value were recorded, and the results are shown in Table 3.

[0112] Table 3 Comparison of cooling effects of mixed cold gas and vortex air

[0113]

[0114] From the test of Table 3, it can be seen that: (1) the method of the present application can control the freezing outlet temperature to be between -53 and -8℃ under relatively mild air flow (i.e. lower gas flow), while the vortex air cooling device as a comparison can only reach a freezing outlet temperature of several tens of degrees below zero under a relatively large air flow, and there is a significant temperature lower limit gap; (2) from the size of the gas impact, the air flow impact force at the outlet of the method of the present application is much more moderate. Therefore, for soft intraocular lens materials with a glass transition temperature generally between several degrees below zero and fifteen degrees Celsius, the method can meet the requirements of the material for hardening under mild air flow impact, that is, the method has great advantages in processing operability.

[0115] 4. Auxiliary haptic processing

[0116] Four kinds of soft intraocular lens semi-finished products in Table 1 were selected as processing test objects, and the glass transition temperature of the semi-finished products to be processed was between -5 and 15℃. The greater the glass transition temperature, the harder the material is relatively, but overall, these materials are foldable soft materials at room temperature. The semi-finished product to be processed refers to an intraocular lens intermediate product with a complete intermediate optical zone and a peripheral haptic reserved area. The semi-finished product to be processed is in a mold pressing state of an intraocular lens semi-finished product that has not been completely removed from the polyolefin plastic mold (i.e. in a way that the sample is retained on one side of the mold) when the haptic processing test is performed. The adhesion stability of the semi-finished product during the auxiliary processing of Examples 9-10 and Comparative Example 6 and the state of the haptic after processing were observed; and after the intraocular lens after processing was ultrasonically cleaned with clean water, the sample was checked for debris adhesion, and the results are shown in Table 4.

[0117] Table 4 Effect of auxiliary processing of Examples 9-10 and Comparative Example 6

[0118]

[0119] From Table 4, it can be seen that: (1) in Examples 10 and Comparative Example 6, whether vortex air or ice water direct injection is used, relatively hard soft samples (A3, A4) are easily blown away or washed away, resulting in processing failure; for relatively soft soft samples (A1, A2), the sample may have a rough edge and a torn skin due to incomplete freezing, and it is difficult to balance the adhesion stability of the sample to the mold and the cooling effect, while the stable agent-mixed gas freezing combination method in Example 9 has good processing effect for soft intraocular lenses A1-A4 with different softness, which has good universality; (2) compared with Examples 10 and Comparative Example 6, the stable agent-mixed gas cooling combination method has excellent debris isolation effect.

[0120] As the above experiment proves, the stabilizing agent can maintain the stability of the sample processing process, and the stabilizing agent can form a complete liquid film on the surface of the intraocular lens material, which can well isolate the processing debris after freezing. The mixed cold gas freezing method has the advantages of low lower limit of freezing temperature and slow outlet gas, and the combination of the stabilizing agent and the mixed gas freezing method has good applicability for assisting the processing of the soft intraocular lens haptic.

[0121] Therefore, the combined method of the stabilizing agent and the mixed gas cooling provided by the present application has significant advantages, which can be summarized as two points: (1) It has more extensive freezing applicability for soft intraocular lens materials, and the impact on the materials is moderate, which is not easy to cause the sample to be detached from the mold during processing; (2) The debris isolation effect is good, which can effectively simplify the subsequent cleaning process of the sample and reduce the manufacturing cost.

[0122] The above is only the preferred embodiment of the present application, and does not limit the patent scope of the present application. For those skilled in the art, the present application can have various modifications and changes. Any modification, equivalent replacement, improvement, etc. within the spirit and principles of the present application shall be included in the patent protection scope of the present application.

Claims

1. A stabilizer for firmly connecting an intraocular lens semi-molded product and a hydrophobic mold, characterized in that: The stabilizer comprises an aqueous solution, and the aqueous solution comprises an aqueous solution containing amphiphilic molecules and / or thickening molecules: The contact angle of the aqueous solution is 40° to 76°, and the viscosity of the aqueous solution is 2 to 60 mPa·s.

2. The stabilizer according to claim 1, wherein The amphiphilic molecule includes one or more of stearic acid, sodium dodecylbenzenesulfonate, poloxamer, quaternary ammonium compounds, fatty acid glycerides, fatty acid sorbitan, and polysorbate; and / or, The thickening molecules include one or more of polyethylene glycol, polyvinyl alcohol, hydroxypropyl methylcellulose, and polyoxyethylene ether.

3. The stabilizer according to claim 1, wherein The stabilizer comprises an aqueous solution of amphiphilic molecules, and the concentration of the aqueous solution of amphiphilic molecules is 2% to 25%; or, The stabilizer comprises an aqueous solution of thickening molecules, and the concentration of the aqueous solution of the thickening molecules is 10% to 20%.

4. A method for assisting the processing of soft intraocular lens haptics, for molding a semi-molded intraocular lens product that has not partially escaped from a hydrophobic mold, characterized in that: The following steps are involved: S1. Applying the stabilizer according to any one of claims 1 to 3 to at least the junction between the hydrophobic mold and the portion of the intraocular lens semi-molded product that has not escaped from the hydrophobic mold; S2, cooling the molded sample coated with the stabilizer to harden the semi-molded intraocular lens product and the coated stabilizer, thereby obtaining a cooled molded sample; S3. Performing milling haptic processing on the cooled molded sample, and cleaning the molded sample after milling haptic processing to remove the stabilizer and milling haptic debris, and removing the hydrophobic mold to obtain an intraocular lens finished product.

5. The method for assisting soft intraocular lens haptic processing according to claim 4, wherein: Step S1 includes: The stabilizer according to any one of claims 1 to 3 is applied to the junction between the hydrophobic mold and the intraocular lens semi-molded product, and to the surface of the intraocular lens semi-molded product that is partially released from the hydrophobic mold.

6. The method for assisting soft intraocular lens haptic processing according to claim 4, wherein: In step S2, the cooling process includes spraying the molded sample coated with the stabilizer with a mixed gas at a temperature T, wherein the mixed gas includes a mixture of dry air and an inert gas; Wherein, T≤the low-temperature curing temperature of the stabilizer, and T<the glass transition temperature of the semi-molded intraocular lens product.

7. The method for assisting soft intraocular lens haptic processing according to claim 6, wherein: The cooling process includes spraying the molded sample coated with the stabilizer with a mixed gas at a temperature T through air; and / or, The T is -65 to -5°C, and the glass transition temperature of the semi-molded intraocular lens product is -5 to 15°C.

8. The method for assisting soft intraocular lens haptic processing according to claim 6, wherein: The flow rate of the mixed gas is 0.5-2.5 Nm 3 / min; and / or, The inert gas includes one or more of helium, neon, argon, krypton, xenon, radon, and nitrogen.

9. The method for assisting soft intraocular lens haptic processing according to claim 4, wherein: In step S3, the cleaning includes ultrasonic cleaning or ultrasonic oscillation cleaning with water.

10. An artificial lens, characterized in that: The invention comprises an intraocular lens manufactured by the method for assisting soft intraocular lens haptic processing as claimed in any one of claims 4 to 9.

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