Intraocular pressure monitoring contact lens and preparation method thereof

Abstract

The invention discloses an intraocular pressure monitoring contact lens and a preparation method thereof. The intraocular pressure monitoring contact lens comprises a packaging layer, a sensing layer and a lens layer which are arranged in sequence, the sensing layer comprises a spiral-line-shaped sensing electrode which is embedded in the glasses layer, and the side face, facing the packaging layer, of the sensing layer is tightly attached to the packaging layer; the sensing layer is prepared from the following raw materials in parts by mass: 63.5 to 80 parts of resin, 15 to 30 parts of conductive filler, 0.5 to 3 parts of initiator and 1.5 to 3.5 parts of diluent; the outer side surface of the glasses layer is in contact with eyeballs, and the inner side surface is tightly attached to the sensing layer and the packaging layer. The spiral-line-shaped sensing layer has the characteristics of a conductive coil, wireless access to an induction electrode in the contact lens can be achieved through an external coupling coil according to the inductive coupling principle, the equivalent inductance change of the induction electrode is reversely deduced through the resonant frequency, and then the change of an intraocular pressure signal is deduced. Meanwhile, the intraocular pressure monitoring contact lens disclosed by the invention is improved in the aspects of optical indexes, material physical and chemical indexes, biological safety indexes and the like of functional contact lenses.

Description

Technical Field

[0001] The present invention relates to the technical field of contact lenses, in particular to an intraocular pressure monitoring contact lens and a preparation method thereof. Background Art

[0002] Intraocular pressure, as an important physiological parameter, plays a key role in maintaining the shape of the eyeball, maintaining normal physiological functions, and ensuring the optical performance of refractive media, and must be stabilized within a certain range. Currently, the mainstream intraocular pressure testing methods used in clinical practice are the Goldmann applanation tonometer and the non-contact air puff tonometer. These methods require large detection equipment and professional medical staff and cannot provide continuous intraocular pressure monitoring.

[0003] Since contact lenses conform to the cornea, and existing research has shown that there is a close relationship between corneal microstrain and intraocular pressure, using microstrain sensor devices integrated in contact lenses for intraocular pressure measurement has become a key research direction for the development of new tonometers in recent years. At present, there is still a blank in domestic intraocular pressure monitoring products based on contact lenses, and there is only one international intelligent contact lens Triggerfish based on a microstrain gauge. However, Triggerfish uses a rigid MEMS circuit for continuous intraocular pressure monitoring and has many problems in terms of wearing comfort, lens thickness, manufacturing cost, circuit battery life, etc., so it has not entered the domestic market.

[0004] The development of flexible electronics technology provides a very rare opportunity for the technological iteration of continuous intraocular pressure monitoring contact lenses. By designing flexible sensor devices on the surface of contact lenses, continuous intraocular pressure monitoring becomes possible. Currently, intraocular pressure monitoring contact lenses based on flexible electronics technology have begun to be studied. However, there are still many problems in existing research results in terms of biosecurity, wearing comfort, and industrial production. Summary of the Invention

[0005] The purpose of the present invention is to provide an intraocular pressure monitoring contact lens and a preparation method thereof, which can realize intraocular pressure monitoring and improve the optical index, material physical and chemical index, biosecurity index, etc. of functional contact lenses. The technical solution adopted by the present invention is as follows.

[0006] On the one hand, the present invention provides an intraocular pressure monitoring contact lens, which includes a packaging layer, a sensing layer, and a lens layer arranged in sequence;

[0007] The sensing layer includes a spiral induction electrode, which is embedded in the lens layer, and one side surface thereof facing the packaging layer is closely attached to the packaging layer; 63.5 - 80 parts of resin, 15 - 30 parts of conductive filler, 0.5 - 3 parts of initiator, and 1.5 - 3.5 parts of diluent;

[0008] The outer side of the spectacle layer is used to contact the eyeball, and the inner side is closely attached to the sensing layer and the encapsulation layer.

[0009] In the above technical solution, the raw materials and their ratios of the sensing layer can be combined well with the transfer printing technology, so as to realize the sensing layer between the spectacle layer and the encapsulation layer. While ensuring the comfort of the contact lens, the sensing layer also has a relatively stable structure and excellent sensing performance.

[0010] When the present invention is applied, the spiral-shaped induction electrode has the characteristics of an inductor coil, and can realize wireless access to the coil of the sensing layer inside the contact lens by the principle of inductive coupling through an external coupling coil. When the intraocular pressure changes, the shape of the sensing layer coil will change accordingly, thereby causing a change in the overall equivalent inductance of the coil, and then a change in the resonant frequency of the sensing layer coil. At this time, the external coupling circuit can detect this resonant frequency, and then the equivalent inductance of the sensing layer coil can be deduced, and finally the change of the intraocular pressure signal can be deduced. The relationship between the equivalent inductance of the sensing layer coil and the intraocular pressure can be pre-fitted.

[0011] Optionally, the mass ratio of the encapsulation layer, the sensing layer and the spectacle layer is: spectacle layer 70% - 95%, sensing layer 1% - 10%, encapsulation layer 1% - 29%.

[0012] Optionally, the spectacle layer and the encapsulation layer are made of hydrogel material or silicone hydrogel material as raw materials;

[0013] Among the raw materials of the sensing layer, the resin uses bisphenol epoxy resin; the conductive filler uses one or a mixture of silver, gold, copper, carbon nanotubes, graphene, gallium indium alloy; the initiator uses one or a mixture of benzoyl peroxide, cumene hydroperoxide, methyl ethyl ketone peroxide, tert-butyl peroxybenzoate; the diluent uses one or a mixture of sodium chloride aqueous solution, deionized water, hydrolyzed lactalbumin solution. Among them, bisphenol epoxy resin can provide appropriate viscosity so that the conductive material in the sensing layer can be transferred between the encapsulation layer and the spectacle layer by transfer printing technology, ensuring the stability of the patterned structure of the spiral electrode during the transfer process, thereby ensuring the reliability of the intraocular pressure monitoring function of the finished intraocular pressure monitoring contact lens.

[0014] Optionally, the contact lens body includes a central region corresponding to the pupil position and a peripheral region outside the central region; the sensing layer includes one of the induction electrodes, and the induction electrode is spirally arranged in the peripheral region of the contact lens body, and the central blank region thereof coincides with the central region of the contact lens body. In addition, two nested induction electrodes can also be set in the sensing layer. However, relatively speaking, the case of a single induction electrode not only has a simpler structure and preparation process, but also has a simpler inference logic for the monitoring results.

[0015] Optionally, in the sensing electrode, the number of turns of the spiral is 1 to 6 turns, the inner diameter of the innermost turn is 2 to 8 mm, the distance between adjacent turns is 0.05 to 1 mm, the width of the spiral is 0.05 to 2.5 mm, and the thickness is 5 to 30 μm. This structural design can generally adapt to the general pupil size, ensure no obstruction to the line of sight, and at the same time have a high sensitivity to intraocular pressure changes.

[0016] Optionally, the total thickness of the encapsulation layer, the sensing layer, and the spectacle layer is 50 to 180 μm, the thickness of the spectacle layer is 40 to 130 μm, the thickness of the sensing layer is 5 to 30 μm, and the thickness of the encapsulation layer is 5 to 40 μm. This size combination can ensure excellent biocompatibility and use comfort, and does not affect the reading of the signal of the sensing layer.

[0017] In a second aspect, the present invention provides a method for preparing the intraocular pressure monitoring contact lens described in the first aspect, including:

[0018] S1, injecting or dropping a hydrogel material or a silicone hydrogel material for preparing the encapsulation layer into a contact lens mold, and performing cold treatment, heat treatment, or light treatment to obtain the encapsulation layer in the mold;

[0019] S2, mixing the raw materials for preparing the sensing layer evenly to obtain conductive ink;

[0020] S3, dropping or injecting the conductive ink obtained in S2 into the patterned grooves on a transfer steel plate, and the pattern of the grooves corresponds to the shape of the sensing layer;

[0021] S4, transferring the patterned conductive ink onto the encapsulation layer in a concave mold, and after drying, obtaining the sensing layer;

[0022] S5, injecting or dropping a hydrogel material or a silicone hydrogel material for preparing the spectacle layer into the concave mold, sealing it with a convex mold, and then performing heat curing or light curing treatment, and peeling off the convex mold and the concave mold to obtain a dry intraocular pressure monitoring contact lens.

[0023] Optionally, the above preparation method further includes step S6, performing a hydration treatment on the dry intraocular pressure monitoring contact lens, and sterilizing the hydrated intraocular pressure monitoring contact lens. Thus, a sterile contact lens product can be obtained.

[0024] Optionally, in step S1, the time of the cold treatment is 5 to 120 s, and the wind speed is 20 to 100 m / s; the time of the heat treatment is 10 to 120 min, and the temperature is 50 to 125 °C; the time of the light treatment is 5 to 300 s, and the light intensity is 30 to 450 mW / cm 2 ;

[0025] In step S4, the time for the drying treatment is 5 - 600 min, and the temperature is 30 - 100 °C;

[0026] In step S5, the time for the thermal curing is 1 - 40 h, and the temperature is 50 - 125 °C; the time for the light curing is 10 - 600 s, and the light intensity is 30 - 450 mW / cm 2 .

[0027] Beneficial effects

[0028] By arranging a sensing layer spiral induction electrode between the lens layer and the encapsulation layer, the intraocular pressure monitoring contact lens of the present invention can achieve continuous detection of intraocular pressure. The formula of the sensing layer induction electrode can be combined with the transfer printing technology to ensure the structural stability of the induction electrode during the preparation process and the performance stability and sensitivity after the preparation is completed. The contact lens body has excellent biocompatibility and wearing comfort. At the same time, the preparation method of the contact lens conforms to the current process of contact lens production and can realize mass production on the production line.

[0029] Through experimental detection, the intraocular pressure monitoring contact lens can meet the needs of conventional intraocular pressure detection. Its optical indexes, appearance indexes, material physical and chemical indexes, biological safety indexes, and mass production and other indexes meet or are close to those of the currently commercial contact lenses, and it has the prospect of industrial application. Description of the drawings

[0030] Figure 1 Shown is the equivalent planar inductance coil model of the induction electrode in the intraocular pressure monitoring contact lens of the present invention;

[0031] Figure 2 Shown is the equivalent RLC circuit diagram between the intraocular pressure monitoring contact lens containing the induction electrode as the sensing end and the peripheral circuit of the detection end;

[0032] Figure 3 Shown is the schematic diagram of the physical object of the intraocular pressure monitoring contact lens in Example 3 - 1;

[0033] Figure 4 Shown is the schematic diagram of the physical object of the intraocular pressure monitoring contact lens in Example 3 - 2;

[0034] Figure 5 Shown is the SEM cross - sectional photo of the intraocular pressure monitoring contact lens in Example 3 - 1;

[0035] Figure 6 (a) and Figure 6 (b) are respectively the schematic diagrams of the wavelength - transmittance curves of Example 3 - 1 and Example 3 - 2;

[0036] Figure 7 (a) and Figure 7(b) show the schematic diagrams of the contact angles of Example 3-1 and Example 3-2 respectively;

[0037] Figure 8 (a) and Figure 8 (b) show the tensile property test interface diagrams of Example 3-3 and Example 3-4 respectively;

[0038] Figure 9 (a) and Figure 9 (b) show the schematic diagrams of the intraocular pressure-frequency curves of Example 3-5 and Example 3-6 respectively;

[0039] Figure 10 (a) and Figure 10 (b) show the schematic diagrams of the sensing linearity curves of Example 3-7 and Example 3-8 respectively. Detailed implementation manners

[0040] The technical concept of the present invention is as follows: to solve many problems existing in the existing intraocular pressure monitoring products in terms of use comfort and industrial production, etc., a continuous intraocular pressure monitoring contact lens is developed. Through the design of the raw material ratio of a specific sensing layer, it can utilize the current mature colored contact lens transfer printing process, so as to prepare a continuous intraocular pressure monitoring contact lens with high biocompatibility, high comfort and the prospect of industrial production.

[0041] The following is further described in conjunction with the accompanying drawings and specific embodiments.

[0042] Example 1

[0043] This example introduces an intraocular pressure monitoring contact lens. Referring to Figure 1 、 Figure 3 and Figure 4 , it includes a packaging layer, a sensing layer and a lens layer which are arranged in sequence; the sensing layer includes a spiral-shaped induction electrode which is embedded in the lens layer, and one side surface thereof facing the packaging layer is closely attached to the packaging layer; the sensing layer includes the following raw materials in parts by mass: 63.5 - 80 parts of resin, 15 - 30 parts of conductive filler, 0.5 - 3 parts of initiator, and 1.5 - 3.5 parts of diluent; the outer side surface of the lens layer is used to contact the eyeball, and the inner side surface is closely attached to the sensing layer and the packaging layer.

[0044] The intraocular pressure monitoring contact lens of this example is designed based on the principle of inductive coupling. The spiral-shaped sensing layer has the characteristics of an inductance coil. Through an external coupling coil, the sensing layer coil encapsulated inside the contact lens can be accessed wirelessly, and then the radio frequency signal of the resonant system is converted into an electrical signal and transmitted to the terminal by using a communication module, and then the real-time value of the intraocular pressure can be obtained. For the specific principle, refer to the equivalent circuit shown in Figure 2 , and the explanation is as follows.

[0045] For a typical planar spiral inductor, its inductance can be approximately obtained by the following formula:

[0046]

[0047] where K1 and K2 are constants, μ0 is the magnetic permeability of vacuum, n is the number of turns of the spiral, is the average diameter of the coil,

[0048] is the graphic filling ratio.

[0049] When the intraocular pressure increases, the shape of the cornea expands, and the contact lens attached to the cornea is radially stretched, causing the shape of the inductance coil of the sensing layer encapsulated inside the contact lens to become larger. In an ideal state, the number of turns of the coil remains unchanged, and the inner diameter and outer diameter increase in proportion, so that d avg becomes larger, while ρ, n and other constants remain unchanged, thus increasing the overall equivalent inductance of the device.

[0050] Figure 2 The total impedance of the equivalent RLC circuit is:

[0051]

[0052] R, L, and C are the equivalent resistance, inductance of the spiral induction electrode, and the equivalent inductive capacitance between the coils respectively; when the RLC circuit resonates, the total impedance of the circuit is the smallest, and at this time the inductive reactance and the capacitive reactance are equal. Therefore, the resonance frequency can be calculated as:

[0053]

[0054] When the equivalent inductance of the circuit increases, the resonance frequency tends to shift to a lower frequency. According to the obtained resonance frequency, the equivalent inductance of the sensing layer coil can be deduced inversely, and then the value of the intraocular pressure can be obtained.

[0055] Example 1-1

[0056] Based on the structure of Example 1 above, in this example, the mass ratio of the encapsulation layer, the sensing layer, and the spectacle layer is: spectacle layer 70% - 95%, sensing layer 1% - 10%, encapsulation layer 1% - 29%;

[0057] The spectacle layer and the encapsulation layer are made of lens materials such as hydrogel materials or silicone hydrogel materials as raw materials;

[0058] In the raw materials of the sensing layer, the resin uses bisphenol epoxy resin, such as C 15 H 16O2 resin; the conductive filler is one or a mixture of silver, gold, copper, carbon nanotubes, graphene, and gallium indium alloy; the initiator is one or a mixture of benzoyl peroxide, cumene hydroperoxide, methyl ethyl ketone peroxide, and tert-butyl peroxybenzoate; the diluent is one or a mixture of aqueous sodium chloride solution, deionized water, and hydrolyzed milk protein solution.

[0059] Among them, bisphenol epoxy resin can provide appropriate viscosity, enabling the conductive material in the sensing layer to be transferred between the encapsulation layer and the lens layer by using the existing colored contact lens transfer technology, and ensuring the stability of the patterned structure of the spiral electrode during the transfer process, thus guaranteeing the reliability of the intraocular pressure monitoring function of the finished intraocular pressure monitoring contact lens.

[0060] Reference Figure 3 and Figure 4 The contact lens body includes a central region corresponding to the pupil position and a peripheral region outside the central region; the sensing layer of this embodiment includes one such induction electrode, which is spirally arranged in the peripheral region of the contact lens body, and the central blank region thereof coincides with the central region of the contact lens body.

[0061] Two nested induction electrodes can also be provided in the sensing layer, which can also achieve intraocular pressure monitoring. However, relatively speaking, the case of a single induction electrode not only has a simpler structure and preparation process, but also has a more simplified reasoning logic for the monitoring results.

[0062] In the sensing layer of this embodiment, the number of turns of the spiral of the induction electrode is 1 to 6 turns, the inner diameter of the innermost turn is 2 to 8 mm, the distance between adjacent turns is 0.05 to 1 mm, the width of the spiral is 0.05 to 2.5 mm, and the thickness is 5 to 30 μm. The total thickness of the encapsulation layer, sensing layer, and lens layer is 50 to 180 μm, the thickness of the lens layer is 40 to 130 μm, the thickness of the sensing layer is 5 to 30 μm, and the thickness of the encapsulation layer is 5 to 40 μm.

[0063] It has been found through research that the number of turns, inner diameter, distance between adjacent turns, and electrode width (width of the spiral) of the induction coil in the sensing layer are positively correlated with the monitoring sensitivity of the induction electrode, and the thickness has a certain impact on the thickness of the overall contact lens and the difficulty of the preparation process. The advantages of the design of each part parameter of the sensing layer coil in this embodiment are as follows: avoiding the induction electrode from affecting the line of sight, ensuring excellent induction monitoring performance, having a small difficulty in forming and transfer operations, and having a small impact on the thickness design of the overall contact lens, so that the finished contact lens can have good biocompatibility and wearing comfort.

[0064] Example 2

[0065] This embodiment describes the preparation method of the intraocular pressure monitoring contact lens in Embodiment 1 and Embodiment 1-1, including:

[0066] S1, Inject or drop the hydrogel material or silicone hydrogel material for preparing the encapsulation layer into the concave die mold of the contact lens, seal it with the convex die, and then perform cold treatment, heat treatment or light treatment to obtain the encapsulation layer placed in the concave die mold;

[0067] S2, Mix the raw materials for preparing the sensing layer evenly to obtain conductive ink;

[0068] S3, Drop or inject the conductive ink obtained in S2 into the patterned grooves on the transfer steel plate, and the pattern of the grooves corresponds to the shape of the sensing layer;

[0069] S4, Transfer the patterned conductive ink in the patterned grooves to the encapsulation layer in the concave die mold, and after drying, the inner and outer surfaces of the concave die mold are covered with the encapsulation layer of the sensing layer;

[0070] S5, Inject or drop the hydrogel material or silicone hydrogel material for preparing the lens layer into the concave die mold, seal it with the convex die, and then perform heat curing or light curing treatment, remove the convex die and the concave die to obtain the dry sheet of the intraocular pressure monitoring contact lens;

[0071] In this embodiment, in step S1, the time of the cold treatment is 5-120 s, and the wind speed is 20-100 m / s; the time of the heat treatment is 10-120 min, and the temperature is 50-125 °C; the time of the light treatment is 5-300 s, and the light intensity is 30-450 mW / cm 2 ; in step S4, the time of the drying treatment is 5-600 min, and the temperature is 30-100 °C; in step S5, the time of the heat curing is 1-40 h, and the temperature is 50-125 °C; the time of the light curing is 10-600 s, and the light intensity is 30-450 mW / cm 2 .

[0072] Combining the above Embodiment 1 and Embodiment 2, the following gives a series of specific examples of the preparation process of the intraocular pressure monitoring contact lens through Embodiment 3.

[0073] Embodiment 3

[0074] Embodiment 3-1

[0075] The intraocular pressure monitoring contact lens of this embodiment is composed of the following raw materials in weight percentage: 70% lens layer, 1% sensor layer, and 29% packaging layer; wherein the lens layer is a commercial hydrogel lens material; the sensor layer is composed of the following raw materials in mass parts: 70 parts of bisphenol epoxy resin, 26 parts of silver element, 0.5 parts of tert-butyl perbenzoate, and 3.5 parts of 0.9% sodium chloride solution; the packaging layer is a commercial hydrogel lens material.

[0076] Step 1: Material preparation: weigh the corresponding mass of raw materials according to the above formula, and prepare the concave mold, the convex mold, the transfer rubber head and the patterned transfer steel plate;

[0077] Step 2: preparing the encapsulation layer: injecting 15 μL of the hydrogel lens material into the concave mold, sealing it with a convex mold, curing it in an oven at 50° C. for 120 min, taking out the mold and removing the convex mold to obtain the encapsulation layer in the concave mold;

[0078] Step 3: preparing conductive ink: mixing bisphenol epoxy resin, silver, tert-butyl perbenzoate, and 0.9% sodium chloride solution for 5 hours to form a uniform mixed solution to obtain conductive ink;

[0079] Step 4: Prepare the sensing layer: drip the prepared conductive ink onto the patterned transfer steel plate, use a scraper to scrape the conductive ink into the patterned grooves, scrape off the excess ink with the scraper, use a transfer rubber head to transfer the patterned conductive ink to the concave mold containing the encapsulation layer, dry it in an oven at 100°C for 5 minutes, and obtain the sensing layer attached to the encapsulation layer in the concave mold; wherein the pattern on the transfer steel plate corresponds to the coil pattern of the sensing electrode;

[0080] Step 5: Prepare the lens layer: inject 35 μL of hydrogel lens material into the concave mold of the existing sensing layer and encapsulation layer obtained in step 4, seal it with a convex mold, and cure it in an oven at 50°C for 40 hours, take out the mold and remove the convex mold, take the contact lens out of the concave mold, and obtain the intraocular pressure monitoring contact lens dry sheet;

[0081] Step 6: Post-processing: Hydrate, sterilize and package the intraocular pressure monitoring contact lens to obtain a hydrogel intraocular pressure monitoring contact lens, such as Figure 3 .

[0082] Example 3-2

[0083] The intraocular pressure monitoring contact lens of this embodiment is composed of the following raw materials in weight percentage: 75% lens layer, 10% sensor layer, and 15% packaging layer; wherein the lens layer is a commercial silicone hydrogel lens material; the sensor layer is composed of the following raw materials in mass parts: 80 parts of bisphenol epoxy resin, 15 parts of silver element, 2.5 parts of tert-butyl perbenzoate, and 2.5 parts of 0.5% hydrolyzed milk protein solution; the packaging layer is a commercial silicone hydrogel lens material.

[0084] Step 1: Material preparation: weigh the corresponding mass of raw materials according to the above formula, and prepare the concave mold, the convex mold, the transfer rubber head and the patterned transfer steel plate;

[0085] Step 2: preparing the encapsulation layer: dripping 4 μL of silicone hydrogel lens material into the concave mold, and sealing with a convex mold, curing in an oven at 125° C. for 10 min, taking out the mold and removing the convex mold, to obtain the encapsulation layer in the concave mold;

[0086] Step 3: preparing conductive ink: mixing bisphenol epoxy resin, silver, tert-butyl peroxybenzoate, and 0.5% hydrolyzed milk protein solution for 5 hours to form a uniform mixed solution to obtain conductive ink;

[0087] Step 4: Prepare the sensing layer: drip the prepared conductive ink onto the patterned transfer steel plate, use a scraper to scrape the conductive ink into the patterned grooves, scrape off the excess ink with the scraper, use a transfer rubber head to transfer the patterned conductive ink to the concave mold containing the encapsulation layer, dry it in an oven at 30°C for 600 minutes, and obtain the sensing layer attached to the encapsulation layer in the concave mold;

[0088] Step 5: preparing the lens layer: injecting 20 μL of silicone hydrogel lens material into the concave mold with the sensing layer in step 4, and sealing it with a convex mold, curing it in an oven at 125° C. for 1 h, taking out the mold and removing the convex mold, taking the contact lens out of the concave mold, and obtaining the intraocular pressure monitoring contact lens dry sheet;

[0089] Step 6: Post-processing: Hydrate, sterilize and package the intraocular pressure monitoring contact lenses to obtain silicone hydrogel intraocular pressure monitoring contact lenses, such as Figure 4 .

[0090] Example 3-3

[0091] The intraocular pressure monitoring contact lens of this embodiment is composed of the following raw materials in weight percentage: 88% lens layer, 5% sensor layer, and 7% packaging layer; wherein the lens layer is a commercial hydrogel lens material; the sensor layer is composed of the following raw materials in parts by weight: 63.5 parts of bisphenol epoxy resin, 30 parts of carbon nanotubes, 3 parts of isopropylbenzene hydroperoxide, and 3.5 parts of deionized water; the packaging layer is a commercial hydrogel lens material.

[0092] Step 1: Material preparation: weigh the corresponding mass of raw materials according to the above formula, and prepare the concave mold, the convex mold, the transfer rubber head and the patterned transfer steel plate;

[0093] Step 2: Prepare the encapsulation layer: drip 3 μL of hydrogel lens material into the concave mold, seal it with a convex mold, dry it for 5 seconds at a wind speed of 100 m / s with a cold air blower, take out the mold and remove the convex mold to obtain the encapsulation layer in the concave mold;

[0094] Step 3: preparing conductive ink: mixing bisphenol epoxy resin, carbon nanotubes, cumene hydroperoxide, and deionized water for 5 hours to form a uniform mixed solution to obtain conductive ink;

[0095] Step 4: Prepare the sensing layer: drip the prepared conductive ink onto the patterned transfer steel plate, use a scraper to scrape the conductive ink into the patterned grooves, scrape off the excess ink with the scraper, use a transfer rubber head to transfer the patterned conductive ink to the concave mold containing the encapsulation layer, and cure it in an oven at 80°C for 100 minutes to obtain the sensing layer attached to the encapsulation layer in the concave mold;

[0096] Step 5: preparing the lens layer: dripping 40 μL of the hydrogel lens material into the concave mold with the sensing layer in step 4, and sealing it with a convex mold, curing it in an oven at 80° C. for 32 hours, taking out the mold and removing the convex mold, taking the contact lens out of the concave mold, and obtaining the intraocular pressure monitoring contact lens dry sheet;

[0097] Step 6: Post-processing: hydrating, sterilizing and packaging the intraocular pressure monitoring contact lenses to obtain hydrogel intraocular pressure monitoring contact lenses.

[0098] Embodiment 3-4

[0099] The intraocular pressure monitoring contact lens of this embodiment is composed of the following raw materials in weight percentage: 90% lens layer, 4% sensor layer, and 6% packaging layer; wherein the lens layer is a commercial silicone hydrogel lens material; the sensing layer is composed of the following raw materials in mass parts: 78 parts of bisphenol epoxy resin, 17 parts of copper element, 2 parts of isopropylbenzene hydroperoxide, and 3 parts of 0.5% hydrolyzed milk protein solution; the packaging layer is a commercial silicone hydrogel lens material.

[0100] Step 1: Material preparation: weigh the corresponding mass of raw materials according to the above formula, and prepare the concave mold, the convex mold, the transfer rubber head and the patterned transfer steel plate;

[0101] Step 2: Prepare the encapsulation layer: drip 2 μL of silicone hydrogel lens material into the concave mold, seal it with a convex mold, dry it for 120 seconds at a wind speed of 20 m / s with a cold air blower, take out the mold and remove the convex mold to obtain the encapsulation layer in the concave mold;

[0102] Step 3: preparing conductive ink: mixing bisphenol epoxy resin, copper element, cumene hydroperoxide, and 0.5% hydrolyzed milk protein solution for 5 hours to form a uniform mixed solution to obtain conductive ink;

[0103] Step 4: Prepare the sensing layer: drip the prepared conductive ink onto the patterned transfer steel plate, use a scraper to scrape the conductive ink into the patterned grooves, scrape off the excess ink with the scraper, use a transfer rubber head to transfer the patterned conductive ink to the concave mold containing the encapsulation layer, and dry it in an oven at 100°C for 5 minutes to obtain the sensing layer attached to the encapsulation layer in the concave mold;

[0104] Step 5: Prepare the lens layer: Inject 30 μL of silicone hydrogel lens material into the concave mold with the sensor layer in step 4 and seal it with a convex mold. The UV light intensity is 450 mW / cm 2 The mold is then cured for 10 seconds, and the convex mold is removed, and the contact lens is removed from the concave mold to obtain the intraocular pressure monitoring contact lens dry sheet;

[0105] Step six: post-processing: hydrating, sterilizing and packaging the intraocular pressure monitoring contact lenses to obtain silicone hydrogel intraocular pressure monitoring contact lenses.

[0106] Embodiment 3-5

[0107] The intraocular pressure monitoring contact lens of this embodiment is composed of the following raw materials in weight percentage: 92% lens layer, 3% sensor layer, and 5% packaging layer; wherein the lens layer is a commercial hydrogel lens material; the sensor layer is composed of the following raw materials in parts by weight: 66 parts of bisphenol epoxy resin, 30 parts of graphene, 2.5 parts of methyl ethyl ketone peroxide, and 1.5 parts of 0.9% sodium chloride solution; the packaging layer is a commercial hydrogel lens material.

[0108] Step 1: Material preparation: weigh the corresponding mass of raw materials according to the above formula, and prepare the concave mold, the convex mold, the transfer rubber head and the patterned transfer steel plate;

[0109] Step 2: Prepare the encapsulation layer: drip 3 μL of hydrogel lens material into the concave mold and seal it with the convex mold. The UV light intensity is 30 mW / cm 2 After curing for 300 seconds, the mold is taken out and the male mold is removed to obtain the encapsulation layer in the female mold;

[0110] Step 3: preparing conductive ink: mixing bisphenol epoxy resin, graphene, methyl ethyl ketone peroxide, and 0.9% sodium chloride solution for 5.5 hours to form a uniform mixed solution to obtain conductive ink;

[0111] Step 4: Prepare the sensing layer: drip the prepared conductive ink onto the patterned transfer steel plate, use a scraper to scrape the conductive ink into the patterned grooves, scrape off the excess ink with the scraper, use a transfer rubber head to transfer the patterned conductive ink to the concave mold containing the encapsulation layer, and dry it in an oven at 95°C for 10 minutes to obtain the sensing layer attached to the encapsulation layer in the concave mold;

[0112] Step 5: Prepare the lens layer: Inject 50 μL of hydrogel lens material into the concave mold with the sensor layer in step 4 and seal it with a convex mold. The UV light intensity is 30 mW / cm 2 The mold is then cured for 600 seconds, and the convex mold is removed, and the contact lens is removed from the concave mold to obtain the intraocular pressure monitoring contact lens dry sheet;

[0113] Step 6: Post-processing: hydrating, sterilizing and packaging the intraocular pressure monitoring contact lenses to obtain hydrogel intraocular pressure monitoring contact lenses.

[0114] Embodiment 3-6

[0115] The intraocular pressure monitoring contact lens of this embodiment is composed of the following raw materials in weight percentage: 93% lens layer, 1% sensor layer, and 6% packaging layer; wherein the lens layer is a commercial silicone hydrogel lens material; the sensor layer is composed of the following raw materials in mass parts: 78 parts of bisphenol epoxy resin, 18 parts of gold element, 2 parts of isopropylbenzene hydroperoxide, and 2 parts of deionized water; the packaging layer is a commercial silicone hydrogel lens material.

[0116] Step 1: Material preparation: weigh the corresponding mass of raw materials according to the above formula, and prepare the concave mold, the convex mold, the transfer rubber head and the patterned transfer steel plate;

[0117] Step 2: Prepare the encapsulation layer: drip 2 μL of silicone hydrogel lens material into the concave mold and seal it with the convex mold. The UV light intensity is 450 mW / cm 2 After curing for 5 seconds, the mold is taken out and the male mold is removed to obtain the encapsulation layer in the female mold;

[0118] Step 3: preparing conductive ink: mixing bisphenol epoxy resin, gold, cumene hydroperoxide, and deionized water for 4.8 hours to form a uniform mixed solution to obtain conductive ink;

[0119] Step 4: Prepare the sensing layer: Drop the prepared conductive ink onto the patterned transfer steel plate, use a scraper to scrape the conductive ink into the patterned grooves, scrape off the excess ink with the scraper, and use a transfer rubber head to transfer the patterned conductive ink into the concave die mold containing the encapsulation layer. Dry it in an oven at 40 °C for 500 min to obtain the sensing layer attached to the encapsulation layer in the concave die mold;

[0120] Step 5: Prepare the lens layer: Drop 35 μL of silicone hydrogel lens material into the concave die mold with the sensing layer in Step 4, and seal it with a convex die mold. Cure it under ultraviolet light with an intensity of 450 mW / cm 2 for 10 s, take out the mold and remove the convex die mold, and take out the contact lens from the concave die mold to obtain the dry piece of the intraocular pressure monitoring contact lens;

[0121] Step 6: Post-treatment: Hydrate, sterilize, and encapsulate the intraocular pressure monitoring contact lens to obtain a silicone hydrogel intraocular pressure monitoring contact lens.

[0122] Examples 3-7

[0123] The intraocular pressure monitoring contact lens in this example is composed of the following raw materials by weight percentage: 95% lens layer, 2% sensing layer, and 3% encapsulation layer; among them, the lens layer is a commercial hydrogel lens material; the sensing layer is composed of the following raw materials in parts by mass: 67 parts of bisphenol epoxy resin, 30 parts of gallium indium alloy, 1 part of tert-butyl perbenzoate, and 2 parts of deionized water; the encapsulation layer is a commercial hydrogel lens material.

[0124] Step 1: Prepare materials: Weigh the corresponding masses of raw materials according to the above formula, and prepare a concave die mold, a convex die mold, a transfer rubber head, and a patterned transfer steel plate;

[0125] Step 2: Prepare the encapsulation layer: Drop 1.5 μL of hydrogel lens material into the concave die mold, and seal it with a convex die mold. Cure it in an oven at 80 °C for 90 min, take out the mold and remove the convex die mold to obtain the encapsulation layer in the concave die mold;

[0126] Step 3: Prepare the conductive ink: Mix and stir bisphenol epoxy resin, gallium indium alloy, tert-butyl perbenzoate, and deionized water for 6.2 h to form a uniform mixed solution to obtain the conductive ink;

[0127] Step 4: Prepare the sensing layer: Drop the prepared conductive ink onto the patterned transfer steel plate, use a scraper to scrape the conductive ink into the patterned grooves, scrape off the excess ink with the scraper, and use a transfer rubber head to transfer the patterned conductive ink into the concave die mold containing the encapsulation layer. Dry it in an oven at 90 °C for 20 min to obtain the sensing layer attached to the encapsulation layer in the concave die mold;

[0128] Step 5: Prepare the lens layer: Drop 50 μL of the hydrogel lens material onto the concave die mold with the sensing layer in Step 4, seal it with the convex die mold, cure it in an oven at 80 °C for 30 h, take out the mold and remove the convex die mold, and take out the contact lens from the concave die mold to obtain the dry piece of the intraocular pressure monitoring contact lens;

[0129] Step 6: Post-treatment: Hydrate, sterilize, and package the intraocular pressure monitoring contact lens to obtain the hydrogel intraocular pressure monitoring contact lens.

[0130] Examples 3 - 8

[0131] The intraocular pressure monitoring contact lens of this example is composed of the following raw materials by weight percentage: 95% of the lens layer, 4% of the sensing layer, and 1% of the encapsulation layer; among them, the lens layer is a commercial silicone hydrogel lens material; the sensing layer is composed of the following raw materials in parts by mass: 72 parts of bisphenol epoxy resin, 23 parts of graphene, 3 parts of tert-butyl perbenzoate, and 2 parts of 0.5% hydrolyzed lactalbumin solution; the encapsulation layer is a commercial silicone hydrogel lens material.

[0132] Step 1: Prepare materials: Weigh the corresponding masses of the raw materials according to the above formula, and prepare a concave die mold, a convex die mold, a transfer rubber head, and a patterned transfer steel plate;

[0133] Step 2: Prepare the encapsulation layer: Drop 0.5 μL of the silicone hydrogel lens raw material into the concave die mold, seal it with the convex die mold, cure it under ultraviolet light with an intensity of 200 mW / cm 2 for 50 s, take out the mold and remove the convex die mold to obtain the encapsulation layer in the concave die mold;

[0134] Step 3: Prepare the conductive ink: Mix and stir bisphenol epoxy resin, graphene, tert-butyl perbenzoate, and 0.5% hydrolyzed lactalbumin solution for 5 h to form a uniform mixed solution to obtain the conductive ink;

[0135] Step 4: Prepare the sensing layer: Drop the prepared conductive ink onto the patterned transfer steel plate, use a scraper to scrape the conductive ink into the patterned grooves, scrape off the excess ink with a scraper, use the transfer rubber head to transfer the patterned conductive ink to the concave die mold containing the encapsulation layer, and dry it in an oven at 60 °C for 330 min to obtain the sensing layer attached to the encapsulation layer in the concave die mold;

[0136] Step 5: Prepare the lens layer: Drop 50 μL of the silicone hydrogel lens material into the concave die mold with the sensing layer in Step 4, seal it with the convex die mold, and cure it under ultraviolet light with an intensity of 200 mW / cm 2 for 240 s, take out the mold and remove the convex die mold, and take out the contact lens from the concave die mold to obtain the dry piece of the intraocular pressure monitoring contact lens;

[0137] Step 6: Post-treatment: Hydrate, sterilize, and encapsulate the intraocular pressure monitoring contact lens to obtain a silicone hydrogel intraocular pressure monitoring contact lens.

[0138] Experimental verification

[0139] Take Examples 3-1 to 3-8 for testing of thickness, light transmittance, contact angle, tensile properties, cytotoxicity, and lipid adsorption rate. Use commercially available hydrogel contact lenses as Comparative Example 1 and commercially available silicone hydrogel contact lenses as Comparative Example 2. The test results are shown in Table 1:

[0140]

[0141]

[0142] As can be seen from Table 1, the examples of the present invention meet the standards of commercial contact lenses in terms of lens thickness, light transmittance, contact angle, elongation rate, cell proliferation rate, and lipid adsorption rate, and at the same time meet the national standards for soft contact lenses, showing the potential for industrial production.

[0143] The following specifically describes the relevant test content.

[0144] Thickness test

[0145] Equipment used: Thickness tester, scanning electron microscope

[0146] Operation method: Measure the lens thickness of Examples 3-1 to 3-8, Comparative Example 1, and Comparative Example 2 using a thickness tester, and detect the thickness of each layer of the lens with a scanning electron microscope. Cut the lens with scissors, place it on the side in the inclined cross-section M4 internal thread SEM sample stage, and after sputtering with gold, observe it under the scanning electron microscope. As Figure 5 shown, according to the results of the SEM cross-sectional diagram, the thickness of the contact lens of Example 3-1 is 123.8 μm, the thickness of the contact lens layer is 86.92 μm, the thickness of the encapsulation layer is 36.49 μm, and the thickness of the sensing layer is 15 μm. The thickness data of the contact lenses of Examples 3-1 to 3-8 are shown in Table 1.

[0147] Light transmittance test

[0148] Equipment used: UV-visible spectrophotometer

[0149] Operation method: After fully equilibrating the contact lenses of Examples 3-1 to 3-8, Comparative Example 1, and Comparative Example 2 in a standard saline solution for 30 minutes, measurements were carried out in a cuvette filled with the standard saline solution. The test method refers to the national standard GBT11417.5-2012, Ophthalmic optics - Contact lenses - Part 5: Test methods for optical properties. According to the standard requirements, the visible light transmittance in the range of 380 - 780 nm was tested, and the visible light transmittance of qualified lenses should not be less than 89%. The test results of Examples 3-1 and 3-2 Figure 6 , and the light transmittance data of the contact lenses of Examples 3-1 to 3-8 are shown in Table 1. It can be seen that the light transmittance of the intraocular pressure monitoring contact lenses of each embodiment of the present invention meets the standard requirements within the visible light range.

[0150] Contact angle test

[0151] Equipment used: Video optical contact angle measuring instrument

[0152] Operation method: The pre-treated moisture absorption test surface should be placed in the environmental chamber of the cylinder with the polished surface of the lens facing up, surrounded by the standard saline solution but not touching the reservoir. For hydrogel lenses, all moisture and wrinkles on the surface should be removed using a cotton swab. To balance the lens surface and the environment, the system should be kept sealed for 3 minutes before use. 2 μL of the standard saline solution was dropped onto the lens surface through a micropipette. The tip of the micropipette was inserted through a 1 mm diameter small hole at the upper end of the sealed environmental chamber and above the test lens sample surface. The width of the contact area between the liquid droplet and the lens surface was about 2 mm - 3 mm, and then it was kept balanced for another 3 minutes.

[0153] The test method refers to the national standard GBT11417.5-2012, Ophthalmic optics - Contact lenses - Part 7: Test methods for physical and chemical properties. The smaller the contact angle, the better the surface hydrophilicity of the lens. The contact angle tests were carried out on the contact lenses of Examples 3-1 to 3-8, Comparative Example 1, and Comparative Example 2. The test results of Examples 3-1 and 3-2 are as Figure 7 shown, and the contact angle data of the contact lenses of Examples 3-1 to 3-8 are shown in Table 1. It can be seen that the intraocular pressure monitoring contact lenses of the present invention have relatively excellent surface hydrophilicity.

[0154] Tensile property test

[0155] Equipment used: Tensile testing machine

[0156] The test method refers to the national standard GBT11417.6-2012, Ophthalmic optics - Contact lenses - Part 6: Test methods for mechanical properties. The higher the elongation rate, the better the mechanical properties of the lens. The tensile property tests were carried out on the contact lenses of Examples 3-1 to 3-8, Comparative Example 1, and Comparative Example 2. The test results of Examples 3-3 and 3-4 are as Figure 8As shown in the figure, the tensile property data of the contact lenses of Examples 3-1 to 3-8 are shown in Table 1. It can be seen that the intraocular pressure monitoring contact lenses of the present invention can meet the tensile property requirements of contact lenses.

[0157] Cytotoxicity test

[0158] Referring to the test method in GBT16886.5-2017 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, the contact lens lenses of Examples 3-1 to 3-8, Comparative Example 1, and Comparative Example 2 were subjected to cytotoxicity tests. The test results refer to the cell proliferation rate data in Table 1. It can be seen that the cell proliferation rate of the intraocular pressure monitoring contact lenses of the present invention is basically equivalent to that of existing contact lens products and can meet the basic requirements.

[0159] Lipid adsorption test

[0160] The contact lens lenses of Examples 3-1 to 3-8, Comparative Example 1, and Comparative Example 2 were subjected to lipid adsorption tests. The test results are shown in Table 1. It can be seen that the lipid adsorption rate of the intraocular pressure monitoring contact lenses of the present invention is basically equivalent to that of existing contact lens products and can meet the basic requirements.

[0161] Intraocular pressure detection test

[0162] Test equipment: Vector network analyzer

[0163] Operation method: The intraocular pressure monitoring contact lens lenses of Examples 3-1 to 3-8 were respectively attached to ex vivo porcine eyes. By recording the change in the radius of curvature of the ex vivo porcine eyes, the simulation of intraocular pressure changes was achieved. An external coil was connected to the vector network analyzer for reading, and the parameter changes occurring in the radius of curvature were recorded. By reading the lowest point of the resonance frequency and performing data processing, it can be obtained that the change in intraocular pressure and the response of the sensor are positively correlated. Figure 9 (a) and Figure 9 (b) are respectively the change situations of voltage and resonance frequency collected for Example 3-5 and Example 3-6 at different radii of curvature. Figure 10 (a) and Figure 10 (b) are the linear relationships between the radius of curvature deformation and the resonance frequency of Example 3-7 and Example 3-8. It can be found that the change in the resonance frequency shows a linear relationship with the change in the radius of curvature of the porcine eye, and the radius of curvature is positively correlated with the intraocular pressure. Therefore, based on the change in the collected resonance frequency, the change in intraocular pressure can be deduced conversely. It can be seen that the lenses prepared in Examples 3-5 to 3-8 have the function of intraocular pressure monitoring, and the same is true for other examples.

[0164] From the above tests and result comparisons, it can be seen that the comfort and safety of the intraocular pressure monitoring hydrogels and silicone hydrogel contact lenses prepared in Examples 3-1 to 3-8 of the present invention have reached or are close to those of existing commercial hydrogels and silicone hydrogel contact lenses. Compared with ordinary hydrogels and silicone hydrogel contact lenses, the intraocular pressure monitoring contact lenses can monitor eye information and thereby predict certain eye diseases related to intraocular pressure, making it easier to open up the sales market.

[0165] The embodiments of the present invention have been described above in conjunction with the accompanying drawings. However, the present invention is not limited to the above specific embodiments. The above specific embodiments are merely illustrative and not restrictive. Under the inspiration of the present invention, those of ordinary skill in the art can also make many forms without departing from the spirit and scope protected by the claims of the present invention, and these all fall within the protection scope of the present invention.

Claims

1. An intraocular pressure monitoring contact lens, characterized in that, It includes a packaging layer, a sensing layer, and a spectacle lens layer arranged in sequence; The sensing layer includes a spiral induction electrode, which is embedded in the spectacle lens layer, and one side of it facing the packaging layer is in close contact with the packaging layer; the sensing layer includes the following raw materials in parts by mass: 63.5 - 80 parts of resin, 15 - 30 parts of conductive filler, 0.5 - 3 parts of initiator, and 1.5 - 3.5 parts of diluent; The outer side of the spectacle lens layer is used to contact the eyeball, and the inner side is in close contact with the sensing layer and the packaging layer.

2. The intraocular pressure monitoring contact lens according to claim 1, wherein The mass ratio of the packaging layer, the sensing layer, and the spectacle lens layer is: 70% - 95% for the spectacle lens layer, 1% - 10% for the sensing layer, and 1% - 29% for the packaging layer.

3. The intraocular pressure monitoring contact lens according to claim 1, characterized in that, The spectacle lens layer and the packaging layer are made of hydrogel material or silicone hydrogel material as raw materials; Among the raw materials of the sensing layer, the resin uses bisphenol epoxy resin; the conductive filler uses one or a mixture of silver, gold, copper, carbon nanotubes, graphene, gallium indium alloy; the initiator uses one or a mixture of benzoyl peroxide, cumene hydroperoxide, methyl ethyl ketone peroxide, tert-butyl peroxybenzoate; the diluent uses one or a mixture of sodium chloride aqueous solution, deionized water, and hydrolyzed milk protein solution.

4. The intraocular pressure monitoring contact lens according to claim 1, characterized in that, The contact lens body includes a central region corresponding to the pupil position and a peripheral region outside the central region; the sensing layer includes one such induction electrode, which is spirally arranged in the peripheral region of the contact lens body, and the central blank region thereof coincides with the central region of the contact lens body.

5. The intraocular pressure monitoring contact lens according to claim 1, characterized in that, In the induction electrode, the number of turns of the spiral is 1 - 6 turns, the inner diameter of the innermost turn is 2 - 8 mm, the distance between adjacent turns is 0.05 - 1 mm, the width of the spiral is 0.05 - 2.5 mm, and the thickness is 5 - 30 μm.

6. The intraocular pressure monitoring contact lens according to claim 1, characterized in that, The total thickness of the packaging layer, the sensing layer, and the spectacle lens layer is 50 - 180 μm, the thickness of the spectacle lens layer is 40 - 130 μm, the thickness of the sensing layer is 5 - 30 μm, and the thickness of the packaging layer is 5 - 40 μm.

7. A method for preparing the intraocular pressure monitoring contact lens according to any one of claims 1-6, characterized in that, It includes: S1, injecting or dropping hydrogel material or silicone hydrogel material for preparing the packaging layer into the contact lens mold, and performing cold treatment, heat treatment, or light treatment to obtain the packaging layer in the mold; S2, mixing the raw materials for preparing the sensing layer evenly to obtain conductive ink; S3, dropping or injecting the conductive ink obtained in S2 into the patterned groove on the transfer steel plate, and the pattern of the groove corresponds to the shape of the sensing layer; S4, transferring the patterned conductive ink to the packaging layer in the concave mold, and after drying treatment, obtaining the sensing layer; S5, injecting or dropping hydrogel material or silicone hydrogel material for preparing the spectacle lens layer into the concave mold, sealing with the convex mold, and then performing heat curing or light curing treatment, and peeling off the convex mold and the concave mold to obtain the dry piece of the intraocular pressure monitoring contact lens.

8. The method for preparing an intraocular pressure monitoring contact lens according to claim 7, wherein, It also includes step S6, performing hydration treatment on the dry piece of the intraocular pressure monitoring contact lens, and sterilizing the hydrated intraocular pressure monitoring contact lens.

9. The method for preparing an intraocular pressure monitoring contact lens according to claim 7 or 8, characterized in that, In step S1, the time of the cold treatment is 5 to 120 s, and the wind speed is 20 to 100 m / s; the time of the heat treatment is 10 to 120 min, and the temperature is 50 to 125 °C; the time of the light treatment is 5 to 300 s, and the light intensity is 30 to 450 mW / cm 2 ; In step S4, the time of the drying treatment is 5 - 600 min, and the temperature is 30 - 100 °C; In step S5, the time for thermal curing is 1 to 40 h, and the temperature is 50 to 125 °C; the time for photocuring is 10 to 600 s, and the light intensity is 30 to 450 mW / cm 2 .

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