Orthokeratology lens embedded with strain sensor, preparation method of orthokeratology lens and analog simulation

Abstract

The invention discloses an orthokeratology lens embedded with a strain sensor and a preparation method and analog simulation of the orthokeratology lens, and belongs to the technical field of ophthalmology implantation instruments.The orthokeratology lens comprises an orthokeratology lens body and the strain sensor embedded in the orthokeratology lens body, and a fan-shaped opening is formed in the orthokeratology lens body; grooves are symmetrically formed in the left side and the right side of the fan-shaped opening, the strain sensors are embedded into the grooves in the two ends, the preparation method of the orthokeratology lens is provided, and the orthokeratology lens embedded with the strain sensors is applied to analog simulation for monitoring eyelid force and intraocular pressure. According to the integrated orthokeratology lens embedded with the strain sensing fibers, in-vivo real-time monitoring of eyelid force and intraocular pressure can be achieved by detecting the resistance of the strain sensing fibers, and the orthokeratology lens embedded with the strain sensing fibers has clinical practical significance in achieving more ideal orthokeratology and eye health monitoring by adjusting the shape of the orthokeratology lens.

Description

Technical Field

[0001] The present invention relates to the technical field of ophthalmic implantable devices, and in particular to a corneal reshaping lens embedded with a strain sensor, and a preparation method and simulation thereof. Background Art

[0002] At present, the quality of life is reduced due to visual problems. Wearing orthokeratology lenses is an effective way to delay the progression of myopia in adolescents. Orthokeratology lenses are specially designed hard contact lenses that are worn at night. Pressure is applied to the orthokeratology lenses through the eyelids to promote the deformation of corneal epithelial cells, change the radius of curvature of the cornea (lens), and thus change the corneal refractive power, achieving the purpose of temporarily changing the corneal morphology and correcting refractive errors.

[0003] Orthokeratology lenses reshape the corneal curvature by positive pressure and negative pressure suction, making the central area of ​​the cornea flatter and the peripheral area steeper. In this reshaping process, eyelid force and intraocular pressure play a key role, and they are crucial for ensuring lens fit and monitoring eye conditions. However, the current level of technology is unable to provide equipment for real-time monitoring of eyelid force and intraocular pressure, which brings considerable challenges and inconveniences in adjusting the shape of orthokeratology lenses to optimize the correction effect and monitoring eye health.

[0004] To better understand this situation, we can further elaborate: Due to the lack of technology to monitor eyelid force and intraocular pressure in real time, the adjustment of orthokeratology lenses often relies on patient feedback and physician experience, which may lead to insufficient accuracy in the correction process. At the same time, without real-time data support, long-term monitoring of eye health becomes more difficult, which may affect the early detection and intervention of potential eye problems. Therefore, the development of equipment that can monitor eyelid force and intraocular pressure in real time is not only crucial to improving the personalized adaptation and correction effect of orthokeratology lenses, but also has far-reaching significance for promoting the development of eye health management.

[0005] Based on this, a corneal reshaping lens embedded with a strain sensor and its preparation method and simulation are proposed. Summary of the invention

[0006] The purpose of the present invention is to provide a corneal reshaping lens embedded with a strain sensor and its preparation method and simulation to solve the problems existing in the background technology.

[0007] To achieve the above-mentioned purpose, the present invention provides a corneal reshaping lens embedded with a strain sensor, comprising a corneal reshaping lens and a strain sensor embedded in the corneal reshaping lens, wherein the corneal reshaping lens is provided with a fan-shaped opening, and grooves are symmetrically arranged on the left and right sides of the fan-shaped opening, and the strain sensor is embedded in the grooves at both ends.

[0008] Preferably, the orthokeratology lens is configured as a three-arc structure, including a central base arc zone, a middle inversion arc zone and an outermost adaptation arc zone; the fan-shaped opening is opened at the adaptation arc zone and the inversion arc zone, the fan angle of the fan-shaped opening is 10° to 150°, and the diameter of the fan-shaped opening is 6mm to 10.5mm.

[0009] Preferably, the strain sensor has a width of 100 μm to 2 mm, and a shape of strip, tubular, paper clip, serpentine, cross-shaped, twisted, zigzag, or Z-shaped. The material is a conductive hydrogel material or a semiconductor material. The conductive hydrogel material is a composite of one or more of ion conductive hydrogel, metal nanoparticle conductive hydrogel, carbon-based conductive hydrogel, and conductive polymer hydrogel.

[0010] Preferably, the strain sensor is manufactured by 3D printing, injection molding, spin coating mask or screen printing, and both ends of the strain sensor are provided with wire ports, and the two wire ports are respectively connected to the positive and negative poles of the digital source meter.

[0011] Preferably, the grooves are symmetrically arranged in one or more groups, the number of the strain sensors is the same as the number of the grooves, the grooves are adapted to the structures of the strain sensors, and both are fan-shaped.

[0012] The present invention also provides a method for preparing a corneal reshaping lens embedded with a strain sensor, comprising the following steps:

[0013] S1. Laser cutting the fan-shaped opening of the orthokeratology lens: determine the size of the orthokeratology lens, create a CAD drawing, define the cutting area and cutting fan angle of the orthokeratology lens, and use a laser cutting machine to cut the orthokeratology lens to obtain a fan-shaped opening;

[0014] S2. Laser engraving the grooves on both sides of the fan-shaped opening: laser engraving grooves on both sides of the fan-shaped opening of the orthokeratology lens, the groove shape is fan-shaped, and the groove sector angle, groove depth and groove width are determined;

[0015] S3. Prepare a strain sensor with a wire connected to the end: determine the shape, width and fan angle of the strain sensor, and connect the positive and negative electrodes of the digital source meter to the wire port of the strain sensor;

[0016] S4. Embed the strain sensor into the grooves at both ends of the fan-shaped opening of the orthokeratology lens.

[0017] The present invention also provides a simulation of a corneal reshaping lens embedded with a strain sensor, and applies the corneal reshaping lens to the simulation of monitoring eyelid force and intraocular pressure.

[0018] Preferably, the simulation process comprises the following steps:

[0019] S1. Use finite element simulation to establish a three-dimensional finite element model of orthokeratology lens-corneosclera coupling with embedded strain sensors;

[0020] S2, applying a uniformly distributed load on the upper part of the orthokeratology lens and inside the cornea as the eyelid force and intraocular pressure;

[0021] S3, assign material properties to orthokeratology lenses, strain sensors, cornea, and sclera, set fixed constraints and contact pairs, mesh the model, run finite element analysis software for calculation and solution, analyze the deformation and stress distribution of the strain sensor, and determine the influence of eyelid force and intraocular pressure on the deformation of the strain sensor;

[0022] S4. Record the resistance change rate of the strain sensor measured by the digital source meter and the change law of the strain sensor deformation. Combined with the simulation data of the finite element analysis, analyze and establish the relationship and linear correlation between the amplitude of the eyelid force and intraocular pressure and the deformation degree and resistance change rate of the strain sensor.

[0023] Therefore, the present invention relates to a corneal reshaping lens embedded with a strain sensor, and a preparation method and simulation thereof. By correlating the dynamic changes of eyelid force and intraocular pressure with the resistance change of the strain sensor, real-time monitoring of these physiological parameters is achieved. There is a direct relationship between the resistance change rate of the strain sensor and the strain of the sensor, the eyelid force and the intraocular pressure. Under the condition of keeping the eyelid force constant, the change of intraocular pressure can be obtained in real time by monitoring the resistance change rate regardless of whether the eyes are closed or open. At the same time, by recording the resistance change during the eye opening and closing actions, the magnitude of the eyelid force can be accurately measured.

[0024] The corneal reshaping lens embedded with strain sensing fibers integrated in the present invention can realize in-vivo real-time monitoring of eyelid force and intraocular pressure by detecting the resistance of the strain sensing fibers, which has clinical practical significance for adjusting the shape of the reshaping lens to achieve more ideal corneal reshaping and eye health monitoring.

[0025] The technical solution of the present invention is further described in detail below through the accompanying drawings and embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 A three-arc structure diagram of a corneal reshaping lens according to an embodiment of the present invention;

[0027] Figure 2 Schematic diagram of the structure of the orthokeratology lens of Example 1 of the present invention Figure 1 ;

[0028] Figure 3The structure of the orthokeratology lens of Example 1 of the present invention is shown in FIG. Figure 2 ;

[0029] Figure 4 It is a cross-sectional view of the connection between the orthokeratology lens and the strain sensor according to Example 1 of the present invention;

[0030] Figure 5 A three-dimensional structural diagram of the orthokeratology lens-strain sensing film according to Example 1 of the present invention;

[0031] Figure 6 A diagram of a three-dimensional model of orthokeratology lens-corneosclera coupling with a strain sensing film embedded therein according to Example 1 of the present invention;

[0032] Figure 7 The distribution of eyelid force and intraocular pressure of the orthokeratology lens-corneosclera coupling three-dimensional model diagram embedded with strain sensing film according to Example 1 of the present invention;

[0033] Figure 8 is a strain cloud diagram of the strain sensor according to Example 1 of the present invention;

[0034] Fig. 9 The figure is a fitting relationship diagram of the strain sensor elongation and intraocular pressure and a center arc line result diagram of Example 1 of the present invention;

[0035] Fig.10 The figure is a fitting relationship diagram of the strain sensor elongation and intraocular pressure and a center arc line result diagram of Example 1 of the present invention;

[0036] Fig.11 A three-dimensional structural diagram of a corneal reshaping lens-semicircular tube strain sensor according to Example 2 of the present invention;

[0037] Fig.12 The three-dimensional processing mold of the orthokeratology lens of Example 2 of the present invention Figure 1 ;

[0038] Fig.13 The three-dimensional processing mold of the orthokeratology lens of Example 2 of the present invention Figure 2 ;

[0039] Fig.14 This is a schematic diagram of the groove at the end of the orthokeratology lens of Example 2 of the present invention;

[0040] Fig.15 Schematic diagram of orthokeratology lens-snake-shaped strain sensor according to embodiment 3 of the present invention

[0041] Fig.16 This is a schematic diagram of a corneal reshaping lens-broken line strain sensor according to Example 4 of the present invention;

[0042] Fig.17This is a schematic diagram of a corneal reshaping lens-Z-type strain sensor according to Example 5 of the present invention;

[0043] Fig.18 This is a schematic diagram of a corneal reshaping lens-X-shaped strain sensor according to Example 6 of the present invention;

[0044] Fig.19 This is a schematic diagram of a corneal reshaping lens-paper clip type strain sensor according to Example 7 of the present invention;

[0045] Fig. 20 This is a schematic diagram of a corneal reshaping lens-twisted strain sensor according to Example 8 of the present invention;

[0046] Fig.21 This is a schematic diagram of a corneal reshaping lens-multi-channel strain sensing fiber according to Example 9 of the present invention;

[0047] Reference numerals:

[0048] 1. Orthokeratology lens; 2. Strain sensor; 3. Cornea; 4. Sclera; 5. Fan-shaped opening; 6. Groove; 7. Slotting. DETAILED DESCRIPTION

[0049] The technical solution of the present invention is further described below through the accompanying drawings and embodiments.

[0050] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments.

[0051] The present invention provides a strain sensor embedded orthokeratology lens, comprising an orthokeratology lens 1 and a strain sensor 2 embedded in the orthokeratology lens 1, wherein the orthokeratology lens 1 is configured as a three-segment arc structure, including a central base arc zone, a middle inversion arc zone, and an outermost adaptation arc zone; a fan-shaped opening is provided on the orthokeratology lens 1, and the fan-shaped opening 5 is provided at the adaptation arc zone and the inversion arc zone, so as not to affect the light transmittance and eyelid force of the central optical zone (with a radius within a range of 3 mm); the fan angle of the fan-shaped opening 5 is 10° to 150°, and the diameter of the fan-shaped opening 5 is 6 mm to 10.5 mm;

[0052] Grooves 6 are symmetrically arranged on the left and right sides of the fan-shaped opening 5, and the strain sensors 2 are embedded in the grooves 6 at both ends. The grooves 6 are symmetrically arranged in one or more groups, and the number of the strain sensors 2 is the same as the number of the grooves 6. The structures of the grooves 6 and the strain sensors 2 are adapted, and the shapes are both fan-shaped. The sensors can be made into arrays to realize multi-channel sensing.

[0053] The width of the strain sensor 2 is 100 μm to 2 mm, and the shape is one of strip, tubular, paper clip, serpentine, zigzag, twist, folded line, and Z-shaped. By changing the length of the resistance wire, the strain sensor 2 can output mechanical deformation as an electrical signal, and produce resistance changes during the stretching process. Its material is a conductive hydrogel material, a semiconductor material, a strain gauge, etc. The conductive hydrogel material is an ion (sodium chloride, potassium chloride and other salts) conductive hydrogel, a metal nanoparticle (such as gold, silver, platinum, etc.) conductive hydrogel, a carbon-based (carbon nanotubes, graphene, carbon black and other carbon-based materials) conductive hydrogel, and a conductive polymer hydrogel (such as polyaniline, polypyrrole, polythiophene, etc.) One or more composite conductive hydrogels.

[0054] The strain sensor 2 is made by 3D printing, injection molding, spin coating mask or screen printing. Both ends of the strain sensor 2 are provided with wire ports, and the two wire ports are respectively connected to the positive and negative poles of the digital source meter. A groove 7 is opened downward at the innermost end of the groove 6 of the orthokeratology lens 1, and the wire port is set in the groove 7.

[0055] A strain sensor 2 is arranged on the orthokeratology lens 1. The strain sensor 2 will be deformed under the action of eyelid force and intraocular pressure, and its total length will change, thereby causing the total resistance of the strain sensor 2 to change. Through mechanical analysis calculation and experiments, the relationship between the resistance change of the strain sensor 2 and the eyelid force and intraocular pressure is obtained, and then the eyelid force and intraocular pressure are measured by testing the change in the resistance of the strain sensor 2.

[0056] Example 1

[0057] A method for preparing a corneal reshaping lens with integrated strip-shaped strain sensing fibers comprises the following steps:

[0058] S1. Orthokeratology lens size design: First, the size of the orthokeratology lens is designed, such as Figure 1 As shown, the orthokeratology lens 1 adopts a CRT three-segment arc design with a total diameter of 10.5mm, a BC base arc width of 6mm, a reversal arc RZD width of 1mm, and an adaptation arc LZA width of 1.25mm. BC = flat K + reduction - correction factor, where the correction factor of CRT is +0.50D. Taking the flat K of 42.5 and the reduction of -3 as an example, BC = 39D, and the calculation formula of the corneal curvature is D = 1000*(n2-n1) / R, D is the corneal diopter, n2 is the corneal refractive index, usually 1.3375, n1 is the refractive index of the refractive medium in front of the cornea, usually air, and the refractive index defaults to 1, so the resulting curvature radius is:

[0059] R=337.5 / 39=8.654mm

[0060] The sagitta of the BC segment:

[0061] Sag=8.654-(8.654 2 -3 2 )=0.537mm

[0062] The sag of RZD is 0.525mm, and the sag of LZA is 0.812 (33°, tangent radius 4.19mm, sag 0.123mm); the effective sag of the lens = BC sag + RZD sag + LZA effective sag = 0.537mm + 0.525mm + 0.123mm = 1.185mm.

[0063] The thickness of the cornea is 0.5mm, which is tangent to the orthokeratology lens. The corneal sagittal height is 1.173mm. The effective sagittal height of the lens is the sum of the corneal sagittal height and the vertex gap, and the vertex gap is 12μm.

[0064] S2. Laser cutting of orthokeratology lens 1: Create a CAD drawing, define the cutting area of ​​orthokeratology lens 1 and use a laser cutting machine to cut the lens. The sector angle of the cutting area is 90°.

[0065] S3, laser engraving on both sides of the cutting area of ​​orthokeratology lens 1: Figure 3 As shown, the left and right sides of the fan-shaped opening 5 obtained after cutting the orthokeratology lens 1 are laser engraved to obtain a groove 6. The engraved shape is a fan surface with a fan surface angle of 30°. The depth of the groove 6 is 100μm and the width of the groove 6 is 1mm.

[0066] S4, preparing the strain sensor 2 with the end connected to the wire: the strain sensor 2 is as follows: Figure 4 As shown, it is a strip strain sensing film with a width of 1mm and a sector angle of 150°, embedded in the cutting area and laser engraving area of ​​the orthokeratology lens, and connected to the positive and negative electrodes of the digital source meter at the wire port. Since the radius of the tangent position between the orthokeratology lens 1 and the cornea is 4.19mm, the size of the sensor is designed to be within the range of 4.19mm±0.5mm.

[0067] S5. Embed the strain sensor 2 into the orthokeratology lens 1: The orthokeratology lens 1 with integrated strain sensing film is as follows: Figure 5 shown.

[0068] The simulation process is:

[0069] S1. Establish a three-dimensional model of orthokeratology lens-corneosclera coupling of strain sensors, such as Figure 6 As shown, the curvature radius of the sclera 4 is 12.8 mm and the thickness is 0.5 mm.

[0070] S2, applying a uniformly distributed load on the upper part of the orthokeratology lens 1 and the inside of the cornea 3 as the eyelid force and intraocular pressure, such as Figure 7Shown are eyelid force as blue arrow and intraocular pressure as red arrow.

[0071] S3, assign material properties to orthokeratology lens, strain sensor, cornea 3, and sclera 4. Orthokeratology lens 1 is a linear elastic material with an elastic modulus of 600 MPa and a Poisson's ratio of 0.49; strain sensor 2 adopts the Ogden model with a shear modulus of 0.25 MPa and a parameter of 6.06; the cornea adopts the Neo-Hookean model with a Young's modulus of 0.86 MPa and a shear modulus of 0.5e6 N / m 2 ; The sclera is a linear elastic material with a Young's modulus of 3MPa and a Poisson's ratio of 0.49. Then, fixed constraints and contact pairs are set, and finite element simulation is performed;

[0072] S4. Record the resistance changes measured by the digital source meter and the finite element simulation results, and analyze and determine the influence of eyelid force and intraocular pressure on the deformation of hydrogel microfibers.

[0073] like Figure 8 As shown, the eyelid force is 0.5 mmHg, the intraocular pressure is 35 mmHg, and the direction of the arrow is the direction of the first principal elongation;

[0074] The central arc segment of the sensor is analyzed by line results, and a fitting relationship diagram between the elongation of the strain sensor 2 and the intraocular pressure is established, as shown in Fig. 9 As shown, the eyelid force is set to 0.5 mmHg, the intraocular pressure is 15 mmHg to 35 mmHg, and the interval is 5 mmHg.

[0075] The central arc segment of the strain sensor is analyzed by line results, and a fitting relationship diagram between the elongation of strain sensor 2 and the eyelid force is established, as shown in Fig.10 As shown, the intraocular pressure is set to 15 mmHg, the eyelid force is 0.5 mmHg to 2.5 mmHg, and the interval is 0.5 mmHg.

[0076] Example 2

[0077] A method for preparing orthokeratology lenses with integrated semicircular tube-shaped strain sensing fibers comprises the following steps:

[0078] A three-dimensional model of orthokeratology lenses embedded with semicircular strain sensing fibers was established. Fig.11 As shown; the prepared orthokeratology lens is then placed in a special mold for pressurization, such as Fig.12 , 13 As shown, a semicircular channel with a radius of 100 μm and an arc of 50° is generated in the area of ​​10 mm diameter of the shaping mirror during pressurization;

[0079] Then, a CAD drawing is created to delineate the cutting area of ​​the orthokeratology lens, and a 30° arc segment at the end is cut using a laser cutting machine; the semicircular pipe is reverse modeled to obtain the mold injection molding part of the semicircular pipe, and the raw materials for preparing strain hydrogel fibers are filled in between.

[0080] like Fig.14 As shown, the orthokeratology lens can be laser cut or punched, the wire at the end of the sensor can be embedded into the groove 7 of the orthokeratology lens, and connected to a digital source meter.

[0081] The preparation of hydrogel microfibers is as follows: 5 g acrylamide, 0.075 g N'N-dimethylformamide, and 0.075 g ammonium persulfate are placed in 20 ml of 2% polyvinyl pyrrolidone solution, and then 5 ml of aqueous polyurethane is added. The mixed solution is magnetically stirred, then transferred to a mold, and cured at 80° for 20 min.

[0082] The strain sensing fiber can be manufactured by reverse modeling and casting, or it can be designed into a tubular shape and manufactured by 3D extrusion.

[0083] Example 3

[0084] A method for preparing orthokeratology lenses with integrated serpentine (S-shaped) strain sensing fibers comprises the following steps:

[0085] S1. Orthokeratology lens size design and laser cutting: First, design the size of the orthokeratology lens as in Example 1, then create a CAD drawing, define the cutting area of ​​the orthokeratology lens and cut the lens with a laser cutting machine.

[0086] S2. Laser engraving on both sides of the cutting area of ​​the orthokeratology lens: Laser engraving is performed on the left and right sides of the cutting area of ​​the orthokeratology lens. The engraving shape is a sector with a sector angle of 30°, an engraving depth of 100μm, and an engraving width of 1mm.

[0087] S3. Prepare the strain sensor with the end connected to the wire: Fig.15 As shown, the strain sensor is a snake-shaped (S-shaped) hydrogel microfiber with a width of 200 μm, which can be produced by 3D extrusion and embedded in the cutting area and laser engraving area of ​​the orthokeratology lens.

[0088] Example 4

[0089] A method for preparing orthokeratology lenses with integrated zigzag strain sensing fibers comprises the following steps:

[0090] S1. Orthokeratology lens size design and laser cutting: First, design the size of the orthokeratology lens as in Example 1, then create a CAD drawing, define the cutting area of ​​the orthokeratology lens and cut the lens with a laser cutting machine.

[0091] S2. Laser engraving on both sides of the cutting area of ​​the orthokeratology lens: Laser engraving is performed on the left and right sides of the cutting area of ​​the orthokeratology lens. The engraving shape is a sector with a sector angle of 30°, an engraving depth of 100μm, and an engraving width of 1mm.

[0092] S3. Prepare the strain sensor with the end connected to the wire: Fig.16 As shown, the strain sensor is a zigzag hydrogel microfiber with a width of 200 μm, which can be manufactured by 3D extrusion and embedded in the cutting area and laser engraving area of ​​the orthokeratology lens.

[0093] Example 5

[0094] A method for preparing a corneal reshaping lens with integrated Z-type strain sensing fiber comprises the following steps:

[0095] S1. Orthokeratology lens size design and laser cutting: First, design the size of the orthokeratology lens as in Example 1, then create a CAD drawing, define the cutting area of ​​the orthokeratology lens and cut the lens with a laser cutting machine.

[0096] S2. Laser engraving on both sides of the cutting area of ​​the orthokeratology lens: Laser engraving is performed on the left and right sides of the cutting area of ​​the orthokeratology lens. The engraving shape is a sector with a sector angle of 30°, an engraving depth of 100μm, and an engraving width of 1mm.

[0097] S3. Prepare the strain sensor with the end connected to the wire: Fig.17 As shown, the strain sensor is a Z-type hydrogel microfiber with a width of 200 μm, which can be manufactured by 3D extrusion and spin coating mask method, and embedded in the cutting area and laser engraving area of ​​the orthokeratology lens.

[0098] Example 6

[0099] A method for preparing a corneal reshaping lens with an integrated X-shaped strain sensor comprises the following steps:

[0100] S1. Orthokeratology lens size design and laser cutting: First, design the size of the orthokeratology lens as in Example 1, then create a CAD drawing, define the cutting area of ​​the orthokeratology lens and cut the lens with a laser cutting machine.

[0101] S2. Laser engraving on both sides of the cutting area of ​​the orthokeratology lens: Laser engraving is performed on the left and right sides of the cutting area of ​​the orthokeratology lens. The engraving shape is a sector with a sector angle of 30°, an engraving depth of 100μm, and an engraving width of 1mm.

[0102] S3. Prepare the strain sensor with the end connected to the wire: Fig.18As shown, the strain sensor is a cross-shaped strain sensing fiber with a width of 200 μm. It can be manufactured by 3D extrusion and spin coating mask methods, and embedded in the cutting area and laser engraving area of ​​the orthokeratology lens.

[0103] Example 7

[0104] A method for preparing orthokeratology lenses with integrated paper clip-type strain sensing fibers comprises the following steps:

[0105] S1. Orthokeratology lens size design and laser cutting: First, design the size of the orthokeratology lens as in Example 1, then create a CAD drawing, define the cutting area of ​​the orthokeratology lens and cut the lens with a laser cutting machine.

[0106] S2. Laser engraving on both sides of the cutting area of ​​the orthokeratology lens: Laser engraving is performed on the left and right sides of the cutting area of ​​the orthokeratology lens. The engraving shape is a sector with a sector angle of 30°, an engraving depth of 100μm, and an engraving width of 1mm.

[0107] S3. Prepare the strain sensor with the end connected to the wire: Fig.19 As shown, the strain sensor is a paper clip type strain sensing fiber with a width of 200 μm. It can be manufactured by 3D printing, embedded in the cutting area and laser engraving area of ​​the orthokeratology lens, and connected to the positive and negative poles of the digital source meter at the wire port.

[0108] Example 8

[0109] A method for preparing orthokeratology lenses with integrated twisted strain sensing fibers comprises the following steps:

[0110] S1. Orthokeratology lens size design and laser cutting: First, design the size of the orthokeratology lens as in Example 1, then create a CAD drawing, define the cutting area of ​​the orthokeratology lens and cut the lens with a laser cutting machine.

[0111] S2. Laser engraving on both sides of the cutting area of ​​the orthokeratology lens: Laser engraving is performed on the left and right sides of the cutting area of ​​the orthokeratology lens. The engraving shape is a sector with a sector angle of 30°, an engraving depth of 100μm, and an engraving width of 1mm.

[0112] S3. Prepare the strain sensor with the end connected to the wire: Fig. 20 As shown, the strain sensor is a twisted hydrogel microfiber with a width of 200 μm. A single microfiber can be prepared by 3D extrusion and twisted into a twisted shape, which is then embedded in the cutting area and laser engraving area of ​​the orthokeratology lens.

[0113] Example 9

[0114] A method for preparing a corneal reshaping lens integrating multiple strain sensing fibers comprises the following steps:

[0115] S1. Orthokeratology lens size design and laser cutting: First, design the size of the orthokeratology lens as in Example 1, then create a CAD drawing, define the cutting area of ​​the orthokeratology lens and cut the lens with a laser cutting machine.

[0116] S2. Laser engraving on both sides of the cutting area of ​​the orthokeratology lens: Laser engraving is performed on the left and right sides of the cutting area of ​​the orthokeratology lens. The engraving shape is a sector with a sector angle of 30°, an engraving depth of 100μm, and an engraving width of 1mm.

[0117] S3. Prepare the strain sensor with the end connected to the wire: Fig.21 As shown, the strain sensor is 4 hydrogel microfibers, which can be produced by 3D extrusion, with a width of 100 μm and a sector angle of 150°, and is embedded in the cutting area and laser engraving area of ​​the orthokeratology lens.

[0118] Therefore, the present invention relates to a corneal reshaping lens embedded with a strain sensor, and its preparation method and simulation. The integrated corneal reshaping lens embedded with strain sensing fibers can realize in-vivo real-time monitoring of eyelid force and intraocular pressure by detecting the resistance of the strain sensing fibers, which has clinical practical significance for adjusting the shape of the reshaping lens to achieve more ideal corneal reshaping and eye health monitoring.

[0119] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention rather than to limit it. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that they can still modify or replace the technical solution of the present invention with equivalents, and these modifications or equivalent replacements cannot cause the modified technical solution to deviate from the spirit and scope of the technical solution of the present invention.

Claims

1. A corneal reshaping lens embedded with a strain sensor, characterized in that: It comprises a corneal reshaping lens and a strain sensor embedded in the corneal reshaping lens. The corneal reshaping lens is provided with a fan-shaped opening, grooves are symmetrically arranged on the left and right sides of the fan-shaped opening, and the strain sensor is embedded in the grooves at both ends.

2. The orthokeratology lens embedded with a strain sensor according to claim 1, characterized in that: The orthokeratology lens is configured as a three-arc structure, including a central base arc zone, a middle inversion arc zone, and an outermost adaptation arc zone; the fan-shaped opening is opened at the adaptation arc zone and the inversion arc zone, the fan angle of the fan-shaped opening is 10° to 150°, and the diameter of the fan-shaped opening is 6mm to 10.5mm.

3. The orthokeratology lens embedded with a strain sensor according to claim 2, characterized in that: The width of the strain sensor is 100 μm to 2 mm, and the shape is one of strip, tubular, paper clip, serpentine, cross-shaped, twisted, zigzag, and Z-shaped. The material is a conductive hydrogel material or a semiconductor material. The conductive hydrogel material is one of ion conductive hydrogel, metal nanoparticle conductive hydrogel, carbon-based conductive hydrogel, and conductive polymer hydrogel, or a composite of several of them.

4. The orthokeratology lens embedded with a strain sensor according to claim 3, characterized in that: The strain sensor is made by 3D printing, injection molding, spin coating mask or screen printing. Both ends of the strain sensor are provided with wire ports, and the two wire ports are respectively connected to the positive and negative poles of the digital source meter.

5. The orthokeratology lens embedded with a strain sensor according to claim 4, characterized in that: The grooves are symmetrically arranged in one or more groups, the number of the strain sensors is the same as the number of the grooves, the grooves are adapted to the structures of the strain sensors, and both are fan-shaped.

6. A method for preparing a corneal reshaping lens embedded with a strain sensor as claimed in any one of claims 1 to 5, characterized in that: The following steps are involved: S1. Laser cutting the fan-shaped opening of the orthokeratology lens: determine the size of the orthokeratology lens, create a CAD drawing, define the cutting area and cutting fan angle of the orthokeratology lens, and use a laser cutting machine to cut the orthokeratology lens to obtain a fan-shaped opening; S2. Laser engraving the grooves on both sides of the fan-shaped opening: laser engraving grooves on both sides of the fan-shaped opening of the orthokeratology lens, the groove shape is fan-shaped, and the groove sector angle, groove depth and groove width are determined; S3. Prepare a strain sensor with a wire connected to the end: determine the shape, width and fan angle of the strain sensor, and connect the positive and negative electrodes of the digital source meter to the wire port of the strain sensor; S4. Embed the strain sensor into the grooves at both ends of the fan-shaped opening of the orthokeratology lens.

7. A simulation of orthokeratology lenses embedded with strain sensors, characterized in that: The orthokeratology lens described in any one of claims 1 to 5 is used in a simulation for monitoring eyelid force and intraocular pressure.

8. The simulation of orthokeratology lens embedded with strain sensor according to claim 7, characterized in that: The simulation process includes the following steps: S1. Use finite element simulation to establish a three-dimensional finite element model of orthokeratology lens-corneosclera coupling with embedded strain sensors; S2, applying a uniformly distributed load on the upper part of the orthokeratology lens and inside the cornea as the eyelid force and intraocular pressure; S3, assign material properties to orthokeratology lenses, strain sensors, cornea, and sclera, set fixed constraints and contact pairs, mesh the model, run finite element analysis software for calculation and solution, analyze the deformation and stress distribution of the strain sensor, and determine the influence of eyelid force and intraocular pressure on the deformation of the strain sensor; S4. Record the resistance change rate of the strain sensor measured by the digital source meter and the change law of the strain sensor deformation. Combined with the simulation data of the finite element analysis, analyze and establish the relationship and linear correlation between the amplitude of the eyelid force and intraocular pressure and the deformation degree and resistance change rate of the strain sensor.

Images