A real-time monitoring system for intraocular pressure and eye movement when eyes are closed

Abstract

This invention relates to the field of medical technology, specifically to a real-time monitoring system for intraocular pressure and eye movement dynamics with eyes closed. It includes an internal multifunctional flexible corneal contact lens and an external data acquisition and processing system. The internal multifunctional flexible corneal contact lens includes two encapsulation films and a sensing layer disposed between the two encapsulation films. The sensing layer includes a first sensing coil, a second sensing coil, and a magnetic thin-film sensing layer, which is positioned between the first and second copper coils to form a capacitor structure. The external data acquisition and processing system includes a lens frame, a receiving coil located inside the lens frame, and multiple teslameters. The receiving coil is located at the center inside the lens frame, and the multiple teslameters are equidistantly surrounding the receiving coil. The receiving coil and the capacitor structure together constitute the intraocular pressure data acquisition system, enabling the detection of intraocular pressure signals. The multiple teslameters and the magnetic thin-film sensing layer constitute the eye movement data acquisition system, enabling the detection of eye movement signals.

Description

Technical Field

[0001] This invention relates to the field of medical technology, specifically to a real-time monitoring system for intraocular pressure and eye movement when the eyes are closed. Background Technology

[0002] Early-stage glaucoma often presents with no symptoms or pain, but it slowly damages and destroys the optic nerve, leading to progressive vision loss. It is a leading cause of irreversible blindness worldwide. Currently, the only intervention to slow the progression of glaucoma is to lower intraocular pressure (IOP) to minimize optic nerve damage. Clinical trials using topical IOP-lowering medications have successfully reduced the risk of glaucoma. However, IOP varies with time of day and season, with nighttime IOP typically being higher than daytime IOP. Even if daytime measurements at a clinic or home show normal IOP, elevated IOP may occur during sleep without the patient noticing. Therefore, continuous 24-hour IOP monitoring is essential for glaucoma patients and suspected cases.

[0003] With the widespread use of smartphones, more and more people are becoming addicted to them. Excessive use of smartphones and tablets can affect vision, leading to eye diseases such as convergence insufficiency and strabismus, and even blindness. People with convergence insufficiency and strabismus typically experience symptoms such as headaches, blurred vision, fatigue, and loss of attention. There are many treatment options for convergence insufficiency, a typical example being convergence correction optics. This method requires patients to visit an optometrist's office for one hour each week for 12 weeks to assess both convergence and accommodation. However, this approach is time-consuming and expensive.

[0004] In recent years, researchers have combined flexible corneal contact lenses with intelligent medical systems, using them as a minimally invasive diagnostic platform to acquire patients' physiological information in real time, playing an important role in intraocular pressure and eye movement monitoring. Chinese patent application number 202111141483.3 discloses an invention entitled "A Flexible Multifunctional Corneal Contact Lens Based on γ-Fe2O3@NiO Magnetic Oxide Nanosheets," which uses γ-Fe2O3@NiO magnetic oxide nanosheet material. By combining this material with an electrochemical signal acquisition system, an external metal coil, and a teslameter, it simultaneously detects three biological signals: nystagmus, intraocular pressure, and glucose signals. However, in practical applications, it has been found that when testing with the eyes open, this flexible multifunctional contact lens exhibits low resolution and sensitivity in intraocular pressure (IOP), and low accuracy in eye movement, especially when the eyes are closed, as visual stimulation is relatively less influential, making it difficult to accurately capture information such as the amplitude and frequency of eye movement responses. Summary of the Invention

[0005] The purpose of this invention is to address the problems existing in the prior art by proposing a real-time dynamic monitoring system for intraocular pressure (IOP) and eye movement (EMD) with eyes closed. This system uses a sandwich-shaped capacitor structure made of magnetic thin film and copper as the sensing layer of a contact lens. Through this sensing layer, it simultaneously monitors two physiological signals: IOP and EMD. This effectively solves the problems of IOP resolution and sensitivity, and EMD accuracy in the aforementioned multifunctional contact lenses. Furthermore, this dynamic real-time monitoring system exhibits excellent stability, low cost, simple manufacturing process, and is easily mass-produced industrially.

[0006] To achieve the above objectives, the present invention adopts the following technical solution:

[0007] A real-time monitoring system for intraocular pressure and eye movement with eyes closed includes an internal multifunctional flexible corneal contact lens and an external data acquisition and processing system.

[0008] The internal multifunctional flexible corneal contact lens includes two encapsulation films and a sensing layer disposed between the two encapsulation films. The sensing layer includes a first sensing coil, a second sensing coil, and a magnetic thin film sensing layer. The magnetic thin film sensing layer is disposed between the first copper coil and the second copper coil to form a capacitor structure.

[0009] The external data acquisition and processing system includes a frame, a receiving coil and multiple Tesla meters located inside the frame. The receiving coil is located at the center inside the frame, and the multiple Tesla meters are equidistantly surrounding the receiving coil.

[0010] The receiving coil and capacitor structure together constitute an intraocular pressure data acquisition system to detect intraocular pressure signals; multiple teslameters and a magnetic thin-film sensing layer constitute an eye movement data acquisition system to detect eye movement signals.

[0011] Furthermore, the receiving coil, the first sensing coil, and the second sensing coil are all metal coils, preferably copper coils.

[0012] Furthermore, the first sensing coil, the magnetic thin film sensing layer, and the second sensing coil are of the same size and their center points coincide.

[0013] Furthermore, the first and second sensing coils are made of wavy copper wire, and the magnetic thin film sensing layer is made of wavy magnetic thin film to form a magnetic thin film coil.

[0014] Furthermore, within the wearable thickness range, the wider the wavy lines forming the magnetic thin film sensing layer and the thicker the layer, the higher the detection accuracy.

[0015] Furthermore, the first sensing coil, the magnetic thin film sensing layer, and the second sensing coil preferably have 3 to 5 turns and a line width of 2 mm.

[0016] Furthermore, the preferred material for the magnetic thin film sensing layer is a mixture of magnetic materials such as neodymium iron boron and iron tetroxide with a polymer curing agent.

[0017] Furthermore, the external data acquisition and processing system also includes an external PC module. The external PC module adopts a small chemical control motherboard, is connected to a small vector network analyzer via USB, and integrates a wireless network module to read and save intraocular pressure signal and eye movement signal detection results, and to interact with mobile devices.

[0018] Furthermore, the encapsulation film is made of a polymeric cured material with a Young's modulus of 10 kPa to 100 MPa, specifically PDMS (polydimethylsiloxane); the thickness of the encapsulation film is 50 μm to 60 μm.

[0019] The mechanism of this invention is as follows: The sensing layer includes a first sensing coil, a second sensing coil, and a magnetic thin-film sensing layer. The magnetic thin-film sensing layer is disposed between the first and second copper coils to form a capacitor structure. The capacitor structure is mutually coupled with the receiving coil. Changes in intraocular pressure cause changes in the curvature of the eyeball, resulting in deformation of the flexible corneal contact lens, affecting the mutual coupling, and causing a frequency shift, thus achieving intraocular pressure detection. The external eye movement data acquisition system is based on the magnetic induction intensity of the magnetic thin-film sensing layer. Eye movement causes displacement of the corneal contact lens, resulting in a change in the magnetic induction intensity of the corneal contact lens at the same position. The change in magnetic induction intensity is monitored by a Tesla meter to reflect eye movement.

[0020] The present invention, by adopting the above technical solution, has the following advantages:

[0021] 1) This invention enhances the sensitivity of the internal multifunctional flexible corneal contact lens through the design of a capacitor structure, enabling the detection of intraocular pressure changes as small as 1 mmHg, thus achieving dynamic intraocular pressure detection and physiological signal monitoring of eye movement. This corneal contact lens exhibits high sensitivity and stability, allowing for real-time detection with the eyes closed. It also boasts a simple structure, low cost, and ease of mass production.

[0022] 2) This invention provides a real-time intraocular pressure and eye movement detection system with eyes closed. It is simple to operate; a corneal contact lens is placed on the eyeball, and portable glasses integrating a copper receiving coil and a teslameter are worn to achieve real-time detection and transmission of intraocular pressure and eye movement data. Furthermore, it can accurately capture information such as the amplitude and frequency of eye movement responses even with eyes closed. Attached Figure Description

[0023] Figure 1 This is a system structure diagram of the present invention;

[0024] Figure 2The following is a physical image of a flexible multifunctional corneal contact lens for a real-time eye pressure and eye movement detection system with eyes closed, as shown in the embodiment. (a) The corneal contact lens is shown on an index finger, (b) The corneal contact lens is shown on a flat surface, and (c) The corneal contact lens is shown on an eyeball model.

[0025] Figure 3 This is an example of a method for preparing an internal multifunctional flexible corneal contact lens in a real-time intraocular pressure and eye movement detection system with eyes closed;

[0026] Figure 4 The following are experimental diagrams of the flexible multifunctional corneal contact lens intraocular pressure test of the real-time intraocular pressure and eye movement detection system for the example: (a) is the resonant frequency diagram under continuously varying intraocular pressure of 1 mmHg, (b) is the linear relationship diagram between resonant frequency and intraocular pressure, (c) is the resonant frequency diagram under dynamic changes in intraocular pressure, and (d) is the diagram of resonant frequency changing with time due to changes in intraocular pressure.

[0027] Figure 5 The figures show the performance curves of eye movement monitoring under closed-eye conditions, where (a) is an eye movement heatmap and (b) is an accuracy graph.

[0028] Figure label:

[0029] External data acquisition and processing system 1, teslameter 3 and copper receiving coil 4; internal multifunctional corneal contact lens 2, PDMS encapsulation film layer (6, 10), magnetic film layer (8), copper serpentine sensing layer (7, 9). Detailed Implementation

[0030] The present invention will now be described in detail with reference to the accompanying drawings and embodiments.

[0031] like Figure 1 As shown, this embodiment provides a real-time monitoring system for intraocular pressure and eye movement dynamics when the eyes are closed, including an internal multifunctional flexible corneal contact lens 2 and an external data acquisition and processing system 1.

[0032] The internal multifunctional flexible corneal contact lens 2 includes two encapsulation films (6, 10) and a sensing layer disposed between the two encapsulation films. The sensing layer includes a first sensing coil 7, a second sensing coil 9, and a magnetic thin-film sensing layer 8. The magnetic thin-film sensing layer 8 is disposed between the first copper coil 7 and the second copper coil 9 to form a capacitor structure. The external data acquisition and processing system 1 includes a lens frame 5, a receiving coil 4 disposed inside the lens frame, and multiple teslameters 3. The receiving coil 4 is located at the center inside the lens frame, and the multiple teslameters 3 are equidistantly surrounding the receiving coil 4. The receiving coil 4 and the capacitor structure together constitute an intraocular pressure data acquisition system to detect intraocular pressure signals. The multiple teslameters 3 and the magnetic thin-film sensing layer 8 constitute an eye movement data acquisition system to detect eye movement signals.

[0033] The encapsulation film described in this embodiment is made of a polymeric cured material with a Young's modulus of 10 kPa to 100 MPa, specifically PDMS (polydimethylsiloxane); the thickness of the encapsulation film is 50 μm to 60 μm. The receiving coil 4, the first sensing coil 7, and the second sensing coil 9 are all metal coils, preferably copper coils. The first sensing coil 7 and the second sensing coil 9 are formed by wavy copper wire, and the magnetic thin-film sensing layer 8 is formed by a wavy magnetic thin film coil. The first sensing coil 7, the magnetic thin-film sensing layer 8, and the second sensing coil 9 are the same size, and their center points coincide. The number of turns of the first sensing coil 7, the magnetic thin-film sensing layer 8, and the second sensing coil 9 is preferably 3 to 5, with a line width of 2 mm. The magnetic thin-film sensing layer is preferably made of a mixture of magnetic materials such as neodymium iron boron and iron(III) oxide with a polymeric cured material. Within the wearable thickness range, the wider the wavy line width and the thicker the magnetic thin-film sensing layer, the higher the detection accuracy.

[0034] In this embodiment, the data processing in the external data acquisition and processing system 1 is an external structure that can be implemented using existing technologies. The external data acquisition and processing system 1 also includes an external PC module, which uses a small chemical control motherboard and is connected to a small vector network analyzer via USB. It integrates a wireless network module to read and save the intraocular pressure signal and eye movement signal detection results, and to interact with mobile devices.

[0035] In use, the flexible corneal contact lens 2 is mutually coupled with the receiving coil 4 via a capacitor structure. Changes in intraocular pressure cause changes in the curvature of the eyeball, resulting in deformation of the contact lens 2, affecting the mutual coupling, and causing a frequency shift, thus completing the acquisition of intraocular pressure data. The external eye data acquisition system is based on the magnetic induction intensity of the magnetic thin-film sensing layer. Eye movement causes displacement of the corneal contact lens, resulting in changes in the magnetic induction intensity of the contact lens at the same location. The changes in magnetic induction intensity are monitored by a teslameter to complete the acquisition of eye movement data. The acquired intraocular pressure data and eye movement data are simultaneously sent to the external data processing system for calculation, then read and saved by the external PC module, and interact with the mobile device.

[0036] Figure 2 (a) Figure 2 (b) Figure 2 (c) are all actual photos of the internal flexible multifunctional corneal contact lens 2. Figure 3 The method for preparing a real-time intraocular pressure and eye movement detection system with eyes closed is demonstrated. For example... Figure 3 As shown, the real-time intraocular pressure and eye movement detection system with eyes closed consists of two parts: an internal flexible multifunctional corneal contact lens 2 and an external data acquisition and processing system 1. The specific operation steps are as follows:

[0037] Fabrication of internal flexible multifunctional corneal contact lenses

[0038] a1. Prepare the first sensing coil 7 and transfer it into PDMS material:

[0039] A water-soluble adhesive is applied to a copper foil, and a laser cutter ablates the material into a wavy structure, which is then coiled into a circle. The number of coils is 3 to 5, and in this embodiment, 5 coils are preferred.

[0040] PDMS solution A and solution B were mixed at a mass ratio of 1:10 and then mixed in a mixer to obtain a mixed liquid. 1.5 ml of the mixed liquid was dropped onto a glass slide and spin-coated using a spin coater to obtain PDMS material. The spin coater speed was 1000 rpm and the spin coating time was 20 s.

[0041] Take a new glass slide, place the spiral coil obtained in a1 on the glass slide, heat at 60°C for 20 minutes, and then transfer the coil into the PDMS material obtained in a1.

[0042] a2. Repeat a1 to prepare the second sensing coil 9 and transfer it into PDMS material;

[0043] a3. Fabrication of magnetic thin film sensor 8, the specific operation steps are as follows;

[0044] a3.1. Mix PDMS solution A and solution B with magnetic particles at a mass ratio of 1:10:3, and then mix them in a mixer to obtain a mixed liquid.

[0045] a3.2. Take 1.5 ml of the mixed liquid obtained in a3 and drop it onto a 5×5 cm glass slide. Use a spin coater to spin coat the liquid at a speed of 1000 rpm for 40 seconds.

[0046] a3.3 Place the glass slide that has been spin-coated in a3.2 into the sample box, attach 5×5cm magnets to the bottom and top of the sample box respectively, and cure in a 60℃ oven for 1 hour to obtain a magnetic thin film layer; then use an ultraviolet nanosecond laser cutting machine to cut it into a ring structure with wavy edges.

[0047] a4. Place the annular structure obtained in a3.3 between the upper and lower coils, and place it in the corneal contact lens mold. Inject PDMS mixed liquid into it, and then place it on a hot table to cure at 60°C for 10 hours. The PDMS mixed liquid is made by uniformly mixing liquid A and liquid B at a mass ratio of 1:10.

[0048] a5. Peel off the sample obtained in step a4 to obtain the internal flexible multifunctional corneal contact lens. The actual object is as follows: Figure 2 As stated above.

[0049] The specific process for preparing an external data acquisition and processing system is as follows:

[0050] In the fabrication of the data acquisition component within the external data acquisition and processing system, a metal coil is integrated at the center of the interior of a square lens frame. Multiple teslameters are arranged around the outer edge of the metal coil, ultimately resulting in an internal flexible multifunctional corneal contact lens. Figure 2 As shown in (a), (b), and (c).

[0051] In this embodiment, the internal flexible multifunctional corneal contact lens 2 forms a capacitive structure through a first sensing coil 7, a magnetic thin-film sensing layer 8, and a second sensing coil 9. During detection, the first sensing coil 7, the magnetic thin-film sensing layer 8, the second sensing coil 9, and the second sensing coil 9 in the capacitive structure form an RLC resonant circuit, resulting in higher resolution and sensitivity, enabling intraocular pressure detection even with the eyes closed. This facilitates accurate intraocular pressure detection. By adding a magnetic thin film to the capacitive structure, multifunctional monitoring of intraocular pressure and eye movement is achieved. Compared to existing resistive flexible multifunctional corneal contact lenses, the flexible multifunctional corneal contact lens 2 of this embodiment does not require chip adjustment. Compared to existing inductive structures, the flexible multifunctional corneal contact lens 2 of this embodiment has higher resolution and sensitivity.

[0052] The quantity processing portion of both the external data acquisition and processing systems is an external structure. This can be achieved using existing technologies.

[0053] To demonstrate the effectiveness of the above-mentioned real-time monitoring system for intraocular pressure and eye movement with eyes closed, this embodiment conducts experimental verification.

[0054] Experiment 1

[0055] The experimental animals were anesthetized and their pupils dilated; an absolute pressure gauge, an infusion pump, and a scalp vein needle were connected via a three-way stopcock; the scalp vein needle was inserted into the posterior chamber of the rabbit's eyeball to perform an intraocular pressure test. The test results are as follows: Figure 4 (a) Figure 4 (b) Figure 4 (c) Figure 4 As shown in (d), the corneal curvature radius changes with intraocular pressure (IOP), causing the flexible contact lens to deform. This alters the mutual coupling frequency of the receiving coil. Continuous IOP testing on rabbits demonstrates that this flexible contact lens can accurately detect IOP changes as small as 1 mmHg, showcasing its excellent performance. Furthermore, it can detect dynamic IOP changes, indicating the stability and accuracy of the contact lens.

[0056] Experiment 2

[0057] An eyeball model covered with goosebumps was used to simulate eye-closed conditions for eye movement detection. The specific principle is as follows: eight Tesla meters, each embedded within a pair of eyeglasses, record changes in the magnetic field strength of the contact lens in eight directions. Eye movements cause changes in the position of the contact lens, thus inducing changes in the magnetic field strength. Then, paradigms and algorithms are used to determine and analyze the magnetic field strength. Figure 5 (a) By continuously moving the eyeball in real time in different directions and recording the changes in the values ​​of an external Tesla meter, the results show that the actual observation of the numbers is highly consistent with the corresponding magnetic intensity distribution. Figure 5 (b) Ten magnetic tests were conducted on the NdFeB magnetic thin film as a magnetic sensor, and the accuracy rate was 96.25%, which is high and has good reproducibility.

[0058] The above embodiments are merely preferred embodiments of the present invention and are not limited to the invention. It should be noted that those skilled in the art, based on the technical teachings provided by the present invention, may make other similar improvements, all of which can achieve the objectives of the present invention and should be included within the scope of protection of the present invention.

Claims

1. A real-time dynamic monitoring system for intraocular pressure and eye movement with eyes closed, comprising an internal multifunctional flexible corneal contact lens and an external data acquisition and processing system, characterized in that: The internal multifunctional flexible corneal contact lens includes two encapsulation films and a sensing layer disposed between the two encapsulation films. The sensing layer includes a first sensing coil, a second sensing coil, and a magnetic thin film sensing layer. The magnetic thin film sensing layer is disposed between the first sensing coil and the second sensing coil to form a capacitor structure. The external data acquisition and processing system includes a frame, a receiving coil, and multiple Tesla meters. The receiving coil is located at the center inside the frame, and the multiple Tesla meters are equidistantly surrounding the receiving coil. The receiving coil and capacitor structure together constitute an intraocular pressure data acquisition system to detect intraocular pressure signals; multiple teslameters and a magnetic thin-film sensing layer constitute an eye movement data acquisition system to detect eye movement signals.

2. The real-time monitoring system for intraocular pressure and eye movement with eyes closed as described in claim 1, characterized in that: The receiving coil, the first sensing coil, and the second sensing coil are all metal coils.

3. The real-time monitoring system for intraocular pressure and eye movement with eyes closed as described in claim 1, characterized in that: The first sensing coil, the magnetic thin film sensing layer, and the second sensing coil are the same size and their center points coincide.

4. The real-time monitoring system for intraocular pressure and eye movement with eyes closed as described in claim 2, characterized in that: Both the first and second sensing coils are surrounded by wavy copper wires, and the magnetic thin film sensing layer is a magnetic thin film coil surrounded by wavy magnetic thin film.

5. The real-time monitoring system for intraocular pressure and eye movement with eyes closed as described in claim 2, characterized in that: The first sensing coil, the magnetic thin film sensing layer, and the second sensing coil have 3 to 5 turns and a line width of 2 mm.

6. The real-time monitoring system for intraocular pressure and eye movement with eyes closed as described in claim 1, characterized in that: The magnetic thin film sensing layer is made of a mixture of neodymium iron boron and a polymer curing agent, or a mixture of iron tetroxide and a polymer curing agent.

7. The real-time monitoring system for intraocular pressure and eye movement with eyes closed as described in claim 1, characterized in that: The encapsulation film is made of a high-molecular-weight cured material with a Young's modulus of 10 kPa to 100 MPa, specifically polydimethylsiloxane; the thickness of the encapsulation film is 50 μm to 60 μm.

8. A real-time monitoring system for intraocular pressure and eye movement dynamics with eyes closed, as described in any one of claims 1 to 7, characterized in that: The external data acquisition and processing system also includes an external PC module. The external PC module uses a small chemical control motherboard, which is connected to a small vector network analyzer via USB. It integrates a wireless network module to read and save intraocular pressure signal and eye movement signal detection results, and to interact with mobile devices.

Images