Sclera lens

Abstract

The invention provides a sclera lens. The sclera lens comprises an optical area, a transition area and a sclera contact area which are sequentially connected from inside to outside in the radial direction of the sclera lens. The transition area is arranged around the optical area, and the sclera contact area is arranged around the transition area; the sclera contact area is used for being attached to the sclera of the eyeball; tear storage spaces can be formed between the optical area and the cornea of the eyeball and between the transition area and the cornea of the eyeball; a wireless communication unit and a plurality of sensors are embedded in the sclera contact area, each sensor is provided with a sensing surface, and the sensing surfaces extend from the sclera contact area to the tear storage space and are attached to the transition area; the wireless communication unit is connected with the plurality of sensors and receives and sends data signals of the sensors; the data signals comprise a first electric signal for identifying ROS concentration, a second electric signal for identifying impedance or osmotic pressure and a third electric signal for identifying PH value. According to the technical scheme, tear detection is achieved, the wireless communication technology and the sensor technology are fused, and a user can conveniently obtain various key parameters of the tear.

Description

Technical Field

[0001] This application relates to the field of intelligent medical technology, and in particular to a scleral lens technology. Background Technology

[0002] The term "scleral lens" originates from its function: a contact lens that covers the cornea and limbus. Designed for daytime wear, these lenses are made of a highly oxygen-permeable rigid material, similar to traditional RGP lenses. However, a significant characteristic of scleral lenses is their larger diameter, allowing them to completely cover the iris and part of the sclera, and their placement above the sclera avoids direct contact between the lens and the cornea. Furthermore, these lenses are suitable for a wider range of people.

[0003] The larger diameter of scleral lenses allows them to rest completely on the sclera, penetrating the bulbar conjunctiva and maintaining a non-contact state with the cornea and limbus, thus creating a gap between the lens and the cornea and limbus. By filling this gap with preservative-free saline solution, a nearly closed fluid pool can be constructed between the anterior corneal surface and the lens. For patients with certain corneal diseases, this fluid layer can effectively correct irregularities on the corneal surface and provide a continuously moist environment for the damaged corneal surface, promoting its repair process.

[0004] For patients with dry eye syndrome, especially those with severe dry eye syndrome who do not respond well to drug treatment and physical therapy, scleral lenses can effectively relieve symptoms.

[0005] The significant advantage of scleral lenses lies in their ability to transcend the limitations of the cornea. By creating a fluid reservoir between the lens and the cornea, they can fill with saline solution or artificial tears to create a moist and comfortable environment for patients with dry eye, effectively relieving ocular surface symptoms. Furthermore, because the lens does not directly contact the cornea, it reduces mechanical friction, protects the cornea from potential impacts from the eyelids and other external factors, and lowers the risk of other complications.

[0006] However, despite the many advantages of scleral lenses, their technical limitations cannot be ignored.

[0007] Tears, as a vital protective barrier on the surface of the eye, are closely related to eye health. Therefore, comprehensive tear analysis is crucial for ophthalmologists to assess patients' eye health and develop treatment plans. Currently, scleral lenses lack the ability to directly detect tear production, limiting their widespread application in ophthalmic diagnosis and treatment. Doctors often need to combine scleral lens examinations with other methods to indirectly assess tear condition, increasing diagnostic complexity and uncertainty. Developing a novel ophthalmic examination tool that integrates scleral observation and tear production detection is of great significance for improving the accuracy and efficiency of ophthalmic disease diagnosis and reducing the risk of misdiagnosis. Summary of the Invention

[0008] To address the aforementioned technical problems, this application proposes a scleral lens capable of detecting and transmitting tear fluid. The scleral lens includes an optical zone, a transition zone, and a scleral contact zone, connected radially from the inside out. The transition zone surrounds the optical zone, and the scleral contact zone surrounds the transition zone. The scleral contact zone is used to abut against the sclera of the eyeball. Both the optical zone and the transition zone can form a tear fluid retention space between themselves and the cornea of ​​the eyeball. A wireless communication unit and multiple sensors are embedded in the scleral contact zone. Each sensor has a sensing surface extending from the scleral contact zone to the tear fluid retention space and attached to the transition zone. The wireless communication unit is connected to the multiple sensors and receives and transmits data signals from the sensors. The data signals include a first electrical signal indicating ROS concentration, a second electrical signal indicating impedance or osmotic pressure, and a third electrical signal indicating pH value.

[0009] Optionally, the multiple sensors include: a ROS sensor, the ROS sensor including: a first reference electrode and at least one first working electrode; the first working electrode is alternately coated with cytochrome C and polyaniline (sulfonic acid);

[0010] When ROS is present, the superoxide (O2-) in ROS reacts with cytochrome C on the first working electrode to generate water and iron ions, causing the potential change of the first working electrode to generate a first electrical signal; the first electrical signal and the first reference signal of the first reference electrode are transmitted to the target end via the wireless communication unit.

[0011] Optionally, the multiple sensors include: an impedance sensor, which includes multiple second working electrodes, through which the impedance of the tear fluid along the surface of the second working electrodes is measured and a second electrical signal is generated.

[0012] Optionally, the multiple sensors include: a pH sensor, which includes: a second reference electrode and a glass electrode.

[0013] The potential signals obtained from the second reference electrode and the glass electrode are used as a third electrical signal to identify the pH value and are transmitted to the target end via a wireless communication unit; wherein, the target end determines the pH value of the tear fluid by the potential difference between the second reference electrode and the glass electrode.

[0014] Optionally, the first reference electrode and the first working electrode are distributed on the first flexible surface; the second working electrode is distributed on the second flexible surface; and the second reference electrode and the glass electrode are distributed on the third flexible surface.

[0015] The first flexible surface, the second flexible surface, and the third flexible surface extend from the scleral contact area to the tear reservoir and are attached to the transition area, and each of them has an electrode side that is in electrical contact with the tear.

[0016] Optionally, the scleral contact area has a double-layer structure, with one end of the first flexible surface, the second flexible surface and the third flexible surface respectively embedded between the double-layer structure, and the other end extending from the double-layer structure to the tear reservoir and attached to the transition area; in the double-layer structure, the wireless communication unit is electrically connected to the ROS sensor, the impedance sensor and the pH sensor respectively.

[0017] Optionally, the dual-layer structure also includes a micro-power supply, which is connected to the ROS sensor, impedance sensor, pH sensor, and wireless communication unit.

[0018] Optionally, a first isolation surface is provided in the scleral contact area along the extension direction of the first flexible surface, and a first support strip is provided in the transition area along the extension direction of the first flexible surface. The first isolation surface and the first support strip are fixed, so that a tear film storage space is formed between the first isolation surface and the cornea, and a first tear film storage sub-space is formed between the first isolation surface and the transition area, opening towards the optical area. The first flexible surface is placed in the first tear film storage sub-space.

[0019] Optionally, a second isolation surface is provided in the scleral contact area along the extension direction of the second flexible surface, and a second support strip is provided in the transition area along the extension direction of the second flexible surface. The second isolation surface and the second support strip are fixed, so that a tear film retention space is formed between the second isolation surface and the cornea, and a second tear film retention sub-space is formed between the second isolation surface and the transition area, opening towards the optical area. The first flexible surface is placed in the second tear film retention sub-space.

[0020] Optionally, a third isolation surface is provided in the scleral contact area along the extension direction of the third flexible surface, and a third support strip is provided in the transition area along the extension direction of the third flexible surface. The third isolation surface and the third support strip are fixed so that a tear film retention space is formed between the third isolation surface and the cornea, and a third tear film retention sub-space is formed between the third isolation surface and the transition area, opening towards the optical area. The third flexible surface is placed in the third tear film retention sub-space.

[0021] Through the above technical solution, the scleral lens of this application not only achieves comprehensive tear film detection, but also cleverly integrates wireless communication and sensor technology, enabling users to conveniently obtain various key parameters of the tear film, providing strong support for the prevention, diagnosis, and treatment of ophthalmic diseases. Specifically, its technical effects are mainly reflected in the following aspects:

[0022] 1. Real-time monitoring and precise measurement: The ROS sensor, impedance sensor, and pH sensor built into the scleral lens can capture key information such as superoxide concentration, impedance or osmotic pressure, and pH value in the tear film in real time. Precise measurement of these parameters provides doctors with a wealth of diagnostic information, helping to more accurately assess the health of the eyes.

[0023] 2. Wireless transmission and convenient operation: With the help of the wireless communication unit, the scleral lens can transmit the sensor data signal to the target end (such as a smartphone, tablet or professional medical device) in real time. Users can obtain test results without directly touching the scleral lens, which greatly improves the convenience and safety of use.

[0024] 3. Personalized design and comfortable wear: The scleral lens adopts a multi-layer structure design to ensure the stable embedding of the sensor and wireless communication unit. At the same time, the combination of the isolation surface and the support strip provides stable support for the tear film retention space, allowing the scleral lens to fit closely to the eyeball and avoiding direct contact between the sensor and the cornea or sclera, thus ensuring the accuracy of the detection and the comfort of wearing.

[0025] 4. Multi-sensor collaborative operation: Through the collaborative action of multiple sensors, the scleral lens of this application can comprehensively cover various physicochemical properties of tears, avoiding the risk of misdiagnosis that may be caused by single parameter detection, and improving the comprehensiveness and accuracy of diagnosis.

[0026] 5. Long battery life and low power consumption: The built-in micro power supply provides stable power support for the scleral lens, while the optimized circuit design enables low power consumption operation, extending the service life of the device and reducing the user's maintenance costs.

[0027] The scleral lens proposed in this application provides a novel and efficient detection method for the ophthalmological medical field, which is expected to promote the early diagnosis and precision treatment of eye diseases and improve the overall level of ophthalmological medical care. Attached Figure Description

[0028] Figures 1 to 2 A schematic diagram of the structure of a scleral lens provided for an embodiment of this application;

[0029] Figure 3 A schematic diagram of wearing scleral lenses provided for embodiments of this application;

[0030] Figure 4 A schematic diagram of the hardware connection of a scleral lens provided for an embodiment of this application.

[0031] Figure label: Optical region 1, transition region 2, scleral contact region 3; wireless communication unit 4; ROS sensor 5; first reference electrode 51, first working electrode 52; impedance sensor 6; second working electrode 61; pH sensor 7; second reference electrode 71; glass electrode 72; micro power supply 8; first isolation surface 9; first support strip 91; second isolation surface 10; second support strip 101; third isolation surface 11; second support strip 111; first flexible surface 20; third flexible surface 30; tear fluid 100. Detailed Implementation

[0032] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0033] like Figure 1-4 As shown, an embodiment of this application provides a scleral lens, which includes an optical zone, a transition zone, and a scleral contact zone connected radially from the inside to the outside. The transition zone surrounds the optical zone, and the scleral contact zone surrounds the transition zone. The scleral contact zone is used to abut against the sclera of the eyeball. Both the optical zone and the transition zone can form a tear retention space between themselves and the cornea of ​​the eyeball. A wireless communication unit and multiple sensors are embedded in the scleral contact zone. Each of the multiple sensors has a sensing surface that extends from the scleral contact zone to the tear retention space and is attached to the transition zone. The wireless communication unit is connected to the multiple sensors and receives and transmits data signals from the sensors. The data signals include a first electrical signal indicating ROS concentration, a second electrical signal indicating impedance or osmotic pressure, and a third electrical signal indicating pH value.

[0034] Optionally, the multiple sensors include a ROS sensor, which comprises a first reference electrode and at least one first working electrode; the first working electrode is alternately coated or alternately coated with cytochrome C and polyaniline (sulfonic acid); the polyaniline (sulfonic acid) layer is used to detect ROS concentration, while the cytochrome C layer serves as an electron transport medium. During the use of the scleral lens, the polyaniline (sulfonic acid) layer reacts with the ROS in the tear fluid to generate an electrical signal, which is transmitted to the wireless communication unit via the first working electrode. The wireless communication unit converts these signals into digital signals and transmits them to an external device, such as a smartphone or medical monitoring system, via a built-in wireless module, thereby enabling real-time monitoring of the ROS concentration in the tear fluid.

[0035] When ROS is present, the superoxide (O2-) in ROS reacts with cytochrome C on the first working electrode to generate water and iron ions, causing the potential change of the first working electrode to generate a first electrical signal; the first electrical signal and the first reference signal of the first reference electrode are transmitted to the target end via the wireless communication unit.

[0036] The changed potential is then detected by the polyaniline (sulfonic acid) layer, which, as part of an electrochemical sensor, responds to changes in ROS concentration. Due to the excellent electrochemical activity of the polyaniline (sulfonic acid) layer, it effectively converts the chemical signal into an electrical signal, which is then transmitted to the wireless communication unit via the first working electrode. Upon receiving these signals, the wireless communication unit performs necessary signal processing, such as amplification and filtering, to ensure the accuracy and reliability of the signal. The processed signal is then converted into digital form and transmitted to an external device, such as a smartphone or medical monitoring system, via a built-in wireless module. In this way, users or medical professionals can monitor the ROS concentration in tears in real time, thereby assessing eye health or diagnosing diseases.

[0037] To ensure the accuracy and reliability of the measurement results, the ROS sensor is also equipped with a first reference electrode. This electrode serves as a reference point, and its potential remains relatively stable, unaffected by external environmental factors. By comparing it with the first electrical signal generated by the first working electrode, the first reference signal emitted by the first reference electrode can effectively eliminate systematic errors in the measurement process and improve the overall measurement accuracy.

[0038] Electrical signals and reference signals are transmitted wirelessly in real time to the target device—which could be a doctor's computer, mobile phone, or telemedicine platform—via a built-in wireless communication unit. This instant communication capability allows doctors to access patients' eye health data anytime, anywhere, enabling timely intervention and precise treatment.

[0039] Furthermore, it's worth mentioning that the design of the scleral lens and its ROS sensor fully considers patient comfort and safety. The choice of flexible surface materials, the miniaturization of the electrodes, and the application of wireless transmission technology are all aimed at minimizing disruption and discomfort to patients' daily lives. At the same time, rigorous biocompatibility testing and clinical trials ensure the safety and reliability of the scleral lens during use.

[0040] Furthermore, to enhance the sensitivity and selectivity of the ROS sensor, this application introduces a second functionalized material. This material can selectively adsorb or repel specific types of ROS molecules, thereby further improving the detection capability for specific ROS. Specifically, a graphene film modified with gold nanoparticles can be coated between the cytochrome C and polyaniline (sulfonic acid) coating of the first working electrode. The gold nanoparticles not only possess excellent conductivity but also increase the surface area of ​​the electrode, promoting the contact reaction between ROS and cytochrome C; while the graphene film, with its unique two-dimensional structure and excellent electron mobility, further accelerates the electron transfer process, improving the sensor's response speed.

[0041] When superoxide (O2-) in ROS passes through the graphene film and comes into contact with cytochrome C, the reaction still produces water and iron ions. However, due to the synergistic effect of graphene and gold nanoparticles, the reaction becomes more efficient and rapid. This change is directly reflected in the potential of the first working electrode, generating a more significant first electrical signal. This enhanced electrical signal not only improves the detection sensitivity but also enables the sensor to produce a reliable response in the presence of lower concentrations of ROS.

[0042] Specifically, the graphene film is composed of graphene nanosheets, which serve as a conductive reinforcement layer and are positioned between the cytochrome C and the polyaniline (sulfonic acid) film. Graphene can effectively promote electron transport between the electrode and the active layer, reduce interfacial resistance, thereby accelerating the reaction rate and improving the signal-to-noise ratio.

[0043] In the preparation process, we first dispersed a small amount of graphene nanosheets (containing gold nanoparticles) in a solvent to form a stable suspension. Then, this suspension was uniformly coated onto the surface of the first working electrode, which was already coated with cytochrome C, using spin coating or drop coating methods. After the solvent evaporated, the graphene nanosheets firmly adhered to the electrode, forming an almost transparent conductive layer.

[0044] Next, we used the same coating technique again to coat the graphene layer with a polyaniline (sulfonic acid) membrane. The sulfonic acid groups of polyaniline (sulfonic acid) not only increased the hydrophilicity and biocompatibility of the membrane, but also enabled it to form a stronger interaction with cytochrome C molecules, further stabilizing the structure of the entire sensing interface.

[0045] Following these improvements, the electrochemical sensor exhibited significantly enhanced performance in detecting target biomolecules. The introduction of graphene films modified with gold nanoparticles not only greatly improved the sensor's current response but also broadened its operating potential window, enabling the sensor to maintain stable operation under a wider range of conditions. Simultaneously, the synergistic effect between cytochrome C and the polyaniline (sulfonic acid) membrane was further strengthened, improving the sensor's selectivity and sensitivity to target analytes.

[0046] Furthermore, to more comprehensively monitor changes in the type and concentration of ROS, the ROS sensor can be expanded into a sensor array. In this array, each sensor unit can be optimized for different types of ROS, for example, by adjusting the coating material on the working electrode or changing the configuration of the reference electrode. Thus, when different types of ROS coexist, the sensor array can simultaneously capture and distinguish the changes in their respective electrical signals. Finally, the electrical signal and the reference signal are transmitted to the target terminal in real time and accurately via a wireless communication unit. At the target terminal, the received signals are analyzed and processed to achieve real-time monitoring and early warning of ROS type, concentration, and dynamic changes. Specifically, the target terminal issues an alarm when the ROS threshold exceeds a warning value; ROS threshold: generates 0. 2- The rate of spontaneous disproportionation to generate H2O2 is greater than 5 x 10. 5 M -1 S -1 This means that the ROS level exceeds the warning threshold.

[0047] Optionally, the multiple sensors include an impedance sensor comprising multiple second working electrodes. These electrodes measure the impedance of the tear fluid along their surfaces and generate a second electrical signal. Specifically, the multiple second working electrodes are arranged in an array to achieve comprehensive and accurate monitoring of impedance changes as the tear fluid flows through the region. When the tear fluid covers and flows across these second working electrodes, its electrolyte components interact with the electrode surfaces, causing a significant change in the resistance between the electrodes. This change directly maps to the osmotic pressure characteristics of the tear fluid, as the osmotic pressure determines the distribution and migration rate of ions in the solution, thus directly affecting the impedance value. By capturing and analyzing these subtle impedance fluctuations, relevant information about the tear fluid osmotic pressure can be obtained. Specifically, analysis can be performed at the target end, which has a model relating tear fluid impedance to osmotic pressure. The normal osmotic pressure is 295-309 mOsm / L; exceeding this value triggers an alarm at the target end.

[0048] To ensure the accuracy and reliability of the measurement results, the impedance sensor is also equipped with a reference electrode. This electrode is used to provide a stable potential reference, resist interference from external environmental factors, and ensure the accuracy and repeatability of the data.

[0049] Optionally, the multiple sensors include: a pH sensor, which includes: a second reference electrode and a glass electrode.

[0050] The potential signals acquired by the second reference electrode and the glass electrode are used as a third electrical signal to identify the pH value and transmitted to the target terminal via a wireless communication unit. The target terminal determines the pH value of the tear fluid based on the potential difference between the second reference electrode and the glass electrode. The pH value range is 5.2-8.35, with an average of 7.35 (±10%, exceeding which is considered a warning line). When the pH value exceeds the warning line, the target terminal issues an alarm.

[0051] Specifically, the glass electrode, serving as the measuring electrode, has a surface covered with a glass film sensitive to hydrogen ions. When in contact with tear fluid, this glass film exchanges hydrogen ions with the aqueous solution, generating a potential directly related to the solution's pH value. The second reference electrode, serving as a reference standard, has a stable and known potential, used to compare its potential with that of the glass electrode, thereby calculating the potential difference between the two.

[0052] In practical applications, the second reference electrode and the glass electrode begin working upon contact with the tear fluid. They each acquire the potential signal at their respective locations and use these signals as a third electrical signal to indicate the pH value. This signal is then transmitted in real-time and accurately to the target device—typically a professional medical testing device or a smartphone application—via a built-in wireless communication unit. At the target device, these electrical signals are processed and converted into a straightforward pH reading, allowing doctors to accurately determine the acidity or alkalinity of the patient's tears.

[0053] Optionally, the first reference electrode and the first working electrode are distributed on the first flexible surface; the second working electrode is distributed on the second flexible surface; and the second reference electrode and the glass electrode are distributed on the third flexible surface.

[0054] The first flexible surface, the second flexible surface, and the third flexible surface extend from the scleral contact area to the tear reservoir and are attached to the transition area, and each of them has an electrode side that is in electrical contact with the tear.

[0055] Optionally, the scleral contact area has a double-layer structure, with one end of the first flexible surface, the second flexible surface and the third flexible surface respectively embedded between the double-layer structure, and the other end extending from the double-layer structure to the tear reservoir and attached to the transition area; in the double-layer structure, the wireless communication unit is electrically connected to the ROS sensor, the impedance sensor and the pH sensor respectively.

[0056] Optionally, the dual-layer structure also includes a micro-power supply, which is connected to the ROS sensor, impedance sensor, pH sensor, and wireless communication unit.

[0057] Optionally, a first isolation surface extends along the extension direction of the first flexible surface in the scleral contact area, and a first support strip is provided in the transition area along the extension direction of the first flexible surface. The first isolation surface and the first support strip are fixed, forming a tear film retention space between the first isolation surface and the cornea, and forming a first tear film retention sub-space opening towards the optical zone between the first isolation surface and the transition area; the first flexible surface is placed in the first tear film retention sub-space. Specifically, the first isolation surface is designed and extended along the extension direction of the first flexible surface in the scleral contact area. Simultaneously, a first support strip is provided in the transition area along the extension direction of the first flexible surface. This first isolation surface and the first support strip are connected by a fixed method to ensure a stable bond between them. This design creates a specific tear film retention space between the first isolation surface and the cornea, and constructs a first tear film retention sub-space opening towards the optical zone between the first isolation surface and the transition area. The first flexible surface is carefully placed within this first tear film retention sub-space to prevent friction between the sensor and the cornea or sclera. This design aims to optimize wearing comfort, improve visual quality, and ensure eye health. Specifically, the tear film retention space between the first insulating surface and the cornea helps maintain corneal moisture, reduces friction, and thus improves wearing comfort. At the same time, this design also helps stabilize the lens position, reducing lens movement on the eyeball and further improving visual quality.

[0058] The presence of the first tear film storage subspace creates a good liquid buffer layer between the transition zone and the cornea. This not only increases the stability of the overall structure but also reduces the irritation caused by direct contact between the sensor and the cornea, which is beneficial to eye health.

[0059] Optionally, a second isolation surface extends along the extension direction of the second flexible surface in the scleral contact area, and a second support strip is provided in the transition area along the extension direction of the second flexible surface. The second isolation surface and the second support strip are fixed, so that a tear film retention space is formed between the second isolation surface and the cornea, and a second tear film retention sub-space opening towards the optical zone is formed between the second isolation surface and the transition area; the first flexible surface is placed in the second tear film retention sub-space. Specifically, a second isolation surface is provided in the scleral contact area along the extension direction of the second flexible surface, and this isolation surface is designed to form a specific structural layout. At the same time, a second support strip is provided in the transition area along the extension direction of the second flexible surface to ensure the stability of the structure. The second isolation surface and the second support strip are fixedly connected. This design allows a tear film retention space to be formed between the second isolation surface and the cornea, and at the same time, a second tear film retention sub-space opening towards the optical zone is formed between the transition area and the second isolation surface. It is worth noting that the first flexible surface is cleverly placed in this second tear film retention sub-space to avoid the first flexible surface from coming into contact with the sclera or cornea. Furthermore, to further enhance wearing comfort and functionality, a series of microchannels can be created between the first and second flexible surfaces. These microchannels effectively promote the flow of tears between them, thereby keeping the eyes moist while also helping to remove any impurities or foreign objects that may accumulate.

[0060] In addition, considering individual differences and comfort needs of wearers, a soft and skin-friendly material can be used to cover or coat the second flexible surface, especially in the area that contacts the eyelids. This not only reduces irritation to the eyelids during wear but also improves the wearer's overall comfort.

[0061] Optionally, a third isolation surface is provided in the scleral contact area along the extension direction of the third flexible surface, and a third support strip is provided in the transition area along the extension direction of the third flexible surface. The third isolation surface and the third support strip are fixed, so that a tear film retention space is formed between the third isolation surface and the cornea, and a third tear film retention sub-space opening towards the optical zone is formed between the third isolation surface and the transition area; the third flexible surface is placed in the third tear film retention sub-space. Specifically, optionally, a third isolation surface is added in the scleral contact area along the extension direction of the third flexible surface, which is designed to form a specific structural layout. At the same time, a third support strip is provided in the transition area along the extension direction of the third flexible surface, and the support strip is stably connected to the third isolation surface. This design ensures that a tear film retention space can be constructed between the third isolation surface and the cornea, and that a third tear film retention sub-space opening towards the optical zone is formed between this space and the transition area. It is worth noting that the third flexible surface is cleverly placed in this third tear film retention sub-space to avoid the third flexible surface contacting the cornea or sclera, causing eye abrasion or affecting wearing comfort. Furthermore, the design of the third tear reservoir helps maintain corneal moisture and comfort. Its opening facing the optical zone ensures even distribution of tears across the corneal surface, reducing dry eye symptoms caused by tear loss or uneven distribution. Simultaneously, the presence of the third support strip provides additional stability and support to the entire scleral contact lens, ensuring the lens is correctly positioned in the eye and reducing visual discomfort caused by lens displacement or rotation.

[0062] Furthermore, to further enhance wearing comfort and fit, the material and shape of the third protective layer can be optimized. For example, soft and breathable materials can be used to reduce pressure on the cornea; at the same time, the curvature and shape of the third protective layer can be adjusted according to individual corneal morphological differences to achieve a more fitting and natural wearing effect.

[0063] Through the above technical solution, the scleral lens of this application not only realizes comprehensive detection of tear film, but also cleverly integrates wireless communication and sensor technology, enabling users to conveniently obtain various key parameters of tear film, providing strong support for the prevention, diagnosis and treatment of ophthalmic diseases.

[0064] The built-in ROS sensor, impedance sensor, and pH sensor in the scleral lens can capture key information such as superoxide concentration, impedance or osmotic pressure, and pH value in the tear film in real time. Precise measurement of these parameters provides doctors with a wealth of diagnostic information, helping to more accurately assess the health of the eyes.

[0065] With the help of a wireless communication unit, the scleraoscope can instantly transmit sensor data signals to the target device (such as a smartphone, tablet, or professional medical device), allowing users to obtain test results without directly touching the scleraoscope, greatly improving the convenience and safety of use.

[0066] The scleral lens adopts a multi-layer structure design to ensure the stable embedding of the sensor and wireless communication unit. At the same time, the combination of the isolation surface and the support strip provides stable support for the tear film retention space, allowing the scleral lens to fit closely to the eyeball and avoiding direct contact between the sensor and the cornea or sclera, thus ensuring the accuracy of the detection and the comfort of wearing it.

[0067] Through the synergistic effect of multiple sensors, the scleral lens of this application can comprehensively cover various physicochemical properties of tears, avoiding the risk of misdiagnosis that may be caused by single parameter detection, and improving the comprehensiveness and accuracy of diagnosis.

[0068] The built-in micro-power supply provides stable power to the scleral lens, while optimized circuit design enables low-energy operation, extending the lifespan of the device and reducing user maintenance costs.

[0069] The scleral lens proposed in this application provides a novel and efficient detection method for the ophthalmological medical field, which is expected to promote the early diagnosis and precision treatment of eye diseases and improve the overall level of ophthalmological medical care.

[0070] By further exploring the advanced functions and applications of the scleral lens in this application, we can further expand its design and usage scenarios.

[0071] Firstly, to optimize the tear retention space, we can introduce a microfluidic channel system. These microfluidic channels can precisely control the flow and retention of tears in different areas of the scleraoscope, ensuring that the sensor can continuously and stably contact high-quality tear samples. This not only improves the accuracy of the test but also extends the lifespan of the scleraoscope and reduces errors caused by tear drying or contamination.

[0072] Secondly, to enhance the user experience, scleral lenses can integrate intelligent temperature control. By embedding a miniature temperature sensor and heating element, the scleral lens can automatically adjust the temperature of the area in contact with the eyeball, keeping it within the optimal temperature range for tear film detection. This design not only improves the stability of the detection but also reduces user discomfort caused by wearing the lens.

[0073] Furthermore, the wireless communication unit of the scleral lens can be upgraded to Bluetooth 5.0 or a higher version to achieve data transmission over longer distances and with lower power consumption. This will allow the scleral lens to easily connect wirelessly to smartphones, tablets, or professional medical devices, enabling users to view tear film test results anytime, anywhere, and allowing doctors to remotely monitor the patient's eye health.

[0074] Furthermore, scleral lenses can be combined with big data analytics to provide users with personalized eye health management recommendations. By comparing and analyzing users' tear film test data with global eye health databases, scleral lenses can identify potential eye problems or disease risks and provide users with corresponding prevention and treatment plans.

[0075] It will be apparent to those skilled in the art that this application is not limited to the details of the exemplary embodiments described above, and that this application can be implemented in other specific forms without departing from the spirit or essential characteristics of this application. Therefore, the embodiments should be considered illustrative and non-limiting in all respects, and the scope of this application is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be embraced within this application. No reference numerals in the claims should be construed as limiting the scope of the claims. Furthermore, the terminology used in the embodiments of this application is for the purpose of describing particular embodiments only and is not intended to limit the invention.

[0076] It should be noted that the terms "first," "second," etc., used in the specification, claims, and accompanying drawings of this application are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that embodiments of the invention described herein can be implemented in orders other than those illustrated or described herein. The singular forms "a," "the," and "the" used in the embodiments of this application are also intended to include the plural forms unless the context clearly indicates otherwise.

[0077] Furthermore, the terms “comprising” and “having”, and any variations thereof, are intended to cover non-exclusive inclusion, such that a process, method, system, product, or apparatus that includes a series of steps or units is not necessarily limited to those steps or units that are explicitly listed, but may include other steps or units that are not explicitly listed or that are inherent to such process, method, product, or apparatus.

[0078] In the description of this application, unless otherwise stated, " / " indicates that the objects before and after it are in an "or" relationship. For example, A / B can mean A or B. "And / or" in this application is merely a description of the relationship between the related objects, indicating that three relationships can exist. For example, A and / or B can represent: A alone, A and B simultaneously, and B alone. A and B can be singular or plural. Depending on the context, the words "if" or "suppose" as used herein can be interpreted as "when," "when," "in response to determination," or "in response to detection." Similarly, depending on the context, the phrases “if determined” or “if detected (the condition or event of the statement)” can be interpreted as “when determined” or “in response to determined” or “when detected (the condition or event of the statement)” or “in response to detected (the condition or event of the statement)”.

[0079] The above embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit it. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this application.

Claims

1. A scleral lens, characterized in that, It includes the optical zone, transition zone, and scleral contact zone, which are connected sequentially from the inside to the outside in the radial direction of the sclera. The transition zone surrounds the optical zone, and the scleral contact zone surrounds the transition zone; the scleral contact zone is used to adhere to the sclera of the eyeball; both the optical zone and the transition zone can form a tear film retention space between themselves and the cornea of ​​the eyeball. A wireless communication unit and multiple sensors are embedded in the scleral contact area. Each sensor has a sensing surface that extends from the scleral contact area to the tear retention space and is attached to the transition area. The wireless communication unit connects to multiple sensors and receives and transmits data signals from the sensors; the data signals include a first electrical signal indicating ROS concentration, a second electrical signal indicating impedance or osmotic pressure, and a third electrical signal indicating pH value.

2. The scleral lens according to claim 1, characterized in that, Multiple sensors include: a ROS sensor, the ROS sensor including: a first reference electrode and at least one first working electrode; the first working electrode is alternately coated with cytochrome C and polyaniline (sulfonic acid); When ROS is present, the superoxide (O2-) in ROS reacts with cytochrome C on the first working electrode to generate water and iron ions, causing the potential change of the first working electrode to generate a first electrical signal; the first electrical signal and the first reference signal of the first reference electrode are transmitted to the target end via the wireless communication unit.

3. The scleral lens according to claim 2, characterized in that, The multiple sensors include: an impedance sensor, which includes multiple second working electrodes, through which the impedance of the tear fluid along the surface of the second working electrodes is measured and a second electrical signal is generated.

4. The scleral lens according to claim 3, characterized in that, Multiple sensors include: a pH sensor, which comprises a second reference electrode and a glass electrode. The potential signals obtained from the second reference electrode and the glass electrode are used as a third electrical signal to identify the pH value and are transmitted to the target end via a wireless communication unit; wherein, the target end determines the pH value of the tear fluid by the potential difference between the second reference electrode and the glass electrode.

5. The scleral lens according to claim 4, characterized in that, The first reference electrode and the first working electrode are distributed on the first flexible surface; the second working electrode is distributed on the second flexible surface; the second reference electrode and the glass electrode are distributed on the third flexible surface; The first flexible surface, the second flexible surface, and the third flexible surface extend from the scleral contact area to the tear reservoir and are attached to the transition area, and each of them has an electrode side that is in electrical contact with the tear.

6. The scleral lens according to claim 5, characterized in that, The scleral contact area has a double-layer structure. One end of the first flexible surface, the second flexible surface, and the third flexible surface are respectively embedded between the double-layer structure, and the other end extends from the double-layer structure to the tear fluid storage space and is attached to the transition area. In the double-layer structure, the wireless communication unit is electrically connected to the ROS sensor, the impedance sensor, and the pH sensor, respectively.

7. The scleral lens according to claim 6, characterized in that, The dual-layer structure also includes a micro-power supply, which is connected to the ROS sensor, impedance sensor, pH sensor, and wireless communication unit.

8. The scleral lens according to claim 6, characterized in that, A first isolation surface is provided in the scleral contact area along the extension direction of the first flexible surface, and a first support strip is provided in the transition area along the extension direction of the first flexible surface. The first isolation surface and the first support strip are fixed so that a tear film storage space is formed between the first isolation surface and the cornea and a first tear film storage sub-space is formed between the first isolation surface and the transition area, opening towards the optical area. The first flexible surface is placed in the first tear film storage sub-space.

9. The scleral lens according to claim 6, characterized in that, A second isolation surface is provided in the scleral contact area along the extension direction of the second flexible surface, and a second support strip is provided in the transition area along the extension direction of the second flexible surface. The second isolation surface and the second support strip are fixed so that a tear film storage space is formed between the second isolation surface and the cornea and a second tear film storage sub-space is formed between the second isolation surface and the transition area, opening towards the optical area. The first flexible surface is placed in the second tear film storage sub-space.

10. The scleral lens according to claim 6, characterized in that, A third isolation surface is provided in the scleral contact area along the extension direction of the third flexible surface, and a third support strip is provided in the transition area along the extension direction of the third flexible surface. The third isolation surface and the third support strip are fixed so that a tear film retention space is formed between the third isolation surface and the cornea and a third tear film retention sub-space is formed between the third isolation surface and the transition area, opening towards the optical zone. The third flexible surface is placed in the third tear film retention sub-space.

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