Wearable corneal contact lens, active continuous intraocular pressure monitoring method and device

Abstract

This invention provides a wearable contact lens, an active continuous intraocular pressure (IOP) monitoring method, and a device. The wearable contact lens includes: a structural layer, the working surface of which conforms to the wearer's cornea and eyelids, and compresses or releases the cornea with eyelid movement; a sensing layer, located on the side of the structural layer closest to the cornea, containing multiple pressure sensor arrays, which acquire current pressure data and current pressure area of ​​the cornea when the wearer's eyelids descend to a preset position; and a control system, which calculates and outputs the current IOP based on the current pressure data and current pressure area acquired by the sensing layer. This invention obtains the user's IOP by acquiring the force and flattened area of ​​the cornea, without requiring any external force, achieving active and continuous IOP monitoring. It is convenient, quick, and provides high accuracy.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a wearable corneal contact lens, an active continuous intraocular pressure monitoring method and device. Background Technology

[0002] The normal range of intraocular pressure (IOP) in the human body is 10 mmHg–21 mmHg, and it fluctuates periodically over time, typically peaking at night or in the early morning. Therefore, a single daytime IOP measurement is insufficient to determine whether the subject's IOP fluctuations are within the normal range. Existing nighttime measurement methods require periodically waking the subject, which not only leads to measurement errors but also disrupts the patient's rest and recovery, making it unsuitable for long-term monitoring. Therefore, achieving continuous 24-hour IOP monitoring is crucial for the rapid and timely diagnosis and treatment of glaucoma patients.

[0003] Currently, intraocular pressure (IOP) measurement devices on the market can be mainly divided into three types: applanation type, spring-loaded type, and sensor type. Among them, the Goldman applanation tonometer has become the gold standard in the IOP monitoring industry due to its high measurement accuracy. Its principle is based on the Imbert-Fick law, which approximates the eyeball as a sphere with an infinitely thin outer wall and filled with fluid. When a certain force is applied to the surface of the instrument's indentation head, the surface of the eyeball is flattened. At this point, the internal pressure of the eyeball is the ratio of the force required for applanation to the flattened area. A similar principle is that of the dynamic profilometry (DCT). Compared to the Goldman applanation tonometer, its indentation head is a curved surface rather than a plane. When a certain force is applied to the indentation head, the surface of the eyeball is deformed. At this point, the internal pressure of the eyeball is the ratio of the force applied to the indentation head to the deformed area. Both of these measurement methods involve the indentation head actively applying force to change the shape of the cornea. The IOP value is obtained based on the mechanical balance of the cornea. The accuracy of the measurement results is guaranteed by the mechanical balance, resulting in high precision. Rebound tonometers use controlled air pulses or probes to strike the eyeball, determining intraocular pressure by monitoring the intensity of the rebounding air or the velocity of the probe. However, these devices are large and can only perform single-point measurements, making them unsuitable for continuous 24-hour intraocular pressure monitoring.

[0004] Wearable contact lens sensors (CLS) integrate a sensing module into the contact lens for wear by the user. They determine intraocular pressure (IOP) by monitoring changes in electrical signals and can acquire real-time IOP values ​​at any time by detecting radio electrical signals transmitted by the sensing module. Current CLSs utilize the principle that changes in IOP lead to changes in corneal curvature, indirectly and passively measuring IOP by detecting these changes. Therefore, before actual measurement, the relationship between IOP and corneal curvature needs to be calibrated for each patient, which significantly limits the accuracy of this measurement method.

[0005] In summary, the gold standard for intraocular pressure measurement in existing technologies is active measurement schemes. However, such methods are difficult to achieve 24-hour continuous intraocular pressure monitoring. CLS can achieve continuous intraocular pressure monitoring, but since the current CLS only passively measures corneal curvature rather than actively applying force to measure deformation, its accuracy is low. Summary of the Invention

[0006] This invention provides a wearable corneal contact lens, an active continuous intraocular pressure monitoring method and device, to solve the problem that the existing continuous intraocular pressure monitoring is all passive and has low measurement accuracy, thereby realizing high-precision and active continuous intraocular pressure monitoring.

[0007] This invention provides a wearable corneal contact lens, comprising:

[0008] A structural layer, the working surface of which is designed to conform to the wearer's cornea and eyelids and to compress or release the cornea with the movement of the eyelids;

[0009] The sensing layer is located on the side of the structural layer closest to the cornea. Multiple pressure sensor arrays are provided in the sensing layer. The pressure sensor arrays are used to acquire the current pressure data and current pressure area of ​​the corneal pressure area when the wearer's eyelid descends to a preset position.

[0010] A control system is configured to calculate and output the current intraocular pressure based on the current pressure data and the current pressure area obtained by the sensing layer.

[0011] According to the present invention, a wearable corneal contact lens is provided, wherein the structural layer comprises:

[0012] A spherical cap, wherein the spherical cap is a spherical arc structure with a radius of curvature of a first preset value; the working surface is located at the top of the spherical cap, and the radius of curvature of the working surface is a second preset value;

[0013] Wherein, the first preset value is less than the second preset value.

[0014] According to the present invention, a wearable corneal contact lens has a spherical crown with a transverse diameter of 10mm-15mm and a first preset value of 7.6mm-8mm.

[0015] The transverse diameter of the working surface is 1.8mm-2.2mm, and the second preset value is 9.8mm-10.2mm.

[0016] According to the present invention, a wearable corneal contact lens is provided, wherein the structural layer is formed by polymerization of methyl methacrylate containing silicon or fluorine.

[0017] According to a wearable corneal contact lens provided by the present invention, the pressure sensor array includes a plurality of concentrically arranged annular pressure sensors, and there is a preset gap between two adjacent annular pressure sensors.

[0018] According to the present invention, a wearable corneal contact lens is provided in which the pressure sensor array covers at least the area of ​​the working surface of the structural layer.

[0019] According to the present invention, a wearable corneal contact lens is provided, wherein the control system includes a chip and a communication component.

[0020] The present invention also provides an active continuous intraocular pressure monitoring method, the method comprising:

[0021] When the wearer's eyelid descends to a preset position, the current pressure data and current pressure area of ​​multiple corneal pressure areas are obtained;

[0022] Sum all the current pressure data and the current pressure area to obtain the total force on the cornea and the total pressure area;

[0023] The current intraocular pressure result is obtained based on the sum of the forces and the sum of the pressure areas.

[0024] According to the present invention, an active continuous intraocular pressure monitoring method is provided, which obtains the current intraocular pressure result based on the total force and the total pressure area, and further includes:

[0025] Obtain the current intraocular pressure (IOP) results at multiple time points within a preset time period to obtain multiple IOP results;

[0026] Images are generated and displayed based on the intraocular pressure results.

[0027] The present invention also provides an active continuous intraocular pressure monitoring device, the device comprising:

[0028] The data acquisition unit is used to acquire current pressure data and current pressure area of ​​multiple corneal pressure areas when the wearer's eyelid descends to a preset position;

[0029] The calculation unit sums all the current pressure data and the current pressure area to obtain the total force on the cornea and the total pressure area.

[0030] The result generation unit is used to obtain the current intraocular pressure result based on the total force and the total pressure area.

[0031] This invention provides a wearable contact lens, an active continuous intraocular pressure monitoring method, and a device. The wearable contact lens includes a structural layer with a working curved surface designed to conform to the wearer's cornea and eyelids, compressing or releasing pressure on the cornea with eyelid movement; a sensing layer located on the side of the structural layer closest to the cornea, containing multiple pressure sensor arrays. These pressure sensor arrays acquire current pressure data and current pressure area of ​​the corneal pressure region when the wearer's eyelid descends to a preset position; and a control system that calculates and outputs the current intraocular pressure based on the current pressure data and current pressure area acquired by the sensing layer. This invention is easy to wear, convenient and quick to operate, and can continuously and actively acquire precise intraocular pressure fluctuations without affecting the user's normal life or work.

[0032] Based on the Imbert-Fick law, this invention measures the force and flattened area of ​​the cornea when the user blinks or closes their eyes. The intraocular pressure is obtained by dividing the force on the cornea by the flattened area. No other form of force is required, which realizes active and continuous intraocular pressure monitoring with high accuracy. It also eliminates the need to calibrate the corneal curvature of each patient, which helps to continuously and accurately monitor the user's intraocular pressure status 24 hours a day. Attached Figure Description

[0033] To more clearly illustrate the technical solutions in this invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0034] Figure 1 This is a side view of an embodiment of the wearable corneal contact lens provided by the present invention;

[0035] Figure 2 This is a top view of an embodiment of the wearable corneal contact lens provided by the present invention;

[0036] Figure 3 This is a schematic diagram of a pressure sensor array of one embodiment of the wearable corneal contact lens provided by the present invention;

[0037] Figure 4 This is a schematic diagram illustrating the principle of pressure measurement when a user blinks, according to an embodiment of the wearable corneal contact lens provided by the present invention.

[0038] Figure 5 This is a schematic diagram illustrating the usage method of one embodiment of the wearable corneal contact lens provided by the present invention;

[0039] Figure 6This is one of the flowcharts of the active continuous intraocular pressure monitoring method provided by the present invention;

[0040] Figure 7 This is the second flowchart of the active continuous intraocular pressure monitoring method provided by the present invention;

[0041] Figure 8 This is a schematic diagram of the active continuous intraocular pressure monitoring device provided by the present invention.

[0042] Reference numerals: 100: Wearable corneal contact lens; 101: Structural layer; 102: Sensing layer; 103: Working surface; 104: Cornea; 105: Chip; 106: Communication component; 107: Visceral cap; 108: Eyelid; 200: Pressure sensor array; 201: First pressure sensor; 202: Second pressure sensor; 203: Third pressure sensor; 204: Fourth pressure sensor; 205: Fifth pressure sensor; 211: Preset gap;

[0043] 810: Data acquisition unit; 820: Calculation unit; 830: Result generation unit. Detailed Implementation

[0044] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this invention. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without creative effort are within the scope of protection of this invention.

[0045] Because many people with eye health risks require 24-hour continuous intraocular pressure (IOP) monitoring, and large IOP measuring devices can only perform single-point measurements, corneal contact lenses integrating miniaturized IOP sensors have become a major research focus. Existing corneal contact lens sensors measure IOP based on the principle that changes in IOP cause changes in corneal curvature. Therefore, strain sensors in the contact lens measure corneal strain, indirectly measuring changes in the user's IOP. However, the relationship between changes in IOP and corneal curvature is complex, influenced by factors such as corneal thickness, hardness, and eye size. Therefore, sensors that indirectly detect IOP using corneal curvature changes have low accuracy. Essentially, this is because these sensors do not actively apply pressure to the cornea; they only passively measure corneal curvature.

[0046] Based on this, the present invention provides a wearable corneal contact lens, an active continuous intraocular pressure monitoring method and device.

[0047] The following is combined with Figures 1-8The present invention describes a wearable corneal contact lens, an active continuous intraocular pressure monitoring method, and a device.

[0048] Figure 1 This is a side view of one embodiment of the wearable corneal contact lens provided by the present invention, as shown below. Figure 1 As shown, in one specific embodiment, the wearable contact lens 100 provided by the present invention includes a structural layer 101, a sensing layer 102, and a control system. The working curved surface 103 of the structural layer 101 is used to conform to the wearer's cornea 104 and eyelid 108, and compresses or releases the cornea 104 with the movement of the eyelid 108, transmitting the pressure of the eyelid when the user blinks to the user's cornea 104, causing the cornea 104 to be flattened. The structural layer 101 has the same shape as commercial contact lenses, but has a working curved surface 103 with a radius of curvature greater than 10 mm at its top.

[0049] During use, because the radius of curvature of the working surface 103 is slightly larger than the radius of curvature of the cornea 104 under normal conditions, the cornea 104 does not adhere tightly to the working surface 103 when no external force is applied. When the user blinks, under the pressure of the eyelid, the cornea 104 is compressed by the working surface 103, and a portion of its area adheres tightly to the working surface 103. The curvature of the cornea 104 changes from its normal state to the curvature of the working surface, and this enlarged area is the area of ​​the cornea 104 that is flattened.

[0050] The sensing layer 102 is located on the side of the structural layer 101 close to the cornea 104. Multiple pressure sensor arrays 200 are provided in the sensing layer 102. The pressure sensor arrays 200 are used to acquire the current pressure data and current pressure area of ​​the pressure area of ​​the cornea 104 when the wearer's eyelid descends to a preset position.

[0051] Specifically, the sensing layer 102 includes a pressure sensor array 200 and a control system. Figure 2 This is a top view of one embodiment of the wearable corneal contact lens 100 provided by the present invention, as shown below. Figure 2 As shown, the pressure sensor array 200 measures the force and flattening area of ​​the cornea 104 when the user blinks and feeds this data back to the control system. The pressure sensors are located inside the sensing layer 102 at the working surface 103. Each pressure sensor in the pressure sensor array 200 is connected to the control system at both ends. Figure 3 As shown, the control system is used to calculate and output the current intraocular pressure based on the current pressure data and the current pressure area obtained by the sensing layer 102.

[0052] Furthermore, in some embodiments, the control system includes a chip 105 and a communication component 106. The chip 105 calculates the user's intraocular pressure using a built-in algorithm and transmits it wirelessly to the user's mobile application via Bluetooth, displaying it graphically; for example, showing fluctuations in the user's intraocular pressure as a graph. Specifically, the chip 105 within the contact lens is an ASIC (Application Specific Integrated Circuit) chip, primarily used to process electrical signals from the pressure sensor array 200, including a signal amplification circuit, an analog-to-digital converter (ADC) module, and a Bluetooth radio frequency module connected to the communication component 106 for transmitting digital signals. The chip 105 within the contact lens is encapsulated in the hydrogel material of the sensing layer 102 and does not directly contact the user's cornea 104, ensuring circuit stability and user safety.

[0053] The communication component 106 is an antenna for wireless Bluetooth communication used by the chip 105 in the control system. It is connected to the contact lens chip 105. The communication component 106 is a transmitting antenna, ring-shaped, located at the edge of the wearable contact lens 100, and has a small width so as not to obstruct the user's vision. The antenna can be made using common antenna materials for radio frequency chips, or it can be made using transparent conductive materials such as ITO (indium tin oxide) or AgNW (silver nanowires), further improving the transparency and aesthetics of the contact lens.

[0054] Furthermore, in another embodiment of the present invention, the control system can also be compatible with other intraocular pressure measurement and transmission schemes. For example, instead of placing the chip 105 inside the wearable contact lens 100 to improve user comfort, the pressure sensor array 200 can be connected to the capacitor-inductor-resistor circuit built into the wearable contact lens 100, and wireless communication with a portable glasses via electromagnetic induction coupling can be achieved. The portable glasses contain an inductor coil for wireless communication with the wearable contact lens 100. A signal processing chip built into the portable glasses processes the information transmitted from the wearable contact lens 100 to obtain the user's intraocular pressure, then stores the obtained intraocular pressure and wirelessly transmits it for the user or medical personnel to view. The advantage of this method is that there is no chip 105 inside the wearable contact lens 100, resulting in higher user comfort and a simpler structure.

[0055] In some embodiments, according to the wearable corneal contact lens 100 provided by the present invention, the structural layer 101 includes a spherical crown 107, the spherical crown 107 being a spherical arc structure with a radius of curvature of a first preset value; the working surface 103 is located at the top of the spherical crown 107, and the radius of curvature of the working surface 103 is a second preset value; wherein, the first preset value is less than the second preset value.

[0056] Specifically, the structural layer 101 supports the entire structure of the wearable corneal contact lens 100, including a spherical crown 107 and a working surface 103, with the working surface 103 located at the top of the spherical crown 107. The radius of curvature of the spherical crown 107 is a first preset value, forming a spherical arc structure for conforming to the wearer's cornea 104. The radius of curvature of the working surface 103 is a second preset value, used to transmit the pressure of the eyelid 108 to the user's cornea 104 when the user blinks, causing the cornea 104 to be flattened.

[0057] In some embodiments, in the wearable corneal contact lens 100 provided according to the present invention, the transverse diameter of the spherical cap 107 is 10mm-15mm, and the first preset value is 7.6mm-8mm; the transverse diameter of the working surface 103 is 1.8mm-2.2mm, and the second preset value is 9.8mm-10.2mm. Specifically, the transverse diameter of the spherical cap 107 is 10mm-15mm, and the radius of curvature of the spherical cap 107 is 7.6mm-8mm, which is comparable to the transverse diameter and radius of curvature of the human cornea, for fitting against the wearer's cornea 104. Preferably, the radius of curvature of the spherical cap 107 is 7.8mm, which allows for better fitting against the wearer's cornea 104.

[0058] The working surface 103 has a radius of curvature of 9.8mm-10.2mm and a transverse diameter of 1.8mm-2.2mm. The radius of curvature of the working surface 103 is slightly larger than that of the human cornea. It is used to transmit the pressure of the eyelid 108 to the user's cornea 104 when the user blinks, causing the cornea 104 to flatten. Preferably, the radius of curvature of the working surface 103 is 10mm, at which point the deformation of the user's cornea 104 is smaller, resulting in higher comfort and more accurate measurement.

[0059] In other words, the structural layer 101 includes two parts: a spherical cap 107 and a working curved surface 103. The two parts have different radii of curvature. This arrangement can better fit the wearer's cornea 104 and eyelid 108, without affecting the transmission of pressure from the eyelid 108 to the cornea 104 through the working curved surface 103 with a larger curvature. When the user blinks, the cornea 104 is flattened, thereby detecting intraocular pressure.

[0060] In some embodiments, the wearable corneal contact lens 100 provided according to the present invention has a structural layer 101 formed by polymerization of methyl methacrylate containing silicon or fluorine.

[0061] Specifically, the structural layer 101 can be prepared using the same materials and methods as commercial rigid contact lenses. Simultaneously, the sensing layer 102 of the wearable contact lens 100 can also be made of hydrogel, prepared using the same methods and materials as commercial flexible contact lenses, and adhered to the side of the structural layer 101 closest to the user's cornea 104. The materials used to adhere the structural layer 101 and the sensing layer 102 can be any biosafe, transparent, and breathable / water-permeable material. PDMS (polydimethylsiloxane), a biocompatible material with high strength and strong adhesion, is preferred to reduce safety risks and improve the performance of this embodiment. Furthermore, the materials used have good transparency, will not affect the user's vision, and the size and weight of the contact lens are the same as common commercial contact lenses, without affecting the user's normal life.

[0062] In some embodiments, the wearable contact lens 100 provided according to the present invention includes a pressure sensor array 200 comprising a plurality of concentrically arranged annular pressure sensors, with a preset gap 211 between adjacent annular pressure sensors.

[0063] Specifically, Figure 3 This is a schematic diagram of a pressure sensor array of an embodiment of the wearable corneal contact lens provided by the present invention, as shown below. Figure 3 As shown, the pressure sensor array 200 includes at least five annular pressure sensors. For ease of explanation, these annular pressure sensors are named, from the inside out, first pressure sensor 201, second pressure sensor 202, third pressure sensor 203, fourth pressure sensor 204, and fifth pressure sensor 205. The annular pressure sensors are densely distributed on the working surface 103 of the sensing layer 102, with a preset gap 211 between adjacent annular pressure sensors. The pressure sensor array 200 can sense the pressure distribution on the working surface 103 at the point of contact with the user's cornea 104. Each annular pressure sensor can be a capacitive pressure sensor, a resistive pressure sensor, or a piezoelectric pressure sensor. To ensure measurement accuracy, the pressure sensor array 200 should be as densely distributed on the working surface 103 as possible. Therefore, the preset gap 211 between adjacent annular pressure sensors should be as small as possible, with a maximum width not exceeding 10 μm. The difference between the inner and outer diameters of the annular pressure sensors can be 100 μm to 400 μm.

[0064] The pressure measurement principle of the pressure sensor array 200 is as follows: Figure 4 As shown. Figure 4This is a schematic diagram illustrating the principle of pressure measurement during blinking in one embodiment of the wearable contact lens provided by the present invention. Figure 4 The right-middle view shows a side view of the user's eye when blinking or closing, and a schematic diagram of the pressure sensor array 200 in the working surface 103 at this time. When the user is not blinking or closing their eyes, the pressure sensor will sense a small pressure due to the gravity of the wearable contact lens 100 and the surface tension of the user's tears. However, this pressure is more than 10 times smaller than the pressure provided by the eyelid when blinking. When the user blinks or closes their eyes, the eyelid 108 applies pressure F to the wearable contact lens 100, which is then transmitted to the user's cornea 104, causing the tip of the user's cornea 104 to adhere to the working surface 103 of the wearable contact lens 100. The threshold for the pressure sensor to sense pressure is set to about 0.5 mmHg. When the user is not blinking or closing their eyes, the pressure caused by the gravity of the wearable contact lens 100 and the surface tension of the user's tears is insufficient to reach this threshold. If a pressure sensor senses a pressure greater than this value, it is considered that the pressure sensor has sensed the pressure. For example, if four annular pressure sensors in the pressure sensor array 200 detect pressure signals while the other sensors do not, and these four annular pressure sensors cover a circular area of ​​radius r, then the radius of the area where the wearable contact lens 100 fits against the working curved surface 103 is r, and the area where the user's cornea 104 is flattened is πr. 2 The pressure F exerted by the eyelid 108 on the wearable contact lens 100 can be approximated by the sum of the pressures from four annular pressure sensors that have measured pressure signals. Assuming the pressure values ​​measured by the four annular pressure sensors are P1, P2, P3, and P4, and the areas of the four annular pressure sensors are S1, S2, S3, and S4, then:

[0065] F = P1S1 + P2S2 + P3S3 + P4S4

[0066] Here, because the area of ​​the preset gap 211 between two adjacent annular pressure sensors is relatively small compared to the area of ​​the annular pressure sensor itself, the error caused by the pressure at the preset gap 211 is ignored. According to Imbert-Fick's law, the user's intraocular pressure is... To further reduce errors, the pressure at the pressure sensor location can be interpolated using the measured pressure to obtain the pressure at the preset gap 211 of the pressure sensor. The pressure at the preset gap 211 between two adjacent pressure sensors can be approximated using linear interpolation. Similarly, the pressure and force at each preset gap 211 can be calculated, and the above formula can be corrected accordingly:

[0067] F = P1S1 + P2S2 + P3S3 + P4S4 + ΔF

[0068] Where ΔF is the pressure at the preset gap 211 of the pressure sensor obtained by interpolation, and the user's intraocular pressure is still [value missing]. At this point, the error caused by the gap in the wearable contact lens is less than 2%. For users with normal intraocular pressure, the resulting error in intraocular pressure measurement will not affect the diagnosis.

[0069] The pressure sensor array within the sensing layer 102 is made of a transparent material. Preferably, the pressure sensor array 200 can be a capacitive pressure sensor, a resistive pressure sensor, or a piezoelectric pressure sensor. If a capacitive pressure sensor is used, the capacitor can be a parallel plate capacitor or an interdigital capacitor, and the electrode material is preferably a transparent conductive material such as ITO (indium tin oxide) or AgNW (silver nanowires). The dielectric between the capacitor plates can be any non-biotoxic transparent dielectric material, preferably PDMS (polydimethylsiloxane) with good transparency and flexibility. If a resistive pressure sensor is used, the pressure-sensitive resistor can be made of graphene or other pressure-sensitive transparent materials. If a piezoelectric pressure sensor is used, the piezoelectric device can be made of a non-biotoxic transparent piezoelectric material such as PVDF (polyvinylidene fluoride). Specific pressure sensor fabrication can be carried out using currently mature micro-nano fabrication technology, which will not be described in detail in this embodiment. The preferred effective intraocular pressure measurement range of this embodiment is 10 mmHg–50 mmHg (1.33 kPa–66.5 kPa). At this point, it is preferable to use 10 pressure sensors, and the relative error can be controlled to be below 5%.

[0070] In some embodiments, in the wearable contact lens 100 provided according to the present invention, the pressure sensor array 200 at least covers the area where the working surface 103 of the structural layer 101 is located.

[0071] Specifically, the working surface 103 is used to transmit the pressure of the eyelid 108 to the user's cornea 104 when the user blinks, causing the cornea 104 to be flattened. When the user blinks or closes their eyes, the eyelid 108 applies pressure F to the wearable contact lens 100, which is then transmitted to the user's cornea 104, causing the tip of the cornea 104 to adhere to the working surface 103. The pressure sensor array 200 is used to sense the aforementioned pressure, therefore the pressure sensor array 200 must at least cover the area where the working surface 103 of the structural layer 101 is located.

[0072] In one specific embodiment, such as Figure 5 As shown, the specific usage method of this invention embodiment is as follows: Figure 5As shown, the user wears the wearable corneal contact lens 100 in the same way as commercial corneal contact lenses and glasses. When the smartphone is within Bluetooth signal range, Bluetooth can be turned on to enable communication between the wearable corneal contact lens 100 and the smartphone. Figure 5 The image shown is an enlarged view of an embodiment of the present invention worn by a user. 501 shows the wireless signal transmission between the chip 105 and an external communication device, and 502 shows the user's intraocular pressure curve displayed graphically on the user's mobile application.

[0073] In practical use, the user wears the wearable contact lens 100 provided by this invention, which is in contact with the user's cornea 104 and eyelid 108. When the user blinks or closes their eyes, when the eyelid 108 descends to a preset position, the eyelid 108 applies pressure F to the wearable contact lens 100, which is then transmitted to the user's cornea 104, causing the tip of the user's cornea 104 to come into contact with the working curved surface 103. The pressure sensor array 200 senses the pressure F. Four annular pressure sensors in the pressure sensor array 200 detect the pressure signal, while the other sensors do not. These four annular pressure sensors cover a circular area of ​​radius r. Therefore, the radius of the area where the wearable contact lens 100 is in contact with the working curved surface 103 is r, and the area where the user's cornea 104 is flattened is πr. 2 The pressure F exerted by the eyelid 108 on the wearable contact lens 100 can be approximated by the sum of the pressures measured by four pressure sensors. Assuming the pressure values ​​measured by the four pressure sensors are P1, P2, P3, and P4, and the areas of the four pressure sensors are S1, S2, S3, and S4, then:

[0074] F = P1S1 + P2S2 + P3S3 + P4S4

[0075] According to Imbert-Fick's law, the user's intraocular pressure is... To further reduce errors, the pressure in the preset gap 211 between two adjacent annular pressure sensors can be approximated using linear interpolation as follows: Similarly, the pressure and force at each preset gap 211 can be calculated, and the above formula can be corrected accordingly:

[0076] F = P1S1 + P2S2 + P3S3 + P4S4 + ΔF

[0077] Here, ΔF represents the pressure at the preset gap 211 obtained through interpolation. The intraocular pressure (IOP) information is then wirelessly transmitted to the user's mobile application via Bluetooth for graphical display. For example, it is acquired every 15 minutes to obtain the current IOP results over 24 hours, resulting in multiple IOP values. Based on these results, a graph is generated and output to more intuitively demonstrate the fluctuations in IOP.

[0078] In the above specific embodiments, the wearable contact lens provided by the present invention includes a structural layer, the working surface of which is used to conform to the wearer's cornea and eyelids, and to compress or release the cornea with the movement of the eyelids; a sensing layer, located on the side of the structural layer closest to the cornea, wherein multiple pressure sensor arrays are disposed within the sensing layer, the pressure sensor arrays being used to acquire current pressure data and current pressure area of ​​the corneal pressure region when the wearer's eyelids descend to a preset position; and a control system, which is used to calculate and output the current intraocular pressure based on the current pressure data and current pressure area acquired by the sensing layer. The wearable contact lens provided by the present invention is easy to wear, convenient and quick to operate, and can continuously and actively acquire the user's precise intraocular pressure fluctuations without affecting the user's normal life or work.

[0079] This invention also provides an active continuous intraocular pressure monitoring method, such as... Figure 6 As shown, Figure 6 This is one of the flowcharts of the active continuous intraocular pressure monitoring method provided by the present invention; the method includes the following steps:

[0080] Step 610: With the wearer's eyelids descending to the preset position, acquire the current pressure data and current pressure area of ​​multiple corneal pressure areas.

[0081] This invention uses the pressure provided by the eyelids when the wearer blinks or closes their eyes as the force source to actively measure the user's intraocular pressure. The measurement principle is based on the Imbert-Fick law. First, it acquires the current pressure data and current pressure area of ​​multiple pressure-bearing areas of the user's cornea. This step mainly measures the current pressure data and current pressure area of ​​multiple pressure-bearing areas of the cornea when the user blinks or closes their eyes.

[0082] Step 620: Sum all the current pressure data and the current pressure area to obtain the total force on the cornea and the total pressure area.

[0083] After measuring the force and flattened area of ​​the user's cornea when the user blinks or closes their eyes, the force and area of ​​each pressure sensor are summed.

[0084] Step 630: Obtain the current intraocular pressure result based on the total force and the total pressure area.

[0085] The total force and area of ​​the cornea are summed based on the force and area of ​​each pressure sensor to obtain the final total force and area of ​​the cornea. The user's intraocular pressure is obtained by dividing the total force of the cornea by the total area of ​​the cornea that has been flattened.

[0086] In some embodiments, according to the active continuous intraocular pressure monitoring method provided by the present invention, the current intraocular pressure result is obtained based on the total force and the total pressure area, and then the method further includes:

[0087] Step 710: Obtain the current intraocular pressure results at multiple time points within a preset time period to obtain multiple intraocular pressure results;

[0088] Step 720: Generate and output display images based on the intraocular pressure results.

[0089] In other words, such as Figure 7 , Figure 7 This is the second flowchart of the active continuous intraocular pressure monitoring method provided by the present invention. Based on the above embodiments of the invention, the intraocular pressure information is wirelessly transmitted to the user's mobile application using Bluetooth communication technology and displayed in a graphical manner. For example, it is acquired every 15 minutes to obtain the current intraocular pressure result within 24 hours, resulting in multiple intraocular pressure results. Based on each intraocular pressure result, a curve is generated and output to more intuitively show the fluctuation of intraocular pressure.

[0090] In practical use, the user wears the wearable contact lens 100 provided by this invention, which is in contact with the user's cornea 104 and eyelid 108. When the user blinks or closes their eyes, when the eyelid 108 descends to a preset position, the eyelid 108 applies pressure F to the wearable contact lens 100, which is then transmitted to the user's cornea 104. This causes the tip of the user's cornea 104 to come into contact with the working curved surface 103 of the contact lens. The pressure sensor array 200 senses the pressure F. Four annular pressure sensors in the pressure sensor array 200 detect the pressure signal, while the other sensors do not. These four annular pressure sensors cover a circular area of ​​radius r. Therefore, the radius of the area where the wearable contact lens 100 is in contact with the working curved surface 103 is r, and the area where the user's cornea 104 is flattened is πr. 2 The pressure F exerted by the eyelid 108 on the wearable contact lens 100 can be approximated by the sum of the pressures measured by four pressure sensors. Assuming the pressure values ​​measured by the four pressure sensors are P1, P2, P3, and P4, and the areas of the four pressure sensors are S1, S2, S3, and S4, then:

[0091] F = P1S1 + P2S2 + P3S3 + P4S4

[0092] According to Imbert-Fick's law, the user's intraocular pressure is... To further reduce errors, the pressure in the preset gap 211 between adjacent pressure sensors can be approximated using linear interpolation as follows: Similarly, the pressure and force at each preset gap 211 can be calculated, and the above formula can be corrected accordingly:

[0093] F = P1S1 + P2S2 + P3S3 + P4S4 + ΔF

[0094] Wherein, ΔF is the pressure at the preset gap 211 of the pressure sensor obtained by interpolation. Then, the intraocular pressure information is wirelessly transmitted to the user's mobile application using Bluetooth communication technology and displayed in a graphical way. For example, it is obtained every 15 minutes to obtain the current intraocular pressure result within 24 hours, resulting in multiple intraocular pressure results; based on each intraocular pressure result, a curve is generated and output to more intuitively show the fluctuation of intraocular pressure.

[0095] In the above specific embodiments, the active continuous intraocular pressure monitoring method provided by the present invention acquires current pressure data and current pressure area of ​​multiple corneal pressure-bearing regions when the wearer's eyelid descends to a preset position; sums all the current pressure data and current pressure areas to obtain the total force and total pressure area of ​​the cornea; and obtains the current intraocular pressure result based on the total force and the total pressure area. Based on the Imbert-Fick law, this invention measures the force and flattening area of ​​the cornea when the user blinks or closes their eyes, and obtains the user's intraocular pressure by dividing the corneal force by the flattened area. It achieves active and continuous intraocular pressure monitoring without the need for external force, is convenient and quick to operate, and provides high accuracy. It can continuously acquire precise intraocular pressure fluctuations, facilitating 24-hour continuous and accurate monitoring of the user's intraocular pressure status.

[0096] The active continuous intraocular pressure monitoring device provided by the present invention will be described below. The active continuous intraocular pressure monitoring device described below can be referred to in correspondence with the active continuous intraocular pressure monitoring method described above.

[0097] The present invention also provides an active continuous intraocular pressure monitoring device, such as... Figure 8 As shown, the device includes:

[0098] The data acquisition unit 810 is used to acquire current pressure data and current pressure area of ​​multiple corneal pressure areas when the wearer's eyelid descends to a preset position;

[0099] The calculation unit 820 is used to sum all the current pressure data and the current pressure area to obtain the total force on the cornea and the total pressure area.

[0100] The result generation unit 830 is used to obtain the current intraocular pressure result based on the total force and the total pressure area.

[0101] According to the active continuous intraocular pressure monitoring device provided by the present invention, the current intraocular pressure result is obtained based on the sum of the applied forces and the sum of the pressure-receiving areas, and then the device further includes:

[0102] Obtain the current intraocular pressure (IOP) results at multiple time points within a preset time period to obtain multiple IOP results;

[0103] Images are generated and displayed based on the intraocular pressure results.

[0104] In the above specific embodiments, the active continuous intraocular pressure monitoring device provided by the present invention acquires current pressure data and current pressure area of ​​multiple corneal pressure regions when the wearer's eyelid descends to a preset position; sums all the current pressure data and current pressure areas to obtain the total force and total pressure area of ​​the cornea; and obtains the current intraocular pressure result based on the total force and the total pressure area. Based on the Imbert-Fick law, the present invention measures the force and flattening area of ​​the cornea when the user blinks or closes their eyes, and obtains the user's intraocular pressure by dividing the corneal force by the flattened area. This achieves active and continuous intraocular pressure monitoring without the need for external force, is convenient and quick to operate, and provides high accuracy. It can continuously acquire precise intraocular pressure fluctuations, facilitating 24-hour continuous and accurate monitoring of the user's intraocular pressure status.

[0105] The device embodiments described above are merely illustrative. The units described as separate components may or may not be physically separate. The components shown as units may or may not be physical units; that is, they may be located in one place or distributed across multiple network units. Some or all of the modules can be selected to achieve the purpose of this embodiment according to actual needs. Those skilled in the art can understand and implement this without any creative effort.

[0106] Through the above description of the embodiments, those skilled in the art can clearly understand that each embodiment can be implemented by means of software plus necessary general-purpose hardware platforms, and of course, it can also be implemented by hardware. Based on this understanding, the above technical solutions, in essence or the part that contributes to the prior art, can be embodied in the form of a software product. This computer software product can be stored in a computer-readable storage medium, such as ROM / RAM, magnetic disk, optical disk, etc., and includes several instructions to cause a computer device (which may be a personal computer, server, or network device, etc.) to execute the methods described in the various embodiments or some parts of the embodiments.

[0107] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention 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; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A wearable corneal contact lens, characterized in that, include: A structural layer, wherein the working surface of the structural layer is designed to conform to the wearer's cornea and eyelids and to compress or release the cornea with the movement of the eyelids; wherein the radius of curvature of the working surface is greater than the radius of curvature of the cornea under normal conditions; The sensing layer is located on the side of the structural layer closest to the cornea. Multiple pressure sensor arrays are disposed within the sensing layer. The pressure sensor arrays are used to acquire the current pressure data and current pressure area of ​​the corneal pressure area when the wearer's eyelid descends to a preset position. When the eyelid descends to the preset position, under the action of eyelid pressure, the cornea is compressed by the working curved surface, and a part of the area will be closely attached to the working curved surface. A control system is configured to calculate and output the current intraocular pressure based on the current pressure data and the current pressure area obtained by the sensing layer. The structural layer includes: A spherical cap, wherein the spherical cap is a spherical arc structure with a radius of curvature of a first preset value; the working surface is located at the top of the spherical cap, and the radius of curvature of the working surface is a second preset value; Wherein, the first preset value is less than the second preset value.

2. The wearable corneal contact lens according to claim 1, characterized in that, The transverse diameter of the spherical crown is 10mm-15mm, and the first preset value is 7.6mm-8mm; The transverse diameter of the working surface is 1.8mm-2.2mm, and the second preset value is 9.8mm-10.2mm.

3. The wearable corneal contact lens according to claim 2, characterized in that, The structural layer is formed by polymerizing methyl methacrylate containing silicon or fluorine.

4. The wearable corneal contact lens according to claim 1, characterized in that, The pressure sensor array includes multiple concentric ring pressure sensors, with a preset gap between adjacent ring pressure sensors.

5. The wearable corneal contact lens according to claim 1, characterized in that, The pressure sensor array at least covers the area of ​​the working surface of the structural layer.

6. The wearable corneal contact lens according to claim 1, characterized in that, The control system includes a chip and communication components.

7. An active continuous intraocular pressure monitoring method, based on a wearable corneal contact lens as described in any one of claims 1-6, characterized in that, The method includes: When the wearer's eyelid descends to a preset position, the current pressure data and current pressure area of ​​multiple corneal pressure areas are obtained; Sum all the current pressure data and the current pressure area to obtain the total force on the cornea and the total pressure area; The current intraocular pressure result is obtained based on the sum of the forces and the sum of the pressure areas.

8. The active continuous intraocular pressure monitoring method according to claim 7, characterized in that, Based on the sum of the forces and the sum of the pressure areas, the current intraocular pressure is obtained, followed by: Obtain the current intraocular pressure (IOP) results at multiple time points within a preset time period to obtain multiple IOP results; Images are generated and displayed based on the intraocular pressure results.

9. An active continuous intraocular pressure monitoring device, characterized in that, The device comprising a wearable corneal contact lens according to any one of claims 1-6, the device comprising: The data acquisition unit is used to acquire current pressure data and current pressure area of ​​multiple corneal pressure areas when the wearer's eyelid descends to a preset position; The calculation unit sums all the current pressure data and the current pressure area to obtain the total force on the cornea and the total pressure area. The result generation unit is used to obtain the current intraocular pressure result based on the total force and the total pressure area.

Images