Sclerotic lens device for non-invasive monitoring of aqueous outflow facility, monitoring method and system

Abstract

The present application provides a kind of outflow facility of aqueous humor non-invasive monitoring scleral mirror device, monitoring method and system, it is related to ophthalmic medical monitoring equipment technical field, solve the problems of strong invasiveness, cannot continuous monitoring, insufficient precision and poor data synchronism of the existing technology in aqueous humor outflow coefficient measurement method;Wherein the scleral mirror device includes: scleral mirror, scleral mirror includes center area, edge landing area and the transition zone connecting center area and edge landing area, edge landing area is used to contact the sclera of user and provide support to transition zone and center area;Phased array transducer matrix, phased array transducer matrix includes multiple ring-shaped distribution in transition zone transducer;Dynamic deflection control module, dynamic deflection control module is set in transition zone, and is electrically connected with each transducer, to control the excitation time delay of each transducer;Intraocular pressure monitoring module, intraocular pressure monitoring module is set in center area;Signal processing module, signal processing module is set in transition zone.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of ophthalmic medical monitoring equipment, in particular to a scleral lens device for non-invasive monitoring of aqueous outflow coefficient, a monitoring method and a system. BACKGROUND

[0002] Glaucoma is the leading irreversible blinding eye disease in the world. Its core pathological mechanism is that the outflow passage of aqueous humor is blocked, leading to the accumulation of aqueous humor in the eye, the increase of intraocular pressure (IOP), and then the compression of the optic nerve causing visual field defects. Aqueous outflow coefficient (C value) is a key indicator for evaluating the outflow function of aqueous humor, which directly reflects the patency of the outflow passage. The C value of glaucoma patients will decrease significantly due to the narrowing or obstruction of the trabecular meshwork, superior scleral vein and other passages. Therefore, the precise and continuous monitoring of the C value has irreplaceable value for the early diagnosis of glaucoma, adjustment of treatment plan and warning of disease progression.

[0003] The existing aqueous outflow coefficient measurement technology mainly includes invasive measurement and non-invasive indirect measurement, but both have technical defects that are difficult to overcome, and cannot meet the core needs of "precision, non-invasiveness, continuity and portability" in clinical practice.

[0004] I. Invasive measurement: poor patient compliance, unable to monitor continuously;

[0005] Traditional aqueous outflow coefficient measurement method requires the injection of fluorescent markers such as fluorescein into the eye through corneal puncture, or direct extraction of aqueous humor samples, and calculation of C value by tracking the metabolic rate of the markers. This method has two major problems: strong invasiveness, low patient tolerance, corneal puncture is an invasive operation that may cause pain, photophobia, corneal damage and other complications, and the patient's (especially the elderly and children) compliance is poor, and it cannot be measured repeatedly. Secondly, it can only be measured instantaneously: the operation is complex, the measurement period is more than 30 minutes, and long-term continuous monitoring cannot be achieved - the course of glaucoma progresses slowly, and single C value data cannot reflect the dynamic changes of the disease, which may lead to missed diagnosis or misjudgment.

[0006] II. Non-invasive indirect measurement: insufficient accuracy, poor data synchronization;

[0007] To solve the defects of invasive measurement, the industry has developed non-invasive technologies such as ultrasound, optical coherence tomography (OCT), etc., but there are still obvious limitations: first, the accuracy of aqueous humor outflow measurement is low: the key channels of aqueous humor outflow (such as the suprachoroidal vein and the trabecular meshwork) are located 2-5mm below the conjunctiva, and the ordinary ultrasound resolution is insufficient, and the sound beam cannot be flexibly deflected, making it difficult to focus on the target area; the existing ultrasound equipment is mostly planar scanning, which cannot obtain multi-angle aqueous humor flow rate data, resulting in large calculation error of flow rate; second, the intraocular pressure and aqueous humor flow rate data are not synchronized: the C value calculation needs to obtain the aqueous humor flow rate and intraocular pressure data at the same time, and the existing technology needs to measure by two devices respectively (such as OCT flow rate + rebound tonometer IOP), the measurement time interval is long, and the data is not synchronized due to factors such as patient position and blinking, which further amplifies the calculation error of C value. SUMMARY

[0008] In view of the above-mentioned shortcomings of the prior art, the technical problem to be solved by the present application is to provide a scleral lens device, a monitoring method and a system for non-invasive monitoring of the aqueous humor outflow coefficient, to solve the problems of strong invasiveness, inability to continuously monitor, insufficient accuracy and poor data synchronization in the existing aqueous humor outflow coefficient measurement method.

[0009] To solve the above technical problems, the present application provides a scleral lens device for non-invasive monitoring of the aqueous humor outflow coefficient, comprising:

[0010] a scleral lens, the scleral lens comprising a central region, an edge landing region and a transition region connecting the central region and the edge landing region, the edge landing region being used to contact the sclera of the user and provide support for the transition region and the central region;

[0011] a phased array transducer matrix, the phased array transducer matrix comprising a plurality of transducers distributed in a ring shape in the transition region, used to emit ultrasonic beams and receive ultrasonic echoes;

[0012] a dynamic deflection control module, the dynamic deflection control module being arranged in the transition region and being electrically connected with each of the transducers, the dynamic deflection control module being used to control the excitation time delay of each transducer to realize the deflection of the sound beam of the phased array transducer matrix;

[0013] an intraocular pressure monitoring module, the intraocular pressure monitoring module being arranged in the central region and being used to obtain the intraocular pressure data of the user's eye;

[0014] a signal processing module, the signal processing module being arranged in the transition region and being electrically connected with the phased array transducer matrix, the dynamic deflection control module and the intraocular pressure monitoring module.

[0015] As a more preferred mode, the spacing between the transducers is less than half the wavelength of the ultrasound, which has the beneficial effect that the transducer spacing is less than half the wavelength of the ultrasound, in accordance with the "half-wavelength spacing principle" of ultrasonic imaging, which can effectively avoid the imaging blur caused by the redundant side lobe, ensure the focusing accuracy of the sound beam emitted by the phased array transducer matrix, improve the signal-to-noise ratio of the ultrasonic echo signal, provide a basis for accurate measurement of the aqueous flow rate, and avoid signal distortion caused by excessive spacing.

[0016] As a more preferred mode, the scleral lens is made of fluorosilicone acrylate or high-oxygen-permeable silicone hydrogel; which has the beneficial effect that fluorosilicone acrylate or high-oxygen-permeable silicone hydrogel is a commonly used biocompatible material in ophthalmology, which has no sensitization and irritation, and can be directly contacted with the sclera without discomfort for long-term wear; The high oxygen permeability of the material can ensure the oxygen supply of the cornea, avoid problems such as dryness and redness caused by corneal hypoxia during wearing, adapt to long-time continuous monitoring scenarios, and improve user tolerance.

[0017] As a more preferred mode, the intraocular pressure monitoring module includes a spiral inductor and an elastic dielectric layer, and the intraocular pressure data is obtained by changing the resonant frequency; which has the beneficial effect that the combination of the spiral inductor and the elastic dielectric layer monitors the intraocular pressure by changing the resonant frequency, compared with the traditional flat type and rebound type tonometer, without the need to apply external pressure, realizing non-invasive and real-time intraocular pressure data acquisition; The structure has high miniaturization degree, can be integrated in the central area of the scleral lens and does not affect the visual field, has fast response speed, can capture the dynamic changes of the intraocular pressure, and provides accurate IOP parameters for the calculation of the aqueous outflow coefficient.

[0018] As a more preferred mode, the scleral lens device for non-invasive monitoring of the aqueous outflow coefficient further comprises an energy module for providing power; which has the beneficial effect that the energy module provides stable power for each functional module of the device, avoids relying on external power supply, and improves the portability and use flexibility of the device; The integrated design of the energy module makes the device structure compact, does not affect the wearing comfort, and ensures the continuity and stability of the monitoring process.

[0019] As a more preferred mode, the scleral lens device for non-invasive monitoring of the aqueous outflow coefficient further comprises a wireless communication module for transmitting data; which has the beneficial effect that the wireless communication module realizes real-time transmission of monitoring data, does not need to export data through a physical interface, facilitates users to complete monitoring in daily activities, and supports remote data sharing at the same time, so that doctors can view patient monitoring results in real time, adapt to clinical follow-up and home management scenarios; The wireless design avoids displacement of the device caused by cable entanglement or pulling, improves use safety and convenience.

[0020] In order to solve the above problems, the present application also provides a monitoring method using the above-mentioned scleral lens device for continuous non-invasive monitoring of the aqueous outflow coefficient, comprising:

[0021] The ultrasonic beam is emitted through a phased array transducer matrix, and the beam angle is dynamically deflected using a dynamic deflection control module.

[0022] Then, the phased array transducer matrix receives the echo signal from the anterior chamber region. The signal processing module extracts the Doppler frequency shift data at each angle based on the echo signal, and then obtains the aqueous humor flow velocity v at each angle according to the flow velocity formula. At the same time, the multi-angle data is fused to obtain the accurate flow velocity value. Finally, the aqueous humor flow rate F is calculated by combining the cross-sectional area of ​​the outflow channel.

[0023] The intraocular pressure (IOP) data is obtained using an intraocular pressure monitoring module, and the aqueous humor outflow coefficient (C) is obtained by combining it with the aqueous humor coefficient formula.

[0024] As a more preferred approach, the flow rate formula includes Where v is the aqueous humor flow velocity; f d The data is obtained by Doppler frequency shift of the echo signal; c is the propagation speed of ultrasound in the aqueous humor, which is a known constant; f0 is the transmission frequency of the ultrasonic micro-transducer array element, which is a fixed parameter; θ is the angle between the sound beam and the direction of aqueous humor flow, which varies with the sound beam deflection angle and is provided by the dynamic deflection control module. Its beneficial effect is that θ is provided in real time by the dynamic deflection control module, realizing dynamic matching of parameters during the measurement process, avoiding the deviation in flow velocity calculation caused by the fixed angle, and ensuring the scientificity and accuracy of aqueous humor flow velocity measurement.

[0025] As a more preferred approach, the formula for the aqueous humor coefficient includes: Where C is the aqueous humor outflow coefficient; F is the aqueous humor flow rate, which is obtained by multiplying the aqueous humor flow velocity v and the cross-sectional area of ​​the outflow channel; IOP is the intraocular pressure data acquired by the intraocular pressure monitoring module; EVP is the superior scleral venous pressure, using the standard value.

[0026] To address the above problems, the present invention also provides a monitoring system, comprising:

[0027] The aforementioned scleral endoscope device for continuous non-invasive monitoring of aqueous humor outflow coefficient;

[0028] The signal processing module includes a memory and a processor. The memory is used to store various parameters and fixed parameters electrically transmitted from the phased array transducer matrix, the dynamic deflection control module, and the intraocular pressure monitoring module. The processor is used to execute the monitoring method described above.

[0029] As described above, the scleral endoscope device, monitoring method, and system for non-invasive monitoring of aqueous humor outflow coefficient of the present invention have the following beneficial effects:

[0030] The scleral lens device for non-invasive monitoring of aqueous humor outflow coefficient of the present invention has a three-section structural design of central area, edge landing area and transition area to ensure the stability of the fit with the sclera and avoid device displacement during monitoring, while providing reasonable layout space for each functional module; the ring-distributed phased array transducer matrix can fully cover the key area of ​​aqueous humor outflow, the dynamic deflection control module achieves flexible scanning of the sound beam by precisely adjusting the transducer excitation delay, and the integrated design of the intraocular pressure monitoring module and the signal processing module realizes a closed-loop process of ultrasound scanning, intraocular pressure acquisition and data processing, which can complete the monitoring of aqueous humor outflow coefficient without invasive operation, solves the pain points of low patient compliance and inability to continuously monitor in traditional invasive monitoring, and has the advantages of non-invasiveness, accuracy and practicality.

[0031] The monitoring method of this invention achieves non-invasive and continuous monitoring of the aqueous humor outflow coefficient through a standardized process of beam dynamic deflection, multi-angle echo acquisition, Doppler frequency shift extraction, flow velocity and flow rate calculation, and outflow coefficient derivation. Compared with traditional invasive methods, it requires no invasive operation, avoids the risk of eye damage, and has high patient compliance. Multi-angle data fusion can offset the error of single-angle measurement, improve the accuracy of flow velocity and flow rate calculation, and provide reliable data support for clinical diagnosis. Furthermore, the use of the same device to simultaneously acquire aqueous humor flow rate F and intraocular pressure (IOP) data results in good data synchronization and more accurate results.

[0032] The monitoring system of this invention combines the scleral endoscope device with the monitoring method in both hardware and software, realizing the integrated functions of data acquisition, storage, calculation and output; the memory can store monitoring parameters and fixed parameters in real time to avoid data loss; the processor can quickly execute the monitoring method and calculate the aqueous humor outflow coefficient in real time without relying on external computing equipment, thus improving the system's independence and response speed; the integrated design makes the system structure compact and adaptable to various monitoring scenarios such as clinical and home settings.

[0033] In summary, the scleral endoscope device, monitoring method, and system for non-invasive monitoring of aqueous humor outflow coefficient of the present invention solves the problems of strong invasiveness, inability to continuously monitor, insufficient accuracy, and poor data synchronization in the existing aqueous humor outflow coefficient measurement methods by using a ring-shaped distributed phased array transducer matrix and a non-invasive monitoring method. Attached Figure Description

[0034] Figure 1 This is a schematic diagram of a scleral lens device for non-invasive monitoring of aqueous humor outflow coefficient according to the present invention.

[0035] Figure 2 This is a schematic diagram from another perspective of the scleral lens device for non-invasive monitoring of aqueous humor outflow coefficient of the present invention.

[0036] Figure 3 The diagram shown is a flowchart of the monitoring method of the present invention.

[0037] Component designation explanation:

[0038] 1 Scleral lens 11 Central zone 12 Peripheral landing zone 13 Transition zone 2 Phased array transducer matrix 3 Dynamic deflection control module 4 Intraocular pressure monitoring module 5 Signal processing module 6 Energy module Detailed Implementation

[0039] The following specific embodiments illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification.

[0040] It should be understood that the structures, proportions, sizes, etc., illustrated in the accompanying drawings are merely for illustrative purposes to aid those skilled in the art and are not intended to limit the implementation of the invention. Therefore, they have no substantial technical significance. Any modifications to the structure, changes in proportions, or adjustments to size, without affecting the effectiveness and purpose of the invention, should still fall within the scope of the disclosed technical content. The following detailed description should not be considered restrictive, and the scope of the embodiments of this application is limited only by the claims of the published patents. The terminology used herein is for describing specific embodiments only and is not intended to limit the application. Spatial terms such as "upper," "lower," "left," "right," "below," "below," "lower part," "above," "upper part," etc., may be used in the text to illustrate the relationship between one element or feature shown in the figures and another element or feature.

[0041] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," "fixing," and "holding" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0042] Furthermore, as used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context indicates otherwise. It should be further understood that the terms “comprising,” “including,” indicate the presence of the stated feature, operation, element, component, item, kind, and / or group, but do not preclude the presence, occurrence, or addition of one or more other features, operations, elements, components, items, kinds, and / or groups. The terms “or” and “and / or” as used herein are interpreted as inclusive, or mean any one or any combination thereof. Thus, “A, B, or C” or “A, B, and / or C” means “any one of: A; B; C; A and B; A and C; B and C; A, B, and C.” Exceptions to this definition arise only when combinations of elements, functions, or operations are inherently mutually exclusive in some manner.

[0043] like Figures 1 to 2 As shown, the present invention provides a scleral endoscope device for non-invasive monitoring of aqueous humor outflow coefficient, comprising:

[0044] Scleral lens 1, the scleral lens 1 includes a central area 11, an edge landing area 12 and a transition area 13 connecting the central area 11 and the edge landing area 12, the edge landing area 12 being used to contact the user's sclera and provide support for the transition area 13 and the central area 11;

[0045] The phased array transducer matrix 2 includes multiple transducers arranged in a ring in the transition region 13 for emitting ultrasonic beams and receiving ultrasonic echoes.

[0046] The dynamic deflection control module 3 is located in the transition region 13 and is electrically connected to each of the transducers. The dynamic deflection control module 3 is used to control the excitation time delay of each transducer to realize the beam deflection of the phased array transducer matrix 2.

[0047] Intraocular pressure monitoring module 4, which is located in the central area 11, is used to acquire intraocular pressure data of the user;

[0048] The signal processing module 5 is located in the transition region 13 and is electrically connected to the phased array transducer matrix 2, the dynamic deflection control module 3, and the intraocular pressure monitoring module 4.

[0049] To better illustrate the non-invasive scleral lens device for monitoring aqueous humor outflow coefficient of the present invention, the following specific application will be used as an example: The non-invasive scleral lens device for monitoring aqueous humor outflow coefficient of the present invention, through a three-section structural design of central area 11, edge landing area 12, and transition area 13, ensures the stability of the fit with the sclera and avoids device displacement during monitoring, while providing reasonable layout space for each functional module; the ring-distributed phased array transducer matrix 2 can fully cover the key area of ​​aqueous humor outflow, the dynamic deflection control module 3 achieves flexible beam scanning by precisely adjusting the transducer excitation delay, and the integrated design of intraocular pressure monitoring module 4 and signal processing module 5 realizes a closed-loop process of ultrasound scanning, intraocular pressure acquisition, and data processing, which can complete aqueous humor outflow coefficient monitoring without invasive operation, solving the pain points of low patient compliance and inability to continuously monitor in traditional invasive monitoring, and combining non-invasiveness, accuracy, and practicality.

[0050] In some possible embodiments of the present invention, such as Figure 1 as well as Figure 2 The beneficial effect of the transducer spacing being less than half the length of the ultrasonic wave is that it conforms to the "half-wavelength spacing principle" of ultrasonic imaging, which can effectively avoid imaging blurring caused by extra side lobes, ensure the focusing accuracy of the sound beam emitted by the phased array transducer matrix 2, improve the signal-to-noise ratio of the ultrasonic echo signal, provide a basis for accurate measurement of aqueous humor flow velocity, and avoid signal distortion caused by excessive spacing.

[0051] In some possible embodiments of the present invention, such as Figure 1 as well as Figure 2 The scleral lens 1 is made of fluorosilicone acrylate or highly oxygen-permeable silicone hydrogel. Its advantages are that fluorosilicone acrylate or highly oxygen-permeable silicone hydrogel are both commonly used biocompatible materials in ophthalmology, which are non-allergenic and non-irritating, can directly contact the sclera and are comfortable to wear for a long time. The high oxygen permeability of the material can ensure the oxygen supply to the cornea, avoid problems such as dryness and redness caused by corneal hypoxia during wear, adapt to long-term continuous monitoring scenarios, and improve user tolerance.

[0052] In some possible embodiments of the present invention, such as Figure 1 as well as Figure 2 The scleral lens 1 has a diameter of 14-16 mm, a base curve radius of 8.0-8.5 mm, and a Dk value greater than 100 barrers. Its advantages include: a diameter of 14-16 mm and a base curve radius of 8.0-8.5 mm that fit the scleral shape of most people, ensuring a tight fit and preventing the device from easily falling off; and a high oxygen permeability design with a Dk value greater than 100 barrers, further enhancing corneal oxygen supply and avoiding eye complications caused by prolonged wear, providing safety support for continuous monitoring. Furthermore, the standardized size parameters facilitate mass production and clinical application.

[0053] In some possible embodiments of the present invention, such as Figure 1 as well as Figure 2 The intraocular pressure monitoring module 4 includes a spiral inductor and an elastic dielectric layer, which acquires intraocular pressure data through changes in resonant frequency. Its advantages are that the combination of the spiral inductor and the elastic dielectric layer monitors intraocular pressure through changes in resonant frequency. Compared with traditional flattening and rebound tonometers, it does not require external pressure and achieves non-invasive, real-time intraocular pressure data acquisition. The structure is highly miniaturized and can be integrated into the central area 11 of the scleral lens 1 without affecting the field of vision. It has a fast response speed and can capture dynamic changes in intraocular pressure, providing accurate IOP parameters for calculating the aqueous humor outflow coefficient.

[0054] In some possible embodiments of the present invention, such as Figure 1 as well as Figure 2 The phased array transducer matrix 2 comprises 64 to 256 transducers, which are made of flexible PMN-PT single-crystal piezoelectric material. The transducers are ultrasonic micro-transducers with a working frequency of 10 to 25 MHz. Each transducer, under electrical signal excitation, converts electrical energy into mechanical energy through the piezoelectric effect, generating ultrasonic waves. When multiple transducers work together to emit sound, their sound waves superimpose in space to form a focused sound beam, which can accurately point to the key monitoring area of ​​aqueous humor outflow. Its advantages include: the high-density array of 64 to 256 transducers improves the focusing accuracy and scanning coverage of the sound beam; the flexible PMN-PT single-crystal piezoelectric material adapts to the curved shape of the scleral lens 1, ensuring accurate sound beam emission direction; the high-frequency ultrasound of 10 to 25 MHz enables high-resolution imaging of the aqueous humor outflow channel; the directional sound beam formed by the coordinated focusing of multiple transducers can accurately point to the monitoring area, reducing interference from surrounding tissues, improving the specificity of the echo signal, and ensuring the accuracy of aqueous humor flow velocity measurement.

[0055] In some possible embodiments of the present invention, such as Figure 1 as well as Figure 2 The scleral lens device for non-invasive monitoring of aqueous humor outflow coefficient also includes an energy module 6, which provides power. The beneficial effect is that the energy module 6 provides a stable power supply for each functional module of the device, avoiding reliance on external power supply and improving the portability and flexibility of the device. The integrated design of the energy module 6 makes the device compact, does not affect wearing comfort, and ensures the continuity and stability of the monitoring process.

[0056] In some possible embodiments of the present invention, the energy module 6 includes a micro battery and an energy harvester. The energy harvester obtains energy through eye movement kinetic energy or tear biofuel cells and stores it in the micro battery. Its beneficial effect is that the combination of the micro battery and the energy harvester achieves a "self-powered" function. The energy harvester obtains energy through eye movement kinetic energy or tear biofuel cells, which can replenish the power of the micro battery, greatly extend the device's battery life, and avoid the trouble of frequent charging or battery replacement. The self-powered design is particularly suitable for long-term home monitoring scenarios, improving the practicality of the device and user experience, while conforming to the concept of green energy saving.

[0057] In some possible embodiments of the present invention, the dynamic deflection control module 3 uses an FPGA control chip to regulate the emission time difference of different transducers. To deflect the sound beam by an angle θ in a certain direction, the array elements on one side of that direction need to be emitted earlier and the array elements on the other side need to be emitted later. By precisely controlling the delay time, the sound waves emitted by each array element are synchronously superimposed and enhanced in the target deflection direction, while canceling each other out in other directions. This ultimately achieves flexible deflection of the sound beam within a range of ±45°, maintaining a scanning frequency of 30Hz to ensure rapid coverage of key monitoring areas. Its beneficial effects are that the FPGA control chip has a fast computing speed and low latency, and can precisely regulate the emission time difference of each transducer to achieve flexible deflection of the sound beam within a range of ±45°, ensuring full coverage of key areas of aqueous humor outflow, such as branches of the episcleral vein. The 30Hz scanning frequency can quickly acquire multi-angle data, avoiding missed detections or data lag, and improving monitoring efficiency. At the same time, the design of superimposing and enhancing the sound beam in the target direction and canceling out in other directions reduces signal interference and enhances the clarity of the echo signal.

[0058] In some possible embodiments of the present invention, the scleral endoscope device for non-invasive monitoring of aqueous humor outflow coefficient further includes a wireless communication module for transmitting data. Its advantages are that the wireless communication module enables real-time transmission of monitoring data without the need to export data through a physical interface, making it convenient for users to complete monitoring during daily activities. It also supports remote data sharing, allowing doctors to view patient monitoring results in real time, which is suitable for clinical follow-up and home management scenarios. The wireless design avoids device displacement caused by cable tangling or pulling, improving safety and convenience of use.

[0059] In some possible embodiments of the present invention, the wireless communication module adopts Bluetooth Low Energy; its advantages are that Bluetooth Low Energy communication technology has extremely low power consumption, which will not significantly increase the burden on the energy module 6 and ensure the device's battery life; the Bluetooth transmission distance is moderate, which meets the communication needs with the host computer during daily monitoring, while the data transmission rate is stable, which can realize real-time and continuous data synchronization, and has strong compatibility, adapting to most smart terminals.

[0060] In some possible embodiments of the present invention, such as Figure 1 as well asFigure 2 The dynamic deflection control module 3 is arranged in a ring structure inside the phased array transducer matrix 2. Its advantages are that the ring structure of the dynamic deflection control module 3 is adapted to the ring distribution of the phased array transducer matrix 2, so that the distance between the control module and each transducer is uniform, the signal transmission delay is consistent, and the accuracy of sound beam deflection is improved. The ring layout saves internal space of the scleral lens 1, ensures that the device structure is compact, does not affect wearing comfort, and avoids electromagnetic interference between modules, ensuring signal transmission stability.

[0061] In some possible embodiments of the present invention, such as Figure 1 as well as Figure 2 The signal processing module 5 and the wireless communication module are packaged together and symmetrically arranged with the energy module 6 about the center of the scleral lens 1. The advantages are that the integrated packaging of the signal processing module 5 and the wireless communication module reduces the size and weight of the device, making the structure more compact; the symmetrical arrangement of the two modules with the energy module 6 about the center of the scleral lens 1 can balance the center of gravity of the device, avoiding displacement or discomfort caused by the center of gravity shift when wearing it. At the same time, the symmetrical layout reduces electromagnetic interference between the modules, ensures the accuracy of signal processing and wireless transmission, and improves the overall stability of the device.

[0062] To solve the above problems, such as Figure 3 As shown, the present invention also provides a monitoring method, utilizing the above-mentioned scleral endoscope device for continuous non-invasive monitoring of aqueous humor outflow coefficient, comprising:

[0063] S01: The ultrasonic beam is emitted through the phased array transducer matrix 2, and the beam angle is dynamically deflected by the dynamic deflection control module 3.

[0064] S02: The phased array transducer matrix 2 receives the echo signal from the anterior chamber region. The signal processing module 5 extracts the Doppler frequency shift data at each angle based on the echo signal, and then obtains the aqueous humor flow velocity v at each angle according to the flow velocity formula. At the same time, it fuses the multi-angle data to obtain the accurate flow velocity value, and finally calculates the aqueous humor flow rate F by combining the cross-sectional area of ​​the outflow channel.

[0065] S03: Use the intraocular pressure monitoring module 4 to obtain intraocular pressure data IOP, and combine it with the aqueous humor coefficient formula to obtain the aqueous humor outflow coefficient C.

[0066] To better illustrate the monitoring method of this invention, the following specific application will be used as an example: The monitoring method of this invention achieves non-invasive and continuous monitoring of the aqueous humor outflow coefficient through a standardized process of beam dynamic deflection, multi-angle echo acquisition, Doppler frequency shift extraction, flow velocity and flow rate calculation, and outflow coefficient derivation. Compared with traditional invasive methods, it requires no invasive operation, avoids the risk of eye damage, and has high patient compliance. Multi-angle data fusion can offset the error of single-angle measurement, improve the accuracy of flow velocity and flow rate calculation, and provide reliable data support for clinical diagnosis. Furthermore, the use of the same device to simultaneously acquire aqueous humor flow rate F and intraocular pressure (IOP) data results in good data synchronization and more accurate results.

[0067] Step S02, "fusing multi-angle data to obtain accurate flow velocity values," specifically includes the following sub-steps:

[0068] S021: Collect multiple angles within a ±45° deflection range, such as 10~20 uniformly distributed angles, and calculate the flow velocity to obtain v1, v2, ..., v n ;

[0069] S022: Based on the principle of maximum likelihood estimation, statistical analysis is performed on multiple flow velocity values. Assuming that the actual flow velocity of the aqueous humor is the true value V, and the measured values ​​at each angle are the superposition of V and the error term, the algorithm is used to find the most likely true value V, which is the value with the highest probability of all measured values.

[0070] S023: Remove outliers, such as extreme values ​​caused by interference, weight and fuse valid measurements, and finally output accurate aqueous humor flow velocity values.

[0071] In some possible embodiments of the present invention, the flow rate formula includes Where v is the aqueous humor flow velocity; f d The data is obtained by Doppler frequency shift of the echo signal; c is the propagation speed of ultrasound in the aqueous humor, which is a known constant; f0 is the transmission frequency of the ultrasonic micro-transducer array element, which is a fixed parameter; θ is the angle between the sound beam and the direction of aqueous humor flow, which varies with the sound beam deflection angle and is provided by the dynamic deflection control module 3. Its beneficial effect is that θ is provided in real time by the dynamic deflection control module 3, realizing dynamic matching of parameters during the measurement process, avoiding the deviation in flow velocity calculation caused by the fixed angle, and ensuring the scientificity and accuracy of aqueous humor flow velocity measurement.

[0072] In some possible embodiments of the present invention, the formula for the aqueous humor coefficient includes Where C is the aqueous humor outflow coefficient; F is the aqueous humor flow rate, which is obtained by multiplying the aqueous humor flow velocity v and the cross-sectional area of ​​the outflow channel; IOP is the intraocular pressure data acquired by the intraocular pressure monitoring module 4; EVP is the superior scleral venous pressure, using the standard value.

[0073] In some possible embodiments of the present invention, the channel cross-sectional area is the effective flow cross-sectional area of ​​the superior scleral vein. The vascular cross-section can be imaged using a phased array transducer matrix 2, and the cross-sectional area data can be obtained based on the vascular cross-section imaging. Combined with the anatomical data of the superior scleral vein in normal populations, the above cross-sectional area data is validated for rationality, and imaging errors are eliminated. The beneficial effect is that the actual effective flow cross-sectional area of ​​the superior scleral vein can be obtained non-invasively through phased array ultrasound imaging, avoiding the errors caused by using fixed standard values. The rationality validation by combining the anatomical data of the superior scleral vein in normal populations can eliminate systematic errors or outliers in the imaging process, ensuring the accuracy of the cross-sectional area data. The accurate cross-sectional area parameter provides a reliable basis for calculating aqueous humor flow rate, thereby improving the monitoring accuracy of the aqueous humor outflow coefficient C.

[0074] To address the above problems, the present invention also provides a monitoring system, comprising:

[0075] The aforementioned scleral endoscope device for continuous non-invasive monitoring of aqueous humor outflow coefficient;

[0076] The signal processing module 5 includes a memory and a processor. The memory is used to store various parameters and fixed parameters electrically transmitted from the phased array transducer matrix 2, the dynamic deflection control module 3, and the intraocular pressure monitoring module 4. The processor is used to execute the monitoring method described above.

[0077] To better illustrate the monitoring system of this invention, the following specific application will be used as an example: The monitoring system of this invention integrates the scleral endoscope device and the monitoring method in both hardware and software, achieving integrated functions of data acquisition, storage, calculation, and output; the memory can store monitoring parameters and fixed parameters in real time, avoiding data loss; the processor can quickly execute the monitoring method and calculate the aqueous humor outflow coefficient in real time without relying on external computing equipment, improving the system's independence and response speed; the integrated design makes the system compact and adaptable to various monitoring scenarios such as clinical and home settings; it can be seen that the scleral endoscope device, monitoring method, and system for non-invasive monitoring of the aqueous humor outflow coefficient of this invention, through the ring-distributed phased array transducer matrix 2 and the non-invasive monitoring method, solves the problems of strong invasiveness, inability to continuously monitor, insufficient accuracy, and poor data synchronization in existing aqueous humor outflow coefficient measurement methods.

[0078] In some possible embodiments of the present invention, the monitoring system further includes a host computer. The scleral lens device for continuous non-invasive monitoring of aqueous humor outflow coefficient transmits the obtained aqueous humor outflow coefficient C to the host computer via a wireless communication module, and the host computer monitors the aqueous humor outflow coefficient C in real time. The beneficial effects are that the addition of the host computer enables real-time monitoring, storage and analysis of monitoring data. Doctors can view the dynamic change curve of the patient's aqueous humor outflow coefficient through the host computer, promptly detect abnormalities and intervene, which is especially suitable for the long-term management of chronic eye diseases such as glaucoma. The wireless transmission method allows patients to complete the monitoring without going to the hospital, reducing medical costs and time costs. At the same time, the host computer can realize multi-patient data management, improving the efficiency of clinical diagnosis and treatment.

[0079] As described above, the scleral endoscope device, monitoring method, and system for non-invasive monitoring of aqueous humor outflow coefficient of the present invention have the following beneficial effects:

[0080] 1. Three-section structural design:

[0081] The three-section structure of the scleral lens 1, consisting of the central area 11, the edge landing area 12, and the transition area 13, ensures stable adhesion to the sclera, prevents device displacement during monitoring, and provides reasonable layout space for each functional module.

[0082] 2. Ring-shaped phased array transducer matrix:

[0083] The phased array transducer matrix 2 includes multiple transducers arranged in a ring in the transition zone 13, which can fully cover the key area of ​​aqueous humor outflow. The dynamic deflection control module 3 achieves flexible beam scanning by precisely adjusting the transducer excitation delay.

[0084] 3. Non-invasive intraocular pressure monitoring:

[0085] The intraocular pressure monitoring module 4 acquires intraocular pressure data non-invasively and in real time by combining a spiral inductor and an elastic dielectric layer and obtaining data through changes in resonant frequency.

[0086] 4. High-density transducer array:

[0087] The phased array transducer matrix 2 includes 64 to 256 transducers, which are made of flexible PMN-PT single crystal piezoelectric material and operate at a frequency of 10 to 25 MHz, improving the focusing accuracy of the acoustic beam and the scanning coverage.

[0088] 5. Self-powered design;

[0089] Energy module 6 includes a micro battery and an energy harvester. Energy is obtained through eye movement kinetic energy or tear biofuel cells and stored in the micro battery, extending the device's battery life and avoiding frequent charging or battery replacement.

[0090] 6. Wireless data transmission;

[0091] The wireless communication module uses Bluetooth Low Energy technology to achieve real-time transmission of monitoring data, support remote data sharing, and improve the flexibility and convenience of use.

[0092] 7. Dynamic deflection control:

[0093] The dynamic deflection control module 3 uses an FPGA control chip to regulate the emission time difference of different transducers, enabling flexible deflection of the sound beam within a range of ±45°, ensuring rapid coverage of key monitoring areas.

[0094] 8. Multi-angle data fusion:

[0095] By collecting flow velocity calculation results from multiple angles, statistical analysis is performed based on the principle of maximum likelihood estimation. Outliers are removed and effective measurements are weighted and fused to output accurate aqueous humor flow velocity values.

[0096] 9. Precise calculation of aqueous humor outflow coefficient:

[0097] By combining aqueous humor flow and intraocular pressure data, the aqueous humor outflow coefficient is calculated using the aqueous humor coefficient formula, providing reliable clinical diagnostic data.

[0098] 10. Real-time monitoring by the host computer:

[0099] The monitoring system also includes a host computer, which transmits the aqueous humor outflow coefficient to the host computer via a wireless communication module, enabling real-time monitoring, storage and analysis of the data, and improving the efficiency of clinical diagnosis and treatment.

[0100] The scleral lens device, monitoring method, and system for non-invasive monitoring of aqueous humor outflow coefficient of this invention solves the problems of high invasiveness, inability to continuously monitor, insufficient accuracy, and poor data synchronization in existing aqueous humor outflow coefficient measurement methods through a ring-shaped phased array transducer matrix 2 and a non-invasive monitoring method. The three-segment structural design ensures the stability of the device and the rational layout of functional modules. The ring-shaped phased array transducer matrix 2 and the dynamic deflection control module 3 achieve comprehensive coverage and flexible scanning of the key area of ​​aqueous humor outflow. The intraocular pressure monitoring module 4 and the high-density transducer array improve the accuracy and reliability of monitoring. The self-powered design and wireless data transmission enhance the portability and flexibility of the device. Multi-angle data fusion and accurate calculation of the aqueous humor outflow coefficient provide reliable data support for clinical diagnosis. The real-time monitoring function of the host computer further enhances the practicality and clinical application value of the system. This innovative design not only improves the overall performance of the monitoring equipment but also significantly enhances its market competitiveness, making it particularly suitable for the long-term management of chronic eye diseases such as glaucoma.

[0101] Therefore, this invention effectively overcomes the various shortcomings of the prior art and has high industrial application value.

[0102] The above embodiments are merely illustrative of the principles and effects of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by those skilled in the art without departing from the spirit and technical concept disclosed in the present invention should still be covered by the claims of the present invention.

Claims

1. A scleral lens device for non-invasive monitoring of aqueous outflow facility, characterized by, Comprising: a scleral lens (1) comprising a central zone (11), an edge landing zone (12) to contact the sclera of a user and provide support to the transition zone (13) and the central zone (11), and a transition zone (13) connecting the central zone (11) and the edge landing zone (12); a phased array transducer matrix (2) comprising a plurality of transducers distributed in a ring shape around the transition zone (13) to emit ultrasound beams and receive ultrasound echoes; a dynamic deflection control module (3) disposed in the transition zone (13) and electrically connected to each of the transducers, the dynamic deflection control module (3) being configured to control the excitation time delay of each transducer to achieve the deflection of the sound beam of the phased array transducer matrix (2); an intraocular pressure monitoring module (4) disposed in the central zone (11) to obtain intraocular pressure data of the user; a signal processing module (5) disposed in the transition zone (13) and electrically connected to the phased array transducer matrix (2), the dynamic deflection control module (3), and the intraocular pressure monitoring module (4).

2. The non-invasive monitoring of aqueous outflow facility scleral lens apparatus of claim 1, wherein: The distance between the transducers is less than half the wavelength of the ultrasound.

3. The non-invasive monitoring of aqueous outflow facility scleral lens apparatus of claim 1, wherein: The scleral lens (1) is made of fluorosilicone acrylate or high oxygen permeable silicone hydrogel.

4. The non-invasive monitoring of aqueous outflow facility scleral lens apparatus of claim 1, wherein: The intraocular pressure monitoring module (4) comprises a spiral inductor and an elastic dielectric layer, and the intraocular pressure data is obtained by the change of the resonant frequency.

5. The non-invasive monitoring of aqueous outflow facility scleral lens apparatus of claim 1, wherein: The scleral lens device for non-invasive monitoring of the aqueous outflow coefficient further comprises an energy module (6) configured to provide power.

6. The non-invasive monitoring of aqueous outflow facility scleral lens apparatus of claim 1, wherein: The scleral lens device for non-invasive monitoring of the aqueous outflow coefficient further comprises a wireless communication module configured to transmit data.

7. A monitoring method using the non-invasive monitoring of the outflow facility of aqueous humor by the scleral lens device according to any one of claims 1 to 6, characterized in that, Comprising: emitting ultrasound beams by the phased array transducer matrix (2) and dynamically deflecting the sound beam angle by the dynamic deflection control module (3); then receiving the anterior chamber area echo signal by the phased array transducer matrix (2), the signal processing module (5) extracting the Doppler shift data at each angle according to the echo signal, then obtaining the aqueous flow rate v at each angle according to the flow rate formula, and finally obtaining the accurate flow rate value by fusing the multi-angle data, and finally calculating the aqueous flow F in combination with the outflow passage cross-sectional area; obtaining the intraocular pressure data IOP by the intraocular pressure monitoring module (4), and obtaining the aqueous outflow coefficient C in combination with the aqueous coefficient formula.

8. The monitoring method of claim 7, wherein: The flow rate formula includes ; wherein v is the aqueous humor flow rate; f d is data obtained by Doppler frequency shift of the echo signal; c is the propagation speed of ultrasonic waves in the aqueous humor, which is a known constant; f0 is the transmission frequency of the ultrasonic micro-transducer array element, which is a fixed parameter; and θ is the included angle between the sound beam and the aqueous humor flow direction, which varies with the sound beam deflection angle and is provided by the dynamic deflection control module (3).

9. The monitoring method of claim 7, wherein: The aqueous humor coefficient formula includes ; wherein C is the outflow coefficient of aqueous humor; F is the flow of aqueous humor, obtained by multiplying the flow velocity v of aqueous humor and the cross-sectional area of the outflow passage; IOP is the intraocular pressure data obtained by the eye pressure monitoring module (4); and EVP is the episcleral venous pressure, using a standard value.

10. A monitoring system, characterized by Comprising: the scleral lens device for non-invasive monitoring of the aqueous outflow coefficient according to any one of claims 1 to 6; the signal processing module (5) comprises a memory and a processor, wherein the memory is configured to store various parameters and fixed parameters transmitted by the phased array transducer matrix (2), the dynamic deflection control module (3), and the intraocular pressure monitoring module (4), and the processor is configured to execute the monitoring method according to any one of claims 7 to 9.

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