Eyeshade type xerophthalmia treatment method integrating low-frequency electrical stimulation and precise hot compress

Abstract

The invention discloses an eyeshade type xerophthalmia treatment method integrating low-frequency electrical stimulation and precise hot compress, relates to the technical field of intelligent medical equipment, and provides an eyeshade main body of which the shape is matched with the peripheral contour of human eyes; an electric hot compress module is integrated in the area, corresponding to the upper and lower eyelids, of the inner side of the eyeshade body and used for generating and conducting heat. Outputting a low-frequency pulse current with a preset waveform through a low-frequency electrical stimulation module; the control module is electrically connected with the electric hot compress module and the low-frequency electrical stimulation module; at least two different collaborative treatment programs are pre-stored in the control module, and each collaborative treatment program defines a fixed combination of the electric hot compress module and the low-frequency electrical stimulation module on treatment duration, working time sequence, temperature parameters and electrical stimulation waveform parameters; the control module is configured to respond to user selection and execute the corresponding collaborative treatment program. The problems that traditional xerophthalmia treatment equipment is single in function, fixed in parameter and complex in operation are solved.

Description

Technical Field

[0001] This invention relates to the field of intelligent medical device technology, specifically to an eye mask-type treatment method for dry eye syndrome that integrates low-frequency electrical stimulation and precise heat therapy. Background Technology

[0002] Dry eye syndrome, a common ocular surface disease, has evolved in its treatment from traditional physical therapy to electronic medical devices. Current technologies suffer from the following significant drawbacks: First, treatment devices are functionally limited; heat therapy and electrical stimulation devices operate independently, failing to achieve a synergistic therapeutic effect. Second, parameter settings are fixed, lacking the ability to dynamically adjust based on individual user differences. More importantly, existing devices lack systematic data acquisition and processing capabilities, hindering the formation of a closed-loop treatment system and making continuous optimization of therapeutic efficacy difficult.

[0003] Therefore, in order to address the above problems, there is an urgent need for an eye mask-type treatment for dry eye syndrome that integrates low-frequency electrical stimulation and precise heat therapy. Summary of the Invention

[0004] To address the shortcomings of existing technologies, this invention provides an eye mask-type dry eye treatment method that integrates low-frequency electrical stimulation and precise hot compress, solving the problems of traditional dry eye treatment devices having limited functions, fixed parameters, and complex operation.

[0005] To achieve the above objectives, the present invention provides the following technical solution: an eye mask-type dry eye treatment device, characterized in that it comprises: an eye mask body, the shape of which is adapted to the contour of the human eye; an electro-heating module integrated inside the eye mask body in the area corresponding to the upper and lower eyelids, for generating and conducting heat; a low-frequency electrical stimulation module, the electrodes of which are disposed in the area of ​​the eye mask body corresponding to the temples on both sides, for outputting a low-frequency pulse current of a preset waveform; and a control module disposed inside the eye mask body, electrically connected to the electro-heating module and the low-frequency electrical stimulation module respectively; wherein, the control module has at least two different collaborative treatment programs pre-stored, each of which defines a fixed combination of the electro-heating module and the low-frequency electrical stimulation module in terms of treatment duration, working sequence, temperature parameters, and electrical stimulation waveform parameters; the control module is configured to execute the corresponding collaborative treatment program in response to user selection.

[0006] Furthermore, it also includes a user interaction unit, which includes a mode selection key and an intensity adjustment key; the mode selection key is used for the user to select among the at least two collaborative treatment programs; the intensity adjustment key is used for the user to adjust the output current intensity of the low-frequency electrical stimulation module in real time during treatment.

[0007] Furthermore, the electrothermal module includes: a flexible electrothermal film attached to the inner side of the eye mask body; a temperature sensing unit including at least one temperature sensor disposed on the flexible electrothermal film for collecting the actual temperature of the treatment area; the control module is configured to perform closed-loop control of the heating power of the flexible electrothermal film based on the difference between the feedback signal of the temperature sensing unit and the target temperature, so as to maintain the actual temperature within a preset constant temperature range, specifically between 40 degrees Celsius and 45 degrees Celsius.

[0008] Furthermore, the control module also includes a storage unit and a communication unit; the storage unit is used to encrypt and store log data for a single treatment, the log data including at least the treatment program identifier used, the total treatment duration, and the final electrical stimulation intensity level; the communication unit is configured to upload the desensitized treatment log data to a remote server via a secure network protocol after authorization.

[0009] Furthermore, the remote server is configured to perform statistical analysis on the aggregated desensitization treatment log data, optimize the parameters of the pre-stored collaborative treatment program based on the statistical distribution of the selection frequency and intensity adjustment of each treatment program, and send the optimized parameter combination to the eye mask-type treatment device through the communication unit to update the local program.

[0010] Furthermore, the control module also includes a safety monitoring unit, which is configured to: monitor the temperature of the electro-heating module and the output current of the low-frequency electrical stimulation module in real time; immediately cut off the power supply to the corresponding module when the temperature exceeds a first safety threshold or the current exceeds a second safety threshold; and automatically adjust the output power to restore it to the normal range when the instantaneous change rate of temperature or current exceeds a preset range.

[0011] Furthermore, a method for using the eye mask-type dry eye treatment device according to any one of claims 1-6 is characterized by comprising the following steps: the user selects one of at least two preset collaborative treatment programs via the mode selection key; the user wears the eye mask-type treatment device and starts the treatment; the control module calls the parameters of the selected collaborative treatment program to control the electro-heating module to start working and heat up to the target temperature; when a preset time point is reached, the control module controls the low-frequency electrical stimulation module to output an electrical stimulation signal according to the parameters of the selected program; during the treatment, the user adjusts the intensity of the electrical stimulation in real time via the intensity adjustment key; after the treatment is completed, the control module generates a treatment log containing a program identifier, duration, and intensity level, and encrypts and stores it locally.

[0012] The present invention has the following beneficial effects: This innovative ophthalmic mask-style treatment for dry eye integrates low-frequency electrical stimulation and precise thermal compresses into a single device, achieving synergistic therapy through physical thermotherapy and neuro-electrical stimulation. Thermal compresses dissolve blocked meibomian gland lipids and improve local blood circulation, while low-frequency electrical stimulation activates periocular nerves and promotes tear secretion. These two treatments address dry eye from different pathological mechanisms, resulting in superior efficacy compared to single-method therapies. Furthermore, by pre-setting multiple synergistic treatment programs, it can provide differentiated parameter combinations for different dry eye subtypes, such as excessive evaporation and insufficient tear secretion, enabling lightweight, personalized treatment based on the subtype.

[0013] Abandoning complex biometrics, AI algorithms, and dense sensor arrays, this design focuses on real-world user scenarios. Users only need two core interactive elements—a mode selection button and an intensity adjustment button—to complete all operations, from mode selection to real-time intensity fine-tuning. The combination of preset modes and manual adjustment ensures targeted treatment plans while returning control to the user, allowing them to find the most comfortable stimulation intensity based on real-time tolerance. This minimalist interactive design significantly reduces the learning curve for users and improves compliance in home settings.

[0014] The device automatically records key log data such as the mode, duration, and intensity of each treatment, which is then uploaded to the cloud after being anonymized and encrypted. The cloud platform statistically analyzes the usage behavior of a large number of real users, such as the frequency of mode selection and manual adjustment preferences, to objectively assess the rationality of the existing treatment program and optimize and update it accordingly before issuing updates to the device. This closed-loop mechanism allows the product to continuously learn and evolve from the experience of group users, achieving dynamic optimization of treatment plans while protecting user privacy and providing real data support for product iteration.

[0015] Of course, any product implementing this invention does not necessarily need to achieve all of the advantages described above at the same time. Attached Figure Description

[0016] Figure 1 This is a flowchart of an eye mask-type dry eye treatment method that integrates low-frequency electrical stimulation and precise heat therapy according to the present invention.

[0017] Figure 2 This is a system module block diagram of an eye mask-type dry eye treatment method that integrates low-frequency electrical stimulation and precise heat therapy according to the present invention.

[0018] Figure 3 This is a control logic flowchart of an eye mask-type dry eye treatment method that integrates low-frequency electrical stimulation and precise heat therapy according to the present invention. Detailed Implementation

[0019] This application embodiment provides a dry eye treatment method that integrates low-frequency electrical stimulation and precise heat therapy, achieving synergistic treatment combining heat therapy and electrical stimulation, lightweight personalized adjustment based on preset modes, and safe and reliable closed-loop data iteration.

[0020] The problem addressed in this application's embodiments can be summarized as follows: By employing two core functional modules—temperature closed-loop control and dual-path collaborative output—the effectiveness of treatment is ensured with minimal engineering costs. Preset modes replace complex algorithms, and 3-4 collaborative treatment programs targeting different dry eye subtypes are solidified based on clinical experience, allowing users to choose as easily as selecting a washing machine mode. At the same time, a manual intensity adjustment button is retained, returning the power of personalized decision-making to the user's real-time experience. A lightweight data closed loop is established, collecting only three core logs: mode, duration, and intensity. After anonymization and uploading, statistical analysis guides program parameter optimization, forming a product evolution chain of use, feedback, and iteration, achieving continuous improvement of the solution while protecting privacy.

[0021] Please see Figure 1 , Figure 2 , Figure 3 This invention provides a technical solution: an eye mask-type dry eye treatment device, characterized in that it includes: an eye mask body, the shape of which is adapted to the contour of the human eye; an electro-heating module integrated inside the eye mask body in the area corresponding to the upper and lower eyelids, used to generate and conduct heat; a low-frequency electrical stimulation module, the electrodes of which are disposed in the area of ​​the eye mask body corresponding to the temples on both sides, used to output a low-frequency pulse current of a preset waveform; and a control module disposed inside the eye mask body, electrically connected to the electro-heating module and the low-frequency electrical stimulation module respectively; wherein, the control module has at least two different collaborative treatment programs pre-stored, each of which defines a fixed combination of the electro-heating module and the low-frequency electrical stimulation module in terms of treatment duration, working sequence, temperature parameters, and electrical stimulation waveform parameters; the control module is configured to execute the corresponding collaborative treatment program in response to user selection.

[0022] Specifically, S1. Simplified hardware system design and initialization The eye mask-type therapeutic device provided in this embodiment of the invention includes the following hardware core: The main body of the goggle is made of flexible, skin-friendly medical-grade silicone or velvet material, with an internal cavity to accommodate the control circuitry.

[0023] Electrothermal Compress Module: This module is the execution unit for the electrothermal function, its core being a flexible graphene electrothermal film covering the eyelid area. This film features uniform heating, good flexibility, and high safety. To monitor temperature, 1-2 high-precision NTC thermistors are integrated on the electrothermal film as temperature sensing units. Optimization: The temperature sensor array is simplified to 1-2 key point sensors, significantly reducing cost and complexity. The temperature control unit dynamically adjusts the heating current based on the temperature signal fed back from the NTC, using a PID algorithm to precisely control the temperature of the eyelid contact surface within a preset constant temperature range, i.e., 40℃-45℃.

[0024] Low-frequency electrical stimulation module: This module includes a waveform generation circuit, a constant current source output circuit, and dual conductive electrodes attached to the temples. The waveform generation circuit can generate various preset composite low-frequency pulse waveforms, such as sparse waves, dense waves, and sparse-dense waves.

[0025] Control Module: A general-purpose microcontroller, such as STMicroelectronics' STM32 series chip, is used. This MCU is responsible for the logic control of the entire system: reading key inputs, driving the electrothermal film, generating electrical stimulation waveforms, and managing data storage and communication. Optimization: Replacing existing high-performance AI processors used to run complex neural networks, a lower-cost general-purpose MCU is used, fully meeting the control requirements.

[0026] User interaction unit: located on the side of the eye mask, including: A mode selection button: used to cycle through different preset treatment programs, such as program A, B, and C.

[0027] A pair of intensity adjustment buttons: used to increase or decrease the intensity of electrical stimulation in real time during treatment.

[0028] Power / start button and several status indicator lights. Optimization: The infrared camera and electrodes used for biometric identification have been completely eliminated; identity management is simplified to personal device use or user settings can be switched via a button.

[0029] When a user uses the app for the first time, they only need to set up an initial program using the mode selection key, without the need for complicated identity registration or biometric data entry.

[0030] S2. Personalized treatment logic based on pre-set programs and manual fine-tuning Core optimization: Replacing real-time AI-generated parameters with fixed procedures and manual adjustments. The control module's firmware pre-programs several collaborative treatment procedures based on clinical experience. Each procedure is a fixed parameter package, clearly defining: Hot compress parameters: target temperature such as 41℃, 43℃, heating time, and constant temperature duration.

[0031] Electrical stimulation parameters: basic waveform, output mode.

[0032] Synergistic timing: When electrical stimulation is initiated after the start of heat therapy.

[0033] For example, the following three typical programs can be preset: Program A (for MGD with excessive evaporation): Target heat temperature 43℃, maintained for 15 minutes; electrical stimulation begins 5 minutes after the start of heat application, using a constant 10Hz sparse wave with a base intensity of level 2. This program focuses on melting meibomian fat through prolonged heat application, while electrical stimulation plays an auxiliary role in neuroregulation.

[0034] Program B (for fluid deficiency): Apply heat at a target temperature of 41℃ for 10 minutes; electrical stimulation and heat application are initiated simultaneously, using alternating sparse and dense waves of 5Hz / 20Hz, with a base intensity of level 4. This program focuses on promoting tear secretion through low-frequency electrical stimulation, while the heat application provides a comfortable foundation.

[0035] Program C (for mixed / general soothing): Heat application target temperature 42℃, constant temperature for 12 minutes; electrical stimulation starts 2 minutes after heat application, using variable frequency waveform, with base intensity at level 3.

[0036] Personalization implementation path: Program selection: Users can determine and select a suitable program based on their doctor's diagnosis or the product instructions. For example, patients with meibomian gland dysfunction can choose program A.

[0037] Intensity fine-tuning: After treatment begins, the user adjusts the electrical stimulation intensity using the "+" and "-" buttons based on real-time sensations until a noticeable sensation is achieved, but the sensation is comfortable and painless. Real-time manual adjustment based on user tolerance is the most direct and reliable way to achieve a final personalized fit. The control module records the final intensity level at the end of the treatment.

[0038] S3. Simplified security monitoring and data management Safety Monitoring: The safety monitoring unit of the control module implements dual monitoring through a hardware comparator and software logic. At the hardware level, it directly monitors the heating current and the electrical stimulation output current, immediately cutting off power if they exceed the absolute threshold. At the software level, it analyzes the rate of change of temperature sensor readings in real time, automatically reducing heating power if the temperature rises too quickly.

[0039] Data logging: After each treatment, the system generates an encrypted treatment log in the local storage unit. The log only contains: treatment program number, total treatment duration, final electrical stimulation intensity level, and date and timestamp.

[0040] Data Upload and Utilization: Users can authorize their devices via a mobile app to upload desensitized treatment logs. The cloud server aggregates and analyzes massive amounts of logs. For example, among users who choose Program A, 70% will adjust the intensity to a level higher than the default level 2. Based on this clinical feedback, developers can determine that the default intensity of Program A may be set too low, and subsequently update and optimize the program parameters for all devices through firmware upgrades, such as adjusting the default intensity of Program A to level 3.

[0041] In summary, this application has at least the following effects: It significantly reduces costs and complexity. Through a basic NTC temperature sensor, a general-purpose MCU, and simple button interaction, hardware costs and engineering difficulty are greatly reduced, making mass production and maintenance easier. Secondly, it ensures core efficacy and safety. The design firmly grasps the proven physical therapy mechanism of synergistic heat therapy and low-frequency electrical stimulation, and ensures the scientific targeting of treatment through preset, clinically subtype-based fixed treatment programs. At the same time, it retains necessary temperature and current safety monitoring to ensure basic safety during treatment. Thirdly, it achieves minimalist personalization and a superior user experience. Replacing complex automatic diagnosis with user-selected preset programs and complex AI parameter generation with manual real-time intensity adjustment makes personalized treatment pathways intuitive, controllable, and without learning costs. Finally, it simplifies data and compliance. Streamlined data items and encrypted transmission that meets basic requirements protect user privacy while avoiding regulatory risks from excessive data collection, making it easier for the product to be marketed as a Class II medical device. Overall, this design achieves an optimal balance between efficacy, cost, ease of use, and time-to-market.

[0042] Those skilled in the art will understand that embodiments of the present invention can be provided as methods. Therefore, the present invention can take the form of a completely hardware embodiment, a completely software embodiment, or an embodiment combining software and hardware aspects. Furthermore, the present invention can take the form of a computer program product embodied on one or more computer-usable storage media (including, but not limited to, disk storage, CD-ROM, optical storage, etc.) containing computer-usable program code.

[0043] This invention is described with reference to a flowchart of a method according to embodiments of the invention. It should be understood that the combination of each step in the flowchart can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, special-purpose computer, embedded processor, or other programmable data processing device to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing device, generate instructions for implementing the process. Figure 1 A device for a function specified in one or more processes.

[0044] These computer program instructions may also be stored in a computer-readable storage medium that can direct a computer or other programmable data processing device to function in a particular manner, such that the instructions stored in the computer-readable storage medium produce an article of manufacture including instruction means, which are implemented in a process Figure 1 The function specified in one or more processes.

[0045] These computer program instructions may also be loaded onto a computer or other programmable data processing equipment to cause a series of operational steps to be performed on the computer or other programmable equipment to produce a computer-implemented process, thereby providing instructions that execute on the computer or other programmable equipment for implementing the process. Figure 1 Steps of a specified function in one or more processes.

[0046] Although preferred embodiments of the invention have been described, those skilled in the art, upon learning the basic inventive concept, can make other changes and modifications to these embodiments. Therefore, the appended claims are intended to be interpreted as including the preferred embodiments as well as all changes and modifications falling within the scope of the invention.

[0047] Obviously, those skilled in the art can make various modifications and variations to this invention without departing from its spirit and scope. Therefore, if these modifications and variations fall within the scope of the claims of this invention and their equivalents, this invention also intends to include these modifications and variations.

Claims

1. A mask-type dry eye treatment device, characterized in that, include: The main body of the eye mask is shaped to fit the contours of the human eye area; An electric heating module is integrated into the inner side of the eye mask body in the area corresponding to the upper and lower eyelids, and is used to generate and conduct heat. The low-frequency electrical stimulation module has electrodes placed in the area of ​​the eye mask body corresponding to the temples on both sides, and is used to output a low-frequency pulse current with a preset waveform. A control module is disposed inside the main body of the eye mask and is electrically connected to the electro-heating module and the low-frequency electrical stimulation module, respectively. The control module has at least two different collaborative treatment programs pre-stored. Each collaborative treatment program defines a fixed combination of the electrothermal module and the low-frequency electrical stimulation module in terms of treatment duration, working sequence, temperature parameters, and electrical stimulation waveform parameters. The control module is configured to execute the corresponding collaborative treatment program in response to user selection.

2. The eye mask-type dry eye treatment device according to claim 1, characterized in that, It also includes a user interaction unit, which includes a mode selection key and an intensity adjustment key; the mode selection key is used for the user to select from the at least two collaborative treatment programs; the intensity adjustment key is used for the user to adjust the output current intensity of the low-frequency electrical stimulation module in real time during treatment.

3. The eye mask-type dry eye treatment device according to claim 1, characterized in that, The electrothermal therapy module includes: A flexible electrothermal film is attached to the inside of the goggle mask body; The temperature sensing unit includes at least one temperature sensor disposed on the flexible electrothermal film for collecting the actual temperature of the treatment area. The control module is configured to perform closed-loop control on the heating power of the flexible electrothermal film based on the difference between the feedback signal from the temperature sensing unit and the target temperature, so as to maintain the actual temperature within a preset constant temperature range, specifically between 40 degrees Celsius and 45 degrees Celsius.

4. The eye mask-type dry eye treatment device according to claim 1, characterized in that, The control module also includes a storage unit and a communication unit; The storage unit is used to encrypt and store log data for a single treatment. The log data includes at least the treatment procedure identifier used, the total treatment duration, and the final electrical stimulation intensity level. The communication unit is configured to upload desensitized treatment log data to a remote server via a secure network protocol after authorization.

5. The eye mask-type dry eye treatment device according to claim 4, characterized in that, The remote server is configured to perform statistical analysis on the aggregated desensitization treatment log data, optimize the parameters of the pre-stored collaborative treatment program based on the statistical distribution of the selection frequency and intensity adjustment of each treatment program, and send the optimized parameter combination to the eye mask-type treatment device through the communication unit to update the local program.

6. The eye mask-type dry eye treatment device according to claim 1, characterized in that, The control module further includes a security monitoring unit, which is configured as follows: Real-time monitoring of the temperature of the electro-heating module and the output current of the low-frequency electrical stimulation module; When the temperature exceeds the first safety threshold or the current exceeds the second safety threshold, the power supply to the corresponding module is immediately cut off. When the instantaneous rate of change of temperature or current is detected to exceed the preset range, the output power is automatically adjusted to restore it to the normal range.

7. A method for using the eye mask-type dry eye treatment device according to any one of claims 1-6, characterized in that, Includes the following steps: Users can select one of at least two preset collaborative treatment programs using the mode selection key; The user wears the eye mask-style treatment device and starts the treatment; The control module calls the parameters of the selected synergistic treatment program to control the electro-heating module to start working and heat up to the target temperature; When the preset timing point is reached, the control module controls the low-frequency electrical stimulation module to output an electrical stimulation signal according to the parameters of the selected program; During treatment, the user can adjust the intensity of the electrical stimulation in real time using the intensity adjustment key; After the treatment is completed, the control module generates a treatment log containing the program identifier, duration, and intensity level, and stores it locally in encryption.

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