Non-invasive neurostimulator device and its application method

Description

1 / 25 “NON-INVASIVE NEUROSTIMULATOR DEVICE AND ITS APPLICATION METHOD” Technical field

[001] The invention reveals a device that operates in the field of medical devices, more specifically neurostimulation technologies.

[002] The device is a non-invasive neurostimulator, meaning that it eliminates the need for surgical procedures to activate the stimulators, and is designed with features for customization and real-time adaptation for the best patient experience and best results. State of the art

[003] It is known that neurostimulation technologies involve the application of electrical, magnetic and / or other energies to modulate neural activity in the body, used to treat various neurological and psychiatric conditions, including chronic pain, epilepsy, anxiety and other conditions related to neural dysfunction.

[004] Available neurostimulation technologies can be categorized into invasive and non-invasive methods, of which: • Invasive Neurostimulation: This involves the surgical implantation of devices such as deep brain stimulators (DBS), spinal cord stimulators (SCS), and vagus nerve stimulators (VNS). These devices deliver electrical impulses directly to specific nerves or brain regions to alter neural activity and treat medical conditions. Despite their effectiveness, invasive neurostimulation techniques carry significant risks, including infection, Petition 870250071347, dated 08 / 13 / 2025, page 10 / 36 2 / 25 Device malfunction and the risks inherent in surgery; • Non-Invasive Neurostimulation: This approach does not require surgery and includes techniques such as transcutaneous electrical nerve stimulation (TENS), transcranial magnetic stimulation (TMS), and transcranial direct current stimulation (tDCS). These methods are safer and more accessible, making them suitable for a wider range of patients. However, their effectiveness may be limited by the inability to provide precise and personalized stimulation.

[005] To exemplify current techniques, patent document BR 112018075776-4 of 2017 is cited, claiming a method that includes defining titration parameters for an electrical signal provided by an implantable medical device, initiating titration with the titration parameters and an aggressiveness profile, performing titration to increase at least one of a current amplitude, frequency, pulse width, or duty cycle of the electrical signal until a limit is reached or a side effect is detected, pausing titration while awaiting commands from the patient or caregiver, and resuming titration in response to receiving authorization from an external device.

[006] Also, document PI 0614132-3 of 2006 claims a method and apparatus for treating people suffering from an eating disorder that includes direct or indirect stimulation of selected brain areas associated with a symptom of the eating disorder. The stimulation regimen is programmable to allow medical optimization of stimulus signal parameters to improve at least one symptom of bulimia or another eating disorder. Petition 870250071347, dated 08 / 13 / 2025, page 11 / 36 3 / 25 Certain methods employ deep brain stimulation and / or sensing along with cranial nerve stimulation and / or sensing.

[007] In any case, although effective, the currently known invasive methods present significant risks, such as infection, bleeding and damage to surrounding tissues, and are generally reserved for patients who do not respond to conventional treatments. Non-invasive devices, on the other hand, have limitations that can be overcome with modernization and customizable tools.

[008] The inventor has found that one of the limitations of existing neurostimulation devices is their invasiveness, since most current neurostimulators require surgical implantation, which is intimidating for patients and involves the risks inherent in any surgical procedure. This invasiveness limits the patient population to those who are severely affected or who do not achieve relief with less invasive treatments.

[009] Another significant limitation is the lack of personalization, as traditional neurostimulators tend to operate with fixed parameters that do not adapt to the changing physiological conditions of the patient, which often leads to suboptimal therapeutic results and potential side effects.

[010] It is also known that the parameters of existing neurostimulators often need to be manually adjusted by healthcare professionals, requiring frequent visits and assessments, making treatment time-consuming and costly for both patients and healthcare systems. Petition 870250071347, dated 08 / 13 / 2025, page 12 / 36 4 / 25

[011] Finally, even the most current devices have limited feedback mechanisms, with most devices lacking integrated feedback systems to monitor the patient's physiological responses in real time. This absence of a feedback circuit means that adjustments to stimulation parameters are based on periodic assessments, not continuous monitoring. Objectives of the invention

[012] The present invention aims to solve the problems of current techniques with an intelligent, non-invasive, AI-driven neurostimulator device designed to stimulate the vagus nerve for therapeutic purposes. The device consists of sensors to monitor physiological parameters, an AI algorithm to analyze the data, and a stimulator to provide personalized neurostimulation.

[013] This intelligent, non-invasive neurostimulator powered by AI represents a significant advance in the field of neurostimulation. By combining non-invasive stimulation techniques with AI-based personalization and real-time feedback mechanisms, the device addresses the limitations of both traditional invasive and non-invasive neurostimulators. Its main features include: • Non-invasive: Safe and easy to use, eliminating the risks associated with surgical procedures; • AI-powered personalization: Real-time analysis of physiological data to customize stimulation parameters for each patient; Petition 870250071347, dated 08 / 13 / 2025, page 13 / 36 5 / 25 • Integrated Sensors: Continuous monitoring of vital signs and neural activity to provide real-time feedback and adjustments; • Wireless Connectivity: Remote monitoring and management capabilities via mobile applications and cloud platforms.

[014] The invention aims to increase the effectiveness and accessibility of neurostimulation therapy, offering a transformative solution for the treatment of various neurological and psychiatric disorders. The integration of AI and advanced sensor technologies positions this device at the forefront of the next generation of neurostimulation therapies, promising better outcomes and quality of life for patients. Description of the figures Figure 1 - illustrates the device assembled in its operating system, i.e., connected to the stimulators, the cloud, and a personal use device {in this case, a smartwatch}; Figure 2A - illustrates the 'main unit' of the device; Figure 2B - illustrates the 'main unit' of the device in exploded view, showing its internal AI processor; Figure 3 - illustrates the device's power supply in exploded view, showing its power management circuits; Figure 4A - illustrates an isolated stimulator indicating its connection via Bluetooth; Figure 4B - illustrates the stimulator in exploded view, showing the communicating electrode via Bluetooth, sensors, and fixation mechanism. Petition 870250071347, dated 08 / 13 / 2025, page 14 / 36 6 / 25 Detailed description of the invention

[015] The device (1) is an intelligent neurostimulator designed to provide ease of application, customization and continuous monitoring of the patient's conditions and progress in treatment. Device structure:

[016] The intelligent neurostimulation device (1) is an advanced non-invasive medical device designed to stimulate the vagus nerve for therapeutic purposes. The device structure includes several main components that work together to provide personalized neurostimulation based on real-time physiological data. The main components are the Main Unit, the Electrode Set, and the Sensors.

[017] The Main Unit (10) is the core of the intelligent neurostimulation device, responsible for data processing, energy management and facilitating communication. It is composed of: • AI Processor: The AI ​​processor (11) is the brain of the device, using advanced machine learning algorithms to analyze the data collected by the sensors. It processes this information to determine the ideal neurostimulation parameters, customized to the individual needs of the patient. The AI ​​processor (1 1) learns and adapts continuously based on the patient's physiological responses, ensuring that the therapy remains effective over time; • Power Supply: The power supply (20) is designed to provide reliable and long-lasting power to Petition 870250071347, dated 08 / 13 / 2025, page 15 / 36 7 / 25 device. Includes a rechargeable battery system that allows for extended use without the need for frequent recharging. The power supply is integrated with power management circuits (21) to optimize consumption and extend battery life; • Wireless Communication Module: The wireless communication module (30) allows the device to connect to external devices such as smartphones, tablets, and cloud platforms. This module supports various wireless communication protocols, including Bluetooth and Wi-Fi, enabling remote monitoring, data transfer, and real-time adjustments by healthcare professionals. Connectivity also facilitates firmware updates to ensure the device is always up-to-date with the latest advancements.

[018] The Electrode Set (40) is designed for non-invasive application and is a critical component for delivering neurostimulation. The set consists of: • Non-Invasive Electrodes (41): These electrodes are designed to be positioned in the concha of the ear, on the skin covering the Arnold nerve, which is connected to the vagus nerve. The electrodes are made of biocompatible materials to ensure safety and comfort during prolonged use. They are flexible and ergonomically shaped to fit securely and comfortably in the ear, providing consistent and effective stimulation; • Positioning and Fixing: The electrodes have a fixing mechanism (42), such as adhesive pads or clips, to ensure that they remain firmly positioned during Petition 870250071347, dated 08 / 13 / 2025, page 16 / 36 8 / 25 use. The design ensures ease of application and removal, allowing patients to use the device without the need for professional assistance.

[019] Sensors (50) are integrated into the device to continuously monitor various physiological parameters. These sensors play a crucial role in providing the data needed for the AI ​​processor to personalize neurostimulation. The main sensors include: • Heart Rate Sensor: This sensor monitors the patient's heart rate in real time. By analyzing heart rate variability, the device can assess the activity of the patient's autonomic nervous system, which is essential for determining the appropriate neurostimulation parameters; • Skin Conductivity Sensor: Also known as a galvanic skin response (GSR) sensor, this component measures the electrical conductance of the skin, which varies according to the activity of the sweat glands. Changes in skin conductivity are associated with stress and emotional states, providing valuable feedback for adjusting neurostimulation.

[020] The integration of these components allows the intelligent neurostimulator (1) to function as an effective and personalized therapeutic device. The AI ​​algorithm

[021] The AI ​​algorithm of the AI ​​processor (1 1) is the central component that drives the functionality and effectiveness of the device. Petition 870250071347, dated 08 / 13 / 2025, page 17 / 36 9 / 25 Intelligent neurostimulation (1). It uses advanced machine learning techniques to process and analyze data collected by integrated sensors, enabling real-time personalization and optimization of neurostimulation therapy. The main functionalities of the AI ​​algorithm include Data Analysis, Personalization, and Predictive Analytics, of which:

[022] a. Data Analysis • Continuous Monitoring: The AI ​​algorithm is configured to continuously monitor a variety of physiological signals collected by the device's sensors, including heart rate, skin conductivity, and brain activity. With this real-time data acquisition, the AI ​​maintains a comprehensive and up-to-date understanding of the patient's physiological state; • Pattern Detection: Using machine learning models, the AI ​​algorithm is configured to identify patterns in physiological data. For example, detecting regularities in heart rate variability, changes in skin conductance, and brainwave patterns that correlate with different states of health and disease; • Anomaly Detection: The algorithm is also configured to recognize anomalies or deviations from the patient's typical physiological patterns. This capability is crucial for identifying acute changes that may indicate the onset of a health problem, allowing for timely intervention; • Data Integration: The AI ​​algorithm is configured to integrate data from multiple sensors to create a holistic view of the patient's physiological state. This analysis Petition 870250071347, dated 08 / 13 / 2025, page 18 / 36 10 / 25 multidimensional ensures that stimulation parameters are adjusted based on a comprehensive assessment, rather than isolated data.

[023] b. Personalization • Real-Time Adjustment: One of the main functions of the AI ​​algorithm is to adjust neurostimulation parameters in real time. Using continuously monitored data, the AI ​​is configured to personalize the intensity, frequency, and duration of stimulation to meet the patient's immediate needs; • Use of Historical Data: The algorithm is not only based on real-time data, but is also configured to consider historical data to enhance personalization. By analyzing past responses to neurostimulation, the AI ​​can identify unique trends and preferences of each patient, refining treatment over time; • Adaptive Learning: With machine learning capabilities, the AI ​​is configured to adapt and improve its performance based on continuously collected data. As more data is collected, the AI ​​models become more accurate in predicting optimal stimulation settings, thus increasing the effectiveness of the therapy; • Personalized Treatment Protocols: Based on patient data, the AI ​​is configured to develop personalized treatment protocols that specify the ideal neurostimulation parameters for different times of day or in response to specific triggers. This level of personalization Petition 870250071347, dated 08 / 13 / 2025, page 19 / 36 11 / 25 ensures that the therapy is effective and minimally intrusive on the patient's daily routine.

[024] c. Predictive Analytics • Problem Anticipation: Through predictive analytics, the AI ​​algorithm is configured to predict potential health problems before they become critical by identifying early warning signs in physiological data. AI can therefore anticipate problems such as impending seizures in patients with epilepsy or severe episodes of depression; • Proactive Adjustments: With predictive insights, the AI ​​is configured to proactively adjust stimulation parameters. For example, if the AI ​​predicts an anxiety episode, it can proactively modulate neurostimulation to mitigate symptoms; • Preventive Strategies: The algorithm is also configured to suggest preventive strategies based on predictive analyses. For example, recommending specific times for neurostimulation sessions or suggesting behavioral changes to the patient that may improve overall therapeutic outcomes; • Long-Term Health Management: Beyond immediate treatment, AI's predictive capabilities contribute to long-term health management. By continuously learning from patient data, AI helps manage chronic conditions more effectively, reducing the likelihood of acute episodes and improving the patient's quality of life. General operation Petition 870250071347, dated 08 / 13 / 2025, page 20 / 36 12 / 25

[025] During the operation, the steps for therapeutic treatment are carried out.

[026] Initialization: The device (1) is paired with a cloud-based mobile application (200) and installed on a personal device (100), such as a smartwatch or smartphone, where the patient’s initial data is entered. The device’s AI processor (11) uses this data to create a reference profile.

[027] Application: The electrodes (40) and sensors (50) are easily positioned in the patient's ear concha by simple positioning according to the characteristics of their fixation mechanism (42).

[028] Continuous Monitoring: The sensors (50) continuously collect physiological data from the patient, which is transmitted to the AI ​​processor (11).

[029] Data Analysis: The AI ​​processor (11) analyzes the data in real time to identify patterns and assess the patient’s current physiological state.

[030] Personalized Stimulation: Based on the analysis, the AI ​​processor (11) adjusts the stimulation parameters and sends signals to the electrode array (40) to provide personalized neurostimulation.

[031] Feedback Loop: The device (1), through its AI processor (11), continuously monitors the patient’s response to stimulation and dynamically adjusts the parameters to ensure optimal therapeutic results.

[032] This sophisticated integration of AI, sensor technology and non-invasive stimulation positions the smart neurostimulator. Petition 870250071347, dated 08 / 13 / 2025, page 21 / 36 13 / 25 (1) as an innovative solution in the field of neurostimulation, offering safe, effective and personalized treatment for various neurological and psychiatric conditions.

[033] The AI ​​algorithm is at the heart of the smart neurostimulator, transforming it from a static medical device into a dynamic, responsive, and intelligent therapeutic tool. By continuously analyzing data, personalizing treatment, and predicting potential problems, the AI-powered neurostimulator (1) offers a revolutionary approach to the management of neurological and psychiatric disorders. Detailed operation

[034] Thus, it is seen that the device (1) is versatile and can be used in various therapeutic applications, such as: • Depression: Modulating neural activity to alleviate symptoms of depression; • Epilepsy: Reducing the frequency and severity of seizures by stabilizing neural networks; • Anxiety: Calming the nervous system and reducing anxiety levels through targeted stimulation.

[035] The operation of the intelligent neurostimulation device (1), as introduced above, involves a seamless integration of initialization, continuous monitoring, targeted stimulation and a dynamic feedback loop. Each phase of operation ensures that the device provides personalized and effective neurostimulation therapy tailored to the patient’s specific needs.

[036] A detailed description of the operational process is provided below:

[037] a. Initialization Petition 870250071347, dated 08 / 13 / 2025, page 22 / 36 14 / 25 • Device Pairing: The first step in operation is device initialization. This is done by pairing the neurostimulator (1) with a dedicated mobile app via Bluetooth or Wi-Fi. The mobile app acts as the device's control center, allowing for easy setup and management; • Patient Data Entry: During initialization, specific patient data is entered into the system. This data includes: Personal information, such as age, weight, and medical history; Physiological baseline measurements, which can be collected during an initial assessment period; Specific therapeutic goals and any known triggers or conditions relevant to the patient's treatment; • Profile Creation: The entered data is used to create a personalized patient profile within the AI ​​system. This profile serves as a reference point for all subsequent monitoring and treatment adjustments; • Calibration: The device undergoes an initial calibration process to adapt the electrode placement and stimulation parameters to the patient's anatomy and baseline physiological state. This step ensures that the device starts with the most effective configuration for each individual patient; Petition 870250071347, dated 08 / 13 / 2025, page 23 / 36 15 / 25 • Electrode placement: The electrodes (40) are positioned in the concha of the patient's ear, over Arnold's nerve which is connected to the vagus nerve.

[038] b. Monitoring • Continuous Data Collection: After initialization, the device’s integrated sensors (50) begin to continuously monitor the patient’s physiological parameters. The main sensors include: Heart Rate Sensor: Tracks heart rate and heart rate variability, providing insights into autonomic nervous system activity; The Skin Conductivity Sensor: Measures the electrical conductance of the skin, which is correlated with sweat gland activity and stress levels; The Brain Activity Sensor: Uses EEG to monitor brain activity patterns, detecting different mental states such as relaxation, focus, and stress; • Real-Time Data Processing: The collected data is transmitted to the AI ​​processor (11) in real time. The AI ​​algorithm processes this data to identify patterns, detect anomalies, and assess the patient’s current physiological state; • Data Integration: AI integrates data from all sensors to form a comprehensive understanding of the patient's condition. This holistic view allows for more precise and effective adjustments to neurostimulation parameters. Petition 870250071347, dated 08 / 13 / 2025, page 24 / 36 16 / 25

[039] c. Customized Stimulation Parameters • Intensity Adjustment: The AI ​​algorithm adjusts the intensity {strength of the electrical impulses delivered by the electrodes (40)} based on the patient’s real-time physiological responses, ensuring that the stimulation is effective and comfortable. Higher intensities can be used for more significant therapeutic effects, while lower intensities are employed for maintenance or during periods of increased sensitivity; • Frequency Adjustment: The AI ​​algorithm modulates the frequency {the rate at which electrical impulses are delivered to the nerves, measured in Hertz (Hz), indicating the number of impulses per second} to optimize therapeutic effects. Different frequencies can target various physiological responses, such as relaxing the nervous system or stimulating alertness. The ideal frequency is determined by analyzing the patient's physiological data and therapeutic needs; • Duration Adjustment: The AI ​​algorithm determines the duration {time of each stimulation session, defining how long the electrical impulses are applied during a single session} based on the patient's condition and the desired therapeutic outcome. Longer sessions may be necessary for chronic conditions, while shorter, more frequent sessions may be used for managing acute symptoms. The algorithm ensures that the duration is sufficient to achieve therapeutic benefits without causing overstimulation or discomfort.

[040] d. Stimulation Petition 870250071347, dated 08 / 13 / 2025, page 25 / 36 17 / 25 • Data Analysis: The AI ​​algorithm continuously monitors the patient's physiological data, including heart rate variability and skin conductance, to assess their current state and response to previous stimulations; • Parameter Determination: Based on data analysis, the AI ​​algorithm determines the ideal intensity, frequency, and duration for the stimulation session. These parameters are customized to the patient's immediate needs and historical responses; • Stimulation Delivery: The ear stimulator, equipped with non-invasive electrodes, delivers electrical impulses according to specified parameters. The electrode placement ensures that the stimulation effectively reaches the vagus nerve; • Real-Time Adjustments: During the stimulation session, the AI ​​algorithm continuously monitors the patient's physiological responses. If necessary, it can make real-time adjustments to intensity, frequency, and duration to ensure that the stimulation remains effective and comfortable; • Feedback Loop: The closed-loop system ensures that stimulation parameters are continuously optimized based on real-time data. This dynamic adjustment helps maximize therapeutic results and minimize side effects.

[041] Here it is seen that the function of the ear stimulator within the intelligent neurostimulation device is to deliver highly personalized and adaptive neurostimulation, based on customized parameters of intensity, frequency and duration. Petition 870250071347, dated 08 / 13 / 2025, page 26 / 36 18 / 25 defined by AI. By leveraging continuous analysis of physiological data and real-time adjustments, the device ensures effective, safe, and personalized therapy for each patient.

[042] The device delivers personalized neurostimulation via a set of electrodes positioned on the auricle, over the Arnold nerve. The stimulation is non-invasive and designed to activate the vagus nerve effectively without causing discomfort to the patient.

[043] The AI ​​algorithm can make real-time adjustments to the stimulation parameters during the therapy session. This ensures that neurostimulation remains effective as the patient's physiological state changes.

[044] e. Feedback Loop • Dynamic Feedback: Continuous monitoring and data analysis create a dynamic feedback loop, where the AI ​​algorithm uses real-time data to adjust stimulation parameters immediately, responding promptly to changes in the patient's condition; • Closed-Loop System: The device operates in a closed-loop system, where the output {neurostimulation} is constantly refined based on sensor feedback. This system ensures that the therapy is always optimized for the patient's current needs, increasing the effectiveness and safety of the treatment; • Proactive Adjustments: AI's predictive analytics capabilities allow the device to anticipate potential problems and make proactive adjustments. For example, if the AI ​​detects early signs... Petition 870250071347, dated 08 / 13 / 2025, page 27 / 36 19 / 25 of a stress episode, can proactively modulate stimulation to prevent or mitigate the episode.

[045] f. Remote Monitoring and Updates • The device’s wireless communication module allows healthcare professionals to monitor patient progress remotely. They can review data, provide feedback, and make adjustments to the treatment plan as needed. The mobile app also facilitates firmware updates, ensuring the device always operates with the latest software enhancements.

[046] The intelligent neurostimulation device operates through a sophisticated integration of initialization, continuous monitoring, targeted stimulation, and a dynamic feedback loop. This comprehensive operation ensures that the device provides personalized and effective neurostimulation therapy tailored to the specific needs of each patient. Leveraging advanced AI algorithms and real-time data analysis, the device offers a safe, non-invasive, and highly adaptable treatment option for a variety of neurological and psychiatric disorders. Technical Implementation

[047] The AI ​​algorithm uses several machine learning models, including supervised learning for pattern recognition and unsupervised learning for anomaly detection. These models are trained on extensive datasets to ensure high accuracy and reliability.

[048] The device operates in a closed-loop system where the AI ​​algorithm receives constant feedback from the sensors. This feedback loop allows for continuous refinement of the parameters of Petition 870250071347, dated 08 / 13 / 2025, pages 28 / 36 20 / 25 neurostimulation, ensuring that the therapy is always optimized for the patient's current condition.

[049] The AI ​​algorithm benefits from integration with the cloud, enabling complex calculations and access to large datasets. Cloud connectivity also allows for remote updates of AI models, ensuring that the device remains at the forefront of technological advancements.

[050] AI outputs are communicated to healthcare professionals and patients through an intuitive user interface. This interface offers real-time data visualization, insights, and recommendations, facilitating understanding and engagement with therapy. Final comments

[051] Recent advances in neurostimulation have focused on improving the accuracy, effectiveness, and personalization of treatment, and this is where the present invention establishes its innovations. The main areas of innovation include: • Integration of Artificial Intelligence (AI): AI and machine learning algorithms can analyze large volumes of physiological data in real time, allowing for the customization of neurostimulation parameters according to each patient's individual needs. This improves therapeutic outcomes and minimizes side effects; • Sensor Technologies: Advanced sensors monitor physiological parameters such as heart rate, skin conductivity, brain activity, and more. These sensors provide valuable feedback that can be used for Petition 870250071347, dated 08 / 13 / 2025, pp. 29 / 36 21 / 25 adjust the stimulation parameters dynamically, creating a closed-loop system that optimizes treatment in real time; • Wireless Connectivity: Modern neurostimulation devices can connect to mobile applications and cloud platforms, allowing for remote monitoring and adjustments by healthcare professionals. This connectivity facilitates continuous care and improves patient adherence to treatment protocols.

[052] Neurostimulation has a wide range of therapeutic applications, including: • Chronic Pain Management: Neurostimulation can modulate pain pathways, providing relief for patients with chronic pain conditions resistant to conventional treatments; • Treatment of Epilepsy: By stabilizing neural activity, neurostimulation can reduce the frequency and severity of epileptic seizures; • Mental Health Disorders: Conditions such as depression, anxiety, and PTSD (post-traumatic stress disorder) can be treated by modulating neural circuits involved in mood regulation; • Movement Disorders: Neurostimulation is used to treat movement disorders, such as Parkinson's disease, by regulating abnormal neural activity; Petition 870250071347, dated 08 / 13 / 2025, pages 30 / 36 22 / 25 • Rehabilitation: Neurostimulation can increase neuroplasticity, aiding in the rehabilitation of patients with stroke, spinal cord injury, and other neurological impairments.

[053] Recent advances in artificial intelligence and machine learning have opened up new possibilities in the field of neurostimulation. AI algorithms can analyze large volumes of data, identify patterns, and make adjustments in real time, making treatments more efficient and personalized. In addition, the development of non-invasive nerve stimulation techniques, such as transcutaneous electrical nerve stimulation (TENS) and transcranial magnetic stimulation (TMS), has shown promising results in various therapeutic applications, offering safer alternatives compared to invasive methods. Technical advantages of the invention

[054] The invention and its features bring to specific treatments new possibilities and advantages not achieved by currently available devices.

[055] In terms of clinical outcomes, the device delivers enhanced efficacy, as traditional neurostimulation techniques often follow a one-size-fits-all approach, leading to variable results among patients. By leveraging AI to personalise treatment parameters in real time, the smart neurostimulator (1) ensures that each patient receives optimal stimulation tailored to their unique physiological responses. This personalisation improves the effectiveness of treatments, resulting in better management of conditions such as depression, epilepsy, anxiety and chronic pain. Petition 870250071347, dated 08 / 13 / 2025, pages 31 / 36 23 / 25

[056] It also brings a reduction in side effects, as the personalized neurostimulation offered by the device (1) not only improves effectiveness, but also minimizes side effects by continuously adjusting the stimulation based on real-time feedback, avoiding overstimulation or understimulation problems common in conventional neurostimulation methods.

[057] Its versatility also allows its use in a wide variety of neurological and psychiatric conditions. This flexibility expands the therapeutic potential of neurostimulation, making it a viable option for more patients and a wider range of disorders.

[058] In terms of health economics, the device (1) reduces costs, since the non-invasive nature of the smart neurostimulator eliminates the need for expensive and risky surgical interventions. This reduction in surgical procedures translates into significant savings for health systems. In addition, the device's ability to be used and monitored remotely reduces the frequency of in-person visits to the clinic, further decreasing health expenditures.

[059] It also brings efficiency in the use of resources, as remote monitoring and adjustments allow healthcare professionals to manage more patients efficiently. This capability enables better allocation of medical resources, ensuring that healthcare professionals can focus on patients who require immediate or intensive care.

[060] It also provides complication prevention by avoiding complications associated with invasive procedures, reducing the incidence of post-surgical infections, hardware failures and others. Petition 870250071347, dated 08 / 13 / 2025, pages 32 / 36 24 / 25 related problems. This reduction in complications not only improves patient outcomes but also decreases the long-term costs associated with managing these complications.

[061] As for quality of life, due to its non-invasive design, the device (1) offers significant convenience for patients, who can use it without the fear and discomfort associated with surgical procedures, which encourages adherence to treatment regimens, leading to better long-term health outcomes.

[062] It also brings adaptability through the device's ability to adapt in real time to the patient's physiological state, ensuring that treatment remains effective and comfortable. Patients can experience immediate adjustments to their therapy, enhancing their overall treatment experience.

[063] It also brings empowerment and engagement through integration with mobile applications and cloud platforms that enable patients to take an active role in their treatment. Access to real-time data and the ability to communicate remotely with healthcare professionals promote a sense of engagement and control over their health.

[064] In the medical field, it brings advances in neurostimulation with the introduction of AI-driven personalization, establishing a new milestone in the field and paving the way for future innovations, encouraging the development of even more sophisticated neurostimulation technologies.

[065] It also allows for better research and development, as the data collected by the smart neurostimulator provides valuable insights into the mechanisms of neurological disorders and Petition 870250071347, dated 08 / 13 / 2025, pages 33 / 36 25 / 25 psychiatric. This wealth of information could drive further research and development in the field, leading to new treatments and therapies.

[066] Finally, it also delivers standardization of care by offering a consistent and adaptable treatment platform, helping to standardize care for neurological disorders. This standardization ensures that patients receive high-quality care, regardless of geographic or socioeconomic barriers. Petition 870250071347, dated 08 / 13 / 2025, pages 34 / 36

Claims

1 / 8 CLAIMS 1) A NON-INVASIVE NEUROSTIMULATOR DEVICE designed for ease of application, customization and continuous monitoring of patient treatment conditions and progress, being a non-invasive medical device for stimulating the vagus nerve for therapeutic purposes, characterized by being composed of a Main Unit, an Electrode and Sensor Set, of which: the Main Unit (10) is the core of the device, responsible for data processing, energy management and facilitation of communication, being composed of: • AI Processor (11) - as the brain of the device, using advanced machine learning algorithms to analyze the data collected by the sensors, capable of processing this information to determine the ideal neurostimulation parameters customized to the individual needs of the patient,whereby said AI processor (1 1) learns and adapts continuously based on the patient's physiological responses; • Power Supply (20) - to provide reliable and long-lasting power to the device, which includes a rechargeable battery system and is integrated with power management circuits (2 1) to optimize consumption and extend battery life; • Wireless Communication Module (30) - for connecting the device to external devices such as smartphones, tablets and cloud platforms, this module supports wireless communication protocols, including Bluetooth and WiFi, the Electrode Set (40) is designed for non-invasive application, i.e., external use, to provide neurostimulation, and is composed of: • Non-Invasive Electrodes (41) - designed for placement in the concha of the ear, on the skin covering the Arnold nerve, connected to the vagus nerve,being made of biocompatible, flexible and ergonomically shaped materials for positioning in the ear; • Fixing Mechanism (42) - such as adhesive pads or clips for stable positioning during use, being removable, the Sensors (50) designed to continuously monitor physiological parameters, providing the data to the AI ​​processor (11) and which include: Heart Rate sensor; and Skin Conductivity Sensor. 2) The DEVICE according to claim 1, characterized in that the AI ​​algorithm of the AI ​​processor (11) uses machine learning to process and analyze the data collected by the sensors, configured to allow real-time personalization and optimization of neurostimulation therapy, wherein said AI algorithm: is configured to continuously monitor a variety of physiological signals collected by the device's sensors, including heart rate, skin conductance and brain activity; Petition 870250012015, dated 02 / 13 / 2025, p. 35 / 45 3 / 8 is configured to identify patterns in physiological data, for example detecting regularities in heart rate variability, changes in skin conductance and brain wave patterns that correlate with different states of health and disease;It is configured to recognize anomalies or deviations from the patient's typical physiological patterns to identify acute changes that may indicate the onset of a health problem; and it is configured to integrate data from multiple sensors for a holistic view of the patient's physiological state, said AI algorithm is also configured to: • adjust neurostimulation parameters in real time, using continuously monitored data to personalize the intensity, frequency, and duration of stimulation; • consider historical data for personalization by identifying unique trends and preferences of each patient, refining treatment over time; • adapt and improve its performance based on continuously collected data; • develop personalized treatment protocols that specify the ideal neurostimulation parameters for different times of day or in response to specific triggers;• predict potential health problems before they become critical by identifying early warning signs in physiological data; Petition 870250012015, dated 02 / 13 / 2025, page 36 / 45 4 / 8 • make proactive adjustments to stimulation parameters, for example, proactively modulating neurostimulation to mitigate the symptoms of a potential anxiety crisis; • suggest preventive strategies based on predictive analyses, for example, recommending specific times for neurostimulation sessions or suggesting behavioral changes to the patient. 3) A METHOD OF APPLYING the neurostimulator device (1) as defined in claim 1, characterized by the following steps: Initialization - where the device (1) is paired with a cloud-based mobile application (200) and installed on a personal device (100), such as a smartwatch or smartphone, where the patient's initial data is entered, and the AI ​​processor (11) uses this data to create a reference profile; Application - where the electrodes (40) and sensors (50) are positioned on the patient's ear concha by simple positioning according to the characteristics of their fixation mechanism (42); Continuous Monitoring - where the sensors (50) continuously collect physiological data from the patient, which are transmitted to the AI ​​processor (11); Data Analysis - where the AI ​​processor (11) analyzes the data in real time to identify patterns and assess the patient's current physiological state;Personalized Stimulation - where, based on analysis, the AI ​​processor (1 1) adjusts the stimulation parameters and sends signals to the Petition 870250012015, dated 02 / 13 / 2025, page 37 / 45 5 / 8 electrode array (40) to provide personalized neurostimulation; Wherein by its AI processor (11), the device (1) continuously monitors the patient's response to stimulation and dynamically adjusts the parameters to ensure optimal therapeutic results.; 4) The APPLICATION METHOD according to claim 3, characterized by the following steps: a. Initialization: • pairing the neurostimulator (1) with a dedicated mobile application via Bluetooth or Wi-Fi, where the mobile application acts as the device's control center; • during initialization, specific patient data is entered into the system, including: o Personal information, such as age, weight, and medical history; o Reference physiological measurements, which may be collected during an initial assessment period; o Specific therapeutic goals and any known triggers or conditions relevant to the patient's treatment; • the entered data is used to create a personalized patient profile within the AI ​​system that serves as a reference point for all subsequent monitoring and adjustments of the treatment; Petition 870250012015, dated 02 / 13 / 2025, p.38 / 45 6 / 8 • the electrodes (40) are positioned on the concha of the patient's ear, over the Arnold nerve which is connected to the vagus nerve. • the device undergoes an initial calibration process to adapt the electrode placement and stimulation parameters to the patient's anatomy and reference physiological state; b.Monitoring • After initialization, the device’s integrated sensors (50) begin to continuously monitor the patient’s physiological parameters, said sensors include: Heart Rate Sensor; Skin Conductivity Sensor; and Brain Activity Sensor; • The collected data is transmitted to the AI ​​processor (11) in real time, where the AI ​​algorithm processes this data to identify patterns, detect anomalies and assess the patient’s current physiological state; • The AI ​​integrates data from all sensors to form a comprehensive understanding of the patient’s condition, forming a holistic view for more precise and effective adjustments to neurostimulation parameters; c.Customized Stimulation Parameters • The AI ​​algorithm adjusts the intensity {strength of the electrical impulses delivered by the electrodes (40)} based on the patient's real-time physiological responses; • The AI ​​algorithm modulates the frequency {rate at which electrical impulses are delivered to the nerves, measured in Hertz Petition 870250012015, dated 02 / 13 / 2025, page 39 / 45 7 / 8 (Hz) indicating the number of impulses per second} to optimize therapeutic effects; • The AI ​​algorithm defines the duration {time of each stimulation session, defining how long the electrical impulses are applied during a single session} based on the patient's condition and the desired therapeutic outcome, ensuring that the duration is sufficient to achieve the therapeutic benefits without causing overstimulation or discomfort; d.Stimulation • The AI ​​algorithm continuously monitors the patient's physiological data, including heart rate variability and skin conductance, to assess their current state and response to previous stimulations; • Based on data analysis, the AI ​​algorithm determines the ideal intensity, frequency, and duration for the stimulation session, with these parameters customized to the patient's immediate needs and historical responses; • The ear stimulator, equipped with non-invasive electrodes, delivers electrical impulses according to the specified parameters; • During the stimulation session, the AI ​​algorithm continues to monitor the patient's physiological responses, making real-time adjustments to intensity, frequency, and duration when necessary; • Stimulation parameters are continuously optimized based on real-time data to maximize therapeutic results while minimizing side effects.Petition 870250012015, dated 02 / 13 / 2025, page 40 / 45 8 / 8 e. Feedback Loop • Continuous monitoring and data analysis create a dynamic feedback loop, where the AI ​​algorithm uses real-time data to adjust stimulation parameters immediately, responding promptly to changes in the patient's condition; • The device operates in a closed-loop system, where the output {neurostimulation} is constantly refined based on sensor feedback; • The AI's predictive analytics capabilities allow the device to anticipate potential problems and make proactive adjustments, for example, proactively modulating stimulation when early signs of a stress episode are detected; f.Remote Monitoring and Updates • The device's wireless communication module allows healthcare professionals to remotely monitor patient progress to review data, provide feedback, and make adjustments to the treatment plan as needed. Petition 870250012015, dated 02 / 13 / 2025, pp. 41 / 45.

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