Neuromodulation device, multi-modal switching method, and computer program product

Abstract

The application relates to a neuromodulation device, a multi-mode switching method and a computer program product, and relates to the technical field of medical devices. The neuromodulation device comprises: a plurality of stimulation links of at least two different stimulation modes, a state monitoring module for monitoring the working state of a current working link in real time, a working link switching module for disabling a faulty link and selecting a standby link as a new working link as soon as a fault feature is detected; on this basis, a working mode switching module automatically judges the stimulation mode difference between the new and old links, and if there is a difference, the working mode switching module synchronously switches to a specific working mode matched with the new link, and then a stimulation module accurately controls the stimulation output of an anatomical region according to the updated mode. The application can realize seamless degradation and continuous intervention between different stimulation modes under the premise of ensuring safety, and improve the continuity and effect of neuromodulation.

Description

Technical Field

[0001] This application relates to the field of medical device technology, specifically to a neuromodulation device, a multi-mode switching method, and a computer program product. Background Technology

[0002] Wearable neuromodulation technology has broad application prospects in perioperative analgesia, postoperative rehabilitation, and sleep management. Existing neuromodulation devices typically employ single or multiple stimulation modes.

[0003] In clinical settings where treatment continuity is critical, existing fault handling mechanisms still have limitations. When the main stimulation pathway malfunctions due to electrode detachment, poor contact, or changes in patient positioning, simply stopping stimulation or issuing a simple alarm would force the neuromodulation intervention to be interrupted, making it difficult to maintain the expected therapeutic effect.

[0004] Therefore, how to achieve continuous intervention of neuromodulation stimulation while ensuring safety remains a technical challenge that urgently needs to be solved in this field. Summary of the Invention

[0005] In view of this, embodiments of this application provide a neuromodulation device, a multi-mode switching method, and a computer program product, which can achieve seamless degradation and continuous intervention between different stimulation modes while ensuring safety, thereby improving the continuity and effectiveness of neuromodulation.

[0006] To achieve the above objectives, this application provides the following technical solution: The first aspect of this application provides a neuromodulation device, comprising: Multiple stimulation pathways, wherein the multiple stimulation pathways include stimulation pathways with at least two different stimulation modes; A status monitoring module is used to monitor the working status of the current working link among the plurality of stimulus links; The working link switching module is used to switch any of the multiple stimulation links, excluding the current working link, to a new working link when the working status indicates that the current working link is faulty. The working mode switching module is used to switch the working mode to the stimulation mode of the new working link if the stimulation mode of the new working link is different from the stimulation mode of the working link before the switch after each switching of the working link. The stimulation module is used to control the working link to stimulate the anatomical region corresponding to the working link according to the working mode.

[0007] In one optional embodiment, the plurality of stimulation links include a first stimulation link and a second stimulation link, and the working link is the first stimulation link; The working link switching module is configured to disable the first stimulus link when the working state indicates a failure of the current working link, and to switch the second stimulus link to a new working link when the second stimulus link is in an enabled state.

[0008] In an optional embodiment, it further includes: An activation status determination module is used to determine the activation status of the second stimulation link based on the electrode contact impedance, electrode connection status, protection status, and the physiological status of the target user. The activation status includes enabling activation and disabling activation.

[0009] In one alternative embodiment, the plurality of stimulation pathways include the concha tVNS pathway and the frontal tDCS pathway; The concha tVNS link includes a concha tVNS stimulation electrode and an ear circuit electrode. The concha tVNS stimulation electrode is used to be disposed in a first anatomical region, and the ear circuit electrode is used to be disposed in an ear circuit region. The concha tVNS stimulation electrode and the ear circuit electrode can form a first stimulation circuit between the first anatomical region and the ear circuit region. The forehead tDCS link includes a first output electrode and a multiplex electrode. The first output electrode is disposed in a second anatomical region, and the multiplex electrode is disposed in a forehead circuit region. The first output electrode and the multiplex electrode can form a second stimulation circuit between the second anatomical region and the forehead circuit region.

[0010] In an optional embodiment, when the current working link is the concha tVNS link, the status monitoring module is used to monitor the electrode connection status of the concha tVNS stimulation electrode and the ear circuit electrode, the output parameters of the concha tVNS stimulation electrode, the ear contact impedance of the ear circuit electrode, and the protection status of the concha tVNS link, and determine the working status of the concha tVNS link based on the electrode connection status, the output parameters, the ear contact impedance, and the protection status; The output parameters include output current and output voltage, and the protection states include current limiting state, overvoltage state, and protection state.

[0011] In an optional embodiment, it further includes: An electrode usage interlock module is provided to prevent the prefrontal multiplex electrode from being simultaneously connected to the EEG reference path and the prefrontal tDCS link. Before the prefrontal multiplex electrode is connected to the prefrontal tDCS link, the EEG reference path of the prefrontal multiplex electrode is disconnected or a preset empty window is entered. Before the prefrontal multiplex electrode is connected to the EEG reference path, it is confirmed that ramp-down, discharge, and residual voltage detection have been performed and that the residual voltage is lower than the safe residual voltage threshold.

[0012] A second aspect of this application provides a multi-mode switching method applied to the neuromodulation device described above, the method comprising: Monitor the current working status of the multiple stimulation links; If the working state indicates a failure of the current working link, switch any of the multiple stimulation links other than the current working link to become the new working link; After each switch of the working link, if the stimulation mode of the new working link is different from the stimulation mode of the working link before the switch, then the working mode is switched to the stimulation mode of the new working link. The working mode controls the stimulation of the corresponding anatomical region by the working link.

[0013] In an optional embodiment, when the operating state indicates a failure of the current working link, switching any one of the plurality of stimulus links, excluding the current working link, as the new working link includes: If the working status indicates a failure of the current working link, then disable the current working link; Among the plurality of stimulus links, any stimulus link other than the currently active link is identified as a candidate link; The activation status of the candidate link is determined based on the electrode contact impedance, electrode connection status, protection status, and the physiological status of the target user. The activation status includes enabling and disabling activation. If the candidate link is in an enabled state, switch the candidate link to a new working link.

[0014] In one optional embodiment, the stimulation modes corresponding to different stimulation links differ in at least one of the following: output waveform, output current limiting threshold, output voltage limiting threshold, stimulation duration, charge release method, electrode polarity configuration, safety monitoring indicators, data window strategy, and data monitoring strategy.

[0015] A third aspect of this application provides a computer program product including a computer program that, when run, causes the multi-mode switching method as described in any of the preceding claims to be executed.

[0016] This application provides a neuromodulation device, a multi-mode switching method, and a computer program product. This solution constructs multiple stimulation links containing at least two different stimulation modes, and coordinates a state monitoring module, a working link switching module, a working mode switching module, and a stimulation module to achieve closed-loop control from fault identification to adaptive mode switching. Specifically, the state monitoring module monitors the current working link's status in real time. Once a fault characteristic is detected, the working link switching module immediately disables the faulty link and selects a backup link as the new working link. Based on this, the working mode switching module automatically determines the difference in stimulation modes between the old and new links. If a difference exists, it synchronously switches to a specific working mode matching the new link. The stimulation module then precisely controls the stimulation output of the anatomical region based on the updated mode. This linkage mechanism of link switching and mode synchronization ensures that the output waveform, charge release method and safety monitoring rules can be automatically adapted when switching between different anatomical targets and stimulation principles (such as pulsed tVNS and DC tDCS). This effectively solves the technical problem of achieving seamless degradation and continuous intervention between different stimulation modes while ensuring safety. Therefore, it avoids treatment interruption caused by a single link failure or safety hazards caused by mode mismatch, and significantly improves the operational reliability and treatment continuity of neuromodulation devices in complex clinical environments. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of this application, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0018] Figure 1 This is a schematic diagram of the structure of a neuromodulation device provided in an embodiment of this application; Figure 2 This is a schematic diagram of the specific stimulation link structure of a neuromodulation device provided in an embodiment of this application; Figure 3 This is a flowchart of a multi-mode switching method provided in an embodiment of this application; Figure 4 This is a comparison diagram of tVNS pulse mode and tDCS ramp-up / continuous / ramp-down mode provided in an embodiment of this application; Figure 5This is a schematic diagram of a computer program product provided in an embodiment of this application. Detailed Implementation

[0019] In the following description, specific details such as particular system architectures and techniques are set forth for illustrative purposes and not for limitation, in order to provide a thorough understanding of the embodiments of this application. However, those skilled in the art will understand that this application may also be implemented in other embodiments without these specific details. In other instances, detailed descriptions of well-known systems, apparatuses, circuits, and methods have been omitted so as not to obscure the description of this application with unnecessary detail.

[0020] It should be understood that, when used in this application specification and the appended claims, the term "comprising" indicates the presence of the described features, integrals, steps, operations, elements and / or components, but does not exclude the presence or addition of one or more other features, integrals, steps, operations, elements, components and / or a collection thereof.

[0021] It should also be understood that the term “and / or” as used in this application specification and the appended claims means any combination of one or more of the associated listed items and all possible combinations, and includes such combinations.

[0022] As used in this application specification and the appended claims, the term "if" may be interpreted, depending on the context, as "when," "once," "in response to determination," or "in response to detection." Similarly, the phrase "if determined" or "if detected [the described condition or event]" may be interpreted, depending on the context, as meaning "once determined," "in response to determination," "once detected [the described condition or event]," or "in response to detection [the described condition or event]."

[0023] Furthermore, in the description of this application and the appended claims, the terms "first," "second," "third," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0024] References to "one embodiment" or "some embodiments" as described in this specification mean that one or more embodiments of this application include a specific feature, structure, or characteristic described in connection with that embodiment. Therefore, the phrases "in one embodiment," "in some embodiments," "in other embodiments," "in still other embodiments," etc., appearing in different parts of this specification do not necessarily refer to the same embodiment, but rather mean "one or more, but not all, embodiments," unless otherwise specifically emphasized. The terms "comprising," "including," "having," and variations thereof mean "including but not limited to," unless otherwise specifically emphasized.

[0025] Example 1: like Figure 1 As shown, this embodiment provides a neuromodulation device 100, which includes: multiple stimulation links 101, a status monitoring module 102, a working link switching module 103, a working mode switching module 104, and a stimulation module 105. The multiple stimulation links include stimulation links with at least two different stimulation modes. Specifically, this design constructs a low-level execution architecture for the neuromodulation device with hardware redundancy and mode diversity. By configuring multiple stimulation links and pre-setting at least two different stimulation modes in these links, such as, but not limited to, transcranial vagus nerve stimulation (tVNS), transcranial direct current stimulation (tDCS), or pulsed electromagnetic stimulation (PEMS), the device can employ differentiated electrophysiological intervention strategies for different anatomical regions or treatment needs. This multi-link, multi-mode layout not only provides a physical basis for system survival under single failure conditions but also provides hardware support for clinicians to flexibly adjust intervention methods based on real-time patient feedback. Each stimulation link can physically include an independent signal generation unit, power amplification unit, and corresponding output interface. The links are electrically isolated to ensure that a failure in any link will not affect the operation of other normal links through common circuit coupling. It should be understood that links in different stimulation modes may have significant differences in output waveform characteristics, voltage and current magnitudes, and load matching impedance. The device has pre-set parameter sets for different modes.

[0026] The status monitoring module is used to monitor the operating status of the currently active link among multiple stimulation links. In this embodiment, the status monitoring module acts as the system's real-time sensing unit, responsible for continuously collecting various operating parameters of the link currently performing the stimulation task to assess its health. To achieve this function, the status monitoring module can obtain key physical quantities such as the output voltage, output current, loop impedance, electrode contact impedance, and internal chip temperature of the currently active link through sampling circuits. For impedance monitoring, a key indicator, the physical relationship typically follows Ohm's law; for example, when the system injects a constant current excitation of known amplitude into the load... And measure the response voltage across the load. Then the circuit impedance Through formula The calculation shows that, among which For the injected test current, This is the detected response voltage. By comparing the calculated impedance value with a preset safety threshold range, typical faults such as electrode detachment, short circuits caused by tissue fluid infiltration, or open circuits can be effectively identified. Furthermore, the status monitoring module can also determine the presence of soft faults such as power transistor overheating, communication packet loss, or abnormal digital-to-analog conversion by monitoring feedback signals from the driver stage. The monitoring results of this module will be updated in real time as a working status characterization, providing a basis for subsequent switching logic.

[0027] The working link switching module is used to switch any of the multiple stimulation links, excluding the current working link, to the new working link when the current working link fails. Specifically, when the status monitoring module detects the aforementioned failure in the current working link and generates a signal indicating the failure (such as a fault flag setting or status code change), the working link switching module responds immediately, triggering the redundancy switching logic. The core function of this module is to quickly transfer the stimulation task from the failed link to a healthy backup link without interrupting the overall treatment process. In practical implementation, the working link switching module can reroute the signal path by controlling a multi-channel analog switch matrix or relay array, disconnecting the faulty link from the output electrode, and selecting the output channel of the backup link. For the selection logic of any stimulation link other than the current working link, in engineering practice, the system can select the first available backup link according to a preset priority list, or select the optimal link based on the most recent self-check health score of each backup link. This design makes the neuromodulation device highly available, especially in scenarios requiring long-term continuous stimulation (such as perioperative monitoring or epilepsy suppression), effectively avoiding treatment interruptions due to single points of failure, thereby significantly improving the clinical robustness and safety of the device.

[0028] The operating mode switching module is used to switch the operating mode to the new stimulation mode of the operating link after each switching of operating links, if the stimulation mode of the new operating link is different from that of the previous operating link. In this structure, the operating mode switching module undertakes the key functions of parameter adaptation and logic synchronization. Since the device integrates multiple links supporting different stimulation modes, and the control parameters (such as frequency, pulse width, duty cycle, current intensity limit, etc.) corresponding to different modes are often completely incompatible, the global operating mode of the system must be updated synchronously when the mode attributes of the backup link are inconsistent with those of the original link. For example, if the original operating link is in tVNS mode (usually involving a pulse train of a specific frequency), and the new link after switching is in tDCS mode (usually involving a constant DC output), directly using the parameters of tVNS to drive the tDCS link without switching the operating mode will lead to output waveform distortion and may even cause electrophysiological damage. After detecting a link switching event, the operating mode switching module reads the mode identifier of the new link and compares it with the historical mode identifier. Once a mode change is confirmed, the parameter configuration table matching the new mode is retrieved from non-volatile memory, the control register is reset, and the algorithm logic of the stimulation module is updated to ensure that subsequent output stimulation signals strictly conform to the physical characteristics requirements of the new mode. This design achieves closed-loop linkage between hardware link switching and software mode configuration, preventing cross-mode malfunctions and ensuring the accuracy and safety of stimulation output.

[0029] The stimulation module controls the stimulation of the corresponding anatomical region according to the working mode. In this embodiment, the stimulation module is the core execution unit that ultimately performs physical intervention. Its function is to convert the digitized working mode parameters into specific electrical signals that can act on human tissue. The stimulation module receives a parameter set (including waveform type, frequency, etc.) configured from the working mode switching module. Pulse width Current intensity And so on, and generate the corresponding voltage or current waveforms through digital-to-analog converters (DACs) or direct digital synthesis (DDS) technologies. For example, in pulse stimulation mode, the relationship between the output frequency and the period satisfies ,in For the signal period, To set the frequency; duty cycle The relationship with pulse width can be expressed as follows: The stimulation module adjusts the timing characteristics of the output waveform in real time based on these mathematical relationships to ensure stimulation accuracy. Along the output path, the stimulation module drives the current working link, applying electrical energy to the corresponding electrode, thereby acting on specific anatomical areas (such as the auricular branch of the vagus nerve, the motor cortex, or the dorsal aspect of the spinal cord). To ensure therapeutic efficacy and safety, the stimulation module typically includes a constant current / constant voltage control loop, which dynamically adjusts the output voltage according to changes in load impedance to maintain a stable preset current intensity. Through this precise closed-loop control, the stimulation module can ensure that, under different tissue environments, it can still deliver neuromodulation signals that meet the treatment requirements to the target anatomical area.

[0030] The core innovation of this application lies in constructing a neuromodulation device with hardware redundancy and a software mode adaptive linkage mechanism. This device overcomes the limitation of traditional single-link devices that cease operation upon failure by integrating multiple stimulation links with at least two different stimulation modes. Simultaneously, through the coordinated operation of a status monitoring module, a working link switching module, and a working mode switching module, a complete fault-tolerant control link is established, from fault detection and link hot-switching to automatic reconfiguration of mode parameters, ensuring strict matching between stimulation parameters and physical links when hardware resources change.

[0031] The working process and principle of this application are as follows: During equipment operation, the status monitoring module collects the electrical parameters (such as impedance, voltage, and current) of the current working link in real time and calculates its working status based on physical models such as Ohm's law. When the monitored data exceeds a preset threshold, indicating a fault in the current working link, the working link switching module is immediately activated, disconnecting the faulty link and selecting one of the remaining stimulation links as the new working link. Next, the working mode switching module intervenes, determining whether the stimulation mode supported by the newly selected link is consistent with the previous mode. If inconsistent, the control parameter set corresponding to the new mode is automatically loaded, and the system configuration is updated. Finally, the stimulation module generates an electrical signal that meets specific waveform requirements based on the updated working mode, which is then applied to the corresponding anatomical area through the new working link, thereby achieving seamless continuation of neuromodulation function.

[0032] Through the above technical solution, this application achieves the following beneficial effects: By employing multiple stimulation links and a state monitoring and switching mechanism, it effectively solves the problem of existing neuromodulation devices being forced to interrupt stimulation therapy when a single link fails, significantly improving the continuity and reliability of the device in long-term treatment scenarios; Because a working mode switching module is set up, it automatically identifies and adapts to the new stimulation mode when switching links, thus avoiding the risk of cross-mode erroneous output due to incorrect mode parameters, eliminating potential electrophysiological safety hazards, and ensuring the accuracy and safety of the treatment process; Because the stimulation module can precisely control the output parameters according to the working mode, it ensures stable and effective neuromodulation effects can be obtained under different anatomical regions and different treatment needs.

[0033] Example 2: This application provides a fault degradation control device for a neuromodulation device. The device includes a first stimulation link and a second stimulation link, as well as a working link switching module. The first stimulation link is the working link currently performing the stimulation task. When the first stimulation link is working normally, it is responsible for outputting a specific pattern of stimulation signal to the corresponding anatomical region, such as pulsed vagus nerve stimulation (tVNS). The second stimulation link serves as a backup stimulation channel, taking over when the first stimulation link fails. Its corresponding anatomical region and stimulation pattern can be different from the first stimulation link, for example, transcranial direct current stimulation (tDCS) of the forehead.

[0034] The working link switching module is used to disable the first stimulation link when its working status indicates a current working link failure, and to switch the second stimulation link to the new working link when it is in an enabled state. When the status monitoring module detects an open circuit, detachment, abnormal contact impedance, abnormal output current or voltage in the first stimulation link, or receives discomfort feedback from the patient, it determines that the current working link is faulty. In this case, the working link switching module first performs a disable operation, stopping the signal output of the first stimulation link and placing it in an open, high-impedance, or safe-discharge state to prevent residual charge from causing harm to the user or generating uncontrolled stimulation. After disabling the first stimulation link, the working link switching module continues to perform a safety status check on the second stimulation link. This check includes the electrode contact impedance, skin condition, polarity configuration, and whether there are any conflicts with other functional modules (such as the EEG monitoring module). Only when it is confirmed that the second stimulation link meets all safety conditions and is in an enabled state will the working link switching module switch the second stimulation link to the new working link, thereby taking over the stimulation output task.

[0035] Through the above technical solution, this application achieves controlled degradation switching in the event of a primary stimulation link failure. By clearly defining the roles of the first and second stimulation links and strictly adhering to the logic of first disabling the failed link, then confirming the status of the backup link, and finally enabling the backup link during the switching process, the safety risks that may arise from direct switching in the event of a failure are effectively avoided. This design ensures that after the failure of the first stimulation link, the neuromodulation device can automatically and smoothly transition to the second stimulation link to continue working while ensuring patient safety, thereby maintaining the continuity and reliability of treatment. It is particularly suitable for applications with high requirements for device continuity, such as perioperative analgesia and sleep management.

[0036] Example 3: The neuromodulation device provided in this embodiment also includes an activation state determination module. This module determines the activation state of the second stimulation link based on its electrode contact impedance, electrode connection status, protection status, and the target user's physiological state. The activation state includes "allowed to activate" and "prohibited to activate." As a key safety gating unit in the fault degradation control process, this module's core function is to perform a multi-dimensional comprehensive assessment of the hardware status, system protection status, and user's physiological state before attempting to activate the second stimulation link after a failure in the first stimulation link, ensuring the stimulation process after switching is safe and controllable. By integrating multi-source heterogeneous data from the hardware, system, and physiological layers, this module constructs a strict safety access mechanism, effectively preventing the hasty activation of the backup stimulation link in cases of poor electrode contact, device protection failure, or unsuitable user condition, thereby preventing ineffective stimulation, skin burns, or other adverse events.

[0037] In its implementation, the state determination module's evaluation of the second stimulation link encompasses four key dimensions. The first is electrode contact impedance, which directly reflects the coupling quality between the electrodes and the skin in the second stimulation link (e.g., a transcranial direct current stimulation (tDCS) link for the forehead). In practical applications, electrode contact impedance can be calculated by injecting a weak detection signal into the electrodes and measuring the feedback voltage. For example, if a constant current is injected... The measured voltage is Then the contact resistance It can be represented as:

[0038] in, To detect the current, its amplitude is usually much smaller than the stimulation current in order to avoid causing a physiological response; The measured voltage response; The calculated contact impedance is used as the basis for determining the activation status. The activation status determination module compares the calculated impedance value with a preset safety threshold range. If the impedance value is too high, it may indicate electrode detachment or poor contact; if the impedance value is too low, there may be a short circuit risk. In both cases, the activation status will be determined as disabled, and activation is only permitted when the impedance is within a reasonable range.

[0039] Secondly, the electrode connection status is monitored, which is used to assess the physical integrity of the second stimulation link. This includes detecting whether there are open or short circuits in the electrode leads, whether the connectors are securely plugged in, and whether the internal circuitry is functioning correctly. The enable / disable status module can acquire the electrode connection status in real time by periodically sending handshake signals or monitoring the continuity of the circuit. If abnormalities such as open circuits, short circuits, or significant fluctuations in contact resistance are detected, it indicates that the physical connection of the second stimulation link is unreliable. In this case, the module will lock the enable status to disable it to prevent abnormal output due to connection problems.

[0040] The third dimension is the protection status, which reflects whether the device's own safety mechanisms are in a ready state. Protection status includes, but is not limited to, output stage overcurrent protection, overvoltage protection, overheat protection, capacitor charge discharge status, and battery charge level. The activation status determination module reads the device's internal system registers or status flags to confirm whether there are any unreset historical fault records, whether the hardware protection lock is active, or whether the device temperature is too high. For example, if the device detects that the temperature of the front tDCS output stage exceeds the safety threshold, or if the discharge circuit has not yet completed the release of residual charge after the previous stimulation, the protection status will indicate that the current output conditions are not met. In this case, the activation status determination module will forcibly determine that activation is disabled until all protection statuses return to normal.

[0041] Finally, there's the target user's physiological state, which assesses the safety and appropriateness of stimulation from the user's perspective. Physiological parameters include heart rate, blood oxygen saturation, blood pressure, skin condition (e.g., presence of redness, swelling, or breakage), and the user's subjective feedback (e.g., whether they experience pain, dizziness, or discomfort). The activation status determination module can receive data from a blood oxygen probe, heart rate sensor, or user input interface. This dimension is particularly important in specific application scenarios such as perioperative sleep or postoperative analgesia management. For example, if the target user's heart rate is detected to be abnormally fast or slow, their blood oxygen saturation is below a preset safety threshold, or the user reports severe headaches or burning sensations on their skin, it indicates that the user's current physical condition may not be able to withstand additional stimulation intervention. In this case, even if the hardware connection and system status are normal, the activation status determination module will determine the activation status as disabled based on the physiological status assessment results, thus prioritizing the stability of the user's vital signs and comfort.

[0042] Through the above technical solution, this application achieves refined and multi-dimensional safety control over the activation conditions of the second stimulation link during fault degradation switching. Because it employs a comprehensive judgment mechanism based on electrode contact impedance, electrode connection status, protection status, and the target user's physiological state, it solves the safety risks that might be missed by single-dimensional detection. This ensures the continuity of neuromodulation while minimizing medical risks caused by improper activation of the backup link, guaranteeing reliable operation of the device in scenarios with extremely high safety requirements, such as perioperative periods and postoperative analgesia.

[0043] Example 4: like Figure 2 As shown, this embodiment provides a specific stimulation link structure for a neuromodulation device. Multiple stimulation links 101 include an auricular concha tVNS link 1011 and a frontal tDCS link 1012; The auricular tVNS link 1011 includes an auricular tVNS stimulation electrode 1013 and an auricular circuit electrode 1014. The auricular tVNS stimulation electrode 1013 is positioned in a first anatomical region, and the auricular circuit electrode 1014 is positioned in an auricular circuit region. The auricular tVNS stimulation electrode 1013 and the auricular circuit electrode 1014 can form a first stimulation circuit between the first anatomical region and the auricular circuit region. In this embodiment, the auricular tVNS link is mainly used to achieve percutaneous auricular vagus nerve stimulation. The first anatomical region can specifically be the concha, tragus, auricular canal opening, auricle, or a related area where the auricular branch of the vagus nerve is distributed. The auricular tVNS stimulation electrode is attached to this region to directly act on the vagus nerve branch. The auricular circuit electrode is positioned in the auricular circuit region, which can be the earlobe, antihelix, or other skin locations on the ear suitable as circuit references. Through the cooperation of the auricular tVNS stimulation electrode and the auricular circuit electrode, a first stimulation circuit is constructed between the first anatomical region and the auricular circuit region, thereby achieving neural modulation through pulsed current. The tVNS stimulation electrode and ear circuit electrode of the concha can be made of materials such as conductive silicone, flexible printed circuit board or metal-coated electrode. Their shape can be customized according to the ear anatomy, such as using an arc-shaped sheet structure that fits the concha cavity to ensure wearing comfort and electrode contact stability.

[0044] The frontal tDCS link 1012 includes a first frontal output electrode 1015 and a frontal multiplexed electrode 1016. The first frontal output electrode 1015 is disposed in a second anatomical region, and the frontal multiplexed electrode 1016 is disposed in a frontal circuit region. The first frontal output electrode 1015 and the frontal multiplexed electrode 1016 can form a second stimulation circuit between the second anatomical region and the frontal circuit region. In this embodiment, the frontal tDCS link is used to achieve transcranial direct current stimulation. The second anatomical region can specifically be the forehead, frontal lobe projection region, or frontal patch region. The first frontal output electrode is attached to this region as an anode or cathode to modulate the excitability of the cerebral cortex. The frontal circuit region can be the other side of the forehead, between the eyebrows, or other suitable locations on the head as a direct current stimulation circuit. The frontal multiplexed electrode is disposed in this region, forming a circuit with the first frontal output electrode. The first frontal output electrode and the frontal multiplexed electrode can form a second stimulation circuit between the second anatomical region and the frontal circuit region to output a low-intensity direct current. The forehead reusable electrode has a reusable function; in addition to serving as the loop electrode for tDCS, it can also be used as a backup reference electrode or contact detection electrode during non-stimulation periods. The first output electrode and the forehead reusable electrode are usually made of highly conductive sponge or rubber electrodes, and should be used with conductive solution or saline to reduce skin resistance.

[0045] In application, the stimulation mode corresponding to the concha tVNS link is the tVNS pulse mode, and the stimulation mode corresponding to the frontal tDCS link is the ramp-up / continuous / ramp-down mode.

[0046] In applications, when switching from tVNS pulse mode to ramp-up / continuous / ramp-down mode, the current ramp-up rate during the ramp-up phase is dynamically determined based on the residual skin impedance value at the end of the tVNS mode.

[0047] This embodiment visualizes the neuromodulation device as a dual-modal structure comprising an auricular tVNS link and a prefrontal tDCS link, clearly defining the anatomical target areas and electrode configurations corresponding to different stimulation modes. The auricular tVNS link targets the vagus nerve distribution area in the ear, forming a local pulse stimulation circuit through the auricular tVNS stimulation electrode and the ear circuit electrode; the prefrontal tDCS link targets the prefrontal cortex region of the brain, forming a transcranial DC stimulation circuit through the first prefrontal output electrode and the prefrontal multiplexing electrode. This structural design establishes a clear mapping relationship between stimulation mode, anatomical region, electrode configuration, and physical circuit, enabling the device to not only change the electrical stimulation parameters when physically switching between different stimulation links, but also match the corresponding anatomical location and electrode layout.

[0048] Through the above technical solution, this application realizes the hardware structure implementation of a neuromodulation device under multiple stimulation modes. By defining the specific electrode composition and corresponding anatomical regions of the auricular tVNS link and the frontal tDCS link, it ensures that different stimulation modes can form effective physical stimulation circuits at the correct anatomical locations. In particular, by setting up a reusable frontal electrode, it can participate in the second stimulation circuit of the frontal tDCS and also be reused as a monitoring electrode, improving electrode utilization and device integration. This clear structural definition provides a solid hardware foundation for subsequent fault detection, link switching, and mode synchronization switching. It ensures that when the auricular tVNS link fails, the system can accurately and safely switch to the frontal tDCS link and continue neuromodulation according to the specific circuit structure and safety rules of the frontal tDCS. This solves the technical problem of treatment interruption caused by a single stimulation link failure and improves the continuity and reliability of the neuromodulation device in perioperative, postoperative analgesia, and sleep management scenarios.

[0049] Example 5: This embodiment provides a status monitoring mechanism for the auricular tVNS link. When the current working link is the auricular tVNS link, the status monitoring module monitors the electrode connection status of the auricular tVNS stimulation electrode and the ear circuit electrode, the output parameters of the auricular tVNS stimulation electrode, the ear contact impedance of the ear circuit electrode, and the protection status of the auricular tVNS link. Based on the electrode connection status, output parameters, ear contact impedance, and protection status, the module determines the working status of the auricular tVNS link. The output parameters include output current and output voltage, and the protection status includes current limiting, overvoltage, and protection states.

[0050] Specifically, the electrode connection status of the tVNS stimulation electrode in the concha and the ear circuit electrode is used to characterize whether the stimulation electrode and the circuit electrode are physically correctly connected to the device output and whether they are securely attached to the human skin surface. This monitoring process is achieved by detecting circuit continuity, connector contact impedance, or electrode detachment signals, and its function is to serve as the basis for determining whether the link can establish a normal stimulation circuit.

[0051] The output current and output voltage in the output parameters are key electrical quantities that reflect the actual output energy and load characteristics of the concha tVNS link. By sampling the current and voltage values ​​at the output terminal in real time, the status monitoring module can identify whether there is an open circuit, short circuit, or waveform distortion caused by abnormal load, thereby ensuring that the stimulation intensity is within the preset safe treatment window.

[0052] Ear contact impedance refers to the equivalent impedance value at the interface between the ear circuit electrode and the human skin at the stimulation frequency. This parameter directly reflects the quality of electrode adhesion and skin readiness. Monitoring ear contact impedance typically employs high-frequency low-voltage detection signals or real-time impedance calculation algorithms based on the output waveform. Its typical relationship can be expressed as follows: ,in, Contact resistance, For output voltage, This is the output current. By continuously monitoring the ear contact impedance, the system can promptly detect poor contact caused by sweat, oil, loose fit, or dry skin, avoiding ineffective stimulation due to excessively high impedance or abnormal energy dissipation due to excessively low impedance.

[0053] In the protection category, the current limiting state indicates that the output current has reached the preset safe upper limit threshold, and the system automatically limits the current from continuing to increase to prevent tissue damage; the overvoltage state indicates that the output voltage exceeds the set maximum safe voltage, which may indicate an abnormal increase in circuit impedance or an open circuit risk; the protection state is a comprehensive fault indication signal that is triggered when the system detects any hardware fault, temperature over-limit, or software logic abnormality, and is used to forcibly cut off the output to ensure patient safety.

[0054] The above-mentioned judgment logic integrates multi-dimensional monitoring data to form a comprehensive assessment of the link's health. When the electrode connection is normal, the output parameters are within the preset range, the ear contact impedance is within a reasonable range, and no protection-related states are triggered, the ear concha tVNS link is determined to be in normal working condition. When any parameter exceeds the threshold or an abnormal logic combination occurs, the system will determine whether the link is in a warning, pause, or fault state based on the severity of the abnormality, thereby providing a precise control basis for subsequent link switching or disabling operations.

[0055] Through the above technical solution, this application achieves comprehensive and refined monitoring of the auricular tVNS link, solving the problem that a single monitoring dimension cannot fully reflect the true health status of the link. By employing a comprehensive judgment logic combining electrode connection status, output parameters, ear contact impedance, and protection status, the system can accurately identify specific fault types such as open circuits, detachment, poor contact, abnormal output, and hardware failures, thereby supporting a tiered fault handling strategy. This not only improves the operational safety and reliability of neuromodulation devices in continuous application scenarios such as perioperative period, postoperative analgesia, and nighttime sleep management, but also provides solid data support and a decision-making basis for timely and accurate switching to the second stimulation link when the first stimulation link fails.

[0056] In one embodiment, when the working state indicates a fault in the concha tVNS link, the concha tVNS link is disabled, and the concha tVNS stimulation electrode and the ear circuit electrode are placed in an open, high-resistance, safe potential, or bleed state. If the preceding tDCS link is in an enabled state, switch the preceding tDCS link to a new working link.

[0057] In one embodiment, the neuromodulation device further includes an activation state determination module, which is used to determine the activation state of the frontal tDCS link based on the electrode connection state of the frontal first output electrode and the frontal multiplexed electrode, the frontal contact impedance and occupancy state of the frontal multiplexed electrode, the protection state of the frontal tDCS link, and the physiological state of the target user. The activation state includes enabling and disabling activation.

[0058] In the case of a prefrontal multiplex electrode included in the prefrontal tDCS link, the occupancy status of the prefrontal multiplex electrode is used to characterize whether the multiplex electrode is occupied by other monitoring functions other than neuromodulation.

[0059] Example 6: This embodiment provides a neuromodulation device, which includes an electrode usage interlock module, a frontal reusable electrode, and an EEG reference pathway. The electrode usage interlock module, as the core control unit, manages the switching logic of the frontal reusable electrode between different functional pathways. The frontal reusable electrode has a dual function: in monitoring mode, it serves as a backup EEG reference electrode; in stimulation mode, it serves as a loop electrode in the transcranial direct current stimulation (tDCS) link. The EEG reference pathway connects the frontal reusable electrode to the EEG acquisition front end to acquire bioelectrical signals.

[0060] The electrode usage interlock module is used to prevent the prefrontal multiplexed electrode from being simultaneously connected to the EEG reference pathway and the prefrontal tDCS link. During fault degradation switching or mode transitions in the neuromodulation device, if the prefrontal tDCS link needs to be activated, the electrode usage interlock module will enforce mutual exclusion logic, disconnecting the electrical connection between the prefrontal multiplexed electrode and the EEG reference pathway. This mechanism prevents high-voltage or high-current stimulation signals from coupling to the high-impedance EEG acquisition circuit, thereby avoiding damage to the back-end amplifier or interference with EEG signal quality. In practical implementation, physical isolation of the path can be achieved through an analog switch matrix, relay array, or solid-state multiplexer, ensuring that at any given time, the prefrontal multiplexed electrode is only connected to one functional loop.

[0061] Before the prefrontal multiplexed electrode is connected to the prefrontal tDCS link, its EEG reference path is disconnected or a preset empty window is entered. The disconnection operation can refer to the electrode-use interlock module controlling the switching device to cut off the signal line from the prefrontal multiplexed electrode to the EEG acquisition circuit; the preset empty window can be a buffer period set during the switching process, during which the prefrontal multiplexed electrode is neither connected to the EEG reference nor to the tDCS output, ensuring complete electrical isolation and stability. This mechanism eliminates the risk of signal crosstalk caused by improper switching timing, ensuring a safe transition from monitoring mode to stimulation mode.

[0062] Before connecting the frontal reusable electrode to the EEG reference pathway, it is confirmed that ramp-down, discharge, and residual voltage detection have been performed, and that the residual voltage is below the safe residual voltage threshold. Ramp-down refers to the process of slowly reducing the output current to zero at a preset slope during the end of frontal tDCS stimulation to avoid patient discomfort caused by sudden current changes. Discharge refers to releasing the residual charge stored in the equivalent capacitance formed at the electrode-skin interface by closing the discharge circuit or connecting an equivalent load after stimulation stops. Residual voltage detection refers to measuring the potential difference between the frontal reusable electrode and the reference ground or the contralateral electrode after discharge. If the detected residual voltage is below the preset safe residual voltage threshold, it indicates that the electrode surface charge has been fully released. Only then can the frontal reusable electrode be reconnected to the high input impedance EEG reference pathway to prevent residual voltage from causing impact or saturation distortion at the EEG front end.

[0063] Through the above technical solution, this application achieves the safe reuse of the forehead reusable electrode between EEG monitoring and tDCS stimulation. By implementing an electrode usage interlock module to forcibly prevent simultaneous conduction of both paths, and by setting up disconnection / window protection and ramp-down, discharge, and residual voltage detection and confirmation processes before and after switching, the potential electrical interference and safety hazards that may arise when switching the same electrode between different functional modules are resolved. This not only avoids damage to the EEG acquisition equipment from the tDCS output signal but also eliminates the risk of skin burns caused by incomplete release of residual charge on the electrode surface, significantly improving the safety and reliability of neuromodulation devices in multimodal integrated applications.

[0064] Example 7: One possible implementation is, such as Figure 3 The diagram shown is a flowchart of a multi-mode switching method provided in an embodiment of this application. The method includes: Step S101: Monitor the working status of the current working link among multiple stimulus links.

[0065] The current working link refers to the physical path and corresponding control loop of the neuromodulation device used to execute stimulation output at the current moment. Through real-time sampling and logical analysis, the operating parameters of the current working link are continuously acquired to determine whether it is in a normal or faulty state. The monitoring process is executed by the control unit or status monitoring module of the neuromodulation device, and the data sources include voltage sampling circuits, current sampling circuits, impedance detection circuits, and connection status detection circuits. The monitoring content covers multi-dimensional parameters characterizing loop integrity and stimulation effectiveness, such as output current value, output voltage value, contact impedance between the electrode and the skin, on / off status of the electrode connector, and hardware protection flags. By comparing the real-time acquired parameters with preset safety thresholds or standard operating ranges, fault conditions such as open circuits, short circuits, detachment, abnormal impedance, or overvoltage / overcurrent can be accurately identified, providing direct logical judgment basis for subsequent link switching decisions. This monitoring process converts real-time electrical characteristics into status signals that the device can recognize, enabling potential physical anomalies to be captured in a timely manner and triggering corresponding protection or switching actions, thereby ensuring the safety and continuity of the neuromodulation process.

[0066] Step S102: If the working status indicates that the current working link is faulty, switch any of the multiple stimulation links except the current working link to become the new working link.

[0067] When monitoring results indicate that the current working link cannot maintain normal stimulation function, such as when output parameters exceed the allowable range or the loop connection is interrupted, fault isolation and path migration are immediately executed. First, the control unit generates a stop command, cuts off the drive signal of the current working link, and places it in a high-impedance, disconnected, or safe-discharge state to prevent fault escalation or uncontrollable residual charge output. Then, available paths are screened among the multiple stimulation links integrated in the device, and any stimulation link other than the faulty link is selected as the new working link. The selection process is based on a preset priority strategy or polling mechanism to ensure that the new working link has an independent hardware channel and corresponding anatomical region coverage capability. Through the action of an electronic switch matrix or analog multiplexer, the stimulation output channel is seamlessly switched from the faulty physical port to the new target port, establishing a new current loop. This step, through rapid link reconstruction, confines a single physical fault to a localized area and utilizes redundant hardware resources to maintain the overall function of the system, avoiding the risk of treatment interruption due to a single point of failure.

[0068] Step S103: After each switch of the working link, if the stimulation mode of the new working link is different from the stimulation mode of the working link before the switch, then switch the working mode to the stimulation mode of the new working link.

[0069] The stimulation modes adapted to the new working link may involve different waveform generation algorithms, charge balancing mechanisms, or safety control logic. After the physical link switching is completed, the attributes of the new working link are identified and compared to determine whether its required stimulation mode is consistent with the previous mode. If they differ, for example, switching from pulsed stimulation to DC stimulation, a global update of the control logic is performed. This process involves modifying the configuration parameters of the control register, calling different waveform generation drivers, or reconstructing the signal processing flow to match the physical characteristics and anatomical requirements of the new link. Specifically, the output parameters are set to the frequency, pulse width, duty cycle, or current intensity curve required by the target mode, and safety constraints such as current limiting, voltage limiting, and monitoring thresholds are updated simultaneously. Through this mode switching, it is ensured that the software logic of the control layer and the physical link of the hardware layer maintain a strict adaptive match, preventing a decrease in therapeutic effect or safety hazards due to control mode misalignment.

[0070] Step S104: Control the working link to stimulate the anatomical area corresponding to the working link according to the working mode.

[0071] After confirming that the working link and working mode are correctly configured, the stimulation output program is initiated. The control unit generates a corresponding control signal based on the currently selected working mode. This signal, after digital-to-analog conversion and power amplification, drives the new working link to output a specific form of electrical energy. This output process precisely targets the anatomical region corresponding to the new working link, for example, migrating from the ear region to the forehead region. During stimulation, output feedback is continuously monitored to ensure that the actual applied stimulation intensity, waveform morphology, and duration strictly adhere to the settings of the current working mode. By translating the patterned control commands into physical stimuli acting on specific biological tissues, precise modulation of different neural nuclei or brain regions is achieved under fault scenarios, ensuring the complete realization of the treatment intention after hardware path changes, thereby maintaining the clinical effectiveness of the neuromodulation device.

[0072] Through the above steps, the real-time status data provided by the status monitoring triggers the link switching action. The result of the link switching then determines the adjustment of the working mode, ultimately executing stimulus output in the correct mode. The collaboration of each link constitutes a closed-loop fault degradation handling process. This process ensures that when the primary path fails, the system can automatically and safely migrate to the backup path and adapt to the corresponding control strategy, thereby maintaining continuous and effective neuromodulation intervention even in the event of hardware failure.

[0073] Example 8: In one possible implementation, the method further includes: disabling the current working link when the working state indicates a failure of the current working link; identifying any stimulation link other than the current working link among multiple stimulation links as a candidate link; determining the activation state of the candidate link based on the electrode contact impedance, electrode connection state, protection class state, and the physiological state of the target user, wherein the activation state includes enabled and disabled; and switching the candidate link to a new working link when the candidate link is in the enabled state.

[0074] If the current working link is faulty due to a faulty working status, disable the current working link.

[0075] Once the monitoring module confirms an abnormal operating status, it immediately sends a fault interruption signal to the control unit. In response to this signal, the control unit either cuts off the drive power to the currently operating link or places its output in a high-impedance state. The disabling operation involves not only power cut-off but also discharge of charge from the energy storage components within the link to prevent unexpected current surges during subsequent operations. Through this rapid isolation mechanism, the faulty link is physically or logically removed from the active control loop, preventing its continued operation from posing a potential risk to the equipment or the target user, and providing a safe operating environment for subsequent switchover to the backup link.

[0076] Among multiple stimulus links, any stimulus link other than the currently active link is identified as a candidate link.

[0077] After disabling the failed link, the system iterates through all configured stimulus link identifiers, filtering out currently active links marked as faulty. The remaining links are assigned candidate attributes, forming a candidate link set. This filtering process does not involve real-time detection of the physical state of candidate links, but rather logical confirmation based on system configuration and the link list. By establishing the candidate link set, the system can systematically assess the availability of each potential replacement in subsequent steps, avoiding blindly switching to equally unavailable links, thereby identifying all potential resources in the system that can be used to replace faulty links for stimulation.

[0078] The activation status of a candidate link is determined based on its electrode contact impedance, electrode connection status, protection status, and the physiological status of the target user. The activation status includes enabling and disabling activation.

[0079] Real-time status data related to candidate links is collected, forming the core basis for determining the activation status. Electrode contact impedance reflects the quality of adhesion between the electrode and the target user's skin. If the impedance exceeds the preset reasonable range, it means poor contact or detachment, and an effective stimulation circuit cannot be formed. Electrode connection status characterizes whether there are open or short circuit faults in the physical leads and connectors. Protection status covers the hardware protection mechanisms inside the link, such as whether it is in the current limiting, overvoltage, or overtemperature protection state. If the hardware protection has been triggered, it indicates that there is a safety hazard in the link. The target user's physiological status assesses the suitability of stimulation from the perspective of the receptor, including heart rate, blood oxygen, level of consciousness, or whether there is any discomfort feedback, to ensure that the user can tolerate the new stimulation mode.

[0080] The logic for determining the enabled state can be formalized as the following decision function:

[0081] in, Indicates the activation status of the candidate link, with values ​​of "enabled" or "disabled". Indicates electrode contact resistance; Indicates the electrode connection status; Indicates a protected status; Indicates the physiological state of the target user. If and only if... Within the preset range The connection is shown to be normal. The display shows that it was triggered without protection and When physiological indicators are stable The system determines which pathways are allowed to be used and which are prohibited from being used. By comprehensively judging these four dimensions, the system can accurately exclude candidate pathways with physical faults, safety hazards, or inappropriate stimuli, and only mark pathways with complete physical pathways and clinical safety conditions as usable. This multi-dimensional verification mechanism ensures the reliability of the switching operation and avoids secondary failures or potential harm to users caused by problems with the pathway itself.

[0082] If the candidate link is in an enabled state, switch the candidate link to the new working link.

[0083] When the determination result indicates that a candidate link is in an enabled state, the configuration parameters corresponding to that link are loaded, its drive circuit is activated, and its status identifier in the system logic is updated to the new working link. The switching process includes establishing a complete stimulation circuit, setting the initial phase of the output signal, and synchronously starting related monitoring tasks. Through this controlled switching operation, the device can seamlessly transition from a faulty link to a backup link, restore neuromodulation intervention for the target user, ensure the continuity of neuromodulation therapy, and maintain the safety of system operation.

[0084] The above steps, through the construction of a closed-loop control logic of fault isolation → resource identification → multi-dimensional verification → secure switching, achieve full automation from fault occurrence to link reconstruction. Fault signals provided by the monitoring module trigger the rapid disabling of the current working link. The subsequent process of candidate link determination and activation status assessment transforms the physical-level link switching into a rigorous decision-making process based on multi-dimensional state data. This synergy ensures that switching is only performed when the physical connection is intact, the hardware is free from protection triggers, and the user's physiological condition permits it. This, in turn, minimizes the security risks that automatic switching might introduce while ensuring the continuity of neural regulation.

[0085] Example 9: One possible implementation is, such as Figure 4 The diagram shown is a comparison of a tVNS pulse mode and a tDCS ramp-up / continuous / ramp-down mode provided in an embodiment of this application. The stimulation modes corresponding to different stimulation links differ in at least one of the following: output waveform, output current limiting threshold, output voltage limiting threshold, stimulation duration, charge release method, electrode polarity configuration, safety monitoring indicators, data window strategy, and data monitoring strategy.

[0086] The aforementioned technical features aim to transform the abstract concept of stimulation patterns into a set of quantifiable and detectable engineering indicators through differentiated definitions of multi-dimensional parameters. This ensures that during link switching, the neuromodulation device can accurately match the physical characteristics and safety constraints of the current anatomical region, rather than simply using the parameter configuration of the previous link.

[0087] The output waveform refers to the morphological curve of the stimulation current changing over time, and is the most intuitive physical quantity for distinguishing different stimulation modes. For the concha tVNS link, the output waveform is usually a pulsed waveform, such as a biphasic or monophasic pulse sequence containing a specific frequency, pulse width, and duty cycle. Its characteristic is that it outputs high energy in a short period of time to induce neural action potentials. For the frontal tDCS link, the output waveform is a low-intensity DC waveform, which usually presents a slowly rising ramp-up phase, a continuous constant current phase, and a slowly falling ramp-down phase. Its characteristic is that it modulates the resting membrane potential of neurons rather than directly inducing action potentials.

[0088] The output current limiting threshold refers to the maximum current value allowed to pass through the stimulation circuit, and this threshold is directly related to tissue safety. In different stimulation pathways, the output current limiting threshold is set according to the anatomical region's tolerance to current. For example, the skin in the concha region is thin and densely innervated, so its output current limiting threshold may be configured to a lower value (e.g., below 2mA) to prevent overstimulation leading to pain; while the forehead region has a larger area, and its output current limiting threshold may be configured to a relatively higher value (e.g., in the range of 2mA to 4mA) to cover a wider cortical area.

[0089] The output voltage limit threshold refers to the maximum voltage that the stimulation power supply can output to overcome the contact resistance between the skin and the electrode. In tVNS mode, the output voltage limit threshold is matched with the pulse transient impedance, which may require a higher transient voltage; while in tDCS mode, since a constant current needs to be maintained for a long time, the output voltage limit threshold focuses more on the withstand voltage under continuous loading, and its setting needs to be adjusted according to the polarization effect of the forehead skin under long-term DC current.

[0090] The duration of stimulation can refer to the total duration of stimulation output in a single stimulation cycle or a single treatment session. In tVNS mode, the duration of stimulation is usually expressed as the duration of a pulse train (such as an intermittent mode with 30 seconds on and 30 seconds off) or the width of a single pulse; while in tDCS mode, the duration of stimulation refers to the duration of the entire DC output (such as continuous output from 15 to 30 minutes), which has a much longer time span than a single pulse cycle of tVNS.

[0091] Charge release methods refer to the processing mechanism that removes residual charge on the electrodes after stimulation. For tVNS mode, a bidirectional symmetrical waveform or active charge balancing circuit is usually used within the pulse to neutralize the charge in a very short time. For tDCS mode, since a large amount of polarized charge accumulates on the skin surface, it is necessary to slowly discharge the charge through a dedicated discharge circuit or by connecting a low-impedance load to both ends of the electrodes after the ramp-down phase to avoid the patient experiencing an electric shock sensation.

[0092] Electrode polarity configuration refers to the positive and negative polarity distribution of the stimulating electrode and the loop electrode in the circuit. In tVNS mode, the electrode polarity configuration may dynamically switch between anodic and cathodic stimulation according to treatment needs; while in tDCS mode, the electrode polarity configuration directly determines the stimulation effect (such as anodic excitation and cathodic inhibition), and usually remains fixed during the treatment cycle. When switching links, the polarity configuration must be reloaded.

[0093] Safety monitoring indicators refer to the set of data parameters collected in real time by the system during stimulation and used to assess safety. In tVNS mode, safety monitoring indicators focus on ear-specific indicators, such as ear contact impedance, vagal reflex-related heart rate variability, blood pressure changes, and the patient's subjective feedback of stinging sensation; while in tDCS mode, safety monitoring indicators focus on frontal region indicators, such as the stability of scalp contact impedance, monitoring of skin redness and swelling, reports of headaches induced by transcranial stimulation, and the presence of abnormal phosphorescence.

[0094] A data windowing strategy refers to a period of time during which the system temporarily suspends data acquisition or output to ensure data integrity or avoid electrical interference when switching stimulation modes or performing specific operations (such as electrode usage interlock switching). In tVNS mode, the data windowing strategy may only set a short window between pulses to filter out switching noise; while in tDCS mode, especially during the transition period when the electrodes switch from EEG reference to stimulation output, a longer preset window is required to completely disconnect the EEG amplifier input and prevent high-voltage stimulation signals from damaging the acquisition front end.

[0095] Data monitoring strategies can refer to the configuration schemes for data sampling rate, filtering bandwidth, and anomaly detection logic under different stimulation modes. In tVNS mode, the data monitoring strategy requires a high sampling rate to capture the characteristics of fast pulse signals and configures a high-pass filter to remove polarization potentials; while in tDCS mode, the data monitoring strategy focuses more on low-frequency drift and DC components, configures a low-pass filter to remove high-frequency interference, and performs periodic skin impedance monitoring during long-term output to assess contact stability.

[0096] Through the differentiated configuration of the above nine dimensions, the method provided in this application embodiment can realize the stimulation mode corresponding to different stimulation links from the conceptual level to the specific electrical parameters and control logic level, so that the working mode switching module has clear parameter benchmarks to call when switching modes, thereby ensuring the effectiveness and safety of neuromodulation in different anatomical regions and avoiding the risk of insufficient stimulation or tissue damage caused by parameter confusion.

[0097] It should be understood that the sequence number of each step in the above embodiments does not imply the order of execution. The execution order of each process should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of this application.

[0098] This application also provides a computer-readable storage medium storing a computer program that, when executed by a processor, implements the steps described in the various method embodiments above.

[0099] like Figure 5As shown, this application embodiment provides a computer program product 50, including a computer program 51, which, when run, causes the steps in the above-described method embodiments to be executed.

[0100] If the integrated unit is implemented as a software functional unit and sold or used as an independent product, it can be stored in a computer-readable storage medium. Based on this understanding, all or part of the processes in the methods of the above embodiments of this application can be implemented by a computer program instructing related hardware. The computer program can be stored in a computer-readable storage medium, and when executed by a processor, it can implement the steps of the various method embodiments described above. The computer program includes computer program code, which can be in the form of source code, object code, executable files, or certain intermediate forms. The computer-readable medium can include at least: any entity or device capable of carrying computer program code to a device / terminal equipment, a recording medium, a computer memory, a read-only memory (ROM), a random access memory (RAM), an electrical carrier signal, a telecommunication signal, and a software distribution medium. Examples include USB flash drives, portable hard drives, magnetic disks, or optical disks. In some jurisdictions, according to legislation and patent practice, computer-readable media cannot be electrical carrier signals or telecommunication signals.

[0101] In the above embodiments, the descriptions of each embodiment have different focuses. For parts that are not described in detail or recorded in a certain embodiment, please refer to the relevant descriptions of other embodiments.

[0102] Those skilled in the art will recognize that the units and algorithm steps of the various examples described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are implemented in hardware or software depends on the specific application and design constraints of the technical solution. Those skilled in the art can use different methods to implement the described functions for each specific application, but such implementation should not be considered beyond the scope of this application.

[0103] In the embodiments provided in this application, it should be understood that the disclosed devices and methods can be implemented in other ways. For example, the device embodiments described above are merely illustrative. For instance, the division of modules or units is only a logical functional division, and in actual implementation, there may be other division methods. For example, multiple units or components may be combined or integrated into another system, or some features may be ignored or not executed. Furthermore, the coupling or direct coupling or communication connection shown or discussed may be an indirect coupling or communication connection through some interfaces, devices, or units, and may be electrical, mechanical, or other forms.

[0104] The units described as separate components may or may not be physically separate. The components shown as units may or may not be physical units; that is, they may be located in one place or distributed across multiple network units. Some or all of the units can be selected to achieve the purpose of this embodiment according to actual needs.

[0105] The above-described embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this application, and should all be included within the protection scope of this application.

Claims

1. A neuromodulation device, characterized in that, include: Multiple stimulation pathways, wherein the multiple stimulation pathways include stimulation pathways with at least two different stimulation modes; A status monitoring module is used to monitor the working status of the current working link among the plurality of stimulus links; The working link switching module is used to switch any of the multiple stimulation links, excluding the current working link, to a new working link when the working status indicates that the current working link is faulty. The working mode switching module is used to switch the working mode to the stimulation mode of the new working link if the stimulation mode of the new working link is different from the stimulation mode of the working link before the switch after each switching of the working link. The stimulation module is used to control the working link to stimulate the anatomical region corresponding to the working link according to the working mode.

2. The neural modulation device as described in claim 1, characterized in that, The plurality of stimulation links include a first stimulation link and a second stimulation link, and the working link is the first stimulation link; The working link switching module is configured to disable the first stimulus link when the working state indicates a failure of the current working link, and to switch the second stimulus link to a new working link when the second stimulus link is in an enabled state.

3. The neural modulation device as described in claim 2, characterized in that, Also includes: An activation status determination module is used to determine the activation status of the second stimulation link based on the electrode contact impedance, electrode connection status, protection status, and the physiological status of the target user. The activation status includes enabling activation and disabling activation.

4. The neural modulation device as described in claim 1, characterized in that, The multiple stimulation pathways include the concha tVNS pathway and the frontal tDCS pathway; The concha tVNS link includes a concha tVNS stimulation electrode and an ear circuit electrode. The concha tVNS stimulation electrode is used to be disposed in a first anatomical region, and the ear circuit electrode is used to be disposed in an ear circuit region. The concha tVNS stimulation electrode and the ear circuit electrode can form a first stimulation circuit between the first anatomical region and the ear circuit region. The forehead tDCS link includes a first output electrode and a multiplex electrode. The first output electrode is disposed in a second anatomical region, and the multiplex electrode is disposed in a forehead circuit region. The first output electrode and the multiplex electrode can form a second stimulation circuit between the second anatomical region and the forehead circuit region.

5. The neural modulation device as described in claim 4, characterized in that, When the current working link is the concha tVNS link, the status monitoring module is used to monitor the electrode connection status of the concha tVNS stimulation electrode and the ear circuit electrode, the output parameters of the concha tVNS stimulation electrode, the ear contact impedance of the ear circuit electrode, and the protection status of the concha tVNS link, and determine the working status of the concha tVNS link based on the electrode connection status, the output parameters, the ear contact impedance, and the protection status; The output parameters include output current and output voltage, and the protection states include current limiting state, overvoltage state, and protection state.

6. The neural modulation device as described in claim 4, characterized in that, Also includes: An electrode usage interlock module is provided to prevent the prefrontal multiplex electrode from being simultaneously connected to the EEG reference path and the prefrontal tDCS link. Before the prefrontal multiplex electrode is connected to the prefrontal tDCS link, the EEG reference path of the prefrontal multiplex electrode is disconnected or a preset empty window is entered. Before the prefrontal multiplex electrode is connected to the EEG reference path, it is confirmed that ramp-down, discharge, and residual voltage detection have been performed and that the residual voltage is lower than the safe residual voltage threshold.

7. A multi-mode switching method, characterized in that, Applied to the neuromodulation device as described in any one of claims 1 to 6, characterized in that the method comprises: Monitor the current working status of the multiple stimulation links; If the working state indicates a failure of the current working link, switch any of the multiple stimulation links other than the current working link to become the new working link; After each switch of the working link, if the stimulation mode of the new working link is different from the stimulation mode of the working link before the switch, then the working mode is switched to the stimulation mode of the new working link. The working mode controls the stimulation of the corresponding anatomical region by the working link.

8. The multi-mode switching method as described in claim 7, characterized in that, When the working state indicates a failure of the current working link, switching any one of the plurality of stimulus links, excluding the current working link, as the new working link includes: If the working status indicates a failure of the current working link, then disable the current working link; Among the plurality of stimulus links, any stimulus link other than the currently active link is identified as a candidate link; The activation status of the candidate link is determined based on the electrode contact impedance, electrode connection status, protection status, and the physiological status of the target user. The activation status includes enabling and disabling activation. If the candidate link is in an enabled state, switch the candidate link to a new working link.

9. The multi-mode switching method as described in claim 7 or 8, characterized in that, The stimulation modes corresponding to different stimulation links differ in at least one of the following: output waveform, output current limiting threshold, output voltage limiting threshold, stimulation duration, charge release method, electrode polarity configuration, safety monitoring indicators, data window strategy, and data monitoring strategy.

10. A computer program product, characterized in that, Includes a computer program, which, when executed, causes the multi-mode switching method as described in any one of claims 7 to 9 to be performed.

Images