Feedback-based neural electrical stimulation system

Abstract

This disclosure provides a feedback-type electrical nerve stimulation system, including a wearable feedback-type electrical nerve stimulation device, wherein the feedback-type electrical nerve stimulation device includes: a sensing module for measuring the user's physiological feedback signals, and including a photoplethysmography (PPG) sensor and an electrical activity of the skin (EDA) sensor; an electrical stimulator for providing electrical stimulation to the user, and including auricular electrodes and concentric ring electrodes; and a digital controller electrically connected to the sensing module and the electrical stimulator, respectively, for receiving the physiological feedback signals from the sensing module and outputting electrical stimulation control signals to the electrical stimulator to control the electrical stimulation.

Description

Technical Field

[0001] This disclosure relates to a feedback-type neuroelectric stimulation system, and more specifically, to a feedback-type neuroelectric stimulation system for neuromodulation. Prior Technology

[0002] While neurostimulation technology has made significant progress in treating various neurological disorders, numerous limitations and challenges remain. Currently, these devices are mainly used to treat chronic pain, depression, and epilepsy; however, there is still room for improvement in their efficacy. Most existing neurostimulation devices use fixed electrical stimulation parameters, such as duration, frequency, and intensity. This unchanging approach cannot adapt to the unique physiological needs of each patient, making it difficult to optimize treatment results. Taking vagus nerve stimulation (VNS) devices as an example, traditional treatment methods often require invasive surgery, which not only increases the risks for patients but also brings many inconveniences, deterring many potential beneficiaries.

[0003] More concerning is that most neurostimulation devices currently on the market lack real-time physiological feedback mechanisms. This deficiency means that the devices cannot adjust stimulation parameters in real time according to the user's current physiological state, greatly limiting the personalization and overall efficiency of treatment. In an era focused on precision medicine, this "one-size-fits-all" approach is clearly insufficient to meet the needs of modern medicine. The lack of physiological feedback may not only reduce treatment effectiveness but also lead to missed opportunities for optimal treatment due to the inability to respond promptly to changes in the patient's condition.

[0004] Furthermore, from a user experience perspective, many existing neurostimulation devices still have considerable room for improvement in terms of convenience and comfort. In particular, some devices are too large or complex to operate, making them unsuitable for long-term wear or daily use. This not only affects patients' quality of life but may also reduce treatment adherence. An ideal neurostimulation device should be lightweight, easy to use, and comfortable, seamlessly integrating into the user's daily life rather than becoming a burden. Summary of the Invention

[0005] A first aspect of this disclosure provides a feedback-type electrical nerve stimulation system, including a wearable feedback-type electrical nerve stimulation device. The feedback-type electrical nerve stimulation device may include: a sensing module for measuring physiological feedback signals from a user, and may include: a photoplethysmography (PPG) sensor for measuring photoplethysmography signals and an electrical skin activity (EDA) sensor for measuring skin electrical activity signals; an electrical stimulator for providing electrical stimulation to the user, and may include: an auricular electrode configured to be attached to the user's auricle and for providing transauricular vagus nerve electrical stimulation; and a concentric ring electrode, including a central electrode and a ring electrode, configured to be attached to the user's skin surface and for providing transcranial direct current stimulation; and a digital controller electrically connected to the sensing module and the electrical stimulator, respectively, for receiving the physiological feedback signals from the sensing module and outputting electrical stimulation control signals to the electrical stimulator to control the electrical stimulation.

[0006] According to one embodiment of the first aspect of this disclosure, the digital controller receives the photoplethysmography (PPG) signal from the sensing module and converts the PPG signal to the frequency domain to obtain the heart rate variability. After analyzing the high-frequency and low-frequency components in the heart rate variability, the controller determines the activity level of the parasympathetic nervous system based on the energy ratio of the high-frequency and low-frequency components, and adjusts the electrical stimulation control signal accordingly to control the electrical stimulation of the electrical stimulator.

[0007] According to one embodiment of the first aspect of this disclosure, the high-frequency component may be in the frequency range of 0.15 to 0.40 Hz, and the low-frequency component may be in the frequency range of 0.06 to 0.15 Hz.

[0008] According to one embodiment of the first aspect of this disclosure, the digital controller receives the skin conductance activity signal from the sensing module and can decompose the skin conductance activity signal into skin conductance level (SCL) and skin conductance response (SCR) components to determine the activity level of the sympathetic nerve based on the skin conductance level, and adjust the electrical stimulation control signal accordingly to control the electrical stimulation of the electrical stimulator.

[0009] According to one embodiment of the first aspect of this disclosure, the digital controller determines the activity level of the parasympathetic nervous system based on the photoplethysmography signal, and can determine the activity level of the sympathetic nervous system based on the skin electrical activity signal. Based on the activity levels of the parasympathetic nervous system and the sympathetic nervous system, the controller adjusts the electrical stimulation control signal to control the stimulation frequency and pulse width of the electrical stimulation.

[0010] According to one embodiment of the first aspect of this disclosure, the feedback neurostimulation system may further include: a mobile control terminal device for wirelessly communicating with the feedback neurostimulation device to display the physiological feedback signal and the electrical stimulation control signal, and to provide control commands to adjust the electrical stimulation control signal; and a server device for wirelessly communicating with the feedback neurostimulation device and the mobile control terminal device to store and analyze the physiological feedback signal and the electrical stimulation control signal.

[0011] According to one embodiment of the first aspect of this disclosure, the feedback-type neurostimulation device may further include: a wireless transmission module for wirelessly communicating with the mobile control terminal device and the server device, and electrically connecting with the digital controller to transmit the physiological feedback signal, the electrical stimulation control signal, and the control command.

[0012] According to one embodiment of the first aspect of this disclosure, the feedback neurostimulation device may further include: a body configured to house the digital controller, wherein the concha electrode and the concentric ring electrode are disposed on the surface of the body; an earplug element coupled to the body for fixing the feedback neurostimulation device to the user's ear; and a sensing element disposed on the surface of the earplug element to contact the user's ear, and configured to house the photoplethysmography sensor and the electrodermal activity sensor.

[0013] According to one embodiment of the first aspect of this disclosure, the concha electrode may be a contact electrode or a snap-on electrode.

[0014] According to one embodiment of the first aspect of this disclosure, the contact electrode may be a direct contact electrode or an electrode with a spring mechanism.

[0015] According to one embodiment of the first aspect of this disclosure, the snap-on electrode includes a male snap and a female snap that can be detachably assembled with each other, wherein one of the male snap and the female snap is an electrode that contacts the user's ear, while the other is disposed on the body. Simple Explanation of the Diagram

[0016] This disclosure will be better understood when the following detailed description is read in conjunction with the accompanying drawings, in which: Figure 1 is a schematic diagram of the system architecture of the feedback nerve electrical stimulation system according to one embodiment of the present disclosure. Figure 2 is a schematic diagram of the basic architecture between the device components in the feedback neural electrical stimulation system disclosed herein. Figure 3 is a schematic diagram of a feedback neurostimulation device according to one embodiment of the present disclosure worn on the user's ear. Figure 4 is a perspective view of the feedback-type electrical nerve stimulation device 1 disclosed herein. Figure 5A is a schematic diagram of a direct contact concha electrode according to one embodiment of the present disclosure. Figure 5B is a schematic diagram of a spring-type concha electrode according to another embodiment of the present disclosure. Figure 6A is a schematic diagram of a directly connected snap-on concha electrode according to one embodiment of this disclosure. Figure 6B is a schematic diagram of an extended connection snap-on concha electrode according to another embodiment of this disclosure. Figure 7 is a schematic diagram of the concentric ring electrode 15 according to one embodiment of the present disclosure. Figure 8 is a schematic diagram of the structure of the feedback neural electrical stimulation device body according to one embodiment of the present disclosure. Implementation

[0017] The following description contains specific information relating to the exemplary embodiments described herein. The accompanying drawings and detailed descriptions in this disclosure are merely exemplary embodiments. However, this disclosure is not limited to these exemplary embodiments. Other variations and embodiments of this disclosure will be apparent to those skilled in the art. Unless otherwise stated, the same or corresponding elements in the drawings are indicated by the same or corresponding reference numerals. Furthermore, the drawings and illustrations in this disclosure are generally not drawn to scale and are not intended to correspond to actual relative dimensions.

[0018] For the purposes of consistency and ease of understanding, the same features are indicated by reference numerals in the exemplary drawings (although this is not the case in some examples). However, features in different embodiments may differ in other respects, and therefore should not be narrowly limited to the features shown in the drawings.

[0019] The terms "at least one embodiment," "one embodiment," "multiple embodiments," "different embodiments," "some embodiments," and "this embodiment" indicate that the embodiments described herein may include specific features, structures, or characteristics, but not every possible embodiment of this disclosure must include those specific features, structures, or characteristics. Furthermore, the repeated use of the phrases "in one embodiment" and "in this embodiment" does not necessarily refer to the same embodiment, although they may be identical. Moreover, the use of phrases such as "embodiment" in connection with "this disclosure" does not imply that all embodiments of this disclosure must include those specific features, structures, or characteristics, and should be understood as "at least some embodiments of this disclosure" including those specific features, structures, or characteristics.

[0020] The term "coupled" is defined as a connection, whether direct or indirect, through an intermediate element, and is not necessarily limited to physical connections, rather than describing a specific order. When the terms "comprising" or "including" and any variations thereof are used, it is intended to cover a non-exclusive inclusion, meaning "including but not limited to," which explicitly indicates an open inclusion or relationship of combinations, groups, series, and equivalents. For example, a process, method, system, product, or apparatus that includes a series of steps or modules is not limited to the listed steps or modules, but may optionally include steps or modules not listed, or optionally other steps or modules inherent to those processes, methods, products, or apparatuses.

[0021] Furthermore, for illustrative and non-restrictive purposes, specific details such as functional entities, technologies, protocols, and standards are elaborated to provide an understanding of the described technologies. In other examples, detailed descriptions of well-known methods, technologies, systems, architectures, etc., are omitted to avoid obscuring the explanatory narrative with unnecessary details.

[0022] The terms "first," "second," and "third," etc., used in the specification and accompanying drawings of this disclosure are used to distinguish different objects, not to describe a specific order.

[0023] The present disclosure will now be described in further detail with reference to the accompanying drawings and embodiments.

[0024] This disclosure essentially relates to a feedback-type neurostimulation device, system, and method of use, which integrates bimodal neuromodulation of transauricular vagus nerve stimulation and transcranial direct current stimulation, and provides more effective treatment options for different types of neurological diseases. For example, it can be used as an adjunct therapy for patients with acute and subacute stroke, providing more effective neurofunctional reconstruction through an immediate physiological feedback mechanism.

[0025] The feedback neurostimulation devices, systems, and methods of use described in this disclosure can be used by a user to assist in medical procedures on a human or mammal (e.g., another patient). In some embodiments, the user may be an individual using the feedback neurostimulation devices, systems, and methods of use described in this disclosure. In some embodiments, the patient may be another individual who performs a medical procedure using the feedback neurostimulation devices, systems, and methods of use described in this disclosure.

[0026] Please refer to Figure 1, which is a schematic diagram of the system architecture of a feedback neural electrical stimulation system 100 according to one embodiment of this disclosure. As shown in the figure, the feedback neural electrical stimulation system 100 may include a feedback neural electrical stimulation device 1, a mobile control terminal device 2, and a server device 3.

[0027] In some embodiments, the feedback neurostimulation device 1 can be a device worn on a patient, which may include one or more sensors for detecting physiological signals such as heart rate, brain waves, skin electrical activity signals, electromyography signals, or nerve signals, and may include one or more stimulators to provide corresponding neurostimulation to the user. The user may also manually adjust the settings of the feedback neurostimulation device 1 as needed, or automatically adjust it through artificial intelligence analysis.

[0028] In some embodiments, the feedback neurostimulation device 1 can utilize an integrated digital controller for efficient edge computing to achieve on-chip signal processing and control, or provide intelligent platform analysis through a mobile control terminal device, so that the feedback neurostimulation device 1 can process physiological signals from the sensors in real time, thereby generating precise control signals to adjust the electrical stimulation output of the stimulator.

[0029] In some implementations, the mobile control device 2 can be an electronic device such as a smartphone, digital assistant, or computer, and the user can use the mobile control device 2 to set the electrical stimulation parameters of the feedback neurostimulation device 1 and perform artificial intelligence analysis. The mobile control device 2 can also receive and display information transmitted from the feedback neurostimulation device 1, which may include detection results, the provided electrical stimulation mode, and artificial intelligence analysis results.

[0030] In some implementations, the mobile control device 2 can perform artificial intelligence analysis through a dedicated application designed for the feedback neurostimulation system 100, allowing users to track and record the effects and responses of each electrical stimulation phase. The data processed by the mobile control device 2 not only helps users find the most suitable electrical stimulation mode, but also provides real-time feedback and suggestions through a user-friendly interface, thereby enhancing the user experience and personalization of stimulation.

[0031] In some implementations, the server device 3 may be a storage library, such as a cloud device, for storing multiple pieces of information. It may also collect information from the mobile control terminal device 2 originating from the feedback neurostimulation device 1, perform signal processing and artificial intelligence analysis on the information, correct the relevant settings in the feedback neurostimulation device 1, and then feed the correction back to the feedback neurostimulation device 1 directly or through the mobile control terminal device 2 to achieve the optimization of the electrical stimulation therapy.

[0032] In some implementations, the server device 3 can serve as a database, collecting and storing electrical stimulation data from all users. By analyzing and processing this large amount of data and using de-identification techniques to protect user privacy, the server device 3 can extract valuable demographic information. This information helps to develop and optimize artificial intelligence models specifically for certain regions or ethnic groups, providing users with more accurate and personalized electrical stimulation treatment plans. It also promotes innovation and progress in the widespread application of electrical stimulation technology across various ethnic groups.

[0033] For a more detailed explanation of the internal architecture of each device, please refer to Figure 2, which is a basic architectural diagram of the device components in the feedback neurostimulation system 100 disclosed herein. The feedback neurostimulation system 100 may include a feedback neurostimulation device 1, a mobile control terminal device 2, and a server device 3. The components and functions of each device will be described below.

[0034] In some embodiments, the feedback-type electrical nerve stimulation device 1 may include a digital controller 110, a wireless transmission module 120, a power management unit 130, a sensing module 140, and an electrical stimulator 150. In some embodiments, the digital controller 110 may have predetermined computing power and a register to receive instructions transmitted from the mobile control terminal device 2 via the wireless transmission module 120. The instructions may include parameters controlling the output of the electrical stimulator 150, such as anodic stimulation intensity, cathodic stimulation intensity, anodic stimulation time, cathodic stimulation time, interval time, stimulation cycle, and total number of stimulations, the specific values ​​of which can be set and adjusted according to the needs of electrical stimulation therapy.

[0035] In some implementations, the wireless transmission module 120 may use wireless transmission technologies such as WiFi or Bluetooth, and different wireless transmission modules may be selected according to factors such as the usage scenario, treatment procedure time, and the amount of sensing data.

[0036] In some embodiments, the power management unit 130 may include a charging interface, a rechargeable battery, a voltage regulator, and a booster, wherein the rechargeable battery can be charged via the charging interface, the voltage regulator is used to convert the battery voltage to the voltage required by the system, and the booster is used to boost the system voltage to the voltage level required by the electrostimulator 150.

[0037] In some embodiments, the sensing module 140 can be used to measure physiological signals and convert them into electrical signals for use by the digital controller 110, which then transmits the sensing data to the mobile control terminal device 2 via the wireless transmission module 120. The physiological signals may be feedback related to electrical stimulation therapy, including photoplethysmography (PPG) signals and electrodermal signals, which will be described in more detail later.

[0038] The following will use an ear-worn regenerative neurostimulation device as an example, along with the embodiments shown in the accompanying drawings, to provide a more detailed description of the regenerative neurostimulation device, system, and its usage method disclosed herein.

[0039] In some embodiments, the ear-worn feedback neurostimulation device may be an ear hook or earplug type, used to fix the feedback neurostimulation device to the user's ear. Please refer to Figure 3, which is a schematic diagram of a feedback neurostimulation device of one embodiment of this disclosure worn on a user's ear. As shown in the figure, the feedback neurostimulation device of this disclosure can be worn on the user's ear in an earplug structure and includes electrodes for providing electrical stimulation to the vagus nerve branches within the concha, and further integrates concentric ring electrodes for providing transcranial direct current stimulation. In a preferred embodiment, the feedback neurostimulation device of this disclosure can be worn on the user's left ear in an earplug structure.

[0040] Please refer to Figure 4, which is a perspective view of the feedback-type electrical nerve stimulation device 1 disclosed herein. The feedback-type electrical nerve stimulation device 1 may include a body 11, an earplug element 12, a sensing element 13, an auricular electrode 14, and a concentric ring electrode 15. The sensing element 13 may be a component of the aforementioned sensing module 140, and the auricular electrode 14 and the concentric ring electrode 15 may be components of the aforementioned electrical stimulator 150. The structural features and functions of the auricular electrode 13 and the sensing element 14 will be described in detail below.

[0041] In some embodiments, the sensing element 13 may include a sensor 131 for detecting photoplethysmography (PPG) and a sensor 132 for detecting electrical activity (EDA). These sensors 131 and 132 are disposed on the surface of the earbud element 12 to contact the wearer's skin, capture physiological signals, and then perform pre-amplification and filtering of the physiological signals via analog front-end circuitry before transmitting them to the digital controller 110 for further processing. In some embodiments, the digital controller 110 may include a drive module for controlling the output power of the PPG sensor 131 and generating a voltage signal for the EDA sensor 132.

[0042] In some embodiments, the PPG sensor 131 may include a light-emitting diode (LED) and a light-receiving element. The LED can emit light of a specific wavelength, the power of which can be controlled by a drive module in the digital controller 110. The light is attenuated to varying degrees by passing through skin tissue and the changing diameter of blood vessels over time; the attenuated reflected light is detected by the light-receiving element. The drive LED and the light-receiving element are fixed to the surface of the earpiece element 12 and can be spaced a predetermined distance from each other to ensure optimal sensing performance.

[0043] In some embodiments, the EDA sensor 132 may include a driving electrode and a capturing electrode. The driving electrode is used to output a voltage signal from the driving module 1105 in the digital controller 110. This voltage signal is then transmitted through the skin tissue impedance of the wearer, and the capturing electrode captures a current signal. The driving electrode and the capturing electrode may be designed with direct contact or with a spring mechanism to ensure close contact with the wearer's skin tissue.

[0044] In some embodiments, the concha electrode 14 can be configured as a contact electrode. Specifically, the concha electrode 14 can employ a direct contact design, allowing the electrode to directly contact the skin surface. This design is particularly suitable for situations requiring precise electrical stimulation. In some embodiments, the concha electrode 14 can also employ a design with a spring mechanism, ensuring that the electrode fits more closely and evenly against the stimulation site. This design is particularly suitable for electrical stimulation of dynamic or irregular surfaces.

[0045] In some embodiments, the concha electrode 14 may be made of medical-grade stainless steel to ensure its durability and safety. Furthermore, during use, a conductive gel may be coated on the surface of the concha electrode 14 to enhance its electrical connection with the wearer's skin and to allow it to adhere firmly to the skin surface.

[0046] Please refer to Figure 5A, which is a schematic diagram of a direct contact concha electrode according to one embodiment of this disclosure. In some embodiments, the direct contact concha electrode 1410 may be made of a medical-grade metal conductor 1411 and, following guidelines for electrical stimulation charge density, possess a contact surface area corresponding to its highest stimulation intensity. The direct contact concha electrode 1410 may be fixed to the surface of a designated location on the reciprocating neurostimulation device 1 to conform to the target skin tissue of the wearer, and is connected via wires to the circuit stimulation output port inside the body 11.

[0047] Please refer to Figure 5B, which is a schematic diagram of a spring-loaded concha electrode according to another embodiment of this disclosure. In some embodiments, the spring-loaded concha electrode 1420 may also be made of a medical-grade metal conductor 1421 and similarly follow the guidelines for electrical stimulation charge density, possessing a contact surface area corresponding to its highest stimulation intensity. The spring-loaded concha electrode 1420 can be floated on the surface of a designated location in the feedback neurostimulation device 1, and through the spring 1422 inside the device, the wearing pressure causes the spring 1422 to expand and contract to conform to the target skin tissue of the wearer, and is connected to the circuit stimulation output port inside the body 11 via a wire.

[0048] In some embodiments, the concha electrode 14 can also be configured as a snap-on electrode, which can be configured to be directly connected to the feedback nerve stimulation device 1, or can be configured to be connected through a connector extending from the feedback nerve stimulation device 1, so as to suit situations requiring precise electrical stimulation, and can be adjusted according to treatment needs to ensure the maximization of treatment effect.

[0049] In some embodiments, the snap-on concha electrode can be made of a conductive material with excellent properties, such as silver or silver chloride, to ensure good electrochemical stability and low skin resistance, thereby effectively promoting the conduction of electrical stimulation. In some embodiments, the snap-on concha electrode can also use a gel or gel-like substance containing electrolytes to significantly enhance the contact between the electrode and the skin, effectively reduce contact resistance and improve conductivity, ensuring effective transmission of electrical stimulation.

[0050] Please refer to Figure 6A, which is a schematic diagram of a directly connected snap-on concha electrode according to one embodiment of this disclosure. In some embodiments, the snap-on concha electrode 1430 may be made of medical-grade metal conductor and consists of a male snap 1431 and a female snap 1432. The male snap 1431 may have an electrode 1434 for contact with the wearer, and the electrode 1434 must comply with guidelines for electrical stimulation charge density and have a contact surface area corresponding to its highest stimulation intensity. The electrode 1434 may include a conductive portion 1433, which may be coated with conductive gel or a gel-like substance. Furthermore, the male snap 1431 and the female snap 1432 may be directly snapped together and fixed to the surface of a designated location on the surface of the feedback neurostimulation device 1, and connected to the circuit stimulation output port inside the body 11 via wires. In some embodiments, the mounting positions of the male buckle 1431 and the female buckle 1432 can be interchanged, that is, the male buckle can be set on the body, while the female buckle is in contact with the user to achieve the same fastening effect.

[0051] Please refer to Figure 6B, which is a schematic diagram of an extended-connection snap-on concha electrode according to another embodiment of this disclosure. In some embodiments, the snap-on concha electrode 1440 may be made of medical-grade metal conductor and consists of a male snap 1441 and a female snap 1442, and further includes a connecting wire 1443 and an electrode 1444. The electrode 1444 must comply with guidelines for electrical stimulation charge density and have a contact surface area corresponding to its highest stimulation intensity. The electrode 1444 may include a conductive portion 1445, and the conductive portion 1445 may be coated with conductive gel or a gel-like substance. The electrode 1444 can be connected to either the male snap 1441 or the female snap 1442 via the wire 1443. The other of the male snap 1441 and female snap 1442 is fixed to the surface of a designated location on the reciprocating nerve electrical stimulation device 1 and connected to the circuit stimulation output port inside the body 11 via the wire 1443.

[0052] In some embodiments, please refer to FIG7, which is a perspective view of a concentric ring electrode 15 according to one embodiment of this disclosure. The concentric ring electrode 15 may include a central electrode 151 and a ring electrode 152, wherein the central electrode 151 and the ring electrode 152 may be made of medical-grade metal conductors and, following guidelines for electrical stimulation charge density, possess a contact surface area corresponding to their highest stimulation intensity. The central electrode 151 may be disposed at the center of the ring electrode 152, and a predetermined distance may be present between the central electrode 151 and the ring electrode 152. In some embodiments, the distance between the central electrode 151 and the ring electrode 152 may be 1-3 cm, preferably 2 cm.

[0053] In some embodiments, the central electrode 151 and the annular electrode 152 can be connected to the circuit stimulation output port inside the body 11 via wires to receive different electrical stimulation signals. The central electrode 151 can act as an anode, and the annular electrode 152 can act as a cathode to produce a precise transcranial direct current stimulation effect. In some embodiments, the central electrode 151 and the annular electrode 152 can also use a gel or gel-like substance containing electrolytes to significantly enhance contact with the skin, effectively reduce contact resistance, and improve conductivity.

[0054] Please refer to Figure 8, which is a schematic diagram of the architecture of the regenerative neurostimulation device body according to one embodiment of this disclosure. In some embodiments, the body 11 can be powered by a rechargeable battery and may include the digital controller 110, transceiver 112, and charging component 113. The transceiver 112 may be a component of the aforementioned wireless transmission module 120, and the charging component 113 may be a component of the aforementioned power management unit 130. In some embodiments, the digital controller 110 can be used to provide control signals to the concha electrode 14 and the concentric ring electrode 15, and process the signals obtained from the sensing element 13 to regulate the control signals.

[0055] In some embodiments, the digital controller 110 in the body 11 of the feedback neurostimulation device may include an analog front-end module 1101, an analog-to-digital converter 1102, a data processing module 1103, an electrical stimulation control module 1104, and a drive module 1105. The analog front-end module 1101 may include a transimpedance amplifier 1111, a filter 1112, and a multiplexer 1113. The analog front-end module 1101 can be used to process PPG signals (i.e., measuring the output current of a photodiode) and EDA physiological signals (i.e., measuring the current applied to the skin impedance). The drive module 1105 can be used to control the LED output power of the PPG sensor 131 and generate the voltage signal required by the EDA sensor 132. In some embodiments, the drive module 1105 may include an LED of a specific wavelength required for the PPG signal and its LED driver, and may include a voltage output device required for the EDA signal.

[0056] In some embodiments, the startup operation of the analog front-end module 1101 can be achieved by a stable voltage supply provided by the charging component 113. The PPG signal measures the output current of the photodiode, while the EDA physiological signal measures the current applied to the skin impedance. The transimpedance amplifier 1111 converts the current to voltage; since the physiological signal feedback is often very small and does not conform to the voltage range of the back-end processing, the transimpedance amplifier 1111 also amplifies the signal. The filter 1112 can be electrically connected after the transimpedance amplifier 1111 to filter the physiological signal, removing noise outside the required frequency band, including wireless and internal circuit board noise coupling, as well as motion artifacts and common-mode signals that may be generated by human movement. The multiplexer 1113 can be electrically connected after the filter 1112 to process the PPG and EDA signals using time-division or frequency-division methods, allowing the signals to share the back-end analog-to-digital converter module 1102.

[0057] In some embodiments, the analog-to-digital conversion module 1102 can be used to convert the signal processed by the analog front-end module 1101 into digital code for further processing by the data processing module 1103. The data processing module 1103 may include digital signal processing circuitry for processing and collecting PPG and EDA physiological signals from the user during electrical stimulation.

[0058] In some embodiments, the data processing module 1103 may further include a computing module for processing PPG and EDA signals. In some embodiments, the computing module may be specifically designed to meet the neurological function monitoring needs of stroke patients, providing real-time and accurate assessments of autonomic nervous function and adjusting stimulation parameters accordingly.

[0059] In some implementations, the computational module can convert the PPG signal into heart rate variability through frequency domain analysis, and then use the heart rate variability to determine the activation level of the parasympathetic component in the autonomic nervous system. Specifically, when processing the PPG signal, the computational module can first convert the photoplethysmography (PPG) signal to the frequency domain, and then calculate the energy ratio of the high-frequency (0.15-0.40 Hz) and low-frequency (0.06-0.15 Hz) components of the heart rate variability. The high-frequency component can represent the activity of the parasympathetic nervous system in the autonomic nervous system, while the low-frequency component can reflect the combined activity of the sympathetic and parasympathetic nervous systems. In some implementations, the computational module can additionally analyze the time-domain indicators of the heart rate variability, including the standard deviation of adjacent heartbeat intervals and the root mean square of the difference between adjacent heartbeat intervals, to meet the needs of stroke patients. In addition, the computational module can also analyze nonlinear indicators, such as approximate entropy and sample entropy, to more comprehensively assess the patient's autonomic nervous system function recovery. The above-mentioned analytical functions of the computational module can also be realized through the artificial intelligence platform of the mobile control terminal device 2.

[0060] In some implementations, the data processing module 1103 can acquire EDA signals through an EDA sensor and then analyze the detected EDA signals using a rolling sphere algorithm. Specifically, the rolling sphere algorithm can dynamically adjust the radius and scale of the sphere according to the signal characteristics, using rolling sphere operations of different scales to decompose and process the signal, decomposing the signal into SCL (skin conductance level) and SCR (skin conductance response) components, where the SCL signal will serve as an indicator of the activation level of the sympathetic nerve components in the autonomic nervous system. A smaller diameter rolling sphere can be used for initial noise filtering, while a larger diameter rolling sphere can be used to separate the slowly changing SCL component. For example, a 0.25-second sphere can be used for initial noise filtering, and a 2.5-second sphere can be used for signal decomposition to separate the slowly changing SCL component. In some implementations, for stroke patients, the computational module can use SCL as the primary indicator for assessing the degree of sympathetic nerve component activation, while simultaneously analyzing the frequency and amplitude characteristics of SCR and establishing a short-term trend graph to assess the patient's immediate response to treatment. The analytical functions of the aforementioned data processing module can also be implemented through the artificial intelligence platform of the mobile control terminal device 2.

[0061] In some implementations, the computational module can establish a comprehensive scoring system to assess the patient's autonomic nervous system function. A high-low frequency ratio (HFR) between 1.5 and 2.0, with SCL fluctuations within ±20% of the baseline, is considered normal. A HFR between 1.0 and 1.5, or SCL fluctuations exceeding ±20% but less than 40% of the baseline, is considered mildly abnormal. A HFR between 0.5 and 1.0, or SCL fluctuations exceeding ±40% but less than 60% of the baseline, is considered moderately abnormal. A HFR below 0.5, or SCL fluctuations exceeding ±60% of the baseline, is considered severely abnormal. The computational module can transmit these analysis results to the electrical stimulation control module 1104 in real time as a basis for adjusting stimulation parameters, providing more precise neuromodulation therapy. The analysis function of the above-mentioned computing module can also be realized through the artificial intelligence platform of the mobile control terminal device 2, and information can be exchanged with the digital controller 110 through the wireless transmission module 120 to achieve the purpose of adjusting the stimulation parameters.

[0062] In some implementations, the data processing module 1103 can transmit the analysis results of the two signals, namely the activation messages representing the sympathetic and parasympathetic nerve components respectively, to the electrical stimulation control module 1104. Under normal circumstances, one of the two incoming signals can be selected for processing; if both signals are received simultaneously, the PPG signal is given priority.

[0063] In some implementations, the digital controller 110 can employ different control strategies based on different physiological signal characteristics. For photoplethysmography (TPM) signals, the digital controller 110 can use standard proportional-derivative (PD) control, where the proportional term can be adjusted according to the deviation between the current high-to-low frequency ratio and the target value, and the derivative term reflects the rate of change of this deviation. The two together determine the adjustment amount of the taVNS stimulation parameters. Specifically, when the deviation is positive and increasing, the controller can correspondingly increase the stimulation intensity; when the deviation is negative and decreasing, the stimulation intensity can be decreased.

[0064] In some implementations, for ESK signals, the digital controller 110 may employ a fuzzy control strategy to fuzzify the SCL value and rate of change into multiple levels (e.g., low, medium, high), and determine the output according to preset fuzzy rules. For example, when the SCL is at a "high" level and the rate of change is "positive," a rule to reduce the stimulus intensity may be triggered; when the SCL is at a "low" level and the rate of change is "negative," a rule to increase the stimulus intensity may be triggered.

[0065] In some embodiments, the electrical stimulator 150 can output various waveforms, including square waves, triangular waves, and trapezoidal waves. The square wave is used as the preset waveform primarily because of its good nerve stimulation effect and ease of implementation. Safety limits are set for the electrical stimulation intensity, maintaining it below 4 mA, and the stimulation time for a single treatment session does not exceed 30 minutes. In some embodiments, taking stroke patients as an example, when used in the acute phase of stroke (e.g., within 2 weeks of onset), the pulse width can be set to 0.2-0.5 ms, and the frequency range to 20-100 Hz; while when used in the subacute phase (e.g., 2 weeks to 3 months after onset), the pulse width can be adjusted to 0.5-1 ms, and the frequency range extended to 20-250 Hz.

[0066] In some embodiments, the electrical stimulation control module 1104 may include a digital-to-analog converter 1141 and a switching module 1142. The digital-to-analog converter 1141 receives instructions and parameters from the digital controller 110, converting digital signals into analog voltages to control the amplitude of the output waveform (e.g., the intensity of a square wave). The switching module 1142 may include multiple electronic switches electrically connected to the digital-to-analog converter 1141 to control the phase and timing characteristics of the stimulation waveform. By precisely controlling the on / off sequence of these switches, the switching module 1142 can achieve different stimulation modes: in monophasic stimulation mode, it can control the anode energizing time and charge release time; while in biphasic stimulation mode, it can control the timing of anode energizing, cathode energizing, and charge release. Furthermore, the switching module 1142 can dynamically adjust the duty cycle of the waveform according to treatment needs to optimize the stimulation effect.

[0067] In some embodiments, the electrical stimulation control module 1104 can use standard proportional-derivative control or fuzzy control to adjust the electrical stimulation signal. Specifically, the electrical stimulation control module 1104 can adjust the intensity of the aVNS electrical stimulation signal based on the received excitation messages from the sympathetic and parasympathetic nerve components. For example, relatively high frequencies (20-250 Hz) and short pulses tend to excite relatively thicker myelinated A fibers, thereby activating the parasympathetic nervous system; while relatively low frequencies (0.5-10 Hz) and longer pulses tend to activate relatively thicker and thinner fibers, thereby activating the sympathetic nervous system. The electrical stimulation control module 1104 can utilize this antagonistic mechanism of the sympathetic and parasympathetic nervous systems for control.

[0068] In some implementations, when transcutaneous auricular vagus nerve stimulation (taVNS) and transcranial direct current stimulation (tDCS) are used simultaneously, the electrical stimulation control module 1104 performs taVNS first, followed by tDCS, to achieve the best therapeutic effect. Specifically, during taVNS stimulation, the electrical stimulation control module 1104 controls the switching module 1142 to divide the output current path into three states: anodic stimulation occurs when the current flows from the digital-to-analog converter 1141 through the anode electrode to the cathode electrode; cathodic stimulation occurs when the current flows in the opposite direction, i.e., through the cathode electrode to the anode electrode; and charge release occurs when both electrodes are simultaneously connected to the system ground. During tDCS stimulation, the digital-to-analog converter 1141 in the electrical stimulation control module 1104 generates a current waveform with an initial rising slope and an ending falling slope, maintaining a stable DC current output during this period. The stimulation intensity does not exceed 4 mA and the duration is up to 30 minutes. Compared to taVNS, tDCS typically requires a longer stimulation time to achieve the therapeutic effect.

[0069] In some implementations, the electrical stimulation control module 1104 can achieve different stimulation modes by controlling the switching sequence of these three current paths. In monophasic stimulation mode, a combination of anodic stimulation and charge release, or a combination of cathodic stimulation and charge release, can be selectively output; while in biphasic stimulation mode, anodic stimulation, cathodic stimulation, and charge release are output sequentially to ensure charge balance of the stimulation. Especially in the acute phase of stroke patients, monophasic stimulation mode is preferred, and after entering the subacute phase, the patient can gradually transition to biphasic stimulation mode according to their tolerance.

[0070] In some implementations, after aVNS stimulation is completed, the electrical stimulation control module 1104 enters a preset rest period (e.g., 2-5 minutes) to avoid the cumulative effect of stimulation. After the rest period, tDCS stimulation is initiated again. At this time, the electrical stimulation control module 1104 controls the current intensity and direction between the central electrode 151 (which can be used as an anode) and the ring electrode 152 (which can be used as a cathode) of the concentric ring electrode 15 to generate the required DC electric field. This timing control design not only avoids interference between the two stimulation modes but also ensures that each stimulation mode achieves the best therapeutic effect.

[0071] In some embodiments, the transceiver assembly 112 in the main body 11 of the regenerative neural electrical stimulation device may include a transmitter 1121, a receiver 1122, an encoder 1123, and a decoder 1124. Digital data can be converted into packets of a specific format by the encoder 1123, then converted into wireless signals by the transmitter 1121 and transmitted via an antenna for reception by the corresponding receiver within range. Conversely, encoded commands and parameters transmitted by the corresponding transmitter within range can be received by the antenna of the receiver 1122, then decapsulated into digital information by the decoder 1124, and transmitted to the data processing module 1103.

[0072] In some embodiments, the charging component 113 in the regenerative neural electrical stimulation device body 11 may include a charging interface 1131, a rechargeable battery 1132, a voltage regulator 1133, a buck-boost converter 1134, and a reference voltage 1135. The charging interface 1131 is used to supply power to the rechargeable battery 1132 for charging, and the voltage regulator 1133 is used to convert the battery voltage and interface voltage to the system voltage, ensuring that the system current load is within specifications and minimizing voltage fluctuations caused by load variations and power coupling.

[0073] In some embodiments, the voltage regulator 1133 can be further subdivided into a digital section and an analog section, mainly used to reduce interference of digital signals through the power supply to the analog circuit, and to separately activate the digital circuit and the analog circuit to reduce power consumption in some operating modes. Since the target tissue being stimulated is capacitive, the stimulation output usually requires a higher voltage to maintain the stimulation level. Therefore, the buck-boost converter 1134 is used to boost the system voltage output by the voltage regulator 1133 to the voltage required by the electrostimulator 150.

[0074] In some implementations, to ensure normal voltage output, the output of the buck-boost converter 1134 can be detected by the analog-to-digital converter module 1102 through voltage division to ensure normal high-voltage output. The reference voltage 1135 is electrically connected after the rechargeable battery 1132 or the voltage regulator 1133 to provide a certain voltage. This fixed voltage has lower voltage, process, and temperature variation effects compared to the system voltage, to be used by the voltage regulator 1133 and other modules in the system that require voltage levels.

[0075] In some implementations, the electrical stimulation control module 1104 automatically adjusts the electrical stimulation mode according to the physiological state. The data processing module 1103 analyzes the PPG and EDA signal results, and when the user is in an anxious state, the stimulation frequency can be adjusted to 20-250 Hz to use short pulses to activate the parasympathetic nervous system.

[0076] In some embodiments, the feedback-type neurostimulation device 1 has multiple safety protection mechanisms. The stimulation control module 1104 has a safety threshold, monitors electrode impedance values ​​and physiological signal changes, has an overcurrent protection mechanism, and has an emergency stop function on the main body 11 and the mobile control terminal device 2. An automatic calibration check of the electrode connection status is performed before each treatment.

[0077] In some embodiments, the feedback-type electrical nerve stimulation device 1 can integrate taVNS and tDCS stimulation modes. In some embodiments, when applied to stroke patients, during the acute phase (e.g., within 2 weeks after onset), milder parameters are used: taVNS frequency of 20-100 Hz and tDCS current intensity of 0.5-1 mA; while during the subacute phase (e.g., 2 weeks to 3 months after onset), the parameters can be increased to: taVNS frequency of 100-250 Hz and tDCS current intensity of 1-2 mA.

[0078] In some implementations, the electrical stimulation control module 1104 employs a timing control strategy. TaVNS stimulation is performed first, followed by tDCS stimulation after charge release. The interval during the acute phase is 5-10 minutes, which can be shortened to 2-5 minutes during the subacute phase. Each parameter adjustment is performed gradually, with a minimum step of 0.5 Hz for the taVNS frequency at intervals of at least 30 seconds, and a minimum step of 0.1 mA for the current intensity at intervals of at least 1 minute.

[0079] In some embodiments, the electrical stimulation control module 1104 includes a digital-to-analog converter 1141 and a switching module 1142. The switching module 1142 can implement three current paths: anodic stimulation, cathodic stimulation, and charge release, and can output monophasic or biphasic stimulation waveforms. Three-stage control is employed during tDCS stimulation: an escalation phase (e.g., 15-30 seconds), a duration phase (e.g., 10-30 minutes), and a deceleration phase (e.g., 15-30 seconds).

[0080] In some implementations, the electrical stimulation control module 1104 employs different control strategies depending on the treatment stage: conservative parameter adjustments are used in the initial stage, flexible adjustments are made based on physiological signals in the stable stage, and a gradual reduction strategy is used in the final stage. If an abnormal signal is detected, parameter adjustments are temporarily frozen until the signal returns to stability.

[0081] In some implementations, the feedback neurostimulation device 1 can establish customized treatment plans. The digital controller 110 records information such as treatment parameter settings, adjustment processes, and effect evaluations, which is transmitted to the mobile control terminal device 2 via the wireless transmission module 120 and uploaded to the server device 3 for analysis. The server device 3 analyzes the user's response patterns to different stimulation parameters, identifies the optimal parameter combination, and sends it back to the mobile control terminal device 2 for reference.

[0082] In some implementations, the mobile control device 2 provides a graphical interface and an artificial intelligence platform, which can display changes in physiological indicators in real time, adjust treatment parameters, and provide personalized suggestions based on the analysis results of the server device 3. The treatment records established by the mobile control device 2 include information such as user data, treatment goals, parameter settings, and physiological signal trends, which can be used for analysis and optimization by the artificial intelligence platform.

[0083] In some implementations, the server device 3 can establish treatment parameter models for different application scenarios based on a large amount of user data. The server device 3 establishes specialized parameter adjustment strategies based on factors such as symptom type and age group, recommending suitable initial parameters for new users, enabling the feedback neural electrical stimulation device 1 to accurately meet the needs of different users. The feedback neural electrical stimulation device 1 can also automatically adjust the treatment schedule according to the user's work-rest patterns and physiological changes.

[0084] In some implementations, the feedback-type electrical nerve stimulation device 1 is primarily used as an adjunct therapy for stroke. During the acute phase, taVNS modulates the autonomic nervous system and is combined with tDCS to promote neural plasticity; during the subacute phase, parameters are adjusted according to recovery progress. The data processing module 1103 and the artificial intelligence platform of the mobile control terminal device 2 analyze PPG and EDA signals to monitor neural function recovery, and the electrical stimulation control module 1104 dynamically adjusts the stimulation parameters accordingly.

[0085] In some embodiments, this feedback-based electrical nerve stimulation device 1 can also be used for other clinical applications. In the treatment of mood disorders, parameters can be adjusted based on physiological signals; for example, the frequency can be increased to 20-250 Hz to activate the parasympathetic nervous system during anxiety. In chronic pain management, analgesic mechanisms are activated by adjusting taVNS parameters, and pain-related brain regions are modulated using tDCS. In daily health management, it can be used for stress management, improving sleep quality, and enhancing concentration.

[0086] The embodiments described above are merely illustrative of the technical solutions of the present invention and are not intended to limit them. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

[0087] 1: Feedback-type neurostimulation device 2: Mobile control terminal device 3: Server device 11:Ontology 12: Earbud components 13: Sensing element 14: Auricular electrode 15: Concentric ring electrode 100: Feedback-type neural electrical stimulation system 110: Digital Controller 120: Wireless transmission module 130: Power Management Unit 131: PPG sensor 132: EDA Sensor 140: Sensing Module 150: Electrical stimulator 151: Central electrode 152: Ring electrode 1101: Analogous to front-end modules 1102: Analog to Digital Conversion Module 1103: Data Processing Module 1104: Electrical Stimulation Control Module 1105: Drive Module 1111: Transimpedance Amplifier 1112: Filter 1113: Multiplexer 1121: Transmitter 1122: Receiver 1123: Encoder 1124: Decoder 1131: Charging port 1132: Rechargeable battery 1133: Voltage regulator 1134: Buck-Boost Converter 1135: Reference voltage 1141: Digital-to-Analog Converter 1142: Switching module 1410: Direct Contact Concha Electrode 1411: Metallic conductor 1420: Spring-loaded concha electrode 1421: Metallic conductor 1422: Spring 1430: Snap-on concha electrode 1431: Public Deduction 1432: Female buckle 1433: Conductive part 1434: Electrode 1440: Snap-on concha electrode 1441: Public Deduction 1442: Female buckle 1443: Conductor 1444: Electrode 1445: Conductive part

[0088] none

Claims

1. A regenerative neurostimulation system, comprising a wearable single regenerative neurostimulation device, wherein the regenerative neurostimulation device includes: A sensing module for measuring a user's physiological feedback signals, comprising: a photoplethysmography (PPG) sensor for measuring a photoplethysmography signal; and an electrical activity of the skin (EDA) sensor for measuring an electrical activity of the skin signal; and an electrical stimulator for providing electrical stimulation to the user, comprising: An auricular electrode, configured to be attached to the user's auricle and used to provide transauricular vagus nerve electrical stimulation; and a concentric ring electrode, including a central electrode and a ring electrode, configured to be attached to the user's skin surface and used to provide transcranial direct current stimulation; and a digital controller, electrically connected to the sensing module and the electrical stimulator respectively, used to receive the physiological feedback signal from the sensing module and output an electrical stimulation control signal to the electrical stimulator to control the electrical stimulation, wherein the digital controller controls the electrical stimulator to provide electrical stimulation in a time sequence through a digital-to-analog converter and a switching module, first providing transauricular vagus nerve electrical stimulation with the auricular electrode, and then providing transcranial direct current stimulation with the concentric ring electrode; During transauricular vagus nerve electrical stimulation, the switching module controls the current path of the electrical stimulator to switch between three states: anodic stimulation, cathodic stimulation, and charge release, so as to output a single-phase or biphasic stimulation waveform; during transcranial direct current stimulation, the digital-to-analog converter generates a three-stage current waveform with an increasing phase, a duration phase, and a decreasing phase.

2. The feedback neural electrical stimulation system as claimed in claim 1, wherein the digital controller receives the photoplethysmography (PPG) signal from the sensing module and converts the PPG signal to the frequency domain to obtain a heart rate variability. After analyzing a high-frequency component and a low-frequency component in the heart rate variability, the controller determines the activity level of the parasympathetic nervous system based on the energy ratio of the high-frequency component to the low-frequency component, and adjusts the electrical stimulation control signal accordingly to control the electrical stimulation of the electrical stimulator.

3. The feedback neural electrical stimulation system as claimed in claim 2, wherein the high-frequency component is in the frequency range of 0.15 to 0.40 Hz and the low-frequency component is in the frequency range of 0.06 to 0.15 Hz.

4. The feedback-type electrical nerve stimulation system as claimed in claim 1, wherein the digital controller receives the skin conductance activity signal from the sensing module and decomposes the skin conductance activity signal into a skin conductance level (SCL) and a skin conductance response (SCR) component, so as to determine the activity level of the sympathetic nerve based on the skin conductance level, and adjust the electrical stimulation control signal accordingly to control the electrical stimulation of the electrical stimulator.

5. The feedback-type electrical nerve stimulation system as claimed in claim 1, wherein the digital controller determines the activity level of the parasympathetic nerve based on the photoplethysmography signal and the activity level of the sympathetic nerve based on the electrodermal activity signal, and adjusts the electrical stimulation control signal to control the stimulation frequency and pulse width of the electrical stimulation based on the activity levels of the parasympathetic nerve and the sympathetic nerve.

6. The reciprocating neural electrical stimulation system as described in claim 1, further comprising: A mobile control terminal device for wirelessly communicating with the feedback neurostimulation device to display the physiological feedback signal and the electrical stimulation control signal, and to provide control commands to adjust the electrical stimulation control signal; and a server device for wirelessly communicating with the feedback neurostimulation device and the mobile control terminal device to store and analyze the physiological feedback signal and the electrical stimulation control signal.

7. The regenerative neural stimulation system as claimed in claim 6, wherein the regenerative neural stimulation device further comprises: A wireless transmission module is used to wirelessly communicate with the mobile control terminal device and the server device, and is electrically connected to the digital controller to transmit the physiological feedback signal, the electrical stimulation control signal, and the control command.

8. The reciprocating neurostimulation system as claimed in claim 1, wherein the reciprocating neurostimulation device further comprises: A body is configured to house the digital controller, and the conchal electrode and the concentric ring electrode are disposed on the surface of the body; An earplug element, coupled to the main body, is used to fix the feedback neurostimulation device to the user's ear; And a sensing element disposed on the surface of the earplug element to contact the user's ear, and configured to house the photoplethysmography sensor and the electrodermal activity sensor.

9. The feedback neurostimulation system as claimed in claim 8, wherein the concha electrode is a contact electrode or a snap-on electrode.

10. The feedback neurostimulation system as claimed in claim 9, wherein the contact electrode is a direct contact electrode or an electrode with a spring mechanism.

11. The feedback neurostimulation system as claimed in claim 9, wherein the snap-on electrode includes a male snap and a female snap that are detachably assembled with each other, and one of the male snap and the female snap is an electrode in contact with the user's ear, while the other is disposed on the body.

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