Device, system and method for neural stimulation, and storage medium

Abstract

A device, system and method for neural stimulation, and a storage medium. The device comprises: a stimulation control module, which is disposed outside of a biological body, and is used for generating a stimulation instruction; a remote control module, which is disposed outside of the biological body, is in communication connection with the stimulation control module, and is used for generating a module activation instruction for activating the stimulation control module; and an electrode module, which is used for being implanted into the biological body, and is in communication connection with the stimulation control module, so as to execute the stimulation instruction sent by the stimulation control module. By means of the solution, intervention can be performed in a timely manner when a patient foresees risks, so as to reduce potential risks; and the volume of an implanted part can also be reduced, thereby reducing surgical trauma and also breaking through power consumption limits, and thus neural stimulation therapy with a better effect is implemented by using an algorithm with a higher precision.

Description

Device, system, method and storage medium for neural stimulation CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This disclosure claims priority to Chinese patent application number 2024103970342, filed on April 2, 2024, entitled “DEVICES, SYSTEMS, METHODS AND STORAGE MEDIUMS FOR NEURAL STIMULATION.” Technical Field

[0002] The present disclosure relates generally to the field of medical technology and more particularly to an apparatus, system, method, and storage medium for neural stimulation. Background Art

[0003] Currently, neurostimulation therapy, delivered via an implanted pulse generator or neurostimulator, is increasingly being used for a variety of chronic diseases and neurological disorders, such as epilepsy, Parkinson's disease, pain management, and movement disorders. The goal of neurostimulation is to modulate a patient's neural tissue in a desired manner to treat the disease or condition itself or to modify the symptoms of the disease or condition. For example, for epilepsy, the goal of neurostimulation may be to reduce the number of seizures a patient experiences. For movement disorders, the goal of neurostimulation may be to reduce tremors.

[0004] Existing closed-loop neurostimulation devices are unable to proactively intervene and intervene when patients are aware of potential risks. Furthermore, due to internal space constraints, the size of implanted devices is limited, limiting their power consumption and failing to meet the power requirements of high-precision detection and stimulation algorithms. Furthermore, overly large devices can cause significant surgical trauma when implanted.

[0005] Given this, there is an urgent need for a neurostimulation solution that can reduce the size of the implantable device, thereby reducing surgical trauma and increasing implant location flexibility to mitigate the limitations imposed by the curvature of the skull. Furthermore, it can overcome the power consumption limitations of existing neurostimulation devices and support patient-initiated intervention, thereby achieving personalized and highly precise neurostimulation therapy. Summary of the Invention

[0006] In order to at least solve one or more of the technical problems mentioned above, the present disclosure provides solutions for neural stimulation in various aspects.

[0007] In a first aspect, the present disclosure provides a device for neural stimulation comprising: a stimulation control module, which is disposed outside the body of a biological organism and is used to generate stimulation instructions; a remote control module, which is disposed outside the body of the biological organism and is communicatively connected to the stimulation control module and is used to generate module activation instructions for activating the stimulation control module; and an electrode module, which is used to be implanted in the body of the biological organism and is communicatively connected to the stimulation control module to execute the stimulation instructions issued by the stimulation control module.

[0008] In some embodiments, the electrode module of the device for neural stimulation is further used to collect bioelectric signals and send them to the stimulation control module; the stimulation control module is further used to analyze the acquired bioelectric signals to generate stimulation instructions.

[0009] In some embodiments, the device for neural stimulation further includes: a power supply module, which is disposed outside the body and is used to supply power to the electrode module.

[0010] In some embodiments, the device for neural stimulation further includes: a remote terminal, which is communicatively connected to the stimulation control module and is configured to receive treatment requests and analysis data from the stimulation control module.

[0011] In some embodiments, the analysis data includes: the patient's bioelectrical signals, analysis results based on the bioelectrical signals, and / or stimulation control content corresponding to the stimulation instructions.

[0012] In some embodiments, the remote control module is further configured to generate a treatment request and send it to the stimulation control module; the stimulation control module is further configured to forward the treatment request to the remote terminal.

[0013] In some embodiments, the stimulation control module includes: an extracorporeal communication component, which is used to establish communication with the remote control module and the electrode module; and an analysis chip, which is connected to the extracorporeal communication component and is used to obtain and analyze the patient's bioelectric signals through the extracorporeal communication component to generate stimulation instructions.

[0014] In some embodiments, the electrode module includes: an in-vivo communication component, which is used to establish communication with an out-vivo communication component; an acquisition unit, which is connected to the in-vivo communication component and is configured to: in response to an acquisition instruction obtained through the in-vivo communication component, acquire the patient's bioelectric signals and send them through the in-vivo communication component; wherein the acquisition instruction is an instruction issued by the stimulation control module through the out-vivo communication component in response to the module activation instruction; and an implanted electrode, which is connected to the in-vivo communication component, and is used to acquire the stimulation instruction through the in-vivo communication component, and output electrical stimulation to the body of the organism according to the stimulation instruction.

[0015] In some embodiments, the remote control module is configured to: generate a module activation instruction and send it to the stimulation control module in response to receiving a preset instruction fed back by the patient at a preset position of the remote control module; and / or generate a module activation instruction and send it to the stimulation control module in response to the sensor component of the remote control module sensing a preset posture.

[0016] In some embodiments, the stimulation control module is configured to: issue an acquisition instruction to the acquisition unit of the electrode module in response to a module activation instruction; analyze the bioelectric signals acquired by the acquisition unit based on the acquisition instruction to determine whether there is a risk of seizure; generate stimulation instructions based on the bioelectric signals in response to the risk of seizure; and send the stimulation instructions to the implanted electrodes of the electrode module for execution.

[0017] In some embodiments, the stimulation control module is further configured to automatically shut down if, after analyzing the bioelectrical signals collected by the collection unit according to the collection instruction, no seizure risk is determined after a preset period of time.

[0018] In some embodiments, the stimulation control module is configured to: determine whether a preset trigger event occurs; in response to the occurrence of the preset trigger event, send a treatment request and analyze data to the remote terminal; receive treatment instructions fed back by the remote terminal; and forward the treatment instructions to the implanted electrodes of the electrode module for execution.

[0019] In some embodiments, the preset trigger event includes: reaching a preset cycle node, an abnormality in the bioelectric signal collected by the electrode module, and / or the stimulation instruction meets a preset abnormal condition.

[0020] In some embodiments, the stimulation control module is in a closed state by default and switches to an active state when a module activation instruction is received or a preset trigger event occurs.

[0021] In a second aspect, the present disclosure provides a system for neural stimulation comprising: a neural stimulation device, which includes a stimulation control module, a remote control module and an electrode module, wherein the stimulation control module and the remote control module are communicatively connected and are both arranged outside the body of a biological body, the remote control module is used to generate a module activation instruction for activating the stimulation control module, the stimulation control module is used to generate a stimulation instruction, and the electrode module is used to be implanted in the body of a biological body and communicatively connected to the stimulation control module to execute the stimulation instruction issued by the stimulation control module; a data storage device, which is communicatively connected to the neural stimulation device, and is used to store the stimulation instructions issued by the stimulation control module.

[0022] In some embodiments, the electrode module is also used to collect bioelectric signals and send them to the stimulation control module; the stimulation control module is also used to analyze the acquired bioelectric signals to generate stimulation instructions; the data storage device is also used to store the bioelectric signals collected by the electrode module.

[0023] In a third aspect, the present disclosure provides a method for neural stimulation, which is applied to a stimulation control module, which is arranged outside the body of a biological body and is communicatively connected to a remote control module and an electrode module, respectively, and includes: switching to an activated state in response to a module activation instruction, wherein the module activation instruction is issued by the remote control module; generating a stimulation instruction; and sending the stimulation instruction to the electrode module for execution.

[0024] In some embodiments, after switching to the activated state, the method further includes: issuing an acquisition instruction to the electrode module; receiving and analyzing the bioelectric signal to determine whether there is a risk of seizure, wherein the bioelectric signal is a signal acquired by the electrode module based on the acquisition instruction; wherein generating the stimulation instruction includes: generating the stimulation instruction according to the bioelectric signal in response to the risk of seizure.

[0025] In some embodiments, after receiving and analyzing the bioelectric signal to determine whether there is a risk of seizure, the method further includes: in response to there being no risk of seizure, continuously monitoring the bioelectric signal for a preset period of time to determine whether there is a risk of seizure; and if the risk of seizure cannot be determined after the preset period of time, turning off the stimulation control module.

[0026] In a fourth aspect, the present disclosure provides a computer-readable storage medium having computer-readable instructions stored thereon, which, when executed by one or more processors, implement the method of any one of the third aspects.

[0027] By using the device for nerve stimulation provided above, the patient can actively activate the stimulation control module through a remote control module disposed outside the body, thereby enabling timely intervention when risks are foreseen, thereby reducing potential risks. Since the stimulation control module is disposed outside the body, the detection and stimulation algorithm executed during nerve stimulation can, to a certain extent, ignore the power consumption limitations caused by the volume, thereby using a higher-precision algorithm to achieve more effective nerve stimulation treatment. Since the function of the electrode module implanted in the body is simplified, the volume is reduced, and the power consumption is reduced, it can be implanted into the body more flexibly and with less trauma. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The above and other objects, features and advantages of the exemplary embodiments of the present disclosure will become readily understood by reading the detailed description below with reference to the accompanying drawings. In the accompanying drawings, several embodiments of the present disclosure are shown in an illustrative and non-limiting manner, and the same or corresponding reference numerals represent the same or corresponding parts, wherein:

[0029] FIG1 shows an exemplary structural diagram of a device for neural stimulation according to some embodiments of the present disclosure;

[0030] FIG2 shows an exemplary structural diagram of a device for neural stimulation according to other embodiments of the present disclosure;

[0031] FIG3 shows an exemplary flow chart of a method for activating a stimulus control module according to an embodiment of the present disclosure;

[0032] FIG4 shows an exemplary flow chart of a neural stimulation control method according to an embodiment of the present disclosure;

[0033] FIG5 shows an exemplary flow chart of a neural stimulation control method according to another embodiment of the present disclosure;

[0034] FIG6 shows an exemplary structural diagram of a device for neural stimulation according to still other embodiments of the present disclosure;

[0035] FIG7 shows an exemplary flowchart of a neural stimulation control method according to other embodiments of the present disclosure. DETAILED DESCRIPTION

[0036] The following will clearly and completely describe the technical solutions in the embodiments of this disclosure in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of this disclosure, not all of them. Based on the embodiments of this disclosure, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of this disclosure.

[0037] It should be understood that the terms “include” and “comprising” used in the specification and claims of the present disclosure indicate the presence of described features, integers, steps, operations, elements and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components and / or collections thereof.

[0038] It should also be understood that the terminology used in this disclosure is for the purpose of describing specific embodiments only and is not intended to limit the disclosure. As used in this disclosure and the claims, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly indicates otherwise. It should be further understood that the term "and / or" as used in this disclosure and the claims refers to any and all possible combinations of one or more of the associated listed items, including and including these combinations.

[0039] As used in this specification and claims, the term "if" can be interpreted as "when" or "upon" or "in response to determining" or "in response to detecting," depending on the context. Similarly, the phrase "if it is determined" or "if [described condition or event] is detected" can be interpreted as meaning "upon determination" or "in response to determining" or "upon detection of [described condition or event]" or "in response to detecting [described condition or event]," depending on the context.

[0040] The specific embodiments of the present disclosure are described in detail below with reference to the accompanying drawings.

[0041] Example application scenarios.

[0042] Neurostimulation is a treatment for chronic diseases and neurological disorders that activates or modulates parts of the nervous system or neural networks. Similar to surgery, neurostimulation targets specific anatomical locations. However, unlike traditional surgery, neurostimulation is adjustable and reversible; the stimulation device can be turned off if necessary. Neurostimulation is suitable for neurological conditions such as epilepsy, Parkinson's disease, pain management, and movement disorders.

[0043] Taking the neurostimulation device for treating epilepsy as an example, existing devices often send stimulation signals based on preset treatment plans / pre-established stimulation rules. First, when the patient perceives signs of an epileptic seizure, the patient cannot actively intervene to control the device. The stimulation signal must be sent only when the device autonomously identifies the epileptic seizure / reaches the stimulation node of the preset treatment plan, resulting in the inability to deal with the signs of epileptic seizure in a timely manner. Second, due to the limited space in the body, the volume of the implanted device is limited, so the power consumption of the implanted device is limited, and existing devices are often unable to use high-precision detection stimulation algorithms. Third, when a device is too large, it will cause greater surgical trauma to the organism when implanted in the body.

[0044] Example application scenarios.

[0045] In light of this, the disclosed embodiments provide a neurostimulation solution that uses a remote control module located outside the body to actively activate a stimulation control module, thereby meeting the patient's need for proactive neurostimulation intervention and reducing the potential risk of seizures. Furthermore, by placing the stimulation control module outside the body, the power consumption limitations imposed by the limited implant volume are overcome, enabling the use of higher-precision algorithms, achieving more effective neurostimulation treatments, and reducing surgical trauma.

[0046] FIG1 shows an exemplary structural diagram of a device for neural stimulation according to some embodiments of the present disclosure. As shown in FIG1 , the device 100 for neural stimulation includes: a stimulation control module 101 , a remote control module 102 and an electrode module 103 .

[0047] The stimulation control module 101 and the remote control module 102 are both disposed outside the body of the organism, and the stimulation control module 101 and the remote control module 102 establish a communication connection via wireless communication or wired communication. For example, when the stimulation control module 101 and the remote control module 102 establish a communication connection via wireless communication, methods such as Bluetooth protocol, wireless local area network, and infrared communication may be used, and are not particularly limited herein.

[0048] In the disclosed embodiments, the remote control module 102 is configured to generate a module activation instruction for activating the stimulation control module 101. Specifically, the remote control module 102 may generate the module activation instruction based on patient behavior. In some embodiments, patient behavior may include the patient proactively providing feedback to the device via the remote control module 102 after determining their own condition. In other embodiments, patient behavior may also include patient behavior proactively sensed by the remote control module 102 without the patient's control. For example, in the case of Parkinson's disease, the remote control module 102 may generate a module activation instruction based on the patient's slow rhythmic tremor.

[0049] To facilitate the patient's feedback to the device via the remote control module 102, the remote control module 102 can be designed to be easy for the patient to operate. For example, the remote control module 102 can be one or a combination of various remote control modules, such as a button-type remote control module, a knob-type remote control module, an inductive remote control module, or a touch-screen remote control module, without further limitation.

[0050] Taking the button-type remote control module as an example, when a patient senses signs of a symptom onset, they can press a designated button on the remote control module 102. The remote control module 102 generates a module activation instruction and transmits it to the stimulation control module 101 via wireless or wired communication. After receiving the instruction, the stimulation control module 101 switches to an active state. When the stimulation control module 101 switches to an active state, it can generate stimulation instructions and send them to the electrode module 103. The electrode module 103 executes the stimulation instructions issued by the stimulation control module 101 to stimulate the patient's nerves.

[0051] Taking the inductive remote control module as an example, when the patient performs a specified action, the remote control module 102 generates a module activation instruction and transmits it to the stimulation control module 101 through wireless communication or wired communication. For example, the remote control module 102 worn on the patient's wrist can issue a module activation instruction by sensing frequent tremors in the patient's hand.

[0052] In the disclosed embodiment, the electrode module 103 is used to be implanted in the body of a living organism and communicate with the stimulation control module 101, thereby executing the stimulation instructions issued by the stimulation control module 101. In some embodiments, the neural stimulation scheme corresponding to the stimulation instruction issued by the stimulation control module 101 is a preset scheme, that is, a neural stimulation treatment scheme with a neural stimulation signal pre-set. Specifically, in this embodiment, the electrode module 103 may not have / may not perform the function of collecting the patient's bioelectric signals. Correspondingly, the stimulation control module 101 may not have / may not perform the function of analyzing the bioelectric signals. When the stimulation control module 101 receives the activation instruction sent by the remote control module 102, it responds and switches to an activated state, and immediately generates a stimulation instruction. The stimulation instruction matches the preset scheme described above. The stimulation control module 101 sends the generated stimulation instruction to the electrode module 103. At this time, the electrode module 103 only executes the stimulation instruction issued by the stimulation control module 101 to perform neural stimulation on the patient.

[0053] Through the neurostimulation solution provided in this embodiment, patients can actively intervene when they foresee the risk of an attack, and the power consumption of the entire neurostimulation device is also greatly reduced.

[0054] In other embodiments, the neural stimulation performed by the electrode module 103 is customized based on the patient's current real-time status. In this embodiment, the electrode module 103 not only needs to perform the action of releasing the neural stimulation signal, but also needs to perform the action of collecting the bioelectric signal. The stimulation control module 101 not only performs the action of sending and receiving signals, but also needs to perform the task of signal processing. Specifically, in this embodiment, the electrode module 103 can collect the bioelectric signals of the patient in which it is implanted in real time and send them to the stimulation control module 101 in real time. When activated, the stimulation control module 101 can analyze the patient's bioelectric signals in real time, thereby generating stimulation instructions and sending them to the electrode module 103. The electrode module 103 executes the stimulation instructions issued by the stimulation control module 101 to perform neural stimulation on the patient.

[0055] Through the neurostimulation solution provided by this embodiment, patients can actively intervene when they foresee the risk of an attack, and the neurostimulation device can apply targeted neurostimulation signals to the patient according to his or her physiological state, thereby achieving personalized and customized neurostimulation treatment, and the neurostimulation effect is better.

[0056] It should be noted that in this embodiment, the bioelectrical signal may be an electroencephalogram (EEG) signal or other electrical signal. For example, when the electrode module 103 is implanted in the heart of a living organism, the electrode module 103 may be used to collect the patient's electrocardiogram (ECG) signal. Similarly, the electrode module 103 may also collect other bioelectrical signals such as electromyographic (EMG) signals, gastric electroencephalogram (EGG) signals, and retinal electroencephalogram (EGG) signals.

[0057] EEG signals are electrical signals generated by the activity of brain neurons. Neurons are connected to each other through synapses to form a complex neural network. When neurons are activated, they generate bioelectric signals. At this time, electrodes implanted in the body can capture the bioelectric signals and observe the changes in their waveform to reflect whether there are abnormalities in the patient's neural activity.

[0058] In this embodiment, EEG signal generation and acquisition occurs in the patient's skull. Due to the unique structure of the skull, high requirements are placed on several properties of the implanted electrode module, such as volume. Because the skull has limited space for device implants and high nerve density, implanting overly large electrodes is not only extremely difficult but also significantly increases the risk of nerve damage during the implantation procedure. Therefore, the neurostimulation device must be designed to minimize the size of the implanted portion.

[0059] Furthermore, FIG2 shows an exemplary structural diagram of a device for neural stimulation according to other embodiments of the present disclosure. As shown in FIG2 , the stimulation control module 101 in the system may include: an extracorporeal communication component 1011 and an analysis chip 1012 .

[0060] Among them, the extracorporeal communication component 1011 is used to establish communication with the remote control module 102 and the electrode module 103, and the analysis chip 1012 is connected to the extracorporeal communication component 1011, and is used to obtain and analyze the patient's bioelectric signals from the electrode module 103 through the extracorporeal communication component 1011, thereby generating stimulation instructions.

[0061] Furthermore, as shown in FIG. 2 , in this embodiment, the electrode module 103 in the system may include: an in-vivo communication component 1031 , a collection unit 1032 and an implanted electrode 1033 .

[0062] Among them, the in-vivo communication component 1031 is used to establish communication with the stimulation control module 101. Specifically, the in-vivo communication component 1031 is used to establish communication with the out-vivo communication component 1011 to receive stimulation instructions issued by the stimulation control module 101 and send bioelectric signals to the stimulation control module 101.

[0063] The acquisition unit 1032 is connected to the in-vivo communication component 1031 and is configured to: in response to an acquisition instruction, acquire the patient's bioelectrical signals and send them via the in-vivo communication component 1031. The acquisition instruction is an instruction sent by the stimulation control module 101 through the in-vivo communication component 1011 in response to the module activation instruction.

[0064] The implanted electrode 1033 is connected to the in-vivo communication component 1031 , and obtains the stimulation instruction issued by the stimulation control module 101 through the in-vivo communication component 1031 , and outputs a stimulation signal to the body according to the stimulation instruction.

[0065] It should be noted that in the device for nerve stimulation shown in Figure 2, data processing of bioelectric signals is performed by an analysis chip located outside the body. This means that modules that require large computing resources or complex algorithms do not occupy space in the patient's skull. This significantly reduces the size of the electrode module that needs to be implanted in the patient. The electrode module implanted in the patient only needs to perform data acquisition and data transmission and reception tasks. The module that implements this function is relatively small, adapts to the volume requirements of the implant space, and is less likely to cause damage to the patient's nerves during implantation.

[0066] Furthermore, the extracorporeal communication component 1011 serves as a component for realizing data transceiver functions in the stimulation control module 101, which may include a communication antenna and a transmitting coil. Similarly, the intracorporeal communication component 1031 serves as a component for realizing data transceiver functions in the electrode module 103, which may include a communication antenna and a receiving coil.

[0067] Based on the system described above in conjunction with FIG. 1 or FIG. 2 , the present disclosure further provides a method for activating a stimulation control module applicable to the above-mentioned remote control module. FIG. 3 shows an exemplary flow chart of a method 300 for activating a stimulation control module according to an embodiment of the present disclosure.

[0068] As shown in FIG3 , in step S301, a module activation instruction is generated in response to receiving a preset instruction fed back by the patient or sensing a preset gesture. In this step, the preset instruction fed back by the patient is an instruction fed back by the patient at a preset position on the remote control module, for example, a trigger instruction generated by the patient pressing an activation button on a push-button remote control module, or a trigger instruction fed back by the patient through a touch operation on a touch-screen remote control module.

[0069] In some embodiments, the remote control module also includes a sensor component that can sense the patient's current movements and postures and, upon sensing a predetermined posture, generate a module activation command. For example, the remote control module can be worn on the patient's hand and, upon detecting a significant limb movement, such as a severe tremor, the remote control module can generate a module activation command.

[0070] In step S302, a module activation instruction is sent to the stimulation control module to activate the stimulation control module. In some embodiments, the stimulation control module is in a closed state by default, and when the module activation instruction is received, it switches to an active state.

[0071] Furthermore, in other embodiments, the stimulation control module also switches to an active state when a preset trigger event occurs, where the preset trigger event may include but is not limited to: reaching a preset time point for neural stimulation, and an abnormality in the bioelectric signal collected by the electrode module.

[0072] It should be noted that the preset trigger event of reaching the preset time point for neural stimulation can be understood as a preset trigger cycle, and each cycle causes the stimulation control module to switch from the off state to the active state. This embodiment does not strictly limit the value of the trigger cycle. In actual application, the trigger cycle can be set to 1 day, 3 days, 1 week, or other durations according to actual conditions, and no excessive restrictions are imposed here.

[0073] After the stimulation control module switches to the active state, it controls the electrode module to collect and analyze bioelectric signals to determine whether to perform nerve stimulation. In order for those skilled in the art to more clearly understand the function of the stimulation control module, the operation process of the stimulation control module is described below with reference to FIG4.

[0074] FIG4 shows an exemplary flow chart of a neural stimulation control method 400 according to an embodiment of the present disclosure. As shown in FIG4 , in step S401, in response to a module activation instruction, the state is switched to the activation state. In this embodiment, the module activation instruction is sent by the remote control module to the stimulation control module. The module activation instruction can be actively issued by the patient by operating the remote control module, or automatically issued by the remote control module by sensing the patient's posture. The operation process of the remote control module has been described in detail in the embodiment described above in conjunction with FIG3 and will not be repeated here.

[0075] In step S402, a stimulation instruction is generated. After the stimulation control module switches to an active state, it can generate a corresponding stimulation instruction based on the pre-set neural stimulation treatment plan for the neural stimulation signal. The stimulation instruction can also be a pre-stored instruction, which is directly called when the stimulation control module switches to an active state.

[0076] In step S403, the stimulation instruction is sent to the electrode module for execution. In this embodiment, after the stimulation control module generates the stimulation instruction, it can send the stimulation instruction to the in-vivo communication component of the electrode module via the in-vivo communication component, and then transmit the stimulation instruction to the implanted electrode of the electrode module via the in-vivo communication component. The implanted electrode executes the stimulation instruction to perform nerve stimulation.

[0077] In the above embodiments, the electrode module may not have / not perform the function of collecting the patient's bioelectrical signals, and correspondingly, the stimulation control module may not have / not perform the function of analyzing the bioelectrical signals. The following describes the operation process of the stimulation control module that has and performs the analysis function.

[0078] FIG5 shows an exemplary flow chart of a neural stimulation control method 500 according to another embodiment of the present disclosure. As shown in FIG5 , in step S501, in response to a module activation instruction, a collection instruction is issued to the electrode module. Specifically, the stimulation control module issues the collection instruction to the in-vivo communication component of the electrode module via the in-vivo communication component, and the implanted electrode receives the collection instruction from the in-vivo communication component.

[0079] In step S502, the bioelectric signal is received and analyzed to determine whether there is a risk of seizure. If so, steps S503 to S504 are executed; if not, step S505 is executed. In this embodiment, the bioelectric signal is the patient's EEG signal collected by the electrode module based on the collection instruction.

[0080] In step S503, a stimulation instruction is generated based on the bioelectric signal. In some embodiments, in addition to analyzing the bioelectric signal to determine whether there is a risk of seizure, the stimulation control module can also generate corresponding stimulation instructions based on the specific waveform of the bioelectric signal for targeted treatment.

[0081] In some embodiments, after receiving the bioelectric signal collected by the electrode module, the stimulation control module can compare it with the bioelectric signal in the historical record. After finding the historical bioelectric signal whose similarity reaches a threshold, the stimulation instruction corresponding to the historical bioelectric signal is issued as the stimulation instruction adapted to the currently collected bioelectric signal, thereby reducing repeated calculations, releasing unnecessary computing resources, and improving the computing efficiency of the stimulation control module.

[0082] In step S504, the stimulation instruction is sent to the implanted electrodes of the electrode module for execution. In this embodiment, the content of step S504 is consistent with that of step S403 in the above embodiment, and will not be repeated here.

[0083] In step S505, the bioelectrical signal is continuously monitored for a predetermined period of time to determine whether a seizure risk exists. If so, steps S503 to S504 are executed; if not, step S506 is executed. If no seizure risk is identified in step S502, the bioelectrical signal is continuously monitored for a predetermined period of time to avoid missing potential risks.

[0084] In step S506, the stimulation control module is turned off. If the patient is still not determined to be at risk of a seizure after the preset time, the stimulation control module is automatically turned off, thereby preventing the stimulation control module from being activated for a long time and achieving the effect of saving power consumption.

[0085] The previous article introduced the equipment and methods for completing neural stimulation control with the help of the stimulation control module. On this basis, a remote terminal can also be introduced to realize a platform for remote control by professionals.

[0086] Figure 6 shows an exemplary structural diagram of a device for neural stimulation in some other embodiments of the present disclosure. As shown in Figure 6, on the basis of the device system shown in Figure 1 or Figure 2, it also includes: a remote terminal 104, which is arranged outside the body and is communicatively connected to the stimulation control module 101. Specifically, the two transmit data through wireless communication.

[0087] It should be noted that in this embodiment, the remote terminal 104 plays the role of remote control. Therefore, the wireless communication method adopted by the remote terminal 104 and the stimulation control module 101 preferably adopts a long-distance communication wireless communication method to ensure that the remote terminal 104 and the stimulation control module 101 can stably interact with each other and ensure the stability of remote control.

[0088] In this embodiment, the remote terminal 104 is capable of receiving treatment requests and analysis data from the stimulation control module 101. The analysis data includes: the patient's bioelectric signals, analysis results based on the bioelectric signals, and / or stimulation control content corresponding to the stimulation instructions. For example, the analysis results based on the bioelectric signals may include: a seizure risk determination result determined based on the bioelectric signals, and the stimulation control content corresponding to the stimulation instructions may include: a treatment plan generated by the stimulation control module.

[0089] In some embodiments, the doctor can view the patient's bioelectric signals, analysis results based on the bioelectric signals, and / or stimulation control content corresponding to the stimulation instructions through the remote terminal, thereby generating or modifying the treatment plan based on the above analysis data. The remote terminal can also return the updated treatment plan to the stimulation control module, which is forwarded to the electrode module by the stimulation control module. In other embodiments, the remote terminal can also communicate directly with the electrode module, receive the bioelectric signals collected by the electrode module, and / or send the updated treatment plan to the electrode module.

[0090] Furthermore, in some embodiments, the remote terminal interventional neural stimulation may be actively triggered by a remote control module or may be triggered by a preset triggering event.

[0091] In the manner of active triggering by the remote control module, the remote control module 102 is further configured to generate a treatment request according to the patient's behavior and send it to the stimulation control module 101 , and the stimulation control module 101 forwards the treatment request to the remote terminal 104 .

[0092] In the manner of being triggered by a preset trigger event, the neural stimulation control method executed by the stimulation control module is shown in FIG7 , which shows an exemplary flow chart of a neural stimulation control method 700 according to other embodiments of the present disclosure.

[0093] In step S701, a treatment request and analysis data are sent to a remote terminal in response to a preset trigger event. In this step, the preset trigger event includes: reaching a preset cycle node, an abnormality in the bioelectric signal collected by the electrode module, and / or the stimulation instruction meeting a preset abnormality condition.

[0094] Specifically, the preset cycle node is the cycle node for uploading the analysis data to the remote terminal. The abnormality of the bioelectric signal collected by the electrode module means that the bioelectric signal reflects that the patient is at risk of seizure. The stimulation instruction meets the preset abnormal conditions, which may include abnormal stimulation instruction or too many stimulation instructions, etc.

[0095] It should be noted that the preset period nodes can be adjusted according to actual conditions. For example, the analysis data can be uploaded to the remote terminal every 1 day, 3 days or 1 week. This is just an example.

[0096] In step S702, a treatment instruction fed back by a remote terminal is received. In this embodiment, the treatment instruction fed back by the remote terminal is a stimulation instruction generated based on a treatment plan generated / modified by the remote terminal.

[0097] In step S703, the treatment instructions are forwarded to the implanted electrodes of the electrode module for execution. In some embodiments, the treatment instructions may first be sent to the stimulation control module, which then forwards them to the electrode module. In other embodiments, the treatment instructions may also be sent directly to the electrode module for execution.

[0098] Furthermore, the stimulation control module is in a closed state by default and switches to an active state when a preset trigger event occurs.

[0099] By incorporating a remote terminal into the neurostimulation system, doctors can remotely access data related to the patient's physiological status from the hospital or at a doctor's remote terminal station, enabling wireless control of the implanted electrode module. Through remote intervention by the doctor, the neurostimulation treatment plan can be further refined based on the patient's physiological status, achieving personalized, customized, and highly precise neurostimulation treatment.

[0100] On the basis of the device for nerve stimulation described above in conjunction with Figures 1, 2 or 6, the device may further include: a power module (not shown in the figure). The power module is arranged outside the body and is used to power the electrode module. The power module is arranged outside the body and can supply power in real time, and there is no volume restriction outside the body. The power module can adopt a large-capacity model to provide sufficient electrical energy. In this embodiment, there is no energy storage device inside the electrode module, the volume of the electrode module is further reduced, and the surgical loss suffered by the patient due to the device implantation surgery is further reduced.

[0101] Based on the neurostimulation device described in the previous embodiments, some embodiments of the present disclosure further provide a neurostimulation system, which, in addition to the neurostimulation device described in the previous embodiments, also includes a data storage device. The neurostimulation device includes a stimulation control module, a remote control module, and an electrode module. The specific structures and functions of the stimulation control module, remote control module, and electrode module have been described in detail in the previous embodiments and will not be repeated here.

[0102] In this system, the data storage device is in communication with the neurostimulation device and is used to store the bioelectric signals collected by the electrode module and / or the stimulation instructions issued by the stimulation control module. For example, when the electrode module does not have / does not perform the collection action, the data storage device may not need to store the bioelectric signals. In order to reduce the volume of the implanted part, the data storage device is set outside the body. It can be integrated with the neurostimulation device in the same area, or it can use cloud storage for data storage.

[0103] The data storage device can associate and store the bioelectric signals collected and emitted by the electrode module and the stimulation instructions generated by the stimulation control module based on the bioelectric signals. In the data storage device, the bioelectric signals can be stored in order according to the time of collection, so that the remote terminal and / or the stimulation control module can call and view them.

[0104] For example, a doctor can issue a viewing request through a remote terminal, and the remote terminal can directly read the bioelectric signals stored in the data storage device, the analysis results based on the bioelectric signals and / or the stimulation control content corresponding to the stimulation instructions, or the remote terminal can also receive such data read and forwarded by the stimulation control module, thereby generating or modifying the treatment plan based on the above analysis data.

[0105] In summary, the disclosed embodiments provide a device for neural stimulation, which is provided with a remote control module that is communicatively connected to a stimulation control module. When a patient perceives signs of an onset of a disease, the patient can operate on the remote control module to issue a module activation instruction to the stimulation control module, thereby activating the stimulation control module to issue a stimulation instruction to instruct the electrode module to perform neural stimulation, thereby ensuring that the patient can intervene in time when risks are foreseen and obtain effective neural stimulation treatment.

[0106] In addition, the device for neural stimulation provided by the disclosed embodiment also places the stimulation control module and the remote control module outside the body, thereby reducing the size of the electrode module. Due to the limited space available for implantation in the patient's body and the limited volume allowed for implantation, it is impossible to support the implantation of a power supply that is too large, which makes it impossible to use an implantable device with high power consumption. The disclosed embodiment further breaks through the power consumption limitation caused by volume by using an external power supply module and analysis chip, thereby facilitating the use of a more accurate neural stimulation algorithm.

[0107] Additionally or optionally, the present disclosure may also be implemented as a non-transitory machine-readable storage medium (or computer-readable storage medium, or machine-readable storage medium) on which computer program instructions (or computer program, or computer instruction code) are stored. When the computer program instructions (or computer program, or computer instruction code) are executed by a processor of an electronic device (or electronic device, server, etc.), the processor is caused to perform part or all of the various steps of the above-mentioned method according to the present disclosure.

[0108] Although a plurality of embodiments of the present disclosure have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Those skilled in the art may conceive of many modifications, changes, and alternatives without departing from the ideas and spirit of the present disclosure. It should be understood that in practicing the present disclosure, various alternatives to the embodiments of the present disclosure described herein may be adopted. The appended claims are intended to define the scope of protection of the present disclosure and therefore cover equivalents or alternatives within the scope of these claims.

Claims

1. A device for nerve stimulation, characterized in that include: a stimulation control module, which is disposed outside the body and is used to generate stimulation instructions; a remote control module, disposed outside the body and in communication with the stimulation control module, for generating a module activation instruction for activating the stimulation control module; as well as The electrode module is used to be implanted in a biological body and is in communication connection with the stimulation control module to execute the stimulation instructions issued by the stimulation control module.

2. The device according to claim 1, characterized in that The electrode module is further configured to collect bioelectric signals and send them to the stimulation control module; the stimulation control module is further configured to analyze the acquired bioelectric signals to generate the stimulation instructions.

3. The device according to claim 1, characterized in that Also includes: The power supply module is arranged outside the body and is used to supply power to the electrode module.

4. The device according to claim 2, characterized in that Also includes: A remote terminal is communicatively connected to the stimulation control module and is used to receive treatment requests and analysis data issued by the stimulation control module.

5. The device according to claim 4, characterized in that The analysis data includes: the patient's bioelectric signal, analysis results based on the bioelectric signal and / or stimulation control content corresponding to the stimulation instruction.

6. The device according to claim 4, characterized in that The remote control module is further configured to generate the treatment request and send it to the stimulation control module; The stimulation control module is further configured to forward the treatment request to the remote terminal.

7. The device according to claim 2, characterized in that The stimulation control module includes: an external communication component, configured to establish communication with the remote control module and the electrode module; and An analysis chip is connected to the extracorporeal communication component and is used to acquire and analyze the patient's bioelectrical signals through the extracorporeal communication component to generate the stimulation instructions.

8. The device according to claim 7, characterized in that The electrode module comprises: an in-vivo communication component, configured to establish communication with the in-vivo communication component; an acquisition unit connected to the intracorporeal communication component and configured to: in response to a collection instruction acquired through the intracorporeal communication component, collect the patient's bioelectrical signals and send them out via the intracorporeal communication component; wherein the collection instruction is an instruction sent by the stimulation control module through the extracorporeal communication component in response to the module activation instruction; and An implanted electrode is connected to the in-vivo communication component and is used to obtain the stimulation instruction through the in-vivo communication component and output electrical stimulation to the body according to the stimulation instruction.

9. The device according to any one of claims 1 to 8, characterized in that The remote control module is configured to: In response to receiving a preset instruction fed back by the patient at a preset position of the remote control module, generating the module activation instruction and sending it to the stimulation control module; and / or, In response to the sensor component of the remote control module sensing a preset gesture, the module activation instruction is generated and sent to the stimulation control module.

10. The device according to claim 9, characterized in that The stimulation control module is configured to: In response to the module activation instruction, issuing a collection instruction to the collection unit of the electrode module; analyzing the bioelectrical signal collected by the collection unit based on the collection instruction to determine whether there is a risk of seizure; In response to a risk of seizure, generating a stimulation instruction according to the bioelectric signal; as well as The stimulation instructions are sent to the implanted electrodes of the electrode module for execution.

11. The device according to claim 10, characterized in that The stimulation control module is further configured to: After analyzing the bioelectrical signal collected by the collection unit according to the collection instruction, if it is not determined that there is a risk of seizure after a preset time period, it will be automatically shut down.

12. The device according to any one of claims 4, 5 and 6, characterized in that The stimulation control module is configured to: Determine whether a preset trigger event occurs; In response to the occurrence of the preset trigger event, sending a treatment request and analyzing data to the remote terminal; receiving treatment instructions fed back by the remote terminal; as well as The treatment instructions are forwarded to the implanted electrodes of the electrode module for execution.

13. The device according to claim 12, characterized in that The preset trigger event includes: reaching a preset period node, an abnormality in the bioelectric signal collected by the electrode module, and / or the stimulation instruction meets a preset abnormal condition.

14. The device according to any one of claims 1 to 8, 10 to 11 and 13, characterized in that The stimulation control module is in a closed state by default, and switches to an active state when a module activation instruction is received or a preset trigger event occurs.

15. A system for neural stimulation, characterized in that include: A neural stimulation device comprising a stimulation control module, a remote control module, and an electrode module, wherein the stimulation control module and the remote control module are communicatively connected and both are disposed outside a living body, the remote control module is configured to generate a module activation instruction for activating the stimulation control module, the stimulation control module is configured to generate stimulation instructions, and the electrode module is configured to be implanted in a living body and communicatively connected to the stimulation control module to execute the stimulation instructions issued by the stimulation control module; A data storage device is communicatively connected to the nerve stimulation device and is used to store the stimulation instructions issued by the stimulation control module.

16. The system according to claim 15, wherein: The electrode module is further used to collect bioelectric signals and send them to the stimulation control module; the stimulation control module is further used to analyze the acquired bioelectric signals to generate the stimulation instructions; the data storage device is further used to store the bioelectric signals collected by the electrode module.

17. A method for neural stimulation, characterized in that Applied to the stimulation control module, which is set outside the body and communicates with the remote control module and the electrode module respectively, including: switching to an active state in response to a module activation instruction, wherein the module activation instruction is an instruction sent by the remote control module to the stimulus control module; generating stimulation instructions; and The stimulation instructions are sent to the electrode module for execution.

18. The method according to claim 17, characterized in that After switching to the active state, the method further includes: issuing a collection instruction to the electrode module; receiving and analyzing a bioelectric signal to determine whether there is a risk of seizure, wherein the bioelectric signal is a signal collected by the electrode module based on the collection instruction; The stimulation instructions include: In response to the risk of a seizure, a stimulation instruction is generated according to the bioelectric signal.

19. The method according to claim 18, characterized in that After receiving and analyzing the bioelectric signal to determine whether there is a risk of seizure, the method further includes: In response to there being no seizure risk, continuously monitoring the bioelectric signal for a preset period of time to determine whether there is a seizure risk; and If the risk of seizure cannot be determined after the preset time, the stimulation control module will be turned off.

20. A computer-readable storage medium having computer-readable instructions stored thereon, wherein when the computer-readable instructions are executed by one or more processors, the method according to any one of claims 17 to 19 is implemented.

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