CN118286598A - Apparatus, system, method, and storage medium for neural stimulation - Google Patents

Abstract

The present disclosure discloses an apparatus, system, method, and storage medium for neural stimulation. The apparatus includes: a stimulation control module, which is arranged outside the organism body and is used for generating a stimulation instruction; the remote control module is arranged outside the organism body and 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 the electrode module is used for being implanted in the organism and is in communication connection with the stimulation control module so as to execute the stimulation instruction sent by the stimulation control module. According to the scheme of the embodiment of the disclosure, intervention can be performed in time under the condition that a patient predicts risks, potential risks are reduced, the size of an implanted part can be reduced, the power consumption limit is broken through while surgical wounds are reduced, and therefore a higher-precision algorithm is used, and nerve stimulation treatment with a better effect is achieved.

Description

Device, system, method and storage medium for neural stimulation

Technical Field

The present disclosure generally relates to the field of medical technology. More specifically, the present disclosure relates to an apparatus, system, method and storage medium for neural stimulation.

Background technique

Currently, neurostimulation therapy delivered by implanted pulse generators or neurostimulators is increasingly used for a variety of chronic diseases and neurological disorders, such as epilepsy, Parkinson's disease, pain management, and movement disorders, among others. The purpose of neurostimulation is to modulate the patient's neural tissue in some desired way to treat the disease or condition itself or to change the symptoms of the disease or condition. For example, for epilepsy, the goal of neurostimulation can be to reduce the number of seizures a patient experiences. For movement disorders, the goal of neurostimulation can be to reduce tremors.

Existing closed-loop neural stimulation devices cannot proactively intervene and intervene when patients are aware of the risks. In addition, due to the limited space in the body, the size of the implanted device is limited, so the power consumption of the device implanted in the body is limited and cannot meet the power consumption requirements of the high-precision detection and stimulation algorithm. Moreover, when a device is too large, it will cause more serious surgical trauma to the patient when implanted in the body.

In view of this, it is urgent to provide a solution for neurostimulation, so as to reduce the volume of the implanted part of the device, thereby reducing the trauma of the implantation surgery, and improving the flexibility of the implantation position to reduce the limitation of the implantation position caused by the curvature of the skull. At the same time, it can also break through the power consumption limitation of existing neurostimulation devices, support patients' autonomous intervention, and thus achieve personalized and high-precision neurostimulation treatment.

Summary of the invention

In order to at least solve one or more of the technical problems mentioned above, the present disclosure proposes a solution for neural stimulation in multiple aspects.

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 body and is used to generate stimulation instructions; a remote control module, which is disposed outside the body of the biological body 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 body and is communicatively connected to the stimulation control module to execute the stimulation instructions issued by the stimulation control module.

In some embodiments, the electrode module of the device for neural stimulation 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.

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.

In some embodiments, the device for neural stimulation further includes: a remote terminal, which is communicatively connected to the stimulation control module and is used to receive treatment requests and analyze data issued by the stimulation control module.

In some embodiments, the analysis data includes: bioelectric signals of the patient, analysis results based on the bioelectric signals, and/or stimulation control content corresponding to the stimulation instructions.

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.

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.

In some embodiments, the electrode module includes: an in vivo communication component, which is used to establish communication with an extracorporeal communication component; an acquisition unit, which is connected to the in vivo communication component and is configured to: in response to acquisition instructions 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 instructions are instructions issued by the stimulation control module through the extracorporeal communication component in response to the module activation instructions; and an implanted electrode, which is connected to the in vivo communication component, and is used to acquire stimulation instructions through the in vivo communication component, and output electrical stimulation to the body of the organism according to the stimulation instructions.

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.

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

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

In some embodiments, the stimulation control module is configured to: determine whether a preset trigger event occurs; in response to the preset trigger event, send a treatment request and analyze data to a 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.

In some embodiments, the preset trigger events include: 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.

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

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 the 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.

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.

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 activation 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.

In some embodiments, after switching to an activated state, the method further includes: issuing an acquisition 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 acquired by the electrode module based on the acquisition instruction; wherein generating a stimulation instruction includes: in response to the risk of seizure, generating a stimulation instruction based on the bioelectric signal.

In some embodiments, after receiving and analyzing the bioelectric signal to determine whether there is a risk of seizure, the method also includes: in response to not having a risk of seizure, continuously monitoring the bioelectric signal for a preset time period to determine whether there is a risk of seizure; and if the risk of seizure cannot be determined after the preset time period, turning off the stimulation control module.

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.

With the device for neural stimulation provided above, the patient can actively activate the stimulation control module through the remote control module disposed outside the body, so as to intervene in time when risks are foreseen, thereby reducing potential risks. Since the stimulation control module is disposed outside the body, the detection stimulation algorithm executed during neural stimulation can ignore the power consumption limitation caused by the volume to a certain extent, thereby using a higher precision algorithm to achieve better neural stimulation treatment. Since the function of the electrode module implanted in the body of the organism is simplified, the volume is reduced, and the power consumption is reduced, it can be implanted into the body of the organism more flexibly and with less trauma.

BRIEF DESCRIPTION OF THE DRAWINGS

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

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

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

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

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

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

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

FIG. 7 shows an exemplary flow chart of a neural stimulation control method according to other embodiments of the present disclosure.

Detailed ways

The following will be combined with the drawings in the embodiments of the present disclosure to clearly and completely describe the technical solutions in the embodiments of the present disclosure. Obviously, the described embodiments are part of the embodiments of the present disclosure, not all of the embodiments. Based on the embodiments in the present disclosure, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present disclosure.

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 exclude the presence or addition of one or more other features, integers, steps, operations, elements, components and/or collections thereof.

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

As used in this specification and claims, the term "if" may 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" may 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.

The specific implementation of the present disclosure is described in detail below with reference to the accompanying drawings.

Example application scenarios

Neurostimulation is the process of activating or modulating parts of the nervous system or neural network to treat chronic diseases and neurological disorders. Similar to surgery, neurostimulation targets specific anatomical locations, but unlike traditional surgery, neurostimulation is adjustable and reversible, and the stimulation device can be turned off when necessary. Neurostimulation is suitable for neurological diseases such as epilepsy, Parkinson's disease, pain management and movement disorders.

Taking the neurostimulation equipment for treating epilepsy as an example, existing equipment often sends out 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 equipment, and must wait for the device to autonomously identify the epileptic seizure/reach the stimulation node of the preset treatment plan before sending out the stimulation signal, 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 size of the implanted device is limited, so the power consumption of the implanted device is limited, and existing equipment often cannot use high-precision detection stimulation algorithms. Third, when a device is too large, it will cause greater surgical trauma to the organism.

Exemplary Application Scenarios

In view of this, the disclosed embodiment provides a solution for nerve stimulation, which actively activates the stimulation control module through a remote control module set outside the body, thereby meeting the patient's need for active intervention in nerve stimulation and reducing the potential risk of seizures. In addition, by setting the stimulation control module outside the body, the power consumption limitation caused by the limited volume of the implant space is broken, so that a higher-precision algorithm can be used to achieve better nerve stimulation treatment and reduce surgical trauma.

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 .

The stimulation control module 101 and the remote control module 102 are both arranged outside the body of the organism, and the stimulation control module 101 and the remote control module 102 establish a communication connection through wireless communication or wired communication. Exemplarily, when the stimulation control module 101 and the remote control module 102 establish a communication connection through wireless communication, such as Bluetooth protocol, wireless local area network and infrared communication can be used, and no excessive restrictions are made here.

In the disclosed embodiment, the remote control module 102 is used to generate a module activation instruction for activating the stimulation control module 101. Specifically, the remote control module 102 can generate the module activation instruction according to the patient's behavior. In some embodiments, the patient's behavior can include the patient's active information feedback behavior to the device through the remote control module 102 after making a judgment on his or her own situation. In other embodiments, the patient's behavior can also include the patient's behavior actively sensed by the remote control module 102 without the patient's control. Taking Parkinson's disease as an example, the remote control module 102 can generate a module activation instruction by sensing the patient's slow rhythmic tremor behavior.

In order to facilitate the patient to provide information feedback to the device through 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 multiple remote control modules such as a button remote control module, a knob remote control module, an inductive remote control module, or a touch screen remote control module, and no excessive restrictions are made here.

Taking the button-type remote control module as an example, when the patient senses that he or she has symptoms of an onset of the disease, the patient can press the 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 through wireless communication or wired communication. After receiving the instruction, the stimulation control module 101 switches to an activated state. When the stimulation control module 101 switches to an activated state, it can generate a stimulation instruction and send it to the electrode module 103. The electrode module 103 executes the stimulation instruction issued by the stimulation control module 101 to perform nerve stimulation on the patient.

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 the frequent tremors of the patient's hands.

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 to execute the stimulation instruction 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/not perform the function of collecting the patient's bioelectric signal, and correspondingly, the stimulation control module 101 may not have/not perform the function of analyzing the bioelectric signal. 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, which matches the preset scheme described above. The stimulation control module 101 sends the generated stimulation instruction to the electrode module 103, and 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.

Through the neural stimulation scheme provided in this embodiment, the patient can actively intervene when the risk of an attack is foreseen, and the power consumption of the entire neural stimulation device is also greatly reduced.

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. The stimulation control module 101 can analyze the patient's bioelectric signals in real time when activated, 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.

Through the neurostimulation scheme provided in 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 with better neurostimulation effects.

It should be noted that, in this embodiment, the bioelectric signal may be an electroencephalogram signal or other electrical signal. For example, when the electrode module 103 is implanted in the heart of a living body, the electrode module 103 may be used to collect the patient's electrocardiogram signal. Similarly, the electrode module 103 may also collect other bioelectric signals such as electromyographic signals, gastric electrical signals, and retinal electrical signals.

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 will 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.

In this embodiment, the generation and collection of EEG signals are located in the patient's skull. Due to the particularity of the skull structure, high requirements are placed on multiple properties of the implanted electrode module, such as volume properties. Since the skull allows limited space for implanted devices and the nerve density is very high, implanting electrodes that are too large is not only extremely difficult, but also greatly increases the risk of damage to the patient's nerves due to the implantation operation. For this reason, the neurostimulation device needs to be designed to minimize the volume of the implanted part.

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 .

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.

Further, 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 .

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 .

The collection unit 1032 is connected to the in-vivo communication component 1031 and is configured to: in response to a collection instruction, collect the patient's bioelectrical signal and send it through the in-vivo communication component 1031. The collection 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.

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 biological body according to the stimulation instruction.

It should be noted that in the device for nerve stimulation shown in FIG. 2, data processing of bioelectric signals is performed by an analysis chip located outside the body, that is, a module that requires a large amount of computing resources or carries a complex algorithm does not occupy the patient's cranial space, which greatly reduces the volume of the electrode module that needs to be implanted in the patient's body. The electrode module implanted in the patient's body only needs to perform the tasks of data collection and data transmission and reception. The module that realizes this function is small in size, adapts to the volume requirements of the implantation space, and is not easy to cause damage to the patient's nerves during implantation.

Furthermore, the extracorporeal communication component 1011, as a component for realizing the data transceiving function in the stimulation control module 101, may include a communication antenna and a transmitting coil. Similarly, the intracorporeal communication component 1031, as a component for realizing the data transceiving function in the electrode module 103, may include a communication antenna and a receiving coil.

Based on the system described above in combination with FIG. 1 or FIG. 2 , the present disclosure further provides a stimulation control module activation method applicable to the above remote control module. FIG. 3 shows an exemplary flow chart of a stimulation control module activation method 300 of an embodiment of the present disclosure.

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

In some embodiments, the remote control module is further provided with a sensor component, which can sense the patient's current movements and postures, and generate a module activation instruction when a preset posture is sensed. For example, the remote control module can be worn on the patient's hand, and if a large limb movement such as severe tremor is detected in the patient, the remote control module can generate a module activation instruction.

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

Furthermore, in other embodiments, the stimulation control module also switches to an activated 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 the presence of an abnormality in the bioelectric signal collected by the electrode module.

It should be noted that the preset trigger event of reaching the preset time point for nerve stimulation can be understood as a preset trigger cycle, and the stimulation control module switches from the closed state to the activated state after each cycle. This embodiment has no strict restrictions on 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 made here.

After the stimulation control module is switched to the activated state, the electrode module is controlled to collect and analyze the bioelectric signal, thereby determining 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 in conjunction with FIG.

FIG4 shows an exemplary flow chart of a neural stimulation control method 400 of 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 an activated 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 the remote control module can be automatically issued by sensing the patient's posture. The operation process of the remote control module has been described in detail in the embodiment described in conjunction with FIG3 above, and will not be repeated here.

In step S402, a stimulation instruction is generated. After the stimulation control module is switched to the activated state, it can generate a corresponding stimulation instruction according to the pre-set neural stimulation treatment plan of the neural stimulation signal. The stimulation instruction can also be a pre-stored instruction, and when the stimulation control module is switched to the activated state, it directly calls the stimulation instruction.

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, the stimulation instruction can be sent to the in-vivo communication component of the electrode module through the in-vivo communication component, and transmitted to the implanted electrode of the electrode module through the in-vivo communication component, and the implanted electrode executes the stimulation instruction to perform nerve stimulation.

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 operation process of the stimulation control module that has and performs the analysis function is described below.

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 a collection instruction to the in-vivo communication component of the electrode module through the in-vitro communication component, and the implanted electrode obtains the collection instruction from the in-vivo communication component.

In step S502, the bioelectric signal is received and analyzed to determine whether there is a risk of seizure. If yes, steps S503 to S504 are executed; if no, 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.

In step S503, a stimulation instruction is generated according to 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 according to the specific waveform of the bioelectric signal for targeted treatment.

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.

In step S504, the stimulation instruction is sent to the implanted electrode 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.

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

In step S506, the stimulation control module is turned off. If the patient is still not determined to have a seizure risk 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, thereby achieving the effect of saving power consumption.

The previous article introduced the equipment and method 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.

FIG6 shows an exemplary structural diagram of a device for neural stimulation according to some other embodiments of the present disclosure. As shown in FIG6 , based on the device system shown in FIG1 or FIG2 , it also includes: a remote terminal 104, which is disposed outside the body and is communicatively connected to the stimulation control module 101. Specifically, the two transmit data by wireless communication.

It should be noted that in the present 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 the wireless communication method of long-distance communication 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.

In this embodiment, the remote terminal 104 can receive the treatment request and analysis data issued by the stimulation control module 101, wherein the analysis data includes: the patient's bioelectric signal, the analysis result based on the bioelectric signal and/or the stimulation control content corresponding to the stimulation instruction. Exemplarily, the analysis result based on the bioelectric signal may include: the seizure risk determination result obtained based on the bioelectric signal, and the stimulation control content corresponding to the stimulation instruction may include: the treatment plan generated by the stimulation control module.

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, so as to generate or modify 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.

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 trigger event.

In the method of active triggering by the remote control module, the remote control module 102 is also used 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.

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 FIG. 7 , which shows an exemplary flow chart of a neural stimulation control method 700 of other embodiments of the present disclosure.

In step S701, in response to a preset trigger event, a treatment request and analysis data are sent to a remote terminal. 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 meets a preset abnormal condition.

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.

It should be noted that the preset periodic 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.

In step S702, the treatment instructions fed back by the remote terminal are received. In this embodiment, the treatment instructions fed back by the remote terminal are stimulation instructions generated based on the treatment plan generated/modified by the remote terminal.

In step S703, the treatment instruction is forwarded to the implanted electrode of the electrode module for execution. In some embodiments, the treatment instruction can be first sent to the stimulation control module, which is then forwarded to the electrode module. In other embodiments, the treatment instruction can also be directly sent to the electrode module for execution.

Furthermore, the stimulation control module is in a closed state by default, and is switched to an activated state when a preset trigger event occurs.

By introducing a remote terminal into the system for neurostimulation, doctors can remotely obtain data related to the patient's physiological status in the hospital or the doctor's diagnosis and treatment remote terminal station, thereby realizing wireless control of the electrode module implanted in the patient's body. Through the doctor's remote intervention, the neurostimulation treatment plan can be further improved according to the patient's physiological state, thereby realizing personalized, customized, and high-precision neurostimulation treatment.

On the basis of the device for nerve stimulation described in the previous text in combination 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 of the organism and is used to power the electrode module. The power module is arranged outside the body to provide 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, no energy storage device is provided 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.

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

In this system, the data storage device is connected to the neurostimulation device for storing 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 disposed outside the body, and it can be integrated with the neurostimulation device in the same area, or it can be stored in the cloud.

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.

Exemplarily, 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 a treatment plan based on the above analysis data.

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 senses 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 receive effective neural stimulation treatment.

In addition, the device for neural stimulation provided by the disclosed embodiment also sets the stimulation control module and the remote control module outside the body, thereby reducing the volume of the electrode module. Since the space available for implantation in the patient's body is limited and the volume allowed for implantation is limited, it is impossible to support the implantation of power supplies that are too large, which makes it impossible to use implant devices with high power consumption. The disclosed embodiment further breaks through the power consumption limitation caused by volume by using external power supply modules and analysis chips, which is conducive to the use of higher-precision neural stimulation algorithms.

Additionally or optionally, the present disclosure may also be implemented as a non-temporary 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 executes part or all of the steps of the above-mentioned method according to the present disclosure.

Although multiple 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 think of many changes, modifications, and alternatives without departing from the thought and spirit of the present disclosure. It should be understood that in the process of practicing the present disclosure, various alternatives to the embodiments of the present disclosure described herein may be adopted. The attached 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 (20)

1. A device for nerve stimulation, comprising: A stimulation control module, which is disposed outside the biological body and is used to generate stimulation instructions; a remote control module, which is disposed outside the biological body and is in communication connection with the stimulation control module, and is used to generate a module activation instruction for activating the stimulation control module; and The electrode module is used to be implanted in a biological body and is communicatively connected with the stimulation control module to execute the stimulation instructions issued by the stimulation control module. 2. The device according to claim 1 is characterized in that 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 the stimulation instructions. 3. The device according to claim 1 is characterized in that it also includes: a power supply module, which is arranged outside the body of the organism and is used to supply power to the electrode module. 4. The device according to claim 2 is characterized in that it also includes: a remote terminal, which 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 is characterized in that the analysis data includes: the patient's bioelectric signal, the analysis result based on the bioelectric signal and/or the stimulation control content corresponding to the stimulation instruction. 6. The device according to claim 4, characterized in that the remote control module is further used to generate the treatment request and send it to the stimulation control module; The stimulation control module is also used to forward the treatment request to the remote terminal. 7. The device according to claim 2, characterized in that the stimulation control module comprises: an external communication component, which is used 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 instruction. 8. The device according to claim 7, characterized in that the electrode module comprises: an in-vivo communication component, used to establish communication with the in-vitro communication component; a collection unit connected to the in-vivo communication component and configured to: in response to obtaining a collection instruction through the in-vivo communication component, collect the patient's bioelectrical signal and send it out through the in-vivo communication component; wherein the collection instruction is an instruction sent by the stimulation control module through the in-vitro 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 biological 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, wherein 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 bioelectric signal collected by the collection unit based on the collection instruction to determine whether there is a risk of seizure; In response to there being a risk of seizure, generating a stimulation instruction according to the bioelectric signal; and 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 bioelectric signal collected by the collection unit according to the collection instruction, if it is still not determined that there is a risk of seizure after a preset time, it will be automatically closed. 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, a treatment request and analysis data are sent to the remote terminal; receiving treatment instructions fed back by the remote terminal; and The treatment instructions are forwarded to the implanted electrodes of the electrode module for execution. 13. The device according to claim 12 is characterized in that the preset trigger event includes: reaching a preset periodic 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 1-8, 10-11 and 13, characterized in that the stimulation control module is in a closed state by default, and switches to an activated state when a module activation instruction is received or a preset trigger event occurs. 15. A system for neural stimulation, comprising: 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 are both arranged outside the body of a living being, 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 living being and is communicatively connected to the stimulation control module to execute the stimulation instruction issued by the stimulation control module; A data storage device is communicatively connected to the neural stimulation device and is used to store stimulation instructions issued by the stimulation control module. 16. The system according to claim 15 is characterized in that 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 the stimulation instructions; and the data storage device is also used to store the bioelectric signals collected by the electrode module. 17. A method for neural stimulation, characterized in that it is applied to a stimulation control module, which is arranged outside the body and is respectively connected to a remote control module and an electrode module for communication, comprising: Switching to an activated 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 activated 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 having a risk of 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 comprises: In response to there being no seizure risk, continuously monitoring the bioelectric signal for a preset time period 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.