WO2024083193A1 - Pulse generator, stimulator, medical system and computer-readable storage medium - Google Patents

Abstract

Provided in the present application are a pulse generator, a stimulator, a medical system and a computer-readable storage medium. The pulse generator comprises a memory and a processor, wherein the processor is configured to: in response to an MRI mode control instruction, enter an MRI mode, the MRI mode control instruction being used for indicating a preset duration of the MRI mode of the pulse generator, stop receiving information sent by an external device, and start the countdown of the preset duration; and when the countdown ends, exit the MRI mode, and resume the reception of the information sent by the external device. The pulse generator ceaselessly sends the real-time remaining duration to a receiving device in the MRI mode, and when the real-time remaining duration displayed by the receiving device is not updated in real time, a caretaker can discover in a timely manner a situation where the pulse generator has been damaged.

Description

Pulse generator, stimulator, medical system and computer readable storage medium

This application claims priority to Chinese Patent Application No. 202211291000.2 filed on October 21, 2022, which is incorporated by reference in its entirety.

Technical Field

The present application relates to the technical fields of implantable devices, deep brain stimulation, and deep learning, for example, to pulse generators, stimulators, medical systems, and computer-readable storage media.

Background technique

With the development of science and technology and social progress, patients are eager to improve their quality of life through various treatment methods. Among them, medical devices, especially implantable devices, have very broad application prospects. Implantable devices refer to medical devices that are fully or partially inserted into the human body or cavity (orifice) with the help of surgery, or are used to replace the human epithelial surface or eye surface, and remain in the human body for 30 days (inclusive) or more after the operation, or are absorbed by the human body. A stimulator is a type of implantable device. The stimulator usually includes an IPG (Implantable Pulse Generator), an extension wire, and an electrode wire. It can provide patients with refined electrical stimulation therapy with controllable parameters and is popular among many consumers in the market.

Implants (i.e., implantable devices) may be affected or even damaged when they enter an MRI (Magnetic Resonance Imaging) device. Specifically, when a patient or a specific part of the patient's body is placed in an MRI device, the MRI device generates various magnetic and electromagnetic fields to obtain an image of the patient, including static magnetic fields, gradient magnetic fields, and radio frequency (RF) fields. If there is an implant in the patient's body, the various fields generated by the MRI device may affect the electrical stimulation therapy of the implant, causing the implant to deliver therapy when it is not needed, or not deliver therapy when it is needed.

Patent CN106110503B discloses a working method of an implantable medical device with an MRI mode, wherein the implantable medical device includes an in-vivo implant device and an external controller, and the in-vivo implant device includes a circuit element sensitive to an external strong magnetic field; the working method of the implantable medical device includes a method for controlling the in-vivo implant device; the method for controlling the in-vivo implant device includes the following steps: step S11, detecting an external strong magnetic field and determining whether the existence of the external strong magnetic field is detected, if yes, proceeding to step S12, if not, continuing to repeat step S11; step S12, recording the detected strong magnetic field The time of the external strong magnetic field and the state of the implanted device in the body, mark it as being in a strong magnetic field environment, and go to step S13; step S13, switch to MRI mode, mark the MRI mode switching event, and go to step S14; step S14, determine whether the external strong magnetic field disappears, if yes, go to step S15, if not, repeat step S14; step S15, record the time of the external strong magnetic field disappearance and the state of the implanted device in the body, mark leaving the strong magnetic field environment, and go to step S16; and step S16, switch to normal mode, mark the MRI mode switching event, and return to step S11. The method can automatically sense the presence of an external strong magnetic field and automatically switch to an MRI mode, and notify an external device when the MRI mode ends.

Based on this, the present application provides a pulse generator, a stimulator, a medical system and a computer-readable storage medium to improve the relevant technology.

Summary of the invention

The purpose of the present application is to provide a pulse generator, a stimulator, a medical system and a computer-readable storage medium. The pulse generator continuously sends the real-time remaining time to a designated external device in the MRI mode. When the real-time remaining time displayed by the receiving device is not updated in real time, the caregiver can promptly discover that the pulse generator is damaged.

The purpose of this application is achieved by the following technical solutions:

In a first aspect, the present application provides a pulse generator, the pulse generator being implanted in a patient's body, the pulse generator comprising a memory and a processor, the memory storing a computer program, the processor being configured to implement the following steps when executing the computer program:

Entering the MRI mode in response to an MRI mode control instruction, wherein the MRI mode control instruction is used to indicate a preset duration of the MRI mode of the pulse generator;

Stop receiving information sent by an external device and start a countdown of a preset duration. When the countdown is not over, send the real-time remaining duration of the countdown to a preset receiving device at a preset frequency so that the receiving device displays the real-time remaining duration. The receiving device includes one or more of a mode control device, a program-controlled device, and a display device; or enter a periodic listening mode. When the countdown is not over, the MRI mode can be exited through a control instruction;

When the countdown ends, exit the MRI mode and resume receiving information sent by external devices.

The related technology does not take into account the possibility that the pulse generator may have been damaged during the MRI detection process, nor does it consider how to notify the caregiver of the situation as soon as possible after the pulse generator is damaged so that the medical staff can take countermeasures (such as replacing or repairing the pulse generator). Therefore, the pulse generators on the market will not actively send the real-time remaining time to the external device at a fixed frequency in the middle of the MRI mode. Some pulse generators can send notification information to the external device after the MRI mode ends, but if the pulse generator is damaged at this time, the notification information cannot be sent smoothly. Even if the caregiver can passively discover that the pulse generator is damaged through the fact that the notification information has not been received or the program control fails, the timing of the knowledge is behind the actual damage of the pulse generator. In other words, it is impossible to make advance preparations for countermeasures such as repairing or replacing the pulse generator, which may delay the patient's condition or cause more serious consequences, because patients using pulse generators may have an urgent need for electrical stimulation treatment, such as patients with severe obsessive-compulsive disorder, mania or drug addicts. If electrical stimulation treatment cannot be resumed in time, it may The concerns caused by these hidden dangers will make it difficult for the family members of the corresponding patients to accept the necessary MRI examinations, which will be detrimental to doctors obtaining the necessary MRI data and making accurate diagnosis and treatment for patients to improve their quality of life.

The beneficial effect of this technical solution is that the pulse generator continuously sends the real-time remaining time to the designated external device (i.e., the receiving device) in the MRI mode. When the real-time remaining time displayed by the receiving device is not updated in real time, the caregiver can promptly discover that the pulse generator is damaged.

The pulse generator implanted in the patient has an MRI mode. After entering the MRI mode, the pulse generator will not respond to all external devices. Therefore, external devices cannot obtain information from it (i.e., the pulse generator), cannot actively obtain the status of the pulse generator, and do not know the real-time remaining time of the pulse generator's MRI mode. Doctors and other caregivers cannot accurately arrange programming, nursing and other work after the MRI test is completed. Therefore, the pulse generator is required to actively push the real-time remaining time to the receiving device.

Specifically, the process of the pulse generator actively pushing the real-time remaining time is as follows: after receiving the MRI mode control instruction, the pulse generator will enter the MRI mode, at which time the processor stops receiving information sent by any external device (including all external devices including the mode control device), and counts down the MRI mode (for example, the preset duration, which can be 10 minutes, 20 minutes, 30 minutes, etc.), and continuously sends the real-time remaining time to the receiving device at a preset frequency (for example, 1Hz or 0.5Hz, and the corresponding preset interval duration is, for example, 1 second or 2 seconds) in the MRI mode, so that the caregiver can observe the changes in the real-time remaining time in real time through the receiving device. Once the real-time remaining time of the pulse generator displayed by the receiving device is not updated in real time or the real-time remaining time of the pulse generator cannot be displayed, it indicates that the pulse generator can no longer operate normally and may have been damaged. Therefore, the use of the pulse generator of the present application facilitates caregivers to promptly discover damage to the pulse generator in the MRI mode.

In addition, when the countdown ends, the pulse generator can automatically exit the MRI mode, and the processor resumes receiving information sent by the external device. If the MRI detection does not cause damage to the pulse generator, the electrical stimulation therapy function of the pulse generator can be restored as soon as possible. The doctor can also use the program-controlled device to establish a program-controlled connection with the pulse generator, and make corresponding program-controlled operations according to the patient's current condition. The program-controlled device sends the program-controlled instructions corresponding to the program-controlled operation to the pulse generator. After receiving the program-controlled instructions sent by the program-controlled device, the pulse generator configures one or more stimulation parameters of the pulse generator to deliver electrical stimulation therapy corresponding to the stimulation parameters to the patient's in vivo tissue (such as brain tissue, spinal cord nerve tissue, sacral nerve tissue, etc.), thereby relieving the patient's pain and controlling the patient's condition.

In one embodiment, the processor is configured to enter the MRI mode in response to the MRI mode control instruction in the following manner when executing the computer program:

In response to the MRI mode control instruction, detecting whether the power of the pulse generator is not less than a preset power threshold;

If the power level of the pulse generator is not less than the preset power threshold, entering the MRI mode;

The processor is further configured to implement the following steps when executing the computer program:

If the power level of the pulse generator is less than the preset power threshold, a first prompt message is sent to the receiving device, where the first prompt message is used to indicate that the power level of the pulse generator is less than the preset power threshold.

The beneficial effect of this technical solution is that: since a certain amount of power is required to continuously send information to the receiving device after entering the MRI mode (i.e., the real-time remaining time), it is possible to detect whether there is a corresponding amount of power before entering the MRI mode, thereby avoiding failure to send information to external devices due to insufficient power and eliminating the situation where the pulse generator is mistakenly judged to be damaged due to power factors.

In one embodiment, the processor is configured to obtain the preset power threshold in the following manner when executing the computer program:

The preset power threshold is obtained based on the preset duration and the preset power consumption per unit time.

The beneficial effect of this technical solution is that different preset power thresholds are set for different preset durations to meet the power consumption requirements of the pulse generator for sending information to the outside during the MRI mode. For example, when the preset duration of the MRI mode is longer, a higher preset power threshold is set (the value range is, for example, 50-80%); when the preset duration of the MRI mode is shorter, a lower preset power threshold is set (the value range is, for example, 10-30%). The power consumption per unit time refers to the power consumption of the pulse generator per unit time acquired in advance, which can be obtained by experiment or measurement in practice. In some embodiments, the preset duration and the power consumption per unit time can be input into a preset polynomial to calculate the preset power threshold, and the preset polynomial can be a linear polynomial or a nonlinear polynomial. In other embodiments, the preset duration and the power consumption per unit time can be input into a power threshold model to obtain a preset power threshold, and the power threshold model can be obtained by training a preset deep learning model using a training set.

In one embodiment, the processor is configured to enter the MRI mode in response to the MRI mode control instruction in the following manner when executing the computer program:

In response to the MRI mode control instruction, detecting whether each stimulation parameter of the pulse generator is within a corresponding preset range;

If all stimulation parameters are within the corresponding preset range, the MRI mode is entered;

The processor is further configured to implement the following steps when executing the computer program:

If one or more stimulation parameters are not within the corresponding preset range, second prompt information is sent to the receiving device, where the second prompt information is used to indicate the stimulation parameters that are not within the corresponding preset range.

The beneficial effect of this technical solution is that in MRI mode, when the patient's whole body or specific parts enter the MRI device, the external field may cause the electromagnetic field generated by the pulse generator implanted in the patient to fluctuate, and this fluctuation may affect the electrical stimulation treatment effect of the pulse generator and even cause human damage. Therefore, each stimulation parameter of the pulse generator can be placed within a given preset range before entering the MRI mode, wherein the preset range is a pre-set value range (the value range can be a numerical value range or a non-numerical value range). When each stimulation parameter is within its corresponding preset range, the pulse generator does not generate an electromagnetic field or the generated electromagnetic field can be less interfered by the MRI device. That is, the pulse generator can be turned off in advance (each stimulation parameter is set to 0, empty, or the default option is used), the electrical stimulation treatment is stopped, and then the MRI mode is entered.

In one embodiment, the processor is further configured to determine the parameter value of each stimulation parameter of the pulse generator in the following manner when executing the computer program:

Using an electrode wire implanted in the patient's body to sense the patient's electrophysiological activity to obtain the patient's electrophysiological signal;

Inputting the electrophysiological signal of the patient into a state classification model to obtain state classification information corresponding to the electrophysiological signal;

When the state classification information corresponding to the electrophysiological signal is used to indicate that the patient's condition is not under control, the electrophysiological signal is input into a parameter configuration model to obtain the parameter configuration information corresponding to the electrophysiological signal, so as to deliver electrical stimulation corresponding to the parameter configuration information to the patient using the electrode wire, and the parameter configuration information is used to indicate the parameter value of each stimulation parameter of the pulse generator.

The beneficial effect of this technical solution is that: the patient's condition is classified based on the electrophysiological signal obtained by real-time sensing, and the state classification information is used to indicate whether the patient's condition is under control or not; when the patient's condition is not under control, the corresponding parameter configuration information is obtained based on the electrophysiological signal obtained by real-time sensing, so as to deliver the electrical stimulation corresponding to the parameter configuration information to the patient. A prerequisite is set for obtaining the parameter configuration information, that is, the parameter configuration information is obtained only when the patient's condition is not under control based on the patient's electrophysiological signal, and when the patient's condition is under control, the parameter configuration information is not obtained. The advantage of this is that the number of times the parameter configuration information is obtained can be reduced, the amount of calculation of the pulse generator can be reduced, the power consumption can be reduced, the charging interval of the rechargeable pulse generator can be extended, or the service life of the non-rechargeable pulse generator can be extended. Among them, the state classification model and the parameter configuration model are used to respectively obtain the state classification information and the parameter configuration information, which has strong real-time performance, high accuracy, and a wide range of applications.

In one embodiment, the pulse generator further comprises a wireless communication module;

The processor is configured to stop receiving information sent by an external device in the following manner when executing the computer program:

disabling the receiving function of the wireless communication module;

The processor is configured to recover the information sent by the external device in the following manner when executing the computer program:

The receiving function of the wireless communication module is enabled.

The beneficial effect of this technical solution is that: since the pulse generator is implanted in the patient's body, wireless communication is adopted between the pulse generator and the external device. Therefore, by disabling the receiving function of the wireless communication module, the processor can stop receiving information sent by the external device. Correspondingly, by enabling the receiving function of the wireless communication module, the processor can resume receiving information sent by the external device.

In one embodiment, the processor is configured to disable the receiving function of the wireless communication module in the following manner when executing the computer program:

Sending a first enable signal to the wireless communication module to disable a receiving function of the wireless communication module;

The processor is configured to enable the receiving function of the wireless communication module in the following manner when executing the computer program:

A second enabling signal is sent to the wireless communication module to enable a receiving function of the wireless communication module.

The beneficial effect of the technical solution is that the disabling and enabling of the receiving function of the wireless communication module are respectively controlled by the first enable signal and the second enable signal, and the control process is simple and easy to implement. The first enable signal is, for example, a high level, and the second enable signal is, for example, a low level; or, the first enable signal is, for example, a low level, and the second enable signal is, for example, a high level.

In one embodiment, the pulse generator has an MRI mode, a sleep mode, a fast listening mode, and a communication mode;

The processor is configured to receive the MRI mode control instruction in the following manner when executing the computer program:

When a magnet is detected approaching the pulse generator, the pulse generator is switched from a sleep mode to a fast listening mode, wherein the listening period of the pulse generator in the sleep mode is a first preset time length, and the listening period of the pulse generator in the fast listening mode is a second preset time length, and the second preset time length is less than the first preset time length;

establishing a communication connection between the pulse generator and the mode control device in a fast listening mode so that the pulse generator enters a communication mode;

The MRI mode control instruction is received in the communication mode.

The beneficial effect of this technical solution is that: in sleep mode, the pulse generator has a long listening period, and it may take a long time to be searched by the mode control device; while in fast listening mode, the pulse generator has a short listening period, and can be quickly searched by the mode control device. Therefore, when it is necessary to perform MRI mode control on a specified pulse generator, a magnet can be used to approach the pulse generator, switch the pulse generator from sleep mode to fast listening mode, establish a communication connection, and receive MRI mode control instructions in communication mode. The advantage of this is that the specified pulse generator can be quickly searched by the mode control device, It also performs MRI mode control, improves MRI mode control efficiency, reduces the time patients have to wait to enter the MRI device, and overall assists patients to quickly complete the MRI detection process and resume normal electrical stimulation treatment, thereby reducing patients' psychological stress and helping to stabilize their condition, especially for patients with severe obsessive-compulsive disorder or drug addicts who are highly dependent on electrical stimulation treatment.

In a second aspect, the present application provides a communication method of a pulse generator, wherein the pulse generator is implanted in a patient, and the method comprises:

In response to an MRI mode control instruction, enter the MRI mode, stop receiving information sent by an external device, and start a countdown of a preset duration, wherein the MRI mode control instruction is used to indicate the preset duration of the MRI mode of the pulse generator;

When the countdown is not over, the real-time remaining time of the countdown is sent to a preset receiving device at a preset frequency, so that the receiving device displays the real-time remaining time, and the receiving device includes one or more of a mode control device, a program control device and a display device, or enters a periodic listening mode;

When the countdown ends, exit the MRI mode and resume receiving information sent by external devices.

In one embodiment, the step of entering the MRI mode in response to the MRI mode control instruction includes:

In response to the MRI mode control instruction, detecting whether the power of the pulse generator is not less than a preset power threshold;

If the power level of the pulse generator is not less than the preset power threshold, entering the MRI mode;

The method further comprises:

If the power level of the pulse generator is less than the preset power threshold, a first prompt message is sent to the receiving device, where the first prompt message is used to indicate that the power level of the pulse generator is less than the preset power threshold.

In one embodiment, the process of obtaining the preset power threshold includes:

The preset power threshold is obtained based on the preset duration and the preset power consumption per unit time.

In one embodiment, the step of entering the MRI mode in response to the MRI mode control instruction includes:

In response to the MRI mode control instruction, detecting whether each stimulation parameter of the pulse generator is within a corresponding preset range;

If all stimulation parameters are within the corresponding preset range, the MRI mode is entered;

The method further comprises:

If one or more stimulation parameters are not within the corresponding preset range, second prompt information is sent to the receiving device, where the second prompt information is used to indicate the stimulation parameters that are not within the corresponding preset range.

In one embodiment, the process of determining the parameter value of each stimulation parameter of the pulse generator includes:

Using an electrode wire implanted in the patient's body to sense the patient's electrophysiological activity to obtain the patient's electrophysiological signal;

Inputting the electrophysiological signal of the patient into a state classification model to obtain state classification information corresponding to the electrophysiological signal;

When the state classification information corresponding to the electrophysiological signal is used to indicate that the patient's condition is not under control, the electrophysiological signal is input into a parameter configuration model to obtain the parameter configuration information corresponding to the electrophysiological signal, so as to deliver electrical stimulation corresponding to the parameter configuration information to the patient using the electrode wire, and the parameter configuration information is used to indicate the parameter value of each stimulation parameter of the pulse generator.

In one embodiment, the pulse generator further comprises a wireless communication module;

The process of stopping receiving information sent by external devices includes:

disabling the receiving function of the wireless communication module;

The process of resuming reception of information sent by external devices includes:

The receiving function of the wireless communication module is enabled.

In one embodiment, disabling the receiving function of the wireless communication module includes:

Sending a first enable signal to the wireless communication module to disable a receiving function of the wireless communication module;

The enabling of the receiving function of the wireless communication module comprises:

A second enabling signal is sent to the wireless communication module to enable a receiving function of the wireless communication module.

In one embodiment, the pulse generator has an MRI mode, a sleep mode, a fast listening mode, and a communication mode;

The process of receiving MRI mode control instructions includes:

When a magnet is detected approaching the pulse generator, the pulse generator is switched from a sleep mode to a fast listening mode, wherein the listening period of the pulse generator in the sleep mode is a first preset time length, and the listening period of the pulse generator in the fast listening mode is a second preset time length, and the second preset time length is less than the first preset time length;

establishing a communication connection between the pulse generator and the mode control device in a fast listening mode so that the pulse generator enters a communication mode;

The MRI mode control instruction is received in the communication mode.

In a third aspect, the present application provides a stimulator, the stimulator is used to be implanted in a patient's body, and the stimulator comprises:

Any of the above pulse generators;

The electrode lead is used for sensing the electrophysiological activity of the patient to obtain an electrophysiological signal, and delivering electrical stimulation to the body tissue of the patient.

In one embodiment, the stimulator further comprises:

An extension wire is provided between the pulse generator and the electrode wire, and is used to realize a communication connection between the pulse generator and the electrode wire.

In a fourth aspect, the present application provides a medical system, the medical system comprising:

Any of the above stimulators;

A mode control device is configured to send an MRI mode control instruction to the pulse generator of the stimulator, and receive a real-time remaining time of the countdown and display the real-time remaining time in real time.

In one embodiment, the mode control device is configured to send the MRI mode control instruction to the pulse generator in the following manner:

In response to the search operation, the pulse generator in the listening state is searched and displayed in real time;

In response to a selection operation on one of the pulse generators in the listening state, establishing a communication connection between the mode control device and the selected pulse generator;

In response to a setting operation for a preset duration, generating the MRI mode control instruction, the MRI mode control instruction being used to indicate a preset duration of the MRI mode of the pulse generator;

The MRI mode control instruction is sent to the selected pulse generator.

In one embodiment, the mode control device is configured to receive and display the real-time remaining time in the following manner:

In response to receiving the MRI operation, the pulse generators in the MRI mode are searched, and the identification and real-time remaining time of each pulse generator in the MRI mode are received and displayed.

In one embodiment, the medical system further comprises:

A programmable device is configured to establish a communication connection with the pulse generator and send a programmable instruction to the pulse generator to adjust the stimulation parameters of the pulse generator.

In one embodiment, the mode control device and the program control device are integrated into one.

In one embodiment, the patient's disease includes one or more of the following:

Spastic disorders, depression, bipolar disorder, anxiety disorders, post-traumatic stress disorder, obsessive-compulsive disorder, behavioral disorders, mood disorders, memory disorders, mental state disorders, tremors, Parkinson's disease, Huntington's disease, Alzheimer's disease, addictive disorders and autism.

In a fifth aspect, the present application provides a computer-readable storage medium, wherein the computer-readable storage medium stores a computer program, and when the computer program is executed by a processor, the computer program implements the steps of any of the above methods or implements the functions of any of the above pulse generators.

BRIEF DESCRIPTION OF THE DRAWINGS

The present application is further described below in conjunction with the accompanying drawings and implementation methods.

FIG1 shows a structural block diagram of a medical system provided in an embodiment of the present application.

FIG2 shows a schematic flow chart of a communication method for a pulse generator provided in an embodiment of the present application.

FIG. 3 is a schematic diagram showing a flow chart of determining a parameter value of each stimulation parameter provided in an embodiment of the present application.

FIG4 shows a structural block diagram of a pulse generator provided in an embodiment of the present application.

FIG5 shows a schematic diagram of the structure of a program product provided in an embodiment of the present application.

Detailed ways

The technical solution in the present application will be described below in conjunction with the drawings and specific implementation methods of the present application. It should be noted that, under the premise of no conflict, the various implementation methods or technical features described below can be arbitrarily combined to form a new implementation method.

In the embodiments of the present application, "at least one" refers to one or more, and "multiple" refers to two or more. "And/or" describes the association relationship of associated objects, indicating that three relationships may exist. For example, A and/or B can represent: A exists alone, A and B exist at the same time, and B exists alone, where A and B can be singular or plural. The character "/" generally indicates that the associated objects before and after are in an "or" relationship. "At least one of the following" or similar expressions refers to any combination of these items, including any combination of single or plural items. For example, at least one of a, b or c can represent: a, b, c, a and b, a and c, b and c, a and b and c, where a, b and c can be single or multiple. It is worth noting that "at least one" can also be interpreted as "one or more items".

It should also be noted that in the embodiments of the present application, words such as "exemplary" or "for example" are used to indicate examples, illustrations or descriptions. Any implementation or design scheme described as "exemplary" or "for example" in the embodiments of the present application should not be interpreted as being more preferred or more advantageous than other implementations or designs. Specifically, the use of words such as "exemplary" or "for example" is intended to present related concepts in a specific way.

Below, one of the application fields (i.e., implantable devices) of the embodiments of the present application is first briefly described.

An implantable neurostimulation system (an implantable medical system) mainly includes a stimulator implanted in the patient's body and a programmable device installed outside the patient's body. Existing neuromodulation technology mainly uses stereotactic surgery to implant electrodes in specific structures (i.e., target points) in the body, and the stimulator implanted in the patient's body emits discharge pulses to the target points through the electrodes, thereby regulating the electrical activity and function of the corresponding neural structures and networks, thereby improving symptoms and relieving pain. Among them, the stimulator can be an implantable neural electrical stimulation device, an implantable cardiac electrical stimulation system (also known as a pacemaker), an implantable drug delivery system (Implantable Drug Delivery System, abbreviated as Any one of an I DDS and a lead switching device. Examples of implantable neural electrical stimulation devices include a deep brain stimulation system (DBS), an implantable cortical nerve stimulation system (CNS), an implantable spinal cord stimulation system (SCS), an implantable sacral nerve stimulation system (SNS), an implantable vagus nerve stimulation system (VNS), etc.

The stimulator may include an IPG, an extension lead and an electrode lead. The IPG (implantable pulse generator) is arranged in the patient's body, responds to the program-controlled instructions sent by the program-controlled device, relies on a sealed battery and a circuit to provide controllable electrical stimulation energy to the tissue in the body, and delivers one or two controllable specific electrical stimulations to specific areas of the tissue in the body through the implanted extension lead and the electrode lead. The extension lead is used in conjunction with the IPG as a transmission medium for the electrical stimulation signal, and transmits the electrical stimulation signal generated by the IPG to the electrode lead. The electrode lead delivers electrical stimulation to specific areas of the tissue in the body through multiple electrode contacts. The stimulator is provided with one or more electrode leads on one side or both sides, and multiple electrode contacts are arranged on the electrode lead. The electrode contacts can be arranged uniformly or non-uniformly in the circumferential direction of the electrode lead. As an example, the electrode contacts can be arranged in an array of 4 rows and 3 columns (a total of 12 electrode contacts) in the circumferential direction of the electrode lead. The electrode contacts can include stimulation electrode contacts and/or collection electrode contacts. The electrode contacts can be in the shape of sheets, rings, dots, etc.

In one embodiment, the stimulated in vivo tissue may be the patient's brain tissue, and the stimulated site may be a specific site of the brain tissue. When the patient's disease type is different, the stimulated site is generally different, and the number of stimulation contacts (single source or multiple sources) used, the use of one or more (single channel or multiple channels) specific electrical stimulation signals, and the stimulation parameter data are also different. The present application embodiment does not limit the applicable disease type, which may be a disease type applicable to deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation. Among them, DBS can be used to treat or manage disease types including, but not limited to: spastic diseases (e.g., epilepsy), pain, migraine, mental illness (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety, post-traumatic stress disorder, mild depression, obsessive-compulsive disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental state disorders, movement disorders (e.g., essential tremor or Parkinson's disease), Huntington's disease, Alzheimer's disease, drug addiction, autism or other neurological or psychiatric diseases and damage.

In one implementation, when a programmable connection is established between a programmable device and a stimulator, the programmable device can be used to adjust the stimulation parameters of the stimulator (or the stimulation parameters of the pulse generator; different stimulation parameters correspond to different electrical stimulation signals), or the stimulator can be used to sense the patient's electrophysiological activity to collect electrophysiological signals, and the collected electrophysiological signals can be used to further adjust the stimulation parameters of the stimulator.

Stimulation parameters may include one or more of the following: electrode contact identification for delivering electrical stimulation (e.g. It can be electrode contact #2 and electrode contact #3), frequency (for example, the number of electrical stimulation pulse signals within a unit time of 1s, in Hz), pulse width (the duration of each pulse, in μs), amplitude (generally expressed in voltage, that is, the intensity of each pulse, in V), timing (for example, it can be continuous or burst, and burst refers to a discontinuous timing behavior composed of multiple processes), stimulation mode (including one or more of current mode, voltage mode, timed stimulation mode and cyclic stimulation mode), doctor-controlled upper and lower limits (the range that can be adjusted by the doctor) and patient-controlled upper and lower limits (the range that can be adjusted autonomously by the patient).

In a specific application scenario, various stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.

The program-controlled device may be a doctor program-controlled device (i.e., a program-controlled device used by a doctor) or a patient program-controlled device (i.e., a program-controlled device used by a patient). The doctor program-controlled device may be, for example, a tablet computer, a laptop computer, a desktop computer, a mobile phone, or other intelligent terminal device equipped with program-controlled software. The patient program-controlled device may be, for example, a tablet computer, a laptop computer, a desktop computer, a mobile phone, or other intelligent terminal device equipped with program-controlled software. The patient program-controlled device may also be other electronic devices with program-controlled functions (e.g., a charger with program-controlled functions, a data acquisition device, etc.).

The embodiment of the present application does not restrict the data interaction between the doctor's programmable device and the stimulator. When the doctor performs remote programming, the doctor's programmable device can interact with the stimulator through the server and the patient's programmable device. When the doctor performs offline programming with the patient face to face, the doctor's programmable device can interact with the stimulator through the patient's programmable device, and the doctor's programmable device can also interact with the stimulator directly.

In one embodiment, the patient programmable device may include a host (communicating with a server) and a slave (communicating with a stimulator), and the host and the slave are communicatively connected. Among them, the doctor programmable device can exchange data with the server through a 3G/4G/5G network, the server can exchange data with the host through a 3G/4G/5G network, the host can exchange data with the slave through a Bluetooth protocol/WIFI protocol/USB protocol, the slave can exchange data with the stimulator through a 401MHz-406MHz working frequency band/2.4GHz-2.48GHz working frequency band, and the doctor programmable device can directly exchange data with the stimulator through a 401MHz-406MHz working frequency band/2.4GHz-2.48GHz working frequency band.

In addition to the application fields of the above-mentioned implantable devices, the embodiments of the present application can also be applied to other technical fields of medical devices or even non-medical devices. The embodiments of the present application are not limited to this. As long as it involves communication in an MRI environment, it can be applied, and the instructions sent by the doctor's programming device to the stimulator are not limited to programming instructions.

(System Implementation Method)

Refer to FIG1 , which shows a structural block diagram of a medical system provided in an embodiment of the present application.

The present application provides a medical system, the medical system comprising:

Stimulator 10;

The mode control device 20 is configured to send an MRI mode control instruction to the pulse generator 11 of the stimulator 10, and receive a real-time remaining time of the countdown and display the real-time remaining time in real time.

Continuing to refer to FIG. 1 , the embodiment of the present application further provides a stimulator 10, the stimulator 10 is used to be implanted in a patient's body, and the stimulator 10 includes:

Pulse generator 11;

The electrode lead 12 is used for sensing the electrophysiological activity of the patient to obtain electrophysiological signals, and delivering electrical stimulation to the body tissue of the patient.

In one implementation, the patient's in vivo tissue may be, for example, brain tissue, spinal cord nerve tissue, sacral nerve tissue, etc.

In one embodiment, the stimulator 10 further comprises:

The extension wire 13 is disposed between the pulse generator 11 and the electrode wire 12 , and is used to realize the communication connection between the pulse generator 11 and the electrode wire 12 .

In one implementation, the number of electrode wires 12 may be one or more, and accordingly, the number of extension wires 13 may be one or more. The extension wires 13 correspond to the electrode wires 12 one by one, and each extension wire 13 is arranged between the corresponding electrode wire 12 and the pulse generator 11 .

In one implementation, the pulse generator 11 and the electrode wire 12 are communicatively connected, and the two can communicate directly or exchange data through an extension wire 13 .

When the pulse generator 11 and the electrode wire 12 are both implanted in the patient's skull, the stimulator 10 may not include the extension wire 13 but only include the pulse generator 11 and the electrode wire 12 .

In one implementation, the electrode wire 12 can be implanted in the patient's skull or other locations in the body. The number of electrode wires 12 can be, for example, 1, 2, 3, 4, 5, 6, etc. The number of electrode contacts of each electrode wire 12 can be, for example, 4, 6, 8, 9, 10, 12, 15, 18, etc. When multiple electrode wires 12 are implanted in the patient's skull, the multiple electrode wires 12 can be implanted in the same hemisphere of the brain, or can be implanted in the two hemispheres of the brain respectively.

In one implementation, the electrode wire 12 can be used to sense the electrophysiological activities of single cells and/or multiple cells to obtain electrophysiological signals of single cells and/or local field potentials. Local field potential (LFP) is a special type of electrophysiological signal. In a living body, the synaptic activity of dendrites in a biological tissue of a certain volume will induce an electric current. When this current flows through the extracellular space with a certain impedance, a certain voltage distribution is formed. The local voltage value recorded at a certain point is called the local field potential.

The mode control device 20 refers to an electronic device having a mode control function. The mode control device 20 may be, for example, an external device having a program control function or not having a program control function. Equipped with mode control software (for example, it can be a computer APP or a mobile APP).

In one embodiment, the mode control device 20 is configured to send an MRI mode control instruction to the pulse generator 11 in the following manner:

In response to the search operation, the pulse generator 11 in the listening state is searched and displayed in real time;

In response to a selection operation for one of the pulse generators 11 in the listening state, establishing a communication connection between the mode control device 20 and the selected pulse generator 11;

In response to a setting operation for a preset duration, generating the MRI mode control instruction, wherein the MRI mode control instruction is used to indicate the preset duration of the MRI mode of the pulse generator 11;

The MRI mode control instruction is sent to the selected pulse generator 11 .

The pulse generator 11 is in the listening state, which means that the pulse generator 11 is in a connectable state, that is, waiting for connection but not yet connected. When the pulse generator 11 is in the sleep mode or the fast listening mode, it may be in the listening state, but the frequency is different, that is, the duration of the listening cycle is different. The pulse generator 11 will send a signal to the outside at the beginning of each listening cycle, and the signal includes the identification of the pulse generator 11 itself. When the pulse generator 11 is in the sleep mode, the duration of a listening cycle is, for example, 3 minutes, 5 minutes, 10 minutes, etc. When the pulse generator 11 is in the fast listening mode, the duration of a listening cycle is, for example, 1 second, 2 seconds, 3 seconds, 5 seconds, etc. Once the pulse generator 11 and the external device (for example, the mode control device 20 or the program control device 30) establish a communication connection, the pulse generator 11 enters the connected state from the listening state and enters the communication mode.

The embodiment of the present application does not limit the way of receiving various manual operations (or user operations) by using the mode control device 20 or the program control device 30. The operations are divided according to the input mode, for example, text input operation, audio input operation, video input operation, key operation, button operation, knob operation, mouse operation, keyboard operation, smart stylus operation, smart touchpad operation, etc. These operations include but are not limited to search operation, selection operation, setting operation, receiving MRI operation, etc. Among them, the search operation can be, for example, clicking the "search" control in the mode control software; after searching for the list of pulse generators 11 waiting to be connected, the selection operation can be, for example, clicking one of the pulse generators 11 in the list of pulse generators 11 in the mode control software; after the mode control device 20 is successfully connected to the pulse generator 11, on the function selection page of the mode control software, click the "MRI" control, the setting operation can be, for example, entering the preset duration of the MRI mode in the text input box in the form of a pop-up window, and the value range can be, for example, 1-120 minutes; the receiving MRI operation can be, for example, clicking the "receive MRI" control in the mode control software. In computer programming, a widget (or component, widget, or control) is a graphical user interface element that displays information in a user-changeable arrangement, such as a window or text box. The defining characteristic of a control is that it provides a single point of interaction for direct manipulation of given data. A control is a basic visual building block that is included in an application and controls all data that the program processes and the information about that data. interactive operations.

In one implementation, the “search” control, the “MRI” control, and the “receive MRI” control in the mode control software may be in the form of buttons, for example.

In one embodiment, the mode control device 20 is configured to receive and display the real-time remaining time in the following manner:

In response to receiving the MRI operation, the pulse generator 11 in the MRI mode is searched, and the identification and real-time remaining time of each pulse generator 11 in the MRI mode are received and displayed.

Here, the identification of each pulse generator 11 in the MRI mode and the real-time remaining duration of the MRI mode of each pulse generator 11 are displayed simultaneously. In order to present a better visual effect, a progress bar can also be displayed simultaneously, with the total length of the progress bar indicating the duration of the entire MRI mode, the length of the highlighted portion of the progress bar indicating the duration of the MRI mode, and the length of the non-highlighted portion of the progress bar indicating the real-time remaining duration.

It should be noted that when the pulse generator 11 is not damaged, the real-time remaining time received and displayed by the mode control device 20 is updated at a fixed frequency, for example, once every 2 seconds. In other words, although the mode control device 20 can set the preset duration of the MRI mode, the mode control device 20 itself does not count or count down the MRI mode of the pulse generator 11, but needs to receive the real-time remaining time sent by the pulse generator 11 in real time. For this reason, it is possible to determine whether the pulse generator 11 is damaged based on whether the mode control device 20 receives the real-time remaining time and whether the received real-time remaining time is updated in real time.

In one embodiment, the medical system further comprises:

The program-controlled device 30 is configured to establish a communication connection with the pulse generator 11 and send a program-controlled instruction to the pulse generator 11 to adjust the stimulation parameters of the pulse generator 11 .

The program-controlled device 30 includes a doctor program-controlled device 30 and/or a patient program-controlled device 30. Each doctor program-controlled device 30 can receive a range configuration operation of the corresponding doctor, and configure the adaptively adjustable numerical range corresponding to each stimulation parameter of the pulse generator 11; the pulse generator 11 is used to perform adaptive adjustment within the adaptively adjustable numerical range corresponding to each stimulation parameter, so as to realize closed-loop control of the stimulation parameters. Thus, the doctor can configure the numerical range that allows the stimulator 10 to adaptively adjust the stimulation parameters to ensure the safety of electrical stimulation therapy. The doctor can set different numerical ranges for each patient according to the severity of the patient's condition, taking into account both safety and treatment effect.

The closed-loop control process of the pulse generator 11 adaptively adjusting the stimulation parameters includes: using the electrode wire 12 to sense the patient's electrophysiological activity in real time to obtain an electrophysiological signal; obtaining parameter configuration information corresponding to the electrophysiological signal, wherein the parameter configuration information is used to indicate each stimulation parameter of the pulse generator 11. parameter value; delivering electrical stimulation corresponding to the parameter configuration information to the patient using the electrode wire 12; the adjustment of the stimulation parameters can have an effect on the patient's condition, thereby causing the electrophysiological activity sensed at the next moment to change and obtain a new electrophysiological signal.

In a specific application scenario, the electrode wire 12 is implanted in the patient's skull, and the electrode contacts of the electrode wire 12 have the functions of sensing electrophysiological activities and delivering electrical stimulation. The pulse generator 11 can use the electrode wire 12 to sense the local field potential of the patient's brain, and when the patient is about to become ill or has become ill (the patient's condition is not under control at this time), it can send precise, intermittent stimulation signals to the patient's brain in an intelligent and automated manner.

The embodiment of the present application does not limit the doctor-controlled device 30, which may include, for example, one or more of a tablet computer, a laptop computer, a desktop computer, a mobile phone, a smart wearable device, or a console or a workstation.

In one embodiment, the mode control device 20 and the program control device 30 are integrated into one. That is, the program control device 30 is disposed outside the patient's body and can be equipped with program control software and mode control software at the same time, and the program control software and mode control software can be integrated into one software for easy installation and use.

In one implementation, the caregiver may be, for example, a medical staff or a family member, friend, or other person who takes care of or looks after the patient. The medical staff may include, for example, a doctor, a nurse, or a care worker.

In one embodiment, the patient's disease includes one or more of the following:

Spastic disorders, depression, bipolar disorder, anxiety disorders, post-traumatic stress disorder, obsessive-compulsive disorder, behavioral disorders, mood disorders, memory disorders, mental state disorders, tremors, Parkinson's disease, Huntington's disease, Alzheimer's disease, addictive disorders and autism.

Therefore, electrical stimulation therapy directly stimulates neural targets (such as tissues, nuclei, fiber bundles, etc. such as the nucleus accumbens, anterior limb of the internal capsule, caudate nucleus, lentiform nucleus, putamen, etc.), which can effectively control the condition of the above diseases, alleviate the patient's symptoms, and relieve the patient's pain.

In one implementation, the pulse generator 11 may be configured to implement the steps of a communication method of the pulse generator 11 . The communication method of the pulse generator 11 will be described first, and then the pulse generator 11 will be described.

(Method Example)

Referring to FIG. 2 , FIG. 2 shows a flow chart of a communication method for a pulse generator provided in an embodiment of the present application.

An embodiment of the present application provides a communication method of a pulse generator, wherein the pulse generator is implanted in a patient's body, and the method includes:

Step S101: In response to the MRI mode control instruction, enter the MRI mode, stop receiving information sent by the external device, and start the countdown of the preset duration. The MRI mode control instruction is used to indicate The preset duration of the MRI mode of the pulse generator;

Step S102: When the countdown is not over, the real-time remaining time of the countdown is sent to a preset receiving device at a preset frequency so that the receiving device displays the real-time remaining time. The receiving device includes one or more of a mode control device, a programmable device and a display device, or enters a periodic listening mode. When the countdown is not over, the user can exit the MRI mode through a control instruction.

Step S103: When the countdown ends, exit the MRI mode and resume receiving information sent by the external device.

In the embodiment of the present application, the listening frequency can be customized by the receiving device before entering the MRI mode. Lowering the listening frequency can reduce power consumption and extend the usage time. Increasing the listening frequency can shorten the response time and improve the user experience. In the present embodiment, the frequency of periodic listening is once every 15 seconds to 30 minutes.

As an example, a pulse generator may have, for example, an MRI mode, a sleep mode, and a fast listening mode.

Mode control devices, program control devices and display devices are all external devices, but external devices include more than just these devices.

In one implementation, in the MRI mode, the pulse generator stops receiving information sent by the external device, which means that the pulse generator stops receiving any information sent by the external device.

The embodiment of the present application does not limit the preset duration, and its value range may be, for example, 1-200 minutes. As an example, the preset duration may be, for example, 1, 3, 5, 8, 10, 20, 30, 50, 100, 120, 150, 200 minutes.

During the countdown process, the pulse generator continuously sends information (i.e., the real-time remaining time) to the receiving device. The embodiment of the present application does not limit the preset frequency of the pulse generator sending information, which can be, for example, 1, 0.5, 0.2 Hz, etc. The interval between two information transmissions of the pulse generator can be, for example, 1, 2, 5 seconds, etc.

The related technology does not take into account the possibility that the pulse generator may have been damaged during the MRI detection process, nor does it consider how to notify the caregiver of the situation as soon as possible after the pulse generator is damaged so that the medical staff can take countermeasures (such as replacing or repairing the pulse generator). Therefore, the pulse generators on the market will not actively send the real-time remaining time to the external device at a fixed frequency in the middle of the MRI mode. Some pulse generators can send notification information to the external device after the MRI mode ends, but if the pulse generator is damaged at this time, the notification information cannot be sent smoothly. Even if the caregiver can passively discover that the pulse generator is damaged through the failure of receiving notification information or program control failure, the timing of the knowledge is behind the actual damage of the pulse generator. In other words, it is impossible to make advance preparations for countermeasures such as repairing or replacing the pulse generator, which may delay the patient's condition or cause more serious consequences, because patients using pulse generators may have an urgent need for electrical stimulation treatment, such as severe strong If patients with obsessive-compulsive disorder, mania or drug addicts cannot resume electrical stimulation treatment in time, their condition may be affected and even relapse. The concerns caused by these hidden dangers will make it difficult for the family members of the corresponding patients to accept the necessary MRI tests (i.e. MRI examinations), which will be detrimental to doctors obtaining the necessary MRI data and making accurate diagnosis and treatment of patients to improve their quality of life.

Therefore, the pulse generator continuously sends the real-time remaining time to the receiving device in the MRI mode. When the real-time remaining time displayed by the receiving device is not updated in real time, the caregiver can promptly discover that the pulse generator is damaged.

The pulse generator implanted in the patient has an MRI mode. After entering the MRI mode, the pulse generator will not respond to all external devices. Therefore, external devices cannot obtain information from it (i.e., the pulse generator), cannot actively obtain the status of the pulse generator, and do not know the real-time remaining time of the pulse generator's MRI mode. Doctors and other caregivers cannot accurately arrange programming, nursing and other work after the MRI test is completed. Therefore, the pulse generator is required to actively push the real-time remaining time to the receiving device.

Specifically, the process of the pulse generator actively pushing the real-time remaining time is as follows: after receiving the MRI mode control instruction, the pulse generator will enter the MRI mode, at which time the processor stops receiving information sent by any external device (including all external devices including the mode control device), and counts down the MRI mode (for example, the preset duration, which can be 10 minutes, 20 minutes, 30 minutes, etc.), and continuously sends the real-time remaining time to the receiving device at a preset frequency (for example, 1Hz or 0.5Hz, and the corresponding preset interval duration is, for example, 1 second or 2 seconds) in the MRI mode, so that the caregiver can observe the changes in the real-time remaining time in real time through the receiving device. Once the real-time remaining time of the pulse generator displayed by the receiving device is not updated in real time or the real-time remaining time of the pulse generator cannot be displayed, it indicates that the pulse generator can no longer operate normally and may have been damaged. Therefore, the use of the pulse generator of the present application facilitates caregivers to promptly discover damage to the pulse generator in the MRI mode.

In addition, when the countdown ends, the pulse generator can automatically exit the MRI mode, and the processor resumes receiving information sent by the external device. If the MRI detection does not cause damage to the pulse generator, the electrical stimulation therapy function of the pulse generator can be restored as soon as possible. The doctor can also use the program-controlled device to establish a program-controlled connection with the pulse generator, and make corresponding program-controlled operations according to the patient's current condition. The program-controlled device sends the program-controlled instructions corresponding to the program-controlled operation to the pulse generator. After receiving the program-controlled instructions sent by the program-controlled device, the pulse generator configures one or more stimulation parameters of the pulse generator to deliver electrical stimulation therapy corresponding to the stimulation parameters to the patient's in vivo tissue (such as brain tissue, spinal cord nerve tissue, sacral nerve tissue, etc.), thereby relieving the patient's pain and controlling the patient's condition.

In one embodiment, the step S101 of entering the MRI mode in response to the MRI mode control instruction includes:

In response to the MRI mode control instruction, detecting whether the power of the pulse generator is not less than a preset power threshold;

If the power level of the pulse generator is not less than the preset power threshold, entering the MRI mode;

The method further comprises:

If the power level of the pulse generator is less than the preset power threshold, a first prompt message is sent to the receiving device, where the first prompt message is used to indicate that the power level of the pulse generator is less than the preset power threshold.

The embodiment of the present application does not limit the preset power threshold, which may be, for example, 10%, 15%, 20%, 30%, 50%, 80%, 90%, etc.

Therefore, since a certain amount of power is required to continuously send information to the receiving device (i.e., the real-time remaining time) after entering the MRI mode, it is possible to detect whether there is a corresponding amount of power before entering the MRI mode to avoid failure to send information to external devices due to insufficient power and to eliminate the situation where the pulse generator is mistakenly judged to be damaged due to power factors.

That is to say, the MRI mode will be entered only when the current power of the pulse generator is greater than or equal to the preset power threshold, and the MRI mode will not be entered when the current power of the pulse generator is less than the preset power threshold.

Methods for sending prompt information include SMS push, email push, in-application push, phone notification, etc. The prompt information here includes first prompt information and/or second prompt information, and the application is, for example, Company A APP, Company B APP, mini program, etc.

In one embodiment, the process of obtaining the preset power threshold includes:

The preset power threshold is obtained based on the preset duration and the preset power consumption per unit time.

Therefore, different preset power thresholds are set for different preset durations to meet the power consumption requirements of the pulse generator for sending information to the outside during the MRI mode. For example, when the preset duration of the MRI mode is longer, a higher preset power threshold is set (the value range is, for example, 50-80%); when the preset duration of the MRI mode is shorter, a lower preset power threshold is set (the value range is, for example, 10-30%). The power consumption per unit time refers to the pre-acquired power consumption of the pulse generator per unit time, which can be obtained through experiments or measurements in practice. Among them, the unit time can be, for example, 1 day, 1 hour, 1 minute, 1 second, 100 milliseconds, etc.

In some implementations, the preset duration and the power consumption per unit time may be input into a preset polynomial to calculate a preset power threshold, and the preset polynomial may be a linear polynomial or a nonlinear polynomial.

In other embodiments, the preset duration and power consumption per unit time may be input into a power threshold model to obtain a preset power threshold. The power threshold model may be obtained by training a preset deep learning model using a training set.

In one embodiment, the step S101 of entering the MRI mode in response to the MRI mode control instruction includes:

In response to the MRI mode control instruction, detecting whether each stimulation parameter of the pulse generator is within a corresponding preset range;

If all stimulation parameters are within the corresponding preset range, the MRI mode is entered;

The method further comprises:

If one or more stimulation parameters are not within the corresponding preset range, second prompt information is sent to the receiving device, where the second prompt information is used to indicate the stimulation parameters that are not within the corresponding preset range.

In MRI mode, the whole body or specific parts of the patient enter the MRI device. The external field may cause the electromagnetic field generated by the pulse generator implanted in the patient to fluctuate. This fluctuation may affect the electrical stimulation treatment effect of the pulse generator and even cause damage to the human body. Therefore, the stimulation parameters of the pulse generator can be placed within a given preset range before entering the MRI mode, wherein the preset range is a pre-set value range (the value range can be a numerical value range or a non-numerical value range). When each stimulation parameter is within its corresponding preset range, the pulse generator does not generate an electromagnetic field or the generated electromagnetic field can be less affected by the MRI device. That is, the pulse generator can be turned off in advance (each stimulation parameter is set to 0, empty, or the default option is used), the electrical stimulation treatment is stopped, and then the MRI mode is entered.

The embodiment of the present application does not limit the preset range corresponding to each stimulation parameter.

In one implementation, stimulation parameters may include, for example, one or more of: electrode contact identification, frequency, pulse width, amplitude, timing, and stimulation pattern for delivering electrical stimulation.

As an example, the preset range corresponding to the electrode contact identification for delivering electrical stimulation may be empty (no electrode contact is selected); the preset range corresponding to the frequency, pulse width, and amplitude may be 0, for example; the preset range corresponding to the timing may be continuous and burst (i.e., not limited); the preset range corresponding to the stimulation mode may be current mode, voltage mode, timed stimulation mode, and cyclic stimulation mode (i.e., not limited).

Referring to FIG. 3 , FIG. 3 shows a schematic diagram of a flow chart of determining a parameter value of each stimulation parameter provided by an embodiment of the present application.

In one embodiment, the process of determining the parameter value of each stimulation parameter of the pulse generator includes:

Step S201: using the electrode wire implanted in the patient's body to sense the patient's electrophysiological activity to obtain the patient's electrophysiological signal;

Step S202: inputting the electrophysiological signal of the patient into a state classification model to obtain state classification information corresponding to the electrophysiological signal;

Step S203: When the state classification information corresponding to the electrophysiological signal indicates that the patient's condition is not under control, the electrophysiological signal is input into a parameter configuration model to obtain the parameter configuration information corresponding to the electrophysiological signal, so as to deliver the parameter configuration information to the patient using the electrode lead. The parameter configuration information is used to indicate the parameter value of each stimulation parameter of the pulse generator.

Thus, the patient's condition is classified based on the electrophysiological signals obtained by real-time sensing, and the condition classification information is used to indicate whether the patient's condition is under control or not. When the patient's condition is not under control, corresponding parameter configuration information is obtained based on the electrophysiological signals obtained by real-time sensing, thereby delivering electrical stimulation corresponding to the parameter configuration information to the patient.

That is to say, a prerequisite is set for obtaining the parameter configuration information, that is, the parameter configuration information is obtained only when it is detected based on the patient's electrophysiological signal that the patient's condition is not under control, and when the patient's condition is under control, the parameter configuration information is not obtained.

The advantage of doing so is that it can reduce the number of times parameter configuration information is obtained, reduce the amount of calculation of the pulse generator, reduce power consumption, extend the charging interval of the rechargeable pulse generator or extend the service life of the non-rechargeable pulse generator.

Among them, the state classification model and the parameter configuration model are used to obtain the state classification information and the parameter configuration information respectively, which has strong real-time performance, high accuracy and wide application range.

The training process of the state classification model may include, for example:

Acquire a first training set, the first training set comprising a plurality of first training data, each of the first training data comprising a sample electrophysiological signal and labeling data of state classification information corresponding to the sample electrophysiological signal, the state classification information corresponding to the sample electrophysiological signal being used to indicate whether the disease condition is under control;

For each first training data in the first training set, perform the following processing:

Inputting the sample electrophysiological signals in the first training data into a preset first deep learning model to obtain prediction data of the state classification information corresponding to the sample electrophysiological signals;

Based on the prediction data and the annotation data of the state classification information corresponding to the sample electrophysiological signal, updating the model parameters of the first deep learning model;

Detect whether a preset first training end condition is met; if yes, use the trained first deep learning model as the state classification model; if not, continue to train the first deep learning model using the next first training data.

The training process of the parameter configuration model includes:

Acquire a second training set, where the second training set includes a plurality of second training data, each of the second training data includes a sample electrophysiological signal and labeled data of parameter configuration information corresponding to the sample electrophysiological signal;

For each second training data in the second training set, perform the following processing:

The sample electrophysiological signals in the second training data are input into a preset second deep learning model. Obtaining prediction data of parameter configuration information corresponding to the sample electrophysiological signal;

Based on the prediction data and the annotation data of the parameter configuration information corresponding to the sample electrophysiological signal, updating the model parameters of the second deep learning model;

Detect whether a preset second training end condition is met; if so, use the trained second deep learning model as the parameter configuration model; if not, continue to train the second deep learning model using the next second training data.

Therefore, by designing, establishing an appropriate amount of neuron computing nodes and a multi-layer operation hierarchy, and selecting appropriate input layers and output layers, a preset deep learning model (including a first deep learning model and a second deep learning model) can be obtained. Through the learning and tuning of the deep learning model, a functional relationship from input to output is established. Although the functional relationship between input and output cannot be found 100%, the actual correlation relationship can be approached as much as possible. The state classification model and parameter configuration model thus trained can obtain corresponding output data based on the input data. It has a wide range of applications, and the calculation results are highly accurate and reliable.

Using sample electrophysiological signals to train the deep learning model can quickly build a model by learning only a small number of samples. The training error of the deep learning model will gradually decrease during the continuous training process. The deep learning model can save the optimal weights and read the weights; record the accuracy of the training set and the validation set to facilitate parameter adjustment (adjusting model parameters); updating the model parameters of the deep learning model can make the model fit the data better, have effective generalization ability, and improve robustness and fitting accuracy.

In one embodiment, the embodiment of the present application can train a state classification model and a parameter configuration model. In other optional implementations, the present application can use a pre-trained state classification model and a parameter configuration model.

In one embodiment, for example, data mining can be performed on historical data to obtain sample electrophysiological signals in a training set (including a first training set and a second training set). In other words, these sample electrophysiological signals can be collected from real patients. In addition, the sample electrophysiological signals can also be automatically generated using a generation network of a GAN model.

Among them, the GAN model is a generative adversarial network, which consists of a generator network and a discriminator network. The generator network randomly samples from the latent space as input, and its output needs to imitate the real samples in the training set as much as possible. The input of the discriminator network is the real sample or the output of the generator network. Its purpose is to distinguish the output of the generator network from the real sample as much as possible. The generator network should deceive the discriminator network as much as possible. The two networks confront each other and constantly adjust the parameters. The ultimate goal is to make the discriminator network unable to judge whether the output of the generator network is true. The GAN model can generate multiple sample electrophysiological signals for the training process of the state classification model and the parameter configuration model, which can effectively reduce the amount of original data collection and greatly reduce the cost of data collection and annotation.

The present application embodiment does not limit the method of obtaining the labeled data. For example, manual labeling can be used. When the sample electrophysiological signals are collected from real patients, real data can be obtained from historical data as labeled data by keyword extraction.

The embodiments of the present application do not limit the training process of the state classification model and the parameter configuration model. For example, the above-mentioned supervised learning training method may be adopted, or a semi-supervised learning training method may be adopted, or an unsupervised learning training method may be adopted.

The embodiments of the present application do not limit the preset training end conditions (including the first training end condition and the second training end condition), which may be, for example, the number of training times reaching a preset number of times (the preset number of times may be, for example, 1 time, 3 times, 10 times, 100 times, 1000 times, 10000 times, etc.), or the training data in the training set may have completed one or more trainings, or the total loss value obtained from this training may be no greater than the preset loss value.

In one embodiment, the pulse generator further comprises a wireless communication module;

The process of stopping receiving information sent by external devices includes:

disabling the receiving function of the wireless communication module;

The process of resuming reception of information sent by external devices includes:

The receiving function of the wireless communication module is enabled.

Therefore, since the pulse generator is implanted in the patient's body and wireless communication is adopted between the pulse generator and the external device, disabling the receiving function of the wireless communication module can make the processor stop receiving information sent by the external device. Correspondingly, enabling the receiving function of the wireless communication module can make the processor resume receiving information sent by the external device.

The embodiment of the present application does not limit the wireless communication module, and its operating frequency band may include, for example, 401 MHz-406 MHz (MICS dedicated implantable medical frequency band) and/or 2.4 GHz-2.48 GHz.

MICS stands for Medical Implant Communication Service, which is used to meet the communication needs between external devices and implants. Implants include pacemakers, defibrillators, stimulators, drug delivery systems, etc.

In one embodiment, disabling the receiving function of the wireless communication module includes:

Sending a first enable signal to the wireless communication module to disable a receiving function of the wireless communication module;

The enabling of the receiving function of the wireless communication module comprises:

A second enabling signal is sent to the wireless communication module to enable a receiving function of the wireless communication module.

Thus, the disabling and enabling of the receiving function of the wireless communication module are controlled by the first enable signal and the second enable signal respectively, and the control process is simple and easy to implement. The first enable signal is, for example, a high level, and the second enable signal is, for example, a low level; or, the first enable signal is, for example, a low level, and the second enable signal is, for example, a high level.

In one embodiment, the pulse generator has an MRI mode, a sleep mode, a fast listening mode, and a communication mode;

The process of receiving MRI mode control instructions includes:

When a magnet is detected approaching the pulse generator, the pulse generator is switched from a sleep mode to a fast listening mode, wherein the listening period of the pulse generator in the sleep mode is a first preset time length, and the listening period of the pulse generator in the fast listening mode is a second preset time length, and the second preset time length is less than the first preset time length;

establishing a communication connection between the pulse generator and the mode control device in a fast listening mode so that the pulse generator enters a communication mode;

The MRI mode control instruction is received in the communication mode.

The embodiment of the present application does not limit the magnet, which may be, for example, a permanent magnet or a soft magnet. Specifically, the magnet may be a magnet or other magnetic object.

Therefore, in the sleep mode, the pulse generator has a longer listening period, and it may take a long time to be searched by the mode control device; while in the fast listening mode, the pulse generator has a shorter listening period, and can be quickly searched by the mode control device.

Therefore, when MRI mode control is required for a designated pulse generator, a magnet can be used to approach the pulse generator, switch the pulse generator from sleep mode to fast listening mode, establish a communication connection, and receive MRI mode control instructions in the communication mode.

The advantage of doing this is that the designated pulse generator can be quickly searched by the mode control device and MRI mode control can be executed, thereby improving the efficiency of MRI mode control and reducing the time patients have to wait to enter the MRI device. This can assist patients in quickly completing the MRI detection process as a whole and resume normal electrical stimulation treatment, reduce patients' psychological stress, and help stabilize their condition, especially for patients with severe obsessive-compulsive disorder or drug addicts who are highly dependent on electrical stimulation treatment.

(Equipment Example)

The present application also provides a pulse generator, the specific implementation of which is consistent with the implementation described in the above method embodiment and the technical effects achieved, and some contents will not be repeated here.

The pulse generator is used to be implanted in a patient's body, and the pulse generator includes a memory and a processor, wherein the memory stores a computer program, and the processor is configured to implement the following steps when executing the computer program:

In response to an MRI mode control instruction, enter the MRI mode, stop receiving information sent by an external device, and start a countdown of a preset duration, wherein the MRI mode control instruction is used to indicate the preset duration of the MRI mode of the pulse generator;

When the countdown is not over, the real-time remaining time of the countdown is sent to the preset receiving Device, so that the receiving device displays the real-time remaining time, the receiving device includes one or more of a mode control device, a program control device and a display device;

When the countdown ends, exit the MRI mode and resume receiving information sent by external devices.

In one embodiment, the processor is configured to enter the MRI mode in response to the MRI mode control instruction in the following manner when executing the computer program:

In response to the MRI mode control instruction, detecting whether the power of the pulse generator is not less than a preset power threshold;

If the power level of the pulse generator is not less than the preset power threshold, entering the MRI mode;

The processor is further configured to implement the following steps when executing the computer program:

If the power level of the pulse generator is less than the preset power threshold, a first prompt message is sent to the receiving device, where the first prompt message is used to indicate that the power level of the pulse generator is less than the preset power threshold.

In one embodiment, the processor is configured to obtain the preset power threshold in the following manner when executing the computer program:

The preset power threshold is obtained based on the preset duration and the preset power consumption per unit time.

In one embodiment, the processor is configured to enter the MRI mode in response to the MRI mode control instruction in the following manner when executing the computer program:

In response to the MRI mode control instruction, detecting whether each stimulation parameter of the pulse generator is within a corresponding preset range;

If all stimulation parameters are within the corresponding preset range, the MRI mode is entered;

The processor is further configured to implement the following steps when executing the computer program:

If one or more stimulation parameters are not within the corresponding preset range, second prompt information is sent to the receiving device, where the second prompt information is used to indicate the stimulation parameters that are not within the corresponding preset range.

In one embodiment, the processor is further configured to determine the parameter value of each stimulation parameter of the pulse generator in the following manner when executing the computer program:

Using an electrode wire implanted in the patient's body to sense the patient's electrophysiological activity to obtain the patient's electrophysiological signal;

Inputting the electrophysiological signal of the patient into a state classification model to obtain state classification information corresponding to the electrophysiological signal;

When the state classification information corresponding to the electrophysiological signal is used to indicate that the patient's condition is not under control, the electrophysiological signal is input into a parameter configuration model to obtain the parameter configuration information corresponding to the electrophysiological signal, so as to deliver electrical stimulation corresponding to the parameter configuration information to the patient using the electrode wire, and the parameter configuration information is used to indicate the parameter value of each stimulation parameter of the pulse generator.

In one embodiment, the pulse generator further comprises a wireless communication module;

The processor is configured to stop receiving information sent by an external device in the following manner when executing the computer program:

disabling the receiving function of the wireless communication module;

The processor is configured to recover the information sent by the external device in the following manner when executing the computer program:

The receiving function of the wireless communication module is enabled.

In one embodiment, the processor is configured to disable the receiving function of the wireless communication module in the following manner when executing the computer program:

Sending a first enable signal to the wireless communication module to disable a receiving function of the wireless communication module;

The processor is configured to enable the receiving function of the wireless communication module in the following manner when executing the computer program:

A second enabling signal is sent to the wireless communication module to enable a receiving function of the wireless communication module.

In one embodiment, the pulse generator has an MRI mode, a sleep mode, a fast listening mode, and a communication mode;

The processor is configured to receive the MRI mode control instruction in the following manner when executing the computer program:

When a magnet is detected approaching the pulse generator, the pulse generator is switched from a sleep mode to a fast listening mode, wherein the listening period of the pulse generator in the sleep mode is a first preset time length, and the listening period of the pulse generator in the fast listening mode is a second preset time length, and the second preset time length is less than the first preset time length;

establishing a communication connection between the pulse generator and the mode control device in a fast listening mode so that the pulse generator enters a communication mode;

The MRI mode control instruction is received in the communication mode.

Referring to FIG. 4 , FIG. 4 shows a structural block diagram of a pulse generator provided in an embodiment of the present application.

The pulse generator may include, for example, one or more memories 210 , one or more processors 220 , and a bus 230 connecting different platform systems.

The memory 210 may include a readable medium in the form of a volatile memory, such as a random access memory (RAM) 211 and/or a cache memory 212 , and may further include a read-only memory (ROM) 213 .

The memory 210 also stores a computer program, which can be executed by the processor 220, so that the processor 220 implements the steps of any of the above methods.

The memory 210 may also include a utility 214 having one or more program modules 215, such program modules 215 including but not limited to: an operating system, one or more application programs, other program modules, and program data, each of which or some combination may include an implementation of a network environment.

Accordingly, the processor 220 may execute the above-mentioned computer program and may execute the utility 214 .

The processor 220 can adopt one or more application specific integrated circuits (ASICs), DSPs, programmable logic devices (PLDs), complex programmable logic devices (CPLDs), field programmable gate arrays (FPGAs), or other electronic components.

Bus 230 may be a local bus representing one or more of several types of bus structures, including a memory bus or memory controller, a peripheral bus, an accelerated graphics port, a processor, or any of a variety of bus architectures.

The pulse generator may also communicate with one or more external devices 240, such as a keyboard, pointing device, Bluetooth device, etc., and may also communicate with one or more devices capable of interacting with the pulse generator, and/or any device that enables the pulse generator to communicate with one or more other computing devices (e.g., a router, a modem, etc.). Such communication may be performed via input/output interface 250. In addition, the pulse generator may also communicate with one or more networks (e.g., a local area network (LAN), a wide area network (WAN), and/or a public network, such as the Internet) via network adapter 260. Network adapter 260 may communicate with other modules of the pulse generator via bus 230. It should be understood that, although not shown in the figure, other hardware and/or software modules may be used in conjunction with the pulse generator, including but not limited to: microcode, device drivers, redundant processors, external disk drive arrays, RAID systems, tape drives, and data backup storage platforms.

(Medium Example)

An embodiment of the present application also provides a computer-readable storage medium, which stores a computer program. When the computer program is executed by a processor, it implements the steps of any of the above methods or implements the functions of any of the above pulse generators. Its specific implementation method is consistent with the implementation method and the technical effect achieved in the above method embodiment, and some contents will not be repeated here.

Referring to FIG. 5 , FIG. 5 shows a schematic diagram of the structure of a program product provided in an embodiment of the present application.

The program product is used to implement the steps of any of the above methods. The program product may be a portable compact disk read-only memory (CD-ROM) and include program code, and can be run on a terminal device, such as a personal computer. However, the program product of the present invention is not limited to this. In one implementation, the readable storage medium may be any tangible medium containing or storing a program, which may be used by or in combination with an instruction execution system, apparatus or device. The program product may be any combination of one or more readable media. The readable medium may be a readable signal medium or a readable storage medium. The readable storage medium may be, for example, a non-readable medium. Systems, devices or components limited to electrical, magnetic, optical, electromagnetic, infrared, or semiconductor, or any combination thereof. More specific examples of readable storage media (a non-exhaustive list) include: an electrical connection with one or more conductors, a portable disk, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), an optical fiber, a portable compact disk read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination thereof.

Computer-readable storage media may include data signals propagated in baseband or as part of a carrier wave, wherein readable program codes are carried. Such propagated data signals may take various forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination of the above. The readable storage medium may also be any readable medium, which may send, propagate, or transmit a program for use by an instruction execution system, an apparatus, or a device or for use in combination with it. The program code contained on the readable storage medium may be transmitted with any appropriate medium, including but not limited to wireless, wired, optical cable, RF, etc., or any suitable combination of the above. The program code for performing the operation of the present invention may be written in any combination of one or more programming languages, including object-oriented programming languages such as Java, C++, etc., and also conventional procedural programming languages such as C language or similar programming languages. The program code may be executed entirely on a user computing device, partially on a user device, as an independent software package, partially on a user computing device, partially on a remote computing device, or entirely on a remote computing device or server. Where a remote computing device is involved, the remote computing device may be connected to the user computing device through any type of network, including a local area network (LAN) or a wide area network (WAN), or may be connected to an external computing device (e.g., through the Internet using an Internet service provider).

Claims (21)

A pulse generator is used to be implanted in a patient's body, the pulse generator comprises a memory and a processor, the memory stores a computer program, and the processor is configured to implement the following steps when executing the computer program: Entering the MRI mode in response to an MRI mode control instruction, wherein the MRI mode control instruction is used to indicate a preset duration of the MRI mode of the pulse generator; Stop receiving information sent by an external device and start a countdown of a preset duration. When the countdown is not over, send the real-time remaining duration of the countdown to a preset receiving device at a preset frequency so that the receiving device displays the real-time remaining duration. The receiving device includes one or more of a mode control device, a program-controlled device, and a display device; or enter a periodic listening mode. When the countdown is not over, the MRI mode can be exited through a control instruction; When the countdown ends, exit the MRI mode and resume receiving information sent by external devices. The pulse generator according to claim 1, wherein the processor is configured to enter the MRI mode in response to the MRI mode control instruction in the following manner when executing the computer program: In response to the MRI mode control instruction, detecting whether the power of the pulse generator is not less than a preset power threshold; If the power level of the pulse generator is not less than the preset power threshold, entering the MRI mode; The processor is further configured to implement the following steps when executing the computer program: If the power level of the pulse generator is less than the preset power threshold, a first prompt message is sent to the receiving device, where the first prompt message is used to indicate that the power level of the pulse generator is less than the preset power threshold. The pulse generator according to claim 2, wherein the processor is configured to obtain the preset power threshold in the following manner when executing the computer program: The preset power threshold is obtained based on the preset duration and the preset power consumption per unit time. The pulse generator according to claim 1, wherein the processor is configured to enter the MRI mode in response to the MRI mode control instruction in the following manner when executing the computer program: In response to the MRI mode control instruction, detecting whether each stimulation parameter of the pulse generator is within a corresponding preset range; If all stimulation parameters are within the corresponding preset range, the MRI mode is entered; The processor is further configured to implement the following steps when executing the computer program: If one or more stimulation parameters are not within the corresponding preset range, a first Second prompt information, the second prompt information is used to indicate a stimulation parameter that is not within its corresponding preset range. The pulse generator according to claim 4, wherein the processor is further configured to determine the parameter value of each stimulation parameter of the pulse generator in the following manner when executing the computer program: Using an electrode wire implanted in the patient's body to sense the patient's electrophysiological activity to obtain the patient's electrophysiological signal; Inputting the electrophysiological signal of the patient into a state classification model to obtain state classification information corresponding to the electrophysiological signal; When the state classification information corresponding to the electrophysiological signal is used to indicate that the patient's condition is not under control, the electrophysiological signal is input into a parameter configuration model to obtain the parameter configuration information corresponding to the electrophysiological signal, so as to deliver electrical stimulation corresponding to the parameter configuration information to the patient using the electrode wire, and the parameter configuration information is used to indicate the parameter value of each stimulation parameter of the pulse generator. The pulse generator according to claim 1, wherein the pulse generator further comprises a wireless communication module; The processor is configured to stop receiving information sent by an external device in the following manner when executing the computer program: disabling the receiving function of the wireless communication module; The processor is configured to recover the information sent by the external device in the following manner when executing the computer program: The receiving function of the wireless communication module is enabled. The pulse generator according to claim 6, wherein the processor is configured to disable the receiving function of the wireless communication module in the following manner when executing the computer program: Sending a first enable signal to the wireless communication module to disable a receiving function of the wireless communication module; The processor is configured to enable the receiving function of the wireless communication module in the following manner when executing the computer program: A second enabling signal is sent to the wireless communication module to enable a receiving function of the wireless communication module. The pulse generator according to any one of claims 1 to 7, wherein the pulse generator has an MRI mode, a sleep mode, a fast listening mode and a communication mode; The processor is configured to receive the MRI mode control instruction in the following manner when executing the computer program: When a magnet is detected approaching the pulse generator, the pulse generator is switched from a sleep mode to a fast listening mode, wherein the listening period of the pulse generator in the sleep mode is a first preset time length, and the listening period of the pulse generator in the fast listening mode is a second preset time length, and the second preset time length is less than the first preset time length; establishing a communication connection between the pulse generator and the mode control device in a fast listening mode so that the pulse generator enters a communication mode; The MRI mode control instruction is received in the communication mode. A communication method for a pulse generator, wherein the pulse generator is implanted in a patient's body, the method comprising: In response to an MRI mode control instruction, enter the MRI mode, stop receiving information sent by an external device, and start a countdown of a preset duration, wherein the MRI mode control instruction is used to indicate the preset duration of the MRI mode of the pulse generator; When the countdown is not over, the real-time remaining time of the countdown is sent to a preset receiving device at a preset frequency, so that the receiving device displays the real-time remaining time, and the receiving device includes one or more of a mode control device, a program control device and a display device, or enters a periodic listening mode; When the countdown ends, exit the MRI mode and resume receiving information sent by external devices. The communication method of a pulse generator according to claim 9, wherein the step of entering the MRI mode in response to the MRI mode control instruction comprises: In response to the MRI mode control instruction, detecting whether the power of the pulse generator is not less than a preset power threshold; If the power level of the pulse generator is not less than the preset power threshold, entering the MRI mode; A communication method for a pulse generator according to claim 10, wherein the method further comprises: If the power level of the pulse generator is less than the preset power threshold, a first prompt message is sent to the receiving device, where the first prompt message is used to indicate that the power level of the pulse generator is less than the preset power threshold. According to the communication method of the pulse generator of claim 11, the process of obtaining the preset power threshold comprises: The preset power threshold is obtained based on the preset duration and the preset power consumption per unit time. A communication method for a pulse generator according to claim 9, wherein if one or more stimulation parameters are not within the corresponding preset range, a second prompt message is sent to the receiving device, The second prompt information is used to indicate that the stimulation parameter is not within the preset range corresponding to itself. A stimulator, the stimulator is used to be implanted in a patient's body, the stimulator comprising: The pulse generator according to any one of claims 1 to 8; The electrode lead is used for sensing the electrophysiological activity of the patient to obtain an electrophysiological signal, and delivering electrical stimulation to the body tissue of the patient. The stimulator according to claim 14, wherein the stimulator further comprises: An extension wire is provided between the pulse generator and the electrode wire, and is used to realize a communication connection between the pulse generator and the electrode wire. A medical system, comprising: The stimulator according to claim 14 or 15; A mode control device is configured to send an MRI mode control instruction to the pulse generator of the stimulator, and receive a real-time remaining time of the countdown and display the real-time remaining time in real time. The medical system according to claim 16, wherein the mode control device is configured to send the MRI mode control instruction to the pulse generator in the following manner: In response to the search operation, the pulse generator in the listening state is searched and displayed in real time; In response to a selection operation on one of the pulse generators in the listening state, establishing a communication connection between the mode control device and the selected pulse generator; In response to a setting operation for a preset duration, generating the MRI mode control instruction, wherein the MRI mode control instruction is used to indicate a preset duration of the MRI mode of the pulse generator; The MRI mode control instruction is sent to the selected pulse generator. The medical system according to claim 17, wherein the mode control device is configured to receive and display the real-time remaining time in the following manner: In response to receiving the MRI operation, the pulse generators in the MRI mode are searched, and the identification and real-time remaining time of each pulse generator in the MRI mode are received and displayed. The medical system according to claim 17, wherein the medical system further comprises: A programmable device is configured to establish a communication connection with the pulse generator and send a programmable instruction to the pulse generator to adjust the stimulation parameters of the pulse generator. The medical system according to claim 19, wherein the mode control device and the program control device are integrated into one. A computer-readable storage medium storing a computer program. When the computer program is executed by a processor, the function of the pulse generator according to any one of claims 1 to 8 is realized.