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

Abstract

The application provides a pulse generator, a stimulator, a medical system and a computer readable storage medium. The pulse generator comprises a memory and a processor. The processor is configured to: enter an MRI mode in response to an MRI mode control instruction, the MRI mode control instruction being 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 preset duration countdown, and when the countdown is not ended, send a 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 comprising one or more of a mode control device, a program control device and a display device; and when the countdown is ended, exit the MRI mode and resume receiving information sent by the external device. The pulse generator continuously sends the real-time remaining duration to the receiving device in the MRI mode. When the real-time remaining duration is not updated in real time, a caregiver can discover that the pulse generator has been damaged in time.

Description

[0001] This application claims priority to Chinese Patent Application No. 202211291000.2, filed on October 21, 2022, which is incorporated herein by reference in its entirety. Technical Field

[0002] This application relates to the technical fields of implantable devices, deep brain stimulation, and deep learning, including pulse generators, stimulators, medical systems, and computer-readable storage media. Background Technology

[0003] With technological advancements and social progress, patients are eager to improve their quality of life through various treatments, among which medical devices, especially implantable devices, have a very broad application prospect. Implantable devices refer to medical devices that are surgically inserted entirely or partially into the human body or cavities (or openings), or used to replace the surface of the human epithelium or eye, and remain in the body for 30 days or more after the surgical procedure or are absorbed by the body. Stimulators are a type of implantable device. Stimulators typically include an IPG (Implantable Pulse Generator), extension leads, and electrode leads, providing patients with precise electrical stimulation therapy with controllable parameters, and are popular with many consumers in the market.

[0004] Implants (i.e., implantable devices) can be affected or even damaged after being placed inside an MRI (Magnetic Resonance Imaging) device. Specifically, when a patient or a specific part of their body is placed inside an MRI device, the device generates various magnetic and electromagnetic fields to obtain images of the patient, including static magnetic fields, gradient magnetic fields, and radio frequency (RF) fields. If an implant is present in the patient, the various fields generated by the MRI device may affect the implant's electrical stimulation therapy, causing the implant to deliver treatment when not needed, or not deliver treatment when needed.

[0005] Patent CN106110503B discloses a method for operating an implantable medical device with an MRI mode. The implantable medical device includes an in-vivo implant and an external controller, and the in-vivo implant includes circuit elements sensitive to external strong magnetic fields. The method for operating the implantable medical device includes a method for controlling the in-vivo implant. The method for controlling the in-vivo implant includes the following steps: Step S11, detecting an external strong magnetic field and determining whether the presence of the external strong magnetic field is detected; if yes, proceed to step S12; if no, repeat step S11; Step S12, recording the detected... The system records the duration of the external strong magnetic field and the status of the implanted device, marks the location as being in a strong magnetic field environment, and proceeds to step S13. In step S13, it switches to MRI mode, marks the MRI mode switching event, and proceeds to step S14. In step S14, it determines whether the external strong magnetic field has disappeared; if so, it proceeds to step S15; otherwise, it repeats step S14. In step S15, it records the time the external strong magnetic field disappeared and the status of the implanted device, marks the location as leaving the strong magnetic field environment, and proceeds to step S16. In step S16, it switches to normal mode, marks the MRI mode switching event, and returns to step S11. This method can automatically sense the presence of an external strong magnetic field and automatically switch to MRI mode, and notify external devices when the MRI mode ends.

[0006] Based on this, this application provides a pulse generator, a stimulator, a medical system, and a computer-readable storage medium to improve related technologies. Summary of the Invention

[0007] The purpose of this application is to provide a pulse generator, stimulator, medical system, and computer-readable storage medium, wherein the pulse generator continuously sends the real-time remaining duration to a designated external device in MRI mode, and caregivers can promptly detect that the pulse generator is damaged when the real-time remaining duration displayed on the receiving device is not updated in real time.

[0008] The objective of this application is achieved through the following technical solution:

[0009] In a first aspect, this application provides a pulse generator for implantation in a patient, the pulse generator including a memory and a processor, the memory storing a computer program, and the processor configured to execute the computer program to perform the following steps:

[0010] In response to an MRI mode control command, the device enters an MRI mode, wherein the MRI mode control command is used to indicate the preset duration of the MRI mode of the pulse generator;

[0011] Stop receiving information from external devices and start a countdown of a preset duration. Before the countdown ends, send the real-time remaining duration of the countdown to a preset receiving device at a preset frequency so that the receiving device can display the real-time remaining duration. The receiving device includes one or more of a mode control device, a programmable device, and a display device; or enter a periodic listening mode. Before the countdown ends, the MRI mode can be exited by a control command.

[0012] When the countdown ends, exit MRI mode and resume receiving information sent by external devices.

[0013] The existing technology does not account for the possibility that the pulse generator may be damaged during MRI, nor does it consider how to promptly notify caregivers if the pulse generator is damaged, so that medical staff can take appropriate measures (such as replacing or repairing the pulse generator). Therefore, commercially available pulse generators do not actively and continuously send real-time remaining duration information to external devices at a fixed frequency during MRI mode. Some pulse generators can send notification information to external devices after the MRI mode ends, but if the pulse generator is damaged at this time, it cannot successfully send notification information. Even if caregivers passively discover that the pulse generator is damaged through non-receiving notification information or program failure, the time of discovery is behind the actual moment of damage. In other words, it is impossible to prepare in advance for measures such as repairing or replacing the pulse generator, which may delay the patient's condition or lead to more serious consequences. This is because patients using pulse generators may have a very urgent need for electrical stimulation therapy, such as patients with severe obsessive-compulsive disorder, bipolar disorder, or drug addicts. If electrical stimulation therapy cannot be resumed in a timely manner, it may affect the stability of these patients' conditions or even cause their conditions to relapse. These concerns may make it difficult for patients' families to accept necessary MRI examinations, which would hinder doctors from obtaining the necessary MRI data and from making accurate diagnoses and treatments to improve patients' quality of life.

[0014] The beneficial effect of this technical solution is that the pulse generator continuously sends the real-time remaining duration to the designated external device (i.e., the receiving device) in MRI mode. When the real-time remaining duration displayed by the receiving device is not updated in real time, caregivers can promptly detect that the pulse generator has been damaged.

[0015] The pulse generator implanted in the patient's body has an MRI mode. Once in MRI mode, the pulse generator will not respond to any external devices. Therefore, external devices cannot acquire information from it (i.e., the pulse generator) and cannot actively obtain information about the pulse generator. They do not know the real-time remaining duration of the pulse generator's MRI mode. Doctors and other caregivers cannot accurately arrange programming, nursing care, and other tasks after the MRI examination. Therefore, the pulse generator needs to actively push the real-time remaining duration to the receiving device.

[0016] Specifically, the process of the pulse generator actively pushing the real-time remaining duration is as follows: After receiving the MRI mode control command, the pulse generator enters MRI mode. At this time, the processor stops receiving information from any external devices (including all external devices such as the mode control device) and starts a countdown for the MRI mode (e.g., a preset duration, such as 10 minutes, 20 minutes, 30 minutes, etc.). Within the MRI mode, it continuously sends the real-time remaining duration to the receiving device at a preset frequency (e.g., 1Hz or 0.5Hz, with a corresponding preset interval of 1 second or 2 seconds), allowing caregivers to observe the changes in the real-time remaining duration through the receiving device. If the real-time remaining duration displayed on the receiving device is not updated in real time or cannot be displayed, it indicates that the pulse generator is malfunctioning and may have been damaged. Therefore, using the pulse generator of this application allows caregivers to promptly detect damage to the pulse generator within the MRI mode.

[0017] Furthermore, when the countdown ends, the pulse generator can automatically exit MRI mode, and the processor resumes receiving information from external devices. If the MRI scan did not damage the pulse generator, its electrical stimulation therapy function can be restored as soon as possible. Doctors can also establish a programmable connection with the pulse generator using a programmable device to perform corresponding programmed operations based on the patient's current condition. The programmable device sends the corresponding programmable instructions to the pulse generator. Upon receiving these instructions, the pulse generator configures one or more stimulation parameters to deliver electrical stimulation therapy corresponding to the parameters to the patient's internal tissues (e.g., brain tissue, spinal cord nerve tissue, sacral nerve tissue, etc.), thereby alleviating the patient's pain and controlling their condition.

[0018] In one embodiment, the processor is configured to enter MRI mode in response to MRI mode control commands when executing the computer program in the following manner:

[0019] In response to the MRI mode control command, it is detected whether the power of the pulse generator is not less than a preset power threshold;

[0020] If the power of the pulse generator is not less than the preset power threshold, then enter MRI mode;

[0021] The processor is also configured to perform the following steps when executing the computer program:

[0022] If the power of the pulse generator is less than the preset power threshold, a first prompt message is sent to the receiving device, the first prompt message indicating that the power of the pulse generator is less than the preset power threshold.

[0023] The beneficial effects of this technical solution are as follows: since a certain amount of power is required after entering MRI mode in order to continuously send information to the receiving device (i.e., the real-time remaining time), it is possible to detect whether there is sufficient power before entering MRI mode, so as to avoid the failure to send information to external devices due to insufficient power and to eliminate the possibility of misjudging the damage to the pulse generator due to power factors.

[0024] In one embodiment, the processor is configured to obtain the preset power threshold when executing the computer program in the following manner:

[0025] Based on the preset duration and the preset power consumption per unit time, the preset power threshold is obtained.

[0026] The beneficial effects of this technical solution are as follows: Different preset power thresholds are set for different preset durations to meet the power consumption requirements of the pulse generator when transmitting information during MRI mode. For example, when the preset duration of the MRI mode is long, a higher preset power threshold is set (e.g., 50-80%); when the preset duration of the MRI mode is short, a lower preset power threshold is set (e.g., 10-30%). 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 measured during practice. In some embodiments, the preset duration and power consumption per unit time can be input into a preset polynomial to calculate the preset power threshold. This preset polynomial can be a linear polynomial or a nonlinear polynomial. In other embodiments, the preset duration and power consumption per unit time can be input into a power threshold model to obtain the preset power threshold. This power threshold model can be obtained by training a preset deep learning model using a training set.

[0027] In one embodiment, the processor is configured to enter MRI mode in response to MRI mode control commands when executing the computer program in the following manner:

[0028] In response to the MRI mode control command, it is detected whether each stimulation parameter of the pulse generator is within the corresponding preset range;

[0029] If all stimulation parameters are within the corresponding preset range, then enter MRI mode;

[0030] The processor is also configured to perform the following steps when executing the computer program:

[0031] If one or more stimulus parameters are not within their corresponding preset range, a second prompt message is sent to the receiving device. The second prompt message is used to indicate the stimulus parameters that are not within their corresponding preset range.

[0032] The beneficial effects of this technical solution are as follows: In MRI mode, when a patient's whole body or a specific part enters the MRI equipment, external fields may cause fluctuations in the electromagnetic field generated by the pulse generator implanted in the patient's body. These fluctuations may affect the electrical stimulation treatment effect of the pulse generator, or even cause damage to the human body. Therefore, the stimulation parameters of the pulse generator can be kept within a given preset range before entering MRI mode. The preset range is a pre-defined range of values ​​(which can be numerical or non-numerical). When each stimulation parameter is within its corresponding preset range, the pulse generator does not generate an electromagnetic field, or the generated electromagnetic field is less affected by the MRI equipment. That is, the pulse generator can be turned off in advance (making each stimulation parameter 0, empty, or using default options), stopping the electrical stimulation treatment, and then entering MRI mode.

[0033] 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:

[0034] Electrophysiological activity of the patient is sensed using electrode wires implanted in the patient's body to obtain the patient's electrophysiological signals;

[0035] The patient's electrophysiological signals are input into a state classification model to obtain state classification information corresponding to the electrophysiological signals;

[0036] 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 the parameter configuration model to obtain the parameter configuration information corresponding to the electrophysiological signal. Then, the electrode wire is used to deliver the electrical stimulation corresponding to the parameter configuration information to the patient. The parameter configuration information is used to indicate the parameter value of each stimulation parameter of the pulse generator.

[0037] The beneficial effects of this technical solution are as follows: Patient states are classified based on real-time sensed electrophysiological signals. State classification information indicates whether the patient's condition is under control or uncontrolled. When the patient's condition is uncontrolled, corresponding parameter configuration information is obtained based on the real-time sensed electrophysiological signals, thereby delivering electrical stimulation corresponding to that parameter configuration information to the patient. A precondition is set for obtaining parameter configuration information: it is only obtained when the patient's condition is detected as uncontrolled based on the patient's electrophysiological signals; otherwise, it is not obtained. This approach reduces the number of times parameter configuration information is obtained, reduces the computational load of the pulse generator, reduces power consumption, and extends the charging interval of rechargeable pulse generators or the lifespan of non-rechargeable pulse generators. Furthermore, using a state classification model and a parameter configuration model to obtain state classification information and parameter configuration information respectively offers strong real-time performance, high accuracy, and wide applicability.

[0038] In one embodiment, the pulse generator further includes a wireless communication module;

[0039] The processor is configured to stop receiving information from external devices when executing the computer program in the following manner:

[0040] Disable the receiving function of the wireless communication module;

[0041] The processor is configured to recover information sent by an external device when executing the computer program in the following manner:

[0042] Enable the receiving function of the wireless communication module.

[0043] The beneficial effects of this technical solution are as follows: Since the pulse generator is implanted in the patient's body, and the pulse generator and the external device communicate wirelessly, disabling the receiving function of the wireless communication module can stop the processor from receiving information sent by the external device, and correspondingly, enabling the receiving function of the wireless communication module can enable the processor to resume receiving information sent by the external device.

[0044] In one embodiment, the processor is configured to disable the receiving function of the wireless communication module when executing the computer program in the following manner:

[0045] Send a first enable signal to the wireless communication module to disable the receiving function of the wireless communication module;

[0046] When the processor is configured to execute the computer program, it enables the receiving function of the wireless communication module in the following manner:

[0047] A second enable signal is sent to the wireless communication module to enable the receiving function of the wireless communication module.

[0048] The beneficial effect of this technical solution is that 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.

[0049] In one embodiment, the pulse generator has an MRI mode, a sleep mode, a fast listening mode, and a communication mode;

[0050] The processor is configured to receive MRI mode control commands in the following manner when executing the computer program:

[0051] When a magnet is detected approaching the pulse generator, the pulse generator is switched from sleep mode to fast listening mode. The listening period of the pulse generator in sleep mode is a first preset duration, and the listening period of the pulse generator in fast listening mode is a second preset duration, the second preset duration being shorter than the first preset duration.

[0052] In the fast listening mode, a communication connection is established between the pulse generator and the mode control device so that the pulse generator enters the communication mode.

[0053] Receive the MRI mode control command in communication mode.

[0054] The beneficial effects of this technical solution are as follows: In sleep mode, the pulse generator has a longer listening cycle, which may take a longer time for it to be detected by the mode control device; while in fast listening mode, the pulse generator has a shorter listening cycle and can be detected quickly by the mode control device. Therefore, when it is necessary to control a specific pulse generator for MRI mode, a magnet can be brought close to the pulse generator to switch it from sleep mode to fast listening mode, establish a communication connection, and receive MRI mode control commands in communication mode. The advantage of this is that it allows the specified pulse generator to be quickly detected by the mode control device and MRI mode control to be executed, improving the efficiency of MRI mode control, reducing the patient's waiting time to enter the MRI equipment, and overall assisting the patient to quickly complete the MRI examination process and resume normal electrical stimulation therapy, reducing the patient's psychological stress and helping to stabilize the patient's condition, especially for patients with severe obsessive-compulsive disorder or drug addicts who are heavily dependent on electrical stimulation therapy.

[0055] Secondly, this application provides a communication method for a pulse generator, the pulse generator being implanted in a patient's body, the method comprising:

[0056] In response to the MRI mode control command, the device enters MRI mode, stops receiving information from external devices, and begins a countdown for a preset duration. The MRI mode control command is used to indicate the preset duration of the MRI mode of the pulse generator.

[0057] When the countdown has not ended, the real-time remaining duration of the countdown is sent to a preset receiving device at a preset frequency so that the receiving device can display the real-time remaining duration. 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.

[0058] When the countdown ends, exit MRI mode and resume receiving information sent by external devices.

[0059] In one embodiment, entering MRI mode in response to an MRI mode control command includes:

[0060] In response to the MRI mode control command, it is detected whether the power of the pulse generator is not less than a preset power threshold;

[0061] If the power of the pulse generator is not less than the preset power threshold, then enter MRI mode;

[0062] The method further includes:

[0063] If the power of the pulse generator is less than the preset power threshold, a first prompt message is sent to the receiving device, the first prompt message indicating that the power of the pulse generator is less than the preset power threshold.

[0064] In one embodiment, the process of obtaining the preset power threshold includes:

[0065] Based on the preset duration and the preset power consumption per unit time, the preset power threshold is obtained.

[0066] In one embodiment, entering MRI mode in response to an MRI mode control command includes:

[0067] In response to the MRI mode control command, it is detected whether each stimulation parameter of the pulse generator is within the corresponding preset range;

[0068] If all stimulation parameters are within the corresponding preset range, then enter MRI mode;

[0069] The method further includes:

[0070] If one or more stimulus parameters are not within their corresponding preset range, a second prompt message is sent to the receiving device. The second prompt message is used to indicate the stimulus parameters that are not within their corresponding preset range.

[0071] In one embodiment, the process of determining the parameter value of each stimulation parameter of the pulse generator includes:

[0072] Electrophysiological activity of the patient is sensed using electrode wires implanted in the patient's body to obtain the patient's electrophysiological signals;

[0073] The patient's electrophysiological signals are input into a state classification model to obtain state classification information corresponding to the electrophysiological signals;

[0074] 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 the parameter configuration model to obtain the parameter configuration information corresponding to the electrophysiological signal. Then, the electrode wire is used to deliver the electrical stimulation corresponding to the parameter configuration information to the patient. The parameter configuration information is used to indicate the parameter value of each stimulation parameter of the pulse generator.

[0075] In one embodiment, the pulse generator further includes a wireless communication module;

[0076] The process of stopping receiving information from external devices includes:

[0077] Disable the receiving function of the wireless communication module;

[0078] The process of recovering information sent by external devices includes:

[0079] Enable the receiving function of the wireless communication module.

[0080] In one embodiment, disabling the receiving function of the wireless communication module includes:

[0081] Send a first enable signal to the wireless communication module to disable the receiving function of the wireless communication module;

[0082] Enabling the receiving function of the wireless communication module includes:

[0083] A second enable signal is sent to the wireless communication module to enable the receiving function of the wireless communication module.

[0084] In one embodiment, the pulse generator has an MRI mode, a sleep mode, a fast listening mode, and a communication mode;

[0085] The process of receiving MRI mode control commands includes:

[0086] When a magnet is detected approaching the pulse generator, the pulse generator is switched from sleep mode to fast listening mode. The listening period of the pulse generator in sleep mode is a first preset duration, and the listening period of the pulse generator in fast listening mode is a second preset duration, the second preset duration being shorter than the first preset duration.

[0087] In the fast listening mode, a communication connection is established between the pulse generator and the mode control device so that the pulse generator enters the communication mode.

[0088] Receive the MRI mode control command in communication mode.

[0089] Thirdly, this application provides a stimulator for implantation in a patient, the stimulator comprising:

[0090] Any of the above pulse generators;

[0091] Electrode leads, the electrode leads being used to sense the electrophysiological activity of the patient to obtain electrophysiological signals, and to deliver electrical stimulation to the patient's internal tissues.

[0092] In one embodiment, the stimulator further includes:

[0093] An extension wire is provided between the pulse generator and the electrode wire, and the extension wire is used to realize the communication connection between the pulse generator and the electrode wire.

[0094] Fourthly, this application provides a medical system, the medical system comprising:

[0095] Any of the above stimulators;

[0096] A mode control device configured to send MRI mode control commands to the pulse generator of the stimulator, and to receive and display the real-time remaining duration of the countdown.

[0097] In one embodiment, the mode control device is configured to send MRI mode control commands to the pulse generator in the following manner:

[0098] In response to a search operation, it searches for pulse generators in a listening state and displays them in real time;

[0099] In response to a selection operation for one of the pulse generators in a listening state, a communication connection is established between the mode control device and the selected pulse generator;

[0100] In response to a setting operation for a preset duration, an MRI mode control command is generated, which indicates the preset duration of the MRI mode of the pulse generator;

[0101] The MRI mode control command is sent to the selected pulse generator.

[0102] In one embodiment, the mode control device is configured to receive and display the real-time remaining duration in the following manner:

[0103] In response to receiving an MRI operation, the system searches for pulse generators in MRI mode, receives and displays the identifier and real-time remaining duration of each pulse generator in MRI mode.

[0104] In one embodiment, the medical system further includes:

[0105] A programmable device is configured to establish a communication connection with the pulse generator and send programmable commands to the pulse generator to adjust the stimulation parameters of the pulse generator.

[0106] In one embodiment, the mode control device and the programmable control device are integrated into one unit.

[0107] In one embodiment, the patient's disease includes one or more of the following:

[0108] Spasmodic disorders, depression, bipolar disorder, anxiety disorder, post-traumatic stress disorder, obsessive-compulsive disorder, behavioral disorders, mood disorders, memory disorders, mental state disorders, tremor, Parkinson's disease, Huntington's disease, Alzheimer's disease, addictive disorders, and autism.

[0109] Fifthly, this application provides a computer-readable storage medium storing a computer program that, when executed by a processor, implements the steps of any of the above methods or the function of any of the above pulse generators. Attached Figure Description

[0110] The present application will be further described below with reference to the accompanying drawings and embodiments.

[0111] Figure 1 A structural block diagram of a medical system provided in an embodiment of this application is shown.

[0112] Figure 2 A schematic flowchart of a communication method for a pulse generator provided in an embodiment of this application is shown.

[0113] Figure 3 This illustration shows a flowchart of a process for determining the parameter value of each stimulus parameter according to an embodiment of this application.

[0114] Figure 4 A structural block diagram of a pulse generator provided in an embodiment of this application is shown.

[0115] Figure 5 A schematic diagram of the structure of a program product provided in an embodiment of this application is shown. Detailed Implementation

[0116] The technical solutions in this application will be described below with reference to the accompanying drawings and specific embodiments. It should be noted that, without conflict, the various embodiments or technical features described below can be arbitrarily combined to form new embodiments.

[0117] In the embodiments of this application, "at least one" refers to one or more, and "more than one" refers to two or more. "And / or" describes the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A alone, A and B simultaneously, or B alone, where A and B can be singular or plural. The character " / " generally indicates that the preceding and following related objects are in an "or" relationship. "At least one of the following" or similar expressions refer 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".

[0118] It should also be noted that, in the embodiments of this application, the words "exemplary" or "for example" are used to indicate that they are examples, illustrations, or descriptions. Any implementation or design scheme described as "exemplary" or "for example" in the embodiments of this application should not be construed as being more preferred or advantageous than other implementations or design schemes. Specifically, the use of words such as "exemplary" or "for example" is intended to present the relevant concepts in a specific manner.

[0119] Below, we will first briefly describe one application area (i.e., implantable devices) of the embodiments of this application.

[0120] An implantable neurostimulation system (an implantable medical system) mainly consists of a stimulator implanted in the patient's body and a programmed device placed outside the patient's body. Current neuromodulation techniques primarily involve stereotactic surgery to implant electrodes into specific structures (target points) within the body. The stimulator implanted in the patient then sends electrical pulses to the target points via the electrodes, modulating the electrical activity and function of the corresponding neural structures and networks, thereby improving symptoms and alleviating pain. The stimulator can be any of the following: an implantable neurostimulation device, an implantable cardiac stimulation system (also known as a pacemaker), an implantable drug delivery system (IDDS), or a lead adapter. Implantable neurostimulation devices include deep brain stimulation (DBS), cortical nerve stimulation (CNS), spinal cord stimulation (SCS), sacral nerve stimulation (SNS), and vagus nerve stimulation (VNS).

[0121] The stimulator may include an IPG (implantable pulse generator), extension leads, and electrode leads. The IPG is placed inside the patient's body and, in response to programmed instructions from a programmable device, provides controllable electrical stimulation energy to the body's tissues using a sealed battery and circuitry. Through the implanted extension leads and electrode leads, it delivers one or two controllable electrical stimuli to specific areas of the body's tissues. The extension leads, used in conjunction with the IPG, serve as a medium for transmitting the electrical stimulation signal, conveying the signal generated by the IPG to the electrode leads. The electrode leads deliver electrical stimulation to specific areas of the body's tissues through multiple electrode contacts. The stimulator has one or more electrode leads on one or both sides, each with multiple electrode contacts arranged uniformly or non-uniformly around the circumference of the electrode leads. As an example, the electrode contacts may be arranged in a 4x3 array (a total of 12 electrode contacts) around the circumference of the electrode leads. The electrode contacts may include stimulating electrode contacts and / or collecting electrode contacts. The electrode contacts may be in shapes such as sheet-like, ring-like, or dot-like.

[0122] In one embodiment, the stimulated tissue may be the patient's brain tissue, and the stimulated site may be a specific location within the brain tissue. Generally, the stimulated site differs depending on the patient's disease type, as do the number of stimulation contacts (single-source or multi-source), the application of one or more specific electrical stimulation signals (single-channel or multi-channel), and the stimulation parameter data. This application does not limit the applicable disease type; it may include deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation. DBS can be used to treat or manage conditions including, but not limited to: spastic disorders (e.g., epilepsy), pain, migraines, mental illnesses (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety disorders, post-traumatic stress disorder, mild depression, obsessive-compulsive disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental state disorders, mobility disorders (e.g., essential tremor or Parkinson's disease), Huntington's disease, Alzheimer's disease, substance addiction, autism, or other neurological or psychiatric disorders and impairments.

[0123] In one implementation, when the programmable device and the stimulator establish a programmable connection, 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). Alternatively, the stimulator can 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.

[0124] Stimulation parameters may include one or more of the following: electrode contact identification for delivering electrical stimulation (e.g., electrode contact #2 and electrode contact #3), frequency (e.g., the number of electrical stimulation pulses per second, in Hz), pulse width (duration of each pulse, in μs), amplitude (generally expressed as voltage, i.e., the intensity of each pulse, in V), timing (e.g., continuous or bursty, bursty refers to 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), physician control upper and lower limits (the range that the physician can adjust), and patient control upper and lower limits (the range that the patient can adjust independently).

[0125] In a specific application scenario, the stimulation parameters of the stimulator can be adjusted in either current mode or voltage mode.

[0126] Programmable devices can be either doctor-controlled (i.e., devices used by doctors) or patient-controlled (i.e., devices used by patients). Doctor-controlled devices can be, for example, smart terminal devices such as tablets, laptops, desktop computers, and mobile phones equipped with programming software. Patient-controlled devices can also be, for example, smart terminal devices such as tablets, laptops, desktop computers, and mobile phones equipped with programming software; they can also be other electronic devices with programming capabilities (e.g., chargers, data acquisition devices, etc.).

[0127] This application does not restrict the data interaction between the doctor's programming device and the stimulator. When the doctor programs remotely, the doctor's programming device can interact with the stimulator through a server or the patient's programming device. When the doctor programs the stimulator face-to-face with the patient, the doctor's programming device can interact with the stimulator through the patient's programming device, and the doctor's programming device can also interact directly with the stimulator.

[0128] In one embodiment, the patient programming device may include a host (communicating with a server) and a slave (communicating with a stimulator), the host and slave being communicatively connected. The doctor programming device can interact with the server via a 3G / 4G / 5G network, the server can interact with the host via a 3G / 4G / 5G network, the host can interact with the slave via Bluetooth / Wi-Fi / USB protocols, the slave can interact with the stimulator via a 401MHz-406MHz / 2.4GHz-2.48GHz operating frequency band, and the doctor programming device can directly interact with the stimulator via the 401MHz-406MHz / 2.4GHz-2.48GHz operating frequency band.

[0129] In addition to the above-mentioned application areas of implantable devices, the embodiments of this application can also be applied to other medical device and even non-medical device technical fields. The embodiments of this application do not limit this, and can be applied to any occasion involving communication in an MRI environment. Furthermore, the instructions sent from the doctor's programming device to the stimulator are not limited to programming instructions.

[0130] (System Implementation)

[0131] See Figure 1 , Figure 1 A structural block diagram of a medical system provided in an embodiment of this application is shown.

[0132] This application provides a medical system, the medical system comprising:

[0133] Stimulator 10;

[0134] The mode control device 20 is configured to send MRI mode control commands to the pulse generator 11 of the stimulator 10, and to receive and display the real-time remaining duration of the countdown.

[0135] See also Figure 1 This application embodiment also provides a stimulator 10, which is used for implantation in a patient's body, and the stimulator 10 includes:

[0136] Pulse generator 11;

[0137] Electrode leads 12 are used to sense the electrophysiological activity of the patient to obtain electrophysiological signals and to deliver electrical stimulation to the patient's tissues.

[0138] In one implementation, the patient's internal tissues may include, for example, brain tissue, spinal nerve tissue, sacral nerve tissue, etc.

[0139] In one embodiment, the stimulator 10 further includes:

[0140] An extension wire 13 is disposed between the pulse generator 11 and the electrode wire 12, and the extension wire 13 is used to realize the communication connection between the pulse generator 11 and the electrode wire 12.

[0141] In one implementation, the number of electrode wires 12 can be one or more, and correspondingly, the number of extension wires 13 can be one or more. Each extension wire 13 corresponds one-to-one with an electrode wire 12, and each extension wire 13 is disposed between its corresponding electrode wire 12 and the pulse generator 11.

[0142] In one implementation, the pulse generator 11 and the electrode wire 12 are communicatively connected. They can communicate directly or exchange data through the extension wire 13.

[0143] When both the pulse generator 11 and the electrode lead 12 are implanted in the patient's brain, the stimulator 10 may also exclude the extension lead 13 and include only the pulse generator 11 and the electrode lead 12.

[0144] In one implementation, the electrode leads 12 can be implanted in the patient's skull or other locations within the body. The number of electrode leads 12 can be, for example, 1, 2, 3, 4, 5, 6, etc. The number of electrode contacts in each electrode lead 12 can be, for example, 4, 6, 8, 9, 10, 12, 15, 18, etc. When multiple electrode leads 12 are implanted in the patient's skull, the multiple electrode leads 12 can be implanted in the same hemisphere of the brain, or they can be implanted in two separate hemispheres of the brain.

[0145] In one implementation, the electrode wire 12 can be used to sense the electrophysiological activity of single cells and / or multiple cells to obtain electrophysiological signals and / or local field potentials of single cells. Local field potential (LFP) is a special type of electrophysiological signal. In a living organism, the activity of dendritic synapses in biological tissues of a certain volume generates 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.

[0146] Mode control device 20 refers to an electronic device with mode control function. Mode control device 20 may be an external device with or without programmable control function. Mode control device 20 may be equipped with mode control software (e.g., a computer-based APP or a mobile APP).

[0147] In one embodiment, the mode control device 20 is configured to send MRI mode control commands to the pulse generator 11 in the following manner:

[0148] In response to the search operation, the pulse generator 11 in the listening state is searched and displayed in real time;

[0149] In response to a selection operation for one of the pulse generators 11 in a listening state, a communication connection is established between the mode control device 20 and the selected pulse generator 11.

[0150] In response to a setting operation for a preset duration, an MRI mode control command is generated, which is used to indicate the preset duration of the MRI mode of the pulse generator 11.

[0151] The MRI mode control command is sent to the selected pulse generator 11.

[0152] The pulse generator 11 being in a listening state means that it is in a connectable state, i.e., waiting to be connected but not yet connected. The pulse generator 11 may be in a listening state when in sleep mode or fast listening mode, but the frequency differs, i.e., the duration of the listening cycle differs. At the beginning of each listening cycle, the pulse generator 11 sends a signal, which includes its own identifier. When the pulse generator 11 is in 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 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 establishes a communication connection with an external device (e.g., mode control device 20 or programmable device 30), the pulse generator 11 transitions from the listening state to the connected state, entering communication mode.

[0153] This application embodiment does not limit the method of receiving various manual operations (or user operations) using the mode control device 20 or the programmable device 30. Operations can be categorized by input method, such as text input, audio input, video input, button input, rotary knob input, mouse input, keyboard input, smart stylus input, and smart touchpad input. These operations include, but are not limited to, search operations, selection operations, setting operations, and receiving MRI operations. For example, a search operation might involve clicking the "Search" control within the mode control software; after obtaining a list of pulse generators 11 waiting to be connected, a selection operation might involve clicking one of the pulse generators 11 in the list within the mode control software; after the mode control device 20 successfully connects to the pulse generator 11, on the function selection page of the mode control software, clicking the "MRI" control allows for setting operations, such as entering the preset duration of the MRI mode in a pop-up text input box, with a value range of, for example, 1-120 minutes; receiving MRI operations might involve clicking the "Receive MRI" control within the mode control software. In computer programming, a control (or widget or control) is a graphical user interface element whose displayed information arrangement can be changed by the user, such as a window or text box. A key characteristic of control definition is that it provides a single point of interaction for direct manipulation of given data. A control is a basic visual building block contained within an application, controlling all the data processed by the program and the interactive operations related to that data.

[0154] In one implementation, the "Search" control, "MRI" control, and "Receive MRI" control within the mode control software can be in the form of buttons.

[0155] In one embodiment, the mode control device 20 is configured to receive and display the real-time remaining duration in the following manner:

[0156] In response to receiving an MRI operation, the system searches for pulse generators 11 in MRI mode, and receives and displays the identifier and real-time remaining duration of each pulse generator 11 in MRI mode.

[0157] Here, the identifier of each pulse generator 11 in MRI mode and the real-time remaining duration of the MRI mode for each pulse generator 11 are simultaneously displayed. For better visual effect, a progress bar can also be displayed at the same time, with the total length of the progress bar indicating the duration of the entire MRI mode, the length of the highlighted part of the progress bar indicating the duration of the MRI mode, and the length of the non-highlighted part of the progress bar indicating the real-time remaining duration.

[0158] It is important to note that when the pulse generator 11 is not damaged, the real-time remaining duration received and displayed by the mode control device 20 is updated at a fixed frequency, for example, every 2 seconds. In other words, although the mode control device 20 can set the preset duration of the MRI mode, it does not itself perform timing or countdown for the MRI mode of the pulse generator 11. Instead, it needs to receive the real-time remaining duration sent by the pulse generator 11. Therefore, whether the pulse generator 11 is damaged can be determined by whether the mode control device 20 receives the real-time remaining duration and whether the received real-time remaining duration is updated in real time.

[0159] In one embodiment, the medical system further includes:

[0160] The programmable device 30 is configured to establish a communication connection with the pulse generator 11 and send programmable commands to the pulse generator 11 to adjust the stimulation parameters of the pulse generator 11.

[0161] The programmable device 30 includes a doctor programmable device 30 and / or a patient programmable device 30. Each doctor programmable device 30 can receive a range configuration operation from the corresponding doctor, configuring the adaptively adjustable numerical range corresponding to each stimulation parameter of the pulse generator 11. The pulse generator 11 is used to adaptively adjust within the adaptively adjustable numerical range corresponding to each stimulation parameter, realizing closed-loop control of the stimulation parameters. Thus, the doctor can configure the stimulator 10 to adaptively adjust the numerical range of stimulation parameters, ensuring the safety of electrical stimulation therapy. The doctor can set different numerical ranges for each patient according to the severity of their condition, balancing safety and treatment effectiveness.

[0162] The closed-loop control process of the pulse generator 11 adaptively adjusting stimulation parameters includes: using electrode leads 12 to sense the patient's electrophysiological activity in real time to obtain electrophysiological signals; acquiring parameter configuration information corresponding to the electrophysiological signals, wherein the parameter configuration information is used to indicate the parameter value of each stimulation parameter of the pulse generator 11; delivering electrical stimulation corresponding to the parameter configuration information to the patient using electrode leads 12; and adjusting the stimulation parameters can affect the patient's condition, thereby causing changes in the sensed electrophysiological activity at the next moment to obtain new electrophysiological signals.

[0163] In a specific application scenario, the electrode lead 12 is implanted in the patient's brain. The electrode contacts of the electrode lead 12 have the functions of sensing electrophysiological activity and delivering electrical stimulation. The pulse generator 11 can use the electrode lead 12 to sense the local field potential of the patient's brain. When the patient is about to have an attack or when the attack occurs (at which time the patient's condition is not under control), it can send precise, intermittent stimulation signals to the patient's brain in an intelligent and automated manner.

[0164] The embodiments of this application do not limit the doctor's programmable device 30, which may include one or more of tablet computers, laptop computers, desktop computers, mobile phones, and smart wearable devices, or it may be a console or workstation.

[0165] In one embodiment, the mode control device 20 and the programmable control device 30 are integrated into one unit. That is, the programmable control device 30 is located outside the patient's body and can simultaneously carry programmable control software and mode control software. The programmable control software and mode control software can be integrated into one software for easy installation and use.

[0166] In one implementation, caregivers can be medical staff, family members, friends, or other personnel who care for and look after the patient. Medical staff can include doctors, nurses, and caregivers.

[0167] In one embodiment, the patient's disease includes one or more of the following:

[0168] Spasmodic disorders, depression, bipolar disorder, anxiety disorder, post-traumatic stress disorder, obsessive-compulsive disorder, behavioral disorders, mood disorders, memory disorders, mental state disorders, tremor, Parkinson's disease, Huntington's disease, Alzheimer's disease, addictive disorders, and autism.

[0169] Therefore, electrical stimulation therapy directly stimulates nerve targets (such as the nucleus accumbens, anterior limb of the internal capsule, caudate nucleus, lentiform nucleus, putamen, and other tissues, nuclei, and fiber bundles), which can effectively control the condition of the above-mentioned diseases, reduce the patient's symptoms, and relieve the patient's pain.

[0170] In one implementation, the pulse generator 11 can be configured to implement the 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.

[0171] (Method Implementation Examples)

[0172] See Figure 2 , Figure 2 A schematic flowchart of a communication method for a pulse generator provided in an embodiment of this application is shown.

[0173] This application provides a communication method for a pulse generator, the pulse generator being implanted in a patient's body, the method comprising:

[0174] Step S101: In response to the MRI mode control command, enter the MRI mode, stop receiving information sent by external devices, and start a countdown for a preset duration. The MRI mode control command is used to indicate the preset duration of the MRI mode of the pulse generator.

[0175] Step S102: When the countdown has not ended, the real-time remaining duration of the countdown is sent 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 programmable device, and a display device, or enters a periodic listening mode. When the countdown has not ended, the user can exit the MRI mode through control commands.

[0176] Step S103: When the countdown ends, exit MRI mode and resume receiving information sent by external devices.

[0177] In this embodiment, the listening frequency can be customized by the receiving device before entering MRI mode. Lowering the listening frequency can reduce power consumption and extend usage time, while increasing the listening frequency can shorten response time and improve user experience. In this embodiment, the frequency of periodic listening is once every 15 seconds to 30 minutes.

[0178] As an example, the pulse generator may have an MRI mode, a sleep mode, and a fast listening mode.

[0179] Mode control devices, programmable control devices, and display devices are all external devices, but external devices include more than just these.

[0180] In one implementation, in MRI mode, stopping the pulse generator from receiving information from external devices means stopping receiving any information from external devices.

[0181] The embodiments of this application do not limit the preset duration, and its value range can be, for example, 1-200 minutes. As an example, the preset duration can be 1, 3, 5, 8, 10, 20, 30, 50, 100, 120, 150, or 200 minutes.

[0182] During the countdown, the pulse generator continuously sends information (i.e., the real-time remaining time) to the receiving device. In this embodiment, the preset frequency of the pulse generator sending information is not limited, and it can be, for example, 1, 0.5, 0.2 Hz, etc. The interval between two transmissions of information by the pulse generator can be, for example, 1, 2, 5 seconds, etc.

[0183] The existing technology does not account for the possibility that the pulse generator may be damaged during MRI, nor does it consider how to promptly notify caregivers if the pulse generator is damaged, so that medical staff can take appropriate measures (such as replacing or repairing the pulse generator). Therefore, commercially available pulse generators do not actively and continuously send real-time remaining duration information to external devices at a fixed frequency during MRI mode. Some pulse generators can send notification information to external devices after the MRI mode ends, but if the pulse generator is damaged at this time, it cannot successfully send notification information. Even if caregivers passively discover that the pulse generator is damaged through non-receiving notification information or program failure, the time of discovery is behind the actual moment of damage. In other words, it is impossible to prepare in advance for measures such as repairing or replacing the pulse generator, which may delay the patient's condition or lead to more serious consequences. This is because patients using pulse generators may have a very urgent need for electrical stimulation therapy, such as patients with severe obsessive-compulsive disorder, bipolar disorder, or drug addicts. If electrical stimulation therapy cannot be resumed in a timely manner, it may affect the stability of these patients' conditions or even cause their conditions to relapse. These concerns may make it difficult for the families of patients to accept necessary MRI examinations, which would hinder doctors from obtaining the necessary MRI data and from making accurate diagnoses and treatments to improve the patients' quality of life.

[0184] Therefore, the pulse generator continuously sends the real-time remaining duration to the receiving device in MRI mode. When the real-time remaining duration displayed by the receiving device is not updated in real time, caregivers can promptly detect that the pulse generator has been damaged.

[0185] The pulse generator implanted in the patient's body has an MRI mode. Once in MRI mode, the pulse generator will not respond to any external devices. Therefore, external devices cannot acquire information from it (i.e., the pulse generator) and cannot actively obtain information about the pulse generator. They do not know the real-time remaining duration of the pulse generator's MRI mode. Doctors and other caregivers cannot accurately arrange programming, nursing care, and other tasks after the MRI examination. Therefore, the pulse generator needs to actively push the real-time remaining duration to the receiving device.

[0186] Specifically, the process of the pulse generator actively pushing the real-time remaining duration is as follows: After receiving the MRI mode control command, the pulse generator enters MRI mode. At this time, the processor stops receiving information from any external devices (including all external devices such as the mode control device) and starts a countdown for the MRI mode (e.g., a preset duration, such as 10 minutes, 20 minutes, 30 minutes, etc.). Within the MRI mode, it continuously sends the real-time remaining duration to the receiving device at a preset frequency (e.g., 1Hz or 0.5Hz, with a corresponding preset interval of 1 second or 2 seconds), allowing caregivers to observe the changes in the real-time remaining duration through the receiving device. If the real-time remaining duration displayed on the receiving device is not updated in real time or cannot be displayed, it indicates that the pulse generator is malfunctioning and may have been damaged. Therefore, using the pulse generator of this application allows caregivers to promptly detect damage to the pulse generator within the MRI mode.

[0187] Furthermore, when the countdown ends, the pulse generator can automatically exit MRI mode, and the processor resumes receiving information from external devices. If the MRI scan did not damage the pulse generator, its electrical stimulation therapy function can be restored as soon as possible. Doctors can also establish a programmable connection with the pulse generator using a programmable device to perform corresponding programmed operations based on the patient's current condition. The programmable device sends the corresponding programmable instructions to the pulse generator. Upon receiving these instructions, the pulse generator configures one or more stimulation parameters to deliver electrical stimulation therapy corresponding to the parameters to the patient's internal tissues (e.g., brain tissue, spinal cord nerve tissue, sacral nerve tissue, etc.), thereby alleviating the patient's pain and controlling their condition.

[0188] In one embodiment, step S101, which involves entering MRI mode in response to an MRI mode control command, includes:

[0189] In response to the MRI mode control command, it is detected whether the power of the pulse generator is not less than a preset power threshold;

[0190] If the power of the pulse generator is not less than the preset power threshold, then enter MRI mode;

[0191] The method further includes:

[0192] If the power of the pulse generator is less than the preset power threshold, a first prompt message is sent to the receiving device, the first prompt message indicating that the power of the pulse generator is less than the preset power threshold.

[0193] The embodiments of this application do not limit the preset power threshold, which can be, for example, 10%, 15%, 20%, 30%, 50%, 80%, 90%, etc.

[0194] Therefore, since a certain amount of power is required to continuously send information to the receiving device after entering MRI mode (i.e., real-time remaining time), it is possible to detect whether there is sufficient power before entering MRI mode. This avoids the inability to send information to external devices due to insufficient power and eliminates the possibility of misjudging the pulse generator as damaged due to power factors.

[0195] In other words, the MRI mode will only be entered 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.

[0196] The notification message can be sent via SMS, email, in-app push, or phone notification. The notification message includes a first notification message and / or a second notification message. The application may be Company A's app, Company B's app, or a mini-program.

[0197] In one embodiment, the process of obtaining the preset power threshold includes:

[0198] Based on the preset duration and the preset power consumption per unit time, the preset power threshold is obtained.

[0199] Therefore, different preset power thresholds are set for different preset durations to meet the power consumption requirements of the pulse generator when transmitting information during MRI mode. For example, when the preset duration of MRI mode is long, a higher preset power threshold is set (e.g., 50-80%); when the preset duration of MRI mode is short, a lower preset power threshold is set (e.g., 10-30%). 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 measured during practice. The unit time can be, for example, 1 day, 1 hour, 1 minute, 1 second, 100 milliseconds, etc.

[0200] In some implementations, a preset duration and power consumption per unit time can be input into a preset polynomial to calculate a preset power threshold. The preset polynomial can be a linear polynomial or a nonlinear polynomial.

[0201] In other implementations, a preset duration and power consumption per unit time can be input into a power threshold model to obtain a preset power threshold. This power threshold model can be obtained by training a preset deep learning model using a training set.

[0202] In one embodiment, step S101, which involves entering MRI mode in response to an MRI mode control command, includes:

[0203] In response to the MRI mode control command, it is detected whether each stimulation parameter of the pulse generator is within the corresponding preset range;

[0204] If all stimulation parameters are within the corresponding preset range, then enter MRI mode;

[0205] The method further includes:

[0206] If one or more stimulus parameters are not within their corresponding preset range, a second prompt message is sent to the receiving device. The second prompt message is used to indicate the stimulus parameters that are not within their corresponding preset range.

[0207] In MRI mode, when a patient's whole body or a specific part is inserted into the MRI machine, external fields may cause fluctuations in the electromagnetic field generated by the pulse generator implanted in the patient's body. These fluctuations may affect the effectiveness of the electrical stimulation therapy and even cause harm to the body. Therefore, it is necessary to ensure that the stimulation parameters of the pulse generator are within a given preset range before entering MRI mode. The preset range is a pre-defined range of values ​​(which can be numerical or non-numerical). When each stimulation parameter is within its corresponding preset range, the pulse generator does not generate an electromagnetic field or the generated electromagnetic field is minimally affected by the MRI equipment. That is, the pulse generator can be turned off in advance (making each stimulation parameter 0, empty, or using the default options) to stop the electrical stimulation therapy before entering MRI mode.

[0208] The embodiments of this application do not limit the preset range corresponding to each stimulus parameter.

[0209] In one implementation, the stimulation parameters may include, for example, one or more of the following: electrode contact identifiers for delivering electrical stimulation, frequency, pulse width, amplitude, timing, and stimulation mode.

[0210] As an example, the preset range corresponding to the electrode contact identifier used to deliver electrical stimulation may be empty (no electrode contact is selected); the preset range corresponding to frequency, pulse width, and amplitude may be 0; the preset range corresponding to timing may be continuous and burst (i.e., not limited); the preset range corresponding to stimulation mode may be current mode, voltage mode, timed stimulation mode, and cyclic stimulation mode (i.e., not limited).

[0211] See Figure 3 , Figure 3 This illustration shows a flowchart of a process for determining the parameter value of each stimulus parameter according to an embodiment of this application.

[0212] In one embodiment, the process of determining the parameter value of each stimulation parameter of the pulse generator includes:

[0213] Step S201: Use the electrode wires implanted in the patient's body to sense the patient's electrophysiological activity in order to obtain the patient's electrophysiological signal;

[0214] Step S202: Input the patient's electrophysiological signal into the state classification model to obtain the state classification information corresponding to the electrophysiological signal;

[0215] Step S203: 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 to the parameter configuration model to obtain the parameter configuration information corresponding to the electrophysiological signal, thereby using the electrode wire to deliver the electrical stimulation corresponding to the parameter configuration information to the patient. The parameter configuration information is used to indicate the parameter value of each stimulation parameter of the pulse generator.

[0216] Therefore, the patient's condition is classified based on the real-time sensed electrophysiological signals. 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 real-time sensed electrophysiological signals, and then the electrical stimulation corresponding to the parameter configuration information is delivered to the patient.

[0217] In other words, a prerequisite is set for obtaining parameter configuration information: parameter configuration information will only be obtained when the patient's condition is not under control based on the patient's electrophysiological signals, and will not be obtained when the patient's condition is under control.

[0218] The advantages of doing this are that it reduces the number of times parameter configuration information is obtained, reduces the amount of calculation in the pulse generator, reduces power consumption, and extends the charging interval of the rechargeable pulse generator or the service life of the non-rechargeable pulse generator.

[0219] Among them, the use of state classification model and parameter configuration model to obtain state classification information and parameter configuration information respectively has strong real-time performance, high accuracy and wide applicability.

[0220] The training process for a state classification model may include, for example:

[0221] A first training set is obtained, which includes multiple first training data. Each first training data includes a sample electrophysiological signal and labeled data of the state classification information corresponding to the sample electrophysiological signal. The state classification information corresponding to the sample electrophysiological signal is used to indicate whether the condition is under control.

[0222] For each piece of first training data in the first training set, perform the following processing:

[0223] The sample electrophysiological signals in the first training data are input into a preset first deep learning model to obtain predicted data of the state classification information corresponding to the sample electrophysiological signals.

[0224] Based on the predicted data and labeled data of the state classification information corresponding to the sample electrophysiological signals, the model parameters of the first deep learning model are updated.

[0225] Check whether the preset first training termination condition is met; if yes, use the trained first deep learning model as the state classification model; if no, continue training the first deep learning model using the next first training data.

[0226] The training process of the parameter configuration model includes:

[0227] Obtain a second training set, which includes multiple second training data sets. Each second training data set includes a sample electrophysiological signal and labeled data of parameter configuration information corresponding to the sample electrophysiological signal.

[0228] For each second training data point in the second training set, perform the following processing:

[0229] The sample electrophysiological signals from the second training data are input into a preset second deep learning model to obtain predicted data of the parameter configuration information corresponding to the sample electrophysiological signals.

[0230] Based on the predicted data and labeled data of the parameter configuration information corresponding to the sample electrophysiological signals, the model parameters of the second deep learning model are updated;

[0231] Check whether the preset second training termination condition is met; if yes, use the trained second deep learning model as the parameter configuration model; if no, continue training the second deep learning model using the next second training data.

[0232] Therefore, by designing and establishing an appropriate number of neural computing nodes and a multi-layered computational hierarchy, and selecting suitable input and output layers, a pre-defined deep learning model (including a first deep learning model and a second deep learning model) can be obtained. Through the learning and optimization of the deep learning model, a functional relationship from input to output can be established. Although it is not possible to find a 100% accurate functional relationship between input and output, it can approximate the real-world correlation as closely as possible. The state classification model and parameter configuration model trained in this way can obtain corresponding output data based on input data, have a wide range of applications, and provide high accuracy and reliability in calculation results.

[0233] Training a deep learning model using sample electrophysiological signals allows for rapid modeling by learning from only a small number of samples. The training error of the deep learning model gradually decreases during continuous training. The deep learning model can save and retrieve the optimal weights; record the accuracy of the training and validation sets for easy parameter tuning; and update the model parameters to better fit the data, resulting in effective generalization ability and improved robustness and fitting accuracy.

[0234] In one embodiment, the present application can train a state classification model and a parameter configuration model. In other optional embodiments, the present application can use a pre-trained state classification model and a parameter configuration model.

[0235] In one embodiment, data mining can be performed on historical data to obtain sample electrophysiological signals from the training set (including a first training set and a second training set). That is, these sample electrophysiological signals can be collected from real patients. Alternatively, the sample electrophysiological signals can be automatically generated using a generative network based on a GAN model.

[0236] The GAN model, or Generative Adversarial Network, consists of a generator network and a discriminator network. The generator network randomly samples data from the latent space as input, and its output should closely mimic real samples from the training set. The discriminator network takes either real samples or the generator network's output as input, aiming to distinguish the generator network's output from real samples as much as possible. The generator network, in turn, tries to deceive the discriminator network. The two networks compete against each other, constantly adjusting their parameters, with the ultimate goal of making it impossible for the discriminator network to determine whether the generator network's output is genuine. Using GAN models, multiple sample electrophysiological signals can be generated for training state classification and parameter configuration models, effectively reducing the amount of raw data collected and significantly lowering the cost of data acquisition and annotation.

[0237] This application does not limit the method of obtaining labeled data. For example, manual labeling, automatic labeling, or semi-automatic 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 through keyword extraction.

[0238] The embodiments of this application do not limit the training process of the state classification model and the parameter configuration model. For example, the training method of supervised learning described above, or the training method of semi-supervised learning, or the training method of unsupervised learning can be used.

[0239] The embodiments of this application do not limit the preset training termination conditions (including the first training termination condition and the second training termination condition). For example, it may be that the number of training sessions reaches a preset number (the preset number of training sessions is, for example, 1 time, 3 times, 10 times, 100 times, 1000 times, 10000 times, etc.), or it may be that the training data in the training set has completed one or more training sessions, or it may be that the total loss value obtained in this training is not greater than the preset loss value.

[0240] In one embodiment, the pulse generator further includes a wireless communication module;

[0241] The process of stopping receiving information from external devices includes:

[0242] Disable the receiving function of the wireless communication module;

[0243] The process of recovering information sent by external devices includes:

[0244] Enable the receiving function of the wireless communication module.

[0245] Therefore, since the pulse generator is implanted in the patient's body and the pulse generator communicates with the external device wirelessly, disabling the receiving function of the wireless communication module will stop the processor from receiving information sent by the external device, and correspondingly, enabling the receiving function of the wireless communication module will allow the processor to resume receiving information sent by the external device.

[0246] The embodiments of this application do not limit the wireless communication module, and its operating frequency band may include, for example, 401MHz-406MHz (MICS dedicated implantable medical frequency band) and / or 2.4GHz-2.48GHz.

[0247] MICS, or Medical Implant Communication Services, is used to facilitate communication between external devices and implants. Implants include pacemakers, defibrillators, stimulators, drug delivery systems, and more.

[0248] In one embodiment, disabling the receiving function of the wireless communication module includes:

[0249] Send a first enable signal to the wireless communication module to disable the receiving function of the wireless communication module;

[0250] Enabling the receiving function of the wireless communication module includes:

[0251] A second enable signal is sent to the wireless communication module to enable the receiving function of the wireless communication module.

[0252] Therefore, the disabling and enabling of the receiving function of the wireless communication module can be controlled by the first enable signal and the second enable signal, respectively. 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.

[0253] In one embodiment, the pulse generator has an MRI mode, a sleep mode, a fast listening mode, and a communication mode;

[0254] The process of receiving MRI mode control commands includes:

[0255] When a magnet is detected approaching the pulse generator, the pulse generator is switched from sleep mode to fast listening mode. The listening period of the pulse generator in sleep mode is a first preset duration, and the listening period of the pulse generator in fast listening mode is a second preset duration, the second preset duration being shorter than the first preset duration.

[0256] In the fast listening mode, a communication connection is established between the pulse generator and the mode control device so that the pulse generator enters the communication mode.

[0257] Receive the MRI mode control command in communication mode.

[0258] The embodiments of this application do 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.

[0259] Therefore, in sleep mode, the pulse generator has a longer listening cycle, which may take a long time to be detected by the mode control device; while in fast listening mode, the pulse generator has a shorter listening cycle and can be detected by the mode control device quickly.

[0260] Therefore, when it is necessary to control the MRI mode of a specific pulse generator, a magnet can be brought close to the pulse generator to switch the pulse generator from sleep mode to fast listening mode, establish a communication connection, and receive MRI mode control commands in communication mode.

[0261] The advantage of this approach is that it enables the designated pulse generator to be quickly detected by the mode control device and execute MRI mode control, improving the efficiency of MRI mode control, reducing the time patients spend waiting to enter the MRI equipment, and helping patients complete the MRI examination process quickly and resume normal electrical stimulation therapy. This reduces the psychological stress on patients and helps stabilize their condition, especially for patients with severe obsessive-compulsive disorder or drug addicts who are heavily dependent on electrical stimulation therapy.

[0262] (Equipment Example)

[0263] This application also provides a pulse generator, the specific implementation of which is consistent with the implementation method and the technical effect achieved in the above method embodiments, and some contents will not be repeated.

[0264] The pulse generator is for implantation in a patient's body. The pulse generator includes a memory and a processor. The memory stores a computer program, and the processor is configured to execute the computer program to perform the following steps:

[0265] In response to the MRI mode control command, the device enters MRI mode, stops receiving information from external devices, and begins a countdown for a preset duration. The MRI mode control command is used to indicate the preset duration of the MRI mode of the pulse generator.

[0266] When the countdown has not ended, the real-time remaining duration of the countdown is sent to a preset receiving device at a preset frequency so that the receiving device can display the real-time remaining duration. The receiving device includes one or more of a mode control device, a programmable device, and a display device.

[0267] When the countdown ends, exit MRI mode and resume receiving information sent by external devices.

[0268] In one embodiment, the processor is configured to enter MRI mode in response to MRI mode control commands when executing the computer program in the following manner:

[0269] In response to the MRI mode control command, it is detected whether the power of the pulse generator is not less than a preset power threshold;

[0270] If the power of the pulse generator is not less than the preset power threshold, then enter MRI mode;

[0271] The processor is also configured to perform the following steps when executing the computer program:

[0272] If the power of the pulse generator is less than the preset power threshold, a first prompt message is sent to the receiving device, the first prompt message indicating that the power of the pulse generator is less than the preset power threshold.

[0273] In one embodiment, the processor is configured to obtain the preset power threshold when executing the computer program in the following manner:

[0274] Based on the preset duration and the preset power consumption per unit time, the preset power threshold is obtained.

[0275] In one embodiment, the processor is configured to enter MRI mode in response to MRI mode control commands when executing the computer program in the following manner:

[0276] In response to the MRI mode control command, it is detected whether each stimulation parameter of the pulse generator is within the corresponding preset range;

[0277] If all stimulation parameters are within the corresponding preset range, then enter MRI mode;

[0278] The processor is also configured to perform the following steps when executing the computer program:

[0279] If one or more stimulus parameters are not within their corresponding preset range, a second prompt message is sent to the receiving device. The second prompt message is used to indicate the stimulus parameters that are not within their corresponding preset range.

[0280] 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:

[0281] Electrophysiological activity of the patient is sensed using electrode wires implanted in the patient's body to obtain the patient's electrophysiological signals;

[0282] The patient's electrophysiological signals are input into a state classification model to obtain state classification information corresponding to the electrophysiological signals;

[0283] 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 the parameter configuration model to obtain the parameter configuration information corresponding to the electrophysiological signal. Then, the electrode wire is used to deliver the electrical stimulation corresponding to the parameter configuration information to the patient. The parameter configuration information is used to indicate the parameter value of each stimulation parameter of the pulse generator.

[0284] In one embodiment, the pulse generator further includes a wireless communication module;

[0285] The processor is configured to stop receiving information from external devices when executing the computer program in the following manner:

[0286] Disable the receiving function of the wireless communication module;

[0287] The processor is configured to recover information sent by an external device when executing the computer program in the following manner:

[0288] Enable the receiving function of the wireless communication module.

[0289] In one embodiment, the processor is configured to disable the receiving function of the wireless communication module when executing the computer program in the following manner:

[0290] Send a first enable signal to the wireless communication module to disable the receiving function of the wireless communication module;

[0291] When the processor is configured to execute the computer program, it enables the receiving function of the wireless communication module in the following manner:

[0292] A second enable signal is sent to the wireless communication module to enable the receiving function of the wireless communication module.

[0293] In one embodiment, the pulse generator has an MRI mode, a sleep mode, a fast listening mode, and a communication mode;

[0294] The processor is configured to receive MRI mode control commands in the following manner when executing the computer program:

[0295] When a magnet is detected approaching the pulse generator, the pulse generator is switched from sleep mode to fast listening mode. The listening period of the pulse generator in sleep mode is a first preset duration, and the listening period of the pulse generator in fast listening mode is a second preset duration, the second preset duration being shorter than the first preset duration.

[0296] In the fast listening mode, a communication connection is established between the pulse generator and the mode control device so that the pulse generator enters the communication mode.

[0297] Receive the MRI mode control command in communication mode.

[0298] See Figure 4 , Figure 4 A structural block diagram of a pulse generator provided in an embodiment of this application is shown.

[0299] 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.

[0300] The memory 210 may include a readable medium in the form of volatile memory, such as random access memory (RAM) 211 and / or cache memory 212, and may further include read-only memory (ROM) 213.

[0301] The memory 210 also stores a computer program, which can be executed by the processor 220 to enable the processor 220 to implement the steps of any of the above methods.

[0302] The memory 210 may also include a utility 214 having one or more program modules 215, including but not limited to: an operating system, one or more application programs, other program modules, and program data, each or some combination of these examples may include an implementation of a network environment.

[0303] Accordingly, processor 220 can execute the aforementioned computer program, and can also execute utility 214.

[0304] The processor 220 may employ 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.

[0305] Bus 230 can be one or more of several types of bus structures, including a memory bus or memory controller, peripheral bus, graphics acceleration port, processor, or a local bus using any bus structure with multiple bus structures.

[0306] The pulse generator can also communicate with one or more external devices 240, such as a keyboard, pointing device, Bluetooth device, etc., and with one or more devices capable of interacting with the pulse generator, and / or with any device that enables the pulse generator to communicate with one or more other computing devices (e.g., a router, modem, etc.). This communication can be performed via input / output interface 250. Furthermore, the pulse generator can communicate with one or more networks (e.g., local area network (LAN), wide area network (WAN), and / or public networks, such as the Internet) via network adapter 260. Network adapter 260 can communicate with other modules of the pulse generator via bus 230. It should be understood that, although not shown in the figures, other hardware and / or software modules can 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.

[0307] (Media Example)

[0308] This application also provides a computer-readable storage medium storing a computer program. When the computer program is executed by a processor, it implements the steps of any of the above methods or the function of any of the above pulse generators. Its specific implementation is consistent with the implementation methods and the technical effects achieved in the above method embodiments, and some contents will not be repeated.

[0309] See Figure 5 , Figure 5 A schematic diagram of the structure of a program product provided in an embodiment of this application is shown.

[0310] The program product is used to implement the steps of any of the methods described above. The program product may employ a portable compact disc read-only memory (CD-ROM) and include program code, and may run on a terminal device, such as a personal computer. However, the program product of the present invention is not limited thereto. In one implementation, the readable storage medium may be any tangible medium containing or storing a program that may be used by or in conjunction with an instruction execution system, apparatus, or device. The program product may employ any combination of one or more readable media. The readable medium may be a readable signal medium or a readable storage medium. A readable storage medium may be, for example, but not limited to, an electrical, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any combination thereof. More specific examples of readable storage media (a non-exhaustive list) include: an electrical connection having one or more wires, a portable disk, a hard disk, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fiber, portable compact disc read-only memory (CD-ROM), optical storage device, magnetic storage device, or any suitable combination thereof.

[0311] Computer-readable storage media may include data signals propagated in baseband or as part of a carrier wave, carrying readable program code. Such propagated data signals may take various forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination thereof. The readable storage medium may also be any readable medium capable of sending, propagating, or transmitting a program for use by or in conjunction with an instruction execution system, apparatus, or device. The program code contained on the readable storage medium may be transmitted using any suitable medium, including but not limited to wireless, wired, optical fiber, RF, or any suitable combination thereof. Program code for performing operations of the present invention may be written in any combination of one or more programming languages, including object-oriented programming languages ​​such as Java and C++, as well as conventional procedural programming languages ​​such as C or similar languages. The program code may be executed entirely on a user computing device, partially on a user device, as a standalone software package, partially on a user computing device and partially on a remote computing device, or entirely on a remote computing device or server. In cases involving remote computing devices, the remote computing devices can be connected to user computing devices via any type of network, including local area networks (LANs) or wide area networks (WANs), or they can be connected to external computing devices (e.g., via the Internet using an Internet service provider).

Claims

1. A pulse generator, characterized in that, The pulse generator is for implantation in a patient's body. The pulse generator includes a memory and a processor. The memory stores a computer program, and the processor is configured to execute the computer program to perform the following steps: In response to an MRI mode control command, the device enters an MRI mode, wherein the MRI mode control command is used to indicate the preset duration of the MRI mode of the pulse generator; Stop receiving information sent by external devices and start a countdown of a preset duration. Before the countdown ends, send the real-time remaining duration of the countdown to a preset receiving device at a preset frequency so that the receiving device can display the real-time remaining duration. The receiving device includes one or more of a mode control device, a programmable device, and a display device. When the countdown ends, exit MRI mode and resume receiving information sent by external devices.

2. The pulse generator according to claim 1, characterized in that, When the processor is configured to execute the computer program, it responds to MRI mode control commands and enters MRI mode in the following manner: In response to the MRI mode control command, it is detected whether the power of the pulse generator is not less than a preset power threshold; If the power of the pulse generator is not less than the preset power threshold, then enter MRI mode; The processor is also configured to perform the following steps when executing the computer program: If the power of the pulse generator is less than the preset power threshold, a first prompt message is sent to the receiving device, the first prompt message indicating that the power of the pulse generator is less than the preset power threshold.

3. The pulse generator according to claim 2, characterized in that, When the processor is configured to execute the computer program, it obtains the preset power threshold in the following manner: Based on the preset duration and the preset power consumption per unit time, the preset power threshold is obtained.

4. The pulse generator according to claim 1, characterized in that, When the processor is configured to execute the computer program, it responds to MRI mode control commands and enters MRI mode in the following manner: In response to the MRI mode control command, it is detected whether each stimulation parameter of the pulse generator is within the corresponding preset range; If all stimulation parameters are within the corresponding preset range, then enter MRI mode; The processor is also configured to perform the following steps when executing the computer program: If one or more stimulus parameters are not within their corresponding preset range, a second prompt message is sent to the receiving device. The second prompt message is used to indicate the stimulus parameters that are not within their corresponding preset range.

5. The pulse generator according to claim 4, characterized in that, The processor is also configured to determine the parameter value of each stimulation parameter of the pulse generator in the following manner when executing the computer program: Electrophysiological activity of the patient is sensed using electrode wires implanted in the patient's body to obtain the patient's electrophysiological signals; The patient's electrophysiological signals are input into a state classification model to obtain state classification information corresponding to the electrophysiological signals; 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 the parameter configuration model to obtain the parameter configuration information corresponding to the electrophysiological signal. Then, the electrode wire is used to deliver the electrical stimulation corresponding to the parameter configuration information to the patient. The parameter configuration information is used to indicate the parameter value of each stimulation parameter of the pulse generator.

6. The pulse generator according to claim 1, characterized in that, The pulse generator also includes a wireless communication module; The processor is configured to stop receiving information from external devices when executing the computer program in the following manner: Disable the receiving function of the wireless communication module; The processor is configured to recover information sent by an external device when executing the computer program in the following manner: Enable the receiving function of the wireless communication module.

7. The pulse generator according to claim 6, characterized in that, The processor is configured to disable the receiving function of the wireless communication module in the following manner when executing the computer program: Send a first enable signal to the wireless communication module to disable the receiving function of the wireless communication module; When the processor is configured to execute the computer program, it enables the receiving function of the wireless communication module in the following manner: A second enable signal is sent to the wireless communication module to enable the receiving function of the wireless communication module.

8. The pulse generator according to any one of claims 1-7, characterized in that, The pulse generator has MRI mode, sleep mode, fast listening mode and communication mode; The processor is configured to receive MRI mode control commands in the following manner when executing the computer program: When a magnet is detected approaching the pulse generator, the pulse generator is switched from sleep mode to fast listening mode. The listening period of the pulse generator in sleep mode is a first preset duration, and the listening period of the pulse generator in fast listening mode is a second preset duration, the second preset duration being shorter than the first preset duration. In the fast listening mode, a communication connection is established between the pulse generator and the mode control device so that the pulse generator enters the communication mode. Receive the MRI mode control command in communication mode.

9. A communication method for a pulse generator, the pulse generator being implanted in a patient's body, characterized in that, The method includes: In response to the MRI mode control command, the device enters MRI mode, stops receiving information from external devices, and begins a countdown for a preset duration. The MRI mode control command is used to indicate the preset duration of the MRI mode of the pulse generator. When the countdown has not ended, the real-time remaining duration of the countdown is sent to a preset receiving device at a preset frequency so that the receiving device can display the real-time remaining duration. The receiving device includes one or more of a mode control device, a programmable device, and a display device. When the countdown ends, exit MRI mode and resume receiving information sent by external devices.

10. A communication method for a pulse generator according to claim 9, characterized in that, The process of entering MRI mode in response to an MRI mode control command includes: In response to the MRI mode control command, it is detected whether the power of the pulse generator is not less than a preset power threshold; If the power of the pulse generator is not less than the preset power threshold, then enter MRI mode.

11. The communication method for a pulse generator according to claim 10, characterized in that, The method further includes: If the power of the pulse generator is less than the preset power threshold, a first prompt message is sent to the receiving device, the first prompt message indicating that the power of the pulse generator is less than the preset power threshold.

12. The communication method for a pulse generator according to claim 11, characterized in that, The process of obtaining the preset power threshold includes: Based on the preset duration and the preset power consumption per unit time, the preset power threshold is obtained.

13. The communication method for a pulse generator according to claim 9, characterized in that, If one or more stimulus parameters are not within their corresponding preset range, a second prompt message is sent to the receiving device. The second prompt message is used to indicate the stimulus parameters that are not within their corresponding preset range.

14. A stimulator for implantation in a patient, characterized in that, The stimulator includes: The pulse generator according to any one of claims 1-8; Electrode leads, the electrode leads being used to sense the electrophysiological activity of the patient to obtain electrophysiological signals, and to deliver electrical stimulation to the patient's internal tissues.

15. The stimulator according to claim 14, characterized in that, The stimulator also includes: An extension wire is provided between the pulse generator and the electrode wire, and the extension wire is used to realize the communication connection between the pulse generator and the electrode wire.

16. A medical system, characterized in that, The medical system includes: The stimulator as described in claim 14 or 15; A mode control device configured to send MRI mode control commands to the pulse generator of the stimulator, and to receive and display the real-time remaining duration of the countdown.

17. The medical system according to claim 16, characterized in that, The mode control device is configured to send MRI mode control commands to the pulse generator in the following manner: In response to a search operation, it searches for pulse generators in a listening state and displays them in real time; In response to a selection operation for one of the pulse generators in a listening state, a communication connection is established between the mode control device and the selected pulse generator; In response to a setting operation for a preset duration, an MRI mode control command is generated, which indicates the preset duration of the MRI mode of the pulse generator; The MRI mode control command is sent to the selected pulse generator.

18. The medical system according to claim 17, characterized in that, The mode control device is configured to receive and display the real-time remaining time in the following manner: In response to receiving an MRI operation, the system searches for pulse generators in MRI mode, receives and displays the identifier and real-time remaining duration of each pulse generator in MRI mode.

19. The medical system according to claim 17, characterized in that, The medical system also includes: A programmable device is configured to establish a communication connection with the pulse generator and send programmable commands to the pulse generator to adjust the stimulation parameters of the pulse generator.

20. The medical system according to claim 19, characterized in that, The mode control device and the programmable control device are integrated into one unit.

21. A computer-readable storage medium, characterized in that, The computer-readable storage medium stores a computer program that, when executed by a processor, implements the steps of the communication method according to any one of claims 9-13.

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