CN115430053A - Pulse generator, stimulator, medical system and computer readable storage medium - Google Patents

Abstract

The application provides a pulse generator, a stimulator, a medical system, and a computer-readable storage medium. The pulse generator includes a memory and a processor, and the processor is configured to: respond to an MRI mode control instruction, enter the MRI mode, and stop receiving The information sent by the external device, and start the countdown of the preset duration; when the countdown is not over, send the real-time remaining duration of the countdown to the preset receiving device at the preset frequency, so that the receiving device displays the real-time remaining duration, the receiving device includes one or more of a mode control device, a program-controlled device and a display device; when the countdown ends, exit the MRI mode and resume receiving information sent by an external device. In the MRI mode, the pulse generator continuously sends the real-time remaining time to the receiving device. When the real-time remaining time displayed by the receiving device is not updated in real time, the caregiver can find out that the pulse generator is damaged in time.

Description

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

technical field

This application relates to the technical fields of implantable devices, deep brain stimulation, and deep learning, and in particular to pulse generators, stimulators, medical systems, and computer-readable storage media.

Background technique

With the development of science and technology and social progress, patients are eager to improve the quality of life through various treatment methods, among which medical devices, especially implantable devices, have a very broad application prospect. Implantable devices refer to those that enter the human body or cavity (mouth) in whole or in part by means of surgery, or are used to replace the epithelial surface of the human body or the surface of the eye, and remain in the human body for more than 30 days (inclusive) after the surgical process, or Medical devices absorbed by the body. A stimulator is a type of implantable device. The stimulator usually includes an IPG (Implantable Pulse Generator, implantable pulse generator), extension wires, and electrode wires. It can provide patients with fine-tuned electrical stimulation therapy with controllable parameters. It is welcomed by many consumers in the market.

Implants (i.e., implantable devices) may be affected or even damaged after entering MRI (Magnetic Resonance Imaging, Magnetic Resonance Imaging) equipment. Specifically, when a patient or a specific part of the patient's body is placed in the MRI apparatus, the MRI apparatus 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 a patient, the various fields generated by the MRI equipment may affect the implant's electrical stimulation therapy, causing the implant to deliver therapy when it is not needed, or not deliver therapy when it is needed.

Patent CN106110503B discloses a working method of an implantable medical device with MRI mode. The implantable medical device includes an implanted device in the body and a peripheral controller, and the implanted device in the body includes a circuit that is sensitive to an external strong magnetic field components; the working method of the implantable medical device includes a method for controlling the implanted device in the body; the method for controlling the implanted device in the body includes the following steps: Step S11, detecting the external strong magnetic field and judging whether the external strong magnetic field is detected Exist, if yes, enter step S12, if no, continue to repeat step S11; step S12, record the time when the external strong magnetic field is detected and the state of the implanted device in the body, mark that it is in a strong magnetic field environment, and enter step S13; step S13, Switch to MRI mode, mark the MRI mode switching event, and enter step S14; step S14, judge whether the external strong magnetic field disappears, if yes, then enter step S15, if not, then repeat step S14; step S15, record the disappearance of the external strong magnetic field time and the state of the implanted device in the body, mark leaving the strong magnetic field environment, and enter step S16; and step S16, switch to normal mode, mark the MRI mode switching event, and return to step S11. The method can automatically sense the existence of an external strong magnetic field, automatically switch to the MRI mode, and notify the external device when the MRI mode ends.

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

Contents of the invention

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

The purpose of this application adopts following technical scheme to realize:

In a first aspect, the present application provides a pulse generator, the pulse generator is used to be implanted in a patient, the pulse generator includes a memory and a processor, the memory stores a computer program, and the processor is controlled by When configured to execute the computer program, the following steps are implemented:

In response to the MRI mode control command, enter the MRI mode, stop receiving information sent by the external device, and start the countdown of the 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 is not over, 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, and the receiving device includes a mode control device, a program-controlled device and a display one or more of the devices;

When the countdown is over, exit the MRI mode and resume receiving the information sent by the external device.

The prior art does not take into account that the pulse generator may have been damaged during the MRI detection process, nor does it consider how to notify the nursing staff of the situation as soon as possible after the pulse generator is damaged so that the medical staff can take countermeasures (such as replacing or maintain the pulse generator), so the pulse generator on the market will not actively send the real-time remaining duration to the external device at a fixed frequency in the middle of the MRI mode. Some pulse generators can send notification information to external devices after the end of the MRI mode, but if the pulse generator is damaged at this time, the notification information cannot be sent smoothly, even if the caregiver can pass the notification information or program control failure, etc. Passively find that the pulse generator has been damaged, and the timing of learning is also behind the actual damage time of the pulse generator, that is to say, it is impossible to make advance preparations for countermeasures such as repairing or replacing the pulse generator, which may delay the patient's condition Or lead to more serious consequences, because patients who use pulse generators may have very urgent needs for electrical stimulation therapy, such as patients with severe obsessive-compulsive disorder, manic patients, or drug addicts. It affects the stability of these patients' condition and even leads to the recurrence of their condition. The concerns caused by these hidden dangers will make it difficult for the family members of the corresponding patients to receive the necessary MRI testing, which is not conducive to the doctor's acquisition of the necessary MRI data, and is not conducive to the doctor's accurate diagnosis and treatment of the patient to improve the quality of life of the patient.

The beneficial effect of this technical solution is that: in the MRI mode, the pulse generator continuously sends the real-time remaining duration to the designated external device (ie, the receiving device). When the real-time remaining duration displayed by the receiving device is not updated in real time, the nursing staff can find out in time A condition where the pulse generator is damaged.

The pulse generator implanted in the patient has an MRI mode. After entering the MRI mode, the pulse generator will not respond to any external equipment. Therefore, the external equipment cannot obtain information about it (that is, the pulse generator), and cannot actively obtain pulse generation. Due to the situation of the pulse generator, the real-time remaining time of the MRI mode of the pulse generator is unknown, and doctors and other nursing staff cannot accurately arrange the program control and nursing after the MRI test. Therefore, the pulse generator needs to actively push the real-time remaining time to the receiving device.

Specifically, the process of the pulse generator actively pushing the real-time remaining duration is as follows: After receiving the MRI mode control command, the pulse generator will enter the MRI mode, and the processor stops receiving any external device (including the mode control device). information sent by all external devices), and count down the MRI mode (for example, the preset duration, which can be 10 minutes, 20 minutes, 30 minutes, etc.), and in the MRI mode at a preset frequency (for example, 1Hz or 0.5 Hz, the corresponding preset interval length is, for example, 1 second or 2 seconds) to continuously send the real-time remaining time to the receiving device, so that the caregiver can observe the change of the real-time remaining time in real time through the receiving device. Once the real-time remaining time of the pulse generator displayed by the receiving device is not updated in real time or cannot display the real-time remaining time of the pulse generator, it indicates that the pulse generator cannot operate normally and may have been damaged. The pulse generator makes it easy for caregivers to detect damage to the pulse generator in time in MRI mode.

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

In some optional implementation manners, the processor is configured to enter the MRI mode in response to the MRI mode control instruction in the following manner when executing the computer program:

Responding to the MRI mode control command, detecting 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, enter the MRI mode;

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

If the electric quantity of the pulse generator is less than the preset electric quantity threshold, then send first prompt information to the receiving device, the first prompt information is used to indicate that the electric quantity of the pulse generator is less than the preset electric quantity threshold.

The beneficial effect of this technical solution is: since entering the MRI mode requires a certain amount of power to continuously send information to the receiving device (that is, the real-time remaining duration), it can be detected whether there is corresponding power before entering the MRI mode, so as to avoid problems caused by insufficient power. Failed to send information to the external device, ruled out the power factor caused by misjudgment of the damage of the pulse generator.

In some optional implementation manners, the processor is configured to acquire the preset power threshold in the following manner when executing the computer program:

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

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

In some optional implementation manners, the processor is configured to enter the MRI mode in response to the MRI mode control instruction in the following manner when executing the computer program:

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

If all stimulation parameters are in the corresponding preset range, enter the MRI mode;

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

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

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

In some optional implementations, 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:

sensing the electrophysiological activity of the patient by using an electrode lead implanted in the patient to obtain an electrophysiological signal of the patient;

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

When the state classification information corresponding to the electrophysiological signal is used to indicate that the condition of the patient 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, so that The electrical stimulation corresponding to the parameter configuration information is delivered to the patient by using the electrode lead, and the parameter configuration information is used to indicate a parameter value of each stimulation parameter of the pulse generator.

The beneficial effect of the technical solution is that the state of the patient is classified based on the electrophysiological signals sensed in real time, and the state classification information is used to indicate that the patient's condition is under control or that the patient's condition is not under control; when the patient's condition is not under control , the corresponding parameter configuration information is obtained based on the electrophysiological signal sensed in real time, so as to deliver the electrical stimulation corresponding to the parameter configuration information to the patient. A precondition is set for obtaining the parameter configuration information, that is, the parameter configuration information will only be obtained when it is detected that the patient's condition is not under control based on the patient's electrophysiological signal, and the parameter configuration information will not be obtained when the patient's condition is under control. The advantage of doing this is that it can reduce the number of acquisitions of parameter configuration information, reduce the amount of calculation of the pulse generator, reduce power consumption, prolong the charging interval of the rechargeable pulse generator or prolong the service life of the non-rechargeable pulse generator. Among them, using the state classification model and the parameter configuration model to obtain state classification information and parameter configuration information respectively has strong real-time performance, high accuracy and wide application range.

In some optional implementation manners, the pulse generator also includes a wireless communication module;

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

Disable the receiving function of the wireless communication module;

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

Enable the receiving function of the wireless communication module.

The beneficial effect of this technical solution is that: since the pulse generator is implanted in the patient's body, the pulse generator and the external device adopt a wireless communication mode, therefore, disabling the receiving function of the wireless communication module can make the processor stop receiving For the information sent by the external device, correspondingly, enabling the receiving function of the wireless communication module enables the processor to resume receiving the information sent by the external device.

In some optional implementation manners, the processor is configured to disable the receiving function of the wireless communication module in the following manner when executing the computer program:

sending a first enabling signal to the wireless communication module to disable the receiving function of the wireless communication module;

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

sending a second enabling signal to the wireless communication module to enable the receiving function of the wireless communication module.

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

In some optional embodiments, the pulse generator has an MRI mode, a sleep mode, a fast listening mode and a communication mode;

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

When it is detected that there is a magnet close to the pulse generator, the pulse generator is switched from the sleep mode to the fast listening mode, and the listening period of the pulse generator in the sleep mode is the first preset duration, so The listening period of the pulse generator in the fast listening mode is a second preset duration, and the second preset duration is shorter than the first preset duration;

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

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

The beneficial effect of this technical solution is: the listening period of the pulse generator is longer in sleep mode, and it may take a long time to be searched by the mode control device; and the listening period of the pulse generator is shorter in the fast listening mode. Short and can be quickly searched by the mode control device. Therefore, when MRI mode control of a specified pulse generator is required, a magnet can be used to approach the pulse generator, switch the pulse generator from sleep mode to fast listening mode, establish a communication connection, and receive MRI mode in communication mode Control instruction. The advantage of this is that the specified pulse generator can be quickly searched by the mode control device, and the MRI mode control can be performed, which improves the efficiency of MRI mode control, reduces the time for patients to wait for access to the MRI equipment, and assists patients to quickly complete MRI as a whole. The detection process and normal electrical stimulation therapy can reduce the patient’s psychological pressure and help stabilize the patient’s condition, especially for patients with severe obsessive-compulsive disorder or drug addicts who rely heavily on electrical stimulation therapy.

In a second aspect, the present application provides a communication method of a pulse generator, the pulse generator is used to be implanted in a patient, and the method includes:

In response to the MRI mode control command, enter the MRI mode, stop receiving information sent by the external device, and start the countdown of the 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 is not over, 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, and the receiving device includes a mode control device, a program-controlled device and a display one or more of the devices;

When the countdown is over, exit the MRI mode and resume receiving the information sent by the external device.

In some optional implementation manners, the entering the MRI mode in response to the MRI mode control instruction includes:

Responding to the MRI mode control command, detecting 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, enter the MRI mode;

The method also includes:

If the electric quantity of the pulse generator is less than the preset electric quantity threshold, then send first prompt information to the receiving device, the first prompt information is used to indicate that the electric quantity of the pulse generator is less than the preset electric quantity threshold.

In some optional implementation manners, the process of obtaining the preset power threshold includes:

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

In some optional implementation manners, the entering the MRI mode in response to the MRI mode control instruction includes:

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

If all stimulation parameters are in the corresponding preset range, enter the MRI mode;

The method also includes:

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

In some optional implementation manners, the process of determining the parameter value of each stimulation parameter of the pulse generator includes:

sensing the electrophysiological activity of the patient by using an electrode lead implanted in the patient to obtain an electrophysiological signal of the patient;

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

When the state classification information corresponding to the electrophysiological signal is used to indicate that the condition of the patient 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, so that The electrical stimulation corresponding to the parameter configuration information is delivered to the patient by using the electrode lead, and the parameter configuration information is used to indicate a parameter value of each stimulation parameter of the pulse generator.

In some optional implementation manners, the pulse generator also includes a wireless communication module;

The process of stopping receiving information from external devices includes:

Disable the receiving function of the wireless communication module;

The process of resuming receiving information sent by the external device includes:

Enable the receiving function of the wireless communication module.

In some optional implementation manners, the disabling the receiving function of the wireless communication module includes:

sending a first enabling signal to the wireless communication module to disable the receiving function of the wireless communication module;

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

sending a second enabling signal to the wireless communication module to enable the receiving function of the wireless communication module.

In some optional embodiments, the pulse generator has an MRI mode, a sleep mode, a fast listening mode and a communication mode;

The process of receiving MRI mode control instructions includes:

When it is detected that there is a magnet close to the pulse generator, the pulse generator is switched from the sleep mode to the fast listening mode, and the listening period of the pulse generator in the sleep mode is the first preset duration, so The listening period of the pulse generator in the fast listening mode is a second preset duration, and the second preset duration is shorter than the first preset duration;

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

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

In a third aspect, the present application provides a stimulator, the stimulator is used to be implanted in a patient, and the stimulator includes:

Any of the above pulse generators;

The electrode leads are used to sense the electrophysiological activity of the patient to obtain electrophysiological signals, and to deliver electrical stimulation to tissues in the patient's body.

In some optional embodiments, the stimulator also includes:

An extension wire, the extension wire is arranged 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.

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

Any of the above stimulators;

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

In some optional implementation manners, the mode control device is configured to send an MRI mode control instruction to the pulse generator in the following manner:

In response to the search operation, search for the pulse generator in the listening state and display it in real time;

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

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

Sending the MRI mode control command to the selected pulse generator.

In some optional implementation manners, the mode control device is configured to receive and display the real-time remaining duration in the following manner:

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

In some optional embodiments, the medical system also includes:

A program-controlled device, the program-controlled device is configured to establish a communication connection with the pulse generator, and send a program-controlled command to the pulse generator to adjust stimulation parameters of the pulse generator.

In some optional implementation manners, the mode control device and the program control device are integrated into one body.

In some optional embodiments, the patient's disease includes at least one of the following:

Spasticity Disorders, Depression, Bipolar Disorders, Anxiety Disorders, PTSD, OCD, Behavior Disorders, Mood Disorders, Memory Disorders, Mental Status Disorders, Tremors, Parkinson's Disease, Huntington's Disease, Alzheimer's disorders, addictive disorders, and autism.

In a fifth aspect, the present application provides a computer-readable storage medium, the computer-readable storage medium stores a computer program, and when the computer program is executed by a processor, it realizes the steps of any of the above methods or realizes any of the above-mentioned function of the pulse generator.

Description of drawings

The present application will be further described below in conjunction with the accompanying drawings and embodiments.

Fig. 1 shows a structural block diagram of a medical system provided by an embodiment of the present application.

Fig. 2 shows a schematic flowchart of a communication method for a pulse generator provided in an embodiment of the present application.

Fig. 3 shows a schematic flowchart of determining the parameter value of each stimulation parameter provided by the embodiment of the present application.

Fig. 4 shows a structural block diagram of a pulse generator provided by an embodiment of the present application.

FIG. 5 shows a schematic structural diagram of a program product provided by an embodiment of the present application.

detailed description

The following will describe the technical solutions in this application in conjunction with the description, drawings and specific implementation methods of the application. Any combination forms a new embodiment.

In the embodiments of the present application, "at least one" means one or more, and "multiple" means two or more. "And/or" describes the association relationship of associated objects, indicating that there may be three types of relationships, for example, A and/or B, which can mean: A exists alone, A and B exist simultaneously, and B exists alone, where A, B can be singular or plural. The character "/" generally indicates that the contextual objects are 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 item (piece) of a, b or c can represent: a, b, c, a and b, a and c, b and c, a and b and c, wherein a, b and c can be It can be single or multiple. It should be noted that "at least one item (item)" can also be interpreted as "one item (item) or multiple items (item)".

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

In the following, one of the application fields (ie, implantable devices) of the embodiments of the present application will be briefly described first.

An implantable neurostimulation system (an implantable medical system) mainly includes a stimulator implanted in the patient's body and a program-controlled device installed outside the patient's body. The existing neuromodulation technology mainly uses stereotaxic surgery to implant electrodes in specific structures (i.e., targets) in the body, and the stimulator implanted in the patient sends electrical pulses to the targets through the electrodes to regulate the corresponding neural structures and networks. Electrical activity and its function, thereby improving symptoms and relieving pain. Among them, the stimulator can be an implantable electrical nerve stimulation device, an implantable cardiac electrical stimulation system (also known as a cardiac pacemaker), an implantable drug infusion device (Implantable Drug Delivery System, referred to as IDDS) and a wire transduction device. any one of the connected devices. Implantable nerve electrical stimulation devices are, for example, Deep Brain Stimulation (DBS for short), Cortical Nerve Stimulation (CNS for short), Implantable Spinal Cord Stimulation (Spinal Cord Stimulation, SCS for short), implantable sacral nerve stimulation system (Sacral Nerve Stimulation, SNS for short), implantable vagus nerve stimulation system (Vagus Nerve Stimulation, VNS for short), etc.

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

In some optional embodiments, the stimulated body tissue may be the patient's brain tissue, and the stimulated site may be a specific part of the brain tissue. When the patient's disease type is different, the stimulated site is generally different, the number of stimulation contacts used (single source or multi-source), one or more channels (single-channel or multi-channel) specific electrical stimulation signals The application and stimulus parameter data are also different. The embodiment of the present application does not limit the applicable disease types, which may be the applicable disease types for deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation. Among the types of disorders that DBS can be used to treat or manage include, but are not limited to: spasticity disorders (e.g., epilepsy), pain, migraine, psychiatric disorders (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety disorders, Post-traumatic stress disorder, hypodepression, obsessive-compulsive disorder (OCD), conduct disorder, mood disorder, memory disorder, mental status disorder, mobility disorder (eg, essential tremor or Parkinson's disease), Huntington's disease, Al Alzheimer's disease, drug addiction, autism, or other neurological or psychiatric conditions and impairments.

In the embodiment of the present application, when the program-controlled device establishes a program-controlled connection with the stimulator, the program-controlled device can be used to adjust the stimulation parameters of the stimulator (or the stimulation parameters of the pulse generator, and the electrical stimulation signals corresponding to different stimulation parameters are different). The electrophysiological activity of the patient can be sensed by the stimulator to collect electrophysiological signals, and the stimulation parameters of the stimulator can be continuously adjusted by using the collected electrophysiological signals.

Stimulation parameters may include at least one of the following: electrode contact identification (for example, 2# electrode contact and 3# electrode contact) for delivering electrical stimulation, frequency (for example, the number of electrical stimulation pulse signals per unit time 1s) number, the unit is Hz), pulse width (the duration of each pulse, the unit is μs), amplitude (generally expressed in voltage, that is, the intensity of each pulse, the unit is V), timing (for example, it can be continuous or cluster Burst 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), upper limit and lower limit of doctor's control ( doctor adjustable range) and patient control upper and lower limits (patient self-adjustable range).

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

The program-controlled device may be a doctor-programmed device (ie, a program-controlled device used by a doctor) or a patient-programmed device (ie, a program-controlled device used by a patient). The doctor's program-controlled device can be, for example, a tablet computer, a notebook computer, a desktop computer, a mobile phone and other smart terminal devices equipped with program-controlled software. The patient program-controlled device can be, for example, smart terminal devices such as tablet computers, notebook computers, desktop computers, and mobile phones equipped with program-controlled software, and the patient program-controlled device can also be other electronic devices with program-controlled functions (such as chargers with program-controlled functions, data collection equipment, etc.).

The embodiment of the present application does not limit the data interaction between the doctor's program-controlled device and the stimulator. When the doctor remotely programs, the doctor's program-controlled device can perform data interaction with the stimulator through the server and the patient's program-controlled device. When the doctor performs program control with the patient face-to-face offline, the doctor's program-controlled device can interact with the stimulator through the patient's program-controlled device, and the doctor's program-controlled device can also directly interact with the stimulator.

In some optional embodiments, the patient programmable device may include a host (communicating with the server) and a slave (communicating with the stimulator), the host and the slave being communicatively connected. Among them, the doctor's program-controlled equipment can exchange data with the server through the 3G/4G/5G network, the server can exchange data with the host through the 3G/4G/5G network, and the host can exchange data with the slave through the Bluetooth protocol/WIFI protocol/USB protocol. Interaction, the sub-machine can exchange data with the stimulator through the 401MHz-406MHz working frequency band/2.4GHz-2.48GHz working frequency band, and the doctor's program-controlled equipment can directly exchange data with the stimulator through the 401MHz-406MHz working frequency band/2.4GHz-2.48GHz working frequency band interact.

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

(system implementation)

Referring to FIG. 1, FIG. 1 shows a structural block diagram of a medical system provided by an embodiment of the present application.

An embodiment of the present application provides a medical system, which includes:

Stimulator 10;

A mode control device 20 configured to send an MRI mode control command to the pulse generator 11 of the stimulator 10 , and receive the real-time remaining duration of the countdown and display the real-time remaining duration in real time.

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

Pulse generator 11;

The electrode lead 12 is used for sensing the electrophysiological activity of the patient to obtain an electrophysiological signal, and delivering electrical stimulation to the tissue in the patient's body.

In the embodiment of the present application, the tissue in the patient's body may be, for example, brain tissue, spinal nerve tissue, sacral nerve tissue, and the like.

In some optional embodiments, the stimulator 10 also includes:

An extension wire 13, the extension wire 13 is arranged between the pulse generator 11 and the electrode wire 12, the extension wire 13 is used to realize the communication between the pulse generator 11 and the electrode wire 12 connect.

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

In the embodiment of the present application, the pulse generator 11 is communicatively connected with the electrode lead 12 , and the two can communicate directly, or realize data interaction through the extension lead 13 .

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

In the embodiment of the present application, the electrode lead 12 can be implanted in the patient's cranium or other positions in the body. The number of electrode wires 12 can be 1, 2, 3, 4, 5, 6, etc., for example. The number of electrode contacts of each electrode wire 12 can be, for example, 4, 6, 8, 9, 10, 12, 15, 18 and so on. When multiple electrode leads 12 are implanted in the patient's cranium, the multiple electrode leads 12 can be implanted in the same hemisphere of the brain, or can be implanted in two hemispheres of the brain respectively.

In the embodiment of the present application, the electrode leads 12 can be used to sense electrophysiological activities of single cells and/or multiple cells, so as to obtain electrophysiological signals and/or local field potentials of single cells. Local Field Potential (LFP) is a special kind of electrophysiological signal. In living organisms, dendritic synaptic activity in biological tissue with a certain volume will trigger a current. When this current flows through the extracellular space with a certain impedance, a certain voltage distribution will be formed. The recorded voltage at a certain point The local voltage value is called the local field potential.

The mode control device 20 refers to an electronic device with a mode control function, and the mode control device 20 may be, for example, an external device with or without a program control function. The mode control device 20 may be equipped with mode control software (for example, it may be a computer terminal APP or a mobile terminal APP).

In some optional implementation manners, the mode control device 20 is configured to send an MRI mode control instruction to the pulse generator 11 in the following manner:

In response to the search operation, search for the pulse generator 11 in the listening state and display it in real time;

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

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

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

The pulse generator 11 being in a listening (LISTENING) state means that the pulse generator 11 is in a connectable state, that is, waiting for a connection but not being connected yet. When the pulse generator 11 is in the dormant mode or the fast listening mode, it may be in the listening state, but the frequency is different, that is, the duration of the listening cycle is different, and the pulse generator 11 will be outward at the beginning of each listening cycle. A signal is sent once, and the signal includes the identification of the pulse generator 11 itself. When the pulse generator 11 is in sleep mode, the duration of a listening period is, for example, 3 minutes, 5 minutes, 10 minutes and so on. When the pulse generator 11 is in the fast listening mode, the duration of a listening cycle is, for example, 1 second, 2 seconds, 3 seconds, 5 seconds, etc. Once the pulse generator 11 establishes a communication connection with the external device (such as the mode control device 20 or the program control device 30), the pulse generator 11 enters the connected state from the listening state and enters the communication mode.

The embodiment of the present application does not limit the manner of receiving various manual operations (or user operations) by using the mode control device 20 or the program-controlled device 30 . Operations are divided according to input methods, for example, text input operations, audio input operations, video input operations, key operations, button operations, knob operations, mouse operations, keyboard operations, smart stylus operations, smart touchpad operations, etc. can be included. These operations include, but are not limited to, search operations, selection operations, setting operations, receiving MRI operations, and the like. Wherein, the search operation can be, for example, clicking on the "search" control in the mode control software; after searching for a list of pulse generators 11 waiting to be connected, the selection operation can be, for example, clicking one of the pulse generators 11 list in the mode control software Pulse generator 11; After the mode control device 20 is successfully connected with the pulse generator 11, click the "MRI" control on the function selection page of the mode control software, and the setting operation can be, for example, input MRI in a text input box in the form of a pop-up window The preset duration of the mode can range from, for example, 1-120 minutes; the operation of receiving MRI can be, for example, clicking the "receive MRI" control in the mode control software. In computer programming, a control (or component, widget or control) is a graphical user interface element whose arrangement of displayed information can be changed by the user, such as a window or a text box. A control definition is characterized by providing a single point of interaction for direct manipulation of given data. A control is a basic visual building block contained in an application program that controls all data that the program processes and interacts with that data.

In the embodiment of the present application, the "search" control, the "MRI" control, and the "receive MRI" control in the mode control software may be in the form of buttons, for example.

In some optional implementation manners, the mode control device 20 is configured to receive and display the real-time remaining duration in the following manner:

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

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

It should be noted 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, the mode control device 20 itself does not count or count down the MRI mode of the pulse generator 11, but needs to receive the real-time information sent by the pulse generator 11. Real-time remaining time. Because of this, it can be judged whether the pulse generator 11 is damaged according to 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.

In some optional embodiments, the medical system also includes:

A program control device 30 , the program control device 30 is configured to establish a communication connection with the pulse generator 11 , and send a program control command to the pulse generator 11 to adjust the stimulation parameters of the pulse generator 11 .

Programmers 30 include physician programmers 30 and/or patient programmers 30 . Each doctor's program-controlled device 30 can receive the range configuration operation corresponding to the doctor, and configure the adaptively adjustable numerical range corresponding to each stimulation parameter of the pulse generator 11; the pulse generator 11 is used for each stimulation parameter Adaptive adjustment is performed within the corresponding adaptively adjustable value range to realize closed-loop control of stimulation parameters. Therefore, the doctor can configure the value range that allows the stimulator 10 to adaptively adjust the stimulation parameters, so as to ensure the safety of the electrical stimulation therapy. Doctors can set different numerical ranges for each patient according to the severity of the condition of different patients, taking into account safety and therapeutic effect.

Among them, the closed-loop control process of the pulse generator 11 adaptively adjusting the stimulation parameters includes: using the electrode wire 12 to sense the patient's electrophysiological activity in real time to obtain the electrophysiological signal; obtaining the parameter configuration information corresponding to the electrophysiological signal, the parameter configuration information Used to indicate the parameter value of each stimulation parameter of the pulse generator 11; use the electrode lead 12 to deliver the electrical stimulation corresponding to the parameter configuration information to the patient; the adjustment of the stimulation parameter can have an effect on the patient's condition, resulting in the following The electrophysiological activity sensed at a moment changes to obtain a new electrophysiological signal.

In a specific application scenario, the electrode lead 12 is implanted in the patient's brain, and 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 patient's The local field potential of the brain sends precise and intermittent stimulation signals to the brain of the patient in an intelligent and automated manner when the patient is about to get sick or when the disease is not under control.

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

In some optional implementation manners, the mode control device 20 and the program control device 30 are combined into one. That is to say, the program-controlled device 30 is set outside the body of the patient, and can be equipped with program-controlled software and mode control software at the same time, and the program-controlled software and mode control software can be integrated into one software to facilitate installation and use.

In the embodiment of the present application, the caregiver may be, for example, a medical staff or a family member or friend of the patient who takes care of the patient. Medical personnel may include, for example, doctors, nurses, nurses, and the like.

In some optional embodiments, the patient's disease includes at least one of the following:

Spasticity Disorders, Depression, Bipolar Disorders, Anxiety Disorders, PTSD, OCD, Behavior Disorders, Mood Disorders, Memory Disorders, Mental Status Disorders, Tremors, Parkinson's Disease, Huntington's Disease, Alzheimer's disorders, addictive disorders, and autism.

Therefore, electrical stimulation therapy directly stimulates nerve targets (such as nucleus accumbens, internal capsule forelimb, caudate nucleus, lenticular nucleus, putamen and other tissues, nuclei, fiber bundles, etc.), which can effectively control the above-mentioned The condition of the disease, relieve the patient's symptoms, relieve the patient's pain.

In the embodiment of the present application, the pulse generator 11 can be configured to implement the steps of the communication method of the pulse generator 11 , and the communication method of the pulse generator 11 will be described below first, and then the pulse generator 11 will be described.

(method example)

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

An embodiment of the present application provides a communication method of a pulse generator, the pulse generator is used to be implanted in a patient, and the method includes:

Step S101: Enter the MRI mode in response to the MRI mode control command, stop receiving information sent by the external device, and start the countdown of the preset duration, the MRI mode control command is used to indicate the preset time of the MRI mode of the pulse generator Set duration;

Step S102: When the countdown is not over, send the real-time remaining duration of the countdown to a preset receiving device at a preset frequency, so that the receiving device displays the real-time remaining duration, and the receiving device includes a mode control device, a program-controlled one or more of a device and a display device;

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

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

Mode control devices, program control devices, and display devices are all peripheral devices, but the peripheral devices are not limited to these devices.

In the embodiment of the present application, in the MRI mode, the pulse generator stops receiving information sent by the external device refers to stopping receiving any information sent by the external device.

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

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

The prior art does not take into account that the pulse generator may have been damaged during the MRI detection process, nor does it consider how to notify the nursing staff of the situation as soon as possible after the pulse generator is damaged so that the medical staff can take countermeasures (such as replacing or maintain the pulse generator), so the pulse generator on the market will not actively send the real-time remaining duration to the external device at a fixed frequency in the middle of the MRI mode. Some pulse generators can send notification information to external devices after the end of the MRI mode, but if the pulse generator is damaged at this time, the notification information cannot be sent smoothly, even if the caregiver can pass the notification information or program control failure, etc. Passively find that the pulse generator has been damaged, and the timing of learning is also behind the actual damage time of the pulse generator, that is to say, it is impossible to make advance preparations for countermeasures such as repairing or replacing the pulse generator, which may delay the patient's condition Or lead to more serious consequences, because patients who use pulse generators may have very urgent needs for electrical stimulation therapy, such as patients with severe obsessive-compulsive disorder, manic patients, or drug addicts. It affects the stability of these patients' condition and even leads to the recurrence of their condition. The concerns caused by these hidden dangers will make it difficult for the family members of the corresponding patients to receive the necessary MRI examination (ie, MRI examination), which is not conducive to doctors obtaining the necessary MRI data, and it is not conducive to doctors to accurately diagnose and treat patients to improve the patient's health. quality of life.

Thus, the pulse generator continuously sends the real-time remaining duration to the receiving device in the MRI mode. When the real-time remaining duration displayed by the receiving device is not updated in real time, the caregiver can find out that the pulse generator is damaged in time.

The pulse generator implanted in the patient has an MRI mode. After entering the MRI mode, the pulse generator will not respond to any external equipment. Therefore, the external equipment cannot obtain information about it (that is, the pulse generator), and cannot actively obtain pulse generation. Due to the situation of the pulse generator, the real-time remaining time of the MRI mode of the pulse generator is unknown, and doctors and other nursing staff cannot accurately arrange the program control and nursing after the MRI test. Therefore, the pulse generator needs to actively push the real-time remaining time to the receiving device.

Specifically, the process of the pulse generator actively pushing the real-time remaining duration is as follows: After receiving the MRI mode control command, the pulse generator will enter the MRI mode, and the processor stops receiving any external device (including the mode control device). information sent by all external devices), and count down the MRI mode (for example, the preset duration, which can be 10 minutes, 20 minutes, 30 minutes, etc.), and in the MRI mode at a preset frequency (for example, 1Hz or 0.5 Hz, the corresponding preset interval length is, for example, 1 second or 2 seconds) to continuously send the real-time remaining time to the receiving device, so that the caregiver can observe the change of the real-time remaining time in real time through the receiving device. Once the real-time remaining time of the pulse generator displayed by the receiving device is not updated in real time or cannot display the real-time remaining time of the pulse generator, it indicates that the pulse generator cannot operate normally and may have been damaged. The pulse generator makes it easy for caregivers to detect damage to the pulse generator in time in MRI mode.

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

In some optional implementation manners, entering the MRI mode in response to the MRI mode control instruction in step S101 includes:

Responding to the MRI mode control command, detecting 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, enter the MRI mode;

The method also includes:

If the electric quantity of the pulse generator is less than the preset electric quantity threshold, then send first prompt information to the receiving device, the first prompt information is used to indicate that the electric quantity of the pulse generator is less than the preset electric quantity threshold.

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

Therefore, after entering the MRI mode, a certain amount of power is required to continuously send information to the receiving device (that is, the remaining time in real time), so it can be detected whether there is corresponding power before entering the MRI mode, so as to avoid failure to send data to the external device due to insufficient power. Send information to eliminate the situation that the power factor causes the wrong judgment that the pulse generator is damaged.

That is to say, 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 will not enter the MRI mode when the current power of the pulse generator is less than the preset power threshold.

The way of sending prompt information is, for example, text message push, email push, in-app push, phone notification, etc. Here, the prompt information includes the first prompt information and/or the second prompt information. program etc.

In some optional implementation manners, the process of obtaining the preset power threshold includes:

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

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

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

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

In some optional implementation manners, entering the MRI mode in response to the MRI mode control instruction in step S101 includes:

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

If all stimulation parameters are in the corresponding preset range, enter the MRI mode;

The method also includes:

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

In the MRI mode, the whole body or specific parts of the patient enter the MRI equipment, and the external field may cause fluctuations in the electromagnetic field generated by the pulse generator implanted in the patient, which may affect the electrical stimulation therapy effect of the pulse generator , and even cause bodily injury. Therefore, each stimulation parameter of the pulse generator can be within a given preset range, and then enter the MRI mode, wherein the preset range is a preset value range (the value range can be a numerical value range or a non-numeric value value range), when each stimulation parameter is within its corresponding preset range, the pulse generator does not generate an electromagnetic field or the generated electromagnetic field can be less interfered by the MRI equipment. That is, the pulse generator can be turned off in advance (make each stimulation parameter 0, empty or use the default option), stop the electrical stimulation treatment, and then enter the MRI mode.

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

In the embodiment of the present application, the stimulation parameters may include at least one of the following, for example: electrode contact identification, frequency, pulse width, amplitude, timing and stimulation mode for delivering electrical stimulation.

As an example, the preset range corresponding to the electrode contact identification used to deliver electrical stimulation is, for example, empty (no electrode contact is selected); the preset range corresponding to frequency, pulse width, and amplitude can be 0, for example; timing corresponds to The preset ranges can be, for example, continuous and burst (that is, not limited); the preset ranges corresponding to the stimulation modes can be, for example, current mode, voltage mode, timed stimulation mode and cycle stimulation mode (that is, not limited).

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

In some optional implementation manners, the process of determining the parameter value of each stimulation parameter of the pulse generator includes:

Step S201: sensing the patient's electrophysiological activity by using the electrode lead implanted in the patient's body to obtain the patient's electrophysiological signal;

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

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

Thus, the state of the patient is classified based on the electrophysiological signals sensed in real time, and the state classification information is used to indicate that the patient's condition is under control or that the patient's condition is not under control; The corresponding parameter configuration information is obtained from the measured electrophysiological signal, so as to deliver the electrical stimulation corresponding to the parameter configuration information to the patient.

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

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

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

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

Acquiring a first training set, the first training set includes a plurality of first training data, each of the first training data includes a sample electrophysiological signal and label data of 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;

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

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

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

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

The training process of the parameter configuration model includes:

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

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

Inputting the sample electrophysiological signals in the second training data into a preset second deep learning model to obtain prediction data of parameter configuration information corresponding to the sample electrophysiological signals;

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

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

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

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

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

In some optional implementation manners, for example, data mining may be performed on historical data to obtain sample electrophysiological signals in the training set (including the first training set and the second training set). That is to say, these sample electrophysiological signals may be collected from real patients. In addition, the sample electrophysiological signal can also be automatically generated by using the generation network of the GAN model.

Among them, the GAN model is the Generative Adversarial Network, which consists of a generation network and a discriminant network. The generator network randomly samples from the latent space as input, and its output needs to imitate the real samples in the training set as much as possible. The input of the discriminative network is the real sample or the output of the generation network, and its purpose is to distinguish the output of the generation network from the real sample as much as possible. The generative network should deceive the discriminative network as much as possible. The two networks fight against each other and constantly adjust the parameters. The ultimate goal is to make the discriminant network unable to judge whether the output of the generating network is true or not. Using the GAN model can generate multiple sample electrophysiological signals for the training process of the state classification model and parameter configuration model, which can effectively reduce the amount of data collected by the original data, and greatly reduce the cost of data collection and labeling.

The embodiment of the present application does not limit the manner of obtaining the labeling data, for example, manual labeling, automatic labeling or semi-automatic labeling may be used. When the sample electrophysiological signals are collected from real patients, real data can be obtained from historical data as labeled data by means of keyword extraction.

The embodiment of the present application does not limit the training process of the state classification model and the parameter configuration model. For example, the training method of the above-mentioned supervised learning, or the training method of semi-supervised learning, or the training method of unsupervised learning can be used.

The embodiment of the present application does not limit the preset training end condition (including the first training end condition and the second training end condition), which can be, for example, that the number of training times reaches the preset number of times (the preset number of times is, for example, 1 time, 3 times, 10 times, 100 times, 1000 times, 10000 times, etc.), or it can be that the training data in the training set has completed one or more trainings, or it can be that the total loss value obtained in this training is not greater than the preset loss value.

In some optional implementation manners, the pulse generator also includes a wireless communication module;

The process of stopping receiving information from external devices includes:

Disable the receiving function of the wireless communication module;

The process of resuming receiving information sent by the external device includes:

Enable the receiving function of the wireless communication module.

Thus, since the pulse generator is implanted in the patient's body, the pulse generator and the external device adopt a wireless communication mode, therefore, disabling the receiving function of the wireless communication module can make the processor stop receiving information sent by the external device Correspondingly, enabling the receiving function of the wireless communication module can enable the processor to resume receiving information sent by the external device.

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

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

In some optional implementation manners, the disabling the receiving function of the wireless communication module includes:

sending a first enabling signal to the wireless communication module to disable the receiving function of the wireless communication module;

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

sending a second enabling signal to the wireless communication module to enable the receiving function of the wireless communication module.

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

In some optional embodiments, the pulse generator has an MRI mode, a sleep mode, a fast listening mode and a communication mode;

The process of receiving MRI mode control instructions includes:

When it is detected that there is a magnet close to the pulse generator, the pulse generator is switched from the sleep mode to the fast listening mode, and the listening period of the pulse generator in the sleep mode is the first preset duration, so The listening period of the pulse generator in the fast listening mode is a second preset duration, and the second preset duration is shorter than the first preset duration;

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

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

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

Therefore, in the dormant mode, the pulse generator has a long listening period, and it may take a long time to be searched by the mode control device; while in the fast listening mode, the pulse generator has a short listening period, and can be quickly detected. The mode control device is searched for.

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

The advantage of this is that the specified pulse generator can be quickly searched by the mode control device, and the MRI mode control can be performed, which improves the efficiency of MRI mode control, reduces the time for patients to wait for access to the MRI equipment, and assists patients to quickly complete MRI as a whole. The detection process and normal electrical stimulation therapy can reduce the patient’s psychological pressure and help stabilize the patient’s condition, especially for patients with severe obsessive-compulsive disorder or drug addicts who rely heavily on electrical stimulation therapy.

(device embodiment)

The present application also provides a pulse generator, the specific implementation manner of which is consistent with the implementation manner and achieved technical effect described in the above-mentioned method embodiments, and part of the content will not be repeated here.

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

In response to the MRI mode control command, enter the MRI mode, stop receiving information sent by the external device, and start the countdown of the 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 is not over, 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, and the receiving device includes a mode control device, a program-controlled device and a display one or more of the devices;

When the countdown is over, exit the MRI mode and resume receiving the information sent by the external device.

In some optional implementation manners, the processor is configured to enter the MRI mode in response to the MRI mode control instruction in the following manner when executing the computer program:

Responding to the MRI mode control command, detecting 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, enter the MRI mode;

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

If the electric quantity of the pulse generator is less than the preset electric quantity threshold, then send first prompt information to the receiving device, the first prompt information is used to indicate that the electric quantity of the pulse generator is less than the preset electric quantity threshold.

In some optional implementation manners, the processor is configured to acquire the preset power threshold in the following manner when executing the computer program:

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

In some optional implementation manners, the processor is configured to enter the MRI mode in response to the MRI mode control instruction in the following manner when executing the computer program:

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

If all stimulation parameters are in the corresponding preset range, enter the MRI mode;

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

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

In some optional implementations, 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:

sensing the electrophysiological activity of the patient by using an electrode lead implanted in the patient to obtain an electrophysiological signal of the patient;

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

When the state classification information corresponding to the electrophysiological signal is used to indicate that the condition of the patient 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, so that The electrical stimulation corresponding to the parameter configuration information is delivered to the patient by using the electrode lead, and the parameter configuration information is used to indicate a parameter value of each stimulation parameter of the pulse generator.

In some optional implementation manners, the pulse generator also includes a wireless communication module;

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

Disable the receiving function of the wireless communication module;

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

Enable the receiving function of the wireless communication module.

In some optional implementation manners, the processor is configured to disable the receiving function of the wireless communication module in the following manner when executing the computer program:

sending a first enabling signal to the wireless communication module to disable the receiving function of the wireless communication module;

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

sending a second enabling signal to the wireless communication module to enable the receiving function of the wireless communication module.

In some optional embodiments, the pulse generator has an MRI mode, a sleep mode, a fast listening mode and a communication mode;

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

When it is detected that there is a magnet close to the pulse generator, the pulse generator is switched from the sleep mode to the fast listening mode, and the listening period of the pulse generator in the sleep mode is the first preset duration, so The listening period of the pulse generator in the fast listening mode is a second preset duration, and the second preset duration is shorter than the first preset duration;

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

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

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

The pulse generator may include, for example, at least one memory 210, at least one processor 220, and a bus 230 connecting different platform systems.

Memory 210 may include readable media 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 .

Wherein, the memory 210 also stores a computer program, and the computer program can be executed by the processor 220, so that the processor 220 implements the steps of any one of the above-mentioned methods.

Memory 210 may also include utility 214 having at least one program module 215 including, but not limited to, an operating system, one or more application programs, other program modules, and program data, each or some of these examples Implementations of network environments may be included in this combination.

Correspondingly, the processor 220 can execute the above-mentioned computer program, and can execute the utility tool 214 .

Processor 220 can adopt one or more application-specific integrated circuits (ASIC, Application Specific Integrated Circuit), DSP, programmable logic device (PLD, ProgrammableLogicDevice), complex programmable logic device (CPLD, Complex Programmable LogicDevice), field programmable Gate array (FPGA, Field-Programmable Gate Array) or other electronic components.

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

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

(Medium Example)

The embodiment of the present application also provides a computer-readable storage medium, the computer-readable storage medium stores a computer program, and when the computer program is executed by a processor, it realizes the steps of any of the above-mentioned methods or realizes any of the above-mentioned The function of the pulse generator, its specific implementation mode is consistent with the implementation mode and the achieved technical effect described in the above-mentioned method embodiments, and part of the content will not be repeated.

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

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

A computer readable storage medium may include a data signal carrying readable program code in baseband or as part of a carrier wave traveling as part of a data signal. Such propagated data signals may take many forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination of the foregoing. A readable storage medium may also be any readable medium that can transmit, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device. The program code contained on the readable storage medium can be transmitted by any appropriate medium, including but not limited to wireless, cable, optical cable, RF, etc., or any suitable combination of the above. The program codes for performing the operations of the present invention can be written in any combination of one or more programming languages, and the programming languages include object-oriented programming languages such as Java, C++, etc., and also include conventional procedural programming languages A programming language such as C or similar. The program code may execute entirely on the user's computing device, partly on the user's device, as a stand-alone software package, partly on the user's computing device and partly on a remote computing device, or entirely on the remote computing device or server to execute. In cases involving a remote computing device, the remote computing device may be connected to the user computing device through any kind of network, including a local area network (LAN) or a wide area network (WAN), or may be connected to an external computing device (e.g., using an Internet service provider). business to connect via the Internet).

This application is elaborated from the perspectives of purpose of use, performance, progress and novelty, etc., and has met the function enhancement and use requirements emphasized by the Patent Law. The above description and drawings of this application are only the preferred implementation of this application. It is just an example, and this application is not limited thereto. Therefore, all the structures, devices, features, etc. that are similar to or identical to those of this application, that is, all equivalent replacements or modifications made according to the patent application scope of this application, shall belong to this application. within the scope of patent application protection.

Claims (16)

1. A pulse generator, characterized in that, the pulse generator is used to be implanted in a patient, the pulse generator includes a memory and a processor, the memory stores a computer program, and the processor is configured to The following steps are implemented when the computer program is executed: In response to the MRI mode control command, enter the MRI mode, stop receiving information sent by the external device, and start the countdown of the 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 is not over, 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, and the receiving device includes a mode control device, a program-controlled device and a display one or more of the devices; When the countdown is over, exit the MRI mode and resume receiving the information sent by the external device. 2. The pulse generator according to claim 1, wherein the processor is configured to enter the MRI mode in response to the MRI mode control instruction in the following manner when executing the computer program: Responding to the MRI mode control command, detecting 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, enter the MRI mode; The processor is also configured to implement the following steps when executing the computer program: If the electric quantity of the pulse generator is less than the preset electric quantity threshold, then send first prompt information to the receiving device, the first prompt information is used to indicate that the electric quantity of the pulse generator is less than the preset electric quantity threshold. 3. The pulse generator according to claim 2, wherein the processor is configured to obtain the preset power threshold in the following manner when executing the computer program: The preset power threshold is acquired based on the preset duration and the preset power consumption per unit time. 4. The pulse generator according to claim 1, wherein the processor is configured to enter the MRI mode in response to the MRI mode control instruction in the following manner when executing the computer program: Responding to the MRI mode control instruction, detecting whether each stimulation parameter of the pulse generator is within a corresponding preset range; If all stimulation parameters are in the corresponding preset range, enter the MRI mode; The processor is also configured to implement the following steps when executing the computer program: If one or more stimulation parameters are not within the corresponding preset range, sending second prompt information to the receiving device, where the second prompt information is used to indicate the stimulation parameters that are not within the corresponding preset range. 5. The pulse generator according to claim 4, wherein the processor is further configured to determine the parameter value of each stimulation parameter of the pulse generator in the following manner when executing the computer program: sensing the electrophysiological activity of the patient by using an electrode lead implanted in the patient to obtain an electrophysiological signal of the patient; Inputting the electrophysiological signal of the patient into a state classification model to obtain state classification information corresponding to the electrophysiological signal; When the state classification information corresponding to the electrophysiological signal is used to indicate that the condition of the patient 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, so that The electrical stimulation corresponding to the parameter configuration information is delivered to the patient by using the electrode lead, and the parameter configuration information is used to indicate a parameter value of each stimulation parameter of the pulse generator. 6. pulse generator according to claim 1, is characterized in that, described pulse generator also comprises wireless communication module; The processor is configured to stop receiving information sent by the external device in the following manner when executing the computer program: Disable the receiving function of the wireless communication module; The processor is configured to resume receiving information sent by the external device in the following manner when executing the computer program: Enable the receiving function of the wireless communication module. 7. The pulse generator according to claim 6, wherein the processor is configured to disable the receiving function of the wireless communication module in the following manner when executing the computer program: sending a first enabling signal to the wireless communication module to disable the receiving function of the wireless communication module; The processor is configured to enable the receiving function of the wireless communication module in the following manner when executing the computer program: sending a second enabling signal 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, wherein the pulse generator has an MRI mode, a sleep mode, a fast listening mode and a communication mode; The processor is configured to receive the MRI mode control instruction in the following manner when executing the computer program: When it is detected that there is a magnet close to the pulse generator, the pulse generator is switched from the sleep mode to the fast listening mode, and the listening period of the pulse generator in the sleep mode is the first preset duration, so The listening period of the pulse generator in the fast listening mode is a second preset duration, and the second preset duration is shorter than the first preset duration; establishing a communication connection between the pulse generator and the mode control device in a fast listening mode, so that the pulse generator enters a communication mode; The MRI mode control instruction is received in a communication mode. 9. A stimulator, characterized in that, the stimulator is used to be implanted in a patient, and the stimulator comprises: The pulse generator according to any one of claims 1-8; The electrode leads are used to sense the electrophysiological activity of the patient to obtain electrophysiological signals, and to deliver electrical stimulation to tissues in the patient's body. 10. The stimulator of claim 9, further comprising: An extension wire, the extension wire is arranged 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. 11. A medical system, characterized in that the medical system comprises: A stimulator as claimed in claim 9 or 10; A mode control device configured to send an MRI mode control instruction to the pulse generator of the stimulator, and receive the real-time remaining duration of the countdown and display the real-time remaining duration in real time. 12. The medical system according to claim 11, wherein the mode control device is configured to send an MRI mode control instruction to the pulse generator in the following manner: In response to the search operation, search for the pulse generator in the listening state and display it in real time; In response to a selection operation for one of the pulse generators in the listening state, establishing a communication connection between the mode control device and the selected pulse generator; generating the MRI mode control instruction in response to the setting operation for the preset duration, the MRI mode control instruction is used to indicate the preset duration of the MRI mode of the pulse generator; Sending the MRI mode control command to the selected pulse generator. 13. The medical system according to claim 12, wherein the mode control device is configured to receive and display the real-time remaining duration in the following manner: In response to receiving the MRI operation, the pulse generators in the MRI mode are searched for, and the identification and real-time remaining duration of each pulse generator in the MRI mode is received and displayed. 14. The medical system according to claim 11, wherein the medical system further comprises: A program-controlled device, the program-controlled device is configured to establish a communication connection with the pulse generator, and send a program-controlled command to the pulse generator to adjust stimulation parameters of the pulse generator. 15. The medical system according to claim 14, wherein the mode control device and the program control device are integrated into one body. 16. A computer-readable storage medium, characterized in that the computer-readable storage medium stores a computer program, and when the computer program is executed by a processor, the pulse generator according to any one of claims 1-8 is implemented. Function.

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