WO2024007823A1 - In-vitro charger, program control system, and computer-readable storage medium - Google Patents

In-vitro charger, program control system, and computer-readable storage medium Download PDF

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Publication number
WO2024007823A1
WO2024007823A1 PCT/CN2023/099721 CN2023099721W WO2024007823A1 WO 2024007823 A1 WO2024007823 A1 WO 2024007823A1 CN 2023099721 W CN2023099721 W CN 2023099721W WO 2024007823 A1 WO2024007823 A1 WO 2024007823A1
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WO
WIPO (PCT)
Prior art keywords
stimulator
information
controller
patient
external
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PCT/CN2023/099721
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French (fr)
Chinese (zh)
Inventor
戴春晓
林凯斌
Original Assignee
景昱医疗科技(苏州)股份有限公司
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Publication of WO2024007823A1 publication Critical patent/WO2024007823A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/378Electrical supply
    • A61N1/3787Electrical supply from an external energy source
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • A61N1/37235Aspects of the external programmer
    • A61N1/37247User interfaces, e.g. input or presentation means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • A61N1/37252Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • A61N1/37254Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals

Definitions

  • This application relates to the technical fields of implantable devices, remote programming and deep learning, for example, involving external chargers, programming systems and computer-readable storage media.
  • the external charger with programmable function acts as a medium for program-controlled connection between the external programmer and the stimulator. If you want the stimulator to stop stimulating, the external programmer needs to generate a programmable command and forward the programmable command through the external charger. to the stimulator, and the external charger itself cannot independently control the stimulator to stop stimulation. This will pose a great safety hazard.
  • the external program controller fails, it cannot send a program-controlled instruction to stop stimulation to the external charger. In case the patient The symptoms of discomfort occur at this time, which will greatly affect the patient's life safety.
  • CN105641808A discloses a wireless charger and an implantable neurostimulator that can be programmed while charging.
  • the charger includes: a charging sending unit for generating wireless charging electromagnetic waves of a first preset frequency; the charger first A communication unit for sending and receiving communication signals at a second preset frequency, the first preset frequency being different from the second preset frequency; a charger micro control unit for first communication between the charging sending unit and the charger.
  • the micro-control unit charger is respectively connected to the charging sending unit and the first communication unit of the charger. This kind of charger cannot independently control the stimulator to stop stimulation during the programming process. Once the external program controller fails, it may cause irreversible damage to the human body.
  • This application provides an external charger, a program control system and a computer-readable storage medium.
  • interactive components are used to realize the emergency stop function, which greatly protects the patient's life safety.
  • the application provides an extracorporeal charger, which is configured to interact with data respectively with an extracorporeal programmer and a stimulator implanted in a patient's body, and the extracorporeal charger includes an interactive component;
  • the extracorporeal charger also includes a controller connected to the interactive component, and the controller is configured to:
  • the stimulator is controlled to stop delivering electrical stimulation.
  • this application provides a program-controlled system, which includes a stimulator implanted in a patient's body, an external program controller, and the above-mentioned external charger.
  • the present application provides a computer-readable storage medium that stores a computer program.
  • the computer program When the computer program is executed by a processor, it implements the functions of the above-mentioned controller.
  • Figure 1 is a structural block diagram of a program-controlled system provided by an embodiment of the present application.
  • Figure 2 is a schematic flow chart of a control method for an external charger provided by an embodiment of the present application
  • FIG. 3 is a schematic flow chart of another control method for an external charger provided by an embodiment of the present application.
  • Figure 4 is a schematic diagram of using an event processing function to process events provided by an embodiment of the present application.
  • Figure 5 is a structural block diagram of a controller provided by an embodiment of the present application.
  • FIG. 6 is a schematic structural diagram of a program product for implementing a control method provided by an embodiment of the present application.
  • At least one means one or more, and “plurality” means two or more.
  • “And/or” describes the association of associated objects, indicating that there can be three 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 related objects are in an “or” relationship.
  • “At least one of the following” or similar expressions thereof refers to any combination of these items, including any combination of a single item (items) or a plurality of items (items).
  • At least one of a, b or c can mean: a, b, c, a and b, a and c, b and c, a and b and c, where a, b and c can It can be single or multiple. It is worth noting that "at least one item (item)” can also be interpreted as “one item (item) or multiple items (item)”.
  • Implantable neurostimulation systems mainly include stimulators implanted in the body and external programmer outside the body.
  • Neuromodulation technology mainly implants electrodes into specific structures (i.e. target points) in the body through stereotaxic surgery, and the stimulator implanted in the patient's body sends electrical pulses to the target point through the electrodes to regulate the electrical activity and activity of the corresponding neural structures and networks. Its functions, thereby improving symptoms and relieving pain.
  • the stimulator can be an implantable nerve electrical stimulation device, an implantable cardiac electrical stimulation system (also known as a pacemaker), an implantable drug delivery device (Implantable Drug Delivery System, IDDS) and a lead adapter device any of them.
  • Implantable neuroelectric stimulation devices include, for example, Deep Brain Stimulation (DBS) systems, Implantable Cortical Nerve Stimulation (CNS) systems, and Implantable Spinal Cord Stimulation (SCS) systems.
  • DBS Deep Brain Stimulation
  • CNS Implantable Cortical Nerve Stimulation
  • SCS Implantable Spinal Cord Stimulation
  • ) system implantable sacral nerve stimulation (Sacral Nerve Stimulation, SNS) system, implantable vagus nerve stimulation (Vagus Nerve Stimulation, VNS) system, etc.
  • the stimulator can include an Implantable Pulse Generator (IPG), extension wires, and electrode wires.
  • IPG Implantable Pulse Generator
  • the IPG is placed in the patient's body and relies on sealed batteries and circuits to provide controllable electrical stimulation energy to tissues in the body through the implanted Extension wires and electrode leads provide one or two channels of controllable specific electrical stimulation energy to specific areas of tissue in the body.
  • the extension lead is used in conjunction with the IPG as a transmission medium for electrical stimulation signals to transmit the electrical stimulation signals generated by the IPG to the electrode leads.
  • the electrode leads transmit the electrical stimulation signals generated by the IPG through multiple electrode contacts to release electrical stimulation energy to specific areas of the body tissue; the implantable medical device has one or more electrode leads on one or both sides, so A plurality of electrode contacts are provided on the electrode lead, and the electrode contacts may be uniformly or non-uniformly arranged in the circumferential direction of the electrode lead. As an example, the electrode contacts are arranged in an array of 4 rows and 3 columns (12 electrode contacts in total) in the circumferential direction of the electrode wire.
  • the electrode contacts may include stimulation electrode contacts and/or collection electrode contacts.
  • the electrode contacts may be in the shape of, for example, a sheet, a ring, a dot, or the like.
  • the stimulated body tissue may be the patient's brain tissue, and the stimulated site may be a specific part of the brain tissue.
  • the stimulated parts are generally different, the number of stimulation contacts used (single source or multiple sources), one or more channels (single channel or multi-channel) specific electrical stimulation signals
  • the application and stimulation parameter data are also different. This application does not limit the applicable disease types, which can be the disease types applicable to DBS, SCS, pelvic stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation.
  • DBS diseases that DBS can be used to treat or manage
  • spasticity eg, epilepsy
  • pain migraine
  • mental illness eg, major depressive disorder (MDD)
  • bipolar disorder e.g., anxiety disorder , post-traumatic stress disorder, mild depression, obsessive compulsive disorder (OCD)
  • OCD obsessive compulsive disorder
  • behavioral disorders mood disorders, memory disorders, mental status disorders, movement disorders (such as essential tremor or Parkinson's disease), Huntington's disease, Alzheimer's disease, drug addiction, autism, or other neurological or psychiatric diseases and impairments.
  • the external programmable controller when the external programmable controller and the stimulator establish a programmable connection, can be used to adjust the stimulation parameters of the electrical stimulation signal of the stimulator, and the stimulator can also be used to sense the bioelectrical activity in the deep brain of the patient, and can use the sensed The measured bioelectrical activity is used to continue to adjust the stimulation parameters of the electrical stimulation signal of the stimulator.
  • the external programmer can be a physician programmer or a patient programmer.
  • the doctor programmer can interact with the stimulator through the server, patient programmer, and stimulator.
  • the doctor's programmer can interact with the stimulator through the patient's programmer, and the doctor's programmer can also directly interact with the stimulator.
  • the patient programmer can also interact directly with the stimulator.
  • Figure 1 shows a structural block diagram of a program control system 100 provided by this application.
  • the program control system 100 includes: a stimulator 103 implanted in the patient's body, an extracorporeal programmer 101 and an extracorporeal charger 102.
  • the extracorporeal charger 102 and the extracorporeal programmer 101 and the stimulator 103 implanted in the patient's body are respectively operated.
  • the external charger 102 includes an interaction component 1021 .
  • the extracorporeal charger 102 also includes a controller 1022 connected to the interactive component, and the controller is configured to implement the steps of the control method.
  • the external programmer 101 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.
  • the external programmer 101 can be integrated with the external charger 102 .
  • Figure 2 is a schematic flowchart of a control method for an external charger provided by an embodiment of the present application.
  • the extracorporeal charger performs data interaction with the extracorporeal program controller and the stimulator implanted in the patient's body respectively.
  • the extracorporeal charger includes interactive components; the method includes:
  • the external charger is equipped with an interactive component, through which the user's trigger operation can be received.
  • the stimulator is not directly stopped to stimulate, but it is detected whether the external programmable controller and the stimulator are in a programmable connection state. Only the external programmable controller The stimulator is controlled to stop delivering electrical stimulation only when it is in a programmed connection state with the stimulator.
  • the interactive component of the external charger can be triggered to emergency stop stimulation.
  • the external charger can independently control the stimulator to stop delivering electrical stimulation during the programming process.
  • the interactive component can be directly used to receive the trigger operation, thereby realizing the emergency stop function and ensuring the patient's life safety to a great extent.
  • the external programmable controller can send program-controlled instructions to the stimulator through the external charger to turn off stimulation.
  • setting up interactive components on the extracorporeal charger can help turn off the stimulation function of the stimulator in special scenarios. For example, if there is a problem with the extracorporeal programmer and the programmable command cannot be sent, the extracorporeal programmable control The connection between the device and the external charger is abnormally interrupted, the patient experiences discomfort under the existing stimulation parameters, and needs to quickly interrupt stimulation, etc.
  • the external charger can directly send program-controlled instructions to the stimulator to stop stimulation output, which greatly reduces the risk of program-controlled system failure.
  • the interactive component may be disposed on the upper cover of the housing of the in vitro charger.
  • the interactive component may be a button, a key, a push button, a knob, etc.
  • the interactive component is configured to emergency shut down the stimulation of the stimulator and reset the stimulation amplitude of the stimulator to zero when the external programmer and the stimulator are in a programmed connection state.
  • the triggering operation can be an operation of pressing a button or pressing a key.
  • the triggering operation can be an operation of rotating the knob.
  • the triggering operation can be a push or pull. Push button operation.
  • the external charger is configured to charge the stimulator
  • the external charger is provided with a rechargeable battery and a display screen
  • the method may further include: obtaining the health of the rechargeable battery.
  • Status score when the health status score is less than the preset score threshold, use the display screen to display prompt information.
  • the prompt information may be one or more of text information, image information and video information.
  • the rechargeable battery may be a lithium battery, for example.
  • the prompt message can be used to remind to replace the rechargeable battery.
  • the prompt message can be a text message with the content "Please replace the battery in time”.
  • the preset score threshold can be, for example, 50 points, 80 points, or 90 points. The higher the score, the better the health status.
  • the external charger can charge the stimulator, which is very important to the patient.
  • an early warning can be issued before the battery is scrapped, thus preventing the patient from being damaged during the use of the external charger. Charging fails due to battery problems, ensuring the patient's life safety.
  • the health status score of the rechargeable battery can be obtained using the lithium-ion battery pack health status evaluation method disclosed in CN105607004A or the battery health status estimation method based on dynamic parameter identification disclosed in CN112269137A.
  • the external charger is also provided with an identity information collection component; the step S101 may include:
  • the identity information collection component uses the identity information collection component to collect the user's identity information to be verified; match the identity information to be verified with each pre-stored verified identity information, when the identity information to be verified matches one of the verified identity information
  • the interactive component is used to receive the user's trigger operation.
  • the identity information collection component may include one or more of the following: vein information collection component, face information collection component, iris information collection component, lip print information collection component, retina information collection component, hand shape information collection component, voice information collection component and Fingerprint information collection component.
  • the identity information to be verified and the identity information that has been verified may include one or more of the following: vein information, face information, iris information, lip print information, retina information, hand shape information, voice information and fingerprint information.
  • the users corresponding to the verified identity information can be the patients themselves, doctors, patients' family members, caregivers and other people who care for the patients.
  • the identity information collection component includes a vein information collection component, and the identity information to be verified and the identity information that has been verified include vein information.
  • the vein information may refer to vein information or palm vein information.
  • the recognition accuracy of veins is higher, and the recognition must be performed on a living body to prevent facial information and fingerprint information from being stolen and used for identity verification in recognition methods such as face recognition and fingerprint recognition. situation, and only when the user actively extends their finger or palm for authentication can identification be carried out, fully respecting the user's wishes.
  • the identity information collection component can be integrated with the interactive component.
  • step S101 may include:
  • the identity information to be verified is received through the interactive component, and the identity information to be verified is matched with each verified identity information to achieve identity authentication.
  • the identity information to be verified successfully matches one of the verified identity information, it indicates that the identity information to be verified is successfully matched. Verify that the user corresponding to the identity information has passed the identity authentication. Only if the identity authentication is passed, the interactive component can be used to receive the user's trigger operation.
  • the interactive component includes a fingerprint recognition button and/or a microphone
  • the identity information to be verified includes fingerprint information and/or voice information
  • the verified identity information may include fingerprint information and/or voice information.
  • the user's fingerprint information can be received through the fingerprint recognition button to implement fingerprint recognition
  • the user's voice information can be received through the microphone to implement voice recognition
  • the interactive component includes a microphone
  • the identity information to be verified includes voice information
  • the verified identity information includes voice information
  • the speech recognition content of the identity information to be verified includes at least one of the following: “turn off stimulation”, “stop stimulation”, “control the stimulator to turn off” and “stop stimulation”
  • the voice recognition content of the identity information to be verified includes at least one of the following: “turn off stimulation”, “stop stimulation”, “control stimulator to turn off” and “stop stimulation” and detect whether the external programmer and the stimulator are in the same position.
  • Programmed connection state when the external programmer and the stimulator are in a programmed connection state, the stimulator is controlled to stop delivering electrical stimulation.
  • step S103 includes:
  • the extracorporeal programmer and the stimulator When the extracorporeal programmer and the stimulator are in a programmed connection state, detect whether a preset event occurs, and when the preset event occurs, control the stimulator to stop delivering electrical stimulation; wherein, the preset event Including one or more of the following: the patient's bioelectrical signal is abnormal; the power of the stimulator is lower than the preset power threshold; the program-controlled application of the external programmable controller does not respond; the external programmable controller and the The connection of the extracorporeal charger is interrupted; the similarity between the actual configuration information of the extracorporeal program controller and the patient's reference configuration information is not greater than the first similarity threshold.
  • the non-response of the program-controlled application of the in vitro programmable controller means that the in vitro programmable controller cannot generate the corresponding program-controlled instructions after receiving the user's parameter configuration operation.
  • the stimulator when a trigger operation is received during the programming process, the stimulator is not directly controlled to stop delivering electrical stimulation, but the stimulator is detected to determine whether a preset event has occurred and whether it is necessary to stop stimulation (a preset event occurs). event indicates that stimulation needs to be stopped, and the absence of a preset event indicates that there is no need to stop stimulation). Only when a preset event occurs will the stimulator be controlled to stop delivering electrical stimulation. If a preset event does not occur, the stimulator will not be controlled to stop delivering electrical stimulation. Stimulate and prevent users from misoperation.
  • the preset event when the preset event includes an abnormality in the patient's bioelectrical signal, the occurrence of the preset event indicates that the patient's status is abnormal and is very likely to become ill, and stimulation needs to be stopped at this time; on the other hand, when the preset event includes an external charger When the power is lower than the preset power threshold, the occurrence of a preset event indicates that the stimulator's power is too low and cannot support long-term electrical stimulation. At this time, stimulation needs to be stopped; on the one hand, when the preset event includes the failure of the program-controlled application of the external programmable controller, When responding, it indicates that the external programmer cannot program the stimulator, and the stimulator is in an uncontrollable state.
  • stimulation needs to be stopped; on the one hand, when the preset event includes the interruption of the connection between the external programmer and the external charger, it indicates that the external programmer is in an uncontrollable state. The programmer cannot program the stimulator through the external charger, and the stimulator is in an uncontrollable state. At this time, stimulation needs to be stopped; on the other hand, when the preset event includes the actual configuration information of the external programmer and the patient's reference configuration information, it is similar.
  • the occurrence of a preset event indicates that the actual configuration information of the external programmable controller is too different from the reference configuration information, and the program control instructions corresponding to the external programmable controller may not be suitable for the patient, and the stimulation needs to be stopped at this time.
  • This application does not limit the preset power threshold, which can be 5%, 8% or 10%.
  • the preset event includes an abnormality in the patient's bioelectrical signal.
  • the process of detecting whether the patient's bioelectrical signal is abnormal is as follows: input the patient's bioelectrical signal into an abnormality detection model, To output the predicted similarity corresponding to the bioelectric signal; wherein, the anomaly detection model is used to compare the bioelectric signal with each abnormal bioelectric signal in the abnormal database to obtain the bioelectric signal and For the similarity of each abnormal bioelectric signal, the highest similarity among the multiple similarities corresponding to the bioelectric signal is used as the predicted similarity corresponding to the bioelectric signal; when the predicted similarity is not less than the second similarity When the predicted similarity is less than the second similarity threshold, it is determined that the bioelectric signal is not abnormal.
  • the abnormality detection model is used to determine the predicted similarity corresponding to the bioelectrical signals.
  • the abnormality detection model can call the abnormality database, which stores a large number of abnormal bioelectrical signals.
  • the abnormal bioelectrical signal can be the bioelectrical signal corresponding to different patients at the time of onset, or the bioelectrical signal corresponding to the current patient himself at the time of onset.
  • the abnormal bioelectrical signal in the abnormal database It can include the bioelectrical signals corresponding to the onset of Parkinson's disease, compare the patient's bioelectrical signals with each abnormal bioelectrical signal in the abnormal database, and use the highest similarity among multiple similarities as the predicted similarity.
  • the patient's bioelectrical signal is compared one by one with multiple abnormal bioelectrical signals pre-stored in the abnormality database to find the abnormal bioelectrical signal with the highest similarity, which improves the accuracy of the abnormality detection results.
  • the patient's bioelectrical signals can be collected using a bioelectrical collection device.
  • the bioelectricity collection equipment may include any one or more of the following: EEG collection equipment (such as electrode caps, cortical electrodes, intracranial electrodes, etc.), ECG collection equipment, and eye electricity collection.
  • the patient's bioelectrical signals may include any one or more of the following: electroencephalographic signals, electrocardiographic signals, electroocular signals, and electromyographic signals.
  • the bioelectrical collection device may be a stimulator implanted in the patient's body.
  • the patient's bioelectrical signals may include brain electrical signals.
  • the stimulator has the functions of sensing brain electrical signals and delivering electrical stimulation.
  • the predicted similarity can be expressed as a number or a percentage. When expressed as a number, the predicted similarity is, for example, 60, 80, or 90; when expressed as a percentage, the predicted similarity is, for example, 60%, 80%, or 90%. The higher the value, the better the predicted similarity. The higher the similarity.
  • This application does not limit the second similarity threshold, which may be 70%, 80% or 90%.
  • the training process of the anomaly detection model may include: obtaining a second training set, the second training set including a plurality of second training data, each of the second training data including a first sample signal used for training, annotation data of the second sample signal and the similarity between the first sample signal and the second sample signal; for each second training data in the second training set, perform the following processing: convert the second The first sample signal and the second sample signal in the training data are respectively input into the preset second deep learning model to obtain prediction data of the similarity between the first sample signal and the second sample signal; based on the The prediction data and annotation data of the similarity between the first sample signal and the second sample signal are used to update the model parameters of the second deep learning model; detect whether the preset second training end condition is met; if it is met If the preset second training end condition is met, the trained second deep learning model will be used as the anomaly detection model; if the preset second training end condition is not met, the next second training data will be used to continue training.
  • the first deep learning model convert the second The first sample
  • This application does not limit the preset second training end condition, which may be, for example, that the number of training times reaches a 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 all the training data in the second training set have 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.
  • the preset event includes that the similarity between the actual configuration information of the extracorporeal programmer and the patient's reference configuration information is not greater than the first similarity threshold;
  • the acquisition process of the reference configuration information is as follows: Enter the patient's disease information into a reference configuration model to obtain the reference configuration information;
  • the training process of the reference configuration model includes: obtaining a first training set, the first training set including a plurality of first training data , each of the first training data includes a sample object's disease disease information and annotation data of the reference configuration information of the sample object; for each first training data in the first training set, perform the following processing: input the disease information of the sample object in the first training data into the preset Assume a first deep learning model to obtain prediction data of the reference configuration information of the sample object; update the model parameters of the first deep learning model based on the prediction data and annotation data of the reference configuration information of the sample object.
  • the preset first deep learning model can be obtained.
  • the learning and tuning of the model establishes the functional relationship from input to output. Although the functional relationship between input and output cannot be found 100%, it can be as close as possible to the realistic correlation relationship.
  • the reference configuration model obtained by training can The reference configuration information corresponding to the stimulator is obtained based on the patient's disease information, and the calculation results are highly accurate and reliable.
  • the patient's disease information includes one or more of the patient's basic information, medical history information, medical imaging information, pre-recorded video information, and real-time video information; where the patient's basic information may include, for example, gender, height, weight , one or more of age; the patient's medical history information may include one or more of chief complaint information, current history information, past history information, and family genetic history information; the patient's medical imaging information may include X-ray information, computerized tomography One or more of scan (Computed Tomography, CT) information, magnetic resonance (Magnetic Resonance, MR) information, positron emission tomography (Positron Emission Tomography, PET) information, PET-CT information, and PET-MR information.
  • CT computerized Tomography
  • MR magnetic resonance
  • PET positron emission tomography
  • PET-CT information PET-CT information
  • PET-MR information PET-MR information
  • both the actual configuration information of the extracorporeal programmer and the patient's reference configuration information are used to indicate the stimulation parameters of the stimulator.
  • the stimulation parameters of the stimulator may include at least one of the following: frequency (for example, the number of electrical stimulation pulse signals per unit time 1 s, in Hz), pulse width (duration of each pulse, in ⁇ s), amplitude (Generally expressed in terms of voltage, that is, the intensity of each pulse, in V), stimulation mode (including one or more of current mode, voltage mode, timing stimulation mode and cyclic stimulation mode), upper and lower limits controlled by the doctor ( The range that the doctor can adjust) and the upper and lower limits of patient control (the range that the patient can adjust independently).
  • frequency for example, the number of electrical stimulation pulse signals per unit time 1 s, in Hz
  • pulse width duration of each pulse, in ⁇ s
  • amplitude Generally expressed in terms of voltage, that is, the intensity of each pulse, in V
  • stimulation mode including one or more of current mode, voltage mode, timing stimulation mode and cyclic stimulation mode
  • upper and lower limits controlled by the doctor The range that the doctor can adjust
  • the upper and lower limits of patient control the range that the patient can adjust
  • each stimulation parameter of the stimulator can be adjusted in current mode or voltage mode.
  • the stimulation parameter identification may be represented by at least one of Chinese characters, letters, numbers, symbols and special symbols. For example “A01”, “Amplitude” or "#01".
  • the actual configuration information of the extracorporeal programmer is the information corresponding to the doctor using the doctor's programmer to set the stimulation parameters of the stimulator, for example, "The stimulation mode is voltage mode, the frequency is 130Hz, and the pulse width is 60 ⁇ s and amplitude 3V”.
  • the actual configuration information of the extracorporeal programmer is the information corresponding to the patient using the patient programmer to set the stimulation parameters of the stimulator, for example, "the stimulation mode is voltage mode, the frequency is 90Hz, The pulse width is 50 ⁇ s and the amplitude is 4V”.
  • the reference configuration information can be preset or automatically generated using artificial intelligence algorithms based on the patient's condition.
  • This application does not limit the first similarity threshold, which may be 70%, 80% or 90%.
  • Figure 3 is a schematic flowchart of another control method for an external charger provided by an embodiment of the present application.
  • the external charger further includes an alarm component
  • the method may further include:
  • Step S104 Receive feedback information from the stimulator, where the feedback information is used to indicate whether the stimulator stops delivering electrical stimulation.
  • Step S105 Based on the feedback information, control the alert state of the alarm component so that the alert component presents different alert states when the feedback information is different.
  • the warning state of the alarm component can be controlled so that the alarm component presents different warning states according to different feedback information.
  • whether the stimulator successfully stops delivering electrical stimulation can be directly determined by the warning state of the alarm component. This allows the patient to know in time whether the stimulation has stopped and reduce the patient's psychological burden.
  • the method may further include:
  • a signal acquisition instruction is generated and sent to the stimulator; the brain electrical signal of the patient collected by the stimulator is received; based on the patient's brain electrical signal to update the model parameters of the reference configuration model.
  • the stimulation of the stimulator must be stopped urgently. After the stimulation is stopped, the stimulator can be used to collect the patient's EEG signals at this time, and the stimulation can be readjusted based on the EEG signals. Parameters, you can update the model parameters of the reference configuration model to make the reference configuration information output by the reference configuration model more suitable for the patient's current status.
  • the patient's EEG signals at this time can also be fed back to the doctor's tablet, mobile phone and other devices, allowing the doctor to understand the patient's status at this time.
  • the alarm component includes a display light
  • the warning state includes one or more of switch status, color, brightness, and flashing frequency.
  • the alarm component may include a display light
  • the warning status may include switch status, color, brightness, flashing frequency, etc.
  • the turning on or off of the display light may be used to indicate whether the stimulator stops delivering electrical stimulation, or the display may be used. Different lighting colors of the lights indicate whether the stimulator has stopped delivering electrical stimulation, or different lighting brightness of the display lights is used to indicate whether the stimulator has stopped delivering electrical stimulation, or different flashing frequencies of the display lights are used to indicate whether the stimulator has stopped delivering electrical stimulation. Electrical stimulation.
  • the alarm component includes a display light
  • the warning status includes color and brightness
  • the color of the display light is controlled to be blue and the brightness is First brightness
  • the color of the display light is controlled to be red and the brightness is a second brightness, and the second brightness is higher than the first brightness.
  • the alarm component includes a display screen, and when the feedback information indicates that the stimulator stops delivering electrical stimulation, the display screen is controlled to display the first prompt information; the feedback information indicates that the stimulator does not When the delivery of electrical stimulation is stopped, the display screen is controlled to display the second prompt information.
  • the form of the first prompt information and the second prompt information may be one or more of text information, image information, and video information.
  • the first prompt message may be a text message saying "The stimulator has stopped stimulating”
  • the second prompt message may be a text message "The stimulator has not stopped stimulating”.
  • the alarm component includes a buzzer
  • the warning state includes one or more of a sounding state, a sounding tone, and a sounding frequency.
  • the buzzer When the feedback information indicates that the stimulator stops delivering electrical stimulation, the buzzer is controlled not to sound; when the feedback information indicates that the stimulator does not stop delivering electrical stimulation, the buzzer is controlled to sound.
  • the extracorporeal charger and the extracorporeal program controller use Bluetooth communication for data interaction
  • the extracorporeal charger and the stimulator use radio frequency communication for data interaction
  • the external charger and the external programmable controller can use Bluetooth communication for data interaction, which has lower power consumption and larger coverage; the external charger and the stimulator can use radio frequency communication for data interaction.
  • Radio frequency communication has a wide communication frequency band, a large amount of information that can be transmitted, and fast data transmission speed and signal processing speed.
  • the external charger can interact with the stimulator through the 401MHz-433MHz operating frequency band or the 2.4GHz-2.5GHz operating frequency band.
  • the external charger can interact with the stimulator through the 433MHz operating frequency band or the 2.4GHz operating frequency band.
  • the patient's disease type includes one or more of epilepsy, tremor, Parkinson's disease, depression, obsessive-compulsive disorder, Alzheimer's disease, and drug addiction.
  • the external charger is suitable for patients with many different disease types and has a wide range of applications.
  • the method may further include: in response to the triggering operation, adding the stop stimulation event corresponding to the triggering operation into the event queue; using an event processing function to process the events in the event queue according to the priority of the event, Wherein, the priority of the stop stimulation event is the highest priority.
  • the priority of the stop stimulation event corresponding to the trigger operation is set to the highest priority.
  • the event processing function can prioritize the stop stimulation event, improve the response speed of the trigger operation, and achieve emergency response in a short time.
  • the shutdown function ensures the patient's life safety.
  • the event processing function may, for example, adopt the event processing function disclosed in CN106598751A, the event processing function disclosed in CN108228330A, or the event processing function disclosed in CN106293969A.
  • Figure 4 is a schematic diagram of using an event processing function to process events according to an embodiment of the present application.
  • the event processing function can be used to monitor multiple types of events in the program-controlled system in real time.
  • the stop stimulation event triggered by the interactive component has the highest priority.
  • the interactive component can be a button, for example. When the button is pressed, a falling edge is generated. External interrupts or rising edge external interrupts are added to the event queue after anti-shake measures.
  • the event processing function prioritizes the stop stimulation event.
  • the external charger sends corresponding instructions to the stimulator through radio frequency communication, thereby controlling the stimulator to stop delivering electricity. Stimulate.
  • This application also provides an external charger, which is configured to interact with data respectively with an external programmer and a stimulator implanted in the patient's body.
  • the external charger includes an interactive component; the external charger
  • the device also includes a controller connected to the interactive component.
  • the implementation of the controller is consistent with the implementation described in the above method implementation and the technical effects achieved, and part of the content will not be described again.
  • the controller is configured to: use the interactive component to receive a trigger operation; in response to the trigger operation, detect whether the extracorporeal program controller and the stimulator are in a program-controlled connection state; when the extracorporeal program controller and the stimulator are in a programmed connection state; When the stimulator is in the programmed connection state, the stimulator is controlled to stop delivering electrical stimulation.
  • the controller is further configured to store one or more verified identity information, and the controller is configured to receive the triggering operation in the following manner: using the interactive component to receive the identity to be verified. Information; match the identity information to be verified with each verified identity information, and when the identity information to be verified successfully matches one of the verified identity information, stop matching and use the interactive component to receive a trigger operation.
  • the interactive component includes a fingerprint recognition button and/or a microphone, and the to-be-verified The identification information includes fingerprint information and/or voice information.
  • the controller is configured to control the stimulator to stop delivering electrical stimulation in the following manner: when the external programmer and the stimulator are in a programmed connection state, detect whether a preset event occurs, When the preset event occurs, the stimulator is controlled to stop delivering electrical stimulation; wherein the preset event includes one or more of the following: an abnormality in the patient's bioelectrical signal; the power of the stimulator Lower than the preset power threshold; the program-controlled application of the external programmable controller does not respond; the connection between the external programmable controller and the external charger is interrupted; the actual configuration information of the external programmable controller and the reference configuration of the patient The similarity of the information is not greater than the first similarity threshold.
  • the preset event includes an abnormality in the patient's bioelectrical signal.
  • the process of detecting whether the patient's bioelectrical signal is abnormal is as follows: input the patient's bioelectrical signal into an abnormality detection model, To output the predicted similarity corresponding to the bioelectric signal; wherein, the anomaly detection model is used to compare the bioelectric signal with each abnormal bioelectric signal in the abnormal database to obtain the bioelectric signal and For the similarity of each abnormal bioelectric signal, the highest similarity among the multiple similarities corresponding to the bioelectric signal is used as the predicted similarity corresponding to the bioelectric signal; when the predicted similarity is not less than the second similarity When the predicted similarity is less than the second similarity threshold, it is determined that the bioelectric signal is not abnormal.
  • the preset event includes that the similarity between the actual configuration information of the extracorporeal programmer and the patient's reference configuration information is not greater than the first similarity threshold;
  • the acquisition process of the reference configuration information is as follows: Enter the patient's disease information into a reference configuration model to obtain the reference configuration information;
  • the training process of the reference configuration model includes: obtaining a first training set, the first training set including a plurality of first training data , each first training data includes annotation data of disease information of a sample object and reference configuration information of the sample object; for each first training data in the first training set, perform the following processing:
  • the disease information of the sample object in the first training data is input into the preset first deep learning model to obtain prediction data of the reference configuration information of the sample object; prediction data and annotation data based on the reference configuration information of the sample object , update the model parameters of the first deep learning model; detect whether the preset first training end condition is met; if the preset first training end condition is met, use the trained first deep learning model as the the classification model;
  • the extracorporeal charger further includes an alarm component
  • the controller is further configured to: receive feedback information from the stimulator, the feedback information being used to indicate whether the stimulator stops delivering electrical stimulation. ; Based on the feedback information, control the alert state of the alarm component so that the alert component presents different alert states when the feedback information is different.
  • the alarm component includes a display light
  • the warning state includes one or more of switch status, color, brightness, and flashing frequency.
  • the extracorporeal charger and the extracorporeal program controller use Bluetooth communication for data interaction
  • the extracorporeal charger and the stimulator use radio frequency communication for data interaction
  • the patient's disease type includes one or more of epilepsy, tremor, Parkinson's disease, depression, obsessive-compulsive disorder, Alzheimer's disease, and drug addiction.
  • the controller is further configured to store an event processing function, and the controller is further configured to: in response to the trigger operation, add the stop stimulation event corresponding to the trigger operation to the event queue;
  • the event processing function is used to process events in the event queue according to the priority of the event, wherein the priority of the stop stimulation event is the highest priority.
  • Figure 5 is a structural block diagram of a controller provided by an embodiment of the present application.
  • the controller 200 may include, for example, at least one memory 210, at least one processor 220, and a bus 230 connecting different platform systems.
  • the memory 210 may include readable media in the form of volatile memory, such as random access memory (Random Access Memory, RAM) 211 and/or cache memory 212, and may also include read-only memory (Read-Only Memory, ROM) 213 .
  • RAM Random Access Memory
  • ROM Read-Only Memory
  • the memory 210 also stores a computer program, which can be executed by the processor 220, so that the processor 220 implements the functions of the above-mentioned controller.
  • the implementation manner is consistent with the implementation described in the above-mentioned method implementation and the technical effects achieved, and some of them are consistent. The content will not be repeated.
  • Memory 210 may also include a utility 214 having at least one program module 215 including: an operating system, one or more application programs, other program modules, and program data, in each or a combination of these examples. May include implementation of network environment.
  • the processor 220 can execute the above-mentioned computer program, and can execute the utility tool 214.
  • the processor 220 may use one or more application specific integrated circuits (Application Specific Integrated Circuit, ASIC), digital signal processor (Digital Signal Processor, DSP), programmable logic device (Programmable Logic Device, PLD), complex programmable logic device (Complex Programmable Logic Device, CPLD), Field-Programmable Gate Array (FPGA) or other electronic components.
  • ASIC Application Specific Integrated Circuit
  • DSP Digital Signal Processor
  • PLD programmable logic device
  • PLD complex programmable logic device
  • CPLD Complex Programmable Logic Device
  • FPGA Field-Programmable Gate Array
  • Bus 230 may represent one or more of several types of bus structures, including a memory bus or memory controller, a peripheral bus, a graphics accelerated port, a processor, or any other bus structure using a variety of bus structures. Bus structure of local bus.
  • the controller 200 may also communicate with one or more external devices 240, such as a keyboard, a pointing device, a Bluetooth device, etc., and may also communicate with one or more devices capable of interacting with the controller 200, and/or with a device that enables the controller 200 to 200 is any device capable of communicating with one or more other computing devices (eg, router, modem, etc.). This communication may occur through the input/output interface 250.
  • the controller 200 can also communicate with one or more networks (such as a local area network (Local Area Network, LAN), a wide area network (Local 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 controller 200 via bus 230.
  • controller 200 may be used in conjunction with the controller 200, including but not limited to: microcode, device drivers, redundant processors, external disk drive arrays, redundant arrays of independent disks (Redundant Arrays of Independent Disks, RAID) systems, tape drives and data backup storage platforms, etc.
  • This application also provides a computer-readable storage medium, which stores a computer program.
  • the computer program When the computer program is executed by a processor, it realizes the functions of the above-mentioned controller or the steps of the above-mentioned control method, which realizes The method is consistent with the implementation described in the implementation of the controller above, and the technical effects achieved are consistent, and part of the content will not be described again.
  • Figure 6 shows a schematic structural diagram of a program product for implementing a control method provided by this application.
  • the program product can adopt a portable compact disk read-only memory (Compact Disc-ROM, CD-ROM) and include program code, and can be run on a terminal device, such as a personal computer.
  • the program product of the present application is not limited thereto.
  • the readable storage medium may be any tangible medium containing or storing a program, which may be used by or in combination with an instruction execution system, apparatus or device.
  • the Program Product may take the form of one or more readable media in any combination.
  • 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.
  • Examples of readable storage media include: electrical connection with one or more wires, portable disk, hard disk, RAM, ROM, Erasable Programmable Read Only Memory (EPROM) or flash memory), optical fiber, CD-ROM, optical storage device, magnetic storage device, or any suitable combination of the above.
  • a computer-readable storage medium may include a data signal propagated in baseband or as part of a carrier wave carrying the readable program code therein. Such propagated data signals may take a variety of forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination of the above.
  • a readable storage medium may also be any readable medium that can transmit, propagate, or transport the program for use by or in connection with an instruction execution system, apparatus, or device.
  • Program code contained on a readable storage medium may be transmitted using any appropriate medium, including but not limited to wireless, wired, optical cable, radio frequency (Radio Frequency, RF), etc., or any suitable combination of the above.
  • the program code for performing the operations of the present application can be written in any combination of one or more programming languages, including object-oriented programming languages such as Java, C++, etc., and also includes conventional procedural programming languages. Such as C language or similar programming language.
  • 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 execute on.
  • the remote computing device may be connected to the user computing device through any kind of network, including a LAN or WAN, or may be connected to an external computing device (such as through the Internet using an Internet service provider) .

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Abstract

Provided are an in-vitro charger, a program control system, and a computer-readable storage medium. Provided are an in-vitro charger, a program control system, and a computer-readable storage medium. The in-vitro charger (102) is configured to perform data interaction with an in-vitro program controller (101) and a stimulator (103) implanted inside a patient's body, and the in-vitro charger comprises an interaction component (1021). The in-vitro charger (102) further comprises a controller (1022) connected to the interaction component (1021), and the controller (1022) is configured to: receive a trigger operation by using the interaction component (1021); detect, in response to the trigger operation, whether the in-vitro program controller (101) and the stimulator (103) are in a program-controlled connection state; and control the stimulator (103) to stop delivering electrostimulation when the in-vitro program controller (101) and the stimulator (103) are in the program-controlled connection state.

Description

体外充电器、程控***和计算机可读存储介质External charger, program control system and computer-readable storage medium
本申请要求在2022年07月05日提交中国专利局、申请号为202210783697.9的中国专利申请的优先权,该申请的全部内容通过引用结合在本申请中。This application claims priority to the Chinese patent application with application number 202210783697.9, which was submitted to the China Patent Office on July 5, 2022. The entire content of this application is incorporated into this application by reference.
技术领域Technical field
本申请涉及植入式器械、远程程控和深度学习的技术领域,例如涉及体外充电器、程控***和计算机可读存储介质。This application relates to the technical fields of implantable devices, remote programming and deep learning, for example, involving external chargers, programming systems and computer-readable storage media.
背景技术Background technique
具备程控功能的体外充电器在程控过程中,充当的是体外程控器和刺激器程控连接的媒介,如果要让刺激器停止刺激,需要体外程控器发生程控指令,通过体外充电器将程控指令转发至刺激器,而体外充电器本身无法单独控制刺激器停止刺激,这样会存在很大的安全隐患,当体外程控器出现故障时,无法向体外充电器发送停止刺激的程控指令,万一患者在这个时候正好出现不适症状,会很大程度影响患者的生命安全。During the programming process, the external charger with programmable function acts as a medium for program-controlled connection between the external programmer and the stimulator. If you want the stimulator to stop stimulating, the external programmer needs to generate a programmable command and forward the programmable command through the external charger. to the stimulator, and the external charger itself cannot independently control the stimulator to stop stimulation. This will pose a great safety hazard. When the external program controller fails, it cannot send a program-controlled instruction to stop stimulation to the external charger. In case the patient The symptoms of discomfort occur at this time, which will greatly affect the patient's life safety.
CN105641808A公开了一种可在充电同时进行程控的无线充电器及植入式神经刺激器,所述充电器包括:充电发送单元,用于产生第一预设频率的无线充电电磁波;充电器第一通信单元,用于在第二预设频率发送和接收通信信号,所述第一预设频率与第二预设频率不同;充电器微控制单元,用于对充电发送单元和充电器第一通信单元进行控制;所述微控制单元充电器分别与充电发送单元和充电器第一通信单元相连接。这种充电器无法在程控过程中独立控制刺激器停止刺激,一旦体外程控器出现故障,可能会对人体造成不可逆转的伤害。CN105641808A discloses a wireless charger and an implantable neurostimulator that can be programmed while charging. The charger includes: a charging sending unit for generating wireless charging electromagnetic waves of a first preset frequency; the charger first A communication unit for sending and receiving communication signals at a second preset frequency, the first preset frequency being different from the second preset frequency; a charger micro control unit for first communication between the charging sending unit and the charger The micro-control unit charger is respectively connected to the charging sending unit and the first communication unit of the charger. This kind of charger cannot independently control the stimulator to stop stimulation during the programming process. Once the external program controller fails, it may cause irreversible damage to the human body.
发明内容Contents of the invention
本申请提供体外充电器、程控***和计算机可读存储介质,在程控过程中,利用交互组件实现急停功能,极大程度上保障了患者的生命安全。This application provides an external charger, a program control system and a computer-readable storage medium. During the program control process, interactive components are used to realize the emergency stop function, which greatly protects the patient's life safety.
第一方面,本申请提供了一种体外充电器,所述体外充电器被配置成与体外程控器以及植入于患者体内的刺激器分别进行数据交互,所述体外充电器包括交互组件;In a first aspect, the application provides an extracorporeal charger, which is configured to interact with data respectively with an extracorporeal programmer and a stimulator implanted in a patient's body, and the extracorporeal charger includes an interactive component;
所述体外充电器还包括与所述交互组件连接的控制器,所述控制器被配置成:The extracorporeal charger also includes a controller connected to the interactive component, and the controller is configured to:
利用所述交互组件接收触发操作; Utilize the interactive component to receive a trigger operation;
响应于所述触发操作,检测所述体外程控器与所述刺激器是否处于程控连接状态;In response to the triggering operation, detect whether the external programmable controller and the stimulator are in a programmed connection state;
当所述体外程控器与所述刺激器处于程控连接状态时,控制所述刺激器停止递送电刺激。When the external programmer and the stimulator are in a programmed connection state, the stimulator is controlled to stop delivering electrical stimulation.
第二方面,本申请提供了一种程控***,所述程控***包括植入于患者体内的刺激器、体外程控器和上述体外充电器。In a second aspect, this application provides a program-controlled system, which includes a stimulator implanted in a patient's body, an external program controller, and the above-mentioned external charger.
第三方面,本申请提供了一种计算机可读存储介质,所述计算机可读存储介质存储有计算机程序,所述计算机程序被处理器执行时实现上述控制器的功能。In a third aspect, the present application provides a computer-readable storage medium that stores a computer program. When the computer program is executed by a processor, it implements the functions of the above-mentioned controller.
附图说明Description of the drawings
图1是本申请实施例提供的一种程控***的结构框图;Figure 1 is a structural block diagram of a program-controlled system provided by an embodiment of the present application;
图2是本申请实施例提供的一种体外充电器的控制方法的流程示意图;Figure 2 is a schematic flow chart of a control method for an external charger provided by an embodiment of the present application;
图3是本申请实施例提供的另一种体外充电器的控制方法的流程示意图;Figure 3 is a schematic flow chart of another control method for an external charger provided by an embodiment of the present application;
图4是本申请实施例提供的一种利用事件处理函数处理事件的原理图;Figure 4 is a schematic diagram of using an event processing function to process events provided by an embodiment of the present application;
图5是本申请实施例提供的一种控制器的结构框图;Figure 5 is a structural block diagram of a controller provided by an embodiment of the present application;
图6是本申请实施例提供的一种用于实现控制方法的程序产品的结构示意图。FIG. 6 is a schematic structural diagram of a program product for implementing a control method provided by an embodiment of the present application.
具体实施方式Detailed ways
下面,结合附图以及具体实施方式,对本申请做描述。Below, the present application is described with reference to the accompanying drawings and specific implementation modes.
在本申请中,“至少一个”是指一个或者多个,“多个”是指两个或两个以上。“和/或”,描述关联对象的关联关系,表示可以存在三种关系,例如,A和/或B,可以表示:单独存在A,同时存在A和B,单独存在B的情况,其中A,B可以是单数或者复数。字符“/”一般表示前后关联对象是一种“或”的关系。“以下至少一项(个)”或其类似表达,是指的这些项中的任意组合,包括单项(个)或复数项(个)的任意组合。例如,a,b或c中的至少一项(个),可以表示:a,b,c,a和b,a和c,b和c,a和b和c,其中a、b和c可以是单个,也可以是多个。值得注意的是,“至少一项(个)”还可以解释成“一项(个)或多项(个)”。In this application, "at least one" means one or more, and "plurality" means two or more. "And/or" describes the association of associated objects, indicating that there can be three 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 related objects are in an "or" relationship. "At least one of the following" or similar expressions thereof refers to any combination of these items, including any combination of a single item (items) or a plurality of items (items). For example, at least one of a, b or c can mean: a, b, c, a and b, a and c, b and c, a and b and c, where a, b and c can It can be single or multiple. It is worth noting that "at least one item (item)" can also be interpreted as "one item (item) or multiple items (item)".
本申请中,“示例性的”或者“例如”等词用于表示作例子、例证或说明。本申请中被描述为“示例性的”或者“例如”的任何实施方式或设计方案不应被解释为比其他实施方式或设计方案更优选或更具优势。确切而言,使用“示例性的”或者 “例如”等词旨在以具体方式呈现相关概念。In this application, the words "exemplary" or "such as" are used to mean examples, illustrations or explanations. Any embodiment or design described herein as "exemplary" or "such as" is not intended to be construed as preferred or advantageous over other embodiments or designs. Rather, use "exemplary" or Words such as "such as" are intended to present the concept in a concrete way.
下面,首先对本申请的应用领域进行说明。Below, the application fields of this application will be described first.
植入式神经刺激***主要包括植入体内的刺激器以及体外的体外程控器。神经调控技术主要是通过立体定向手术在体内特定结构(即靶点)植入电极,并由植入患者体内的刺激器经电极向靶点发放电脉冲,调控相应神经结构和网络的电活动及其功能,从而改善症状、缓解病痛。其中,刺激器可以是植入式神经电刺激装置、植入式心脏电刺激***(又称心脏起搏器)、植入式药物输注装置(Implantable Drug Delivery System,IDDS)和导线转接装置中的任意一种。植入式神经电刺激装置例如是脑深部电刺激(Deep Brain Stimulation,DBS)***、植入式脑皮层神经刺激(Cortical Nerve Stimulation,CNS)***、植入式脊髓电刺激(Spinal Cord Stimulation,SCS)***、植入式骶神经电刺激(Sacral Nerve Stimulation,SNS)***、植入式迷走神经电刺激(Vagus Nerve Stimulation,VNS)***等。Implantable neurostimulation systems mainly include stimulators implanted in the body and external programmer outside the body. Neuromodulation technology mainly implants electrodes into specific structures (i.e. target points) in the body through stereotaxic surgery, and the stimulator implanted in the patient's body sends electrical pulses to the target point through the electrodes to regulate the electrical activity and activity of the corresponding neural structures and networks. Its functions, thereby improving symptoms and relieving pain. Among them, the stimulator can be an implantable nerve electrical stimulation device, an implantable cardiac electrical stimulation system (also known as a pacemaker), an implantable drug delivery device (Implantable Drug Delivery System, IDDS) and a lead adapter device any of them. Implantable neuroelectric stimulation devices include, for example, Deep Brain Stimulation (DBS) systems, Implantable Cortical Nerve Stimulation (CNS) systems, and Implantable Spinal Cord Stimulation (SCS) systems. ) system, implantable sacral nerve stimulation (Sacral Nerve Stimulation, SNS) system, implantable vagus nerve stimulation (Vagus Nerve Stimulation, VNS) system, etc.
刺激器可以包括植入式脉冲发生器(Implantable Pulse Generator,IPG)、延伸导线和电极导线,IPG设置于患者体内,依靠密封电池和电路向体内组织提供可控制的电刺激能量,通过植入的延伸导线和电极导线,为体内组织的特定区域提供一路或两路可控制的特定电刺激能量。延伸导线配合IPG使用,作为电刺激信号的传递媒体,将IPG产生的电刺激信号,传递给电极导线。电极导线将IPG产生的电刺激信号,通过多个电极触点,向体内组织的特定区域释放电刺激能量;所述植入式医疗设备具有单侧或双侧的一路或多路电极导线,所述电极导线上设置有多个电极触点,所述电极触点可以均匀排列或者非均匀排列在电极导线的周向上。作为一个示例,所述电极触点以4行3列的阵列(共计12个电极触点)排列在电极导线的周向上。电极触点可以包括刺激电极触点和/或采集电极触点。电极触点例如可以采用片状、环状、点状等形状。The stimulator can include an Implantable Pulse Generator (IPG), extension wires, and electrode wires. The IPG is placed in the patient's body and relies on sealed batteries and circuits to provide controllable electrical stimulation energy to tissues in the body through the implanted Extension wires and electrode leads provide one or two channels of controllable specific electrical stimulation energy to specific areas of tissue in the body. The extension lead is used in conjunction with the IPG as a transmission medium for electrical stimulation signals to transmit the electrical stimulation signals generated by the IPG to the electrode leads. The electrode leads transmit the electrical stimulation signals generated by the IPG through multiple electrode contacts to release electrical stimulation energy to specific areas of the body tissue; the implantable medical device has one or more electrode leads on one or both sides, so A plurality of electrode contacts are provided on the electrode lead, and the electrode contacts may be uniformly or non-uniformly arranged in the circumferential direction of the electrode lead. As an example, the electrode contacts are arranged in an array of 4 rows and 3 columns (12 electrode contacts in total) in the circumferential direction of the electrode wire. The electrode contacts may include stimulation electrode contacts and/or collection electrode contacts. The electrode contacts may be in the shape of, for example, a sheet, a ring, a dot, or the like.
在一些实现方式中,受刺激的体内组织可以是患者的脑组织,受刺激的部位可以是脑组织的特定部位。当患者的疾病类型不同时,受刺激的部位一般来说是不同的,所使用的刺激触点(单源或多源)的数量、一路或多路(单通道或多通道)特定电刺激信号的运用以及刺激参数数据也是不同的。本申请对适用的疾病类型不做限定,其可以是DBS、SCS、骨盆刺激、胃刺激、外周神经刺激、功能性电刺激所适用的疾病类型。其中,DBS可以用于治疗或管理的疾病类型包括:痉挛疾病(例如,癫痫)、疼痛、偏头痛、精神疾病(例如,重度抑郁症(Major Depressive Disorder,MDD))、躁郁症、焦虑症、创伤后压力心理障碍症、轻郁症、强迫症(Obsessive Compulsive Disorder,OCD)、行为障碍、情绪障碍、记忆障碍、心理状态障碍、移动障碍(例如,特发性震颤 或帕金森氏病)、亨廷顿病、阿尔茨海默症、药物成瘾症、自闭症或其他神经学或精神科疾病和损害。In some implementations, 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 patients have different types of diseases, the stimulated parts are generally different, the number of stimulation contacts used (single source or multiple sources), one or more channels (single channel or multi-channel) specific electrical stimulation signals The application and stimulation parameter data are also different. This application does not limit the applicable disease types, which can be the disease types applicable to DBS, SCS, pelvic stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation. Among them, the types of diseases that DBS can be used to treat or manage include: spasticity (eg, epilepsy), pain, migraine, mental illness (eg, major depressive disorder (MDD)), bipolar disorder, anxiety disorder , post-traumatic stress disorder, mild depression, obsessive compulsive disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental status disorders, movement disorders (such as essential tremor or Parkinson's disease), Huntington's disease, Alzheimer's disease, drug addiction, autism, or other neurological or psychiatric diseases and impairments.
本申请中,体外程控器和刺激器建立程控连接时,可以利用体外程控器调整刺激器的电刺激信号的刺激参数,也可以通过刺激器感测患者脑深部的生物电活动,并可以通过所感测到的生物电活动来继续调节刺激器的电刺激信号的刺激参数。In this application, when the external programmable controller and the stimulator establish a programmable connection, the external programmable controller can be used to adjust the stimulation parameters of the electrical stimulation signal of the stimulator, and the stimulator can also be used to sense the bioelectrical activity in the deep brain of the patient, and can use the sensed The measured bioelectrical activity is used to continue to adjust the stimulation parameters of the electrical stimulation signal of the stimulator.
体外程控器可以是医生程控器或者患者程控器。The external programmer can be a physician programmer or a patient programmer.
当医生远程程控时,医生程控器可以通过服务器、患者程控器与刺激器进行数据交互。当医生线下和患者面对面进行程控时,医生程控器可以通过患者程控器与刺激器进行数据交互,医生程控器还可以直接与刺激器进行数据交互。患者程控器还可以直接与刺激器进行数据交互。When a doctor remotely controls the program, the doctor programmer can interact with the stimulator through the server, patient programmer, and stimulator. When the doctor performs face-to-face programming with the patient offline, the doctor's programmer can interact with the stimulator through the patient's programmer, and the doctor's programmer can also directly interact with the stimulator. The patient programmer can also interact directly with the stimulator.
参见图1,图1示出了本申请提供的一种程控***100的结构框图。Referring to Figure 1, Figure 1 shows a structural block diagram of a program control system 100 provided by this application.
所述程控***100包括:植入于患者体内的刺激器103、体外程控器101和体外充电器102,所述体外充电器102与体外程控器101以及植入于患者体内的刺激器103分别进行数据交互,所述体外充电器102包括交互组件1021。The program control system 100 includes: a stimulator 103 implanted in the patient's body, an extracorporeal programmer 101 and an extracorporeal charger 102. The extracorporeal charger 102 and the extracorporeal programmer 101 and the stimulator 103 implanted in the patient's body are respectively operated. For data interaction, the external charger 102 includes an interaction component 1021 .
所述体外充电器102还包括与交互组件连接的控制器1022,所述控制器被配置成实现控制方法的步骤。The extracorporeal charger 102 also includes a controller 1022 connected to the interactive component, and the controller is configured to implement the steps of the control method.
体外程控器101例如可以包括平板电脑、笔记本电脑、台式机、手机和智能穿戴设备中的一种或多种。The external programmer 101 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.
在一些实施例中,所述体外程控器101可以与所述体外充电器102集成为一体。In some embodiments, the external programmer 101 can be integrated with the external charger 102 .
下文将先对控制方法进行说明。The control method will be explained first below.
参见图2,图2是本申请实施例提供的一种体外充电器的控制方法的流程示意图。Referring to Figure 2, Figure 2 is a schematic flowchart of a control method for an external charger provided by an embodiment of the present application.
所述体外充电器与体外程控器以及植入于患者体内的刺激器分别进行数据交互,所述体外充电器包括交互组件;所述方法包括:The extracorporeal charger performs data interaction with the extracorporeal program controller and the stimulator implanted in the patient's body respectively. The extracorporeal charger includes interactive components; the method includes:
S101:利用所述交互组件接收触发操作。S101: Use the interactive component to receive a trigger operation.
S102:响应于所述触发操作,检测所述体外程控器与所述刺激器是否处于程控连接状态。S102: In response to the triggering operation, detect whether the external programmable controller and the stimulator are in a programmable connection state.
S103:当所述体外程控器与所述刺激器处于程控连接状态时,控制所述刺激器停止递送电刺激。 S103: When the external programmer and the stimulator are in a programmed connection state, control the stimulator to stop delivering electrical stimulation.
由此,体外充电器设置有交互组件,通过交互组件可以接收用户的触发操作,此时不直接让刺激器停止刺激,而是检测体外程控器与刺激器是否处于程控连接状态,只有体外程控器与刺激器处于程控连接状态时,才控制刺激器停止递送电刺激。Therefore, the external charger is equipped with an interactive component, through which the user's trigger operation can be received. At this time, the stimulator is not directly stopped to stimulate, but it is detected whether the external programmable controller and the stimulator are in a programmable connection state. Only the external programmable controller The stimulator is controlled to stop delivering electrical stimulation only when it is in a programmed connection state with the stimulator.
只有在程控过程中,体外充电器的交互组件才可以触发,用来紧急停止刺激,这样的话,体外充电器可以在程控过程中独立控制刺激器停止递送电刺激,当体外程控器出现故障导致无法向体外充电器发送停止刺激的程控指令时,可以直接利用交互组件接收触发操作,从而实现急停功能,极大程度上保障了患者的生命安全。Only during the programming process, the interactive component of the external charger can be triggered to emergency stop stimulation. In this case, the external charger can independently control the stimulator to stop delivering electrical stimulation during the programming process. When the external program controller fails, it cannot When sending a program-controlled instruction to stop stimulation to the external charger, the interactive component can be directly used to receive the trigger operation, thereby realizing the emergency stop function and ensuring the patient's life safety to a great extent.
正常使用场景下,体外程控器可以通过体外充电器发送程控指令给刺激器,从而关闭刺激。但是鉴于整个程控***健壮性和完整性的考虑,在体外充电器上设置交互组件,有助于在特殊场景下关闭刺激器的刺激功能,比如体外程控器出现问题导致无法发送程控指令,体外程控器与体外充电器的连接异常中断,患者在现有刺激参数下出现不适,需要快速中断刺激等。此时通过直接触发交互组件,体外充电器可以直接发送程控指令给刺激器停止刺激输出,极大程度上降低了程控***失效的风险。Under normal use scenarios, the external programmable controller can send program-controlled instructions to the stimulator through the external charger to turn off stimulation. However, in view of the robustness and integrity of the entire programmable control system, setting up interactive components on the extracorporeal charger can help turn off the stimulation function of the stimulator in special scenarios. For example, if there is a problem with the extracorporeal programmer and the programmable command cannot be sent, the extracorporeal programmable control The connection between the device and the external charger is abnormally interrupted, the patient experiences discomfort under the existing stimulation parameters, and needs to quickly interrupt stimulation, etc. At this time, by directly triggering the interactive component, the external charger can directly send program-controlled instructions to the stimulator to stop stimulation output, which greatly reduces the risk of program-controlled system failure.
在一些实施方式中,所述交互组件可以设置于所述体外充电器的外壳的上盖,所述交互组件例如是按钮、按键、推钮或者旋钮等。In some embodiments, the interactive component may be disposed on the upper cover of the housing of the in vitro charger. The interactive component may be a button, a key, a push button, a knob, etc.
该交互组件被配置成在体外程控器和刺激器处于程控连接状态时紧急关闭刺激器的刺激,将刺激器的刺激幅值归零。The interactive component is configured to emergency shut down the stimulation of the stimulator and reset the stimulation amplitude of the stimulator to zero when the external programmer and the stimulator are in a programmed connection state.
当交互组件是按钮或者按键时,触发操作可以是按压按钮或者按压按键的操作,当交互组件是旋钮时,触发操作可以是旋转旋钮的操作,当交互组件是推钮时,触发操作可以是推拉推钮的操作。When the interactive component is a button or a key, the triggering operation can be an operation of pressing a button or pressing a key. When the interactive component is a knob, the triggering operation can be an operation of rotating the knob. When the interactive component is a push button, the triggering operation can be a push or pull. Push button operation.
在一些实施方式中,所述体外充电器被配置成为所述刺激器进行充电,所述体外充电器设置有可充电电池和显示屏,所述方法还可以包括:获取所述可充电电池的健康状态评分;当所述健康状态评分小于预设评分阈值时,利用所述显示屏显示提示信息。In some embodiments, the external charger is configured to charge the stimulator, the external charger is provided with a rechargeable battery and a display screen, and the method may further include: obtaining the health of the rechargeable battery. Status score: when the health status score is less than the preset score threshold, use the display screen to display prompt information.
所述提示信息可以是文字信息、图像信息和视频信息的一种或多种。The prompt information may be one or more of text information, image information and video information.
可充电电池例如可以是锂电池。The rechargeable battery may be a lithium battery, for example.
提示信息可以用于提醒更换该可充电电池,例如,提示信息可以是一条内容为“请及时更换电池”的文字信息。The prompt message can be used to remind to replace the rechargeable battery. For example, the prompt message can be a text message with the content "Please replace the battery in time".
本申请对预设评分阈值不做限定,预设评分阈值例如可以是50分、80分或者90分,分值越高,健康状态越好。 This application does not limit the preset score threshold. The preset score threshold can be, for example, 50 points, 80 points, or 90 points. The higher the score, the better the health status.
体外充电器可以为刺激器进行充电,对患者而言十分重要,通过实时评估体外充电器的可充电电池的健康状态,可以在电池报废之前进行预警,避免患者在使用体外充电器的过程中因为电池的问题而充电失败,保障患者的生命安全。The external charger can charge the stimulator, which is very important to the patient. By evaluating the health status of the rechargeable battery of the external charger in real time, an early warning can be issued before the battery is scrapped, thus preventing the patient from being damaged during the use of the external charger. Charging fails due to battery problems, ensuring the patient's life safety.
可充电电池的健康状态评分可以采用CN105607004A公开的锂离子电池包健康状态评估方法或者CN112269137A公开的基于动态参数识别的电池健康状态估算方法获取。The health status score of the rechargeable battery can be obtained using the lithium-ion battery pack health status evaluation method disclosed in CN105607004A or the battery health status estimation method based on dynamic parameter identification disclosed in CN112269137A.
在一些实施方式中,所述体外充电器还设置有身份信息采集组件;所述步骤S101可以包括:In some embodiments, the external charger is also provided with an identity information collection component; the step S101 may include:
利用所述身份信息采集组件采集用户的待验证身份信息;将所述待验证身份信息与预先存储的每个已验证身份信息进行匹配,当所述待验证身份信息与其中一个已验证身份信息匹配成功时,利用所述交互组件接收所述用户的触发操作。Use the identity information collection component to collect the user's identity information to be verified; match the identity information to be verified with each pre-stored verified identity information, when the identity information to be verified matches one of the verified identity information When successful, the interactive component is used to receive the user's trigger operation.
身份信息采集组件可以包括以下一种或多种:静脉信息采集组件、人脸信息采集组件、虹膜信息采集组件、唇纹信息采集组件、视网膜信息采集组件、手形信息采集组件、语音信息采集组件和指纹信息采集组件。The identity information collection component may include one or more of the following: vein information collection component, face information collection component, iris information collection component, lip print information collection component, retina information collection component, hand shape information collection component, voice information collection component and Fingerprint information collection component.
相应地,待验证身份信息和已验证身份信息可以包括以下一种或多种:静脉信息、人脸信息、虹膜信息、唇纹信息、视网膜信息、手形信息、语音信息和指纹信息。Accordingly, the identity information to be verified and the identity information that has been verified may include one or more of the following: vein information, face information, iris information, lip print information, retina information, hand shape information, voice information and fingerprint information.
只有当前用户的待验证身份信息与其中一个已验证身份信息匹配成功,也就是该用户身份认证通过时,才可以成功触发交互组件。Only when the current user's identity information to be verified successfully matches one of the verified identity information, that is, when the user's identity authentication passes, can the interactive component be successfully triggered.
已验证身份信息所对应的用户可以是患者本人、医生、患者家属、护工等照护患者的人。The users corresponding to the verified identity information can be the patients themselves, doctors, patients' family members, caregivers and other people who care for the patients.
在一应用中,身份信息采集组件包括静脉信息采集组件,待验证身份信息和已验证身份信息包括静脉信息。静脉信息可以是指静脉信息或者掌静脉信息。In an application, the identity information collection component includes a vein information collection component, and the identity information to be verified and the identity information that has been verified include vein information. The vein information may refer to vein information or palm vein information.
相比于人脸识别、指纹识别来说,静脉的识别精度更高,且必须是活体才能执行识别,避免人脸识别、指纹识别等识别方式中人脸信息、指纹信息被盗用来进行身份验证的情况,并且,只有用户主动伸出手指或者手掌认证才可以进行识别,充分尊重用户意愿。Compared with face recognition and fingerprint recognition, the recognition accuracy of veins is higher, and the recognition must be performed on a living body to prevent facial information and fingerprint information from being stolen and used for identity verification in recognition methods such as face recognition and fingerprint recognition. situation, and only when the user actively extends their finger or palm for authentication can identification be carried out, fully respecting the user's wishes.
在一些实施方式中,所述身份信息采集组件可以与交互组件集成为一体。In some implementations, the identity information collection component can be integrated with the interactive component.
在一些实施例中,所述步骤S101可以包括:In some embodiments, step S101 may include:
利用所述交互组件接收待验证身份信息;将所述待验证身份信息与预先存 储的每个已验证身份信息进行匹配,当所述待验证身份信息与其中一个已验证身份信息匹配成功时,停止匹配并利用所述交互组件接收触发操作。Utilize the interactive component to receive identity information to be verified; combine the identity information to be verified with pre-stored Each stored verified identity information is matched. When the identity information to be verified successfully matches one of the verified identity information, the matching is stopped and the interactive component is used to receive a trigger operation.
由此,通过交互组件接收待验证身份信息,将待验证身份信息与每个已验证身份信息进行匹配,以实现身份认证,当待验证身份信息与其中一个已验证身份信息匹配成功时,表明待验证身份信息对应的用户通过了身份认证,只有身份认证通过才可以利用交互组件接收该用户的触发操作。Therefore, the identity information to be verified is received through the interactive component, and the identity information to be verified is matched with each verified identity information to achieve identity authentication. When the identity information to be verified successfully matches one of the verified identity information, it indicates that the identity information to be verified is successfully matched. Verify that the user corresponding to the identity information has passed the identity authentication. Only if the identity authentication is passed, the interactive component can be used to receive the user's trigger operation.
并不是所有用户的触发操作都是有效的,只有通过身份认证的用户的触发操作才是有效的,避免无关人员有意或者无意中触发体外充电器的急停功能,导致刺激突然停止,保障患者的生命安全。Not all users' trigger operations are valid. Only those of users who have passed identity authentication are valid. This prevents unrelated persons from triggering the emergency stop function of the external charger intentionally or unintentionally, causing the stimulation to suddenly stop, and ensuring the safety of the patient. life safety.
在一些实施例中,所述交互组件包括指纹识别按钮和/或麦克风,所述待验证身份信息包括指纹信息和/或语音信息。相应地,所述已验证身份信息可以包括指纹信息和/或语音信息。In some embodiments, the interactive component includes a fingerprint recognition button and/or a microphone, and the identity information to be verified includes fingerprint information and/or voice information. Correspondingly, the verified identity information may include fingerprint information and/or voice information.
由此,通过指纹识别按钮可以接收用户的指纹信息,以实现指纹识别,通过麦克风可以接收用户的语音信息,以实现语音识别。Therefore, the user's fingerprint information can be received through the fingerprint recognition button to implement fingerprint recognition, and the user's voice information can be received through the microphone to implement voice recognition.
在一些实施方式中,所述交互组件包括麦克风,所述待验证身份信息包括语音信息,相应地,所述已验证身份信息包括语音信息;当所述待验证身份信息与其中一个所述已验证身份信息匹配成功时,检测所述待验证身份信息的语音识别内容是否包括以下至少一种:“关闭刺激”、“停止刺激”、“控制刺激器关闭”和“停掉刺激”;若所述待验证身份信息的语音识别内容包括以下至少一种:“关闭刺激”、“停止刺激”、“控制刺激器关闭”和“停掉刺激”,检测所述体外程控器与所述刺激器是否处于程控连接状态;当所述体外程控器与所述刺激器处于程控连接状态时,控制所述刺激器停止递送电刺激。In some embodiments, the interactive component includes a microphone, the identity information to be verified includes voice information, and accordingly, the verified identity information includes voice information; when the identity information to be verified is consistent with one of the verified When the identity information is successfully matched, it is detected whether the speech recognition content of the identity information to be verified includes at least one of the following: "turn off stimulation", "stop stimulation", "control the stimulator to turn off" and "stop stimulation"; if The voice recognition content of the identity information to be verified includes at least one of the following: "turn off stimulation", "stop stimulation", "control stimulator to turn off" and "stop stimulation", and detect whether the external programmer and the stimulator are in the same position. Programmed connection state; when the external programmer and the stimulator are in a programmed connection state, the stimulator is controlled to stop delivering electrical stimulation.
在一些实施例中,所述步骤S103包括:In some embodiments, step S103 includes:
当所述体外程控器与所述刺激器处于程控连接状态时,检测是否发生预设事件,当发生所述预设事件时,控制所述刺激器停止递送电刺激;其中,所述预设事件包括以下一种或几种:所述患者的生物电信号发生异常;所述刺激器的电量低于预设电量阈值;所述体外程控器的程控应用未响应;所述体外程控器与所述体外充电器的连接发生中断;所述体外程控器的实际配置信息与所述患者的参考配置信息的相似度不大于第一相似度阈值。When the extracorporeal programmer and the stimulator are in a programmed connection state, detect whether a preset event occurs, and when the preset event occurs, control the stimulator to stop delivering electrical stimulation; wherein, the preset event Including one or more of the following: the patient's bioelectrical signal is abnormal; the power of the stimulator is lower than the preset power threshold; the program-controlled application of the external programmable controller does not respond; the external programmable controller and the The connection of the extracorporeal charger is interrupted; the similarity between the actual configuration information of the extracorporeal program controller and the patient's reference configuration information is not greater than the first similarity threshold.
所述体外程控器的程控应用未响应是指:当所述体外程控器接收到用户的参数配置操作后,无法生成对应的程控指令。The non-response of the program-controlled application of the in vitro programmable controller means that the in vitro programmable controller cannot generate the corresponding program-controlled instructions after receiving the user's parameter configuration operation.
由此,在程控过程中接收到触发操作时,不直接控制刺激器停止递送电刺激,而是检测是否发生了预设事件,确认是否有停止刺激的必要(发生预设事 件则表明需要停止刺激,未发生预设事件表明没有停止刺激的必要),只有发生了预设事件才控制刺激器停止递送电刺激,没有发生预设事件,则不会控制刺激器停止递送电刺激,避免用户误操作。Therefore, when a trigger operation is received during the programming process, the stimulator is not directly controlled to stop delivering electrical stimulation, but the stimulator is detected to determine whether a preset event has occurred and whether it is necessary to stop stimulation (a preset event occurs). event indicates that stimulation needs to be stopped, and the absence of a preset event indicates that there is no need to stop stimulation). Only when a preset event occurs will the stimulator be controlled to stop delivering electrical stimulation. If a preset event does not occur, the stimulator will not be controlled to stop delivering electrical stimulation. Stimulate and prevent users from misoperation.
一方面,当预设事件包括患者的生物电信号发生异常时,发生预设事件表明患者的状态异常,极有可能发病,此时需要停止刺激;一方面,当预设事件包括体外充电器的电量低于预设电量阈值时,发生预设事件表明刺激器的电量过低,不能支持长时间的电刺激,此时需要停止刺激;一方面,当预设事件包括体外程控器的程控应用未响应时,表明体外程控器无法对刺激器进行程控,刺激器处于不可控状态,此时需要停止刺激;一方面,当预设事件包括体外程控器与体外充电器的连接发生中断时,表明体外程控器无法通过体外充电器对刺激器进行程控,刺激器处于不可控状态,此时需要停止刺激;另一方面,当预设事件包括体外程控器的实际配置信息与患者的参考配置信息的相似度不大于预设相似度阈值时,发生预设事件表明体外程控器的实际配置信息与参考配置信息相差太大,体外程控器对应的程控指令可能并不合适该患者,此时需要停止刺激。On the one hand, when the preset event includes an abnormality in the patient's bioelectrical signal, the occurrence of the preset event indicates that the patient's status is abnormal and is very likely to become ill, and stimulation needs to be stopped at this time; on the other hand, when the preset event includes an external charger When the power is lower than the preset power threshold, the occurrence of a preset event indicates that the stimulator's power is too low and cannot support long-term electrical stimulation. At this time, stimulation needs to be stopped; on the one hand, when the preset event includes the failure of the program-controlled application of the external programmable controller, When responding, it indicates that the external programmer cannot program the stimulator, and the stimulator is in an uncontrollable state. At this time, stimulation needs to be stopped; on the one hand, when the preset event includes the interruption of the connection between the external programmer and the external charger, it indicates that the external programmer is in an uncontrollable state. The programmer cannot program the stimulator through the external charger, and the stimulator is in an uncontrollable state. At this time, stimulation needs to be stopped; on the other hand, when the preset event includes the actual configuration information of the external programmer and the patient's reference configuration information, it is similar. When the degree is not greater than the preset similarity threshold, the occurrence of a preset event indicates that the actual configuration information of the external programmable controller is too different from the reference configuration information, and the program control instructions corresponding to the external programmable controller may not be suitable for the patient, and the stimulation needs to be stopped at this time.
本申请对预设电量阈值不作限定,其可以是5%、8%或者10%。This application does not limit the preset power threshold, which can be 5%, 8% or 10%.
在一些实施例中,所述预设事件包括所述患者的生物电信号发生异常,检测所述患者的生物电信号是否发生异常的过程如下:将所述患者的生物电信号输入异常检测模型,以输出所述生物电信号对应的预测相似度;其中,所述异常检测模型用于将所述生物电信号与异常数据库中的每个异常生物电信号进行比对,得到所述生物电信号与每个异常生物电信号的相似度,将所述生物电信号对应的多个相似度中最高的相似度作为所述生物电信号对应的预测相似度;当所述预测相似度不小于第二相似度阈值时,确定所述生物电信号发生异常;当所述预测相似度小于所述第二相似度阈值时,确定所述生物电信号没有发生异常。In some embodiments, the preset event includes an abnormality in the patient's bioelectrical signal. The process of detecting whether the patient's bioelectrical signal is abnormal is as follows: input the patient's bioelectrical signal into an abnormality detection model, To output the predicted similarity corresponding to the bioelectric signal; wherein, the anomaly detection model is used to compare the bioelectric signal with each abnormal bioelectric signal in the abnormal database to obtain the bioelectric signal and For the similarity of each abnormal bioelectric signal, the highest similarity among the multiple similarities corresponding to the bioelectric signal is used as the predicted similarity corresponding to the bioelectric signal; when the predicted similarity is not less than the second similarity When the predicted similarity is less than the second similarity threshold, it is determined that the bioelectric signal is not abnormal.
由此,通过将患者的生物电信号输入异常检测模型,利用异常检测模型确定生物电信号对应的预测相似度,其中,异常检测模型可以调用异常数据库,异常数据库存储着大量的异常生物电信号,异常生物电信号可以是不同的病患在发病时对应的生物电信号,还可以是当前患者本人在发病时对应的生物电信号,当前患者患有帕金森病时,异常数据库的异常生物电信号可以包括帕金森患者在发病时对应的生物电信号,将患者的生物电信号与异常数据库中的每个异常生物电信号进行比对,将多个相似度中最高的相似度作为预测相似度,通过比较预测相似度和预设相似度阈值的大小来判断患者的生物电信号是否发生异常,预测相似度越高,患者的生物电信号越有可能发生异常,患者越有可能 发病,将患者的生物电信号与异常数据库预先存储的多个异常生物电信号逐一进行比对,找出相似度最高的异常生物电信号,提高了异常检测结果的准确性。Therefore, by inputting the patient's bioelectrical signals into the abnormality detection model, the abnormality detection model is used to determine the predicted similarity corresponding to the bioelectrical signals. The abnormality detection model can call the abnormality database, which stores a large number of abnormal bioelectrical signals. The abnormal bioelectrical signal can be the bioelectrical signal corresponding to different patients at the time of onset, or the bioelectrical signal corresponding to the current patient himself at the time of onset. When the current patient suffers from Parkinson's disease, the abnormal bioelectrical signal in the abnormal database It can include the bioelectrical signals corresponding to the onset of Parkinson's disease, compare the patient's bioelectrical signals with each abnormal bioelectrical signal in the abnormal database, and use the highest similarity among multiple similarities as the predicted similarity. By comparing the predicted similarity and the preset similarity threshold, it is determined whether the patient's bioelectrical signal is abnormal. The higher the predicted similarity, the more likely the patient's bioelectrical signal will be abnormal, and the more likely the patient is to have abnormality. When the disease occurs, the patient's bioelectrical signal is compared one by one with multiple abnormal bioelectrical signals pre-stored in the abnormality database to find the abnormal bioelectrical signal with the highest similarity, which improves the accuracy of the abnormality detection results.
在一些实施方式中,患者的生物电信号可以利用生物电采集设备采集得到。In some embodiments, the patient's bioelectrical signals can be collected using a bioelectrical collection device.
本申请对生物电采集设备不作限定,生物电采集设备可以包括以下任意一种或多种:脑电采集设备(例如电极帽、皮层电极、颅内电极等)、心电采集设备、眼电采集设备、肌电采集设备。相应地,患者的生物电信号可以包括以下任意一种或多种:脑电信号、心电信号、眼电信号、肌电信号。This application does not limit the bioelectricity collection equipment. The bioelectricity collection equipment may include any one or more of the following: EEG collection equipment (such as electrode caps, cortical electrodes, intracranial electrodes, etc.), ECG collection equipment, and eye electricity collection. Equipment, EMG collection equipment. Correspondingly, the patient's bioelectrical signals may include any one or more of the following: electroencephalographic signals, electrocardiographic signals, electroocular signals, and electromyographic signals.
在一应用中,生物电采集设备可以是植入于患者体内的刺激器,患者的生物电信号可以包括脑电信号,刺激器兼具感测脑电信号和递送电刺激的功能。In one application, the bioelectrical collection device may be a stimulator implanted in the patient's body. The patient's bioelectrical signals may include brain electrical signals. The stimulator has the functions of sensing brain electrical signals and delivering electrical stimulation.
预测相似度可以用数字或者百分数表示,用数字表示时,预测相似度例如是60、80或者90;用百分数表示时,预测相似度例如是60%、80%或者90%,数值越高,预测相似度越高。The predicted similarity can be expressed as a number or a percentage. When expressed as a number, the predicted similarity is, for example, 60, 80, or 90; when expressed as a percentage, the predicted similarity is, for example, 60%, 80%, or 90%. The higher the value, the better the predicted similarity. The higher the similarity.
本申请对第二相似度阈值不作限定,其可以是70%、80%或者90%。This application does not limit the second similarity threshold, which may be 70%, 80% or 90%.
所述异常检测模型的训练过程可以包括:获取第二训练集,所述第二训练集包括多个第二训练数据,每个所述第二训练数据包括用于训练的第一样本信号、第二样本信号以及所述第一样本信号和所述第二样本信号的相似度的标注数据;针对所述第二训练集中的每个第二训练数据,执行以下处理:将所述第二训练数据中的第一样本信号和第二样本信号分别输入预设的第二深度学习模型,得到所述第一样本信号和所述第二样本信号的相似度的预测数据;基于所述第一样本信号和所述第二样本信号的相似度的预测数据和标注数据,对所述第二深度学习模型的模型参数进行更新;检测是否满足预设的第二训练结束条件;如果满足预设的第二训练结束条件,则将训练出的第二深度学习模型作为所述异常检测模型;如果不满足预设的第二训练结束条件,则利用下一个所述第二训练数据继续训练所述第一深度学习模型。The training process of the anomaly detection model may include: obtaining a second training set, the second training set including a plurality of second training data, each of the second training data including a first sample signal used for training, annotation data of the second sample signal and the similarity between the first sample signal and the second sample signal; for each second training data in the second training set, perform the following processing: convert the second The first sample signal and the second sample signal in the training data are respectively input into the preset second deep learning model to obtain prediction data of the similarity between the first sample signal and the second sample signal; based on the The prediction data and annotation data of the similarity between the first sample signal and the second sample signal are used to update the model parameters of the second deep learning model; detect whether the preset second training end condition is met; if it is met If the preset second training end condition is met, the trained second deep learning model will be used as the anomaly detection model; if the preset second training end condition is not met, the next second training data will be used to continue training. The first deep learning model.
本申请对预设的第二训练结束条件不作限定,其例如可以是训练次数达到预设次数(预设次数例如是1次、3次、10次、100次、1000次、10000次等),或者可以是第二训练集中的训练数据都完成一次或多次训练,或者可以是本次训练得到的总损失值不大于预设损失值。This application does not limit the preset second training end condition, which may be, for example, that the number of training times reaches a 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 all the training data in the second training set have 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.
在一些实施例中,所述预设事件包括所述体外程控器的实际配置信息与所述患者的参考配置信息的相似度不大于第一相似度阈值;所述参考配置信息的获取过程如下:将所述患者的疾病信息输入参考配置模型,得到所述参考配置信息;其中,所述参考配置模型的训练过程包括:获取第一训练集,所述第一训练集包括多个第一训练数据,每个所述第一训练数据包括一个样本对象的疾 病信息以及所述样本对象的参考配置信息的标注数据;针对所述第一训练集中的每个第一训练数据,执行以下处理:将所述第一训练数据中的样本对象的疾病信息输入预设的第一深度学习模型,得到所述样本对象的参考配置信息的预测数据;基于所述样本对象的参考配置信息的预测数据和标注数据,对所述第一深度学习模型的模型参数进行更新;检测是否满足预设的第一训练结束条件;如果满足预设的第一训练结束条件,则将训练出的第一深度学习模型作为所述分类模型;如果不满足预设的第一训练结束条件,则利用下一个所述第一训练数据继续训练所述第一深度学习模型。In some embodiments, the preset event includes that the similarity between the actual configuration information of the extracorporeal programmer and the patient's reference configuration information is not greater than the first similarity threshold; the acquisition process of the reference configuration information is as follows: Enter the patient's disease information into a reference configuration model to obtain the reference configuration information; wherein the training process of the reference configuration model includes: obtaining a first training set, the first training set including a plurality of first training data , each of the first training data includes a sample object's disease disease information and annotation data of the reference configuration information of the sample object; for each first training data in the first training set, perform the following processing: input the disease information of the sample object in the first training data into the preset Assume a first deep learning model to obtain prediction data of the reference configuration information of the sample object; update the model parameters of the first deep learning model based on the prediction data and annotation data of the reference configuration information of the sample object. ; Detect whether the preset first training end condition is met; if the preset first training end condition is met, use the trained first deep learning model as the classification model; if the preset first training end condition is not met If the condition is met, use the next first training data to continue training the first deep learning model.
由此,通过设计,建立适量的神经元计算节点和多层运算层次结构,选择合适的输入层和输出层,就可以得到预设的第一深度学习模型,通过该预设的第一深度学习模型的学习和调优,建立起从输入到输出的函数关系,虽然不能100%找到输入与输出的函数关系,但是可以尽可能地逼近现实的关联关系,由此训练得到的参考配置模型,可以基于患者的疾病信息获取刺激器对应的参考配置信息,且计算结果准确性高、可靠性高。Therefore, through design, establish an appropriate number of neuron computing nodes and a multi-layer computing hierarchy, and select the appropriate input layer and output layer, the preset first deep learning model can be obtained. Through the preset first deep learning The learning and tuning of the model establishes the functional relationship from input to output. Although the functional relationship between input and output cannot be found 100%, it can be as close as possible to the realistic correlation relationship. The reference configuration model obtained by training can The reference configuration information corresponding to the stimulator is obtained based on the patient's disease information, and the calculation results are highly accurate and reliable.
所述患者的疾病信息包括所述患者的基本信息、病史信息、医学影像信息、预先录制视频信息和实时视频信息中的一个或多个;其中,患者的基本信息例如可以包括性别、身高、体重、年龄中的一个或多个;患者的病史信息可以包括主诉信息、现病史信息、既往史信息和家族遗传史信息的一个或多个;患者的医学影像信息可以包括X光信息、电子计算机断层扫描(Computed Tomography,CT)信息和磁共振(Magnetic Resonance,MR)信息、正电子发射断层扫描(Positron Emission Tomography,PET)信息、PET-CT信息、PET-MR信息中的一个或多个。The patient's disease information includes one or more of the patient's basic information, medical history information, medical imaging information, pre-recorded video information, and real-time video information; where the patient's basic information may include, for example, gender, height, weight , one or more of age; the patient's medical history information may include one or more of chief complaint information, current history information, past history information, and family genetic history information; the patient's medical imaging information may include X-ray information, computerized tomography One or more of scan (Computed Tomography, CT) information, magnetic resonance (Magnetic Resonance, MR) information, positron emission tomography (Positron Emission Tomography, PET) information, PET-CT information, and PET-MR information.
在一些实施方式中,体外程控器的实际配置信息与患者的参考配置信息均用于指示刺激器的刺激参数。In some embodiments, both the actual configuration information of the extracorporeal programmer and the patient's reference configuration information are used to indicate the stimulation parameters of the stimulator.
刺激器的刺激参数可以包括以下至少一种:频率(例如是单位时间1s内的电刺激脉冲信号个数,单位为Hz)、脉宽(每个脉冲的持续时间,单位为μs)、幅值(一般用电压表述,即每个脉冲的强度,单位为V)、刺激模式(包括电流模式、电压模式、定时刺激模式和循环刺激模式中的一种或多种)、医生控制上限及下限(医生可调节的范围)和患者控制上限及下限(患者可自主调节的范围)。The stimulation parameters of the stimulator may include at least one of the following: frequency (for example, the number of electrical stimulation pulse signals per unit time 1 s, in Hz), pulse width (duration of each pulse, in μs), amplitude (Generally expressed in terms of voltage, that is, the intensity of each pulse, in V), stimulation mode (including one or more of current mode, voltage mode, timing stimulation mode and cyclic stimulation mode), upper and lower limits controlled by the doctor ( The range that the doctor can adjust) and the upper and lower limits of patient control (the range that the patient can adjust independently).
在一应用中,可以在电流模式或者电压模式下对刺激器的每个刺激参数进行调节。In one application, each stimulation parameter of the stimulator can be adjusted in current mode or voltage mode.
刺激参数标识可以使用中文、字母、数字、符号和特殊符号中的至少一种来表示。例如“A01”、“幅值”或者“#01”。 The stimulation parameter identification may be represented by at least one of Chinese characters, letters, numbers, symbols and special symbols. For example "A01", "Amplitude" or "#01".
当体外程控器为医生程控器时,体外程控器的实际配置信息是医生利用医生程控器设置刺激器的刺激参数所对应的信息,例如是“刺激模式为电压模式、频率为130Hz、脉宽为60μs和幅值为3V”。When the extracorporeal programmer is a doctor's programmer, the actual configuration information of the extracorporeal programmer is the information corresponding to the doctor using the doctor's programmer to set the stimulation parameters of the stimulator, for example, "The stimulation mode is voltage mode, the frequency is 130Hz, and the pulse width is 60μs and amplitude 3V”.
相应地,当体外程控器为患者程控器时,体外程控器的实际配置信息是患者利用患者程控器设置刺激器的刺激参数所对应的信息,例如是“刺激模式为电压模式、频率为90Hz、脉宽为50μs和幅值为4V”。Correspondingly, when the extracorporeal programmer is a patient programmer, the actual configuration information of the extracorporeal programmer is the information corresponding to the patient using the patient programmer to set the stimulation parameters of the stimulator, for example, "the stimulation mode is voltage mode, the frequency is 90Hz, The pulse width is 50μs and the amplitude is 4V”.
参考配置信息可以是预先设置好的,也可以是根据患者的病情利用人工智能算法自动生成的。The reference configuration information can be preset or automatically generated using artificial intelligence algorithms based on the patient's condition.
本申请对第一相似度阈值不作限定,其可以是70%、80%或者90%。This application does not limit the first similarity threshold, which may be 70%, 80% or 90%.
参见图3,图3是本申请实施例提供的另一种体外充电器的控制方法的流程示意图。Referring to Figure 3, Figure 3 is a schematic flowchart of another control method for an external charger provided by an embodiment of the present application.
在一些实施例中,所述体外充电器还包括警报组件,所述方法还可以包括:In some embodiments, the external charger further includes an alarm component, and the method may further include:
步骤S104:接收所述刺激器的反馈信息,所述反馈信息用于指示所述刺激器是否停止递送电刺激。Step S104: Receive feedback information from the stimulator, where the feedback information is used to indicate whether the stimulator stops delivering electrical stimulation.
步骤S105:基于所述反馈信息,控制所述警报组件的警示状态,以使所述警报组件在所述反馈信息不同时呈现不同的警示状态。Step S105: Based on the feedback information, control the alert state of the alarm component so that the alert component presents different alert states when the feedback information is different.
由此,通过设置警报组件,可以控制警报组件的警示状态,以使警报组件根据不同的反馈信息呈现不同的警示状态,这样的话,刺激器是否成功停止递送电刺激可以直接通过警报组件的警示状态得知,使患者及时知晓刺激有没有停止,减轻患者的心理负担。Therefore, by setting the alarm component, the warning state of the alarm component can be controlled so that the alarm component presents different warning states according to different feedback information. In this case, whether the stimulator successfully stops delivering electrical stimulation can be directly determined by the warning state of the alarm component. This allows the patient to know in time whether the stimulation has stopped and reduce the patient's psychological burden.
在一些实施方式中,所述方法还可以包括:In some embodiments, the method may further include:
当所述反馈信息指示所述刺激器停止递送电刺激时,生成信号采集指令并发送至所述刺激器;接收所述刺激器所采集的所述患者的脑电信号;基于所述患者的脑电信号,更新所述参考配置模型的模型参数。When the feedback information indicates that the stimulator stops delivering electrical stimulation, a signal acquisition instruction is generated and sent to the stimulator; the brain electrical signal of the patient collected by the stimulator is received; based on the patient's brain electrical signal to update the model parameters of the reference configuration model.
在程控过程中,由于体外程控器设置的刺激参数不合适,要紧急停止刺激器的刺激,刺激停止之后,可以利用刺激器采集患者此时的脑电信号,根据该脑电信号,重新调整刺激参数,可以更新参考配置模型的模型参数,使参考配置模型输出的参考配置信息更适用于患者当前的状态。During the programming process, because the stimulation parameters set by the external programmer are inappropriate, the stimulation of the stimulator must be stopped urgently. After the stimulation is stopped, the stimulator can be used to collect the patient's EEG signals at this time, and the stimulation can be readjusted based on the EEG signals. Parameters, you can update the model parameters of the reference configuration model to make the reference configuration information output by the reference configuration model more suitable for the patient's current status.
还可以将患者此时的脑电信号反馈至医生的平板电脑、手机等设备,让医生了解患者此时的状态。The patient's EEG signals at this time can also be fed back to the doctor's tablet, mobile phone and other devices, allowing the doctor to understand the patient's status at this time.
在一些实施例中,所述警报组件包括显示灯,所述警示状态包括开关状态、颜色、亮度和闪烁频率中的一种或几种。 In some embodiments, the alarm component includes a display light, and the warning state includes one or more of switch status, color, brightness, and flashing frequency.
由此,警报组件可以包括显示灯,警示状态可以包括开关状态、颜色、亮度和闪烁频率等,这样的话,可以利用显示灯的开启或关闭来指示刺激器是否停止递送电刺激,或者,利用显示灯不同的发光颜色来指示刺激器是否停止递送电刺激,或者,利用显示灯不同的发光亮度来指示刺激器是否停止递送电刺激,或者,利用显示灯不同的闪烁频率来指示刺激器是否停止递送电刺激。Thus, the alarm component may include a display light, and the warning status may include switch status, color, brightness, flashing frequency, etc. In this case, the turning on or off of the display light may be used to indicate whether the stimulator stops delivering electrical stimulation, or the display may be used. Different lighting colors of the lights indicate whether the stimulator has stopped delivering electrical stimulation, or different lighting brightness of the display lights is used to indicate whether the stimulator has stopped delivering electrical stimulation, or different flashing frequencies of the display lights are used to indicate whether the stimulator has stopped delivering electrical stimulation. Electrical stimulation.
在一应用中,所述警报组件包括显示灯,所述警示状态包括颜色和亮度;所述反馈信息指示所述刺激器停止递送电刺激时,控制所述显示灯的颜色为蓝色,亮度为第一亮度;所述反馈信息指示所述刺激器没有停止递送电刺激时,控制所述显示灯的颜色为红色,亮度为第二亮度,所述第二亮度高于所述第一亮度。In one application, the alarm component includes a display light, and the warning status includes color and brightness; when the feedback information indicates that the stimulator stops delivering electrical stimulation, the color of the display light is controlled to be blue and the brightness is First brightness; when the feedback information indicates that the stimulator has not stopped delivering electrical stimulation, the color of the display light is controlled to be red and the brightness is a second brightness, and the second brightness is higher than the first brightness.
在一些实施方式中,所述警报组件包括显示屏,所述反馈信息指示所述刺激器停止递送电刺激时,控制所述显示屏显示第一提示信息;所述反馈信息指示所述刺激器没有停止递送电刺激时,控制所述显示屏显示第二提示信息。In some embodiments, the alarm component includes a display screen, and when the feedback information indicates that the stimulator stops delivering electrical stimulation, the display screen is controlled to display the first prompt information; the feedback information indicates that the stimulator does not When the delivery of electrical stimulation is stopped, the display screen is controlled to display the second prompt information.
第一提示信息和第二提示信息的形式可以是文字信息、图像信息、视频信息中的一种或几种。The form of the first prompt information and the second prompt information may be one or more of text information, image information, and video information.
例如,第一提示信息可以是一条“刺激器已经停止刺激”的文字信息,第二提示信息可以是一条“刺激器未停止刺激”的文字信息。For example, the first prompt message may be a text message saying "The stimulator has stopped stimulating", and the second prompt message may be a text message "The stimulator has not stopped stimulating".
在一些实施方式中,所述警报组件包括蜂鸣器,所述警示状态包括发声状态、发声音调和发声频率中的一种或几种。In some embodiments, the alarm component includes a buzzer, and the warning state includes one or more of a sounding state, a sounding tone, and a sounding frequency.
所述反馈信息指示所述刺激器停止递送电刺激时,控制所述蜂鸣器不发声;所述反馈信息指示所述刺激器没有停止递送电刺激时,控制所述蜂鸣器发声。When the feedback information indicates that the stimulator stops delivering electrical stimulation, the buzzer is controlled not to sound; when the feedback information indicates that the stimulator does not stop delivering electrical stimulation, the buzzer is controlled to sound.
在一些实施例中,所述体外充电器与所述体外程控器采用蓝牙通信的方式进行数据交互,所述体外充电器与所述刺激器采用射频通信的方式进行数据交互。In some embodiments, the extracorporeal charger and the extracorporeal program controller use Bluetooth communication for data interaction, and the extracorporeal charger and the stimulator use radio frequency communication for data interaction.
由此,体外充电器与体外程控器可以采用蓝牙通信的方式进行数据交互,蓝牙通信的方式功耗较低,覆盖范围较大;体外充电器与刺激器可以采用射频通信的方式进行数据交互,射频通信的方式通信频带较宽,可传输的信息量大,数据传输速度和信号处理速度快。Therefore, the external charger and the external programmable controller can use Bluetooth communication for data interaction, which has lower power consumption and larger coverage; the external charger and the stimulator can use radio frequency communication for data interaction. Radio frequency communication has a wide communication frequency band, a large amount of information that can be transmitted, and fast data transmission speed and signal processing speed.
在一些实施方式中,体外充电器可以通过401MHz-433MHz工作频段或者2.4GHz-2.5GHz工作频段与刺激器进行数据交互。In some embodiments, the external charger can interact with the stimulator through the 401MHz-433MHz operating frequency band or the 2.4GHz-2.5GHz operating frequency band.
在一应用中,体外充电器可以通过433MHz工作频段或者2.4GHz工作频段与刺激器进行数据交互。 In one application, the external charger can interact with the stimulator through the 433MHz operating frequency band or the 2.4GHz operating frequency band.
在一些实施例中,所述患者的疾病类型包括癫痫、震颤、帕金森病、抑郁症、强迫症、阿尔茨海默症和药物成瘾症中的一个或多个。In some embodiments, the patient's disease type includes one or more of epilepsy, tremor, Parkinson's disease, depression, obsessive-compulsive disorder, Alzheimer's disease, and drug addiction.
由此,体外充电器适用于多种不同疾病类型的患者,适用范围较广。Therefore, the external charger is suitable for patients with many different disease types and has a wide range of applications.
在一些实施例中,所述方法还可以包括:响应于所述触发操作,将所述触发操作对应的停止刺激事件加入事件队列;利用事件处理函数根据事件的优先级处理事件队列中的事件,其中,所述停止刺激事件的优先级为最高优先级。In some embodiments, the method may further include: in response to the triggering operation, adding the stop stimulation event corresponding to the triggering operation into the event queue; using an event processing function to process the events in the event queue according to the priority of the event, Wherein, the priority of the stop stimulation event is the highest priority.
由此,将触发操作对应的停止刺激事件的优先级设置为最高优先级,这样的话,事件处理函数可以优先处理停止刺激事件,提升触发操作的响应速度,在较短的时间内就可以实现急停功能,保障了患者的生命安全。Therefore, the priority of the stop stimulation event corresponding to the trigger operation is set to the highest priority. In this case, the event processing function can prioritize the stop stimulation event, improve the response speed of the trigger operation, and achieve emergency response in a short time. The shutdown function ensures the patient's life safety.
本申请对事件处理函数不做限定,事件处理函数例如可以采用CN106598751A公开的事件处理函数、CN108228330A公开的事件处理函数或者CN106293969A公开的事件处理函数。This application does not limit the event processing function. The event processing function may, for example, adopt the event processing function disclosed in CN106598751A, the event processing function disclosed in CN108228330A, or the event processing function disclosed in CN106293969A.
参见图4,图4是本申请实施例提供的一种利用事件处理函数处理事件的原理图。Referring to Figure 4, Figure 4 is a schematic diagram of using an event processing function to process events according to an embodiment of the present application.
在一应用中,利用事件处理函数可以实时监测程控***中多类事件,其中通过交互组件触发的停止刺激事件有最高的优先级,交互组件例如可以是按键,当按键按下时,产生下降沿外部中断或者上升沿外部中断,经过防抖措施后加入事件队列,事件处理函数优先处理该停止刺激事件,体外充电器通过射频通信的方式发送对应的指令给刺激器,从而控制刺激器停止递送电刺激。In an application, the event processing function can be used to monitor multiple types of events in the program-controlled system in real time. Among them, the stop stimulation event triggered by the interactive component has the highest priority. The interactive component can be a button, for example. When the button is pressed, a falling edge is generated. External interrupts or rising edge external interrupts are added to the event queue after anti-shake measures. The event processing function prioritizes the stop stimulation event. The external charger sends corresponding instructions to the stimulator through radio frequency communication, thereby controlling the stimulator to stop delivering electricity. Stimulate.
本申请还提供了一种体外充电器,所述体外充电器被配置成与体外程控器以及植入于患者体内的刺激器分别进行数据交互,所述体外充电器包括交互组件;所述体外充电器还包括与交互组件连接的控制器,所述控制器的实现方式与上述方法实施方式中记载的实施方式、所达到的技术效果一致,部分内容不再赘述。This application also provides an external charger, which is configured to interact with data respectively with an external programmer and a stimulator implanted in the patient's body. The external charger includes an interactive component; the external charger The device also includes a controller connected to the interactive component. The implementation of the controller is consistent with the implementation described in the above method implementation and the technical effects achieved, and part of the content will not be described again.
所述控制器被配置成:利用所述交互组件接收触发操作;响应于所述触发操作,检测所述体外程控器与所述刺激器是否处于程控连接状态;当所述体外程控器与所述刺激器处于程控连接状态时,控制所述刺激器停止递送电刺激。The controller is configured to: use the interactive component to receive a trigger operation; in response to the trigger operation, detect whether the extracorporeal program controller and the stimulator are in a program-controlled connection state; when the extracorporeal program controller and the stimulator are in a programmed connection state; When the stimulator is in the programmed connection state, the stimulator is controlled to stop delivering electrical stimulation.
在一些实施例中,所述控制器还被配置成存储有一个或多个已验证身份信息,所述控制器被配置成采用如下方式接收所述触发操作:利用所述交互组件接收待验证身份信息;将所述待验证身份信息与每个已验证身份信息进行匹配,当所述待验证身份信息与其中一个已验证身份信息匹配成功时,停止匹配并利用所述交互组件接收触发操作。In some embodiments, the controller is further configured to store one or more verified identity information, and the controller is configured to receive the triggering operation in the following manner: using the interactive component to receive the identity to be verified. Information; match the identity information to be verified with each verified identity information, and when the identity information to be verified successfully matches one of the verified identity information, stop matching and use the interactive component to receive a trigger operation.
在一些实施例中,所述交互组件包括指纹识别按钮和/或麦克风,所述待验 证身份信息包括指纹信息和/或语音信息。In some embodiments, the interactive component includes a fingerprint recognition button and/or a microphone, and the to-be-verified The identification information includes fingerprint information and/or voice information.
在一些实施例中,所述控制器被配置成采用如下方式控制所述刺激器停止递送电刺激:当所述体外程控器与所述刺激器处于程控连接状态时,检测是否发生预设事件,当发生所述预设事件时,控制所述刺激器停止递送电刺激;其中,所述预设事件包括以下一种或几种:所述患者的生物电信号发生异常;所述刺激器的电量低于预设电量阈值;所述体外程控器的程控应用未响应;所述体外程控器与所述体外充电器的连接发生中断;所述体外程控器的实际配置信息与所述患者的参考配置信息的相似度不大于第一相似度阈值。In some embodiments, the controller is configured to control the stimulator to stop delivering electrical stimulation in the following manner: when the external programmer and the stimulator are in a programmed connection state, detect whether a preset event occurs, When the preset event occurs, the stimulator is controlled to stop delivering electrical stimulation; wherein the preset event includes one or more of the following: an abnormality in the patient's bioelectrical signal; the power of the stimulator Lower than the preset power threshold; the program-controlled application of the external programmable controller does not respond; the connection between the external programmable controller and the external charger is interrupted; the actual configuration information of the external programmable controller and the reference configuration of the patient The similarity of the information is not greater than the first similarity threshold.
在一些实施例中,所述预设事件包括所述患者的生物电信号发生异常,检测所述患者的生物电信号是否发生异常的过程如下:将所述患者的生物电信号输入异常检测模型,以输出所述生物电信号对应的预测相似度;其中,所述异常检测模型用于将所述生物电信号与异常数据库中的每个异常生物电信号进行比对,得到所述生物电信号与每个异常生物电信号的相似度,将所述生物电信号对应的多个相似度中最高的相似度作为所述生物电信号对应的预测相似度;当所述预测相似度不小于第二相似度阈值时,确定所述生物电信号发生异常;当所述预测相似度小于所述第二相似度阈值时,确定所述生物电信号没有发生异常。In some embodiments, the preset event includes an abnormality in the patient's bioelectrical signal. The process of detecting whether the patient's bioelectrical signal is abnormal is as follows: input the patient's bioelectrical signal into an abnormality detection model, To output the predicted similarity corresponding to the bioelectric signal; wherein, the anomaly detection model is used to compare the bioelectric signal with each abnormal bioelectric signal in the abnormal database to obtain the bioelectric signal and For the similarity of each abnormal bioelectric signal, the highest similarity among the multiple similarities corresponding to the bioelectric signal is used as the predicted similarity corresponding to the bioelectric signal; when the predicted similarity is not less than the second similarity When the predicted similarity is less than the second similarity threshold, it is determined that the bioelectric signal is not abnormal.
在一些实施例中,所述预设事件包括所述体外程控器的实际配置信息与所述患者的参考配置信息的相似度不大于第一相似度阈值;所述参考配置信息的获取过程如下:将所述患者的疾病信息输入参考配置模型,得到所述参考配置信息;其中,所述参考配置模型的训练过程包括:获取第一训练集,所述第一训练集包括多个第一训练数据,每个所述第一训练数据包括一个样本对象的疾病信息以及所述样本对象的参考配置信息的标注数据;针对所述第一训练集中的每个第一训练数据,执行以下处理:将所述第一训练数据中的样本对象的疾病信息输入预设的第一深度学习模型,得到所述样本对象的参考配置信息的预测数据;基于所述样本对象的参考配置信息的预测数据和标注数据,对所述第一深度学习模型的模型参数进行更新;检测是否满足预设的第一训练结束条件;如果满足预设的第一训练结束条件,则将训练出的第一深度学习模型作为所述分类模型;如果不满足预设的第一训练结束条件,则利用下一个所述第一训练数据继续训练所述第一深度学习模型。In some embodiments, the preset event includes that the similarity between the actual configuration information of the extracorporeal programmer and the patient's reference configuration information is not greater than the first similarity threshold; the acquisition process of the reference configuration information is as follows: Enter the patient's disease information into a reference configuration model to obtain the reference configuration information; wherein the training process of the reference configuration model includes: obtaining a first training set, the first training set including a plurality of first training data , each first training data includes annotation data of disease information of a sample object and reference configuration information of the sample object; for each first training data in the first training set, perform the following processing: The disease information of the sample object in the first training data is input into the preset first deep learning model to obtain prediction data of the reference configuration information of the sample object; prediction data and annotation data based on the reference configuration information of the sample object , update the model parameters of the first deep learning model; detect whether the preset first training end condition is met; if the preset first training end condition is met, use the trained first deep learning model as the the classification model; if the preset first training end condition is not met, use the next first training data to continue training the first deep learning model.
在一些实施例中,所述体外充电器还包括警报组件,所述控制器还被配置成:接收所述刺激器的反馈信息,所述反馈信息用于指示所述刺激器是否停止递送电刺激;基于所述反馈信息,控制所述警报组件的警示状态,以使所述警报组件在所述反馈信息不同时呈现不同的警示状态。 In some embodiments, the extracorporeal charger further includes an alarm component, and the controller is further configured to: receive feedback information from the stimulator, the feedback information being used to indicate whether the stimulator stops delivering electrical stimulation. ; Based on the feedback information, control the alert state of the alarm component so that the alert component presents different alert states when the feedback information is different.
在一些实施例中,所述警报组件包括显示灯,所述警示状态包括开关状态、颜色、亮度和闪烁频率中的一种或几种。In some embodiments, the alarm component includes a display light, and the warning state includes one or more of switch status, color, brightness, and flashing frequency.
在一些实施例中,所述体外充电器与所述体外程控器采用蓝牙通信的方式进行数据交互,所述体外充电器与所述刺激器采用射频通信的方式进行数据交互。In some embodiments, the extracorporeal charger and the extracorporeal program controller use Bluetooth communication for data interaction, and the extracorporeal charger and the stimulator use radio frequency communication for data interaction.
在一些实施例中,所述患者的疾病类型包括癫痫、震颤、帕金森病、抑郁症、强迫症、阿尔茨海默症和药物成瘾症中的一个或多个。In some embodiments, the patient's disease type includes one or more of epilepsy, tremor, Parkinson's disease, depression, obsessive-compulsive disorder, Alzheimer's disease, and drug addiction.
在一些实施例中,所述控制器还被配置成存储有事件处理函数,所述控制器还被配置成:响应于所述触发操作,将所述触发操作对应的停止刺激事件加入事件队列;利用所述事件处理函数根据事件的优先级处理事件队列中的事件,其中,所述停止刺激事件的优先级为最高优先级。In some embodiments, the controller is further configured to store an event processing function, and the controller is further configured to: in response to the trigger operation, add the stop stimulation event corresponding to the trigger operation to the event queue; The event processing function is used to process events in the event queue according to the priority of the event, wherein the priority of the stop stimulation event is the highest priority.
参见图5,图5是本申请实施例提供的一种控制器的结构框图。Referring to Figure 5, Figure 5 is a structural block diagram of a controller provided by an embodiment of the present application.
控制器200例如可以包括至少一个存储器210、至少一个处理器220以及连接不同平台***的总线230。The controller 200 may include, for example, at least one memory 210, at least one processor 220, and a bus 230 connecting different platform systems.
存储器210可以包括易失性存储器形式的可读介质,例如随机存取存储器(Random Access Memory,RAM)211和/或高速缓存存储器212,还可以包括只读存储器(Read-Only Memory,ROM)213。The memory 210 may include readable media in the form of volatile memory, such as random access memory (Random Access Memory, RAM) 211 and/or cache memory 212, and may also include read-only memory (Read-Only Memory, ROM) 213 .
存储器210还存储有计算机程序,计算机程序可以被处理器220执行,使得处理器220实现上述控制器的功能,其实现方式与上述方法实施方式中记载的实施方式、所达到的技术效果一致,部分内容不再赘述。The memory 210 also stores a computer program, which can be executed by the processor 220, so that the processor 220 implements the functions of the above-mentioned controller. The implementation manner is consistent with the implementation described in the above-mentioned method implementation and the technical effects achieved, and some of them are consistent. The content will not be repeated.
存储器210还可以包括具有至少一个程序模块215的实用工具214,这样的程序模块215包括:操作***、一个或者多个应用程序、其它程序模块以及程序数据,这些示例的每一个或一种组合中可能包括网络环境的实现。Memory 210 may also include a utility 214 having at least one program module 215 including: an operating system, one or more application programs, other program modules, and program data, in each or a combination of these examples. May include implementation of network environment.
相应的,处理器220可以执行上述计算机程序,以及可以执行实用工具214。Correspondingly, the processor 220 can execute the above-mentioned computer program, and can execute the utility tool 214.
处理器220可以采用一个或多个应用专用集成电路(Application Specific Integrated Circuit,ASIC)、数字信号处理器(Digital Signal Processor,DSP)、可编程逻辑器件(ProgrammableLogic Device,PLD)、复杂可编程逻辑器件(Complex Programmable Logic Device,CPLD)、现场可编程门阵列(Field-Programmable Gate Array,FPGA)或其他电子元件。The processor 220 may use one or more application specific integrated circuits (Application Specific Integrated Circuit, ASIC), digital signal processor (Digital Signal Processor, DSP), programmable logic device (Programmable Logic Device, PLD), complex programmable logic device (Complex Programmable Logic Device, CPLD), Field-Programmable Gate Array (FPGA) or other electronic components.
总线230可以为表示几类总线结构的一种或多种,包括存储器总线或者存储器控制器、***总线、图形加速端口、处理器或者使用多种总线结构的任意 总线结构的局域总线。Bus 230 may represent one or more of several types of bus structures, including a memory bus or memory controller, a peripheral bus, a graphics accelerated port, a processor, or any other bus structure using a variety of bus structures. Bus structure of local bus.
控制器200也可以与一个或多个外部设备240例如键盘、指向设备、蓝牙设备等通信,还可与一个或者多个能够与该控制器200交互的设备通信,和/或与使得该控制器200能与一个或多个其它计算设备进行通信的任何设备(例如路由器、调制解调器等)通信。这种通信可以通过输入输出接口250进行。并且,控制器200还可以通过网络适配器260与一个或者多个网络(例如局域网(Local Area Network,LAN),广域网(Local Area Network,WAN)和/或公共网络,例如因特网)通信。网络适配器260可以通过总线230与控制器200的其它模块通信。应当明白,尽管图中未示出,可以结合控制器200使用其它硬件和/或软件模块,包括但不限于:微代码、设备驱动器、冗余处理器、外部磁盘驱动阵列、独立磁盘冗余阵列(Redundant Arrays of Independent Disks,RAID)***、磁带驱动器以及数据备份存储平台等。The controller 200 may also communicate with one or more external devices 240, such as a keyboard, a pointing device, a Bluetooth device, etc., and may also communicate with one or more devices capable of interacting with the controller 200, and/or with a device that enables the controller 200 to 200 is any device capable of communicating with one or more other computing devices (eg, router, modem, etc.). This communication may occur through the input/output interface 250. Moreover, the controller 200 can also communicate with one or more networks (such as a local area network (Local Area Network, LAN), a wide area network (Local 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 controller 200 via bus 230. It should be understood that, although not shown in the figures, other hardware and/or software modules may be used in conjunction with the controller 200, including but not limited to: microcode, device drivers, redundant processors, external disk drive arrays, redundant arrays of independent disks (Redundant Arrays of Independent Disks, RAID) systems, tape drives and data backup storage platforms, etc.
本申请还提供了一种计算机可读存储介质,所述计算机可读存储介质存储有计算机程序,所述计算机程序被处理器执行时实现上述控制器的功能或者实现上述控制方法的步骤,其实现方式与上述控制器的实施方式中记载的实施方式、所达到的技术效果一致,部分内容不再赘述。This application also provides a computer-readable storage medium, which stores a computer program. When the computer program is executed by a processor, it realizes the functions of the above-mentioned controller or the steps of the above-mentioned control method, which realizes The method is consistent with the implementation described in the implementation of the controller above, and the technical effects achieved are consistent, and part of the content will not be described again.
参见图6,图6示出了本申请提供的一种用于实现控制方法的程序产品的结构示意图。程序产品可以采用便携式紧凑盘只读存储器(Compact Disc-ROM,CD-ROM)并包括程序代码,并可以在终端设备,例如个人电脑上运行。然而,本申请的程序产品不限于此,在本申请中,可读存储介质可以是任何包含或存储程序的有形介质,该程序可以被指令执行***、装置或者器件使用或者与其结合使用。程序产品可以采用一个或多个可读介质的任意组合。可读介质可以是可读信号介质或者可读存储介质。可读存储介质例如可以为但不限于电、磁、光、电磁、红外线、或半导体的***、装置或器件,或者任意以上的组合。可读存储介质的例子(非穷举的列表)包括:具有一个或多个导线的电连接、便携式盘、硬盘、RAM、ROM、可擦式可编程只读存储器(Erasable Programmable Read Only Memory,EPROM或闪存)、光纤、CD-ROM、光存储器件、磁存储器件、或者上述的任意合适的组合。Referring to Figure 6, Figure 6 shows a schematic structural diagram of a program product for implementing a control method provided by this application. The program product can adopt a portable compact disk read-only memory (Compact Disc-ROM, CD-ROM) and include program code, and can be run on a terminal device, such as a personal computer. However, the program product of the present application is not limited thereto. In the present application, the readable storage medium may be any tangible medium containing or storing a program, which may be used by or in combination with an instruction execution system, apparatus or device. The Program Product may take the form of one or more readable media in any combination. 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. Examples of readable storage media (a non-exhaustive list) include: electrical connection with one or more wires, portable disk, hard disk, RAM, ROM, Erasable Programmable Read Only Memory (EPROM) or flash memory), optical fiber, CD-ROM, optical storage device, magnetic storage device, or any suitable combination of the above.
计算机可读存储介质可以包括在基带中或者作为载波一部分传播的数据信号,其中承载了可读程序代码。这种传播的数据信号可以采用多种形式,包括但不限于电磁信号、光信号或上述的任意合适的组合。可读存储介质还可以是任何可读介质,该可读介质可以发送、传播或者传输用于由指令执行***、装置或者器件使用或者与其结合使用的程序。可读存储介质上包含的程序代码可以用任何适当的介质传输,包括但不限于无线、有线、光缆、射频(Radio Frequency, RF)等,或者上述的任意合适的组合。可以以一种或多种程序设计语言的任意组合来编写用于执行本申请操作的程序代码,程序设计语言包括面向对象的程序设计语言诸如Java、C++等,还包括常规的过程式程序设计语言诸如C语言或类似的程序设计语言。程序代码可以完全地在用户计算设备上执行、部分地在用户设备上执行、作为一个独立的软件包执行、部分在用户计算设备上部分在远程计算设备上执行、或者完全在远程计算设备或服务器上执行。在涉及远程计算设备的情形中,远程计算设备可以通过任意种类的网络,包括LAN或WAN,连接到用户计算设备,或者,可以连接到外部计算设备(例如利用因特网服务提供商来通过因特网连接)。 A computer-readable storage medium may include a data signal propagated in baseband or as part of a carrier wave carrying the readable program code therein. Such propagated data signals may take a variety of forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination of the above. A readable storage medium may also be any readable medium that can transmit, propagate, or transport the program for use by or in connection with an instruction execution system, apparatus, or device. Program code contained on a readable storage medium may be transmitted using any appropriate medium, including but not limited to wireless, wired, optical cable, radio frequency (Radio Frequency, RF), etc., or any suitable combination of the above. The program code for performing the operations of the present application can be written in any combination of one or more programming languages, including object-oriented programming languages such as Java, C++, etc., and also includes conventional procedural programming languages. Such as C language or similar programming language. 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 execute on. In situations involving remote computing devices, the remote computing device may be connected to the user computing device through any kind of network, including a LAN or WAN, or may be connected to an external computing device (such as through the Internet using an Internet service provider) .

Claims (14)

  1. 一种体外充电器,所述体外充电器(102)被配置成与体外程控器(101)以及植入于患者体内的刺激器(103)分别进行数据交互,所述体外充电器包括交互组件(1021);An extracorporeal charger. The extracorporeal charger (102) is configured to perform data interaction with an extracorporeal program controller (101) and a stimulator (103) implanted in the patient's body. The extracorporeal charger includes an interactive component ( 1021);
    所述体外充电器(102)还包括与所述交互组件(1021)连接的控制器(1022),所述控制器(1022)被配置成:The extracorporeal charger (102) also includes a controller (1022) connected to the interactive component (1021), and the controller (1022) is configured to:
    利用所述交互组件(1021)接收触发操作;Utilize the interactive component (1021) to receive a trigger operation;
    响应于所述触发操作,检测所述体外程控器(101)与所述刺激器(103)是否处于程控连接状态;In response to the triggering operation, detect whether the external programmer (101) and the stimulator (103) are in a programmable connection state;
    在所述体外程控器(101)与所述刺激器(103)处于程控连接状态的情况下,控制所述刺激器(103)停止递送电刺激。When the external programmer (101) and the stimulator (103) are in a programmed connection state, the stimulator (103) is controlled to stop delivering electrical stimulation.
  2. 根据权利要求1所述的体外充电器,其中,所述控制器(1022)还被配置成存储有至少一个已验证身份信息,所述控制器(1022)被配置成采用如下方式利用所述交互组件(1021)接收所述触发操作:The external charger according to claim 1, wherein the controller (1022) is further configured to store at least one verified identity information, and the controller (1022) is configured to utilize the interaction in the following manner Component (1021) receives the trigger operation:
    利用所述交互组件(1021)接收待验证身份信息;Utilize the interactive component (1021) to receive identity information to be verified;
    将所述待验证身份信息与每个已验证身份信息进行匹配,在所述待验证身份信息与所述至少一个已验证身份信息中一个已验证身份信息匹配成功的情况下,停止匹配并利用所述交互组件(1021)接收所述触发操作。Match the identity information to be verified with each verified identity information. If the identity information to be verified successfully matches one of the at least one verified identity information, stop matching and use all the identity information to be verified. The interactive component (1021) receives the trigger operation.
  3. 根据权利要求2所述的体外充电器,其中,所述交互组件(1021)包括指纹识别按钮和麦克风中的至少之一,所述待验证身份信息包括指纹信息和语音信息中的至少之一。The external charger according to claim 2, wherein the interactive component (1021) includes at least one of a fingerprint recognition button and a microphone, and the identity information to be verified includes at least one of fingerprint information and voice information.
  4. 根据权利要求1所述的体外充电器,其中,所述控制器(1022)被配置成采用如下方式控制所述刺激器(103)停止递送电刺激:The extracorporeal charger of claim 1, wherein the controller (1022) is configured to control the stimulator (103) to stop delivering electrical stimulation in the following manner:
    在所述体外程控器(101)与所述刺激器(103)处于程控连接状态的情况下,检测是否发生预设事件,响应于发生所述预设事件,控制所述刺激器(103)停止递送电刺激;When the external programmer (101) and the stimulator (103) are in a programmed connection state, detect whether a preset event occurs, and control the stimulator (103) to stop in response to the occurrence of the preset event. Deliver electrical stimulation;
    其中,所述预设事件包括以下至少一种:Wherein, the preset events include at least one of the following:
    所述患者的生物电信号发生异常;The patient's bioelectrical signals are abnormal;
    所述刺激器(103)的电量低于预设电量阈值;The power of the stimulator (103) is lower than the preset power threshold;
    所述体外程控器(101)的程控应用未响应;The program-controlled application of the external programmable controller (101) did not respond;
    所述体外程控器(101)与所述体外充电器(102)的连接发生中断; The connection between the external program controller (101) and the external charger (102) is interrupted;
    所述体外程控器(101)的实际配置信息与所述患者的参考配置信息的相似度不大于第一相似度阈值。The similarity between the actual configuration information of the extracorporeal programmer (101) and the patient's reference configuration information is not greater than the first similarity threshold.
  5. 根据权利要求4所述的体外充电器,其中,所述预设事件包括所述患者的生物电信号发生异常,检测所述患者的生物电信号是否发生异常的过程如下:The extracorporeal charger according to claim 4, wherein the preset event includes an abnormality in the patient's bioelectrical signal, and the process of detecting whether the patient's bioelectrical signal is abnormal is as follows:
    将所述患者的生物电信号输入异常检测模型,以输出所述生物电信号对应的预测相似度;其中,所述异常检测模型用于将所述生物电信号与异常数据库中的每个异常生物电信号进行比对,得到所述生物电信号与每个异常生物电信号的相似度,将所述生物电信号对应的多个相似度中最高的相似度作为所述生物电信号对应的预测相似度;The patient's bioelectrical signal is input into the abnormality detection model to output the predicted similarity corresponding to the bioelectrical signal; wherein the abnormality detection model is used to compare the bioelectrical signal with each abnormal biological entity in the abnormality database. The electrical signals are compared to obtain the similarity between the bioelectric signal and each abnormal bioelectric signal, and the highest similarity among the multiple similarities corresponding to the bioelectric signal is used as the predicted similarity corresponding to the bioelectric signal. Spend;
    在所述预测相似度不小于第二相似度阈值的情况下,确定所述生物电信号发生异常;When the predicted similarity is not less than the second similarity threshold, it is determined that the bioelectric signal is abnormal;
    在所述预测相似度小于所述第二相似度阈值的情况下,确定所述生物电信号没有发生异常。When the predicted similarity is less than the second similarity threshold, it is determined that the bioelectric signal is not abnormal.
  6. 根据权利要求4所述的体外充电器,其中,所述预设事件包括所述体外程控器(101)的实际配置信息与所述患者的参考配置信息的相似度不大于第一相似度阈值;The extracorporeal charger according to claim 4, wherein the preset event includes that the similarity between the actual configuration information of the extracorporeal programmer (101) and the patient's reference configuration information is not greater than a first similarity threshold;
    所述参考配置信息的获取过程如下:The process of obtaining the reference configuration information is as follows:
    将所述患者的疾病信息输入参考配置模型,得到所述参考配置信息;Enter the patient's disease information into a reference configuration model to obtain the reference configuration information;
    其中,所述参考配置模型的训练过程包括:Wherein, the training process of the reference configuration model includes:
    获取第一训练集,所述第一训练集包括多个第一训练数据,每个第一训练数据包括一个样本对象的疾病信息以及所述样本对象的参考配置信息的标注数据;Obtain a first training set, the first training set includes a plurality of first training data, each first training data includes annotation data of disease information of a sample object and reference configuration information of the sample object;
    针对所述第一训练集中的每个第一训练数据,执行以下处理:For each first training data in the first training set, perform the following processing:
    将所述第一训练数据中的样本对象的疾病信息输入预设的第一深度学习模型,得到所述样本对象的参考配置信息的预测数据;Enter the disease information of the sample object in the first training data into the preset first deep learning model to obtain prediction data of the reference configuration information of the sample object;
    基于所述样本对象的参考配置信息的预测数据和标注数据,对所述第一深度学习模型的模型参数进行更新;Update the model parameters of the first deep learning model based on the prediction data and annotation data of the reference configuration information of the sample object;
    检测是否满足预设的第一训练结束条件;响应于满足所述预设的第一训练结束条件,将训练出的第一深度学习模型作为所述分类模型;响应于不满足所述预设的第一训练结束条件,利用下一个第一训练数据继续训练所述第一深度学习模型。 Detect whether the preset first training end condition is met; in response to satisfying the preset first training end condition, use the trained first deep learning model as the classification model; in response to not satisfying the preset first training end condition The first training end condition is to use the next first training data to continue training the first deep learning model.
  7. 根据权利要求1所述的体外充电器,其中,所述体外充电器(102)还包括警报组件,所述控制器(1022)还被配置成:The external charger according to claim 1, wherein the external charger (102) further includes an alarm component, and the controller (1022) is further configured to:
    接收所述刺激器(103)的反馈信息,其中,所述反馈信息用于指示所述刺激器(103)是否停止递送电刺激;Receive feedback information from the stimulator (103), wherein the feedback information is used to indicate whether the stimulator (103) stops delivering electrical stimulation;
    基于所述反馈信息,控制所述警报组件的警示状态,以使所述警报组件在所述反馈信息不同的情况下呈现不同的警示状态。Based on the feedback information, the alert state of the alarm component is controlled so that the alert component presents different alert states when the feedback information is different.
  8. 根据权利要求7所述的体外充电器,其中,所述警报组件包括显示灯,所述警示状态包括开关状态、颜色、亮度和闪烁频率中的至少一种。The external charger according to claim 7, wherein the alarm component includes a display light, and the warning state includes at least one of switch state, color, brightness and flashing frequency.
  9. 根据权利要求1所述的体外充电器,其中,所述体外充电器(102)与所述体外程控器(101)采用蓝牙通信的方式进行数据交互,所述体外充电器(102)与所述刺激器(103)采用射频通信的方式进行数据交互。The external charger according to claim 1, wherein the external charger (102) and the external program controller (101) use Bluetooth communication for data interaction, and the external charger (102) and the external programmable controller (101) The stimulator (103) uses radio frequency communication for data exchange.
  10. 根据权利要求1所述的体外充电器,其中,所述患者的疾病类型包括癫痫、震颤、帕金森病、抑郁症、强迫症、阿尔茨海默症和药物成瘾症中的至少一个。The external charger according to claim 1, wherein the patient's disease type includes at least one of epilepsy, tremor, Parkinson's disease, depression, obsessive-compulsive disorder, Alzheimer's disease and drug addiction.
  11. 根据权利要求1所述的体外充电器,其中,所述控制器(1022)还被配置成存储有事件处理函数,所述控制器(1022)还被配置成:The external charger according to claim 1, wherein the controller (1022) is further configured to store an event processing function, and the controller (1022) is further configured to:
    响应于所述触发操作,将所述触发操作对应的停止刺激事件加入事件队列;In response to the trigger operation, add the stop stimulation event corresponding to the trigger operation into the event queue;
    利用所述事件处理函数根据事件的优先级处理所述事件队列中的事件,其中,所述停止刺激事件的优先级为最高优先级。The event processing function is used to process events in the event queue according to the priority of the event, wherein the priority of the stop stimulation event is the highest priority.
  12. 一种程控***,所述程控***包括植入于患者体内的刺激器、体外程控器和权利要求1-11任一项所述体外充电器。A program-controlled system, which includes a stimulator implanted in a patient's body, an external program controller, and an external charger according to any one of claims 1-11.
  13. 根据权利要求12所述的程控***,其中,所述体外程控器与所述体外充电器集成为一体。The program control system according to claim 12, wherein the external program controller and the external charger are integrated into one body.
  14. 一种计算机可读存储介质,所述计算机可读存储介质存储有计算机程序,所述计算机程序被处理器执行时实现权利要求1-11任一项所述控制器的功能。 A computer-readable storage medium stores a computer program. When the computer program is executed by a processor, it implements the functions of the controller of any one of claims 1-11.
PCT/CN2023/099721 2022-07-05 2023-06-12 In-vitro charger, program control system, and computer-readable storage medium WO2024007823A1 (en)

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